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Statistics | Values are summarized as mean (standard deviation) or median (interquartile range). Continues data of normal distribution were compared using students t-test. Within-individual comparisons between baseline and follow-up echocardiographies were performed using the paired t-test. Fisher’s Exact test was used to compare categorical variables. Mean difference in changes was calculated as the between group difference in paired estimates to control for random differences in baseline measurements. Thus, the presented results represent absolute changes between study groups. Estimated differences are presented with 95% confidence intervals (95%CI). General linear models were used to assess the correlation between p-K and echocardiographic measurements and presented with R | PMC10673982 | ||
Sample size calculation | To detect a clinically meaningful difference in changes in GLS of 1% with a standard deviation of 1.5 and with a two-tailed α = 0.05 and 1-β = 0.8 in a 1:1 randomization design, 21 patients in each group were needed. A total of 50 patients were included to account for potential dropouts. | PMC10673982 | ||
Results | DILATED CARDIOMYOPATHY, ISCHEMIC HEART DISEASE, ATRIAL FIBRILLATION, IHD, MINERALOCORTICOIDS | Fifty patients with low normal to moderately reduced LVEF were randomized: 26 patients to the intervention group and 24 to the control group. The participants had a mean age of 58 years (SD 14) and 81% were male. The mean p-K was 3.95 mmol/l (SD 0.19), mean LVEF was 48% (SD 7), and mean GLS was − 14.6% (SD 3.1%). Baseline clinical history, medication, blood test results, and echocardiographic parameters were similar in the two groups (Table
Baseline characteristics for patients in the intervention and control groupDisplayed as mean (± SD) or number (%). A: Late diastolic mitral inflow velocity, ACEi: Angiotensin converting enzyme inhibitor, Afib: Atrial fibrillation, ARB: Angiotensin-II receptor blocker, DCM: Dilated cardiomyopathy, E: early diastolic mitral inflow velocity, e’: Early diastolic mitral annular velocity, GLS: Global Longitudinal Strain, IHD: ischemic heart disease, LVEF: Left ventricular ejection fraction, MD: Mechanical dispersion, MRA: Mineralocorticoid receptor antagonist, RV FWS: Right ventricular free wall strain, TAPSE: Tricuspid annular plane systolic excursion | PMC10673982 | |
Follow-up | ATRIAL FIBRILLATION, MAY, HEART | All patients completed the study and all patients in the intervention group reported full compliance to medication during the study period. Patients in the intervention group were given a mean daily dose of oral potassium supplement of 2,700 mg (~ 36 mmol) and mean dose of MRA of 23 mg. The mean difference in changes in p-K was 0.52 mmol/l (0.35; 0.69), P < 0.001 higher in the intervention as compared to the control group.The follow-up echocardiography was performed after a mean of 44 days (SD 18) after baseline, 47 days (SD 17) in the intervention group and 40 days (SD 18) in the control group (P = 0.22). Three patients were excluded from the final analysis: two due to poor image quality and one due to differences in rhythm at baseline and follow-up (sinus rhythm and atrial fibrillation) — Fig.
Flowchart showing patient randomization in the POTCAST trial from June 1st 2020 until May 31st 2021 and derivation of study population in the current substudy
Changes in clinical characteristics and echocardiographic parameters between the intervention group (n = 25) and the control group (n = 22) from baseline to follow-up. Difference in changes is calculated as change in the intervention group relative to the control groupP-value for difference in mean change in the intervention group and the control groupDisplayed as mean (± SD) or number (%). A: Late diastolic mitral inflow velocity, E: early diastolic mitral inflow velocity, e’: Early diastolicmitral annular velocity, HR: Heart rate, LVEF: Left ventricular ejection fraction, GLS: Global Longitudinal Strain, MD: Mechanical dispersion, RV FWS: Right ventricular free wall strain, TAPSE: Tricuspid annular plane systolic excursion | PMC10673982 | |
Systolic function | CONTRACTION | At follow-up, the intervention group had improved myocardial longitudinal contraction measured by GLS with a mean difference in changes of -1.0% (-2.0; -0.02), P < 0.05 compared to controls (Fig.
