Quality Indicators for Pain in Adults: A Review of Performance Measures by the American College of Physicians.

Pain is a debilitating symptom generally caused by injuries or various conditions. It can be acute, subacute, or chronic and can have a significant impact on a patient's quality of life. The goal of managing pain is to relieve or reduce suffering and improve patient functioning. Several performance measures that address the treatment of pain are used in payment, public reporting, or accountability programs. The American College of Physicians (ACP) embraces performance measurement as a means to improve quality of care. ACP believes that a performance measure must be methodologically sound and evidence-based to be considered for inclusion in payment, accountability, or reporting programs. However, a plethora of performance measures that provide minimal or no value to patient care have inundated physicians, practices, and systems with the burden of collecting and reporting data. ACP's Performance Measurement Committee (PMC) reviews performance measures using a validated process to recognize high-quality performance measures, address gaps and areas for improvement in performance measures, and help reduce reporting burden. There is a need for a higher standard for a performance measure when reputation and reimbursement are on the line. This paper aims to present a review of current performance measures for pain to inform physicians, payers, and policymakers in their selection and use of performance measures. The PMC reviewed 6 performance measures for pain relevant to internal medicine physicians, of which 3 were considered valid at their intended levels of attribution ("Use of Imaging for Low Back Pain," "Use of Opioids at High Dosage in Persons Without Cancer," and "Use of Opioids From Multiple Providers in Persons Without Cancer"). This paper also proposes a performance measure concept to address a quality-of-care gap based on the current clinical guideline from ACP and the American Academy of Family Physicians, "Nonpharmacologic and Pharmacologic Management of Acute Pain From Non-low Back, Musculoskeletal Injuries in Adults."

HIV broadly neutralizing antibody escapability drives the therapeutic efficacy of vectored immunotherapy.

Broadly neutralizing antibodies (bNAbs) have shown great promise for prevention and treatment of HIV infection. Breadth of bNAb neutralization, measured in vitro across panels of diverse viral isolates, is often used as a predictor of clinical potential. However, recent prevention studies demonstrate that the clinical efficacy of a broad and potent bNAb (VRC01) is undermined by neutralization resistance of circulating strains. Using HIV-infected humanized mice, we find that therapeutic efficacy of bNAbs delivered as Vectored ImmunoTherapy (VIT) is a function of both the fitness cost and resistance benefit of mutations that emerge during viral escape, which we term 'escapability'. Applying this mechanistic framework, we find that the sequence of the envelope V5-loop alters the resistance benefits of mutants that arise during escape, thereby impacting the therapeutic efficacy of VIT-mediated viral suppression. We also find that an emtricitabine-based antiretroviral drug regimen dramatically enhances the efficacy of VIT, by reducing the fitness of mutants along the escape path. Our findings demonstrate that bNAb escapability is a key determinant to consider in the rational design of antibody regimens with maximal efficacy and illustrates a tractable means of minimizing viral escape from existing bNAbs.

Client preferences for the design and delivery of injectable opioid agonist treatment services: Results from a best-worst scaling task.

BACKGROUND AND AIMS: Clinical trials support injectable opioid agonist treatment (iOAT) for individuals with opioid use disorder (OUD) for whom other pharmacological management approaches are not well-suited. However, despite substantial research indicating that person-centered care improves engagement, retention and health outcomes for individuals with OUD, structural requirements (e.g. drug policies) often dictate how iOAT must be delivered, regardless of client preferences. This study aimed to quantify clients' iOAT delivery preferences to improve client engagement and retention. DESIGN: Cross-sectional preference elicitation survey. SETTING: Metro Vancouver, British Columbia, Canada. PARTICIPANTS: 124 current and former iOAT clients. MEASUREMENTS: Participants completed a demographic questionnaire package and an interviewer-led preference elicitation survey (case 2 best-worst scaling task). Latent class analysis was used to identify distinct preference groups and explore demographic differences between preference groups. FINDINGS: Most participants (n = 100; 81%) were current iOAT clients. Latent class analysis identified two distinct groups of client preferences: (1) autonomous decision-makers (n = 73; 59%) and (2) shared decision-makers (n = 51; 41%). These groups had different preferences for how medication type and dosage were selected. Both groups prioritized access to take-home medication (i.e. carries), the ability to set their own schedule, receiving iOAT in a space they like and having other services available at iOAT clinics. Compared with shared decision-makers, fewer autonomous decision-makers identified as a cis-male/man and reported flexible preferences. CONCLUSIONS: Injectable opioid agonist treatment (iOAT) clients surveyed in Vancouver, Canada, appear to prefer greater autonomy than they currently have in choosing OAT medication type, dosage and treatment schedule.

