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Data collection and measurements | PMC10193595 | |||
Unplanned ED return visits (URVs) | Data on ED return visits were collected from the electronic hospital system (EHS). ED return visits that could not be foreseen were defined as URVs [ | PMC10193595 | ||
Baseline data | We used baseline data that were associated with URVs in previous studies, including demographics (age [ | PMC10193595 | ||
Determination of reasons for URVs | Prior to the start of the study, reasons for URVs were defined and categorized, based on findings in the literature (see Additional file 1) [ | PMC10193595 | ||
Statistical analysis | Categorical data are presented as numbers and percentages. Continuous data were skewed and therefore presented as median and interquartile ranges (IQR). Differences in characteristics of patients with and without URVs were analyzed using XThe XInter-rater reliability regarding the initial determination of reasons and categories of URVs was measured with Cohen’s kappa coefficient.Statistical analyses were performed using the Statistical Package for the Social Sciences (IBM Corp. Released 2019. IBM SPSS Statistics, Version 26.0. Armonk, NY, USA). | PMC10193595 | ||
Results | Of the 1659 patients, 222 (13.4%) had at least one URV within 30 days. The total number of URVs within 30 days was 279. | PMC10193595 | ||
Reasons for unplanned ED return | EMERGENCY | Figure Reasons for unplanned Emergency Department (ED) return visits ( | PMC10193595 | |
Inter-rater reliability regarding assessment of reasons and categories for URVs | The inter-rater reliability after initial independent determination and categorization of the reasons for the URVs, measured with Cohen’s kappa coefficient, was 0.57. All disagreements concerning the determination of the reasons for URVs were solved by discussion between the two researchers and hence, the judgement of a third researcher for the final decision was not needed. | PMC10193595 | ||
Discussion | DISEASE | In this study, we found that 222 of the 1659 (13.4%) older adults had at least one URV within 30 days after being discharged from the ED. Of them, 171 (77%) returned for medical reasons, including 95 (43%) for illness-related problems and 76 (34%) for new medical complaints unrelated to the presenting problem of the index ED visit. URVs for patient-related reasons occurred in only 31 (14%) patients. Also, patients with more than one URV returned mainly for illness-related reasons.The URV rate in our study was comparable with URV rates among older adults reported in other studies [Although transitional care programs that focus on patient education and post-discharge support may have a positive effect on the patient’s capacity for self-care, disease control and perceived support [ | PMC10193595 | |
Strengths and limitations | We were able to compare an extensive set of patient and ED visit characteristics between patients with and without URVs. Although previous studies mentioned reasons for URVs in older adults, this is one of the few studies that investigated the frequencies of the different reasons for URVs in older adults [Some limitations, however, could be considered. The reasons for URVs were defined and categorized prior to the start of the study and based on explicit criteria, used in previous studies. However, the reasons for URVs were determined retrospectively. By having the URVs assessed by two independent researchers, we tried to comply with the classification criteria as much as possible. The Cohen’s kappa coefficient of 0.57, reflecting a moderate inter-rater reliability of the categorization system, may be a limitation.Furthermore, not all data about health determinants that are associated with hospital return were available. Finally, this study was conducted in two EDs of a non-academic hospital in the Netherlands. The findings may not be generalizable to all EDs. However, two studies, one conducted in a Dutch academic ED and one in two Australian large referral hospital EDs, reported comparable percentages of URVs for illness-related and patient-related reasons [ | PMC10193595 | ||
Conclusion | In this study, most older patients returned unplanned to the ED for medical reasons, whereas URVs for patient-related reasons, such as uncertainty about health or misunderstanding of discharge instructions, were less common. These findings may explain why many transitional care programs that focus on patient education and post-discharge support are ineffective in reducing URVs. In addition, the results suggest that most patients who return to the ED require urgent care. This fuels the discussion as to whether URVs can or need to be prevented. | PMC10193595 | ||
Acknowledgements | Not applicable | PMC10193595 | ||
