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Introduction | lung cancer, Lung cancer, ILD, Interstitial lung abnormalities | LUNG CANCER, INTERSTITIAL LUNG DISEASE, LUNG CANCER | Interstitial lung abnormalities (ILA) are relatively common incidental findings in participants undergoing low-dose CT screening for lung cancer. Some ILA are transient and inconsequential, but others represent interstitial lung disease (ILD). Lung cancer screening therefore offers the opportunity of earlier diagnosis ... | PMC10450038 |
Methods | LUNG | The prevalence of ILA in participants in the baseline screening round of the Yorkshire Lung Screening Trial is reported, along with the proportion referred to a regional ILD service, eventual diagnoses, outcomes and treatments. | PMC10450038 | |
Results | sarcoidosis, idiopathic non-specific interstitial pneumonia, asbestosis, respiratory bronchiolitis ILD | SARCOIDOSIS, HYPERSENSITIVITY PNEUMONITIS, ASBESTOSIS, IDIOPATHIC INTERSTITIAL PNEUMONIA, PLEUROPARENCHYMAL FIBROELASTOSIS, IDIOPATHIC PULMONARY FIBROSIS | Of 6650 participants undergoing screening, ILA were reported in 169 (2.5%) participants. Following review in a screening review meeting, 56 participants were referred to the ILD service for further evaluation (0.8% of all screening participants). 2 participants declined referral, 1 is currently awaiting review and the ... | PMC10450038 |
Discussion | lung cancer, Lung cancer | LUNG CANCER, LUNG CANCER | Lung cancer screening detects clinically significant cases of ILD allowing early commencement of disease-modifying treatment in a proportion of participants. This is the largest screening cohort to report eventual diagnoses and treatments and provides an estimate of the level of clinical activity to be expected by ILD ... | PMC10450038 |
WHAT IS ALREADY KNOWN ON THIS TOPIC | lung cancer, ILD, Interstitial lung abnormalities | LUNG CANCER, INTERSTITIAL LUNG DISEASE | Interstitial lung abnormalities are common findings on low-dose CT screening scans performed in lung cancer screening programmes, and in some cases may represent interstitial lung disease (ILD) for which effective pharmacotherapy is now available. | PMC10450038 |
WHAT THIS STUDY ADDS | lung cancer | LUNG CANCER | Few previous studies have reported the eventual diagnoses and treatments of cases of screen-detected ILD; here, we report the largest lung cancer screening cohort to include eventual ILD diagnoses and treatments. Overall, 0.8% of participants undergoing baseline screening were diagnosed with ILD and 0.15% have commence... | PMC10450038 |
HOW THIS STUDY MIGHT AFFECT RESEARCH, PRACTICE OR POLICY | lung cancer | LUNG CANCER | This study shows that lung cancer screening detects clinically significant cases of ILD fulfilling criteria for pharmacotherapy. The proportions of participants needing referral to ILD services and requiring eventual treatment reported here will help capacity planning for services alongside future roll-out of lung canc... | PMC10450038 |
Introduction | lung cancer, interstitial lung abnormalities | LUNG CANCER, LUNG | Low-dose CT (LDCT) screening for lung cancer has been shown to reduce lung cancer-specific and all-cause mortality in the National Lung Screening Trial (NLST)The term interstitial lung abnormalities (ILA) refers to a variety of incidental radiological findings on CT imaging, some of which are transient and inconsequent... | PMC10450038 |
Methods | PMC10450038 | |||
YLST study design | The full protocol of YLST has been published previously. | PMC10450038 | ||
Patient and public involvement (PPI) | Mesothelioma, Lung Cancer | EVENTS, MESOTHELIOMA, LUNG CANCER | Patients and members of the public were closely involved in the YLST design. A group of four PPI representatives met regularly during the study design period, providing feedback on the design and suggesting amendments which were incorporated. PPI feedback was presented to both the Research Ethics Committee and Confiden... | PMC10450038 |
Participant history and symptoms | exertional breathlessness, exhaled carbon monoxide, cough, bronchitis, dyspnoea, wheeze | RESPIRATORY DISEASE, BRONCHITIS | At the LHC, participants were asked about a history of respiratory disease, presence of respiratory symptoms (exertional breathlessness, chronic cough, regular sputum production, wheeze, frequent winter bronchitis), number of hospital admissions for chest problems, number of antibiotic courses in the last 12 months, mo... | PMC10450038 |
