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Client satisfaction among participants in a randomized trial comparing oral methadone and injectable… Marchand, Kirsten I; Oviedo-Joekes, Eugenia; Guh, Daphne; Brissette, Suzanne; Marsh, David C; Schechter, Martin T Jul 26, 2011

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RESEARCH ARTICLE Open AccessClient satisfaction among participants in arandomized trial comparing oral methadone andinjectable diacetylmorphine for long-termopioid-dependencyKirsten I Marchand1, Eugenia Oviedo-Joekes1,2*, Daphne Guh1, Suzanne Brissette3, David C Marsh2,4,5 andMartin T Schechter1,2AbstractBackground: Substitution with opioid-agonists (e.g., methadone) has shown to be an effective treatment forchronic long-term opioid dependency. Patient satisfaction with treatment has been associated with improvedaddiction treatment outcomes. However, there is a paucity of studies evaluating patients’ satisfaction with OpioidSubstitution Treatment (OST). In the present study, participants’ satisfaction with OST was evaluated at 3 and 12months. We sought to test the relationship between satisfaction and patients’ characteristics, the treatmentmodality received and treatment outcomes.Methods: Data from a randomized controlled trial, the North American Opiate Medication Initiative (NAOMI),conducted in Vancouver and Montreal (Canada) between 2005-2008, was analyzed. The NAOMI study comparedthe effectiveness of oral methadone vs. injectable diacetylmorphine over 12 months. A small sub-group of patientsreceived injectable hydromorphone on a double blind basis with diacetylmorphine. The Client SatisfactionQuestionnaire (CSQ-8) was used to measure satisfaction with treatment. CSQ-8 scores, as well as retention andresponse to treatment, did not differ between those receiving hydromorphone and diacetylmorphine at 3 or 12months assessments; therefore, these two groups were analyzed together as the ‘injectable’ treatment group.Results: A total of 232 (92%) and 237 (94%) participants completed the CSQ-8 at 3 and 12 months, respectively.Participants in both groups were highly satisfied with treatment. Independent of treatment group, participantssatisfied with treatment at 3 months were more likely to be retained at 12 months. Multivariate analysis indicatedthat satisfaction was greater among those randomized to the injection group after controlling for treatmenteffectiveness. Participants who were retained, responded to treatment, and had fewer psychological symptomswere more satisfied with treatment. Finally, open-ended comments were made by 149 (60.3%) participants;concerns about the randomization process and the study ending were most commonly reported by participantsreceiving the oral and injectable medications, respectively.Conclusions: The higher satisfaction among those receiving medically prescribed injectable diacetylmorphine (orhydromorphone) supports current evidence regarding the attractiveness of this treatment for long-term, opioid-dependent individuals not benefiting sufficiently from other treatments. In addition, the measurement of treatmentsatisfaction provides valuable information about participants at risk of relapse and in need of additional services.Trial Registration: ClinicalTrials.gov Identifier: NCT00175357* Correspondence: eugenia@mail.cheos.ubc.ca1Centre for Health Evaluation & Outcome Sciences, Providence Health Care,St. Paul’s Hospital 620B - 1081 Burrard Street, Vancouver, BC, V6Z 1Y6,CanadaFull list of author information is available at the end of the articleMarchand et al. BMC Health Services Research 2011, 11:174http://www.biomedcentral.com/1472-6963/11/174© 2011 Marchand et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the CreativeCommons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, andreproduction in any medium, provided the original work is properly cited.BackgroundOpioid dependence is a chronic relapsing disease thatwhen untreated can lead to moderate to severe healthconsequences such as blood-borne viral infections,endocarditis, and drug overdoses [1,2]. Treatment foropioid dependence can be focused on achieving absti-nence of any drugs or aimed at reducing the adversehealth consequences associated with opioid dependence.Also, delivery of opioid dependence treatment can beshort or long-term and at in or out-patient settings. Psy-chotherapy and counselling can be provided alone or incombination with other treatments [3-5].Substitution with opioid-agonists (e.g., methadone) is along-term treatment aimed at reducing the use of illicitopioids and its associated problems, including reducedillicit drug use and illegal activities, human immunodefi-ciency virus (HIV) infections, as well as improved gen-eral health and psychosocial adjustment [2,3,6]. Inaddition, patients on Opioid Substitution Treatment(OST) are effectively retained [7], and studies haveshown that the time patients remain in treatment isassociated with greater improvements in the above men-tioned areas [8]. The delivery of OST varies widely, evenin the same region, in