scholarly journals Follow-Up of Cancer Patients Receiving Anti-PD-(L)1 Therapy Using an Electronic Patient-Reported Outcomes Tool (KISS): Prospective Feasibility Cohort Study

10.2196/17898 ◽  
2020 ◽  
Vol 4 (10) ◽  
pp. e17898
Author(s):  
Sanna Iivanainen ◽  
Tuomo Alanko ◽  
Pia Vihinen ◽  
Teemu Konkola ◽  
Jussi Ekstrom ◽  
...  
Keyword(s):  
Side Effects ◽  
Cancer Patients ◽  
Prediction Models ◽  
Checkpoint Inhibitors ◽  
Patient Reported Outcome ◽  
Treatment Benefit ◽  
Wide Range ◽  
Patient Reported ◽  
Loss Of Appetite

Background Immune checkpoint inhibitors (ICIs) have become a standard of care for various tumor types. Their unique spectrum of side effects demands continuous and long-lasting assessment of symptoms. Electronic patient-reported outcome (ePRO) follow-up has been shown to improve survival and quality of life of cancer patients treated with chemotherapy. Objective This study aimed to investigate whether ePRO follow-up of cancer patients treated with ICIs is feasible. The study analyzed (1) the variety of patient reported symptoms, (2) etiology of alerts, (3) symptom correlations, and (4) patient compliance. Methods In this prospective, one-arm, multi-institutional study, we recruited adult cancer patients whose advanced cancer was treated with anti-programmed cell death protein 1 (PD)- ligand (L)1 agents in outpatient settings. The ePRO tool consisted of a weekly questionnaire evaluating the presence of typical side effects, with an algorithm assessing the severity of the symptom according to National Cancer Institute Common Terminology Criteria for Adverse Events and an urgency algorithm sending alerts to the care team. A patient experience survey was conducted monthly. The patients were followed up to 6 months or until disease progression. Results A total of 889 symptom questionnaires was completed by 37 patients (lung cancer, n=15; melanoma, n=9; genitourinary cancer, n=9; head and neck cancer, n=4). Patients showed good adherence to ePRO follow-up. The most common grade 1 symptoms were fatigue (28%) and itching (13%), grade 2 symptoms were loss of appetite (12%) and nausea (12%), and grade 3-4 symptoms were cough (6%) and loss of appetite (4%). The most common reasons for alerts were loss of appetite and shortness of breath. In the treatment benefit analysis, positive correlations were seen between clinical benefit and itching as well as progressive disease and chest pain. Conclusions According to the results, ePRO follow-up of cancer patients receiving ICIs is feasible. ePROs capture a wide range of symptoms. Some symptoms correlate to treatment benefit, suggesting that individual prediction models could be generated. Trial Registration Clinical Trials Register, NCT3928938; https://clinicaltrials.gov/ct2/show/NCT03928938

scholarly journals Follow-Up of Cancer Patients Receiving Anti-PD-(L)1 Therapy Using an Electronic Patient-Reported Outcomes Tool (KISS): Prospective Feasibility Cohort Study (Preprint)

2020 ◽  
Author(s):  
Sanna Iivanainen ◽  
Tuomo Alanko ◽  
Pia Vihinen ◽  
Teemu Konkola ◽  
Jussi Ekstrom ◽  
...  
Keyword(s):  
Side Effects ◽  
Cancer Patients ◽  
Prediction Models ◽  
Checkpoint Inhibitors ◽  
Patient Reported Outcome ◽  
Treatment Benefit ◽  
Wide Range ◽  
Patient Reported ◽  
Loss Of Appetite

