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Time-limited trials in the ICU: a mixed-methods sequential explanatory study of intensivists at two academic centres

Por: Viglianti · E. M. · Ervin · J. N. · Newton · C. A. · Kruser · J. M. · Iwashyna · T. J. · Valley · T. S.
Objective

To understand intensivist perceptions of the appropriateness of time-limited trials (TLTs)—a strategy to align life-sustaining care with patient goals and values in the midst of clinical uncertainty.

Design

We conducted a mixed-methods sequential explanatory study of intensive care unit (ICU) intensivists regarding appropriateness of utilising TLTs in three vignettes centred on invasive mechanical ventilation (IMV); continuous renal replacement therapy (CRRT); and heated high-flow nasal cannula (HHFNC). Semistructured interviews were conducted using the Tailored Implementation of Chronic Diseases framework. Data were analysed using thematic and matrix analysis.

Setting

Two academic medical centres in the USA participated in the randomised surveys and one centre participated in the semistructured interviews.

Participants

Pulmonary and critical care intensivists and fellows.

Primary and secondary outcomes

To understand intensivists perceptions of the appropriateness in using TLTs.

Results

Of 115 physicians surveyed, 71 initiated the survey and 44 completed the entire survey with a response rate of 38% (N=44/115) and a completion rate of 62% (N=44/71). While 35% (N=23/66) of intensivists had never heard of a TLT, of the intensivists who had heard of a TLT, 77% (N=33/43) had participated in one. In response to the vignettes, appropriateness of using a TLT varied (IMV: 74% (N=46/62); CRRT 78% (N=49/63); HHFNC 92% (N=56/61) as did the durations of the TLT. Semistructured interviews with 11 intensivists revealed having clarity about patient goals and clinical endpoints facilitated successful TLTs while lack of an evidenced-based framework was a barrier.

Conclusion

More than half of the physicians who responded had conducted or participated in a TLT. To increase the use of TLTs in the ICU, clinicians desire a more robust, evidence-based framework on how to conduct TLTs.

Experiences of patients and health care professionals on the quality of telephone follow-up care during the COVID-19 pandemic: a large qualitative study in a multidisciplinary academic setting

Por: van Erkel · F. M. · Pet · M. J. · Bossink · E. H. · van de Graaf · C. F. M. · Hodes · M. T. J. · van Ogtrop · S. N. · Mourits · M. J. E. · Welker · G. A. · Halmos · G. B. · van Leeuwen · B. · Racz · E. · Reyners · A. K. L. · van Munster · B. C. · van der Zaag-Loonen · H. J.
Objective

To evaluate the perceived quality of follow-up telephone consultations (TCs) from the perspective of patients and healthcare professionals (HCPs) of multiple medical disciplines during the COVID-19 pandemic.

Design

A qualitative study using semi-structured interviews and reflexive thematic analysis.

Setting

Seven medical disciplines (general dermatology, dermato-oncology, head and neck oncology, internal medicine, medical oncology, gynaecological oncology and surgical oncology) at a large university hospital in the Netherlands.

Participants

Patients who received and HCPs who provided TCs as a substitute for outpatient follow-up appointments during the COVID-19 pandemic.

Results

Eighty-two patients and 58 HCPs were interviewed. Predominantly, patients and HCPs were satisfied with the quality of care by TCs. They regarded TCs as efficient, accessible and of acceptable quality, provided there was an established patient-HCP relationship, medical complaints were absent and physical examination was not indicated. However, most patients were worried about the accuracy of their health assessment in the absence of physical examination and non-verbal communication. Both patients and HCPs wish to use TCs in the future alternatively with face-to-face consultations.

Conclusion

This study concludes that TCs seem a valuable contribution to the context of follow-up care and could partially replace face-to-face consultations. TCs can be performed in stable, chronic patients with whom a doctor-patient relationship has already been established. Face-to-face consultations are considered more appropriate in the case of new patients, challenging or emotionally charged consultations and when clinically relevant physical examination is indicated. Due to the context-dependent nature of experiences of patients and HCPs, TCs should be used with an individually customised approach based on patient and disease specifics, in which shared decision-making plays an extensive role. Before major implementation is considered, sufficient data on the safety regarding missed diagnoses or cancer recurrences should be assembled first.

