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Sex
REGRESSION
Multinomial logistic regression with “sex” as moderating variable was calculated with cessation as dependent and “age”, “degree of education”, “primary healthcare utilization”, “social support”, “moods”, and “QoL” as predictor variables. The overall the model was significant (Being woman was associated with lower perce...
PMC10466828
Degree of education
REGRESSION
Multinomial logistic regression was calculated with “degree of education” as moderating variable, “cessation” as a dependent variable, and “age”, “healthcare utilization”, “social support”, “moods”, and “QoL” as predictor variables. The overall model was significant (For all groups (very early, early, and late cessatio...
PMC10466828
Predictors of chronic stress
mood disturbances
REGRESSION
Multinomial logistic regression with “chronic stress” as an outcome variable and “age”, “degree of education”, “healthcare utilization”, “social support”, and “QoL” as predictor variables indicated that overall model significance (Medium–low, medium–high, and high stress groups were associated with lower QoL for both p...
PMC10466828
Chronic stress—Independence of the significant predictors from BMI
REGRESSION
Two logistic regression models were calculated with chronic stress as the dependent variable. The first model was calculated with “BMI” as the predictor variable (
PMC10466828
Sex and degree of education as moderating variables for chronic stress
PMC10466828
Sex
REGRESSION
Multinomial logistic regression with sex as moderating variable was calculated with “age”, “degree of education”, “primary healthcare utilization”, “social support”, and “QoL”. The overall the model was significant (Being man or woman was found to moderate the associations for low-medium and high stress. For low-medium...
PMC10466828
Degree of education
REGRESSION, SECONDARY
Multinomial logistic regression with “degree of education” as moderating variable was calculated. The overall model was significant (Also, degree of education moderated the association for low-medium and high stress groups. For the low-medium stress group university degree was associated with lower psychological health...
PMC10466828
Discussion
fatigue, As mood disturbances
REGRESSION
Achieving weight-loss and weight-loss maintenance, key components of T2D-prevention, can be very challenging even when supportive behavioral interventions are offered [As expected based on the previous research, overall lower QoL was associated with both intervention cessation and chronic stress [In accordance with pre...
PMC10466828
Acknowledgements
Hyvärinen, Anne-Thea
ANDERSEN, RECRUITMENT, HANSEN, GILBERT, BRODIE
PREVIEW Study concept and design: Edith Feskens, Wageningen University, Netherlands.PREMIT behaviour modification intervention: Daniela Kahlert and Annelie Unyi-Reicherz (University of Stuttgart, Germany).The following contributors listed below assisted in conduct of the trial during recruitment, intervention and/or da...
PMC10466828
Authors’ contributions
LARSEN
The PREVIEW project was designed by Anne Raben, Jennie Brand- Miller, Margriet Westerterp-Plantenga, Mikael Fogelholm, Wolfgang Schlicht, and Edith Feskens. The PREVIEW intervention study (RCT) for the adult participants was designed by Anne Raben, Mikael Fogelholm, and Thomas Meinert Larsen. The PREMIT behavior modifi...
PMC10466828
Funding
Nordisk, Diabetes
DIABETES
Open Access funding enabled and organized by Projekt DEAL. The EU framework programme 7 (FP7/2007–2013) grant agreement # 312057. National Health and Medical Research Council – EU Collaborative Grant, AUS 8, ID 1067711. The Glycemic Index Foundation Australia through royalties to the University of Sydney. The NZ Health...
PMC10466828
Availability of data and materials
Data not available due to ethical/legal/commercial restrictions.Due to the nature of this research, participants of this study did not agree for their data to be shared publicly, so supporting data is not available. With reasonable request from the reviewers and subject to written agreement from all study sites and stu...
PMC10466828
Declarations
PMC10466828
Ethics approval and consent to participate
Each Intervention site (University Copenhagen (Denmark), University of Helsinki (Finland), University of Nottingham (United Kingdom), University of Sydney (Australia), University of Maastricht (The Netherlands), Medical University of Sofia (Bulgaria), University of Navarra (Spain), University of Auckland (New Zealand))...
PMC10466828
Consent for publication
Each participant was required to provide written informed consent before participation. This included information about how data was used. Participants could request data withdrawal at any time point before its publication.
