scholarly journals Surgical treatment for colorectal cancer: analysis of the influence of an enhanced recovery programme on long-term oncological outcomes—a study protocol for a prospective, multicentre, observational cohort study

BMJ Open ◽  
2020 ◽  
Vol 10 (10) ◽  
pp. e040316
Author(s):  
Jose-M Ramirez-Rodriguez ◽  
Javier Martinez-Ubieto ◽  
Jose-L Muñoz-Rodes ◽  
Jose-R Rodriguez-Fraile ◽  
Jose-A Garcia-Erce ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Colorectal Cancer ◽  
Cohort Study ◽  
Enhanced Recovery ◽  
Intervention Group ◽  
Rank Test ◽  
Control Group ◽  
The Impact

IntroductionThe evidence currently available from enhanced recovery after surgery (ERAS) programmes concerns their benefits in the immediate postoperative period, but there is still very little evidence as to whether their correct implementation benefits patients in the long term. The working hypothesis here is that, due to the lower response to surgical aggression and lower rates of postoperative complications, ERAS protocols can reduce colorectal cancer-related mortality. The main objective of this study is to analyse the impact of an ERAS programme for colorectal cancer on 5-year survival. As secondary objectives, we propose to analyse the weight of each of the predefined items in the oncological results as well as the quality of life.Methods and analysisA multicentre prospective cohort study was conducted in patients older than 18 years of age who are scheduled to undergo surgery for colorectal cancer. The study involved 12 hospitals with an implemented enhanced recovery protocol according to the guidelines published by the Spanish National Health Service. The intervention group includes patients with a minimum implementation level of 70%, and the control group includes those who fail to reach this level. Compliance will be studied using 18 key performance indicators, and the results will be analysed using cancer survival indicators, including overall survival, cancer-specific survival and relapse-free survival. The time to recurrence, perioperative morbidity and mortality, hospital stay and quality of life will also be studied, the latter using the validated EuroQol Five questionnaire. The propensity index method will be used to create comparable treatment and control groups, and a multivariate regression will be used to study each variable. The Kaplan-Meier estimator will be used to estimate survival and the log-rank test to make comparisons. A p value of less than 0.05 (two-tailed) will be considered to be significant.Ethics and disseminationEthical approval for this study was obtained from the Aragon Ethical Committee (C.P.-C.I. PI20/086) on 4 March 2020. The findings of this study will be submitted to peer-reviewed journals (BMJ Open, JAMA Surgery, Annals of Surgery, British Journal of Surgery). Abstracts will be submitted to relevant national and international meetings.Trial registration numberNCT04305314.

Impact of a 12-month web and smartphone-based intervention initiated during spa therapy to improve long-term physical activity of patients with chronic diseases: randomized controlled trial. (Preprint)

2021 ◽  
Author(s):  
Florie FILLOL ◽  
Ludivine PARIS ◽  
Sébastien PASCAL ◽  
Aurélien MULLIEZ ◽  
Christian-François ROQUES ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Physical Activity ◽  
Waist Circumference ◽  
Controlled Trial ◽  
Intervention Group ◽  
Group Versus ◽  
Control Group ◽  
Spa Therapy

