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Ethical Approval | This study was approved by the institutional review board and retrospectively registered at | PMC9851777 | ||
Conflicts of Interest | The authors declare that there are no conflicts of interest. | PMC9851777 | ||
Supplementary Materials | drowsiness, Pain, postoperative nausea and vomiting, pain, PONV | REGRESSION, POSTOPERATIVE COMPLICATIONS | Supplementary material: the supplementary material was the raw data of this study.Click here for additional data file.The CONSORT study participant flow diagram.(a) Pain score at rest. (b) Pain score upon movement. (c) Pain score upon movement in the combination group. (d) Cumulative dose of sufentanil. (e) High-sensit... | PMC9851777 |
Keywords | PMC10689247 | |||
Malaria elimination and control over the past decades | Malaria | PARASITIC DISEASE, MALARIA | Malaria is a parasitic disease transmitted by infected | PMC10689247 |
Rethinking malaria | malaria | MALARIA | High- and low-burden countries require different approaches to increase the impact of malaria-related interventions. Value-based health services delivery is a relatively new key term for sub-national tailoring of malaria control strategies in line with the needs of local communities | PMC10689247 |
CHW as an extension of health care- and surveillance systems | malaria | MALARIA, DISEASE, DISEASES | An important factor contributing to preventable malaria morbidity and mortality, as well as morbidity and mortality from other preventable diseases is a lack of access to the healthcare system CHWs often are lay people trained on program-specific health care interventions. Due to their access to hard-to-reach communiti... | PMC10689247 |
Community health workers in clinical research | RECRUITMENT | In research, CHWs can be deployed to improve post-hospital outcomes or adherence to routine medical interventions An equally important basis for the successful conduct of clinical research projects is a trusting relationship between CHWs and communities. As CHWs often live in the communities they serve, CHW-centered re... | PMC10689247 | |
Importance of adequate training | An important prerequisite for a functional collaboration with and inclusion of CHWs into the health care system is provision of adequate protocols and training [ | PMC10689247 | ||
The role of CHW in the CANTAM- | malaria, HIV or viral hepatitis | MALARIA | The CANTAM-The trial was conducted at six centers in five African countries with the main objective to assess the safety of PA in malaria patients with underlying liver function abnormalities, comorbidities like HIV or viral hepatitis, and in children under 1 year of age To evaluate safety and real-world effectiveness,... | PMC10689247 |
Community health worker training and participant follow-up in the CANTAM- | bleeding, contusions, nausea;, fatigue, fever, malaria, stomachache, faintness, hepatotoxicity, Hypersensitivity, rash, jaundice, pruritus, breathlessness, ill, flushing | BLEEDING, ADVERSE EVENTS, MALARIA, HYPERSENSITIVITY, LOSS OF APPETITE, REMISSION, MALARIA, EVENTS, HYPERSENSITIVITY | To neither jeopardize participants’ reporting behavior nor overlook important safety signals, continuous training was paramount for CHWs to remain alert of their responsibilities. Training was given during the site initiation visit and included an explanation of material and procedures as well as role play. Role plays ... | PMC10689247 |
Other examples of community health workers-centered research | CHW-centered approaches are also being implemented by other research projects and surveillance programs. An example of a CHW-centered research project is the MiMBa Pregnancy Registry to assess the safety of antimalarial use in pregnancy | PMC10689247 | ||
Conclusion | malaria | MALARIA | CHW involvement can be key to targeting hard-to-reach and vulnerable populations and constitutes a crucial role in malaria control and elimination in sub-Saharan Africa. In the CANTAM-The CANTAM- | PMC10689247 |
Declarations of competing interest | MALARIA | IBF and SD are full-time employees at Medicines for Malaria Venture, JS is a full-time employee at Shin-Poong Pharmaceutical and SAB is a consultant paid by Shin-Poong Pharmaceutical. The other authors declare no conflict of interest. | PMC10689247 | |
