Inequity in clinical research access for service users presenting comorbidity within alcohol treatment settings: findings from a focused ethnographic study.

BACKGROUND: While healthcare policy has fostered implementation strategies to improve inclusion and access of under-served groups to clinical care, systemic and structural elements still disproportionately prevent service users from accessing research opportunities embedded within clinical settings. This contributes to the widening of health inequalities, as the absence of representativeness prevents the applicability and effectiveness of evidence-based interventions in under-served clinical populations. The present study aims to identify the individual (micro), organisational (meso) and structural (macro) barriers to clinical research access in patients with comorbid alcohol use disorder and alcohol-related liver disease. METHODS: A focused ethnography approach was employed to explore the challenges experienced by patients in the access to and implementation of research processes within clinical settings. Data were collected through an iterative-inductive approach, using field notes and patient interview transcripts. The framework method was utilised for data analysis, and themes were identified at the micro, meso and macro levels. RESULTS: At the micro-level, alcohol-related barriers included encephalopathy and acute withdrawal symptoms. Alcohol-unrelated barriers also shaped the engagement of service users in research. At the meso-level, staff and resource pressures, as well as familiarity with clinical and research facilities were noted as influencing intervention delivery and study retention. At the wider, macro-level, circumstances including the 'cost of living crisis' and national industrial action within healthcare settings had an impact on research processes. The findings emphasise a 'domino effect' across all levels, demonstrating an interplay between individual, organisational and structural elements influencing access to clinical research. CONCLUSIONS: A combination of individual, organisational and structural barriers, exacerbated by the COVID-19 pandemic, and the socioeconomic landscape in which the study was conducted further contributed to the unequal access of under-served groups to clinical research participation. For patients with comorbid alcohol use disorder and alcohol-related liver disease, limited access to research further contributes towards a gap in effective evidence-based treatment, exacerbating health inequalities in this clinical population.

A study protocol for a European, mixed methods, prospective, cohort study of the effectiveness of naloxone administration by community members, in reversing opioid overdose: NalPORS.

BACKGROUND: Worldwide, opioid use causes more than 100,000 overdose deaths annually. Naloxone has proven efficacy in reversing opioid overdoses and is approved as an emergency antidote to opioid overdose. Take home naloxone (THN) programmes have been introduced to provide 'community members', who are likely to observe opioid overdoses, with naloxone kits and train them to recognise an overdose and administer naloxone. The acceptability and feasibility of THN programmes has been demonstrated, but the real-life effectiveness of naloxone administration by community members is not known. In recent years, the approval of several concentrated naloxone nasal-spray formulations (in addition to injectable formulations, eg.prenoxad) potentially increases acceptability and scope for wider provision. This study aims to determine the effectiveness of THN (all formulations) in real-world conditions. METHODS: A European, multi-country, prospective cohort study, to assess the use of THN by community members to reverse opioid overdoses in a six-month, follow-up period. Participants provided with THN from participating harm reduction and drug treatment sites will be recruited to the study and followed-up for six months. We are particularly interested in the experiences of community members who have been provided with THN and have witnessed an opioid overdose. All participants who witness an opioid overdose during the six-month period (target approx. 600) will be asked to take part in a structured interview about this event. Of these, 60 will be invited to participate in a qualitative interview. A Post Authorisation Efficacy Study (PAES) for the concentrated nasal naloxone, Nyxoid, has been integrated into the study design. DISCUSSION: There are many challenges involved in evaluating the real-life effectiveness of THN. It is not possible to use a randomised trial design, recruitment of community members provided with THN will depend upon recruitment sites distributing THN kits, and the type of THN received by participants will depend on regulations and on local clinical and policy decision-makers. Following up this population, some of whom may be itinerant, over the 6-month study period will be challenging, but we plan to maintain contact with participants through regular text message reminders and staff contact. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05072249. Date of Registration: 8.10.2021.

Non-Prescribed Substance Use during the First Month of Treatment by People Receiving Depot Buprenorphine for Opioid Use Disorder.

