The effectiveness of chronic disease management planning on self-management among patients with diabetes at general practice settings in Australia: a scoping review.

BACKGROUND: Medicare provides significant funding to improve, encourage and coordinate better practices in primary care. Medicare-rebated Chronic Disease Management (CDM) plans are a structured approach to managing chronic diseases in Australia. These chronic disease care plans are intended to be a vehicle to deliver guideline-based / evidence-based care.. However, recommended care is not always provided, and health outcomes are often not achieved. This scoping review aimed to identify the specific components of CDM plans that are most effective in promoting self-management, as well as the factors that may hinder or facilitate the implementation of these plans in general practice settings in Australia. METHOD: A comprehensive search was conducted using multiple electronic databases, considering inclusion and exclusion criteria. Two reviewers independently screened the titles and abstracts of the identified studies via Covidence, and the full texts of eligible studies were reviewed for inclusion. A data extraction template was developed based on the Cochrane Effective Practice and Organization of Care Group (EPOC) to classify the intervention methods and study outcomes. A narrative synthesis approach was used to summarize the findings of the included studies. The quality of the included studies was assessed using the JBI Critical Appraisal Checklist. RESULTS: Seventeen articles were included in the review for analysis and highlighted the effectiveness of CDM plans on improving patient self-management. The findings demonstrated that the implementation of CDM plans can have a positive impact on patient self-management. However, the current approach is geared towards providing care to patients, but there are limited opportunities for patients to engage in their care actively. Furthermore, the focus is often on achieving the outcomes outlined in the CDM plans, which may not necessarily align with the patient's needs and preferences. The findings highlighted the significance of mutual obligations and responsibilities of team care for patients and healthcare professionals, interprofessional collaborative practice in primary care settings, and regular CDM plan reviews. CONCLUSION: Self-management support remains more aligned with a patient-centred collaboration approach and shared decision-making and is yet to be common practice. Identifying influential factors at different levels of patients, healthcare professionals, and services affecting patients' self-management via CDM plans can be crucial to developing the plans.

Immune and metabolic markers for identifying and investigating severe Coronavirus disease and Sepsis in children and young people (pSeP/COVID ChYP study): protocol for a prospective cohort study.

INTRODUCTION: Early recognition and appropriate management of paediatric sepsis are known to improve outcomes. A previous system's biology investigation of the systemic immune response in neonates to sepsis identified immune and metabolic markers that showed high accuracy for detecting bacterial infection. Further gene expression markers have also been reported previously in the paediatric age group for discriminating sepsis from control cases. More recently, specific gene signatures were identified to discriminate between COVID-19 and its associated inflammatory sequelae. Through the current prospective cohort study, we aim to evaluate immune and metabolic blood markers which discriminate between sepses (including COVID-19) from other acute illnesses in critically unwell children and young persons, up to 18 years of age. METHODS AND ANALYSIS: We describe a prospective cohort study for comparing the immune and metabolic whole-blood markers in patients with sepsis, COVID-19 and other illnesses. Clinical phenotyping and blood culture test results will provide a reference standard to evaluate the performance of blood markers from the research sample analysis. Serial sampling of whole blood (50 µL each) will be collected from children admitted to intensive care and with an acute illness to follow time dependent changes in biomarkers. An integrated lipidomics and RNASeq transcriptomics analyses will be conducted to evaluate immune-metabolic networks that discriminate sepsis and COVID-19 from other acute illnesses. This study received approval for deferred consent. ETHICS AND DISSEMINATION: The study has received research ethics committee approval from the Yorkshire and Humber Leeds West Research Ethics Committee 2 (reference 20/YH/0214; IRAS reference 250612). Submission of study results for publication will involve making available all anonymised primary and processed data on public repository sites. TRIAL REGISTRATION NUMBER: NCT04904523.

Evaluation of interprofessional student teams in the emergency department: opportunities and challenges.