Type of terrain and infant and young child feeding practices: cross-sectional study findings on children below 2 years of age from northern Bangladesh

Por: Farzana · F. D. · Choudhury · N. · Haque · M. A. · Ali · M. · Raihan · M. J. · Tanvir Ahmed · S. · Rahman · S. S. · Siddiqua · T. J. · Naz · F. · Faruque · A. · Ahmed · T.
Introduction

Optimal feeding practices are vital for the subsistence, adequate nutrition, physical growth and mental development of infants and young children. This study aimed to examine the prevalence of core infant and young child feeding (IYCF) indicators and their associations with the type of terrain, that is, geographical area or zone among the beneficiaries of a large-scale nutrition programme, Suchana, being carried out in the northern part of rural Bangladesh.

Methodology

A cross-sectional study was conducted from November 2016 to February 2017 in Sylhet and Moulvibazar districts of Sylhet Division, Bangladesh. Data pertaining to 5440 children aged below 24 months were analysed for this study. Univariate analysis was carried out to establish the prevalence of the indicators; selected variables were subjected to multiple regression model to identify independent relationships between the IYCF indicators and the type of terrain stratified as plain land, hilly area, flash-flood prone area and haor (wetland).

Results

In logistic regression analysis, flash-flood prone areas were significantly associated with higher exclusive breast feeding (1.92, 95% CI 1.12 to 3.30; p=0.019), minimum meal frequency (1.45, 95% CI 1.07 to 1.97; p=0.018) and minimum dietary diversity (1.63, 95% CI 1.01 to 2.63; p=0.046) compared with plain land. Moreover, hilly areas were associated with significantly lower introduction of solid, semisolid or soft foods (0.39, 95% CI 0.18 to 0.82; p=0.013) compared with plain land.

Conclusion

The observed prevalence of the indicators can be set as benchmark while prioritising interventions aimed at improving IYCF practices among underprivileged families residing in different types of rural setting in Bangladesh.

Assessing tobacco smoke exposure in pregnancy from self-report, urinary cotinine and NNAL: a validation study using the New Hampshire Birth Cohort Study

Por: Peacock · J. L. · Palys · T. J. · Halchenko · Y. · Sayarath · V. · Takigawa · C. A. · Murphy · S. E. · Peterson · L. A. · Baker · E. R. · Karagas · M. R.
Objectives

Accurate assessment of tobacco smoke exposure is key to evaluate its effects. We sought to validate and establish cut-offs for self-reported smoking and secondhand smoke (SHS) exposure during pregnancy using urinary cotinine and 4-(methylnitrosamino)-1-(-3-pyridyl)-1-butanol (NNAL) in a large contemporary prospective study from the USA, with lower smoking prevalence than has previously been evaluated.

Design

Prospective birth cohort.

Setting

Pregnancy clinics in New Hampshire and Vermont, USA.

Participants

1396 women enrolled in the New Hampshire Birth Cohort Study with self-reported smoking, urinary cotinine, NNAL and pregnancy outcomes.

Primary and secondary outcome measures

Cut-offs for urinary cotinine and NNAL concentrations were estimated from logistic regression models using Youden’s method to predict SHS and active smoking. Cotinine and NNAL were each used as the exposure in separate multifactorial models for pregnancy outcomes.

Results

Self-reported maternal smoking was: 72% non-smokers, 5.7% ex-smokers, 6.4% SHS exposure, 6.2% currently smoked, 10% unreported. Cotinine and NNAL levels were low and highly intercorrelated (r=0.91). Geometric mean cotinine, NNAL were 0.99 ng/mL, 0.05 pmol/mL, respectively. Cotinine cut-offs for SHS, current smoking were 1.2 ng/mL and 1.8 ng/mL (area under curve (AUC) 95% CI: 0.52 (0.47 to 0.57), 0.90 (0.85 to 0.94)). NNAL cut-off for current smoking was 0.09 pmol/mL (AUC=0.82 (95% CI 0.77 to 0.87)). Using cotinine and NNAL cut-offs combined gave similar AUC to cotinine alone, 0.87 (95% CI 0.82 to 0.91). Cotinine and NNAL gave almost identical effect estimates when modelling pregnancy outcomes.

