What is quality in long covid care? Lessons from a national quality improvement collaborative and multi-site ethnography.

BACKGROUND: Long covid (post covid-19 condition) is a complex condition with diverse manifestations, uncertain prognosis and wide variation in current approaches to management. There have been calls for formal quality standards to reduce a so-called "postcode lottery" of care. The original aim of this study-to examine the nature of quality in long covid care and reduce unwarranted variation in services-evolved to focus on examining the reasons why standardizing care was so challenging in this condition. METHODS: In 2021-2023, we ran a quality improvement collaborative across 10 UK sites. The dataset reported here was mostly but not entirely qualitative. It included data on the origins and current context of each clinic, interviews with staff and patients, and ethnographic observations at 13 clinics (50 consultations) and 45 multidisciplinary team (MDT) meetings (244 patient cases). Data collection and analysis were informed by relevant lenses from clinical care (e.g. evidence-based guidelines), improvement science (e.g. quality improvement cycles) and philosophy of knowledge. RESULTS: Participating clinics made progress towards standardizing assessment and management in some topics; some variation remained but this could usually be explained. Clinics had different histories and path dependencies, occupied a different place in their healthcare ecosystem and served a varied caseload including a high proportion of patients with comorbidities. A key mechanism for achieving high-quality long covid care was when local MDTs deliberated on unusual, complex or challenging cases for which evidence-based guidelines provided no easy answers. In such cases, collective learning occurred through idiographic (case-based) reasoning, in which practitioners build lessons from the particular to the general. This contrasts with the nomothetic reasoning implicit in evidence-based guidelines, in which reasoning is assumed to go from the general (e.g. findings of clinical trials) to the particular (management of individual patients). CONCLUSION: Not all variation in long covid services is unwarranted. Largely because long covid's manifestations are so varied and comorbidities common, generic "evidence-based" standards require much individual adaptation. In this complex condition, quality improvement resources may be productively spent supporting MDTs to optimise their case-based learning through interdisciplinary discussion. Quality assessment of a long covid service should include review of a sample of individual cases to assess how guidelines have been interpreted and personalized to meet patients' unique needs. STUDY REGISTRATION: NCT05057260, ISRCTN15022307.

Prevalence of orthostatic intolerance in long covid clinic patients and healthy volunteers: A multicenter study.

Orthostatic intolerance (OI), including postural orthostatic tachycardia syndrome (PoTS) and orthostatic hypotension (OH), are often reported in long covid, but published studies are small with inconsistent results. We sought to estimate the prevalence of objective OI in patients attending long covid clinics and healthy volunteers and associations with OI symptoms and comorbidities. Participants with a diagnosis of long covid were recruited from eight UK long covid clinics, and healthy volunteers from general population. All undertook standardized National Aeronautics and Space Administration Lean Test (NLT). Participants' history of typical OI symptoms (e.g., dizziness, palpitations) before and during the NLT were recorded. Two hundred seventy-seven long covid patients and 50 frequency-matched healthy volunteers were tested. Healthy volunteers had no history of OI symptoms or symptoms during NLT or PoTS, 10% had asymptomatic OH. One hundred thirty (47%) long covid patients had previous history of OI symptoms and 144 (52%) developed symptoms during the NLT. Forty-one (15%) had an abnormal NLT, 20 (7%) met criteria for PoTS, and 21 (8%) had OH. Of patients with an abnormal NLT, 45% had no prior symptoms of OI. Relaxing the diagnostic thresholds for PoTS from two consecutive abnormal readings to one abnormal reading during the NLT, resulted in 11% of long covid participants (an additional 4%) meeting criteria for PoTS, but not in healthy volunteers. More than half of long covid patients experienced OI symptoms during NLT and more than one in 10 patients met the criteria for either PoTS or OH, half of whom did not report previous typical OI symptoms. We therefore recommend all patients attending long covid clinics are offered an NLT and appropriate management commenced.

Implementing a system for the real-time risk assessment of patients considered for intensive care.