References | PMC10689247 | |||
Funding | MALARIA | This work was supported by Medicines for Malaria Venture (MMV), Geneva, Switzerland. A full list of donors to MMV is available on its website [ | PMC10689247 | |
Ethical approval | Ethical approval was not required for this manuscript. | PMC10689247 | ||
Author contributions | Conceptualization: IBF, SAB, MG, SD, GMN; Data curation: not applicable; Formal analysis: not applicable; Funding acquisition: SD, IBF, JS, SAB; Investigation: MG; Methodology: MG, IBF, SD, GMN; Project administration: SD, MG, FN, AAA, GTL, GMN, SBA, JDB, NYN; Resources: SD, IBF, SAB, JS, PGK, FN, AAA, GTL, GMN, SBA, J... | PMC10689247 | ||
Purpose | advanced/metastatic | ASTRIS study aimed the largest to evaluate the effectiveness and safety of second- or higher-line osimertinib in patients with advanced/metastatic epidermal growth factor receptor ( | PMC10423102 | |
Methods | Adults with | PMC10423102 | ||
Results | TTD | EVENTS, ADVERSE EVENT | A total of 1350 patients were included. Response rate was 55.7% (95% confidence interval [CI] 0.53–0.58). The median PFS and the median TTD were 11.7 months (95% CI 11.1–12.5) and 13.9 months (95% CI 13.1–15.2), respectively. Overall, 389 patients (28.8%) had at least one protocol-specified adverse event (AE); AEs of i... | PMC10423102 |
Conclusion | T790M-positive NSCLC | EVENTS | Osimertinib was effective in Chinese patients with T790M-positive NSCLC who had progressed after first- or second-generation EGFR-TKI in real-word setting and the results were consistent with ASTRIS study overall population and AURA studies. No new safety signals or events were identified. | PMC10423102 |
Clinical trial number | NCT02474355. | PMC10423102 | ||
Keywords | PMC10423102 | |||
Introduction | NSCLC, deaths, Lung cancer | LUNG CANCER, NSCLC | Lung cancer is the leading cause of cancer-related deaths worldwide, with a mortality rate of 18% (Sung et al. Epidermal growth factor receptor-tyrosine kinase inhibitors (EGFR-TKIs) are the recommended first-line treatment strategy for patients with advanced NSCLC harboring the Osimertinib is an oral, irreversible EGF... | PMC10423102 |
Materials and methods | PMC10423102 | |||
Study design | ASTRIS is an open-label, single-arm, multinational, real-world study. The study was approved by the Institutional Review Board/Ethics Committee and conducted in accordance with the International Conference on Harmonization Good Clinical Practice guidelines, the Declaration of Helsinki, local regulatory requirements, an... | PMC10423102 | ||
Participants | NSCLC, ILD | INTERSTITIAL LUNG DISEASE, SYSTEMIC DISEASE, NSCLC, CNS METASTASES | Chinese adults (≥ 18 years) with locally advanced (stage IIIB) or metastatic (stage IV) NSCLC (based on TNM staging, AJCC 7th edition), WHO performance status (PS) score of 0–2, confirmed T790M mutation and who had received prior EGFR-TKI therapy in any treatment line were included in the study. Patients with asymptoma... | PMC10423102 |
Interventions | Patients were given 80 mg osimertinib orally once daily and were continued on treatment if they still receiving clinical benefit, as judged by the investigator. | PMC10423102 | ||
Study outcomes and endpoints | death, TTD | ADVERSE EVENTS, EVENTS | The effectiveness and safety data were collected at the treatment visit (every 6 weeks) and termination visit (30 days post last dose). The outcomes included investigator-assessed response rate, PFS, time-to-treatment discontinuation (TTD) and safety profile. This study only collected the incidence of protocol-defined ... | PMC10423102 |
Statistical analysis | TTD | ADVERSE EVENT | All time-to-event outcomes and safety analyses were performed on the full analysis set (FAS) that included all patients receiving at least one dose of osimertinib. The response rate analyses were assessed on the response evaluable set, defined as those patients in the FAS who had at least one documented response assess... | PMC10423102 |
Results | PMC10423102 | |||