BACKGROUND: Interprofessional education opportunities are commonly university-based and require further development during clinical practice. Many clinical contexts offer the potential for meaningful learning of both collaborative and discipline-specific practice. The emergency department (ED) demands efficient teamwork, so presents a logical location for interprofessional learning. METHODS: An interprofessional clinical placement program was implemented with the aim to enhance students' capacity and self-efficacy for collaborative practice. Fifty-five medical and nursing students participated as interdisciplinary pairs in a two-week clinical placement in the ED. Students' perceptions of the learning environment were measured pre- and post-placement with the Self-efficacy for Interprofessional Experiential Learning Scale and the Interprofessional Clinical Placement Learning Inventory was completed post-placement. Non-parametric tests were used to establish change differences. RESULTS: The Placement Learning Inventory revealed positive outcomes; the majority (16/19) agreed/agreed strongly that the placement provided sufficient learning opportunities, was interesting, and made them feel as if they belonged and most (14/19) reported they achieved the discipline specific learning objectives set by the university. Self-efficacy improved significantly (p = 0.017), showing promise for future use of the placement model Challenges were identified in the organisation and supervision of students. In the absence of additional dedicated student supervision, this model of interprofessional student pairs in the ED was challenging. CONCLUSIONS: Interprofessional clinical placements in ED are an effective clinical learning approach for final year undergraduate medicine and nursing students. Recommendations for improvements for students' clinical supervision are proposed for the placement model.

Developing principles for sharing information about potential trial intervention benefits and harms with patients: report of a modified Delphi survey.

BACKGROUND: The way information about potential harms of trial intervention is shared within participant information leaflets (PILs) varies widely and can cause subjective 'nocebo' harms. This study aimed to develop principles to improve the composition of information about potential trial intervention benefits and harms within PILs so that variability and avoidable harms are reduced. METHODS: We conducted a two-round modified online Delphi survey, followed by a consensus meeting. For the first round of the survey, 27 statements were developed based on previous research and relevant guidance from the UK, the USA and the World Health Organization. Participants included members from each of the following stakeholder groups: patient and public representatives, research ethics committee members, industry representatives, medico-legal experts, psychologists and trial managers. Each participant was asked to rate their degree of agreement or disagreement with each statement on a 9-point Likert scale. In the second round, participants were invited to reappraise their ratings after reviewing the results of the first round. Finally, two members from each stakeholder group participated in a meeting to confirm those statements for which there was agreement. RESULTS: Two hundred and fifty participants completed round 1, and 201 participants completed round 2. In round 1, consensus was reached for 16 statements. In round 2, consensus was reached for an additional three statements. The consensus meeting confirmed the survey results and consolidated the statements. This process resulted in seven principles: (1) all potential harms of a given intervention should be listed, (2) all potential harms should be separated into serious and less serious, (3) it must be made explicit that not all potential harms are known, (4) all potential benefits should be listed, (5) all potential benefits and harms need to be compared with what would happen if the participant did not take part in the trial, (6) suitable visual representations should be added where appropriate and (7) information regarding potential benefits and harms should not be presented apart by one or more pages. CONCLUSIONS: Our modified Delphi process successfully generated seven principles that can and should be used to guide how information is conveyed to patients in information leaflets regarding potential trial benefits and harms.

A systematic review investigating the use of microbiology outcome measures in randomized controlled trials evaluating antimicrobial stewardship interventions published between 2011 and 2021.

INTRODUCTION: Antimicrobial stewardship interventions (ASIs) aim to reduce the emergence of antimicrobial resistance. We sought to systematically evaluate how microbiological outcomes have been handled and analysed in randomized controlled trials (RCTs) evaluating ASIs. METHODS: We searched PubMed and Embase from 2011-21. Studies were selected if they were RCTs evaluating ASIs. A narrative synthesis approach was taken, identifying whether the study reported any microbiological data (bacterial genus/species; bacterial colony counts; prevalence of bacterial, microbiologically defined infections; and antibiotic susceptibility, measured pre-randomization or post-randomization in one arm only) or outcomes (post-randomization data compared between arms). Studies with or without microbiological data/outcomes were summarized in terms of study characteristics, methods of reporting and analysis of these outcomes. RESULTS: We identified 117 studies, with 34 (29.1%) collecting microbiological data and 18 (15.4%) reporting microbiological outcomes. Most studies with microbiological outcomes were conducted in secondary care (12/18, 66.7%) and targeted adult populations (14/18, 77.8%), and the intervention involved biomarker-guided rapid diagnostic testing (7/18, 38.9%). The overall quality of reporting and analysing microbiological outcomes was low and inconsistent. The selected study population in analyses and methods of handling missing data were unclear. CONCLUSIONS: This review demonstrates that the quality of handling and reporting microbiological outcomes in RCTs of ASIs was low. The lack of consistency and clarity made it difficult to compare the findings across studies, limiting policy- and clinical decision-making. Therefore, there is a clear need for the development of guidance for handling microbiological outcomes in RCTs and adopting appropriate methods to evaluate these data carefully.