Background: Non-prescribed substance use (NPSU) during the treatment of opioid use disorder (OUD) is a recognized phenomenon. The use of non-prescribed substances is associated with discontinuing treatment and drop-out can occur within the early weeks of treatment, before benefit from treatment occurs. Recent developments in treatment include long-acting, slow-release depot buprenorphine injections. This article focuses on NPSU during the first month of treatment with depot buprenorphine, addressing the frequency with which it occurs, the substances used, and reasons for use. Methods: 70 semi-structured interviews (held at three time-points) were conducted with 26 patients initiating depot buprenorphine as part of a longitudinal qualitative study. Analysis prioritized content and framework analyses. Findings: 17/26 participants self-reported NPSU at various times during the first month of treatment. NPSU typically involved heroin, crack-cocaine and some use of benzodiazepines and/or cannabis. Participants' reasons for heroin use were connected to their subjective accounts of opioid withdrawal symptoms, the management of pain, and experimentation (to test the blockade effect of buprenorphine). Frequency of heroin use was typically episodic rather than sustained. Participants associated crack-cocaine use with stimulant-craving and social connections, and considered their use of this substance to be difficult to manage. Conclusions: Patients' initial engagement with treatment for OUD is rarely examined in qualitative research. This study highlights how NPSU amongst patients receiving new forms of such treatment continues to be a challenge. As such, shared decision-making (between providers and patients) regarding treatment goals and NPSU should be central to the delivery of depot buprenorphine treatment programmes.

Inflammatory diseases in hematology: a review.

Hematopoietic cells are instrumental in generating and propagating protective inflammatory responses to infection or injury. However, excessive inflammation contributes to many diseases of the blood, bone marrow, and lymphatic system. We review three clinical categories of hematological inflammatory diseases in which recent clinical and translational advances have been made. The first category is monogenic inflammatory diseases. Genotype-driven research has revealed that previously mysterious diseases with protean manifestations are characterized by mutations that may be germline (e.g., deficiency of ADA2 or GATA2 deficiency) or somatic [e.g., vacuoles, enzyme E1, X-linked, autoinflammatory, somatic (VEXAS) syndrome]. The second category is the cytokine storm syndromes, including hemophagocytic lymphohistiocytosis, and Castleman disease. Cytokine storm syndromes are characterized by excessive production of inflammatory cytokines including interleukin-6 and interferon-γ, causing end-organ damage and high mortality. Finally, we review disorders associated with monoclonal and polyclonal hypergammaglobulinemia. The serum protein electrophoresis (SPEP) is typically ordered to screen for common diseases such as myeloma and humoral immunodeficiency. However, monoclonal and polyclonal hypergammaglobulinemia on SPEP can also provide important information in rare inflammatory diseases. For example, the autoinflammatory disease Schnitzler syndrome is notoriously difficult to diagnose. Although this orphan disease has eluded precise genetic or histological characterization, the presence of a monoclonal paraprotein, typically IgM, is an obligate diagnostic criterion. Likewise, polyclonal hypergammaglobulinemia may be an important early, noninvasive diagnostic clue for patients presenting with rare neoplastic diseases such as Rosai-Dorfman disease and angioimmunoblastic T-cell lymphoma. Applying these three categories to patients with unexplained inflammatory syndromes can facilitate the diagnosis of rare and underrecognized diseases.

Emotional reactions of trained overdose responders who use opioids following intervention in an overdose event.

Background: Our aim was to explore emotional reactions to intervening in an overdose event from the perspective of individuals who use opioids (peer responders). In addition, we were interested in the impact this experience may have on peer responders' feelings about helping in an overdose situation in the future. Methods: For this qualitative sub-study of a randomized controlled trial (RCT), data from 61 interviews were analyzed thematically using an inductive approach. Results: Peer responders had diverse emotional reactions to the overdose event. These ranged from a sense of pride and other positive feelings associated with their ability to help to ambivalence about being involved in situations perceived as challenging and burdensome. There were few reports of the overdose event as an exclusively negative experience. Many peer responders perceived it as their duty to use naloxone again if required. However, some had ambivalent feelings toward this responsibility, which may be related to negative experiences with previous intervention efforts. Conclusions: The capacity of people who use opioids to help reduce the harms associated with opioid overdose is experienced as empowering by some. Nonetheless, engaging peer responders in strategies to reduce opioid-related mortality should be coupled with appropriate resources to process their experiences and emotional responses.

Wild data: how front-line hospital staff make sense of patients' experiences.

