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Method | The present study was approved by the ethics committee of our hospital and adhered to the tenets of the Declaration of Helsinki. Additionally, all the parents of patients signed the consent form before participating in the study. | PMC10782327 | ||
Research design | congenital heart disease, congenital malformations, gastrointestinal abnormalities, intestinal obstruction | SKIN DISEASE, PREMATURE, COMPLICATIONS, INTESTINAL OBSTRUCTION | This study was a prospective randomized controlled study conducted in the Department of Neonatology in a hospital on the southeast coast of China from June 2019 to October 2020. Based on the difference in the incidence of feeding intolerance (13% vs 35%) between the two groups from the pre-experiment, and assuming that the alpha value was set at 0.05 with a power of 0.80, the required number of participants was calculated to be 45 in each group. Assuming a 10% rate of missing data, the total sample size was set at 100 (50 per group). A total of 100 Premature infants were enrolled in this study.The inclusion criteria were as follows: 1) preterm infants who received enteral feeding, 2) a gestational age of 28-36 weeks, 3) vital sign stationarity, 4) no intestinal obstruction or abdominal surgery, 5) no skin disease, and 6) parents' informed consent. The exclusion criteria were as follows: 1) unstable medical condition; 2) complications of severe congenital malformations, such as severe congenital heart disease and gastrointestinal abnormalities, etc.; and 3) weight<1000 g.\ | PMC10782327 |
Recruitment | Participants were recruited according to the inclusion criteria and given written information regarding the study. Informed consent was obtained from all parents of patients. Withdrawal from the study was possible at any time without any negative consequences. | PMC10782327 | ||
Randomization | Simple randomization was done according to a software-generated random number sequence posted on a dedicated and secure website available on a 24/7 basis. The website generated the randomization, but the sequence was concealed from investigators. Participants who were eligible were randomized to either the intervention group received Chinese pediatric Tuina intervention by professional chiropractors or the control group received standard care. Patients randomized to one arm could not cross over to the others during the study. | PMC10782327 | ||
Standard care | ml/kg/ | In all preterm infants, orogastric tubes were inserted. A 6 Fr orogastric tube is generally inserted in these infants. Bolus feedings were given by gravity drainage after priming the tubing every three hours in the two groups. Continuous feeds were given using an automatic syringe pump. Gastric residuals were checked every three hours in infants in the two groups, regardless of assignment. In the unit, preterm infants were fed eight meals a day. The feeding of the preterm infants was started with a 2- or 3-ml feeding bolus for the first feeding. As food toleration developed, this amount was increased to 20 ml/kg/ day and continued until it reached 140-160 ml/kg/day. During infant gavage feeding, the flow rate of milk was caused by gravity using the suspension technique without applying pressure to the injector. Body weight was measured and recorded daily before the 9:00 a.m. feeding during the study. | PMC10782327 | |
Chinese pediatric Tuina | The intervention group was treated with Chinese pediatric Tuina on the basis of standard care. Two professionals pediatric Tuina doctors who had 5 years of experience in Chinese pediatric | PMC10782327 | ||
Data collection | gastrointestinal bleeding, liver insufficiency, abdominal distension, bloody, intolerance, | BILE REFLUX, NECROTIZING ENTEROCOLITIS, GASTRIC RETENTION, COMPLICATIONS | Before the intervention, the following data were collected: gestational age, age, sex, body weight, head circumference, albumin and prealbumin. After one week of intervention, the following data were collected: body weight, head circumference, albumin, prealbumin and complications including feeding intolerance, gastrointestinal bleeding, necrotizing enterocolitis, and liver insufficiency. The diagnostic criteria of feeding intolerance, based on those from American Academy of Pediatrics guidelines, were any of the following: 1) severe abdominal distension; 2) gastric retention ≥ 25%-50% of the total amount of 2-3 feedings; 3) obvious bloody stools; and 4) bile reflux or vomiting. | PMC10782327 |
Statistical Analysis | We used SPSS 25.0 software for statistical analysis. Continuous data are presented as the mean ± standard deviation and range. Clinical parameters between the two groups were compared with an independent-sample t-test. The χ | PMC10782327 | ||
Result | gastrointestinal bleeding, liver insufficiency | GASTROINTESTINAL BLEEDING, NECROTIZING ENTEROCOLITIS, COMPLICATIONS | Before intervention, there were no statistically significant differences in gestational age, age, sex, body weight, head circumference, albumin or prealbumin between the two groups, which indicated that the two groups were homogenous and comparable (Comparison of general data between the two groupsAfter 1 week of intervention, the body weight, head circumference, albumin and prealbumin of preterm infants in the intervention group were significantly better than those in the control group (P<0.05) (Comparison of the nutritional status between the two groups after one-week interventionAfter 1 week of intervention, the incidence of feeding intolerance in the intervention group was significantly lower than that in the control group (14% vs 30%, P= 0.032). Although there were no statistically significant differences (P>0.05), the incidences of gastrointestinal bleeding, necrotizing enterocolitis, and liver insufficiency were lower in the intervention group than in the control group (Comparison of the complications between the two groups after one-week intervention | PMC10782327 |
Discussion | oral).Studies | Many premature infants are transferred to the neonatal intensive care unit after birth and are fed via a tube (nasal or oral).Studies have shown that direct stimulation of the vagus nerve can regulate gastric peristalsis, enhance food digestion, and increase nutrient utilization.Chinese pediatric This study has some limitations. The participants were recruited from one hospital, thus reducing the generalizability of these findings. | PMC10782327 | |
Conclusion | Chinese pediatric | PMC10782327 | ||
Acknowledgements | We appreciated the help of all doctors and nurses in our center. | PMC10782327 | ||
