scholarly journals Rationale and Study Design of an Early Care, Therapeutic Education, and Psychological Intervention for the Management of Post-intensive Care Syndrome and Chronic Pain After Coronavirus Disease 2019 (PAIN-COVID): Study protocol for a randomized controlled trial

2021 ◽  
Author(s):  
Antonio Ojeda ◽  
Andrea Calvo ◽  
Tomas Cuñat ◽  
Ricard Mellado Artigas ◽  
Oscar Comino-Trinidad ◽  
...  
Keyword(s):  
Chronic Pain ◽  
Hospital Discharge ◽  
Psychological Intervention ◽  
Life Quality ◽  
Therapeutic Education ◽  
Early Care ◽  
Randomized Controlled ◽  
Health Related ◽  
Post Intensive Care Syndrome

Abstract Background: Critically ill patients with COVID-19 disease are an especially susceptible population to develop Post-intensive Care Syndrome (PICS) due to acute respiratory distress syndrome (ARDS). Patients can suffer acute severe pain and may have long-term deterioration in mental, cognitive, and functional health after discharge. However, few controlled trials are evaluating interventions for the prevention and treatment of PICS. The study hypothesis is that a specific care program based on early therapeutic education and a psychological intervention improves the quality of life of patients at risk of developing PICS and chronic pain after COVID-19 disease. The primary objective is to determine if the program is superior to standard-of-care on health-related life quality at six months after hospital discharge. The secondary objectives are to determine if the intervention is superior to standard care, evaluating the health-related life quality, the incidence of chronic pain and the degree of functional limitation, the incidence of anxiety, depression, and post-traumatic stress syndrome at 3 and 6 months after hospital discharge.Methods: The PAINCOVID trial is a unicentric randomized, controlled, patient blinded superiority trial with two parallel groups. The primary endpoint is the health-related quality of life at six months after hospital discharge, and randomization will be performed with a 1:1 allocation. This paper details the methodology and statistical analysis plan of the trial and was submitted before outcome data were available.The sample size calculated is 84 patients, 42 for each arm. Estimating a loss of follow up of 20%, a sample size of 102 patients is necessary (51 each group). Discussion: This is the first randomized clinical trial assessing the effectiveness of an early care therapeutic education, and psychological intervention for the management of PICS and Chronic Pain after COVID-19. The intervention will serve as a sample of the need to implement early care programs on early stages, having an incalculable impact given the current scenario of the pandemic.Trial registration: This study is being in accordance with the tenets of the Helsinki Declaration, and has been approved by the authors’ institutional review board Comité Ético de Investigación Clínica del Hospital Clinic de Barcelona (approval number: HCB/2020/0549) and was registered on May 9, 2020 at clinicaltrials.gov (NCT04394169).

scholarly journals Rationale and Study Design of an Early Care, Therapeutic Education, and Psychological Intervention for the Management of Post-intensive Care Syndrome and Chronic Pain After Coronavirus Disease 2019 (PAIN-COVID): Study protocol for a randomized controlled trial

2020 ◽  
Author(s):  
Antonio Ojeda ◽  
Andrea Calvo ◽  
Tomas Cuñat ◽  
Ricard Mellado Artigas ◽  
Oscar Comino-Trinidad ◽  
...  
Keyword(s):  
Chronic Pain ◽  
Hospital Discharge ◽  
Psychological Intervention ◽  
Life Quality ◽  
Therapeutic Education ◽  
Early Care ◽  
Randomized Controlled ◽  
Health Related ◽  
Post Intensive Care Syndrome

