UNASSIGNED: The BigMove intervention aims to improve the functioning and quality of life of people with physical and mental health conditions via an integrated care approach. This pilot study evaluates the impact of the intervention on self-perceived health (SPH), quality of life (QoL), active coping behaviour, and mental and social functioning.
UNASSIGNED: Data were analysed from N = 457 participants who had been referred to the intervention by their general practitioner (mean age 48.98 years; 76% female). Three patient-reported and one clinician-rated measures were used: SPH, QoL (MANSA), active coping behaviour (UPCC-ACT), mental and social functioning (HoNOS). Pre- and post-intervention measurements (from 2011 to 2018) were compared using paired-samples t-tests. Due to missing data, analyses were conducted with 205-257 participants per completed outcome. Associations with age and sex were assessed using repeated-measures ANOVA. Clinically relevant change was evaluated with the Edwards-Nunnally index and standard error of measurement (SEM) scores.
UNASSIGNED: Post-intervention, there were statistically significant improvements for all outcomes (p < 0.0001) with moderate to large effect sizes (d = 0.41 to 1.02). The observed changes in outcomes can be considered as clinically relevant improvements.
UNASSIGNED: This pilot study provides preliminary evidence that the intervention has positive effects on SPH, QoL, active coping behaviour, and mental and social functioning.

BACKGROUND: An innovative, integrative care model for people with Parkinson (PRIME Parkinson) has gradually been implemented in a selected region of the Netherlands since 2021. A prospective evaluation of this model (PRIME-NL study) was initiated in parallel, spanning the year prior to implementation (baseline) and the implementation period. Following publication of the original study protocol, the COVID-19 crisis delayed implementation of the full PRIME Parkinson care model by two years and hampered the recruitment of study participants.
OBJECTIVE: To describe which methodological adjustments were made to the study protocol because of these developments.
METHODS: We compare various outcomes between a region where PRIME Parkinson care was implemented (innovation region) versus the rest of the Netherlands (usual care region). We use healthcare claims data of virtually all people with Parkinson in the Netherlands and annual questionnaires in a representative subsample of 984 people with Parkinson, 566 caregivers and 192 healthcare professionals. Four major methodological adjustments had to be made since publication of the original protocol. First, we extended the evaluation period by two years. Second, we incorporated annual process measures of the stage of implementation of the new care model. Third, we introduced a real-time iterative feedback loop of interim results to relevant stakeholders. Fourth, we updated the statistical analysis plan.
CONCLUSIONS: This manuscript provides transparency in how the design and analyses of the evaluation study had to be adapted to control for external influences in a dynamic environment, including eruption of the COVID-19 crisis. Our solutions could serve as a template for evaluating other complex healthcare interventions in a dynamic environment.

BACKGROUND: Antimicrobial resistance (AMR) represents a growing concern for public health.
OBJECTIVE: We sought to explore the challenges associated with development and implementation of a complex intervention designed to improve AMS in hospitals.
METHODS: We conducted a qualitative evaluation of a complex AMS intervention with educational, behavioral, and technological components in 5 wards of an English hospital. At 2 weeks and 7 weeks after initiating the intervention, we interviewed 25 users of the intervention, including senior and junior prescribers, a senior nurse, a pharmacist, and a microbiologist. Topics discussed included perceived impacts of different elements of the intervention and facilitators and barriers to effective use. Interviews were supplemented by 2 observations of ward rounds to gain insights into AMS practices. Data were audio-recorded, transcribed, and inductively and deductively analyzed thematically using NVivo12.
RESULTS: Tracing the adoption and impact of the various components of the intervention was difficult, as it had been introduced into a setting with competing pressures. These particularly affected behavioral and educational components (eg, training, awareness-building activities), which were often delivered ad hoc. We found that the participatory intervention design had addressed typical use cases but had not catered for edge cases that only became visible when the intervention was delivered in real-world settings (eg, variations in prescribing workflows across different specialties and conditions).
CONCLUSIONS: Effective user-focused design of complex interventions to promote AMS can support acceptance and use. However, not all requirements and potential barriers to use can be fully anticipated or tested in advance of full implementation in real-world settings.