Authors’ contributions | MvLvG and MCvdL conceived and designed the study, which was further developed with advice from IEV, JG and RCvdM. IEV and MvLvG independently determined and categorized the reason for each URV. MvLvG and IEV managed the data. MvLvG analyzed the data and MCvdL, JG and RCvdM provided statistical advice. MvLvG drafted the manuscript. All authors have contributed to the manuscript. All authors read and approved the final version of the manuscript. MvLvG takes responsibility for the article as a whole. | PMC10193595 | ||
Funding | The corresponding author (Merel van Loon-van Gaalen) received a grant from the Jacobus Foundation in The Hague, The Netherlands, for the conduction of this study. The Jacobus Foundation is a non-commercial trust that supports education and research projects with a focus on Neurology and Psychiatry within the Haaglanden Medical Center. The sponsor had neither a role in the design and conduct of the study, nor in the data collection, analysis and interpretation of the data, and in the preparation of the manuscript. | PMC10193595 | ||
Availability of data and materials | The dataset used and analyzed during the current study is available from the corresponding author on reasonable request and with permission of the Board of Directors of Haaglanden Medical Center. | PMC10193595 | ||
Declarations | PMC10193595 | |||
Ethics approval and consent to participate | The Medical Ethics Review Committee of Southwest Holland waived the necessity for formal approval of the study as it closely followed routine care (nr. 17–028).Informed consent was obtained from all subjects and their legal guardian(s).All procedures performed in this study were in accordance with the 1964 Declaration of Helsinki and its later amendments. | PMC10193595 | ||
Consent for publication | Not applicable. | PMC10193595 | ||
Competing interests | The authors declare that they have no competing interests. | PMC10193595 | ||
References | PMC10193595 | |||
Introduction and hypothesis | vaginal vault prolapse | The objective of this study was to evaluate long-term outcomes of laparoscopic sacrocolpopexy (LSC) versus abdominal sacrocolpopexy (ASC) for vaginal vault prolapse (VVP). | PMC9483545 | |
Methods | Long-term follow-up of a multicenter randomized controlled trial (SALTO trial). A total of 74 women were randomly assigned to LSC ( | PMC9483545 | ||
Results | GENITAL PROLAPSE | We analyzed 22 patients in the LSC group and 19 patients in the ASC group for long-term follow-up, with a median follow-up of 109 months (9.1 years). Disease-specific quality of life did not differ after long-term follow-up with median scores of 0.0 (LSC: IQR 0–17; ASC: IQR 0–0) on the “genital prolapse” domain of the Urogenital Distress Inventory in both groups ( | PMC9483545 | |
Conclusions | COMPLICATIONS | At long-term follow-up no substantial differences in quality of life, anatomical results, complications, or reinterventions between LSC and ASC were observed. Therefore, the laparoscopic approach is preferable, considering the short-term advantages. | PMC9483545 | |
Trial registration | Dutch Trial Register NTR6330, 18 January 2017, | PMC9483545 | ||
Keywords | PMC9483545 | |||
Introduction | pelvic organ prolapse, vaginal vault prolapse | The prevalence of vaginal vault prolapse (VVP), requiring apical surgery, has been reported in 23% of women who underwent vaginal hysterectomy for pelvic organ prolapse (POP) [Sacrocolpopexy is one of the surgical options in the treatment of VVP, with success rates between 93 and 99% [Evidence for long-term clinical outcomes of LSC versus ASC is essential to reach consensus on the optimal surgical treatment, adequate patient selection and preoperative counselling. Therefore, this follow-up study was performed to evaluate the long-term outcome in terms of disease-specific quality of life of patients who participated in the SALTO trial. | PMC9483545 | |
Materials and methods | PMC9483545 | |||
Study design | Details of the SALTO trial were published previously [This observational long-term follow-up study was approved by the ethical research committee (METC) of the Máxima Medical Centre (file number METC W17.015, CCMO NL60618.015.17) and by the board of directors of each of the participating hospitals, separately from the original SALTO trial. This trial was registered in the Dutch Trial Register (NTR6330). The study was developed and described in accordance with the Consolidated Standards of Reporting Trials (CONSORT) 2010 statement [ | PMC9483545 | ||
Primary and secondary outcomes | STRESS URINARY INCONTINENCE, COMPLICATIONS | The primary outcome of this trial was long-term disease-specific quality of life, measured with the Urogenital Distress Inventory (UDI). The primary outcome in our follow-up study is similar to the original SALTO trial. Secondary outcomes were the effects of the surgical treatment on POP-related functional symptoms such as micturition, defecation, sexuality, and patient satisfaction, using validated questionnaires. Moreover, long-term complications such as mesh exposure and retreatment were evaluated. Surgical retreatment was categorized according to the joint IUGA/ICS recommendations for reporting outcomes. Surgeries were subdivided into repeat surgery for the apical compartment, surgery for a different site (anterior or posterior compartment), surgery for complications, and surgery for non-POP-related conditions (e.g., stress urinary incontinence) [More outcome definitions were used in the literature after the initial SALTO study [ | PMC9483545 | |