its setting, philosophy, availabilityof ancillary services, and policies. Several manuals andguidelines for best practices have been developed forhealth care providers as well as for specific professionalroles [9,10].It is common for health care services to routinelyassess patient’s satisfaction with received treatments inorder to gain feedback which can be used to improvethe services provided. Satisfaction with received care canbe used as a measure of quality of care and perceivedbenefits of a service [11,12]; however, this is a multi-dimensional concept and it is affected by a wide rangeof factors. For instance, satisfaction may be influencedby the characteristics of the patient (e.g., expectations,demographic characteristics, beliefs, previous treatmentexperiences, etc.), the illness being treated (e.g., acute vs.chronic), the treatment modalities being used (e.g., inpa-tient vs. outpatient), and the characteristics of the indivi-dual providing the treatment (e.g., authoritarian,tolerant, etc.) [11-16].Client satisfaction has been evaluated in addictiontreatment services, including OST, though, to a muchlesser degree than other areas of care [17-20]. Althoughpatients tend to report high levels of satisfaction withaddiction treatment [12,13,15,21,22], patients receivingOST have also expressed concerns related to thedemands of this treatment. For example, concernsregarding the procedures of clinics, including dispensingschedules [20], prolonged waiting times and lack ofaccess to ancillary services [23] have been perceived ashaving an impact on patients’ satisfaction with OST.Moreover, Perez de los Cobos et al., [18] reported thatthe number of hours per week that methadone was dis-pensed was independently associated with treatmentsatisfaction, and a later study found that patients’ whohad a high regard of methadone as a medication fortreating opioid dependence were more satisfied [19].Client satisfaction has also been linked with a numberof favourable addiction treatment outcomes, includinghigher service use [15,24], reduction in substance use[15,24-27], greater physical and mental health [25], psy-chosocial improvements [26], and greater retention intreatment [12,16,26]. For example, Kelly et al. [26]recently determined a negative association betweenpatients’ treatment satisfaction and illicit drug use andillegal activity at 3 months after OST initiation and apositive association with treatment retention at 12months. In contrast, in an outpatient alcohol and drugtreatment setting that provided intensive treatment bypatient education, group therapy, and social support,McLellan & Hunkeler [28] did not find an associationbetween patient satisfaction and treatment outcomes at6 months follow-up.Between 2005 and 2008 a randomized controlled trial(RCT) comparing the effectiveness of two OST modal-ities for the treatment of long-term, treatment-resistantopioid dependence, was carried out in Vancouver andMontreal (Canada). This study analyses data from thattrial with the purpose to: a) determine participants’satisfaction with the treatment received; and b) test ifsatisfaction scores vary according to patients’ character-istics, the treatment modality received and treatmentoutcomes.MethodsDesign, Setting and ParticipantsThe North American Opiate Medication Initiative(NAOMI) was an open-label, phase III RCT comparingsupervised injectable diacetylmorphine and oral metha-done in the treatment of long-term opioid dependence.For the purpose of validating self-reported use of streetheroin by urine testing, a small group of participantswere randomized to receive injectable hydromorphonein double-blind basis instead of diacetylmorphine. Parti-cipants were aged 25 or greater, with at least 5 years ofopioid dependence (according to DSM-IV criteria), cur-rent daily injection of opioids, a minimum of two pre-vious treatments for opioid dependence, including atleast one OST attempt and no enrolment in OSTwithin the prior 6 months. Data regarding participantsdemographics, substance use before and during thestudy, dosage and monitoring issues have been pub-lished elsewhere [29-31]. Briefly, at treatment entry,Marchand et al. BMC Health Services Research 2011, 11:174http://www.biomedcentral.com/1472-6963/11/174Page 2 of 10participants in both sites were deemed poly drug users,with heroin and cocaine being the two most frequentdrugs reported in lifetime and prior month. Compari-sons between Vancouver and Montreal showed that ahigher proportion of Vancouver participants wereAboriginal (31.6% vs. 0.0%), had unstable housing(88.5% vs. 22.0%) and had more days of smoked crackcocaine use (16.88 vs. 2.25) in relation to Montreal [31].During treatment, illicit heroin use declined drasticallyamong those randomized to injectable diacetylmorphine(from 26.6 to 5.3 days), while days of cocaine useremained stable, as per intention-to-treat (ITT) analysis[29]. After excluding each participant’s initial 90 daydose adjustment, the average dose during the study per-iod for participants receiving diacetylmorphine, hydro-morphone, or