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Purpose To explore the association between the degree of Chronic illness management and survival rates at 1-, 3-, 5-years post heart transplantation. Methods Exploratory secondary analysis of a cross-sectional, international study (Building Research Initiative Group study). Latent profile analysis was performed to classify 36 heart transplant centers according to the degree of chronic illness management. Results The analysis resulted in 2 classes with 29 centers classified as “low-degree chronic illness management” and 7 centers as “high-degree chronic illness management”. After 1-year posttransplantation, the high-degree chronic illness management class had a significantly greater mean survival rate compared to the low-degree chronic illness management class (88.4% vs 84.2%, p = 0.045) and the difference had a medium effect size (η2 = .06). No difference in survival for the other time points was observed. Patients in high-degree chronic illness management centers had 52% lower odds of moderate to severe drinking (95% confidence interval .30–.78, p = 0.003). No significant associations between degree of chronic illness management and the other recommended health behaviors were observed. Conclusions The findings from this exploratory study offer preliminary insight into a system-level pathway (chronic illness management) for improving outcomes for heart transplant recipients. The signals observed in our data support further investigation into the effectiveness of chronic illness management-based interventions in heart transplant follow-up care.

IntroductionHospital admissions in many countries fell dramatically at the onset of the COVID-19 pandemic. Less is known about how care patterns differed by patient groups. We sought to determine whether areas with higher levels of socioeconomic deprivation or larger ethnic minority populations saw larger falls in emergency and planned admissions in England.MethodsWe conducted a national observational study of hospital care in the English National Health Service (NHS) in 2019–2020. Weekly volumes of elective (planned) and emergency admissions in 2020 compared with 2019 were calculated for each census area. Multiple linear regression analysis was used to estimate the reductions in volumes for areas in different quintiles of socioeconomic deprivation and ethnic minority populations after controlling for national time trends and local area composition.ResultsBetween March and December 2020, there were 35.5% (3.0 million) fewer elective admissions and 22.0% (1.2 million) fewer emergency admissions with a non-COVID-19 primary diagnosis than in 2019. Areas with the largest share of ethnic minority populations experienced a 36.7% (95% CI 24.1% to 49.3%) larger reduction in non-primary COVID-19 emergency admissions compared with those with the smallest. The most deprived areas experienced a 10.1% (95% CI 2.6% to 17.7%) smaller reduction in non-COVID-19 emergency admissions compared with the least deprived. These patterns are not explained by differential prevalence of COVID-19 cases by area.ConclusionsEven in a healthcare system founded on the principle of equal access for equal need, the impact of COVID-19 on NHS hospital care for non-COVID patients has not been spread evenly by ethnicity and deprivation in England. While we cannot conclusively determine the mechanisms behind these differences, they risk exacerbating prepandemic health inequalities.

Purpose The objective of this scientometric analysis was to recognize the top 100 cited articles on 'Male infertility and Antioxidants' and analyze its publication characteristics. Materials and methods The Scopus database was used to retrieve related articles and the top 100 identified based on citation rate. Results The articles were published in 56 journals between 1995 and 2019 with a median (interquartile range) citation score of 17 (5-62). Among the top 100 articles, 69 were clinical studies, which included controlled and blinded (33.33%), prospective (27.54%), randomized-controlled trials (26.09%), uncontrolled (11.59%), and retrospective (1.45%) studies. In addition to conventional semen parameters, advanced sperm function tests such as oxidative stress (51%) and sperm DNA damage (23%) were reported. Pregnancy rate (33%) was found to be the most reported reproductive outcome. Antioxidant therapy was mostly investigated in male cohorts with sperm abnormalities such as asthenozoospermia (28%) and clinical conditions such as idiopathic male infertility (20%), varicocele/varicocelectomy (17%) and general male infertility (16%). Conclusions The most influential publications on antioxidants and male infertility were identified for the first time in the literature. This will serve as a reliable source of information for researchers and clinicians alike.

Background It is known that drug shortages represent a major challenge for all stakeholders involved in the process, but there is little evidence regarding insights into patients′ awareness and perspectives. This study aimed to investigate the patients-perceived drug shortages experience and their view on outcomes in different European hospital settings. Furthermore, we wanted to explore information preferences on drug shortages. Methods A retrospective, cross sectional, a mixed method study was conducted in six European hospital settings. One hospital (H) from each of this country agreed to participate: Bosnia and Herzegovina (H-BiH), Croatia (H-CR), Germany (H-GE), Greece (H-GR), Serbia (H-SE) and Poland (H-PO). Recruitment and data collection was conducted over 27 months from November 2017 until January 2020. Overall, we surveyed 607 patients which completed paper-based questionnaire. Questions related to: general information (demographic data), basic knowledge on drug shortages, drug shortages experienced during hospitalization and information preferences on drug shortage. Differences between hospital settings were analyzed using Chi-squared test or Fisher’s exact test. For more complex contingency tables, Monte Carlo simulations (N = 2000) were applied for Fisher’s test. Post-hoc hospital-wise analyses were performed using Fisher’s exact tests. False discovery rate was controlled using the Bonferroni method. Analyses were performed using R: a language and environment for statistical computing (v 3.6.3). Results 6 % of patients reported experiences with drug shortages while hospitalized which led to a deterioration of their health. The majority of affected patients were hospitalized at hematology and/or oncology wards in H-BiH, H-PO and H-GE. H-BiH had the highest number of affected patients (18.1 %, N = 19/105, p N = 1/100, p = 0.001). In addition, 82.5 %, (N = 501/607) of respondents wanted to be informed of alternative treatment options if there was a drug shortage without a generic substitute available. Majority of these patients (66.4 %, N = 386/501) prefer to be informed by a healthcare professional. Conclusions Although drug shortages led to serious medical consequences, our findings show that most of the patients did not perceive shortages as a problem. One possible interpretation is that good hospital management practices by healthcare professionals helped to mitigate the perceived impact of shortages. Our study highlights the importance of a good communication especially between patients and healthcare professionals in whom our patients have the greatest trust.

Background Non-pharmaceutical interventions (NPIs) are the cornerstone of infectious disease outbreak response in the absence of effective pharmaceutical interventions. Outbreak strategies often involve combinations of NPIs that may change according to disease prevalence and population response. Little is known with regard to how costly each NPI is to implement. This information is essential to inform policy decisions for outbreak response. Objective To address this gap in existing literature, we conducted a systematic review on outbreak costings and simulation studies related to a number of NPI strategies, including isolating infected individuals, contact tracing and quarantine, and school closures. Methods Our search covered the MEDLINE and EMBASE databases, studies published between 1990 and 24 March 2020 were included. We included studies containing cost data for our NPIs of interest in pandemic, epidemic, and outbreak response scenarios. Results We identified 61 relevant studies. There was substantial heterogeneity in the cost components recorded for NPIs in outbreak costing studies. The direct costs of NPIs for which costing studies existed also ranged widely: isolating infected individuals per case: US$141.18 to US$1042.68 (2020 values), tracing and quarantine of contacts per contact: US$40.73 to US$93.59, social distancing: US$33.76 to US$167.92, personal protection and hygiene: US$0.15 to US$895.60. Conclusion While there are gaps and heterogeneity in available cost data, the findings of this review and the collated cost database serve as an important resource for evidence-based decision-making for estimating costs pertaining to NPI implementation in future outbreak response policies. Supplementary Information The online version contains supplementary material available at 10.1007/s40258-021-00659-z.

PurposeThe purpose of the article is to present standard set of outcomes for people with personality disorder (PD), in order to facilitate patient outcome measurement worldwide.MethodsThe International Consortium for Health Outcomes Measurement (ICHOM) gathered a multidisciplinary international working group, consisting of 16 experts, including clinicians, nurses, psychologists, methodologists and patient representatives, to develop a standard set of outcome measures for people with PD. The Delphi method was used to reach consensus on the scope of the set, outcome domains, outcome measures, case-mix variables and time points for measuring outcomes in service users. For each phase, a project team prepared materials based on systematic literature reviews and consultations with experts.ResultsThe working group decided to include PD, as defined by International Classification of Diseases 11th revision (ICD-11). Eleven core outcomes and three optional outcomes across four health domains (mental health, behaviour, functioning and recovery) were defined as those relevant for people with PD. Validated measures for the selected outcomes were selected, some covering more than one outcome. Case-mix variables were aligned to other ICHOM mental health standard sets and consisted of demographic factors and those related to the treatment that people received. The group recommended that most outcomes are measured at baseline and annually.ConclusionThe international minimum standard set of outcomes has the potential to improve clinical decision making through systematic measurement and comparability. This will be key in improving the standard of health care for people with PD across the world.