Patient-centred care has become the touchstone of healthcare policy in developed healthcare systems. The ensuing commodification of patients' experiences has resulted in a mass of data but little sense of whether and how such data are used. We sought to understand how front-line staff use patient experience data for quality improvement in the National Health Service (NHS). We conducted a 12-month ethnographic case study evaluation of improvement projects in six NHS hospitals in England in 2016-2017. Drawing on the sociology of everyday life, we show how front-line staff worked with a notion of data as interpersonal and embodied. In addition to consulting organisationally sanctioned forms of data, staff used their own embodied interactions with patients, carers, other staff and the ward environment to shape improvements. The data staff found useful involved face-to-face interaction and dialogue; were visual, emotive, and allowed for immediate action. We draw on de Certeau to re-conceptualise this as 'wild data'. We conclude that patient experience data are relational, and have material, social and affective dimensions, which have been elided in the literature to date. Practice-based theories of the everyday help to envision 'patient experience' not as a disembodied tool of managerialism but as an embedded part of healthcare staff professionalism.

Identification of factors influencing tampering of codeine-containing medicines in England: a qualitative study.

BACKGROUND: Tampering of psychoactive medicines presents challenges to regulation and public health. However, little is currently known about what influences the decisions to treat codeine-containing medicines (CCM) with cold water extraction (CWE) from the perspective of individuals employing these techniques. The article identifies factors influencing utilisation of CWE to separate codeine from compounded analgesics, such as paracetamol and ibuprofen, found in CCM. METHODS: Purposive sampling of 27 participants residing in England who took part in a qualitative interview. Of these, 14 individuals (11 males and 3 females) reported tampering of psychoactive medicines, and the relevant transcripts were included in the analyses for the study. Participants were recruited from one addiction treatment service and from an online survey. The mean age of the participants was 31.5 years (range = 18-42 years). Qualitative data analysis followed the processes of iterative categorization (IC). The codes 'harm reduction', 'information sources' and 'changes on the drug markets' were grouped and summarised. The coding of the data was done in a Microsoft® Word document. RESULTS: Two groups of participants were identified in the data analysis: (i) individuals who used CCM (n = 5), and (ii) individuals who used CCM and heroin (n = 9). Participants in both groups used CWE due to concerns of paracetamol overdose from the use of excessive dosages of CCM. For both of them, information obtained from the internet encouraged the use of CWE. Participants using CCM described how the many steps involved in conducting CWE, including sourcing codeine boxes from pharmacies (over the counter), presented a barrier against using CWE. Participants using CCM and heroin explained how reduced availability in the local heroin supply influenced utilisation of CWE techniques to maintain their use of opioids and avoid withdrawal. Withdrawal symptoms and cravings outweighed the concerns about the quality of the extracted codeine mixtures in this participant group, especially the ability of CWE to remove paracetamol and tablet fillers. CONCLUSIONS: Utilisation of CWE of codeine was influenced by several factors including drug market supply, the availability of detailed information on the internet about CWE and restrictions on codeine sourcing in pharmacies. Risks identified with CWE include consumption of unknown doses of paracetamol if the CWE techniques are not used correctly. Attempts at extracting codeine from CCM should be considered in risk assessments of opioid medicines.

Implementing new care models: learning from the Greater Manchester demonstrator pilot experience.

BACKGROUND: Current health policy focuses on improving accessibility, increasing integration and shifting resources from hospitals to community and primary care. Initiatives aimed at achieving these policy aims have supported the implementation of various 'new models of care', including general practice offering 'additional availability' appointments during evenings and at weekends. In Greater Manchester, six 'demonstrator sites' were funded: four sites delivered additional availability appointments, other services included case management and rapid response. The aim of this paper is to explore the factors influencing the implementation of services within a programme designed to improve access to primary care. The paper consists of a qualitative process evaluation undertaken within provider organisations, including general practices, hospitals and care homes. METHODS: Semi-structured interviews, with the data subjected to thematic analysis. RESULTS: Ninety-one people participated in interviews. Six key factors were identified as important for the establishment and running of the demonstrators: information technology; information governance; workforce and organisational development; communications and engagement; supporting infrastructure; federations and alliances. These factors brought to light challenges in the attempt to provide new or modify existing services. Underpinning all factors was the issue of trust; there was consensus amongst our participants that trusting relationships, particularly between general practices, were vital for collaboration. It was also crucial that general practices trusted in the integrity of anyone external who was to work with the practice, particularly if they were to access data on the practice computer system. A dialogical approach was required, which enabled staff to see themselves as active rather than passive participants. CONCLUSIONS: The research highlights various challenges presented by the context within which extended access is implemented. Trust was the fundamental underlying issue; there was consensus amongst participants that trusting relationships were vital for effective collaboration in primary care.

