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Conclusions | This study confirmed that | PMC10032012 |
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Methods | PMC10032012 |
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Animal models and treatments | IUA | A total of 32 female adult SPF BALB/C mice (HUNAN SJA Laboratory animal co., LTD), weighing 22–26 g and aged 6–8 weeks, were employed in this experiment. The mice were placed in a clean, cozy, air-conditioned space with unrestricted access to food and drink. The temperature, lighting, noise, ventilation and other conditions of the observation room are controlled within the specified range. After one week of adaptation, 32 mice with similar body weight and strong adaptability were selected and divided into 3 groups, including the control group (C, n = 8) and 2 experimental groups (n = 12 per group). These experimental groups were divided into M (model of IUA) and L (IUA + After adaptation, the IUA model of mice in all experimental groups was established by using the same mechanical injury method as Yang Huan’s [ | PMC10032012 |
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Histological analysis | Histological examination was carried out in accordance with earlier studies [ | PMC10032012 |
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Cytokine assays | Mouse serum was obtained by centrifugation at 1000x g for 20 min at 4 ° C, after which serum cytokine concentrations were measured using ELISA kits for IL-1β(Cat#SEA563Mu; mouse; Cloud-Clone Crop; sensitivity range: 15.6–1,000 pg/mL; concentration range used for generating calibration curves: 1,000, 500, 250, 125, 62.5, 31.2, 15.6 and 0 pg/mL) and TNF-a (Cat# SEA133Mu; mouse; Cloud-Clone Crop; sensitivity range: 15.6–1,000 pg/mL; concentrations used for generating calibration curves: 1,000, 500, 250, 125, 62.5, 31.2, 15.6 and 0 pg/mL), according to the manufacturer’s instructions. | PMC10032012 |
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Q-PCR assays | As previously reported [ | PMC10032012 |
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Western blot analysis | Standard methods were used to perform Western blotting [ | PMC10032012 |
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Patient samples and treatments | organic gynecological diseases, IUA | FALLOPIAN TUBE, ADHESIONS, DISEASES, HYDROSALPINX | January 1, 2019 to June 30, 2020, a total of 125 patients diagnosed with IUA by hysteroscopy in the Jiangxi and Jiujiang maternal and child health hospital in China were enrolled. Patients with untreated IUA were included in I group, and the inclusion criteria were(i) age ranged from 18 to 40; (ii) IUA was the hysteroscopy’s underlying diagnostic in the outpatient setting; (iii) endocrines and ovulation were normal. The exclusion criteria included: (i) fallopian tube problems include hydrosalpinx or obstruction; (ii) other organic gynecological diseases and other basic diseases related to hormones; and (iii) refuse, irregular use of medication and loss to follow-up. Participants were randomly divided into E group (Estrogen therapy) and L group (Groups E or L were randomly assigned to each participant, and adhesions should be separated by hysteroscopy after completion of relevant examinations and a small amount of endometrium was collected during the operation for routine pathological examination. The most widely utilized hormone therapy was employed to treat the patients in group E [ | PMC10032012 |
DNA extraction and highthroughput sequencing | Vaginal secretions were collected from mice and patients in each group, and bacterial genomic DNA was extracted according to the instructions for use of DNA kit from Tiangen Biotech Co., Ltd. The nano drop spectrophotometer (NanoDrop; Thermo Fisher Scientifc, Inc.) to measure the concentration and quality of DNA. The 16 S ribosomal DNA (rDNA) V4 region was amplified using primers (F, AYTGGGYDTAAAGNG; R, TACNVGGGTATCTAATCC) in each sample, and the Q-PCR products were sequenced on the IlluminaHiSeq 2000 platform (GenBank accession number PRJNA 882,985 and PRJNA 883,005). Amplicon generation and sequencing were completed in PersonalbioCo., Ltd. (Shanghai, China). | PMC10032012 |
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Statistical analysis | QIIME (v1.8.0, | PMC10032012 |
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Acknowledgements | We would like to thank the Ethics Committee for approving this study and the JiangXi Natural Science Foundation and the National Natural Science Foundation of China for supporting this research. | PMC10032012 |
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Author Contribution | T.T.C., Z.X.L. and X.R.D. designed the study and funded it.，Q.X., L.J.H, X.T. and Y.J.L. carried out the experiments, W.J.C., D.F.L. and J.W. sorted out the experimental data，F.W. and Y.K. finished writing the article. All authors read and approved the manuscript and agree to be accountable for all aspects of the research in order to ensure that the integrity of any part of the study. | PMC10032012 |
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Funding | Open Access funding enabled and organized by Projekt DEAL.Grants from the JiangXi Natural Science Foundation helped to fund this work (grant no. 20192ACBL20034 and grant no. 20202ACBL206010). The National Natural Science Foundation of China (grant no.82260298 and grant no. 82060638) and Jiangxi Province “Double Thousand Talents Program” (Science and Technology Innovation High-level Talents Program) also supported this research. | PMC10032012 |
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Data Availability | Database bacteria for high-throughput sequencing in animal and clinical trials are available at the National Center for Biotechnology Information (NCBI), and accession number can be found below: PRJNA 882,985 and PRJNA 883,005, respectively ( | PMC10032012 |
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Declarations | PMC10032012 |
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Ethics approval and consent to participate | The animal study was approved by Ethical Committee of Nanchang Royo Biotech Co., Ltd (reference number RYE2019121702). All experiments were performed in accordance with relevant guidelines and regulations. The study is reported in accordance with ARRIVE guidelines ( The clinical experiment was approved by the Institutional Review Board (IRB) of the Second Affiliated Hospital of Nanchang University, registered in the Chinese Clinical Trial Registry (registration number: ChiCTR1900022522), which was conducted according to the ethical principles of the Declaration of Helsinki and Good Clinical Practice guidelines. All participants in clinical experiment also provided a signed written informed consent. | PMC10032012 |
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Consent for publication | Not applicable. | PMC10032012 |
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Competing interests | The study was conducted in the absence of any business or financial relationships that could be interpreted as potential conflicts of interest. | PMC10032012 |
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References | PMC10032012 |
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Subject terms | pneumonia, weight loss | PNEUMONIA | Barium sulfate and iohexol are commonly used as contrast agents for videofluoroscopic swallowing study (VFSS). This study compared their usefulness as contrast agents in visualizing components of swallowing predictable of subsequent pneumonia and unintentional weight loss after VFSS. This was a randomized, controlled, crossover trial. The two contrast agents were alternately used in the same participants, and the order in which the contrast agent was tested first was randomly assigned. After VFSS, we followed the participants for 3 months and the association between VFSS findings of each contrast agent and the subsequent pneumonia and unintentional weight loss were analyzed. A total of 30 participants were included in the analysis. We recorded 11 cases of subsequent pneumonia and 13 of unintentional weight loss. Regarding the risk of subsequent pneumonia after VFSS, only the oral transit time and number of swallows tested with barium sulfate indicated significant differences between participants with and without subsequent pneumonia. For unintentional weight loss, oral transit time and pharyngeal wall coating after swallowing tested with barium sulfate, as well as oral transit time, nasal penetration, residue in the valleculae, PAS scores, and number of swallows when testing with iohexol demonstrated significant differences between those with and without unintentional weight loss. | PMC10700337 |
