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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 c...
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 ...
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 in...
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 limitati...
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 ...
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...
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...
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 ...
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 ...
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 ou...
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 ...
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 suc...
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 vari...
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 fasc...
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 ...
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 U...
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 ...
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 e...
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...
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,...
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 plai...
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 ...
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 prev...
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 com...
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 ...
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 mi...
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 signif...
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 d...
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 co...
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...
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...
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 ut...
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...
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 pl...
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 findi...
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 d...
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 patien...
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....
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 pr...
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 prot...
PMC10098968