Progression-Free survival | death | DISEASE PROGRESSION | Disease progression or death was reported in 1059 patients (78.4%). The median PFS was 11.7 months (95% CI 11.1–12.5) for the overall population. The median PFS by tissue testing and plasma testing was 13.1 months (95% CI 12.5–13.8) and 10.0 months (95% CI 9.5–11.0), respectively (Fig. Kaplan-Meir plot for PFS in | PMC10423102 |
Clinical response rate | T790M-positive | CNS METASTASES | Response evaluation was available from 1322 patients; of them, 736 patients (55.7%) had an investigator-assessed best overall response as “responding” (95% CI 52.9–58.4). The response rate in patients with T790M-positive status by tissue testing and plasma testing was 60.4% (95% CI 56.9–63.9) and 48.9% (95% CI 44.6–53.... | PMC10423102 |
Time to treatment discontinuation | T790M-positive, TTD | Of 1350 enrolled patients, 349 patients (25.9%) transitioned to the commercial drug at the time of national reimbursement; the remaining 1001 patients (74.1%) discontinued the treatment, with a median TTD of 13.9 months (95% CI 13.1–15.2). The median TTD in patients with T790M-positive status by tissue testing and plas... | PMC10423102 | |
Discussion | CNS METASTASES | This study aimed to assess the effectiveness and safety of second-line or higher osimertinib in a real-world setting in patients with The median PFS observed in our study was 11.7 months (95% CI 11.1–12.5), which was comparable with that reported in ASTRIS global population (Marinis et al. The effectiveness was also an... | PMC10423102 | |
Acknowledgements | The authors thank all the patients and their families, investigators, trial staff, and participants of the study. The authors also thank Dr. Tanushree Goswami and Dr. Ramandeep Singh from Indegene Pvt. Ltd. for providing medical writing and editorial services in accordance with Good Publication Practice (GPP3) guidelin... | PMC10423102 | ||
Author contributions | W-LZ, C-YZ | QZ conceptualization, methodology, and writing-review and editing. H-LZ writing-review and editing. L-YJ writing-review and editing. Y-KS writing-review and editing. YC Writing-review and editing. J-MY writing-review and editing. C-CZ writing-review and editing. YH writing-review and editing. Y-PH writing-review and ed... | PMC10423102 | |
Funding | This study was supported by AstraZeneca (Södertälje, Sweden). | PMC10423102 | ||
Data availability | The datasets that were used and analysed during the current study are available from the corresponding authors on reasonable request. | PMC10423102 | ||
Declarations | PMC10423102 | |||
Conflict of interest | ONCOLOGY | QZ reports honoraria from AstraZeneca, Boehringer Ingelheim, BMS, Eli Lilly, MSD, Pfizer, Roche, and Sanofi. C–C Z reports personal fees from Lily China, Sanofi, BI, Roche China, MSD, Qilu, Hengrui, Innovent Biologics, C-stone, LUYE Pharma, TopAlliance Biosciences Inc, Amoy Diagnostics. SL received research support and... | PMC10423102 | |
Ethical approval | The study was conducted in accordance with the International Conference on Harmonization Good Clinical Practice guidelines, the Declaration of Helsinki, local regulatory requirements, and the policy on bioethics and human biologic samples of AstraZeneca. | PMC10423102 | ||
Consent to participate | Informed consent was obtained from all the participants included in the study. | PMC10423102 | ||
Consent to publish | Not applicable. | PMC10423102 | ||
References | PMC10423102 | |||
Purpose | postoperative pain, Femoral nerve block | Femoral nerve block (FNB) is widely used in patients undergoing knee arthroscopy. However, the most commonly used concentration of ropivacaine (0.2% or above) may cause an unexpected decrease in the muscle strength of the quadriceps. Therefore, a lower concentration of ropivacaine (0.1%) for FNB was administered to inv... | PMC10598127 | |
Methods | knee mobility, NRS, pain | REGRESSION | This was a double-blind, randomized, controlled trial (ChiCTR2000041404). A total of 83 patients scheduled for elective knee arthroscopy were randomized to receive 0.1% or 0.2% ropivacaine for FNB under ultrasound guidance. The primary outcomes were quadriceps strength and numerical rating scale (NRS) pain score. Quadr... | PMC10598127 |
Results | The mean (SD) quadriceps strength at 6 h after surgery was 7.5 (5.7) kg for the 0.1% ropivacaine group and 3.0 (4.4) kg for the 0.2% ropivacaine group. The mean difference adjusted for baseline characteristics was − 5.2 (95% CI − 7.2 to − 3.1) kg ( | PMC10598127 | ||