Ethics approval and consent to participate | The present study was approved by the ethics committee of our hospital and adhered to the tenets of the Declaration of Helsinki. Additionally, all the parents of patients signed the consent form before participating in the study. | PMC10782327 | ||
Authors' contributions | Su-xian Lai and Shao-Shu Li designed the study, collected the clinical data, performed the statistical analysis, drafted the manuscript and revised the article. Xiu-Yao Lin, Xin Li, Ya-Di Zhang and Li-Qiong Wang participated in the statistical analysis and drafted the manuscript. All authors read and approved the final manuscript. | PMC10782327 | ||
Consent for publication | All authors read and approved the final manuscript and publication. | PMC10782327 | ||
Competing interests | The authors declare that they have no competing interests. | PMC10782327 | ||
Funding | Our research was funded by the “Quanzhou Science and Technology Plan Project (2018N065S)”. | PMC10782327 | ||
ABSTRACT | PMC10413913 | |||
Background | depressive disorder, ’, ’ depressive symptoms | Globally, an estimated five percent of adults have major depressive disorder. However, little is known about the relationship between these individuals’ depressive symptoms and their household members’ mental health and well-being. | PMC10413913 | |
Objectives | depressive disorder, depressive symptoms | We aimed to investigate the prevalence and predictors of depressive symptoms among adult household members of patients living with major depressive disorder in Neno District, Malawi. | PMC10413913 | |
Methods | depressive disorder, depression | As part of a cluster randomized controlled trial providing depression care to adults with major depressive disorder, we conducted surveys with patients’ household members ( | PMC10413913 | |
Results | depressive disorder, greater disability, depressed, Elevated depression | We observed that roughly one in five household members (19%) screened positive for a depressive disorder (PHQ-9 > 9). More than half of household members endorsed six or more of the nine symptoms, with 68% reporting feeling ‘down, depressed, or hopeless’ in the prior two weeks. Elevated depression symptom severity was associated with greater disability (β = 0.17, | PMC10413913 | |
Conclusions | depressive disorder, depression | In the Malawian context, we find that depressive disorder and depression symptoms are shared attributes among household members. This has implications for both screening and treatment, and it suggests that mental health should be approached from the vantage point of the broader social ecology of the household and family unit. | PMC10413913 | |
Trial Registration | ClinicalTrials.gov (NCT04777006) - March 2, 2021. | PMC10413913 | ||
Background | Human Immunodeficiency Virus (HIV), diabetes, depressive disorder, depressive symptoms, MDD, depression, hypertension | HYPERTENSION | Mental health conditions affect approximately one billion people around the globe [Individuals with chronic health conditions – such as Human Immunodeficiency Virus (HIV), diabetes, and hypertension – are more likely to be affected by mental health conditions [Common forms of behavioral therapy that address MDD in high HIV burden settings include Problem-Solving Therapy [Nevertheless, these therapeutic approaches have limited consideration for social-ecological factors likely to shape everyday environments – particularly household dynamics [Malawi represents a model collectivist setting for examining the interplay of household dynamics, mental health, and well-being. The country has one of the highest HIV incidence rates in the world [This study aimed to investigate the household dynamics of adults living with MDD and other chronic health conditions (predominately HIV) in rural Malawi. Specifically, we investigated the prevalence and correlates of depressive symptoms and depressive disorder among household members of individuals with MDD and other chronic health conditions. The study is part of a randomized controlled trial that introduced and evaluated an evidence-based model of depression care at integrated chronic care clinic (IC3) facilities [ | PMC10413913 |
Methods | PMC10413913 | |||
Setting and study design | epilepsy, type-2 diabetes, asthma, depression disorder, depression | HYPERTENSION, DISEASES, ASTHMA, EPILEPSY | This study is a part of a randomized controlled trial investigating an evidence-based model of depression care at IC3 in 14 health facilities throughout Neno District, Malawi. The IC3 paradigm represents an expansion of a care delivery system that was historically focused on HIV services alone. Since its inception, patients would travel to clinics on a quarterly basis to collect antiretroviral medications, creating a longitudinal pattern of care into which other chronic conditions could be integrated. Over the past eight years this has been broadened to include screening and treatment for a range of non-communicable diseases (NCDs) such as type-2 diabetes, hypertension, asthma, and epilepsy [At baseline, 60% of individuals who met study inclusion criteria, including diagnosis of depression disorder (see below), were randomly selected to have a household member interviewed, pending the study member’s consent. This household interview, conducted in the month prior to the participant’s treatment initiation, examined clinical, health, and sociodemographic characteristics of household members in relation to the study participant; the study design is therefore cross-sectional. The study received institutional review board approval from the National Health Sciences Research Committee in Malawi and the RAND Corporation Institutional Review Board in the United States. | PMC10413913 |
