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Risk factors for addiction among patients receiving prescribed opioids: a systematic review protocol Cragg, Amber; Hau, Jeffrey P; Woo, Stephanie A; Liu, Christine; Doyle-Waters, Mary M; Hohl, Corinne M Dec 28, 2017

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PROTOCOL Open AccessRisk factors for addiction among patientsreceiving prescribed opioids: a systematicreview protocolAmber Cragg1, Jeffrey P. Hau1, Stephanie A. Woo2, Christine Liu3, Mary M. Doyle-Waters4 and Corinne M. Hohl1,2,5*AbstractBackground: Opioid addiction prevention has become an urgent public health priority, with several countries declaringa state of emergency due to rising death tolls from opioid abuse. Reducing the risk of developing addiction amongopioid-naïve patients exposed to prescribed opioids during the process of medical care may be an important primaryprevention strategy. Our objective is to synthesize the available evidence about factors associated with the developmentof addiction among patients first exposed to prescribed opioids, with a focus on opioid-naïve patients.Methods: We will perform a systematic search of MEDLINE, Embase, Cochrane Central Register of Controlled Trials, andother databases in collaboration with a health information specialist using a comprehensive search strategy. We will alsosupplement our search with a scan of the grey literature to identify relevant ongoing and unpublished studies. We willinclude studies reporting on risk factors for opioid addiction in patients prescribed opioid analgesic therapy through aprescription from a licensed medical professional, with a focus on opioid-naïve patients. We will exclude studies focusingon patients who are first exposed to illicit opioids, those who use prescription opioids for cancer pain, and/or who arepalliative. Two reviewers will independently review titles, abstracts, and full texts for inclusion and exclusion criteria. Theywill then extract data from included full texts using standardized piloted data extraction forms and assess study qualitythrough risk of bias assessment. We will synthesize the effect sizes of risk factors derived from clinically homogenousstudies with similar designs and the remaining ones qualitatively.Discussion: Understanding risk factors for opioid addiction among patients who require analgesia has the potential toinform clinical care and opioid prescribing guidelines aiming to reduce opioid addiction. We will also use this informationas a starting point for developing interventions for primary prevention.Keywords: Medication safety, Opioid addiction, Risk factors, Opioid-naïve, Opioid prescribing, Opioid dependence,Opioid use disorder, Systematic review, ProtocolBackgroundIntroductionPrescription opioids have made pain associated withotherwise debilitating medical conditions treatable.Unfortunately, the medical use of opioids can lead toaddiction, dependence, or non-medical use. Addictionis characterized by a strong desire to take the drug,difficulties in controlling its use, persisting in its usedespite harmful consequences, a higher priority given todrug use than to other activities and obligations, increasedtolerance, and sometimes a physical withdrawal state [1–3].Addiction to prescription opioids is associated withtransition to illicit opioid use like heroin [4], greaterhealth services utilization [5, 6], and increased mortality[1, 7]. Illicit drug users are more likely to experiencesocial isolation [8], incarceration and criminalization[9], homelessness [10], disability or unemployment [7],mental health illness, and acute and chronic infections[7, 11]. Opioid addiction prevention has become anurgent public health priority internationally, as theUSA and Canada have experienced sharply rising deathtolls from opioid overdoses [12, 13].* Correspondence: chohl@mail.ubc.ca1Department of Emergency Medicine, University of British Columbia, 855West 12th Avenue, Vancouver, BC V5Z 1M9, Canada2Vancouver General Hospital, 855 West 12th Avenue, Vancouver, BC V5Z1M9, CanadaFull list of author information is available at the end of the article© The Author(s). 2017 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, andreproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link tothe Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver(http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.Cragg et al. Systematic Reviews  (2017) 6:265 DOI 10.1186/s13643-017-0642-0While policies to promote responsible opioid prescribinghave been implemented across North America to preventinappropriate use at the population-level [14, 15], opioidscontinue to be the mainstay of treatment for acutely pain-ful medical and surgical conditions, such as fractures, orrenal or biliary colic. Preventing opioid prescribing amongopioid-naïve patients who are at high-risk of addictionto prevent their development of tolerance and transi-tion into to long-term use and abuse may be helpful