Data collection | RECURRENCE, VAGINA | All patients from the initial SALTO trial were sent a letter to ask for participation in this observational follow-up study. When they failed to respond, they were called and asked to participate. All participants gave new informed consent to participate in the long-term follow-up trial. They were asked to fill in various Dutch validated questionnaires and were invited to visit an outpatient clinic to undergo pelvic examination. The observer was an independent researcher, gynecologist or resident who had not performed the surgery and was trained in the POP-Q examination [Disease-specific quality of life was tested with the UDI [Bothersome bulge symptoms were measured using the UDI. A positive answer to any of the following questions is scored as a subjective recurrence: “Do you experience a sensation of bulging or protrusion from the vagina?” and “Do you have a bulge or something protruding that you can see in the vagina?”, in combination with a response “moderately bothersome” or “greatly bothersome” to the question “how much does this bother you?” | PMC9483545 | |
Interventions | PMC9483545 | |||
Laparoscopic sacrocolpopexy | Laparoscopic sacrocolpopexy was performed under general anesthesia using four trocars, one for the scope and three side trocars. The vaginal vault was elevated with a vaginal probe. The peritoneum from the promontory to the vault was incised laparoscopically by scissors to expose the rectovaginal and vesicovaginal fascia. A type 1 polypropylene mesh was used, which was cut into two pieces; 3 cm wide and approximately 15 cm long. One piece of the mesh was attached anteriorly and another as low as possible on the posterior vaginal wall, using non-absorbable multifilament sutures. The mesh was fixated to the anterior part of the vaginal vault with four stitches, and six stitches were used to fixate the mesh posteriorly. The mesh was attached to the sacral promontory using staples and was peritonealized [ | PMC9483545 | ||
Abdominal sacrocolpopexy | VAGINA | The ASC was performed by a laparotomy under general anesthesia, preferably using a Pfannenstiel incision. The essence of the procedure was the same as for the laparoscopic procedure. The peritoneum from the promontory to the vault was incised to expose the rectovaginal and vesicovaginal fascia, extending to the sacral promontory. One piece of type 1 polypropylene mesh was attached between the vagina and the bladder anteriorly, and another as far down the posterior vaginal wall as possible. The sutures, the size of the mesh and its fixation were the same as in the laparoscopic approach. The two meshes were sutured to each other, after which only the posterior mesh was fixed to the longitudinal vertebral ligament by staples or non-absorbable sutures, depending on the surgeon’s preference. The mesh was peritonealized. All centers used polypropylene meshes and the same sutures [ | PMC9483545 | |
Sample size | Sample size calculation was performed for the initial SALTO trial and 74 patients were included accordingly [ | PMC9483545 | ||
Statistical analysis | The domain scores were calculated for the UDI, DDI, IIQ, PISQ, and PGI-I questionnaires. To examine differences between the two groups the independent-samples | PMC9483545 | ||
Discussion | PMC9483545 | |||
Main findings | RECURRENCE, GENITAL PROLAPSE | This observational long-term follow-up study of a multicenter randomized controlled trial shows that there was no difference in disease-specific quality of life whether after laparoscopic or after abdominal sacrocolpopexy, with median scores of 0.0 (LSC: IQR 0–17; ASC: IQR 0–0) on the “genital prolapse” domain of the UDI in both groups (Composite outcome of success, surgical failure, and anatomical failure were the same in both groups for all compartments. We found no relation between the type of surgery and the compartment of the recurrence. Also, no relation was found between the pre-operative POP-Q stage and the compartment of the recurrence. Some patients had a recurrence in the same compartment as they did pre-operatively; others did not.In our study, mesh exposures were reported in 12.5% and 7.7% in the LSC and ASC groups respectively. A retrospective cohort study from 2019 reports exposure rates of 1.4% [Patient satisfaction on the PGI-I is 57.9% ( | PMC9483545 | |