Participants | depression | RECRUITMENT | At the stage of study participant recruitment, participants were asked if they would be open to a household member being interviewed, provided the household member was not informed of the study participant’s diagnosis. Of 487 study participants, 427 (88%) verbally consented to have a household member interviewed. Of the 427 consenting individuals, 258 were randomly selected for the household interview. Study participants were then asked to provide the name and (if available) contact information of an adult (age 18+) residing within their household and representing their primary social support, if they were not living alone.One month prior to the initiation of the study member’s depression treatment, a data collector traveled to the individual’s household to meet with the household member. If the household member was unavailable during the visit, the data collector returned later. Out of the 258 household members identified by study participants, 237 were successfully contacted and 236 provided verbal consent to participate. Apart from residing in the same household as the study participant and being 18 years or older, there were no other inclusion or exclusion criteria.Household participants were informed that the data collector was conducting a district-wide survey on household health and wellbeing throughout Neno District and that they were selected to participate. To protect confidentiality, household members were not informed of the depression diagnosis of those they were residing with, nor did we inform them that anyone else in their household was participating in a research study. The interview took approximately 30 minutes to complete, and participants were compensated with 2,500 Malawian Kwacha (roughly $3) for their time, an amount equivalent to opportunity costs. | PMC10413913 |
Measures | depressive disorder, Depressive, [Functional impairment | The household interview comprised six instruments, the first of which gathered an overview of the household member’s sociodemographic characteristics – such as sex, age, marital status, and source of income. The remaining instruments are described below.Depressive symptoms and depressive disorder were evaluated using the nine-item version of the Patient Health Questionnaire (PHQ-9) [Functional impairment was evaluated using the World Health Organization Disability Assessment Schedule, version 2.0 (WHODAS), which has been implemented in countries throughout sub-Saharan Africa, including Malawi [Overall health was evaluated using the EuroQol, covering five dimensions of health at five levels (EQ-5D-5 L) [Social support was assessed using the Multidimensional Scale of Perceived Social Support (MSPSS), previously adapted to the Malawian context [We evaluated the household burden of care using the Burden Assessment Scale (BAS), which has been locally adapted to the study context [We gathered data from all the same instruments for corresponding study participants from the trial, except for the BAS, which was only collected during household interviews. | PMC10413913 | |
Statistical methods | depressive disorder, depression, depressive | REGRESSION | Based on our sample size, the present study had 80% power to detect relationships between patient and household member measures that were ≥ 0.19. As a first step in analysis, we drew from baseline interviews to generate descriptive statistics that characterized patients and household members. This included frequencies for discrete variables and means and standard deviations for continuous variables. The chief interest in this study was the prevalence of depression symptoms (PHQ-9 score > 0) and the prevalence of depressive disorder (PHQ-9 score > 9) among household participants.Next, we conducted multivariable linear regression to assess correlates of depressive symptom severity among household members, including health and sociodemographic characteristics as independent variables. We separately configured this analysis as a multivariable logistic regression, with the outcome structured as whether the household member had an indication of depressive disorder, based on a PHQ-9 score greater than nine (1=yes; 0=no). | PMC10413913 |
Results | PMC10413913 | |||
Prevalence estimates | depressive disorder, depressed, depressive symptoms | Overall, 16% of household members were classified as moderately depressed and three percent as severely depressed, based on PHQ-9 scores. This represents a 19% prevalence of depressive disorder. Greater than nine in 10 household members endorsed one or more depressive symptoms (see Prevalence of depressive symptoms and depressive disorder among household members. | PMC10413913 | |
Discussion | depressive disorder, ’ depressive symptoms, depressive symptoms, MDD, depression | DISEASES, DISORDERS | To our knowledge, this is one of the first studies to assess the prevalence and correlates of depressive symptoms and depressive disorder among household members of patients with MDD. We found a high prevalence of depressive symptoms: 91% of household respondents endorsed one or more symptoms, a figure similar to that observed by Docrat and colleagues (2019) among household members within a primary healthcare setting in South Africa [The prevalence of depressive disorder among household members (19%) was higher than estimates reported for other sub-populations in Malawi [We also found that specific constructs were associated with greater or lesser depression severity. For example, household members who reported high levels of social support also reported lower levels of depression symptoms. This corroborates a previous study set in Malawi, which found the same pattern among caregivers of children in vulnerable households [Among household members, screening positive for depressive disorder was associated with greater functional impairment. Significant functional impairment and/or distress are requirements for the diagnosis of major depressive disorder according to the Diagnostic and Statistical Manual of Mental Disorders (DSM) and International Classification of Diseases (ICD) criteria [In contrast with past studies, we do not find evidence that household members’ depressive symptoms and depression were related to demographic characteristics such as age, gender, marital status, or income [Our study has several limitations. First, as just noted, study participants were relatively homogeneous. This reduces variance and limits our ability to generalize findings to other Malawian or similar regional settings. Second, unlike prior investigations, we did not restrict analyses to principal caregivers of the patients and instead extended eligibility to all adult household members. This determination was based, in part, on the age range of our sample. Third, all significant relationships reported in this study are correlational. To conclude directionality of relationships would require an experimental or quasi-experimental approach. Likewise, some relationships of interest (e.g. CD4 count) were unmeasurable due to resource limitations in the setting. Lastly, we quantified depressive symptoms using the PHQ-9. While the PHQ-9 has been validated for use in Malawi [ | PMC10413913 |
