Search

Background: Current incidence estimates of SARS-CoV-2 in Germany rely to a large extent on case notifications. However, the large number of mild or asymptomatic infections is likely to result in underestimation. Population-based studies can provide valid estimates of the SARS-CoV-2 incidence and thus support health authorities to monitor the epidemiological situation and to initiate, maintain, strengthen or relax effective countermeasures. Methods: This study was conducted in Cologne, Germany. Six-thousand randomly drawn Cologne residents, 18 years of age or older, were contacted by mail in March 2021. Study envelopes contained a kit for self-administered saliva sample and access details to a questionnaire on sociodemographic characteristics, previous positive SARS-CoV-2 RT-qPCR and completed COVID-19 vaccinations. Participants were again invited for a second round in June 2021, while those who declined participation were replaced by additional randomly drawn Cologne residents in order to reach a total of 6000 potential participants again. The saliva samples were sent to the laboratory by mail and tested for SARS-CoV-2 using RT-qPCR. The incidence estimates were adjusted for sensitivity and specificity of the test procedure and compared with the official numbers of new SARS-CoV-2 cases in the adult Cologne population. Results: The first surveillance round in March 2021 (response rate: 34.08%, N = 2045) showed a SARS-CoV-2 seven-day incidence of 85 cases per 100,000 adult Cologne residents (95% CI: 9 to 319). In the same period, the officially registered cases were 125 per 100,000. The second surveillance round in June 2021 (response rate: 36.53%, N = 2192) showed a seven-day incidence of 27 per 100,000 adult Cologne residents (95% CI: 1 to 142), while the official figures for newly registered SARS-CoV-2 cases in the same period were 15 per 100,000. Conclusions: The incidence estimates do not indicate relevant underestimation of new SARS-CoV-2 infections based on cas

Background Lipedema is a chronic disorder of the adipose tissue that affects mainly women, characterised by symmetrical, excessive fatty tissue on the legs and pain. Standard conservative treatment is long-term comprehensive decongestive therapy (CDT) to alleviate lipedema-related pain and to improve psychosocial well-being, mobility and physical activity. Patients may benefit from surgical removal of abnormally propagated adipose tissue by liposuction. The LIPLEG trial evaluates the efficacy and safety of liposuction compared to standard CDT. Methods/design LIPLEG is a randomised controlled multicentre investigator-blinded trial. Women with lipedema (n=405) without previous liposuction will be allocated 2:1 to liposuction or CDT. The primary outcome of the trial is leg pain reduction by >= 2 points on a visual analogue scale ranging 0-10 at 12 months on CDT or post-completion of liposuction. Secondary outcomes include changes in leg pain severity, health-related quality of life, depression tendency, haematoma tendency, prevalence of oedema, modification physical therapy scope, body fat percentage, leg circumference and movement restriction. The primary analysis bases on intention-to-treat. Success proportions are compared using the Mantel-Haenszel test stratified by lipedema stage at a 5% two-sided significance level. If this test is statistically significant, the equality of the response proportions in the separate strata is evaluated by Fisher's exact test in a hierarchical test strategy. Discussion LIPLEG assesses whether surgical treatment of lipedema is safe and effective to reduce pain and other lipedema-related health issues. The findings of this trial have the potential to change the standard of care in lipedema. Trial status Protocol version is 02_0, December 17, 2019

BackgroundSurveillance strategies are critical to cope with the current SARS-CoV-2 pandemic and to evaluate, as well as adjust government-imposed countermeasures. Incidence estimates are widely based on laboratory confirmed cases reported by health authorities. Prevalence and incidence data of SARS-CoV-2 is still scarce, along with demographic and behavioural factors associated with infection risk.MethodsThe Cologne Corona Surveillance Study will be conducted in the City of Cologne, which is the fourth-largest city in Germany with a population of approximately 1.1 million. Researchers will apply self-sampling surveillance to a rolling cohort of Cologne residents. Random samples of 6000 Cologne residents 18years of age and older will be drawn from the registration office. Upon receiving the information and saliva sample kit, participants will be asked to fill out a questionnaire online or via phone, sign written informed consent, and send back written consent, as well as saliva sample. The saliva samples will be tested for SARS-CoV-2 by reverse PCR. The questionnaire will be administered to gather information about personal characteristics such as health status and risks. A second round of testing will take place 6 weeks after the first.DiscussionSelf-administered saliva sampling proved to be a legitimate and feasible alternative to nasopharyngeal swabs taken by health professionals. However, it is unclear whether the targeted response rate of 40% can be achieved and whether the results are representative of the population.Trial registrationDRKS.de, German Clinical Trials Register (DRKS), Identifier: DRKS00024046, Registered on 25 February 2021.