LDCT scan reporting and review | cancers, incidental abnormalities, Lung Cancer | CANCERS, TRACTION BRONCHIECTASIS, LUNG CANCER | LDCT scans for YLST are reported by a team of eight consultant radiologists with a subspecialty interest in thoracic imaging. Scans are reported using Veolity (MeVis AG), a bespoke software package for Lung Cancer screening including automated volumetry and computer-aided detection. In addition to protocolised reportin... | PMC10450038 |
Data collection | death, interstitial lung abnormality, ILD, respiratory bronchiolitis ILD, interstitial pneumonia, fibrosis, lung cancer | CRYPTOGENIC ORGANISING PNEUMONIA, DISEASE, FIBROSIS, LUNG CANCER, IDIOPATHIC PULMONARY FIBROSIS, DESQUAMATIVE INTERSTITIAL PNEUMONIA, BRONCHIOLITIS OBLITERANS ORGANISING PNEUMONIA | All participants with ILA discussed at an SRM were prospectively logged, including the outcome of the telephone consultation. In order to identify ILA that did not meet the predefined criteria for clinically significant disease, a search was performed on a dataset of all baseline LDCT scans for terms in the comments or... | PMC10450038 |
Statistical analysis | Statistical analysis was performed using GraphPad Prism, with comparison between those with ILD (known and newly referred) and those without ILD using methodologically appropriate tests. YLST is registered with the ISRCTN (reference ISRCTN42704678). | PMC10450038 | ||
Results | interstitial lung abnormality, cancer, fibrosis, IPF, emphysema, lung cancer, infection, pneumoconiosis, interstitial lung abnormalities, interstitial lung diseaseFEVTwo | CANCER, FIBROSIS, EMPHYSEMA, LUNG CANCER, INFECTION, PLEURAL FIBROSIS, PNEUMOCONIOSIS, IDIOPATHIC PULMONARY FIBROSIS, RESPIRATORY BRONCHIOLITIS INTERSTITIAL LUNG DISEASE, HEART FAILURE, NON-SPECIFIC INTERSTITIAL PNEUMONIA | Baseline LDCT screening scans were performed on 6650 participants during the prevalent round of screening between November 2018 and February 2021. ILA were reported in 169 cases (2.5%) of which 153 cases were discussed in the SRM, usually because these cases were flagged as clinically significant, but occasionally at t... | PMC10450038 |
Discussion | idiopathic interstitial pneumonia, ILD | IDIOPATHIC INTERSTITIAL PNEUMONIA | In this analysis of ILA reported in a prevalence LDCT screening round, 2.5% of cases had mention of ILA in their CT report and 0.8% of cases were deemed clinically significant needing referral to the ILD service. Of those cases referred, IPF was the most common specific diagnosis (14 cases comprising 26% of referred ca... | PMC10450038 |
Strengths and limitations | decline in lung function | This is the largest study to date to describe downstream impacts of screen-detected ILA including the proportion of screening participants needing review in an ILD service and the proportion eventually receiving pharmacotherapy. The main limitation is that findings are only available from the baseline round of screenin... | PMC10450038 | |
Data availability statement | All data relevant to the study are included in the article or uploaded as supplementary information. | PMC10450038 | ||
Ethics statements | PMC10450038 | |||
Patient consent for publication | Not applicable. | PMC10450038 | ||
Ethics approval | WEST | This study involves human participants and was approved by the North West—Greater Manchester West Research Ethics Committee. REC reference:18/NW/0012. Participants gave informed consent to participate in the study before taking part. | PMC10450038 | |
References | PMC10450038 | |||
1. Introduction | VLBW, Hyperglycemia | HYPERGLYCEMIA, VERY LOW BIRTH WEIGHT INFANT | Hyperglycemia (HG) is an independent risk factor of mortality and morbidity in very low birth weight newborns (VLBW). Achievement of high nutritional intakes in the first days of life (DoL) by parenteral nutrition (PN) increases the risk of HG. We aim to assess if a delayed achievement of the PN macronutrient target do... | PMC10005207 |
2. Materials and Methods | PMC10005207 | |||
2.1. Standard Protocol Approval, Ethics and Patient Consent | The study is a single center prospective randomized controlled trial. The study was conducted in conformity with World Medical Association Declaration of Helsinki for medical research involving human subjects; it was approved by Ethics Committee of Policlinico Umberto I, University La Sapienza of Rome (number 5089). We... | PMC10005207 | ||
