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Material and Methods
swelling, incisors, Trismus, pain, trismus
SYSTEMIC DISEASE, IMPACTED MOLARS, POSTOPERATIVE COMPLICATIONS, TRISMUS, FACIAL SWELLING, DRY SOCKET, TRISMUS, COMPLICATIONS
- Study design and sampleThis randomized, prospective, three-arm clinical study consisted of patients who presented to the Department of Oral and Maxillofacial Surgery for surgical removal of a bilaterally impacted mandibular third molar from October 2021 to April 2022. Patients participated voluntarily and signed an i...
PMC10499349
Results
postoperative pain, hematoma, alveolitis, nerve injury
HEMATOMA, ALVEOLITIS, COMPLICATIONS
Demographic characteristics are described in In the comparison between the three groups on the 1st day after surgery, all values were better in the buccal drainage method group than in the airtight suture method and the no-suture method group, but not significantly. Compared to the first day, the buccal drainage method...
PMC10499349
Comparison of treatment time and pain killer difference between three groups.
PMC10499349
Comparison of VAS and QOL scores difference between three groups.
Clinical photograph of the surgical area. (a) Airtight suture method, one stitch in the mesio-buccal incision and another stitch in the distal incision. (b) Buccal drainage method, with only one stitch in the distal incision. (c) No-suture method, with no sutures used for closure. (d) Clinical outcomes of the airtight...
PMC10499349
Discussion
swelling, alveolitis, fibrosis, pain, Dehiscence, trismus
ACUTE INFLAMMATORY RESPONSE, ALVEOLAR OSTEITIS, IMPACTION, ALVEOLITIS, FIBROSIS, SECONDARY, WOUND DEHISCENCE, ABSCESSES, DEHISCENCE, TRISMUS
The alleviation of patient discomfort from pain, swelling, and trismus following an impacted mandibular third molar removal presents a continual challenge to oral surgeons. Thus, there are many kinds of flap designs used while removing an impacted mandibular third molar with the aim of recovering the soft tissues for b...
PMC10499349
Abstract
PMC10501244
Background
LUNG CANCER
ONO‐4538‐52/TASUKI‐52 was performed in Japan, Korea, and Taiwan to determine the oncological effectiveness and safety of combining nivolumab or placebo with bevacizumab plus platinum chemotherapy for the initial (first‐line) treatment of patients with advanced non‐squamous non‐small cell lung cancer (nsNSCLC). At the i...
PMC10501244
Methods
treatment‐naïve stage IIIB/IV
Here, we present the updated OS data. Patients with treatment‐naïve stage IIIB/IV or recurrent nsNSCLC without driver mutations in
PMC10501244
Results
Overall, 550 patients were randomized. At the time of the analysis (minimum follow‐up: 19.4 months), the median OS was longer in the nivolumab arm than in the placebo arm (30.8 vs. 24.7 months; hazard ratio 0.74, 95% confidence interval 0.58–0.94). The 12‐month OS rates were 81.3% vs. 76.3% in the nivolumab vs. placebo...
PMC10501244
Conclusion
NSCLC, treatment‐naive
LUNG CANCER, ONCOLOGY, NSCLC
Nivolumab plus platinum chemotherapy and bevacizumab demonstrated longer OS vs. the placebo combination. We believe this regimen is viable as a standard, first‐line treatment for patients with advanced nsNSCLC without driver mutations in The ONO‐4538‐52/TASUKI‐52 study investigated the efficacy and safety of nivolumab ...
PMC10501244
INTRODUCTION
NSCLC, tumor
LUNG CANCER, TUMOR, NSCLC
Clinical trials have demonstrated that immune checkpoint inhibitors, when administered as monotherapy or administered together with appropriate chemotherapy regimens, are promising as first‐line treatments for non‐small cell lung cancer (NSCLC) in the absence of driver mutationsIn a Japanese phase II study, nivolumab n...
PMC10501244
MATERIAL AND METHODS
As previously described,The eligibility criteria are described in detail in our previous report.Overall, 550 patients (275 per arm)Only data for OS were analyzed through to the cutoff date of February 10, 2021 (minimum follow‐up, 19.4 months) using the intention‐to‐treat analysis set. We used the Kaplan–Meier analysis ...
PMC10501244
RESULTS
PD‐L1, Cancer
ONCOLOGY, MALIGNANT TUMORS, CANCER
The baseline characteristics of patients in the nivolumab and placebo arms are presented in Table Baseline patient characteristics.Abbreviations: ECOG PS, Eastern Cooperative Oncology Group performance status; PD‐L1, programmed death‐ligand 1; TNM, the TNM classification of malignant tumors; UICC, Union for Internation...