Conclusions | Compared with 0.2% ropivacaine, 0.1% ropivacaine for FNB preserved quadriceps strength at 6 h after knee arthroscopy while providing similar analgesic effects. | PMC10598127 | ||
Level of evidence | I. | PMC10598127 | ||
Keywords | PMC10598127 | |||
Introduction | Postoperative pain, arthroplasty | Postoperative pain after knee arthroscopy and arthroplasty is a main factor affecting the early postoperative joint mobility and rehabilitation of patients [Ropivacaine is a pure S (-) isomer named S-(-)-1-propyl-2′,6′-pipecoloxylidide hydrochloride monohydrate. It has a pKa of 8.07 in 0.1 M KCl solution, which is appr... | PMC10598127 | |
Materials and methods | PMC10598127 | |||
Study design and participants | ligament rupture, knee pain, trauma | CHRONIC PAIN | This blinded randomized study was approved by the Ethical Committee of the Shanghai Tenth People’s Hospital, Shanghai, China (No. SHSY-IEC-KY-4.0/19-79/01) and was registered with a clinical trials registry (ChiCTR2000041404). Written informed consent was obtained from all patients. This study was conducted between Jul... | PMC10598127 |
Randomization | Using computer-generated random sequence tables and sealed envelopes, patients were randomized to one of two groups: 0.1% ropivacaine or 0.2% ropivacaine. The envelopes, which contained the prepared local anaesthetics for FNB and a computer-generated number, were opened just before the surgery when the patients arrived... | PMC10598127 | ||
Anaesthesia and surgical procedure | femoral nerve block | All surgeries were performed according to the standard hospital protocol. Before the induction of general anaesthesia, patients in the 0.1% ropivacaine group received 20 ml of 1 mg/ml ropivacaine, while patients in the 0.2% ropivacaine group received 20 ml of 2 mg/ml ropivacaine for ultrasound-guided femoral nerve bloc... | PMC10598127 | |
Outcomes | NRS pain, pain | Data collection, including conducting all functional tests, was performed by blinded research assistants. The primary outcomes were NRS pain score and quadriceps strength. NRS pain score (0 = no pain and 10 = worst possible pain) was assessed before the operation, at the PACU, and 6 h and 24 h after the operation. The ... | PMC10598127 | |
Statistical analysis | NRS | Forty participants were needed to reach significance with a power of 85% and an alpha error of 0.025 when the noninferiority margin of the NRS was set to 0.5 and the standard deviation (SD) was set to 1. Taking patient withdrawal and other reasons for loss to follow-up during the study period into consideration, 45 par... | PMC10598127 | |
Discussion | postoperative pain, fascia iliaca block, Postoperative pain, nerve block, pain, NRS | HAND INFECTION, LOCAL INFILTRATION | The most important finding of the present study was that 0.1% ropivacaine for FNB showed less impact on quadriceps strength at 6 h after knee arthroscopy. Effective pain management and early mobilization are crucial for patients following knee surgery [Various types of regional anaesthesia, including FNB, ACB, fascia i... | PMC10598127 |
Conclusions | Compared with 0.2% ropivacaine, 0.1% ropivacaine for FNB had less effect on quadriceps strength at 6 h after knee arthroscopy, while the analgesic effects of the two doses were equivalent within 24 h. | PMC10598127 | ||
Acknowledgements | The authors thank Yingyi Qin (Ph.D., department of Military Health Statistics, Naval Medical University, Shanghai, China), statistical and methodological consultant, for his advice and assistance in the statistical analyses. The authors also thank Biao Chen (M.D., Ph.D., department of orthopaedics, Tongji Hospital, Sha... | PMC10598127 | ||
Author contributions | TZ conceived of this project, performed study design and conception, assisted with analysing data, and wrote the manuscript. TZ helped devise the statistical analysis plan, interpreted the data, and wrote the manuscript. XN helped obtain data, analyse the data, and reviewed and edited the manuscript. LL helped obtain t... | PMC10598127 | ||
Funding | This work was supported by grants from the National Natural Science Foundation of China (82201362) to Tingting Zhang, and Clinical Research Project from Shanghai Tenth People’s Hospital (YNCR2C024) to Xiaoyin Niu and (SHYCS03) to Xuan Zhao. | PMC10598127 | ||