It is widely accepted that oxidative stress plays an important role in the pathophysiology of male infertility and that antioxidants could have a significant role in the treatment of male infertility. The main objectives of this study are: 1) to systematically review the current evidence for the utility of antioxidants in the treatment of male infertility; and 2) propose evidence-based clinical guidelines for the use of antioxidants in the treatment of male infertility. A systematic review of the available clinical evidence was performed, with articles published on Scopus being manually screened. Data extracted included the type of antioxidant used, the clinical conditions under investigation, the evaluation of semen parameters and reproductive outcomes. The adherence to the Cambridge Quality Checklist, Cochrane Risk of Bias for randomized controlled trials (RCTs), CONSORT guidelines and JADAD score were analyzed for each included study. Further, we provided a Strength Weakness Opportunity Threat (SWOT) analysis to analyze the current and future value of antioxidants in male infertility. Of the 1,978 articles identified, 97 articles were included in the study. Of these, 52 (53.6%) were uncontrolled (open label), 12 (12.4%) unblinded RCTs, and 33 (34.0%) blinded RCTs, whereas 44 (45.4%) articles tested individual antioxidants, 31 (32.0%) a combination of several products in variable dosages, and 22 (22.6%) registered antioxidant products. Based on the published evidence, we 1) critically examined the necessity of additional double-blind, randomized, placebo-controlled trials, and 2) proposed updated evidence-based clinical guidelines for antioxidant therapy in male infertility. The current systematic review on antioxidants and male infertility clearly shows that antioxidant supplementation improves semen parameters. In addition, it provides the indications for antioxidant treatment in specific clinical conditions, including varicocele, unexplained and idiopathic male infertility, as well as in cases of altered semen quality.

Background Missing data are common in randomised controlled trials (RCTs) and can bias results if not handled appropriately. A statistically valid analysis under the primary missing-data assumptions should be conducted, followed by sensitivity analysis under alternative justified assumptions to assess the robustness of results. Controlled Multiple Imputation (MI) procedures, including delta-based and reference-based approaches, have been developed for analysis under missing-not-at-random assumptions. However, it is unclear how often these methods are used, how they are reported, and what their impact is on trial results. This review evaluates the current use and reporting of MI and controlled MI in RCTs. Methods A targeted review of phase II-IV RCTs (non-cluster randomised) published in two leading general medical journals (The Lancet and New England Journal of Medicine) between January 2014 and December 2019 using MI. Data was extracted on imputation methods, analysis status, and reporting of results. Results of primary and sensitivity analyses for trials using controlled MI analyses were compared. Results A total of 118 RCTs (9% of published RCTs) used some form of MI. MI under missing-at-random was used in 110 trials; this was for primary analysis in 43/118 (36%), and in sensitivity analysis for 70/118 (59%) (3 used in both). Sixteen studies performed controlled MI (1.3% of published RCTs), either with a delta-based (n = 9) or reference-based approach (n = 7). Controlled MI was mostly used in sensitivity analysis (n = 14/16). Two trials used controlled MI for primary analysis, including one reporting no sensitivity analysis whilst the other reported similar results without imputation. Of the 14 trials using controlled MI in sensitivity analysis, 12 yielded comparable results to the primary analysis whereas 2 demonstrated contradicting results. Only 5/110 (5%) trials using missing-at-random MI and 5/16 (31%) trials using controlled MI reported complete details on MI methods. Conclusions Controlled MI enabled the impact of accessible contextually relevant missing data assumptions to be examined on trial results. The use of controlled MI is increasing but is still infrequent and poorly reported where used. There is a need for improved reporting on the implementation of MI analyses and choice of controlled MI parameters.

RATIONALE, AIMS AND OBJECTIVES: The rise in chronic diseases urges for an identification of interventions that improve adherence. However, no golden standard exists for evaluating adherence in polymedicated patients. The objectives were to investigate the impact of a pharmacist-led medication use review (MUR) service on adherence implementation rates for chronic medication, and to evaluate the appropriateness of two adherence calculation approaches in this regard. METHOD: Before-after study (SIMENON study) including ambulatory, aged, polymedicated patients. Refill data were used to calculate the proportion of days covered (PDC) per medication before and after the MUR. Adherence was assessed for chronic, solid, oral medication using a prescription-based and interval-based approach, and the performance of both approaches was compared. RESULTS: Adherence was evaluated for 1483 medications from 316 patients. The median baseline PDC per medication was 0.95 (prescription-based method) and 0.91 (interval-based approach). Pearson correlation between both approaches was 0.616 (P

Data privacy mechanisms are essential for rapidly scaling medical training databases to capture the heterogeneity of patient data distributions toward robust and generalizable machine learning systems. In the current COVID-19 pandemic, a major focus of artificial intelligence (AI) is interpreting chest CT, which can be readily used in the assessment and management of the disease. This paper demonstrates the feasibility of a federated learning method for detecting COVID-19 related CT abnormalities with external validation on patients from a multinational study. We recruited 132 patients from seven multinational different centers, with three internal hospitals from Hong Kong for training and testing, and four external, independent datasets from Mainland China and Germany, for validating model generalizability. We also conducted case studies on longitudinal scans for automated estimation of lesion burden for hospitalized COVID-19 patients. We explore the federated learning algorithms to develop a privacy-preserving AI model for COVID-19 medical image diagnosis with good generalization capability on unseen multinational datasets. Federated learning could provide an effective mechanism during pandemics to rapidly develop clinically useful AI across institutions and countries overcoming the burden of central aggregation of large amounts of sensitive data.

Context There are few UK data on the prevalence and clustering of risky behaviours in ethnically diverse adolescents. Objectives To investigate the prevalence of reported alcohol use, smoking and vaping, and explore whether these behaviours are associated with increased numbers of sexual partners. Design Questionnaire survey of ‘Test n Treat’ chlamydia screening trial participants. Setting and participants Sexually active students attending six London technical colleges completed confidential questionnaires and provided genitourinary samples. Results The median age of the 509 participants was 17 years (IQR: 16‐18), 47% were male, 50% were of black ethnicity, 55% reported ≥2 sexual partners in the past year (67% of males and 45% of females) and 6.2% had chlamydia infection and 0.6% gonorrhoea. Almost half (48%) reported getting drunk in the past month, 33% smoked cigarettes and 7% had ever vaped. A larger percentage of students with ≥2 sexual partners than 0‐1 partners reported getting drunk in the past month (53.7%, 144/268% versus 42.2% 94/223, adjusted prevalence ratio: 1.33, 95% confidence interval: 1.11‐1.61) and smoking cigarettes (36.6%, 100/273% versus 30.2%, 67/222, 1.34 (1.05‐1.70)). By contrast, multiple sexual partners were not associated with vaping or chlamydia infection, but numbers were small. Conclusions We found high prevalences of risky behaviour and an association between multiple sexual partners and smoking and/or getting drunk. Findings support the introduction of compulsory sex and relationship education in UK secondary schools, including information about the adverse effects of alcohol and smoking. Public contribution Participants helped with study design, conduct and interpretation.

Introduction It has become increasingly important to include patient preference information in decision-making processes for drug development. As neuromuscular disorders represent multisystem, debilitating, and progressive rare diseases with few treatment options, this study aimed to explore unmet health care needs and patient treatment preferences for two neuromuscular disorders, myotonic dystrophy type 1 (DM1) and mitochondrial myopathies (MM) to inform early stages of drug development. Methods Fifteen semi-structured interviews and five focus group discussions (FGDs) were held with DM1 and MM adult patients and caregivers. Topics discussed included (1) reasons for study participation; (2) disease signs/symptoms and their impact on daily lives; (3) top desired benefits; and (4) acceptability of risks and tolerance levels for a hypothetical new treatment. Data were analyzed following a thematic ‘code’ approach. Results A total of 52 participants representing a wide range of disease severities participated. ‘Muscle strength’ and ‘energy and endurance’ were the disease-related unmet needs most often mentioned. Additionally, improved ‘balance’, ‘cognition’ and ‘gut function’ were the top desired treatment benefits, while ‘damage to the liver, kidneys or eyes’ was the most concerning risk. Factors influencing their tolerance to risks related to previously having experienced the risk and differentiation between permanent and temporary risks. A few differences were elicited between patients and caregivers. Conclusions This qualitative study provided an open forum to elicit treatment-desired benefits and acceptable risks to be established by patients themselves. These findings can inform decisions for developing new treatments and the design of clinical trials for DM1 and MM.

Tayana Soukup,1 Ged Murtagh,2 Benjamin W Lamb,3,4 James SA Green,5,* Nick Sevdalis1,* 1Centre for Implementation Science, King’s College London, London, UK; 2Imperial College London, London, UK; 3Department of Urology, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK; 4Faculty of Health, Education, Medicine and Social Care, Anglia Ruskin University, Cambridge, United Kingdom; 5Whipps Cross University Hospital, Barts Health NHS Trust, London, UK*These authors contributed equally to this workCorrespondence: Tayana SoukupKing’s College London, Health Service and Population Research Department, Demark Hill, London, SE5 8AF, UKTel +44 20 7848 0683Email tayana.soukup@kcl.ac.ukPurpose: Despite an increase in research on multidisciplinary team (MDT) meetings, the implementation of MDT-driven decision-making, ie, its fidelity, remains unstudied. We report fidelity using an observational protocol measuring degree to which MDTs in their weekly meetings in the UK adhere to 1) the stages of group decision-making as per the ‘Orientation-Discussion-Decision-Implementation’ framework, and 2) cancer guidelines on the composition and characteristics of their weekly meetings produced by the UK’s Department of Health, UK’s National Cancer Action Team, Cancer Research UK, World Health Organization, and The Expert Advisory Group on Cancer to the Chief Medical Officers of England and Wales.Patients and Methods: This is a prospective cross-sectional observational study of MDT meetings in the UK. Breast, colorectal, and gynecological cancer MDTs across three hospitals in the UK were video recorded over 12 weekly meetings, respectively, encompassing 822 case-reviews. A cross-section of 24 case-reviews was analysed with the main outcomes being adherence to the ‘Orientation-Discussion-Decision-Implementation’ framework, and the cancer guidelines.Results: Eight percent of case-reviews in the MDT meetings involved all five core disciplines including surgeons, oncologists, radiologists, histopathologists, and specialist cancer nurses, and 38% included four. The majority of case-reviews (54%) were between two (25%) or three (29%) disciplines only. Surgeons (83%) and oncologists (8%) most consistently engaged in all stages of decision-making. While all patients put forward for MDT meeting were actually reviewed, 4% of them either bypassed the orientation (case presentation), and 8% did not articulate the final decision to the entire team.Conclusion: We found that, despite being a set policy, cancer case-reviews in MDT meetings are not entirely MDT-driven, with more than half of the case-reviews not adhering to the cancer guidelines, and just over 10% not adhering to the group decision-making framework. The findings are in line with the UK recommendation on streamlining MDT meetings and could help decide how to re-organise the meetings to be most efficient. Implications are discussed in relation to quality and safety of care.Keywords: cancer multidisciplinary team meetings, cancer care, decision-making, fidelity