PMC10501244
DISCUSSION
tumor, PD‐L1
TUMOR
We performed updated analyses of treatment‐naïve patients with advanced nsNSCLC without driver mutations who were enrolled in a placebo‐controlled randomized trial in three Asian countries. At the data cutoff at which time the minimum follow‐up was 19.4 months, the nivolumab arm showed longer OS vs. placebo (HR 0.74, 9...
PMC10501244
AUTHOR CONTRIBUTIONS
PMC10501244
FUNDING INFORMATION
This study was funded by Ono Pharmaceutical Co., Ltd., and Bristol‐Myers Squibb.
PMC10501244
CONFLICT OF INTEREST STATEMENT
EPS
Ono Pharmaceutical Co., Ltd. and Bristol‐Myers Squibb funded the study, provided the study drugs, and were involved in the collection, analysis, and interpretation of the data. Employees of the sponsors reviewed and commented on the manuscript. The authors had full access to the data and took final responsibility for t...
PMC10501244
ETHICS STATEMENT
The study was approved by the Institutional Review Board or Independent Ethics Committee at all participating sites. All patients provided informed consent to participate in this study. The study was registered on
PMC10501244
ACKNOWLEDGMENTS
We wish to thank all of the patients together with their families for participating in this study, as well as the investigators and staff at each study site for their contributions. We also thank Yuki Fukuyama of Ono Pharmaceutical Co., Ltd., Osaka, Japan, for providing essential statistical support. The authors thank ...
PMC10501244
DATA AVAILABILITY STATEMENT
Qualified researchers may request Ono Pharmaceutical Co., Ltd. to disclose individual patient‐level data from clinical studies through the following website:
PMC10501244
REFERENCES
PMC10501244
Background
sarcopenic obesity
The effects of dietary intervention in managing sarcopenic obesity are controversial, and behavior change techniques are lacking in previous studies which are important for the success of dietary intervention. This study aimed to evaluate the feasibility and preliminary effects of a dietary behaviour change (DBC) inter...
PMC10521482
Methods
sarcopenic obesity
A two-armed, RCT was conducted. Sixty community-dwelling older adults (≥ 60 years old) with sarcopenic obesity were randomised into either the experimental group (n = 30), receiving a 15-week dietary intervention combined with behaviour change techniques guided by the Health Action Process Approach model, or the contro...
PMC10521482
Results
RECRUITMENT
The feasibility of the DBC intervention was confirmed by an acceptable recruitment rate (57.14%) and a good retention rate (83.33%). Compared with the control group, the experimental group significantly reduced their body weight (
PMC10521482
Conclusion
The DBC intervention could reduce body weight, and has positive trends in managing handgrip strength, gait speed, and waist circumference. Interestingly, the subtle difference between the two groups in the change of muscle mass index warrants futures investigation. This study demonstrated the potential for employing di...
PMC10521482
Trial registration
Registered retrospectively on ClinicalTrailas.gov (31/12/2020, NCT04690985).
PMC10521482
Supplementary Information
The online version contains supplementary material available at 10.1186/s12877-023-04327-w.
PMC10521482
Keywords
PMC10521482
Background
sarcopenic obesity, sarcopenic
SECONDARY, ADIPOSITY
Low muscle mass/function and excess adiposity, known as sarcopenic obesity, often coexist in older adults [A systematic review [Among the different nutritional interventions, dietary modification is a good way of managing sarcopenic obesity and may produce longer-term benefits than oral supplements alone [Two RCTs show...
PMC10521482
Methods
This study was reported according to the Consolidated Standards of Reporting Trials (CONSORT) for randomised pilot and feasibility trials [
PMC10521482
Trial design
This study was conducted as a prospective, two-armed, assessor-blinded, parallel-group, pilot randomised controlled trial (RCT) with an allocation ratio of 1:1. A qualitative interview of the experimental group was conducted after the pilot RCT. This trial was conducted between Jun 2020 and Feb 2021, and it has been re...
PMC10521482
Participants
illness, cognitive impairment, overweight or obese [ Inclusion and exclusion, dementia, sarcopenic obesity, Sarcopenia, weight loss, hearing and vision
AUTOIMMUNE DISEASE, SARCOPENIA, HEART DISEASE, METABOLIC DISORDERS
Participants were recruited from June 2020 to November 2020 by convenience sampling. The study was promoted by displaying the posters in three largest community health centres which provided a free annual physical health examination to all citizens from the age of 60 in Nanjing, China, and community staffs also helped ...