methadone was 395.8 mg, 186.7 mg and96.0 mg, respectively [32]. High-performance liquidchromatography testing was used to detect the presenceof morphine and 6-monoacetylmorphine, as evidence ofillicit heroin use in urine samples of the methadone andhydromorphone groups, which showed a significantlyhigher use of illicit heroin in the methadone comparedto hydromorphone group [33].A total of 251 individuals were randomized to receiveeither oral methadone (n = 111), injectable diacetylmor-phine (n = 115) or injectable hydromorphone (n = 25),the latter two on a double blind basis. Participantsadministered the injection medications up to threetimes daily (up to 1,000 mg per day) under the supervi-sion of clinic staff; oral methadone was dispensed daily.Participants were offered psychosocial and primarycare; in keeping with Health Canada Best Practices, allservices were delivered in a patient-centred fashion [9].Participants received their allocated treatment for 12months. Since the injectable medications are notlicensed in Canada for the treatment of opioid-depen-dency, an additional 3-month period was provided totaper and transition those participants to other treat-ment modalities (primarily methadone). The Universityof British Columbia/Providence Health Care researchethics board approved the study, and all participantsprovided written informed consent.MeasuresA separate research team obtained outcome evaluationsat baseline and follow-up (3, 6, 9 and 12 months), usingthe European Addiction Severity Index (EuropASI; [34])and Maudsley Addiction Profile (MAP; [35]). Partici-pants were considered retained to addiction treatment ifthey received study medication on at least 10 out of the14 days prior to the follow-up assessment or were con-firmed to be in any other treatment program or absti-nent of opioids during this interval. Participants wereregarded as treatment compliant if they received thetreatment they were allocated to for at least 20 out ofthe prior 30 days (i.e., those that were randomized toinjectable medication continued to receive injectable;those randomized to optimised methadone were stillreceiving methadone at the study clinic). Overall clinicalresponse was defined as an improvement of at least 20%in Drug and/or Legal EuropASI composite scores, withno deterioration higher than 10% in more than one ofthe remaining composite scores. All participants lost tofollow-up were considered non-retained.Participants’ satisfaction with treatment was evaluatedat 3 and 12 months using the Client Satisfaction Ques-tionnaire (CSQ; [36], 8-item version [37]. The CSQ-8assesses global patient satisfaction with a 4-point Likerttype scale and also provides a general score rangingfrom 8 to 32. This questionnaire has been used in psy-chiatric inpatient and outpatient treatment evaluations[38,39] as well as in substance abuse treatment settings[40], including OST [21,22,41-44]. The CSQ-8 includesthe following questions: 1) How would you rate thequality of service received?; 2) Did you get the kind ofservice you wanted?; 3) To what extent has our pro-gramme met your needs?; 4) If a friend were in need ofsimilar help, would you recommend our programme tohim or her?; 5) How satisfied are you with the amountof help you have received?; 6) Have the services youreceived helped you to deal more effectively with yourproblems?; 7) In an overall, general sense, how satisfiedare you with the service you have received?; 8) If youwere to seek help again, would you come back to ourprogramme? At the end of the questionnaire partici-pants had the option to make comments or suggestions.AnalysisItem and total mean treatment satisfaction scores werecalculated for each participant and to obtain a globalsatisfaction score. The groups receiving hydromorphoneand diacetylmorphine did not differ at 3 or 12 monthsassessments in their CSQ-8 scores; therefore, these twogroups were analyzed together as the ‘injectable’ treat-ment group. Comparisons of client satisfaction betweentreatment groups (injectable diacetylmorphine or hydro-morphone vs. oral methadone) were carried out usingStudent’s t and Mann-Whitney U depending on variabledistribution, as well as for retention in addiction treat-ment and clinical response.Similar to other studies [12,13,15], participants scoredvery high on treatment satisfaction, and as a conse-quence the variable’s distribution was skewed. To fitinto the multivariate models, mean satisfaction scoreswere organized according to 3 levels of satisfaction: 1)dissatisfied or least satisfied (8-16); 2) satisfied (17-30);and 3) very satisfied (31-32). Satisfaction scores wereevaluated in relation to patient characteristics (age,Marchand et al. BMC Health Services Research 2011, 11:174http://www.biomedcentral.com/1472-6963/11/174Page 3 of 10gender, site, ethnicity) as well as their scores at baseline,3 and 12 months follow-up (EuropASI; MAP). A multi-variate logistic regression analysis, adjusted by treatmentgroup, was used to determine if total and each item ofthe client satisfaction questionnaire at 3 months