Mean GLS, e’, E/e’ along with 95% Confidence Interval in the intervention- and control group at baseline and follow-up | PMC10673982 | |
Diastolic function | The intervention group had improved diastolic function as measured by e’ with mean difference in changes of 0.9 cm/s (0.02; 1.7), P = 0.04 and improvement in E/e’ with mean difference in changes of -1.5 (-2.9; -0.1), P = 0.03 compared to controls. No significant difference in changes was found between groups for E, A, or E/A. | PMC10673982 | ||
Relation between p-K and mechanical function | REGRESSION | In multiple linear regression models, no correlation was found between p-K and any of the echocardiographic parameters that were improved with the intervention. GLS (ß=-0.9, P = 0.22, R | PMC10673982 | |
Sensitivity analysis | Patients in the intervention group only receiving potassium as a supplement (n = 15) had similar baseline characteristics as the control group (Supplementary Table Interobserver variability analysis showed close correlation between the two independent observers. Intraclass correlation coefficient: ICC = 0.72, P = 0.006. | PMC10673982 | ||
Safety | renal failure | RENAL FAILURE, ELECTROLYTE DISTURBANCE | No patient in either group was hospitalized due to electrolyte disturbance or renal failure between baseline and follow-up. | PMC10673982 |
Discussion | This study was designed to determine whether increased potassium levels influence systolic and diastolic myocardial performance. It is the first randomized intervention study to indicate that targeting high-normal p-K levels using dietary guidance, oral potassium supplements and MRAs improves echocardiographic indices of myocardial systolic and diastolic function. No difference in changes was found in contractile heterogeneity measured by MD between groups.The findings of the present study are in line with previous experimental and observational studies investigating myocardial mechanical function in relation to potassium depletion. Induced potassium depletion in a canine-model (n = 27) has been associated with impaired systolic and diastolic responses to stress tests with epinephrine and increased preload [In exploratory analysis of a subset of 131 patients from the TOPCAT trial, there was a trend towards improvement of Longitudinal Strain in patients treated with spironolactone (1.1% [-0.2;-2.4], P = 0.09) [ | PMC10673982 | ||
The effects of potassium on cardiovascular risk | arrhythmias, hypertensive, strokes | ARRHYTHMIAS, STROKES | The protective effects of high potassium intake on cardiovascular outcomes have been reported in several studies. The potassium-induced lowering effect on blood pressure in hypertensive patients and reduction in the risk of strokes is particularly well documented [To our knowledge this is the first study to investigate myocardial function after actively increasing potassium levels in a randomized controlled setting. The study showed an improvement in GLS which has been repeatedly reported to be a strong predictor of arrhythmias [ | PMC10673982 |
Possible mechanism for improved myocardial function with higher potassium levels | myocardial Na, heart failure, hypokalemic | HEART FAILURE, DEPOLARIZATION | Changes in potassium concentrations in- and around the cardiomyocyte affect several aspects of myocardial electrophysiology which could result in altered mechanical function. P-K determines the resting membrane potential of the myocyte and significantly impacts depolarization velocity. Additionally, cardiac repolarization is mainly driven by an outward potassium flux and a low p-K lengthens the repolarization time and increases QT dispersion and active relaxation of the myocardium as well as the action potential- and refractory period durations [The effects of variations in potassium levels are likely to be more pronounced in patients with heart failure as the remodeling of the myocardium during deterioration of left ventricular function and increased hemodynamic load, even in early stages of heart failure, includes downregulation of potassium ion channels as well as of myocardial Na,K- ATPase concentration [Patients in the present study were increased from mid-normal to high-normal levels of p-K and there could be a greater improvement by increasing patients from low or even hypokalemic levels to high-normal levels. These considerations are left for future studies. Studies with hard endpoints are needed to elucidate if the present findings improve clinical patient outcomes. | PMC10673982 |
Strength and limitations | The randomized controlled design strengthens the causal inference of the findings. The present study was open labelled and therefore patients in the control group could have been motivated to increase their potassium intake independent of the trial. This is not likely to be an important factor as p-K levels in the control group were unchanged from baseline to follow-up. The study was limited by a low sample size and larger trials are needed to confirm the findings. Further, the study was designed as an all-comer trial of patients with low-normal- to moderately reduced left ventricular ejection fraction. Thus, the cohort is heterogeneous which could affect the generalizability of the results. The primary analysis is not conclusive on whether the effects seen with the intervention on myocardial function is caused by changes in potassium homeostasis per se or the effects of MRAs. However, the sensitivity analysis of patients only receiving potassium supplements showing similar results strengthens confidence in the main hypothesis. | PMC10673982 | ||
Conclusion | Targeting p-K between 4.5 and 5.0 mmol/l with dietary guidance on a potassium rich diet, oral potassium supplements and MRAs improved indices of systolic and diastolic left ventricular function in patients with low-normal to moderately reduced LVEF. These findings may in part explain previously reported beneficial effects of increased potassium intake and prove to be of clinical importance. | PMC10673982 | ||
Acknowledgements | None. | PMC10673982 | ||
Authors’ contributions | All co-authors have contributed to the study conception and design. Material preparation and data collection were done by Ulrik Winsløw, Tharsika Sakthivel, Chaoqun Zheng, and Emil Frandsen and analysis were performed by Ulrik Winsløw, Christian Jøns, Henning Bundgaard, and Niels Risum. The first draft of the manuscript was written by Ulrik Winsløw and was critically revised by all co-authors. All co-authors read and approved the final manuscript. | PMC10673982 | ||
Funding | HEART | Open access funding provided by Royal Library, Copenhagen University Library. This study was supported by the Danish Council for Independent Research, Medical Science, the Danish Heart Foundation, Snedkermester Sophus Jacobsen og hustru Astrid Jacobsens Fond, the Hartmann Foundation, and the Novo Nordisk Foundation. The funders were not involved in planning the study design, execution, analyses, or interpretation of data. | PMC10673982 | |
Data Availability | The data is available from the corresponding author on reasonable request in accordance with the Danish Data Protection Act and the General Data Protection Regulation and after the approval by the steering committee of the POTCAST trial. | PMC10673982 | ||
Declarations | PMC10673982 | |||
Disclosures | The authors report no conflicts of interest. HB received lecture fees from Amgen, MSD, BMS and Sanofi. | PMC10673982 | ||
Transparency statement | The authors had full access to and take full responsibility for the integrity of the data. All authors have read and agree to the manuscript as written. | PMC10673982 | ||
Competing interests | The authors declare no competing interests. | PMC10673982 | ||
References | PMC10673982 | |||
Abstract | PMC9939179 | |||
Objective | DISEASE, MULTIPLE MYELOMA, MULTIPLE MYELOMA (MM), IMMUNE DEFICIENCY | Despite the availability of new agents, elderly patients with multiple myeloma (MM) usually present with poor outcomes due to the heterogeneity of disease conditions, especially immune deficiency. Regulatory B cells (Bregs) can be involved in immune defects by exerting immune regulatory functions in MM. In order to provide more evidence‐based practice for the elderly MM, the study established and assessed a stratified therapeutic model with studies on Bregs for Chinese Elderly Multiple Myeloma in 2021 (CEMM2021). | PMC9939179 | |
Methods | In this open‐label, non‐interventional, prospective study in the real world, 159 newly diagnosed MM (NDMM) patients over | PMC9939179 | ||
Results | Based on the CEMM2021 model, 147 patients had received at least one cycle of induction therapy, including bortezomib/dexamethasone (Bd) ( | PMC9939179 | ||
Conclusions | MM | MULTIPLE MYELOMA, DISEASE, IMMUNE DEFICIENCY | For the elderly NDMM, the CEMM2021 algorithm in our center might provide a valuable reference for the guidance of therapeutic strategies, with the combination of Bregs resulting in an effective and clinically meaningful prediction in contemporary treatment.The management of elderly patients with MM remains challenging due to the heterogeneity of disease conditions, especially immune deficiency. In order to provide more evidence‐based practice for the elderly MM, the study established and assessed a stratified therapeutic model with studies on Regulatory B cells for Chinese Elderly Multiple Myeloma in 2021 (CEMM2021).