Introduction | dysphagia, Dysphagia, pneumonia, weight loss | DYSPHAGIA, DYSPHAGIA, ASPIRATION PNEUMONIA, PNEUMONIA | Dysphagia is difficulty or inability to form or move the alimentary bolus from the mouth to the stomachVideofluoroscopic swallowing study (VFSS) has been considered one of the gold standard assessments for evaluating dysphagia, as it can provide detailed information of the anatomical landmarks of the patient as well as swallowing physiology in real-time, which assists clinicians in determining the safety and efficiency of swallowing, developing a treatment plan, and providing appropriate dietary prescription for patients with dysphagiaBarium sulfate and iohexol are commonly used as contrast agents for VFSSThe purpose of this study was to determine which contrast agent, barium sulfate or iohexol, is superior in visualizing the components of swallowing predictable of subsequent aspiration pneumonia and unintentional weight loss when used in the VFSS. The objectives of this study includes: (1) to compare VFSS findings when barium sulfate and iohexol was used as a contrast agent, (2) to compare whether there was a difference in the VFSS findings of participants with and without subsequent pneumonia by contrast agents used, (3) to compare the VFSS findings of participants with and without unintentional weight loss by contrast agents used, and (4) to compare the VFSS findings of participants who died and who survived by contrast agents used. | PMC10700337 |
Methods | This study was conducted in accordance with the Declaration of Helsinki and was reviewed and approved by the Institutional Review Board of the Yeungnam University Hospital (IRB NO.2021-07-021-002). Written informed consent was obtained from all participants. This study was not registered. | PMC10700337 |
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Trial design | dysphagia, muscle mass, pneumonia, dehydration, infection, sepsis, weight loss | DYSPHAGIA, PNEUMONIA, PULMONARY DISEASE, DEHYDRATION, INFECTION, INFLAMMATION OR INFECTION, SEPSIS, ASPIRATION PNEUMONIA, DISEASES | This study was a randomized controlled trial with a crossover design conducted from September 2021 to March 2022 in a tertiary university hospital. Because various characteristics of the patients are associated with the development of aspiration pneumonia and unintentional weight loss (e.g., age, need for bronchial suctioning, the presence of dysphagia and/or dehydration, muscle mass, catabolic conditions such as inflammation or infection, and underlying diseases of the patients)Iohexol (Bonorex 300, iohexol 647 mg/ml) and barium sulfate powder (Baritop HD, 99%w/w) 300 g mixed with 80 ml of water were compared in a singular VFSS. We postulated that the contrast agent that was previously used did not affect the subsequent VFSS findings, as it is assumed that previously tried food did not affect the later in the usual VFSS procedures, where various foods with different consistencies are tried in one examinationDesign and flowchart of the study participants.Demographic data, including age, gender, and past medical history, were obtained from hospital records. In data collection, pneumonia was not included in pulmonary disease, and recent systematic infection history was defined as sepsis that occurred within 1 months of the date of VFSS. Initial dietary type was the type of diet at the time of VFSS. All participants were prospectively followed for 3 months after the VFSS. If the participant was still hospitalized at that point, data were obtained through hospital records, and if the participant was discharged, data was obtained by phone interviewing the participants or their guardian. | PMC10700337 |
Participants | The inclusion criteria were as follows: (1) patients who were admitted in a tertiary university hospital and referred to the Department of Physical Medicine and Rehabilitation for VFSS to evaluate the safety of swallowing, (2) patients who could maintain a sitting position during VFSS, (3) patients who could stay alert for at least 20 min, and (4) patients who have sufficient cognitive function to follow simple directions during VFSS. The exclusion criteria were as follows: (1) patients aged All the inpatients who were referred to our department for VFSS were assessed for eligibility based on medical records. All participants were provided study-related information directly from the researchers and gave written informed consent 1 or 2 days prior to VFSS. Figure | PMC10700337 |
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Intervention | VFSS was performed using an X-ray flat-panel detector system (FPD, Zexira®, Toshiba, Tokyo, Japan). Swallowing images were digitally recorded at a rate of 30 frames/s from a lateral viewing plane. The VFSS protocol consisted of (1) 3-ml thin liquid (barium sulfate solution or iohexol) provided with a spoon, (2) 5-ml yogurt mixed with each contrast agent provided with a spoon, (3) 5-ml banana mixed with each contrast agent provided with a spoon, and (4) 10-ml thin liquid (barium sulfate solution or iohexol) provided with a cup. Each of the consistencies was given twice to the participants, and the two contrast agents were given alternately for each time (a total of 8 boluses; 4 boluses mixed with barium sulfate and 4 boluses mixed with iohexol) (Fig. VFSS findings were categorized according to the penetration–aspiration scale (PAS) | PMC10700337 |
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Outcome measures | pneumonia, weight loss, community-acquired pneumonia | PNEUMONIA, SECONDARY, ASPIRATION PNEUMONIA, HOSPITAL-ACQUIRED PNEUMONIA, ASPIRATION PNEUMONIA, COMMUNITY-ACQUIRED PNEUMONIA | Development of subsequent pneumonia after VFSS during the follow-up period was the primary outcome of this study and secondary outcome was unintentional weight loss. A case of pneumonia was identified based on chest imaging and antibiotic prescription. Aspiration pneumonia is accepted as a part of the continuum of community-acquired pneumonia and hospital-acquired pneumonia rather than a distinct entity, and there have been no robust diagnostic criteria for the diagnosis of aspiration pneumonia | PMC10700337 |
Statistical analysis | pneumonia, weight loss | PNEUMONIA | This study is a preliminary study and required sample size was calculated using G*Power 3.1Statistical analyses were performed using the Statistical Package for Social Sciences (version 22.0; IBM Corp., Armonk, NY, USA). The Wilcoxon signed-rank test was used to compare the VFSS findings (PAS, FDS, and number of swallows) for barium sulfate and iohexol. The Mann–Whitney test was used to compare the VFSS findings of each contrast agent in participants with or without subsequent pneumonia and unintentional weight loss. Receiver operating characteristic (ROC) curve analysis was performed to evaluate the predictive accuracy of VFSS findings for subsequent pneumonia and unintentional weight loss during the 3-month follow-up period. An area under the ROC curve (AUC) of 0.5, 0.7 to 0.8, 0.8 to 0.9, and more than 0.9 suggests no discrimination, acceptable diagnostic value, excellent diagnostic value, and an outstanding diagnostic value, respectively | PMC10700337 |
