Text message questionnaires for Patient-Reported Outcome Measures after Cesarean section-A feasibility study.

BACKGROUND: Inadequate pain relief with moderate to severe pain remains a challenge after cesarean section and may significantly impair postoperative recovery. However, detailed assessment on the timing of severe pain, opioid consumption, influence on activities such as mobilization, breastfeeding, and caring for the infant are difficult to conduct, especially after discharge. Short message services (SMS)-based questionnaires may offer a low-cost way of providing such data but with the risk of insufficient response rates. We assessed the feasibility of collecting detailed, prospective data on postoperative pain and recovery during the initial hours and days following cesarean section using SMS-based questionnaires. METHODS: Prospective Danish single-center cohort study involving elective cesarean sections under spinal anesthesia with fentanyl and bupivacaine. The postoperative pain regimen consisted of paracetamol, NSAID and oral morphine by request. Patients received an SMS-based questionnaire at 6, 12, 18, 24, and 48 h postoperatively, as well as on days 7 and 30. PRIMARY OUTCOME: Response rate and time from receiving the SMS to completion of the questionnaires. SECONDARY OUTCOMES: Opioid consumption and Patient Reported Outcomes Measures on pain and recovery. RESULTS: From December 2022 to June 2023; 100 patients were included. The response rate was 78% at 6 h postoperatively, decreasing to 63% at 24 h. The median response time from receiving to answering the SMS-based questionnaire at 6 h after cesarean section was 23 min (IQR 2-72), decreasing to 20 min (IQR 2-78) after 24 h. Severe pain, corresponding to a Numeric Rating Scale (NRS) score >6, was reported by 57% (95% CI 65-84) at 6 h, decreasing to 28% (95% CI 34-58) at 24 h. Median opioid consumption within the first 24 h was 30 mg (IQR 20-50). CONCLUSION: SMS-based questionnaires on Patient Reported Outcome Measures are a feasible and cost-effective way of prospectively collecting frequent data with acceptable response rates, even shortly after cesarean section. Secondarily 66% of patients reported severe pain during the first 24 h following cesarean section, with the highest pain scores within the initial 12 h. Future studies should focus on optimizing pain-management within this timeframe.

Patients' and relatives' experiences of cognitive impairment following an intensive care unit admission. A qualitative study.

BACKGROUND: Cognitive impairment poses a significant challenge following critical illness in the intensive care unit. A knowledge gap exists concerning how patients experience cognitive impairments. OBJECTIVES: The aim was to explore patients' and relatives' experiences of patients' cognitive impairment due to critical illness following an intensive care unit admission. METHODS: A qualitative multicentre study was conducted in Denmark with 3- and 6-month follow-ups using single and dyadic interviews. A phenomenological hermeneutic approach was adopted using a Ricoeur-inspired textual in-depth analysis method. The Consolidated Criteria for Reporting Qualitative Research checklist was used. RESULTS: Three themes emerged from interviews with 18 patients and 14 relatives: 'It feels like living in a parallel world', 'Getting back to a normal everyday life with a vulnerable self', and 'Managing everyday life using self-invented strategies'. Patients used self-invented strategies to manage their vulnerability and newly acquired cognitive impairments when no help or support was provided specifically targeting their cognitive impairments. Not being as cognitively capable as they previously had been turned their lives upside down. Losing control and not being themselves made them vulnerable. Patients did not want to burden others. However, support from relatives was invaluable in their recovery and rehabilitation. CONCLUSIONS: Patients experienced multiple cognitive impairments affecting their adaption to everyday life. They strove to overcome their vulnerability using a variety of self-invented strategies and activities.

Associations of anemia and blood transfusions with mortality in old, critically ill COVID-19 patients - Results from the prospective COVIP Study.

AIMS: Anemia is common in the old and often observed in critically ill patients. Increased age is associated with higher mortality following a COVID-19 infection, making old patients prone to poor outcomes. We investigated whether anemia at admission to the ICU or the need for blood transfusion was associated with 90-day mortality in older, critically ill COVID-19 patients. METHODS: In this prospective multicenter study, the 90-day mortality of COVID-19 patients≥70 years treated in 138 intensive care units (ICU) was analyzed. Associations between anemia (WHO definition) at admission and discharge from ICU and the use of red blood cell (RBC) transfusions with mortality were assessed. Hemoglobin thresholds of RBC transfusions in old, critically ill COVID-19 patients were recorded. RESULTS: In 493 patients (350 anemic, 143 non-anemic), anemia (WHO definition) at the time of ICU admission was not associated with impaired overall survival. Transfusion and severe anemia (hemoglobin≤10 g/dL) at ICU discharge were independently associated with a higher risk of 90-day mortality. CONCLUSION: The need for red blood cell transfusions and severe anemia at ICU discharge, but not at the timepoint of admission, were independently associated with 90-day mortality in critically-ill old COVID-19 patients.