| PMC9939179 |
INTRODUCTION | Multiple myeloma, tumor, MM | MULTIPLE MYELOMA, MULTIPLE MYELOMA, TUMOR | Multiple myeloma (MM), which is the second most common hematological tumor with the mean annual age‐adjusted incidence of around six per 100,000 per year in the European and American areas,Recently, regulatory B cells (Bregs) have been proven to be involved in immune defects by exerting immune regulatory functions.Aiming to provide more evidence‐based practice for elderly patients with MM, the study established and assessed a stratified therapeutic model with studies on Bregs for Chinese Elderly Multiple Myeloma in 2021 (CEMM2021). First, the CEMM2021 model designed personal total therapy plans for the elder newly diagnosed MM (NDMM) at a referral | PMC9939179 |
METHODS | PMC9939179 | |||
Patients and study design | ONCOLOGY, WEST, DISEASE | The prospective study was designed to be an open‐label, noninterventional, observational study in real‐world clinical practice, detailing how to optimize and stratify the use of current therapy regimens for elderly patients with NDMM (chiCTR2000029925). NDMM patients 65 years old and above were sequentially recruited between January 1, 2017 and April 1, 2021 and followed until July 10, 2021. This study was approved by the Ethics Committee of West China Hospital, Sichuan University (WCHSCU). All subjects provided written informed consent.The inclusion criteria were previously untreated and symptomatic MM patients 65 years of age or older and ineligible for hematopoietic stem cell transplantation. The exclusion criteria included patients participating in other clinical trials. In addition, detailed baseline clinical data were collected, including Eastern Cooperative Oncology Group (ECOG) performance status, disease stage, and laboratory test results. The definition of the high cytogenetic risk group was in accordance with the IMWG definition, | PMC9939179 | |
Treatment algorithm | MULTIPLE MYELOMA | To ascertain the best possible qualitative stratification, the final reasonable treatment decisions for all the enrolled patients were discussed with the The treatment algorithm and details for the elderly newly diagnosed with multiple myeloma. BCd, bortezomib/cyclophosphamide/dexamethasone; BRd, bortezomib/lenalidomide/dexamethasone; BTd, bortezomib/thalidomide/dexamethasone; Dara‐Bd, daratumumab/bortezomib/dexamethasone; VMP, bortezomib/melphalan/prednisone. | PMC9939179 | |
Examination of bone marrow‐derived CD19 | The detailed procedures of examination of BM‐derived Bregs by flow cytometry were described in our previous work. | PMC9939179 | ||
FDG‐PET/CT scan | The operation of FDG‐PET/CT scan was carried out following the guidelines of the European Association of Nuclear Medicine. | PMC9939179 | ||
Statistics analysis | The analysis of differences between groups was calculated by the t test or ANOVA for continuous variables and the chi‐square test or Fisher's exact test for categorical variables. Univariate analysis of survival curves was conducted according to the Kaplan–Meier method and log‐rank test. Cox proportional hazards model was applied for multivariate analysis of the prognostic factor for survival. A two‐sided α error of 0.05 was considered the statistical significance threshold. All the statistical analyses were performed by the SPSS 25.0 software and plotted by GraphPad Prism 8.0. | PMC9939179 | ||
RESULTS | PMC9939179 | |||
Baseline characteristics | multiple myeloma, Renal insufficiency, MM | MULTIPLE MYELOMA, DISEASE, ONCOLOGY, T(4;14), DELETION, T(14;16), RENAL INSUFFICIENCY | Between January 1, 2017 and April 1, 2021, a total of 159 NDMM no younger than 65 years old were recruited with a median age of 70 years old and 25.2% of MM patients were more than 75 years old. The baseline clinical characteristics of the elderly MM patients were shown in Table Baseline characteristics and treatment efficacy of the elderly multiple myeloma patients
Abbreviations: CR, complete response; DS, Durie‐Salmon; ECOG PS, Eastern Cooperative Oncology Group performance status; FISH, fluorescent in situ hybridization; ISS, International Staging System; MR, minimal response; ORR, overall response; PR, partial response; R‐ISS, Revised International Staging System; sCR, stringent complete response; SD, stable disease; VGPR, very good partial response.High‐risk was defined as the presence of t(4;14) or t(14;16) or 17p deletion.The Renal insufficiency was defined as the serum creatinine of >177 μmol/L.The ratios of comorbidities in the elderly multiple myeloma patients at enrollment. | PMC9939179 |
Treatment characteristics | Among them, 147 (92.5%) elderly NDMM patients had received at least one cycle of induction therapy, and the treatment details were illustrated in Figure In the Rd group, four (14.8%) patients with hemoglobin less than 70 g/L and 10 (37.0%) patients with platelets less than 150 × 10 | PMC9939179 | ||
Treatment efficacy | MM | Response assessments were available for 138 elderly MM patients and are summarized in Table The median treatment cycles of Bd, Bd + X, and Rd regimens were six, four, and eight, respectively ( | PMC9939179 | |
Survival outcomes | multiple myeloma | MULTIPLE MYELOMA, ONCOLOGY | The median follow‐up time was 20.8 months for the entire cohort. The median PFS was 24.5 months (95% Confidence interval [CI] 18.2–30.7) and the median OS was not reached, while the estimated 24‐month OS rate was 75.4%. At the time of analysis, 67 (42.1%) patients had progressed, and 34 (21.4%) had died in total.The median PFS of the Bd, Bd + X, and Rd regimens for the elderly NDMM patients were 24.9 months (95% CI 17.3–32.4), 24.4 months (95% CI 10.8–38.1), and not reached, respectively (Progression‐free survival and overall survival for the elderly multiple myeloma patients grouped according to different factors.The analysis of potential risk factors for PFS and OS in the whole cohort was conducted by the Kaplan–Meier method and Cox proportional hazards model (Figure Univariate and multivariate analyses of risk factors for PFS and OS