Nursing degree students' clinical placement experiences in Australia: A survey design.

AIM: This study aimed to evaluate Australian nursing students' views of placements at seven tertiary education institutions with the use of the Placement Evaluation Tool (PET). BACKGROUND: Clinical placements are a core element of healthcare education programs around the world (Chuan and Barnett, 2012) with undergraduate nursing students required to complete a prescribed number of hours as part of their degree. The quality of nursing clinical placements varies with a range of positive and negative learning experiences. DESIGN: A survey design was used with a contemporary survey tool- the Placement Evaluation Tool (PET). Using Qualtrics software (Qualtrics, 2005) the on-line survey was distributed to approximately 6265 undergraduate nursing students at six Australian universities and one Technical and Further Education (TAFE) college where Bachelor of Nursing degree students were enrolled. Three Australian States were covered. Sites were selected where a project team member was employed. METHODS: A total of 1263 nursing students completed the Placement Evaluation Tool (PET) - 19 items (rated 1-5), one global rating (rated 1-10) - following placement in three Australian States (July 2019-February 2020). Most - 618 (48.9%) completed a placement in acute care with placements positively rated overall. RESULTS: The total PET mean score was 78.3% with 29.8% being 'extremely satisfied' (10 out of 10 - Item 20). However, 11.0% were dissatisfied with global ratings of four or less, whilst ratings between States differed significantly (p = <0.001). One third of respondents answered a free text statement relating to placement experiences, with significantly more comments from older students (p = <0.001) and from those with ratings in the lower range (p = <0.001). Three core themes emerged: 1. Staff Attitudes to Students, 2. Environment and 3. Lifestyle. CONCLUSIONS: Whilst students' clinical experiences in Australia tend to be positive a minority reported exposure to negative staff attitudes, in unsafe environments, with lifestyle detriments. Further work is required to understand and enhance student experiences.

Neurofeedback Training versus Treatment-as-Usual for Alcohol Dependence: Results of an Early-Phase Randomized Controlled Trial and Neuroimaging Correlates.

INTRODUCTION: Alcohol dependence is one of the most common substance use disorders, and novel treatment options are urgently needed. Neurofeedback training (NFT) based on real-time functional magnetic resonance imaging (rtf-MRI) has emerged as an attractive candidate for add-on treatments in psychiatry, but its use in alcohol dependence has not been formally investigated in a clinical trial. We investigated the use of rtfMRI-based NFT to prevent relapse in alcohol dependence. METHODS: Fifty-two alcohol-dependent patients from the UK who had completed a detoxification program were randomly assigned to a treatment group (receiving rtfMRI NFT in addition to standard care) or the control group (receiving standard care only). At baseline, alcohol consumption was assessed as the primary outcome measure and a variety of psychological, behavioral, and neural parameters as secondary outcome measures to determine feasibility and secondary training effects. Participants in the treatment group underwent 6 NFT sessions over 4 months and were trained to downregulate their brain activation in the salience network in the presence of alcohol stimuli and to upregulate frontal activation in response to pictures related to positive goals. Four, 8, and 12 months after baseline assessment, both groups were followed up with a battery of clinical and psychometric tests. RESULTS: Primary outcome measures showed very low relapse rates for both groups. Analysis of neural secondary outcome measures indicated that the majority of patients modulated the salience system in the desired directions, by decreasing activity in response to alcohol stimuli and increasing activation in response to positive goals. The intervention had a good safety and acceptability profile. CONCLUSION: We demonstrated that rtfMRI-neurofeedback targeting hyperactivity of the salience network in response to alcohol cues is feasible in currently abstinent patients with alcohol dependence.

Protocol for an open label: phase I trial within a cohort of foetal cell transplants in people with Huntington's disease.

