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Background
The Delphi technique is a structured approach to group communication process developed by the RAND Corporation in the 1950s to obtain more reliable opinion from knowledgeable individuals [Despite the “fixed” components that are its hallmark, Delphi studies show great variability in their implementation. Over the years,...
PMC10436639
Methods
PMC10436639
Study design and population
cardiovascular diseases
CARDIOVASCULAR DISEASES
A randomized controlled parallel group trial design embedded in an online Delphi study was used to conduct this research. The Delphi study aimed to identify the top organizational priorities shared by patients and clinicians regarding the management of cardiovascular diseases and risk factors in primary care settings. ...
PMC10436639
Sample size
This nested trial was opportunistic in nature and statistical hypothesis testing should be viewed as exploratory. The sample size was determined by the number of participants in the Delphi study, which aimed to recruit 40 participants roughly balanced between patients and clinicians. Assuming a 15% loss to follow-up, t...
PMC10436639
Ethical considerations
The study was performed in accordance with the ethical standards of the Declaration of Helsinki [
PMC10436639
e-Delphi process
The Delphi process took place entirely online on the SurveyMonkey platform. The number of rounds was predetermined at three to minimize attrition and because this was deemed sufficient to identify the prioritization of items [
PMC10436639
Randomization
BLIND
After round 1, participants were randomly allocated 1:1 to a rating or ranking assessment procedure for the remainder of the Delphi process, which proceeded independently in the study groups. Stratified permuted block randomization was performed without involvement of the researchers by the CHUM Center for the Integrat...
PMC10436639
Rating and ranking procedures
During the second and third rounds, panelists were sent the questionnaire version that made use of their assigned assessment mode to appraise the items. Aside from specific instructions regarding each assessment procedure and related survey design questions, the content of both versions of the survey questionnaires was...
PMC10436639
Trial outcomes and statistical analyses
SECONDARY
The main outcome of this trial was the level of agreement on the top organizational items between the two study groups after round 3. This was assessed by examining the overlap between the most important items in each group and by calculating Krippendorff’s alpha coefficient on the aggregate rank order of items in the ...
PMC10436639
Agreement on top priorities
groupsAbbreviations
The subset of items reassessed in the final round coincidentally included 16 items in each study group (Table Prioritization of top items in the study groupsAbbreviations in braces refer to item themes (
PMC10436639
Discussion
PMC10436639
Main findings
In this randomized trial, we found moderately high reliability between the prioritization of top items in a rating arm and a ranking arm at the end of a Delphi process (Krippendorff alpha = 0.811, 95% CI = 0.669–0.920). Krippendorff states that it is customary to require alpha ≥ 0.8 to ensure that the data under consid...
PMC10436639
Strengths and limitations
heterogenous
The main strength of this study was the stratified random allocation of panelists to the rating or ranking study groups. This ensured both groups would be heterogenous and balanced in terms of clinical and experiential expertise as well as other potential confounders. Our Delphi panels also reflected the importance of ...
PMC10436639
Conclusions
bipolar
In this randomized trial, the use of a rating or ranking procedure led to a modestly similar prioritization of items in a Delphi survey with 30 panelists. We found that both experimental groups identified the same highest priorities but also that discrepancies became increasingly frequent when moving away from the most...
PMC10436639
Acknowledgements
We would like to thank the Delphi panelists who participated in the study, Marie-Pascale Pomey for helpful guidance during the Delphi process, and Jocelyne Gagné for the administrative support provided. We also acknowledge the two reviewers and the editor for their insightful comments which allowed us to improve the ma...
PMC10436639
Authors’ contributions
CDG
CDG and JK conceived the study. CDG was responsible for the acquisition, analysis, and interpretation of data and wrote the original draft of the manuscript. JK contributed to the interpretation of data and revised the manuscript draft. All authors read and approved the final manuscript.
PMC10436639
Funding
This work was supported by the Fonds de Recherche du Québec – Santé [award number 36266] and the Dr. Sadok Besrour Chair in Family Medicine. The funders had no role in study design; in the collection, analysis, and interpretation of data; in the writing of the manuscript; and in the decision to submit the article for p...
PMC10436639
Availability of data and materials
The dataset generated and/or analyzed during the current study is available in the Figshare repository,
PMC10436639
Declarations
PMC10436639
Ethics approval and consent to participate
All participants provided online consent to participate in the study after reviewing the information and consent form. The study was approved by the University of Montreal Hospital Research Centre’s research ethics committee (project number 17.305).