BACKGROUND Immune checkpoint inhibitors (ICIs) have become a standard of care for various tumor types. Their unique spectrum of side effects demands continuous and long-lasting assessment of symptoms. Electronic patient-reported outcome (ePRO) follow-up has been shown to improve survival and quality of life of cancer patients treated with chemotherapy. OBJECTIVE This study aimed to investigate whether ePRO follow-up of cancer patients treated with ICIs is feasible. The study analyzed (1) the variety of patient reported symptoms, (2) etiology of alerts, (3) symptom correlations, and (4) patient compliance. METHODS In this prospective, one-arm, multi-institutional study, we recruited adult cancer patients whose advanced cancer was treated with anti-programmed cell death protein 1 (PD)- ligand (L)1 agents in outpatient settings. The ePRO tool consisted of a weekly questionnaire evaluating the presence of typical side effects, with an algorithm assessing the severity of the symptom according to National Cancer Institute Common Terminology Criteria for Adverse Events and an urgency algorithm sending alerts to the care team. A patient experience survey was conducted monthly. The patients were followed up to 6 months or until disease progression. RESULTS A total of 889 symptom questionnaires was completed by 37 patients (lung cancer, n=15; melanoma, n=9; genitourinary cancer, n=9; head and neck cancer, n=4). Patients showed good adherence to ePRO follow-up. The most common grade 1 symptoms were fatigue (28%) and itching (13%), grade 2 symptoms were loss of appetite (12%) and nausea (12%), and grade 3-4 symptoms were cough (6%) and loss of appetite (4%). The most common reasons for alerts were loss of appetite and shortness of breath. In the treatment benefit analysis, positive correlations were seen between clinical benefit and itching as well as progressive disease and chest pain. CONCLUSIONS According to the results, ePRO follow-up of cancer patients receiving ICIs is feasible. ePROs capture a wide range of symptoms. Some symptoms correlate to treatment benefit, suggesting that individual prediction models could be generated. CLINICALTRIAL Clinical Trials Register, NCT3928938; https://clinicaltrials.gov/ct2/show/NCT03928938

scholarly journals A Novel Digital Patient-Reported Outcome Platform for Head and Neck Oncology Patients–-A Pilot Study

2016 ◽  
Vol 9 ◽  
pp. CMENT.S40219 ◽  
Author(s):  
Maria K. Peltola ◽  
Joel S. Lehikoinen ◽  
Lauri T. Sippola ◽  
Kauko Saarilahti ◽  
Antti A. Mäkitie
Keyword(s):  
Quality Of Life ◽  
Pilot Study ◽  
Side Effects ◽  
Head And Neck ◽  
Cancer Patients ◽  
Early Stage ◽  
Patient Reported Outcome ◽  
Patient Reported

Introduction The patient's role in toxicity reporting is increasingly acknowledged. There is also a need for developing modern communication methods between the patient and the medical personnel. Furthermore, the increasing number of head and neck cancer (HNC) patients is reflected in the volume of treatment follow-up visits, which remains a challenge for the health care. Electronic patient-reported outcome (ePRO) measures may provide a cost-efficient way to organize follow-up for cancer patients. Materials and Methods We tested a novel ePRO application called Kaiku®, which enables real-time, online collection of patient-reported outcomes, such as side effects caused by treatment and quality of life. We conducted a pilot study to assess the suitability of Kaiku® for HNC patients at the Department of Oncology, Helsinki University Hospital, Helsinki, Finland. Patients used Kaiku® during and one month after radiotherapy to report treatment-related side effects and quality of life. Two physicians and a nurse performed the practical electronic communication part of the study. Results Five of the nine patients agreed to participate in the study: three of them had local early-stage larynx cancer (T2N0, T1aN0, and T2N0) and the remaining two patients had early-stage base of tongue cancer (T2N0 and T1N2b). The degree of side effects reported by the patients via Kaiku® ranged from mild to life threatening. The number of outcome data points on patients' progress was significantly increased, which resulted in a better follow-up and improved communication between the patient and the care team. Conclusions Kaiku® seems to be a suitable tool to monitor side effects and quality of life during and after radiotherapy among HNC patients. Kaiku® and similar tools could be useful in organizing a cost-effective follow-up process for HNC patients. We recommend conducting a larger study to further assess the impact of an ePRO solution in routine clinical practice. • ePRO solutions may aid in the follow-up for cancer patients. • They seem suitable to monitor, for example, side effects and quality of life. • These systems ensure fast patient-driven reporting.