Strengths and limitations | pelvic organ prolapse | We performed a randomized controlled trial, which is considered to yield the highest level of evidence when comparing two different treatment options. One of the main strengths of our study is the duration of follow-up, with a median of 109 months (9.1 years), which may be stated as “very long” (> 5 years) duration of follow-up, according to the IUGA/ICS joint report on the terminology for reporting outcomes of surgical procedures for pelvic organ prolapse [One of the limitations of our study is the relatively high rate of loss to follow-up. However, the statistical power remains >80% for the primary outcome measure disease-specific quality of life. From the 36 eligible patients in the LSC group, 14 patients (38.9%) were lost to follow-up, compared with 16 (45.7%) of the 35 eligible participants in the ASC group. Nine patients died and eight patients were not able to participate owing to old age or serious health issues, which was beyond our control. Perhaps the SARS-CoV-2 pandemic added to the loss to follow-up; however, we have no complete data on this matter. Other studies reported attrition rates of 46% at 5 years [Most of our study population were postmenopausal and multiparous, with two or more vaginal births. This makes our results mainly applicable for patients with comparable characteristics. | PMC9483545 | |
Interpretation | blood loss | BLOOD LOSS | The laparoscopic approach to sacrocolpopexy is preferable, compared with the open abdominal technique, mainly because of better short-term outcomes. The laparoscopic approach has less blood loss and a shorter hospital stay [ | PMC9483545 |
Authors’ contributions | Anique M.J. van Oudheusden: project development, data analysis, manuscript writing; Josephine Eissing: data collection, manuscript writing; Ivon M. Terink: project development, data collection, manuscript editing; Maarten D.H. Vink: data collection, manuscript editing; Sander M.J. van Kuijk: data analysis, manuscript editing; Marlies Y. Bongers: project development, manuscript editing; Anne-Lotte W.M. Coolen: project development, manuscript editing | PMC9483545 | ||
Declarations | PMC9483545 | |||
Conflicts of interest | None. | PMC9483545 | ||
References | PMC9483545 | |||
Abbreviations: | The Scientific Advisory Committee on Nutrition (SACN) advised daily fibre intakes of 30 g for adults (with proportionally lower recommendations for children from the age of 2 years)It is well recognised that a diet rich in fibre contributes to maintaining a healthy gut microbiota associated with increased diversity and functions, such as the production of SCFA in the colon, mainly acetate, propionate and butyrateThe current UK food supply does not have sufficient dietary fibre for everyone to meet the 30 g/d recommendationBroad bean (Therefore, this study assessed the bean hulls’ suitability to be used as a source of dietary fibre in order to help contribute to dietary recommendations and promote diversity while contributing to agricultural waste reduction. | PMC10551484 | ||
Materials and methods | PMC10551484 | |||
Volunteer recruitment | ± | Nine healthy volunteers (four men and five women, age 54·1 ± 16·9, BMI: 25·6 ± 2·0 kg/mProspective volunteers who registered an interest in the study signed the consent form and attended a screening visit at the Human Nutrition Unit (HNU) at the Rowett Institute. The volunteers completed a general health questionnaire, and their height and weight were measured in the fasted state. A fasting blood sample was also collected to assess glucose 6 phosphate dehydrogenase deficiency deficiency, performed at Aberdeen Royal Infirmary Hospital in Foresterhill. Eligible volunteers participated in two randomised cross-over intervention visits to the HNU, each lasting 3 days and separated by a minimum washout period of 1 week. | PMC10551484 | |
Study design | digestive biscuit | BLOOD | Before one of the two intervention sessions, the volunteers recorded their habitual diet for seven consecutive days in food diaries. The evening before each visit, volunteers were provided with a standardised meal consisting of a vegetarian paella (made in-house), a glass of semi-skimmed milk, toffee yoghurt and a plain digestive biscuit. Supplementary Table On the morning of the day of each intervention session, the volunteers arrived and fasted at the HNU, and their fat mass was measured using BodPod® (COSMED Srl). Their blood pressure was also measured using a blood pressure monitor (OMRON Healthcare). Participants consumed the test meal within 10 min, and their blood samples (45 ml in total) were collected using a cannula at baseline (before the test meal consumption) and at 15, 30, 45, 60, 90, 120, 180 and 240 min from the start of the meal (see intervention day diagram,
Human dietary intervention study diagram. Each volunteer (Blood glucose levels were measured for 240 min postprandially using a Continuous Glucose Monitoring system (iPro2, Medtronic MiniMed), which determined interstitial glucose concentrations every 5 min. Faecal samples were collected before the beginning of the intervention (see intervention day diagram, The study was conducted in accordance with the Declaration of Helsinki, and all procedures involving human subjects were reviewed and approved by the Human Studies Management Committee of the Rowett Institute, University of Aberdeen, UK, and the Rowett Institute Ethics Panel and registered with clinicaltrial.gov (study ID number: NCT05252013). Participants were recruited between January 2019 and March 2020. | PMC10551484 |