inprimary prevention at the population-level. This couldbe done by prioritizing high-risk patients for regionalanesthetic or other procedures to treat painful conditionsfor which wait times are usually lengthy, or by using alter-native agents more aggressively in the acute setting (e.g.,non-steroidal anti-inflammatories, ketamine). To identifyhigh-risk patients to avoid or minimize the use of opioidsin these patients, we must identify risk factors for subse-quent addiction prior to patients’ initial exposure.Two systematic reviews published before 2008 inves-tigated the proportion and predictors of opioid misuseamong chronic pain patients [16, 17]. One study foundbetween 3.3–14.5% of long-term prescription-opioidusers became addicted after an average exposure timeof 22.1 months, indicating that the duration of opioidexposure was an important factor in the developmentof addiction [16]. In the other review, risk factors wereinconsistently measured across studies and demonstratedmixed effects as predictors [17]. The latter study did notfocus on opioid-naïve patients in whom risk factors maybe different, and for whom primary prevention strategiesneed to be developed to prevent addiction [17].ObjectivesOur main objective is to synthesize the available evidenceabout patient-, provider-, medication-, and system-levelrisk factors, as well as protective factors, for the develop-ment of opioid addiction among patients exposed to pre-scribed opioids, with a focus on opioid-naïve patients. Wewill focus on risk factors that are observable at the point-of-care and modifiable, in order to inform clinical careand the development of primary prevention strategies.Specific objectives are to synthesize the availableevidence on:1. Patient-, provider-, medication-, and system-levelrisk factors for the development of opioid addiction,and their effect sizes overall, and in opioid-naïvepatients, to understand factors that potentiate thesubsequent development of addiction2. The characteristics of the clinical indication,prescriber (e.g., practice location, specialty), andprescription (e.g., type of medication, dosage,quantity dispensed, length of exposure) of the initialopioid prescription after which patients developaddiction to understand the clinical context of theopioid exposure3. The effect of varying addiction outcome definitionsat follow-up on the identified risk factors and thestrength of their associationMethodsWe will conduct a systematic review of the literature thatwill adhere to the PRISMA guidelines for the reporting ofsystematic reviews (Additional file 1: Appendix A) [18].Eligibility criteriaWe adapted the Population, Intervention, Comparisonand Outcome (PICO) framework for our systematicreview, as we did not seek to synthesize information onthe effectiveness of interventions. We will use Population,Outcome, Topic, and Study selection (POTS) to describeour study selection criteria (Fig. 1).PopulationWe will include studies in which adults or childrenwere first exposed, or report being first exposed toopioid therapy that was prescribed by a licensed med-ical professional. We will exclude studies in which allincluded patients were first exposed to illicit opioids.Studies with patients prescribed opioids for cancerpain or palliative care will also be excluded, as with-holding analgesia from these patients is deemed un-ethical [19]. If studies do not report these baselinevariables, we will include them, and perform sensitiv-ity analyses on the effect of including these studies’results on our review findings. If studies do not disag-gregate the patient population based on these vari-ables, we will attempt to contact study authors forpatient-level data. If we are unable to access patient-level data, we will exclude studies in which more than50% of patients meet our exclusion criteria, as thesepatients’ risk factors for developing addiction arelikely different from patients first exposed to prescribedopioids. We will exclude studies reporting on patients onopioid receptor agonists used for non-pain indications,such as loperamide and dihydrocodeine.OutcomeOpioid addiction has been defined as any of the followingfeatures: the pronounced craving for the drug, obsessivethinking about the drug, erosion of inhibitory controlefforts to refrain from drug use, and compulsive drugtaking [20]. As of 1964, the WHO has replaced the term“opioid addiction” with “opioid dependence” and definedit as “a cluster of behavioural, cognitive, and physiologicalphenomena that develop after repeated substance use andthat typically include a strong desire to take the drug, diffi-culties in controlling its use, persisting in its use despiteCragg et al. Systematic Reviews  (2017) 6:265 Page 2 of 8harmful consequences, a higher priority given to drug usethan to other activities and obligations, increased toler-ance, and sometimes a physical withdrawal state.”