'Matters-of-concern' associated with discontinuation of long-acting injectable buprenorphine: Findings from a longitudinal qualitative study.

BACKGROUND: Discontinuation of medications such as methadone and buprenorphine amongst patients receiving opioid agonist treatment (OAT) is an international phenomenon. Recent developments in OAT medication include depot-injections of buprenorphine. Circumstances underlying discontinuation of these new formulations of medication are not fully understood from a qualitative perspective. METHODS: Data derive from a longitudinal qualitative study of patients' experience of long-acting injectable buprenorphine (LAIB), involving semi-structured telephone-interviews held at six-points in time. The relevant dataset for this article consists of 44 interview transcripts, generated from 8 participants who were each affected by discontinuation of LAIB prescriptions (during the first 12-months of treatment). Analyses sought to identify circumstances associated with LAIB discontinuation and data were further situated within a framework of 'evidence making intervention' and associated 'matters-of-concern'. Matters-of-concern relate to the ways in which an intervention is 'made' and constructed through engagement and practice, from the perspective of the recipient. FINDINGS: In this study, participants experienced either 'discontinuation of LAIB prescriptions by treatment services' or patient-led 'opt-out' from treatment. Matters-of-concern underlying the former were associated with late attendance for scheduled appointments, non-prescribed substance use or receiving a custodial sentence. Matters-of-concern relating to patient-initiated discontinuation were associated with personal circumstances that affected treatment motivation, side-effects (of buprenorphine), a preference to resume heroin use, or because individual treatment goals had been achieved. CONCLUSION: The assorted matters-of-concern that influence discontinuation of LAIB demonstrate that such OAT is complex and multi-faceted, is neither fixed nor stable, and does not generate universally shared outcome. Experiences of LAIB discontinuation are shaped by a wide range of social, temporal and treatment-related effects that include disconnected therapeutic alliance between patient and treatment providers. In order to maximise the benefits of LAIB it is necessary to develop meaningful therapeutic alliances (notwithstanding policy boundaries) to enable exploration of matters-of-concern during treatment.

Use of Transdermal Alcohol Sensors in Conjunction With Contingency Management to Reduce Alcohol Consumption in People With Alcohol Dependence Attending Alcohol Treatment Services: Protocol for a Pilot Feasibility Randomized Controlled Trial.

BACKGROUND: Wearable technology for objective, continuous, and reliable alcohol monitoring has been developed. These are known as transdermal alcohol sensors (TASs). They can be worn on the wrist or ankle with the sensor pressed against the skin and can measure sweat vapors being emitted from the skin, to record transdermal alcohol concentration (TAC). Previous studies have investigated the accuracy and acceptability of the available TAS brands, but there has been little research into their use in people with alcohol use disorders (AUD). OBJECTIVE: This feasibility randomized controlled trial aims to explore the feasibility, strengths, and limitations of using a TAS to monitor alcohol consumption in individuals in treatment for AUD with or without contingency management (CM) to promote abstinence or low-level alcohol consumption. METHODS: The target sample size is 30 (15 randomized to each group). Participants will be recruited through poster adverts at alcohol services. Both groups (control and CM) will wear the TAS (BACtrack Skyn) for 2 weeks in the context of their usual treatment, meeting with the researcher every other weekday. In the last meeting, the participants will complete a postwear survey on their experience of wearing the TAS. The CM group will also receive small financial incentives for low or no alcohol consumption, as measured by the TAS. On days where the TAC peak is below a set threshold (<115.660 g/L), CM group participants will be rewarded with a £5 (US $6.38) voucher. There are financial bonuses if this target is achieved on consecutive days. The researcher will monitor TAC for each day of the study at each research visit and allocate financial incentives to participants according to a set reinforcement schedule. RESULTS: The first participant was enrolled in June 2023, and the last in December 2023. Data analysis is underway and is estimated to be completed by June 2024. A total of 32 participants were enrolled. CONCLUSIONS: Most TAS brands have had limited application in clinical settings, and most studies have included healthy adults rather than people with AUD. TAS has the potential to enhance treatment outcomes in clinical alcohol treatment. The accuracy, acceptability, and feasibility of TAS for people with AUD in clinical settings need to be investigated. This is the first study to use TAS in specialized alcohol services with diagnosed AUD individuals currently receiving treatment from a south London alcohol service. TRIAL REGISTRATION: ISRCTN Registry ISRCTN46845361; https://www.isrctn.com/ISRCTN46845361. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/57653.