Test meals | The preparation of the control and the bean hull bread rolls has been described previously | PMC10551484 | ||
General reagents | Standards and general laboratory reagents were purchased from Sigma-Aldrich (Gillingham, England) and Fisher Scientific UK Ltd or synthesised as described previously | PMC10551484 | ||
Macronutrient and micronutrients composition of bread rolls | Macronutrients (protein, fibre measured as soluble and insoluble NSP and fat) were measured as previously describedMicronutrient analysis was conducted as previously described | PMC10551484 | ||
Phytic acid content analysis of the bread rolls | The phytic acid content of the samples was measured and calculated using the Phytic Acid Assay Kit (Megazyme), as described previously | PMC10551484 | ||
Determination of | Anaerobic incubations were carried out in Hungate tubes as described previously | PMC10551484 | ||
Extraction of plant metabolites from bread rolls | The bread rolls were freeze-dried then freeze-milled in liquid nitrogen (Spex 6700; Edison). Plant metabolites were extracted as previously described | PMC10551484 | ||
Human sample processing | The blood sample at each time point was collected directly into 5 ml Aprotinin K | PMC10551484 | ||
Samples analysis | PMC10551484 | |||
Plasma and faecal metabolites | Plasma (baseline, 30, 60, 120, 180 and 240 min and the fasted sample from day 4) and faecal samples (days 1 and 4) were processed as previously described | PMC10551484 | ||
SCFA analysis | SCFA concentrations were measured in volunteers’ faecal samples and in | PMC10551484 | ||
DNA extractions and quantitative PCR | MP | DNA extractions were performed with a FastDNA spin kit for soil (MP Biomedicals) according to the manufacturer’s instructions. DNA concentrations were measured using Qubit 2·0 Fluorometer (Thermo Fisher Scientific). The total number of 16S rRNA gene copies per ml and abundance of several bacterial genera or species of the communities in the anaerobic faecal incubation experiments was determined by quantitative PCR as described previously | PMC10551484 | |
Metabolic profile | Total PYY (peptide YY), total ghrelin, total glucagon and total glucagon-like peptide 1 (GLP-1) were analysed from postprandial plasma samples at baseline, 15, 30, 45, 60, 90, 120, 180 and 240 min following the bean hull and control bread rolls using Human Metabolic Hormone Magnetic Bead Panel (Merck Millipore) as previously described | PMC10551484 | ||
Breath samples | Breath samples were collected at baseline (0 h) and every 15 min for 240 min and were analysed by MS. At each time point, five breath tubes were collected by the participants, and four of these were analysed using Elementar iso FLOW coupled to an isoprime precisION MS (Elementar). Gastric emptying rate analysis was completed by the analytical facilities based at the Rowett Institute. | PMC10551484 | ||
The LC-MS/MS analysis | Bread plant metabolites were analysed as described previously | PMC10551484 | ||
Statistical analysis | The samples size of nine volunteers was predicted to detect a treatment effect 1·1 times the magnitude of the within-volunteer variation in the difference, with 80 % power at the 5 % significance level | PMC10551484 | ||
Results | PMC10551484 | |||
Human volunteer baseline characteristics | The baseline characteristics and body composition of the participants are summarised in
Baseline characteristics and body composition of the participantsAll values are mean ± | PMC10551484 | ||
Composition of the bread rolls | PMC10551484 | |||
Macronutrient content | Two bean hull bread rolls provide over 85 % of daily fibre recommendation: The monosaccharide composition of the soluble and insoluble NSP for each portion of the control and bean hull bread roll is shown in
Monosaccharide composition of soluble non-starch polysaccharides (NSP) and insoluble NSP content, expressed as % of dry weight ± Contribution to dietary fibre (DF) calculated according to SACN 2015 guidelines (recommending 30 g DF/day). | PMC10551484 | ||
Micronutrient content | Two bean hull bread rolls contribute towards daily micronutrient recommendations: bean hull bread roll was also a rich source of several minerals. Overall, the micronutrient content in the bean hull bread roll was higher than the control bread roll. Bean hull bread roll had a significantly higher content of P (
Main micronutrients expressed in mg ± | PMC10551484 | ||
Bean hull fibre fermentability | Bean hull fibre has a very low fermentability
Bean hull fibre fermentability | PMC10551484 | ||
Bread roll plant metabolite composition | The bean hull bread rolls are a rich source of phenolics, specifically flavonoids. The most abundant plant metabolites measured in the study bread rolls are presented in
The most abundant plant metabolites measured in the bean hull and control bread rolls (mg/portion of bread rolls consumed ± | PMC10551484 | ||
