THE RUS-AUDIT VALIDATION STUDY PROTOCOL

Adapting and validating the Alcohol Use Disorders Identification Test (AUDIT) in the Russian Federation

THE RUS-AUDIT VALIDATION STUDY PROTOCOLAdapting and validating the Alcohol Use Disorders Identification Test (AUDIT) in the Russian Federation

ABSTRACTThe Alcohol Use Disorders Identification Test (AUDIT) is internationally recognized as one of the most successful instruments in screening for problematic alcohol use, including possible alcohol use disorders. However, inconsistent use of different existing Russian-language translations of the AUDIT has been observed in the Russian Federation as well as other countries, and none of the existing versions appears to have been formally validated using an established study protocol.

Inconsistency in the way the various AUDIT versions that currently exist are applied in different settings creates problems both in their application and in the interpretation of results. Furthermore, it presents a significant barrier to the implementation of a screening and brief intervention strategy at primary health-care (PHC) level in the Russian Federation for early detection of individuals who consume alcohol in a way that puts them at risk.

The present study protocol describes the steps that were required to validate the AUDIT in the Russian Federation. It documents several pre-studies that were conducted as part of an extended problem analysis and provides guidance on the specific steps that need to be taken to translate and adapt the AUDIT for use in the Russian language. It also gives an overview of study procedures aimed at determining the best AUDIT thresholds for different risk levels and thus implementing interventions at PHC level in the Russian Federation.

The study protocol can inform validation efforts in other countries, while the study result has potential to be used in other countries that have drinking patterns and health-care systems similar to those in the Russian Federation.

KEYWORDSALCOHOL USE DISORDERSPRIMARY HEALTH CARERUSSIAN FEDERATIONSCREENING AND BRIEF INTERVENTIONTEST TRANSLATION AND ADAPTATION

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CONTENTSAcknowledgements v

Abbreviations v

Executive summary vi

1. Background: the AUDIT as a screening instrument 1

2. Purpose and objective of the Russian validation 4

3. Preliminary studies and problem analysis 7

3.1 Systematic review of Russian AUDIT translations and validation studies 7

3.2 Qualitative expert interviews on the perception of the AUDIT 8

3.3 Main outcomes and recommendations of the pre-studies 10

4. Translation and adaptation procedures of the AUDIT 11

4.1. Adaptation procedure of the AUDIT to assess alcohol use in the Russian Federation 11

4.2 Translation and back-translation of the AUDIT and expert panel 11

4.3 Piloting the revised version with the target audience and cognitive interviewing 12

4.4 Panel discussion, revision and broader piloting of final forms 13

5. Main validation study 14

5.1 Objectives 14

5.2 Study design and sample 15

5.3 Data collection 16

5.4 Data processing and quality control 19

6. Ethical considerations 21

7. Implications for SBI in the Russian Federation 22

References 24

Annex 1. Advisory Board for the RUS-AUDIT validation project in the Russian Federation 30

Annex 2. Interview guide for the qualitative expert interview study (qualitative pilot) 31

Annex 3. Protocol for the pilot study (quantitative pilot), including questionnaire 33

Annex 4. Power calculations for the validation study 36

Annex 5. The constructed and adapted RUS-AUDIT as used in the questionnaire form in the main validation study (back-translated from Russian) 38

Annex 6. THE RUS-AUDIT show card and conversion table as used in the questionnaire form in the main validation study (back-translated from Russian) 40

Annex 7. Overview of training modules and activities of interviewer training 41

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ACKNOWLEDGEMENTSThe WHO Regional Office for Europe expresses its gratitude to the Ministry of Health of the Russian Federation for its support for the WHO European Office for the Prevention and Control of Noncommunicable Diseases. The study protocol was developed as a collaborative project by the RUS-AUDIT Project Advisory Board under the guidance of the Ministry of Health of the Russian Federation, the WHO Country Office in the Russian Federation and the WHO European Office for the Prevention and Control of Noncommunicable Diseases. The Regional Office for Europe would like to thank all the members of the Project Advisory Board of the RUS-AUDIT project for their overall contributions to developing the technical concept of the protocol, providing technical support in conducting the pre-studies and discussing the results that have informed the final version of the protocol.

Development of the study protocol – including development of the technical concept, the study design, data collection and data analysis for the various pre-studies – and the writing and review of this publication were carried out Maria Neufeld, consultant, WHO European Office for the Prevention and Control of Noncommunicable Diseases; Jürgen Rehm, WHO Collaborating Centre and Institute for Mental Health Policy Research, Centre for Addiction and Mental Health, Toronto, Canada, Institute of Clinical Psychology and Psychotherapy, Technische Universität Dresden, Germany, Agència de Salut Pública de Catalunya, Barcelona, Spain, and Department of International Health Projects, Institute for Leadership and Health Management, I.M. Sechenov First Moscow State Medical University, Moscow, Russian Federation; and Carina Ferreira-Borges, Acting Head, WHO European Office for the Prevention and Control of Noncommunicable Diseases, and Programme Manager, Alcohol and Illicit Drugs, WHO European Office for the Prevention and Control of Noncommunicable Diseases.

The WHO Regional Office for Europe would also like to extend its gratitude to the following experts for their contributions in carrying out several pre-studies and discussing their results in the context of the study protocol: Anna Bunova, junior researcher, National Medical Research Center for Therapy and Preventive Medicine, Moscow, Russian Federation; Artyom Gil, associate professor, Institute for Leadership and Health Management, I.M. Sechenov First Moscow State Medical University, Moscow, Russian Federation; Boris Gornyi, leading researcher, National Medical Research Center for Therapy and Preventive Medicine, Moscow, Russian Federation; Eugenia Fadeeva, Head of the Department of Organization of Preventive Care in Narcology, National Research Centre on Addictions – branch, V.P. Serbsky National Medical Research Center for Psychiatry and Narcology, Moscow, Russian Federation; Anna Kalinina, Head of the Department of Primary Prevention of Chronic Noncommunicable Diseases, National Medical Research Center for Therapy and Preventive Medicine, Moscow, Russian Federation; Anna Kontsevaya, Deputy Director, National Medical Research Center for Therapy and Preventive Medicine, Moscow, Russian Federation; Evgenia Koshkina, Aleksey Nadezhdin and Elena Tetenova, leading researchers, Moscow Research and Practical Center for Narcology of the Department of Public Health, Moscow, Russian Federation; and Konstantin Vyshinsky, National Research Centre on Addictions – branch, V.P. Serbsky National Medical Research Center for Psychiatry and Narcology, Moscow, Russian Federation.

The WHO European Office for the Prevention and Control of Noncommunicable Diseases is also grateful to Melita Vujnovic, WHO country representative in the Russian Federation, and Elena Yurasova, NCD Technical Officer, WHO Office in the Russian Federation, for leading technical consultations and contributing critical ideas to the content development of the protocol and the overall RUS-AUDIT validation project.

The activities associated with the validation of the RUS-AUDIT protocol were fully or partially funded through a grant of the Government of the Russian Federation in the context of the WHO European Office for the Prevention and Control of Noncommunicable Diseases.

ABBREVIATIONSAUC area under [the ROC] curveAUD alcohol use disorderAUDIT Alcohol Use Disorders Identification TestAUDIT-C Alcohol Use Disorders Identification Test – ConsumptionCIDI Composite International Diagnostic InterviewDSM-5 Diagnostic and Statistical Manual of Mental Disorders, 5th revisionICD-10 International Statistical Classification of Diseases and Related Health Problems, 10th revision ICD-11 International Statistical Classification of Diseases and Related Health Problems, 11th revision NCD noncommunicable diseasePHC primary health careROC receiver operating characteristicRUS-AUDIT Russian (Russian Federation-specific) Alcohol Use Disorders Identification TestSBI screening and brief interventionWMH World Mental Health

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EXECUTIVE SUMMARYThe Russian Federation has successfully implemented several alcohol control measures, such as WHO’s “best buys”, to reduce the burden of disease attributable to alcohol use and to increase life expectancy. In 2016 the Ministry of Health of the Russian Federation launched an initiative to implement screening and brief intervention (SBI) for alcohol problems in the primary health-care (PHC) setting; SBI is an evidence- based practice used to identify, reduce and prevent problematic use and abuse of alcohol and illicit drugs, as well as substance use disorders. As is recognized in the WHO Global Strategy to Reduce the Harmful Use of Alcohol and in the WHO European Action Plan to Reduce the Harmful Use of Alcohol 2012–2020, delivering SBI for alcohol-related problems in PHC settings can be an effective and efficient way to reduce alcohol consumption by hazardous and risky drinkers and to raise general awareness of alcohol-related problems.

The Alcohol Use Disorders Identification Test (AUDIT) was developed by WHO as the main instrument for delivering SBI and was validated in PHC facilities in six different countries across four continents. However, a systematic translation, adaptation and validation of the instrument in the Russian Federation are all still missing, which poses a significant barrier to the implementation of SBI at country level. Thus, by validating the AUDIT to conduct screening for alcohol consumption among patients in primary care, the present study will lay the groundwork for implementing the SBI strategy in the Russian Federation.

The present protocol describes the background and history of the AUDIT, the specific scope and purpose of the validation in the Russian Federation, and the preliminary studies that systematically analysed existing problems in application of the AUDIT in various settings in the Russian Federation. The steps that were required to carry out the main validation study are also described and explained.

The availability of a quick, effective and reliable screening tool as part of the SBI strategy is a crucial cornerstone of its success. Delivering SBI will contribute to increasing opportunities to educate patients about lower-risk alcohol consumption levels and the risks of excessive alcohol use; it will also be a starting point for discussions with them about the implications of their drinking for current symptoms and future health. The SBI strategy may alert clinicians to the need to advise patients whose alcohol consumption might adversely affect their use of medications and other aspects of their treatment and may also improve referral pathways. Finally, it will be a step towards making alcohol SBI part of health-care systems more widely and contribute to further reductions in alcohol-attributable mortality and morbidity at population level.

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1

BACKGROUND: THE AUDIT AS A SCREENING INSTRUMENT

The Alcohol Use Disorders Identification Test (AUDIT) has been one of the most successful and frequently used screening instruments for hazardous and harmful alcohol use and potential alcohol dependence (Babor et al., 2001; Saunders et al., 1993b). The instrument was developed by WHO in 1989 as a simple method of screening for excessive drinking and to assist in brief assessment. It was primarily intended for screening in the health-care system and to initiate interventions, but suggestions were also made for its use in many other settings, such as in workplace and employee assistance programmes, the military services, the courts, and jail and prison settings (Babor et al., 2001). Since then, the AUDIT has been used not only in many of these settings but also as a part of monitoring systems of the general population and for research purposes (Lange et al., 2019; Lundin et al., 2015).

The original AUDIT was validated by research centres in Australia, Bulgaria, Kenya, Mexico, Norway and the United States, using primary health-care (PHC) facilities to gather empirical data from study participants on alcohol intake and drinking practices, general medical history, and any physical or psychosocial problems related to alcohol (Saunders et al., 1993a and 1993b). The goal was to develop an international instrument to screen for hazardous and harmful alcohol consumption. These two key terms have been defined by WHO as follows (WHO, 1994):

⋅ Hazardous use • A pattern of alcohol use that increases the risk of harmful consequences for the user, including consequences that affect physical and mental health (as in harmful use) and social consequences. In contrast to harmful use, hazardous use refers to patterns of use that are of public health significance despite the absence of any current disorder in the individual user.

