Clinical and cost-effectiveness of PCF versus ACD in the treatment of cervical brachialgia (FORVAD trial).

BACKGROUND: Cervical radiculopathy occurs when a nerve root is compressed in the spine, if symptoms fail to resolve after 6 weeks surgery may be indicated. Anterior Cervical Discectomy (ACD) is the commonest procedure, Posterior Cervical Foraminotomy (PCF) is an alternative that avoids the risk of damage to anterior neck structures. This prospective, Phase III, UK multicentre, open, individually randomised controlled trial was performed to determine whether PCF is superior to ACD in terms of improving clinical outcome as measured by the Neck Disability Index (NDI) 52 weeks post-surgery. METHOD: Following consent to participate and collection of baseline data, subjects with cervical brachialgia were randomised to ACD or PCF in a 1:1 ratio on the day of surgery. Clinical outcomes were assessed on day 1 and patient reported outcomes on day 1 and weeks 6, 12, 26, 39 and 52 post-operation. A total of 252 participants were planned to be randomised. Statistical analysis was limited to descriptive statistics. Health economic outcomes were also described. RESULTS: The trial was closed early (n = 23). Compared to baseline, the median (interquartile range (IQR)) NDI score at 52 weeks reduced from 44.0 (36.0, 62.0) to 25.3 (20.0, 42.0) in the PCF group and increased from 35.6 (34.0, 44.0) to 45.0 (20.0, 57.0) in the ACD group. ACD may be associated with more swallowing, voice and other complications and was more expensive; neck and arm pain scores were similar. CONCLUSIONS: The trial was closed early, therefore no definitive conclusions on clinical or cost-effectiveness could be made.

Posterior cervical foraminotomy versus anterior cervical discectomy for Cervical Brachialgia: the FORVAD RCT.

Background: Posterior cervical foraminotomy and anterior cervical discectomy are routinely used operations to treat cervical brachialgia, although definitive evidence supporting superiority of either is lacking. Objective: The primary objective was to investigate whether or not posterior cervical foraminotomy is superior to anterior cervical discectomy in improving clinical outcome. Design: This was a Phase III, unblinded, prospective, United Kingdom multicentre, parallel-group, individually randomised controlled superiority trial comparing posterior cervical foraminotomy with anterior cervical discectomy. A rapid qualitative study was conducted during the close-down phase, involving remote semistructured interviews with trial participants and health-care professionals. Setting: National Health Service trusts. Participants: Patients with symptomatic unilateral cervical brachialgia for at least 6 weeks. Interventions: Participants were randomised to receive posterior cervical foraminotomy or anterior cervical discectomy. Allocation was not blinded to participants, medical staff or trial staff. Health-care use from providing the initial surgical intervention to hospital discharge was measured and valued using national cost data. Main outcome measures: The primary outcome measure was clinical outcome, as measured by patient-reported Neck Disability Index score 52 weeks post operation. Secondary outcome measures included complications, reoperations and restricted American Spinal Injury Association score over 6 weeks post operation, and patient-reported Eating Assessment Tool-10 items, Glasgow-Edinburgh Throat Scale, Voice Handicap Index-10 items, PainDETECT and Numerical Rating Scales for neck and upper-limb pain over 52 weeks post operation. Results: The target recruitment was 252 participants. Owing to slow accrual, the trial closed after randomising 23 participants from 11 hospitals. The qualitative substudy found that there was support and enthusiasm for the posterior cervical FORaminotomy Versus Anterior cervical Discectomy in the treatment of cervical brachialgia trial and randomised clinical trials in this area. However, clinical equipoise appears to have been an issue for sites and individual surgeons. Randomisation on the day of surgery and processes for screening and approaching participants were also crucial factors in some centres. The median Neck Disability Index scores at baseline (pre surgery) and at 52 weeks was 44.0 (interquartile range 36.0-62.0 weeks) and 25.3 weeks (interquartile range 20.0-42.0 weeks), respectively, in the posterior cervical foraminotomy group (n = 14), and 35.6 weeks (interquartile range 34.0-44.0 weeks) and 45.0 weeks (interquartile range 20.0-57.0 weeks), respectively, in the anterior cervical discectomy group (n = 9). Scores appeared to reduce (i.e. improve) in the posterior cervical foraminotomy group, but not in the anterior cervical discectomy group. The median Eating Assessment Tool-10 items score for swallowing was higher (worse) after anterior cervical discectomy (13.5) than after posterior cervical foraminotomy (0) on day 1, but not at other time points, whereas the median Glasgow-Edinburgh Throat Scale score for globus was higher (worse) after anterior cervical discectomy (15, 7, 6, 6, 2, 2.5) than after posterior cervical foraminotomy (3, 0, 0, 0.5, 0, 0) at all postoperative time points. Five postoperative complications occurred within 6 weeks of surgery, all after anterior cervical discectomy. Neck pain was more severe on day 1 following posterior cervical foraminotomy (Numerical Rating Scale - Neck Pain score 8.5) than at the same time point after anterior cervical discectomy (Numerical Rating Scale - Neck Pain score 7.0). The median health-care costs of providing initial surgical intervention were £2610 for posterior cervical foraminotomy and £4411 for anterior cervical discectomy. Conclusions: The data suggest that posterior cervical foraminotomy is associated with better outcomes, fewer complications and lower costs, but the trial recruited slowly and closed early. Consequently, the trial is underpowered and definitive conclusions cannot be drawn. Recruitment was impaired by lack of individual equipoise and by concern about randomising on the day of surgery. A large prospective multicentre trial comparing anterior cervical discectomy and posterior cervical foraminotomy in the treatment of cervical brachialgia is still required. Trial registration: This trial is registered as ISRCTN10133661. Funding: This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 27, No. 21. See the NIHR Journals Library website for further project information.