Plasma metabolite composition | The phenolics from bean hull bread rolls have a poor systemic availability. The PCA (
Plasma composition (over 4 h) following bean hull (orange) and control (blue) bread rolls consumption. (a) The PCA analysis of average postprandial plasma metabolites (The chronic consumption of bean hull bread rolls leads to a significant increase in plasma indole-3-propionic acid, a microbial metabolite of tryptophan. The composition of fasting plasma metabolites collected following the chronic consumption of study bread rolls for 3 d (days 1 to 4 – It was also observed that after consuming both bread rolls for 3 days, there was a significant increase of 4-hydroxy-3-methoxyphenyl propionic acid, phenyl pyruvic acid, phenyl lactic acid in the day 4 plasma sample compared with the baseline (day 1), indicating a high microbial metabolism of tyrosine. In addition, enterolactone and secoisolariciresinol significantly increased following the consumption of bean hull and plain bread rolls on day 4 compared with the baseline (online Supplementary Table | PMC10551484 | ||
Plasma gastrointestinal hormones composition | The consumption of bean hull bread rolls has no effect on postprandial plasma gut hormone levels. None of the test meals have significantly affected ghrelin and GLP-1 postprandial plasma concentrations over 4 hours (AUC, | PMC10551484 | ||
Plasma glucose and lipids profile | The consumption of bean hull bread rolls has no effect on blood glucose and lipid levels. The blood glucose levels were not significantly different following the consumption of bean hull bread compared with the control bread rolls on day 1, for 4 hours postprandially and on day 4, on faster plasma samples following 3 days bread consumption (online Supplementary Fig. | PMC10551484 | ||
Faecal metabolites composition | The chronic consumption of the bean hull bread rolls significantly decreased faecal concentration of putrescine and deoxycholic acid while significantly increased taurocheno-deoxycholic acid. The PCA plot shows discrimination between the faecal metabolites produced on day 4 after 3 days of chronic consumption of the control and bean hull bread rolls (D4 control
Faecal metabolites concentrations before (day 1) and after (day 4) the consumption of the study bread rolls. The PCA plot of average faecal metabolites (
Average concentration (
| PMC10551484 | ||
Faecal SCFA concentrations | Consumption of bean hull bread rolls does not promote microbial SCFA production. Total SCFA concentrations in faecal samples remained mostly unchanged after interventions (
Faecal SCFA concentrations (mM) Percentage change between baseline and post-intervention (day 1 % change between the two test meals on day 4. | PMC10551484 | ||
The gut microbiota composition | Bean hull bread rolls consumption did not affect the abundance and composition of the gut microbes. The absolute abundance of total bacteria was determined by qPCR, but no significant differences were observed. The abundance of several genera or species within the two major phyla Bacteroidetes and Firmicutes as well as Archaea also did not appear to be influenced by the consumption of bean hull bread (
Abundance of total faecal microbiota and specific genera or species at day 1 (baseline), day 4 (chronic consumption), determined by qPCR. Average and standard error of 16S rRNA gene copies per gram faeces. ANOVA with terms for volunteer, baseline and diet was used to compare bean hull with control. qPCR, quantitative PCR. | PMC10551484 | ||
Gastric emptying | Consumption of bean hull bread rolls had no effect on gastric emptying markers. The latency and lag phases were significantly delayed (
Gastric emptying markers on day 1 following the control and bean hull bread rolls | PMC10551484 | ||
Satiety and hunger | fullness | Consumption of bean hull bread rolls has no effect on hunger. There were no significant differences between the intervention and control bread for the visual analogue scale measures (hunger, fullness, desire, quantity) from baseline to 4 hours post the bread consumption ( | PMC10551484 | |
Discussion | hyperglycaemia, mineral deficiencies | HYPERGLYCAEMIA, CHRONIC DISEASES | Most UK adults consume their dietary fibre from wheat-based cerealsOverall, bean hull bread had a significantly higher mineral content than the control bread roll. Thus, regular consumption of bean hull bread roll could further contribute towards meeting the recommended daily intake compared with the control bread, and it can be an alternative cost-effective approach to control some mineral deficiencies. In addition, bean hull bread had low phytic acid content, suggesting that microelements from bean hull bread potentially are bioavailableThe most abundant phenolic compounds found in the bean hull bread roll were ferulic acid, the hydrogenated product of the 5–5 linked dimer and the 8–5 linked ferulic dimer. These are components of the wheat from the bean hull bread, as wheat flour is rich in 5–5 linked