The term “hazardous use” was not included in the 10th revision of the International Statistical Classification of Diseases and Related Health Problems (ICD-10) (WHO, 2019b), but was nevertheless used by WHO to denote a drinking pattern carrying a risk of harmful consequences to the drinker (Babor & Higgins-Biddle, 2001). However, it was introduced in the 11th revision (ICD-11), where it is defined as a pattern of psychoactive substance use that increases the risk of harmful physical or mental health consequences to the user or to others to an extent that it warrants attention and advice from health-care professionals; the increased risk may be from the frequency of substance use, from the amount used on a given occasion, from risky behaviours associated with substance use or the context of use, from a harmful route of administration, or from a combination of these (WHO, 2020a).

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⋅ Harmful use • A pattern of alcohol use that is causing damage to health. The damage may be physical (such as liver damage following chronic drinking) or mental (such as depressive episodes following heavy alcohol intake). At the time of its development, the AUDIT did not allow social consequences alone to justify a diagnosis of harmful use.

The term was introduced in ICD-10 and revised in ICD-11 under the heading “Harmful pattern of use of alcohol”, where a distinction between continuous and episodic patterns of use was also made (WHO, 2020b).

Importantly, harm to the health of others was included in the definition of harmful use in ICD-11. Harm to the health of others may be intentional, as in the case of homicides or interpersonal violence during intoxication with alcohol (or drugs), or it may result from the substance user’s difficulty in performing social, professional or family roles, as in the case of negligence towards minors. Accordingly, in ICD-11, a harmful pattern of use is defined as one that has caused clinically significant harm to a person’s physical or mental health, or in which substance-induced behaviour has caused clinically significant harm to the health of other people. Again, harm may be caused by the intoxicating effects of a substance, the direct or secondary toxic effects on body organs and systems, or a harmful route of administration (WHO, 2020b).

For further discussion of hazardous and harmful use, see Higgins-Biddle & Babor, 2018; Poznyak, Reed & Medina-Mora, 2018; and Saunders, Peacock & Degenhardt, 2018.

The AUDIT contains 10 items which are classified in three domains: alcohol use, dependence symptoms and harmful use (Table 1); the responses to each item are scored between 0 and 4, and then summed to yield a potential score between 0 and 40 (Babor et al., 2001). AUDIT results can be used in a brief intervention to help patients who drink too much to stop drinking or to cut down on their drinking to avoid the harmful consequences of their alcohol use. They can also serve as a basis for a referral for further assessment and treatment in patients with a more severe alcohol use disorder (AUD).

Table 1. The AUDIT’s three domains and 10 items

Domain Item number Item content

Hazardous alcohol use

1 Frequency of drinking

2 Typical quantity

3 Frequency of heavy drinking

Dependence symptoms

4 Impaired control over drinking

5 Increased salience of drinking

6 Morning drinking

Harmful alcohol use

7 Guilt after drinking

8 Blackouts

9 Alcohol-related injuries

10 Others concerned about drinking

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The original intention was to create a screening instrument that did not include consumption items (akin to the ICD definition), but this proved to be impossible as much of the variation in screening for alcohol is determined by levels and patterns of consumption. Accordingly, the final AUDIT included three consumption items (questions 1–3 in Table 1), which are responsible for the vast majority of the variance seen in most populations (see, for example, Bush et al., 1998). For a description of the close relationship between drinking level and AUDs, see Rehm et al., 2013 and 2014. The three consumption items have also been used as a shorter version of the AUDIT under the name AUDIT-C (Alcohol Use Disorders Identification Test – Consumption) (Bradley et al., 2003 and 2007; Bush et al., 1998; CIHS, 2018).

From the outset, the aims of the AUDIT were twofold:

⋅ To develop a screening tool to be used in clinical settings to identify hazardous drinkers requiring brief advice or more formalized brief interventions, in addition to identifying people with potential AUDs who might require treatment at PHC level or referral for more specialized treatment (Babor et al., 2001).

To achieve this, three thresholds were needed: (1) one for simple advice on reduction of hazardous drinking (AUDIT scores 8–15); (2) another for brief counselling and continued monitoring (AUDIT scores 16–19); and (3) a third for further diagnostic evaluation for alcohol dependence, often in specialized settings (AUDIT scores ≥ 20).

⋅ To allow for cross-cultural comparability and standardization.

Two major obstacles in the AUDIT’s development needed to be overcome: first, health-care systems differ in how and where they treat AUDs (Klingemann, Takala & Hunt, 1992); and second, measurement of consumption was conceptualized by the concept of a standard drink, often operationalized as 10–14 g of pure alcohol (in the original version it was 10 g). However, the definition of a standard drink differs between cultures (Kalinowski & Humphreys, 2016), and some cultures do not have such a concept at all.

To surmount these problems for implementation, validation studies have been con-ducted for different countries and health-care systems. Cultural adaptations for other concepts used in the AUDIT may also be necessary, and additional test items may be needed in order to improve the test’s characteristics. For examples of local adaptation and validation studies of the AUDIT, see Gache et al., 2005; Higgins-Biddle & Babor, 2018; Leung & Arthur, 2000; and Tsai et al., 2005.

The need for such a local adaptation for the Russian Federation became apparent when, in 2016, the WHO Regional Office for Europe and the Ministry of Health of the Russian Federation tried to introduce screening and brief intervention at PHC level by developing appropriate training materials and modules (WHO, 2016). Many experts involved in the initiative expressed their concern that the AUDIT might not give an adequate assessment of specific drinking patterns common in the Russian Federation as well as in neighbouring countries. As a consequence, a new study was initiated to empirically lay the basis for an AUDIT, adapted to these drinking patterns and the needs of the Russian health-care system.

The following study protocol proposes a methodology to conduct a new validation study of the AUDIT, taking into account current drinking patterns and health-service needs in the Russian Federation. It describes the results of various preliminary studies that were carried out to inform the validation procedures and a step-by-step approach towards a screening instrument validated at country level (Bunova et al., 2021; Neufeld et al., 2021a–d; Rehm et al., 2020).

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PURPOSE AND OBJECTIVE OF THE RUSSIAN VALIDATION

As outlined above, the AUDIT is one of the most commonly used screening in-struments and an efficient tool to identify persons with harmful and hazardous alcohol consumption before health and social consequences become pronounced. Screening for excessive alcohol consumption assesses whether a person is at risk of experiencing problems from alcohol use, including possible AUDs. As part of the screening and brief intervention (SBI) approach, screening is followed by brief intervention, which targets at-risk drinkers rather than those who already have a pronounced AUD and would therefore require more intensive care. However, brief interventions might serve as an initial step in the treatment process of patients seeking extended treatment as they can be referred to specialists as part of the brief intervention, if they wish to.

International research has shown that brief interventions at PHC level are low in cost compared to specialized treatment and have proven to be effective (Angus et al., 2014; Babor et al., 2004; Wutzke et al., 2001). By adopting the SBI model, several countries have committed to fill the gap between preventive and PHC settings and the more intensive specialized treatment required for persons with AUDs. Facilitating access to screening, brief interventions and treatment has been included in the WHO-led SAFER initiative as one of the five most cost-effective interventions to reduce alcohol consumption and harm and has become a standard element of any comprehensive alcohol policy approach (WHO, 2021b).

In 2016 the Russian Federation launched a new initiative to implement the SBI programme within PHC settings. Leading Russian experts in the field of narcology, addiction and prevention, practising physicians from hospitals in the Moscow Oblast, and international consultants and representatives from the WHO Regional Office for Europe set up a working group to develop training modules and materials for SBI that could meet the needs of the Russian Federation. In the course of the joint undertaking made by the WHO Regional Office for Europe and the Ministry of Health of the Russian Federation to tailor the resources to the Russian context and translate the WHO “training for trainers” SBI toolkit (WHO, 2017), it became evident that there were a number of problems affecting the available Russian translations of the training manual and, specifically, the AUDIT, the toolkit’s screening instrument.

As well as identifying inconsistencies in the various translations of the instrument and in the way it was applied in different settings, the experts involved in the Russian SBI initiative were concerned that the AUDIT might not give an accurate assessment of specific drinking patterns that were common in the Russian Federation and neighbouring countries, and thus fail to correctly classify individuals with hazardous and harmful drinking. The principal area of concern was prolonged heavy episodic drinking, which involves maximal alcohol intake on a single drinking occasion followed by prolonged periods of abstinence. It was also noted that consumption of unrecorded alcohol was not adequately captured by the AUDIT. This comprises alcohol that is consumed as a beverage but is not recorded and taxed as such, and includes homemade alcohol, smuggled or illegally produced alcohol, and alcohol surrogates. According to recent WHO estimates, consumption of unrecorded alcohol accounts for one third of total alcohol consumption in the Russian Federation, and it poses specific challenges to the existing surveillance systems and to the screening initiatives and treatments associated with them (Neufeld et al., 2019; WHO, 2019a). Finally, a major concern affecting the application of the

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AUDIT in the context of the Russian Federation was that the concept of a “standard drink” as defined in the instrument was not understood in the Russian Federation (or in many other countries) – a problem that had previously been noted by several research groups (Balachova et al., 2012; Cook et al., 2011).

For these reasons, it was concluded that a validation of the AUDIT was required as the basis for a successful implementation of the SBI programme in the Russian Federation. As a follow-up to this recommendation, the Alcohol and Illicit Drugs Programme of the WHO Regional Office for Europe and the WHO Country Office in the Russian Federation initiated the RUS-AUDIT (Russian AUDIT) review process, dedicated to supporting the Ministry of Health of the Russian Federation in the revision, adaptation and validation of the AUDIT. WHO invited key stakeholders involved in the prevention and control of health risks, diseases and injuries due to alcohol consumption to form an advisory board. Experts from the fields of public health, preventive medicine, health administration, epidemiology and specialized addiction medicine (a discipline known as “narcology” in the Russian Federation) were invited to join forces in creating a reliable and valid alcohol screening instrument to meet the specific needs of the local context.

The RUS-AUDIT Project Advisory Board was constituted in 2018 to provide advice to WHO and the Ministry of Health of the Russian Federation on the adaptation and validation of the AUDIT (Annex 1). Based on the initial discussions, the advisory board agreed to the following objectives of the RUS-AUDIT validation project:

1. to operationalize alcohol use in order to allow optimal identification of hazardous use patterns in the Russian context;

2. to determine the best cutoff values for brief advice/interventions in PHC settings for the Russian Federation;

3. to determine the best cutoff values for AUDs and for treatment interventions that are needed in PHC settings or for referral to specialized treatment.