Building Capacity for Injectable Diacetylmorphine and Hydromorphone for the Treatment of Opioid Use Disorder: Identifying Typical Doses.

Identifying typical doses of existing opioid use disorder medications, such as injectable opioid agonist treatment (iOAT), can support client and program needs, and potentially increase iOAT expansion. Longitudinal data from participants in a cohort study (n = 131), along with clinic dispensation records from August 2014 to April 2020, were used to examine physician prescribed as well as used doses of injectable diacetylmorphine and hydromorphone. Dosage groups, by medication and prescribed dose per session, were created for both hydromorphone and diacetylmorphine. A total of 534, 522 injections were registered during the study period among 129 participants. Mean received diacetylmorphine doses ranged from 106 to 989 mg per day, with most clients using 125-262 mg per session (mean 192.99 mg) and attending 2.40 sessions per day. Mean received hydromorphone doses ranged from 51.09 to 696.06 mg per day, with the majority using 88-154 mg per session (mean 121.32 mg; 2.43 sessions). Average daily doses remained stable overtime and, while mid-range doses were most typical, participants used the whole spectrum of allowable dose prescriptions. Evidence supporting typical doses of iOAT can be integrated into program planning to better allow providers and prescribers to anticipate program needs and engage in individualized care.

Quality Indicators for Major Depressive Disorder in Adults: A Review of Performance Measures by the American College of Physicians.

Major depressive disorder (MDD) is a severe mood disorder that affects at least 8.4% of the adult population in the United States. Characteristics of MDD include persistent sadness, diminished interest in daily activities, and a state of hopelessness. The illness may progress quickly and have devastating consequences if left untreated. Eight performance measures are available to evaluate screening, diagnosis, and successful management of MDD. However, many performance measures do not meet the criteria for validity, reliability, evidence, and meaningfulness.The American College of Physicians (ACP) embraces performance measurement as a means to externally validate the quality of care of practices, medical groups, and health plans and to drive reimbursement processes. However, a plethora of performance measures that provide low or no value to patient care have inundated physicians, practices, and systems and burdened them with collecting and reporting of data. The ACP's Performance Measurement Committee (PMC) reviews performance measures using a validated process to inform regulatory and accreditation bodies in an effort to recognize high-quality performance measures, address gaps and areas for improvement in performance measures, and help reduce reporting burden. Out of 8 performance measures, the PMC found only 1 measure (suicide risk assessment) that was valid at all levels of attribution. This paper presents a review of MDD performance measures and highlights opportunities to improve performance measures addressing MDD management.

Postoperative outcomes and identification of risk factors for complications after emergency intestinal stoma surgery - a multicentre retrospective study.