With an increasing proportion of UK healthcare delivered by independent sector providers (ISPs) it is important that performance data is reviewed with a similar rigour as within the public sector. However, there is a relative paucity of work considering quotients of performance in the independent healthcare sector. This study sets out to measure organizational health within ISPs in the UK and juxtapose this with contemporaneous data taken from public sector NHS organizations. Survey data was tested for construct validity with fit of the existing factor structure of the Healthcare-OH survey examined using confirmatory factor analysis (CFA). Multiple-group CFA was used to establish measurement invariance to permit comparison of latent sum scores between ISP and NHS organizations. Measurement invariance analysis evaluated the fit of sequential invariance models, proceeding iteratively to establish partial metric and scalar invariance. Latent sum scores comparisons demonstrated ISPs outperformed NHS trusts across all elements of organizational health. This is the first time organizational health has been measured in ISPs explicitly for comparison with results in the public sector. Comparative measurement and analysis in this way is novel and has the potential of fostering a two-way learning process for the ultimate benefit of both NHS and ISP organizations.

Background and Objectives Globally, a number of countries have developed guidelines that describe the design and conduct of economic evaluations as part of health technology assessment (HTA) or pharmacoeconomic analysis for decision making. The current scoping review was undertaken with an objective to summarize the recommendations made on methods of economic evaluation by the national healthcare economic evaluation (HEE) guidelines. Methodology A comprehensive search was undertaken in the website repositories of the International Society for Pharmacoeconomic and Outcomes Research (ISPOR) and Guide to Economic Analysis and Research (GEAR), and websites of national HTA agencies and ministries of health of individual countries. All guidelines in the English language were included in this review. Data were extracted with respect to general and methodological characteristics, and a descriptive analysis of recommendations made across the countries was undertaken. Results Overall, our review included 31 national HEE guidelines, published between 1997 and August 2020. Nearly half (45%) of the guidelines targeted the evaluation of pharmaceuticals. The nature of the guidelines was either mandatory (31%), recommendatory (42%), or voluntary (16%). There was a substantial consensus among the guidelines on several key principles, including type of economic evaluation (cost-utility analysis), time horizon of the analysis (long enough), health outcome measure (quality-adjusted life-years) and use of sensitivity analyses. The recommendations on study perspective, comparator, discount rate and type of costs to be included (particularly the inclusion of indirect costs) varied widely. Conclusion Despite similarity in the overall processes, variation in several recommendations given by various national HEE guidelines was observed. This is perhaps unsurprising given the differences in the health systems and financing mechanisms, capacity of local researchers, and data availability. This review offers important lessons and a starting point for countries that are planning to develop their own HEE guidelines. Supplementary Information The online version contains supplementary material available at 10.1007/s41669-020-00250-7.

Objectives: The standard framework of economic evaluation of health programs, which is increasingly used for policy funding decisions, is insufficiently equipped to reflect the full range of health and economic benefits conferred by vaccines and thus undervalues vaccination. Methods: In 2019, a group of Belgian health economic and clinical experts, supported by 2 senior international vaccination experts (1 American, 1 Belgian), convened 4 roundtable meetings to highlight which particular value elements of vaccination remain neglected in economic evaluations. Results: They concluded that the standard economic evaluation framework fails to reflect the full value of vaccination with respect to prevention of complications linked to some vaccine-preventable diseases, health gains for caregivers, herd effects, changes in exposure to and distribution of serotypes, the effect on antimicrobial resistance, productivity gains for caregivers and patients, and the distributive implications of vaccination programs. Conclusions: Here, suggestions are made regarding how these shortcomings can be addressed in future economic evaluations of vaccines and how a more level playing field between vaccines and other health programs can be created., SCOPUS: ar.j, info:eu-repo/semantics/published

Medicine regulators rely on pivotal clinical trials to make decisions about approving a new drug, but little is known about how they judge whether pivotal trials justify the approval of new drugs. We explore this issue by looking at the positions of 3 major regulators: the European Medicines Agency, Food and Drug Administration, and Health Canada. Here we report their views and the implications of those views for the approval process. On various points, the 3 regulators are ambiguous, consistent, and demonstrate flexibility. The range of views may well reflect different regulatory cultures. Although clinical trial information from pivotal trials is becoming more available, regulators are still reluctant to provide detailed information about how that information is interpreted. As medicines and vaccines come up for approval for treatment of COVID-19, transparency in how pivotal trials are interpreted will be critical in determining how these treatments should be used. ispartof: INTERNATIONAL JOURNAL OF HEALTH SERVICES vol:51 issue:1 pages:5-13 ispartof: location:United States status: published

Background Parallel intervention studies involving volunteers usually require a procedure to allocate the subjects to study-arms. Statistical models to evaluate the different outcomes of the study-arms will include study-arm as a factor along with any covariate that might affect the results. To ensure that the effects of the covariates are confounded to the least possible extent with the effects of the arms, stratified randomization can be applied. However, there is at present no clear-cut procedure when there are multiple covariates. Methods For parallel study designs with simultaneous enrollment of all subjects prior to intervention, we propose a D-optimal blocking procedure to allocate subjects with known values of the covariates to the study arms. We prove that the procedure minimizes the variances of the baseline differences between the arms corrected for the covariates. The procedure uses standard statistical software. Results We demonstrate the potential of the method by an application to a human parallel nutritional intervention trial with three arms and 162 healthy volunteers. The covariates were gender, age, body mass index, an initial composite health score, and a categorical indicator called first-visit group, defining groups of volunteers who visit the clinical centre on the same day (17 groups). Volunteers were allocated equally to the study-arms by the D-optimal blocking procedure. The D-efficiency of the model connecting an outcome with the study-arms and correcting for the covariates equals 99.2%. We simulated 10,000 random allocations of subjects to arms either unstratified or stratified by first-visit group. Intervals covering the middle 95% of the D-efficiencies for these allocations were [82.0, 92.0] and [93.2, 98.4], respectively. Conclusions Allocation of volunteers to study-arms with a D-optimal blocking procedure with the values of the covariates as inputs substantially improves the efficiency of the statistical model that connects the response with the study arms and corrects for the covariates. Trial registration Dutch Trial Register NL7054 (NTR7259). Registered May 15, 2018.

Background: Biobanks increasingly employ public involvement and engagement strategies, though few studies have explored their impact. This review aims to (a) investigate how the impact of public involvement in biobanks is reported and conceptualized by study authors; in order to (b) suggest how the research community might re‐conceptualize the impact of public involvement in biobanks. Methods: A systematic literature search of three electronic databases and the INVOLVE Evidence Library in January 2019. Studies commenting on the impact of public involvement in a biobank were included, and a narrative review was conducted. Results and discussion: Forty‐one studies covering thirty‐one biobanks were included, with varying degrees of public involvement. Impact was categorized according to where it was seen: ‘the biobank’, ‘people involved’ and ‘the wider research community’. Most studies reported involvement in a ‘functional’ way, in relation to improved rates of participation in the biobank. Broader forms of impact were reported but were vaguely defined and measured. This review highlights a lack of clarity of purpose and varied researcher conceptualizations of involvement. We pose three areas for further research and consideration by biobank researchers and public involvement practitioners. Conclusions: Functional approaches to public involvement in biobanking limit impact. This conceptualization of involvement emerges from an entrenched technical understanding that ignores its political nature, complicated by long‐standing disagreement about the values of public involvement. This study urges a re‐imagination of impact, re‐conceptualized as a two‐way learning process. More support will help researchers and members of the public to undergo such reflective exercises. Published version

Background To differentiate five formulations of Interferon Beta for the treatment of multiple sclerosis (MS) in clinical practice, by analysing persistence, adherence, healthcare resource utilisation and costs at population level. Methods In this population-based study, we included individuals with MS living in the Campania Region of Italy from 2015 to 2017, on treatment with intramuscular Interferon Beta-1a (Avonex® = 618), subcutaneous pegylated Interferon Beta-1a (Plegridy® = 259), subcutaneous Interferon Beta-1a (Rebif® = 1220), and subcutaneous Interferon Beta-1b (Betaferon® = 348; and Extavia® = 69). We recorded healthcare resource utilisation from administrative databases (hospital discharges, drug prescriptions, MS-related outpatients), and derived costs from the Regional formulary. We classified hospital admissions into MS-related and non-MS-related. Persistence (time to switch to other disease modifying treatments (DMTs)), and adherence (medication possession ratio (MPR) = medication supply obtained/medication supply expected during follow-up period) were calculated. Results Patients treated with Rebif® were younger, when compared with other Interferon Beta formulations (p p p p = 0.03), when compared with Rebif®. The probability of MS-related hospital admissions was 40% higher in Avonex® (p = 0.03), 400% higher in Betaferon® (p p = 0.04), resulting into higher non-DMT-related costs, when compared with Rebif®. Discussion Interferon Beta formulations presented with different prescription patterns, persistence, adherence, healthcare resource utilisation and costs, with Rebif® being used in younger patients and with less MS-related hospital admissions.

