Investigating the factorial structure and measurement invariance of the parent-reported strengths and difficulties questionnaire at 11 years of age from the UK Millennium Cohort Study.

The strengths and difficulties questionnaire (SDQ) consist of five sub-scales that have been used to measure internalising and externalising symptoms in children, typically by combining sum scores of two sub-scales each, and pro-social behaviours. However, the different possible factorial structures that represent these symptoms have not been formally tested in a nationally representative sample of UK children. In addition, it is necessary to assess whether the SDQ is interpreted similarly across subgroups of the population. Exploratory and confirmatory factor analysis were used to test three competing structures for the parent-reported SDQ collected at age 11, the start of adolescence, in the UK Millennium Cohort Study (n = 11,519), and measurement invariance was assessed according to sex and a measure of deprivation of the area in which households lived. Internal consistency using ordinal alpha, internal convergent validity and external discriminant validity using average variance explained (AVE), and predictive validity were assessed. A five-factor model and a model with two second-order factors for internalising and externalising symptoms had better model fit than a three-factor model. For both structures, invariance was demonstrated across sex and area-level deprivation. AVE scores for the five-factor model indicated that peer and emotional problems factors were measuring a similar construct, as were the hyperactivity and conduct factors. In the second-order model, AVE scores indicated internalising and externalising symptoms were distinct constructs. A second-order model with two factors for internalising and externalising symptoms is appropriate for use in a cohort of UK children born in 2001/02, and our finding of invariance across sex and area-level deprivation indicate that the SDQ can be used in analysis investigating differences in symptoms across subgroups of the population.

Longitudinal pathways between childhood BMI, body dissatisfaction, and adolescent depression: an observational study using the UK Millenium Cohort Study.

BACKGROUND: Globally, more adolescents are having depressive symptoms than in the past. High BMI is a risk factor for depressive symptoms, potentially acting via increased body dissatisfaction. Robust longitudinal evidence of these associations could help to inform preventive interventions, but such evidence remains scarce. We investigated the longitudinal associations between BMI at age 7 years and depressive symptoms at age 14 years (objective 1), BMI at age 7 years and body dissatisfaction at age 11 years (objective 2), and body dissatisfaction at age 11 years and depression at age 14 years (objective 3). We also investigated the extent to which body dissatisfaction mediated the association between BMI and depressive symptoms (objective 4). METHODS: This study used data from the Millennium Cohort Study, a representative longitudinal general population cohort of UK children born between Sept 1, 2000, and Jan 11, 2002. We used univariable and multivariable linear regression models to investigate the associations in objectives 1-3 adjusting for a range of child-level and family-level confounders. For mediation analyses we used non-parametric g-formula (objective 4). We reported stratified results in presence of sex differences. All analyses were based on participants with complete BMI data and imputed confounders and outcomes. FINDINGS: Our sample included 13 135 participants. Of these, 6624 (50·4%) were male participants and 6511 (49·6%) were female participants; 11 096 (84·4%) were of White ethnicity and 2039 (15·6%) were from a minority ethnic background. At baseline, mean age was 7·2 years (SD 0·25, range 6·3-8·3). In multivariable models, an SD increase in BMI at age 7 years was associated with greater depressive symptoms at age 14 years (estimated regression coefficient [coeff]: 0·30, 95% CI 0·17-0·43) and greater body dissatisfaction at age 11 years (coeff 0·15, 0·12-0·18). Greater body dissatisfaction at age 11 years was associated with higher depressive symptoms at age 14 years (coeff 0·60, 0·52-0·68). All these associations were twice as large in girls as in boys. Body dissatisfaction explained 43% of the association between BMI and depression in girls. INTERPRETATION: Our findings bear relevance for interventions aimed at reducing weight in childhood and reducing body dissatisfaction. Implementation of evidence-based body image interventions and identification of drivers of weight stigma should be key public health priorities. Interventions aiming to reduce weight in childhood need to avoid increasing body dissatisfaction and should target environmental drivers of weight rather than individuals. FUNDING: Wellcome Trust; The Royal Society; Economic and Social Research Council; and the National Institute for Health and Care Research.