(ICD-10definition) [3, 20, 21]. According to the DSM-5, opioid usedisorder also includes taking the opioid in larger amountsor for longer than intended, not being able to cut down orquit, and spending a lot of time getting, using, or recoveringfrom the use of the substance [20]. We will use the termsopioid addiction, opioid use disorder, and opioiddependence interchangeably and define them as evidenceof any one of the features listed in any of the above def-initions (Additional file 1: Appendix B). We will includestudies that ascertain the outcome opioid use disorder,addiction, or dependence using any method presentedin the literature, including but not limited to clinicalopinion, evidence of aberrant drug-related behavior(ADB) (Fig. 2) [22], urine toxicology screening, and/orenrollment in a rehabilitation program [17].TopicWe will include studies that report on at least one riskfactor for opioid addiction. We define risk factor as anattribute, characteristic, or exposure that increases thelikelihood of developing disease. Such factors will includepatient-, provider-, medication-, and system-level risk fac-tors, including well-known psychosocial and social factors,and will include protective factors (Fig. 3). Recent litera-ture has indicated that previously unknown provider-levelrisk factors, such as the provider’s intensity of opioid pre-scribing, are related to subsequent addiction risk [23].Medication-level factors such as the medication pre-scribed, and system-level risk factors such as the ability todispense opioids in some healthcare settings, may also beassociated with addiction risk. In our analysis, we seek tosynthesize the available information on such factors, whileemphasizing risk factors that are observable by cliniciansat the point-of-care, as well as modifiable in order toFig. 1 Study selection criteriaCragg et al. Systematic Reviews  (2017) 6:265 Page 3 of 8produce information that will be directly relevant to clin-ical care activities and the development of preventativestrategies.Study designWe will include prospective and retrospective observa-tional and experimental studies, including but not limitedto randomized control trials and cross-sectional and case-control studies [24, 25].Search strategyWe will develop a systematic search strategy with a pro-fessional librarian (MDW). We will develop search termsand concepts by examining MeSH subject headings fromsix papers included in a prior systematic review [17].These subject headings and an environmental scan ofthe literature will help us refine our search concepts. Wedeveloped a preliminary search in MEDLINE by com-bining the concepts opioids AND pain AND risk factors(Additional file 1: Appendix B). We will develop add-itional searches by expanding and combining differentsearch concepts, including appropriate subject headingsand keywords as needed. We will adapt searches foradditional databases and will include studies publishedin English, French, and German after 1964, the year thatthe definition of “opioid dependence” was formalized bythe WHO [3, 21].Information sourcesWe will search the following electronic reference data-bases: MEDLINE, Embase, Cochrane Central Registerof Controlled Trials (CENTRAL), Database of Abstracts ofReviews of Effects (DARE) available through Ovid;CINAHL—Cumulative Index to Nursing and Allied HealthLiterature through EBSCO; and the Science Citation Index(Web of Science Core Collection) from Thomson Reuters.We will search social sciences databases includingPsycINFO through EBSCO, Social Sciences CitationIndex (Web of Science Core Collection) from ThomsonReuters, and the Sociology Collection through ProQuest.We will conduct snowballing searches for cited and citingstudies of all papers meeting our inclusion criteria usingthe Web of Science Core Collection and ScienceDirect(Elsevier). We will also hand-search the bibliographies ofrelevant reviews and included studies for other potentialtitles for inclusion. We will search for ongoing studies byreviewing the following trial registries for unpublishedtrials, including the ISRCTN Registry, ClinicalTrials.gov,EU Clinical Trials Register and South African NationalClinical Trials Register, Open Trials, and the Quebec PainRegistry. We will complete a grey literature search foradditional unpublished studies using a combination ofsearch terms and concepts derived from our electronicreference database search using the web search engineGoogle. We will review the top 100 hits for each search toFig. 