Huntington's disease is a progressive neurodegenerative disorder characterized by motor, cognitive and psychiatric symptoms. Currently, no disease-modifying therapies are available to slow or halt disease progression. Huntington's disease is characterized by relatively focal and specific loss of striatal medium spiny neurons, which makes it suitable for cell-replacement therapy, a process involving the transplantation of donor cells to replace those lost due to disease. TRIal DEsigns for delivery of Novel Therapies in neurodegeneration is a phase I Trial Within a Cohort designed to assess safety and feasibility of transplanting human foetal striatal cells into the striatum of people with Huntington's disease. A minimum of 18 participants will be enrolled in the study cohort, and up to five eligible participants will be randomly selected to undergo transplantation of 12-22 million foetal cells in a dose escalation paradigm. Independent reviewers will assess safety outcomes (lack of significant infection, bleeding or new neurological deficit) 4 weeks after surgery, and ongoing safety will be established before conducting each subsequent surgery. All participants will undergo detailed clinical and functional assessment at baseline (6 and 12 months). Surgery will be performed 1 month after baseline, and transplant participants will undergo regular clinical follow-up for at least 12 months. Evaluation of trial processes will also be undertaken. Transplant participants and their carers will be interviewed ∼1 month before and after surgery. Interviews will also be conducted with non-transplanted participants and healthcare staff delivering the intervention and involved in the clinical care of participants. Evaluation of clinical and functional efficacy outcomes and intervention costs will be carried out to explore plausible trial designs for subsequent randomized controlled trials aimed at evaluating efficacy and cost-effectiveness of cell-replacement therapy. TRIal DEsigns for delivery of Novel Therapies in neurodegeneration will enable the assessment of the safety, feasibility, acceptability and cost of foetal cell transplants in people with Huntington's disease. The data collected will inform trial designs for complex intra-cranial interventions in a range of neurodegenerative conditions and facilitate the development of stable surgical pipelines for delivery of future stem cell trials. Trial Registration: ISRCTN52651778.

Measuring the quality of nursing clinical placements and the development of the Placement Evaluation Tool (PET) in a mixed methods co-design project.

BACKGROUND: The quality of nursing clinical placements has been found to vary. Placement evaluation tools for nursing students are available but lack contemporary reviews of clinical settings. Therefore, the aim of this study was to develop a feasible, valid and reliable clinical placement evaluation tool applicable to nursing student placements in Australia. METHODS: An exploratory mixed methods co-design project. Phase 1 included a literature review; expert rating of potential question items and Nominal Group Technique meetings with a range of stakeholders for item development. Phase 2 included on-line pilot testing of the Placement Evaluation Tool (PET) with 1263 nursing students, across all year levels at six Australian Universities and one further education college in 2019-20, to confirm validity, reliability and feasibility. RESULTS: The PET included 19-items (rated on a 5-point agreement scale) and one global satisfaction rating (a 10-point scale). Placements were generally positively rated. The total scale score (19 items) revealed a median student rating of 81 points from a maximum of 95 and a median global satisfaction rating of 9/10. Criterion validity was confirmed by item correlation: Intra-class Correlation Co-efficient ICC = .709; scale total to global score r = .722; and items to total score ranging from .609 to .832. Strong concurrent validity was demonstrated with the Clinical Learning Environment and Supervision Scale (r = .834). Internal reliability was identified and confirmed in two subscale factors: Clinical Environment (Cronbach's alpha = .94) and Learning Support (alpha = .96). Based on the short time taken to complete the survey (median 3.5 min) and students' comments, the tool was deemed applicable and feasible. CONCLUSIONS: The PET was found to be valid, reliable and feasible. Use of the tool as a quality assurance measure is likely to improve education and practice in clinical environments. Further international evaluation of the instrument is required to fully determine its psychometric properties.

The Early Positive Approaches to Support (E-PAtS) study: study protocol for a feasibility cluster randomised controlled trial of a group programme (E-PAtS) for family caregivers of young children with intellectual disability.