PMC10521482
Sample size
The primary objective of a pilot study is to explore the feasibility of the study. Therefore, a formal calculation of sample size is not required [
PMC10521482
Randomisation and blinding
The block randomisation method (block size = 4) was utilized, to ensure that an equally balanced number of participants were allocated to each study group (i.e., the experimental or control groups). The randomisation table was obtained from the Research Randomiser software (
PMC10521482
Statistical methods
RA
RECRUITMENT
Descriptive statistics (absolute number and percentage of participants) were used to present the length of recruitment, recruitment rate, retention rate, adherence rate, and completion rate of all the measurements. The recruitment rate of 50% and the adherence rate of 60% indicated an acceptable level, and the proporti...
PMC10521482
Results
PMC10521482
Feasibility of the intervention
RECRUITMENT
The recruitment process lasted for around six months. The recruitment rate was 57.1% (60/105), and the overall retention rate was 83.3% (50/60) (see Fig. 
PMC10521482
Acceptability of the intervention
Twenty-one participants (mean age = 68.19 ± 6.30 years old) from the experimental group attended the semi-structured interview. The adherence of the interviewees to keeping a food diary was diverse, from moderate to good (8/21) and bad (13/21). Four themes with corresponding sub-themes were synthesised from the data: (...
PMC10521482
Discussion
sarcopenic obesity
This study demonstrated that the DBC intervention is feasible and acceptable among the target population, as reflected by the relatively high attendance and retention rates, and by the positive feedback from the interviews. This study showed that the DBC could effectively reduce body weight and improve dietary quality ...
PMC10521482
Feasibility and acceptability of the intervention
We screened around 2,000 people and only 105 people were eligible. The relatively low eligibility rate (5.25%) indicates that extensive screening may be needed in a future study. It is difficult to compare the eligibility rate in this study with those of previous interventional studies because the eligibility rate vari...
PMC10521482
Preliminary effects of the intervention
The findings on preliminary effects demonstrated that body weight could decreased significantly, with a simultaneous decrease in skeletal muscle. This preliminary finding is similar to that in previous interventional studies [On the other hand, we could observe a non-significant increase in handgrip strength and gait s...
PMC10521482
Limitations and strengths
There were some limitations to this study. First, it was challenging to perform double-blinding (blinding of the interventionist and participants) due to the nature of the study. Although we maintained continuous social contact with the control group to avoid the confounding effects of psychosocial contact, it was not ...
PMC10521482
Conclusion
sarcopenic obesity
This pilot study supports the view that a dietary intervention combined with behaviour change techniques is a feasible and acceptable programme for older adults with sarcopenic obesity. The DBC intervention could reduce body weight, and has positive trends in managing handgrip strength, gait speed, and waist circumfere...
PMC10521482
Electronic supplementary material
Below is the link to the electronic supplementary material. Supplementary Material 1
PMC10521482
Acknowledgements
We sincerely thank the community health centres in Nanjing, China for the support in providing data collection settings. We thank faculties of Nanjing Medical University for helping connect the research settings. We also thank the experts involved in Delphi methods for their professional comments, research assistants f...
PMC10521482
Authors’ contributions
YHY, JYWL and MV were all involved in the design of the study and initiated the study. YHY was accountable throughout for the data collection and data analysis, and drafted the manuscript. JYWL was accountable for the quality control of the study. JYWL and MV both commented and rewrote the manuscript. All authors read ...
PMC10521482
Funding
This study is funded by The Hong Kong Polytechnic University for supporting postgraduate students, the grant number is not available.
PMC10521482
Data Availability
The data and materials are not publicly availabe as the participants did not consenting to share their data. Further detials about the data and ethical conditions are available from the corresponding author on reasonable request.
PMC10521482
Declarations
PMC10521482
Ethics approval and consent to participate
All methods were performed in accordance with the Declaration of Helsinki. This study obtained ethical approval from the research committee of The Hong Kong Polytechnic University (HSEARS20191007001) and the community centres. The written informed consent of the participants was obtained prior to the collecting of data...
PMC10521482
Consent for publication
Not applicable.
PMC10521482
Competing interests
The authors declare no competing interests.
PMC10521482
References
PMC10521482
Purpose
The opportunities for surgical training and practice in the operating room are in decline due to limited resources, increased efficiency demands, growing complexity of the cases, and concerns for patient safety. Virtual reality (VR) offers a novel opportunity to enhance surgical training and provide complementary three...
PMC10796652
Methods
Thirty medical students were randomized into two groups and taught mastoidectomy in a structured manner. One group utilized a VR temporal bone model during the training while the other group used more traditional materials such as anatomy books. After the training, all participants completed a mastoidectomy on a 3D-pri...
