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Addressing the growing threat of antimicrobial resistance is, in part, reliant on the complex challenge of changing human behaviour-in terms of reducing inappropriate antibiotic use and preventing infection. Whilst there is no 'one size fits all' recommended behavioural solution for improving antimicrobial stewardship, the behavioural and social sciences offer a range of theories, frameworks, methods and evidence-based principles that can help inform the design of behaviour change interventions that are context-specific and thus more likely to be effective. However, the state-of-the-art in antimicrobial stewardship research and practice suggests that behavioural and social influences are often not given due consideration in the design and evaluation of interventions to improve antimicrobial prescribing. In this paper, we discuss four potential areas where the behavioural and social sciences can help drive more effective and sustained behaviour change in antimicrobial stewardship: (i) defining the problem in behavioural terms and understanding current behaviour in context; (ii) adopting a theory-driven, systematic approach to intervention design; (iii) investigating implementation and sustainability of interventions in practice; and (iv) maximizing learning through evidence synthesis and detailed intervention reporting. [ABSTRACT FROM AUTHOR]

Objectives: The Demand-Control (DC) and Effort-Reward Imbalance (ERI) models predict health in a work context. Self-report measures of the four key constructs (demand, control, effort, and reward) have been developed and it is important that these measures have good content validity uncontaminated by content from other constructs. We assessed relevance (whether items reflect the constructs) and representativeness (whether all aspects of the construct are assessed, and all items contribute to that assessment) across the instruments and items.Methods: Two studies examined fourteen demand/control items from the Job Content Questionnaire and seventeen effort/reward items from the Effort-Reward Imbalance measure using discriminant content validation and a third study developed new methods to assess instrument representativeness. Both methods use judges' ratings and construct definitions to get transparent quantitative estimates of construct validity. Study 1 used dictionary definitions while studies 2 and 3 used published phrases to define constructs.Results: Overall, 3/5 demand items, 4/9 control items, 1/6 effort items, and 7/11 reward items were uniquely classified to the appropriate theoretical construct and were therefore 'pure' items with discriminant content validity (DCV). All pure items measured a defining phrase. However, both the DC and ERI assessment instruments failed to assess all defining aspects.Conclusions: Finding good discriminant content validity for demand and reward measures means these measures are usable and our quantitative results can guide item selection. By contrast, effort and control measures had limitations (in relevance and representativeness) presenting a challenge to the implementation of the theories. Statement of contribution What is already known on this subject? While the reliability and construct validity of Demand-Control and Effort-Reward-Imbalance (DC and ERI) work stress measures are routinely reported, there has not been adequate investigation of their content validity. This paper investigates their content validity in terms of both relevance and representativeness and provides a model for the investigation of content validity of measures in health psychology more generally. What does this study add? A new application of an existing method, discriminant content validity, and a new method of assessing instrument representativeness. 'Pure' DC and ERI items are identified, as are constructs that are not fully represented by their assessment instruments. The findings are important for studies attempting to distinguish between the main DC and ERI work stress constructs. The quantitative results can be used to guide item selection for future studies. [ABSTRACT FROM AUTHOR]

Introduction: This paper is a report on a study exploring a potential typology of primary care patients referred for integrated behavioral health care (IBHC) services. We considered whether primary care patients could be grouped into meaningful clusters based on perceived need for behavioral health services, barriers to accessing care, and past-year service utilization. We also described the development of a working partnership between our university-based research team and a federally qualified health center (FQHC).Method: A total of 105 adult primary care patients referred for same-day behavioral health appointments completed a brief self-report questionnaire assessing past-year behavioral health concerns, service utilization, and perceived barriers to utilization.Results: Hierarchical and k-means cluster analyses revealed 3 groups: (a) Well-Served patients, characterized by high perceived need for services, high service use, and low barriers to service use (40%); (b) Underserved patients, characterized by high perceived need, low service utilization, and high barriers to service use (20%); and (c) Subclinical patients, characterized by low perceived need, low service use, and low barriers to service use (20%). Clusters were reliably differentiated by age, primary language, insurance status, and global functioning.Discussion: We found primary care patients could be grouped into 3 categories and that 60% (Underserved and Subclinical) represented groups less commonly seen in traditional mental health (MH) settings. IBHC may be a promising approach for extending the reach of MH care, and partnerships between FQHCs and university-based research teams may be a promising approach for conducting research on the IBHC service-delivery model. (PsycINFO Database Record [ABSTRACT FROM AUTHOR]