BACKGROUND: Children with intellectual disability have an IQ < 70, associated deficits in adaptive skills and are at increased risk of having clinically concerning levels of behaviour problems. In addition, parents of children with intellectual disability are likely to report high levels of mental health and other psychological problems. The Early Positive Approaches to Support (E-PAtS) programme for family caregivers of young children (5 years and under) with intellectual and developmental disabilities is a group-based intervention which aims to enhance parental psychosocial wellbeing and service access and support positive development for children. The aim of this study is to assess the feasibility of delivering E-PAtS to family caregivers of children with intellectual disability by community parenting support service provider organisations. The study will inform a potential, definitive RCT of the effectiveness and cost-effectiveness of E-PAtS. METHODS: This study is a feasibility cluster randomised controlled trial, with embedded process evaluation. Up to 2 family caregivers will be recruited from 64 families with a child (18 months to 5 years) with intellectual disability at research sites in the UK. Participating families will be allocated to intervention: control on a 1:1 basis; intervention families will be offered the E-PAtS programme immediately, continuing to receive usual practice, and control participants will be offered the opportunity to attend the E-PAtS programme at the end of the follow-up period and will continue to receive usual practice. Data will be collected at baseline, 3 months post-randomisation and 12 months post-randomisation. The primary aim is to assess feasibility via the assessment of: recruitment of service provider organisations; participant recruitment; randomisation; retention; intervention adherence; intervention fidelity and the views of participants, intervention facilitators and service provider organisations regarding intervention delivery and study processes. The secondary aim is preliminary evaluation of a range of established outcome measures for individual family members, subsystem relationships and overall family functioning, plus additional health economic outcomes for inclusion in a future definitive trial. DISCUSSION: The results of this study will inform a potential future definitive trial, to evaluate the effectiveness and cost-effectiveness of the E-PAtS intervention to improve parental psychosocial wellbeing. Such a trial would have significant scientific impact internationally in the intellectual disability field. TRIAL REGISTRATION: ISRCTN70419473.

Anxiety, flipped approach and self-efficacy: Exploring nursing student outcomes.

BACKGROUND: Self-efficacy is crucial for student success. Studies have demonstrated a positive relationship between flipped learning approach and self-efficacy. Anxiety, however, can reduce self-efficacy. OBJECTIVE: Testing the relationship between the flipped approach and self-efficacy by flipping a nursing module within an externally-imposed and once-off anxiety-inducing context. METHOD: Students completed a self-efficacy survey before (n = 71) and after (n = 91) a compressed semester, which provided the anxiety-inducing context. RESULTS: Pre-semester self-efficacy was 2.93/4, and post-semester was 2.98/4. The results demonstrated no significant change in students' self-efficacy. CONCLUSION: We argue the flipped approach counters anxiety-inducing effects to maintain self-efficacy. In less anxiety-inducing contexts, we argue the flipped approach would develop students' confidence, capability, persistence and strength beliefs, collectively enhancing self-efficacy perceptions.

Barriers and facilitators to primary health care for people with intellectual disabilities and/or autism: an integrative review.

BACKGROUND: Globally, people with intellectual disabilities and/or autism experience health inequalities. Death occurs at a younger age and the prevalence of long-term morbidities is higher than in the general population. Despite this, their primary healthcare access rates are lower than the general population, their health needs are often unmet, and their views and experiences are frequently overlooked in research, policy, and practice. AIM: To investigate the barriers and facilitators reported by individuals with intellectual disabilities, autism, or both, and/or their carers, to accessing and utilising primary health care for their physical and mental health needs. DESIGN & SETTING: An integrative review was undertaken, which used systematic review methodology. METHOD: Electronic databases MEDLINE, Embase, CINAHL (Cumulative Index to Nursing and Allied Health Literature), and Cochrane were searched for relevant studies (all languages) using a search strategy. Two researchers independently screened the results and assessed the quality of the studies. RESULTS: Sixty-three international studies were identified. Six main themes relating to barriers and facilitators emerged from an analysis of these studies. The main themes were: training; knowledge and awareness; communication; fear and embarrassment; involvement in healthcare decision-making; and time. All the themes were underpinned by the need for greater care, dignity, respect, collaborative relationships, and reasonable adjustments. Opposing barriers and facilitators were identified within each of the main themes. CONCLUSION: Adolescents and adults with intellectual disabilities and/or autism experience several barriers to accessing and utilising primary health care. The findings highlight the reasonable adjustments and facilitators that can be implemented to ensure that these individuals are not excluded from primary health care.

Health professionals' perspectives on delivering home and hospital management at diagnosis for children with type 1 diabetes: A qualitative study from the Delivering Early Care in Diabetes Evaluation trial.