PMC10436639
Consent for publication
Not applicable.
PMC10436639
Competing interests
The authors declare that they have no competing interests.
PMC10436639
References
PMC10436639
Introduction
obesity
OBESITY, INSULIN RESISTANCE
Edited by: Claire Joanne Stocker, Aston University, United KingdomReviewed by: Sahar Foshati, Shiraz University of Medical Sciences, Iran; Maryam Ekramzadeh, Harbor-UCLA Medical Center, United StatesThis study investigated the effects of 12 weeks of high-intensity functional training (HIFT) combined with spinach-derive...
PMC10422041
Method
±
Sixty-eight participants (mean age: 27.6 ± 8.4 yrs.; mean height: 168.4 ± 2.6 cm; mean weight: 95.7 ± 3.8 kg, mean BMI: 32.6 ± 2.6 kg/m
PMC10422041
Results
There were significant interactions (p<0.001 for all) between exercise and time for adiponectin (ES:0.48), leptin (ES:0.46), resistin (ES:0.3), omentin (ES:0.65), vaspin (ES:0.46), visfatin (ES:0.62), apelin (ES:0.42), RBP4 (ES:0.63), chemrin (0.36) and semaphorin3c (ES: 0.5). Plasma levels of semaphorin3c were signifi...
PMC10422041
Discussion
obesity
OBESITY, INSULIN RESISTANCE
Our findings indicate that 12 weeks of HIFT supplemented with spinach-derived thylakoid reduced levels of leptin, resistin, vaspin, visfatin, apelin, RBP4, chemrin, semaphorin3c and insulin resistance while increasing adiponectin and omentin levels in men with obesity.
PMC10422041
Introduction
Obesity, obesity
OBESITY, OBESITY, OBESE, RECRUITMENT, INSULIN RESISTANCE, METABOLIC DISORDERS
Obesity is a chronic condition with increased global prevalence (High-intensity functional training (HIFT) is a newly described exercise training program that emphasizes functional, multi-joint movements, that can be prescribed for individuals with all fitness levels, and causes greater muscle recruitment compared to t...
PMC10422041
Materials and methods
±
RECRUITMENT
The study had an initial recruitment of 100 male volunteers, of which 32 were ineligible and leaving 68 participants in the study (mean age: 27.6 ± 8.4 yrs.; mean height: 168.4 ± 2.6 cm; mean weight: 95.7 ± 3.8 kg, mean BMI: 32.6 ± 2.6 kg/m
PMC10422041
Experimental design
TG
The participants were familiarized with all study procedures one week prior to the start of the training programs. Height, weight, and body composition were measured for each of the participants, who were then randomly assigned into one of the four equally sized groups (17 per each): Control group (CG), Supplement grou...
PMC10422041
Body composition and cardio-respiratory fitness assessments
Body weights and heights were measured using a calibrated scale (Seca, Germany) and stadiometer (Seca, Germany), respectively, and were used to calculate body mass index (BMI) (kg/m
PMC10422041
Preparation of spinach thylakoids and placebo
Fresh baby spinach leaves (Spinacia oleracea) were used to prepare of thylakoid membranes according to previously registered protocols (Powder samples were packed in identical sachets with each sachet containing 5 g of thylakoid or 5 g of cornstarch powder. The contents of the sachets were dissolved in a glass of water...
PMC10422041
Training protocols
Participants completed 36 sessions in the HIFT program that lasted up to 60 min per session. The CrossFit program was used and HIFT sessions were led by a CrossFit trainer where the first two sessions were structured as an introduction to common movements used in HIFT (e.g., squats, deadlift, press, jerks, barbell, dum...
PMC10422041
Nutrient intake and dietary analysis
Three-day food records (two weekdays and one weekend day) were obtained before and after the study to assess changes in habitual dietary intake over time (Nutritional intake in the four study groups.CG, Control group; SG, Supplement group; TG, Training group; TSG, Training supplement group. *Indicates significant diffe...
PMC10422041
Blood markers
INSULIN RESISTANCE, BLOOD, INSULIN RESISTANCE
All tests were performed between 8-10 am under standard conditions of temperature and humidity. Fasting blood samples were taken from the right arm between 12 hours and 72 hours before the first exercise session and 72 hours after the last session. Blood samples were transferred to EDTA-containing tubes, centrifuged fo...