Declarations | PMC10598127 | |||
Conflict of interest | The author(s) declare that they have no competing interests. | PMC10598127 | ||
Ethical approval | This study was approved by the Ethical Committee of the Shanghai Tenth People’s Hospital, Shanghai, China (No. SHSY-IEC-KY-4.0/19-79/01), and was registered with a clinical trials registry ( | PMC10598127 | ||
Informed consent | Informed consent was obtained from all individual participants included in this study. | PMC10598127 | ||
References | PMC10598127 | |||
Aims | Lazarus [Lazarus and Folkman in Stress | The aim of this study was to investigate whether shifting the focus to solution orientation and developing coping strategies for common errors could increase the efficiency of laparoscopic training and influence learning motivation. The concept of coping has been particularly defined by the psychologist Richard Lazarus... | PMC10156798 | |
Methods | 55 laparoscopically naive medical students learned a standardized laparoscopic knot tying technique with video-based instructions. The control group was only offered a mastery video that showed the ideal technique and was free from mistakes. The intervention group was instructed on active error analysis and watched fre... | PMC10156798 | ||
Results | There was no statistically significant difference between the intervention and control groups for number of knot tying attempts until proficiency was reached (18.8 ± 5.5 vs. 21.3 ± 6.5, | PMC10156798 | ||
Conclusion | COMPLICATIONS | Using video-based learning of coping strategies for common errors improves learning motivation and understanding of the technique with a significant difference in its qualitative implementation in laparoscopy training. The ability to think in a solution-oriented, independent way is necessary in surgery in order to reco... | PMC10156798 | |
Supplementary Information | The online version contains supplementary material available at 10.1007/s00464-023-09969-w. | PMC10156798 | ||
Keywords | Open Access funding enabled and organized by Projekt DEAL.Laparoscopic suturing and knot tying is a complex skill to learn and is a key competence for many basic and advanced laparoscopic surgical procedures [A widely used instructional approach in laparoscopy training is 1:1 instruction and supervision by an expert [A... | PMC10156798 | ||
Materials and methods | PMC10156798 | |||
Setting and participants | This study was conducted as part of a voluntary elective course for medical students in the clinical part of their studies at Heidelberg University. This study took place in the training center for MIS of the Department of General, Visceral and Transplantation Surgery at Heidelberg University Hospital. Only laparoscopi... | PMC10156798 | ||
Study design | mistakes | In this randomized controlled monocentric study, subjects were assigned to either the control or intervention group. Both groups learned laparoscopic suturing and knot tying in teams of two by video-based instructions. The intervention group was provided with laparoscopic suturing and knot tying instruction videos with... | PMC10156798 | |
Materials | Tissue damage, ‟Needle | PAD, BITE | The study was performed on a Szabo–Berci–Sackier box trainer and a standard laparoscopy tower (KARL STORZ GmbH & Co. KG, Tuttlingen, Germany). Participants sutured with two laparoscopic needle holders and a braided, absorbable Polysorb 3-0 suture with CV-25 cone ½ 22-mm needle (Medtronic Minimally Invasive Therapies TM... | PMC10156798 |
Ethical considerations | The study protocol was approved by the institutional ethics committee at Heidelberg Faculty of Medicine (S-436/2018) and informed consent was obtained from every participant. | PMC10156798 | ||
Statistical analysis | All continuous data are presented as mean values with standard deviation and were compared using Mann–Whitney | PMC10156798 | ||
Results | anxiety | SECONDARY | A total of 60 participants were recruited for the study. 55 were included in the analysis. Two participants did not meet the inclusion criteria. Three additional participants dropped out during the study and thus were not analyzed.