OBJECTIVE: To explore the delivery of home and hospital management at diagnosis of type 1 diabetes in childhood and any impact this had on health professionals delivering care. METHODS: This qualitative study was undertaken as part of the Delivering Early Care in Diabetes Evaluation randomized controlled trial where participants were individually randomized to receive initiation of management at diagnosis, to home or hospital. Semi-structured telephone interviews were planned with a purposive sample of health professionals involved with the delivery of home and hospital management, to include consultants, diabetes and research nurses, and dieticians from the eight UK centres taking part. The interview schedule focused on their experiences of delivering the two models of care; preferences, impact, and future plans. Data were subject to thematic analysis. RESULTS: Twenty-two health professionals participated, represented by consultants, diabetes and research nurses, and dieticians. Overall, nurses preferred home management and perceived it to be beneficial in terms of facilitating a unique opportunity to understand family life and provide education to extended family members. Nurses described a special bond and lasting relationship that they developed with the home managed children and families. Consultants expressed concern that it jeopardized their relationship with families. Dieticians reported being unable to deliver short bursts of education to families in the home managed arm. All health professionals were equally divided over which was logistically easier to deliver. CONCLUSIONS: A hybrid approach, of a brief stay in hospital and early home management, offers a pragmatic solution to the advantages and challenges presented by both systems.

Assessing predictors of respiratory tract infections in infants born to teenage mothers: secondary analysis of the Building Blocks trial data.

BACKGROUND: Respiratory tract infections (RTIs) are estimated to account for 60% of infants' primary care visits. There is limited research into risk factors for infant RTIs in those born to teenage mothers. AIMS: To identify risk factors for primary and secondary care RTI attendances, in infants of teenage mothers, and to identify risk factors associated with high primary care RTI consultations. METHOD: Secondary analysis of a data set from the Building Blocks trial of special home visiting support in England containing 1510 infants born to teenage mothers recruited to the study. Maternally reported and routinely collected data were examined. Multivariable logistic regression models were performed to determine independent predictors. Primary care data analysis also focused on infant risk factors for RTI consultation. RESULTS: No independently predictive risk factors for infant RTI were identified in primary care. Lower maternal antenatal attendances (odds ratio = 0.96, 95% confidence interval = 0.92-0.99), infants born in autumn (vs. spring; 0.54, 0.36-0.80) and neonatal unit (NNU) admissions (0.51, 0.30-0.89) had increased odds of attending accidents and emergencies with an RTI. Male infants (1.52, 1.03-2.25), NNU admissions (3.21, 1.98-5.22) and birth season had increased odds of RTI-associated hospital admissions. High infant RTI primary care consulters were more likely to have an RTI-associated hospital admission (2.11, 1.17-3.81) and less likely to have breastfed (0.55, 0.38-0.78). CONCLUSION: Risk factors previously found to increase the risk of an RTI infant admission in the broader population have been identified here. This study is one of the first to identify modifiable risk factors of high primary care RTI consulters.

The Nominal Group Technique: Generating Consensus in Nursing Research.

The purpose of this article is to describe the Nominal Group Technique and its application as a consensus-generating approach in nursing research. The approach incorporates face-to-face meetings to explore opinions, generate ideas, and determine priorities. The nominal group technique process, which is based on a study designed to develop a nursing student clinical placement (clinical practicum) evaluation tool, is described. Advantages of the approach include creative face-to-face discussions with minimal resource demands. The nominal group technique is beneficial and can be used to achieve consensus in nursing research, but a lack of anonymity may preclude the process in some investigations. [J Nurs Educ. 2020;59(2):65-67.].

Costs and consequences of the Family Nurse Partnership (FNP) programme in England: evidence from the Building Blocks trial.

Background: The Family Nurse Partnership (FNP) is a licensed intensive home visiting intervention programme delivered to teenage mothers which was originally introduced in England in 2006 by the Department of Health and is now provided through local commissioning of public health services and supported by a national unit led by a consortium of partners. The Building Blocks (BB) trial aimed to explore the effectiveness and cost-effectiveness of this programme. This paper reports the results of an economic evaluation of the Building Blocks randomised controlled trial (RCT) based on a cost-consequence approach. Methods: A large sample of 1618 families was followed-up at various intervals during pregnancy and for two years after birth. A cost-consequence approach was taken to appraise the full range of costs arising from the intervention including both health and social measures of cost alongside the consequences of the trial, specifically, the primary outcomes. Results: A large number of potential factors were identified that are likely to attract additional costs beyond the implementation costs of the intervention including both health and non-health outcomes. Conclusion: Given the extensive costs and only small beneficial consequences observed within the two year follow-up period, the cost-consequence model suggests that the FNP intervention is unlikely to be worth the substantial costs and policy makers may wish to consider other options for investment. Trial registration: ISRCTN23019866 (20/04/2009).