dimer ferulic acid. Catechin, epicatechin, gallocatechin, epigallocatechin and quercetin were also found in higher concentrations in the bean hull bread roll; however, they were found in much lower quantities than in well-known sources such as green tea (10 to 20 times higher in catechins than bean hull bread roll)The present study showed that chronic consumption of the bean hull bread rolls significantly increases plasma indole-3-propionic acid (IPA). IPA is a microbial product from dietary tryptophan metabolite absorbed from the gut into the bloodstreamThe isorhamnetin was also present in significantly higher quantities in plasma on day 4 following bean hull bread roll consumption. Isorhamnetin is a methylated flavanol and has positive impacts on many health functions, including risks of hyperglycaemia and CVDThree days consumption of bean hull bread rolls also led to a decrease of polyamine putrescine, in volunteers’ faecal samples compared with the control bread. High levels of polyamines are toxic and associated with various chronic diseases, including cancerThe dietary fibre can affect health through multiple mechanisms, including its fermentation in the large intestine to yield SCFA | PMC10551484 |
Study limitations | The present study has several limitations. A relatively small sample size of nine participants limits the conclusions that can be drawn from the study; however, this sample size does not weaken the significant differences which have been found. | PMC10551484 | ||
Conclusion | cancer, T2D | CANCER, DNA DAMAGE | The habitual consumption of the bean hull bread rolls could potentially provide some benefits against T2D due to the increased production of indole-3-propionic acid, and against cancer, by reducing the production of putrescine and deoxycholic acid, which can cause DNA damage. Bean hull fortified bread rolls could be utilised as a source of fibre in the diet and contribute to the daily micronutrient requirements. However, further food formulation work is necessary to improve the bean hulls’ phytochemicals systemic bioavailability and increase its fibre microbial fermentation in healthy adults. | PMC10551484 |
Acknowledgements | P. | The authors are grateful to all the volunteers for their participation in this human study. The authors also are thankful for the assistance from Karen Taylor for the diet design, Jean Bryce, Sylvia Stephen, David Bremner, Claire Kidd and Alicia Bryce for the food diary analysis and their support in the Human Nutrition Unit. Furthermore, the authors would like to thank Donna Henderson for performing the proximate analysis.We acknowledge financial support from The Scottish Government’s Rural and Environment Science and Analytical Services (RESAS) division.Study concept and design M. N., V. R.; Diet design V. Rk.; Food preparation N. J. H., H. E. H.; Human study coordination and sample collection Q. Q. N.; Sample analysis M. Sy., Q. Q. N., N. J. H., H. E. H., G. D., L. C., M. Sv., F. F.; Data analysis M. Sy., M. N., P. L.; Data interpretation M. Sy., M. N., P. L., G. H., F. T., W. R. R.; Manuscript drafting M. Sy., M. N., P. L.; Statistical analysis G. W. H.; The authors declare that there are no conflicts of interest. | PMC10551484 | |
Supplementary material | For supplementary material accompanying this paper visit https://doi.org/10.1017/S0007114523000491.click here to view supplementary material | PMC10551484 | ||
References | PMC10551484 | |||
Key Points | PMC10098968 | |||
Question | pleural infections | PLEURAL INFECTION | Is an algorithm comparing tissue plasminogen activator plus deoxyribonuclease therapy with surgical decortication in patients with complicated pleural infections feasible, safe, and efficacious? | PMC10098968 |
Findings | MINOR | In this pilot randomized clinical trial of 20 participants, there was 100% enrollment to study completion, no protocol deviations, 2 minor protocol amendments, and no screen to enrollment failures. | PMC10098968 | |
Meaning | pleural infections | PLEURAL INFECTION, CAVITY | The study algorithm was feasible, safe, and efficacious, providing evidence to move forward with a multicenter randomized clinical trial.This randomized clinical trial compares chest tube drainage of the pleural cavity using intrapleural fibrinolytic therapy and surgical decortication among patients with complicated pleural infections. | PMC10098968 |
Importance | pleural infections | PLEURAL INFECTION | There is a paucity of high-quality prospective randomized clinical trials comparing intrapleural fibrinolytic therapy (IPFT) with surgical decortication in patients with complicated pleural infections. | PMC10098968 |
Objective | pleural infections | PLEURAL INFECTION | To assess the feasibility, safety, and efficacy of an algorithm comparing tissue plasminogen activator plus deoxyribonuclease therapy with surgical decortication in patients with complicated pleural infections. | PMC10098968 |