Introduction: A practice embarks on a radical reformulation of how care is designed and delivered when it decides to integrate medical and behavioral health care for its patients and success depends on managing complex change in a complex system. We examined the ways change is managed when integrating behavioral health and medical care.Method: Observational cross-case comparative study of 19 primary care and community mental health practices. We collected mixed methods data through practice surveys, observation, and semistructured interviews. We analyzed data using a data-driven, emergent approach.Results: The change management strategies that leadership employed to manage the changes of integrating behavioral health and medical care included: (a) advocating for a mission and vision focused on integrated care; (b) fostering collaboration, with a focus on population care and a team-based approaches; (c) attending to learning, which includes viewing the change process as continuous, and creating a culture that promoted reflection and continual improvement; (d) using data to manage change, and (e) developing approaches to finance integration.Discussion: This paper reports the change management strategies employed by practice leaders making changes to integrate care, as observed by independent investigators. We offer an empirically based set of actionable recommendations that are relevant to a range of leaders (policymakers, medical directors) and practice members who wish to effectively manage the complex changes associated with integrated primary care. (PsycINFO Database Record [ABSTRACT FROM AUTHOR]

Interest and incentives are increasing around strategies whereby the health care sector can better identify and address patients' social and economic needs in the context of primary care delivery. This interest is likely to accelerate during the economic recession following the OVID-19 pandemic. Yet effective and sustainable strategies for integrating social care practices (eg, patient-facing social risk screening and activities to address identified needs) have not been clearly established. Lessons learned from more than 2 decades of research on behavioral health integration could be applied to efforts to integrate social care into primary care. In this article, we synthesize learnings from primary care and behavioral health care integration, and translate them into organizing principles with the goal of advancing social care integration practices to improve the health of both patients and communities. [ABSTRACT FROM AUTHOR]

Objective: This systematic review examined the impact of health homes on cardiometabolic risk among adults with serious mental illness.Methods: The Preferred Reporting Items for Systematic Reviews and Meta-Analyses procedures were used to conduct the systematic review. Databases were searched for peer-reviewed articles published between 1946 and August 2018 that compared health homes with a control condition (e.g., usual care and secondary data analyses using matched samples). Participants, interventions, comparisons, outcomes, and study design criteria were used to assess study eligibility. Studies were assessed for methodological quality by using the Quality Assessment of Before and After Studies With No Control Group and the Quality Assessment of Controlled Intervention Studies.Results: Eighteen studies (i.e., 11 observational studies, four quasi-experimental studies, and three randomized controlled trials) reported on 17 health homes. Most studies reported increases in receipt of screening for cardiometabolic risk factors and service use. There was a modest reduction in selected cardiometabolic risk factors among people with serious mental illness, but clinical outcomes varied widely among studies.Conclusions: Improvement in cardiometabolic risk factors varied across the studies, and the clinical significance of these reductions was not clear. Peer support and self-management training may represent strategies to improve cardiometabolic risk factors. Colocation of services may not be enough to significantly affect cardiometabolic risk factors. Health homes that include standardized screening, peer support and self-management training, and intervention components that target interdependent risk factors may have a greater impact on clinical outcomes. [ABSTRACT FROM AUTHOR]