A qualitative exploration of the experiences of transdermal alcohol sensor devices amongst people in receipt of treatment for alcohol use disorder.

Introduction: Transdermal alcohol sensors (TAS) have the potential to be used as a clinical tool in alcohol treatment, but there is limited research with individuals with alcohol dependence using TAS. Our study is a qualitative evaluation of the views of people attending alcohol treatment and their experiences of wearing the BACtrack Skyn, within alcohol services in South London. Methods: Participants with alcohol dependence wore a BACtrack Skyn TAS for one week and met with the researcher every two days, for a total of four meetings (for example: Monday, Wednesday, Friday, and Monday). In the final meeting, a post-wear survey (on their physical, social and comfort experience of the TAS) and semi-structured interview were completed. The Technology Acceptance Model (TAM) informed the topic guide and data analysis. Results: Adults (N = 16) receiving alcohol treatment were recruited. Three core topics guided analysis: perceived usefulness, perceived ease of use and attitudes towards use. Participants found the TAS easy to wear and felt positive about its appearance and comfort. The only challenges reported were side effects, mostly skin irritation. The main two perceived uses were 1) TAS working as a drinking deterrent and 2) reducing daily breathalyser visits during detox. Conclusion: Findings support the use of TAS amongst alcohol service users. Wearing the TAS for one week was acceptable and feasible for objective alcohol concentration measurement. Participants reported high perceived ease of use and usefulness of the Skyn in the context of alcohol treatment. These results are encouraging for the use of TAS in clinical settings.

Treatment engagement in comorbid alcohol use disorder and alcohol-related liver disease: A qualitative exploration of barriers and facilitators with service users.

BACKGROUND: Effective interventions to improve patient outcomes in comorbid alcohol use disorder (AUD) and alcohol-related liver disease (ARLD) remain a clinical unmet need. While the choice of abstinence is the cornerstone for the prevention of disease progression and mortality, evidence suggests a suboptimal engagement with treatment supporting recovery. This qualitative investigation aims to understand barriers and facilitators to treatment as experienced by this clinical population by applying a multidimensional adherence model proposed by the World Health Organization. METHODS: Twenty-four participants with comorbid AUD and ARLD were recruited from an inpatient clinical setting. Data for this study were collected through semistructured, in-depth interviews. Deductive analysis was organized by the Framework method, and theory-driven themes were identified according to the multidimensional adherence model. This included factors across the social and economic, patient, condition, treatment, and healthcare system levels. RESULTS: The findings in this study indicate systematic challenges in maintaining continuity between primary, secondary, and community care. Aspects related to social and economic context, treatment, and healthcare systems were found to hinder engagement. Identified facilitators to engagement included the participatory role of family, shared lived experience of addiction/recovery, and therapeutic alliance with healthcare providers. CONCLUSION: The understanding of these barriers and facilitators from a service user's perspective can bridge the treatment gap for this clinical population. This can provide an opportunity for the implementation of effective interventions and inform the development of policies promoting accessible care. Government and public health bodies have fundamental roles in shifting treatment paradigms in comorbid AUD and ARLD.

Voucher-based contingency management to promote treatment engagement in comorbid alcohol use disorder and alcohol-related liver disease: A pilot theory-informed qualitative study with service users.

