Effectiveness of dexmedetomidine on patient-centred outcomes in surgical patients: a systematic review and Bayesian meta-analysis.

BACKGROUND: Dexmedetomidine is increasingly used for surgical patients requiring general anaesthesia. However, its effectiveness on patient-centred outcomes remains uncertain. Our main objective was to evaluate the patient-centred effectiveness of intraoperative dexmedetomidine for adult patients requiring surgery under general anaesthesia. METHODS: We conducted a systematic search of MEDLINE, Embase, CENTRAL, Web of Science, and CINAHL from inception to October 2023. Randomised controlled trials (RCTs) comparing intraoperative use of dexmedetomidine with placebo, opioid, or usual care in adult patients requiring surgery under general anaesthesia were included. Study selection, data extraction, and risk of bias assessment were performed by two reviewers independently. We synthesised data using a random-effects Bayesian regression framework to derive effect estimates and the probability of a clinically important effect. For continuous outcomes, we pooled instruments with similar constructs using standardised mean differences (SMDs) and converted SMDs and credible intervals (CrIs) to their original scale when appropriate. We assessed the certainty of evidence using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology. Our primary outcome was quality of recovery after surgery. To guide interpretation on the original scale, the Quality of Recovery-15 (QoR-15) instrument was used (range 0-150 points, minimally important difference [MID] of 6 points). RESULTS: We identified 49,069 citations, from which 44 RCTs involving 5904 participants were eligible. Intraoperative dexmedetomidine administration was associated with improvement in postoperative QoR-15 (mean difference 9, 95% CrI 4-14, n=21 RCTs, moderate certainty of evidence). We found 99% probability of any benefit and 88% probability of achieving the MID. There was a reduction in chronic pain incidence (odds ratio [OR] 0.42, 95% CrI 0.19-0.79, n=7 RCTs, low certainty of evidence). There was also increased risk of clinically significant hypotension (OR 1.98, 95% CrI 0.84-3.92, posterior probability of harm 94%, n=8 RCTs) and clinically significant bradycardia (OR 1.74, 95% CrI 0.93-3.34, posterior probability of harm 95%, n=10 RCTs), with very low certainty of evidence for both. There was limited evidence to inform other secondary patient-centred outcomes. CONCLUSIONS: Compared with placebo or standard of care, intraoperative dexmedetomidine likely results in meaningful improvement in the quality of recovery and chronic pain after surgery. However, it might increase clinically important bradycardia and hypotension. SYSTEMATIC REVIEW PROTOCOL: PROSPERO (CRD42023439896).

Adaptation and content validation of measure yourself medical outcomes profile (MYMOP) for 7-11 year-old children.

BACKGROUND: The Measure Yourself Medical Outcome Profile (MYMOP) is an individualised tool designed for adults but used with children without any evidence of validation in this population. Individualised instruments are patient-specific rather than disease-specific and therefore can be applied across various health conditions. This study sought to adapt, and content validate the MYMOP for application in 7-11 year old children. METHODS: There were two main phases of the four iterations: expert consultation (three rounds) and interviews with child-parent pairs at the Outpatient clinics of a Children's Hospital. Thematic analysis was undertaken using an inductive, interpretative approach. RESULTS: Four paediatricians completed the first survey, five paediatricians participated in the focus group, and four paediatric health-related quality of life (HRQOL) research experts completed the second survey. Several changes were recommended to the MYMOP by the expert groups. Twenty-five children (17 general medicine, and 8 diabetes/endocrine clinic) aged 7-11 years completed the draft paediatric MYMOP (P-MYMOP) and were interviewed. Results demonstrated that the majority of participants were able to identify their own problems and activity limitations, and all participants understood the 7-point faces scale. Most parents and children perceived that the P-MYMOP would be useful to complete before clinic appointments. CONCLUSIONS: The P-MYMOP is the first content-validated generic individualised HRQOL measure for children 7-11 years old. Given that validation is an iterative process, further research to assess its feasibility, reliability, and construct validity is required.

Effectiveness of peer-delivered sleep health education and social support in increasing OSA evaluation among at-risk blacks.