Abbreviations: Bd, bortezomib/dexamethasone; ECOG, Eastern Cooperative Oncology Group; OS, overall survival; PFS, progression‐free survival; PR, partial response; Rd, lenalidomide/dexamethasone. | PMC9939179 |
Characteristics of bone marrow regulatory B cells and PET‐CT scan in the elderly NDMM patients | MM | MULTIPLE MYELOMA | Flow cytometry analysis was applied to characterize the BM‐derived CD19Analysis of bone marrow‐derived regulatory B cells and PET/CT scan in the elderly with multiple myeloma. (A). Bone marrow from MM patients was stained with CD19, CD24, and CD38 by flow cytometry. Bregs are phenotypically identified as a distinct subset of CD19Fifty‐seven patients received PET/CT scans at diagnosis and 80.7% presented positive lesions. The median SUVmax was 3.68 (interquartile range 2.85–5.76). The difference in induction efficacy between patients with SUVmax >4.2 or SUVmax ≤4.2 was insignificant. However, the median PFS was shorter in patients with SUVmax >4.2 than in patients with SUVmax ≤4.2 (16.0 m vs. not reached, Since Bregs' ratio <10% and SUVmax >4.2 were significantly correlated with more inferior OS, we stratified the elderly MM patients into different groups according to the number of adverse risk factors. Among patients with available Breg and PET/CT scan data, 23.8% had two adverse factors, 33.3% had only one adverse factor, and 42.9% had neither of the two adverse factors. As a result, patients with both Bregs' ratio < 10% and SUVmax >4.2 experienced inferior PFS and OS than the other two groups ( | PMC9939179 |
DISCUSSION | MM | RECRUITMENT | There is no consensus on the treatment of elderly patients with MM in real‐world practice, although clinical trials have proven the efficacy of novel agents in MM. The management of elderly MM is challenging due to various comorbidities and compromised health status, generally ineligible for clinical trials limiting the evidence for the elderly.Under the guidance of the CEMM2021 model based on elderly patients' general condition, less than 20% of elderly NDMM are eligible to initiate the continuous Rd regimen as frontline therapy, which was solidly supported by the FIRST trial.On the other hand, by bortezomib‐based primary treatment, the majority of elderly NDMM in the study, not satisfying all the strict criteria mentioned above to initiate Rd, achieved comparable response and survival benefits. Similarly, a real‐world study in transplant‐ineligible NDMM from Spain revealed that bortezomib‐containing regimens (81.7%) were the most commonly prescribed primary therapy, and only 3.6% of patients received the Rd regimen.It is also noteworthy that the management of older patients with MM, presenting a highly heterogeneous nature, is often challenging due to insufficient recruitment for clinical trials. And data in real‐world settings are not yet sufficient to meet the demand, specifically, merely based on only a few reports that enrolled several hundreds of elderly NDMM patients among the globally dispersing medical centers and one Canadian study enrolled 1156 transplant‐ineligible MM from the national web‐based database.This study also confirmed that for elderly patients with MM, the proportion of BM‐derived Bregs is related to the OS, while the proportions of Bregs and SUVmax were significantly associated with OS but not PFS, which was similar to our previous studies.The CEMM 2021 treatment model provides a solid basis for small molecular inhibitors for elderly cases with MM and requires an urgent upgrade to improve survival for currently diagnosed patients in the near future. To be specific, the treatment of MM has entered the era of cellular immunotherapy and antibody‐containing immunotherapies have been recently recommended as the frontline therapy for the elderly MM by the guidelines. | PMC9939179 |
CONCLUSION | PLASMA CELL DISORDER | With the aging of the population, the interest in studies concerning elderly patients with NDMM, the most common malignant plasma cell disorder, has dramatically increased. Our data reported in Southwest China herein indicates that the treatment algorithm described above might provide a valuable reference for the guidance of therapeutic strategies in elderly NDMM. Besides, the combination of the model with Bregs led to practical and clinically meaningful stratification in the contemporary treatment for the elder NDMM. | PMC9939179 | |
AUTHOR CONTRIBUTIONS | PMC9939179 | |||
FUNDING INFORMATION | This study was supported by the National Natural Science Foundation of China for the general program (817780218) and the Natural Science Foundation of Sichuan Province (2022NSFSC1299). | PMC9939179 | ||
CONFLICT OF INTEREST | There is no conflict of interest to declare. | PMC9939179 | ||
ETHICS APPROVAL | WEST | This study was approved by the ethics committee of West China Hospital, Sichuan University (WCHSCU) and all the procedures involving human participants have complied with the Helsinki Declaration. | PMC9939179 | |
CLINICAL TRIAL REGISTRATION NUMBER | chiCTR2000029925. | PMC9939179 | ||
INFORMED CONSENT | All the participants provided written informed consent. | PMC9939179 | ||
Supporting information |
Figure S1
Click here for additional data file.