Currently, there are no lower-risk drinking guidelines for the Russian Federation, which are commonly used in some other countries to determine minimum thresholds for hazardous use (Rehm, Bondy & Room, 1996). Determining such thresholds from the literature alone, rather than on the basis of local empirical evidence, is problematic. Research has clearly shown that harmful use (in terms of its impact on mortality rates) starts at fairly low levels of alcohol consumption (GBD 2016 Alcohol Collaborators, 2018; Shield et al., 2017; Wood et al., 2018), in some cases at less than 12 g of pure alcohol per day (depending on methodology). However, it is neither effective nor cost-effective to start brief interventions for patients in PHC at such low levels of alcohol use (Rehm et al., 2016). Moreover, it has been shown that, in general, interventions for lower levels of alcohol use seem to be less effective than interventions for higher levels (Kaner et al., 2007 and 2018). Finally, the Russian Federation and surrounding countries are known for their distinct heavy episodic drinking patterns, which translate into detrimental health outcomes with a higher level of harm per litre of alcohol consumed than is found elsewhere in the WHO European Region (Popova et al., 2007; Shield & Rehm, 2015; Shield, Rylett & Rehm, 2016). Consumption of spirits and highly concentrated alcoholic products, including unrecorded alcoholic products such as non-beverage alcohol and antiseptic lotions with an alcohol content of up to 95%, is also frequently discussed in the literature as one of the main drivers of alcohol-attributable harm in the Russian Federation and neighbouring countries (Korotayev et al., 2018; Lachenmeier, Neufeld & Rehm, 2021; Leon et al., 2007; Neufeld & Rehm, 2018). This relationship between drinking patterns and harm outcomes should also be taken into account when discussing the scoring scheme and the thresholds for intervention of a screening instrument for hazardous and harmful use.

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To determine the optimal intervention threshold for daily use or thresholds for other patterns of use (such as frequency or level of heavy drinking occasions), a protocol for a large-scale validation study at PHC level was developed and subsequently carried out in several regions of the Russian Federation (Neufeld et al., 2021d; Rehm et al., 2020; WHO, 2021a).

The present protocol proposes a methodology for conducting the RUS-AUDIT validation study that takes account of local drinking patterns and health-service needs in the Russian Federation. However, there are many other countries that face similar challenges in the translation and implementation of screening tools for excessive alcohol use. Inconsistencies in translation and diagnostic thresholds and lack of the concept of a standard drink are issues common to various locations. This protocol aims to detail the methodology of validating the AUDIT for the Russian Federation in a format that can be transposed into other settings – most importantly, other countries with similar drinking patterns. This would allow the knowledge and experience of practitioners who consistently identify excessive drinking and provide appropriate interventions to be shared more widely among WHO Member States.

The RUS-AUDIT validation study was a multistage process involving stakeholders from different health-care settings. To achieve the objective and purpose of the study outlined above, the following steps were required:

1. Pre-studies and extended problem analysis to inform the validation study, including:

⋅ a systematic review of validation studies of the AUDIT in the Russian Federation and all Russian translations of the instrument;

⋅ qualitative expert interviews on the perception of the AUDIT instrument by health-care workers and patients (in PHC and narcology settings); and

⋅ a pilot study on the feasibility of using a revised version of the AUDIT to assess alcohol use in PHC settings.

2. The main validation study to determine the optimal thresholds for using the AUDIT in PHC settings.

The protocols for each step in the validation process are detailed below.

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PRELIMINARY STUDIES AND PROBLEM ANALYSIS

In order to address the concerns raised by members of the advisory board, the RUS- AUDIT validation project took a stepwise approach to analysing the existing problems in the application of the AUDIT in the Russian Federation. This was achieved by developing two preliminary studies (pre-studies).

3.1 SYSTEMATIC REVIEW OF RUSSIAN AUDIT TRANSLATIONS AND VALIDATION STUDIES

Two systematic searches in Russian-language electronic bibliographic databases were conducted and search engines were used in order to document and analyse all existing Russian translations of the AUDIT and their applicability in Russian- language populations. These various searches served to document and systematize any reported issues with the application of the AUDIT in the Russian Federation specifically.

The objective of the first systematic search for validation studies of the AUDIT in the Russian Federation was to document any kind of correspondence between the AUDIT and other means of assessing alcohol consumption, such as the WHO Composite International Diagnostic Interview (CIDI), drinking diaries, biomarkers or established AUD diagnoses by a specialist (for more information on CIDI, see section  5.3.2.2 below). The objective of the second search was to identify all Russian-language translations of the AUDIT anywhere in the world and to document any differences, such as thresholds for hazardous and harmful use, and recommendations for inter-vention and referral.

The objectives of the two searches can thus be summarized as follows:

1. What Russian-language versions of the AUDIT exist globally and what are their main differences?

2. What are the documented problems and solutions in the application of the AUDIT in Russian-language populations and specifically in the Russian Federation?

3. What validation studies of the AUDIT exist in the Russian Federation?

4. What are the documented AUDIT thresholds for intervention and referral in the Russian Federation?

The systematic searches were conducted independently by two researchers and thoroughly documented as part of a separate publication (Neufeld et al., 2019).

In the course of the review, only one validation study of the AUDIT was identified in the context of the Russian Federation that reported specificity and sensitivity of the thresholds in comparison to the CIDI as an assessment method for AUDs (Yanov et al., 2009). However, the study was conducted with a small sample of 252 patients (183 males and 69 females) treated in a tuberculosis hospital in the Tomsk Oblast, Siberia. Given the scale of the study and the fact that the sample was drawn from a specific population of patients, the reported parameters of the AUDIT – namely, 91.7% sensitivity and 44.6% specificity for 12 months AUD prevalence for AUDIT scores of > 8, and a sensitivity of 45.8% and specificity of 60.0% for AUDIT scores of > 20 – should be interpreted with caution.

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In total, 61 unique Russian-language translations of the AUDIT were identified, the majority of which were from the Russian Federation. In addition, several distinct AUDIT versions were identified in official WHO publications (including manuals and guidelines), as well as in clinical guidelines and recommendations from preventive medicine and narcology specialists.

More than half of these versions failed to provide a definition of a standard drink size, or the definition was not apparent from the source material. Many incorpo-rated the concept of a standard drink as containing 10 g of pure alcohol, while one version from Ukraine suggested a standard drink of 13 g, even though there is no official definition of a Ukrainian standard drink. Various methods were employed to demonstrate the information conveyed by the term “standard drink”. The majority of the sources that had a standard drink definition explained it in the accompanying material but not within the test itself – for instance, the definition appeared not in the main text of a publication but in an appendix. The remaining sources either featured an in-text explanation/definition that was part of the AUDIT instructions or defined standard drink in the test’s second and third consumption items (questions 2 and 3 in Table 1 above). Some versions included pictures, a formula for calculating individual consumption levels, or even conversion tables. Considerable inconsis- tencies between the different versions were found, both in the presented volumes of alcoholic beverages and in their conversion into standard drinks, as well as in the proposed method to translate the information into an AUDIT score.

In addition, there were some other difficulties encountered, including incompre-hensible questions, response options that deviated considerably from the original AUDIT, and alternative cutoff points for hazardous and harmful use and possible dependence. For instance, two sources from the Russian Federation stated that individuals scoring 15 or more were likely to meet the criteria for current alcohol dependence (Medpsy.ru, 2019; Petrov, 2003). The same low threshold was found in a Russian AUDIT version from Israel (Ashdod.muni.il, 2019) and in an official WHO publication, which stated that scores of 15 or more for men and 13 or more for women could point to possible alcohol dependence (Graham et al., 2013). None of these versions were properly validated empirically, nor did they mention a predetermined protocol for systematic translation and back-translation of the tool.

These inconsistencies in the concept of a standard drink, translations of the AUDIT and diagnostic thresholds confirmed that a single validated version of the question-naire was needed in order to make correct assessments.

3.2 QUALITATIVE EXPERT INTERVIEWS ON THE PERCEPTION OF THE AUDIT

In addition to the two systematic reviews, qualitative semi-structured interviews with experts on the perception of the AUDIT were carried out (for more details, see Neufeld at al., 2021c). In this case, experts were defined to include both health-care professionals and patients in primary and specialized health care. The latter were considered to be experts in the sense that they understood their own consumption patterns and could judge whether the different versions of the AUDIT were capable of assessing these patterns (Bogner, Littig & Menz, 2009).

The expert interviews had the following aims:

⋅ to explore problems in understanding the current AUDIT items (patients and health-care providers);

⋅ to improve the clarity of any AUDIT items that were difficult to understand (patients and health-care providers);

⋅ to explore possible solutions and existing practices of screening and quantification (health-care providers only); and

⋅ to integrate experiences of using the AUDIT from earlier studies (both published and unpublished) and applications (health-care providers only).

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The interview guide for the study (Annex 2) probed the following areas:

⋅ the perception of frequency–volume questions and their importance (AUDIT-C);

⋅ the perception of different versions of the AUDIT – specifically, two distinct Russian translations from the main AUDIT website (auditscreen.org) featuring either the concept of a standard drink or a predefined frequency–volume table; and

⋅ the specificity of Russian drinking patterns – most importantly, single occasions of drinking where intoxication is reached and specific markers for problematic alcohol consumption in the Russian Federation.

The interviews were audiotaped for later content analyses. The interview guide (Annex 2) gives an example of the kind of exploratory work that was needed to inform the study protocol at this stage.

A total of 25 patients and 12 health-care professionals from PHC and narcological care from the city of Moscow were interviewed as part of a convenience sampling method.

Of the patient sample, nine were recruited from inpatient narcological facilities (only those being treated for alcohol-related conditions were recruited); nine from an inpatient internal medicine unit of a general hospital specializing in preventive medicine; and eight from an outpatient general polyclinic, who had presented to a general practitioner. Twenty-one of the patients were current drinkers – that is, they had consumed alcohol in the past 12 months; these patients were given the AUDIT-C as part of the interview and were asked to report on the feasibility of the method of standard drink quantification employed (that is, either pictorial material or the volume quantification table).

Of the health-care professionals interviewed, seven were narcologists and five were cardiologists and/or preventive medicine doctors. All the interviewed doctors had worked with the AUDIT as part of their clinical practice or research and were thus familiar with the instrument.

The overall results of the content analysis carried out on the interview data corrob-orated the results from the systematic review. The difficulties in using the AUDIT encountered by both patients and health-care providers were mainly related to the first three items of the test – the consumption items that constitute AUDIT-C – and their measurement of drinking volumes and intensity. The most frequently raised issues related to (1) the usual problems of self-reported drinking volumes due to memory bias and difficulties in understanding container and glass sizes; (2) the unfamiliar concept of a standard drink and its applicability to the Russian context where it is not used; and (3) the difficulty in defining a “single occasion” of drinking and a different understanding of heavy episodic drinking. Both patients and doctors expressed their concerns about the applicability of the concept of a standard drink, as alcohol volumes in the Russian Federation were generally communicated in grams and millilitres, as well as in glasses and bottles, although a more in-depth discussion and analysis of this revealed that these notions were subjective and interchange-able. At the same time, some health professionals from the PHC setting suggested that the standard drink concept (which sounded neutral to patients) might be used at PHC level for educational purposes, when informing patients about alcohol-related harm; and it might also serve as an entry point to motivational interviewing and general non-stigmatizing discussion about alcohol and health.