Cervical brachialgia is pain that starts in the neck and passes down into the arm. Although most people with cervical brachialgia recover quickly, in some patients pain persists, and in 15% of patients pain is so severe that they are unable to work. In the posterior cervical FORaminotomy Versus Anterior cervical Discectomy in the treatment of cervical brachialgia trial, we investigated two neck surgeries used to treat this problem: posterior cervical foraminotomy (surgery from the back of the neck) and anterior cervical discectomy (surgery from the front of the neck). This trial aimed to find out if one of them is better than the other at relieving pain and more cost-effective for the National Health Service. We assessed patients' quality of life 1 year after their surgery and how their pain changed over the course of the year. We also measured the number of complications patients had in the first 6 weeks after their operation. Recruitment was slow and so the trial was stopped early, after only 23 patients from 11 hospitals had been randomly allocated to the two surgery groups. We had planned to recruit 252 participants to the trial; the number of participants we were able to recruit in practice was too small to enable us to determine which surgery is better at relieving pain. To find out why the trial had struggled to recruit, we asked hospital staff and participants about their experiences. We found that hospital staff sometimes struggled to organise everything needed to randomise patients on the day of surgery. Some staff also found it difficult to randomise patients as they had an opinion on which surgery they thought the patient should receive. The data collected in the trial will still be useful to help design future research. Finding out which surgery is better at relieving pain remains important, and the data we have collected will support answering this question in future.

Derivation of a UK preference-based value set for the Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS) to allow estimation of Mental Well-being Adjusted Life Years (MWALYs).

BACKGROUND: The Mental Well-being Adjusted Life Year (MWALY) is an alternative outcome measure to the quality-adjusted life year (QALY) in economic evaluations of interventions aimed at improving mental well-being. However, there is a lack of preference-based mental well-being instruments for capturing population mental well-being preferences. OBJECTIVES: To derive a UK preference-based value set for the Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS). METHODS: 225 participants that were interviewed between December 2020 and August 2021 completed 10 composite time trade-off (C-TTO) and 10 discrete choice experiment (DCE) interviewer-administered exercises. Heteroskedastic Tobit and conditional logit models were used to model C-TTO and DCE responses respectively. The DCE utility values were rescaled to a C-TTO comparable scale through anchoring and mapping. An inverse variance weighting hybrid model (IVWHM) was used to derive weighted-average coefficients from the modelled C-TTO and DCE coefficients. Model performance was assessed using statistical diagnostics. RESULTS: The valuation responses confirmed the feasibility and face validity of the C-TTO and DCE techniques. Apart from the main effects models, statistically significant associations were estimated between the predicted C-TTO value and participants' SWEMWBS scores, gender, ethnicities, education levels, and the interaction terms between age and useful feeling. The IVWHM was the most optimal model with the fewest logically inconsistent coefficients and the lowest pooled standard errors. The utility values generated by the rescaled DCE models and the IVWHM were generally higher than those of the C-TTO model. The predictive ability of the two DCE rescaling methods was similar according to the mean absolute deviation and root mean square deviation statistics. CONCLUSIONS: This study has produced the first preference-based value set for a measure of mental well-being. The IVWHM provided a desirable blend of both C-TTO and DCE models. The value set derived by this hybrid approach can be used for cost-utility analyses of mental well-being interventions.

Mobile Health Pulmonary Rehabilitation Compared to a Center-Based Program for Cost-Effectiveness and Effects on Exercise Capacity, Health Status, and Quality of Life in People With Chronic Obstructive Pulmonary Disease: A Protocol for a Randomized Controlled Trial.

OBJECTIVE: The use of digital health is a novel way to improve access to comprehensive pulmonary rehabilitation for people with chronic obstructive pulmonary disease (COPD). This study aims to determine if a home-based pulmonary rehabilitation program supported by mobile health (mHealth) technology is equivalent to center-based pulmonary rehabilitation in terms of improvements in exercise capacity and health status in people with COPD. METHODS: This study is a prospective, multicenter, equivalence randomized controlled trial (RCT) with intention-to-treat analysis. A hundred participants with COPD will be recruited from 5 pulmonary rehabilitation programs. Following randomization, participants will be assigned in a concealed manner to receive either home-based pulmonary rehabilitation supported by mHealth or center-based pulmonary rehabilitation. Both programs will be 8 weeks and will include progressive exercise training, disease management education, self-management support, and supervision by a physical therapist. Co-primary outcome measures will be the 6-Minute Walk Test and the COPD Assessment Test. Secondary outcome measures will include the St George's Respiratory Questionnaire, the EuroQol 5 Dimension 5 Level, the modified Medical Research Council dyspnea scale, the 1-minute sit-to-stand test, the 5 times sit-to-stand test, the Hospital Anxiety and Depression Scale, daily physical activity levels, health care utilization, and costs. Outcomes will be measured at baseline and at the end of the intervention. Participant experience will be assessed through semi-structured interviews at the end of the intervention. Utilization of health care and costs will be measured again after 12 months. IMPACT: This study will be the first rigorous RCT to examine the effects of a home-based pulmonary rehabilitation program supported by mHealth technology that includes comprehensive clinical outcome evaluation, assessment of daily physical activity, a health economic analysis, and qualitative analysis. If findings demonstrate that there is equivalence in clinical outcomes, that the mHealth program costs the least amount (and is thus cost-effective), and that the mHealth program is acceptable to participants, such programs should be widely implemented to improve access to pulmonary rehabilitation.