Discussion | dysphagia, comorbidity, pneumonia, fatigue, acute stroke, neurodegenerative diseases, pulmonary disease, weight loss, muscle fatigue | DYSPHAGIA, PNEUMONIA, ACUTE STROKE, NEURODEGENERATIVE DISEASES, ASPIRATION PNEUMONIA, PULMONARY DISEASE, DISEASES | No significant differences were observed in the PAS and FDS total scores according to the contrast agent used in the test. This might suggest that the difference in physical properties of the two contrast agents is not critical enough to make a difference in the anatomical depth to which food bolus penetrates when ingested. However, significant differences between the two contrast agents were seen in the FDS subcategories, scores for “residue in pyriform sinuses”. The reason for this difference between PAS and FDS scores could be because the FDS was developed to supplement PAS and it can report more qualitative aspects of VFSS findings than PAS. Additionally, a greater number of swallows were required with barium sulfate than with iohexol. According to a previous study, iohexol demonstrated a faster transit time in gastrointestinal studies than barium sulfate because iohexol has higher water solubilityOur study reveals that a longer oral transit time and greater number of swallows when testing with barium sulfate were associated with the development of subsequent pneumonia after VFSS. Of note, when these two factors were analyzed using ROC analysis, only the number of swallows demonstrated an excellent diagnostic value for predicting subsequent pneumonia. According to previous studies, prolonged swallowing time, including oral transit time, is associated with an increased risk of aspiration pneumoniaOur study also found significant differences in VFSS findings including oral transit time, coating of the pharyngeal wall after swallowing, and number of swallows in participants with and without unintentional weight loss when using barium sulfate. By contrast, when using iohexol, oral transit time, nasal penetration, residue in the valleculae, PAS scores, and number of swallows demonstrated significant differences between those with and without unintentional weight loss. Among these findings, oral transit time and the number of swallows when using barium sulfate had acceptable diagnostic values for predicting unintentional weight loss; however, the number of swallows when using iohexol may have an excellent diagnostic value for predicting unintentional weight loss, while the PAS scores when using iohexol had an acceptable diagnostic value. Similarly to subsequent pneumonia discussed earlier, due to the VFSS protocol of our study, oral transit time and number of swallows are thought to be able to better indicate the efficiency of swallowing compared to other metrics. Additionally, it is well known that unintentional weight loss is significantly associated with dysphagiaTo the best of our knowledge, this is the first study designed as a randomized, controlled, crossover trial to directly compare barium sulfate and iohexol as contrast agents for VFSS in predicting subsequent pneumonia and unintentional weight loss in patients with dysphagia. Because the two contrast agents were compared in the same participants, minimizing the influence of different patient characteristics on the results of the analysis was possible. Previous studies that compared barium sulfate and iohexol as contrast agents for VFSS focused on safety when the participants aspirated during the test, and since each contrast agent was administered to two different groups, the possibility of selection bias could not be completely excluded even if factors including age and sex were controlled.However, this study has several limitations. First, the sample size was relatively small; future studies with larger sample sizes would provide more information for selecting the superior contrast agent between barium sulfate and iohexol. Second, underlying diseases of the participants were varied without restrictions. For example, although the characteristics and/or clinical course of dysphagia in patients with acute stroke and those with neurodegenerative diseases can be very different, our study was conducted without excluding specific diseases or targeting only specific diseases. To compare the ability of contrast agent to predict long-term prognosis of dysphagia, including various underlying diseases may have advantages in terms of generalizability, but the limitations due to this are also clear. Also, it should be noted that that although the statistical significance was not reached, more participants in barium sulfate-first group had pulmonary disease as medical comorbidity, which has close association with pneumonia and unintentional weight loss. Third, inability for blinding to the contrast agents used in the VFSS was another limitation of this study. Forth, the IDDSI levels of the two contrast agents were different, and this might well affect the study outcomes. Future study using equal IDDSI level of the liquid barium sulfate and iohexol would be necessary to better understand how the different physical properties of the two contrasts other than viscosity affect findings of VFSS. Fifth, subsequent pneumonia does not necessarily mean aspiration pneumonia. Despite efforts to include only aspiration pneumonia in the analysis, the possibility that other types of pneumonia may also be included cannot be completely ruled out. Sixth, although efforts were made to reduce the difference and make the conditions for testing the two contrast agents as similar as possible, muscle fatigue, which can be induced by performing multiple swallowing motions during the VFSS, may have had an effect for the results. To reduce the effect of fatigue, further study testing the two contrast agents in a differentiated participants would be needed. Last, we assumed that the previously administered contrast agent did not affect the subsequent VFSS findings; however, the lack of a washout period might have affected the study results. Although the previously used contrast agent was not detected using fluoroscopy, it might have affected the subsequent VFSS findings. | PMC10700337 |
Acknowledgements | The authors would like to thank Editage ( | PMC10700337 |
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Author contributions | Conceptualization: S.K. and M.C.C.; Methodology: S.K., M.K., and M.C.C.; Formal analysis and investigation: S.K., M.K., and M.C.C.; Writing—original draft preparation: S.K., M.K., and M.C.C.; Writing—review & editing: S.K. and M.C.C.; Funding acquisition: S.K.; Resources: S.K. and M.C.C.; Supervision: S.K. | PMC10700337 |
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Funding | The present study was supported by a National Research Foundation of Korea Grant funded by the Korean government (Grant No. NRF-2022R1F1A1072553). | PMC10700337 |
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Data availability | The data that support the findings of this study are available from the corresponding author upon reasonable request. | PMC10700337 |
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Competing interests | The authors declare no competing interests. | PMC10700337 |
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References | PMC10700337 |
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Background | inflammation, T2D, type 2 diabetes | INFLAMMATION, TYPE 2 DIABETES | While a low-carbohydrate diet (LCD) reduces HbA1c in patients with type 2 diabetes (T2D), the associated high intake of fat may adversely affect cardiovascular risk factors. To address this, we examined the effect of a non-calorie-restricted LCD high in fat on endothelial function and markers of low-grade inflammation in T2D over 6 months. | PMC10436534 |
Methods | T2D | VASODILATION | In an open-label randomized controlled trial, 71 patients with T2D were randomized 2:1 to either a LCD (< 20 E% carbohydrates, 50–60 E% fat) or a control diet (50–60 E% carbohydrates, 20–30 E% fat) for six months. Flow-mediated vasodilation (FMD) and nitroglycerine-induced vasodilation (NID) were assessed by ultrasound in the brachial artery together with plasma interleukin-6 (IL-6) and serum high-sensitivity C-reactive protein (hsCRP) in the participants at baseline (n = 70) and after six months (n = 64). | PMC10436534 |
Results | The FMD and NID were unaltered in both groups after six months, and there were no between-group differences in change of either FMD (p = 0.34) or NID (p = 0.53) in response to the interventions. The circulating hsCRP and IL-6 levels decreased only in response to LCD (both p < 0.05). However, comparing changes over time with the control diet, the LCD did not reduce either IL-6 (p = 0.25) or hsCRP (p = 0.07) levels. The lack of changes in FMD and NID in response to LCD persisted after adjustment for cardiovascular risk factors. | PMC10436534 |
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Supplementary Information | The online version contains supplementary material available at 10.1186/s12933-023-01956-8. | PMC10436534 |
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Keywords | Open access funding provided by University Library of Southern Denmark | PMC10436534 |