Background: Considering social cognitive theory and current literature about successful advance care planning in nursing homes, sufficient knowledge and self-efficacy are important preconditions for staff to be able to carry out advance care planning in practice. Aim: Exploring to what extent nurses’ knowledge about and self-efficacy is associated with their engagement in advance care planning in nursing homes. Design: Survey study as part of a baseline measurement of a randomised controlled cluster trial (NCT03521206). Setting/participants: Nurses in a purposive sample of 14 nursing homes in Belgium. Methods: A survey was distributed among nurses, evaluating knowledge (11 true/false items), self-efficacy (12 roles and tasks on 10-point Likert-type scale) and six advance care planning practices (yes/no), ranging from performing advance care planning conversations to completing advance directives. Results: A total of 196 nurses participated (66% response rate). While knowledge was not significantly associated with advance care planning practices, self-efficacy was. One unit’s increase in self-efficacy was statistically associated with an estimated 32% increase in the number of practices having carried out. Conclusions: Nurses’ engagement in advance care planning practices is mainly associated with their self-efficacy rather than their knowledge. Further research is necessary to improve the evidence regarding the causal relationship between constructs. However, these results suggest that educational programmes that focus solely on knowledge might not lead to increasing uptake of advance care planning in nurses.

The routine measurement of gastric residual volume to guide the initiation and delivery of enteral feeding is widespread in paediatric intensive care and neonatal units, but has little underlying evidence to support it.To answer the question: is a trial of no gastric residual volume measurement feasible in UK paediatric intensive care units and neonatal units?A mixed-methods study involving five linked work packages in two parallel arms: neonatal units and paediatric intensive care units. Work package 1: a survey of units to establish current UK practice. Work package 2: qualitative interviews with health-care professionals and caregivers of children admitted to either setting. Work package 3: a modified two-round e-Delphi survey to investigate health-care professionals' opinions on trial design issues and to obtain consensus on outcomes. Work package 4: examination of national databases to determine the potential eligible populations. Work package 5: two consensus meetings of health-care professionals and parents to review the data and agree consensus on outcomes that had not reached consensus in the e-Delphi study.Parents of children with experience of ventilation and tube feeding in both neonatal units and paediatric intensive care units, and health-care professionals working in neonatal units and paediatric intensive care units.Baseline surveys showed that the practice of gastric residual volume measurement was very common (96% in paediatric intensive care units and 65% in neonatal units). Ninety per cent of parents from both neonatal units and paediatric intensive care units supported a future trial, while highlighting concerns around possible delays in detecting complications. Health-care professionals also indicated that a trial was feasible, with 84% of staff willing to participate in a trial. Concerns expressed by junior nurses about the intervention arm of not measuring gastric residual volumes were addressed by developing a simple flow chart and education package. The trial design survey and e-Delphi study gained consensus on 12 paediatric intensive care unit and nine neonatal unit outcome measures, and identified acceptable inclusion and exclusion criteria. Given the differences in physiology, disease processes, environments, staffing and outcomes of interest, two different trials are required in the two settings. Database analyses subsequently showed that trials were feasible in both settings in terms of patient numbers. Of 16,222 children who met the inclusion criteria in paediatric intensive care units, 12,629 stayed for 3 days. In neonatal units, 15,375 neonates 32 weeks of age met the inclusion criteria. Finally, the two consensus meetings demonstrated 'buy-in' from the wider UK neonatal communities and paediatric intensive care units, and enabled us to discuss and vote on the outcomes that did not achieve consensus in the e-Delphi study.Two separate UK trials (one in neonatal units and one in paediatric intensive care units) are feasible to conduct, but they cannot be combined as a result of differences in outcome measures and treatment protocols, reflecting the distinctness of the two specialties.Current Controlled Trials ISRCTN42110505.This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inNurses looking after babies and children on intensive care units in the UK usually pass a tube and aspirate whatever food or fluid is in the baby’s stomach before they give a feed. The idea is to ensure that the stomach is not overdistended with food and prevent the baby vomiting or, worse, aspirating food into the lungs. However, there is little justification for this practice. It is rarely done in many other countries. It may not be pleasant for the child and perhaps is unnecessary. Some experts have suggested that the policy should be evaluated in a randomised controlled trial. This would mean allocating a large number of children at random to either have the stomach aspirated before feeds, or not. Such a trial would be a major undertaking and we are unsure if parents or staff would be willing to allow children to participate. The aim of this study was to see if it is possible to conduct such a large trial in the UK. Two surveys (of 119 units) showed us that regularly measuring the stomach contents when starting and increasing feeds is common practice for both newborn and older children in UK intensive care units. However, in some countries, such as France, this practice is rarely done. We asked 31 parents and 51 health-care professionals about a future study. Overall, parents were supportive of a trial if it was explained to them well by a knowledgeable and caring professional, and if they were approached at the right time. Some concerns were expressed about not picking up complications early if gastric residual volume was not measured. Health-care professionals were also mainly positive about a future trial, but mentioned similar concerns about not picking up complications early and the difficulty of changing a long-standing routine practice. Parents suggested study outcomes that were important to them. These, along with other outcomes, were voted on in a further survey of 106 professionals and at face-to-face meetings involving 41 participants. Overall, our findings suggest that a trial is feasible to perform and acceptable to parents. However, because of differences in both treatments and important outcomes between children’s intensive care units and newborn baby intensive care units, two trials would be needed, one in each type of intensive care unit. These two trials will test whether or not the benefits of not measuring gastric residual volume (e.g. improved calorie intake) outweigh the potential harms (e.g. delayed diagnosis of complications).

OBJECTIVES: The objectives of this review were: i) to identify and synthesize the best available evidence on the effectiveness on health-related outcomes of health literacy interventions for enabling socioeconomically disadvantaged people living in the community to access, understand, appraise and apply health information; and ii) to identify components of health literacy interventions associated with improved health-related outcomes. INTRODUCTION: Health literacy is defined as a person's competence in accessing, understanding, appraising and applying health information in order to make sound health decisions. A high level of health literacy is positively related to better health outcomes. However, nearly half of the American and European populations have low health literacy levels. Socioeconomically disadvantaged groups in particular present with the weakest health literacy levels, suggesting that differences in health literacy levels contribute to health disparities. Therefore, there is a need to understand the conditions under which health literacy interventions aiming at improving health-related outcomes among socioeconomically disadvantaged people can be implemented. INCLUSION CRITERIA: This review considered studies on socioeconomically disadvantaged adults living in the community identified using the socially stratifying PROGRESS factors (Place of residence, Race/ethnicity, Occupation, Gender, Religion, Education, Socioeconomic status, Social capital).This review considered studies evaluating the following interventions: i) targeting health literacy based on either a clinical and/or a public health approach, ii) delivered at the individual, interpersonal, community or societal level, iii) delivered by any healthcare/social work professional, and iv) using a single or multicomponent strategy. The comparator was no treatment, standard care or a variation of the intervention. All randomized and non-randomized controlled trials as well as quasi-experimental designs were included. Outcomes considered were: i) health-related quality of life and health-related outcomes, ii) health behavior outcomes, and iii) outcomes related to the access and use of healthcare services. METHODS: A three-step strategy was conducted for primary research published up to May 2018 across seven databases without any language restriction. A search for gray literature was also conducted. Titles and abstracts were screened for assessment against the inclusion criteria. Studies that met the inclusion criteria were retrieved in full and then assessed in detail against the inclusion criteria. Critical appraisal was undertaken using the standardized critical appraisal instruments from JBI. Data were extracted from included studies using standardized data extraction tools from JBI. A meta-analysis was not possible; findings have been presented in a narrative form. RESULTS: Twenty-one studies were included in the review. Three studies addressed the health literacy competency of understanding health information, and 18 addressed the competency of applying health information. Thirteen studies were found as effective based on a variety of health-related outcomes (mainly clinical outcomes), preventive health practices and behaviors, and health-promoting behaviors. Results enabled identification of some effective intervention operational components, including cultural appropriateness, tailoring, skills building, goal setting and active discussions. Multi-faceted interventions, combining both an information transfer medium and contact with an interventionist, appear to be more effective than single modality interventions. The use of an appropriate theoretical foundation is also an important factor for successful interventions. CONCLUSION: To improve health-related outcomes among socioeconomically disadvantaged people, health literacy interventions are more likely to be successful if they are theory-based, are multi-faceted and use person-centered operational components such as cultural appropriateness, tailoring, skills building, goal setting and active discussions. ispartof: JBI EVIDENCE SYNTHESIS vol:18 issue:7 pages:1389-1514 ispartof: location:United States status: published

BackgroundPatients often carry medication lists to mitigate information loss across healthcare settings. We aimed to identify mechanisms by which these lists could be used to support safety, key supporting features, and barriers and facilitators to their use.MethodsWe used a mixed-methods design comprising two focus groups with patients and carers, 16 semistructured interviews with healthcare professionals, 60 semistructured interviews with people carrying medication lists, a quantitative features analysis of tools available for patients to record their medicines and usability testing of four tools. Findings were triangulated using thematic analysis. Distributed cognition for teamwork models were used as sensitising concepts.ResultsWe identified a wide range of mechanisms through which carrying medication lists can improve medication safety. These included improving the accuracy of medicines reconciliation, allowing identification of potential drug interactions, facilitating communication about medicines, acting as an aide-mémoire to patients during appointments, allowing patients to check their medicines for errors and reminding patients to take and reorder their medicines. Different tools for recording medicines met different needs. Of 103 tools examined, none met the core needs of all users. A key barrier to use was lack of awareness by patients and carers that healthcare information systems can be fragmented, a key facilitator was encouragement from healthcare professionals.ConclusionOur findings suggest that patients and healthcare professionals perceive patient-held medication lists to have a wide variety of benefits. Interventions are needed to raise awareness of the potential role of these lists in enhancing patient safety. Such interventions should empower patients and carers to identify a method that suits them best from a range of options and avoid a ‘one size fits all’ approach.