Table S1
Click here for additional data file. | PMC9939179 | ||
ACKNOWLEDGMENTS | We are grateful to all patients and their families and study group members, including co‐investigators and research nurses. | PMC9939179 | ||
DATA AVAILABILITY STATEMENT | The data that support the findings of this study are available on request from the corresponding author. | PMC9939179 | ||
REFERENCES | PMC9939179 | |||
Objectives | Orthodontic | PLAQUE | Orthodontic patients struggle with interdental cleaning calling for simpler mechanical devices to reduce the high plaque levels. The present study aimed to compare the cleansing efficacy of an oral irrigator with that of dental flossing in patients with fixed braces after 4 weeks of home-use. | PMC10160186 |
Materials and methods | PLAQUE, GINGIVAL BLEEDING | The study design is a randomized and single-blinded cross-over study. After 28 days using the products at home, hygiene indices (Rustogi Modified Navy Plaque Index (RMNPI); gingival bleeding index (GBI)) were compared between test (oral irrigator) and control product (dental floss). | PMC10160186 | |
Results | Seventeen adult individuals finalized the study. After 28 days of cleaning with the oral irrigator, RMNPI was 54.96% (46.91–66.05) compared to 52.98% (42.75–65.60) with dental floss ( | PMC10160186 | ||
Conclusions | GINGIVAL BLEEDING, PLAQUE | Oral irrigators do not remove plaque and reduce gingival bleeding as efficiently as dental floss in easily accessible regions. However, in posterior regions, where the patients struggled with the application of dental floss, the oral irrigator showed similar results. | PMC10160186 | |
Clinical relevance | orthodontic | Oral irrigators should only be recommended to orthodontic patients who cannot use interdental brushes and are not compliant with dental flossing. | PMC10160186 | |
Keywords | Open access funding provided by University of Innsbruck and Medical University of Innsbruck. | PMC10160186 | ||
Introduction | carious lesions, gingivitis, young orthodontic, enamel decalcification, orthodontic, teeth [In orthodontic | PERIODONTAL DISEASE, GINGIVITIS | Recent studies have shown that interdental cleaning in a high frequency (4 to 7 times per week) is associated with less carious lesions, less periodontal disease, and a lower number of missing teeth [In orthodontic patients, fixed braces promote supra- and subgingival accumulation of biofilm by impeding oral hygiene resulting in an altered oral microbiome, enamel decalcification, and gingivitis [In the predominantly young orthodontic patients, interdental spaces are often too narrow to use interdental brushes and flossing is challenging and time-consuming. There is a wide range of interdental cleaning devices, which should facilitate the process of interdental cleaning, since impracticability is seen as an important cause for incompliance. Oral irrigators are easy to use even in the presence of orthodontic braces and are therefore favored by many patients [Since experience shows that effective oral hygiene with fixed orthodontic appliances is time-consuming and tedious, we aim to find simpler mechanical devices for interdental cleaning. The objective of the present randomized and single-blinded cross-over study was to compare the cleansing efficacy of microburst technology with that of dental flossing in orthodontic patients with fixed braces after 4 weeks of home-use. The null hypothesis states no difference between the two methods. | PMC10160186 |
Material and methods | This study was approved by the Ethics committee of the Medical University of Innsbruck, Austria (ID AN 5123). The study was conducted in accordance with the 1964 Helsinki declaration and its later amendments. Prior to inclusion all subjects signed an informed written consent. | PMC10160186 | ||
Study subjects | gingivitis | ADHESION, SYSTEMIC DISEASE, GINGIVITIS, PLAQUE | Twenty adult subjects of the University Hospital of Orthodontic Dentistry, Innsbruck, Austria, were recruited in the period from November 5th, 2020, to January 9th, 2021. Inclusion criteria were fixed braces attached buccally at a minimum of four teeth per quadrant and existing contact points between all teeth. Exclusion criteria were pregnancy, minority, oral or systemic diseases other than gingivitis, and the need for frequent drug consumption to prevent hormonal or drug-induced distortion, especially of the gingival index. Teeth with ceramic restorations and implants were excluded from analysis due to different plaque adhesion compared to natural teeth. Data collection was performed from January 26th, 2021, to June 30th, 2021. | PMC10160186 |
Clinical intervention | bleeding, tooth | BLEEDING, GINGIVAL BLEEDING, PLAQUE, PCP, PLAQUE | The cleansing efficacy of the microburst technology (The study design consisted of four appointments for each subject. At the first appointment all probands were thoroughly informed about the study protocol, inclusion and exclusion criteria were surveyed, and an informed consent was signed. Moreover, baseline hygiene indices were evaluated using the Rustogi Modified Navy Plaque Index (RMNPI) [The Rustogi Modified Navy Plaque Index (RMNPI) splits every buccal and lingual tooth surface into nine sections (A–I) that are assessed for the presence or absence of plaque. The index allows to draw a distinction between marginal areas of the teeth (A–C), interdental areas (D, F), or overall surface areas (A–I). RMNPI is calculated as the percentage of biofilm adhering sites to measured sites. For the assessment of the gingival bleeding index (GBI), a periodontal probe (PCP 12, Hu Friedy, Chicago, USA) was inserted into the gingival sulcus to decide dichotomously at six sites per tooth (mesiobuccal–buccal–distobuccal–mesiolingual–lingual–distolingual) if bleeding occurred or not. The percentage of bleeding sites to measured sites was calculated. Teeth that were not integrated in the fixed orthodontic treatment were excluded. All examinations were conducted by one trained examinator.Randomization of the test products was computer-generated prior to investigation using After 28 days using the first test product, the study subjects presented for their second visit. The hygiene indices and inclusion/exclusion criteria were surveyed again. After a wash out phase of 28 days where the probands were practicing their usual oral hygiene procedures, they presented for the third visit. Again, plaque was disclosed, and the subjects were thoroughly instructed to use the second product followed by a professional dental cleaning. In analogy to the first test phase, the subjects used the product for 28 days and then presented for examination of the plaque and gingival index in the context of the fourth and final appointment of the study. | PMC10160186 |