BACKGROUND: Delay in identifying deterioration in hospitalised patients is associated with delayed admission to an intensive care unit (ICU) and poor outcomes. For the HAVEN project (HICF ref.: HICF-R9-524), we have developed a mathematical model that identifies deterioration in hospitalised patients in real time and facilitates the intervention of an ICU outreach team. This paper describes the system that has been designed to implement the model. We have used innovative technologies such as Portable Format for Analytics (PFA) and Open Services Gateway initiative (OSGi) to define the predictive statistical model and implement the system respectively for greater configurability, reliability, and availability. RESULTS: The HAVEN system has been deployed as part of a research project in the Oxford University Hospitals NHS Foundation Trust. The system has so far processed > 164,000 vital signs observations and > 68,000 laboratory results for > 12,500 patients and the algorithm generated score is being evaluated to review patients who are under consideration for transfer to ICU. No clinical decisions are being made based on output from the system. The HAVEN score has been computed using a PFA model for all these patients. The intent is that this score will be displayed on a graphical user interface for clinician review and response. CONCLUSIONS: The system uses a configurable PFA model to compute the HAVEN score which makes the system easily upgradable in terms of enhancing systems' predictive capability. Further system enhancements are planned to handle new data sources and additional management screens.

Measuring Sleep in the Intensive Care Unit: A Critical Appraisal of the Use of Subjective Methods.

OBJECTIVES: To collate and appraise the use of subjective measures to assess sleep in the intensive care unit (ICU). DESIGN: A systematic search and critical review of the published literature. DATA SOURCES: Medline, Scopus, and Cumulative Index to Nursing and Allied Health Literature were searched using combinations of the key words "Sleep," "Critical Care," "Intensive Care," and "Sleep Disorders," and this was complemented by hand searching the most recent systematic reviews on related topics. STUDY ELIGIBILITY CRITERIA: Papers were limited to non-gray English-language studies of the adult population, published in the last 10 years. OUTCOME MEASURES: Primary outcomes were the number and categorization of quantitative studies reporting measures of sleep, the number of participants for each data collection method, and a synthesis of related material to appraise the use of survey tools commonly used for sleep measurement in the ICU. RESULTS: Thirty-eight papers reported quantitative empirical data collection on sleep, 17 of which used a primary method of subjective assessment of sleep by the patient or nurse. Thirteen methods of subjective sleep assessment were identified. Many of these tools lacked validity and reliability testing. CONCLUSIONS: Research using questionnaires to assess sleep is commonplace in light of practical barriers to polysomnography or other measures of sleep. A methodologically sound approach to tool development and testing is crucial to gather meaningful data, and this robust approach was lacking in many cases. Further research measuring sleep subjectively in ICU should use the Richards Campbell Sleep Questionnaire, and researchers should maintain a commitment to transparency in describing methods.

Pathophysiological Mechanisms in Long COVID: A Mixed Method Systematic Review.

INTRODUCTION: Long COVID (LC) is a global public health crisis affecting more than 70 million people. There is emerging evidence of different pathophysiological mechanisms driving the wide array of symptoms in LC. Understanding the relationships between mechanisms and symptoms helps in guiding clinical management and identifying potential treatment targets. METHODS: This was a mixed-methods systematic review with two stages: Stage one (Review 1) included only existing systematic reviews (meta-review) and Stage two (Review 2) was a review of all primary studies. The search strategy involved Medline, Embase, Emcare, and CINAHL databases to identify studies that described symptoms and pathophysiological mechanisms with statistical analysis and/or discussion of plausible causal relationships between mechanisms and symptoms. Only studies that included a control arm for comparison were included. Studies were assessed for quality using the National Heart, Lung, and Blood Institute quality assessment tools. RESULTS: 19 systematic reviews were included in Review 1 and 46 primary studies in Review 2. Overall, the quality of reporting across the studies included in this second review was moderate to poor. The pathophysiological mechanisms with strong evidence were immune system dysregulation, cerebral hypoperfusion, and impaired gas transfer in the lungs. Other mechanisms with moderate to weak evidence were endothelial damage and hypercoagulation, mast cell activation, and auto-immunity to vascular receptors. CONCLUSIONS: LC is a complex condition affecting multiple organs with diverse clinical presentations (or traits) underpinned by multiple pathophysiological mechanisms. A 'treatable trait' approach may help identify certain groups and target specific interventions. Future research must include understanding the response to intervention based on these mechanism-based traits.