The lack of interoperability in Britain’s medical records systems precludes the realisation of benefits generated by increased spending elsewhere in healthcare. Growing concerns regarding the security of online medical data following breaches, and regarding regulations governing data ownership, mandate strict parameters in the development of efficient methods to administrate medical records. Furthermore, consideration must be placed on the rise of connected devices, which vastly increase the amount of data that can be collected in order to improve a patient’s long-term health outcomes. Increasing numbers of healthcare systems are developing Blockchain-based systems to manage medical data. A Blockchain is a decentralised, continuously growing online ledger of records, validated by members of the network. Traditionally used to manage cryptocurrency records, distributed ledger technology can be applied to various aspects of healthcare. In this manuscript, we focus on how Electronic Medical Records in particular can be managed by Blockchain, and how the introduction of this novel technology can create a more efficient and interoperable infrastructure to manage records that leads to improved healthcare outcomes, while maintaining patient data ownership and without compromising privacy or security of sensitive data.

IntroductionSuccessful adoption of POCTs (Point-of-Care tests) for COVID-19 in care homes requires the identification of ideal use cases and a full understanding of contextual and usability factors that affect test results and minimise biosafety risks. This paper presents findings from a scoping-usability and test performance study of a microfluidic immunofluorescence assay for COVID-19 in care homes.MethodsA mixed-methods evaluation was conducted in four UK care homes to scope usability and to assess the agreement with qRT-PCR. A dry run with luminescent dye was carried out to explore biosafety issues.ResultsThe agreement analysis was carried out on 227 asymptomatic participants (159 staff and 68 residents) and 14 symptomatic participants (5 staff and 9 residents). Asymptomatic specimens showed 50% (95% CI: 1.3%-98.7%) positive agreement and 96% (95% CI: 92.5%-98.1%) negative agreement with overall prevalence and bias-adjusted Kappa (PABAK) of 0.911 (95% CI: 0.857-0.965). Symptomatic specimens showed 83.3% (95% CI: 35.9%-99.6%) positive agreement and 100% (95% CI: 63.1%-100%) negative agreement with overall prevalence and bias-adjusted Kappa (PABAK) of 0.857 (95% CI: 0.549-1).The dry run showed four main sources of contamination that led to the modification of the standard operating procedures. Simulation after modification showed no further evidence of contamination.ConclusionCareful consideration of biosafety issues and contextual factors associated with care home are mandatory for safe use the POCT. Whilst POCT may have some utility for ruling out COVID-19, further diagnostic accuracy evaluations are needed to promote effective adoption.

BackgroundAntibiotics are extensively prescribed in intensive care units (ICUs), yet little is known about how antibiotic-related decisions are made in this setting. We explored how beliefs, perceptions and contextual factors influenced ICU clinicians’ antibiotic prescribing.MethodsWe conducted 4 focus groups and 34 semistructured interviews with clinicians involved in antibiotic prescribing in four English ICUs. Focus groups explored factors influencing prescribing, whereas interviews examined decision-making processes using two clinical vignettes. Data were analysed using thematic analysis, applying the Necessity Concerns Framework.ResultsClinicians’ antibiotic decisions were influenced by their judgement of the necessity for prescribing/not prescribing, relative to their concerns about potential adverse consequences. Antibiotic necessity perceptions were strongly influenced by beliefs that antibiotics would protect patients from deterioration and themselves from the ethical and legal consequences of undertreatment. Clinicians also reported concerns about prescribing antibiotics. These generally centred on antimicrobial resistance; however, protecting the individual patient was prioritised over these societal concerns. Few participants identified antibiotic toxicity concerns as a key influencer. Clinical uncertainty often complicated balancing antibiotic necessity against concerns. Decisions to start or continue antibiotics often represented ‘erring on the side of caution’ as a protective response in uncertainty. This approach was reinforced by previous experiences of negative consequences (‘being burnt’) which motivated prescribing ‘just in case’ of an infection. Prescribing decisions were also context-dependent, exemplified by a lower perceived threshold to prescribe antibiotics out-of-hours, input from external team members and local prescribing norms.ConclusionEfforts to improve antibiotic stewardship should consider clinicians’ desire to protect with a prescription. Rapid molecular microbiology, with appropriate communication, may diminish clinicians’ fears of not prescribing or of using narrower-spectrum antibiotics.

Objective It is increasingly recognized that patient safety requires heterogeneous insights from a range of stakeholders, yet incident reporting systems in health care still primarily rely on staff perspectives. This paper examines the potential of combining insights from patient complaints and staff incident reports for a more comprehensive understanding of the causes and severity of harm. Methods Using five years of patient complaints and staff incident reporting data at a large multi-site hospital in London (in the United Kingdom), this study conducted retrospective patient-level data linkage to identify overlapping reports. Using a combination of quantitative coding and in-depth qualitative analysis, we then compared level of harm reported, identified descriptions of adjacent events missed by the other party and examined combined narratives of mutually identified events. Results Incidents where complaints and incident reports overlapped (n = 446, reported in 7.6%’ of all complaints and 0.6% of all incident reports) represented a small but critical area of investigation, with significantly higher rates of Serious Incidents and severe harm. Linked complaints described greater harm from safety incidents in 60% of cases, reported many surrounding safety events missed by staff (n = 582), and provided contesting stories of why problems occurred in 46% cases, and complementary accounts in 26% cases. Conclusions This study demonstrates the value of using patient complaints to supplement, test, and challenge staff reports, including to provide greater insight on the many potential factors that may give rise to unsafe care. Accordingly, we propose that a more holistic analysis of critical safety incidents can be achieved through combining heterogeneous data from different viewpoints, such as through the integration of patient complaints and staff incident reporting data.

Background Virtual reality (VR) has gained popularity in daily life, and VR food cues seem to elicit food cravings, similar to real food cues. However, little is known about the impact of VR food cues on actual food intake. Objective In real life (RL), exposure to food cues in a situation in which the desire to eat food interferes with the completion of a food-related task reduces the subsequent food intake (ie, the pre-exposure effect). In this study, we examine, on the one hand, whether the pre-exposure effect could be replicated in RL and, on the other hand, whether this effect could be extended to VR contexts. Methods The study used a 2 (stimulus type: food vs nonfood) × 2 (mode: VR vs RL) between-subject design (n=175). Participants were randomly assigned to 1 of the 4 conditions. Results We found the main effect of mode on food intake, with a higher food intake after both VR conditions than after RL conditions (P=.02). In addition, among female participants, we found that exposure to both food cues (ie, VR and RL) resulted in lower food intake than exposure to both nonfood cues (P=.05). In contrast, this effect was not observed among male participants (P=.34). Additionally, VR and RL cues generated similar emotional and behavioral responses (eg, arousal and game difficulty). Conclusions We were unable to replicate the exposure effect in our complete sample. Subgroup analyses, however, showed that for women, exposure to food cues (either in VR or in RL) reduces food intake, indicating that a VR pre-exposure procedure may effectively be applied exclusively for women. Trial Registration ClinicalTrials.gov NCT05169996; https://clinicaltrials.gov/ct2/show/NCT05169996

BACKGROUND: Sodium-glucose cotransporter-2 inhibitors (SGLT2Is) are a recent class of medication approved for the treatment of type 2 diabetes (T2D). Previous meta-analyses have quantified the benefits and harms of SGLT2Is; however, these analyses have been limited to specific outcomes and comparisons and included trials of short duration. We comprehensively reviewed the longer-term benefits and harms of SGLT2Is compared to placebo or other anti-hyperglycemic medications. METHODS: We searched PubMed, Scopus, and clinicaltrials.gov from inception to July 2019 for randomized controlled trials of minimum 52 weeks’ duration that enrolled adults with T2D, compared an SGLT2I to either placebo or other anti-hyperglycemic medications, and reported at least one outcome of interest including cardiovascular risk factors, microvascular and macrovascular complications, mortality, and adverse events. We conducted random effects meta-analyses to provide summary estimates using weighted mean differences (MD) and pooled relative risks (RR). The study was registered a priori with PROSPERO (CRD42018090506). RESULTS: Fifty articles describing 39 trials (vs. placebo, n = 28; vs. other anti-hyperglycemic medication, n = 12; vs. both, n = 1) and 112,128 patients were included in our analyses. Compared to placebo, SGLT2Is reduced cardiovascular risk factors (e.g., hemoglobin A1c, MD − 0.55%, 95% CI − 0.62, − 0.49), macrovascular outcomes (e.g., hospitalization for heart failure, RR 0.70, 95% CI 0.62, 0.78), and mortality (RR 0.87, 95% CI 0.80, 0.94). Compared to other anti-hyperglycemic medications, SGLT2Is reduced cardiovascular risk factors, but insufficient data existed for other outcomes. About a fourfold increased risk of genital yeast infections for both genders was observed for comparisons vs. placebo and other anti-hyperglycemic medications. DISCUSSION: We found that SGLT2Is led to durable reductions in cardiovascular risk factors compared to both placebo and other anti-hyperglycemic medications. Reductions in macrovascular complications and mortality were only observed in comparisons with placebo, although trials comparing SGLT2Is vs. other anti-hyperglycemic medications were not designed to assess longer-term outcomes. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s11606-021-07227-0.