Conclusions

In this population, we observed high concordance between self-complete questionnaire smoking data and urinary cotinine and NNAL. With respect to biomarkers, either cotinine or NNAL can be used as a measure of tobacco smoke exposure overall but only cotinine can be used to detect SHS.

'Trying to fly the plane while we were building it. Applying a learning health systems approach to evaluate early-stage barriers and facilitators to implementing primary care transformation: a qualitative study

Por: Pestka · D. L. · White · K. M. · DeRoche · K. K. · Benson · B. J. · Beebe · T. J.
Objective

A learning health system (LHS) uses data to generate evidence and answer questions required to continually improve system performance and patient care. Given the complexities of practice transformation, an area where LHS is particularly important is the study of primary care transformation (PCT) as PCT generates several practice-level questions that require study where the findings can be readily implemented. In May 2019, a large integrated health delivery system in Minnesota began implementation of a population management PCT in two of its 40 primary care clinics. In this model of care, patients are grouped into one of five service bundles based on their complexity of care; patient appointment lengths and services provided are then tailored to each service bundle. The objective of this study was to examine the use of a LHS in PCT by utilising the Consolidated Framework for Implementation Research (CFIR) to categorise implementation lessons from the initial two PCT clinics to inform further implementation of the PCT within the health system.

Design

This was a formative evaluation in which semistructured qualitative interviews were carried out. Observational field notes were also taken. Inductive coding of the data was performed and resultant codes were mapped to the CFIR.

Setting

Two suburban primary care clinics in the Twin Cities, Minnesota.

Participants

Twenty-two care team members from the first two clinics to adopt the PCT.

Results

Seventeen codes emerged to describe care team members’ perceived implementation influences. Codes occurred in each of the five CFIR domains (intervention characteristics, outer setting, inner setting, characteristics of individuals and process), with most codes occurring in the ‘inner setting’ domain.

Conclusions

Using an LHS approach to determine early-stage implementation influences is key to guiding further PCT implementation, understanding modifications that need to be made and additional research that needs to occur.

Association between surgeon grade and implant survival following hip and knee replacement: a systematic review and meta-analysis

Por: Fowler · T. J. · Aquilina · A. L. · Blom · A. W. · Sayers · A. · Whitehouse · M. R.
Objective

To investigate the association between surgeon grade (trainee vs consultant) and implant survival following primary hip and knee replacement.

Design

A systematic review and meta-analysis of observational studies.

Data sources

MEDLINE and Embase from inception to 6 October 2021.

Setting

Units performing primary hip and/or knee replacements since 1990.

Participants

Adult patients undergoing either a primary hip or knee replacement, predominantly for osteoarthritis.

Intervention

Whether the surgeon recorded as performing the procedure was a trainee or not.

Primary and secondary outcome measures

The primary outcome was net implant survival reported as a Kaplan-Meier survival estimate. The secondary outcome was crude revision rate. Both outcomes were reported according to surgeon grade.

Results

Nine cohort studies capturing 4066 total hip replacements (THRs), 936 total knee replacements (TKRs) and 1357 unicompartmental knee replacements (UKRs) were included (5 THR studies, 2 TKR studies and 2 UKR studies). The pooled net implant survival estimates for THRs at 5 years were 97.9% (95% CI 96.6% to 99.2%) for trainees and 98.1% (95% CI 97.1% to 99.2%) for consultants. The relative risk of revision of THRs at 5 and 10 years was 0.88 (95% CI 0.46 to 1.70) and 0.68 (95% CI 0.37 to 1.26), respectively. For TKRs, the net implant survival estimates at 10 years were 96.2% (95% CI 94.0% to 98.4%) for trainees and 95.1% (95% CI 93.0% to 97.2%) for consultants. We report a narrative summary of UKR outcomes.