Abstract Background: Critically ill patients with COVID-19 disease are an especially susceptible population to develop Post-intensive Care Syndrome (PICS) due to acute respiratory distress syndrome (ARDS). Patients can suffer acute severe pain and may have long-term deterioration in mental, cognitive, and functional health after discharge. However, few controlled trials are evaluating interventions for the prevention and treatment of PICS. The study hypothesis is that a specific care program based on early therapeutic education and a psychological intervention improves the quality of life of patients at risk of developing PICS and chronic pain after COVID-19 disease. The primary objective is to determine if the program is superior to standard-of-care on health-related life quality at six months after hospital discharge. The secondary objectives are to determine if the intervention is superior to standard care, evaluating the health-related life quality, the incidence of chronic pain and the degree of functional limitation, the incidence of anxiety, depression, and post-traumatic stress syndrome at 3 and 6 months after hospital discharge.Methods: The PAINCOVID trial is a unicentric randomized, controlled, patient blinded superiority trial with two parallel groups. The primary endpoint is the health-related quality of life at six months after hospital discharge, and randomization will be performed with a 1:1 allocation. This paper details the methodology and statistical analysis plan of the trial and was submitted before outcome data were available.Discussion: This the first randomized clinical trial assessing the effectiveness of an early care therapeutic education, and psychological intervention for the management of PICS and Chronic Pain after COVID-19. The intervention will serve as a sample of the need to implement early care programs on early stages, having an incalculable impact given the current scenario of the pandemic.Trial registration: This study is being in accordance with the tenets of the Helsinki Declaration, and has been approved by the authors’ institutional review board Comité Ético de Investigación Clínica del Hospital Clinic de Barcelona (approval number: HCB/2020/0549) and was registered on May 9, 2020 at clinicaltrials.gov (NCT04394169).

scholarly journals 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

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Antonio Ojeda ◽  
Andrea Calvo ◽  
Tomas Cuñat ◽  
Ricard Mellado Artigas ◽  
Oscar Comino-Trinidad ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Chronic Pain ◽  
Hospital Discharge ◽  
Psychological Intervention ◽  
Therapeutic Education ◽  
Health Related Quality ◽  
Early Care ◽  
Related Quality ◽  
Health Related

Abstract Background Critically ill patients with COVID-19 are an especially susceptible population to develop post-intensive care syndrome (PICS) due to acute respiratory distress syndrome (ARDS). Patients can suffer acute severe pain and may have long-term mental, cognitive, and functional health deterioration after discharge. However, few controlled trials are evaluating interventions for the prevention and treatment of PICS. The study hypothesis is that a specific care program based on early therapeutic education and psychological intervention improves the quality of life of patients at risk of developing PICS and chronic pain after COVID-19. The primary objective is to determine whether the program is superior to standard-of-care on health-related quality of life at 6 months after hospital discharge. The secondary objectives are to determine whether the intervention is superior to standard-of-care on health-related quality of life, incidence of chronic pain and degree of functional limitation, incidence of anxiety, depression, and post-traumatic stress syndrome at 3 and 6 months after hospital discharge. Methods The PAINCOVID trial is a unicentric randomized, controlled, patient-blinded superiority trial with two parallel groups. The primary endpoint is the health-related quality of life at 6 months after hospital discharge, and randomization will be performed with a 1:1 allocation ratio. This paper details the methodology and statistical analysis plan of the trial and was submitted before outcome data were available. The estimated sample size is 84 patients, 42 for each arm. Assuming a lost to follow-up rate of 20%, a sample size of 102 patients is necessary (51 for each arm). Discussion This is the first randomized clinical trial assessing the effectiveness of an early care therapeutic education, and psychological intervention program for the management of PICS and chronic pain after COVID-19. The intervention will serve as proof of the need to implement early care programs at an early stage, having an incalculable impact given the current scenario of the pandemic. Trial registration This study is being conducted in accordance with the tenets of the Helsinki Declaration and has been approved by the authors’ institutional review board Comité Ético de Investigación Clínica del Hospital Clínic de Barcelona (approval number: HCB/2020/0549) and was registered on May 9, 2020, at clinicaltrials.gov (NCT04394169).

Health related quality of life of rosacea patients in China assessed by DLQI and willingness to pay: Cross-Sectional Questionnaire Study (Preprint)

2020 ◽  
Author(s):  
Yaqun Huang ◽  
Sha Yan ◽  
Hongfu Xie ◽  
Ben Wang ◽  
Zhixiang Zhao ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Willingness To Pay ◽  
Disease Duration ◽  
Life Quality ◽  
Cross Sectional Study ◽  
Health Related Quality ◽  
Cross Sectional ◽  
Related Quality ◽  
Health Related