Collaboration for Evidence-based Practice and Research in Anaesthesia (CEPRA): A consortium initiative for perioperative research.

Evidence in perioperative care is insufficient. There is an urgent need for large perioperative research programmes, including pragmatic randomised trials, testing daily clinical treatments and unanswered question, thereby providing solid evidence for effects of interventions given to a large and growing number of patients undergoing surgery and anaesthesia. This may be achieved through large collaborations. Collaboration for Evidence-based Practice and Research in Anaesthesia (CEPRA) is a novel collaborative research network founded to pursue evidence-based answers to major clinical questions in perioperative medicine. The aims of CEPRA are to (1) improve clinical treatment and outcomes and optimise the use of resources for patients undergoing anaesthesia and perioperative care, and (2) disseminate results and inform caretakers, patients and relatives, and policymakers of evidence-based treatments in anaesthesia and perioperative medicine. CEPRA is inclusive in its concept. We aim to extend our collaboration with all relevant clinical collaborators and patient associations and representatives. Although initiated in Denmark, CEPRA seeks to develop an international network infrastructure, for example, with other Nordic countries. The work of CEPRA will follow the highest methodological standards. The organisation aims to structure and optimise any element of the research collaboration to reduce economic costs and harness benefits from well-functioning research infrastructure. This includes successive continuation of trials, harmonisation of outcomes, and alignment of data management systems. This paper presents the initiation and visions of the CEPRA network. CEPRA aims to be inclusive, patient-focused, methodologically sound, and to optimise all aspects of research logistics. This will translate into faster research conduct, reliable results, and accelerated clinical implementation of results, thereby benefiting millions of patients whilst being cost and labour-saving.

Patients' experiences of cognitive impairment following critical illness treated in an intensive care unit: A scoping review.

INTRODUCTION: Treatment with modern technology in an intensive care unit has increased critical illness survival. However, many patients are affected by their critical illness for months or years following discharge, as they experience cognitive impairments. Long-term cognitive impairments can severely affect patients' quality of life. Exploring patients' experiences on how and which cognitive impairments affect their everyday lives is important to improve planning of relevant research into interventions that may alleviate the burden of post-intensive cognitive impairments. AIM: To review the literature on patients' experiences of cognitive impairment following critical illness treated in an intensive care unit. METHODS: A systematic search was conducted in PubMed, Cinahl, PsycInfo and Embase in March-May 2021. References and citations in relevant studies were explored. The Covidence tool was used by two independent researchers to identify relevant studies for inclusion. The Mixed Methods Appraisal Tool was used for critical appraisal. The JBI methodology for scoping reviews and the PRISMA-ScR checklist were used (Supporting Information File 1). RESULTS: We identified 11 relevant qualitative and/or quantitative studies. Four themes were found: 'Experiencing poor memory', 'Managing everyday life', 'Unsupported by the healthcare system' and 'Strategies for support in recovery'. Patients used various strategies during their recovery and rehabilitation to regain independence and avoid being a burden. They needed information to support their recovery and rehabilitation; otherwise, they felt unsupported and betrayed by the healthcare system. CONCLUSION: Patients experienced various cognitive impairments following critical illness in the intensive care unit, affecting and challenging their quality of life and adaption to everyday life. RELEVANCE TO CLINICAL PRACTICE: Knowledge gained by exploring patients' experience of cognitive impairments following critical illness in the intensive care unit can contribute to improve clinical practice by targeting and optimising patients' rehabilitation process. PATIENT OR PUBLIC CONTRIBUTION: No patient or public involvement in this scoping review.

Patients' experiences of cognitive impairment following critical illness: a scoping review protocol.