Factors that influence the implementation of (inter)nationally endorsed health and social care standards: a systematic review and meta-summary.

BACKGROUND: Health and social care standards have been widely adopted as a quality improvement intervention. Standards are typically made up of evidence-based statements that describe safe, high-quality, person-centred care as an outcome or process of care delivery. They involve stakeholders at multiple levels and multiple activities across diverse services. As such, challenges exist with their implementation. Existing literature relating to standards has focused on accreditation and regulation programmes and there is limited evidence to inform implementation strategies specifically tailored to support the implementation of standards. This systematic review aimed to identify and describe the most frequently reported enablers and barriers to implementing (inter)nationally endorsed standards, in order to inform the selection of strategies that can optimise their implementation. METHODS: Database searches were conducted in Medline, CINAHL (Cumulative Index to Nursing and Allied Health Literature), SocINDEX, Google Scholar, OpenGrey and GreyNet International, complemented by manual searches of standard-setting bodies' websites and hand searching references of included studies. Primary qualitative, quantitative descriptive and mixed methods studies that reported enablers and barriers to implementing nationally or internationally endorsed standards were included. Two researchers independently screened search outcomes and conducted data extraction, methodological appraisal and CERQual (Confidence in Evidence from Reviews of Qualitative research) assessments. An inductive analysis was conducted using Sandelowski's meta-summary and measured frequency effect sizes (FES) for enablers and barriers. RESULTS: 4072 papers were retrieved initially with 35 studies ultimately included. Twenty-two thematic statements describing enablers were created from 322 descriptive findings and grouped under six themes. Twenty-four thematic statements describing barriers were created from 376 descriptive findings and grouped under six themes. The most prevalent enablers with CERQual assessments graded as high included: available support tools at local level (FES 55%); training courses to increase awareness and knowledge of the standards (FES 52%) and knowledge sharing and interprofessional collaborations (FES 45%). The most prevalent barriers with CERQual assessments graded as high included: a lack of knowledge of what standards are (FES 63%), staffing constraints (FES 46%), insufficient funds (FES 43%). CONCLUSIONS: The most frequently reported enablers related to available support tools, education and shared learning. The most frequently reported barriers related to a lack of knowledge of standards, staffing issues and insufficient funds. Incorporating these findings into the selection of implementation strategies will enhance the likelihood of effective implementation of standards and subsequently, improve safe, quality care for people using health and social care services.

Predicting Severe Complications from Cytoreductive Surgery with Hyperthermic Intraperitoneal Chemotherapy: A Data-Driven, Machine Learning Approach to Augment Clinical Judgment.

BACKGROUND: CRS-HIPEC provides oncologic benefit in well-selected patients with peritoneal carcinomatosis; however, it is a morbid procedure. Decision tools for preoperative patient selection are limited. We developed a risk score to predict severity of 90 day complications for cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (CRS-HIPEC). PATIENTS AND METHODS: Adults who underwent CRS-HIPEC at the University of Pittsburgh Medical Center (March 2001-April 2020) were analyzed as part of this study. Primary endpoint was severe complications within 90 days following CRS-HIPEC, defined using Comprehensive Complication Index (CCI) scores as a dichotomous (determined using restricted cubic splines) and continuous variable. Data were divided into training and test sets. Several machine learning and traditional algorithms were considered. RESULTS: For the 1959 CRS-HIPEC procedures included, CCI ranged from 0 to 100 (median 32.0). Adjusted restricted cubic splines model defined severe complications as CCI > 61. A minimum of 20 variables achieved optimal performance of any of the models. Linear regression achieved the highest area under the receiving operator characteristic curve (AUC, 0.74) and outperformed the NSQIP Surgical Risk calculator (AUC 0.80 vs. 0.66). Factors most positively associated with severe complications included peritoneal carcinomatosis index score, symptomatic status, and undergoing pancreatectomy, while American Society of Anesthesiologists 2 class, appendiceal diagnosis, and preoperative albumin were most negatively associated with severe complications. CONCLUSIONS: This study refines our ability to predict severe complications within 90 days of discharge from a hospitalization in which CRS-HIPEC was performed. This advancement is timely and relevant given the growing interest in this procedure and may have implications for patient selection, patient and referring provider comfort, and survival.