BACKGROUND Lack of physical activity (PA) and sedentary behaviors are leading risk factors for non-communicable diseases (NCD). Web-based interventions are effective in increasing PA in older adults and in NCD patients. In many countries a course of spa therapy is commonly prescribed to NCD patients and represents an ideal context to initiating lifestyle changes. OBJECTIVE The main objective of this study was to evaluate in NCD patients the effectiveness of an intervention combining an individual face-to-face coaching during spa therapy and, when returning home, a web- and smartphone-based PA program including a connected wrist pedometer and a connected weighing scale, on the achievement of physical activity guidelines (PAG) 12 months after the end of spa therapy. METHODS This was a 12-month, prospective, parallel-group, randomized controlled trial. Patients were enrolled during spa therapy and randomized 1:1 to intervention or control group who received usual advices about PA. From the end of spa therapy, PA, weight, waist circumference, and quality of life of the participants in both groups, were assessed by phone every 2 months. Primary outcome was meeting PAG (PA≥600 METs) at 12 months after the end of spa therapy. Secondary outcomes were: meeting current PAG at 6 months of follow-up; sedentary time, weight and waist circumference, PA and quality of life, at 6 and 12 months. Objective use data of the web-and smartphone-based PA program were collected. Analytic methods include intention-to-treat and constrained longitudinal data analyses. RESULTS The study sample was 228 patients (female : 77.2% (176/228), mean age: 62.4 years (SD 6.7), retired: 53.9% (123/228), mean BMI = 28.2 kg.m-2 (SD 4.2)). No group differences were found for any baseline variable. At 12 months, the proportion of patients achieving PAG was significantly higher in intervention group versus control group (81% vs 67% respectively, OR = 2.34 (95% CI 1.02- 5.38; P=.045). No difference between intervention and control group was found neither in achieving PAG at 6 months nor for sedentary time, weight and waist circumference, at 6 and 12 months. Regarding quality of life, the physical component subscale score was significantly higher at 12 months in intervention group versus control group (mean difference: 4.1 (95% CI 1.9-6.3; P<.001). The mean duration use of the program was 7.1 months (SD 4.5). Attrition rate during the first 2 months of the program was 20.4% (23/113) whereas 39.8% (45/113) of the participants used the program for at least 10 months. CONCLUSIONS The results showed significantly more participants meeting PAG at one year in the intervention group compared to controls. A course of spa therapy offers the ideal time and setting to implement education in PA. Digital coaching seems to be more efficient than usual coaching for increasing the level of PA and decreasing sedentariness on the long term. CLINICALTRIAL ClinicalTrials.gov NCT02694796; https://clinicaltrials.gov/ct2/show/NCT02694796.

scholarly journals Impact of a Postoperative Intervention Educational Program on the Quality of Life of Patients with Hip Fracture: A Randomized, Open-Label Controlled Trial

2020 ◽  
Vol 17 (24) ◽  
pp. 9327
Author(s):  
Francisco Javier Amarilla-Donoso ◽  
Raúl Roncero-Martín ◽  
Jesus Lavado-García ◽  
María de la Luz Canal-Macías ◽  
María Pedrera-Canal ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Hip Fracture ◽  
Social Functioning ◽  
Educational Program ◽  
Bodily Pain ◽  
Intervention Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
The Impact

The objective of this study was to determine the impact of a postoperative educational intervention program on the health-related quality of life (HRQoL) of patients with hip fracture using a controlled clinical trial in a randomized, multicenter study. In total, 102 patients (45.5%) from trauma units at the two University Hospitals of the province of Cáceres received the educational program, whereas 122 (54.5%) did not. Patients were consecutively included in either an intervention or a control group. Patients from the intervention group received an educational program during admission and the postoperative period. Patients from the control group did not receive any educational program. These patients were managed according to routine protocols. The patients were predominantly female (76.3%), aged 84.6 years (SD 6.1). All dimensions in both groups at 12 months showed a significant decrease with respect to baseline, except for bodily pain in both groups (p = 0.447; p = 0.827) and social functioning in the intervention group (p = 0.268). Patients receiving the educational program showed higher levels in the dimensions of the Mental Component Summary (MCS-12) (p = 0.043), vitality (p = 0.010), and social functioning (p < 0.001), as well as in the dimensions of the SF-12 health survey questionnaire of HRQoL 12 months after surgery. In conclusion, our study of the intervention group showed that there were significant improvements in MCS-12, vitality, and social function dimensions compared to the control group.

scholarly journals A single Epley manoeuvre can improve self-perceptions of disability (quality of life) in patients with cp-BPPV: A randomised controlled trial in primary care.

2020 ◽  
Author(s):  
Ricard Carrillo Muñoz ◽  
Jose Luis Ballve Moreno ◽  
Ivan Villar Balboa ◽  
Yolanda Rando Matos ◽  
Oriol Cunillera Puertolas ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Primary Care ◽  
Intervention Group ◽  
Control Group ◽  
Perceived Disability ◽  
Self Perceptions ◽  
Perceptions Of Disability ◽  
The Impact