Conclusion | depressive disorder, depressive symptoms, MDD, depression, disability | We found a high prevalence of depressive symptoms and depression among household members of chronic care patients with MDD. The overall paucity of resources presently available to households – coupled with difficulties in social support, overall health, and disability – make a collective case for the importance of interventions that address these complexities. While certain forms of aid may be unavailable in rural Malawi, depression care interventions could directly consider household dynamics, the role of social support and social networks in shaping trajectories, and even extend treatment to household members who screen positive for depressive disorder. | PMC10413913 | |
Acknowledgments | We would like to thank the clinicians, data collectors, and other staff at Partners In Health/APZU who spend their days making Integrated Chronic Care a reality throughout Neno District. Zikomo. | PMC10413913 | ||
Author contributions | KM, OM, and RM contributed to the study conception and design. KM, OM, and MK performed data collection. R M, KM, and TeR performed data preparation and analysis. RM, KM, and TeR wrote the first draft of the manuscript. All authors reviewed, commented, and provided feedback on all versions of the manuscripts. All authors read and approved the final manuscript. | PMC10413913 | ||
Consent for participation and publication | We obtained written informed consent from all participants to participate in the study. Patients signed informed consent regarding publishing their data. The research was carried out in accordance with the RAND Human Subjects Protection Committee guidelines. | PMC10413913 | ||
Disclosure statement | No potential conflict of interest was reported by the author(s). | PMC10413913 | ||
Ethics | The study has received ethics approval from the RAND Human Subjects Protection Committee as well as the National Health Science Research Committee of Malawi (20/11/2626). The research was carried out in accordance with the RAND Human Subjects Protection Committee guidelines. | PMC10413913 | ||
Paper context | depressive disorder, depressive disorders, depressive symptoms | Among household members of adults living with major depressive disorder, we find a high prevalence of depressive symptoms and moderate-to-severe depressive disorders. The findings shed new light on the social ecology of major depressive disorder, including the correspondence of elevated depressive symptoms among co-habiting household members. The findings indicate that mental health screening and treatment should extend beyond the individual perspective – to consider screenings among household members and interventions that account for household dynamics. | PMC10413913 | |
Data availability statement | Deidentified data and code are available upon request (email: rmcbain@bwh.harvard.edu). | PMC10413913 | ||
References | PMC10413913 | |||
Background | malignant pancreatobiliary strictures | Endoscopic retrograde cholangiopancreatography (ERCP) with biliary brush cytology is commonly used to diagnose malignant pancreatobiliary strictures. This trial compared the sensitivity of two intraductal brush cytology devices. | PMC10234858 | |
Methods | extrahepatic biliary strictures | A randomized controlled trial in which consecutive patients with suspected malignant, extrahepatic biliary strictures were randomized (1:1) to a dense or conventional brush cytology device. Primary endpoint was sensitivity. Interim analysis was conducted after 50% of the patients completed follow-up. Results were interpreted by a data safety monitoring board. | PMC10234858 | |
Results | benign disease, Malignancy | MALIGNANCY, SENSITIVITY | Between June 2016 and June 2021, 64 patients were randomized to the dense (27 patients, 42%) or conventional brush (37 patients, 58%). Malignancy was diagnosed in 60 patients (94%) and benign disease in 4 patients (6%). Diagnoses were confirmed by histopathology in 34 patients (53%), cytopathology in 24 patients (38%), and clinical or radiological follow up in 6 patients (9%). Sensitivity of the dense brush was 50%, compared to 44% for the conventional brush ( | PMC10234858 |
Discussion | The results of this randomized controlled trial showed that the sensitivity of a dense brush is not superior to a conventional brush for diagnosing malignant extrahepatic pancreatobiliary strictures. This trial was prematurely ended for reasons of futility. | PMC10234858 | ||
Trial registration | Netherlands Trial Register number; NTR5458. | PMC10234858 | ||
Supplementary Information | The online version contains supplementary material available at 10.1007/s00464-023-09916-9. | PMC10234858 | ||
Keywords | Malignant pancreatobiliary strictures, PDAC, cholangiocarcinoma, pancreatic ductal adenocarcinoma | PANCREATIC DUCTAL ADENOCARCINOMA, DISEASE, CHOLANGIOCARCINOMA | Malignant pancreatobiliary strictures are most commonly caused by pancreatic ductal adenocarcinoma (PDAC) and distal cholangiocarcinoma (CCA). Due to the late presentation in advanced stages of disease, only 20% of the patients can be treated with curative intent. Chemotherapy is the mainstay of treatment as it prolongs overall survival in both the curative and the palliative setting [ | PMC10234858 |
Materials and methods | PMC10234858 | |||
Study design | extrahepatic biliary strictures | We performed a single-blinded, randomized controlled trial to prove superior sensitivity of the dense Infinity® brush (US Endoscopy, Northeast Ohio, USA. CE 02,112) over the conventional RX cytology® brush (Boston scientific Corporation, Marlborough, MA, USA. CE 616,288) for diagnosing malignant, extrahepatic biliary strictures. The study was performed in the Amsterdam University Medical Centers (location Academic Medical Center and VU Medical Center, Amsterdam), a tertiary care centre in the Netherlands. The study was approved on January 14th, 2016 by the local institutional review board of the Academic Medical Center (approval number METC 2015_240). The independent data safety monitoring board (DSMB) consisted of two gastroenterologists and a clinical epidemiologist. The DSMB evaluated the results of the interim analysis (after 50% of the patients completed follow-up, | PMC10234858 | |
Participants | extrahepatic biliary stricture, malignant stricture, pancreatitis, biliary stricture, biliary obstruction | BILIARY OBSTRUCTION, PANCREATITIS | All consecutive patients ≥ 18 years with a suspected malignant, extrahepatic biliary stricture who underwent ERCP and had an indication to obtain a cytological sample via biliary brush cytology were eligible for inclusion. Patients provided written informed consent prior to the procedure. Exclusion criteria were: Intrahepatic or hilar biliary obstruction (defined as biliary stricture located within 2 cm of the hilum), failed biliary cannulation, contraindication for sphincterotomy, and the absence of a malignant stricture during ERCP. During the course of this study, another randomized trial on the value of endoscopic sphincterotomy prior to fully covered self-expandable metal stent placement for the prevention of pancreatitis was conducted [ | PMC10234858 |