A Multi-Modal Approach to Islet and Pancreas Transplantation With Calcineurin-Sparing Immunosuppression Maintains Long-Term Insulin Independence in Patients With Type I Diabetes.

Long-term success in beta-cell replacement remains limited by the toxic effects of calcineurin inhibitors (CNI) on beta-cells and renal function. We report a multi-modal approach including islet and pancreas-after-islet (PAI) transplant utilizing calcineurin-sparing immunosuppression. Ten consecutive non-uremic patients with Type 1 diabetes underwent islet transplant with immunosuppression based on belatacept (BELA; n = 5) or efalizumab (EFA; n = 5). Following islet failure, patients were considered for repeat islet infusion and/or PAI transplant. 70% of patients (four EFA, three BELA) maintained insulin independence at 10 years post-islet transplant, including four patients receiving a single islet infusion and three patients undergoing PAI transplant. 60% remain insulin independent at mean follow-up of 13.3 ± 1.1 years, including one patient 9 years after discontinuing all immunosuppression for adverse events, suggesting operational tolerance. All patients who underwent repeat islet transplant experienced graft failure. Overall, patients demonstrated preserved renal function, with a mild decrease in GFR from 76.5 ± 23.1 mL/min to 50.2 ± 27.1 mL/min (p = 0.192). Patients undergoing PAI showed the greatest degree of renal impairment following initiation of CNI (56% ± 18.7% decrease in GFR). In our series, repeat islet transplant is ineffective at maintaining long-term insulin independence. PAI results in durable insulin independence but is associated with impaired renal function secondary to CNI dependence.

Hand-Assisted Versus Pure Minimally-Invasive Distal Pancreatectomy: Is There a Downside to Lending a Hand?

BACKGROUND: Hand-assisted laparoscopic distal pancreatectomy (HALDP) is suggested to offer similar outcomes to pure laparoscopic distal pancreatectomy (LDP). However, given the longer midline incision, it is unclear whether HALDP increases the risk of postoperative hernia. Our aim was to determine the risk of postoperative incisional hernia development after HALDP. METHODS: We retrospectively collected data from patients undergoing HALDP or LDP at a single center (2012-2020). Primary endpoints were postoperative incisional hernia and operative time. All patients had at minimum six months of follow-up. Outcomes were compared using unadjusted and multivariable regression analyses. RESULTS: Ninety-five patients who underwent laparoscopic distal pancreatectomy were retrospectively identified. Forty-one patients (43%) underwent HALDP. Patients with HALDP were older (median, 67 vs. 61 years, p = 0.02). Sex, race, Body Mass Index (median, 27 vs. 26), receipt of neoadjuvant chemotherapy, gland texture, wound infection rates, postoperative pancreatic fistula, overall complications, and hospital length-of-stay were similar between HALDP and LDP (all p > 0.05). In unadjusted analysis, operative times were shorter for HALDP (164 vs. 276 min, p < 0.001), but after adjustment, did not differ significantly (MR 0.73; 0.49-1.07, p = 0.1). Unadjusted incidence of hernia was higher in HALDP versus LDP (60% vs. 24%, p = 0.004). After adjustment, HALDP was associated with an increased odds of developing hernia (OR 7.52; 95% CI 1.54-36.8, p = 0.014). After propensity score matching, odds of hernia development remained higher for HALDP (OR 4.62; 95% CI 1.28-16.65, p = 0.031) p = 0.03). CONCLUSIONS: Compared with LDP, HALDP was associated with increased likelihood of postoperative hernia with insufficient evidence that HALDP shortens operative times. Our results suggest that HALDP may not be equivalent to LDP.

Definitions of health and social care standards used internationally: A narrative review.