AIM: Approximately 4000 patients in the UK have an emergency intestinal stoma formed each year. Stoma-related complications (SRCs) are heterogeneous but have previously been subcategorized into early or late SRCs, with early SRCs generally occurring within 30 days postoperatively. Early SRCs include skin excoriation, stoma necrosis and high output, while late SRCs include parastomal hernia, retraction and prolapse. There is a paucity of research on specific risk factors within the emergency cohort for development of SRCs. This paper aims to describe the incidence of SRCs after emergency intestinal surgery and to identify potential risk factors for SRCs within this cohort. METHOD: Consecutive patients undergoing emergency formation of an intestinal stoma (colostomy, ileostomy or jejunostomy) were identified prospectively from across three acute hospital sites over a 3-year period from the ELLSA (Emergency Laparotomy and Laparoscopic Scottish Audit) database. All patients were followed up for a minimum of 1 year. A multivariate logistic regression model was used to identify risk factors for early and late SRCs. RESULTS: A total of 455 patients were included (median follow-up 19 months, median age 64 years, male:female 0.52, 56.7% ileostomies). Early SRCs were experienced by 54.1% of patients, while 51% experienced late SRCs. A total of 219 patients (48.1%) had their stoma sited preoperatively. Risk factors for early SRCs included end ileostomy formation [OR 3.51 (2.24-5.49), p < 0.001], while preoperative stoma siting was found to be protective [OR 0.53 (0.35-0.83), p = 0.005]. Patient obesity [OR 3.11 (1.92-5.03), p < 0.001] and reoperation for complications following elective surgery [OR 4.18 (2.01-8.69), p < 0.001] were risk factors for late SRCs. CONCLUSION: Stoma-related complications after emergency surgery are common. Preoperative stoma siting is the only truly modifiable risk factor to reduce SRCs, and further research should be aimed at methods of improving the frequency and accuracy of this in the emergency setting.

Shared decision-making and client-reported dose satisfaction in a longitudinal cohort receiving injectable opioid agonist treatment (iOAT).

BACKGROUND: Across different types of oral Opioid Agonist Treatment for people with Opioid Use Disorder, receiving a dose that meets their needs is associated with better outcomes. Evidence also shows patients are more likely to receive an "adequate dose" when their prescribers are involving them in decision making. Neither of these findings have been studied in the context of injectable Opioid Agonist Treatment, which is the purpose of this study. METHODS: This study was a retrospective analysis of an 18-month prospective longitudinal cohort study of 131 people receiving injectable Opioid Agonist Treatment. In the 18-month study, observations were collected every two months for one year, and then once more at 18 months. At 6 months, participants were asked whether their dose was satisfactory to them (outcome variable). Generalized Estimating Equations were used, to account for multiple observations from each participant. The final multivariate model was built using a stepwise approach. RESULTS: Five hundred forty-five participant-observations were included in the analysis. Participant-observations were grouped by "dose is satisfactory" and "wants higher dose". From unadjusted analyses, participants were less likely to report being satisfied with their dose if they: were Indigenous, had worse psychological or physical health problems, had ever attempted suicide, were younger when they first injected any drug, were a current smoker, felt troubled by drug problems, gave their medication a lower "drug liking" score, and felt that their doctor was not including them in decisions the way they wanted to be. In the final multivariate model, all previously significant associations except for "current smoker" and "troubled by drug problems" were no longer significant after the addition of the "drug liking" score. CONCLUSIONS: Patients in injectable Opioid Agonist Treatment who are not satisfied with their dose are more likely to: be troubled by drug problems, be a current smoker, and report liking their medication less than dose-satisfied patients. Prescribers' practicing shared decision-making can help patients achieve dose-satisfaction and possibly alleviate troubles from drug problems. Additionally, receiving a satisfactory dose may be dependent on patients being able to access an opioid agonist medication (and formulation) that they like.

PD-L1 expression in fine-needle aspiration cell blocks of head and neck squamous-cell carcinoma and its cytohistological concordance.

BACKGROUND: PD-L1 immunoexpression in head and neck squamous-cell carcinoma (HNSCC) determines immunotherapy eligibility. Patients are often diagnosed using fine-needle aspiration (FNA) of metastatic lymph nodes, however, the cytohistologic correlation of the combined positive score (CPS) is largely unknown. METHODS: This study retrospectively identified 96 paired histologic (HS) and cytologic specimens (CyS), between 2016 and 2020, diagnosed with HNSCC. Cases with <100 tumor cells (n = 54) or missing block(s) (n = 8) were excluded. All 34 case pairs were scored with CPS using the PD-L1 22C3 pharmDx assay at clinically relevant cut-offs of <1%, 1%-19%, and ≥20% independently by three observers blinded to the case pairs (CyS with corresponding HS). RESULTS: The CPS (<1/1-19/≥20) for CyS and HS were as follows: 10(29.4%)/10(29.4%)/14(41.2%) and 2(5.9%)/13(38.2%)/19(55.9%), respectively. There was fair overall cytohistologic agreement (OA) of 76.5% (k = 0.261) at the CPS cut-off of 1. The OA did not differ significantly between site-matched (n = 13) and -unmatched (n = 21) case pairs (p = .4653). CyS has a specificity and positive predictive value (PPV) of 100% but a negative predictive value (NPV) of only 20% as compared to its paired HS. CONCLUSIONS: Our study demonstrates fair CPS cytohistologic correlation in HNSCC specimens using the PD-L1 IHC 22C3 pharmDx assay with high PPV but low NPV. This suggest that determining PD-L1 status in FNA specimens can play an important role in the clinical management of HNSCC patients.