pre-dicted treatment outcomes at 12 months. Finally, a mul-tivariate proportional odds model estimated byGeneralized Estimating Equation (GEE) algorithm wasperformed to determine predictors of treatment satisfac-tion for total score and each individual question. Rando-mization group, gender, ethnicity, age, and site wereincluded in the model whether significant or not. Allother variables remained in the model only if significant.Missing values were considered as missing. Analyseswere performed by an ITT basis. Data was analyzedusing SAS® (version 9.1.3).The open-ended qualitative responses provided in theCSQ-8 ‘comments and suggestions’ section were alsoanalysed. To start, two researchers read all comments(EOJ; KM) and an initial list of themes were developed.The researchers then independently coded each com-ment according to these themes. Finally, the researchersdecided on a list of 12 common categories based on thefrequency which participants mentioned them: positiveor negative comments about the staff and the program,desire that study eligibility criteria were easier, frustra-tion with the randomization process, dissatisfaction withmedication dose received, lack of attention to their painmanagement, extension of clinic operation hours,request for more ancillary services, request of nutritionalservices, concerns regarding the interactions in the clinicwhile waiting for the medication, lengthy pre-post injec-tion assessment, insufficient time allotted to inject, anddisappointments of the study ending. A univariate logis-tic GEE model was applied to find subgroups ofparticipants most likely to make open-ended commentsat 3 and 12 months follow-up.ResultsA total of 88 (91%) women and 144 (93%) men com-pleted the CSQ-8 at 3 months; at 12 months, 91 (94%)women and 146 (95%) men completed the CSQ-8. Com-pared to participants in the oral methadone group, thoserandomized to the injection group had a significantlyhigher total satisfaction score at both 3 and 12 months(Table 1). These participants also showed significantlyhigher satisfaction scores for CSQ item 3 (programmeeting their needs), item 6 (the services helped themto deal with their problems) and item 8 (willingness toreturn for treatment in the future).After adjusting for treatment group, the CSQ item 3(to what extent has our programme met your needs) at3 months significantly predicted retention outcomes at12 months. Compared to participants who answeredthat none or few of their needs had been met, thosemost satisfied and satisfied at 3 months, were morelikely to be retained to addiction treatment at 12months (most satisfied Odds Ratio [OR] = 6.2; 95%Confidence Interval [CI] = 2.23, 17.39; p = 0.001; satis-fied OR = 3.3; 95% CI = 1.5-7.1; p = 0.003). Similarresults were obtained for retention to allocated treat-ment; however, 3 month satisfaction did not predict 12month treatment response.Table 2 displays the multivariate GEE analysis for totalsatisfaction and each item score of the CSQ-8. Rando-mization to the injectable group, younger age, betterpsychological health, and less drug use predicted treat-ment satisfaction in most of the scores. Compared towomen, and non-Aboriginal participants, men andAboriginal participants tend to be less satisfied.Table 1 Treatment Satisfaction by treatment group and timeT3 T12Treatment Satisfaction Questions a Oral Injection Oral InjectionM SD M SD M SD M SDQuality of service received 3.2 0.95 3.4 0.76 3.3 0.85 3.3 0.86Get the kind of service wantedb 2.7 1.15 3.5 0.64 3.0 1.11 3.2 0.86The program met the needsb; c 2.4 1.03 3.2 0.70 2.7 1.02 3.2 0.83Would recommend the programb 3.3 0.96 3.8 0.45 3.3 0.93 3.6 0.84Satisfied with the amount of help receivedb 2.9 0.97 3.4 0.67 3.1 0.95 3.2 0.89The services helped to deal with problemsb; c 2.8 0.95 3.6 0.63 3.0 0.88 3.3 0.80General satisfaction with the service receivedb 2.9 1.02 3.4 0.70 3.1 0.91 3.2 0.92Would come backb; c 3.2 0.92 3.7 0.53 3.4 0.86 3.6 0.68Total Satisfactionb; c 23.6 6.41 28.0 3.78 24.8 6.00 26.5 5.28a Refers to questions and total score from CSQ-8b Differences between groups significant (p < 0.01) at 3 monthsc Differences between groups significant (p < 0.04) at 12 months.Marchand et al. BMC Health Services Research 2011, 11:174http://www.biomedcentral.com/1472-6963/11/174Page 4 of 10Table 2 Multivariate Generalized Estimating Equation model for predictors of treatment satisfactionVariable TotalS i † Q1i † Q2i † Q3 i † Q4i † Q5i † Q6i † Q7 i † Q8 i †Randomization group:Injectable vs. Oral1.32(0.81-2.16)1.05(0.74-1.50)1.81(1.26-2.59)2.40(1.61-3.56)1.94(1.26-2.98)1.14(0.78-1.67)2.35(1.62-3.41)1.16(0.79-1.72)2.29(1.51-3.48)Gender:Male vs. Female0.65(0.41-1.03)0.84(0.58-1.21)0.75(0.52-1.07)0.82(0.56-1.20)0.55(0.36-0.86)0.74(0.51-1.09)0.74(0.51-1.08)0.86(0.60-1.25)0.63(0.42-0.96)Age 0.71(0.54-0.95)0.99(0.80-1.22)0.81(0.65-1.00)0.69(0.55-0.86)0.68(0.52-0.88)0.74(0.58-0.93)0.79(0.63-1.00)0.75(0.60-0.94)0.78(0.60-1.00)Ethnicity:Aboriginal vs. Non-Aboriginal0.70(0.41-1.20)0.80(0.53-1.22)0.76(0.50-1.15)0.99(0.65-1.49)0.55(0.34-0.89)1.01(0.67-1.54)0.99(0.63-1.55)0.72(0.47-1.11)0.50(0.31-0.81)Site:Vancouver