Background: China has witnessed a rapid increase of cesarean section (CS) rates in recent years. Several non-clinical factors have been cited as contributing to this trend including maternal request and perceived convenience. We aimed to assess preferences for mode of delivery and reasons for preferences for CS in China to inform the development of future interventions to mitigate unnecessary CSs, which are those performed in the absence of medical indications.Methods and Findings: We conducted a mixed-methods systematic review and included longitudinal, cross-sectional, and qualitative studies in mainland China, Hong Kong, and Taiwan that investigated preferences for mode of delivery among women and family members and health professionals, and the reasons underlying such preferences. We searched MEDLINE/PubMed, Embase, CINAHL, POPLINE, PsycINFO, Global Health Library, and one Chinese database (CNKI) using a combination of the key terms 'caesarean section', 'preference', 'choice', 'knowledge', 'attitude', 'culture', 'non-clinical factors', and 'health professionals-patient relations' between 1990 and 2018 without language restriction. Meta-analysis of quantitative studies and meta-synthesis of qualitative studies were applied. We included 66 studies in this analysis: 47 quantitative and 19 qualitative. For the index pregnancy, the pooled proportions of preference for CS reported by women in longitudinal studies were 14% in early or middle pregnancy (95% CI 12%-17%) and 21% in late pregnancy (95% CI 15%-26%). In cross-sectional studies, the proportions were 17% in early or middle pregnancy (95% CI 14%-20%), 22% in late pregnancy (95% CI 18%-25%), and 30% postpartum (95% CI 19%-40%). Women's preferences for CS were found to rise as pregnancy progressed (preference change across longitudinal studies: mean difference 7%, 95% CI 1%-13%). One longitudinal study reported that the preference for CS among women's partners increased from 8% in late pregnancy to 17% in the immediate postpartum period. In addition, 18 quantitative studies revealed that some pregnant women, ranging from 4% to 34%, did not have a straightforward preference for a mode of delivery, even in late pregnancy. The qualitative meta-synthesis found that women's perceptions of CS as preferable were based on prioritising the baby's and woman's health and appeared to intensify through interactions with the health system. Women valued the convenience of bypassing labour because of fear of pain, antagonistic relations with providers, and beliefs of deteriorating quality of care during labour and vaginal birth, fostering the feeling that CS was the safest option. Health professionals' preference for CS was influenced by financial drivers and malpractice fears. This review has some limitations, including high heterogeneity (despite subgroup and sensitivity analysis) in the quantitative analysis, and the potential for over-reporting of women's preferences for CS in the qualitative synthesis (due to some included studies only including women who requested CS).Conclusions: Despite a minority of women expressing a preference for CS, individual, health system, and socio-cultural factors converge, contributing to a high CS rate in mainland China, Hong Kong, and Taiwan. In order to reduce unnecessary CSs, interventions need to address all these non-clinical factors and concerns.Systematic Review Registry: Prospero CRD42016036596. [ABSTRACT FROM AUTHOR]

Background: How can we use stories from other people to promote better health experiences, improve judgments about health, and increase the quality of medical decisions without introducing bias, systematically persuading the listeners to change their attitudes, or altering behaviors in nonoptimal ways? More practically, should narratives be used in health education, promotion, or behavior change interventions?Method: In this article, we address these questions by conducting a narrative review of a diverse body of literature on narratives from several disciplines to gain a better understanding about what narratives do, including their role in communication, engagement, recall, persuasion, and health behavior change. We also review broad theories about information processing and persuasion from psychology and more specific models about narrative messaging found in the health communication and marketing literatures to provide insight into the processes by which narratives have their effect on health behavior.Results: To address major gaps in our theoretical understanding about how narratives work and what effects they will have on health behavior, we propose the Narrative Immersion Model, whose goal is to identify the parameters that predict the specific impact of a particular narrative (e.g. persuade, inform, comfort, etc.) based on the type of narrative message (e.g. process, experience, or outcome narrative). Further, the Narrative Immersion Model describes the magnitude of the effect as increasing through successive layers of engagement with the narrative: interest, identification, and immersion. Finally, the Narrative Immersion Model identifies characteristics of the narrative intervention that encourage greater immersion within a given narrative.Conclusions: We believe there are important communication gaps in areas areas of behavioral medicine that could be addressed with narratives; however, more work is needed in order to employ narrative messaging systematically. The Narrative Immersion Model advances our theoretical understanding about narrative processing and its subsequent effects on knowledge, attitudes, and behavior. [ABSTRACT FROM AUTHOR]

