Efficacy of cursory intervention for drug misuse in primary intendance facilities: systematic review and meta-analysis protocol

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  1. http://orcid.org/0000-0002-4269-4800Ethan Sahkeri,2,
  2. http://orcid.org/0000-0002-5358-5263Masatsugu Sakata1,
  3. Rie Toyomoto1,
  4. Chiyoung Hwang1,iii,
  5. Kazufumi Yoshidaone,
  6. Yan Luo1,
  7. Norio Watanabeane,
  8. Toshi A Furukawa1
  1. 1 Section of Health Promotion and Homo Behavior, Graduate School of Medicine, School of Public Wellness, Kyoto University, Kyoto, Japan
  2. 2 Nihon Lodge for the Promotion of Science (JSPS), Overseas Fellowship Segmentation, Kojimachi, Chiyoda-ku, Tokyo, Japan
  3. three Nippon Guild for the Promotion of Science (JSPS), Research Fellowship Division, Kojimachi, Chiyoda-ku, Tokyo, Nihon
  1. Correspondence to Dr Ethan Sahker; sahker.ethan.2e{at}kyoto-u.ac.jp

Abstruse

Introduction Drug misuse is associated with significant global morbidity, bloodshed, economic costs and social costs. Many master care facilities have integrated drug misuse screening and brief intervention (BI) into their usual intendance delivery. However, the efficacy of BI for drug misuse in primary care has not been substantiated through meta-assay. The aim of this systematic review and meta-assay is to decide the efficacy of BI for drug misuse in primary care settings.

Methods and assay We will include all randomised controlled trials comparison primary care-delivered BI for drug misuse with no intervention or minimal screening/assessment and usual care. Primary outcomes are (i) drug use frequency scores and (2) severity scores at intermediate follow-up (4–8 months). We will call back all studies through searches in Central, Embase, MEDLINE and PsycINFO until 31 May 2020. The reference list will be supplemented with searches in trial registries (eg, world wide web.clinicaltrials.gov) and through relevant existing study reference lists identified in the literature. Nosotros volition bear a random-upshot pairwise meta-analysis for main and secondary outcomes. Nosotros will assess statistical heterogeneity though visual inspection of a forest plot and calculate I 2 statistics. We will assess risk of bias using the Cochrane Take chances of Bias Tool Five.2 and evaluate the certainty of evidence through the Grading of Recommendations Cess, Development and Evaluation (GRADE) arroyo. Sensitivity analyses volition account for studies with control grouping variations and studies with a loftier take a chance of bias. If heterogeneity is present, subgroup analyses volition consider patient variables of age, sex activity/gender, race/ethnicity, per cent insured, baseline severity and primary drug misused.

Ideals and broadcasting This study will use published aggregate information and volition non require upstanding approval. Findings will be disseminated in a peer-reviewed journal.

  • substance misuse
  • primary care
  • mental health

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  • substance misuse
  • primary care
  • mental health

Strengths and limitations of this written report

  • Our systematic review and meta-analysis will be the kickoff to examine the efficacy of brief intervention (BI) for drug misuse in principal intendance.

  • This study will investigate the efficacy of BI for drug employ frequency and severity at multiple time points.

  • Limitations of private studies volition be judged with the revised Cochrane Risk of Bias Tool V.2.

  • This study will not investigate treatment referral and is limited to screening and BI in master care.

  • Significant heterogeneity will exist assessed through subgroup analyses past prespecified patient characteristics.

Background

Drug misuse is associated with significant global morbidity, mortality, economical costs and social costs.1 Drug misuse is defined by hazardous use of whatsoever non-alcohol-related drug (eg, cannabis, opioids and stimulants) beyond legal and medical guidelines.2 Drug misuse may increment the chance of harmful consequences in mental, concrete and social domains, regardless of any diagnosed substance utilise disorder (SUD).1 Additionally, drug misuse may signal a need for treatment as part of a diagnosable SUD characterised past risky use, dumb control, social damage, tolerance or withdrawal for a specific substance.3 In 2017, it was estimated that globally, about 5% of adults report illicit drug use and 0.four% fit criteria for a drug-related SUD.i Nonetheless, only nigh x% of people with an SUD receive treatment.4 5 About patients who receive specialised SUD treatment are referred through criminal justice or cocky-referral sources,6 which means that 10% who receive handling are likely to be highly motivated or compelled to change. This leaves a 90% disparity known as the treatment gap. The treatment gap led to using main care facilities as a method of identifying those who may benefit from handling.