Relation of the Dietary Approaches to Stop Hypertension Dietary Pattern to Heart Failure Risk and Socioeconomic Status (from the Southern Community Cohort Study).

The Dietary Approaches to Stop Hypertension (DASH) dietary pattern has been associated with a lower risk of incident heart failure (HF); however, previous studies were conducted in mostly middle-income White populations. The association between DASH and incident HF risk in lower income and Black individuals is less well understood. We analyzed 25,300 White and Black adults without a history of HF at enrollment (2002 to 2009) in the Southern Community Cohort Study receiving Centers for Medicare and Medicaid Services. Alignment with DASH was assessed at enrollment using a validated food frequency questionnaire. Incident HF was ascertained from Centers for Medicare and Medicaid Services claims through 2016. The association between DASH diet alignment and incident HF was examined in multivariable-adjusted Cox proportional hazards regression models, including an interaction term testing effect modification by income. The cohort was predominantly middle-aged (median 54 years), Black (68%), female (63%), and low-income (88% <$25,000/year/household). Socioeconomic factors, including education and annual income, were larger contributors to the variance in DASH score than were cardiovascular co-morbidities. The association between DASH dietary alignment and HF risk was not significant overall (hazard ratio [HR] 1.00; 95% confidence interval [CI] 0.96 to 1.04) or in race-sex groups. However, the association between alignment with the DASH diet and HF risk significantly varied by income (interaction p = 0.030), with neutral and inverse associations in lower (<$25,000/year) and higher ($≥25,000) income participants, respectively. In conclusion, income modified the association between healthier dietary patterns and risk of incident HF. In lower income participants, greater alignment with the DASH diet was not associated with lower HF risk.

Demand for Essential Nonambulatory Neurosurgical Care Decreased While Acuity of Care Increased During the Coronavirus Disease 2019 (COVID-19) Surge.

BACKGROUND: In times of health resource reallocation, capacities must remain able to meet a continued demand for essential, nonambulatory neurosurgical acute care. This study sought to characterize the demand for and provision of neurosurgical acute care during the coronavirus disease 2019 (COVID-19) pandemic. METHODS: This single-center cross-sectional observational analysis compared nonambulatory neurosurgical consult encounters during the peri-surge period (March 9 to May 31, 2020) with those during an analogous period in 2019. Outcomes included consult volume, distribution of problem types, disease severity, and rate of acute operative intervention. RESULTS: A total of 1494 neurosurgical consults were analyzed. Amidst the pandemic surge, 583 consults were seen, which was 6.4 standard deviations below the mean among analogous 2016-2019 periods (mean 873; standard deviation 45, P = 0.001). Between 2019 and 2020, the proportion of degenerative spine consults decreased in favor of spinal trauma (25.6% vs. 34% and 51.9% vs. 41.4%, P = 0.088). Among aneurysmal subarachnoid hemorrhage cases, poor-grade (Hunt and Hess grades 4-5) presentations were more common (30% vs. 14.8%, P = 0.086). A greater proportion of pandemic era consults resulted in acute operative management, with an unchanged absolute frequency of acutely operative consults (123/583 [21.1%] vs. 120/911 [13.2%], P < 0.001). CONCLUSIONS: Neurosurgical consult volume during the pandemic surge hit a 5-year institutional low. Amidst vast reallocation of health care resources, demand for high-acuity nonambulatory neurosurgical care continued and proportionally increased for greater-acuity pathologies. In our continued current pandemic as well as any future situations of mass health resource reallocation, neurosurgical acute care capacities must be preserved.

Economics of mental well-being: a prospective study estimating associated health care costs and sickness benefit transfers in Denmark.

BACKGROUND: Previous literature has examined the societal costs of mental illness, but few studies have estimated the costs associated with mental well-being. In this study, a prospective analysis was conducted on Danish data to determine 1) the association between mental well-being (measured in 2016) and government expenditure in 2017, specifially healthcare costs and sickness benefit transfers. METHODS: Data stem from a Danish population-based survey of 3,508 adults (aged 16 + years) in 2016, which was linked to Danish registry data. A validated scale (WEMWBS) was used for the assessment of mental well-being. Costs are expressed in USD PPP. A two-part model was applied to predict costs in 2017, adjusting for sociodemographics, health status (including psychiatric morbidity and health behaviour), as well as costs in the previous year (2016). RESULTS: Each point increase in mental well-being (measured in 2016) was associated with lower healthcare costs ($- 42.5, 95% CI = $- 78.7, $- 6.3) and lower costs in terms of sickness benefit transfers ($- 23.1, 95% CI = $- 41.9, $- 4.3) per person in 2017. CONCLUSIONS: Estimated reductions in costs related to mental well-being add to what is already known about potential savings related to the prevention of mental illness. It does so by illustrating the savings that could be made by moving from lower to higher levels of mental well-being both within and beyond the clinical range. Our estimates pertain to costs associated with those health-related outcomes that were included in the study, but excluding other social and economic outcomes and benefits. They cover immediate cost estimates (costs generated the year following mental well-being measurement) and not those that could follow improved mental well-being over the longer term. They may therefore be considered conservative from a societal perspective. Population approaches to mental health promotion are necessary, not only to potentiate disease prevention strategies, but also to reduce costs related to lower levels of mental well-being in the non-mental illness population. Our results suggest that useful reductions in both health care resource use and costs, as well as in costs due to sick leave from the workplace, could be achieved from investment in mental well-being promotion within a year.