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Introduction | obesity, T2D, inflammation, CVD, adiposity, T2D a LCD | OBESITY, CARDIOVASCULAR DISEASE, CVD, INFLAMMATION, ADIPOSITY, EVENTS, TYPE 2 DIABETES, ENDOTHELIAL DYSFUNCTION | One of the major causes of mortality in type 2 diabetes (T2D) is cardiovascular disease (CVD) [T2D management includes lifestyle changes involving both diet and physical activity and is important to improve glycemic control and decrease risk of CVD [Along with endothelial dysfunction, circulating markers of low-grade inflammation such as hsCRP and IL-6 are often elevated in obesity and T2D and associated with a higher risk of cardiovascular events [Previously, we reported that in patients with T2D a LCD high in fat for 6 months reduced HbA1c, weight and abdominal adiposity compared to a control diet, while blood pressure and lipid levels were unaffected [ | PMC10436534 |
Methods | PMC10436534 |
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Study design and participants | T2D | As previously reported [Briefly described, the inclusion criteria included an established diagnosis of T2D [Out of 345 persons eligible for screening [Informed consent was obtained from all individuals before participation. The study was approved by the Regional Committees on Health Research Ethics for Southern Denmark and was performed in accordance with the Declaration of Helsinki Declaration II. The RCT was registered at ClinicalTrials.gov (NCT03068078). | PMC10436534 |
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Diet intervention and physical activity | This was a free-living study and no food was provided to the participants. The LCD group was instructed to follow a diet consisting of a maximum of 20 E% carbohydrates, 50–60 E% fats 25–30 E% protein with a recommendation of a high intake monounsaturated fatty acids (MUFAs) and as low intake of saturated fatty acids (SFA) as possible [All participants were individually introduced to the diet by a licensed clinical dietitian, had opportunity for on-demand visits and could attend group-specific discussion meetings supervised by the dietitian. The dietitian contacted every participant per telephone one week after starting the new diet and hereafter every month. A five-days startup menu plan based on pre-study calorie intake was provided as well as weekly newsletters to all participants. Participants had access to a recipe-database that was continuously updated and were instructed to register food intake in MadLog (MadLog ApS, Kolding, Denmark). Based on the estimated energy requirement at baseline, participants were guided to maintain their calorie-intake during the entire intervention. Furthermore, the participants were instructed maintain their usual physical activity level throughout the study period. As reported [ | PMC10436534 |
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Assessment of flow-mediated vasodilation (FMD and nitroglycerine induced dilation (NID) | FMD and NID in the brachial artery were assessed by a single investigator at baseline and after 6 months of diet change using a Phillips iE33 ultrasound machine with a L15-7io linear array transducer and automated settings for FMD/NID. The participant’s right arm was examined in the morning after an overnight fast, minimum 8 h. The participants were instructed to discontinue antihypertensive medication, vitamins and sildenafil three days before the examination and to refrain from strenuous exercise, tea and juice for 48 h and coffee, alcohol and nicotine for 12 h prior to the examination. Any ongoing cholesterol-lowering treatment continued but was not taken on the day of examination. One participant was examined at noon both times.Following a 15 min rest in supine position, blood pressure was measured in the left arm to ensure cuff inflation minimum 20 mmHg above systolic blood pressure (minimum 200 mmHg). A rapid inflation/deflation cuff was applied with upper crease in the cubital fossa on the right forearm (Hokanson E20, Bellevue USA), where after a suitable segment of the brachial artery proximal of the cubital fossa was identified. Anatomical markers and cuff pressure were noted for follow-up examinations. The resting brachial artery diameter (RDSequences were exported as AVI-files or DICOM for off-line analyses. The same trained person who executed the FMD measurements also analyzed offline the individual sequences blinded for patient ID and clinical data using a semi-automated, commercial software (Brachial Analyzer, Medical Imaging Application, version 6.9.1, Coralville, Iowa, USA) [The following variables were estimated: The resting diameters (RDOut of the 71 FMD and NID sequences obtained at baseline, the FMD and NID in one person from the control group could not be analyzed due to low image quality and the NID from one person in the LCD group was missing due to damaged files (LCD), leaving a total of 70 FMD and 69 NID sequences for analysis at baseline. Given the seven drop-outs (see above), 64 FMD- and NID sequences were available for analysis at the 6 month follow-up. None of the participants FMD- or NID data were excluded due to outliers. | PMC10436534 |
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Other outcome measures | All participants attended three visits during the study (baseline, 3 months and 6 months) with collection of fasting blood samples for measuring lipids, insulin, HbA1c, fasting plasma glucose and blood-ketones as reported [Serum hsCRP was measured in duplicates by an in-house ELISA using commercially available monoclonal antibodies and reagents (Biotechne, R&D Systems, MN, USA) according to the manufacturers instructions. The limit of detection was 0.05 µg/L and the intra- and inter-assay CVs were below 15%. Circulating IL-6 was measured in singlets on fasting EDTA plasma by the human high-sensitive IL-6 ELISA assay essentially as described (R&D Systems, Abingdon, UK). Mean CV% between runs was 6.9% (EDTA plasma pool, level 8.1 pg/ml). CV% of assay controls were 20% (level 0.5 pg/ml), 12.6%, (level 3.2 pg/ml) and 18.5% (level 5.9 pg/ml). | PMC10436534 |
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Statistical analysis | SE | CVD, REGRESSION, SECONDARY, REGRESSIONS | Statistical analysis was done with STATA for Windows (STATA 16.0, StataCorp LLC, Texas, USA). The vascular function was one of the pre-specified secondary outcomes in this study. The estimation of the sample size was based on the primary outcome, HbA1c, and this showed that 36 in the LCD group and 18 in the control group were sufficient to obtain a power of 80% as reported [All residuals were tested for normal distribution, and if the residuals did not meet criteria of normal distribution, the dependent variables were log-transformed prior to the statistical analyses. For analyses of changes over time within and between groups, a mixed model with randomization- and time interaction was applied. The mean difference in change (MDIC) between groups from baseline to 6 month is reported as the effect of LCD versus control diet. The relationship between FMD and NID and several measured CVD risk factors including circulating IL-6 and hsCRP levels at baseline was examined using univariate linear regression or Spearman’s rank correlation coefficient if residuals were not normally distributed. Estimates of MDIC and linear regressions are reported as coefficients ± SE. All other data are reported as mean ± SD. Statistical significance was assumed at p < 0.05. | PMC10436534 |
Results | PMC10436534 |
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Baseline characteristics | SD, diabetes | DIABETES | Among study participants with valid FMD measurements at baseline (n = 70), the two groups were comparable with respect to age, duration of diabetes, HbA1c, gender distribution, smoking status, lipid levels and BMI (Table Baseline characteristicsData are means ± SD or number (%) | PMC10436534 |
Changes in clinical parameters | As reported previously [ | PMC10436534 |
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Measures of endothelial function | flow-mediated vasodilation | VASODILATION | At baseline, 41 of 49 (84%) in the LCD group and 20 of 21 (95%) in the control group had FMD < 7.1% (p = 0.42), and 20 of 48 (42%) in the LCD group and 14 of 21 (67%) in the control group had NID < 15.6% (p = 0.06). These proportions did not change significantly after 6 months (data not shown). In the LCD group, the resting diameters (RDBaseline and effects of 6 months the LCD and control diet on endothelial functionMDIC are reported as β-coefficient ± SEOther data as mean ± SDFMD, flow-mediated vasodilation; LCD, low carbohydrate diet; MDIC, mean difference in change; NID, nitroglycerin-induced vasodilation; RD, resting diameter*p < 0.05 or **p < 0.01 vs baselineIndividual changes in | PMC10436534 |