Selecting a PRO-CTCAE based subset for patient reported symptom monitoring during lung cancer treatment (Preprint)

2020 ◽  
Author(s):  
Evalien Veldhuijzen ◽  
Iris Walraven ◽  
Jose Belderbos
Keyword(s):  
Lung Cancer ◽  
Clinical Practice ◽  
Cancer Patients ◽  
Treatment Modalities ◽  
European Organization ◽  
Specific Patient ◽  
Symptom Monitoring ◽  
Lung Cancer Patients ◽  
Wide Range ◽  
Patient Reported

BACKGROUND The Patient Reported Outcomes Version of the Common Terminology Criteria of Adverse Events (PRO-CTCAE) item library covers a wide range of symptoms relevant for oncology care. To enable implementation of PRO-CTCAE-based symptom monitoring in clinical practice, there is a need to select a subset of items relevant for specific patient populations. OBJECTIVE The aim of this study was to develop a PRO-CTCAE subset relevant for patients with lung cancer. METHODS The PRO-CTCAE-based subset for lung cancer patients was generated using a mixed methods approach based on the European Organization for Research and Treatment of Cancer (EORTC) guidelines for developing questionnaires, consisting of a literature review and semi-structured interviews with both lung cancer patients and health care practitioners (HCPs). Both patients and HCPs were queried on the relevance and impact of all PRO-CTCAE items. Results were summarized and, after a final round of expert review, a selection of clinically relevant items for lung cancer patients was made. RESULTS A heterogeneous group of lung cancer patients (n=25) from different treatment modalities and HCPs (n=22) participated in the study. A final list of eight relevant PRO-CTCAE items was created: decreased appetite, cough, shortness of breath, fatigue, constipation, nausea, sadness, and pain (general). CONCLUSIONS Based on literature and both professional and patient input, a subset of PRO-CTCAE items has been identified for use in lung cancer patients in clinical practice. Future work is needed to confirm the validity and effectiveness of this PRO-CTCAE lung cancer subset internationally, and in the real-world clinical practice setting.

scholarly journals Electronic patient-reported outcomes and machine learning in predicting immune-related adverse events of immune checkpoint inhibitor therapies

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Sanna Iivanainen ◽  
Jussi Ekstrom ◽  
Henri Virtanen ◽  
Vesa V. Kataja ◽  
Jussi P. Koivunen
Keyword(s):  
Machine Learning ◽  
Early Detection ◽  
Adverse Events ◽  
Cancer Patients ◽  
Immune Checkpoint ◽  
Patient Reported Outcomes ◽  
Prediction Models ◽  
Accuracy Score ◽  
Patient Reported ◽  
Auc Value

Abstract Background Immune-checkpoint inhibitors (ICIs) have introduced novel immune-related adverse events (irAEs), arising from various organ systems without strong timely dependency on therapy dosing. Early detection of irAEs could result in improved toxicity profile and quality of life. Symptom data collected by electronic (e) patient-reported outcomes (PRO) could be used as an input for machine learning (ML) based prediction models for the early detection of irAEs. Methods The utilized dataset consisted of two data sources. The first dataset consisted of 820 completed symptom questionnaires from 34 ICI treated advanced cancer patients, including 18 monitored symptoms collected using the Kaiku Health digital platform. The second dataset included prospectively collected irAE data, Common Terminology Criteria for Adverse Events (CTCAE) class, and the severity of 26 irAEs. The ML models were built using extreme gradient boosting algorithms. The first model was trained to detect the presence and the second the onset of irAEs. Results The model trained to predict the presence of irAEs had an excellent performance based on four metrics: accuracy score 0.97, Area Under the Curve (AUC) value 0.99, F1-score 0.94 and Matthew’s correlation coefficient (MCC) 0.92. The prediction of the irAE onset was more difficult with accuracy score 0.96, AUC value 0.93, F1-score 0.66 and MCC 0.64 but the model performance was still at a good level. Conclusion The current study suggests that ML based prediction models, using ePRO data as an input, can predict the presence and onset of irAEs with a high accuracy, indicating that ePRO follow-up with ML algorithms could facilitate the detection of irAEs in ICI-treated cancer patients. The results should be validated with a larger dataset. Trial registration Clinical Trials Register (NCT3928938), registration date the 26th of April, 2019

Midterm results of a new personalized knee implant for total knee arthroplasty: implant survivorship and patient-reported outcome after five years’ follow-up