INTRODUCTION: Critical illness and admission to an intensive care unit (ICU) can affect patients for months or years following discharge as many suffer from cognitive impairment. Long-term cognitive impairment affects patients' quality of life and ability to adapt to everyday life. Exploring their experiences on how and which cognitive impairments are affecting their everyday lives facilitates planning of relevant research on interventions that may serve to alleviate the burden of post-ICU cognitive impairment. The objective of this scoping review is to map the existing research on patients' experiences of cognitive impairment following critical illness. METHODS AND ANALYSIS: The methodology will follow the Joanna Briggs Institute guidelines for scoping reviews. The databases MEDLINE, CINAHL, PsycINFO and Embase will be searched to identify studies appropriate for inclusion. Any peer-reviewed original studies meeting the inclusion criteria and include statements from adult patients about how they experience cognitive impairment following critical illness and ICU admission will be considered. Studies published in English and Scandinavian languages will be included, with no further geographical or cultural limitations. The included studies will be screened by two independent researchers using a standardised data extraction tool and the Mixed Methods Appraisal Tool will be used for critical appraisal. The results will be presented in a tabular form, and data will be supported by narrative descriptions or a narrative summary. ETHICS AND DISSEMINATION: Since the scoping review methodology aims at synthetising existing research on patients' experiences of cognitive impairment following critical illness, the scoping review does not require ethical approval. The results will be disseminated though a peer-reviewed publication in a scientific journal.

Failure of non-sedation strategy in critically ill, mechanically ventilated patients - a retrospective, post-hoc analysis of the NONSEDA trial.

PURPOSE: There is a growing awareness on minimizing sedation in ICUs. In the NONSEDA trial 700 critically ill patients were randomized to light sedation or non-sedation during mechanical ventilation. Approximately 40% of patients randomized to non-sedation needed sedation. The aim of this study is to obtain knowledge on patients, who experienced failure of non-sedation. MATERIALS AND METHODS: This study is a retrospective post-hoc analysis of the NONSEDA trial. Patients, who were randomized to non-sedation are sub-divided into those who did not require sedation during mechanical ventilation ("non-sedation success"), and those who needed continuous sedation at least once ("non-sedation failure"). RESULTS: 348 patients were randomized to non-sedation, 199 experienced non-sedation success, whereas 149 experienced non-sedation failure. Patients in the two groups were comparable with regards to age, BMI, disease severity scores and admission diagnoses. Patients with non-sedation failure were more often male. Propofol was mainly used as rescue sedation. Patients with non-sedation failure had less days alive without sedation, coma, delirium, organ support, mechanical ventilation, ICU- and hospital admission. Mortality and long-term outcomes did not differ between groups. CONCLUSION: Patients with non-sedation success had better in-hospital outcomes, but mortality and long-term outcomes were not affected by success or failure of non-sedation.

[Generalised, symmetric muscle weakness in survivors after intensive therapy].

ICU-acquired weakness (ICUAW) is often found in critically ill patients and is characterised by a generalised, symmetric weakness, affecting limb (proximal more than distal) and respiratory muscles. It is a diagnosis of exclusion. ICUAW is associated with increased morbidity and mortality, and decreased quality of life. The aetiology is not completely understood, and there is no established treatment or prevention yet. The most important risk factors are high disease severity, multiorgan failure, systemic inflammation and prolonged immobilisation. Individual needs for rehabilitation must be defined, as argued in this review.

Effect of Nonsedation on Cognitive Function in Survivors of Critical Illness.

OBJECTIVES: Critical illness can cause severe cognitive impairments. The objective of this trial was to assess the effect of nonsedation versus sedation with a daily wake-up call during mechanical ventilation on cognitive function in adult survivors of critical illness. DESIGN: Single-center substudy of the multicenter, randomized Non-sedation Versus Sedation With a Daily Wake-up Trial in Critically Ill Patients Receiving Mechanical Ventilation trial. Three months after ICU-discharge participants were tested for cognitive function by a neuropsychologist. SETTING: Mixed 14-bed ICU in teaching hospital. PATIENTS: A total of 205 critically ill, orally intubated, and mechanically ventilated adults. INTERVENTIONS: Patients were randomized within the first 24 hours from intubation to either nonsedation with sufficient analgesia or light sedation with a daily wake-up call during mechanical ventilation. MEASUREMENTS AND MAIN RESULTS: A total of 118 patients survived to follow-up and 89 participated (75%). The participating survivors in the two groups did not differ regarding baseline data or premorbid cognitive impairments. Sedated patients had received more sedatives, whereas doses of morphine and antipsychotics were equal. The primary outcome was that no significant difference was found in the number of patients with mild/moderate cognitive impairments (six nonsedated patients vs four sedated patients) or severe cognitive impairments (16 nonsedated patients vs 17 sedated patients; p = 0.71). Secondary outcomes were cognitive test scores, and no differences were found between the scores in nonsedated and sedated patients. Hypothetical worst case scenarios where all patients, who had not participated in follow-up assessment, were assumed to have severe cognitive impairments were analyzed, but still no difference between the groups was found. We found more patients with delirium in the sedated group (96% vs 69% of patients; p = 0.002) and increased duration of delirium in sedated patients (median 5 vs 1 d; p < 0.001). Delirium subtypes were equally distributed between the groups, with hypoactive delirium most frequent (61%), followed by mixed delirium (39%). CONCLUSIONS: Nonsedation did not affect cognitive function 3 months after ICU-discharge.