Background: Tobacco addiction is a complex, multicomponent phenomenon stemming from nicotine's pharmacology and the user's biology, psychology, sociology, and environment. After decades of public denial, the tobacco industry now agrees with public health authorities that nicotine is addictive. In 2000, Philip Morris became the first major tobacco company to admit nicotine's addictiveness. Evolving definitions of addiction have historically affected subsequent policymaking. This article examines how Philip Morris internally conceptualized addiction immediately before and after this announcement.Methods and Findings: We analyzed previously secret, internal Philip Morris documents made available as a result of litigation against the tobacco industry. We compared these documents to public company statements and found that Philip Morris's move from public denial to public affirmation of nicotine's addictiveness coincided with pressure on the industry from poor public approval ratings, the Master Settlement Agreement (MSA), the United States government's filing of the Racketeer Influenced and Corrupt Organizations (RICO) suit, and the Institute of Medicine's (IoM's) endorsement of potentially reduced risk products. Philip Morris continued to research the causes of addiction through the 2000s in order to create successful potentially reduced exposure products (PREPs). While Philip Morris's public statements reinforce the idea that nicotine's pharmacology principally drives smoking addiction, company scientists framed addiction as the result of interconnected biological, social, psychological, and environmental determinants, with nicotine as but one component. Due to the fragmentary nature of the industry document database, we may have missed relevant information that could have affected our analysis.Conclusions: Philip Morris's research suggests that tobacco industry activity influences addiction treatment outcomes. Beyond nicotine's pharmacology, the industry's continued aggressive advertising, lobbying, and litigation against effective tobacco control policies promotes various nonpharmacological determinants of addiction. To help tobacco users quit, policy makers should increase attention on the social and environmental dimensions of addiction alongside traditional cessation efforts. [ABSTRACT FROM AUTHOR]

Background: Early childhood interventions have potential to offset the negative impact of early adversity. We evaluated the impact of a community-based parenting group intervention on child development in Zambia.Methods and Findings: We conducted a non-masked cluster-randomized controlled trial in Southern Province, Zambia. Thirty clusters of villages were matched based on population density and distance from the nearest health center, and randomly assigned to intervention (15 clusters, 268 caregiver-child dyads) or control (15 clusters, 258 caregiver-child dyads). Caregivers were eligible if they had a child 6 to 12 months old at baseline. In intervention clusters, caregivers were visited twice per month during the first year of the study by child development agents (CDAs) and were invited to attend fortnightly parenting group meetings. Parenting groups selected "head mothers" from their communities who were trained by CDAs to facilitate meetings and deliver a diverse parenting curriculum. The parenting group intervention, originally designed to run for 1 year, was extended, and households were visited for a follow-up assessment at the end of year 2. The control group did not receive any intervention. Intention-to-treat analysis was performed for primary outcomes measured at the year 2 follow-up: stunting and 5 domains of neurocognitive development measured using the Bayley Scales of Infant and Toddler Development-Third Edition (BSID-III). In order to show Cohen's d estimates, BSID-III composite scores were converted to z-scores by standardizing within the study population. In all, 195/268 children (73%) in the intervention group and 182/258 children (71%) in the control group were assessed at endline after 2 years. The intervention significantly reduced stunting (56/195 versus 72/182; adjusted odds ratio 0.45, 95% CI 0.22 to 0.92; p = 0.028) and had a significant positive impact on language (β 0.14, 95% CI 0.01 to 0.27; p = 0.039). The intervention did not significantly impact cognition (β 0.11, 95% CI -0.06 to 0.29; p = 0.196), motor skills (β -0.01, 95% CI -0.25 to 0.24; p = 0.964), adaptive behavior (β 0.21, 95% CI -0.03 to 0.44; p = 0.088), or social-emotional development (β 0.20, 95% CI -0.04 to 0.44; p = 0.098). Observed impacts may have been due in part to home visits by CDAs during the first year of the intervention.Conclusions: The results of this trial suggest that parenting groups hold promise for improving child development, particularly physical growth, in low-resource settings like Zambia.Trial Registration: ClinicalTrials.gov NCT02234726. [ABSTRACT FROM AUTHOR]