vs. Montreal0.97(0.54-1.74)0.72(0.45-1.16)1.51(0.98-2.33)1.31(0.82-2.10)2.16(1.31-3.54)1.19(0.75-1.88)1.07(0.68-1.69)1.00(0.63-1.58)1.74(1.06-2.84)Treatment Compliance:aYes vs. No1.80(1.08-3.01)- 2.18(1.51-3.12)- 2.44(1.60-3.72)1.97(1.37-2.86)2.10(1.45-3.03)- 1.95(1.29-2.94)Treatment Response:bYes vs. No- - 1.53(1.09-2.13)- - 1.52(1.06-2.17)- -Treatment Retention:cYes vs. No- - - 2.31(1.41-3.80)- - - 2.15(1.36-3.40)Current Psychological Symptomsd 0.94(0.91-0.97)- 0.95(0.93-0.97)0.95(0.93-0.97)0.95(0.93-0.97)0.96(0.94-0.98)0.95 (0.93-0.97) 0.95 (0.93-0.97) 0.95 (0.92-0.97)Current Physical Healthd - 0.95(0.93-0.97)- - - - - - -Current Legal Situatione - - - 0.92(0.85-0.99)- - - - -Current Drug Usee 0.81(0.72-0.92)0.96(0.93-0.99)- 0.79(0.71-0.87)0.89(0.80-0.99)0.90(0.82-1.00)0.85(0.78-0.94)0.81(0.74-0.89)-Family/Social Relationse - - - - - - - - 0.90(0.82-0.99)Heroin Use at Baselinef - - - - - 0.96(0.94-0.99)- - -† Refers to CSQ-8 (TotalS: Total Satisfaction score; Q1: How would you rate the quality of service received; Q2: Did you get the kind of service you wanted; Q3: To what extent has our program met your needs; Q4: Ifa friend were in need of similar help, would you recommend our program to him or her; Q5: How satisfied are you with the amount of help you have received; Q6: Have the services you received helped you to dealmore effectively with your problems; Q7: In an overall, general sense, how satisfied are you with the service you have received; Q8: If you were to seek help again, would you come back to our program?)i Odds Ratio (95% Confidence Interval). P values highlighted: p ≤ 0.05(a) Retention to allocated treatment: at least 20 out of prior 30 days;(b) Treatment response defined as improvement of at least 20% in Drug and/or Legal EuropASI composite scores, with no deterioration higher than 10% in more than one of the remaining composite scores;(c) Retention to addiction treatment or abstinent: at least 10 out of prior 14 days;(d) MAP (Maudsley Addiction Profile) in the prior month. Scores range from 0 to 40; higher scores are indicative of more severe problems. Higher scores are indicative of more severe problems;(e) EuropASI (European version of the Addiction Severity Index) in the prior month. Sub-scale scores range from 0 to 1; higher scores are indicative of more severe problems;(f) In the prior 30 days.Marchandetal.BMCHealthServicesResearch2011,11:174http://www.biomedcentral.com/1472-6963/11/174Page5of10Participants who were compliant, retained andresponded to treatment also tended to be more satisfied.Open-ended comments about treatment satisfactionand perceptions were provided by 149 (60.3%) of theparticipants. Participants who were older (OR = 1.5;95% CI = 1.2- 1.9; p = 0.002), interviewed in Vancouver(OR = 6.8; 95% CI = 3.9- 12.0; p = < 0.0001), and whowere receiving their allocated treatment in the priormonth (OR = 6.8; 95% CI = 3.9-12.0; p = 0.0251) weresignificantly more likely to make open-ended comments.Table 3 shows that general comments about staff andthe program were made by 43 (38.7%) and 54 (58.7%)participants at 3 months and at 12 months, respectively.Concerns about randomization were mostly mentionedat 3 months compared to the 12 month evaluation,while disappointments about the end of study werementioned more frequently at 12 months. When com-paring comments made by oral (n = 86) and injectable(n = 120) treatment groups, individuals in the lattergroup made more general comments about the staff andprogram and these also tended to be more positive.Only participants receiving the oral medicationexpressed their frustration with the randomization pro-cess, while disappointments about the study endingwere mentioned more by those in the injection group.DiscussionThe present study determined participants’ satisfactionwith received treatments in the first North AmericanRCT to provide injectable diacetylmorphine or hydro-morphone compared to oral methadone for the treat-ment of long-term, treatment resistant, opioid-dependency. At 3 and 12 months, participants weresatisfied with the treatment received during the studyperiod, although satisfaction was greater for those ran-domized to receive injectable treatments. At 3 months,participants who reported that the program met theirneeds were more likely to be retained at 12 months. Toour knowledge this is the first study to assess treatmentsatisfaction among participants receiving supervisedinjectable diacetylmorphine or hydromorphone.Regardless of the outcome of the randomization, parti-cipants in the trial were highly satisfied with the treat-ment received. This follows previous studies which haveconsistently found that patients tend to report highlevels of treatment satisfaction, including communityhealth services [45], services for mental health [13],addiction [46], and opioid dependence [20]. In a meta-analytic review of patient satisfaction with mental healthservices, it was suggested that the high skewnesstowards positive satisfaction scores might be due to