Non-sedation versus sedation with a daily wake-up trial in critically ill patients recieving mechanical ventilation - effects on long-term cognitive function: Study protocol for a randomized controlled trial, a substudy of the NONSEDA trial.

BACKGROUND: The effects of non-sedation on cognitive function in critically ill patients on mechanical ventilation are not yet certain. This trial is a substudy of the NONSEDA trial where critically ill patients are randomized to non-sedation or to sedation with a daily wake-up attempt during mechanical ventilation in the intensive care unit (ICU). The aim of this substudy is to assess the effects of non-sedation versus sedation with a daily wake-up attempt on long-term cognitive function. METHODS: This is an investigator-initiated, randomized, clinical, parallel-group, superiority trial, including 200 patients. Inclusion criteria will be adult patients who are intubated and on mechanical ventilation with an expected duration of more than 24 hours. Exclusion criteria will be patients who are comatose at admission and patients with conditions requiring therapeutic coma (i.e., severe head trauma, status epilepticus, patients treated with therapeutic hypothermia and patients with severe hypoxia). The experimental intervention will be non-sedation supplemented with pain management during mechanical ventilation. The control intervention will be sedation with a daily wake-up attempt. The primary outcome will be cognitive function 3 months after discharge from intensive care. The secondary outcomes will be the results of seven specific cognitive tests, performed 3 months after discharge from intensive care, and the association between hypoactive and agitated delirium during ICU admission and long-term cognitive function. DISCUSSION: If non-sedation can improve long-term cognitive function, it could be an approach worth considering for a larger group of critically ill patients. TRIAL REGISTRATION: The study has been approved by the relevant scientific ethics committee and is registered at ClinicalTrials.gov (ID: NCT02035436 , registered on 10 January 2014).

Non-sedation versus sedation with a daily wake-up trial in critically ill patients receiving mechanical ventilation--effects on physical function: study protocol for a randomized controlled trial: a substudy of the NONSEDA trial.

BACKGROUND: Critically ill patients rapidly loose much of their muscle mass and strength. This can be attributed to prolonged admission, prolonged mechanical ventilation and increased mortality, and it can have a negative impact on the degree of independence and quality of life. In the NONSEDA trial we randomize critically ill patients to non-sedation or sedation with a daily wake-up trial during mechanical ventilation in the intensive care unit. It has never been assessed whether non-sedation affects physical function. The aim of this study is to assess the effects of non-sedation versus sedation with a daily wake-up trial on physical function after discharge from intensive care unit. METHODS/DESIGN: Investigator-initiated, randomized, clinical, parallel-group, superiority trial, including 700 patients in total, with a substudy concerning 200 of these patients. Inclusion criteria will be intubated, mechanically ventilated patients with expected duration of mechanical ventilation >24 h. Exclusion criteria will be patients with severe head trauma, coma at admission or status epilepticus, patients treated with therapeutic hypothermia, patients with PaO2/FiO2<9 where sedation might be necessary to ensure sufficient oxygenation or placing the patient in a prone position. The experimental intervention will be non-sedation supplemented with pain management during mechanical ventilation. The control intervention will be sedation with a daily wake-up trial. The co-primary outcome will be quality of life regarding physical function (SF-36, physical component) and degree of independence in activities of daily living (Barthel Index), and this will be assessed for all 700 patients participating in the NONSEDA trial. The secondary outcomes, which will be assessed for the subpopulation of 200 NONSEDA patients in the trial site, Kolding, will be 6-min walking distance, handgrip strength, muscle size (ultrasonographic measurement of the rectus femoris muscle cross-sectional area) and biomechanical data on lower extremity function (maximal voluntary contraction, rate of force development and endurance). DISCUSSION: This study is the first to investigate the effect of no sedation during critical illness on physical function. If an effect is found, it will add important information on how to prevent muscle weakness following critical illness. TRIAL REGISTRATION: The study has been approved by the relevant scientific ethics committee and is registered at ClinicalTrials.gov (ID: NCT02034942, 9 January 2014).