Both groups showed similar demographic distribution (Table Baseline characteristicsMean ... | PMC10156798 |
Discussion | In the present randomized controlled study, the use of video-based learning of coping strategies for common errors in laparoscopy training [Video-based learning of coping strategies for common errors did not reduce total training time but significantly improved technical implementation of laparoscopic suturing and knot... | PMC10156798 | ||
Limitations | In contrast to the mastery video, the coping videos were only available from a right-handed perspective. The influence of this circumstance remains questionable, since the focus of the coping videos was on individual technical errors and not on the overall motion sequence. In addition, a total of only four left-handers... | PMC10156798 | ||
Conclusion | The use of video-based training for coping strategies for common errors resulted in improved implementation of the knot tying technique, but the total training duration could not be reduced. The motivation to learn, especially the interest in the task, was increased. Understanding of the technique and subjective confid... | PMC10156798 | ||
Author contributions | FN, FL, AG, and MS contributed to conception and design. FL, AG, and CW contributed to acquisition of data. AG, FN, MW, and FL contributed to analysis and interpretation of data. FL and AG contributed to preparation of manuscript and graphics. FN, EW, MS, MW, and BPM-S contributed to critical reviewing. | PMC10156798 | ||
Funding | Open Access funding enabled and organized by Projekt DEAL. | PMC10156798 | ||
Declarations | PMC10156798 | |||
Disclosures | P. | SCHMIDT | Franziska Lang, Annabelle Sofia Gerhäuser, Caroline Wild, Erica Wennberg, Mona Schmidt, Martin Wagner, Beat P. Müller-Stich, and Felix Nickel have no conflicts of interest or financial ties to disclose. | PMC10156798 |
References | PMC10156798 | |||
Objective | To assess the impact of different vertical positions on lung aeration in
patients receiving invasive mechanical ventilation. | PMC10802776 | ||
Methods | An open-label randomized crossover clinical trial was conducted between
January and July 2020. Adults receiving invasive mechanical ventilation for
> 24 hours and < 7 days with hemodynamic, respiratory and neurological
stability were randomly assigned at a 1:1 ratio to the sitting position
followed by passive orthostas... | PMC10802776 | ||
Results | orthostasis | A total of 186 subjects were screened; of these subjects, 19 were enrolled
(57.8% male; mean age, 73.2 years). All participants were assigned to
receive at least one verticalization protocol. Passive orthostasis resulted
in mean lung ultrasound scores that did not differ significantly from the
sitting position (11.0 | PMC10802776 | |
Conclusion | orthostasis | This analysis did not find significant differences in lung aeration between
the sitting and passive orthostasis groups. A randomized crossover clinical
trial assessing the impact of vertical positioning on lung aeration in
patients receiving invasive mechanical ventilation is feasible.
Unfortunately, the study was inte... | PMC10802776 | |
INTRODUCTION | critically ill, ventilator-associated lung aeration/perfusion, neuromuscular damage | CRITICALLY ILL | Invasive mechanical ventilation (IMV), despite saving lives in the intensive care
unit (ICU), may result in neuromuscular damage and represents a risk factor for
developing ventilator-associated lung aeration/perfusion and impairment of
respiratory system function.Body positioning is associated with lung ventilation (a... | PMC10802776 |
METHODS | arrhythmia | MYOCARDIAL ISCHEMIA, ARRHYTHMIA | The present study was designed as an open-label, randomized, crossover, two-center
clinical trial to assess the impact of different vertical positions on lung aeration
in hospitalized ICU patients receiving IMV. Patients were enrolled from January to
July 2020 and followed from the medical-surgical ICUs of All consecut... | PMC10802776 |
Randomization, washout, and blinding | orthostasis | Subjects were randomized at a 1:1 ratio to one of two verticalization groups: the
sitting position followed by passive orthostasis group or the passive
orthostasis followed by the sitting position group. Participants were randomized
on the same day they were deemed to be suited to participate in the study.
Randomizatio... | PMC10802776 | |
Outcomes | bradycardia, tachycardia, arrhythmia, orthostasis, agitation, hypotension, tachypnea, hypertension, loss of lung aeration | LUNG, ARRHYTHMIA, ADVERSE EVENTS, LUNG CONSOLIDATION, HYPERTENSION | The primary outcome was lung aeration assessed using the lung ultrasound score
(LUS) at the end of each verticalization protocol (sitting position and passive
orthostasis), while the patients were in the vertical position. The LUS was also
measured at 3 additional time points to assess the consistency of the findings:
... | PMC10802776 |
Sample size | Thirty-six subjects were required to achieve a power of 90% to detect an absolute
mean difference (MD) in the LUS of 2.0 points (standard deviation - SD, 3.5
points) | PMC10802776 | ||
Statistical analysis | SECONDARY | Baseline categorical variables are described as absolute and relative
frequencies, while baseline quantitative variables are expressed as the mean and
SD or median and interquartile range (IQR). Subjects were analyzed according to
their randomization group, regardless of the treatment they received. Data
distribution w... | PMC10802776 |
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