PMC10466828
Competing interests
Obesity, Thomas, diabetes
OBESITY, LARSEN, DIABETES
Anne Raben has received honorariums from the International Sweeteners Association and Unilever. Pia Siig Vestentoft has received travel grants from the Cambridge Weight Plan, UK. Ian Macdonald was a member of the UK Government Scientific Advisory Committee on Nutrition, Treasurer of the Federation of European Nutrition...
PMC10466828
References
PMC10466828
Background
Pain, pain
Pain intensity may be varied during the needle advancing through different skin layers, injection into the intradermal layer may exclude mixed pain from deeper planes. This study aimed to investigate whether compressing a three-dimensional (3D)-printed disk against the skin may relieve pain associated with intradermal ...
PMC10148480
Methods
pain
After institutional review board approval, 3D-printed disks with projections were designed for this study. Enrolled patients were randomized to receive either a disk compressing against the axillary skin during the intradermal injection of local anesthesia (compressing disk group) or an intradermal injection of local a...
PMC10148480
Results
Pain
Ninety patients with American Society of Anesthesiologists I–II physical status receiving intradermal local anesthesia prior to an ultrasound-guided axillary approach were included. Eighty-seven patients completed the study, with 44 and 43 patients in disk and no disk groups, respectively. Pain scores were significantl...
PMC10148480
Conclusion
nerve block, pain
Compressing a 3D-printed disk against the skin may reduce intradermal needle pain and offers an effective alternative for nerve block induction.
PMC10148480
Supplementary Information
The online version contains supplementary material available at 10.1186/s12871-023-02088-y.
PMC10148480
Keywords
PMC10148480
Introduction
brachial plexus block, ®, pain
In the setting of brachial plexus block for elective surgery, anesthetizing the local tissues is common for reducing this kind of pain intensity during the needle insertion process [To the best of our knowledge, there are no published studies on the use of ShotBlocker® for intradermal needle insertion and injection pai...
PMC10148480
Methods
PMC10148480
Study design and patients
This prospective randomized controlled study was approved by the ethics committee of our hospital on February 28, 2022 (approval number: LW2022004) and was registered in the Chinese Clinical Trial Registry (No. ChiCTR2200057324, date of first registration: 08/03/ 2022) before the first patient enrollment. All patients ...
PMC10148480
Inclusion and exclusion criteria
allergic, anxiety, skin pain, impaired or unstable coagulation, infection
INFECTION
The patient inclusion criteria were 1) age ≥ 16 years Asian, 2) undergoing orthopedic surgery distal to the elbow, 3) American Society of Anesthesiologists (ASA) I–II physical status, 4) hospitalized patients who receiving intradermal injection of local anesthesia (intradermal lidocaine injection) prior to the ultrasou...
PMC10148480
Randomization and 3D-printed disk design
Using a Research Randomizer (We used 3-matic (Materialize; Leuven, Belgium) to compress the disks according to the design (including shape, projection arrangement) of ShotBlocker®. The disks were printed using UV-curable resins into a smooth U shape with projections on one side. The detailed design parameters were as f...
PMC10148480
Anesthesia
nerve block
STERILE
After confirming the inclusion and exclusion criteria in the operating room, all enrolled patients underwent pulse oximetry monitoring (fingertip pulse oximeter YX303, Jiangsu Yuyue Medical Equipment & Supply Co., Ltd., Jiangsu, China), without any analgesic or sedative medications. Sterile preparation was applied to t...
PMC10148480
Outcome measurement
All patients consented to the study and were instructed in completing a 100-mm horizontal line visual analog scale (VAS) [
PMC10148480
Sampling and statistical analyses
The sample size was calculated using PASS (version 21.0.3; NCSS, Kaysville, UT, USA). With a significance level (alpha) of 0.05, using a one-sided two-sample unequal-variance t-test, group sample sizes of 36 and 36 achieved 99% power to reject the null hypothesis when the means of the compressing and no compressing dis...
PMC10148480
Discussion
anxiety, pain
The findings of this study clearly indicate that the 3D-printed compressing disk may reduce the pain intensity associated with axillary intradermal needle insertion and injection. Using physical methods to relieve pain may improve patients’ quality of life by minimizing painful sensation and reducing the use of analges...