Cumulative risk of compromised physical, mental and social health in adulthood due to family conflict and financial strain during childhood: a retrospective analysis based on survey data representative of 19 European countries.

BACKGROUND: Childhood adversity (CA) has previously been linked to various health problems in adulthood. Investigations into the differential impact of distinct types of CA on a wide range of outcomes are scarce. This study aimed to assess the impact of self-reported childhood family conflict and/or financial strain on health and social functioning in adulthood among Europeans, while taking into account the mediating role of adulthood socioeconomic disadvantage (SED) in these associations. METHODS: Using the European Social Survey (ESS) collected in 2014, nationally representative cross-sectional data from 35 475 participants aged 15 years and older in 19 European countries were analysed. Logistic regressions were conducted to assess associations of retrospectively reported family conflict and/or financial strain in childhood with physical and mental health as well as health behaviours and social functioning in adulthood. RESULTS: A quarter of the European population reported having experienced family conflict, financial strain or both in childhood. Financial strain was reported more among older age groups and conflict more among younger age groups. A dose-response pattern with increased risk was demonstrated for almost all physical, behavioral, mental and social outcomes for these aspects of CA compared with no CA, with the highest risk observed in those who experienced both financial strain and family conflict. Adulthood SED mediated a significant proportion of the associations with financial strain (ranging from 5.4% to 72.4%), but did not mediate the associations with conflict. CONCLUSION: Individuals reporting family conflict or financial strain during childhood are at increased risk of developing a wide range of health and social problems. Those who report financial strain in childhood are more likely to experience SED in adulthood, which in turn increases their risk of experiencing health and social problems. Reported family conflict during childhood conferred increased risk of health and social problems, but adulthood SED did not appear to operate as an indirect pathway.

Health system interventions for adults with type 2 diabetes in low- and middle-income countries: A systematic review and meta-analysis.

BACKGROUND: Effective health system interventions may help address the disproportionate burden of diabetes in low- and middle-income countries (LMICs). We assessed the impact of health system interventions to improve outcomes for adults with type 2 diabetes in LMICs. METHODS AND FINDINGS: We searched Ovid MEDLINE, Cochrane Library, EMBASE, African Index Medicus, LILACS, and Global Index Medicus from inception of each database through February 24, 2020. We included randomized controlled trials (RCTs) of health system interventions targeting adults with type 2 diabetes in LMICs. Eligible studies reported at least 1 of the following outcomes: glycemic change, mortality, quality of life, or cost-effectiveness. We conducted a meta-analysis for the glycemic outcome of hemoglobin A1c (HbA1c). GRADE and Cochrane Effective Practice and Organisation of Care methods were used to assess risk of bias for the glycemic outcome and to prepare a summary of findings table. Of the 12,921 references identified in searches, we included 39 studies in the narrative review of which 19 were cluster RCTs and 20 were individual RCTs. The greatest number of studies were conducted in the East Asia and Pacific region (n = 20) followed by South Asia (n = 7). There were 21,080 total participants enrolled across included studies and 10,060 total participants in the meta-analysis of HbA1c when accounting for the design effect of cluster RCTs. Non-glycemic outcomes of mortality, health-related quality of life, and cost-effectiveness had sparse data availability that precluded quantitative pooling. In the meta-analysis of HbA1c from 35 of the included studies, the mean difference was -0.46% (95% CI -0.60% to -0.31%, I2 87.8%, p < 0.001) overall, -0.37% (95% CI -0.64% to -0.10%, I2 60.0%, n = 7, p = 0.020) in multicomponent clinic-based interventions, -0.87% (-1.20% to -0.53%, I2 91.0%, n = 13, p < 0.001) in pharmacist task-sharing studies, and -0.27% (-0.50% to -0.04%, I2 64.1%, n = 7, p = 0.010) in trials of diabetes education or support alone. Other types of interventions had few included studies. Eight studies were at low risk of bias for the summary assessment of glycemic control, 15 studies were at unclear risk, and 16 studies were at high risk. The certainty of evidence for glycemic control by subgroup was moderate for multicomponent clinic-based interventions but was low or very low for other intervention types. Limitations include the lack of consensus definitions for health system interventions, differences in the quality of underlying studies, and sparse data availability for non-glycemic outcomes. CONCLUSIONS: In this meta-analysis, we found that health system interventions for type 2 diabetes may be effective in improving glycemic control in LMICs, but few studies are available from rural areas or low- or lower-middle-income countries. Multicomponent clinic-based interventions had the strongest evidence for glycemic benefit among intervention types. Further research is needed to assess non-glycemic outcomes and to study implementation in rural and low-income settings.

Exploring and understanding the scope and value of the Parkinson's nurse in the UK (The USP Project): a realist economic evaluation protocol.