An investigation of sound levels on intensive care units with reference to the WHO guidelines.

INTRODUCTION: Patients in intensive care units (ICUs) suffer from sleep deprivation arising from nursing interventions and ambient noise. This may exacerbate confusion and ICU-related delirium. The World Health Organization (WHO) suggests that average hospital sound levels should not exceed 35 dB with a maximum of 40 dB overnight. We monitored five ICUs to check compliance with these guidelines. METHODS: Sound levels were recorded in five adult ICUs in the UK. Two sound level monitors recorded concurrently for 24 hours at the ICU central stations and adjacent to patients. Sample values to determine levels generated by equipment and external noise were also recorded in an empty ICU side room. RESULTS: Average sound levels always exceeded 45 dBA and for 50% of the time exceeded between 52 and 59 dBA in individual ICUs. There was diurnal variation with values decreasing after evening handovers to an overnight average minimum of 51 dBA at 4 AM. Peaks above 85 dBA occurred at all sites, up to 16 times per hour overnight and more frequently during the day. WHO guidelines on sound levels could be only achieved in a side room by switching all equipment off. CONCLUSION: All ICUs had sound levels greater than WHO recommendations, but the WHO recommended levels are so low they are not achievable in an ICU. Levels adjacent to patients are higher than those recorded at central stations. Unit-wide noise reduction programmes or mechanical means of isolating patients from ambient noise, such as earplugs, should be considered.

Design and validation of a new Healthcare Systems Usability Scale (HSUS) for clinical decision support systems: a mixed-methods approach.

OBJECTIVE: To develop and validate a questionnaire to assess the usability of clinical decision support systems (CDSS) and to assist in the early identification of usability issues that may impact patient safety and quality of care. DESIGN: Mixed research methods were used to develop and validate the questionnaire. The qualitative study involved scale item development, content and face validity. Pilot testing established construct validity using factor analysis and facilitated estimates for reliability and internal consistency using the Cronbach's alpha coefficient. SETTING: Two hospitals within a single National Health Service Trust. PARTICIPANTS: We recruited a panel of 7 experts in usability and questionnaire writing for health purposes to test content validity; 10 participants to assess face validity and 78 participants for the pilot testing. To be eligible for this last phase, participants needed to be health professionals with at least 3 months experience using the local hospital electronic patient record system. RESULTS: Feedback from the face and content validity phases contributed to the development and improvement of scale items. The final Healthcare Systems Usability Scale (HSUS) proved quick to complete, easy to understand and was mostly worded by potential users. Exploratory analysis revealed four factors related to patient safety, task execution, alerts or recommendations accuracy, the effects of the system on workflow and ease of system use. These separate into four subscales: patient safety and decision effectiveness (seven items), workflow integration (six items), work effectiveness (five items) and user control (four items). These factors affect the quality of care and clinician's ability to make informed and timely decisions when using CDSS. The HSUS has a very good reliability with global Cronbach's alpha 0.914 and between 0.702 and 0.926 for the four subscales. CONCLUSION: The HSUS is a valid and reliable tool for usability testing of CDSS and early identification of usability issues that may cause medical adverse events.

Mobilisation in the EveNing to prevent and TreAt deLirium (MENTAL): a mixed-methods, randomised controlled feasibility trial.