PMC10422041
Statistical analysis
PMC10422041
Results
Measurements of nutritional intake variables are presented in Measurements of body composition and cardio-respiratory fitness variables are presented in Mean ( ± SD) and effect sizes of logical anthropomorphic levels in the all groups.CG, Control group; SG, Supplement group; TG, Training group; TSG, Training supplement...
PMC10422041
Discussion
Obesity, inflammation, hunger sensations, respiratory and musculoskeletal systems, satiety, weight loss, HIT
OBESITY, OBESE, INFLAMMATION, DISORDERS, INSULIN RESISTANCE, OXIDATIVE STRESS, TYPE 2 DIABETES, INFLAMMATORY DISEASE, ENDOTHELIAL DYSFUNCTION
The main findings of our study were that 12 weeks HIFT and spinach-derived thylakoid alone or combined improved the adipokine profiles and insulin resistance in obese men, which was greater in the TSG group, representing the synergistic effect of spinach-derived thylakoid ingestion with HIFT. Obesity is an inflammatory...
PMC10422041
Study limitations
RECRUITMENT
Our study has several limitations. Firstly, we did not identify the mechanisms by which bioactive components of spinach-derived thylakoid can improve adipokines levels. Second, our study cannot be generalized as females were not included in patient recruitment. The third is that we did not measure levels of chlorophyll...
PMC10422041
Conclusions
FM
INSULIN RESISTANCE, OBESE
Our study provides novel information on the beneficial effects of a combination of spinach-derived thylakoid supplementation with HIFT in the management of adipokines in obese males. Our data suggests that nondrug strategies such as spinach- derived thylakoid supplementation with HIFT can have protective effects on adi...
PMC10422041
Data availability statement
The raw data supporting the conclusions of this article will be made available by the authors, without undue reservation.
PMC10422041
Ethics statement
The studies involving human participants were reviewed and approved by The Research and Ethics Committee of the Islamic Azad University approved all procedures of this study (Ethics code: IR-IAU1400-46). All procedures were performed according to the latest revision of the Declaration of Helsinki. The patients/particip...
PMC10422041
Author contributions
All authors contributed equally to data collection. They read and approved the submission of the final version of the manuscript.
PMC10422041
Acknowledgments
The authors thank all the volunteers for their enthusiastic participation in this study.
PMC10422041
Conflict of interest
The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.
PMC10422041
Publisher’s note
All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or ...
PMC10422041
References
PMC10422041
Background
Inadequate bowel preparation, adenoma
ADENOMA
Inadequate bowel preparation for colonoscopy remains an issue resulting in lower adenoma detection rates and increased cost. We assessed the efficacy, safety and tolerability of high-dose bowel preparations in subjects who previously had an inadequate colonoscopy preparation.
PMC10173556
Methods
inadequate colon
We performed a multi-step prospective trial of high-dose bowel preparations with subjects assigned to the dose higher than their previous inadequate preparation. Step 1: 1.5 times the standard-dose of polyethylene glycol 3350 (PEG, 459 g) and Gatorade; and Step 2: 2.0 times the standard-dose of PEG (612 g) and Gatorade...
PMC10173556
Results
When compared to controls consuming standard-dose bowel preparations, subjects consuming high-dose preparations had no statistically significant difference in colon cleanliness as measured by the modified or total Chicago BPS scores or differences in tolerability. Baseline and post-cleaning BMPs were not significantly ...
PMC10173556
Supplementary Information
The online version contains supplementary material available at 10.1186/s12876-023-02663-0.
PMC10173556
Keywords
PMC10173556
Background
Inadequate bowel, constipation
An adequate bowel preparation for colonoscopy is necessary to visualize the mucosa and safely reach the cecum. Inadequate bowel cleansing remains an issue for up to 20% of those undergoing a colonoscopy [A high percentage of those who had a previous inadequate preparation for colonoscopy have a subsequent inadequate pr...
PMC10173556
Methods
PMC10173556
Study design and oversight
high-dose bowel, P., NCT02661750
RECRUITMENT
The protocol was approved by the AMITA Institutional Review Board (AMITA 2015-0004-02, ClinicalTrials.gov NCT02661750 first registered January 22, 2016). The trial was designed by the authors with no outside input. All authors contributed to the study conception and design, material preparation, data collection and ana...