INTRODUCTION: There are multiple configurations of specialist nurses working in the field of Parkinson's. Parkinson's Nurse Specialists (PNSs) are recognised as playing a pivotal role; however, there is little published evidence to demonstrate their effectiveness. Further evidence is needed to establish which aspects of the PNSs provide the greatest benefit to people with Parkinson's and their families, and the cost-effectiveness of different models of care. METHODS AND ANALYSIS: Realist approaches explain how and why programmes work (or not) through striving to answer the question: what works, for whom and under what circumstances. This research uses a realist evaluation and aims to integrate an economic analysis within the realist framework. We refer to this as 'realist economic evaluation'. It comprises four phases: (1) developing resource-sensitive initial programme theories (IPTs) using surveys to gain a better understanding of the role and impact (costs and benefits) of the PNSs; (2) testing the IPTs through qualitative interviews and quantitative data analysis; (3) evaluating the cost and resource use implications alongside the benefits associated with the role of the PNSs and (4) iteratively refining the IPTs throughout the project. The IPTs will draw on both quantitative and qualitative data. The result of the study will be a series of refined programme theories, which will explain how specialist nurses work in the field of Parkinson's in the UK, what impact they have on people with Parkinson's and their families and carers, and at what cost. ETHICS AND DISSEMINATION: Northumbria University, the Health Research Authority and Health and Care Research Wales have approved this study. Key findings will be disseminated throughout the duration of the project online and through social media, and via annual and regional Parkinson's meetings and the Parkinson's UK Excellence Network. Academic dissemination will occur through publication and conference presentations.

Multiple Interventions for Diabetic Foot Ulcer Treatment Trial (MIDFUT): study protocol for a randomised controlled trial.

INTRODUCTION: Diabetes affects more than 425 million people worldwide with a lifetime risk of diabetic foot ulcer (DFU) of up to 25%. Management includes wound debridement, wound dressings, offloading, treatment of infection and ischaemia, optimising glycaemic control; use of advanced adjuvant therapies is limited by high cost and lack of robust evidence. METHODS AND ANALYSIS: A multicentre, seamless phase II/III, open, parallel group, multi-arm multi-stage randomised controlled trial in patients with a hard-to-heal DFU, with blinded outcome assessment. A maximum of 447 participants will be randomised (245 participants in phase II and 202 participants in phase III). The phase II primary objective will determine the efficacy of treatment strategies including hydrosurgical debridement ± decellularised dermal allograft, or the combination with negative pressure wound therapy, as an adjunct to treatment as usual (TAU), compared with TAU alone, with patients randomised in a 1:1:1:2 allocation. The outcome is achieving at least 50% reduction in index ulcer area at 4 weeks post randomisation.The phase III primary objective will determine whether one treatment strategy, continued from phase II, reduces time to healing of the index ulcer compared with TAU alone, with participants randomised in a 1:1 allocation. Secondary objectives will compare healing status of the index ulcer, infection rate, reulceration, quality of life, cost-effectiveness and incidence of adverse events over 52 weeks post randomisation. Phase II and phase III primary endpoint analysis will be conducted using a mixed-effects logistic regression model and Cox proportional hazards regression, respectively. A within-trial economic evaluation will be undertaken; the primary economic analysis will be a cost-utility analysis presenting ICERs for each treatment strategy in rank order of effectiveness, with effects expressed as quality-adjusted life years.The trial has predefined progression criteria for the selection of one treatment strategy into phase III based on efficacy, safety and costs at 4 weeks. ETHICS AND DISSEMINATION: Ethics approval has been granted by the National Research Ethics Service (NRES) Committee Yorkshire and The Humber - Bradford Leeds Research Ethics Committee; approved 26 April 2017; (REC reference: 17/YH/0055). There is planned publication of a monograph in National Institute for Health Research journals and main trial results and associated papers in high-impact peer-reviewed journals. TRIAL REGISTRATION NUMBER: ISRCTN64926597; registered on 6 June 2017.

Pressure Relieving Support Surfaces for Pressure Ulcer Prevention (PRESSURE 2): Clinical and Health Economic Results of a Randomised Controlled Trial.

BACKGROUND: Pressure ulcers (PUs) are complications of serious acute/chronic illness. Specialist mattresses used for prevention lack high quality effectiveness evidence. We aimed to compare clinical and cost effectiveness of 2 mattress types. METHODS: Multicentre, Phase III, open, prospective, parallel group, randomised controlled trial in 42 UK secondary/community in-patient facilities.2029 high risk (acutely ill, bedfast/chairfast and/or Category 1 PU/pain at PU site) adult in-patients were randomised (1:1, allocation concealment, minimisation with random element) factors including: centre, PU status, facility and consent type. Interventions were alternating pressure mattresses (APMs) or high specification foam (HSF) for maximum treatment phase 60 days. Primary outcome was time to development of new PU Category ≥ 2 from randomisation to 30 day post-treatment follow-up in intention-to treat population. Trial registration: ISRCTN 01151335. FINDINGS: Between August 2013 and November 2016, we randomised 2029 patients (1016 APMs: 1013 HSF) who developed 160(7.9%) PUs. There was insufficient evidence of a difference between groups for time to new PU Category ≥ 2 Fine and Gray Model Hazard Ratio HR = 0.76, 95%CI0.56-1.04); exact P = 0.0890; absolute difference 2%). There was a statistically significant difference in the treatment phase time to event sensitivity analysis, Fine and Gray model HR = 0.66, 95%CI, 0.46-0.93; exact P = 0.0176); 2.6% absolute difference). Economic analyses indicate that APM are cost-effective.There were no safety concerns. INTERPRETATION: In high risk (acutely ill, bedfast/chairfast/Category 1 PU/ pain on a PU site) in-patients, we found insufficient evidence of a difference in time to PU development at 30-day final follow-up, which may be related to a low event rate affecting trial power. APMs conferred a small treatment phase benefit. Patient preference, low PU incidence and small group differences suggests the need for improved targeting of APMs with decision making informed by patient preference/comfort/rehabilitation needs and the presence of potentially modifiable risk factors such as being completely immobile, nutritional deficits, lacking capacity and/or altered skin/Category1 PU.