PMC10148480
Strengths and limitations of this study
pain
INFILTRATION
As strengths, the present study used randomization and uniform application sites, insertion layer, needle gauge, and patient conditions to investigate whether a compression disk with projections may reduce pain intensity during intradermal infiltration anesthesia. Our results supported compression disk use.This study h...
PMC10148480
Acknowledgements
We acknowledge Fei Xiong for her advice on statistics, Menglu Jiang for her suggestions on anesthesia procedures, and Haihong Qu and Jiali Wang for their assistance with data collection. We thank Tong Zhou from Shanghai Black Flame Medical Technology Co., Ltd., for his assistance and technical support in the field of t...
PMC10148480
Authors’ contributions
Study conception and design: JY; Grant funding application: JY and JYM; Research ethics board application and maintenance: JY and JYM; Data collection: WXC and QYL; Writing of the paper: JY; Reviewing and approval of the paper: JYM. The author(s) read and approved the final manuscript.
PMC10148480
Funding
This study received funding from the Duo-Innovative and Excellent Doctors Project of Wuxi 9
PMC10148480
Availability of data and materials
All data generated or analysed during this study are included in this published article and its supplementary information files.
PMC10148480
Declarations
PMC10148480
Ethics approval and consent to participate
The study was approved by the ethics committee of Wuxi 9
PMC10148480
Consent for publication
Not applicable.
PMC10148480
Competing interests
The authors declare no competing interests.
PMC10148480
References
PMC10148480
Subject terms
breast cancer
BREAST CANCER, THYROID, COMPLICATION, DISSECTION, BREAST
The purpose is to analyze and compare postoperative recovery and complication incidence between a periareolar incision combined with Suspension-type Mastoscopic Axillary Lymph Node Dissection (SMALND) and traditional inflated Mastoscopic Axillary Lymph Node Dissection (MALND). This was a randomized trial conducted from...
PMC10372002
Introduction
upper limb edema, paresthesia, breast cancer
DISSECTION, PARESTHESIA, POSTOPERATIVE COMPLICATIONS, BREAST CANCER
Although the incidence of breast cancer increases every year, when early-stage breast cancer patients undergo standardized treatment, their five-year survival rate can be as high as over 90%. With the rapid development of modern medical and treatment technologies, life expectancy of breast cancer patients has markedly ...
PMC10372002
Method
PMC10372002
Clinical data
breast cancer
THYROID, BREAST, BREAST CANCER
This study was conducted from June 2020 to April 2022 in the Department of Second Breast Surgery, Shengjing Hospital of China Medical University, and the Department of Thyroid and Breast Surgery, Zibo Central Hospital. The same group of doctors consecutively completed tracking and following up the breast cancer patient...
PMC10372002
Group inclusion criteria
Breast Cancer, stage-II breast cancer, tumor
TUMOR, INFILTRATION, BREAST CANCER, METASTASIS, SENTINEL LYMPH NODE
Each patient should be informed of and consent to his or her treatment;A patient should have clinical stage-I or stage-II breast cancer, without obvious skin or deep infiltration, and his or her axillary lymph node should be categorized as N1 or N0 via ultrasonic, X-ray, and breast nuclear magnetic resonance clinical ...
PMC10372002
Group exclusion criteria
chronic disease or disability, comorbidity, breast cancer patient;Those, diabetes
HYPERTENSION, DIABETES
A patient should not have comorbidity of any other severe chronic disease or disability, such as hypertension, diabetes, etc.;A patient should not be someone who could not correctly understand and make a choice due to intelligence or mental issues;A patient is not clinically above-stage-II breast cancer patient;Those ...
PMC10372002
Study methodology
paresthesia, upper limb edema
PARESTHESIA
The same group of doctors consecutively completed tracking and following up of the patients who underwent periareolar-incision breast-conserving surgery combined with SMALND or MALND. After screening and according to the inclusion and exclusion criteria, 126 patients met to the entry conditions. Of them, 64 underwent S...
PMC10372002
Surgical procedure
cancer, tumor, N0
INVASIVE DUCTAL CARCINOMA OF BREAST, CANCER, TUMOR, BREAST TUMORS
After a patient received general anesthesia, the surgeons had him or her take a supine position, abducted the upper limb on the patient’s side, disinfected the person with povidone iodine solution, and covered the body with a surgical drape. Then, surgeons made an incision on the areola of the side of the breast, and r...