Statistical analysis | GINGIVAL BLEEDING, PLAQUE | The sample size calculation was based on mean values and standard deviations of overall plaque scores provided by Heiß-Kisielewsky et al. comparing the cleansing efficacy of microburst technology (On a proband-level, RMNPI values were calculated as the total number of areas with plaque present divided by the total number of sites scored and were then compared between the two tooth brushing procedures by Wilcoxon signed-rank test. The gingival bleeding index was calculated in the same manner. If not stated otherwise, median and interquartile range are given. Significance level was set at | PMC10160186 | |
Results | Twenty individuals were recruited. Seventeen participants (seven females and ten males) finished the study with a mean age of 27.12 ± 9.23 (range 18–49) years. The drop-out rate was 15%. One participant quit because of scheduling difficulties; two participants were excluded because of antibiotic treatment during the test phase. A total of 446 teeth were included in this study. | PMC10160186 | ||
Plaque scores | bleeding, tooth | PLAQUE, BLEEDING, GINGIVAL BLEEDING, PLAQUE | At baseline, the median of overall RMNPI was 61.35% (53.29–69.56). After 28 days of interdental cleaning with microburst technology, the median of overall RMNPI was 54.96% (46.91–66.05) and statistically significantly higher than after 28 days of interdental cleaning with the control procedure dental flossing (median of overall RMNPI 52.98%; range 42.75–65.60) (Rustogi Modified Navy Plaque Index (RMNPI) after 28 days of home-use of an oral irrigator in comparison to dental floss. Rustogi modified plaque index splits every buccal and lingual tooth surface into nine sections (A–I) and was calculated as percentage of biofilm adhering sites to measured sites of Subgroup analysis revealed that the higher cleansing efficacy of the dental floss is mainly attributable to buccal and marginal areas (see Fig. Plaque and bleeding levels after 1 month of home-use. The Rustogi modified plaque index splits every buccal and lingual tooth surface into nine sections (A–I) and was calculated as percentage of biofilm adhering sites to measured sites. Gingival bleeding was calculated dichotomously at 6 sites per tooth as percentage of bleeding sites to measured sites. Data was presented using median and interquartile ranges
| PMC10160186 |
Gingival bleeding index | bleeding | GINGIVAL BLEEDING, BLEEDING, GINGIVAL BLEEDING, PLAQUE | At baseline, the median of GBI was 26.45% (range 14.49–31.55). After 28 days of interdental cleaning with the oral irrigator, GBI was 12.96% (7.14–24.31) and statistically significantly higher compared to 8.33% (5.84–15.33) after interdental cleaning with dental floss (Subgroup analysis revealed that unlike the plaque index, gingival bleeding was statistically significantly different not only at marginal sites but also at approximal sites (see Fig. Gingival bleeding index after 28 days of home-use of an oral irrigator in comparison to dental floss. Gingival bleeding index was calculated dichotomously as percentage of bleeding sites to measured sites of | PMC10160186 |
Availability of data and materials | Not applicable for this research. | PMC10160186 | ||
Author contribution | All authors contributed to the study conception and design. Material preparation, data collection, and analysis were performed by Vera Wiesmüller, Desiree Zotz, and Baran Zengin. The first draft of the manuscript was written by Vera Wiesmüller and Ines Kapferer-Seebacher and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript. | PMC10160186 | ||
Funding | Open access funding provided by University of Innsbruck and Medical University of Innsbruck. | PMC10160186 | ||
Declarations | PMC10160186 | |||
Ethical approval | The present study was carried out in accordance with the 1964 Declaration of Helsinki and its later amendments, and ethical approval was obtained by the Ethics committee of the Medical University of Innsbruck, Austria (study ID AN 5123). | PMC10160186 | ||
Informed consent | All subjects signed an informed written consent prior to the study enrolment. | PMC10160186 | ||
Competing interests | The authors declare no competing interests. | PMC10160186 | ||
References | PMC10160186 | |||
Introduction | obesity, Weight loss, weight loss | OBESITY | Weight loss through behavioural weight management interventions can have important health benefits for people with obesity. However, to maximise the health benefits, weight loss must be maintained. Evidence suggests that behavioural weight loss interventions do not exacerbate inequalities in the short term. However, no study has yet considered whether inequalities exist in long-term weight change following intervention. We aimed to investigate if there are inequalities in weight change following weight loss intervention. | PMC10028366 |
Methods | We conducted a cohort analysis of data from the Weight Loss Referrals for Adults in Primary Care (WRAP) trial ( | PMC10028366 | ||
Results | Of the 1,267 participants in WRAP, 708 had weight change data available. Mean weight change between 1- and 5-years was +3.30 kg (SD 9.10 kg). A 1 year difference in age at baseline was associated with weight change of 0.11 kg ((95% CI 0.06, 0.16), | PMC10028366 | ||
Conclusion | Except for age, we did not find evidence of inequalities in weight change following a behavioural intervention. Findings further support the use of behavioural weight management interventions as part of a systems-wide approach to improving population health. | PMC10028366 | ||