PMC10796652
Results
injuries
The VR training method was rated better by the participants, and they also needed less guidance during the mastoidectomy. There were no significant differences in operational time, the occurrence of injuries, self-assessment scores, and the surgical outcome between the two groups.
PMC10796652
Conclusion
Our results support the utilization of VR training in complete novices as it has higher trainee satisfaction and leads to at least as good results as the more traditional methods.
PMC10796652
Supplementary Information
The online version contains supplementary material available at 10.1007/s00405-023-08143-1.
PMC10796652
Keywords
Open access funding provided by University of Eastern Finland (UEF) including Kuopio University Hospital.
PMC10796652
Introduction
Increased concern for patient safety and operating room efficiency, shorter workweeks and the ever-increasing complexity of the surgical cases have decreased the number of opportunities the residents have for hands-on training [Numerous studies have suggested that utilizing virtual reality (VR) technology in surgical t...
PMC10796652
Materials and methods
PMC10796652
Study design
This study was designed as a prospective randomised study. We recruited medical students with minimal experience in surgery and randomly split them into two groups: the virtual reality group (VRT) and the traditional training, control group (TT). Both groups received identical training utilizing two different methods a...
PMC10796652
Mastoidectomy drilling procedure
SCHMIDT
All participants performed a mastoidectomy on 3D-printed temporal bone models (Temporal Bone Patient “Schmidt”, Phacon, USA, Atlanta) using a surgical microscope (Zeiss Omni Pico), a surgical high-speed drill with irrigation and a suction tool (Image Task 1: Identify the correct starting position from the landmarks on ...
PMC10796652
Factors and performance metrics
PMC10796652
Evaluation of the training method
APPENDIX
After the training session, each participant filled out a structured evaluation form (Appendix 1.) in which they evaluated the training method used. Free-form feedback was also collected about the possible advantages or the drawbacks of each method. The result of the survey was also utilized for monitoring quality cont...
PMC10796652
Operational time and the need for assistance
APPENDIX
During the procedure, the authors recorded the timestamps of completed subtasks related to the important landmarks using custom-made software (Python 3.9) (Appendix 4.). The software also logged the total operational time and the timestamps of participants’ requests for assistance.
PMC10796652
Self-assessment
ANDERSEN, APPENDIX
After the procedure, the participants assessed their own performance using a structured form (Appendix 2.) by Andersen et al. [
PMC10796652
Surgical outcome
injuries
A blinded evaluation of the drilled 3D-printed temporal bones was carried out by two experts using a modified Welling Scale [For getting an overall and the most objective evaluation of the participants’ performance, a non-weighted composite variable was formed based on Possible correlations between the time to completi...
PMC10796652
Statistics
Statistical analysis was conducted in the SPSS Base 27.0 Statistical Software Package (SPSS Inc, Chicago, IL, USA). The performance of the two groups were compared with the independent samples Mann—Whitney
PMC10796652
Discussion
infections, mistakes
INFECTIONS, COMPLICATIONS
In this prospective randomized study, we taught mastoidectomy to 30 volunteer medical students with two training methods (VR and traditional) and assessed their performance using multiple subjective and objective metrics related to mastoidectomy performance. We recruited medical students without any prior experience in...
PMC10796652
Funding
Open access funding provided by University of Eastern Finland (UEF) including Kuopio University Hospital. State Research Funding of the Kuopio University Hospital. The Finnish Medical Foundation. Suomen korvakirurgiyhdistys.
PMC10796652
Data Availability
The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.
PMC10796652
Declarations
PMC10796652
Conflict of interest
The authors have no conflict of interest to disclose.
PMC10796652
References
PMC10796652
Objectives
SWo and SG are joint senior authors.‘Healthier Wealthier Families’ (HWF) seeks to reduce financial hardship in the early years by embedding a referral pathway between Australia’s universal child and family health (CFH) services and financial counselling. This pilot study investigated the feasibility and short-term impa...
PMC10668198
Methods
Setting: CFH services in five sites across two states, coinciding with the COVID-19 pandemic. Participants: Caregivers of children aged 0–5 years experiencing financial hardship (study-designed screen). Design: Mixed methods. With limited progress using a randomised trial (RCT) design in sites 1–3 (March 2020–November ...
PMC10668198
Results
including reduced stress
355/434 caregivers completed the screen (60%–100% across sites). In RCT sites (1–4), 79/365 (19%–41%) reported hardship but less than one-quarter enrolled. In site 5, n=66/69 (96%) caregivers reported hardship and 44/66 (67%) engaged with financial counselling; common issues were utility debts (73%), and obtaining enti...