PMC10372002
MALND group
First of all, the operation of breast surgery is consistent with the SMALND group.A tumescent fluid was prepared, with 125 ml 0.9% sodium chloride solution, 125 ml distilled water, 20 ml lidocaine, and 0.5 ml epinephrine hydrochloride. This solution was injected into the subcutaneous tissue of the axilla; a massage was...
PMC10372002
Statistical analysis
All data were analyzed with the software SPSS 22.0. Normal distribution of measuring data was examined with single sample Kolmogorov–Smirnov test and expressed as mean ± standard deviation. The paired data designated as “t” were used to examine, analyze, and compare the postoperative axillary daily drainage volume and ...
PMC10372002
Results
PMC10372002
Surgical characteristics
INTRAOPERATIVE BLOOD LOSS
Intraoperative blood loss, axillary processing time and daily drainage, and average drain removal time in SMALND group were lower than in MALND group. There were no significant differences in axillary lymph nodes between the two groups (Surgical characteristics.
PMC10372002
Postoperative complications
PMC10372002
Upper limb edema incidence rate
upper limb edema
REFLUX
7th day: The patient 's general elastic bandage oppresses the axillary area for 10 days after surgery. At this time, upper limb edema cannot be rule out as the pressure bandage oppresses the axillary too tightly and may affect lymphatic reflux and drainage. So the results may have certain errors. The rate was 3.12% (2/...
PMC10372002
Paresthesia incidence rate
7th day: the rate was 18.75% (12/64) in the SMALND Group and 17.74% (11/62) in the MALND Group, without differences between the groups (30th day: the rate of the patients was 6.25% (4/64) in the SMALND Group and 6.45% (4/62) in the MALND Group, without differences between the groups (90th day: the rate was 4.69% (3/64)...
PMC10372002
Discussion
tumor, breast cancer, violent lipolysis, intraoperative hemorrhage, paresthesia, allergy, hemorrhage, hypercapnia, upper limb edema
TUMOR, RECURRENCE, SUBCUTANEOUS EMPHYSEMA, SCAR, POSTOPERATIVE COMPLICATIONS, BREAST CANCER, INTRAOPERATIVE HEMORRHAGE, DISEASE, PARESTHESIA, ALLERGY, POSTOPERATIVE HEMORRHAGE, HEMORRHAGE, LENS, GAS EMBOLISM, LEAKAGE, COMPLICATIONS
In this breast cancer study, two approaches for periareolar-incision breast-conserving surgery were compared: first, a combination with traditional MALND, and, second, a combination with SMALND. The second case had little postoperative drainage volume, short drain removal time with quicker recovery, and satisfying brea...
PMC10372002
Author contributions
J.Q. L, Y.W. Z, J. C and G.J. H carried out the studies, participated in collecting data and drafted the manuscript. L.N. K, M.M.Yahya and M. Pak-Kai Wong performed the statistical analysis and participated in its design. M.M.Yahya participated in acquisition, analysis, and interpretation of data and drafted the manusc...
PMC10372002
Data availability
The datasets used and/or analyszed during the current study are available from the corresponding author on reasonable request.
PMC10372002
Competing interests
The authors declare no competing interests.
PMC10372002
References
PMC10372002
Methods
EOS, CRC, neuropathy
NEUROPATHY
This pilot randomized controlled trial of a 12-week mHealth, home-based exercise intervention, randomly assigned CRC survivors to a high-intensity interval training (HIIT) or moderate-intensity continuous exercise (MICE) prescription. The following assessments were carried out at baseline and end-of-study (EOS): handgr...
PMC10286977
Results
Seven participants were included in this pilot study (MICE: n = 5, HIIT: n = 2). Median age was 39 years (1
PMC10286977
Conclusion
CRC
An mHealth, home-based delivered exercise intervention, including a HIIT prescription, among stage II-III CRC survivors’ post-resection and adjuvant therapy was tolerable and showed trends towards acceptability.
PMC10286977
Data Availability
All relevant data are within the paper and its
PMC10286977
Introduction
cancer, colorectal cancer, CRC
CANCER, COLORECTAL CANCER
It is estimated over 151, 000 individuals will be diagnosed with colorectal cancer (CRC) in 2022, resulting in nearly 8% of all new cancer cases [Exercise oncology was identified as one of three focus areas for the expansion of mHealth, along with initiation and self-management support and survivorship care delivery [M...