2.2. Population and Randomization | death, congenital malformations | CONGENITAL INFECTIONS, BLIND, INBORN ERRORS OF METABOLISM | We included all newborns with a gestational age (GA) <32 weeks or body birth weight (BW) <1500 g, consecutively admitted to the NICU of Policlinico Umberto I, La Sapienza University of Rome over a 4-year period. We excluded from the analysis neonates with major congenital malformations, inborn errors of metabolism, con... | PMC10005207 |
2.3. Outcome | hyperglycemia | HYPERGLYCEMIA | The primary outcome measure was the rate reduction of patients experiencing severe hyperglycemia (HG) between Group 1 (HG 30%) and Group 2 (15%) during the first week of life. | PMC10005207 |
2.4. Nutritional Protocol | bradycardia, Human milk, emesis, apnea, abdominal distension, ileus | HEMODYNAMIC INSTABILITY, ILEUS | In both groups, PN was initiated within 24 h after admission into the NICU. The macronutrient dose varied according to group assignment (Neonatologists in charge prescribed PN on a daily basis to preterm neonates based upon each clinical condition, laboratory results and weight by using a specific software. The require... | PMC10005207 |
2.5. Data Collection | hypo-phosphoremia, NEC, ROP, prematurity, IVH) stage ≥ 2, periventricular leukomalacia, IVH, intraventricular hemorrhage, ’s stage ≥ 2,, BPD, sepsis, PVL | NECROTIZING ENTEROCOLITIS, BRONCHOPULMONARY DYSPLASIA (BPD), HYPONATREMIA, HYPERCALCEMIA, BLOOD, SEPSIS, COMPLICATIONS, RETINOPATHY OF PREMATURITY | All patient data were stored in a logged database that was closed 90 days after enrollment of the last patient. The HG was defined as two consecutive blood glucose levels greater than 180 mg/dL at least 3 h apart. Blood glucose levels were monitored by a validated micro-method from capillary blood and analyzed by point... | PMC10005207 |
2.6. Statistical Analysis | Statistical analysis performed using Statistical Package for Social Science Software for Microsoft Windows (SPSS Inc., Chicago, IL, USA), version 27.0. We checked for normality using a Shapiro–Wilk test. The mean and standard deviation or median summarized continuous variables. We used a chi-square test for categorical... | PMC10005207 | ||
3. Results | hypoglycemia, BPD, ROP | HYPOGLYCEMIA, REGRESSION | A total of 321 patients underwent randomization and were included in the analysis, (At baseline, the characteristics of the patients were similar between the two groups, (Group 1 showed a significantly decreased duration of PN compared with Group 2 (13.43 DoL vs. 17.65 DoL; The rate of HG within 0–7 DoL is reported in ... | PMC10005207 |
4. Discussion | critically ill, ROP, Malnutrition, metabolic complications, hyperglycemia, BPD, sepsis | CRITICALLY ILL, MALNUTRITION, HYPERGLYCEMIA, REGRESSION, SEPSIS, COMPLICATIONS | Delayed target achievement of recommended nutritional intake reduces the risk of HG in preterm newborns. The occurrence of HG in the first week of life is an independent risk factor for mortality during hospitalization. Additionally, early target achievement reduces the risk of sepsis but is associated with an increase... | PMC10005207 |
Supplementary Materials | The following supporting information can be downloaded at: Click here for additional data file. | PMC10005207 | ||
Author Contributions | Conceptualization, M.D.C. and G.T.; methodology M.D.C., E.T., G.L., R.P., C.S., G.B. and G.T.; validation M.D.C. and G.T.; formal analysis M.D.C. and G.T.; investigation, E.T., G.L., R.P., C.S., L.D., D.R., P.P., R.B., B.D.S. and G.B.; data curation, M.D.C. and G.T.; writing—original draft preparation, M.D.C. and G.T.;... | PMC10005207 | ||
Institutional Review Board Statement | The study was conducted in conformity with World Medical Association Declaration of Helsinki for medical research involving human subjects, and it was approved by Ethics Committee of Policlinico Umberto I, University La Sapienza of Rome (number 5089, 24 June 2020). | PMC10005207 | ||
Informed Consent Statement | Written Informed consent to participate in this study was provided by the participants’ legal guardian/next of kin. | PMC10005207 | ||