Another outcome of the interview study was the strong association between (perceived) alcohol dependence and certain markers of problematic alcohol use, as based on previous large-scale epidemiological studies in the Russian Federation (Leon et al., 2007). These behaviours were seen, by both patients and doctors, as strong indica-tors for AUDs and, specifically, for severe forms of alcohol dependence. The three following criteria are arranged according to the severity level of the associated AUD – in other words, the specificity of the criteria is perceived as increasing with the severity level of alcohol dependence:

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⋅ two or more episodes per week of excessive alcohol consumption, hangover or going to sleep at night clothed because of drunkenness;

⋅ one or more days of continuous drunkenness when the person is withdrawn from normal social life (the operational definition of zapoi given by Leon et al., 2007);

⋅ consumption of surrogate alcohol – that is, alcoholic products not officially intended for drinking, such as colognes, lotions and alcohol for technical/ industrial purposes.

Specifically, the last criterion of surrogate alcohol consumption was strongly associated with severe forms of AUD and marginalization by all interviewed subgroups of the sample, including self-reports of consumers of surrogate alcohol from the narcology setting.

3.3 MAIN OUTCOMES AND RECOMMENDATIONS OF THE PRE-STUDIES

Based on both the systematic review of all AUDIT translations and the qualitative interview study, the following conclusions were made to further guide the adaptation and validation process:

⋅ The concept of a standard drink alone, without assistive devices such as pictorial support or conversion tables, is not feasible in the Russian Federation, as there is no accepted definition of a standard drink known to patients in the PHC or narcology settings (or to the general population).

⋅ The term “single occasion of drinking” was not understandable to at least one group of patients (very heavy drinkers who consume without interruption for more than one day); this may lead to follow-up questions posed by inter-viewers who have different understandings of what “one occasion” means. This would make the AUDIT more dependent on the interviewer and the level of their training and experience – an uncertainty that should be avoided in the case of a standardized tool. This issue can be resolved by defining “occasion” as a time period of 24 hours – in other words, to formulate the third consumption item of the AUDIT in the same way as the second consumption item and ask about a day of drinking instead of an occasion of drinking.

⋅ The use of conversion tables, conversion formulas and/or show cards puts the cognitive load on respondents, as well as on interviewers/physicians, which will lead to biases (Schwarz, 2007; Sudman, Bradburn & Schwarz, 1996). However, when choosing between the two, putting the cognitive load on patients should be avoided, as the interviewer’s level of training is likely to lead to less bias in this respect.

⋅ Alternatively, we suggest that a pictorial form of quantity consumed is presented, supported by a conversion table, and that respondents are asked only to enumerate the number of glasses/bottles consumed and to help interviewers with conversion of drinking volumes into standard drinks and AUDIT scores. The concept of a standard drink can be retained as part of this assessment to facilitate preventive and educational work, as outlined by health-care professionals.

⋅ Another option is computer-assisted tools, including animated assessment elements such as sliders to indicate how much of a typical bottle of a particular beverage would still be left after a respondent had poured their usual quantity into a glass. All the conversions would be done by the computer program as part of the computer-assisted personal interview, so neither the respondent nor the interviewer would have to do any computations.

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TRANSLATION AND ADAPTATION PROCEDURES OF THE AUDIT

4.1 ADAPTATION PROCEDURE OF THE AUDIT TO ASSESS ALCOHOL USE IN THE RUSSIAN FEDERATION

Although there are internationally well-established methodological approaches and documented best practices for translating, adapting and validating instruments in health-care research, the quality of the instruments actually produced is known to vary greatly, either because the multistep process is not considered important enough to justify the resources required or because the process is carried out inconsistently (Sousa & Rojjanasrirat, 2011).

WHO has an established multistep process of translation and adaptation of instruments, the aim of which is to achieve different language versions of instruments that are conceptually equivalent in each of their target countries/cultures (WHO, 2009). Such an instrument should be equally acceptable and perform practically in the same way, providing objective, reliable and valid measurements of a concept. For this reason, the focus is on cross-cultural and conceptual (rather than linguistic and literal) equivalence, which makes translation of instruments a very specific task, often involving many experts from different fields.

The existing WHO guidelines for translation of instruments are based on several studies and include the following steps:

⋅ forward translation

⋅ expert panel

⋅ back-translation

⋅ pre-testing and cognitive interviewing

⋅ construction of final version

⋅ documentation of the process.

In the following, the process was followed step by step to construct a Russian Federation-specific version of the AUDIT, the so-called RUS-AUDIT (for a more detailed description, see Neufeld et al., 2021b).

4.2 TRANSLATIONANDBACK-TRANSLATIONOFTHEAUDIT AND EXPERT PANEL

In the first step, a forward translation from English into Russian was made by a group of specialists as part of the Russian translation of the WHO “training for trainers” SBI toolkit (WHO, 2017). This version was discussed in a group discussion by the RUS-AUDIT Project Advisory Board, which constituted the first expert panel. A second expert panel, made up of professional translators, communication specialists and linguists, was consulted as a separate part of the process. Existing translations that had been identified in the systematic review were circulated and discussed,

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and different versions of possible translations were considered and discussed by a smaller group of experts, who had experience in instrument development, trans-lation and validation.

As a result of this multistep consultation process and based on the systematic review and expert interviews, an adapted Russian version of the AUDIT was constructed, which used pictorial material as part of the second test item to represent drinking volumes and to convert them into standard drinks (Annex 3). A back-translation of this penultimate version was then made by an independent expert, whose mother tongue was English and who had no previous knowledge of the questionnaire. Some issues and discrepancies were discussed again in a smaller expert group and a version was prepared for a quantitative pilot study with cognitive debriefing elements.

4.3 PILOTING THE REVISED VERSION WITH THE TARGET AUDIENCE AND COGNITIVE INTERVIEWING

In the next step, the adapted instrument was pre-tested on the target audience – specifically, patients from PHC facilities. The main objective of this quantitative pilot study was to empirically test if the constructed version of the AUDIT was under- standable to respondents and whether it was comprehensive enough to detect hazardous alcohol consumption and potential AUDs.

In the pilot study, 79 patients from a PHC facility in Moscow, all of whom had con-sumed alcohol in the past 12 months, were interviewed. The sample included patients from a preventive medicine health centre and from cardiology, surgery and internal medicine inpatient units. Additionally, participants of an ongoing study in preventive medicine were included in the sample as they had reached out to the preventive services of the PHC facility, which is part of PHC services according to Russian legislation. Patients were approached in the facility by two interviewers and asked for informed verbal consent to participate in the study in accordance with a standardized script. Interviews were conducted face to face, either in a separate room or in the hall of the medical unit concerned, and audiotaped. The protocol and the questionnaire form used in the pilot study can be found in Annex 3.

All patients were administered the first three test items of the adapted version of the AUDIT and randomly assigned to one third of the remaining items (to save time, as these items were not found to be problematic). Cognitive debriefing was carried out after each test item by means of several questions, and general observations were documented by the interviewers (Ryan, Gannon-Slater & Culbertson, 2012). Simple linguistic changes were introduced during the pilot phase and thoroughly documented. All such changes were made as part of an iterative process of adaptation, testing, cognitive debriefing, data analysis and discussion in a small expert group consisting of the interviewers and WHO and national experts. A show card with a frequency–volume conversion table was developed to assist the interviewer with standard drink quantification and score calculation as part of the second test item. Different versions of the show card were tested, including more abstract pictograms of alcoholic beverages and black-and-white pictures (shown in Annex 3). Overall, it was found that a coloured show card with realistic (photographic) pictures of alcoholic beverages worked better as part of the assessment and quantification because it considerably reduced the reaction times of patients navigating the table and attempting to recall typical drinking volumes.

A short report of the pilot phase documented all the changes and decisions made, as well as the main outcomes of each interview, and was then presented to the Project Advisory Board to inform further decisions.

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4.4 PANEL DISCUSSION, REVISION AND BROADER PILOTING OF FINAL FORMS

The revised version of the RUS-AUDIT instrument, based on the results of the pilot study, was then presented to the Project Advisory Board expert panel and thoroughly discussed in the course of a one-day meeting (Fig. 1). The instrument was then changed again, based on the recommendations and suggestions of the advisory board, and a further round of pilot-testing was initiated, this time encompassing not only pre-ventive facilities and hospital units but also narcology and polyclinic settings. In addition to the joint Project Advisory Board expert group, two separate consulta-tions, restricted to preventive medicine and narcology specialists, were carried out.

The revised version was then piloted in the relevant settings in full-study form, incorporating the other instruments intended for the main validation study, to test how well the questionnaire that had been developed worked with the target audi-ence. The additional phase was organized in a two-step process, using an interim expert panel and following further adaptation. The first pilot phase was carried out with 41 patients, 12 of whom were recruited from a general polyclinic in Moscow and 29 from two narcology clinics. It was found that, compared to PHC patients, narcology patients had greater difficulty understanding the concepts of a “single occasion of drinking” and a “typical drinking day”; they also struggled to find a suitable frame in which to recall their drinking behaviours over the past 12 months because most of their drinking patterns could be characterized as heavy episodic drinking, with prolonged periods of heavy alcohol intake (the so-called Russian zapoi) followed by abstention. These problems were not surprising, as the AUDIT was developed as a screening (not a diagnostic) instrument and therefore behaves differently when used in clinical populations. At the same time, the results of this pilot phase corroborated the findings of the qualitative interviews and the systematic research, suggesting that particular attention needed to be paid to heavy drinking occasions and the specific nature of drinking patterns as such. Following the work of the interim expert panel, some changes to the items on heavy episodic drinking were made and a second pilot phase in the relevant facilities was initiated. This last pilot encompassed a total of 16 patients, 11 from a polyclinic and five from a narcology clinic.

Based on this iterative process, a final version of the RUS-AUDIT was constructed (Annex 5), which was a paper-and-pencil interview version only, following requests from the Project Advisory Board representatives. However, it was anticipated that electronic and auto-administered versions of the tool could be developed and tested in future pilot studies, based on the experience of the adaptation process described here.

Fig. 1. The Project Advisory Board and collaborators meeting to discuss the RUS-AUDIT following revision based on the pilot study

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5 MAIN VALIDATION STUDY

5.1 OBJECTIVESThe validity of a research instrument is the extent to which it measures what it is designed to measure, while validation is the process of producing sound evidence to demonstrate this link (AERA, 1999; Kimberlin & Winterstein, 2008). There are various procedures commonly employed to validate a test (Angoff, 1988; Boateng et al., 2018). For instance, one method is evaluation by expert and target population judges (face validity and content validity); another involves examining the association between the test scores and an external criterion to which the test ought to be related (criterion validity, predictive and concurrent); and a third involves comparison of test results with other tests that measure similar qualities to see how closely correlated the two measures are (construct validity). The purpose of validation studies is to observe, document and understand variation in the data generated under specific laboratory conditions. Validation helps define the scope or range of conditions under which reliable results may be obtained.

The RUS-AUDIT validation was carried out in PHC facilities to determine the best thresholds for use of the instrument in PHC settings. As there were no guidelines on hazardous and harmful alcohol use in the Russian Federation, the following criteria to determine the threshold for initiating brief advice and interventions for patients were suggested:

1. having more than 20 g of pure alcohol on average per day for women, or 40 g of pure alcohol for men, based on the medium-risk drinking levels for chronic disease from the European Medicines Agency (EMA, 2010); or

2. showing at least one drinking occasion with at least 100 g of pure alcohol or higher in the past three months; or

3. showing at least two drinking occasions with at least 60 g of pure alcohol per week.