To assess the effectiveness of culturally and linguistically tailored, peer-delivered obstructive sleep apnea education and of social support to increase adherence to physician-recommended obstructive sleep apnea evaluation among blacks. In a two-arm randomised controlled trial, we ascertained the effectiveness of peer-delivered obstructive sleep apnea education in increasing obstructive sleep apnea evaluation among 319 blacks at risk of obstructive sleep apnea (intervention = 159 and control = 160); their average age was 47 ± 12.9 years, and 41% were male. Obstructive sleep apnea risk was assessed with the Apnea Risk Evaluation System questionnaire, administered in community venues. Participants in the intervention arm received tailored obstructive sleep apnea education during a 6 month period; those in the control arm received standard sleep and healthy lifestyle information. Analysis focussed on the effectiveness of peer-delivered obstructive sleep apnea education on adherence to obstructive sleep apnea evaluation, but also considered the role of psychosocial factors. The results showed no significant differences in baseline demographic and clinical measures when contrasting participants in the study arms. The adherence rates for home-based obstructive sleep apnea evaluation in the intervention and control arms were 45.9% and 45.6%, respectively. Overall, participants in both study arms (adherers) who underwent obstructive sleep apnea evaluations were likely to experience a greater level of social support (8.2 ± 2.4 vs. 7.3 ± 2.4; p = 0.06). Moreover, adherers showed greater psychosocial scores (i.e., Dysfunctional Beliefs and Attitudes about Sleep scale, Apnea Beliefs Scale (ABS) (and Apnea Knowledge) compared with non-adherers (6.0 ± 1.8 vs. 4.9 ± 2.2; p = 0.02; 77.0 ± 7.1 vs. 73.2 ± 7.4; p = 0.04, and 6.4 ± 3.1 vs. 7.6 ± 2.4; p = 0.06, respectively). The results of the present randomised controlled trial favoured a potential role of peer-based social support and psychosocial factors, associated with obstructive sleep apnea adherence behaviour.

Clinical effectiveness/child-patient and parent satisfaction of two topical fluoride treatments for caries: a randomised clinical trial.

Knowledge gaps exist regarding optimal silver diammine fluoride (SDF) regimens and the efficacy of new products for arresting dental caries in young children. We evaluated the effectiveness of 38%-SDF (SDI-RivaStar), Tiefenfluorid (TF) comparing with Placebo (P), all in conjunction with behavioural modification (BM), in preventing major complications (endodontic/extractions/pain)-a patient-centred outcome-due to early childhood caries over 12 months in children under 71-months. A six-arm, patient/parent-blinded, superiority, placebo-controlled randomised control trial at the university clinic in Riga, Latvia, from 1/9/20-31/8/22 (Protocol registration ISRCTN17005348). The trial tested six protocols, using three compounds (P/SDF/TF) under two regimes: annual and biannual (P1/P2/TF1/TF2/SDF1/SDF2) for major complications. Secondary outcomes included minor complications and parental satisfaction. All groups received BM. 373/427 randomised children (87.3%) completed the study. SDF2 had a significantly lower rate and risk of major (21.5%, OR = 0.28, 95%CI [0.11, 0.72], p < 0.05) and minor complications (OR = 0.16 (95%CI [0.05, 0.50], p = 0.002). Overall satisfaction was 96% (p > 0.05). SDF biannual application with BM effectively prevented major complications of early childhood caries and was well accepted by children and their parents. Trial registration number: ISRCTN17005348, principal investigator: Ilze Maldupa, registration date: 30/06/2021.Clinical trial registration number: ISRCTN registry: ISRCTN17005348, https://doi.org/10.1186/ISRCTN17005348 , registration date: 30/06/2021.

How to measure patient and family important outcomes in extremely preterm infants: A scoping review.