Keywords | PMC10028366 | |||
Introduction | PMC10028366 | |||
Background and Rationale | cancers, weight loss, post-menopausal breast cancers | CANCERS, CARDIOVASCULAR DISEASE, OVERWEIGHT AND OBESITY, TYPE 2 DIABETES, DISEASES | Overweight and obesity are associated with an increased risk of several non-communicable diseases such as type 2 diabetes, cardiovascular disease, and some cancers (for example, bowel and post-menopausal breast cancers) [Inequalities in health outcomes and processes (such as intervention uptake and adherence) are known to occur across many measures summarised by the PROGRESS-Plus criteria − place of residence, race/ethnicity, occupation, gender/sex, education, socioeconomic status (SES), social capital, plus other factors for which discrimination could occur such as age and sexual orientation [We have previously conducted a systematic review that considered inequalities in the uptake of, adherence to, and effectiveness of behavioural weight management interventions [The Weight Loss Referrals for Adults in Primary Care (WRAP) trial has completed follow-up data collection at the 5-year time point, allowing for a rare opportunity to study inequalities in weight change following weight loss intervention over an extended time period. All participants in the WRAP trial received a behavioural weight loss intervention (brief intervention information booklet or vouchers for 12- or 52-weeks of WW (formerly WeightWatchers)). Previous analyses of this trial have found that trial uptake (the number of invited vs. recruited participants) was higher in older participants, people from less deprived areas, and women (although the proportion of males in WRAP was much higher than seen in similar trials or routine primary care referral) [ | PMC10028366 |
Methods | This study analysed data from the Weight Loss Referrals for Adults in Primary Care (WRAP) trial as a cohort. | PMC10028366 | ||
The WRAP Trial | weight loss | The WRAP trial is a three-group randomised controlled trial of behavioural weight loss interventions. Full information about the trial design has been published elsewhere [ | PMC10028366 | |
Participants | Participants were required to be ≥18-years-old, residing in the UK, and have a BMI of ≥28 kg/m | PMC10028366 | ||
Interventions | HEART | Participants in the behavioural programmes were given vouchers and asked to attend local WW weekly meetings and access WW web tools at no cost for the duration of the intervention (12-weeks or 52-weeks). Participants allocated to the brief intervention were given a 32-page booklet from the British Heart Foundation that comprised advice and strategies on how to lose weight. Research staff read a scripted introduction that drew attention to each section of the booklet. There were no restrictions on participants in any group accessing other weight management interventions during follow-up. | PMC10028366 | |
Outcomes | Participants completed outcome assessments at baseline, 3-months, 1-year, 2-years, and 5-years. The primary outcome for this analysis was change in weight between 1-year and 5-years.Weight measurements were made at participants' primary care practice or at the research centre by trained clinical or research staff, in line with standard operating procedures and with informed consent. Participants also reported their self-measured weight, and we collected weight data from primary care records. At the 5-year time point, if clinic-measured weight data were unavailable, the self-reported weight or weight from GP records was used (The exposure variables considered for possible association with change in weight between 1- and 5-years were: (1) ethnic group | PMC10028366 | ||
Statistical Analysis | We analysed data from the WRAP trial as a cohort rather than consider intervention versus control arms separately to estimate intervention effects. We conducted data analyses using Stata v16 (StataCorp. 2019, | PMC10028366 | ||
Sensitivity Analyses | REGRESSION | To investigate the impact of missing data on the findings, we performed a sensitivity analysis using Multiple Imputation by Chained Equations (MICE). MICE assumes that data are missing at random conditional on observed participant characteristics. Variables with ≥5% and <25% missing data had missing values imputed. The number of imputations was set to be the same as the percentage of missing data.We conducted a further sensitivity analysis to consider if the source of the 5-year weight measurement had an impact on the results. The analysis excluded participants whose weight at the 5-year time point was collected through GP records or self-reported information. The final sensitivity analysis, added following peer review feedback, was conducting a single regression model containing all PROGRESS-Plus inequality characteristic variables included in this study to account for potential confounding between them. | PMC10028366 | |
Results | PMC10028366 | |||
Participant Characteristics | A total of 1,267 participants were randomised to one of the three groups (211 brief intervention, 528 12-week, 528 52-week intervention). The majority of the recruited participants were women (67.8%) and of white ethnicity (89.7%). Weight data were available for 823 participants at the 1-year follow-up. At 5-year follow-up, weight data were available for 871 participants in total. Study-measured weight was available for 632 participants; weight data were extracted from GP records for 146 participants (11.5%) and collected by self-report from 93 participants (7.3%). No weight values were available for 396 (31.3%) of participants at the 5-year follow-up.Data were available at the 1- and 5-year follow-ups for 708 participants (55.5%, Table | PMC10028366 | ||
Association between PROGRESS-Plus Criteria and Weight Change from 1- to 5-Years | weight loss | Being 1-year older compared to other participants at baseline was associated with experiencing 0.11 kg less weight regain, or greater weight loss ((95% CI: 0.06, 0.16), | PMC10028366 | |
