Abstract
Background
Critically unwell babies in intensive care units may develop acute renal failure. Options for renal replacement therapy are limited by their small size and available technology.
...Objectives
To determine the clinical efficacy, outcomes and safety profile of the NIDUS
®
(a novel infant haemodialysis device) for babies under 8 kg, compared with current renal replacement therapy.
Design
A clinical investigation using a non-blinded cluster stepped wedge design with paediatric intensive care units randomised to sequences.
Setting
Paediatric intensive care units in six UK hospitals.
Participants
Children under 8 kg who required renal replacement therapy for fluid overload or biochemical disturbance.
Interventions
Continuous renal replacement therapy was provided by the usual methods: peritoneal dialysis and continuous haemofiltration (during control periods) and by the NIDUS (during intervention periods), a novel device designed for babies with a smaller circuit and filter and volumetric control of ultrafiltration.
Main outcome measures
Primary outcome was precision of ultrafiltration compared with prescription; secondary outcomes included biochemical clearances, accuracy of reported ultrafiltration and mortality.
Data sources
Bedside study data collected by weighing bags of fluid entering and leaving the device were entered into the study database along with case descriptors. Some secondary outcome data was collected via the Paediatric Intensive Care Audit Network.
Results
Ninety-seven participants were recruited by study closure, 62 to control and 35 to intervention. The primary outcome was obtained from 62 control but only 21 intervention patients, largely because of technical difficulties using NIDUS. The analysis comparing the available primary outcomes showed that ultrafiltration with NIDUS was closer to that prescribed than with control: standard deviations controls 18.75, intervention 2.95 (ml/hour), adjusted ratio 0.13, 95% confidence interval (0.03 to 0.71);
p
= 0.018.
The mean clearances for creatinine, urea and phosphate were lower on peritoneal dialysis than NIDUS, which were in turn lower than continuous veno-venous haemofiltration. The variability in the clearances was in the same order.
Of the 62 control patients, 10 died (2/62 on peritoneal dialysis; 7/13 on continuous haemofiltration) before discharge from paediatric intensive care unit (16%), compared with 12 out of 35 (34%) in the NIDUS group:
p
= 0.04, 95% confidence interval for difference (0 to 36%).
Harms
No important adverse events occurred and the NIDUS has an acceptable safety profile compared with other renal replacement therapies in this critically ill population with multi-organ failure. Mortality was lowest for Peritoneal Dialysis, highest for continuous haemofiltration, with the NIDUS in-between. Only one serious adverse device event which was reported to the Medicines and Healthcare products Regulatory Agency.
Conclusions
NIDUS works effectively, delivering appropriate blood clearances and accurate, controllable fluid removal (ultrafiltration), indicating that it has an important place alongside other dialysis modalities for infant renal replacement therapy.
Future work
Findings from this study indicate some modifications are required to NIDUS to improve usability. Further studies on use of the NIDUS device in other populations of babies for example those with chronic renal failure, and long-term outcomes are required.
Trial registration
This trial is registered as ISRCTN 13787486.
Funding
This award was funded by the National Institute for Health and Care Research (NIHR) Efficacy and Mechanism Evaluation Programme (NIHR award ref: 14/23/26) and is published in full in
Efficacy and Mechanism Evaluation
; Vol. 11, No. 1. See the NIHR Funding and Awards website for further award information.
By relying on data from existing patient-reported outcome measures of quality of life, the true impact of skin conditions on patients’ lives may be underestimated. This study systematically reviewed ...all dermatology-specific (used across skin conditions) patient-reported outcome measures and makes evidence-based recommendations for their use. The study protocol is registered on PROSPERO (CRD42018108829). PubMed, PsycInfo and CINAHL were searched from inception to 25 June 2018. The Consensus-based Standards for the Selection of Health Measurement Instruments (COSMIN) criteria were used to assess the measurement properties and methodological quality of studies. A total of 12,925 abstracts were identified. Zero patient-reported outcome measures were assigned to category A (ready for use without further validation), 31 to category B (recommended for use, but only with further validation) and 5 to category C (not recommended for use). There is no gold-standard dermatology-specific patient-reported outcome measure that can be recommended or used without caution. A new measure that can comprehensively capture the impact of dermatological conditions on the patient’s life is needed.