Background: Delirium is common in critically ill patients and associated with longer hospital stays, increased morbidity and higher healthcare costs. Non-pharmacological interventions have been advocated for delirium management, however there is little evidence evaluating feasibility and acceptability of physical interventions administered in the evening. The aim of this study was to conduct a feasibility trial of evening mobilisation to prevent and treat delirium in patients admitted to intensive care. Methods: In this mixed-methods, randomised controlled feasibility trial we recruited participants from intensive care units at two university hospitals in the United Kingdom. Eligible participants who were able to respond to verbal stimulus (Richmond agitation and sedation scale ≥3) and expected to stay in intensive care for at least 24 h were randomly assigned (1:1) to receive usual care or usual care plus evening mobilisation. The evening mobilisation was delivered between 19:00 and 21:00, for up to seven consecutive evenings or ICU discharge, whichever was sooner. All outcome assessments were completed by a team member blinded to randomisation and group allocation. Primary objective was to assess feasibility and acceptability of evening mobilisation. Primary feasibility outcomes were recruitment, consent and retention rates, and intervention fidelity. Intervention acceptability was evaluated through semi-structured interviews of participants and staff. Secondary outcomes included prevalence in incidence and duration of delirium, measured using the Confusion Assessment Method for ICU. This trial is registered at ClinicalTrials.gov, NCT05401461. Findings: Between July 16th, 2022, and October 31st, 2022, 58 eligible patients (29 usual care; 29 usual care plus evening mobilisation) were enrolled. We demonstrated the feasibility and acceptability of both the trial design and evening mobilisation intervention. Consent and retention rates over three months were 88% (58/66) and 90% (52/58) respectively, with qualitative analysis demonstrating good acceptability reported by both participants and staff. Secondary outcomes for the evening intervention group compared with the control group were: delirium incidence 5/26 (19%; 95% CI: 6-39%) vs 8/28 (29%; 95% CI: 13-49%) and mean delirium duration 2 days (SD 0.7) vs 4.25 days (SD 2.0). Interpretation: Results of this trial will inform the development of a definitive full-scale randomised controlled trial investigating the effects of evening mobilisation to treat delirium and improve health-related outcomes. Funding: None.

Three-year efficacy of complex insulin regimens in type 2 diabetes.

BACKGROUND: Evidence supporting the addition of specific insulin regimens to oral therapy in patients with type 2 diabetes mellitus is limited. METHODS: In this 3-year open-label, multicenter trial, we evaluated 708 patients who had suboptimal glycated hemoglobin levels while taking metformin and sulfonylurea therapy. Patients were randomly assigned to receive biphasic insulin aspart twice daily, prandial insulin aspart three times daily, or basal insulin detemir once daily (twice if required). Sulfonylurea therapy was replaced by a second type of insulin if hyperglycemia became unacceptable during the first year of the study or subsequently if glycated hemoglobin levels were more than 6.5%. Outcome measures were glycated hemoglobin levels, the proportion of patients with a glycated hemoglobin level of 6.5% or less, the rate of hypoglycemia, and weight gain. RESULTS: Median glycated hemoglobin levels were similar for patients receiving biphasic (7.1%), prandial (6.8%), and basal (6.9%) insulin-based regimens (P=0.28). However, fewer patients had a level of 6.5% or less in the biphasic group (31.9%) than in the prandial group (44.7%, P=0.006) or in the basal group (43.2%, P=0.03), with 67.7%, 73.6%, and 81.6%, respectively, taking a second type of insulin (P=0.002). [corrected] Median rates of hypoglycemia per patient per year were lowest in the basal group (1.7), higher in the biphasic group (3.0), and highest in the prandial group (5.7) (P<0.001 for the overall comparison). The mean weight gain was higher in the prandial group than in either the biphasic group or the basal group. Other adverse event rates were similar in the three groups. CONCLUSIONS: Patients who added a basal or prandial insulin-based regimen to oral therapy had better glycated hemoglobin control than patients who added a biphasic insulin-based regimen. Fewer hypoglycemic episodes and less weight gain occurred in patients adding basal insulin. (Current Controlled Trials number, ISRCTN51125379.)

Variability of environmental sound levels: An observational study from a general adult intensive care unit in the UK.