Those who demonstrate drug misuse are likely to present in primary care facilities, are more probable to be admitted and take college odds of substance-related health complications than those who practise not misuse drugs.7 viii However, healthcare professionals historically demonstrate some of the everyman referral rates to SUD treatment.9 ten Ideally, drug misuse would exist universally screened and treated in primary care facilities. While drug misuse screenings have improved, follow-upwardly interventions may notwithstanding be defective. For example, a good 75% of those who see a healthcare provider report existence screened for alcohol use.11 Unfortunately, when patients practise report substance misuse, providers rarely follow-upward with communication (twenty%) or SUD treatment referral (7%).11

The current trend of SUD and intervention research focuses on preparation programmes, counselling and motivational interviewing (MI).12 To accost the SUD treatment gap and referral inconsistency in primary intendance, the Substance Corruption and Mental Health Services (SAMHSA) developed and funded a large-scale program called screening, brief intervention and referral to handling (SBIRT).13 SBIRT identifies patients in primary care who would not usually seek treatment, provides a brusk motivational intervention and, if needed, refers to exterior specialty treatments. Many resources, including millions of dollars and healthcare professional fourth dimension, have been invested on research and service implementation of SBIRT programmes across the earth.xiv xv Cost analysis suggests information technology is worth the price to initiate patient change behaviours.16 However, the significant bodies of enquiry investigating SBIRT findings accept been mixed, with supportive findings for booze misuse, simply lacking evidence for drug misuse.13 17–nineteen Additionally, there is insufficient evidence to back up the efficacy of the SBIRT referral to treatment component due to poor referral follow-ups.20 The incongruent evidence for substance misuse outcomes and lack of evidence for referral efficacy is idea to exist due to issues in data drove, intervention facilitation uniformity and site biases.21 These mixed SBIRT findings suggest focused investigations of the brief intervention (BI) component for drug misuse are required.19 22

Many main care facilities have integrated drug misuse screening and BI into their usual intendance delivery; both SAMHSA-related SBIRT and non-SBIRT programmes. Because many people visit primary care facilities regularly, they are an optimal setting to screen for drug misuse and to follow upwards with BI on site. BI in primary care targets patients who otherwise may non seek handling. Notwithstanding, the efficacy of BI for drug misuse was not well substantiated prior to a major SAMHSA-funded BI program deployment in 2004 and remains unclear over 15 years afterwards its inception.23 A systematic review and meta-analysis is necessary to decide BI efficacy for drug misuse in primary intendance.

Brief intervention

BI consists of one to five individual sessions lasting 5–60 min each for low to moderate misuse, commonly conducted on site as presently as possible.24 A meta-assay showed the median BI length is 25 min.25 Extended BIs may include boosted sessions or a follow-upwards telephone phone call of five–thirty min ('booster') to improve motivation after discharge from primary intendance.18 26 A meta-analysis showed the median extended BI length is 100 min over multiple sessions.25 BI can be conducted by physicians, comedical professionals, trained laypersons and through figurer programmes. BI is undergirded by a significant number of efficacy and effectiveness studies for alcohol utilize in many master intendance facilities.21

BI was developed out of social, cognitive and behavioural approaches to psychotherapy.26 In a systematic review and meta-analysis of BI for alcohol misuse, Kaner and colleagues26 outlined key BI components to include (one) feedback about personal employ and damage, (two) risks of connected utilise, (3) benefits of reducing one'southward use, (4) advice on how to reduce one's use, (five) motivational enhancement and (vi) developing a plan to reduce utilise. BI is grounded in the transtheoretical model of modify.27 BI uses the FRAMES approach: feedback, responsibleness to change, communication, menu of treatment options, empathy and supporting of cocky-efficacy.18 23 26 28 In improver, BI relies heavily on MI29 and motivational enhancement therapy (MET),30 which are directive, client-centred and aimed at resolving ambivalence through provider feedback to elicit behaviour modify. MI and MET are both evidence-based treatments for SUDs with potent research back up.31