Background The ability to successfully transfer knowledge across international boundaries to improve health across the European Region is dependent on an in-depth understanding of the many factors involved in policy creation. Across countries we can observe various approaches to evidence usage in the policy-making process. This study, which was a part of the Models of Child Health Appraised (MOCHA) project assessing patterns of children’s primary care in Europe, focused on how and what kind of evidence is used in child health policy-making processes in European countries and how it is applied to inform policy and practice. Method In this study, a qualitative approach was used. The data were analysed in accordance with the thematic analysis protocol. The MOCHA project methodology relies on experienced country agents (CA) recruited for the project and paid to deliver child health data in each of 30 European countries. CAs are national experts in the child health field who defined the country-specific structured information and data. A questionnaire designed as a semi-structured survey instrument asked CAs to indicate the sources of evidence used in the policy-making process and what needed to be in place to support evidence uptake in policy and practice. Results In our data we observed two approaches to evidence usage in child health policy formulation. The scientific approach in our understanding refers to the so-called bottom-up initiatives of academia which identify and respond to the population’s needs. Institutional approaches can be informed by scientific resources as well; however, the driving forces here are governmental institutions, whose decisions and choices are based not only on the population needs but also on political, economic and organizational factors. The evidence used in Europe can also be of an external or internal nature. Various factors can affect the use of evidence in child health policy-making. Facilitators are correlated with strong scientific culture development, whereas barriers are defined by a poor tradition of implementing changes based on reliable evidence. Conclusions Focusing on the facilitators and actively working to reduce the barriers can perceivably lead to faster and more robust policy-making, including the development of a culture of scientific grounding in policy creation.

Background Governments around the world own multiple datasets related to the policy domain of health. Datasets range from vaccination rates to the availability of health care practitioners in a region to the outcomes of certain surgeries. Health is believed to be a promising subject in the case of open government data policies. However, the specific properties of health data such as its sensibilities regarding privacy, ethics, and ownership encompass particular conditions either enabling or preventing datasets to become freely and easily accessible for everyone. Objective and methods This paper aims to map the ecosystem of open health data. By analyzing the foundations of health data and the commonalities of open data ecosystems via literature analysis, the socio-technical environment in which health data managed by governments are opened up or potentially stay closed is created. After its theoretical development, the open health data ecosystem is tested via a case study concerning the Data for Better Health initiative from the government of Belgium. Results Creation and assessment of an open health data ecosystem consisting of stakeholders, interests, information policies, and data preparation activities. Conclusions The policy domain of health includes de-identification activities, bioethical assessments, and the specific role of data providers within its open data ecosystem. However, the concept of open data does not always fully apply to the topic of health. Such several health datasets may be findable via government portals but not directly accessible. Differentiation within types of health data and data user capacities are recommendable for future research.

BackgroundWith the onset of COVID-19, primary care has swiftly transitioned from face-to-face to virtual care, yet it remains largely unknown how this has impacted on the quality and safety of care.AimTo evaluate patient use of virtual primary care models during COVID-19 in terms of change in uptake, perceived impact on the quality and safety of care, and willingness of future use.Design and settingAn online cross-sectional survey was administered to the public across the United Kingdom, Sweden, Italy and Germany.MethodsMcNemar tests were conducted to test pre- and post pandemic differences in uptake for each technology. One-way analysis of variance was conducted to examine patient experience ratings and perceived impacts on healthcare quality and safety across demographic characteristics.ResultsRespondents (N=6,326) reported an increased use of telephone consultations (+6.3%, PConclusionFuture work must examine the drivers and determinants of positive experiences using remote care to co-create a supportive environment that ensures equitable adoption and use across different patient groups. Comparative analysis between countries and health systems offers the opportunity for policymakers to learn from best practices internationally.

Background Vascular prevention trials typically use dichotomous event outcomes although this may be inefficient statistically and gives no indication of event severity. We assessed whether ordinal outcomes would be more efficient and how to best analyse them. Methods Chief investigators of vascular prevention randomised controlled trials that showed evidence of either benefit or harm, or were included in a systematic review that overall showed benefit or harm, shared individual participant data from their trials. Ordered categorical versions of vascular event outcomes (such as stroke and myocardial infarction) were analysed using 15 statistical techniques and their results then ranked, with the result with the smallest p-value given the smallest rank. Friedman and Duncan’s multiple range tests were performed to assess differences between tests by comparing the average ranks for each statistical test. Results Data from 35 trials (254,223 participants) were shared with the collaboration. 13 trials had more than two treatment arms, resulting in 59 comparisons. Analysis approaches (Mann Whitney U, ordinal logistic regression, multiple regression, bootstrapping) that used ordinal outcome data had a smaller average rank and therefore appeared to be more efficient statistically than those that analysed the original binary outcomes. Conclusions Ordinal vascular outcome measures appear to be more efficient statistically than binary outcomes and provide information on the severity of event. We suggest a potential role for using ordinal outcomes in vascular prevention trials.

Background User-friendly information at the point of care for health care professionals should be well structured, rapidly accessible, comprehensive, and trustworthy. The reliability of information and the associated methodological process must be clear. There is no standard tool to evaluate the trustworthiness of such point-of-care (POC) information. Objective We aim to develop and validate a new tool for assessment of trustworthiness of evidence-based POC resources to enhance the quality of POC resources and facilitate evidence-based practice. Methods We designed the Critical Appraisal of Point-of-Care Information (CAPOCI) tool based on the criteria important for assessment of trustworthiness of POC information, reported in a previously published review. A group of health care professionals and methodologists (the authors of this paper) defined criteria for the CAPOCI tool in an iterative process of discussion and pilot testing until consensus was reached. In the next step, all criteria were subject to content validation with a Delphi study. We invited an international panel of 10 experts to rate their agreement with the relevance and wording of the criteria and to give feedback. Consensus was reached when 70% of the experts agreed. When no consensus was reached, we reformulated the criteria based on the experts’ comments for a next round of the Delphi study. This process was repeated until consensus was reached for each criterion. In a last step, the interrater reliability of the CAPOCI tool was calculated with a 2-tailed Kendall tau correlation coefficient to quantify the agreement between 2 users who piloted the CAPOCI tool on 5 POC resources. Two scoring systems were tested: a 3-point ordinal scale and a 7-point Likert scale. Results After validation, the CAPOCI tool was designed with 11 criteria that focused on methodological quality and author-related information. The criteria assess authorship, literature search, use of preappraised evidence, critical appraisal of evidence, expert opinions, peer review, timeliness and updating, conflict of interest, and commercial support. Interrater agreement showed substantial agreement between 2 users for scoring with the 3-point ordinal scale (τ=.621, P Conclusions The CAPOCI tool may support validation teams in the assessment of trustworthiness of POC resources. It may also provide guidance for producers of POC resources.

Objectives For anaemic elective surgery patients, current clinical practice guidelines weakly recommend the routine use of iron, but not erythrocyte-stimulating agents (ESAs), except for short-acting ESAs in major orthopaedic surgery. This recommendation is, however, not based on any cost-effectiveness studies. The aim of this research was to (1) systematically review the literature regarding cost effectiveness of preoperative iron and/or ESAs in anaemic, elective surgery patients and (2) update existing economic evaluations (EEs) with recent data. Methods Eight databases and registries were searched for EEs and randomized controlled trials (RCTs) reporting cost-effectiveness data on November 11, 2020. Data were extracted, narratively synthesized and critically appraised using the Philips reporting checklist. Pre-existing full EEs were updated with effectiveness data from a recent systematic review and current cost data. Incremental cost-effectiveness ratios were expressed as cost per (quality-adjusted) life-year [(QA)LY] gained. Results Only five studies (4 EEs and 1 RCT) were included, one on intravenous iron and four on ESAs + oral iron. The EE on intravenous iron only had an in-hospital time horizon. Therefore, cost effectiveness of preoperative iron remains uncertain. The three EEs on ESAs had a lifetime time horizon, but reported cost per (QA)LY gained of 20–65 million (GBP or CAD). Updating these analyses with current data confirmed ESAs to have a cost per (QA)LY gained of 3.5–120 million (GBP or CAD). Conclusions Cost effectiveness of preoperative iron is unproven, whereas routine preoperative ESA therapy cannot be considered cost effective in elective surgery, based on the limited available data. Future guidelines should reflect these findings. Supplementary Information The online version contains supplementary material available at 10.1007/s40273-021-01044-3.