PMC10286977
Methods
PMC10286977
Study design
HEART
This parallel randomized controlled trial was a 12-week mHealth, home-based exercise intervention. Exercise was remotely monitored utilizing the Polar® A370 (Polar Electro: Kempele, Finland) fitness tracking device and Polar® H10 Heart Rate (HR) sensor, that is worn around the chest. Participants were randomized to eit...
PMC10286977
CONSORT diagram.
PMC10286977
Participant recruitment and eligibility
renal disease, CRC, Cancer
RENAL DISEASE, RECURRENT DISEASE, CANCER
Stage II-III CRC survivors less than five years post-resection and adjuvant chemotherapy were recruited from the gastrointestinal medical oncology clinics at the Huntsman Cancer Institute at the University of Utah. Other eligibility criteria included: age 19–75 years; currently engaging in less than 90-minutes of struc...
PMC10286977
Assessment sessions
Baseline and EOS assessments were completed at a research center located on the University of Utah campus, which is adjacent to the health sciences/medical campus. The study team aimed to schedule assessments at times that aligned with standard of care visits with each participant’s gastroenterologist medical oncologis...
PMC10286977
Demographics questionnaire
This instrument inquired about age, race/ethnicity, marital status, education level, employment status, annual household income, and current smoking status.
PMC10286977
Exit survey
All participants completed a EOS assessment that contained space for open-text response to expand on acceptability of the exercise intervention and use of mHealth technology.
PMC10286977
Anthropometrics & body composition
Weight (kg) and height (cm) were measured using standard procedures [
PMC10286977
Cardiopulmonary exercise testing
The cardiopulmonary exercise test followed the modified Balke protocol [
PMC10286977
Peak heart rate estimation
FOX
Peak HR measured during each participant’s baseline cardiopulmonary exercise test dictated exercise intensity for that individual’s exercise prescription throughout the 12-week intervention. Data collection for this trial started in Fall 2019. After March 2020, due to COVID-19 research restrictions, we were unable to c...
PMC10286977
Handgrip strength
Physical function assessment consisted of tests for muscular strength and physical performance. The handgrip strength test is a widely used marker of muscular strength, as such we included this procedure in our investigation. A portable, hydraulic dynamometer (Jamar 5030J1) was used following a static endurance handgri...
PMC10286977
Short physical performance battery (SPPB)
The short physical performance battery was used to assess physical function and performance. SPPB is widely used both in a research and clinical setting to evaluate physical function. This method consists of three components [
PMC10286977
PROMIS physical function
The PROMIS Physical Function Short Form 6b complemented the objective measures of physical function. This version, 6b, was selected as opposed to other versions of the PROMIS Physical Function due to its strong reliability and minimal participant burden. The questionnaire consists of six items requiring a response on a...
PMC10286977
Neuropathy total symptom score-6 (NTSS-6)
CIPN
Both subjective and objective measures were used to evaluate prevalence and change in CIPN signs and symptoms. The NTSS-6 is a widely used 15-item questionnaire inquiring about whether (yes or no) an individual is experiencing the specified feeling in his/her legs and feet. It has an internal consistency of α > 0.7 and...
PMC10286977
Utah early neuropathy scale (UENS)
The UENS is a clinical examination focused on small fiber sensory function. The interrater reliability of UENS is 94% [
PMC10286977
Modified Godin leisure time physical activity questionnaire (Godin)
The modified Godin questionnaire inquires weekly frequency (times per week and average number of minutes each time) of participation in strenuous, moderate, and mild aerobic exercise. This questionnaire has a reliability coefficient of 0.81, along with significant correlations with peak aerobic capacity [
PMC10286977
Intervention
PMC10286977
Equipment and exercise protocol familiarization session
SESSION
Following completion of baseline assessment procedures, both HIIT and MICE participants completed an Equipment and Exercise Protocol Familiarization Session pertaining to the activity tracking device and randomly assigned exercise intervention. Study personnel helped participants set up the Polar® A370 (Polar Electro O...