thelack of clarity of norms against which to compare thetreatments, the psychometric properties of the instru-ments used, and the lack of a specific theoretical frame-work of patient satisfaction [13]. The factor structure(uni-dimensional vs. multi-dimensional) of an instru-ment can also have an impact on the sensitivity andvalidity of the instrument’s ability to measure satisfac-tion [47]; therefore, uni-dimensional instruments mightoverestimate participants’ satisfaction because partici-pants are dichotomously categorized as being eithersatisfied or dissatisfied. More recently, in a Europeanreview of outpatient care, Saila et al. [12] suggested thatthe generally high levels of satisfaction may also reflectTable 3 Categories of comments by groupComments a Oraln = 86Injectionn = 120Totaln = 206n (%) n (%) n (%)Comments about staff and program 28 32.6 69 57.5 97 47.1Positive 24 27.9 54 45.0 78 80.4Negative 4 4.7 15 12.5 19 19.6Easier eligibility 5 5.8 4 3.3 9 4.4Dissatisfaction with Dosage 1 1.2 7 5.8 8 3.9Frustration with Randomization 31 36.0 0 0.0 31 15.0Insufficient Pain Management 3 3.5 1 0.8 4 1.9Extension of Clinic Operation Hours 8 9.3 4 3.3 12 5.8Request More Ancillary services 3 3.5 5 4.2 8 3.9Request More Nutritional services 3 3.5 5 4.2 8 3.9Concerns of Interactions in the Waiting Room 0 0.0 8 6.7 8 3.9Lengthy Pre-Post Injection Assessment 0 0.0 8 6.7 8 3.9Insufficient Time Allotted to Inject 0 0.0 4 3.3 4 1.9Disappointments of the Study Ending 3 3.5 20 16.7 23 11.2a All comments were derived from the open-ended remarks section of the CSQ-8. Comments were not mandatory.Marchand et al. BMC Health Services Research 2011, 11:174http://www.biomedcentral.com/1472-6963/11/174Page 6 of 10a publication bias, where researchers are more likely topublish findings that are favourable to their particularprograms or services. Another hypothesis to consider isthat an ill person who receives care will most likely begrateful to the caregiver, adding to the positive skewnessin satisfaction scores found in the literature as well as inthis study.In spite of being highly satisfied, participants whoreported that the program met their needs at three-months were more likely to be retained in treatment at12 months. Several other studies have reported a similarassociation between satisfaction and retention to addic-tion treatment services [12,26,41,46]. In particular, Kellyet al. [26] recently found that those participants whowere retained in OST at 12 months were more satisfiedwith the program at 3 months. Therefore, the integra-tion of client satisfaction surveys early in the treatmentprogram may be a useful tool to identify participantswho are at risk for treatment dropout and relapse.In the present study, participants randomized toreceive injectable medications were significantly moresatisfied than those randomized to oral methadone evenafter controlling for age, gender, ethnicity, treatmentretention, treatment compliance and treatment response.Furthermore, differences in satisfaction scores betweentreatment groups were not the result of patient charac-teristics at baseline (e.g., age, gender, education, druguse severity, health). To date, there is very limited dataon treatment satisfaction among opioid-dependent indi-viduals receiving injectable OST. In the only study (toour knowledge) that assessed client satisfaction amongpatients receiving (in the UK) injectable OST (diacetyl-morphine or methadone), those receiving diacetylmor-phine were more satisfied, indicating the treatment wasmore beneficial because of the ease of injecting diacetyl-morphine as well as their preference for this drug overmethadone [20]. The higher client satisfaction scoresamong participants receiving injectable diacetylmorphine(or hydromorphone) indicate that this is a treatmentthat long-term opioid-dependent individuals would liketo receive. This is highly relevant when considering thatthese individuals are often difficult to engage and retainin treatment, and when untreated are at greater risk formortality and morbidity [1,2,48].In our multivariate analysis, older age was stronglyassociated with treatment satisfaction. In addition, menand Aboriginal participants were less likely to recom-mend the program to friends or relatives (CSQ-Q4) andto respond that they would return in the future for asimilar program (CSQ-Q8). Studies in psychiatric andprison based settings have found older participants to bemore satisfied with treatment [49,50], and it was sug-gested that older patients may be more adaptable,respectful, and have lower expectations as a result ofhaving more previous treatment experiences. In con-trast, younger patients have fewer previous experienceswith which to compare their treatment, and may bemore defiant toward other patients and staff. The asso-ciation between gender and treatment satisfaction is lessconsistent; however, in one review of treatment satisfac-tion with general health care services, it was suggestedthat women and older patients tend to be more satisfiedwith treatment [51]. Regarding ethnicity, there