AIM: Parents of children born preterm have identified outcomes to be measured for audit and research at 18-24 months of age: child well-being, quality of life/function, socio-emotional/behavioural outcomes, respiratory, feeding, sleeping, and caregiver mental health. The aim was to identify the best tools to measure these seven domains. METHODS: Seven working groups completed literature reviews and evaluated potential tools to measure these outcomes in children aged 18-24 months. A group of experts and parents voted on the preferred tools in a workshop and by questionnaire. Consensus was 80% agreement. RESULTS: Consensus was obtained for seven brief, inexpensive, parent friendly valid measures available in English or French for use in a minimum dataset and potential alternative measures for use in funded research. CONCLUSION: Valid questionnaires and tools to measure parent-identified outcomes in young preterm children exist. This study will facilitate research and collection of data important to families.

What are the anticipated benefits, risks, barriers and facilitators to implementing person-centred outcome measures into routine care for children and young people with life-limiting and life-threatening conditions? A qualitative interview study with key stakeholders.

BACKGROUND: There is a growing evidence-base underpinning implementation of person-centred outcome measures into adult palliative care. However evidence on how best to achieve this with children facing life-threatening and life-limiting conditions is limited. AIM: To identify the anticipated benefits, risks, barriers and facilitators to implementing person-centred outcome measures for children with life-limiting and life-threatening conditions. DESIGN: Cross-sectional qualitative semi-structured interview study with key stakeholders analysed using Framework analysis informed by the adapted-Consolidated Framework for Implementation Research. SETTING/PARTICIPANTS: A total of n = 26 children with life-limiting or life-threatening conditions, n = 40 parents/carers, n = 13 siblings and n = 15 health and social care professionals recruited from six hospitals and three children's hospices and n = 12 Commissioners of health services. RESULTS: All participants were supportive of future implementation of person-centred outcome measures into care. Anticipated benefits included: better understanding of patient and family priorities, improved communication and collaborative working between professionals and families and standardisation in data collection and reporting. Anticipated risks included increased workload for staff and measures not being used as intended. Implementation barriers included: acceptability and usability of outcome measures by children; burden and capacity of parents/carers regarding completion; privacy concerns; and language barriers. Implementation facilitators included designing measures using language that is meaningful to children and families, ensuring potential benefits of person-centred outcome measures are communicated to encourage 'buy-in' and administering measures with known and trusted professional. CONCLUSIONS: Implementation of person-centred outcome measures offer potential benefits for children with life-limiting and life-threatening conditions. Eight recommendations are made to maximise benefits and minimise risks in implementation.

What matters to people and families affected by cerebral small vessel disease (SVD)? A qualitative grounded theory investigation.

Background: Cerebral small vessel disease (SVD) is a common neurological disorder contributing to stroke, dementia, and disability. No treatment options exist although clinical trials are ongoing. We aimed to understand what matters to people and families affected by SVD to inform future research. Methods: We thematically analysed unsolicited correspondences from members of the public addressed to members of the Edinburgh SVD Research Group on a variety of subjects related to SVD. We used inductive thematic codes, categorised under concerns, requests, emotions, and contributions, to form a grounded theory that categorised and ranked concerns raised. Results: 101 correspondents expressed 346 concerns between August 2015 and February 2021, mostly via email. 60 correspondents (59.4 %) disclosed a SVD diagnosis, 39 (38.6 %) disclosed a previous stroke or TIA, and 40 (39.6 %) were family of people living with SVD. Primary concerns related to cognitive problems (number of correspondents (n)=43 (42.6 %)), lack of support or information from healthcare services (n = 41 (40.6 %)), prognosis (n = 37 (36.6 %)), sensory disturbances (n = 27 (26.7 %)), functional problems (n = 24, (23.8 %)), impact on daily life (n = 24 (23.8 %)), and causes of SVD (n = 19 (18.8 %)). 57 correspondents (56.4 %) expressed support for research, 43 (42.6 %) expressed an eagerness to understand SVD, 35 (34.7 %) expressed helplessness, and 19 (18.8 %) expressed frustration. Conclusions: Cognitive decline was the main concern for people and families living with SVD who corresponded with the Edinburgh SVD research group. These findings also indicate a need for more accessible services and better information about SVD for patients and families.

Intraoperative pharmacologic opioid minimisation strategies and patient-centred outcomes after surgery: a scoping review.

