Influences on recruitment to randomised controlled trials in mental health settings in England: a national cross-sectional survey of researchers working for the Mental Health Research Network

Background: Recruitment to trials is complex and often protracted; selection bias may compromise generalisability. In the mental health field (as elsewhere), diverse factors have been described as hindering researcher access to potential participants and various strategies have been proposed to overcome barriers. However, the extent to which various influences identified in the literature are operational across mental health settings in England has not been systematically examined. Methods: A cross-sectional, online survey of clinical studies officers employed by the Mental Health Research Network in England to recruit to trials from National Health Service mental health services. The bespoke questionnaire invited participants to report exposure to specified influences on recruitment, the perceived impact of these on access to potential participants, and to describe additional positive or negative influences on recruitment. Analysis employed descriptive statistics, the framework approach and triangulation of data. Results: Questionnaires were returned by 98 (58%) of 170 clinical studies officers who reported diverse experience. Data demonstrated a disjunction between policy and practice. While the particulars of trial design and various marketing and dommunication strategies could influence recruitment, consensus was that the culture of NHS mental health services is not donducive to research. Since financial rewards for recruitment paid to Trusts and feedback about studies seldom reaching frontline services, clinicians were described as distanced from research. Facing continual service change and demanding clinical workloads, clinicians generally did not prioritise recruitment activities. Incentives to trial participants had variable impact on access but recruitment could be enhanced by engagement of senior investigators and integrating referral with routine practice. Comprehensive, robust feasibility studies and reciprocity between researchers and clinicians were considered crucial to successful recruitment. Conclusions: In the mental health context, researcher access to potential trial participants is multiply influenced. Gatekeeping clinicians are faced with competing priorities and resources constrain research activity. It seems that environmental adjustment predicated on equitable resource allocation is needed if clinicians in NHS mental health services are to fully support the conduct of randomised controlled trials. Whilst cultural transformation, requiring changes in assumptions and values, is complex, our findings suggest that attention to practical matters can support this and highlight issues requiring careful consideration

Use of contingency management incentives to improve completion of hepatitis B vaccination in people undergoing treatment for heroin dependence: a cluster randomised trial

Background: Poor adherence to treatment diminishes its individual and public health benefit. Financial incentives, provided on the condition of treatment attendance, could address this problem. Injecting drug users are a high-risk group for hepatitis B virus (HBV) infection and transmission, but adherence to vaccination programmes is poor. We aimed to assess whether contingency management delivered in routine clinical practice increased the completion of HBV vaccination in individuals receiving opioid substitution therapy. Methods: In our cluster randomised controlled trial, we enrolled participants at 12 National Health Service drug treatment services in the UK that provided opioid substitution therapy and nurse-led HBV vaccination with a super-accelerated schedule (vaccination days 0, 7, and 21). Clusters were randomly allocated 1:1:1 to provide vaccination without incentive (treatment as usual), with fixed value contingency management (three £10 vouchers), or escalating value contingency management (£5, £10, and £15 vouchers). Both contingency management schedules rewarded on-time attendance at appointments. The primary outcome was completion of clinically appropriate HBV vaccination within 28 days. We also did sensitivity analyses that examined vaccination completion with full adherence to appointment times and within a 3 month window. The trial is registered with Current Controlled Trials, number ISRCTN72794493. Findings: Between March 16, 2011, and April 26, 2012, we enrolled 210 eligible participants. Compared with six (9%) of 67 participants treated as usual, 35 (45%) of 78 participants in the fixed value contingency management group met the primary outcome measure (odds ratio 12·1, 95% CI 3·7–39·9; p<0·0001), as did 32 (49%) of 65 participants in the escalating value contingency management group (14·0, 4·2–46·2; p<0·0001). These differences remained significant with sensitivity analyses. Interpretation: Modest financial incentives delivered in routine clinical practice significantly improve adherence to, and completion of, HBV vaccination programmes in patients receiving opioid substitution therapy. Achievement of this improvement in routine clinical practice should now prompt actual implementation. Drug treatment providers should employ contingency management to promote adherence to vaccination programmes. The effectiveness of routine use of contingency management to achieve long-term behaviour change remains unknown

Using a pragmatically adapted, low-cost contingency management intervention to promote heroin abstinence in individuals undergoing treatment for heroin use disorder in UK drug services (PRAISE): a cluster randomised trial