Sensitivity Analyses | weight loss | Only one variable, education, met the conditions for performing MICE to impute missing data (between 5% and 25% missing data). The observed results using 11 imputed datasets were comparable to the primary analysis, and no associations were identified (online suppl. Table S3).In the sensitivity analysis using only study-measured weight at the 5-year follow-up (online suppl. Table S1), being older at baseline remained associated with lower weight regain or greater weight loss, but the effect size was smaller (coefficient −0.092 (95% CI: −0.15, −0.04), The final sensitivity analysis was of all independent variables included in a single model, which also adjusted for the intervention group, baseline weight, weight change between baseline and 1-year, research centre, and source of the 5-year weight data (full results available in online suppl. Table S4). In this model, older age at baseline remained associated with lower weight regain or greater weight loss (coefficient −0.15 (95% CI: −0.25, −0.04), | PMC10028366 | |
Discussion | weight loss | REGRESSION | In this study, we explored inequalities in weight change following participation in a weight loss intervention using data from the WRAP trial. Given that 55.5% of participants regained weight between the 1- and 5-year follow-up time points, the coefficients produced from the regression analyses were interpreted as indicating either less weight regain or greater weight loss compared to the reference group. We found that age at baseline was correlated with weight change between 1- and 5-years, showing that older participants experienced less weight change, and this effect was consistent across models that only used study-measured data and a model controlling for all other PROGRESS-Plus characteristics. No association was observed in our primary analysis between weight change between 1- and 5-years and other PROGRESS-Plus characteristics (ethnicity, occupation, sex, education, IMD, household income) included in our study, although in a sensitivity analysis controlling for all PROGRESS-Plus characteristics, being male was associated with greater weight regain or lesser weight loss. | PMC10028366 |
Comparison with Existing Literature | Inequalities have previously been considered in trial participation and intervention uptake, intervention adherence, and at 1-year follow-up both in the WRAP trial and other UK-based trials of behavioural weight management interventions [In the previous studies that considered differential weight outcomes at 12 months, most found no association between SES or gender and weight change outcome [There may be several reasons why older participants regained less weight than younger participants. First, in WRAP, older participants tended to have better attendance at intervention sessions [ | PMC10028366 | ||
Strengths and Limitations | weight loss | This study is the first to consider if there are inequalities in weight loss maintenance following participation in a weight loss trial at the 5-year follow-up time point. The demographics of the WRAP trial sample are similar to those of the UK population in terms of SES and ethnicity [A limitation of our study is the large amount of missing data for our primary outcome; complete outcome data were available for 55.5% of the total sample [ | PMC10028366 | |
Implications | obesity, weight loss | OBESITY, DISEASES | Despite obesity being socially patterned, with the exception of age, we did not find evidence of inequalities in weight change following weight loss intervention. Younger participants of behavioural weight management interventions may need additional support when maintaining weight loss following intervention. However, overall, our findings support the continued use of behavioural weight management interventions as part of a system-wide approach to reducing obesity and related diseases without widening existing health inequalities. Such an approach would also include population-level interventions that could support all people with obesity in maintaining weight after treatment. | PMC10028366 |
Conclusion | Except for age, we did not find evidence of inequalities in weight change following a behavioural intervention, demonstrating that behavioural weight management interventions are unlikely to generate inequalities in weight change following intervention. | PMC10028366 | ||
Statement of Ethics | WEST | Ethical approval for up to 2-year post-randomisation assessment was received by East of England Cambridge East and local approvals from the NRES Committee North West Liverpool Central and the NRES Committee South Central Oxford. Ethical approval for 5-years post-randomisation assessment was received from West Midlands-Coventry and Warwickshire Research Ethics Committee on December 8, 2017. The original trial (ISRCTN82857232) and 5-year follow-up (ISRCTN64986150) were prospectively registered with Current Controlled Trials on October 15, 2012, and February 01, 2018 ( | PMC10028366 | |
Conflict of Interest Statement | Obesity, obesity, Jason C.G., Nordisk | OBESITY, OBESITY | WRAP was a publicly funded, independent, investigator-led trial, in which WW provided the intervention at no cost and provided funds for blood sampling and analysis for the first 2-years via an MRC Industrial Collaboration Award. Neither the funders nor WW had any role in the study design, data collection, data analysis, data interpretation, or writing of the report. Amy L. Ahern is principal investigator on two publicly funded (NIHR, MRC) trials where the intervention is provided by WW at no cost. Simon J. Griffin is principal investigator on a publicly funded (NIHR) trial in which the intervention is provided by WW at no cost. Julia Mueller is a trustee for the Association for the Study of Obesity (unpaid role). Michael P. Kelly has undertaken consultancy for Slimming World and led the obesity and weight management guidelines development for NICE from 2005 until 2014. Jason C.G. Halford has undertaken consultancy from Dupont/iFF, Mars, and Novo Nordisk (all monies paid to the University of Leeds). | PMC10028366 |
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