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DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, UILJ, UKNU, UL, UM, UPUK
Introduction:
Elevated levels of blood-based proinflammatory cytokines are linked to acute moderate to severe traumatic brain injuries (TBIs), yet less is known in acute mild (m)TBI cohorts. The ...current study examined whether blood-based cytokines can differentiate patients with mTBI, with and without neuroimaging findings (CT and MRI).
Material and Methods:
Within 24 h of a mTBI, determined by a Glasgow Coma Scale (GCS) between 13 and 15, participants (
n
= 250) underwent a computed tomography (CT) and magnetic resonance imaging (MRI) scan and provided a blood sample. Participants were classified into three groups according to imaging findings; (1) CT+, (2) MRI+ (CT–), (3) Controls (CT– MRI–). Plasma levels of circulating cytokines (IL-6, IL-10, TNFα), and vascular endothelial growth factor (VEGF) were measured using an ultra-sensitive immunoassay.
Results:
Concentrations of inflammatory cytokines (IL-6, TNFα) and VEGF were elevated in CT+, as well as MRI+ groups (
p
< 0.001), compared to controls, even after controlling for age, sex and cardiovascular disease (CVD)-related risk factors; hypertension, and hyperlipidemia. Post-concussive symptoms were associated with imaging groupings, but not inflammatory cytokines in this cohort. Levels of VEGF, IL-6, and TNFα differentiated patients with CT+ findings from controls, with the combined biomarker model (VEGF, IL-6, TNFα, and IL-10) showing good discriminatory power (AUC 0.92, 95% CI 0.87–0.97). IL-6 was a fair predictor of MRI+ findings compared to controls (AUC 0.70, 95% CI 0.60–0.78). Finally, the combined biomarker model discriminated patients with MRI+ from CT+ with an AUC of 0.71 (95% CI 0.62–0.80).
Conclusions:
When combined, IL-6, TNFα, and VEGF may provide a promising biomarker cytokine panel to differentiate mTBI patients with CT+ imaging vs. controls. Singularly, IL-6 was a fair discriminator between each of the imaging groups. Future research directions may help elucidate mechanisms related to injury severity and potentially, recovery following an mTBI.
Existing dermatology-specific Patient-Reported Outcome Measures (PROMs) do not fully capture the substantial physical, psychological and social impact of dermatological conditions on patients' lives ...and are not recommended for use according to the COSMIN criteria. Most were developed with insufficient patient involvement and relied on classical psychometric methods. We are developing the new Patient-Reported Impact of Dermatological Diseases (PRIDD) measure for use in research and clinical practice in partnership with patients.
To examine the factor structure of PRIDD, determine the definitive selection of items for each subscale, and establish structural validity and internal consistency through classical and modern psychometric methods.
Two cross-sectional online surveys were conducted. Adults (≥ 18 years) worldwide living with a dermatological condition were recruited through the membership network of the International Alliance of Dermatology Patient Organizations (GlobalSkin). They completed the PRIDD questionnaire and a demographics questionnaire via an online survey. We examined missing data and distribution of scores for each item. The factor structure was assessed using confirmatory and exploratory factor analysis (Survey 1). Internal consistency was examined using Cronbach's α. Rasch measurement theory analyses were conducted, including iterative assessment of rating scale function, fit to the Rasch model, unidimensionality, reliability, local dependence, targeting and differential item functioning (DIF) (Surveys 1 and 2).