Background: Intensive care units are significantly louder than WHO guidelines recommend. Patients are disturbed by activities around them and frequently report disrupted sleep. This can lead to slower recovery and long-term health problems. Environmental sound levels are usually reported as LAeq24, a single daily value that reflects mean sound levels over the previous 24-h period. This may not be the most appropriate measure for intensive care units (ICUs) and other similar areas. Humans experience sound in context, and disturbance will vary according to both the individual and acoustic features of the ambient sounds. Loudness is one of a number of measures that approximate the human perception of sound, taking into account tone, duration, and frequency, as well as volume. Typically sounds with higher frequencies, such as alarms, are perceived as louder and more disturbing. Methods: Sound level data were collected from a single NHS Trust hospital general adult intensive care unit between October 2016 and May 2018. Summary data (mean sound levels (LAeq) and corresponding Zwicker calculated loudness values) were subsequently analysed by minute, hour, and day. Results: The overall mean LAeq24 across the study duration was 47.4 dBA. This varied by microphone location. We identified a clear pattern to sound level fluctuations across the 24-h period. Weekends were significantly quieter than weekdays in statistical terms but this reduction of 0.2 dB is not detectable by human hearing. Peak loudness values over 90 dB were recorded every hour. Conclusions: Perception of sound is sensitive to the environment and individual characteristics and sound levels in the ICU are location specific. This has implications for routine environmental monitoring practices. Peak loudness values are consistently between 90 and 100 dB. These may be driven by alarms and other sudden high-frequency sounds, leading to more disturbance than LAeq24 sound levels suggest. Addressing sounds with high loudness values may improve the ICU environment more than an overall reduction in the 24-h mean decibel value.

Non-contact physiological monitoring of post-operative patients in the intensive care unit.

Prolonged non-contact camera-based monitoring in critically ill patients presents unique challenges, but may facilitate safe recovery. A study was designed to evaluate the feasibility of introducing a non-contact video camera monitoring system into an acute clinical setting. We assessed the accuracy and robustness of the video camera-derived estimates of the vital signs against the electronically-recorded reference values in both day and night environments. We demonstrated non-contact monitoring of heart rate and respiratory rate for extended periods of time in 15 post-operative patients. Across day and night, heart rate was estimated for up to 53.2% (103.0 h) of the total valid camera data with a mean absolute error (MAE) of 2.5 beats/min in comparison to two reference sensors. We obtained respiratory rate estimates for 63.1% (119.8 h) of the total valid camera data with a MAE of 2.4 breaths/min against the reference value computed from the chest impedance pneumogram. Non-contact estimates detected relevant changes in the vital-sign values between routine clinical observations. Pivotal respiratory events in a post-operative patient could be identified from the analysis of video-derived respiratory information. Continuous vital-sign monitoring supported by non-contact video camera estimates could be used to track early signs of physiological deterioration during post-operative care.

Risk factors for new-onset atrial fibrillation during critical illness: A Delphi study.

Background: New-onset atrial fibrillation (NOAF) is common during critical illness and is associated with poor outcomes. Many risk factors for NOAF during critical illness have been identified, overlapping with risk factors for atrial fibrillation in patients in community settings. To develop interventions to prevent NOAF during critical illness, modifiable risk factors must be identified. These have not been studied in detail and it is not clear which variables warrant further study. Methods: We undertook an international three-round Delphi process using an expert panel to identify important predictors of NOAF risk during critical illness. Results: Of 22 experts invited, 12 agreed to participate. Participants were located in Europe, North America and South America and shared 110 publications on the subject of atrial fibrillation. All 12 completed the three Delphi rounds. Potentially modifiable risk factors identified include 15 intervention-related variables. Conclusions: We present the results of the first Delphi process to identify important predictors of NOAF risk during critical illness. These results support further research into modifiable risk factors including optimal plasma electrolyte concentrations, rates of change of these electrolytes, fluid balance, choice of vasoactive medications and the use of preventative medications in high-risk patients. We also hope our findings will aid the development of predictive models for NOAF.

Monitoring sound levels in the intensive care unit: A mixed-methods system development project to optimize design features for a new electronic interface in the healthcare environment.

BACKGROUND: Intensive care units (ICU) are busy round the clock and it is difficult to maintain low sound levels that support patient rest. To help ICU staff manage activities we developed a visual display that monitors and reports sound levels in real-time. This facilitates immediate feedback, encouraging proactive behavior change to limit disturbances. METHODS: Following the principles of user-centered design practices we created our 'user persona' to understand the needs and goals of potential users of the system. We then conducted iterative user testing with current members of the ICU team, primarily using the 'think aloud' method to refine the design and functionality of our novel system. Ethnography evaluated team use of the display. RESULTS: The final design was simple, clear, and efficient, and both functional and aesthetically pleasing for the key user demographic. We identified challenges in the implementation and adoption process that were separate from the 'usability' of the system itself. CONCLUSIONS: Embedding the design process within the core user demographic ensured the final product delivered relevant information for key users, and that this information was intuitive to interpret. Initiating sustainable change is not straightforward. It requires recognition of cultural practices within teams, departments, professions, organizations, and strategies to maximize engagement.