Setting standards is a quality improvement mechanism and an important means for shaping the provision of health and social care services. Standards comprise statements describing a process or outcome of care. Setting standards is a global practice. It would be useful to have an understanding of the underpinning definitions of standards used internationally. Therefore, the aim of this review was to examine definitions of health and social care standards used internationally and identify similarities and differences. A targeted grey literature search of standard-setting bodies' websites and related health legislation was conducted to retrieve explicit definitions of standards. Of 15 standard-setting bodies that were searched, 12 definitions of standards were narratively synthesised. Terms that appeared in two or more of the definitions were extracted. Counts and percentages were calculated for these terms to determine magnitude of use. The commonalities among definitions included 'quality' (n = 6, 50%), 'statements' (n = 5, 42%), 'performance' (n = 5, 42%), and 'measureable' (n = 4, 33%). The less commonly used terms were 'processes' (n = 3, 25%), 'set' (n = 3, 25%), 'evidence based' (n = 2, 17%), 'outcome' (n = 2, 17%), 'safe' (n = 2, 17%), and 'guidance' (n = 2, 17%). Explicit definitions of standards were not retrieved from health legislation documents. Standard-setting bodies develop standards in the context of the health systems in which they are implemented; some are aspirational levels of quality, while others are minimum levels of quality. Researchers, standards developers and policy makers should be cognisant of this when comparing standards between countries.

Comparison of Biliary Complications Rates After Brain Death, Donation After Circulatory Death, and Living-Donor Liver Transplantation: A Single-Center Cohort Study.

Donation-after-circulatory-death (DCD), donation-after-brain-death (DBD), and living-donation (LD) are the three possible options for liver transplantation (LT), each with unique benefits and complication rates. We aimed to compare DCD-, DBD-, and LD-LT-specific graft survival and biliary complications (BC). We collected data on 138 DCD-, 3,027 DBD- and 318 LD-LTs adult recipients from a single center and analyzed patient/graft survival. BC (leak and anastomotic/non-anastomotic stricture (AS/NAS)) were analyzed in a subset of 414 patients. One-/five-year graft survival were 88.6%/70.0% for DCD-LT, 92.6%/79.9% for DBD-LT, and, 91.7%/82.9% for LD-LT. DCD-LTs had a 1.7-/1.3-fold adjusted risk of losing their graft compared to DBD-LT and LD-LT, respectively (p < 0.010/0.403). Bile leaks were present in 10.1% (DCD-LTs), 7.2% (DBD-LTs), and 36.2% (LD-LTs) (ORs, DBD/LD vs. DCD: 0.7/4.2, p = 0.402/<0.001). AS developed in 28.3% DCD-LTs, 18.1% DBD-LTs, and 43.5% LD-LTs (ORs, DBD/LD vs. DCD: 0.5/1.8, p = 0.018/0.006). NAS was present in 15.2% DCD-LTs, 1.4% DBDs-LT, and 4.3% LD-LTs (ORs, DBD/LD vs. DCD: 0.1/0.3, p = 0.001/0.005). LTs w/o BC had better liver graft survival compared to any other groups with BC. DCD-LT and LD-LT had excellent graft survival despite significantly higher BC rates compared to DBD-LT. DCD-LT represents a valid alternative whose importance should increase further with machine/perfusion systems.

Proof-of-concept for intervention to prevent post-operative ileus in patients undergoing ileostomy formation.