Participants in Surveys 1 and 2 numbered 483 and 504 people, respectively. All items had ≤ 3% missing scores and all five response options were used. A four-factor model showed the best fit. PRIDD and all four subscales were internally consistent but showed some misfit to the Rasch measurement model. Adjustments were made to rectify disordered thresholds, remove misfitting items, local dependency and DIF, and improve targeting. The resulting 16-item version and subscales fit the Rasch model, showed no local dependency or DIF at the test level, and were well targeted.
This field test study produced the final PRIDD measure, consisting of 16 items across four domains. The data triangulated and refined the conceptual framework of impact and provide evidence of PRIDD's structural validity and internal consistency. The final step in the development and validation of the PRIDD measure is to test the remaining measurement properties.
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BFBNIB, FZAB, GIS, IJS, KILJ, OILJ, SBCE, SBMB, UPUK
Abstract Background Patient-reported outcome measures (PROMs) are crucial for assessing the impact of dermatological conditions on patients’ lives, but the existing dermatology-specific PROMs are not ...recommended for use according to the Consensus-based Standards for the Selection of Health Measurement Instruments (COSMIN). We developed the Patient-Reported Impact of Dermatological Diseases (PRIDD) measure in partnership with patients. It has strong evidence of content validity, structural validity, internal consistency, acceptability, and feasibility. Objectives To test PRIDD’s remaining measurement properties and establish the interpretability of scores against the COSMIN criteria using classic and modern psychometric methods. Methods A global longitudinal study consisting of two online surveys administered two to four weeks apart. Adults (≥ 18 years) living with a dermatological condition were recruited through the International Alliance of Dermatology Patient Organizations’ (GlobalSkin) membership network. Participants completed PRIDD, a demographics questionnaire, and other related measures including the Dermatology Life Quality Index (DLQI). We tested PRIDD’s criterion validity, construct validity and responsiveness (Spearman’s ρ, independent-samples t-tests and ANOVA), test-retest reliability (interclass correlation coefficient ICC), measurement error (Smallest Detectable Change or Limits of Agreement LoA, distribution-based Minimally Important Change MIC), floor and ceiling effects (number of minimum and maximum scores and Person-Item Location Distribution Maps), score bandings (κ coefficient of agreement) and anchor-based MIC. Results 504 patients with 35 dermatological conditions from 38 countries participated. Criterion validity (ρ = 0.79), construct validity (76% hypotheses met), test-retest validity (ICC = 0.93), and measurement error (LoA = 1.3 < MIC = 4.14) were sufficient. Floor and ceiling effects were in the acceptable range (< 15%). Score bandings were determined (κ = 0.47), however, the anchor-based MIC could not be calculated due to an insufficient anchor. Conclusions PRIDD is a valid and reliable tool to evaluate the impact of dermatological disease on patients’ lives in research and clinical practice. It is the first dermatology-specific PROM to meet the COSMIN criteria. These results support the value of developing and validating PROMs with a patient-centred approach and using classic and modern psychometric methods. Further testing of responsiveness and MIC, cross-cultural translation, linguistic validation, and global data collection are planned.
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BFBNIB, FZAB, GIS, IJS, KILJ, OILJ, SBCE, SBMB, UPUK
Abstract Fatigue is prevalent amongst people with long COVID, but is poorly understood. The sensory attenuation framework proposes that impairments in sensory processing lead to heightened perception ...of effort, driving fatigue. This study aims to investigate the role of somatosensory processing impairments in long COVID fatigue and quantify how sensory processing relates to other prominent symptoms of long COVID including autonomic dysfunction, mood and illness beliefs in driving the experience of fatigue. We will recruit 44 individuals with long COVID fatigue and 44 individuals with neither long COVID nor fatigue (controls). Our primary objective is to compare baseline somatosensory processing between individuals with long COVID fatigue and controls. Additionally, we will explore the associations between somatosensory processing, fatigability and the level of fatigue induced by cognitive and physical exertion. Due to the complex nature of fatigue, we will also investigate how long COVID, state fatigue, perceived effort, mood, illness beliefs, autonomic symptoms and autonomic nervous system function interact to predict trait fatigue. This comprehensive investigation aims to elucidate how sensory processing and other prominent symptoms interact to impact the experience of fatigue.