is a pau-city of data reporting an association between treatmentsatisfaction and participants’ ethnicity. In their review,Aharony et al. [51] briefly mention one study that foundlower satisfaction among African American participantscompared to Caucasian participants. Therefore, giventhe state of the current literature it is difficult to inter-pret our findings regarding the association betweensocio-demographic factors and treatment satisfaction.To our knowledge this is the first study that has consid-ered Aboriginal ethnicity in the evaluation of treatmentsatisfaction with OST in Canada. Previous analyses ofthis study data have demonstrated no differences intreatment effectiveness by ethnicity [52]. However, inour multivariate model that controls for treatment effec-tiveness, Aboriginal participants were less satisfied withthe treatment program. These findings are highly rele-vant when considering that there is data indicating thatAboriginal people are less likely to access methadonemaintenance treatment [52,53] and face specific barriers[54]. Treatment satisfaction might be a useful tool toidentify treatment needs among Aboriginal people withchronic long-term opioid dependence.Treatment compliance, response, retention and druguse have previously been associated with treatmentsatisfaction [12]. For example, studies have found anassociation between client satisfaction and a reductionin substance use during [26] and after the treatmentperiod [25,27,55,56]. Therefore, the results obtained inour study, where lower drug use, higher retention,response and compliance with treatment were positivelyassociated with treatment satisfaction, were expected.Satisfaction with treatment in the present study wasalso more likely among those with better psychologicalstatus. In a recent study, Hser et al. [46] found that par-ticipants with severe psychological and physical healthsymptoms at treatment initiation were more satisfiedwhen provided with additional intense services. More-over, Kelly et al. [26] found that patients with the great-est treatment needs had more psychological problems.Together, these results suggest that unmet treatmentneeds may be greater among participants with worsepsychological health, which may contribute to lowersatisfaction with the services provided. Thus, satisfactionwith treatment may be an indicator of participants’treatment needs.Marchand et al. BMC Health Services Research 2011, 11:174http://www.biomedcentral.com/1472-6963/11/174Page 7 of 10In the open-ended comments sections, participants inthe oral group expressed their concern with the rando-mization process, while those in the injection groupwere more worried about the study ending. It is wellknown that in clinical trials, randomization to the lessdesired treatment condition (e.g., placebo, treatment asusual) might have a significant impact on participantswillingness to adhere and comply with the study proto-col; this is especially true in drug and alcohol treatmentsettings where attendance is already low [57]. Reviews ofrecruitment in RCTs have established that one of themost common concerns participants express is theiruncertainty with the study medications and not beingrandomized to their preferred treatment [58,59]. As aresult, participants are often dissatisfied with their treat-ment allocation [59]. Although participants in this studyunderstood the probability of being randomized to theoral group, the desired treatment condition was inject-able diacetylmorphine. Thus, it is critical to considerand assess how the randomization process impacts par-ticipants, and highlight the need of the provision ofadditional supports for participants and recruitmentstaff in this phase of a study.In addition to common concerns among participantsin RCTs, comments regarding the provision of OSTwere also expressed in the present study. Clinic operat-ing hours, as an aspect of the treatment delivery thatcould be improved, were mentioned in participants’comments, and mostly by those in the oral treatmentgroup. This result is consistent with a previous study oftreatment satisfaction among patients receiving MMT,where the number of hours per week that methadonewas dispensed was the only variable that predicted clientsatisfaction [18]. Comments that were specific to thosein the injectable group included interactions in the wait-ing room, the lengthy time required for pre- and post-injection assessments as well as insufficient time per-mitted in the injection room. It is well known that thedemands of injectable OST are much greater for bothpatients and staff; patients receiving injectable treatmentin the NAOMI study attended the clinic up to 3 timesdaily, for approximately 1 hour each visit. Consideringthe benefits associated with injectable treatments andthe overall greater satisfaction among patients receivingthis form of treatment, these issues are being furtherexplored with both patients and staff for future studies.Limitations derived from the design of the parentstudy have been discussed elsewhere [29]. It is impor-tant to note that the