Conclusions

There is no strong evidence in the existing literature that trainee surgeons have worse outcomes compared with consultants, in terms of the net survival or crude revision rate of hip and knee replacements at 5–10 years follow-up. These findings are limited by the quality of the existing published data and are applicable to countries with established orthopaedic training programmes.

PROSPERO registration number

CRD42019150494.

Incidence of post-traumatic epilepsy following paediatric traumatic brain injury: protocol for systematic review and meta-analysis

Por: Mariajoseph · F. P. · Rewell · S. S. · O'Brien · T. J. · Semple · B. D. · Antonic-Baker · A.
Introduction

Post-traumatic epilepsy (PTE) is a recognised complication of traumatic brain injury (TBI), and is associated with higher rates of mortality and morbidity when compared with patients with TBI who do not develop PTE. The majority of the literature on PTE has focused on adult populations, and consequently there is a paucity of information regarding paediatric cohorts. Additionally, there is considerable heterogeneity surrounding the reported incidence of PTE following childhood TBI in the current literature. The primary aim of our study is to summarise reported PTE incidences in paediatric populations to derive an accurate estimate of the global incidence of PTE following childhood TBI. Our secondary aim is to explore risk factors that increase the likelihood of developing PTE.

Methods and analysis

A systematic literature search of Embase (1947–2021), PubMed (1996–2021) and Web of Science (1900–2021) will be conducted. Publications in English that report the incidence of PTE in populations under 18 years of age will be included. Publications that evaluate fewer than 10 patients, report an alternative cause of epilepsy, or in which a paediatric cohort is not discernable, will be excluded. Independent investigators will identify the relevant publications, and discrepancies will be adjudicated by a third independent investigator. Data extracted will include incidence of PTE, time intervals between TBI and PTE, seizure characteristics, injury characteristics, patient demographics and clinical data. Data extraction will be performed by two independent investigators and cross-checked by a third investigator. A descriptive analysis of PTE incidence will be conducted and a weighted mean will be calculated. If sufficient data are available, stratified meta-analysis of subgroups will also be conducted.

Ethics and dissemination

Ethics approval was not required for this study. We intend to publish our findings in a high-quality peer-reviewed journal on completion.

PROSPERO registration number

CRD42021245802.

A pilot randomised controlled trial of a structured, home-based exercise programme on cardiovascular structure and function in kidney transplant recipients: the ECSERT study design and methods

Por: Billany · R. E. · Vadaszy · N. · Bishop · N. C. · Wilkinson · T. J. · Adenwalla · S. F. · Robinson · K. A. · Croker · K. · Brady · E. M. · Wormleighton · J. V. · Parke · K. S. · Cooper · N. J. · Webster · A. C. · Barratt · J. · McCann · G. P. · Burton · J. O. · Smith · A. C. · Graham-B
Background

Cardiovascular disease (CVD) is a major cause of morbidity and mortality in kidney transplant recipients (KTRs). CVD risk scores underestimate risk in this population as CVD is driven by clustering of traditional and non-traditional risk factors, which lead to prognostic pathological changes in cardiovascular structure and function. While exercise may mitigate CVD in this population, evidence is limited, and physical activity levels and patient activation towards exercise and self-management are low. This pilot study will assess the feasibility of delivering a structured, home-based exercise intervention in a population of KTRs at increased cardiometabolic risk and evaluate the putative effects on cardiovascular structural and functional changes, cardiorespiratory fitness, quality of life, patient activation, healthcare utilisation and engagement with the prescribed exercise programme.

Methods and analysis

Fifty KTRs will be randomised 1:1 to: (1) the intervention; a 12week, home-based combined resistance and aerobic exercise intervention; or (2) the control; usual care. Intervention participants will have one introductory session for instruction and practice of the recommended exercises prior to receiving an exercise diary, dumbbells, resistance bands and access to instructional videos. The study will evaluate the feasibility of recruitment, randomisation, retention, assessment procedures and the intervention implementation. Outcomes, to be assessed prior to randomisation and postintervention, include: cardiac structure and function with stress perfusion cardiac MRI, cardiorespiratory fitness, physical function, blood biomarkers of cardiometabolic health, quality of life and patient activation. These data will be used to inform the power calculations for future definitive trials.