Lipids with negative spontaneous curvature decrease the solubility of the cancer drug paclitaxel in liposomes.

Paclitaxel (PTX) is a hydrophobic small-molecule cancer drug that loads into the membrane (tail) region of lipid carriers such as liposomes and micelles. The development of improved lipid-based carriers of PTX is an important objective to generate chemotherapeutics with fewer side effects. The lipids 1,2-dioleoyl-sn-glycero-3-phosphoethanolamine (DOPE) and glyceryl monooleate (GMO) show propensity for fusion with other lipid membranes, which has led to their use in lipid vectors of nucleic acids. We hypothesized that DOPE and GMO could enhance PTX delivery to cells through a similar membrane fusion mechanism. As an important measure of drug carrier performance, we evaluated PTX solubility in cationic liposomes containing GMO or DOPE. Solubility was determined by time-dependent kinetic phase diagrams generated from direct observations of PTX crystal formation using differential-interference-contrast optical microscopy. Remarkably, PTX was much less soluble in these liposomes than in control cationic liposomes containing univalent cationic lipid 1,2-dioleoyl-3-trimethylammonium-propane (DOTAP) and 1,2-dioleoyl-sn-glycero-3-phosphatidylcholine (DOPC), which are not fusogenic. In particular, PTX was not substantially soluble in GMO-based cationic liposomes. The fusogenicity of DOPE and GMO is related to the negative spontaneous curvature of membranes containing these lipids, which drives formation of nonlamellar self-assembled phases (inverted hexagonal or gyroid cubic). To determine whether PTX solubility is governed by lipid membrane structure or by local intermolecular interactions, we used synchrotron small-angle X-ray scattering. To increase the signal/noise ratio, we used DNA to condense the lipid formulations into lipoplex pellets. The results suggest that local intermolecular interactions are of greater importance and that the negative spontaneous curvature-inducing lipids DOPE and GMO are not suitable components of liposomal carriers for PTX delivery.

The Impact of Injectable Opioid Agonist Treatment (iOAT) on Involvement in Criminalized Activities: A Secondary Analysis from a Clinical Trial in Vancouver, BC.

Purpose: A significant portion of the economic consequences of untreated Opioid Use Disorder (OUD) relate to individuals' involvement in the criminal justice system. The present study uncovers if treatment with iOAT is related to the number of criminal charges amongst participants, what type of crime participants were involved in, and the frequency with which participants were victims of crime. This study contributes to the body of research on the effectiveness of iOAT reducing criminal involvement. Patients and Methods: This is a secondary analysis of police record data obtained from the Vancouver Police Department over a three-year period during the Study to Assess Longer-term Opioid Medication Effectiveness clinical trial. The data was obtained from participants (N = 192) enrolled in the trial through a release of information form. Results: During the three-year period, most charges (45.6%) were property offences, and 25.5% of participants were victims of crime. Participants with no treatment prior to randomization into the SALOME trial were 2.61 (95% CI = 1.64-4.14) more likely to have been charged with a crime than during the iOAT state. Conclusion: IOAT can reduce individuals' involvement with the criminal justice system and is thus a crucial part of the continuum of care. Addiction should be conceptualized as a healthcare rather than criminal issue.

Quality Indicators for Osteoporosis in Adults: A Review of Performance Measures by the American College of Physicians.