Effectiveness of a multimodal intervention in functionally impaired older people with type 2 diabetes mellitus.

BACKGROUND: Type 2 diabetes, a highly prevalent chronic disease, is associated with increasing frailty and functional decline in older people. We aimed to evaluate the effectiveness of a multimodal intervention on functional performance in frail and pre-frail participants aged ≥70 years with type 2 diabetes mellitus. METHODS: The MID-Frail study was a cluster-randomized multicenter clinical trial conducted in 74 trial sites across seven European countries. The trial recruited 964 participants who were aged >70 years [mean age in intervention group, 78.4 (SD 5.6) years, 49.2% male and 77.6 (SD 5.29) years, 52.4% male in usual care group], with type diabetes mellitus and determined to be frail or pre-frail using Fried's frailty phenotype. Participants were allocated by trial site to follow either usual care (UCG) or intervention procedures (IG). Intervention group participants received a multimodal intervention composed of (i) an individualized and progressive resistance exercise programme for 16 weeks; (ii) a structured diabetes and nutritional educational programme over seven sessions; and (iii) Investigator-linked training to ensure optimal diabetes care. Short Physical Performance Battery (SPPB) scores were used to assess change in functional performance at 12 months between the groups. An analysis of the cost-effectiveness of the intervention was undertaken using the incremental cost-effectiveness ratio (ICER). Secondary outcomes included mortality, hospitalization, institutionalization, quality of life, burden on caregivers, the frequency and severity of hypoglycaemia episodes, and the cost-effectiveness of the intervention. RESULTS: After 12 months, IG participants had mean SPPB scores 0.85 points higher than those in the UCG (95% CI, 0.44 to 1.26, P < 0.0001). Dropouts were higher in frail participants and in the intervention group, but significant differences in SPPB between treatment groups remained consistent after sensitivity analysis. Estimates suggest a mean saving following intervention of 428.02 EUR (2016) per patient per year, with ICER analysis indicating a consistent benefit of the described health care intervention over usual care. No statistically significant differences between groups were detected in any of the other secondary outcomes. CONCLUSIONS: We have demonstrated that a 12 month structured multimodal intervention programme across several clinical settings in different European countries leads to a clinically relevant and cost-effective improvement in the functional status of older frail and pre-frail participants with type 2 diabetes mellitus.

Rapid overview of systematic reviews of nocebo effects reported by patients taking placebos in clinical trials.

BACKGROUND: Trial participants in placebo groups report experiencing adverse events (AEs). Existing systematic reviews have not been synthesized, leaving questions about why these events occur as well as their prevalence across different conditions unanswered. OBJECTIVES: (1) To synthesize the evidence of prevalence of AEs in trial placebo groups across different conditions. (2) To compare AEs in trial placebo groups with AEs reported in untreated groups within a subset of randomized trials. SEARCH METHODS: We searched PubMed for records with the word "nocebo" in the title and "systematic" in any field. We also contacted experts and hand-searched references of included studies. STUDY ELIGIBILITY: We included any systematic review of randomized trials where nocebo effects were reported. We excluded systematic reviews of non-randomized studies. PARTICIPANTS AND INTERVENTIONS: We included studies in any disease area. STUDY APPRAISAL AND SYNTHESIS METHODS: We appraised the quality of the studies using a shortened version of the Assessment of Multiple Systematic Reviews tool (AMSTAR) tool. We reported medians and interquartile ranges (IQRs) of AEs. Among the trials within the review that included untreated groups, we compared the prevalence of AEs in untreated groups with the prevalence of AEs in placebo groups. RESULTS: We identified 20 systematic reviews. These included 1271 randomized trials and 250,726 placebo-treated patients. The median prevalence of AEs in trial placebo groups was 49.1% (IQR 25.7-64.4%). The median rate of dropouts due to AEs was 5% (IQR 2.28-8.4%). Within the 15 of trials that reported AEs in untreated groups, we found that the AE rate in placebo groups (6.51%) was higher than that reported in untreated groups (4.25%). LIMITATIONS: This study was limited by the quality of included reviews and the small number of trials that included untreated groups. CONCLUSIONS AND IMPLICATIONS OF KEY FINDINGS: AEs in trial placebo groups are common and cannot be attributed entirely to natural history. Trial methodologies that reduce AEs in placebo groups while satisfying the requirement of informed consent should be developed and implemented.