Identification of Racial Inequities in Access to Specialized Inpatient Heart Failure Care at an Academic Medical Center.

BACKGROUND: Racial inequities for patients with heart failure (HF) have been widely documented. HF patients who receive cardiology care during a hospital admission have better outcomes. It is unknown whether there are differences in admission to a cardiology or general medicine service by race. This study examined the relationship between race and admission service, and its effect on 30-day readmission and mortality Methods: We performed a retrospective cohort study from September 2008 to November 2017 at a single large urban academic referral center of all patients self-referred to the emergency department and admitted to either the cardiology or general medicine service with a principal diagnosis of HF, who self-identified as white, black, or Latinx. We used multivariable generalized estimating equation models to assess the relationship between race and admission to the cardiology service. We used Cox regression to assess the association between race, admission service, and 30-day readmission and mortality. RESULTS: Among 1967 unique patients (66.7% white, 23.6% black, and 9.7% Latinx), black and Latinx patients had lower rates of admission to the cardiology service than white patients (adjusted rate ratio, 0.91; 95% CI, 0.84-0.98, for black; adjusted rate ratio, 0.83; 95% CI, 0.72-0.97 for Latinx). Female sex and age >75 years were also independently associated with lower rates of admission to the cardiology service. Admission to the cardiology service was independently associated with decreased readmission within 30 days, independent of race. CONCLUSIONS: Black and Latinx patients were less likely to be admitted to cardiology for HF care. This inequity may, in part, drive racial inequities in HF outcomes.

Comparing alternating pressure mattresses and high-specification foam mattresses to prevent pressure ulcers in high-risk patients: the PRESSURE 2 RCT.

BACKGROUND: Pressure ulcers (PUs) are a burden to patients, carers and health-care providers. Specialist mattresses minimise the intensity and duration of pressure on vulnerable skin sites in at-risk patients. PRIMARY OBJECTIVE: Time to developing a new PU of category ≥ 2 in patients using an alternating pressure mattress (APM) compared with a high-specification foam mattress (HSFM). DESIGN: A multicentre, Phase III, open, prospective, planned as an adaptive double-triangular group sequential, parallel-group, randomised controlled trial with an a priori sample size of 2954 participants. Randomisation used minimisation (incorporating a random element). SETTING: The trial was set in 42 secondary and community inpatient facilities in the UK. PARTICIPANTS: Adult inpatients with evidence of acute illness and at a high risk of PU development. INTERVENTIONS AND FOLLOW-UP: APM or HSFM - the treatment phase lasted a maximum of 60 days; the final 30 days were post-treatment follow-up. MAIN OUTCOME MEASURES: Time to event. RESULTS: From August 2013 to November 2016, 2029 participants were randomised to receive either APM (n = 1016) or HSFM (n = 1013). Primary end point - 30-day final follow-up: of the 2029 participants in the intention-to-treat population, 160 (7.9%) developed a new PU of category ≥ 2. There was insufficient evidence of a difference between groups for time to new PU of category ≥ 2 [Fine and Gray model HR 0.76, 95% confidence interval (CI) 0.56 to 1.04; exact p-value of 0.0890 and 2% absolute difference]. Treatment phase sensitivity analysis: 132 (6.5%) participants developed a new PU of category ≥ 2 between randomisation and end of treatment phase. There was a statistically significant difference in the treatment phase time-to-event sensitivity analysis (Fine and Gray model HR 0.66, 95% CI 0.46 to 0.93; p = 0.0176 and 2.6% absolute difference). Secondary end points - 30-day final follow-up: new PUs of category ≥ 1 developed in 350 (17.2%) participants, with no evidence of a difference between mattress groups in time to PU development, (Fine and Gray model HR 0.83, 95% CI 0.67 to 1.02; p-value = 0.0733 and absolute difference 3.1%). New PUs of category ≥ 3 developed in 32 (1.6%) participants with insufficient evidence of a difference between mattress groups in time to PU development (Fine and Gray model HR 0.81, 95% CI 0.40 to 1.62; p = 0.5530 and absolute difference 0.4%). Of the 145 pre-existing PUs of category 2, 89 (61.4%) healed - there was insufficient evidence of a difference in time to healing (Fine and Gray model HR 1.12, 95% CI 0.74 to 1.68; p = 0.6122 and absolute difference 2.9%). Health economics - the within-trial and long-term analysis showed APM to be cost-effective compared with HSFM; however, the difference in costs models are small and the quality-adjusted life-year gains are very small. There were no safety concerns. Blinded photography substudy - the reliability of central blinded review compared with clinical assessment for PUs of category ≥ 2 was 'very good' (kappa statistic 0.82, prevalence- and bias-adjusted kappa 0.82). Quality-of-life substudy - the Pressure Ulcer Quality of Life - Prevention (PU-QoL-P) instrument meets the established criteria for reliability, construct validity and responsiveness. LIMITATIONS: A lower than anticipated event rate. CONCLUSIONS: In acutely ill inpatients who are bedfast/chairfast and/or have a category 1 PU and/or localised skin pain, APMs confer a small treatment phase benefit that is diminished over time. Overall, the APM patient compliance, very low PU incidence rate observed and small differences between mattresses indicate the need for improved indicators for targeting of APMs and individualised decision-making. Decisions should take into account skin status, patient preferences (movement ability and rehabilitation needs) and the presence of factors that may be potentially modifiable through APM allocation, including being completely immobile, having nutritional deficits, lacking capacity and/or having altered skin/category 1 PU. FUTURE WORK: Explore the relationship between mental capacity, levels of independent movement, repositioning and PU development. Explore 'what works for whom and in what circumstances'. TRIAL REGISTRATION: Current Controlled Trials ISRCTN01151335. FUNDING: This project was funded by the National Institute for Health Research Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 52. See the NIHR Journals Library website for further project information.