Primary osteoporosis is characterized by decreasing bone mass and density and reduced bone strength that leads to a higher risk for fracture, especially hip and spine fractures. The prevalence of osteoporosis in the United States is estimated at 12.6% for adults older than 50 years. Although it is most frequently diagnosed in White and Asian females, it still affects males and females of all ethnicities. Osteoporosis is considered a major health issue, which has prompted the development and use of several performance measures to assess and improve the effectiveness of screening, diagnosis, and treatment. These performance measures are often used in accountability, public reporting, and/or payment programs. However, the reliability, validity, evidence, attribution, and meaningfulness of performance measures have been questioned. The purpose of this paper is to present a review of current performance measures on osteoporosis and inform physicians, payers, and policymakers in their selection of performance measures for this condition. The Performance Measurement Committee identified 6 osteoporosis performance measures relevant to internal medicine physicians, only 1 of which was found valid at all levels of attribution. This paper also proposes a performance measure concept to address a performance gap for the initial approach to therapy for patients with a new diagnosis of osteoporosis based on the current American College of Physicians guideline.

Lipids with negative spontaneous curvature decrease the solubility of the cancer drug paclitaxel in liposomes.

Paclitaxel (PTX) is a hydrophobic small-molecule cancer drug that loads into the membrane (tail) region of lipid carriers such as liposomes and micelles. The development of improved lipid-based carriers of PTX is an important objective to generate chemotherapeutics with fewer side effects. The lipids 1,2-dioleoyl-sn-glycero-3-phosphoethanolamine (DOPE) and glyceryl monooleate (GMO) show propensity for fusion with other lipid membranes, which has led to their use in lipid vectors of nucleic acids. We hypothesized that DOPE and GMO could enhance PTX delivery to cells through a similar membrane fusion mechanism. As an important measure of drug carrier performance, we evaluated PTX solubility in cationic liposomes containing GMO or DOPE. Solubility was determined by time-dependent kinetic phase diagrams generated from direct observations of PTX crystal formation using differential-interference-contrast optical microscopy. Remarkably, PTX was much less soluble in these liposomes than in control cationic liposomes containing univalent cationic lipid 1,2-dioleoyl-3-trimethylammonium-propane (DOTAP) and 1,2-dioleoyl-sn-glycero-3-phosphatidylcholine (DOPC), which are not fusogenic. In particular, PTX was not substantially soluble in GMO-based cationic liposomes. The fusogenicity of DOPE and GMO is related to the negative spontaneous curvature of membranes containing these lipids, which drives formation of nonlamellar self-assembled phases (inverted hexagonal or gyroid cubic). We used synchrotron small-angle x-ray scattering to determine whether PTX solubility is governed by lipid membrane structure (condensed with DNA in pellet form) or by local intermolecular interactions. The results suggest that local intermolecular interactions are of greater importance and that the negative spontaneous curvature-inducing lipids DOPE and GMO are not suitable components of lipid carriers for PTX delivery regardless of carrier structure.

Improved Detection of Fibrotic Nonalcoholic Fatty Liver Disease in Community-Based Referrals.

Background: Nonalcoholic fatty liver disease (NAFLD) is the leading cause of chronic liver disease with increasing rates globally. Patients with type 2 diabetes mellitus have higher risk of developing NAFLD. Patients with a higher degree of liver fibrosis in NAFLD are at an increased risk for liver-related mortality, but get missed easily during the referral process. This project aims to improve early detection and linkage-to-care of fibrotic NAFLD patients. Methods: We utilized a combination of automated electronic health record (EHR)-based fibrosis (FIB)-4 score and directed provider education. A health-system wide FIB-4 score calculator that providers can easily add to their workflow for NAFLD patient triaging. Data were analyzed at 6 and 12 months after implementation. Results: Postimplementation, there was an increase in patients referred to hepatology with higher degree of liver fibrosis and decreased referral to hepatology with low risk of liver fibrosis, measured by FIB-4 score. At baseline, ∼55% of referred patient to hepatology had FIB-4 score <1.3 compared to 38% at 12 months postimplementation. There was an increase in referral of patients with FIB-4 scores >1.3 when compared to preinterventions, 62% versus 45%. This is most pronounced in patients with severe fibrotic disease with FIB-4 score >2.67, 30% versus 12%. Conclusions: Automated FIB-4 score in EHR can improve appropriate linkage-to-care for at-risk fibrotic NAFLD, especially when coupled with targeted provider education. The durability of such improvement is essential to study along with the need to increase broad acceptance across health systems.