Ethics and dissemination

The protocol was reviewed and given favourable opinion by the East Midlands-Nottingham 2 Research Ethics Committee (reference: 19/EM/0209; 14 October 2019). Results will be published in peer-reviewed academic journals and will be disseminated to the patient and public community via social media, newsletter articles and presentations at conferences.

Trial registration number

NCT04123951.

COVID outcome prediction in the emergency department (COPE): using retrospective Dutch hospital data to develop simple and valid models for predicting mortality and need for intensive care unit admission in patients who present at the emergency department

Por: van Klaveren · D. · Rekkas · A. · Alsma · J. · Verdonschot · R. J. C. G. · Koning · D. T. J. J. · Kamps · M. J. A. · Dormans · T. · Stassen · R. · Weijer · S. · Arnold · K.-S. · Tomlow · B. · de Geus · H. R. H. · van Bruchem-Visser · R. L. · Miedema · J. R. · Verbon · A. · van Nood
Objectives

Develop simple and valid models for predicting mortality and need for intensive care unit (ICU) admission in patients who present at the emergency department (ED) with suspected COVID-19.

Design

Retrospective.

Setting

Secondary care in four large Dutch hospitals.

Participants

Patients who presented at the ED and were admitted to hospital with suspected COVID-19. We used 5831 first-wave patients who presented between March and August 2020 for model development and 3252 second-wave patients who presented between September and December 2020 for model validation.

Outcome measures

We developed separate logistic regression models for in-hospital death and for need for ICU admission, both within 28 days after hospital admission. Based on prior literature, we considered quickly and objectively obtainable patient characteristics, vital parameters and blood test values as predictors. We assessed model performance by the area under the receiver operating characteristic curve (AUC) and by calibration plots.

Results

Of 5831 first-wave patients, 629 (10.8%) died within 28 days after admission. ICU admission was fully recorded for 2633 first-wave patients in 2 hospitals, with 214 (8.1%) ICU admissions within 28 days. A simple model—COVID outcome prediction in the emergency department (COPE)—with age, respiratory rate, C reactive protein, lactate dehydrogenase, albumin and urea captured most of the ability to predict death. COPE was well calibrated and showed good discrimination for mortality in second-wave patients (AUC in four hospitals: 0.82 (95% CI 0.78 to 0.86); 0.82 (95% CI 0.74 to 0.90); 0.79 (95% CI 0.70 to 0.88); 0.83 (95% CI 0.79 to 0.86)). COPE was also able to identify patients at high risk of needing ICU admission in second-wave patients (AUC in two hospitals: 0.84 (95% CI 0.78 to 0.90); 0.81 (95% CI 0.66 to 0.95)).

Conclusions

COPE is a simple tool that is well able to predict mortality and need for ICU admission in patients who present to the ED with suspected COVID-19 and may help patients and doctors in decision making.

Host blood transcriptomic biomarkers of tuberculosis disease in people living with HIV: a systematic review protocol

Por: Mendelsohn · S. C. · Mulenga · H. · Mbandi · S. K. · Darboe · F. · Shelton · M. · Scriba · T. J. · Hatherill · M.
Introduction

Current tuberculosis triage and predictive tools offer poor accuracy and are ineffective for detecting asymptomatic disease in people living with HIV (PLHIV). Host tuberculosis transcriptomic biomarkers hold promise for diagnosing prevalent and predicting progression to incident tuberculosis and guiding further investigation, preventive therapy and follow-up. We aim to conduct a systematic review of performance of transcriptomic signatures of tuberculosis in PLHIV.