Randomization and masking | After biliary cannulation was obtained, patients were randomly assigned (1:1) by the coordinating investigator to either the intervention group (dense brush) or the control group (conventional brush) with the use of sealed opaque envelopes. The randomization sequence was computer-generated before trial commencement by SL. Patients were enrolled and assigned to trial groups by the coordinating investigators (SL, NvH, MG). Participants were masked to group assignment (they were not told which group they were allocated to), whereas the endoscopist was not masked to the outcome of randomization. Pathologists were blinded to group assignment. The study coordinator was not blinded to treatment allocation during the assessment of the outcomes and the analyses of the study data. The members of the DSMB were blinded to group allocation. | PMC10234858 | ||
Procedures | STRICTURE | ERCP procedures were performed by or under direct supervision of a dedicated interventional endoscopist using standard techniques. Because of the diameter (9 French) of the dense brush, all patients in the intervention group underwent concomitant sphincterotomy. In the control group, sphincterotomy was performed at the discretion of the endoscopist. Cytology was obtained by pulling the brush back and forth through the stricture for 10 times in both groups. Hereafter, the brush was covered with the sheet and pulled back. Brushes were placed in a standard cytology vial and the cover of the brush was flushed in the vial to optimize cellular yield. The samples were evaluated by pancreatobiliary-dedicated pathologists as part of standard care. Deoxyribonucleic acid (DNA) mutation analysis, immunohistochemical staining, and central reading of the brush cytology samples were not standardly performed. Brush cytology samples were classified according to the Bethesda score [ | PMC10234858 | |
Outcomes | cholangitis, malignancy, benign disease, perforation, gastro-intestinal bleeding | METASTASIS, CHOLANGITIS, ADVERSE EVENTS, ADVERSE EVENT, PANCREATITIS | The primary outcome was sensitivity, defined as brush cytology specimen showing at least suspicion of malignancy (Bethesda ≥ 4) in patients with malignant diagnosis, as confirmed by histopathology results (surgical specimen or biopsy of either the primary mass or distant metastasis) or cytopathology results (ultrasound-or computed tomography (CT)-guided fine needle aspiration of distant metastasis or endoscopic ultrasonography-guided fine-needle aspiration (EUS-FNA) of the primary mass) showing at least suspicion of malignancy, or clinical and/or radiological follow-up. Secondary endpoints were specificity (defined as Bethesda ≤ 3 in patients with benign disease), positive predictive value (PPV, defined as the rate of true-positive results among all positive tests), negative predictive value (NPV, defined as the rate of true-negative results among all negative test results), and adverse events. Adverse events were classified according to the Cotton criteria (pancreatitis, gastro-intestinal bleeding, perforation, and cholangitis) [ | PMC10234858 |
Statistical analysis | Sample size calculation was based on the results of a meta-analysis which evaluated the sensitivity of conventional brush cytology in 1556 patients from 16 studies [ | PMC10234858 | ||
Early termination | ADVERSE EVENTS | According to protocol, the trial would be terminated after the interim analysis in case of a statistically significant higher rate of adverse events in the intervention group without a clinically relevant increase in sensitivity. Furthermore, rules for efficacy (according to the Haybittle-Peto rule) and futility (based on the O’Brien & Fleming method) were incorporated in the study protocol. The results of the interim analysis at 50% ( | PMC10234858 | |
Discussion | malignant extrahepatic biliary strictures | This randomized controlled trial compared the sensitivity of two intraductal brush cytology devices and showed that the dense brush was not superior to the conventional brush in diagnosing malignant extrahepatic biliary strictures. Following the recommendation from the DSMB, this study was interrupted after the interim analysis for reasons of futility.Several studies have investigated the sensitivity of brush cytology devices in identifying malignant extrahepatic biliary strictures. The modest sensitivity (44–50%) in our study is in line with results from two systematic reviews that reported sensitivity rates of 42% (± 3.2%) and 45% (95%-CI 40–50%), respectively. [In addition, three retrospective studies showed conflicting results on the increased sensitivity of dense brush cytology devices. Two of these studies did show higher sensitivity for the dense brush when compared to conventional brush cytology devices, although Bank et al. did not observe a higher sensitivity [The results of this randomized study should be interpreted in light of some limitations. First, this study was ended prematurely as recommended by the DSMB for reasons of futility. As a consequence, the sample size calculated for this study was not accomplished, thereby implicating the robustness of the conclusions that can be drawn from our data. Second, it is impossible to draw any conclusions regarding the equality of both brushes since this trial was designed as a superiority trial. In addition, because block randomization was not used in this study, the number of patients allocated to each group appears unequal (In conclusion, this randomized controlled trial showed that the dense brush is not superior to the conventional brush in terms of sensitivity in diagnosing malignant extrahepatic biliary strictures. As a consequence, this study was prematurely terminated for reasons of futility. Future studies should focus on the application of new techniques to evaluate biliary brush specimens (e.g., DNA mutation analysis) and on the value of advanced endoscopic procedures to obtain biliary samples (e.g., intraductal biopsies). | PMC10234858 | |
Supplementary Information | Below is the link to the electronic supplementary material.Supplementary file1 (DOCX 22 KB) | PMC10234858 | ||