BACKGROUND: Preventing post-operative ileus (POI) is important given its associated morbidity and increased cost of care. The authors' prior work showed that POI in patients with newly created ileostomies is associated with a post-operative day (POD) 2 net fluid balance of > + 800 mL. The purpose of this study was to conduct an initial assessment of the efficacy of a pilot intervention. METHODS: This is a single-institution, pre-post-intervention, proof-of-concept study conducted on the Colorectal Surgery service at the University of California, San Francisco. The study included 58 procedures with ileostomy formation by board-certified colorectal surgeons between August 13, 2020 and June 1, 2021. The intervention included three adjustments to the standard Enhanced Recovery After Surgery protocol: addition of diuresis, delay in advancement to solid food, and earlier stoma intubation. Demographics, intraoperative factors, post-operative fluid balance, and outcomes (POI, post-procedure length of stay [LOS], hospitalization cost, and re-admissions) were compared between patients pre- and post-intervention. RESULTS: Eight (13.8%) of the 58 procedures in the intervention period were associated with POI vs. a baseline POI rate of 32.6% (p = 0.004). Compared to patients without intervention, those with intervention had 67% less odds of POI (OR 0.33, 95% CI 0.15-0.73, p = 0.01). This difference remained significant when adjusted for age, gender, body mass index, procedure duration, and operative approach (adjusted OR 0.32, 95% CI 0.14-0.72, p = 0.01). Average POD2 stoma output was 0.3 L greater (1.1 L vs. 0.8L; p < 0.001) and net fluid balance was 1.8 L lower (+ 0.3 L vs. + 2.1 L; p < 0.00001) for these 58 cases. Average post-procedure LOS was 1.9 days lower (5.3 vs. 7.2 days, p < 0.001) and direct cost was $5561 lower ($21,652 vs. $27,213, p = 0.004), with no difference in 30-day readmissions (p = 0.43). CONCLUSIONS: This pilot intervention shows promise for reduction in POI in patients with newly created ileostomies. Additional assessment is needed to confirm these initial findings.

Effects of Multi-stage Procurement on the Viability and Function of Human Donor Parathyroid Glands.

INTRODUCTION: Parathyroid allotransplantation is an emerging treatment for severe hypoparathyroidism. Ensuring the viability and functional integrity of donor parathyroid glands following procurement is essential for optimal transplantation outcomes. METHODS: Cellular viability, calcium-responsive hormone secretion, and gland xenograft survival were assessed in a series of deceased donor parathyroid glands following a two-stage procurement procedure recently developed by our group (en bloc cadaveric dissection with subsequent gland isolation after transport to the laboratory). RESULTS: Parathyroid glands resected in this manner and stored up to 48 h in 4°C University of Wisconsin (UW) media retained in vitro viability with no induction of hypoxic stress (HIF-1α) or apoptotic (caspase-3) markers. Ex vivo storage did not significantly affect parathyroid gland calcium sensing capacity, with comparable calcium EC50 values and suppression of parathyroid hormone secretion at high ambient calcium concentrations. The isolated glands engrafted readily, vascularizing rapidly in vivo following transplantation into mice. CONCLUSIONS: Parathyroid tissue retains viability, calcium-sensing capacity, and in vivo engraftment capability after en bloc cadaveric resection, ex vivo dissection, and extended cold storage.

Procurement of Deceased Donor Parathyroid Glands With the Aid of Near-infrared Autofluorescence Imaging.

Parathyroid allotransplantation is a burgeoning treatment for severe hypoparathyroidism. Deceased donor parathyroid gland (PTG) procurement can be technically challenging due to lack of normal intraoperative landmarks and exposure constraints in the neck of organ donors. In this study, we assessed standard 4-gland exposure in situ and en bloc surgical techniques for PTG procurement and ex vivo near-infrared autofluorescence (NIRAF) imaging for identification of PTGs during organ recovery. Methods: Research tissue consent was obtained from organ donors or donor families for PTG procurement. All donors were normocalcemic, brain-dead, solid organ donors between 18 and 65 y of age. PTGs were procured initially using a standard 4-gland exposure technique in situ and subsequently using a novel en bloc resection technique after systemic organ preservation flushing. Parathyroid tissue was stored at 4 °C in the University of Wisconsin solution up to 48 h post-procurement. Fluoptics Fluobeam NIRAF camera and Image J software were utilized for quantification of NIRAF signal. Results: Thirty-one brain-dead deceased donor PTG procurements were performed by abdominal transplant surgeons. In the initial 8 deceased donors, a mean of 1.75 glands (±1.48 glands SD) per donor were recovered using the 4-gland in situ technique. Implementation of combined en bloc resection with ex vivo NIRAF imaging in 23 consecutive donors yielded a mean of 3.60 glands (±0.4 SD) recovered per donor (P < 0.0001). Quantification of NIRAF integrated density signal demonstrated >1-fold log difference in PTG (2.13 × 105 pixels) versus surrounding anterior neck structures (1.9 × 104 pixels; P < 0.0001). PTGs maintain distinct NIRAF signal from the time of recovery (1.88 × 105 pixels) up to 48 h post-procurement (1.55 × 105 pixels) in organ preservation cold storage (P = 0.34). Conclusions: The use of an en bloc surgical technique with ex vivo NIRAF imaging significantly enhances the identification and recovery of PTG from deceased donors.