Abstract Background: Posterior canal benign paroxysmal positional vertigo (pc-BPPV) causes physical, functional, and emotional impairment. The treatment of choice is the Epley manoeuvre (EM). The purpose of the study was to compare the impact of the EM and a sham manoeuvre in primary care on self-perceived disability. Method: Randomised, double-blind, sham-controlled clinical trial conducted in primary care with a follow-up of 1 year. Patients aged ≥18 years old diagnosed with pc-BPPV according to the Dix-Hallpike test (DHT) were randomised to an intervention (EM) group or a control (sham manoeuvre) group. The main study covariables were age, sex, history of depression and anxiety, presence of nystagmus in the DHT, patient-perceived disability assessed with the Dizziness Handicap Inventory-screening version (DHI-S). Data were analyzed using bivariate and multivariate mixed Tobit analyses. Results: Overall, 134 patients were studied: 66 in the intervention group and 68 in the control group. Median age was 52 years (interquartile range [IQR], 38.25–68.00 years) and 76.12% of the patients were women. The DHT triggered nystagmus in 40.30% of patients. The median total DHI-S score for the overall sample at baseline was 16 (IQR, 8.00–22.00); 16 [IQR, 10.5–24.0] vs 10 [6.0–14.0] for women vs men ( P <0.001) and 16 [IQR, 10.0-24.0] vs 12 [IQR, 8.0–18.0] for patients without nystagmus vs those with nystagmus ( P =0.033).Patients treated with the EM experienced a mean reduction of 2.03 points in DHI-S score over the follow-up period compared with patients in the sham group. Conclusion: Pc-BPPV affects the quality of life of primary care patients. A single EM can improve self-perceptions of disability by around 2 points on the DHI-S scale, Trial registration : ClinicalTrials.gov Identifier: NCT01969513. Retrospectively registered. First Posted: October 25, 2013. https://clinicaltrials.gov/ct2/show/NCT01969513

scholarly journals Long Covid in adults discharged from UK hospitals after Covid-19: A prospective, multicentre cohort study using the ISARIC WHO Clinical Characterisation Protocol.

2021 ◽  
Author(s):  
Louise Sigfrid ◽  
Tom M Drake ◽  
Ellen Pauley ◽  
Edwin C Jesudason ◽  
Piero Olliaro ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Cohort Study ◽  
Outcome Measures ◽  
Symptom Onset ◽  
Persistent Symptoms ◽  
Patient Reported ◽  
The Impact

Structured Abstract Objectives: The long-term consequences of severe Covid-19 requiring hospital admission are not well characterised. The objective of this study was to establish the long-term effects of Covid-19 following hospitalisation and the impact these may have on patient reported outcome measures. Design: A multicentre, prospective cohort study with at least 3 months follow-up of participants admitted to hospital between 5th February 2020 and 5th October 2020. Setting: 31 hospitals in the United Kingdom. Participants: 327 hospitalised participants discharged alive from hospital with confirmed/high likelihood SARS-CoV-2 infection. Main outcome measures and comparisons: The primary outcome was self-reported recovery at least ninety days after initial Covid-19 symptom onset. Secondary outcomes included new symptoms, new or increased disability (Washington group short scale), breathlessness (MRC Dyspnoea scale) and quality of life (EQ5D-5L). We compared these outcome measures across age, comorbidity status and in-hospital Covid-19 severity to identify groups at highest risk of developing long-term difficulties. Multilevel logistic and linear regression models were built to adjust for the effects of patient and centre level risk factors on these outcomes. Results: In total 53.7% (443/824) contacted participants responded, yielding 73.8% (327/443) responses with follow-up of 90 days or more from symptom onset. The median time between symptom onset of initial illness and completing the participant questionnaire was 222 days (Interquartile range (IQR) 189 to 269 days). In total, 54.7% (179/327) of participants reported they did not feel fully recovered. Persistent symptoms were reported by 93.3% (305/325) of participants, with fatigue the most common (82.8%, 255/308), followed by breathlessness (53.5%, 175/327). 46.8% (153/327) reported an increase in MRC dyspnoea scale of at least one grade. New or worse disability was reported by 24.2% (79/327) of participants. Overall (EQ5D-5L) summary index was significantly worse at the time of follow-up (median difference 0.1 points on a scale of 0 to 1, IQR: -0.2 to 0.0). Females under the age of 50 years were five times less likely to report feeling recovered (adjusted OR 5.09, 95% CI 1.64 to 15.74), were more likely to have greater disability (adjusted OR 4.22, 95% CI 1.12 to 15.94), twice as likely to report worse fatigue (adjusted OR 2.06, 95% CI 0.81 to 3.31) and seven times more likely to become more breathless (adjusted OR 7.15, 95% CI 2.24 to 22.83) than men of the same age. Conclusions: Survivors of Covid-19 experienced long-term symptoms, new disability, increased breathlessness, and reduced quality of life. These findings were present even in young, previously healthy working age adults, and were most common in younger females. Policymakers should fund further research to identify effective treatments for long-Covid and ensure healthcare, social care and welfare support is available for individuals with long-Covid.  