2021 ◽  
Author(s):  
Cristina Dauder Gallego ◽  
Irene Blanca Moreno Fenoll ◽  
José Luis Patiño Contreras ◽  
Francisco Javier Moreno Coronas ◽  
María del Carmen Torrejón de la Cal ◽  
...  
Keyword(s):  
Total Knee Arthroplasty ◽  
Knee Arthroplasty ◽  
Patient Reported Outcome ◽  
Midterm Results ◽  
Implant Survivorship ◽  
Patient Reported ◽  
Total Knee

scholarly journals Strain Elastography and Tendon Response to an Exercise Program in Patients With Supraspinatus Tendinopathy: An Exploratory Study

2020 ◽  
Vol 8 (12) ◽  
pp. 232596712096518
Author(s):  
Karen Brage ◽  
Birgit Juul-Kristensen ◽  
John Hjarbaek ◽  
Eleanor Boyle ◽  
Per Kjaer ◽  
...  
Keyword(s):  
Patient Reported Outcomes ◽  
Structural Changes ◽  
Supraspinatus Tendon ◽  
Patient Reported Outcome ◽  
Minimal Detectable Change ◽  
Detectable Change ◽  
Tendon Stiffness ◽  
Patient Reported ◽  
Tendon Thickness

Background: Shoulder pain is common, with a lifetime prevalence of up to 67%. Evidence is conflicting in relation to imaging findings and pain in the shoulder. Sonoelastography can be used to estimate tissue stiffness and may be a clinically relevant technique for diagnosing and monitoring tendon healing. Purpose: To evaluate changes in supraspinatus tendon stiffness using strain elastography (SEL) and associations with changes in patient-reported outcomes, supraspinatus tendon thickness, and grade of tendinopathy after 12 weeks of unilateral shoulder exercises in patients with supraspinatus tendinopathy. Study Design: Controlled laboratory study. Methods: A total of 23 patients with unilateral clinical supraspinatus tendinopathy performed 12 weeks of “standard care” exercises. At baseline and follow-up, supraspinatus tendon stiffness was measured bilaterally using SEL and compared with tendinopathy grading on magnetic resonance imaging scans and tendon thickness measured using conventional ultrasound. Patient-reported outcome measures included physical function and symptoms from the Disabilities of the Arm, Shoulder and Hand questionnaire and pain rating (visual analog scale). Results: No significant changes in SEL within or between groups (asymptomatic vs symptomatic tendon) were seen. All patient-reported outcomes showed significant improvement from baseline to follow-up, but with no change in tendinopathy grading and tendon thickness. No significant differences in the proportion of patients changing above the minimal detectable change in SEL and PROM were seen, except for discomfort while sleeping. Conclusion: Despite no significant within-group or between-group changes in SEL, significant improvements were found in patient-reported outcomes. An acceptable agreement between patients changing above the minimal detectable change in SEL and patient-reported outcome measure was seen. Further studies should explore the use of SEL to detect changes after tendon repair and long-term training potentially in subgroups of different tendinopathy phases. Clinical Relevance: In the short term, structural changes in supraspinatus tendons could not be visualized using SEL, indicating that a longer time span should be expected in order to observe structural changes, which should be considered before return to sports. Subgrouping based on stage of tendinopathy may also be important in order to evaluate changes over time with SEL among patients with supraspinatus tendinopathy. Registration: NCT03425357 ( ClinicalTrials.gov identifier).

Significance of patient-reported outcomes for occupational resumption and quality of life after cardiac rehabilitation

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
A Salzwedel ◽  
I Koran ◽  
E Langheim ◽  
A Schlitt ◽  
J Nothroff ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Physical Performance ◽  
Well Being ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Funding Source ◽  
Patient Reported ◽  
Returning To Work