The latter two drinking scenarios or styles were derived from work done by a group studying alcohol as a risk factor for mortality in the Russian Federation (Leon et al., 2007).

In addition, the validation study set out to determine the threshold for AUDs requiring treatment at either primary or specialized health-care level. For this purpose, the World Mental Health (WMH) Survey Initiative version of the WHO Composite International Diagnostic Interview (CIDI 3.0) was used. This instrument is a com-prehensive, fully structured interview designed to be used by trained interviewers for assessment of mental disorders in various settings (Kessler & Üstün, 2004). The Kessler Psychological Distress Scale (K10) was also used in order to assess psycho-logical distress as an additional measure to detect any clinically relevant behaviours (Furukawa et al., 2003; Kessler et al., 2003; see also section 5.3.2.3 below).

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5.2 STUDY DESIGN AND SAMPLE

5.2.1 Study designA cross-sectional design was used with only one data collection round.

5.2.2 Site and settingThe study protocol was implemented at PHC facilities selected on the recommendation of the RUS-AUDIT Project Advisory Board. Participating PHC facilities were not required to be representative of the Russian Federation in a statistical sense, but it was important that distinct drinking styles within the country were represented. For this reason, it was recommended that at least two rural study sites should be included in the sample, as there was considerable variation in drinking patterns between rural and urban populations.

According to WHO definitions, a PHC facility is an entry point to the health system, where individuals first present with their problem. However, taking into account specific aspects of the Russian health-care system, the study also included PHC facilities that had primary preventive purposes, as part of the dispanserization effort among the adult population. Dispanserization is a complex of measures that include a preventive medical examination and additional examinations by specialists in order to assess a person’s health status; it is carried out regularly in certain population groups in accordance with Russian legislation (Ministry of Health of the Russian Federation, 2017). Dispanserization is a measure aimed at early detection and prevention of chronic noncommunicable diseases, as well as the risk factors for their development, including elevated blood pressure, hypercholesterolemia, elevated blood glucose levels, tobacco and harmful alcohol consumption, unhealthy diet and low physical activity. The examination is free of charge and carried out once every three years for the 18–39 age group, and once a year for the 40+ age group.

5.2.3 Study populationThe study was conducted among patients seeking treatment and/or consultation in PHC facilities such as local polyclinics or health centres (PHC facilities and health professionals were defined according to national regulations). The study included the adult population (18 years and over) of the Russian Federation only. Adults in specialized care settings such as narcology and trauma care were excluded from the target population as they were considered to be appropriate to a separate validation study.

5.2.4 Sampling designA probability sample was recruited in participating PHC facilities and all patients who visited on a certain day were approached and asked to participate. The inten-tion was that, in each PHC facility, at least 50 patients would be interviewed, and the interviewers would be responsible for recruiting at least 25 participants from each sex. The inclusion criteria were that patients should: (1) be at least 18 years of age; (2) have consumed alcohol within the previous 12 months; and (3) be able to give consent to the interview.

5.2.5 Sample sizeIn general, translating and adapting a test are not procedures that necessarily require large sample sizes, although this is highly dependent on the particular nature of the test and the specific context. Statistical validation procedures and determination of test cutoff values, on the other hand, do require large sample sizes to ensure correct classification of individuals and hence the diagnostic value of the adapted test.

In the RUS-AUDIT validation study, receiver operating characteristic (ROC) analyses were used to determine the validity and classification accuracy of the adapted instrument (Hanley & McNeil, 1982; Kryzanowski & Hand, 2009). The sample size

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depends on the level of precision the study aims to achieve, the expected number of drop-outs, and the sociodemographic indicators (including sex and age) of the sampled patients. The number can vary as it is based on the key objectives of the study – specifically, the precision of the ROC statistic of the AUDIT to detect AUDs (see Annex 4 and Florkowski, 2008; Zweig & Campbell, 1993).

The sample size calculations for the study were based on available data on the estimated prevalence of AUDs in the Russian Federation, the anticipated drop-out rate, and experience derived from the pilot studies, which highlighted that many patients who were interviewed in PHC settings had not consumed alcohol in the previous 12 months. (For further details of the sample size calculations, see Annex 4.)

5.3 DATA COLLECTION

5.3.1 Patient recruitment and interview processPersonal paper-and-pencil interviews were conducted by trained interviewers after seeking informed verbal consent. The following instruments were used.

5.3.2 Data collection forms5.3.2.1 Revised RUS-AUDIT based on the pilot, with additional items and show cardThe revised version of the RUS-AUDIT – that is, the 13 Russian AUDIT questions of the modified version developed in the pilot study – were administered to all patients as part of the validation (Annexes 5 and 6).

5.3.2.2 CIDI module for AUDsThe AUDs module of the CIDI was used to assess possible AUDs (that is, harmful use of alcohol and alcohol dependence, as defined in ICD-10), following translation and back-translation (Kessler & Üstün, 2004).

The CIDI is a fully structured diagnostic interview developed by the WHO/ADAMHA (Alcohol, Drug Abuse, and Mental Health Administration) Project on Diagnosis and Classification of Mental Disorders and Alcohol- and Drug-related Problems. It can be used by nonmedical staff and has a modular structure that gives diagnoses according to ICD and DSM classification. It has been used in a variety of settings across the world and adapted for use in cross-cultural studies.

5.3.2.3 Kessler Psychological Distress Scale (K10)The Kessler Psychological Distress Scale (K10) was used, following translation and back-translation (Furukawa et al., 2003; Kessler et al., 2003). The K10 includes a total of 10 questions about anxiety and depressive symptoms that a person has experienced in the most recent four-week period. It has been widely used in a variety of settings to assess psychological distress in general and clinical populations.

5.3.3 Administration of interviewsThe participating facilities were responsible for choosing the most appropriate people as potential candidates for training in conducting interviews; these could be nurses, medical doctors, other health-care workers and other suitable personnel linked to the facilities. All interviewers had to undergo formal training to administer the various questionnaires and to solve any possible issues with data collection en-countered in the field. Each participating institution nominated at least one regional coordinator who helped to organize interviewer trainings and was responsible for coordinating the data collection procedure in participating facilities. The study teams remained in correspondence with the WHO European Office for the Prevention and Control of Noncommunicable Diseases as the central coordinating body.

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Standardized script to end interview

Unrecorded alcohol consumption items WHO CIDI AUDs module

K10

RUS-AUDIT score < 5 RUS-AUDITscore≥5

RUS-AUDIT Every third respondent: K10

Sociodemographic questions and smoking status

No Yes

5.3.4 Data collection scheme and processFor all patients who had not consumed alcohol over the previous year, only a few sociodemographic characteristics (sex, age, socioeconomic and marital status) were assessed as part of the CIDI standard form. For these patients, the interview lasted less than five minutes.

For people with an AUDIT score above 5, the WHO WMH CIDI 3.0 for AUDs and the Kessler K10 were used, in addition to a collection of sociodemographic information and two additional questions on unrecorded alcohol consumption as a Russian Federation-specific marker for alcohol use problems. For these patients, interviews took about 20–30 minutes.

For people with an AUDIT score of 5 or less, one third were randomly selected and asked the same questions (WHO WMH CIDI 3.0, Kessler K10 and sociodemographic questions). For the random selection process, every third patient for each inter-viewer was given the full questionnaire. For the remaining two thirds of patients who had a score of 5 or less, the interview consisted only of the RUS-AUDIT and sociodemographic questions and took 5–10 minutes to complete.

The interview process was carried out according to the scheme shown in Fig. 2.

Fig. 2. Flowchart showing the interview process used in the RUS-AUDIT validation study

Every third respondent

Standardized script with greeting and verbal consent to interview Respondent’s sex and age

Filter question: “Have you consumed alcohol in the last 12 months?”

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The basic principles of confidentiality, privacy and objectivity were observed through-out the data collection phase. Anonymous interviews were conducted in private rooms at the PHC facilities and verbal informed consent was obtained.

At the end of each interview, patients were asked if they wanted to receive feed-back on their AUDIT score and were given a handout to explain the interpretation of scores, including the international cutoffs (≥ 8 for hazardous alcohol use, ≥ 16 for harmful use, ≥ 20 for potential AUDs). The handout material also included brief guidance on steps that patients could take – for instance, it was recommended that patients with an AUDIT score of ≥ 20 should seek professional help and information was given on how patients could obtain further support. However, patients were not actively referred to any specialized treatment on the basis of their interview outcomes, and interviewers provided information on local health-care providers only if explicitly asked to do so.

During the interview, each answer was registered by the interviewer on the paper- and-pencil questionnaire form. Interviews were not linked to patients’ personal data, either directly in the interview context or subsequently, and the information obtained was not recorded.

All original data collection forms and instructions for their administration were prepared in Russian, while the CIDI module for AUDs and the Kessler K10 were trans-lated and back-translated with the help of the expert panel that was responsible for the translation and adaptation of the RUS-AUDIT. Translations were carried out in accordance with the established WHO protocols for translation and adaptation of instruments. Translated forms were carefully checked for discrepancies against the original English versions. The back-translation was done by a professional translator independently of the initial translation from English and discussed several times with the expert panel.

5.3.5 Interviewer training and standardization5.3.5.1 Training for trainers and interviewersA pool of trainers was prepared as part of a WHO “training for trainers” programme. Trainers from facilities participating in the RUS-AUDIT project were put forward and then selected by WHO. The training for trainers session was conducted in Russian and English and lasted approximately five hours. Trainers were prepared to deliver a standardized interviewer training in the regions, following a jointly developed scheme. WHO developed specific training modules and a detailed manual for inter- viewers, and these were approved by the trainers. Training modules of all three original instruments, available in English and Spanish, were translated into Russian and tailored to meet local needs.

5.3.5.2 Training modules and materialsThe modularized interviewer training was carried out by at least two trainers in each region; training sessions were carried out in Russian and lasted 7–8 hours. Potential interviewers were put forward by PHC facilities participating in the study, with a preference for people with a professional background in health and some experience in data collection. The training modules that were developed included a general introductory section on alcohol and health, the AUDIT and the RUS-AUDIT validation study, an introduction to the basics of interviewing techniques, and a detailed hands-on module on the application of the various instruments as shown in the interview flowchart (Fig. 2) (Annex 7). The training involved role plays and specific case examples of typical or challenging interview situations. Interviewers were also given instruction on the practical aspects of data collection and documentation and quality control. At the end of the training session, each interviewer was given a test to demonstrate their ability to carry out the interviews as per the study protocol.

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5.3.6 Timing of data collectionParticipating facilities were requested to participate in data collection during the period August–December 2019. There was an option to extend the data collection window by up to two months if a special need arose.

5.4 DATA PROCESSING AND QUALITY CONTROL

5.4.1 Data processingEach PHC facility participating in the study nominated at least one regional coordi-nator to be in direct contact with the WHO focal point for the purpose of feedback, data management and data control.

Each patient’s unique identifier consisted of a code for their region, their institution, and a unique interviewer code, which allowed subsequent quality control, follow-ups and feedback if needed.