Data Availability Statement | The datasets analyzed during the current study are available from the corresponding author on reasonable request. | PMC10005207 | ||
Conflicts of Interest | The authors declare no conflict of interest. | PMC10005207 | ||
1. Introduction | cancer, death | CHRONIC ILLNESS, DISEASE, CANCER | Background: Hope is widely considered a subjective phenomenon able to bring beneficial consequences to human health and existence. Maintaining hope amid a life-threatening disease and during palliative care is critical. The study aims to examine the effectiveness of a psychosocial supportive Hope Promotion Program (HPP... | PMC9861685 |
2. Materials and Methods | PMC9861685 | |||
2.1. Study Design | This was a two-group, parallel Randomized Control Trial (RCT), with a pre-test post-test control group design and repeated post-test measures. This RCT was retrospectively registered in the United States of America Clinical Trials Registry Platform (NCT02723799) according to the investigation protocol (see | PMC9861685 | ||
2.2. Setting and Participants | DISEASE | Participants were recruited from the day hospitals of two medical institutions in the central region of Portugal. The services in both contexts are especially dedicated to providing healthcare to chronic patients at different stages of the disease, including the palliative phase, in a clinic with less than 24 h access ... | PMC9861685 | |
2.2.1. Eligibility Criteria | After agreeing to participate, participants were thoroughly screened for eligibility by the main researcher (palliative care and mental health nurse). Screening involved completion of the Mini-Mental State Examination (MMSE) [ | PMC9861685 | ||
2.2.2. Random Assignment | The principal investigator (AQ) randomly allocated eligible participants to one of the two group using blocks of eight individuals, in a 1:1 distribution system, in order to guarantee an approximate number of individuals allocated to each group. Thus, for each block of eight individuals, a white ball/black ball system ... | PMC9861685 | ||
2.3. Intervention—Hope Promotion Program (HPP) | DISEASE, COMPLICATIONS | The intervention was designed based on the Narrative Communication Model of Hope Seeking Intervention [The participants randomly assigned to the intervention group were given the individual-based intervention (HPP) in three home visitation sessions conducted by a nurse. Each session lasted between 90 min and 2 h 30 min... | PMC9861685 | |
2.4. Sample Size | CHRONIC DISEASE | The sample size was calculated using power analysis based on four components: the level of significance or alpha (α), sample size, population effect size (ES), and power (1-β) [Given the inherent characteristics of individuals with advanced chronic disease, and the expected missing data and high attrition of the study,... | PMC9861685 | |
2.5. Outcome Variables and Measurements | The primary outcome was hope, as measured using the Portuguese version of the Herth Hope Index (HHI) validated for chronic conditions [Secondary outcomes were:(a) Comfort, as measured by the Portuguese version of the Hospice Comfort Questionnaire (HCQ) [(b) QoL, as measured by the Portuguese version of McGill Quality o... | PMC9861685 | ||
2.6. Data Collection Procedure | depression, illness, fatigue, pain | BLIND | Data collection took place over an 8-month period. Participants completed baseline (T1) instruments upon enrolment. Follow-up instruments were collected immediately after the intervention (T2—15 days later), and one month after the program was completed (T3). Baseline data collected for all participants included: (1) d... | PMC9861685 |
2.7. Analysis | A per-protocol analysis was done for all outcome variables and included only those patients who accomplished all assessments. Descriptive statistics were calculated to summarize patients’ characteristics and other baseline variables. The normality of distribution was checked using the Shapiro-Wilk test. Therefore, comp... | PMC9861685 | ||
2.8. Ethical Issues | BLIND | The project received ethical clearance from the Ethics Committees for Health of the hospitals where the research was conducted, which is in line with the principles of the Helsinki Declaration and later amendments [All subjects provided informed consent prior to any evaluation during the enrolment phase. All participan... | PMC9861685 | |
3. Results | PMC9861685 | |||