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FZAB, GIS, IJS, KILJ, NLZOH, NUK, OILJ, SAZU, SBCE, SBMB, UL, UM, UPUK
ObjectivesTo investigate the impact of SARS-CoV-2 on self-reported mood, coping and health behaviours of people living with existing health conditions in the UK to understand how to improve coping ...responses to the threat of SARS-CoV-2.DesignQuantitative design using a cross-sectional survey.SettingOnline survey in the UK.ParticipantsUK adults (18+ years) were eligible to participate. A total of 9110 people participated. Of these, 4377 (48%) reported at least one existing health condition, 874 (10%) reported having two or more existing conditions, and 715 (8%) reported having an existing mental health condition.Primary and secondary outcome measuresMultivariable linear regression and sequential multiple mediation analysis were used to estimate differences in average scores for active and avoidant coping response scores due to pre-existing health conditions, and to investigate the extent to which these differences are explained by differences in perceptions, beliefs, concerns and mood.ResultsPeople with pre-existing physical (+1.11 higher; 95% CI 0.88 to 1.34) and especially mental health conditions (3.06 higher; 95% CI 2.65 to 3.48) reported poorer health and used more avoidant coping compared with healthy participants. Under some strong untestable assumptions, we estimate that experiencing low mood or concern related to SARS-CoV-2 mostly explained the relationship between existing health conditions and avoidant coping.ConclusionPsychological support and interventions including behaviour change are required to mitigate the psychological burden of the SARS-CoV-2 pandemic and increase autonomy in people with and without pre-existing conditions during this highly uncertain time. Psychologists are well placed to support clinicians and people with existing health conditions to minimise the psychological impact of SARS-CoV-2, in order to alleviate the subsequent strain on healthcare services.
Aim
To examine Registered Nurses (RNs') and nursing students' perspectives on factors contributing to moral distress and the effects on their health, well‐being and professional and career ...intentions.
Design
Joanna Briggs Institute mixed‐methods systematic review and thematic synthesis. Registered in Prospero (Redacted).
Methods
Five databases were searched on 5 May 2021 for studies published in English since January 2010. Methodological quality assessment was conducted in parallel with data extraction.
Results
Searches yielded 2343 hits. Seventy‐seven articles were included. Most were correlational design and used convenience sampling. Studies were mainly from North America and Asia and situated in intensive and critical care settings. There were common, consistent sources of moral distress across continents, specialities and settings. Factors related to perceived inability or failure to enact moral agency and responsibility in moral events at individual, team and structural levels generated distress. Moral distress had a negative effect on RNs health and psychological well‐being.
Patient or Public Contribution
No patient or public contribution to this systematic review.
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FZAB, GIS, IJS, KILJ, NLZOH, NUK, OILJ, SAZU, SBCE, SBMB, UL, UM, UPUK, VSZLJ
Existing patient-reported outcome measures cannot comprehensively capture the full impact of living with a dermatological condition. The aim of this study was to develop a conceptual framework on ...which to build a new Patient-Reported Impact of Dermatological Diseases (PRIDD) measure. Adults (≥ 18 years of age) living with a dermatological condition, worldwide and/or representatives from a patient organization recruited via a global patient organization network, were invited to an individual or group interview. Data were analyzed thematically. Sixty-five people from 29 countries, representing 29 dermatological conditions, participated. Key themes were: (i) impacts at the individual, organizational and societal levels; (ii) impacts were point-in-time and cumulative; and (iii) impact is a multifaceted construct, with two subthemes (iiia) common impacts and (iiib) psychological and social impacts are most significant. The conceptual framework shows that impact is a multifaceted concept presenting across physical, psychological, social, financial, daily functioning and healthcare, and provides the basis for co-constructing the PRIDD with patients.
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DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, UILJ, UKNU, UL, UM, UPUK
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