The infiltration and invasion of nerve trunks, nerve roots, and cranial nerves by lymphomatous malignant cells is defined as "neurolymphomatosis". It is mainly caused by lymphoma cells directly infiltrating the peripheral nerves, with a low incidence. Neurolymphomatosis is a rare condition of neoplastic endoneurial invasion, which is primary or secondary to non-Hodgkin's lymphoma and leukemia. We describe a case of primary peripheral neurolymphomatosis of multifocal involvement in a 77-year-old male patient. He presented with left lower limb pain and was diagnosed with CD20+ diffuse large B cell lymphoma (DLBCL). Magnetic resonance imaging (MRI), fluorine-18 fluorodeoxyglucose (18F-FDG) positron emission tomography (PET) computed tomography (CT), and nerve biopsy contributed to the diagnosis. Genomic profiling, programmed death ligand-1 (PD-L1) expression and tumor mutational burden (TMB) were also assessed. CDKN2A/CDKN2B deletions have been identified. PD-L1 expression assessed by 28-8 antibody was 1% positivity, and TMB of the sample was 11.6 muts/Mb. The patient responded well to rituximab combined with chemotherapy, however, he died after 3 cycles of chemotherapy due to severe lung infection and subsequent complication of respiratory failure. Here we report the clinical, radiological, pathological and molecular findings of the patient affected by multifocal neurolymphomatosis without systemic involvement of other organs.

Deep vein thrombosis (DVT) is a blood clot most commonly found in the leg, which can lead to fatal pulmonary embolism (PE). Compression ultrasound of the legs is the diagnostic gold standard, leading to a definitive diagnosis. However, many patients with possible symptoms are not found to have a DVT, resulting in long referral waiting times for patients and a large clinical burden for specialists. Thus, diagnosis at the point of care by non-specialists is desired. We collect images in a pre-clinical study and investigate a deep learning approach for the automatic interpretation of compression ultrasound images. Our method provides guidance for free-hand ultrasound and aids non-specialists in detecting DVT. We train a deep learning algorithm on ultrasound videos from 255 volunteers and evaluate on a sample size of 53 prospectively enrolled patients from an NHS DVT diagnostic clinic and 30 prospectively enrolled patients from a German DVT clinic. Algorithmic DVT diagnosis performance results in a sensitivity within a 95% CI range of (0.82, 0.94), specificity of (0.70, 0.82), a positive predictive value of (0.65, 0.89), and a negative predictive value of (0.99, 1.00) when compared to the clinical gold standard. To assess the potential benefits of this technology in healthcare we evaluate the entire clinical DVT decision algorithm and provide cost analysis when integrating our approach into diagnostic pathways for DVT. Our approach is estimated to generate a positive net monetary benefit at costs up to £72 to £175 per software-supported examination, assuming a willingness to pay of £20,000/QALY.

Background: The early stages of the coronavirus disease 2019 pandemic prompted unprecedented displays of gratitude to healthcare workers. In the United Kingdom, gratitude was a hotly debated topic in public discourse, catalysing compelling displays of civic togetherness but also attracting criticism for being an unhelpful distraction that authorized unrealistic expectations of healthcare workers. Expressions of thanks tend to be neglected as drivers of transformation, and yet, they are important indicators of qualities to which people attach significance. Objective: This study aimed to use discursive analysis to explore how the National Health Service (NHS) was constructed in attention-attracting tweets that expressed and/or discussed gratitude to the NHS. Methods: Having determined that Twitter was the most active site for traffic relating to gratitude and the NHS, we established a corpus of 834 most-liked tweets, purposively sampled from Twitter searches on a day-by-day basis over the period of the first lockdown in the United Kingdom (22 March–28 May 2020). We developed a typology for tweets engaging with gratitude as well as analysing what the NHS was thanked for. Results: Our analysis, informed by a discursive psychology approach, found that the meanings attributed to gratitude were highly mobile and there were distinct patterns of activity. The NHS was predominantly—and sometimes idealistically—thanked for working, effort, saving and caring. Displays of gratitude were seen as incommensurable with failures of responsibility. The clap-for-carers campaign was a potent driver of affect, especially in the early parts of the lockdown. Conclusions: The social value of gratitude is implicated in the re-evaluation of the risks and rewards of healthcare and social care work in the wake of the pandemic. We caution against cynicism about gratitude overshadowing the well-being effects that expressing and receiving gratitude can engender, particularly given concerns over the detrimental effects of the pandemic on mental health. Public Contribution: This study involves the analysis of data provided by the public and published on social media.

BACKGROUND: Previous meta-analyses of the benefits and harms of glucagon-like peptide-1 receptor agonists (GLP1RAs) have been limited to specific outcomes and comparisons and often included short-term results. We aimed to estimate the longer-term effects of GLP1RAs on cardiovascular risk factors, microvascular and macrovascular complications, mortality, and adverse events in patients with type 2 diabetes, compared to placebo and other anti-hyperglycemic medications. METHODS: We searched PubMed, Scopus, and clinicaltrials.gov (inception–July 2019) for randomized controlled trials ≥ 52 weeks’ duration that compared a GLP1RA to placebo or other anti-hyperglycemic medication and included at least one outcome of interest. Outcomes included cardiovascular risk factors, microvascular and macrovascular complications, all-cause mortality, and treatment-related adverse events. We performed random effects meta-analyses to give summary estimates using weighted mean differences (MD) and pooled relative risks (RR). Risk of bias was assessed using the Cochrane Collaboration risk of bias in randomized trials tool. Quality of evidence was summarized using the Grading of Recommendations, Assessment, Development, and Evaluation approach. The study was registered a priori with PROSPERO (CRD42018090506). RESULTS: Forty-five trials with a mean duration of 1.7 years comprising 71,517 patients were included. Compared to placebo, GLP1RAs reduced cardiovascular risk factors, microvascular complications (including renal events, RR 0.85, 0.80–0.90), macrovascular complications (including stroke, RR 0.86, 0.78–0.95), and mortality (RR 0.89, 0.84–0.94). Compared to other anti-hyperglycemic medications, GLP1RAs only reduced cardiovascular risk factors. Increased gastrointestinal events causing treatment discontinuation were observed in both comparisons. DISCUSSION: GLP1RAs reduced cardiovascular risk factors and increased gastrointestinal events compared to placebo and other anti-hyperglycemic medications. GLP1RAs also reduced MACE, stroke, renal events, and mortality in comparisons with placebo; however, analyses were inconclusive for comparisons with other anti-hyperglycemic medications. Given the high costs of GLP1RAs, the lack of long-term evidence comparing GLP1RAs to other anti-hyperglycemic medications has significant policy and clinical practice implications. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s11606-021-07105-9.

Background Providing sufficient numbers of human resources for health is essential for effective and accessible health services. Between 2013 and 2018, the Brazilian Ministry of Health implemented the Programa Mais Médicos (PMM) (More Doctors Programme) to increase the supply of primary care doctors in underserved areas of the country. This study investigated the association between PMM and infant health outcomes and assessed if heterogeneity in the impact of PMM varied by municipal socio-economic factors and health indicators. Methods An ecological longitudinal (panel) study design was employed to analyse data from 5565 Brazilian municipalities over a 12-year period between 2007 and 2018. A differences-in-differences approach was implemented using longitudinal fixed effect regression models to compare infant health outcomes in municipalities receiving a PMM doctor with those that did not receive a PMM doctor. The impact of PMM was assessed on aggregate and in municipality subgroups. Results On aggregate, the PMM was not significantly associated with changes in infant or neonatal mortality, but the PMM was associated with reductions in infant mortality rate (IMR) (of − 0.21; 95% CI: − 0.38, − 0.03) in municipalities with highest IMR prior to the programme’s implementation (where (IMR) > 25.2 infant deaths per 1000 live births). The PMM was also associated with an increase in the proportion of expectant mothers receiving seven or more prenatal care visits but only in municipalities with a lower IMR at baseline and high density of non-PMM doctors and community health workers before the PMM. Conclusions The PMM was associated with reduced infant mortality in municipalities with the highest infant mortality rate prior to the programme. This suggests effectiveness of the PMM was limited only to the areas of greatest need. New programmes to improve the equitable provision of human resources for health should employ comprehensive targeting approaches balancing health needs and socio-economic factors to maximize effectiveness.

Purpose Allogeneic stem cell transplantation would benefit from re-engineering care towards an integrated eHealth-facilitated care model. With this paper we aim to: (1) describe the development of an integrated care model (ICM) in allogeneic SteM-cell-transplantatIon faciLitated by eHealth (SMILe) by combining implementation, behavioral, and computer science methods (e.g., contextual analysis, Behavior Change Wheel, and user-centered design combined with agile software development); and (2) describe that model’s characteristics and its application in clinical practice. Methods The SMILe intervention’s development consisted of four steps, with implementation science methods informing each: (1) planning its set-up within a theoretical foundation; (2) using behavioral science methods to develop the content; (3) choosing and developing its delivery method (human/technology) using behavioral and computer science methods; and (4) describing its characteristics and application in clinical practice. Results The SMILe intervention is embedded within the eHealth enhanced Chronic Care Model, entailing four self-management intervention modules, targeting monitoring and follow-up of important medical and symptom-related parameters, infection prevention, medication adherence, and physical activity. Interventions are delivered partly face-to-face by a care coordinator embedded within the transplant team, and partly via the SMILeApp that connects patients to the transplant team, who can monitor and rapidly respond to any relevant changes within 1 year post-transplant. Conclusion This paper provides stepwise guidance on how implementation, behavioral, and computer science methods can be used to develop interventions aiming to improve care for stem cell transplant patients in real-world clinical settings. This new care model is currently being tested in a hybrid I effectiveness-implementation trial.