PMC10286977
Mode of aerobic exercise for the intervention
Participants, in both groups, self-selected the mode of weight-bearing aerobic exercise (i.e., walking, jogging, elliptical, calisthenic exercises). Only weight-bearing activity was performed since the goal HR zones were based on peak HR measured during weight-bearing exercise (cardiopulmonary exercise testing on a tre...
PMC10286977
High-intensity interval training (HIIT)
RECURRENCE
The goal HIIT prescription consisted of four, 50-minute workouts per week. Each workout consisted of a 10-minute warm-up at 50–75% peak HR followed by five, 4-minute intervals at 85–90% peak HR with four minutes of active recovery at 50–75% peak HR following each 4-minute interval. This prescription was selected to fac...
PMC10286977
Moderate-intensity continuous aerobic exercise (MICE)
The goal MICE prescription was matched with HIIT in dose, and consisted of five, 60-minute workouts per week, at 50–70% peak HR. Both exercise prescriptions included a 4-week progression in time and intensity to goal exercise prescription.
PMC10286977
Monitoring exercise adherence
The Polar A370 device and Polar H10 HR chest sensor enables participants to monitor HR during each workout. The Polar®A370 device synchronized with the Polar Flow application on any smartphone device or computer. Participants were able to monitor their progress and view all exercise information with the Polar Flow appl...
PMC10286977
Statistical analysis
Participant characteristics were evaluated with descriptive statistics and presented as either frequency and percentage or median and first and third quartiles. Feasibility of HIIT was assessed at EOS. We considered our intervention feasible based on both the number of prescribed workouts completed throughout the inter...
PMC10286977
Results
PMC10286977
Participant characteristics
colorectal cancer
COLORECTAL CANCER, RECRUITMENT
Data for this trial was collected between November 2019 and February 2021. The target sample size was 30 evaluable participants; however, the trial was ended prematurely due to the impact of the COVID-19 pandemic on recruitment. A total of seven evaluable participants completed the trial (n = 2 in HIIT, n = 5 in MICE)....
PMC10286977
Participant characteristics.
HIIT = High Intensity Interval Training (n = 2), due to n of 2 raw data provided for age and BMI; MICE = Moderate Intensity Continuous Exercise (n = 5).
PMC10286977
Feasibility and acceptability of the remotely supervised exercise intervention
On average, participants completed 88.6% (95% CI 79.4, 97.8; range: 63–100%) of the number of prescribed workouts throughout the 12-week intervention. Participants, in both groups, self-selected the mode of weight-bearing aerobic exercise. Most participants reported either walking or running as their mode of exercise. ...
PMC10286977
Percent of training intervals vonsistent with the prescribed heart rate zones among HIIT participants (
HIIT = High Intensity Interval Training.Data from EOS assessments were used to evaluate acceptability of the intervention. Thematic analysis from EOS assessments related to the exit survey prompt ‘what participants liked about the exercise intervention’ coalesced around the themes of ‘personal accountability’, ‘motivat...
PMC10286977
Results from qualitative thematic analysis of open text responses.
PMC10286977
Change in health outcomes from baseline to end-of-study.
N/A = 95% confidence intervals could not be calculated because standard deviation is zero; HIIT = High Intensity Interval Training; MICE = Moderate Intensity Continuous Exercise.
PMC10286977
Anthropometrics & body composition
reductions in fat-free mass
On average, participants experienced a 0.12 kg (95% CI -1.33, 1.09 kg)) reduction in body weight upon completion of the intervention. Mean change in body composition for all participants was as follows: -0.30 kg fat-free mass (95%CI -1.41, 0.81 kg), -0.14 percent fat-free mass (95%CI -1.27, 0.99%), 0.18 kg fat mass (95...
PMC10286977
Handgrip strength
Descriptive statistics indicate a change in handgrip strength for all participants from baseline to EOS was 1.82 kg (95%CI 0.71, 2.93 kg), however, change in handgrip strength did not meet or exceed established Minimal Clinically Important Difference thresholds.
PMC10286977
Short physical performance battery (SPPB)
MINOR
We observed a mean change in SPPB score for all participants of 0.57 (95%CI -0.02, 1.15) with no change observed in HIIT and a minor increase in strength observed in MICE. No changes were observed in the HIIT group, with a modest increase in Sit-to-Stand time observed in the MICE group. Change in SPPB score did not mee...
PMC10286977