Measures of low-grade inflammation | CVD | In the LCD group, both hsCRP (p = 0.004) and IL-6 (p = 0.013) decreased after 6 months on the diet, whereas no significant changes were seen in the control group (Fig. Changes in Using Spearman’s rank correlation coefficient in the total cohort (n = 70) at baseline, we found that plasma Il-6 levels correlated positively with BMI (p < 0.001), and abdominal (p = 0.004) and total body fat percentage (p = 0.011), but not with the other CVD risk factors listed in Table Association of endothelial function with cardiovascular risk factorshsCRP, high sensitivity CRP*p < 0.05, **p < 0.01 | PMC10436534 |
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Adjusting for covariates correlated to FMD or NID | CVD | To adjust the analysis for between-group differences in CVD risk factors at baseline, we evaluated the relationship between FMD and NID and all the CVD risk factors listed in Table When adjusting our analysis for these significant covariates, there was, however, still no effect of LCD for 6 months on FMD (adjusted MDIC: − 0.44 ± 0.45%, p = 0.335) or NID (adjusted MDIC: + 0.56 ± 0.92%, p = 0.543). | PMC10436534 |
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Description of changes in cholesterol and blood pressure lowering medication | There were no changes in cholesterol-lowering treatment during the study, except for two LCD participants who reported sporadic use of statins. In the LCD-group, one patient treated with both an angiotensin-converting enzyme (ACE) inhibitor and an angiotensin II receptor blocker (ARB) had the ACE inhibitor discontinued. Another patient in the LCD group discontinued thiazide treatment and was reduced in beta-blocker treatment. In two other patients in the LCD group, the dose of ARB treatment dose reduced (25 mg and 50 mg, respectively) due to orthostatism. In one patient in the control group, the dosage of ACE inhibitor combined with hydrochlorthiazide was increased. | PMC10436534 |
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Discussion | obesity, inflammation, T2D | CVD, INFLAMMATION, VASODILATION, OBESITY | In this second study from an open-label RCT [Population-based studies have provided evidence that correction of a suboptimal diet may be a powerful approach to reduce the risk of CVD [There might, however, be transient effects of an increased intake of fat on endothelial function that are attenuated or eventually lost over time. Thus, the brachial FMD increased markedly in response to a low-fat diet for 3 weeks, but not with a VLCD in patients with T2D, even though both groups lost abdominal weight [Markers of systemic low-grade inflammation such as IL-6 and hsCRP are often elevated in obesity and T2D and associated with an increased risk of CVD [The strengths of the present study include the randomized design, the well-matched study groups, and the sample size, which according to a non-inferiority analysis was sufficiently large to rule out a change in FMD higher than 20%. In addition, the participants were instructed to maintain their level of physical activity and medication, which allowed us to study the isolated effect of a non-calorie-restricted LCD, which is feasible for patients with T2D under free-living conditions. The limitations include the unblinded (open-label) study design, the lack of strict control with regard to changes in physical activity, medication, and diet macronutrient composition including different types of fat, the latter leading to a higher intake of saturated fat than generally recommended. Moreover, the inability to demonstrate a between-group difference in change of IL-6 and hsCRP levels despite a reduction of both markers in the LCD group suggests that a larger sample size would have been needed to make a conclusion whether a LCD reduces low-grade-inflammation.In summary, the present study provides evidence that a LCD high in fat for 6 months in patients with T2D instructed to maintain their daily energy intake and level of physical activity does not adversely affect neither the endothelium-dependent (FMD) nor –independent (NID) vasodilation in the brachial artery or selected markers of systemic low-grade inflammation compared with a control diet low in fat. These findings together with the previously reported lack of changes in blood lipids and blood pressure [ | PMC10436534 |
Acknowledgements | Diabetes | HANSEN, DIABETES | We would like to thank L. Hansen and C. B. Olsen, the Steno Diabetes Center Odense, Odense University Hospital, as well as A. R. Madsen, Department of Endocrinology, Odense University Hospital, for their skilled technical assistance. We also owe great thanks to professor DHJ Thijssen and ACCM van Mil for expertise and training in FMD measurements. | PMC10436534 |
Author contributions | CDH | EMG-K, CDH, AK, HB-N, MHO, and KH contributed to the conception and design of the study. EMG-K, CDH, MBH, and JMJ conducted the intervention study. EMG-K, TBO and AH contributed to the ultrasound and biomarker analyses. EMG-K, CDH, AK, HB-N, MHO, TBO, AH and KH analysed and interpreted data, and EMG-K and KH wrote the manuscript. All the authors have revised the manuscript critically for important intellectual content and given final approval of the version to be published. KH and AK are guarantors of this work, and as such had full access to all the data in the study and take full responsibility for the integrity of the data and the accuracy of the data analysis. | PMC10436534 |
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Funding | Diabetes | DIABETES | Open access funding provided by University Library of Southern Denmark. The present study was supported by grants from the Region of Southern Denmark, Odense University Hospital, the Danish Diabetes Academy funded by the Novo Nordisk Foundation, the Novo Nordisk Foundation, University of Southern Denmark, the AP Møller Foundation, Overlæge Johan Boserup og Lise Boserups Legat and Christenson-Cesons Familiefond. | PMC10436534 |
Availability of data and materials | The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request. | PMC10436534 |
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Declarations | PMC10436534 |
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Ethics approval and consent to participate | Informed consent was obtained from all individuals before participation. The study was approved by the Regional Committees on Health Research Ethics for Southern Denmark and was performed in accordance with the Declaration of Helsinki Declaration II. The RCT was registered at ClinicalTrials.gov (NCT03068078). | PMC10436534 |
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Consent for publication | I, the undersigned, give my consent for the publication to be published in the Cardiovascular Diabetology Journal. | PMC10436534 |
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Competing interests | AK reports speaker honorarium from Norgine, Siemens and Nordic Bioscience, outside the submitted work. | PMC10436534 |
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References | PMC10436534 |
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Abstract | Nicole E. Billingy and Vashti N. M. F. Tromp contributed equally to this work as joint first authors.Annemarie Becker-Commissaris, Corina J. G. van den Hurk and Iris Walraven contributed equally to this work as joint senior authors. | PMC10699799 |
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Background | PROM, cancer, lung cancer | LUNG CANCER, CANCER | Previous studies using patient-reported outcomes measures (PROMs) to monitor symptoms during and after (lung) cancer treatment used alerts that were sent to the health-care provider, although an approach in which patients receive alerts could be more clinically feasible. The primary aim of this study was to compare the effect of weekly PROM symptom monitoring via a reactive approach (patient receives alert) or active approach (health-care provider receives alert) with care as usual on health-related quality of life (HRQOL) at 15 weeks after start of treatment in lung cancer patients. | PMC10699799 |