On the day of the interview, each filled-in questionnaire was checked by the inter-viewer for completeness. The questionnaires were then collected and checked again by the regional coordinators and sent on a weekly basis to the WHO European Office for the Prevention and Control of Noncommunicable Diseases (NCDs). Electronic copies of completed paper-and-pencil assessment forms were uploaded by the regional coordinators to a secure password-protected online drive set up by the WHO European Office for NCDs, with access limited to designated WHO personnel only.

Data from the electronic copies were entered by the technical focal point in the WHO European Office for NCDs. Dual data entry procedures were followed for at least some random sets of data, and random quality assurance checks were performed by selected experts from the Project Advisory Board expert group.

5.4.2 Data quality controlFour methods were used for purposes of data quality assurance. First, the electronic spreadsheets were set up so that only eligible values could be entered; for instance, if valid answers to a question were limited to the numbers 0, 1, 2, 3, 4 and the

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symbol “.” (to denote a refusal to answer), no other number, character or symbol could be entered. Second, the PHC facilities kept the filled-in questionnaires for random control checks. Third, routines to check plausibility were set up by WHO, and if these routines signalled problems, answers were checked again, first by going back to the questionnaires, and then, if questions remained, by asking the focal point and the responsible interviewers directly. Finally, randomly selected interviews were observed by the trainers for compliance with interview rules and a random sample of voice recordings were listened to.

After quality control procedures had been followed, the data were entered into the RUS-AUDIT database, which was managed by WHO. Serving as the basis for data analyses, the dataset would be made available upon request to project coordinating centres from participating institutions.

5.4.3 Data management and analysisThe data analyses involved:

⋅ giving descriptive analyses to characterize the feasibility of using the instruments in the Russian Federation (including missing values analyses);

⋅ establishing the main analyses to test the hypotheses of the validation and to determine best thresholds for brief advice interventions at PHC level – determination of sensitivity and specificity of the AUDIT for detecting AUDs; determining receiver operating characteristics (Florkowski, 2008; Zweig & Campbell, 1993);

⋅ conducting sensitivity analyses based on different severity of AUDs and for alcohol dependence;

⋅ analysing the potential influence of gender, age and comorbidity on these outcomes.

ROC analysis is a method used to determine the classification of individuals according to a test. It allows appropriate thresholds with optimal sensitivity and specificity to be determined. In the case of a diagnostic test, sensitivity is the proportion of diseased persons the test classifies as positive, while specificity is the proportion of nondiseased persons the test classifies as negative. The area under the ROC curve (AUC) is widely recognized as the measure of a diagnostic test’s discriminatory power and thus provides a means to determine an “ideal” threshold with high sensitivity (true positives) and high specificity (true negatives). The maximum value for an AUC is 1.0, which indicates a hypothetical perfect test (that is, 100% sensitive and 100% specific), whereas an AUC value of 0.5 indicates no discriminative value (that is, 50% sensitive and 50% specific) and hence a useless test whose outcome is as random as the toss of a coin.

An important task of an alcohol screening test is to strike a proper balance between the desire to detect AUDs in people who really have them and thus the need of some kind of intervention and the desire to avoid falsely detecting AUDs in people who do not have them and thereby risking stigmatizing them.

The results of the analyses were presented to the Project Advisory Board. Recom-mended cutoffs were discussed on the basis of the data; the objectives were (1) to provide basic information on alcohol to patients who might be at risk but do not meet the criteria of AUDs; (2) to avoid overloading the system with too much demand for brief interventions and referrals to specialists; and (3) to avoid misclassification and possible stigmatization of individuals with no AUDs, who are wrongly identified by the test (false positives).

Based on the discussions of the Project Advisory Board, a project report was com-piled; the recommended final version of the RUS-AUDIT was also prepared, in longer and shorter forms, each with its corresponding cutoffs. Final recommendations on use of the two versions within the health-care system of the Russian Federation, based on the study findings, were proposed.

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ETHICAL CONSIDERATIONS

As the main aim of the study was to improve the quality of health-care services in relation to screening for risky alcohol use in the participating PHC facilities without collecting any identifying information, it was considered to be part of routine care and thus part of routine care procedures. In this respect, it was similar to other implementation studies for screening and brief advice/interventions in other countries (Anderson et al., 2017). However, participating project partners were expected to secure ethical approval at the level of their own institutions.

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IMPLICATIONS FOR SBI IN THE RUSSIAN FEDERATION

The Russian Federation has successfully implemented various alcohol control measures, such as WHO’s “best buys”, as well as various other interventions as part of its national strategy to reduce alcohol abuse and alcohol dependence in the popula-tion and to decrease alcohol-attributable mortality (Khaltourina & Korotayev, 2015; Nemtsov, Neufeld & Rehm, 2019; Neufeld & Rehm, 2013 and 2018; Neufeld et al., 2020a and 2020b; WHO, 2019a).

However, implementation of routine SBI for alcohol at national level as an additional measure to reduce the alcohol-attributable burden and increase life expectancy has not yet been realized, and use of the AUDIT has to date been limited to the dis-panserization setting only (Bunova et al., 2021). As is recognized in the WHO Global Strategy to Reduce the Harmful Use of Alcohol and in the WHO European Action Plan to Reduce the Harmful Use of Alcohol 2012–2020, delivering SBI for alcohol-related problems in primary health care can be an effective and efficient way to reduce alcohol consumption by hazardous and risky drinkers and to raise general awareness of alcohol-related problems. Moreover, one of the five high-impact strategies of the WHO global SAFER alcohol control initiative is “to facilitate access to screening, brief interventions and treatment”. Compared to three other areas of the SAFER initiative (availability restrictions, marketing bans, drink–driving countermeasures), this is an area where relatively little progress has so far been observed, with only pricing measures being more poorly implemented (WHO, 2021c).

The availability of a quick, effective and reliable screening tool as part of the SBI strategy is a crucial cornerstone of its success. Thus, by validating the AUDIT to con-duct screening for alcohol consumption among patients in primary care, our study is expected to lay the groundwork for implementing SBI in the Russian Federation (Rehm et al., 2020). This should contribute to greater opportunities to educate patients about lower-risk consumption levels and the risks of excessive alcohol use, as well as starting discussions with them about the implications of their drinking for current symptoms and future health. It may alert clinicians to the need to advise patients whose alcohol consumption might adversely affect their use of medications and other aspects of their treatment and may also improve referral pathways. Finally, it will be a step forward towards making alcohol SBI a standard procedure and routine part of health care in other countries.

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Wood AM, Kaptoge S, Butterworth AS, Willeit P, Warnakula S, Bolton T et al. (2018). Risk thresholds for alcohol consumption: combined analysis of individual-participant data for 599 912 current drinkers in 83 prospective studies. Lancet. 391(10129):1513–23. doi:10.1016/S0140-6736(18)30134-X.

Wutzke SE, Shiell A, Gomel MK, Conigrave KM (2001). Cost effectiveness of brief interventions for reducing alcohol consumption. Soc Sci Med. 52(6):863–70. doi:10.1016/s0277-9536(00)00189-1.

Yanov SA, Bokhan NA, Mathew T, Shin S, Greenfield S, Shields A et al. (2009). Chuvstvitel’nost’ i specifichnost’ skrining-testa “AUDIT” pri vyjavlenii rasstrojstv v rezul’tate upotreblenija alkogolja sredi bol’nyh tuberkulezom legkih [Sensitivity and specificity of the AUDIT screening test in detecting alcohol use disorders in pulmonary TB patients]. Siberian Bulletin of Psychiatry and Narcology. 4:34–6 (in Russian).

Zweig MH, Campbell G (1993). Receiver-operating characteristic (ROC) plots: a fundamental evaluation tool in clinical medicine. Clin Chem. 39(4):561–77. PMID: 8472349.

30

ANNEX 1. ADVISORY BOARD FOR THE RUS-AUDIT VALIDATION PROJECT IN THE RUSSIAN FEDERATION

GOALTo provide advice to WHO and the Ministry of Health of the Russian Federation on implementation of the project “AUDIT adaptation and validation in the Russian Federation, RUS-AUDIT”

PARTICIPATING INSTITUTIONSMinistry of Health of the Russian Federation

WHO Country Office in the Russian Federation

WHO European Office for the Prevention and Control of Noncommunicable Diseases

Federal Research Institute for Health Organization and Informatics of the Ministry of Health of the Russian Federation

I.M. Sechenov First Moscow State Medical University

National Medical Research Center for Therapy and Preventive Medicine

Moscow Research and Practical Center for Narcology of the Moscow Department of Health

National Research Centre on Addictions of the Ministry of Health of the Russian Federation

31

ANNEX 2. INTERVIEW GUIDE FOR THE QUALITATIVE EXPERT INTERVIEW STUDY (QUALITATIVE PILOT)

1 Always make clear that this is about problems with the use of alcohol, which is a behaviour and not a judgement of personality or traits.

OBJECTIVETo explore problems in the understanding of the current AUDIT item. To explore specific markers of hazardous and harmful alcohol use.

METHODOLOGICAL CHARACTERISTICSQualitative pilotPersonal in-depth interview on the perception of frequency–volume questions, specific markers for problematic alcohol consumption in the Russian Federation, and the perception of different versions of the AUDIT (two Russian translations from the AUDIT website (auditscreen.org)).

⋅ N = 25 patients in primary health care and specialized narcological care who had consumed alcohol in the previous year

⋅ N = 10 health-care professionals from primary health care and specialized narcological care who have worked with the AUDIT test as part of their professional history

Audiotaping of interview for later analyses.

DELIVERABLESShort report on existing problems with the current versions of the AUDIT, specifically in relation to the first three frequency–volume items. Specific suggestions to improve the clarity of any AUDIT items causing difficulty with comprehension in the modified version.

STANDARDIZED INTERVIEW SCRIPT FOR THE QUALITATIVE EXPERT INTERVIEWS [To be delivered verbally by the interviewer.]Good day,My name is . I work in the European Office of the World Health Organization in Moscow.Together with Russian experts, the World Health Organization is conducting a study in which we want to develop a questionnaire that could quickly inform doctors and medical professionals whether their patients might consume alcohol in a risky or hazardous way. This is done to help health-care professionals to improve their services and to provide better care. In order to achieve this, we conduct anonymous expert interviews with medical professionals and patients [primary care/specialized medical care] in which we want to find out how certain questions about alcohol consumption are perceived by doctors and patients and what they think about them.If you don’t mind giving me 15–20 minutes of your time, then I would like to ask you some questions.

INFORMED CONSENT[To be delivered verbally by the interviewer.]The interview will be conducted anonymously and for research purposes only and will last 15–20 minutes. You have the right not to answer any question(s) and to interrupt or terminate the interview at any time.Do you agree with this procedure? [The interviewer waits for oral informed consent.]