BACKGROUND: Postoperative patient-centred outcome measures are essential to capture the patient's experience after surgery. Although a large number of pharmacologic opioid minimisation strategies (i.e. opioid alternatives) are used for patients undergoing surgery, it remains unclear which strategies are most promising in terms of patient-centred outcome improvements. This scoping review had two main objectives: (1) to map and describe evidence from clinical trials assessing the patient-centred effectiveness of pharmacologic intraoperative opioid minimisation strategies in adult surgical patients, and (2) to identify promising pharmacologic opioid minimisation strategies. METHODS: We searched MEDLINE, Embase, CENTRAL, Web of Science, and CINAHL databases from inception to February 2023. We included trials investigating the use of opioid minimisation strategies in adult surgical patients and reporting at least one patient-centred outcome. Study screening and data extraction were conducted independently by at least two reviewers. RESULTS: Of 24,842 citations screened for eligibility, 2803 trials assessed the effectiveness of intraoperative opioid minimisation strategies. Of these, 457 trials (67,060 participants) met eligibility criteria, reporting at least one patient-centred outcome. In the 107 trials that included a patient-centred primary outcome, patient wellbeing was the most frequently used domain (55 trials). Based on aggregate findings, dexmedetomidine, systemic lidocaine, and COX-2 inhibitors were promising strategies, while paracetamol, ketamine, and gabapentinoids were less promising. Almost half of the trials (253 trials) did not report a protocol or registration number. CONCLUSIONS: Researchers should prioritise and include patient-centred outcomes in the assessment of opioid minimisation strategy effectiveness. We identified three potentially promising pharmacologic intraoperative opioid minimisation strategies that should be further assessed through systematic reviews and multicentre trials. Findings from our scoping review may be influenced by selective outcome reporting bias. STUDY REGISTRATION: OSF - https://osf.io/7kea3.

Advancing Universal Oral Health Coverage via Person-Centred Outcomes.

The World Health Organization member states proposed a comprehensive "Global Strategy on Oral Health," which includes achieving universal oral health coverage by 2030. Challenges and barriers, including persistent inequalities, will hamper the achievement of universal oral health coverage. In low- and middle-income countries, the oral health of a large proportion of the population has been neglected, increasing oral health inequalities. In high-income countries, some receive excessive dental treatment, whilst particularly those with higher needs receive too little dental care. Therefore, an analysis of individual countries' needs, encompassing the training of oral health professionals in a new philosophy of care and attention and the optimisation of the existing resources, is necessary. Distancing from a person-centred focus has prompted individual and societal issues, including under-/overdiagnosis and under-/overtreatment. The person-centred approach considers the perceptions, needs, preferences, and circumstances of individuals and populations. Patient-reported outcome measures, such as self-rated and -reported health, reflect an individual's overall perception of health and are designed to mediate human biology (ie, the disease) and psychology. The usage of patient-reported outcome measures in dentistry to place the individual at the centre of treatment is delayed compared to other areas. This paper discusses some challenges and potential solutions of patient-reported outcome measures in dentistry for achieving universal oral health coverage.

Association of preoperative anaesthesia consultation prior to elective noncardiac surgery with patient and health system outcomes: a population-based study.

BACKGROUND: Surgical volumes and use of preoperative anaesthesia consultations are increasing. However, contemporary data estimating the association between preoperative anaesthesia consultation and patient (days alive and at home [DAH30], mortality) and system (costs, length of stay, and readmissions) outcomes are not available. METHODS: We conducted a population-based comparative effectiveness study using linked health administrative data among patients aged ≥40 yr who underwent intermediate-risk to high-risk elective, inpatient, noncardiac surgery in Ontario, Canada (2009-17). Our primary outcome was DAH30. Secondary outcomes included DAH90, 30-day and 1-yr mortality, 30-day health system costs, length of index admission, and 30-day readmissions. Propensity score overlap weights were used to adjust for confounders. Prespecified effect modifier analyses focused on high-risk subgroups. RESULTS: Among 364 149 patients, 274 365 (75.3%) received a preoperative anaesthesia consultation. No adjusted association was found (22.5 days vs 22.5 days; adjusted ratio of means 1.00, 95% CI 1.00-1.00) between consultation and DAH30 in the full population. We identified significant effect modification (significantly more DAH30) among patients with ischaemic heart disease, ASA physical status ≥4, frailty index score ≥0.21, and who underwent vascular surgery. Secondary outcomes were associated with preoperative consultation, including greater DAH90, decreased length of stay, lower 30-day and 1-yr mortality, and reduced 30-day costs. CONCLUSIONS: Preoperative anaesthesia consultation was not associated with greater DAH30 across the overall study population. However, important potential benefits were observed among high-risk subgroups. Research is needed to identify optimal patient populations and consultation processes.