Methods and analysis

We will search MEDLINE (PubMed), WOS Core Collection, Biological Abstracts, and SciELO Citation Index (Web of Science), Africa-Wide Information and General Science Abstracts (EBSCOhost), Scopus, and Cochrane Central Register of Controlled Trials databases for articles published in English between 1990 and 2020. Case–control, cross-sectional, cohort and randomised controlled studies evaluating performance of diagnostic and prognostic host-response transcriptomic signatures in PLHIV of all ages and settings will be included. Eligible studies will include PLHIV in signature test or validation cohorts, and use microbiological, clinical, or composite reference standards for pulmonary or extrapulmonary tuberculosis diagnosis. Study quality will be evaluated using the ‘Quality Assessment of Diagnostic Accuracy Studies-2’ tool and cumulative review evidence assessed using the ‘Grading of Recommendations Assessment, Development and Evaluation’ approach. Study selection, quality appraisal and data extraction will be performed independently by two reviewers. Study, cohort and signature characteristics of included studies will be tabulated, and a narrative synthesis of findings presented. Primary outcomes of interest, biomarker sensitivity and specificity with estimate precision, will be summarised in forest plots. Expected heterogeneity in signature characteristics, study settings, and study designs precludes meta-analysis and pooling of results. Review reporting will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses of Diagnostic Test Accuracy Studies guidelines.

Ethics and dissemination

Formal ethics approval is not required as primary human participant data will not be collected. Results will be disseminated through peer-reviewed publication and conference presentation.

PROSPERO registration number

CRD42021224155.

Adequate maternal pre-conceptional folate status may reduce the risk of gestational diabetes mellitus

Por: Best · K. · Green · T. J.

Commentary on: Li M, Li S, Chavarro JE, et al. Prepregnancy habitual intakes of total, supplemental, and food folate and risk of gestational diabetes mellitus: a prospective cohort study. Diabetes Care 2019;42:1034–41.

Implications for practice and research

  • Recent data show that gestational diabetes mellitus (GDM) prevalence has increased during the past 20 years.1 Pre-pregnancy supplementation with folic acid may be a simple, low-cost strategy to reduce maternal and infant morbidities associated with GDM.

  • Further studies are needed to identify the optimal dose of pre-pregnancy folic acid to reduce the incidence of GDM and to investigate long-term effects in offspring.

  • Context

    Rates of GDM are rising worldwide and associated with adverse perinatal outcomes and long-term cardiometabolic risk in mothers and their offspring.1 This large prospective cohort study investigates the association between pre-pregnancy habitual folate intake and the risk GDM.2

    ...

    Mealtime and patient factors associated with meal completion in hospitalised older patients: An exploratory observation study

    Abstract

    Aims and Objectives

    To examine mealtime and patient factors associated with meal completion among hospitalised older patients. We also considered contextual factors such as staffing levels and ward communication.

    Background

    Sub-optimum nutrition is a modifiable risk factor for hospital associated decline (HAD) in older patients. Yet, the quality of mealtime experiences can be overlooked within ward routinised practice.

    Design

    Cross sectional, descriptive observation study.

    Methods

    We undertook structured observation of mealtimes examining patient positioning, mealtime set-up and feeding assistance. The outcome was meal completion categorised as 0, 25%, 50%, 75% or 100%. Data were collected on patient characteristics and ward context. We used mixed-effects ordinal regression models to examine patient and mealtime factors associated with higher meal completion producing odds ratios (OR) and 95% confidence intervals (CI). The study was reported as per STROBE guidelines.

    Results

    We included 60 patients with a median age of 82 years (IQR 76–87) and clinical frailty score of 5 IQR (4–6). Of the 279 meals, 51% were eaten completely, 6% three quarters, 15% half, 18% a quarter and 10% were not eaten at all. Mealtime predictors with a weak association with less-meal completion were requiring assistance, special diets, lying in bed, and red tray (indicator of nutrition risk), but were not statistically significant. Significant patient-level factors were higher values for frailty (OR 0.34 [0.11–1.04]) and Malnutrition Universal Screening Tool (OR 0.22 [0.08–0.62]). The average nurse-to-patient ratio was 1:5.5.

    Conclusion

    Patient factors were the strongest predictors for meal completion, but mealtime factors had a subtle influence. The nursing teams' capacity to prioritise mealtimes above competing demands is important as part of a comprehensive nutrition strategy.

    Relevance to clinical practise

    Nurses are central to optimising nutrition for frail older patients. It requires ward leadership to instil a culture of prioritising assisted mealtimes, improved communication, greater autonomy to tailor nutrition strategies and safe staffing levels.

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