INTERVIEW GUIDE FOR THE QUALITATIVE EXPERT INTERVIEWSDo you think that questions about frequency of drinking (current AUDIT question No. 1) could tell us whether someone has problems with alcohol or not? [Is frequency of drinking an indicator for alcohol problems?1]

⋅ Yes

⋅ No

32

[Follow-up question] Why do you think so? Please elaborate. Do you think that the maximum amount of alcohol a person drinks on one occasion (defined as 24 hours) in the last three months could tell us whether someone has a problem with alcohol or not?[Follow-up questions] Why do you think so?Do you think it is important to ask this question to assess alcohol problems, if only three questions about alcohol consumption can be asked? [In other words, is it one of the three most important questions in order to determine problems with alcohol?][For patients only] How much alcohol did you drink when you consumed the most on one occasion (defined as 24 hours)? [Please indicate in bottles of beer, wine or vodka.]How often have you consumed this amount of alcohol in the course of the last 30 days? How old were you when you started to consume alcohol [age of drinking initiation]? And how old are you now? [Interviewer note: check how the respondents answer an open-format question, and if they do not use terms like “standard drink” or other standardized quantifications, check if they believe that the usual AUDIT is feasible!][Make sure that the interviewee understands that the last question refers to age of drinking initiation and not the first time the person ever tasted alcohol.][For health-care professionals only] How long have you been working as a health-care professional?How long have you been working [with patients] on the topic of alcohol consump-tion in your practice as a health-care provider? [What would you say? How much experience do you have in asking your patients about their alcohol consumption?]Did I understand correctly that you are already working with the AUDIT (the Alcohol Use Disorders Identification Test) or have worked with it in the past? [Follow-up questions] If so: for how long?What are your experiences with the test so far?Do you use this test regularly?Would you consider it to be a good test? Why? [If needed, interviewer clarifies that by “good” we mean useful for everyday work with patients.]When you look at your daily work, what do you think are certain barriers or problems with this test in your daily practice?There are studies on problematic drinking in the Russian Federation that suggest that the following indicators could tell us whether somebody has a problem with alcohol or not:

⋅ having one or more episodes of zapoi in the past year (a period of two or more days of continuous drunkenness when the person is withdrawn from normal social life);

⋅ twice a week or more: occurrence of excessive drunkenness, hangover, or going to sleep at night clothed because of being drunk;

⋅ consumption of surrogate alcohol (alcoholic products officially not intended for drinking, such as colognes, lotions, alcohol for technical/industrial purposes).

What do you think about these questions? Are they helpful in telling us whether somebody has a problem with alcohol or not? Why do you think so?What other questions about alcohol use could be used to inform whether a person has alcohol problems or not? What are your ideas?What do you think marks/characterizes harmful or hazardous drinking? What drinking behaviours lead to negative health outcomes and social consequences?

33

ANNEX 3. PROTOCOL FOR THE PILOT STUDY (QUANTITATIVE PILOT), INCLUDING QUESTIONNAIRE

OBJECTIVETo empirically test an AUDIT version in Russian, which is understandable by respond-ents and which allows detection of hazardous alcohol consumption and potential alcohol use disorders.

METHODOLOGICAL CHARACTERISTICSMain pilotPersonal interview on four consumption questions, plus two of seven non- consumption questions of the AUDIT.N = 50 patients in primary health care who had consumed alcohol in the previous year; at least 20 of each gender; age distribution 18 and above, with the majority of people in ages 25–65.Cognitive debriefing after every question.Setting: primary health care.Technical support: show card to show usual servings to respondents.Audiotaping of interview for later analyses.For each question, please measure the time it takes to respond without the cognitive debriefing questions (via audiotape).

DELIVERABLESShort report on the feasibility of both modes of assessment.

STANDARDIZED INTERVIEW SCRIPT FOR THE PILOT INTERVIEW (TO BE DELIVERED BY THE INTERVIEWER)Good day, my name is . The Center for Therapy and Preventive Medicine, together with the World Health Organization, is conducting a study in which a screening tool will be developed to help medical personnel to identify risky drinking patterns. The developed tool will help medical staff to provide medical care quickly and efficiently.

INFORMED CONSENT [To be delivered verbally by the interviewer.]I would like to ask you some questions about consumption of alcoholic beverages in the last 12 months and record our conversation. This is done anonymously and for research purposes only. You can stop the interview and stop answering questions at any time. The interview will take no more than five minutes. Do you consent to the interview?[The interviewer waits for oral informed consent.]

QUESTIONNAIRE FORM OF THE QUANTITATIVE PILOT STUDY[Tested on N = 79 patients from the primary health-care setting.]Now I am going to ask you some questions about your use of alcoholic beverages during the past 12 months.[If there is any doubt, please explain what is meant by “alcoholic beverages” by using local examples of beer, wine, vodka, etc. Please note how many people ask spontaneously.]

34

How often do you drink alcoholic beverages?

Never 0 Once a month or less 1 2–4 times a month 2 2–3 times a week 3 ≥ 4 times a week 4

[Get the answer first!]Did you have any difficulties understanding this question?Did you have any difficulties answering the question?What did you consider alcoholic beverages? [Note any questions/remarks/doubts about unrecorded alcohol.]

How many alcoholic drinks (how many servings) do you usually drink (i.e. on one day of drinking)?

1–2 servings 0 3–4 servings 1 5–6 servings 2 7–9 servings 3 ≥ 10 servings 4

Each picture shows one standard serving of alcohol. One standard serving contains approximately 10 g of pure alcohol.

Sparkling wine100 mlAlcohol volume 13%

Wine100 mlAlcohol volume 13%

Regular beer285 mlAlcohol volume 4.9%

Fortified wine60 mlAlcohol volume 20%

Spirits30 mlAlcohol volume 40%

[Get the answer first!]Did you have any problem understanding this question?Did you have any problem answering the question?How did you answer this question? What did you think about?

How often do you drink three bottles of beer or almost a bottle of wine or more than one third of a bottle of vodka during one occasion?

Never 0 Less than once a month 1 Once a month 2 Once a week 3 Daily or almost daily 4

[Get the answer first!]Did you have any problem understanding this question?Did you have any problem answering the question?How did you answer this question? What did you think about?

Please remember the occasion when you consumed the greatest amount of alcohol in the last three months. Describe what kind of alcohol and the beverages you consumed.

Two additional AUDIT questions from questions 4–10

[Then two of the additional AUDIT questions selected from a predefined list (so each question is answered by at least 10 of the 50 interviewees). Use one of the translations that has some empirical validation.] [Get the answer first!]Did you have any problem understanding this question?Did you have any problem answering the question?How did you answer this question? What did you think about?

35

Alternative show card of the conversion table using black-and-white pictograms and pictures, back- translated from Russian (tested on N = 9 patients from the primary health-care setting).

How many alcoholic drinks (standard drinks) do you drink on a typical day when you drink? A standard drink (SD) contains 10 g of ethyl alcohol. To determine how many standard drinks you have, please use the table. If on a typical day you drink several different alcoholic beverages, then you can choose different options from the table.

Small glass of wine or sparkling wine,

100 mlAlcohol volume 13%

Half a glass of regular beer,

250 mlAlcohol volume 5%

Glass of fortified wine,

60 mlAlcohol volume 20%

Small shot of spirits,

30 mlAlcohol volume 40%

0 1–2 SDs 50–249 ml 150–699 ml 15–149 ml 30–74 ml

1 3–4 SDs 250–449 ml 700 ml–1.3 litre 150–269 ml 75–134 ml

2 5–6 SDs 450–649 ml 1.4–1.8 litre 270–389 ml 135–194 ml

3 7–9 SDs 650–949 ml 1.9–2.6 litre 390–569 ml 195–284 ml

4 10 SDs or more 950 ml or more 2.7 litre or more 570 ml or more 285 ml or more

How many alcoholic drinks (standard drinks) do you drink on a typical day when you drink? A standard drink (SD) contains 10 g of ethyl alcohol. To determine how many standard drinks you have, please use the table. If on a typical day you drink several different alcoholic beverages, then you can choose different options from the table.

Small glass of wine or sparkling wine,

100 mlAlcohol volume 13%

Half a glass of regular beer,

250 mlAlcohol volume 5%

Glass of fortified wine,

60 mlAlcohol volume 20%

Small shot of spirits,

30 mlAlcohol volume 40%

0 1–2 SDs 50–249 ml 150–699 ml 15–149 ml 30–74 ml

1 3–4 SDs 250–449 ml 700 ml–1.3 litre 150–269 ml 75–134 ml

2 5–6 SDs 450–649 ml 1.4–1.8 litre 270–389 ml 135–194 ml

3 7–9 SDs 650–949 ml 1.9–2.6 litre 390–569 ml 195–284 ml

4 10 SDs or more 950 ml or more 2.7 litre or more 570 ml or more 285 ml or more

36

ANNEX 4. POWER CALCULATIONS FOR THE VALIDATION STUDY

2 See Hanley JA, McNeil BJ. The meaning and use of the area under a receiver operating characteristic (ROC) curve. Radiology. 1982;143(1):29–36. doi:10.1148/radiology.143.1.7063747 and Kryzanowski WJ, Hand DJ. ROC curves for continuous data. Boca Raton (FL): Chapman & Hall/CRC Press; 2009.

Power analysis and sample size estimation were carried out to determine the sample size needed for the study. Estimating the required sample size in advance is an important step to take before carrying out the study because a sample size that is too small will yield results that are unreliable, while a sample size that is too large will use up too many resources, often with only minimal gains.In the following, confidence intervals (CIs) for the area under the receiver operating characteristic (ROC) curve (AUC) for different sample sizes were calculated (Table A4.1).2 The table highlights that a sample size of 888 patients will enable us to de-termine an AUC of 70% with a 95% confidence level within an error margin +/− 5%.

Table A4.1. Numeric results for two-sided CI for ROC curve’s AUC

Confidence

TotalN

Ratio ofsubjects

R

Numberpositive

N1

Numbernegative

N2

SampleAUC

CI width

UCL–LCL

Lower confidence

limit(LCL)

Upper confidencelimit (UCL)

0.95 632 3 158 474 0.7 0.1 0.65 0.75

0.95 888 5 148 740 0.7 0.1 0.65 0.75

0.95 1551 10 141 1410 0.7 0.1 0.65 0.75

0.95 496 3 124 372 0.8 0.1 0.75 0.85

0.95 708 5 118 590 0.8 0.1 0.75 0.85

0.95 1254 10 114 1140 0.8 0.1 0.75 0.85

0.95 280 3 70 210 0.9 0.1 0.85 0.95

0.95 414 5 69 345 0.9 0.1 0.85 0.95

0.95 737 10 67 670 0.9 0.1 0.85 0.95

DefinitionsConfidence level is the proportion of CIs (constructed with this same confidence level, sample size, etc.) that would contain the true coefficient alpha.N is the total number of subjects sampled.N1 is the number of subjects sampled from the “positive” group.N2 is the number of subjects sampled from the “negative” group.R is N2/N1, so that N2 = R x N1.Sample AUC is the anticipated value of the sample area under the ROC curve.CI width (UCL–LCL) is the width of the CI. It is the distance from the lower limit to the upper limit.Lower and upper confidence limits are the actual limits that would result from a dataset with these statistics. They may not be exactly equal to the specified values because of the discrete nature of N1 and N2.

37

Additionally, a dropout-inflated sample size was calculated so that the sample size could be adjusted for anticipated dropouts during the course of the validation study (Table A4.2).