PMC10173556
Measurements
A questionnaire was filled out by each subject immediately before the colonoscopy is provided in Additional file A questionnaire was filled out by the gastroenterologist immediately after the colonoscopy rating the cleanliness of the bowel preparation and is provided in Additional file A primary endpoint of this study ...
PMC10173556
Data analysis
Continuous variables were compared using Student’s t-test (unpaired, two-tailed). Categoric variables with 2 outcomes were compared using the Fisher's exact test (two-tailed). Categoric variables with more than 2 outcomes were compared using Pearson’s Chi-squared test (non-directional).
PMC10173556
Power calculation
A power calculation was performed as part of the study design process
PMC10173556
Results
PMC10173556
Discussion
polyps, renal insufficiency
RECRUITMENT, RENAL INSUFFICIENCY, HYPOTONIC
Our prospective, non-blinded study of high doses of PEG (459 g to 612 g) and Gatorade given as part of a multi-step escalating extended cleansing protocol is the first to report the efficacy, tolerance and safety of any high-dose preparation for subjects whose colons were inadequately cleansed for a previous colonoscop...
PMC10173556
Conclusions
inadequate bowel
Step 1 (1.5 times the standard-dose of PEG) and Step 2 (2.0 times the standard-dose of PEG) preparations from our multi-step escalating high-dose extended cleansing protocol using PEG and Gatorade were highly efficacious, safe, well tolerated and well accepted by subjects whose previous colon preparations were inadequa...
PMC10173556
Acknowledgements
The authors thank our office personnel: Karina, Joanne, Elena, Maria, Jackie, Robin and Terri; the Hinsdale Hospital GI lab nurses. The authors thank Russell D Cohen, MD for reviewing a draft version of this paper.
PMC10173556
Author contributions
DG: study concept and design; data entry; analysis and interpretation of data; drafting of the manuscript; critical revision of the manuscript for important intellectual content; statistical analysis. SG: study concept and design; data entry; analysis and interpretation of data; drafting of the manuscript; critical rev...
PMC10173556
Funding
None. AMITA waived the fee for the Institutional Review Board. All other expenses associated with this study were paid for by the authors. Subjects received no financial reward and paid for their own preparations.
PMC10173556
Availability of data and materials
All data generated or analyzed during this study are included in this published article as an EXCEL file in Additional file
PMC10173556
Declarations
PMC10173556
Ethics approval and consent to participate
Approved by the AMITA Institutional Review Board (AMITA 2015-0004-02). All methods were carried out in accordance with relevant guidelines and regulations. Informed consent was obtained from all subjects.
PMC10173556
Consent for publication
Not applicable.
PMC10173556
Competing interests
The authors declare no competing interests.
PMC10173556
References
PMC10173556
Objectives
SSI, pilon fractures
SURGICAL SITE INFECTION
In this study, we try to investigate the risk factors of postoperative surgical site infection (SSI) in closed pilon fractures and establish a nomogram prediction model.
PMC10408134
Methods
pilon fracture, Pilon fracture
From January 2012 to June 2021, 516 closed pilon fracture patients were included in this study. Of these, 387 patients were randomly assigned to the training group and 129 patients were assigned to the validation group (3:1). By univariate and multivariate Cox analysis, we identified independent risk factors for postop...
PMC10408134
Results
SSI, fracture
SSI occurred in 71 patients in the training group and 23 patients in the validation group. Ultimately, age, preoperative blood sugar, operative time, Tscherne classification and fracture classification were identified as independent risk factors for SSI. The AUC values for SSI of the training and validation group were ...
PMC10408134
Conclusion
pilon fracture
Our nomogram model had good discrimination and calibration power, so it could be used to predict SSI risk in patients with pilon fracture.
PMC10408134
Keywords
PMC10408134
Introduction
pilon fractures, infection, SSI, fractures, comminution [Postoperative infection, injuries
INFECTION, SURGICAL SITE INFECTION
In 1911, French radiologist Etienne Destot first described pilon fractures as injuries to the distal tibia's articular weight-bearing surface [In the AO/OTA classification of long bone fractures, pilon fractures are classified as extra-articular (43A), partially articular (43B), and intra-articular (43C), and are furth...
PMC10408134
Materials and methods
PMC10408134
Inclusion and exclusion criteria
pilon fractures, wire or external fixation, fracture, pilon fracture, trimalleolar ankle fracture, Trauma
PATHOLOGICAL FRACTURE
This study was approved by the Ethics Committee of our Institute (NO. 2021-K-241-01) in accordance with the guiding principles of the Declaration of Helsinki. All electronic medical records and image data were anonymised and personal identifiers were completely removed.Patients who underwent surgical treatment for pilo...