Acknowledgements | We would like to acknowledge and thank the members of the data safety monitoring board (Robert C. Verdonk [chair; Department of Gastroenterology and Hepatology, St. Antonius Hospital, Nieuwegein, the Netherlands], Lydi M.J.W. van Driel [Department of Gastroenterology and Hepatology Erasmus Medical Center, Rotterdam, the Netherlands], and Susan van Dieren [Department of Surgery, Amsterdam UMC, Amsterdam, the Netherlands], for their kind participation and critical evaluation of our study data. | PMC10234858 | ||
Author contributions | SL, NvH and MG coordinated the trial during the inclusion period and JEvH supervised the study. MG performed the statistical analysis, JEvH checked the statistical analysis. SL, MG and NvH had access to the data and MG and NvH verified the data. MG drafted the manuscript. All authors critically assessed the study design, included patients in the study, edited the manuscript, and read and approved the final version of the manuscript. All authors vouch for the accuracy and completeness of the data and its analyses. The corresponding author has full access to all the data in the study and had final responsibility for the decision to submit this manuscript for publication. | PMC10234858 | ||
Funding | This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. | PMC10234858 | ||
Data availability | The data that support the findings of this study are available from the corresponding author upon reasonable request. Individual patient data will be shared after de-identification and approval by the study team. Furthermore, a data transfer agreement has to be set up prior to data sharing. | PMC10234858 | ||
Declarations | PMC10234858 | |||
Disclosures | Jeanin E. van Hooft has received research support from Cook Medical and acted as consultant for Cook Medical, Boston Scientific, Medtronics, Olympus, and Abbvie. Rogier Voermans received a research grant and acted as consultant for Boston Scientific. Paul Fockens acted as a consultant for Cook Endoscopy and Olympus. Roy L.J. van Wanrooij acted as a consultant for Boston Scientific. Myrte Gorris, Nadine C.M. van Huijgevoort, Sybren L. Meijer, Joanne Verheij, and Selma Lekkerkerker declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. | PMC10234858 | ||
References | PMC10234858 | |||
Introduction | T1DM, HF, cardiovascular death, myocardial and skeletal muscles, hypoxia, Diabetes mellitus, T2DM, Type 2 Diabetes, heart failure, type 2 diabetes, insulin-dependent diabetes, diabetes | VOLUME OVERLOAD, TYPE 1 DIABETES, INFLAMMATION, HYPOXIA, EVENTS, DIABETES MELLITUS, CHRONIC METABOLIC DISEASE, INCREASING INSULIN, INSULIN RESISTANCE, INSULIN RESISTANCE, TYPE 2 DIABETES, HEART FAILURE, TYPE 2 DIABETES, INSULIN-DEPENDENT DIABETES, DIABETES | Diabetes mellitus is a chronic metabolic disease, in which there is a marked elevation in the blood glucose level. This elevation is associated with damaging effects on nerves, eyes, blood vessels, heart, and kidney. There are 2 main subtypes of diabetes: Type 1 Diabetes (T1DM), in which the pancreas is producing little or no insulin due to destruction of insulin-producing beta cells by autoimmune process. This type is known as insulin-dependent diabetes. Type 2 Diabetes (T2DM), in which the body become resistant to insulin causing functional deficit of insulinGlimepiride is a member of sulfonylureas family, which are used for the management of patients with T2DM. It works by increasing insulin secretion from pancreatic beta cellsHomeostatic Model Assessment of Insulin Resistance (HOMA-IR) is a method for assessing insulin resistance from fasting insulin and fasting glucose concentration. The model has been proved to be a robust clinical and epidemiological tool. It has become one of the standard tools in the armamentarium of the clinical physiologistOne of the most important approaches of developing insulin resistance is the change in glucose transporters (GLUT)Interleukin-34 (IL-34) is a cytokine that has been found to be expressed on adipocyte, and to be positively correlated with insulin resistance. IL-34 was found to significantly inhibits insulin-stimulated glucose transport in human differentiated adipocyte, which may explain its role in insulin resistance and making it a suitable marker to reflect insulin resistance status in T2DM patientsNatriuretic peptides (NP) are biomechanical biomarkers that are released from cardiac myocytes in response to inflammation, volume overload, hypoxia, and myocardial stretching. Natriuretic peptides action antagonizes the effects of renin angiotensin aldosterone system (RAAS), moreover, they reduce insulin resistance in the myocardial and skeletal muscles. Serum level of NP is used as a diagnostic tool for heart failure (HF) development and risk of cardiovascular death, as their serum level increase with the development of heart failure. NP have markedly used in the prediction of incident HF and total cardiovascular events in patients with type 2 diabetes | PMC10113266 |
Aim of the work | This study aims to compare the effect of dapagliflozin versus glimepiride on glycemic control, HOMA-IR, and on markers like IRAPe, IL-34, and NT-proBNP, and to establish relationship between these parameters.Primary outcomes: change in the glycemic control and IRAPe.Secondary outcomes: change in the levels of IL-34 and NT-proBNP. | PMC10113266 | ||
Patients and methods | PMC10113266 | |||
Study design and participation | diabetic, Diabetes | BLIND, DIABETES | This is a 3-month prospective double blind parallel randomized study, that involve 60 type 2 diabetic patients of both sexes recruited from outpatient clinics of Diabetes and Endocrinology Unit, Department of Internal Medicine, Tanta University hospitals, Tanta, Egypt. The study took place from January 2021 to February 2022. All the procedures were done according to standards ethical guidelines and were approved by the research and ethics committee of Damanhour University (No. 1219PP20). The trial was registered on clinical trial.gov by (NCT04240171). All the study subjects have agreed to take part in the trial and provided a written informed consent. The study participants were asked to keep the usual dietary and activity habits throughout the study period. Patients were randomly assigned to either dapagliflozin group (n = 30) or glimepiride group (n = 30) in 1:1 ratio manner. All the patients were on metformin 1000 mg daily for at least a year before the beginning of the study. The dapagliflozin group received dapagliflozin 10 mg daily in addition to their usual dose of metformin, while the glimepiride group received glimepiride 4 mg daily in addition to their usual dose of metformin.