Nutritional Intervention to Prevent Weight Gain in Patients Commenced on Olanzapine: A Randomizedcontrolled Trial

2005 ◽  
Vol 39 (6) ◽  
pp. 479-486 ◽  
Author(s):  
Sherryn Evans ◽  
Richard Newton ◽  
Sally Higgins
Keyword(s):  
Quality Of Life ◽  
Body Image ◽  
Weight Gain ◽  
Treatment Group ◽  
Nutrition Education ◽  
Intervention Group ◽  
Control Group ◽  
Average Weight ◽  
The Impact

Objective: Olanzapine is the most commonly prescribed atypical antipsychotic medication in Australia. Research repor ts an average weight gain of between 4.5 and 7 kg in the 3 months following its commencement. Trying to minimize this weight gain in a population with an already high prevalence of obesity, mor tality and morbidity is of clinical and social importance. This randomized controlled trial investigated the impact of individual nutrition education provided by a dietitian on weight gain in the 3 and 6 months following the commencement of olanzapine. Method: Fifty-one individuals (29 females, 22 males) who had star ted on olanzapine in the previous 3 months (mean length of 27 days 20) were recruited through Peninsula Health Psychiatric Services and were randomly assigned to either the intervention (n = 29) or the control group (n = 22). Individuals in the intervention group received six 1 hour nutrition education sessions over a 3-month period. Weight, waist circumference, body mass index (BMI) and qualitative measures of exercise levels, quality of life, health and body image were collected at baselineat 3 and 6 months. Results: After 3 months, the control group had gained significantly more weight than the treatment group (6.0 kg vs 2.0 kg, p≤0.002). Weight gain of more than 7% of initial weight occurred in 64% of the control group compared to 13% of the treatment group. The control group's BMI increased significantly more than the treatment group's (2 kg/m2 vs 0.7 kg/m2, p ≤0.03). The treatment group reported significantly greater improvements in moderate exercise levels, quality of life, health and body image compared to the controls. At 6 months, the control group continued to show significantly more weight gain since baseline than the treatment group (9.9 kg vs 2.0 kg, p≤0.013) and consequently had significantly greater increases in BMI (3.2 kg/m2vs 0.8 kg/m2, p ≤0.017). Conclusion: Individualnutritional intervention provided bya dietitian is highly successful at preventing olanzapine-induced weight gain.

scholarly journals Quality of Life of Diabetic Foot Ulcer Patients with Hyperbaric Oxygen Therapy

2019 ◽  
Vol 55 (2) ◽  
pp. 127
Author(s):  
Kusnanto Kusnanto ◽  
Dismalyansa Dismalyansa ◽  
Retnayu Pradanie ◽  
Hidayat Arifin
Keyword(s):  
Quality Of Life ◽  
Hyperbaric Oxygen ◽  
Diabetic Foot ◽  
Intervention Group ◽  
Foot Ulcer ◽  
Foot Ulcers ◽  
Rank Test ◽  
Control Group ◽  
Signed Rank Test

DM with ulcer can result in a decrease in the quality of life of patients and need to reduce the intensity of pain and odor on the ulcer, preventing amputation and Hyperbaric Oxygen as an adjuvant therapy in accelerating wound healing. This study aims to explain the effect of HBO on the quality of life of patients with diabetic foot ulcers at RSAL Dr. Ramelan Surabaya. Methods: The research used quasi-experimental design with a non-equivalent control group design approach. The samples were 70 patients from population of all diabetes patients who suffered from diabetic foot ulcers at RSAL Dr. Ramelan. Data were collected by WHOQOL-BREF questionnaire. Analyzed byWilcoxon signed rank test and Mann Whitney U test. Result: Mann Whitney in the post test, the physical p-value domain (0.000), psychological domain (0.012), social domain (0.003), and environmental domain (0,001), where the intervention group has a better value than the control group. Wilcoxon signed rank test results on the physical domain (0,000), psychological (0,012), social (0,003), and environmental (0,001), meaning there were significant differences between pre post test in intervention group. Discussion: Diabetes mellitus patients with foot ulcers given hyperbaric oxygen showed improvement on wound condition, thus reducing pain and medical needs. This makes patients motivated, reduce anxiety, and improve interpersonal support and confidence. Therefore, it is necessary to socialize the effect of HBO on DM patients with foot ulcer, as a treatment option in improving the quality of life of DM patients with foot ulcers.