Background: Although not routinely established during cardiopulmonary resuscitation (CPR), video-assisted CPR has been described as beneficial in the communication with emergency medical service (EMS) authorities in out-of-hospital cardiac arrest scenarios. Since the influence of video quality has not been investigated systematically and due to variation of quality of a live-stream video during video-assisted CPR, we investigated the influence of different video quality levels during the evaluation of CPR performance in video sequences. Methods: Seven video sequences of CPR performance were recorded in high quality and artificially reduced to medium and low quality afterwards. Video sequences showed either correct CPR performance or one of six typical errors: too low and too high compression rate, superficial and increased compression depth, wrong hand position and incomplete release. Video sequences were randomly assigned to the different quality levels. During the randomised and double-blinded evaluation process, 46 paramedics and 47 emergency physicians evaluated seven video sequences of CPR performance in different quality levels (high, medium and low resolution). Results: Of 650 video sequences, CPR performance was evaluable in 98.2%. CPR performance was correctly evaluated in 71.5% at low quality, in 76.8% at medium quality, and in 77.3% at high quality level, showing no significant differences depending on video quality (p = 0.306). In the subgroup analysis, correct classification of increased compression depth showed significant differences depending on video quality (p = 0.006). Further, there were significant differences in correct CPR classification depending on the presented error (p < 0.001). Allegedly errors, that were not shown in the video sequence, were classified in 28.3%, insignificantly depending on video quality. Correct evaluation did not show significant interprofessional differences (p = 0.468). Conclusion: Video quality has no significant im

Background Lipedema is a chronic disorder of the adipose tissue that affects mainly women, characterised by symmetrical, excessive fatty tissue on the legs and pain. Standard conservative treatment is long-term comprehensive decongestive therapy (CDT) to alleviate lipedema-related pain and to improve psychosocial well-being, mobility and physical activity. Patients may benefit from surgical removal of abnormally propagated adipose tissue by liposuction. The LIPLEG trial evaluates the efficacy and safety of liposuction compared to standard CDT. Methods/design LIPLEG is a randomised controlled multicentre investigator-blinded trial. Women with lipedema (n=405) without previous liposuction will be allocated 2:1 to liposuction or CDT. The primary outcome of the trial is leg pain reduction by >= 2 points on a visual analogue scale ranging 0-10 at 12 months on CDT or post-completion of liposuction. Secondary outcomes include changes in leg pain severity, health-related quality of life, depression tendency, haematoma tendency, prevalence of oedema, modification physical therapy scope, body fat percentage, leg circumference and movement restriction. The primary analysis bases on intention-to-treat. Success proportions are compared using the Mantel-Haenszel test stratified by lipedema stage at a 5% two-sided significance level. If this test is statistically significant, the equality of the response proportions in the separate strata is evaluated by Fisher's exact test in a hierarchical test strategy. Discussion LIPLEG assesses whether surgical treatment of lipedema is safe and effective to reduce pain and other lipedema-related health issues. The findings of this trial have the potential to change the standard of care in lipedema. Trial status Protocol version is 02_0, December 17, 2019

BackgroundSurveillance strategies are critical to cope with the current SARS-CoV-2 pandemic and to evaluate, as well as adjust government-imposed countermeasures. Incidence estimates are widely based on laboratory confirmed cases reported by health authorities. Prevalence and incidence data of SARS-CoV-2 is still scarce, along with demographic and behavioural factors associated with infection risk.MethodsThe Cologne Corona Surveillance Study will be conducted in the City of Cologne, which is the fourth-largest city in Germany with a population of approximately 1.1 million. Researchers will apply self-sampling surveillance to a rolling cohort of Cologne residents. Random samples of 6000 Cologne residents 18years of age and older will be drawn from the registration office. Upon receiving the information and saliva sample kit, participants will be asked to fill out a questionnaire online or via phone, sign written informed consent, and send back written consent, as well as saliva sample. The saliva samples will be tested for SARS-CoV-2 by reverse PCR. The questionnaire will be administered to gather information about personal characteristics such as health status and risks. A second round of testing will take place 6 weeks after the first.DiscussionSelf-administered saliva sampling proved to be a legitimate and feasible alternative to nasopharyngeal swabs taken by health professionals. However, it is unclear whether the targeted response rate of 40% can be achieved and whether the results are representative of the population.Trial registrationDRKS.de, German Clinical Trials Register (DRKS), Identifier: DRKS00024046, Registered on 25 February 2021.

Background: Although not routinely established during cardiopulmonary resuscitation (CPR), video-assisted CPR has been described as beneficial in the communication with emergency medical service (EMS) authorities in out-of-hospital cardiac arrest scenarios. Since the influence of video quality has not been investigated systematically and due to variation of quality of a live-stream video during video-assisted CPR, we investigated the influence of different video quality levels during the evaluation of CPR performance in video sequences. Methods: Seven video sequences of CPR performance were recorded in high quality and artificially reduced to medium and low quality afterwards. Video sequences showed either correct CPR performance or one of six typical errors: too low and too high compression rate, superficial and increased compression depth, wrong hand position and incomplete release. Video sequences were randomly assigned to the different quality levels. During the randomised and double-blinded evaluation process, 46 paramedics and 47 emergency physicians evaluated seven video sequences of CPR performance in different quality levels (high, medium and low resolution). Results: Of 650 video sequences, CPR performance was evaluable in 98.2%. CPR performance was correctly evaluated in 71.5% at low quality, in 76.8% at medium quality, and in 77.3% at high quality level, showing no significant differences depending on video quality (p = 0.306). In the subgroup analysis, correct classification of increased compression depth showed significant differences depending on video quality (p = 0.006). Further, there were significant differences in correct CPR classification depending on the presented error (p < 0.001). Allegedly errors, that were not shown in the video sequence, were classified in 28.3%, insignificantly depending on video quality. Correct evaluation did not show significant interprofessional differences (p = 0.468). Conclusion: Video quality has no significant im