PMC10668198
Conclusions
Financial hardship screening via CFH was acceptable to caregivers, direct referral was feasible, but individual randomisation was infeasible. Larger-scale implementation will require careful, staged adaptations where CFH populations and the intervention are well matched and low burden evaluation.
PMC10668198
Trial registration number
ACTRN12620000154909.
PMC10668198
STRENGTHS AND LIMITATIONS OF THIS STUDY
The lessons from this pilot can inform planning for implementation and evaluation at scale, to maximise the potential benefits generated by the model.Limitations included small sample sizes, short-term follow-up, lack of control group and lack of quantitative data on non-financial impacts.The study prioritised families...
PMC10668198
Introduction
adversity
Strengthening financial security can buffer families from early adversity and enhance the environments that help children thrive.While the mechanisms are complex, it is understood that increased household income benefits children directly through better food, stable housing and healthcare (the investment model), as wel...
PMC10668198
Methods and analysis
PMC10668198
Setting
adversity
DISEASE
Australia’s universal Child and Family Health (CFH) services offer free, community-based healthcare to families with children from birth to school entry. Available in all Australian jurisdictions, CFH services are delivered by nurses, often in partnership with allied health providers and working with interpreters as ne...
PMC10668198
Design
RECRUITMENT
When the HWF pilot study was registered with the Australian and New Zealand Controlled Trials Registry (ACTRN12620000154909, 13 February 2020), it was designed as a feasibility RCT in one Victorian site. However, implementation and evaluation during the COVID-19 pandemic required protocol iterations developed through c...
PMC10668198
Design iterations
For site 4, the RCT protocol was simplified. Research processes such as informed consent and questionnaires were shortened, and follow-up was reduced from two caregiver surveys at 3 and 6 months to one at 6 months (see More substantive design changes were implemented for site 5. Instead of an RCT, the model employed di...
PMC10668198
Patient and public involvement
Patients and service providers were involved in the design and conduct of this research. During the feasibility stage, the choice and acceptability of financial hardship items was informed by discussions with CFH providers and financial counsellors, and between CFH providers and their clients. During the implementation...
PMC10668198
Results
PMC10668198
Feasibility (aim 1)
PMC10668198
Disclosure of financial hardship (eligibility)
In the universal CFH service sites,
PMC10668198
Consent/enrolment and follow-up in the study
Across the four RCT sites (1–4), 79 caregivers disclosed financial hardship and were thus eligible (
PMC10668198
Caregivers who accessed, attended and completed the intervention
In site 3, the two caregivers who were allocated to the control group subsequently identified as high priority and were referred to financial counselling. All six caregivers enrolled in site 3 engaged with the financial counsellor, but no follow-up data were provided. Across the other RCT sites, no other intervention o...
PMC10668198
Outcome of feasibility
Overall, the feasibility measures for sites 1–4 met definite Stop criteria for progressing to a larger scale evaluation (defined in
PMC10668198
Short-term impacts identified by quantitative evaluation (aim 2)
PMC10668198
Financial impacts
Centrepay
The lack of follow-up data from caregivers and financial counsellors in the RCT sites 1–4 precludes the analysis described in the published Protocol.Activities and benefits of financial counselling in site 5Centrelink is a government service which provides support to Australians who face financial hardship. Centrepay i...
PMC10668198
Other (non-financial) impacts
As above, the lack of follow-up data across the RCT sites (1–4) precluded the analysis of non-financial impacts described in the published protocolAt CFH screening:Of 28, 11 (39%) caregivers completed the MGMQ, of which 8/11 (73%) disclosed emotional distress (vs not).Only 4/28 (8%) caregivers completed the PWI, mean 4...
PMC10668198
Short-term impacts identified by qualitative evaluation (aim 2)
PMC10668198
Caregiver characteristics (site 5)
In site 5, at the final appointment, the financial counsellor invited 39 caregivers to take part in the qualitative interview on behalf of the research team. Ten caregivers agreed and eight took part including one with an interpreter. Of the two who were not interviewed, one was unavailable at their scheduled time, and...
PMC10668198
Caregiver perspectives (site 5)
SAID, COLD
Caregivers who engaged with financial counselling were unanimous in finding the intervention beneficial. Four core themes (benefits) emerged and are presented with illustrative quotes, noting some overlap between themes.Theme 1: Reduced stress and gratitude for emotional support and advocacy received.Caregivers describ...
PMC10668198
Discussion
This Australian pilot study aimed to test the feasibility and short-term impacts of a systematic referral pathway between universal CFH and financial counselling services. While financial hardship screening by CFH providers was broadly acceptable to caregivers of young children, a feasible referral model was establishe...
PMC10668198