Consent to organ offers from public health service "Increased Risk" donors decreases time to transplant and waitlist mortality.

BACKGROUND: The Public Health Service Increased Risk designation identified organ donors at increased risk of transmitting hepatitis B, hepatitis C, and human immunodeficiency virus. Despite clear data demonstrating a low absolute risk of disease transmission from these donors, patients are hesitant to consent to receiving organs from these donors. We hypothesize that patients who consent to receiving offers from these donors have decreased time to transplant and decreased waitlist mortality. METHODS: We performed a single-center retrospective review of all-comers waitlisted for liver transplant from 2013 to 2019. The three competing risk events (transplant, death, and removal from transplant list) were analyzed. 1603 patients were included, of which 1244 (77.6%) consented to offers from increased risk donors. RESULTS: Compared to those who did not consent, those who did had 2.3 times the rate of transplant (SHR 2.29, 95% CI 1.88-2.79, p < 0.0001), with a median time to transplant of 11 months versus 14 months (p < 0.0001), as well as a 44% decrease in the rate of death on the waitlist (SHR 0.56, 95% CI 0.42-0.74, p < 0.0001). All findings remained significant after controlling for the recipient age, race, gender, blood type, and MELD. Of those who did not consent, 63/359 (17.5%) received a transplant, all of which were from standard criteria donors, and of those who did consent, 615/1244 (49.4%) received a transplant, of which 183/615 (29.8%) were from increased risk donors. CONCLUSIONS: The findings of decreased rates of transplantation and increased risk of death on the waiting list by patients who were unwilling to accept risks of viral transmission of 1/300-1/1000 in the worst case scenarios suggests that this consent process may be harmful especially when involving "trigger" words such as HIV. The rigor of the consent process for the use of these organs was recently changed but a broader discussion about informed consent in similar situations is important.

The Clustering of Adverse Childhood Experiences in the Avon Longitudinal Study of Parents and Children: Are Gender and Poverty Important?

Previous research has demonstrated a graded relationship between the number of Adverse Childhood Experiences reported (an ACE score) and child outcomes. However, ACE scores lack specificity and ignore the patterning of adversities, which are informative for interventions. The aim of the present study was to explore the clustering of ACEs and whether this clustering differs by gender or is predicted by poverty. Data on 8,572 participants of the Avon Longitudinal Study of Parents and Children (ALSPAC) were used. ALSPAC is a regionally representative prenatal cohort of children born between 1991 and 1992 in the Avon region of South-West England. ACEs included parental divorce, death of a close family member, interparental violence, parental mental health problems, parental alcohol misuse, parental drug use, parental convictions, and sexual, emotional, and physical abuse, between birth and 19 years. Latent class analysis was used to derive ACE clusters and associations between poverty, gender, and the derived classes tested using multinomial logistic regression. Five latent classes were identified: "Low ACEs" (55%), "Parental separation and mother's mental health problems" (18%), "Parental mental health problems, convictions and separation" (15%), "Abuse and mental health problems" (6%), and "Poly adversity" (6%). Death of a close family member and sexual abuse did not cluster with other adversities. The clustering did not differ by gender. Poverty was strongly related to both individual ACEs and clusters. These findings demonstrate that ACEs cluster in specific patterns and that poverty is strongly related to this. Therefore, reducing child poverty might be one strategy for reducing ACEs.