The association between social determinants of health and patient-centred outcomes in adults with heart failure with reduced ejection fraction.

AIMS: To explore the associations between social determinants of health and patient-centred outcomes among adults with chronic heart failure with reduced ejection fraction. DESIGN: Cross-sectional online self-report survey. METHODS: A survey assessing social determinants of health (demographics, socio-economic position, affordability of care and social support) and patient-centred outcomes, including the Kansas City Cardiomyopathy Questionnaire-12 and validated measures of medication adherence, treatment satisfaction, treatment burden and mental health, was completed by 512 adults with chronic heart failure with a reduced ejection fraction between 06 March and 29 June 2020. Multivariable analyses included linear and logistic regression. RESULTS: Female gender, having a care partner, and being offered financial assistance with medications were associated with worse health status, while perceiving medication as affordable and being married were associated with better health status. Females and having Medicaid, dual Medicaid/Medicare or no medical insurance were associated with a higher likelihood of depression, and non-white race/ethnicity was associated with less depression. Medication adherence was lower in patients having a care partner and offered financial assistance. Patients being offered financial and medication management assistance were more likely to be overwhelmed by the treatment burden, whereas those having some college education were less so. CONCLUSIONS: Social determinants of health are associated with patients' disease-specific health status, mental health and treatment satisfaction and burden. These findings underscore the importance of assessing social determinants of health in clinical practice and the need for developing and testing novel strategies to determine whether they improve patients' health. IMPACT: The relationship between social determinants of health- and patient-centred outcomes was assessed; affordability of care and social support factors were most strongly associated with outcomes for patients with chronic heart failure and reduced ejection fraction, underscoring the importance of assessing social determinants of health in routine clinical care. IMPLICATIONS FOR THE PROFESSION AND/OR PATIENT CARE: Social determinants of health data could potentially inform care delivery for patients with heart failure and reduced ejection fraction by helping to identify those who require additional support to manage their symptoms, access care and adhere to treatment. Social support and affordability of treatment were associated with most patient-centred outcomes, suggesting these factors may provide clinicians with an indicator of a patient's level of general well-being that could be assessed during routine follow-up care. REPORTING METHOD: This research followed the STROBE checklist for cross-sectional studies. PATIENT OR PUBLIC CONTRIBUTION: Adults who have heart failure with reduced ejection fraction that consented to participate in the study provided the data used for all analyses reported on in the manuscript. Service users, caregivers or members of the public had no involvement in the study.

Unmet needs in clinical trials in CKD: questions we have not answered and answers we have not questioned.

Many advances have been made in the field of nephrology over the last decade. These include an increasing focus on patient-centred involvement in trials, exploration of innovative trial designs and methodology, the growth of personalized medicine and, most importantly, novel therapeutic agents that are disease-modifying for large groups of patients with and without diabetes and chronic kidney disease. Despite this progress, many questions remain unanswered and we have not critically evaluated some of our assumptions, practices and guidelines despite emerging evidence to challenge current paradigms and discrepant patient-preferred outcomes. How best to implement best practices, diagnose various conditions, examine better diagnostic tools, treat laboratory values versus patients and understand prediction equations in the clinical context remain unanswered. As we enter a new era in nephrology, there are extraordinary opportunities to change the culture and care. Rigorous research paradigms enabling both the generation and the use of new information should be explored. We identify here some key areas of interest and suggest renewed efforts to describe and address these gaps so that we can develop, design and execute trials of importance to all.