Introduction: Most individuals treated for heroin use disorder receive opioid agonist treatment (OAT)(methadone or buprenorphine). However, OAT is associated with high attrition and persistent, occasional heroin use. There is some evidence for the effectiveness of contingency management (CM), a behavioural intervention involving modest financial incentives, in encouraging drug abstinence when applied adjunctively with OAT. UK drug services have a minimal track record of applying CM and limited resources to implement it. We assessed a CM intervention pragmatically adapted for ease of implementation in UK drug services to promote heroin abstinence among individuals receiving OAT. Design: Cluster randomised controlled trial. Setting and participants: 552 adults with heroin use disorder (target 660) enrolled from 34 clusters (drug treatment clinics) in England between November 2012 and October 2015. Interventions: Clusters were randomly allocated 1:1:1 to OAT plus 12× weekly appointments with: (1) CM targeted at opiate abstinence at appointments (CM Abstinence); (2) CM targeted at on-time attendance at appointments (CM Attendance); or (3) no CM (treatment as usual; TAU). Modifications included monitoring behaviour weekly and fixed incentives schedule. Measurements: Primary outcome: heroin abstinence measured by heroin-free urines (weeks 9–12). Secondary outcomes: heroin abstinence 12 weeks after discontinuation of CM (weeks 21–24); attendance; self-reported drug use, physical and mental health. Results: CM Attendance was superior to TAU in encouraging heroin abstinence. Odds of a heroin-negative urine in weeks 9–12 was statistically significantly greater in CM Attendance compared with TAU (OR=2.1; 95% CI 1.1 to 3.9; p=0.030). CM Abstinence was not superior to TAU (OR=1.6; 95% CI 0.9 to 3.0; p=0.146) or CM Attendance (OR=1.3; 95% CI 0.7 to 2.4; p=0.438) (not statistically significant differences). Reductions in heroin use were not sustained at 21–24 weeks. No differences between groups in self-reported heroin use. Conclusions: A pragmatically adapted CM intervention for routine use in UK drug services was moderately effective in encouraging heroin abstinence compared with no CM only when targeted at attendance. CM targeted at abstinence was not effective. Trial registration number: ISRCTN 01591254

Key Management for Secure Multicast in Hybrid Satellite Networks

This paper proposes a design for key management for secure multicast in hybrid satellite networks. Communication satellites offer an efficient way to extend IP multicast services for groups in wide-area networks. In order to be commercially viable, the multicast traffic should be accessible only to paying subscribers. Access control can be achieved by data encryption. This requires secure and efficient methods to generate, distribute and update the keys. Most current key management protocols do not scale well when applied to large dynamic groups in wide-area networks. This paper attempts to solve the above problem for groups in a hybrid network that is composed of terrestrial Ethernet LANs interconnected by ATM-based satellite channels. We investigate current group key management protocols, and design a framework for secure and scalable key management for the multicast routing architecture in the satellite network. The proposed framework is presented in detail, alongwith analysis and simulation results

Positive reinforcement targeting abstinence in substance misuse (PRAISe): Study protocol for a Cluster RCT &amp; process evaluation of contingency management

There are approximately 256,000 heroin and other opiate users in England of whom 155,000 are in treatment for heroin (or opiate) addiction. The majority of people in treatment receive opiate substitution treatment (OST) (methadone and buprenorphine). However, OST suffers from high attrition and persistent heroin use even whilst in treatment. Contingency management (CM) is a psychological intervention based on the principles of operant conditioning. It is delivered as an adjunct to existing evidence based treatments to amplify patient benefit and involves the systematic application of positive reinforcement (financial or material incentives) to promote behaviours consistent with treatment goals. With an international evidence base for CM, NICE recommended that CM be implemented in UK drug treatment settings alongside OST to target attendance and the reduction of illicit drug use. While there was a growing evidence base for CM, there had been no examination of its delivery in UK NHS addiction services. The PRAISe trial evaluates the feasibility, acceptability, clinical and cost effectiveness of CM in UK addiction services. It is a cluster randomised controlled effectiveness trial of CM (praise and financial incentives) targeted at either abstinence from opiates or attendance at treatment sessions versus no CM among individuals receiving OST. The trial includes an economic evaluation which explores the relative costs and cost effectiveness of the two CM intervention strategies compared to TAU and an embedded process evaluation to identify contextual factors and causal mechanisms associated with variations in outcome. This study will inform UK drug treatment policy and practice. Trial registration ISRCTN 01591254

Using a pragmatically adapted, low-cost contingency management intervention to promote heroin abstinence in individuals undergoing treatment for heroin use disorder in UK drug services (PRAISE): a cluster randomised trial

