Evaluating the effects of lymphoedema management strategies on functional status and health-related quality of life following treatment for head and neck cancer: Protocol for a systematic review

Introduction/Background: Patients living with and after head and neck cancer often experience treatment-related consequences. Head and neck lymphoedema can be described as a common chronic side effect of head and neck cancer and recognised as a contributing factor to impairment of functional status, symptom burden and health-related quality of life. The effects of head and neck lymphoedema can limit patients’ involvement in daily activities and alter their appearance, increasing symptom burden and negatively affecting health-related quality of life. Objective: The protocol outlines the rationale and aims for the systematic review. The main aim of the systematic review is to identify and systematically synthesise the literature on the effectiveness of head and neck lymphoedema management strategies, on both function status and health-related quality of life for head and neck cancer patients. Methods and analysis: This protocol will be conducted according to the PRISMA-P guidelines. Electronic databases will be systematically searched using MEDLINE via Ovid and PubMed, CINAHL, Cochrane Central Register of Controlled Trials and Scopus. Inclusion criteria will involve intervention studies for head and neck lymphoedema management, English language, and adult human participants following head and neck cancer. The software Covidence will be used to export, manage, and screen results. Risk of bias and quality will be assessed in included studies using the Cochrane Handbook of Systematic Reviews of Intervention risk of bias and GRADE tools. A meta-analysis will be performed if there are sufficient homogenous studies. Alternatively, a narrative synthesis will be completed on study findings. Ethics and dissemination: No ethical approval is required as the study does not involve patient and public involvement. The findings of the review will be disseminated in conferences and submitted for approval to be published in a peer-reviewed journal. Prospero registration number: CRD42022378417. (S1 Appendix)

Heads or tails first? Evolution of fetal orientation in ichthyosaurs, with a scrutiny of the prevailing hypothesis

According to a longstanding paradigm, aquatic amniotes, including the Mesozoic marine reptile group Ichthyopterygia, give birth tail-first because head-first birth leads to increased asphyxiation risk of the fetus in the aquatic environment. Here, we draw upon published and original evidence to test two hypotheses: (1) Ichthyosaurs inherited viviparity from a terrestrial ancestor. (2) Asphyxiation risk is the main reason aquatic amniotes give birth tail-first. From the fossil evidence, we conclude that head-first birth is more prevalent in Ichthyopterygia than previously recognized and that a preference for tail-first birth likely arose in derived forms. This weakens the support for the terrestrial ancestry of viviparity in Ichthyopterygia. Our survey of extant viviparous amniotes indicates that fetal orientation at birth reflects a broad diversity of factors unrelated to aquatic vs. terrestrial habitat, further undermining the asphyxiation hypothesis. We propose that birth preference is based on parturitional mechanics or carrying efficiency rather than habitat

Reducing the Risk of Hospitalization for Nursing Home Residents: Effects and Facility Variation From OPTIMISTIC

Objectives The Optimizing Patient Transfers, Impacting Medical Quality, and Improving Symptoms: Transforming Institutional Care (OPTIMISTIC) project led to significant decreases in potentially avoidable hospitalizations of long-stay nursing facility residents in external evaluation. The purpose of this study was to quantify hospitalization risk from the start of the project and describe the heterogeneity of the enrolled facilities in order to better understand the context for successful implementation. Design Pre-post analysis design of a prospective intervention within a single group. Setting and Participants A total of 4320 residents in the 19 facilities were included from admission until time to the first hospitalization. Measures Data were extracted from Minimum Data Set assessments and linked with facility-level covariates from the LTCFocus.org data set. Kaplan-Meier and Cox proportional hazards regression were used to assess risk of hospitalization during the preintervention period (2011-2012), a “ramp-up” period (2013-2014), and an intervention period (2015-2016). Results The cohort consisted of 4230 long-stay nursing facility residents. Compared with the preintervention period, residents during the intervention period had an increased probability of having no hospitalizations within 1 year, increasing from 0.51 to 0.57, which was statistically significant ( P < .001). In adjusted Cox models, the risk of hospitalization was lower in the ramp-up period compared to the pre-period [hazard ratio (HR) 0.85, 95% confidence interval (CI) 0.75-0.95] and decreased further during the intervention period (HR 0.74, 95% CI 0.65-0.84). Conclusions and Implications As part of a large multisite demonstration project, OPTIMISTIC has successfully reduced hospitalizations. However, this study highlights the magnitude and extent to which results differ across facilities. Implementing the OPTIMISTIC program was associated with a 16% risk reduction after the first 18 months and continued to a final risk reduction of 26% after 5½ years. Although this model of care reduces hospitalizations overall, facility variation should be expected