BACKGROUND: POINCARE-2 trial aimed to assess the effectiveness of a strategy designed to tackle fluid overload through daily weighing and subsequent administration of treatments in critically ill patients. Even in highly standardized care settings, such as intensive care units, effectiveness of such a complex intervention depends on its actual efficacy but also on the extent of its implementation. Using a process evaluation, we aimed to provide understanding of the implementation, context, and mechanisms of change of POINCARE-2 strategy during the trial, to gain insight on its effectiveness and inform the decision regarding the dissemination of the intervention.
METHODS: We conducted a mixed-method process evaluation following the Medical Research Council guideline. Both quantitative data derived from the trial, and qualitative data from semi-structured interviews with professionals were used to explain implementation, mechanisms of change of the POINCARE-2 strategy, as well as contextual factors potentially influencing implementation of the strategy.
RESULTS: Score of actual exposure to the strategy ranged from 29.1 to 68.2% during the control period, and from 61.9 to 92.3% during the intervention period, suggesting both potential contamination and suboptimal fidelity to the strategy. Lack of appropriate weighing devices, lack of human resources dedicated to research, pre-trial rooted prescription habits, and anticipated knowledge of the strategy have been identified as the main barriers to optimal implementation of the strategy in the trial context.
CONCLUSIONS: Both contamination and suboptimal fidelity to POINCARE-2 strategy raised concerns about a potential bias towards the null of intention-to-treat (ITT) analyses. However, optimal fidelity seemed reachable. Consequently, a clinical strategy should not be rejected solely on the basis of the negativity of ITT analyses\' results. Our findings showed that, even in highly standardized care conditions, the implementation of clinical strategies may be hindered by numerous contextual factors, which demonstrates the critical importance of assessing the viability of an intervention, prior to any evaluation of its effectiveness.
BACKGROUND: Number NCT02765009.

BACKGROUND: The SPHERe (Supervised Pulmonary Hypertension Exercise Rehabilitation) trial is a multi-centre, pragmatic, randomised controlled trial assessing the clinical and cost-effectiveness of supervised exercise rehabilitation with psychosocial and motivational support compared to best-practice usual care for people with pulmonary hypertension (PH). The original protocol was published in BMC Pulmonary Medicine (accessible online). We randomised our first participant in January 2020. In response to the COVID-19 pandemic, the trial was stopped in March 2020. In person delivery of the SPHERe intervention to a vulnerable population was not possible during the COVID-19 pandemic. We describe here how trial procedures and intervention delivery were adapted in response to the COVID-19 pandemic.
METHODS: Restrictions imposed by the COVID-19 pandemic on the clinically vulnerable PH population meant that trial delivery was changed from a centre-based rehabilitation programme to remotely delivered group online sessions. This led to minor alterations to the eligibility criteria. These changes followed a consultation process with stakeholders and people with PH and were approved by the funder and independent trial committees.
CONCLUSIONS: We describe the modified SPHERe trial protocol in response to restrictions imposed by the COVID-19 pandemic. SPHERe is the first randomised controlled trial to assess the clinical and cost-effectiveness of an online group rehabilitation programme for people with PH compared to usual care.
BACKGROUND: ISRCTN no. 10608766. Prospectively registered on 18th March 2019, updated 16th August 2023.

Although nursing seems to understand itself and its practice as complex, the literature is less clear about what this actually means. While complexity is discussed as an attribute of nursing, it is also suggested that complexity in nursing remains misunderstood and poorly articulated, is devalued, is not considered as a measure of health outcomes and remains invisible. Despite the overarching lack of a definition, some nurse scholars have conceptualized complexity as a complex intervention. For these authors, complexity becomes a complex intervention defined as that which is composed of component parts interacting in a variety of ways that influence the delivery of and outcomes of health-related interventions for populations. Conceptualizing complexity as a complex intervention forces nursing to embrace and adopt a received interpretation of complexity as expressed through complexity theory and complexity science. While complexity theory may afford us some tools for thinking about complexity, when we deconstruct nursing complexity to explicitly determinate and quantifiable tasks, this artificially narrowed orientation to complexity reveals an oversimplified explanation of the complexities associated with nursing and serves to blind us to its real qualities. Through a consideration of complexity from a Western philosophical tradition, I demonstrate that when nursing adopts the received interpretation of complexity as a complex intervention, this perspective on complexity contains nursing epistemologically and ontologically. I offer an extended conceptualization of complexity framed upon the consideration that nurses assume complexity and do not reduce it; that nurses have the capacity to not be paralysed by complexity and have developed logics to mobilize it in productive ways. Mobilizing complexity through navigating paradox and contradiction shapes an orientation to complexity that embraces an extended epistemology. This extended epistemology is characterized by a \'yes/and\' mindset that expresses the dynamic and generative relationship between forms of knowledge which reflects complexity that characterizes nursing.

OBJECTIVE: Adults with intellectual and developmental disabilities (IDD) have a significantly higher prevalence of Type 2 diabetes than the general population. Evidence that lifestyle and/or behavioural interventions, such as participation in Special Olympics, decreases the risk of developing diabetes in adults with IDD could help minimize health disparities and promote overall health in this population.
METHODS: This was a 20-year retrospective cohort study of adults with IDD (30-39 years) in the province of Ontario, Canada, that compared hazard rates of diabetes among Special Olympics participants (n = 4145) to non-participants (n = 31,009) using administrative health databases housed at ICES. Using cox proportional hazard models, crude and adjusted hazard ratios were calculated for the association between the primary independent variable (Special Olympics participation status) and the dependent variable (incident diabetes cases).
RESULTS: After controlling for other variables, the hazard ratio comparing rates for developing diabetes between Special Olympics participants and non-participants was 0.85. This represents a 15% reduction in the hazard among Special Olympics participants when followed for up to 20 years. This result was statistically significant and represents a small effect size.
CONCLUSIONS: Special Olympics could be considered a complex intervention that promotes physical activity engagement through sport participation, health screenings, and the promotion of healthy eating habits through educational initiatives. This study provides evidence that Special Olympics participation decreases the rate for developing diabetes.