Pressure ulcers (PUs) are patches of damaged skin, mainly caused by sitting/lying in one position. PUs are graded based on how serious they are, ranging from red patches (category 1) through small skin breaks/blisters (category 2) to serious wounds (category 4). Special mattresses are used to help prevent PUs. This study compared alternating pressure mattresses (APMs) with high-specification foam mattresses (HSFMs), to see which is better at preventing PUs. The study included adults admitted to hospital for acute illness who were at a high risk of developing PUs. Patients were randomly allocated to HSFM or APM. Nurses checked patients' skin and recorded changes. A total of 132 patients developed at least one new PU of category ≥ 2 before the end of treatment (60 days maximum). Of these, 53 patients were allocated to the APM arm and 79 to the HSFM arm, a difference of 2.6%. This is a small but significant difference. Nurses looked at patients' skin again 30 days after the patient had stopped using a trial mattress. At this point, 160 patients had at least one new PU (of category ≥ 2). Of these, 70 patients were allocated to the APM arm and 90 to the HSFM arm, a very small difference of 2.0%. Some patients asked to change mattresses; this happened more in the APM group. This study focused on high-risk patients; however, only a small number of people developed PUs, suggesting that prevention is possible with either mattress. Results also suggest that certain groups of patients may benefit more from APMs, for example people who cannot give consent or who have skin redness. When planning prevention and choosing mattresses, professionals and patients need to consider a number of factors, such as comfort, existing PUs and people's ability to self-care. Further research is recommended to understand what sort of prevention works, for whom and in what circumstances.

Impact of Child and Maternal Weight on Healthcare Trainee Clinical Assessment Decision Making: A Virtual Human Study.

BACKGROUND: Adult literature documents that healthcare providers rely on patient characteristics, such as age, race, and weight, when making clinical decisions. However, little research has examined these biases among pediatric populations. This study aimed to examine the impact of child and maternal weight and race on clinical decision-making of healthcare trainees in the context of a pediatric pain assessment using standardized virtual pediatric patients and mothers. METHODS: Ninety-two healthcare trainees read a standardized clinical vignette describing a child with chronic pain, which was accompanied by eight virtual human (VH) scenes-each with a child and mother. Scenes varied by the dyad's race, child's weight status, and mother's weight status. For each scene, participants were asked to make six healthcare assessment ratings. RESULTS: Participants rated children (M = 42.44 vs. 48.69; p < 0.001) and mothers (M = 51.06 vs. 65.31; p < 0.001) with obesity as being less likely to adhere to physician recommendations compared with healthy weight children and mothers. Child patients with obesity (M = 38.88 vs. 30.08; p < 0.001) and mothers with obesity (M = 49.71 vs. 43.71; p < 0.001) were also rated as bearing more responsibility for the child's health status compared with healthy weight peers. CONCLUSIONS: This study provides evidence that child and mother weight can impact clinical decision-making, as well as for the utility of VH technology in studying decision-making among healthcare trainees and providers.

Alternative tumour necrosis factor inhibitors (TNFi) or abatacept or rituximab following failure of initial TNFi in rheumatoid arthritis: the SWITCH RCT.