PMC10408134
Risk factors and outcome measures
pilon fractures, Polytrauma, trauma, infection, tissue damage, Fractures
INFECTION, DISEASE, SURGICAL SITE INFECTION
Demographic information including, age, gender, hemoglobin, serum albumin, c-reactive protein (CRP), blood platelet, leukocyte, preoperative blood sugar, waiting time for surgery, current smoking status and drinking status were extracted from the medical records. Among the causes of injury were falling from height, tra...
PMC10408134
Statistical analysis
Patients were randomly divided into a training group and a validation group (3:1). The data from the training group were used to search for independent risk factors to establish nomogram model. Data from the validation group were used to evaluate the prediction effectiveness of the nomogram model. Measurement data are ...
PMC10408134
Results
pilon fracture, pneumonia, fracture
REGRESSION, PNEUMONIA
From January 2012 to June 2021, 516 pilon fracture patients who underwent open reduction and internal fixation were included in this study. Of these, 387 patients were randomly assigned to the training group and 129 patients were assigned to the validation group (3:1). The baseline data of the training group and the va...
PMC10408134
Discussion
pilon fractures, fracture, infection, SSI, pilon fracture, injuries, diabetes
INFECTION, DIABETES
Ruedi and Allgower first published their surgical technique and early follow-up results for the treatment of pilon fractures in 1968, a key shift in treatment [In our research, 71 (18.35%) patients in the training group developed SSI and 23 (17.83%) patients in the validation group developed SSI. Previous studies have ...
PMC10408134
Acknowledgements
The authors gratefully acknowledge all individuals who participated in this study.
PMC10408134
Author contributions
CK, JZ and GX contributed to the idea and design. GX, XD and JZ contributed to the data acquisition and analysis. CK and JZ contributed to the manuscript writing and revision. All authors contributed to data acquisition and analysis and to manuscript writing and revision, and agreed to all aspects of the work.
PMC10408134
Funding
This research was supported by Wenzhou Basic Scientific Research project funding (Nos. Y20210421, Y20220820).
PMC10408134
Availability of data and materials
The data used to support the findings of this study are available from the corresponding author upon request. Patient data comes from our hospital's medical records follow-up database, transparent and available.
PMC10408134
Declarations
PMC10408134
Ethics approval and consent for publications
This study followed the guidelines of the “Declaration of Helsinki” and was approved by the ethics committee of our hospital (The Second Affiliated Hospital and Yuying Children’s Hospital of Wenzhou Medical University, Wenzhou, China, NO.2021-K-241-01). All data is analyzed anonymously, and personal identifiers are com...
PMC10408134
Informed consent
All the participants have given informed consent for the present study.
PMC10408134
Competing interests
The authors declare no competing interests.
PMC10408134
References
PMC10408134
Background
For years it has been stated that the need for prevention and rehabilitation is not always identified early enough. Although many individuals have regular contact with a general practitioner (GP), this access path for applying for a prevention or rehabilitation service has not been fully exploited. The important role o...
PMC10116757
Methods
The study is designed as a two-arm, pragmatic 1:1 randomised controlled study (RCT), which will be conducted in about 20 general practices in the German states of Berlin and Brandenburg. Patients (Primary outcome is the proportion of applications for prevention or rehabilitation services financed by the German Pension ...
PMC10116757
Discussion
Prevention and rehabilitation need is insufficiently identified and addressed so far. This study will determine the effectiveness of the “check-up 45 + ” in primary care.
PMC10116757
Trial registration
German Clinical Trials Register (DRKS00028303, 03.03.2022).
PMC10116757
Supplementary Information
The online version contains supplementary material available at 10.1186/s12913-023-09392-w.
PMC10116757
Keywords
Open Access funding enabled and organized by Projekt DEAL.
PMC10116757
Background
PMC10116757
Maintaining employability
Due to later retirement age and the increasing lack of qualified personnel, the importance of maintaining or restoring the work ability of older employees is increasing [
PMC10116757
Needs, application procedure and barriers
A central function of the German Pension Insurance is to promote and maintain the work ability of insured persons by financing rehabilitation measures in specialized rehabilitation facilities with a usual duration of three to four weeks. Furthermore, the German Pension Insurance is to provide prevention services for in...
PMC10116757