Objective: This systematic review aims to provide an update of the scientific evidence regarding tobacco-free/smoke-free campus policies (TFC/SFC), using a complex interventions approach.
METHODS: We searched the PubMed, Scopus and Web of Science databases using a combination of \'tobacco-free\' or \'smoke-free\', \'campus\', \'university or college\' and \'policy\' search terms on all indexed articles published up until June 2023. Studies were included if they presented research on pre-/post-implementation of TFC/SFC or policy components. Two coders extracted and synthesized the data and assessed the risk of bias.
RESULTS: A total of 113 studies were included, reporting data from 2005 to 2023 across 17 countries. The data was categorized into three of the four phases of the Medical Research Council (MRC) framework, i.e. \"feasibility (n=24), \"implementation\" (n=34), and \"evaluation\" (n=69). This review finds that a policy draft, communication, enforcement strategies, and cessation services are critical policy components. TCF/SFC are effective for reducing tobacco use and secondhand smoke exposure, but they also increase vaping. Little research has investigated the effect of TFC/SFC on smokeless tobacco use.
CONCLUSIONS: This review addresses remaining uncertainties in evidence on the TFC/SFC implementation process. We go on to provide a series of recommendations for university administrators.

Adaptation seeks to transfer and implement healthcare interventions developed and evaluated in one context to another. The aim of this scoping review was to understand current approaches to the adaptation of complex interventions for people with long-term conditions (LTCs) and to identify issues for studies performed in low- and middle-income countries (LMICs). Bibliographic databases were searched from 2000 to October 2022. This review involved five stages: (i) definition of the research question(s); (ii) identifying relevant studies; (iii) study selection; (iv) data charting; and (v) data synthesis. Extraction included an assessment of the: rationale for adaptation; stages and levels of adaptation; use of theoretical frameworks, and quality of reporting using a checklist based on the 2021 ADAPT guidance. Twenty-five studies were included from across 21 LTCs and a range of complex interventions. The majority (16 studies) focused on macro (national or international) level interventions. The rationale for adaptation included intervention transfer across geographical settings [high-income country (HIC) to LMIC: six studies, one HIC to another: eight studies, one LMIC to another: two studies], or transfer across socio-economic/racial groups (five studies), or transfer between different health settings within a single country (one study). Overall, studies were judged to be of moderate reporting quality (median score 23, maximum 46), and typically focused on early stages of adaptation (identification and development) with limited outcome evaluation or implementation assessment of the adapted version of the intervention. Improved reporting of the adaptation for complex interventions targeted at LTCs is needed. Development of future adaptation methods guidance needs to consider the needs and priorities of the LMIC context.
Limited finance and human capacity may reduce access to new treatments for people with long-term conditions. This is especially true in low- and middle-income countries. One solution is to transfer treatments developed in one place for use in other areas. This paper provides a current summary of international research on adapting treatments. We used a checklist to assess study reporting quality, based on published advice. Our findings showed the need for better conduct and reporting of adaptation. Future guidance should consider the specific needs of low- and middle-income countries.

BACKGROUND: The prevalence of diabetes and coexisting multimorbidity rises worldwide. Treatment of this patient group can be complex. Providing an evidence-based, coherent, and patient-centred treatment of patients with multimorbidity poses a challenge in healthcare systems, which are typically designed to deliver disease-specific care. We propose an intervention comprising multidisciplinary team conferences (MDTs) to address this issue. The MDT consists of medical specialists in five different specialities meeting to discuss multimorbid diabetes patients. This protocol describes a feasibility test of MDTs designed to coordinate care and improve quality of life for people with diabetes and multimorbidity.
METHODS: A mixed-methods one-arm feasibility test of the MDT. Feasibility will be assessed through prospectively collected data. We will explore patient perspectives through patient-reported outcomes (PROs) and assess the feasibility of electronic questionnaires. Feasibility outcomes are recruitment, PRO completion, technical difficulties, impact of MDT, and doctor preparation time. During 17 months, up to 112 participants will be recruited. We will report results narratively and by the use of descriptive statistics. The collected data will form the basis for a future large-scale randomised trial.
CONCLUSIONS: A multidisciplinary approach focusing on better management of diabetic patients suffering from multimorbidity may improve functional status, quality of life, and health outcomes. Multimorbidity and diabetes are highly prevalent in our healthcare system, but we lack a solid evidence-based approach to patient-centred care for these patients. This study represents the initial steps towards building such evidence. The concept can be efficiency tested in a randomised setting, if found feasible to intervention providers and receivers. If not, we will have gained experience on how to manage diabetes and multimorbidity as well as organisational aspects, which together may generate hypotheses for research on how to handle multimorbidity in the future.
UNASSIGNED: Protocol version: 01 TRIAL REGISTRATION: NCT05913726 - registration date: 21 June 2023.