Background: Poor early childhood development (ECD) in low- and middle-income countries is a major concern. There are calls to universalise access to ECD interventions through integrating them into existing government services but little evidence on the medium- or long-term effects of such scalable models. We previously showed that a psychosocial stimulation (PS) intervention integrated into a cash transfer programme improved Colombian children's cognition, receptive language, and home stimulation. In this follow-up study, we assessed the medium-term impacts of the intervention, 2 years after it ended, on children's cognition, language, school readiness, executive function, and behaviour.Methods and Findings: Study participants were 1,419 children aged 12-24 months at baseline from beneficiary households of the cash transfer programme, living in 96 Colombian towns. The original cluster randomised controlled trial (2009-2011) randomly allocated the towns to control (N = 24, n = 349), PS (N = 24, n = 357), multiple micronutrient (MN) supplementation (N = 24, n = 354), and combined PS and MN (N = 24, n = 359). Interventions lasted 18 months. In this study (26 September 2013 to 11 January 2014), we assessed impacts on cognition, language, school readiness, executive function, and behaviour 2 years after intervention, at ages 4.5-5.5 years. Testers, but not participants, were blinded to treatment allocation. Analysis was on an intent-to-treat basis. We reassessed 88.5% of the children in the original study (n = 1,256). Factor analysis of test scores yielded 2 factors: cognitive (cognition, language, school readiness, executive function) and behavioural. We found no effect of the interventions after 2 years on the cognitive factor (PS: -0.031 SD, 95% CI -0.229-0.167; MN: -0.042 SD, 95% CI -0.249-0.164; PS and MN: -0.111 SD, 95% CI -0.311-0.089), the behavioural factor (PS: 0.013 SD, 95% CI -0.172-0.198; MN: 0.071 SD, 95% CI -0.115-0.258; PS and MN: 0.062 SD, 95% CI -0.115-0.239), or home stimulation. Study limitations include that behavioural development was measured through maternal report and that very small effects may have been missed, despite the large sample size.Conclusions: We found no evidence that a scalable PS intervention benefited children's development 2 years after it ended. It is possible that the initial effects on child development were too small to be sustained or that the lack of continued impact on home stimulation contributed to fade out. Both are likely related to compromises in implementation when going to scale and suggest one should not extrapolate from medium-term effects of small efficacy trials to scalable interventions. Understanding the salient differences between small efficacy trials and scaled-up versions will be key to making ECD interventions effective tools for policymakers.Trial Registration: ISRCTN18991160. [ABSTRACT FROM AUTHOR]

Background: Eastern European countries have some of the highest rates of cardiovascular disease (CVD) mortality, much of which cannot be adequately accounted for by conventional CVD risk factors. Psychosocial and socioeconomic factors may affect risk of CVD, but relatively few studies on this issue have been undertaken in Eastern Europe. We investigated whether various psychosocial factors are associated with CVD mortality independently from each other and whether they can help explain differences in CVD mortality between Eastern European populations.Methods: Participants were from the Health, Alcohol and Psychological factors in Eastern Europe (HAPIEE) cohort study in Russia, Poland and the Czech Republic, including a total of 20,867 men and women aged 43-74 years and free of CVD at baseline examination during 2002-2005. Participants were followed-up for CVD mortality after linkage to national mortality registries for a median of 7.2 years.Results: During the follow-up, 556 participants died from CVD. After mutual adjustment, six psychosocial and socioeconomic factors were associated with increased risk of CVD death: unemployment, low material amenities, depression, being single, infrequent contacts with friends or relatives. The hazard ratios [HRs] for these six factors ranged between 1.26 [95% confidence interval 1.14-1.40] and 1.81 [95% confidence interval 1.24-2.64], fully adjusted for each other, and conventional cardiovascular risk factors. Population-attributable fractions ranged from 8% [4%-13%] to 22% [11%-31%] for each factor, when measured on average across the three cohorts. However, the prevalence of psychosocial and socioeconomic risk factors and their HRs were similar between the three countries. Altogether, these factors could not explain why participants from Russia had higher CVD mortality when compared to participants from Poland/Czech Republic. Limitations of this study include measurement error that could lead to residual confounding; and the possibilities for reverse causation and/or unmeasured confounding from observational studies to lead to associations that are not causal in nature.Conclusions: Six psychosocial and socioeconomic factors were associated with cardiovascular mortality, independent of each other. Differences in mortality between cohorts from Russia versus Poland or Check Republic remained unexplained. [ABSTRACT FROM AUTHOR]