Abstract Introduction Comprehensive cardiac rehabilitation (CR) programs based on the bio-psycho-social approach of the international classification of functioning and disease are carried out to achieve improved prognosis, superior health-related quality of life (HRQL) and social integration. We aimed to identify predictors of returning to work (RTW) and HRQL among cardiovascular risk factors and physical performance as well as patient-reported outcome measures (PROMs) modifiable during CR. Methods We designed a prospective observational multi-center study and enrolled 1,586 patients (2017/18) in 12 German rehabilitation centers regardless of their primary allocation diagnoses (e.g. acute myocardial infarction (AMI), coronary artery bypass grafting (CABG), coronary artery disease (CAD), valvular disease). Besides general data (e.g. age, gender, diagnoses), parameters of risk factor management (e.g. smoking, lipid profile, hypertension, lifestyle change motivation), physical performance (e.g. maximum exercise capacity, endurance training load, 6-min walking distance), and PROMs (e.g. depression, heart-focused anxiety, HRQL, subjective well-being, somatic and mental health, pain, general self-efficacy, pension desire as well as self-assessment of occupational prognosis using several questionnaires) were documented at CR admission and discharge. 6 months after discharge, status of RTW and HRQL (SF-12) were captured by a follow-up (FU) survey and analyzed in multivariable regression models with multiple imputation of missing values. Results Out of the study participants, 1,262 patients (54±7 years, 77% men) responded to the follow-up survey and could be analyzed regarding the outcome parameters. Most of them were assigned to CR primarily due to AMI (40%) or CAD without myocardial infarction (18%), followed by heart valve diseases in 12% of patients and CABG (8%). 864 patients (69%) returned to work within the follow-up period. Pension desire, negative self-assessed occupational prognosis, heart-focussed anxiety, major life events, smoking and heart failure were negatively associated with RTW, while higher endurance training load, HRQL and work stress were positively associated (Figure 1). HRQL after 6 months was determined more by PROMs (e.g. pension desire, heart-focused anxiety, physical/mental HRQL in SF-12, physical/mental health in indicators of rehab-status questionnaire (IRES-24), stress, well-being in the World Health Organization well-being index and self-efficacy expectations) than by clinical parameters or physical performance. Conclusions Patient-reported outcome measures predominantly influenced RTW and HRQL in heart-disease patients, whereas patients' pension desire and heart-focussed anxiety had a dominant impact on all investigated endpoints. Therefore, the multi-component CR approach focussing on psychosocial support is crucial for subjective health prognosis and occupational resumption. Figure 1. Predictors of returning to work Funding Acknowledgement Type of funding source: Public grant(s) – National budget only. Main funding source(s): German pension insurance

scholarly journals The impact of hyperbaric oxygen therapy on late radiation toxicity and quality of life in breast cancer patients

2021 ◽  
Author(s):  
Marilot C. T. Batenburg ◽  
Wies Maarse ◽  
Femke van der Leij ◽  
Inge O. Baas ◽  
Onno Boonstra ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Side Effects ◽  
Cancer Patients ◽  
Oxygen Therapy ◽  
Radiation Toxicity ◽  
Breast Pain ◽  
Breast Cancer Patients

Abstract Purpose To evaluate symptoms of late radiation toxicity, side effects, and quality of life in breast cancer patients treated with hyperbaric oxygen therapy (HBOT). Methods For this cohort study breast cancer patients treated with HBOT in 5 Dutch facilities were eligible for inclusion. Breast cancer patients with late radiation toxicity treated with ≥ 20 HBOT sessions from 2015 to 2019 were included. Breast and arm symptoms, pain, and quality of life were assessed by means of the EORTC QLQ-C30 and -BR23 before, immediately after, and 3 months after HBOT on a scale of 0–100. Determinants associated with persistent breast pain after HBOT were assessed. Results 1005/1280 patients were included for analysis. Pain scores decreased significantly from 43.4 before HBOT to 29.7 after 3 months (p < 0.001). Breast symptoms decreased significantly from 44.6 at baseline to 28.9 at 3 months follow-up (p < 0.001) and arm symptoms decreased significantly from 38.2 at baseline to 27.4 at 3 months follow-up (p < 0.001). All quality of life domains improved at the end of HBOT and after 3 months follow-up in comparison to baseline scores. Most prevalent side effects of HBOT were myopia (any grade, n = 576, 57.3%) and mild barotrauma (n = 179, 17.8%). Moderate/severe side effects were reported in 3.2% (n = 32) of the patients. Active smoking during HBOT and shorter time (i.e., median 17.5 vs. 22.0 months) since radiotherapy were associated with persistent breast pain after HBOT. Conclusion Breast cancer patients with late radiation toxicity reported reduced pain, breast and arm symptoms, and improved quality of life following treatment with HBOT.

scholarly journals Acceptability of no-test medical abortion provided via telemedicine: analysis of patient-reported outcomes