3.1. Demographic and Clinical Characteristics | death, fatigue | A total of 165 eligible participants were assessed for potential enrolment. Of these, 72 individuals did not meet the inclusion criteria, 29 participants declined to participate mainly due to fatigue, five people had their clinical situation worsen, and three individuals died. A total of 56 patients consented to partic... | PMC9861685 | |
3.2. Relationship between Hope, Comfort and QoL in the Sample | The resulting matrix shows positive, moderate and very significant relationships between hope, global comfort and total QoL. The highest correlation was found between hope and QoL (ρ = 0.605, | PMC9861685 | ||
3.3. Effect of Intervention | The global median scores were graphically represented for each outcome, before and after the intervention in both groups (see | PMC9861685 | ||
3.3.1. Primary Outcome | In the intervention group, there was a significant increase (+3.5; | PMC9861685 | ||
3.3.2. Secondary Outcomes | There were no significant differences in comfort scores in either group between T1 and T2. However, there was a significant increase in global comfort median scores in the intervention group one month after the HPP (T1/T3) (+13.5; Regarding the state of ease, there was a statistically significant increase between basel... | PMC9861685 | ||
4. Discussion | chronic illness, hope-promoting, illness, death | CHRONIC ILLNESSES, CHRONIC ILLNESS, DISEASE PROGRESSION | Comparison between the IG and CG suggests that the HPP had a positive effect on hope over time. The most expressive increases were in the levels of total hope and positive interior disposition and expectations, with significant differences in each period. Regarding temporality, trust and interconnection, differences we... | PMC9861685 |
4.1. Study Limitations | tiredness, ill | DISEASE, RECRUITMENT | Our study had several limitations. Firstly, only one nurse provided the intervention, which might have influenced the results. Secondly, the rapid deterioration in the health status of the participants implied a decrease in the number of patients in each group, which might impact the results. Indeed, participants’ numb... | PMC9861685 |
4.2. Implications | This study can be a useful contribution to updating the International Classification for Nursing Practice (ICNP | PMC9861685 | ||
5. Conclusions | ill | The HPP may be an effective intervention to increase hope and improve comfort and quality of life among palliative patients. This RCT suggests that is important to create training programs for nurses and nursing students within the scope of hope-promotion in order to promote the development of the personal and professi... | PMC9861685 | |
Author Contributions | Conceptualization, A.Q.; Methodology, A.Q.; Software, A.Q.; Validation, A.Q.; Formal analysis, A.Q.; Investigation, A.Q.; Resources, A.Q.; Data curation, A.Q.; Writing—original draft preparation, C.L. and A.Q.; Writing—review and editing, C.L. and A.Q.; Visualization, C.L. and A.Q.; Supervision, A.Q.; Project administr... | PMC9861685 | ||
Institutional Review Board Statement | The study was conducted in accordance with the Declaration of Helsinki and approved by the Institutional Review Boards (protocol approvals no. GIC/584; 942/C.A.). | PMC9861685 | ||
Informed Consent Statement | Informed consent was obtained from all subjects involved in the study. | PMC9861685 | ||
Data Availability Statement | The data are available upon reasonable request. | PMC9861685 | ||
Conflicts of Interest | The authors declare that they have no conflict of interest. | PMC9861685 | ||
References | SECONDARY | Participant flow through the phases of the RCT.Global median scores evolution of the primary and secondary outcome measures.Investigation protocol.* IG—Intervention Group; ** CG—Control Group.Participants’ baseline features.Differences in means and results of the Mann-Whitney tests to assess the equivalence between bot... | PMC9861685 | |
1. Introduction | milk, ’ gastrointestinal tolerance, gastrointestinal (GI) disturbances, human milk or infant formula, weight gain | SECONDARY, DISEASES | Membership of the HASI Study Group is provided in the Acknowledgements.The evaluation of secondary parameters of a prospective, randomised, controlled, multicentre intervention trial aimed to analyse gastrointestinal tolerance of an infant formula manufactured from extensively hydrolysed whey protein (eHF) compared to ... | PMC10647512 |