BACKGROUND: Effective interventions for the management of alcohol-related liver disease (ARLD) remain a gap in clinical practice, and patients' engagement with alcohol services is suboptimal. Based upon the principles of operant conditioning, contingency management (CM) is a psychosocial intervention th at involves gradual, increasing incentives upon completion of treatment-related goals such as treatment attendance. METHODS: A pilot feasibility trial was conducted with 30 adult patients recruited from an inpatient clinical setting. Consecutive sampling was used to recruit patients presenting comorbid alcohol use disorder (AUD) and ARLD. Participants were randomized to integrated liver care (ILC), receiving hepatology and AUD care, or ILC with a voucher-based CM intervention (intervention arm). A longitudinal qualitative approach was adopted to explore anticipated (Stage 1) and experienced acceptability (Stage 2). The Theoretical Framework of Acceptability (TFA) guided semi-structured in-depth interviews and deductive analysis. RESULTS: Thirty participants were enrolled in the pilot trial, and interviews were conducted with 24 participants at Stage 1 and seven at Stage 2. Over half of the cohort (54.2%, n = 13) presented decompensated liver disease, and an average of 179 units of alcohol were consumed per week. Overall positive views toward voucher-based CM were noted, and explanatory data emerged across five TFA domains (intervention coherence, ethicality, self-efficacy, perceived effectiveness, and affective attitude). The core aspects of the voucher-based CM intervention matched participants' preferences and needs. Participants regarded CM as having a symbolic value and strengthening the therapeutic alliance with healthcare providers. CONCLUSION: The data support the scope of voucher-based CM intervention to promote engagement with treatment services, and its potential to address the gaps in the care continuum in ARLD. The findings are of practical significance for developing person-centered, tailored interventions for this clinical population. The outcomes of this investigation can inform decision-making among stakeholders and healthcare providers and improve health outcomes for this clinical population.

Comparison of transdermal alcohol concentration and self-reported alcohol consumption in people with alcohol dependence attending community alcohol treatment services.

AIM: We aimed to assess the accuracy and wearability of a transdermal alcohol sensor (TAS) (BACtrack Skyn) with people currently receiving treatment at alcohol services. METHOD: A mixed methods observational study involving three NHS alcohol services in south London was conducted. All participants (7=male, 9=female) wore a TAS for 1 week and met with the researcher every other weekday to complete the TAS data download and a TimeLine Follow Back (TLFB). At the end of the week, a post-wear survey was completed. Transdermal Alcohol Concentration (TAC) from the TAS was compared to the TLFB. Post-wear survey responses, attendance voucher incentives and descriptive TAS data (removals, missing and skin temperature data) were analysed. We investigated different drinking event thresholds changing the criteria of TAC level and length of time TAC was increased and analysed each drinking threshold sensitivity, specificity, positive and negative predicative values, and percentage accuracy classification. RESULTS: The TAS recorded the number of alcohol-drinking days with a high degree of accuracy compared to the TLFB as gold-standard. However, of the participation time of the 16 participants, 14.5% of the TAS data was missing in output and 16.4% of the recorded data suggests the TAS was not currently being worn. Of the data recorded, in line with the drinking event threshold of >15 ug/l TAC, >15minutes, we found that sensitivity = 93%, specificity = 84% and a Pearson correlation of r(16) =.926, p = <.001, BCa 95% CI [.855 -.981]. The threshold with the highest accuracy was TAC>15 ug/l, >60minutes which classified alcohol events with 90% accuracy, AUC =.910, sensitivity = 90%, specificity = 96%. The post-wear survey reported that most participants found it comfortable and that wearing it did not interfere with daily activities. Six participants reported side effects, including itching and a rash, but these would not deter them from wearing it again with all six reporting they would wear the TAS again and for longer than one week. CONCLUSIONS: The TAS did not capture every drinking event that was self-reported but maintained a high correlation. There were instances of missing TAS data and TAS removals. Overall, our findings would support the acceptability and feasibility of TAS as a tool that could be used in clinical settings for objective alcohol monitoring with patients being responsible for the TAS.

Belantamab mafodotin, pomalidomide, and dexamethasone for triple class exposed/refractory relapsed multiple myeloma: a subgroup analysis of the ALGONQUIN trial.

Given the early use of triplet and quadruplet regimens, most patients with multiple myeloma (MM) will be exposed and/or refractory to PIs, IMiDs, and anti-CD38 mAbs after first- or second-line treatment. Effective treatment for this group of triple class exposed/refractory (TCE/R) patients is crucial. Here we present a post-hoc subgroup analysis of TCE/R patients treated on the ALGONQUIN study of belantamab mafodotin plus pomalidomide-dexamethasone (belamaf-Pd) for relapsed MM. Of the 99 patients treated on the ALGONQUIN study, 69 were TCE and 56 were TCR and were included in this analysis. Patients had a median of three prior lines of therapy. The ORR was 86.4% in TCE patients and 84.9% in TCR patients, with ≥ very good partial response rates of 64% and 68% respectively. The median progression free survival was 18.3 months in TCE patients and 19.6 months in TCR patients, with overall survival not yet reached and 34.4 months, respectively for TCE and TCR patients. No new safety signals were identified. The most common Grade ≥ 3 AEs were keratopathy (48%), decreased visual acuity (42%), neutropenia (36%), thrombocytopenia (27%), and infection (25%). In this subgroup analysis of the ALGONQUIN study, patients with TCE/TCR disease treated with belamaf-Pd achieved high clinical response rates with durable remissions, comparable to other novel therapeutics in this space.