| PMC10113266 |
Inclusion criteria | diabetic | The selected patients were with uncontrolled type 2 diabetic with age ranging from 18 to 70 year and having glycated hemoglobin A1c% (HbA1c%) level ≥ 7. There were no limits to the duration of DM and gender. | PMC10113266 | |
Exclusion criteria | malignancy, abnormal liver function, hypersensitivity, renal impairment | RENAL IMPAIRMENT, ISCHEMIC HEART DISEASE, TYPE 1 DIABETES, BLADDER CANCER, HEART FAILURE, HYPERSENSITIVITY | Patients excluded from the study were those with type 1 diabetes, hepatic impairment, malignancy, heart failure, history of ischemic heart disease, planned surgical intervention, and both pregnant and nursing women, hypersensitivity to the study drugs, abnormal liver function, renal impairment (eGFR ≤ 60 ml/min) or history of bladder cancer. | PMC10113266 |
Demographic data and baseline evaluation | Complete medical examination was performed for each subject to evaluate their health status. Data on weight, height, sex, age, medical history, and medication were collected. BMI was calculated for each patient using the formula BMI = weight (kg)/height | PMC10113266 | ||
Study procedure and biomarker measurement | BLOOD, INSULIN RESISTANCE | The blood samples were collected from each patient after overnight 12 hours (h) fasting period, a drop of blood was used to determine the fasting blood glucose using the glucometer. Patients were allowed to have breakfast, then after 2 h, the glucometer was used to determine the 2 h post prandial glucose. All these samples were collected at the beginning of the study and after 3 months of receiving the medication of interest. Blood samples were centrifuged at 2000–3000 rpm for 20 min, separated, collected in tubes, and stored at – 80 °C until biochemical analysis was performed. Fasting glucose, and 2 h. Post prandial glucose were determined using glucometer (Rightest, Bionime Corporation, Taiwan). Enzyme-Linked ImuunoSorbent Assay (ELISA) kits (Sunred biological technology Co., Ltd., Shanghai) were used in duplicate to determine fasting insulin (kit catalogue number: 201-12-0011, sensitivity: 0.352 mU/l, and assay range: 0.4–100 mU/l), glycated hemoglobin (Turbidimetric kit catalogue number: HBT1-100-0100, sensitivity: 1.4%, and assay range: 1.4%–14%), interleukin-34 (IL-34) (kit catalogue number: 201-12-0044, sensitivity: 4.336 ng/ml, and assay range: 5–1500 ng/ml), extracellular domain of insulin regulated aminopeptidase (IRAPe) (kit catalogue number: 201–12-4150, sensitivity: 0.236 ng/ml, and assay range: 0.25–72 ng/ml), and natriuretic peptides (NT-proBNP) (kit catalogue number: 201-12-1240, sensitivity: 1.117 pg/ml, and assay range: 2–360 pg/ml). Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) was calculated from the equation: | PMC10113266 | |
Follow up and adherence | All the study participants were followed up during the 3-month interval of the study, and all have confirmed adherence to their medications and their usual dietary and activity habits during the study. | PMC10113266 | ||
Sample size calculation | Heinrich Heine Universität | The required sample size was calculated using G*Power software version 3.1.0 (Institut für Experimentelle Psychologie, Heinrich Heine Universität, Dusseldorf, Germany). It was estimated that a total sample size of 60 patients would have a power of 95.4% to detect a medium to large effect size of 0.87 in the outcome measured. | PMC10113266 | |
Statistical analysis | Statistical analysis of the data was performed, and box plots were created using IBM SPSS statistics software version 24 (IBM, Armonk, New York). Continuous variables are expressed as mean ± SD. Unpaired t-test was used to compare between the 2 groups, while paired t-test was used to detect the difference within the group between the beginning of the study and after 3 months. Categorical variables are expressed as numbers (percentage) and were compared using chi-square (X | PMC10113266 | ||
Effects of glimepiride vs. dapagliflozin on insulin resistance as indicated by HOMA-IR | Table | PMC10113266 | ||
Discussion | inflammation, heart failure, hypoxia, type 2 diabetes | HYPOXIA, INFLAMMATION, INSULIN RESISTANCE, HEART FAILURE, TYPE 2 DIABETES | To our knowledge this is the first study that compares the effects of dapagliflozin and glimepiride on glycemic control, insulin resistance and different biomarkers as IRAPe, IL-34, and NT-pro BNP.Our results show that both glimepiride and dapagliflozin have significantly improved the glycemic control in the study patients as they have significantly improved the levels of fasting and 2-h post prandial blood glucose level, and glycated hemoglobin. These findings are in accordance with the findings of Goldberg et al. that showed that glimepiride significantly reduce the levels of FBG, 2-H PPBG, and HbA1C (p < 0.001)HOMA-IR is widely used to assess insulin resistance using fasting glucose and fasting insulinIRAP plays an essential role in the translocation of GLUT-4 to plasma membrane, which plays an important role in the development of insulin resistance. When this translocation happens, the extracellular domain of IRAP (IRAPe) is released into the bloodOur study observed that glimepiride decreased insulin resistance without having a significant effect on IRAPe level this may be attributed to HOMA-IR, that used as indicator for insulin resistance, which calculated based on fasting insulin and fasting glucose concentration. Glimepiride was found to stimulate glucose transport by affecting GLUT-1 and GLUT-4Another possible explanation is that IRAPe may require more time to be improved in response to glimepiride or may require higher doses of glimepiride. And since our study is relatively short and the sample size is relatively small we cannot confirm the exact explanation.We also found that dapagliflozin has significantly improved the level of IRAPe, but since the significance level is very close to the significance threshold and since our sample size is relatively small and the duration of the study is relatively short, this result needs to be confirmed with longer duration and larger sample size study. The difference between dapagliflozin and glimepiride effects on IRAPe is non-significant. We found that Glimepiride has significantly improved the level of IL-34, unlike dapagliflozin that do not have significant effect on its level. There is a significant difference between the effect of both drugs on IL-34. These findings may be explained as IL-34 is alternative ligand for colony stimulating factor-1 (CSF-1). IL-34 has been found to be involved in the inflammation and development of insulin resistanceNT-proBNP are biomarkers that are released from the heart in response to inflammation, hypoxia, or myocardial stretching. They have been proved to be a useful marker for the prediction of the development of heart failure in patients with type 2 diabetes | PMC10113266 |