BACKGROUND: Rheumatoid arthritis (RA), the most common autoimmune disease in the UK, is a chronic systemic inflammatory arthritis that affects 0.8% of the UK population. OBJECTIVES: To determine whether or not an alternative class of biologic disease-modifying antirheumatic drugs (bDMARDs) are comparable to rituximab in terms of efficacy and safety outcomes in patients with RA in whom initial tumour necrosis factor inhibitor (TNFi) bDMARD and methotrexate (MTX) therapy failed because of inefficacy. DESIGN: Multicentre, Phase III, open-label, parallel-group, three-arm, non-inferiority randomised controlled trial comparing the clinical and cost-effectiveness of alternative TNFi and abatacept with that of rituximab (and background MTX therapy). Eligible consenting patients were randomised in a 1 : 1 : 1 ratio using minimisation incorporating a random element. Minimisation factors were centre, disease duration, non-response category and seropositive/seronegative status. SETTING: UK outpatient rheumatology departments. PARTICIPANTS: Patients aged ≥ 18 years who were diagnosed with RA and were receiving MTX, but had not responded to two or more conventional synthetic disease-modifying antirheumatic drug therapies and had shown an inadequate treatment response to a first TNFi. INTERVENTIONS: Alternative TNFi, abatacept or rituximab (and continued background MTX). MAIN OUTCOME MEASURES: The primary outcome was absolute reduction in the Disease Activity Score of 28 joints (DAS28) at 24 weeks post randomisation. Secondary outcome measures over 48 weeks were additional measures of disease activity, quality of life, cost-effectiveness, radiographic measures, safety and toxicity. LIMITATIONS: Owing to third-party contractual issues, commissioning challenges delaying centre set-up and thus slower than expected recruitment, the funders terminated the trial early. RESULTS: Between July 2012 and December 2014, 149 patients in 35 centres were registered, of whom 122 were randomised to treatment (alternative TNFi, n = 41; abatacept, n = 41; rituximab, n = 40). The numbers, as specified, were analysed in each group [in line with the intention-to-treat (ITT) principle]. Comparing alternative TNFi with rituximab, the difference in mean reduction in DAS28 at 24 weeks post randomisation was 0.3 [95% confidence interval (CI) -0.45 to 1.05] in the ITT patient population and -0.58 (95% CI -1.72 to 0.55) in the per protocol (PP) population. Corresponding results for the abatacept and rituximab comparison were 0.04 (95% CI -0.72 to 0.79) in the ITT population and -0.15 (95% CI -1.27 to 0.98) in the PP population. General improvement in the Health Assessment Questionnaire Disability Index, Rheumatoid Arthritis Quality of Life and the patients' general health was apparent over time, with no notable differences between treatment groups. There was a marked initial improvement in the patients' global assessment of pain and arthritis at 12 weeks across all three treatment groups. Switching to alternative TNFi may be cost-effective compared with rituximab [incremental cost-effectiveness ratio (ICER) £5332.02 per quality-adjusted life-year gained]; however, switching to abatacept compared with switching to alternative TNFi is unlikely to be cost-effective (ICER £253,967.96), but there was substantial uncertainty in the decisions. The value of information analysis indicated that further research would be highly valuable to the NHS. Ten serious adverse events in nine patients were reported; none were suspected unexpected serious adverse reactions. Two patients died and 10 experienced toxicity. FUTURE WORK: The results will add to the randomised evidence base and could be included in future meta-analyses. CONCLUSIONS: How to manage first-line TNFi treatment failures remains unresolved. Had the trial recruited to target, more credible evidence on whether or not either of the interventions were non-inferior to rituximab may have been provided, although this remains speculative. TRIAL REGISTRATION: Current Controlled Trials ISRCTN89222125 and ClinicalTrials.gov NCT01295151. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 22, No. 34. See the NIHR Journals Library website for further project information.

Development and use of the art therapy seizure assessment sculpture on an inpatient epilepsy monitoring unit.

•Patients diagnosed with PNES created sculptures notably different than patients diagnosed with epilepsy.•Art therapy may help both PNES and Epilepsy patients with emotional expression.•Along with a conventional diagnostic interview, SAS could help could provide important information at a much quicker rate.

Use of Risk Model for Assessment of Residents' Perception of Complexity of Surgical Steps: Example of Modular Component Steps of Lumbar Spinal Fusion Surgery.

BACKGROUND: Quality improvement projects increasingly emphasize standardization of surgical work flow to optimize operative room efficiency. Removing special cause variability resulting from nonsurgical waste is an obvious target; however, resident surgical education must be maintained, even in the setting of process improvement. OBJECTIVE: To describe the impact of resident-identified "risky" or "uncomfortable" procedural steps on operative time during transforaminal lumbar interbody fusion (TLIF). METHODS: TLIF procedure steps were defined. An 8 2-part questions survey regarding comfort level and perceived risk assessment at each step was developed and completed by junior (17) and senior residents (10), and by faculty (6) from orthopedic, and neurological surgery. A risk matrix was constructed defining 2 zones: a "danger zone"; responses were high risk (3-5) and low comfort (1-3), and a "safe zone"; responses were low risk (1-2) and high comfort (4-5). One-tailed Chi-square with Yates correction was performed. RESULTS: Risk matrix analysis showed a statistical difference among "danger zone" respondents between junior resident and faculty groups for exposure, pedicle screw placement, neural decompression, interbody placement, posterolateral fusion, and hemostasis. A radar graph identifies percent of respondents who fall within the "danger zone". CONCLUSION: Resident perception of surgical complexity can be evaluated for procedural steps using a risk matrix survey. For TLIF, residents may assign more risk and may be less comfortable performing steps in a training-level-dependent manner. Identification of particular high-risk or uncomfortable steps should prompt strict faculty oversight to improve patient safety, monitor resident education, and reduce operative time.

Mental Health Professionals' Suicide Risk Assessment and Management Practices.

BACKGROUND: Approximately 20% of suicide decedents have had contact with a mental health professional within 1 month prior to their death, and the majority of mental health professionals have treated suicidal individuals. Despite limited evidence-based training, mental health professionals make important clinical decisions related to suicide risk assessment and management. AIMS: The current study aimed to determine the frequency of suicide risk assessment and management practices and the association between fear of suicide-related outcomes or comfort working with suicidal individuals and adequacy of suicide risk management decisions among mental health professionals. METHOD: Mental health professionals completed self-report assessments of fear, comfort, and suicide risk assessment and management practices. RESULTS: Approximately one third of mental health professionals did not ask every patient about current or previous suicidal thoughts or behaviors. Further, comfort, but not fear, was positively associated with greater odds of conducting evidence-based suicide risk assessments at first appointments and adequacy of suicide risk management practices with patients reporting suicide ideation and a recent suicide attempt. LIMITATIONS: The study utilized a cross-sectional design and self-report questionnaires. CONCLUSION: Although the majority of mental health professionals report using evidenced-based practices, there appears to be variability in utilization of evidence-based practices.