scholarly journals Long-term Outcomes in Adolescents and Adults with a Cleft Lip and/or palate: Esthetics, Employment and Functioning

2021 ◽  
Author(s):  
Cassandra Alighieri ◽  
Evelien D'haeseleer ◽  
Kim Bettens ◽  
Katrien Bonte ◽  
Hubert Vermeersch ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Well Being ◽  
Self Report ◽  
Control Group ◽  
Older Individuals ◽  
Significant Difference ◽  
Adolescents And Adults ◽  
The Impact

Abstract Background. To date, there seems to be no consensus on the long-term quality of life outcomes in patients living with a cleft of the lip and/or palate (CL/P) with regard to well-being and functioning. Some studies report a substantial influence of having a cleft while other studies report no influence of living with a cleft. The purpose of this study was to investigate the impact of living with a CL/P on esthetics, employment and functioning in Dutch-speaking adolescents and adults with a CL/P. Methods. 30 Patients with a CL/P (19 men and 11 women) were included in the study. The mean age of the participants was 26.93 years (SD = 11.688 years, range = 15 – 66 years). An age and gender matched control group was included consisting of 30 participants (19 men and 11 women) without a CL/P with a mean age of 26.87 years (SD = 11.729 years, range = 16-67 years). Esthetics, employment and functioning were assessed using different standardized self-report questionnaires. Results. No statistically significant difference in educational level, employment, monthly net income, marital status and having children was found between participants with and without a CL/P. In addition, the quality of life scores did not differ between the two groups. Within the group of individuals with a CL/P, the findings revealed that the proportion of participants who reported an influence of the CL/P on daily functioning, general well-being, social contacts, family life, applying for a job, work, education and leisure time differed by age. Older individuals experienced more influence of their CL/P compared to younger individuals. With regard to esthetics, the findings revealed that participants without a CL/P were less satisfied with the appearance of their jaws compared to participants with a CL/P. Conclusion. In general, the findings of our study revealed no significant differences between adolescents and adults with and without a CL/P with regard to employment and functioning. Considering age within the group of participants with a CL/P, however, the results demonstrated that older individuals were more likely to experience a negative impact of their cleft on well-being and functioning. These findings suggest that older individuals with a CL/P might benefit from additional socio-emotional support, for example peer contacts and support groups or psychological guidance. Longitudinal research on this topic is highly needed to determine possible fluctuations in the impact of living with a CL/P.

scholarly journals CAN CONTINUOUS, INTER-GENERATIONAL COOPERATION POSITIVELY IMPACT THE QUALITY OF LIFE OF ELDERLY ALZHEIMER’S SUFFERERS?: AN INTERIM REPORT

2014 ◽  
pp. 1-4
Author(s):  
R. Rokkaku ◽  
A. Homma ◽  
S. Kobayashi ◽  
Y. Seki
Keyword(s):  
Quality Of Life ◽  
Day Care ◽  
Rating Scale ◽  
Care Service ◽  
Intervention Group ◽  
Control Group ◽  
Care Services ◽  
Service Staff ◽  
The Impact

This article summarizes the impact of inter-generational cooperation on the quality of life of elderly Alzheimer’s sufferers. The study is a continuing, two-year intervention and reports the results of the first year. It consists of an intervention and a control group of eight and six sufferers, respectively, who have been diagnosed with Alzheimer's disease. Both groups attend day care services. The intervention group participates in the inter-generational program with children, while the control group does not. On the Philadelphia Geriatric Center Affect Rating Scale, three items have been proved statistically significant. Pleasure, Interest, and Contentment have increased with inter-generational cooperation. The magnitude of the change was not so remarkable as to influence QOL-AD at home. However, the present results may imply a reduction on the burden of the day care service staff and family carers. Another advantage may be in the educating of the children’s parents, whose understanding of dementia was poor.