Belantamab mafodotin, pomalidomide and dexamethasone in refractory multiple myeloma: a phase 1/2 trial.

Due to evolving treatment standards for newly diagnosed multiple myeloma, many patients will be triple-class exposed after initial relapses and have poor survival. Novel therapies and combinations are therefore required to improve outcomes. B cell maturation antigen (BCMA)-targeted biologics have emerged as an important new area of therapeutics for relapsed multiple myeloma. The two-part ALGONQUIN trial evaluated various doses and schedules of the anti-BCMA antibody-drug conjugate belantamab mafodotin plus pomalidomide and dexamethasone for patients who are lenalidomide refractory and proteosome inhibitor exposed. The primary endpoints, including evaluating dose-limiting toxicities, establishing the recommended Part 2 dose (RP2D) and overall response rate for patients treated at the RP2D, were met. Secondary efficacy endpoints included progression-free survival and overall survival. Patients treated on study (N = 87) had a median of three previous regimens and 55.2% were triple-class refractory. At the RP2D the most common adverse events were decrease in best-corrected visual acuity (71.1%), keratopathy (65.8%), fatigue (57.9%), infection (47.4%; 7.9% grade ≥3), neutropenia (39.5%) and thrombocytopenia (39.5%). For RP2D patients (n = 38), the overall response rate was 85.3%, ≥very good partial response 75.7% and estimated two-year progression-free survival 52.8% (95% confidence interval, 33.9% to 82.4%), at a median follow-up of 13.9 months. The RP2D schedule was associated with manageable antibody-drug conjugate-associated corneal adverse events and improved tolerability without compromising efficacy. Belantamab mafodotin plus pomalidomide and dexamethasone induced durable responses with promising overall survival in relapsed multiple myeloma, the results of which are yet to be confirmed in the phase 3 DREAMM-8 study. ClinicalTrials.gov Identifier: NCT03715478 .

Conceptualising retention in treatment with long-acting injectable buprenorphine (for opioid use disorder) as a journey: Findings from a longitudinal qualitative study.

BACKGROUND: Conceptualisations of the 'patient journey' are popular within health service research. Patient journeys provide a person-centred approach to health care that typically prioritise subjective patient experience with the aim of improving relevant forms of intervention. This article explores the conceptualisation of retention in treatment for opioid use disorder (OUD) using long-acting injectable buprenorphine (LAIB) as a journey. METHODS: Data derive from a longitudinal qualitative study, involving semi-structured interviews (held at six time-points), with participants who each initiated LAIB for the first time. Data analysis for this article focuses exclusively upon the experiences of those who had continued with LAIB treatment throughout one year (11 participants). Framework and thematic narrative analyses of 64 interviews with 11 participants sought to identify 'retention-narratives' that would indicate a 'retention journey' associated with LAIB treatment. FINDINGS: Shared treatment experiences consisted of three distinct phases (Withdrawal and Separation, Transformation, and Engagement) that progressed in a linear and intersecting manner through time. Each phase had features that defined treatment experiences at a given time but changed as treatment progressed. All 11 participants experienced multiple features within each of the three treatment phases and all participants reported separation from their respective service provider throughout the first 12 months of treatment. Although some valued the latter separation, most were dissatisfied by reduced levels of contact. CONCLUSION: Retention in treatment for OUD with LAIB, for at least 12-months, can be conceptualised as a journey. This conceptualisation emphasises the benefits (and challenges) clinicians and patients may expect to encounter during the first year of a LAIB treatment programme. An added implication of conceptualising LAIB treatment in this manner is that optimal benefits of the medication (as observed by participants) began to emerge during 'months 7-12' of the retention journey.

Patients' goals when initiating long-acting injectable buprenorphine treatment for opioid use disorder: findings from a longitudinal qualitative study.