2021 ◽  
pp. bmjsrh-2020-200954
Author(s):  
Chelsey Porter Erlank ◽  
Jonathan Lord ◽  
Kathryn Church
Keyword(s):  
Patient Reported Outcomes ◽  
Medical Abortion ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Post Procedure ◽  
High Satisfaction ◽  
First Choice ◽  
Patient Reported ◽  
At Home

IntroductionThe English government approved both stages of early medical abortion (EMA), using mifepristone and misoprostol under 10 weeks’ gestation, for at-home use on 30 March 2020. MSI Reproductive Choices UK (MSUK), one of the largest providers of abortion services in England, launched a no-test telemedicine EMA pathway on 6 April 2020. The objectives of this study were to report key patient-reported outcome measures and to assess whether our sample was representative of the whole population receiving no-test telemedicine EMA.MethodsA sample of all MSUK’s telemedicine EMA patients between April and August 2020 were invited to opt in to a follow-up call to answer clinical and satisfaction questions. A total of 1243 (13.7% of all telemedicine EMAs) were successfully followed-up, on average within 5 days post-procedure.ResultsPatients reported high confidence in telemedicine EMA and high satisfaction with the convenience, privacy and ease of managing their abortion at home. The sample responding were broadly equivalent to the whole population receiving telemedicine. No patient reported that they were unable to consult privately. The majority (1035, 83%) of patients reported preferring the telemedicine pathway, with 824 (66%) indicating that they would choose telemedicine again if COVID-19 were no longer an issue.ConclusionsTelemedicine EMA is a valued, private, convenient and more accessible option that is highly acceptable for patients seeking an abortion, especially those for whom in-clinic visits are logistically or emotionally challenging. Evidence that this pathway would be a first choice again in future for most patients supports the case to make telemedicine EMA permanent.

scholarly journals Changes in fatigue, barriers, and predictors towards physical activity in advanced cancer patients over a period of 12 months—a comparative study

2021 ◽  
Author(s):  
J. Frikkel ◽  
M. Beckmann ◽  
N. De Lazzari ◽  
M. Götte ◽  
S. Kasper ◽  
...  
Keyword(s):  
Physical Activity ◽  
Cancer Patients ◽  
Advanced Cancer ◽  
Physical Functioning ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Advanced Cancer Patients ◽  
Psychological Conditions ◽  
Patient Reported

Abstract Purpose Physical activity (PA) is recommended to improve advanced cancer patients’ (ACP) physical functioning, fatigue, and quality of life. Yet, little is known about ACPs’ attitude towards PA and its influence on fatigue and depressiveness over a longer period. This prospective, non-interventional cohort study examined ACPs’ fatigue, depression, motivation, and barriers towards PA before and after 12 months of treatment among ACP Methods Outpatients with incurable cancer receiving treatment at a German Comprehensive Cancer Center reporting moderate/severe weakness/tiredness during self-assessment via MIDOS II were enrolled. Fatigue (FACT-F), depression (PHQ-8), cancer-related parameters, self-assessed PA behavior, motivation for and barriers against PA were evaluated (T0). Follow-up data was acquired after 12 months (T1) using the same questionnaire. Results At follow-up, fatigue (p=0.017) and depressiveness (p=0.015) had increased in clinical relevant extent. Physically active ACP did not show significant progress of FACT-F (p=0.836) or PHQ-8 (p=0.799). Patient-reported barriers towards PA remained stable. Logistic regression analyses identified motivation as a positive predictor for PA at both time points (T0, β=2.152, p=0.017; T1, β =2.264, p=0.009). Clinically relevant depression was a negative predictor for PA at T0 and T1 (T0, β=−3.187, p=0.044; T1, β=−3.521, p=0.041). Conclusion Our findings emphasize the importance of psychological conditions in physical activity behavior of ACP. Since psychological conditions seem to worsen over time, early integration of treatment is necessary. By combining therapy approaches of cognitive behavioral therapy and exercise in interdisciplinary care programs, the two treatment options might reinforce each other and sustainably improve ACPs’ fatigue, physical functioning, and QoL. Trial registration German Register of Clinical Trials, DRKS00012514, registration date: 30.05.2017

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