scholarly journals Abdominal Massage for the Relief of Constipation in People with Parkinson’s: A Qualitative Study

2016 ◽  
Vol 2016 ◽  
pp. 1-10 ◽  
Author(s):  
D. McClurg ◽  
K. Walker ◽  
P. Aitchison ◽  
K. Jamieson ◽  
L. Dickinson ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Intervention Group ◽  
Lifestyle Changes ◽  
Control Group ◽  
Lifestyle Advice ◽  
Care Programme ◽  
Semistructured Interviews ◽  
Abdominal Massage ◽  
The Impact

Objectives.To explore the experiences of people with Parkinson’s (PwP) who suffer from constipation, the impact this has on their lives, and the effect of using lifestyle changes and abdominal massage as a form of constipation management.Method.Fourteen semistructured interviews were completed (8 males and 6 females; mean age 72.2 years) at the end of a care programme, which consisted of either lifestyle advice and abdominal massage (intervention group;n=7) or lifestyle advice only (control group;n=7). Data were analysed using constant-comparison techniques and Framework methods. Themes and key quotes were identified to depict major findings.Findings.Four key themes were identified: (i) the adverse impact of bowel problems on quality of life; (ii) positive experience of behaviour adjustments: experimentation; (iii) abdominal massage as a dynamic and relaxing tool: experiential learning (intervention group only); (iv) abdominal massage as a contingency plan: hesitation (control group only). Constipation was reported as having a significant impact on quality of life. Participants in both groups perceived lifestyle advice to relieve symptoms. Specific improvements were described in those who also received the abdominal massage.Conclusions.Both lifestyle advice and abdominal massage were perceived to be beneficial in relieving symptoms of constipation for PwP.

scholarly journals Identification of cardiovascular and molecular prognostic factors for the medium-term and long-term outcomes of sepsis (ICROS): protocol for a prospective monocentric cohort study

BMJ Open ◽  
2020 ◽  
Vol 10 (6) ◽  
pp. e036527
Author(s):  
Sina M Coldewey ◽  
Charles Neu ◽  
Philipp Baumbach ◽  
Andre Scherag ◽  
Björn Goebel ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Cohort Study ◽  
Prognostic Factors ◽  
Functional Capacity ◽  
Septic Cardiomyopathy ◽  
Long Term Outcomes ◽  
Medium Term ◽  
The Impact

IntroductionSepsis is one of the most prevalent life-threatening conditions in the intensive care unit. Patients suffer from impaired organ function, reduced physical functional capacity and decreased quality of life even after surviving sepsis. The identification of prognostic factors for the medium-term and long-term outcomes of this condition is necessary to develop personalised theragnostic approaches. Sepsis can cause cardiac impairment. The impact of this septic cardiomyopathy on patient’s long-term outcome remains unclear. This study aims to evaluate cardiovascular risk factors, particularly the occurrence of septic cardiomyopathy, regarding their suitability as prognostic factors for the short-term and long-term outcomes of septic patients. Additionally, the study seeks to validate preclinical pathophysiological findings of septic cardiomyopathy in the clinical setting.Methods and analysisIn this prospective monocentric cohort study, patients will be clinically assessed during the acute and postacute phase of sepsis and two follow-ups after 6 and 12 months. To determine the effect of septic cardiomyopathy and concomitant cellular and molecular changes on patient mortality and morbidity, a comprehensive cardiovascular and molecular deep phenotyping of patients will be performed. This includes an echocardiographic and electrocardiographic assessment, and the evaluation of heart rate variability, body composition, mitochondrial oxygen metabolism, macrocirculation and microcirculation, and endothelial barrier function. These analyses are complemented by routine immunological, haematological and biochemical laboratory tests and analyses of the serum metabolome and lipidome, microbiome and epigenetic modifications of immune cells. The reversibility of patients’ organ dysfunction, their quality of life and physical functional capacity will be investigated in the follow-ups. Patients with cardiomyopathy without infection and healthy subjects will serve as control groups.Ethics and disseminationApproval was obtained from the Ethics Committee of the Friedrich Schiller University Jena (5276-09/17). The results will be published in peer-reviewed journals and presented at appropriate conferences.Trial registration numbersDRKS00013347; NCT03620409.

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