Cost-effectiveness of exercise referral schemes enhanced by self-management strategies to battle sedentary behaviour in older adults: Protocol for an economic evaluation alongside the SITLESS three-armed pragmatic randomised controlled trial

Introduction: Promoting physical activity (PA) and reducing sedentary behaviour (SB) may exert beneficial effects on the older adult population, improving behavioural, functional, health and psychosocial outcomes in addition to reducing health, social care and personal costs. This paper describes the planned economic evaluation of SITLESS, a multicountry three-armed pragmatic randomised controlled trial (RCT) which aims to assess the short-term and long-term effectiveness and cost-effectiveness of a complex intervention on SB and PA in community-dwelling older adults, based on exercise referral schemes enhanced by a group intervention providing self-management strategies to encourage lifestyle change. Methods and analysis: A within-trial economic evaluation and long-term model from both a National Health Service/personal social services perspective and a broader societal perspective will be undertaken alongside the SITLESS multinational RCT. Healthcare costs (hospitalisations, accident and emergency visits, appointment with health professionals) and social care costs (eg, community care) will be included in the economic evaluation. For the cost-utility analysis, quality-adjusted life-years will be measured using the EQ-5D-5L and capability well-being measured using the ICEpop CAPability measure for Older people (ICECAP-O) questionnaire. Other effectiveness outcomes (health related, behavioural, functional) will be incorporated into a cost-effectiveness analysis and cost-consequence analysis. The multinational nature of this RCT implies a hierarchical structure of the data and unobserved heterogeneity between clusters that needs to be adequately modelled with appropriate statistical and econometric techniques. In addition, a long-term population health economic model will be developed and will synthesise and extrapolate within-trial data with additional data extracted from the literature linking PA and SB outcomes with longer term health states. Methods guidance for population health economic evaluation will be adopted including the use of a long-time horizon, 1.5% discount rate for costs and benefits, cost consequence analysis framework and a multisector perspective. Ethics and dissemination: The study design was approved by the ethics and research committee of each intervention site: the Ethics and Research Committee of Ramon Llull University (reference number: 1314001P) (Fundació Blanquerna, Spain), the Regional Committees on Health Research Ethics for Southern Denmark (reference number: S-20150186) (University of Southern Denmark, Denmark), Office for Research Ethics Committees in Northern Ireland (ORECNI reference number: 16/NI/0185) (Queen’s University of Belfast) and the Ethical Review Board of Ulm University (reference number: 354/15) (Ulm, Germany). Participation is voluntary and all participants will be asked to sign informed consent before the start of the study. This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement number 634 270. This article reflects only the authors' view and the Commission is not responsible for any use that may be made of the information it contains. The findings of the study will be disseminated to different target groups (academia, policymakers, end users) through different means following the national ethical guidelines and the dissemination regulation of the Horizon 2020 funding agency. Use of the EuroQol was registered with the EuroQol Group in 2016. Use of the ICECAP-O was registered with the University of Birmingham in March 2017. Trial registration number: NCT02629666; Pre-results

Cost-effectiveness of a programme to address sedentary behaviour in older adults: results from the SITLESS RCT

Background: This study details the within-trial economic evaluation and long-term economic model of SITLESS, a multi-country, three-armed randomized controlled trial comparing a combined intervention of exercise referral schemes (ERS) enhanced by self-management strategies (SMS) against ERS alone and usual care (UC). Methods: A cost-utility analysis, conducted from the base-case perspective of the National Health Service and personal and social services, estimated the incremental cost per incremental quality-adjusted life year (QALY) and years in full capability (YFC). A secondary analysis combined the costs with a broad set of outcomes within a cost-consequence framework, from a societal perspective. A Markov-type decision-analytic model was developed to project short-term changes in physical activity to long-term outcomes and costs, over a 5- and 15-year time horizon. Results: The results of the within-trial analysis show that SMS+ERS is highly likely to be cost-effective compared to ERS alone (ICER €4270/QALY), but not compared to UC. Participants allocated to the SMS+ERS group also showed an improvement in YFC compared to ERS alone and UC. The long-term analysis revealed that SMS+ERS is likely to be a cost-effective option compared to ERS and UC over a 5-year, but not with a 15-year horizon, being then dominated by ERS alone. Conclusion: This research provides new evidence that SMS is a cost-effective add-on to ERS strategies. This economic evaluation informs the case for further, cost-effective, refinement of lifestyle change programmes targeted to older adults, with the aim of ultimately reducing the impact of non-communicable diseases in this population

