Rationale and study design of an early care, therapeutic education, and psychological intervention program for the management of post-intensive care syndrome and chronic pain after COVID-19 infection (PAIN-COVID): study protocol for a randomized controlled trial

Ojeda, Antonio; Calvo, Andrea; Cuñat, Tomás; Artigas, Ricard Mellado; Comino-Trinidad, Oscar; Aliaga, Jorge; Arias, Marilyn; Ahuir, Maribel; Ferrando, Carlos; Dürsteler, C.

doi:10.1186/s13063-021-05463-7

Cited by 13 publications

(10 citation statements)

References 22 publications

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“…However, a meta‐analysis of 10 RCTs has reported that post‐ICU physical rehabilitation may not necessarily improve health and mental quality of life at 6‐ to 12‐month 136 . Nonetheless, more RCTs are ongoing that sought to test other potential non‐pharmaceutical therapies (e.g., neuromuscular electrical stimulation, virtual reality and rehabilitation programs) for post‐ICU survivors of COVID‐19 137–141 …”

Section: Resultsmentioning

confidence: 99%

Proposed subtypes of post‐COVID‐19 syndrome (or long‐COVID) and their respective potential therapies

Yong

Liu

2021

Reviews in Medical Virology

116

113

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The effects of coronavirus disease 2019 (COVID-19), a highly transmissible infectious respiratory disease that has initiated an ongoing pandemic since early 2020, do not always end in the acute phase. Depending on the study referred, about 10%-30% (or more) of COVID-19 survivors may develop long-COVID or post-COVID-19 syndrome (PCS), characterised by persistent symptoms (most commonly fatigue, dyspnoea, and cognitive impairments) lasting for 3 months or more after acute COVID-19. While the pathophysiological mechanisms of PCS have been extensively described elsewhere, the subtypes of PCS have not. Owing to its highly multifaceted nature, this review proposes and characterises six subtypes of PCS based on the existing literature. The subtypes are non-severe COVID-19 multi-organ sequelae (NSC-MOS), pulmonary fibrosis sequelae (PFS), myalgic encephalomyelitis or chronic fatigue syndrome (ME/CFS), postural orthostatic tachycardia syndrome (POTS), post-intensive care syndrome (PICS) and medical or clinical sequelae (MCS).Original studies supporting each of these subtypes are documented in this review, as well as their respective symptoms and potential interventions. Ultimately, the subtyping proposed herein aims to provide better clarity on the current understanding of PCS.

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Section: Resultsmentioning

confidence: 99%

Proposed subtypes of post‐COVID‐19 syndrome (or long‐COVID) and their respective potential therapies

Yong

Liu

2021

Reviews in Medical Virology

116

113

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“…We included adult patients who were admitted to the Intensive Care Unit (ICU) for SARS-CoV-2 infection from April to December 2020. From an initial cohort of 102 COVID-19 survivors that were evaluated one-month follow-up after hospital discharge by the PAIN-COVID protocol (see ( Ojeda et al, 2021 )); 58 COVID-19 survivors agreed to participate in our study and were assessed 6 months after hospital discharge (See Flowchart 1 ).…”

Section: Methodsmentioning

confidence: 99%

Neuropsychological functioning in post-ICU patients after severe COVID-19 infection: The role of cognitive reserve