Non-contact vital sign monitoring of patients in an intensive care unit: A human factors analysis of staff expectations.

BACKGROUND: Infra-red and thermal imaging enable wireless systems to monitor patients' vital signs and absence of wires may improve patient experiences. No studies have explored staff perceptions of the concept of this specific type of technology in the adult population. Understanding existing working systems before introducing technology could improve adoption. METHODS: We conducted semi-structured interviews with Intensive Care Unit (ICU) staff exploring perceptions of wireless patient monitoring. We used the Systems Engineering Initiative for Patient Safety (SEIPS) model to guide thematic analysis. RESULTS: We identified usability themes relating to staff perceptions of current patient monitoring experiences, staff perceptions of patient/relative expectations of ICU care, troubleshooting, hierarchy of monitoring, and consensus of trust. CONCLUSION: The concept of wireless monitoring has perceived benefits for patients and staff. The Systems Engineering Initiative for Patient Safety model guided a systems-based exploratory evaluation. Results highlight the social and environmental factors which may influence usability, adoption, or abandonment of wireless technology in the ICU.

Measuring sleep in the intensive care unit: Electroencephalogram, actigraphy, or questionnaire?

BACKGROUND: Studies consistently report deranged sleep in patients admitted to intensive care unit. Poor sleep has harmful physical and cognitive effects, and an evidence-based intervention to improve sleep is needed. It is, however, difficult to measure sleep in the intensive care unit. 'Gold standard' monitoring (polysomnography) is unsuitable for usual care. METHODS: We collected concurrent sleep data from electroencephalograph recordings, activity monitoring, and nurse- and patient-completed Richards-Campbell Sleep Questionnaires (RCSQ). RESULTS: Electroencephalograph data (n = 34) confirm poor sleep. Individual bouts last approximately 1 min and around 2 h of sleep overnight is common. Correlation between electroencephalograph, self-report, nurse-report, actigraphy and overall activity score is low (ρ = 0.123 (n = 24), 0.127 (n = 22), and 0.402 and - 0.201 (n = 13), respectively). Correlation between nurse and patient assessment is limited (ρ = 0.537 (n = 444)). CONCLUSIONS: No current method of sleep monitoring seems suitable in the intensive care unit. However, to facilitate comparison across studies, the patient-completed RCSQ seems the most meaningful measure.

Correction: "I Can Remember Sort of Vivid People but to Me They Were Plasticine." Delusions on the Intensive Care Unit: What Do Patients Think Is Going On?

[This corrects the article DOI: 10.1371/journal.pone.0153775.].

"I Can Remember Sort of Vivid People but to Me They Were Plasticine." Delusions on the Intensive Care Unit: What Do Patients Think Is Going On?

INTRODUCTION: Patients who develop intensive care unit (ICU) acquired delirium stay longer in the ICU, and hospital, and are at risk of long-term mental and physical health problems. Despite guidelines for patient assessment, risk limitation, and treatment in the ICU population, delirium and associated delusions remain a relatively common occurrence on the ICU. There is considerable information in the literature describing the incidence, suspected causes of, and discussion of the benefits and side-effects of the various treatments for delirium in the ICU. But peer-reviewed patient-focused research is almost non-existent. There is therefore a very limited understanding of the reality of delusions in the intensive care unit from the patient's point of view. METHOD: A secondary analysis of the original interviews conducted by the University of Oxford Health Experiences Research Group was undertaken to explore themes relating specifically to sleep and delirium. RESULTS: Patients describe a liminal existence on the ICU. On the threshold of consciousness their reality is uncertain and their sense of self is exposed. Lack of autonomy in an unfamiliar environment prompts patients to develop explanations and understandings for themselves with no foothold in fact. CONCLUSION: Patients on the ICU are perhaps more disoriented than they appear and early psychological intervention in the form of repeated orientation whilst in the ICU might improve the patient experience and defend against development of side-effects.