Conclusion | diabetic | CVD, INSULIN RESISTANCE, INSULIN SENSITIVITY, CARDIOVASCULAR DISEASES | Both glimepiride or dapagliflozin significantly improved glycemic control, insulin resistance (as indicated by HOMA-IR), and NT-proBNP with no significant difference between them in type 2 diabetic patients. However, dapagliflozin has a borderline significant effect on IRAPe, and did not affect IL-34 significantly, while glimepiride has a significant effect on IL-34 but not IRAPe.Since both drugs have improved the levels of NT-proBNP they can be recommended for diabetic patients who are at high risk for developing cardiovascular diseases (CVD). Both drugs have improved insulin sensitivity so they can be very useful for patients with high insulin resistance, with glimepiride more recommended for patients with high level of IL-34. Although, larger scale studies with longer follow-up duration are still needed to determine the benefits of both medications in diabetic patients. | PMC10113266 |
Study limitations | The main limitation of this study is relatively small sample size and short time of follow-up period. Hence, further large-scale studies seem necessary. Another limitation of our study is that it did not assess post prandial insulin resistance. | PMC10113266 | ||
Supplementary Information | The online version contains supplementary material available at 10.1038/s41598-023-33417-3. | PMC10113266 | ||
Acknowledgements | Diabetes | DIABETES | The authors are so thankful to all participants and to the physicians in Endocrinology and Diabetes unit at Tanta University Hospitals for their help and valuable recommendations. | PMC10113266 |
Author contributions | R.Z., G.A.O. and R.H.W. reviewed the literature, constructed the study design, and performed laboratory investigation of collected samples. Eligibility assessment, participant selection, enrolment and collection of clinical data were performed by N.M.E.-G. All authors shared in statistical analysis of collected data, wrote and revised the Manuscript. All authors read and approved the final manuscript. | PMC10113266 | ||
Funding | Open access funding provided by The Science, Technology & Innovation Funding Authority (STDF) in cooperation with The Egyptian Knowledge Bank (EKB). | PMC10113266 | ||
Data availability | All data generated or analysed during this study are included in this published article [and its | PMC10113266 | ||
Competing interests | The authors declare no competing interests. | PMC10113266 | ||
References | PMC10113266 | |||
Background | pain, Knee osteoarthritis, OA, arthritis | KNEE OSTEOARTHRITIS, ARTHRITIS, DEGENERATION | Knee osteoarthritis (OA) is the most common kind of arthritis that occurs due to degeneration of the joint articular cartilage, producing pain, stiffness, and impaired movement. The objective of the study was to evaluate the short-term effectiveness of Kinesio taping (KT) plus conventional physical therapy (CPT) and CPT alone in subjects with knee OA. | PMC10522526 |
Materials and methods | pain | OSTEOARTHRITIS | Forty male subjects were divided into two groups at random using a parallel assignment, double-blinded study design, viz., KT with CPT (transcutaneous electrical nerve stimulation and exercise therapy), and CPT alone for the period of 6 weeks of treatment. At baseline, third, and sixth weeks, the following outcome measures were taken, such as pain intensity (NPRS), knee range of motion (goniometry), Western Ontario and McMaster Osteoarthritis Index (WOMAC), and the Time Up and Go (TUG) test. | PMC10522526 |
Statistical analysis | To reveal the patient’s demographic profile concerning the outcome parameters, a descriptive statistic was applied. Furthermore, two-way mixed ANOVA and Tukey HSD post hoc tests were used to analyze within and between-group comparisons in SPSS 20.0. | PMC10522526 | ||
Results | pain | In both groups, pain and knee flexion were significantly improved during the 6-week period of interventions ( | PMC10522526 | |
Conclusion | pain | KT combined with CPT was found to be more effective than CPT alone in the third and sixth weeks of the treatment. In knee OA, this combination of treatments was found to reduce pain, enhance range of motion, and improve physical functioning. | PMC10522526 | |
Keywords | PMC10522526 | |||
Introduction | knee OA, Knee osteoarthritis, OA, pain | OSTEOARTHRITIS OF THE KNEE, KNEE OSTEOARTHRITIS, JOINT DISEASE | Knee osteoarthritis (OA) joint disease most commonly occurs in the elderly population, and it causes significant pain and functional limitations [Kinesio taping (KT) is a therapeutic technique commonly used to treat knee OA [Exercise therapy (ET) is an important component of the treatment for osteoarthritis of the knee [ | PMC10522526 |
Methodology | PMC10522526 | |||
Study design | knee osteoarthritis | KNEE OSTEOARTHRITIS | The effectiveness of Kinesio taping and transcutaneous electrical nerve stimulation with exercises on knee osteoarthritis was evaluated using a parallel assignment; a double-blinded study design was used in this study. | PMC10522526 |
Protocol registration | The study was approved by the Ethics committee (IRB), University of Tabuk and is registered with ClinicalTrial.gov (NCT05151627). | PMC10522526 | ||
Subjects and Randomization | osteoarthritis, OA, knee pain | OSTEOARTHRITIS | The study included all male subjects with knee pain who visited two government hospitals. All the subjects were referred to the physical therapy clinic by an orthopedic surgeon with a diagnosis of osteoarthritis (OA) in the knee. Both radiography and a clinical examination showed that they had OA changes in the knee joint. Among them, 49 subjects were between the ages of 40 and 70. Based on the application of both inclusion and exclusion criteria, nine patients were excluded, making a total of 40 subjects, and they participated in this study (Fig. Flow chart diagram for the study design model | PMC10522526 |
Inclusion and exclusion criteria | degenerative knee arthritis, pain, knee pain, knee injuries, loss of active and passive ROM | HAND SWELLING | The participants in the study had to meet the following requirements: complaining of knee pain that has lasted longer than 3 months, and a pain level that is medium (pain score greater than or equal to 4) with no knee injuries, treatment not received in another physical therapy clinic in the past three months, painful range of motion (ROM), significant loss of active and passive ROM due to pain, stiffness, and swelling in the knee joint. Subjects were excluded if they had a history of knee surgery, any other neural, articular, or muscular conditions affecting lower limb function, a systemic arthritic condition, or had received an intra-articular injection or physical therapy in the past 3 months. Following a diagnosis of degenerative knee arthritis based on medical imaging such as X-rays, MRI, or bone scanning, patients are referred to the physical therapy department by an orthopedic consultant. An information leaflet explaining the study was given to the participants. Participants were enrolled and given the option to withdraw at any time by signing an informed consent form. During the initial evaluation, experienced PTs collected demographic information. | PMC10522526 |
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