BACKGROUND: Long-acting injectable buprenorphine (LAIB) is a new treatment for opioid use disorder that has been introduced against an international policy backdrop of recovery and person-centred care. This paper explores the goals that people want to achieve from LAIB to identify potential implications for policy and practice. METHODS: Data derive from longitudinal qualitative interviews conducted with 26 people (18 male; 8 female) initiating LAIB in England and Wales, UK (June 2021-March 2022). Participants were interviewed up to five times by telephone over six months (107 interviews in total). Transcribed interview data relating to each participant's treatment goals were coded, summarised in Excel, and then analysed via a process of Iterative Categorization. RESULTS: Participants often articulated a desire to be abstinent without defining exactly what they meant by this. Most intended to reduce their dosage of LAIB but did not want to rush. Although participants seldom used the term 'recovery', almost all identified objectives consistent with current definitions of this concept. Participants articulated broadly consistent goals over time, although some extended the timeframes for achieving treatment-related goals at later interviews. At their last interview, most participants remained on LAIB, and there were reports that the medication was enabling positive outcomes. Despite this, participants were aware of the complex personal, service-level, and situational factors that hindered their treatment progress, understood the additional support they needed to achieve their goals, and voiced frustrations when services failed them. CONCLUSIONS: There is a need for wider debate regarding the goals people initiating LAIB are seeking and the diverse range of positive treatment outcomes LAIB could potentially generate. Those providing LAIB should offer regular on-going contact and other forms of non-medical support so that patients have the best opportunity to succeed. Policies relating to recovery and person-centred care have previously been criticised for responsibilising patients and service users to take better care of themselves and to change their own lives. In contrast, our findings suggest that these policies may, in fact, be empowering people to expect a greater range of support as part of the package of care they receive from service providers.

How do patients feel during the first 72 h after initiating long-acting injectable buprenorphine? An embodied qualitative analysis.

BACKGROUND AND AIMS: Long-acting injectable buprenorphine (LAIB) is a new treatment for opioid use disorder that is generating positive outcomes. Negative effects are typically mild and transient, but can occasionally be serious, resulting in treatment discontinuation/non-adherence. This paper aims to analyse patients' accounts of how they felt during the first 72 h after initiating LAIB. METHODS: Semi-structured interviews were conducted (June 2021-March 2022) with 26 people (18 males and 8 females) who had started LAIB within the previous 72 h. Participants were recruited from treatment services in England and Wales and were interviewed by telephone using a topic guide. Interviews were audio-recorded, transcribed and coded. The concepts of embodiment and embodied cognition framed the analyses. Data on participants' substance use, initiation onto LAIB and feelings were tabulated. Next, participants' accounts of how they felt were analysed following the stages of Iterative Categorization. RESULTS: Participants reported complex combinations of changing negative and positive feelings. Bodily experiences included withdrawal symptoms, poor sleep, injection-site pain/soreness, lethargy and heightened senses inducing nausea ('distressed bodies'), but also enhanced somatic wellbeing, improved sleep, better skin, increased appetite, reduced constipation and heightened senses inducing pleasure ('returning body functions'). Cognitive responses included anxiety, uncertainties and low mood/depression ('the mind in crisis') and improved mood, greater positivity and reduced craving ('feeling psychologically better'). Whereas most negative effects reported are widely recognized, the early benefits of treatment described are less well-documented and may be an overlooked distinctive feature of LAIB. CONCLUSIONS: During the first 72 h after initiating long-acting injectable buprenorphine, new patients report experiencing a range of interconnected positive and negative short-term effects. Providing new patients with information about the range and nature of these effects can prepare them for what to expect and help them manage feelings and reduce anxiety. In turn, this may increase medication adherence.

A critical analysis of respondent quotes used as titles of qualitative research papers that are published in peer-reviewed journals.

The use of respondent quotes to headline qualitative research papers is a popular literary device found in many academic journals. This practice has increased over the last four decades and now appears normalised within qualitative research writing. This article provides a critical analysis of this trend in academic writing and concomitant publishing. Content and framework analyses of 40 papers employing this literary device to summarise the respective studies identified (i) a lack of methodological rigor, (ii) incomplete analysis, (iii) an overall mis-representation of the wider qualitative dataset, and (iv) possible investigator bias associated with using respondent quotes as titles of qualitative research papers. This article questions the credibility of purposely selecting a single experience that reduces the wider collective experience into one deterministic statement. This article contends that such practice is antithetical to the principles of qualitative research. Recommendations are provided to better monitor this practice throughout the academy.