Background: Neurogenic bladder dysfunction represents one of the most common and devastating sequelae of traumatic spinal cord injury (SCI). As early prediction of bladder outcomes is essential to counsel patients and to plan neurourological management, we aimed to develop and validate a model to predict urinary continence and complete bladder emptying 1 y after traumatic SCI.Methods and Findings: Using multivariate logistic regression analysis from the data of 1,250 patients with traumatic SCI included in the European Multicenter Spinal Cord Injury study, we developed two prediction models of urinary continence and complete bladder emptying 1 y after traumatic SCI and performed an external validation in 111 patients. As predictors, we evaluated age, gender, and all variables of the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) and of the Spinal Cord Independence Measure (SCIM). Urinary continence and complete bladder emptying 1 y after SCI were assessed through item 6 of SCIM. The full model relies on lower extremity motor score (LEMS), light-touch sensation in the S3 dermatome of ISNCSI, and SCIM subscale respiration and sphincter management: the area under the receiver operating characteristics curve (aROC) was 0.936 (95% confidence interval [CI]: 0.922-0.951). The simplified model is based on LEMS only: the aROC was 0.912 (95% CI: 0.895-0.930). External validation of the full and simplified models confirmed the excellent predictive power: the aROCs were 0.965 (95% CI: 0.934-0.996) and 0.972 (95% CI 0.943-0.999), respectively. This study is limited by the substantial number of patients with a missing 1-y outcome and by differences between derivation and validation cohort.Conclusions: Our study provides two simple and reliable models to predict urinary continence and complete bladder emptying 1 y after traumatic SCI. Early prediction of bladder function might optimize counselling and patient-tailored rehabilitative interventions and improve patient stratification in future clinical trials. [ABSTRACT FROM AUTHOR]

Background: Chronic musculoskeletal pain is the leading cause of disability worldwide. The effectiveness of pharmacological treatments for chronic pain is often limited, and there is growing concern about the adverse effects of these treatments, including opioid dependence. Nonpharmacological approaches to chronic pain may be an attractive alternative or adjunctive treatment. We describe the effectiveness of a novel, theoretically based group pain management support intervention for chronic musculoskeletal pain.Methods and Findings: We conducted a multi-centre, pragmatic, randomised, controlled effectiveness and cost-effectiveness (cost-utility) trial across 27 general practices and community musculoskeletal services in the UK. We recruited 703 adults with musculoskeletal pain of at least 3 mo duration between August 1, 2011, and July 31, 2012, and randomised participants 1.33:1 to intervention (403) or control (300). Intervention participants were offered a participative group intervention (COPERS) delivered over three alternate days with a follow-up session at 2 wk. The intervention introduced cognitive behavioural approaches and was designed to promote self-efficacy to manage chronic pain. Controls received usual care and a relaxation CD. The primary outcome was pain-related disability at 12 mo (Chronic Pain Grade [CPG] disability subscale); secondary outcomes included the CPG disability subscale at 6 mo and the following measured at 6 and 12 mo: anxiety and depression (Hospital Anxiety and Depression Scale [HADS]), pain acceptance (Chronic Pain Acceptance Questionnaire), social integration (Health Education Impact Questionnaire social integration and support subscale), pain-related self-efficacy (Pain Self-Efficacy Questionnaire), pain intensity (CPG pain intensity subscale), the census global health question (2011 census for England and Wales), health utility (EQ-5D-3L), and health care resource use. Analyses followed the intention-to-treat principle, accounted for clustering by course in the intervention arm, and used multiple imputation for missing or incomplete primary outcome data. The mean age of participants was 59.9 y, with 81% white, 67% female, 23% employed, 85% with pain for at least 3 y, and 23% on strong opioids. Symptoms of depression and anxiety were common (baseline mean HADS scores 7.4 [standard deviation 4.1] and 9.2 [4.6], respectively). Overall, 282 (70%) intervention participants met the predefined intervention adherence criterion. Primary outcome data were obtained from 88% of participants. There was no significant difference between groups in pain-related disability at 6 or 12 mo (12 mo: difference -1.0, intervention versus control, 95% CI -4.9 to 3.0), pain intensity, or the census global health question. Anxiety, depression, pain-related self-efficacy, pain acceptance, and social integration were better in the intervention group at 6 mo; at 12 mo, these differences remained statistically significant only for depression (-0.7, 95% CI -1.2 to -0.2) and social integration (0.8, 95% CI 0.4 to 1.2). Intervention participants received more analgesics than the controls across the 12 mo. The total cost of the course per person was £145 (US$214). The cost-utility analysis showed there to be a small benefit in terms of quality-adjusted life years (QALYs) (0.0325, 95% CI -0.0074 to 0.0724), and on the cost side the intervention was a little more expensive than usual care (i.e., £188 [US$277], 95% CI -£125 [-US$184] to £501 [US$738]), resulting in an incremental cost-effectiveness ratio of £5,786 (US$8,521) per QALY. Limitations include the fact that the intervention was relatively brief and did not include any physical activity components.Conclusions: While the COPERS intervention was brief, safe, and inexpensive, with a low attrition rate, it was not effective for reducing pain-related disability over 12 mo (primary outcome). For secondary outcomes, we found sustained benefits on depression and social integration at 6 and 12 mo, but there was no effect on anxiety, pain-related self-efficacy, pain acceptance, pain intensity, or the census global health question at 12 mo. There was some evidence that the intervention may be cost-effective based on a modest difference in QALYs between groups.Trial Registration: ISRCTN Registry 24426731. [ABSTRACT FROM AUTHOR]