The impact of relaxing restrictions on take-home doses during the COVID-19 pandemic on program effectiveness and client experiences in opioid agonist treatment: a mixed methods systematic review.

BACKGROUND: The COVID-19 pandemic led to an unprecedented relaxation of restrictions on take-home doses in opioid agonist treatment (OAT). We conducted a mixed methods systematic review to explore the impact of these changes on program effectiveness and client experiences in OAT. METHODS: The protocol for this review was registered in PROSPERO (CRD42022352310). From Aug.-Nov. 2022, we searched Medline, Embase, CINAHL, PsycInfo, Web of Science, Cochrane Register of Controlled Trials, and the grey literature. We included studies reporting quantitative measures of retention in treatment, illicit substance use, overdose, client health, quality of life, or treatment satisfaction or using qualitative methods to examine client experiences with take-home doses during the pandemic. We critically appraised studies using the Mixed Methods Appraisal Tool. We synthesized quantitative data using vote-counting by direction of effect and presented the results in harvest plots. Qualitative data were analyzed using thematic synthesis. We used a convergent segregated approach to integrate quantitative and qualitative findings. RESULTS: Forty studies were included. Most were from North America (23/40) or the United Kingdom (9/40). The quantitative synthesis was limited by potential for confounding, but suggested an association between take-home doses and increased retention in treatment. There was no evidence of an association between take-home doses and illicit substance use or overdose. Qualitative findings indicated that take-home doses reduced clients' exposure to unregulated substances and stigma and minimized work/treatment conflicts. Though some clients reported challenges with managing their medication, the dominant narrative was one of appreciation, reduced anxiety, and a renewed sense of agency and identity. The integrated analysis suggested reduced treatment burden as an explanation for improved retention and revealed variation in individual relationships between take-home doses and illicit substance use. We identified a critical gap in quantitative measures of patient-important outcomes. CONCLUSION: The relaxation of restrictions on take-home doses was associated with improved client experience and retention in OAT. We found no evidence of an association with illicit substance use or overdose, despite the expansion of take-home doses to previously ineligible groups. Including patient-important outcome measures in policy, program development, and treatment planning is essential to ensuring that decisions around take-home doses accurately reflect their value to clients.

The mobilization of nurse-client therapeutic relationships in injectable opioid agonist treatment: Autonomy, advocacy and action.

INTRODUCTION: Injectable opioid agonist treatment (iOAT) is an evidence-based treatment that serves an important minority of people with opioid use disorder who require specialized care. Unique to iOAT care is the consistency with which clients access treatment (up to three times daily), a condition that creates repeated opportunities for health care engagement. To date, no study has examined therapeutic relationships in this life saving, nurse-led treatment that can have lasting implications in the equitable delivery of other forms of addictions care. METHODS: This study used grounded theory to generate a dynamic framework for therapeutic relationship building in iOAT. Researchers collected semi-structured interviews from registered nurses working in iOAT sites (n=24) form January 2020 through June 2022. The study analyzed collected data through a constant comparative analysis; explored through open, axial, and selective coding; and assessed in a conditional relationship matrix. The team reviewed key findings with stakeholders through formalized processes of engagement to confirm saturation of coding categories. Throughout data collection and analysis, researchers integrated feedback from additional knowledge users and member checking. Reported findings adhered to the COREQ1 standardized checklist. RESULTS: We identified five interrelated categories that created a distinct culture of care for iOAT nurses: Ways of Knowing, Personal Investment, Leveraging Empathy, Finding Flexibility, and Collaborating to Overcome. Through creating a safe, nonjudgmental environment, nurses establish therapeutic relationships that build trust to identify client needs outside of medication administration. In turn, nurses participate in team-based problem solving to advocate for client needs. If nurses cannot find flexibility within and outside of the health care system to improve client engagement, tensions can arise and therapeutic relationships can be strained. CONCLUSIONS: Therapeutic relationships are an integral part of building and maintaining trust with a population that has been precariously involved with other forms of health care. Nurses make a substantial effort to create a safe and nonjudgmental environment to manifest a culture of care that bridges client needs and program access. Without the expansion of access to iOAT programs and their embedded services, nurses are limited in their ability to provide individualized care for clients with diverse needs.