Table A4.2. Dropout-inflated sample size

DefinitionsDropout rate (DR) is the percentage of subjects (or items) that are expected to be lost at random during the course of the study and for whom no response data will be collected (that is, will be treated as “missing”).N1, N2 and N are the evaluable sample sizes at which the CI is computed. If N1 and N2 subjects are evaluated out of the N1’ and N2’ subjects that are enrolled in the study, the design will achieve the stated CI.N1’, N2’ and N’ are the number of subjects that should be enrolled in the study in order to end up with N1, N2 and N evaluable subjects, based on the assumed DR. After solving for N1 and N2, N1’ and N2’ are calculated by inflating N1 and N2 using the formulas N1’ =  N1/(1 – DR) and N2’ = N2/(1 – DR), with N1’ and N2’ always rounded up.D1, D2 and D are the expected numbers of dropouts. D1 = N1’ – N1, D2 = N2’ – N2, and D = D1 + D2.

Dropout rate

Sample size Dropout-inflated enrolment sample size

Expected number of dropouts

N1 N2 N N1’ N2’ N’ D1 D2 D

20% 158 474 632 198 593 791 40 119 159

20% 148 740 888 185 925 1110 37 185 222

20% 141 1410 1551 177 1763 1940 36 353 389

20% 124 372 496 155 465 620 31 93 124

20% 118 590 708 148 738 886 30 148 178

20% 114 1140 1254 143 1425 1568 29 285 314

20% 70 210 280 88 263 351 18 53 71

20% 69 345 414 87 432 519 18 87 105

20% 67 670 737 84 838 922 17 168 185

38

ANNEX 5. THE CONSTRUCTED AND ADAPTED RUS-AUDIT AS USED IN THE QUESTIONNAIRE FORM IN THE MAIN VALIDATION STUDY (BACK-TRANSLATED FROM RUSSIAN)

1. How often do you drink alcoholic beverages? audit 1

Never0

Once a month or less 1

2–4 times a month 2

2–3 times a week 3

4 times a week or more 4

Difficult to answer 97

Refuse to answer98

[Interviewer – Specify how much alcohol the respondent consumes. Use the table below to convert volumes of alcoholic beverages into SDs. Indicate the number of SDs and record the scores.]

Wine or sparkling wine Beer Fortified wine Strong alcohol

Up to 250 ml Up to 650 ml Up to 170 ml Up to 80 ml 1–2 SDs 0

251–450 ml 651–1200 ml 171–300 ml 81–140 ml 3–4 SDs 1

451–660 ml 1201–1750 ml 301–430 ml 141–210 ml 5–6 SDs 2

661–970 ml 1751–2500 ml 431–640 ml 211–300 ml 7–9 SDs 3

More than 970 ml More than 2500 ml More than 640 ml More than 300 ml 10 SDs or more 4

Difficult to answer 97

Refuse to answer 98

2. How many alcoholic drinks (standard drinks) do you drink on a typical day when you drink? A standard drink (SD) contains 10 g of ethyl alcohol. The table shows examples of one SD.If on a typical day you drink several different alcoholic beverages, then add up the number of SDs.[Interviewer – Show a colour chart of the conversion of volumes of alcoholic beverages into SDs.]

audit 2

A small glass of wine or

sparkling wine,100 ml

Alcohol 12–13%

Half a glass of beer,

250 ml

Alcohol 4.5–5%

A glass of fortified wine,

60 mlAlcohol 16–22%

A small glass of strong alcohol,

30 mlAlcohol 40%

3. How often do you consume at least 1.5 litre of beer, or at least 180 ml of strong alcohol, or at least a bottle of wine or champagne (750 ml) within 24 hours? audit 3

Never 0

Less than once a month 1

Monthly 2

Weekly 3

Daily or almost daily 4

Difficult to answer 97

Refuse to answer 98

auditcom3Comments:

4. How often in the past 12 months have you been unable to stop drinking alcohol once you have started to drink? audit 4

Never 0

Less than once a month 1

Monthly 2

Weekly 3

Daily or almost daily 4

Difficult to answer 97

Refuse to answer 98

39

5. How often over the past 12 months did you not do what was normally expected of you because of alcohol? audit 5

Never 0

Less than once a month 1

Monthly 2

Weekly 3

Daily or almost daily 4

Difficult to answer 97

Refuse to answer 98

6. How often over the past 12 months did you need to drink in the morning to recover after drinking the night before (to hangover-drink)? audit 6

Never 0

Less than once a month 1

Monthly 2

Weekly 3

Daily or almost daily 4

Difficult to answer 97

Refuse to answer 98

7. How often in the past 12 months have you felt guilt or regret after drinking? audit 7

Never 0

Less than once a month 1

Monthly 2

Weekly 3

Daily or almost daily 4

Difficult to answer 97

Refuse to answer 98

8. How often over the past 12 months have you been unable to recall what happened the day before because you were drinking? audit 8

Never 0

Less than once a month 1

Monthly 2

Weekly 3

Daily or almost daily 4

Difficult to answer 97

Refuse to answer 98

11.1. Please recall a situation within the last three months when you drank the maximum amount of alcohol. Indicate which types of drink you consumed and in what quantity.

 ml beer (4.5–5%)

 ml wine or sparkling wine (12–13%)

 ml strong alcohol (40%)

Other  ml %

Difficult to answer 97

Refuse to answer 98

audit 11.1 beer

audit 11.1 wine

audit 11.1 strong

audit 11.1 other

audit 11.1 ml

audit 11.1 %

auditprob 11.1

Comments: auditcom 11.1

11.2. How often in the past three months have you drunk so much alcohol that you had a hangover the next day? audit 11.2

Interviewer – Write down the respondent’s quantitative answer in an open form.

Difficult to answer 97 Refuse to answer 98 auditprob 11.2

11.3. How often in the past three months have you had so much to drink that you went to bed without undressing? audit 11.3

Interviewer – Write down the respondent’s quantitative answer in an open form.

Difficult to answer 97 Refuse to answer 98 auditprob 11.3

Indicate total score [without items 11.1, 11.2 and 11.3] The maximum score number is 40. audit.sum

9. Did your drinking cause injury to you or other people? audit 9

Never 0

Yes, more than 12 months ago 2

Yes, during the last 12 months 4

Difficult to answer97

Refuse to answer98

10. Has someone close to you, or a relative, friend or doctor, ever worried about your drinking or advised you to drink less? audit 10

Never 0

Yes, more than 12 months ago 2

Yes, during the last 12 months 4

Difficult to answer97

Refuse to answer98

40

ANNEX 6. THE RUS-AUDIT SHOW CARD AND CONVERSION TABLE AS USED IN THE QUESTIONNAIRE FORM IN THE MAIN VALIDATION STUDY (BACK-TRANSLATED FROM RUSSIAN)

How many alcoholic drinks (standard drinks) do you drink on a typical day when you drink? A standard drink (SD) contains 10 g of ethyl alcohol. The pictures show examples of one SD.

A small glass of wine or sparkling

wine,100 ml

Alcohol 12–13%

Half a glass of beer,

250 ml

Alcohol 4.5–5%

A glass of fortified wine, 60 ml

Alcohol 16–22%

A small glass of strong alcohol,

30 ml

Alcohol 40%

Choose how much alcohol you consume on a typical day. Look at the chosen volume and see how many SDs this corresponds to. If you drink several different alcoholic beverages, then add up the number of SDs.

Wine or sparkling wine Beer Fortified wine Strong alcohol

Up to 250 ml Up to 650 ml Up to 170 ml Up to 80 ml 1–2 SDs

251–450 ml 651–1200 ml 171–300 ml 81–140 ml 3–4 SDs

451–660 ml 1201–1750 ml 301–430 ml 141–210 ml 5–6 SDs

661–970 ml 1751–2500 ml 431–640 ml 211–300 ml 7–9 SDs

More than 970 ml More than 2500 ml More than 640 ml More than 300 ml 10 SDs and more

41

ANNEX 7. OVERVIEW OF TRAINING MODULES AND ACTIVITIES OF INTERVIEWER TRAINING

Time Topics and activities Description of learning activities Materials needed

10 minutes

IntroductionGoal and objectives of the trainingTraining rulesOverview of training programme

Trainers and participants introduce themselves.Trainers explain goals and objectives of the training, discuss and agree on training rules, and provide an overview of the programme.

Training slides

20 minutes

Basic facts on alcohol and continuum of alcohol use Screening and brief intervention (SBI) for alcoholMain ideas of screening

Trainers introduce participants to the basic facts on alcohol and the alcohol use risk pyramid, explain the main ideas behind SBI for alcohol use, and introduce the AUDIT as one of the most frequently used screening instruments.

Training slides, interview manual

20 minutes Overview of the RUS-AUDIT project

Trainers explain the goal and purpose of the validation study and the most important details of sampling and inclusion criteria and sampling quota, and introduce the flowchart of the interview. Recruitment of study participants is explained, as well as data collection procedures, quality control and ethical aspects of the study.

Training slides, interview manual, interview flowchart

10 minutes Questions and discussion

10 minutes Break

30 minutesBasic introduction of the interview as a method and main interviewing techniques

Trainers introduce the interview as a method. The most common dos and don’ts of interviewing are discussed, based on examples, including the role of the interviewer and the most common biases. The main interviewing techniques are introduced.

Training slides, interview manual

42

Time Topics and activities Description of learning activities Materials needed

20 minutesOverview of the instrumentsDetailed explanation of the sociodemographic form

Trainers introduce the main tally sheet and the first section of the main indicators and the sociodemographic form.

Training slides, interview manual, tally sheet, interview flowchart

10 minutes Questions and discussion

40 minutes Break

40 minutes

Detailed explanation of the RUS-AUDIT form and role playExercises to calculate standard drinks with the show card

Trainers introduce and explain the RUS-AUDIT form and the show card with standard drinks. Participants learn to transform drinking volumes into standard drinks and scores with the help of the show card.

Training slides and interview manual, tally sheet, show card, role play materials

10 minutes Questions and discussion

15 minutesDetailed explanation of the unrecorded alcohol form and role play

Trainers introduce the form on unrecorded alcohol consumption and explain the differences in subtypes of unrecorded alcohol and supervise a role play.

Training slides, interview manual, tally sheet

15 minutes Detailed explanation of the K10 form and role play

Trainers introduce the K10 and supervise a role play.

Training slides, interview manual, tally sheet

15 minutesDetailed explanation of the CIDI module for alcohol use disorders (AUDs) and role play

Trainers introduce the AUDs CIDI module and supervise a role play.

Training slides, interview manual, tally sheet

10 minutes Questions and discussion

10 minutes Break

15 minutes Explanation of the interviewer journal

Trainers introduce the interviewer journal and explain how to monitor quotas and generate unique interview codes for each participant.

Training slides, interview manual, interview journal, tally sheet, interview flowchart

40–60 minutesRole plays and practical skills developmentAssessment and feedback

Role plays in groups (participant, interviewer and observer) fol-lowing the interview script. Indi-vidual assessment and feedback for each training participant and final evaluation.

Interview manual, tally sheet, show card, role play materials, feedback and assessment sheet

20 minutes Open questions and discussion

Trainers summarize the results of the training and discuss logistical details of data collection with the interviewers and coordinators.

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