BI in primary care works by first identifying drug misuse through screening. Patients present to primary intendance facilities seeking medical care. Patients are screened equally office of access/sign-in procedures. If unhealthy substance use is reported, further assessment determines the appropriate level of care, either no treatment, BI or referral to outside specialty treatment. Screenings may consist of a simple prescreen to determine any drug use. If positive, a formal screening would be activated. For example, some programmes use the drug abuse screening test (DAST)32 33 to screen for drug misuse. The National Plant on Drug Abuse34 outlined the DAST-10 every bit scored from 0 to 10 and divided into zones indicating appropriate intervention levels. Scores from 0 to 2 suggest no/depression level problems and may indicate monitoring, feedback or no treatment. Scores of 3–eight, moderate/substantial bug, advise farther assessment and BI may be indicated. Scores of ix–10, severe bug, suggest intensive assessment and may betoken referral to specialty treatment providers.

Gap in the noesis

BI in primary care is well documented to exist effective, but just for reducing alcohol use frequency and severity.eighteen 26 28 35 Screening and BI for alcohol have been given a B Class recommendation from the Us Preventive Services Chore Forcefulness.36 Additionally, alcohol findings may not generalise to the treatment of other drug misuse. Evidence from BI for drug misuse studies remains equivocal.17 18 22 23 28 35 37 38 For instance, a multisite observational report reported pregnant reductions in drug use outcomes.eighteen Conversely, the Us Preventive Services Task Force concluded there was insufficient evidence to assess the risks and benefits of master care screening or BI for drug misuse.39 However, no meta-analyses have been conducted. Furthermore, patient variables such as sex,18 age40 and chief trouble substance41 42 moderate drug utilise outcomes take not been evaluated in a systematic manner. In response to a call for further research into drug misuse BI,22 43 several randomised controlled trials (RCTs) accept been completed in the past x years, and a meta-analysis would now aid to determine BI efficacy in principal care.

Present study

This written report aimed to address the gap in the research base by investigating the efficacy of BI for drug misuse frequency and severity in primary intendance settings through a pairwise systematic review and meta-analysis. Findings will assist to determine if the use of BI for drug misuse in primary care is warranted or if changes to treatment protocols are needed. We aimed to evaluate the overall efficacy of BI compared with no intervention through (1) drug use frequency at intermediate follow-up (4–8 months) and (two) drug apply severity at intermediate follow-upwardly (iv–8 months). Secondary outcomes nether investigation aimed to discover BI efficacy in terms of frequency and severity at short-term follow-up (<4 months) and long-term follow-up (>8 months). Additionally, event comparisons past patient characteristics volition be assessed for age, sex activity/gender, race/ethnicity, insurance and primary trouble drug.

Methods

We submitted this study protocol to PROSPERO (CRD42020157733). Methods for this systematic review and pairwise meta-assay follow the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols.44

Criteria for considering studies

Types of studies

Studies volition be limited to RCTs, including cluster randomised trials, comparing BI with control conditions. Control conditions may be considered usual intendance, no intervention, minimal screening/assessment or informational pamphlets on drug utilize. Quasi-randomised trials, RCTs without control conditions and implementation studies only investigating provider adherence or cost effectiveness will be excluded.

Participants

Participants in the study include people presenting in primary care facilities for concrete health concerns who are screened for and report drug misuse. Drug misuse includes legal cannabis, illicit substances, over-the-counter drugs and prescription drugs. Booze misuse volition not be included. No restrictions volition be made in terms of historic period, sex/gender or country.

Intervention

We aimed to include BI studies with a range of one to 5 sessions, with each session lasting from 5 to lx min. The intervention may be composed of any one treatment or a combination of the following delivery modalities: in-person, telephone, mailed letter or figurer. The intervention may be facilitated by whatsoever healthcare provider of any education level.

Comparators

We volition include 'no intervention' controls consisting of minimal screening/assessment only. No intervention may besides be referred to equally usual care and may include drug screening and an information pamphlet about drug misuse and self-assist resource. Comparators that include more than screening/assessments needed for written report inclusion and randomisation, or an data pamphlet, will exist included in the main analysis merely excluded in a sensitivity analysis.