Clients' experiences on North America's first take-home injectable opioid agonist treatment (iOAT) program: a qualitative study.

BACKGROUND: To support public health measures during the COVID-19 pandemic, oral opioid agonist treatment (OAT) take-home doses were expanded in Western countries with positive results. Injectable OAT (iOAT) take-home doses were previously not an eligible option, and were made available for the first time in several sites to align with public health measures. Building upon these temporary risk-mitigating guidelines, a clinic in Vancouver, BC continued to offer two of a possible three daily doses of take-home injectable medications to eligible clients. The present study explores the processes through which take-home iOAT doses impacted clients' quality of life and continuity of care in real-life settings. METHODS: Three rounds of semi-structured qualitative interviews were conducted over a period of seventeen months beginning in July 2021 with eleven participants receiving iOAT take-home doses at a community clinic in Vancouver, British Columbia. Interviews followed a topic guide that evolved iteratively in response to emerging lines of inquiry. Interviews were recorded, transcribed, and then coded using NVivo 1.6 using an interpretive description approach. RESULTS: Participants reported that take-home doses granted them the freedom away from the clinic to have daily routines, form plans, and enjoy unstructured time. Participants appreciated the greater privacy, accessibility, and ability to engage in paid work. Furthermore, participants enjoyed greater autonomy to manage their medication and level of engagement with the clinic. These factors contributed to greater quality of life and continuity of care. Participants shared that their dose was too essential to divert and that they felt safe transporting and administering their medication off-site. In the future, all participants would like more accessible treatment such as access longer take-home prescriptions (e.g., one week), the ability to pick-up at different and convenient locations (e.g., community pharmacies), and a medication delivery service. CONCLUSIONS: Reducing the number of daily onsite injections from two or three to only one revealed the diversity of rich and nuanced needs that added flexibility and accessibility in iOAT can meet. Actions such as licencing diverse opioid medications/formulations, medication pick-up at community pharmacies, and a community of practice that supports clinical decisions are necessary to increase take-home iOAT accessibility.

Changes in daily dose in open-label compared to double-blind: The role of clients' expectations in injectable opioid agonist treatment.

Introduction: Though double-blind studies have indicated that hydromorphone and diacetylmorphine produce similar effects when administered through injectable opioid agonist treatment (iOAT) programs, participant preference may influence some aspects of medication dispensation such as dose. Methods:  This is a retrospective longitudinal analysis. Participants (n = 131) were previously enrolled in a double-blind clinical trial for iOAT who continued to receive treatment in an open-label follow up study. Data included medication dispensation records from 2012 to 2020. Using linear regression and paired t-tests, average daily dose totals of hydromorphone and diacetylmorphine were examined comparatively between double-blind and open-label periods. A subgroup analysis explored dose difference by preference using the proxy, blinding guess, a variable used to facilitate the measurement of treatment masking during the clinical trial by asking which medication the participant thought they received. Results: During the open-label period, participants prescribed diacetylmorphine received 49.5 mg less than during the double-blind period (95% CI -12.6,-86.4). Participants receiving hydromorphone did not see a significant dose decrease. Participants who guessed they received hydromorphone during the clinical trial, but learned they were on diacetylmorphine during the open-label period, saw a decrease in total daily dose of 78.3 mg less (95% CI -134.3,-22.4) during the open-label period. Conclusion: If client preference is considered in the treatment of chronic opioid use disorder, clients may be able to better moderate their dose to suit their individual needs. Together with their healthcare providers, clients can participate in their treatment trajectories collaboratively to optimize client outcomes and promote person-centered treatment options.