2 Included aberrant drug-related behaviors (ADB) [21, 23]Cragg et al. Systematic Reviews  (2017) 6:265 Page 4 of 8identify relevant guidelines, reports, plain language publi-cations, and websites of relevant professional associations.We will search for additional unpublished papers in theconference proceedings of the World Congress on Pain(IASP) and the International Conference and Exhibitionon Pain Medicine and by looking through the table ofcontents for all published issues of Pain Medicine, PainResearch & Management, Anesthesia & Analgesia, andthe Journal of Pain and Symptom Management since 1964for relevant titles. We will search the websites of key med-ical associations, addiction, pain agencies (e.g., AmericanSociety of Addiction Medicine, National Institute of DrugAbuse, Chronic Pain Research Alliance), and governmentorganizations (e.g., Centre for Disease Control, HealthCanada) for additional unpublished literature and policypapers. Finally, we will contact study authors and expertsin the field for additional unpublished studies.Data managementWe will create a search report of all searches and theirsources and capture the records of all eligible papersusing RefWorks. We will use unique folders for eachstep of the search process within a common team Ref-Works account (Fig. 4). We will de-duplicate search re-sults using RefWorks and Excel. We will record thereason for exclusion for each record at the full text screen-ing stage (Additional file 1: Appendix C).Fig. 3 Potential risk factor categories [28]Fig. 4 Study flow diagramCragg et al. Systematic Reviews  (2017) 6:265 Page 5 of 8Selection processTwo reviewers will independently review titles andabstracts of all identified references for inclusion andexclusion criteria (Fig. 1). All potentially relevant titlesidentified by either or both reviewers will be movedforward for full-text review (Fig. 4). Two authors willindependently review all potentially relevant full texts forinclusion and exclusion criteria (Fig. 4; Additional file 1:Appendix C). We will resolve disagreements relating tothe inclusion or exclusion of full-text articles throughdiscussion until we achieve consensus. If consensuscannot be reached, a third reviewer will adjudicate.Both reviewers will pilot test the inclusion and exclusioncriteria data collection form on the first 100 search resultsto ensure we adequately describe and consistently applythe criteria (Additional file 1: Appendix C). One authorwill review the Google search result pages to collect rele-vant websites using combinations of the most pertinentsearch terms and will track the search terms, searchengine used, and date of each search.Data collection processTwo reviewers will independently extract relevant datafrom each included study using a standard data extractionform (Additional file 1: Appendix D). We will resolve anydisagreements through discussion until we achieve con-sensus. If consensus cannot be reached, a third reviewerwill adjudicate. Both reviewers will pilot test the datacollection form on the first five included studies(Additional file 1: Appendix D).Data itemsWe will collect information about the study design,methodology, participants, setting, prevalence of opioidaddiction, potential and actual risk factors, timelines,and prevalence of opioid abuse. We will contact studyauthors for any missing information or clarificationsrequired for data synthesis. We will attempt to contactauthors by email a maximum of two times with theemails sent three weeks apart.Risk of bias in individual studiesTwo reviewers will independently appraise each includedstudy for potential sources of bias. We will assess thequality of observational studies using the NICE qualityappraisal checklist for quantitative studies reportingcorrelation and associations (Additional file 1: Appendix E)and the NICE quality appraisal checklist for quantitativeintervention studies (Additional file 1: Appendix F) [26].Randomized control trials will be assessed using theCochrane Risk of Bias Tool. We will assess each studyfor selection, performance, attrition, and reporting bias,and possible conflicts of interest using these tools. Inthe case of disagreement, two reviewers will discusstheir rating until consensus is reached. If consensuscannot be reached, a third reviewer will adjudicate. Wewill perform subgroup analyses by the quality of theprimary studies to assess how study quality affects ouroverall findings.Data synthesisIf we identify two or more clinically homogenous studiesreporting effect sizes of the same outcome measure, wewill synthesize the available information using randomeffects meta-analysis using RevMan5.3. We will reportdata on factors positively and negatively associated withopioid addiction using odds ratios along with their 95%confidence intervals. We will not pool data from studiesof different designs, as their effect size estimates areexpected to vary. We will assess heterogeneity usingthe I statistic [2]. If insufficient studies are found formeta-analysis, or studies are not homogenous, we willsynthesize the data narratively.Sensitivity analysisWe will identify studies enrolling opioid-naïve patientsand conduct a sensitivity analysis to identify their riskfactors and effect size estimates in comparison to allincluded patients. For this purpose, we will defineopioid-naïve patients, according to thresholds outlinedby the Food and Drug Administration, as patients whohave never taken daily opioid medications in excess of60 mg oral morphine/day, 25 μg transdermal fentanyl/hour, 30 mg