Age-specific rates of hospital transfers in long-stay nursing home residents

Introduction hospital transfers and admissions are critical events in the care of nursing home residents. We sought to determine hospital transfer rates at different ages. Methods a cohort of 1,187 long-stay nursing home residents who had participated in a Centers for Medicare and Medicaid demonstration project. We analysed the number of hospital transfers of the study participants recorded by the Minimum Data Set. Using a modern regression technique, we depicted the annual rate of hospital transfers as a smooth function of age. Results transfer rates declined with age in a nonlinear fashion. Rates were the highest among residents younger than 60 years of age (1.30-2.15 transfers per year), relatively stable between 60 and 80 (1.17-1.30 transfers per year) and lower in those older than 80 (0.77-1.17 transfers per year). Factors associated with increased risk of transfers included prior diagnoses of hip fracture (annual incidence rate ratio or IRR: 2.057, 95% confidence interval (CI): [1.240, 3.412]), dialysis (IRR: 1.717, 95% CI: [1.313, 2.246]), urinary tract infection (IRR: 1.755, 95% CI: [1.361, 2.264]), pneumonia (IRR: 1.501, 95% CI: [1.072, 2.104]), daily pain (IRR: 1.297, 95% CI: [1.055,1.594]), anaemia (IRR: 1.229, 95% CI [1.068, 1.414]) and chronic obstructive pulmonary disease (IRR: 1.168, 95% CI: [1.010,1.352]). Transfer rates were lower in residents who had orders reflecting preferences for comfort care (IRR: 0.79, 95% CI: [0.665, 0.936]). Discussion younger nursing home residents may require specialised interventions to reduce hospital transfers; declining transfer rates with the oldest age groups may reflect preferences for comfort-focused care

Facility and resident characteristics associated with variation in nursing home transfers: evidence from the OPTIMISTIC demonstration project

Background: Centers for Medicare and Medicaid Services (CMS) funded demonstration project to evaluate financial incentives for nursing facilities providing care for 6 clinical conditions to reduce potentially avoidable hospitalizations (PAHs). The Optimizing Patient Transfers, Impacting Medical Quality, and Improving Symptoms: Transforming Institutional Care (OPTIMISTIC) site tested payment incentives alone and in combination with the successful nurse-led OPTIMISTIC clinical model. Our objective was to identify facility and resident characteristics associated with transfers, including financial incentives with or without the clinical model. Methods: This was a longitudinal analysis from April 2017 to June 2018 of transfers among nursing home residents in 40 nursing facilities, 17 had the full clinical + payment model (1726 residents) and 23 had payment only model (2142 residents). Using CMS claims data, the Minimum Data Set, and Nursing Home Compare, multilevel logit models estimated the likelihood of all-cause transfers and PAHs (based on CMS claims data and ICD-codes) associated with facility and resident characteristics. Results: The clinical + payment model was associated with 4.1 percentage points (pps) lower risk of all-cause transfers (95% confidence interval [CI] - 6.2 to - 2.1). Characteristics associated with lower PAH risk included residents aged 95+ years (- 2.4 pps; 95% CI - 3.8 to - 1.1), Medicare-Medicaid dual-eligibility (- 2.5 pps; 95% CI - 3.3 to - 1.7), advanced and moderate cognitive impairment (- 3.3 pps; 95% CI - 4.4 to - 2.1; - 1.2 pps; 95% CI - 2.2 to - 0.2). Changes in Health, End-stage disease and Symptoms and Signs (CHESS) score above most stable (CHESS score 4) increased the risk of PAH by 7.3 pps (95% CI 1.5 to 13.1). Conclusions: Multiple resident and facility characteristics are associated with transfers. Facilities with the clinical + payment model demonstrated lower risk of all-cause transfers compared to those with payment only, but not for PAHs