BACKGROUND Rosacea is a chronic inflammatory dermatosis with facial skin involved, leading to physical and emotional problems, which greatly affected quality of life (QoL) of patients. Dermatology Life Quality Index (DLQI) and willingness to pay (WTP) are well-established instruments assessing the health-related quality of life (HRQoL), while very few studies have been focused on this topic about rosacea in China. OBJECTIVE To investigate HRQoL in Chinese rosacea patients assessed by DLQI and WTP and investigate potential predictors for patients with HRQoL severely affected. METHODS This cross-sectional study was conducted on 973 patients with rosacea. Sociodemographic data, clinical features and DLQI were collected, and WTP was assessed by three standardized items. Multivariable logistic analysis was performed to investigate independent factors influencing QoL. RESULTS 921 questionnaires were accomplished by participants. The mean DLQI score was 11.6 (median 11). Patients were willing to pay an average of $1050.2 or € 896.2 (median $431.4 or € 368.1) for complete cure. 33.3% would like to pay more than 20% of their monthly income to achieve sustainable control. There were positive correlations between WTP with DLQI (P < .05). DLQI could be independently impacted by age (21-30 and 31-40, OR = 3.242 and 3.617, respectively), the occupational requirement of appearance (high, OR = 4.410), disease duration (< 2 years, OR = 1.582), oedema (OR = 1.844) and severity of flushing, burning, stinging and pruritus (severe, OR = 2.003, 1.981, 2.491, 2.249, respectively). There were no significant associations between WTP and most of the clinical factors. CONCLUSIONS The QoL was negatively affected and should not be ignored among rosacea patients in China. Patients aged 21-40y, having occupational requirement of appearance, with the disease duration less than 2 years, and suffering severe flushing and related symptoms were more likely to have severe or very severe limitation of QoL.

scholarly journals Prospective observational study to examine health-related quality of life and develop models to predict long-term patient-reported outcomes 6 months after hospital discharge with blunt thoracic injuries

BMJ Open ◽  
2021 ◽  
Vol 11 (7) ◽  
pp. e049292
Author(s):  
Edward Baker ◽  
Ceri Battle ◽  
Abhishek Banjeri ◽  
Edward Carlton ◽  
Christine Dixon ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Hospital Discharge ◽  
Brief Pain Inventory ◽  
Thoracic Injuries ◽  
Patient Reported ◽  
Related Quality ◽  
Paindetect Questionnaire ◽  
Health Related

ObjectiveThis study aimed to examine the long-term outcomes and health-related quality of life in patients with blunt thoracic injuries over 6 months from hospital discharge and develop models to predict long-term patient-reported outcomes.DesignA prospective observational study using longitudinal survey design.SettingThe study recruitment was undertaken at 12 UK hospitals which represented diverse geographical locations and covered urban, suburban and rural areas across England and Wales.Participants337 patients admitted to hospital with blunt thoracic injuries were recruited between June 2018–October 2020.MethodsParticipants completed a bank of two quality of life surveys (Short Form-12 (SF-12) and EuroQol 5-Dimensions 5-Levels) and two pain questionnaires (Brief Pain Inventory and painDETECT Questionnaire) at four time points over the first 6 months after discharge from hospital. A total of 211 (63%) participants completed the outcomes data at 6 months after hospital discharge.Outcomes measuresThree outcomes were measured using pre-existing and validated patient-reported outcome measures. Outcomes included: Poor physical function (SF-12 Physical Component Score); chronic pain (Brief Pain Inventory Pain Severity Score); and neuropathic pain (painDETECT Questionnaire).ResultsDespite a trend towards improving physical functional and pain at 6 months, outcomes did not return to participants perceived baseline level of function. At 6 months after hospital discharge, 37% (n=77) of participants reported poor physical function; 36.5% (n=77) reported a chronic pain state; and 22% (n=47) reported pain with a neuropathic component. Predictive models were developed for each outcome highlighting important data collection requirements for predicting long-term outcomes in this population. Model diagnostics including calibration and discrimination statistics suggested good model fit in this development cohort.ConclusionsThis study identified the recovery trajectories for patients with blunt thoracic injuries over the first 6 months after hospital discharge and present prognostic models for three important outcomes which after external validation could be used as clinical risk stratification scores.

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