oral oxycodone/day, 8 mg oral hydromor-phone/day, 25 mg oral oxymorphone/day, or an equianal-gesic dose of another opioid for more than one weekconsecutively [27]. We will also perform sensitivity ana-lyses on the route of first exposure to determine the effectof including studies in which some patients were first ex-posed to illicit opioids, were prescribed opioids for cancerpain, or were palliative. We will also conduct sensitivityanalyses on the length of the initial opioid prescription, theoutcome definition, and method and timing of addictionascertainment.Confidence in cumulative evidenceWe will present results of our meta-analysis using aGRADE summary of findings table, by method ofoutcome ascertainment. This table will present thesummarized effect sizes alongside a score for the qualityof the evidence used to generate that value. We will assignthe quality of evidence scores (or GRADEs) based on thenumber and quality of the component studies and theconsistency and generalizability within them. We willuse funnel plots to assess for publication bias, if wehave more than the necessary ten included studies.Cragg et al. Systematic Reviews  (2017) 6:265 Page 6 of 8DiscussionDissemination of results and publication policyWe will disseminate the results of this project throughtraditional methods, including abstracts to national andinternational meetings, and peer-reviewed papers. Wewill produce patient-friendly summaries in lay languageto disseminate relevant results to the public through ourwebsites, in the bulletins of patient safety organizationsand in the lay press. We will produce briefing notes fordiverse knowledge user groups including healthcaremanagers and decision makers within healthcare institu-tions, patient safety organizations, and government.LimitationsThe main limitation of our proposal is that we will only beable to perform meta-analysis if the risk factors measuredin the primary studies are homogenous across studies. Wewill narratively synthesize all other data. Other limitationsinclude the inclusion of publications in English, French,and German and quantitative publications only.Potential impactUp-to-date information on risk factors for opioid addic-tion among patients receiving opioids has the potential toinform clinical care and opioid prescribing guidelines, andencourage the derivation and validation of screening toolsto identify risk of addiction in patients being prescribedopioid analgesics.Additional fileAdditional file 1: Appendix A. PRISMA-P 2015 Checklist [18]. Appendix B.MEDLINE Search from June 26, 2017. Appendix C. Inclusion/Exclusion Form.Appendix D. Data Collection Form. Appendix E. NICE Quality AppraisalChecklist for Quantitative Studies Reporting Correlations and Associations[26]. Appendix F. NICE Quality Appraisal Checklist for Quantitative InterventionStudies [26]. (DOCX 98.8 kb)AbbreviationsADB: Aberrant drug-related behavior; WHO: World Health OrganizationAcknowledgementsNot applicable.FundingThis study was funded by a CIHR Foundation grant. The funding body had norole in the study’s design, analysis, interpretation, or manuscript generation.Availability of data and materialsThe datasets generated and/or analyzed during the current study will beavailable from the corresponding author on reasonable request.Authors’ contributionsAC and CH conceived of and designed the study. MDW contributedexpertise in the systematic review methods and will design the searchstrategy. CL will conduct the grey literature search. AC, JH, and SW will pilotall the forms, review titles, abstracts, and full texts for inclusion and exclusioncriteria, extract data, and complete risk of bias assessments. All authorsattended the study meetings where they contributed to the manuscriptcontent. AC drafted the protocol manuscript, and all authors revised it forintellectual content. All authors read and approved the final manuscript.Ethics approval and consent to participateCanadian clinical research ethics boards waive the need for ethics approvalfor all systematic review studies.Consent for publicationNot applicable.Competing interestsThe authors declare that they have no competing interests.Publisher’s NoteSpringer Nature remains neutral with regard to jurisdictional claims inpublished maps and institutional affiliations.Author details1Department of Emergency Medicine, University of British Columbia, 855West 12th Avenue, Vancouver, BC V5Z 1M9, Canada. 2Vancouver GeneralHospital, 855 West 12th Avenue, Vancouver, BC V5Z 1M9, Canada.3Department of Medicine, University of British Columbia, 2194 HealthSciences Mall, Vancouver, BC V6T 1Z3, Canada. 4Centre for ClinicalEpidemiology and Evaluation, Vancouver Coastal Health Research Institute,828 West 10th Avenue, Vancouver, BC V5Z 1M9, Canada. 5EmergencyDepartment, Vancouver General Hospital, 855 West 12th Avenue, Vancouver,BC V5Z 1M9, Canada.Received: 24 July 2017 Accepted: 23 November 2017References1. 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