Adaptation and multicentre validation of a patient-centred outcome scale for people severely ill with COVID (IPOS-COV).

BACKGROUND: Patient-centred measures to capture symptoms and concerns have rarely been reported in severe COVID. We adapted and tested the measurement properties of the proxy version of the Integrated Palliative care Outcome Scale-IPOS-COV for severe COVID using psychometric approach. METHODS: We consulted experts and followed consensus-based standards for the selection of health status measurement instruments and United States Food and Drug Administration guidance for adaptation and analysis. Exploratory Factor Analysis and clinical perspective informed subscales. We tested the internal consistency reliability, calculated item total correlations, examined re-test reliability in stable patients, and also evaluated inter-rater reproducibility. We examined convergent and divergent validity of IPOS-COV with the Australia-modified Karnofsky Performance Scale and evaluated known-groups validity. Ability to detect change was examined. RESULTS: In the adaptation phase, 6 new items were added, 7 items were removed from the original measure. The recall period was revised to be the last 12-24 h to capture fast deterioration in COVID. General format and response options of the original Integrated Palliative care Outcome Scale were preserved. Data from 572 patients with COVID from across England and Wales seen by palliative care services were included. Four subscales were supported by the 4-factor solution explaining 53.5% of total variance. Breathlessness-Agitation and Gastro-intestinal subscales demonstrated good reliability with high to moderate (a = 0.70 and a = 0.67) internal consistency, and item-total correlations (0.62-0.21). All except the Flu subscale discriminated well between patients with differing disease severity. Inter-rater reliability was fair with ICC of 0.40 (0.3-0.5, 95% CI, n = 324). Correlations between the subscales and AKPS as predicted were weak (r = 0.13-0.26) but significant (p < 0.01). Breathlessness-Agitation and Drowsiness-Delirium subscales demonstrated good divergent validity. Patients with low oxygen saturation had higher mean Breathlessness-Agitation scores (M = 5.3) than those with normal levels (M = 3.4), t = 6.4 (186), p < 0.001. Change in Drowsiness-Delirium subscale correctly classified patients who died. CONCLUSIONS: IPOS-COV is the first patient-centred measure adapted for severe COVID to support timely management. Future studies could further evaluate its responsiveness and clinical utility with clinimetric approaches.

In perspective: the patient at the heart of research in acute cardiovascular care.

Patient and public involvement is a fundamental part of research design and is increasingly required by research funders and regulators. In addition to the moral and ethical arguments in its favour, it has the potential to improve the accessibility and transparency of research and to optimize study recruitment and retention. Whilst clinical trials in acute cardiovascular care have traditionally focussed on 'hard' outcomes, such as mortality or major adverse cardiovascular events, there is increasing recognition that these fail to capture the full breadth of patient experience. Patient-centred outcomes aim to measure things of greater value to patients, using validated tools to quantify symptoms, patient self-reports, or novel outcomes such as days alive and outside hospital. This In Perspective commentary explores the rationale behind patient and public involvement and the background to and evidence supporting the use of patient-centred outcomes and discusses potential challenges and how they can be mitigated.

Institution-free days after critical illness: A multicenter retrospective study.

BACKGROUND: Patient-centered outcomes beyond mortality such as institution-free days (IFD) are becoming increasingly relevant in critical care trials. METHODS: We calculated IFD using three definitions which differed in the way death and censoring of after-hospital deaths were handled analysing data from adult patient databases admitted to four ICUs of North Brisbane, Australia. Differences in distribution of IFD using different definitions were explored with descriptive statistics and histograms. Six pre-specified variables (age, illness severity, comorbidities index, elective status, surgical/medical admission and treatment limitations) were assessed and reported as determinants of IFDs for the proposed definitions. RESULTS: Data from 25,371 ICU admissions was analysed. The density distribution of IFD was bimodal with a peak at 0 days and a variable right-sided peak depending on the definition used. The mean IFD varied from 253 (standard deviation(SD) 151.3) to 295 (SD 116.2) depending on definition used. Multivariable zero-inflated negative binomial regression modelling showed that the six pre-specified variables had significant associations with IFD and their magnitude of effect varied with the definition used. CONCLUSIONS: IFD is a simple, easily measurable patient-centered outcome that varies depending on the definition used. Patient input should be sought to define the optimum definition and clinical use of IFD.