Introduction: Most individuals treated for heroin use disorder receive opioid agonist treatment (OAT)(methadone or buprenorphine). However, OAT is associated with high attrition and persistent, occasional heroin use. There is some evidence for the effectiveness of contingency management (CM), a behavioural intervention involving modest financial incentives, in encouraging drug abstinence when applied adjunctively with OAT. UK drug services have a minimal track record of applying CM and limited resources to implement it. We assessed a CM intervention pragmatically adapted for ease of implementation in UK drug services to promote heroin abstinence among individuals receiving OAT. Design: Cluster randomised controlled trial. Setting and participants: 552 adults with heroin use disorder (target 660) enrolled from 34 clusters (drug treatment clinics) in England between November 2012 and October 2015. Interventions: Clusters were randomly allocated 1:1:1 to OAT plus 12× weekly appointments with: (1) CM targeted at opiate abstinence at appointments (CM Abstinence); (2) CM targeted at on-time attendance at appointments (CM Attendance); or (3) no CM (treatment as usual; TAU). Modifications included monitoring behaviour weekly and fixed incentives schedule. Measurements: Primary outcome: heroin abstinence measured by heroin-free urines (weeks 9–12). Secondary outcomes: heroin abstinence 12 weeks after discontinuation of CM (weeks 21–24); attendance; self-reported drug use, physical and mental health. Results: CM Attendance was superior to TAU in encouraging heroin abstinence. Odds of a heroin-negative urine in weeks 9–12 was statistically significantly greater in CM Attendance compared with TAU (OR=2.1; 95% CI 1.1 to 3.9; p=0.030). CM Abstinence was not superior to TAU (OR=1.6; 95% CI 0.9 to 3.0; p=0.146) or CM Attendance (OR=1.3; 95% CI 0.7 to 2.4; p=0.438) (not statistically significant differences). Reductions in heroin use were not sustained at 21–24 weeks. No differences between groups in self-reported heroin use. Conclusions: A pragmatically adapted CM intervention for routine use in UK drug services was moderately effective in encouraging heroin abstinence compared with no CM only when targeted at attendance. CM targeted at abstinence was not effective. Trial registration number: ISRCTN 01591254

Health care professionals’ perspectives on the secondary use of health records to improve quality and safety of care in England: qualitative study

Background: Health care professionals (HCPs) are often patients’ first point of contact in what concerns the communication of the purposes, benefits, and risks of sharing electronic health records (EHRs) for nondirect care purposes. Their engagement is fundamental to ensure patients’ buy-in and a successful implementation of health care data sharing schemes. However, their views on this subject are seldom evaluated. Objective: This study aimed to explore HCPs’ perspectives on the secondary uses of health care data in England. Specifically, we aimed to assess their knowledge on its purposes and the main concerns about data sharing processes. Methods: A total of 30 interviews were conducted between March 27, 2017, and April 7, 2017, using a Web-based interview platform and following a topic guide with open-ended questions. The participants represented a variety of geographic locations across England (London, West Midlands, East of England, North East England, and Yorkshire and the Humber), covering both primary and secondary care services. The transcripts were compiled verbatim and systematically reviewed by 2 independent reviewers using the framework analysis method to identify emerging themes. Results: HCPs were knowledgeable about the possible secondary uses of data and highlighted its importance for patient profiling and tailored care, research, quality assurance, public health, and service delivery planning purposes. Main concerns toward data sharing included data accuracy, patients’ willingness to share their records, challenges on obtaining free and informed consent, data security, lack of adequacy or understanding of current policies, and potential patient exposure and exploitation. Conclusions: These results suggest a high level of HCPs’ understanding about the purposes of data sharing for secondary purposes; however, some concerns still remain. A better understanding of HCPs’ knowledge and concerns could inform national communication policies and improve tailoring to maximize efficiency and improve patients’ buy-in

Key Management Schemes for Stateless Receivers Based on Time Varying Heterogeneous Logical Key Hierarchy

Abstract. This paper proposes a family of key management schemes for broadcast encryption based on a novel underlying structure- Time Varying Heterogeneous Logical Key Hierarchy (TVH-LKH). Note that the main characteristics of the previously reported key management schemes include the following: employment of a static underlying structure for key management, and addressing the subset covering problem over the entire underlying structure. Oppositely, the main underlying ideas for developing of the novel key management schemes based on TVH-LKH include the following: (i) employment of a reconfigurable underlying structure; and (ii) employment of a divide-and-conquer approach related to the underlying structure and an appropriate communications-storageprocessing trade-off (for example, a small increase of the communication overload and large reduction of the storage and processing overload) for addressing the subset covering problem and optimization of the overloads. The design is based on a set of ”static ” keys at a receiver (stateless receiver) which are used in all possible reconfiguration of the underlying structure for key management, and accordingly, in a general case, a key plays different roles depending on the employed underlying structure. A particular family of the components for developing TVH-LKH, is also proposed and discussed. The proposed technique is compared with the recently reported schemes, and the advantages of the novel one are pointed out