Background: Sepsis has a mortality rate of 40 %, which can be halved if the evidence-based "Sepsis Six" care bundle is implemented within 1 h. UK audit shows low implementation rates. Interventions to improve this have had minimal effects. Quality improvement programmes could be further developed by using theoretical frameworks (Theoretical Domains Framework (TDF)) to modify existing interventions by identifying influences on clinical behaviour and selecting appropriate content. The aim of this study was to illustrate using this process to modify an intervention designed using plan-do-study-act (P-D-S-A) cycles that had achieved partial success in improving Sepsis Six implementation in one hospital.Methods: Factors influencing implementation were investigated using the TDF to analyse interviews with 34 health professionals. The nursing team who developed and facilitated the intervention used the data to select modifications using the Behaviour Change Technique (BCT) Taxonomy (v1) and the APEASE criteria: affordability, practicability, effectiveness, acceptability, safety and equity.Results: Five themes were identified as influencing implementation and guided intervention modification. These were:(1) "knowing what to do and why" (TDF domains knowledge, social/professional role and identity); (2) "risks and benefits" (beliefs about consequences), e.g. fear of harming patients through fluid overload acting as a barrier to implementation versus belief in the bundle's effectiveness acting as a lever to implementation; (3) "working together" (social influences, social/professional role and identity), e.g. team collaboration acting as a lever versus doctor/nurse conflict acting as a barrier; (4) "empowerment and support" (beliefs about capabilities, social/professional role and identity, behavioural regulation, social influences), e.g. involving staff in intervention development acting as a lever versus lack of confidence to challenge colleagues' decisions not to implement acting as a barrier; (5) "staffing levels" (environmental context and resources), e.g. shortages of doctors at night preventing implementation. The modified intervention included six new BCTs and consisted of two additional components (Sepsis Six training for the Hospital at Night Co-ordinator; a partnership agreement endorsing engagement of all clinical staff and permitting collegial challenge) and modifications to two existing components (staff education sessions; documents and materials).Conclusions: This work demonstrates the feasibility of the TDF and BCT Taxonomy (v1) for developing an existing quality improvement intervention. The tools are compatible with the pragmatic P-D-S-A cycle approach generally used in quality improvement work. [ABSTRACT FROM AUTHOR]