Outcomes

Our outcomes are past 30 days' drug use frequency or severity. Primary outcomes are (1) drug employ frequency and (2) severity at intermediate follow-up (four–8 months). Secondary outcomes are (one) frequency and (ii) severity at short-term follow-upwardly (<iv months) and (3) frequency and (4) severity at long-term follow-up (>8 months). If studies use multiple severity measures, we will prioritise based on the majority to accept a more than congruent effect. This will not be necessary for frequency, which is a count of days in the past month, and different measures are on the same metric. Typically, studies report follow-ups in intervals of three, 6, 9 or 12 months. If a report reports two split follow-ups that both fall within our intermediate range (ie, 4 and 6 months), we will prioritise the follow-up closest to the midpoint (ie, half dozen months).

Outcomes include

  • Frequency (count)—Frequency is measured as the number of days in the past calendar month the primary problem substance was used. Multiple instruments may exist appropriate for analysis and will include but will not exist limited to the timeline followback (TLFB)45 and the Addiction Severity Index (ASI)-Lite Frequency Score.46

  • Severity (continuous)—Severity is measured as a blended score which accounts for by xxx days' utilize frequency and includes measures of cravings, withdrawal and drug use consequences in physical, psychological, social and vocational domains. Once again, multiple instruments may be advisable for analysis and will include, simply will not be limited to, the Alcohol, Smoking and Substance Involvement Screening Test (Aid)47 and the ASI46 blended scores.

Setting

Post-obit previous inquiry, primary intendance is divers as immediately accessible and general care to a broad range of health concerns in the community or hospital settings.25 26 Examples include emergency departments, family practice, women'south health clinics and community clinics.

Search strategy

Nosotros will search studies in Key, Embase, MEDLINE and PsycINFO until 31 May 2020. The preliminary search strategy for MEDLINE (see online supplementary appendix 1) will be adapted for other database terms. Searches will exist supplemented with trial registries (eg, www.clinicaltrials.gov) and through relevant existing literature review and RCT reference lists. Nosotros volition not place any restrictions on language, date, certificate type or publication status for inclusion. We volition apply keywords drug misuse, intervention, setting and study method. A database search professional will be enlisted and consulted for the initial search. We will evaluate similar systematic and not-systematic reviews to find potentially eligible trials. Search queries, dates and identified records volition exist made available in the online supplementary appendix ane and will exist represented in a Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) flowchart.

Supplemental cloth

Study option

Reviewers will independently examine titles and abstracts of studies identified in the initial search. Irrelevant or indistinguishable reports will be removed. Reviewers will so meet to form a consensus on study inclusions. Next, we will obtain full texts of potentially relevant articles. Teams will independently appraise each paper for inclusion per criteria, then consensus will be fabricated on conflicting assessments. Coauthors not involved in choice will supervise and course final judgements if consensus cannot be fabricated. If it is however not possible to determine written report eligibility, study authors will be contacted for further information. We will report the inter-rater reliability for study inclusion. Multiple published papers related to the aforementioned study will exist collated and included in the report. The study selection process volition be recorded in item to produce a PRISMA flowchart.

Data extraction

Reviewers will independently summarise the study details to include methods, participants, interventions, referral information, comparator interventions, handling outcomes, dropouts and potential biases using a standardised information extraction form. We volition develop and pilot the information extraction course for this review. For inconsistencies, review teams will discuss lacking information. Two senior researchers will provide mediation for reporting discrepancies. Information will be entered into Review Manager V.5 software and all authors will independently bank check entries for inconsistencies.

Assessment of chance of bias in included studies

2 review authors will independently assess the gamble of bias for each study using the Cochrane Chance of Bias Tool V.ii (RoB 2).48 Risk of bias will be rated for each domain at three levels: high, low and unclear. Evidence will be provided by means of a quotation exemplar. Evidence and justification for judgement of gamble of bias will exist presented in a table. Studies providing few or no details virtually randomisation or blinding will be contacted for clarification. We will evaluate studies providing outcomes on bias due to randomisation process, deviations from intended interventions, missing outcomes, measurement of result and pick of reported results.48 We volition report the inter-rater reliability for assessment of bias.