Despite widespread use of genomic sequencing (GS) in clinical care, there has been little exploration of actual experiences of genetic health professionals (GHPs) using GS in clinical practice worldwide. To address this, semi-structured interviews were conducted with 31 clinical geneticists and genetic counselors across Europe, Australia, and Canada to explore their experiences with returning results from GS to patients. GHPs remarked that patients' reactions to receiving causative results vary; some patients are relieved or appreciative at identification of a genetic cause, while others express frustration that finding an answer does not lead to a treatment. GHPs discussed the importance of managing expectations in pre-test counseling to minimize disappointment. Although some patients experience mild distress, they generally cope well receiving unsolicited findings and appreciate being informed of their increased risk. While many GHPs felt patients understand what a variant of uncertain significance (VUS) means, a proportion found VUS quite difficult to convey and had concerns for patients' level of understanding. A proportion mentioned concerns regarding potential negative repercussions of non-genetic clinicians misinterpreting the significance of VUS. These results provide important insights into the challenges GHPs can experience returning GS results to patients, highlighting a need for additional training for GHPs and non-genetic clinicians. ispartof: JOURNAL OF GENETIC COUNSELING vol:29 issue:5 pages:807-815 ispartof: location:United States status: published

Missing data are a common issue in cost‐effectiveness analysis (CEA) alongside randomised trials and are often addressed assuming the data are ‘missing at random’. However, this assumption is often questionable, and sensitivity analyses are required to assess the implications of departures from missing at random. Reference‐based multiple imputation provides an attractive approach for conducting such sensitivity analyses, because missing data assumptions are framed in an intuitive way by making reference to other trial arms. For example, a plausible not at random mechanism in a placebo‐controlled trial would be to assume that participants in the experimental arm who dropped out stop taking their treatment and have similar outcomes to those in the placebo arm.Drawing on the increasing use of this approach in other areas, this paper aims to extend and illustrate the reference‐based multiple imputation approach in CEA. It introduces the principles of reference‐based imputation and proposes an extension to the CEA context. The method is illustrated in the CEA of the CoBalT trial evaluating cognitive behavioural therapy for treatment‐resistant depression. Stata code is provided. We find that reference‐based multiple imputation provides a relevant and accessible framework for assessing the robustness of CEA conclusions to different missing data assumptions.

Background The aim of this systematic review was to synthesise peer-reviewed literature assessing the impact of electronic prescribing (eP) systems on the working practices of healthcare professionals (HCPs) in the inpatient setting and identify implications for practice and research. Methods We searched PubMed, Medline, Embase, Cochrane and the Cumulative Index to Nursing Allied Health Literature databases for studies published from inception to November 2018. We included controlled, uncontrolled, observational and descriptive studies that explored the effect of eP on HCPs’ working practices in an inpatient setting. Data on setting, eP system and impact on working practices were extracted. Methodological quality was assessed using the Mixed Methods Appraisal Tool. Emergent themes were identified and subjected to narrative synthesis. The protocol was registered with PROSPERO (registration CRD42017075804). Results Searches identified 1301 titles and abstracts after duplicate removal. 171 papers underwent full-text review. A total of 25 studies met the inclusion criteria, from nine different countries. Nineteen were of commercial eP systems. There were a range of study designs; most (n = 14) adopted quantitative methods such as cross-sectional surveys, ten adopted qualitative approaches and a further one used mixed methods. Fourteen of the 25 studies were deemed to be of high quality. Four key themes were identified: communication, time taken to complete tasks, clinical workflow, and workarounds. Within each theme, study findings differed as to whether the effects of eP on HCPs’ working practices were positive or negative. Conclusion There is a lack of consensus within the literature on the impact of eP on HCPs’ working practices. Future research should explore the strategies resulting in a positive impact on HCPs’ working practices and learn from those that have not been successful.

The Ghent Older People's Prescriptions community Pharmacy Screening (GheOP3 S)-tool was recently developed as an explicit screening tool to detect drug-related problems (DRPs) and to help in performing medication reviews. In this study, we aimed (a) to describe the characteristics of the detected DRPs and the subsequent pharmacists' recommendations with their acceptance and implementation rate resulting from a pharmacist-led medication review using the GheOP3 S-tool and (b) to assess the potential impact of the intervention., info:eu-repo/semantics/published

Background: The Health and Social Care Act 2012 represents the most complex National Health Service reforms in history. High-quality clinical leadership is important for successful implementation of health service reform. However, little is known about the effectiveness of current leadership training. Purpose: This study describes the use of a behavioral simulation to improve the knowledge and leadership of a cohort of medical doctors expected to take leadership roles in the National Health Service. Methodology: A day-long behavioral simulation (The Crucible) was developed and run based on a fictitious but realistic health economy. Participants completed pre- and postsimulation questionnaires generating qualitative and quantitative data. Leadership skills, knowledge, and behavior change processes described by the "theory of planned behavior" were self-assessed pre- and postsimulation. Results: Sixty-nine medical doctors attended. Participants deemed the simulation immersive and relevant. Significant improvements were shown in perceived knowledge, capability, attitudes, subjective norms, intentions, and leadership competency following the program. Nearly one third of participants reported that they had implemented knowledge and skills from the simulation into practice within 4 weeks. Conclusions: This study systematically demonstrates the effectiveness of behavioral simulation for clinical management training and understanding of health policy reform. Potential future uses and strategies for analysis are discussed. Practice Implications: High-quality care requires understanding of health systems and strong leadership. Policymakers should consider the use of behavioral simulation to improve understanding of health service reform and development of leadership skills in clinicians, who readily adopt skills from simulation into everyday practice.

BACKGROUND: High performance work systems (HPWSs) are successful work systems in the context of safety climate and patient safety. The 10-item HPWS questionnaire is a validated instrument developed to assess existing HPWS structures in hospitals. The objectives of this cross-sectional study were to translate the English HPWS questionnaire into German (HPWS-G), to rate its content validity, and to examine its psychometric properties. METHODS: Content validity was examined by a panel of 12 physicians and nurses, and I-CVI and S-CVI calculated. For internal consistency, Cronbach's α and item-scale correlations were determined. Construct validity was measured via confirmatory factor analysis. A convenience sample of 782 nurses and physicians in a University hospital setting in Switzerland's German-speaking region was surveyed. Four inclusion criteria were applied: working in intensive care, emergency department or operating room; having daily patient contact; having worked in the current clinical area for more than three months; and more than 40% employment. RESULTS: A total of 281 questionnaires were completed (response rate: 35.9%). Overall, the 10-item HPWS-G questionnaire showed good content validity (I-CVI = .83-1; S-CVI = .86) and internal consistency (Cronbach's α = .853). HPWS-G scores correlated significantly with safety climate (rs = .657, p

Background Patients are increasingly recognized as playing important roles in improving health services. Little is known about the mechanisms by which patients develop and diffuse local innovations in a complex health-care system. Objective To ascertain how diffusion of an innovation, My Medication Passport, occurred and roles played by patients in it. Design Case study: quantitative mapping of innovation's diffusion and analysis of the routes and occupations of those through whom the innovation spread; documentary analysis; reflective assessment of patient's roles. Setting and participants NHS Trusts, third sector organizations, patients and health-care professionals. Interventions studied Co-produced action to raise awareness and influence use of the innovation; order database which enabled ease of access to the innovation. Main outcome measures Geographical spread of innovation; occupations of individuals; types of organizations using the innovation. Results The innovation spread from initial development and use in Northwest London across the UK and beyond. Key roles played by patients were as follows: co-producer; advocate; relationship builder; relationship broker; planner; presenter; awareness raiser; trainer; networker. Patients identified and introduced potential audiences and users to MMP, using social, organizational, sectoral, lay and professional networks to do so. They organized a range of awareness-raising and communication activities, monitored feedback, evaluated the impact and responded to new interest. Discussion and conclusions The roles of patients in diffusing innovations are under-recognized. Collaborative working between patients, carers and health-care professionals in planning and progressing the use and supporting diffusion of the innovation was important. Principles described in this study are relevant to progressing other patient-led ideas for innovative changes relating to health service development.

BACKGROUND: Research has been mainly focused on how to elicit patient preferences, with less attention on why patients form certain preferences. OBJECTIVES: To assess which psychological instruments are currently used and which psychological constructs are known to have an impact on patients' preferences and health-related decisions including the formation of preferences and preference heterogeneity. METHODS: A systematic database search was undertaken to identify relevant studies. From the selected studies, the following information was extracted: study objectives, study population, design, psychological dimensions investigated, and instruments used to measure psychological variables. RESULTS: Thirty-three studies were identified that described the association between a psychological construct, measured using a validated instrument, and patients' preferences or health-related decisions. We identified 33 psychological instruments and 18 constructs, and categorized the instruments into 5 groups, namely, motivational factors, cognitive factors, individual differences, emotion and mood, and health beliefs. CONCLUSIONS: This review provides an overview of the psychological factors and related instruments in the context of patients' preferences and decisions in healthcare settings. Our results indicate that measures of health literacy, numeracy, and locus of control have an impact on health-related preferences and decisions. Within the category of constructs that could explain preference and decision heterogeneity, health locus of control is a strong predictor of decisions in several healthcare contexts and is useful to consider when designing a patient preference study. Future research should continue to explore the association of psychological constructs with preference formation and heterogeneity to build on these initial recommendations. ispartof: VALUE IN HEALTH vol:22 issue:4 pages:491-501 ispartof: location:United States status: Published online