Methods | lung cancer, PROM | LUNG CANCER, REGRESSION, LUNG | The SYMPRO–Lung trial is a multicenter randomized controlled trial using a stepped wedge design. Stage I-IV lung cancer patients in the reactive and active groups reported PROM symptoms weekly, which were linked to a common alerting algorithm. HRQOL was measured by the EORTC QLQ-C30 at baseline and after 15 weeks. Linear regression analyses and effect size estimates were used to assess mean QOL–C30 change scores between groups, accounting for confounding. | PMC10699799 |
Results | A total of 515 patients were included (160 active group, 89 reactive group, 266 control group). No differences in HRQOL were observed between the reactive and active group (summary score: unstandardized beta [B] = 0.51, 95% confidence interval [CI] = -3.22 to 4.24, Cohen | PMC10699799 |
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Conclusions | lung cancer, cancer, Lung cancer, cancer deaths | LUNG CANCER, CANCER, LUNG CANCER, LUNG | Weekly PRO symptom monitoring statistically and clinically significantly improves HRQOL in lung cancer patients. The logistically less intensive, reactive approach may be a better fit for implementation.Lung cancer is the second most common cancer diagnosed worldwide, and the most common cause of cancer deaths per year (Previous randomized controlled trials (RCTs) investigated the effect of patient-reported outcomes (PRO) symptom monitoring on overall survival and HROQL. These studies reported significantly better HRQOL and overall survival compared with care as usual (A more ‘reactive’ patient-centered approach in which the patient receives the alert and is encouraged to contact the hospital following an alert might be equally effective while significantly lowering the workload for the health-care providers. The primary aim of the SYMPRO–Lung study was to compare the effect of weekly online PRO symptom monitoring via a reactive approach (patient receives alert) or an active approach (health-care provider receives alert) with care as usual on the HRQOL of lung cancer patients at 15 weeks after start of treatment. | PMC10699799 |
Methods | PMC10699799 |
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Study design and study sample | We conducted a multicenter RCT using a stepped wedge design, the details of which have been reported previously (The stepped wedge cluster randomized design involved sequential transition of the participating hospitals in a randomized order. Over a period of 16 months, 13 Dutch hospitals (3 academic and 10 nonacademic) consecutively switched from care as usual (the control group) to an intervention period (see All patients provided written informed consent upon inclusion. The study was approved by the institutional review board and medical ethical committee of the Amsterdam University Medical Centers (UMC), location Vrije Univeristeit medical center (VUmc), as well as by the review boards of all participating centers. The study was registered in the Netherlands trial register NL7897. | PMC10699799 |
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Intervention | lung cancer, Toxicity | LUNG CANCER, ADVERSE EVENT | There were 2 intervention groups differing in the way the alerts were handled; 1 reactive group in which patients themselves received an alert via a pop-up notification and (secure) e-mail containing the advice to contact the hospital within 24 hours on weekdays; 1 active group in which the health-care providers received an alert via a (secure) e-mail instructing them to contact the patient within 24 hours on weekdays (during office hours). Directly following initiation of an alert, patients were asked if the symptoms were still present and, if not, that they would opt-out of being contacted by their health-care provider. This was done to prevent unnecessary phone calls from their health-care provider, because the Patient-Reported Outcomes version of the Common Toxicity Criteria for Adverse Events (PRO-CTCAE) (Both intervention groups were given access to the online application on weekdays to report their symptoms weekly. Patients were able to contact the study staff via telephone or e-mail if they experienced problems using the application.The lung cancer subset (Set of predefined conditions that prompted the web application to create an alert. PRO-CTCAE = Patient-Reported Outcomes–Common Terminology Criteria for Adverse Events. | PMC10699799 |
Control group | Patients in the control group received care as usual. This consisted of the standard procedure at their hospital for assessing and documenting symptoms (predominantly discussing symptoms with their health-care provider during outpatient visits and a documentation in their medical record). | PMC10699799 |
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Study measures | PMC10699799 |
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Primary outcomes | Cancer | SECONDARY, CANCER | The primary outcome was the mean change from baseline to 15 weeks (T1) after the start of treatment in HRQOL as assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) (Additional information on the EORTC QLQ-C30 scales, interpretation of clinically relevant change scores, our secondary outcomes, and sensitivity analyses can be found in the | PMC10699799 |
Statistical analysis | REGRESSION | The trial protocol included a sample size of 584, yielding 80% power to detect a Cohen’s Data were analyzed on an intention-to-treat basis. Patient characteristics are presented as proportions: mean (SD). Differences in baseline characteristics and HRQOL were compared using independent samples Comparisons were made between the reactive and active intervention groups and between the combined intervention groups vs the control group. Between-groups differences in mean changes in QLQ-C30 scores from baseline to 15 weeks after start of treatment were analyzed using multivariable linear regression analyses. Because we only compared 2 time points, multivariable linear regression analyses were conducted, adjusted for all confounding variables at baseline: baseline QLQ-C30 scale score, transfer sequence of the hospitals, and the baseline characteristics that were significantly different between the intervention groups. Group differences in mean change scores over time between the groups were accompanied by Cohen’s All analyses were performed in SPSS version 28.0. All tests were 2-sided with an assumed statistical significance level of a | PMC10699799 |
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Results | LUNG | A total of 515 patients completed the baseline questionnaire (CONSORT diagram of the Symptom Reporting with Patient-Reported Outcomes–Lung trial. | PMC10699799 |
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Baseline characteristics | ONCOLOGY | Most baseline sociodemographic and clinical characteristics were balanced across groups (Baseline characteristicsImmunotherapy combined: immunotherapy (combined with chemotherapy or chemoradiation and/or surgery and/or targeted therapy. Radiotherapy combined: radiotherapy (combined with surgery). Chemotherapy combined: chemotherapy or chemoradiation (combined with radiotherapy, and/or targeted therapy and/or surgery). ECOG = Eastern Cooperative Oncology Group; M− = no targetable driver mutation or unknown status; M+ = targetable driver mutation.Between the reactive and active intervention groups, exceptions were found in the same baseline characteristics (stage distribution, histology, and treatment). In addition, the reactive group had statistically significantly fewer patients with an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 compared with the active intervention group (52% vs 38%; Patients who did not complete the follow-up questionnaire had a statistically significantly worse ECOG performance status and stage distribution (data not shown). However, no differences were observed between patients in the control vs the intervention group. | PMC10699799 |
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Symptom reporting and alert interventions | Of the 249 intervention patients, 244 (98%) completed at least 1 weekly symptom checklist. In total, 2412 symptom checklists were completed by the intervention group (see | PMC10699799 |
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Primary HRQOL outcomes | PMC10699799 |