NAOMI sample is a very homoge-nous group of opioid-dependent individuals with severalprevious drug treatment attempts that have been inject-ing drugs for an average of 15 years and were not bene-fiting from the available addiction treatment system.Also, for our theoretical framework regarding theparameters from which treatment satisfaction is beingcompared in this study, it is important to consider that:a) participants were not receiving any treatment for atleast six months before randomization; b) most partici-pants enrolled into this treatment hoping to receiveinjectable medications; c) the ‘methadone’ group neverreceived injectable medications, however the injectablegroup (as well as the oral group) did in the past receiveoral methadone (the gold standard to compare with);and d) the unidimensional factor structure of the CSQ-8may have yielded an overestimation of satisfaction. A‘social desirability bias’ (reply in a manner that will beviewed favourably by others) may also have influencedsome participants’ responses, accounting for the positiveresponses.ConclusionsAmong long-term chronic opioid injectors participatingin a randomized clinical trial prescribing injectable dia-cetylmorphine or hydromorphone and oral methadone,those receiving injectable medications were more satis-fied with treatment. Independent of treatment group,treatment satisfaction was also an indicator of retentionin treatment, as well as treatment response, including areduction in substance use. As the first study in NorthAmerica to provide injectable OST, these findings havevaluable implications for future RCTs, which shouldcontinue to measure satisfaction in order to identifyareas of improvement. These findings also provide evi-dence-based knowledge for good clinical practice guide-lines in the treatment of chronic opioid dependence inCanada as they highlight the association between treat-ment satisfaction and improved treatment outcomes,particularly for those receiving more innovative treat-ment medications.Author DisclosuresRole of Funding SourceThe study was funded by the Canadian Institutes ofHealth Research (CIHR). CIHR had no further role instudy design; in the collection, analysis and interpreta-tion of data; in the writing of the report; or in the deci-sion to submit the paper for publication.AcknowledgementsThe NAOMI trial was funded through an operating grant from the CanadianInstitutes of Health Research with additional support from the CanadaFoundation for Innovation, the Canada Research Chairs Program, theUniversity of British Columbia, Providence Health Care, the University ofMontreal, Centre de Recherche et Aide aux Narcomanes, the Government ofQuebec, Vancouver Coastal Health Authority and the BC Centre for DiseaseControl. The authors wish to acknowledge the dedication of N. Laliberté, C.Gartry, K. Sayers, P-A Guevremont, P. Schneeberger, K. Lock, J. Chettiar, J.Lawlor, P. Pelletier, S. Maynard, M-I Turgeon, G. Brunelle, A. Chan, S.MacDonald, T. Corneil, J. Geller, S. Jutha, S. Chai, M. Piacsezna, S. Sizto, themany remaining staff and members of the DSMB (A. Marlatt, N. El-Guebaly, J.Marchand et al. BMC Health Services Research 2011, 11:174http://www.biomedcentral.com/1472-6963/11/174Page 8 of 10Raboud, D. Roy). The authors also wish to recognize the many U.S. andCanadian (J. Rehm, B. Fischer) scientists who contributed to the early designdiscussions but ultimately were unable to participate in the trial. Mostimportantly, the authors wish to acknowledge and thank the NAOMI studyparticipants.Author details1Centre for Health Evaluation & Outcome Sciences, Providence Health Care,St. Paul’s Hospital 620B - 1081 Burrard Street, Vancouver, BC, V6Z 1Y6,Canada. 2School of Population and Public Health, University of BritishColumbia, 2206 East Mall Vancouver, BC, V6T 1Z3, Canada. 3Centre deRecherche du Centre Hospitalier de l’Université de Montréal (CHUM), 1058St-Denis Montréal, QC, H2X 3J4 Canada. 4Centre for Addiction Research BC,University of Victoria, 2300 McKenzie Ave, Victoria, BC, V8P 5C2, Canada.5Northern Ontario School of Medicine, 935 Ramsey Lake Road, Sudbury, ON,P3E 2C6, Canada.Authors’ contributionsMTS, SB, DM made substantial contributions to conception and design ofthe parent study; MTS, SB, DM, EOJ and DG, made substantial contributionsto acquisition of data, and analysis and interpretation of data; KM madesubstantial contributions to analysis and interpretation of data. 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BMCHealth Services Research 2011 11:174.Submit your next manuscript to BioMed Centraland take full advantage of: • Convenient online submission• Thorough peer review• No space constraints or color figure charges• Immediate publication on acceptance• Inclusion in PubMed, CAS, Scopus and Google Scholar• Research which is freely available for redistributionSubmit your manuscript at www.biomedcentral.com/submitMarchand et al. BMC Health Services Research 2011, 11:174http://www.biomedcentral.com/1472-6963/11/174Page 10 of 10


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