Days alive and out of hospital after left ventricular assist device implantation.

AIMS: Implantation of left ventricular assist devices (LVADs) as a bridge to transplant or as destination therapy is increasing. The selection of suitable patients and outcome assessment belong to the key challenges. Mortality has traditionally been a focus of research in this field, but literature on quality of life is very limited. This study aimed to identify perioperative factors influencing patients' life as measured by days alive and out of hospital (DAOH) in the first year after LVAD implantation. METHODS AND RESULTS: This retrospective single-centre cohort study screened 227 patients who underwent LVAD implantation at the University Hospital Duesseldorf, Germany, between 2010 and 2020. First, the influence of 10 prespecified variables on DAOH was investigated by univariate analysis. Second, multivariate quantile regression was conducted including all factors with significant influence on DAOH in the univariate model. Additionally, the impact of all variables on 1 year mortality was investigated using Kaplan-Meier curves to oppose DAOH and mortality. In total, 221 patients were included into analysis. As pre-operative factors, chronic kidney disease (CKD), pre-operative mechanical circulatory support (pMCS), and Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) stadium < 3 were associated with lower DAOH at 1 year [CKD: 280 (155-322) vs. 230 (0-219), P = 0.0286; pMCS: 294 (155-325) vs. 243 (0-293), P = 0.0004; INTERMACS 1: 218 (0-293) vs. INTERMACS 2: 264 (6-320) vs. INTERMACS 3: 299 (228-325) vs. INTERMACS 4: 313 (247-332), P ≤ 0.0001]. Intra-operative additional implantation of a right ventricular assist device (RVAD) was also associated with lower DAOH [RVAD: 290 (160-325) vs. 174 (0-277), P ≤ 0.0001]. As post-operative values that were associated with lower DAOH, dialysis and tracheotomy could be identified [dialysis: 300 (252-326) vs. 186 (0-300), P ≤ 0.0001; tracheotomy: 292 (139-325) vs. 168 (0-269), P ≤ 0.0001]. Multivariate analysis revealed that all of these factors besides pMCS were independently associated with DAOH. According to Kaplan-Meier analysis, only post-operative dialysis was significantly associated with increased mortality at 1 year (survival: no dialysis 89.4% vs. dialysis 70.1%, hazard ratio: 0.56, 95% confidence interval: 0.33-0.94; P = 0.031). CONCLUSIONS: The results of this study indicate that there can be a clear discrepancy between hard endpoints such as mortality and more patient-centred outcomes reflecting life impact. DAOH may relevantly contribute to a more comprehensive selection process and outcome assessment in LVAD patients.

Delivery of drinking, eating and mobilising (DrEaMing) and its association with length of hospital stay after major noncardiac surgery: observational cohort study.

BACKGROUND: Enhanced recovery pathways are associated with improved postoperative outcomes. However, as enhanced recovery pathways have become more complex and varied, compliance has reduced. The 'DrEaMing' bundle re-prioritises early postoperative delivery of drinking, eating, and mobilising. We investigated relationships between DrEaMing compliance, postoperative hospital length of stay (LOS), and complications in a prospective multicentre major surgical cohort. METHODS: We interrogated the UK Perioperative Quality Improvement Programme dataset. Analyses were conducted in four stages. In an exploratory cohort, we identified independent predictors of DrEaMing. We quantified the association between delivery of DrEaMing (and its component variables) and prolonged LOS in a homogenous colorectal subgroup and assessed generalisability in multispecialty patients. Finally, LOS and complications were compared across hospitals, stratified by DrEaMing compliance. RESULTS: The exploratory cohort comprised 22 218 records, the colorectal subgroup 7230, and the multispecialty subgroup 5713. DrEaMing compliance was 59% (13 112 patients), 60% (4341 patients), and 60% (3421), respectively, but varied substantially between hospitals. Delivery of DrEaMing predicted reduced odds of prolonged LOS in colorectal (odds ratio 0.51 [0.43-0.59], P<0.001) and multispecialty cohorts (odds ratio 0.47 [0.41-0.53], P<0.001). At the hospital level, complications were not the primary determinant of LOS after colorectal surgery, but consistent delivery of DrEaMing was associated with significantly shorter LOS. CONCLUSIONS: Delivery of bundled and unbundled DrEaMing was associated with substantial reductions in postoperative LOS, independent of the effects of confounder variables. Consistency of process delivery, and not complications, predicted shorter hospital-level length of stay. DrEaMing may be adopted by perioperative health systems as a quality metric to support improved patient outcomes and reduced hospital length of stay.