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Noninferiority analyses (reactive vs active intervention group) | cancer stage | REGRESSION, ONCOLOGY | The reactive and active intervention groups were comparable in terms of baseline summary score (mean = 76.6 [SD = 16.0] in the reactive group; mean = 75.8 [SD = 14.1] in the active group; Multivariable linear regression analysis for health-related quality of life from baseline to 15 weeks reactive vs active intervention group including confoundersEORTC quality of life score and functioning scales: higher score = better quality of life and/or functioning. EORTC symptom scales: higher score = worse symptoms. T1 = 15 weeks; B = unstandardized beta; ES = Cohen’s Clinical relevance according to guidelines of Cocks et al. (Multivariable analyses were controlled for histology, treatment, cancer stage, Eastern Cooperative Oncology Group Performance Status, baseline score, and transfer sequence of the hospitals.After controlling for confounders, between the reactive and active intervention group in the multivariable linear regression analyses, no statistically or clinically significant differences were found between the summary score (unstandardized beta [B] = 0.51, 95% confidence interval [CI] = -3.22 to 4.24, ES = 0.06; | PMC10699799 |
Superiority analyses (intervention vs control group) | cancer stage | REGRESSION | The intervention and control groups were comparable in terms of baseline summary score and physical functioning (Multivariable linear regression analysis for health-related quality of life from baseline to 15 weeks intervention vs control group including confoundersEORTC quality-of-life score and functioning scales: higher score = better quality of life and/or functioning. EORTC symptom scales: higher score = worse symptoms. T1 = 15 weeks; B = unstandardized beta; SE = Cohen’s Clinical relevance according to guidelines of Cocks et al. (Multivariable analyses were controlled for histology, treatment, cancer stage, baseline score, and transfer sequence of the hospitals.n = 416.The summary score improved (to any degree) from baseline to 15 weeks after start of treatment among statistically significantly more patients in the intervention group than in the control group (62% vs 46%) and deteriorated among fewer patients (38% vs 54%; Proportion of patients with health-related quality of life changes at 15 weeks (T1) compared with baseline. For the clinically relevant change in physical functioning Cock et al. (After controlling for confounders, both the summary score (B = 4.85, 95% CI = 1.96 to 7.73, ES = 0.57; | PMC10699799 |
Secondary HRQOL | For the majority of the remaining QLQ-C30 scale scores, mean differences between the reactive and active intervention groups also reached an effect size below our threshold of 0.2, indicating noninferiority (The mean (change) scores for all functioning and symptom scales can be found in | PMC10699799 |
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Sensitivity analyses (multiple imputation) | Multiple imputation analyses did not result in statistically significantly different associations (see | PMC10699799 |
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Discussion | lung cancer | LUNG CANCER, SECONDARY, RECRUITMENT, METASTATIC CANCER | In this trial assessing the effect of patient-reported symptom monitoring on HRQOL in lung cancer patients, we observed that a reactive approach (patient receives alert) and an active approach (health-care provider receives alert) are equally effective on HRQOL. Furthermore, we confirmed that patient-reported outcomes symptom monitoring was significantly associated with improved HRQOL across almost all scales compared with care as usual. Because of the increasing time demands placed on health-care providers (Our findings are consistent with earlier studies on PRO symptom monitoring, which reported similar results with respect to HRQOL in metastatic cancer patients (Several limitations of our study should be noted. First, random assignment at the level of hospital resulted in some differences between the study groups with regard to the characteristics of the patients recruited. However, we were able to adjust for these baseline differences and still observed large effect sizes. Second, primarily because of the COVID-19 pandemic, we did not reach our intended sample size in the reactive intervention group. However, when taking the observed differences into account, using a noninferiority margin of 0.2*standard deviation, a power of 59% was reached for the summary score and 99% power for physical functioning. We believe that this provides sufficient evidence that the 2 approaches yield comparable HRQOL outcomes. Third, 58 (11%) still living patients did not complete their T1 HRQOL questionnaire of which 40 (69%) were from the intervention group. The dropout rate could be a sign of selective dropout in the intervention group due to worse health statuses. Therefore, it might be that the reported effects are a slight overrepresentation. However, the patients for whom data were missing in the intervention and control groups were similar in their baseline health status characteristics. Thus, we assume that this effect is marginal. Additionally, only 15 (25%) patients in the intervention groups reported that using the app was too burdensome compared with 4 (10%) patients in the control group (There may have been selection bias during the recruitment phase because the application was only available on an electronic device. However, of the 112 patients who received study information and declined participation, only 8 (7%) patients reported that it was because of the electronic aspect of the intervention. Although, the minimal role of internet access as a barrier is reinforced by the fact that in 2022, 96% of the Dutch population aged 65-75 years and 80% of age those aged 75 years and older made use of the internet (A major strength of our study is that we conducted a head-to-head comparison of a reactive and an active approach to web-based symptom monitoring. By including hospitals in our study from throughout the Netherlands and recruiting patients with all stages of lung cancer who were receiving all types of treatment, our study population is comparable to the real-world population, improving generalizability. Finally, the multicenter, stepped wedge cluster design made it possible to implement the intervention in daily clinical practice, specifically adapting the logistics to the work method of each participating hospital. This increases the relevance of our findings to the real world of clinical care for patients with lung cancer. Future research will further reveal the effect of PRO symptom monitoring on long-term HRQOL and our secondary outcomes overall survival, cost-effectiveness, usefulness, and implementation fidelity of the application.In conclusion, our results indicate that PRO symptom monitoring statistically and clinically significantly improves HRQOL in lung cancer patients. The reactive approach was equally effective to the standard active approach. Therefore, the reactive approach, which is logistically less intensive and less demanding for health-care providers, may be a better fit for efficient implementation within real-world clinical practice. Health-care providers can choose the symptom-altering approach that best suits their situation and that of their patients. | PMC10699799 |
Supplementary Material | Click here for additional data file. | PMC10699799 |
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Acknowledgements | ONCOLOGY | We thank the patients for their participation. We appreciate and acknowledge the helpful contributions made by Evalien Veldhuijzen, Chermaine Noortman-van Meteren, and the research nurses and specialized nurses of the participating hospitals.The funder had no role in the design of the study; the collection, analysis, or interpretation of the data; or the writing of the manuscript and decision to submit it for publication. The results of the study have been presented in part elsewhere at: European Society for Medical Oncology (ESMO) Conference September 2022, Paris France | PMC10699799 |
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Data availability | LUNG | Data from the SYMPRO–Lung study are available upon request and permission by the principal investigators (PIs). Please contact Nicole Billingy ( | PMC10699799 |