2. Methods and Materials | The study design and methods are described here briefly; they have been published in detail elsewhere [ | PMC10647512 | ||
2.1. Study Design and Population | ICH, Breastfed | SECONDARY | The study was designed as a prospective, multicentre, randomised, double-blind, parallel-group, controlled, non-inferiority trial. It was carried out from March to October 2021 in 21 centres in four European countries (11 in Bulgaria, one in Germany, eight in Hungary, and one in the Czech Republic). The study was condu... | PMC10647512 |
2.2. Study Product | The two infant formulae complied with the requirements defined in Art. 3 Del. Regulation (EU) 2016/127 [ | PMC10647512 | ||
2.3. Safety Evaluation | In addition and as already published [ | PMC10647512 | ||
2.4. Parameters of Gastrointestinal Tolerance | PMC10647512 | |||
2.4.1. Stool Characteristics | GI tolerance was estimated using data from 3-day diaries completed prior to each visit. From these diaries, stool frequency as average daily number of stools (number of stools/day) and stool characteristics, using the Amsterdam infant stool scale (AISS) [ | PMC10647512 | ||
2.4.2. Infant Gastrointestinal Symptom Questionnaire (IGSQ) | GI disturbances | Furthermore, the IGSQ was completed during each visit to assess GI disturbances [ | PMC10647512 | |
2.4.3. Sleeping Behaviour | Four adapted questions of the Sleep and Behaviour Questionnaire [ | PMC10647512 | ||
2.5. Statistical Analysis | PMC10647512 | |||
2.5.1. Stool Characteristics | REGRESSION | Stool characteristics were analysed using a mixed Poisson regression model for repeated measurements, with the visit (from V2 to V4), the infant formula group, the interaction between visit and infant formula group and the sex as fixed effects, and the subject and centre as random effects (with the total number of stoo... | PMC10647512 | |
2.5.2. IGSQ | The IGSQ total score at each visit was analysed using a linear mixed model for repeated measurements, with the visit (from V2 to V4), the infant formula group, the interaction between visit and infant formula group, and the sex as fixed effects, and the subject and centre as random effects. For the specific analysis of... | PMC10647512 | ||
2.5.3. Sleeping Behaviour | Sleeping behaviour was analysed using a linear mixed model (for repeated measurements) with the visit (from V2 to V4), the infant formula group, the interaction between visit and infant formula group, and sex as fixed effects, and the subject and centre as random effects. | PMC10647512 | ||
2.5.4. Study Population | weight gain | The data analysis presented herein was performed using the full analysis set (FAS) and per protocol set (PPS). FAS contained all randomised infants in FF and all infants in BF, except those who turned out to be a screening failure, who did not participate in V1 or who did not receive the study product at least once (if... | PMC10647512 | |
3. Results | PMC10647512 | |||
3.1. Study Participants and Population Characteristics | weight gain, birth [ | As reported previously [Birth characteristics, including gestational age, mode of birth, sex, and anthropometric parameters, as well as parental characteristics including maternal age, BMI, and weight gain during pregnancy, were comparable between eHF and CF, as previously reported in detail [Characteristics of BF were... | PMC10647512 | |
3.2. Compliance | Study compliance was very high. Seven infants in eHF and nine infants in CF had major deviations in feeding instructions and were thus excluded from PPS; most of these deviations were related to the consumption of low amounts of water and non-sweetened tea. No complementary foods were given before V4. All infants in BF... | PMC10647512 | ||
3.3. Safety Evaluation | Details on safety reporting are described in detail elsewhere [With regard to concomitant medications, approximately 30% of infants received a product which could potentially positively influence GI tolerance, such as simeticone, lactase, or aromatic oils ( | PMC10647512 | ||
3.4. Gastrointestinal Tolerance | PMC10647512 | |||