The Relationship of Cobalamin and/or Folate to the Patient-Centred Outcomes in Multiple Sclerosis: A Systematic Review and Meta-analysis.

Background: To examine the relationship of vitamin B12 and folate concentrations to cognitive function, fatigue measures, physical function, quality of life (patient-centred outcomes) and homocysteine plasma concentrations (intermediate marker of cobalamin and folate deficiency) for patients with Multiple Sclerosis (MS). Methods: Systematic searches for eligible articles of MEDLINE, CINAHL, EMBASE, Scopus, Web of Science and OpenGray databases were conducted from 1983 in March 2021. Heterogeneity, Weighted Mean Difference (WMD) and Confidence Intervals (CI) calculated using Random Effects Model. Results: Sixteen studies were included involving; 616 MS patients and 655 healthy controls. 14 of these had acceptable or better quality but there was high heterogeneity. No difference was found between MS, healthy controls for folate and cobalamin concentrations; WMD 0.00ug/L (95% CI: -0.01, 0.01) and WMD 7.01pmol/L (95% CI: -25.54, 39.55) respectively. MS group showed mild-to-moderate disability WMD was 2.78 (95% CI: 2.00, 3.56). MS may be associated with elevated plasma homocysteine concentrations on average 2.47µmol/L more than healthy controls. Discussion: Physical ability of MS group was worse than healthy controls, but there was no difference in folate and cobalamin concentrations. This suggests folate and cobalamin are not influential factors in worsening physical function. There may be an association between worse cognitive function, and increased homocysteine concentrations. Results were inconclusive due to high heterogeneity and limited number of studies. A core outcome set would enable easier synthesis of future results.

Factors to Consider During Identification and Invitation of Individuals in a Multi-stakeholder Research Partnership.

BACKGROUND: Health research teams increasingly partner with stakeholders to produce research that is relevant, accessible, and widely used. Previous work has covered stakeholder group identification. OBJECTIVE: We aimed to develop factors for health research teams to consider during identification and invitation of individual representatives in a multi-stakeholder research partnership, with the aim of forming equitable and informed teams. DESIGN: Consensus development. PARTICIPANTS: We involved 16 stakeholders from the international Multi-Stakeholder Engagement (MuSE) Consortium, including patients and the public, providers, payers of health services/purchasers, policy makers, programme managers, peer review editors, and principal investigators. APPROACH: We engaged stakeholders in factor development and as co-authors of this manuscript. Using a modified Delphi approach, we gathered stakeholder views concerning a preliminary list of 18 factors. Over two feedback rounds, using qualitative and quantitative analysis, we concentrated these into ten factors. KEY RESULTS: We present seven highly desirable factors: 'expertise or experience', 'ability and willingness to represent the stakeholder group', 'inclusivity (equity, diversity and intersectionality)', 'communication skills', 'commitment and time capacity', 'financial and non-financial relationships and activities, and conflict of interest', 'training support and funding needs'. Additionally, three factors are desirable: 'influence', 'research relevant values', 'previous stakeholder engagement'. CONCLUSIONS: We present factors for research teams to consider during identification and invitation of individual representatives in a multi-stakeholder research partnership. Policy makers and guideline developers may benefit from considering the factors in stakeholder identification and invitation. Research funders may consider stipulating consideration of the factors in funding applications. We outline how these factors can be implemented and exemplify how their use has the potential to improve the quality and relevancy of health research.