Report classification per RoB 248 are as follows:

  • Low run a risk of bias: All domains are rated at low risk of bias.

  • Some concerns: At to the lowest degree one domain is rated as apropos, and no domain is rated at high chance of bias.

  • High risk of bias: At least one domain is rated to be at high chance of bias, or multiple domains are concerning.

Measures of treatment consequence

Information synthesis

For studies assessing drug apply frequency on the aforementioned outcome metric (eg, days used per TLFB or ASI), we will summate the mean difference (MD) with 95% CIs. Because dissimilar instruments measure the same count metric, they can be combined and compared with MD. For studies assessing drug use severity using different outcome measures (eg, severity per ASI or ASSIST), we will summate the standardised Medico with 95% CIs. The SMD is interpreted as small effect (0.2), moderate consequence (0.5) and large effect (0.eight).49 ASI and ASSIST accept been shown to accept strong concurrent validity (r=0.73–0.82, p<0.001) for derived composite severity scores.50–52 Studies with more than than ii treatment arms can cause problems in pairwise meta-analysis. When multiple arms are reported in a single study, we will include simply relevant arms. If two treatment arms are relevant, the control will be split and compared with each arm separately.48 53

We will analyse results from cluster RCTs48 by taking account of intracluster correlation coefficients (ICCs). When the ICC is not reported, we will contact the authors. If the ICC is unavailable, we will utilise comparable study estimates as a correction, in accordance with the Cochrane Handbook for Systematic Review of Interventions.48 In cluster RCTs, nosotros will extract data that account for the clustering. If the trial accounted for cluster level effects by using multilevel modelling or generalised estimating equations, nosotros will directly extract the information. If the study has non statistically accounted for cluster effects, we will use the generic inverse variance arroyo. The inverse variance approach weights studies to business relationship for small samples, such as when studies are cluster randomised.54 Cluster analysis decisions volition be made based on the number of clusters, outcome information bookkeeping for cluster pattern and ICC past boilerplate cluster size.55

If data are missing, we will contact written report authors to request the data where needed. We volition endeavour to use data from intention-to-care for (ITT) analyses. We will present ITT analyses for all primary outcomes using information corrected by mixed-outcome models for repeated measures. If studies imputed missing data using final observation carried forward (LOCF), nosotros will include them in the primary meta-analysis but will exclude them during the sensitivity analysis due to uncertainty of reliability in LOCF methods.

Statistical heterogeneity

Given the potential heterogeneity between studies, we volition conduct a random-effect pairwise meta-assay for all analyses. A random-result model assumes that the furnishings are different merely sampled from a related representation of a larger population distribution, improving generalisability.48 56 We will assess statistical heterogeneity using CIs for individual trials visually represented in a forest plot. Nosotros will summate the I two statistic with the suggested interpretation: 0%–40% may not be important; 30%–60% moderate heterogeneity; 50%–90% substantial heterogeneity; 75%–100% considerable heterogeneity.54 I 2 heterogeneity intervals overlap to allow for subjective conclusion-making that accounts for (ane) outcome magnitude and direction, (two) strength of prove (ie, p value size) and (iii) detection of significant simply very modest effects in highly powered studies.54

Assessment of reporting biases

If the analysis contains 10 or more studies, data from included RCTs will exist represented in a funnel plot to appraise disproportion. We will consider possible reasons of funnel plot asymmetry, including publication bias.

Sensitivity analysis

Nosotros will conduct sensitivity analyses to examine results robustness from chief analyses. We volition assess the effects of excluding studies with, and controls receiving more than usual care, studies using LOCF and studies with a high take a chance of bias in the areas of randomisation procedure, deviations from intended interventions, missing outcomes, measurement of outcome and selection of reported results.

Subgroup analyses

We volition conduct subgroup analyses to examine differences betwixt subsets of the population of involvement and to sympathize heterogeneity. We will assess differences based on the following patient and trial characteristics: age, sexual practice/gender, race/ethnicity, per cent insured, baseline severity and primary drug misused.

Patient and public involvement

No patient was involved in the protocol evolution nor will be involved in the review.

Ideals and dissemination

This study uses published amass data and does not require ethical approval. Findings volition exist disseminated in a peer-reviewed journal.

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