3.4.1. Stool Characteristics | ±, watery | Daily stool frequency varied strongly among individuals but did not differ between FF groups at any visit (While mean daily stool frequency in BF also decreased from V1 to V4, trending towards the levels of FF infants, it was higher at all visits compared to FF (4.0 ± 1.0 (range: 1.7–6.3) stools per day at V1 to 2.2 ± ... | PMC10647512 | |
3.4.2. IGSQ | Mean IGSQ total score decreased from V1 to V4 in both FF groups and did not differ between FF groups at any visit (Similarly, in BF, mean IGSQ score decreased throughout the study period and showed a tendency to lower values compared to FF until V3. At V4, this trend was no longer visible (Consistent with IGSQ total sc... | PMC10647512 | ||
3.4.3. Sleeping Behaviour | There were no differences observed in any of the sleep parameters (24 h sleep, nocturnal sleep, interrupted nocturnal sleep, time to fall asleep) between eHF and CF throughout the study period. While 24 h sleep decreased from V1 to V4 by approximately 18% in both eHF and CF, the duration of nocturnal sleep increased in... | PMC10647512 | ||
4. Discussion | SECONDARY | In this secondary analysis of a multicentre, randomised, controlled, double-blind trial, the GI tolerance of eHF was compared to that of CF. No significant differences were observed during the first 120 days of life, as reflected by similar stool characteristics, IGSQ and sleeping patterns.The daily number of stools de... | PMC10647512 | |
5. Conclusions | The infant formula manufactured from extensively hydrolysed whey protein used in this study led to comparable results in various parameters of GI tolerance, including stool characteristics, IGSQ, and sleep behaviour, as the control infant formula manufactured from intact cow’s milk protein. Based on these findings, it ... | PMC10647512 | ||
Supplementary Materials | The following supporting information can be downloaded at Click here for additional data file. | PMC10647512 | ||
Author Contributions | Conceptualization: R.C., J.G., A.G. and F.J. Methodology: R.C., J.G., A.G. and F.J. Validation: R.C., J.G., A.G., F.J., A.N. and H.P. Resources: R.C., J.G., A.G. and F.J. Data Curation: R.C., J.G. and A.G. Writing—Original draft preparation: L.O., E.S. and A.N. Writing—Review & Editing: R.C., J.G., A.G., F.J., A.N., L.... | PMC10647512 | ||
Institutional Review Board Statement | The study was conducted according to the guidelines of the Declaration of Helsinki, and approved by the independent ethics committees in Germany (Ärztekammer Berlin; protocol version n. 1.1 approved on 11 January 2021), Bulgaria (Ethics Committee for Clinical Trials, Sofia; protocol version no. 1.1 approved on 26 Febra... | PMC10647512 | ||
Informed Consent Statement | Informed consent was obtained from both parents/legal guardians involved in the study. | PMC10647512 | ||
Data Availability Statement | The original contributions presented in the study are included in the article/ | PMC10647512 | ||
Conflicts of Interest | L.O., E.S., H.P., A.N., F.J. are employed by the Evangelisches Waldkrankenhaus Spandau, a nonprofit hospital. The department does paid research for different companies in the field of infant nutrition. The employer and F.J. have received support for scientific and educational activities by companies that market food pr... | PMC10647512 | ||
References | Flow chart of infant enrolment and distribution into formula-fed groups and the breastfed reference group (modified from Otten et al. [Mean daily stool frequency (daily number of stools; mean ± SD) from 3-day diary (PPS). Missing values in eHF: V4: Stool consistency from 3-day diary (% ± SD; PPS). Missing values in eHF... | PMC10647512 | ||
Background\Objectives | OUD, overdose | Concomitant with low rates of pharmacotherapy for incarcerated individuals with OUD, there is a high rate of opioid overdose following re-entry into the community. Our research objective was to develop a better understanding of the factors that influence health-related quality-of-life (HRQoL) among this population duri... | PMC10210389 | |
Methods | anxiety/depression | REGRESSIONS | Secondary longitudinal analysis of data from a clinical trial where participants were randomized 1:1 to pre-release extended-release naltrexone (XR-NTX) + referral to community XR-NTX, vs. referral only. We conducted individual, multivariable regressions of EQ-5D domains (mobility, pain/discomfort, anxiety/depression; ... | PMC10210389 |
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