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Author contributions | Nicole E. Billingy, MSc (Conceptualization; Data curation; Formal analysis; Investigation; Methodology; Project administration; Resources; Software; Validation; Visualization; Writing—original draft; Writing—review & editing), Vashti N.M.F. Tromp, MSc (Conceptualization; Data curation; Investigation; Methodology; Project administration; Resources; Software; Writing—original draft; Writing—review & editing), Neil K. Aaronson, Prof, PhD (Conceptualization; Methodology; Resources; Software; Supervision; Writing—review & editing), Rianne J.A. Hoek, MSc (Data curation; Investigation; Methodology; Project administration; Resources; Software), Harm Jan Bogaard, Prof, PhD, MD (Conceptualization; Methodology; Resources; Software; Supervision; Writing—review & editing), Bregje D. Onwuteaka-Philipsen, Prof, PhD (Conceptualization; Methodology; Resources; Software; Supervision; Writing—review & editing), Lonneke van de Poll-Franse, Prof, PhD (Conceptualization; Methodology; Resources; Software; Supervision; Writing—review & editing), Jacqueline G. Hugtenburg, Prof, PhD, MD (Conceptualization; Methodology; Resources; Software; Supervision; Writing—review & editing), José Belderbos, PhD, MD (Conceptualization; Methodology; Resources; Software; Supervision; Writing—review & editing), Annemarie Becker-Commissaris, PhD, MD (Conceptualization; Funding acquisition; Methodology; Resources; Software; Supervision; Writing—review & editing), Corina J.G. van den Hurk, PhD (Conceptualization; Funding acquisition; Methodology; Resources; Software; Supervision; Writing—review & editing), and Iris Walraven, PhD (Conceptualization; Formal analysis; Funding acquisition; Methodology; Resources; Software; Supervision; Validation; Writing—original draft; Writing—review & editing). The remaining members of the SYMPRO-Lung Consortium contributed to (Investigation; Resources; Writing—review & editing). | PMC10699799 |
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List of contributors | Cancer | PULMONARY DISEASES, BREDA, CANCER | In addition to the authors, the SYMPRO-Lung Consortium consists of the following other members: N.C. van Walree, MD, Amphia Hospital, Department of Pulmonary Medicine, Breda, the Netherlands; K. de Jaeger, MD, Catharina Hospital Eindhoven, Department of Catharina Cancer Institute, Eindhoven, the Netherlands; S. Samii, MD, Deventer Hospital, Department of Pulmonary Medicine, Deventer, the Netherlands; W.Y. Lam-Wong, MD, Elkerliek Hospital, Department of Pulmonary Diseases, Helmond, the Netherlands; F. Koppe, MD, Institute Verbeeten, Department of Radiotherapy, Tilburg, the Netherlands; J.A. Stigt, MD, Isala Clinics, Department of Pulmonary Medicine, Zwolle, the Netherlands; G.J.M. Herder, MD, Meander Medical Center, Department of Pulmonary Medicine, Amersfoort, the Netherlands; A. Welling, MD, Northwest Clinics, Department of Pulmonary Diseases, Alkmaar, the Netherlands; O.C.J. Schuurbiers-Siebers, MD, Radboudumc, Department of Pulmonary Diseases, Nijmegen, the Netherlands; J.M. Smit, MD, Rijnstate Hospital, Department of Pulmonary Medicine, Arnhem, the Netherlands; A.J. Staal-van den Brekel, MD, Hospital group Twente, Department of Pulmonary Medicine, Hengelo, the Netherlands; W.K. de Jong, MD, Hospital Gelderse Vallei, Department of Pulmonary Medicine, Ede, the Netherlands. | PMC10699799 |
Funding | This work was supported by Zorg Innovatiefonds (Innovatiefonds Zorgverzekeraars, Sparrenheuvel 16, Postbus 304, 3700 AH Zeist), Roche (Roche Nederland B.V., Beneluxlaan 2A, 3446 GR Woerden), and Stichting Kwaliteitsgelden Medisch Specialisten (SKMS, Mercatorlaan 1200, Postbus 20057, 3502 LB Utrecht). | PMC10699799 |
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Conflicts of interest | Corina J.G. van den Hurk: IKNL received research funding from for-profit health care company AstraZeneca, Boehringer-Ingelheim, Bristol Myers Squibb, Ipsen and Merck. All other authors have no conflicts of interest. The rest of the SYMPRO-Lung Consortium has nothing to declare. | PMC10699799 |
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References | PMC10699799 |
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Background | fatigue, visual impairment | Over 50% of adults with visual impairment experience severe fatigue. Therefore, we developed a guided E-health intervention based on cognitive behavioral therapy and self-management to reduce fatigue in this population. This pilot study evaluated the usability, feasibility, fidelity and potential effectiveness of E-nergEYEze. | PMC10655361 |
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Methods | fatigue, visual impairment, Fatigue | E-nergEYEze was developed by a design team and customized by conducting a pilot study using an iterative development strategy. The intervention was first tested in a usability study among adults with visual impairment (n = 5). Participants were asked to think-aloud while exploring the intervention features and a semi-structured interview was performed afterwards. Subsequently, the enhanced intervention was tested in a feasibility study. Adults with visual impairment and severe fatigue (n = 10) followed the intervention partially with guidance from a social worker and one-time computer trainer support. Fatigue severity (Checklist Individual Strength), fatigue impact (Modified Fatigue Impact Scale) and cognitive behavioral therapy skills (Competencies of Cognitive Therapy Scale-Self Report) were measured at baseline and at three months follow-up and analyzed with the Wilcoxon signed-rank test. The intervention was evaluated through evaluation forms. | PMC10655361 |
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Results | fatigue | The usability study resulted in adjustments to content and lay-out with regard to optically shortened text sentences, separate pages for information and assignments with one read-aloud audio and an additional descriptive explanation of page content. Digital challenges were overcome with mandatory computer training and e-platform modifications. The feasibility study showed a positive trend in reducing fatigue severity (Z -6.108; P < .001; SD 8.4), impact of fatigue (Z − 4.451; P < .001; SD 11.4) and cognitive behavioral therapy skills (Z -2.278; P = .023; SD 19.3). Participants gave useful feedback regarding accessibility, content and guidance, with an overall positive experience. The intervention was rated with a median score of 8 (range 7–10). | PMC10655361 |
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Conclusion | fatigue, visual impairment | We developed, evaluated and optimized E-nergEYEze by applying a user-centered and iterative approach. E-nergEYEze showed a promising trend to reduce fatigue severity and impact of fatigue and to increase cognitive behavioral therapy skills. The study methods were feasible and the fidelity of the intervention protocol was suitable. Performing a randomized controlled trial is warranted to give insight into whether E-nergEYEze is cost-effective in reducing severe fatigue in adults with visual impairment. | PMC10655361 |
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Trial registration | International Clinical Trial Registry Platform: NL7764. Date registered: 28-05-2019. | PMC10655361 |
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Keywords | PMC10655361 |
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Introduction | chronic diseases with cognitive behavioral, vision loss, fatigue, visual impairment | The global population with vision loss has increased to over three billion people [There is evidence on effective interventions to treat fatigue in other chronic diseases with cognitive behavioral therapy (CBT) and self-management (SM) [People with visual impairment are increasingly using technology as a tool for safety, mobility, independence and social access [Capitalizing on the lack of evidence-based care regarding reducing fatigue severity using digital technology for people with visual impairment, we developed E-nergEYEze, a blended vision-specific E-health intervention based on cognitive behavioral therapy and self-management. We applied a user-centered and iterative approach to develop, evaluate and optimize E-nergEYEze, which have been recognized as key factors for successful E-health products [ | PMC10655361 |
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Methods | PMC10655361 |
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