Design, Setting, and Participants | pleural infection | PLEURAL INFECTION | This parallel pilot randomized clinical trial was performed at a single urban community-based center from March 1, 2019, to December 31, 2021, with follow-up for 90 days. Seventy-four individuals were screened and 48 were excluded. Twenty-six patients 18 years or older with clinical pleural infection and positive findings of pleural fluid analysis were included. Of these, 20 patients underwent randomized selection (10 in each group), and 6 were observed. | PMC10098968 |
Interventions | Intrapleural tissue plasminogen activator plus deoxyribonuclease therapy vs surgical decortication. | PMC10098968 | ||
Main Outcomes and Measures | Primary outcomes were the percentage of patients enrolled to study completion and multidisciplinary adherence. Secondary outcomes included the number of patients with and the reason for inadequate screening, screening to enrollment failures, time to accrual of 20 patients or the number accrued at 1 year, and clinical data. | PMC10098968 | ||
Results | deaths, Infection, failure | RENAL, MINOR, COMPLICATIONS, INFECTION | Twenty-six patients were enrolled, 10 were randomized to each group, and 6 were observed. There was 100% enrollment to study completion in each treatment group, no protocol deviations, 2 minor protocol amendments, and no screening to enrollment failures. It took 32 months to enroll 26 patients. The 20 randomized patients had a median age of 57 (IQR, 46-65) years, were predominantly men (15 [75%]), and had a median RAPID (Renal, Age, Purulence, Infection Source, and Dietary Factors) score of 2 (IQR, 1-3). Treatment failure occurred in 1 patient and 2 crossover treatments occurred, all of which were in the IPFT group. Intraprocedure and postprocedure complications were similar between the groups. There were no reoperations or in-hospital deaths. Median duration of chest tube use was comparable in the IPFT (5 [IQR, 4-8] days) and surgery (4 [IQR, 3-5] days) groups ( | PMC10098968 |
Conclusions and Relevance | In this pilot randomized clinical trial, the study algorithm was feasible, safe, and efficacious. This provides evidence to move forward with a multicenter randomized clinical trial. | PMC10098968 | ||
Trial Registration | ClinicalTrials.gov Identifier: | PMC10098968 | ||
Introduction | pleural infections, Sepsis, empyemas | PARAPNEUMONIC EFFUSION, CAVITY, SEPSIS, PLEURAL INFECTION | Complicated pleural infections (CPIs), including complicated parapneumonic effusions and empyemas, are common, affecting approximately 80 000 patients each year in the US and United Kingdom combined.Initial treatment of CPI requires antibiotic therapy and drainage; however, more aggressive management is often required. Next management steps include surgery or intrapleural fibrinolytic therapy (IPFT) with tissue plasminogen activator and deoxyribonuclease. There is a paucity of evidence directly comparing the efficacy and outcomes of IPFT management with surgery, and most published studies have significant methodological weaknesses. This lack of evidence leads to challenging decision-making for clinicians. Even though the Multicenter Intrapleural Sepsis Trial (MIST II) demonstrated IPFT to be an effective treatment more than a decade ago,High-quality, adequately powered prospective randomized clinical trials are needed to definitively compare these 2 management strategies and guide clinical decision-making. This pilot study of CPI management compared chest tube drainage of the pleural cavity using IPFT and surgical decortication with the intent to inform on the study algorithm and end point performance in anticipation of a multicenter randomized clinical trial. | PMC10098968 |
Methods | PMC10098968 | |||
Study Design | This pilot parallel randomized clinical trial was conducted at a single center in Seattle, Washington, between March 1, 2019, and December 31, 2021, with follow-up for 90 days. Ethical and regulatory approval for the study was obtained from the Providence St Joseph Health Institutional Review Board. All participants provided written informed consent. We followed the Consolidated Standards of Reporting Trials ( | PMC10098968 | ||
Patient Identification and Eligibility | pleural infection, purulent, fever | THORACIC, PLEURAL INFECTION, LEUKOCYTOSIS | Patients admitted to or consulting with the Department of Thoracic Surgery and Interventional Pulmonology were screened for eligibility daily. Patients were eligible if they were 18 years or older, had a clinical pleural infection (fever and/or leukocytosis, elevated procalcitonin level, and/or elevated C-reactive protein level) and positive results of pleural fluid analysis (macroscopically purulent, positive Gram stain or culture, lactate dehydrogenase level >1000 U/L [to convert to microkatals per liter, multiply by 0.0167], or glucose level <40 mg/dL [to convert to millimoles per liter, multiply by 0.0555]). Pleural fluid sampling and timing was performed as per standard clinical care. Exclusion criteria are provided in eTable 1 in | PMC10098968 |
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