Costas-Carrera¹,

Sánchez-Rodríguez²,

Cañizares³

et al. 2022

Brain, Behavior, & Immunity - Health

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Background Cognitive manifestations associated with Severe Acute Respiratory Syndrome by Coronavirus 2 (SARS-CoV-2) are yet to be described in the existing literature. The aim of this exploratory study is to analyze the impact of severe SARS-CoV-2 infection on neuropsychological performance 6 months following hospital discharge, and to identify which medical variables predict worse outcome. In this context, we study if cognitive reserve (CR) may play a protective role on cognitive impairment. Methods We enrolled a cohort of 102 severe SARS-CoV-2 survivors who had been admitted to the Intensive Care Unit (ICU) and were contacted 6-months post discharge. A total of 58 agreed to participate in this 6-month follow-up study. Patients with previously known cognitive impairment were excluded. Demographic, clinical and laboratory data were collected. Firstly, to test the magnitude of neurocognitive sequalae two standard deviations below normative group were considered. Secondly, to analyze the main effects of medical variables on cognition and the interaction with cognitive reserve, ANCOVA analyses were performed. Results 53.4% obtained a score below the cutoff point (<26) in the screening test MOCA. ICU variables including mechanical ventilation, days of sedation or high CRP days were related with cognition. Cognitive Reserve (CR) interacted with delirium (F = 6.8, p = 0.01) and sedation days (F = 9.40, p = 0.003) to predict verbal memory and interacted with high CRP to predict phonemic fluency (F = 6.47, p = 0.01). Finally, no differences in neuropsychological performance were found depending on subjective cognitive impairment (SCI). However, patients with SCI had a higher score in the HAD anxiety subscale (t = −2.2; p < 0.05). Conclusions In our cohort, cognitive dysfunction was related with ICU variables such as delirium, mechanical ventilation, and inflammation. CR modulated the impact of these variables on cognition. Cognitive complaints were related with anxiety but not with cognitive performance. Despite some limitations, including the need of replication of the findings with larger samples and control groups, our study suggests that high CR may be protective for severe COVID-19-related cognitive impairment.

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“…The study was approved by the Ethics Committee of the Hospital Clinic of Barcelona (approval number HCB/2020/0549) on 14 May 2020. The study protocol has been submitted for publication (Ojeda et al, 2021 ). Participants were enrolled 1 month after hospital discharge after giving their written informed consent.…”

Section: Methodsmentioning

confidence: 99%

Characteristics and influence on quality of life of new‐onset pain in critical COVID‐19 survivors

Ojeda

Calvo

Cuñat

et al. 2021

European Journal of Pain

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Background: Pain is a clinical feature of COVID-19, however, data about persistent pain after hospital discharge, especially among ICU survivors is scarce. The aim of this study was to explore the incidence and characteristics of new-onset pain and its impact on Health-Related Quality of Life (HRQoL), and to quantify the presence of mood disorders in critically ill COVID-19 survivors.Methods: This is a preliminary report of PAIN-COVID trial (NCT04394169) presenting a descriptive analysis in critically ill COVID-19 survivors, following in person interview 1 month after hospital discharge. Pain was assessed using the Brief Pain Inventory, the Douleur Neuropathique 4 questionnaire and the Pain Catastrophizing Scale. HRQoL was evaluated with the EQ 5D/5L, and mood disorders with the Hospital Anxiety and Depression Scale (HADS).Results: From 27 May to 19 July 2020, 203 patients were consecutively screened for eligibility, and 65 were included in this analysis. Of these, 50.8% patients reported new-onset pain; 38.5% clinically significant pain (numerical rating score ≥3 for average pain intensity); 16.9% neuropathic pain; 4.6% pain catastrophizing thoughts, 44.6% pain in ≥2 body sites and 7.7% widespread pain. Patients with new-onset pain had a worse EQ-VAS and EQ index value (p < 0.001). Pain intensity was negatively correlated to both the former (Spearman ρ: −0.546, p < 0.001) and the latter (Spearman ρ: −0.387, p = 0.001). HADS anxiety and depression values equal or above eight were obtained in 10.8% and 7.7% of patients, respectively. Conclusion: New-onset pain in critically ill COVID-19 survivors is frequent, and it is associated with a lower HRQoL. Trial registration No.: NCT04394169. Registered 19 May 2020. https://clini caltr ials.gov/ct2/show/NCT04 394169. Significance: A substantial proportion of severe COVID-19 survivors may develop clinically significant persistent pain, post-intensive care syndrome and chronic ICU-related pain. Given the number of infections worldwide and the unprecedented size of the population of critical illness survivors, providing

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Rationale and study design of an early care, therapeutic education, and psychological intervention program for the management of post-intensive care syndrome and chronic pain after COVID-19 infection (PAIN-COVID): study protocol for a randomized controlled trial

Cited by 13 publications

References 22 publications

Proposed subtypes of post‐COVID‐19 syndrome (or long‐COVID) and their respective potential therapies

Proposed subtypes of post‐COVID‐19 syndrome (or long‐COVID) and their respective potential therapies

Neuropsychological functioning in post-ICU patients after severe COVID-19 infection: The role of cognitive reserve

Characteristics and influence on quality of life of new‐onset pain in critical COVID‐19 survivors

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