Parental mental health, socioeconomic position and the risk of asthma in children-a nationwide Danish register study.

BACKGROUND: Parental mental illness affects child health. However, less is known about the impact of different severities of maternal depression and anxiety as well as other mental health conditions. The objective of this study was to examine the impact of different severities of maternal and paternal mental health conditions on child asthma. METHODS: This nationwide, register-based cohort study included all children in Denmark born from 2000 to 2014. Exposure was parental mental health conditions categorized in three severities: minor (treated at primary care settings), moderate (all ICD-10 F-diagnoses given at psychiatric hospital) and severe (diagnoses of severe mental illness). The children were followed from their third to sixth birthday. Child asthma was identified by prescribed medication and hospital-based diagnoses. Incidence rate ratios were calculated using negative binomial regression analyses. RESULTS: The analyses included 925 288 children; 26% of the mothers and 16% of the fathers were classified with a mental health condition. Exposed children were more likely to have asthma (10.6-12.0%) compared with unexposed children (8.5-9.0%). The three severities of mental health conditions of the mother and the father increased the risk of child asthma, most evident for maternal exposure. Additive interaction between maternal mental health conditions and disadvantaged socioeconomic position was found. CONCLUSION: We found an increased risk of asthma in exposed children, highest for maternal exposure. Not only moderate and severe, but also minor mental health conditions increased the risk of child asthma. The combination of mental health condition and disadvantaged socioeconomic position for mothers revealed a relative excess risk.

Risk factors and outcomes associated with postoperative ileus following ileostomy formation: a retrospective study.

BACKGROUND: Postoperative ileus (POI) is associated with increased patient discomfort, length of stay (LOS), and healthcare cost. There is a paucity of literature examining POI in patients who have an ileostomy formed at the time of surgery. We aimed to identify risk factors for and outcomes associated with POI following ileostomy formation. METHODS: We included 261 consecutive non-emergent cases that included formation of an ileostomy by a board-certified colorectal surgeon at our institution from July 1, 2015, to June 30, 2020. Demographic, clinical, and intraoperative factors associated with increased odds of POI were evaluated. Post-procedure LOS, hospitalization cost, and re-admissions between patients with and without POI were compared. RESULTS: Out of 261 cases, 85 (32.6%) were associated with POI. Patients with POI had significantly higher body mass index (BMI) than those without POI (26.6 kg/m2 vs. 24.8kg/m2; p = 0.01). Intraoperatively, patients with POI had significantly longer procedure duration than those without POI (313 min vs. 279 min; p = 0.02). Patients with POI had a significantly higher net fluid balance at postoperative day (POD) 2 than those without POI (+ 2.65 L vs. + 1.80 L; p = 0.004), with POD2 fluid balance greater than + 807 mL (determined as the maximum Youden index for sensitivity over 80%) associated with a higher rate of POI (p = 0.006). This difference remained significant when adjusted for age, gender, BMI, pre-operative opioid use, procedure duration, and operative approach (p = 0.01). Patients with POI had significantly longer LOS (11.40 days vs. 5.12 days; p < 0.001) and direct cost of hospitalization ($38K vs. $22K; p < 0.001). CONCLUSIONS: Minimizing fluid overload, particularly in the first 48 h after surgery, may be a strategy to reduce POI in patients undergoing ileostomy formation, and thus decrease postoperative LOS and hospitalization cost. Fluid restriction, diuresis, and changes in diet advancement or early stoma intubation should be considered measures that may improve outcomes and should be studied more intensively.

Evaluating the effectiveness and cost effectiveness of the 'strengthening families, strengthening communities' group-based parenting programme: study protocol and initial insights.

BACKGROUND: Up to 20% of UK children experience socio-emotional difficulties which can have serious implications for themselves, their families and society. Stark socioeconomic and ethnic inequalities in children's well-being exist. Supporting parents to develop effective parenting skills is an important preventive strategy in reducing inequalities. Parenting interventions have been developed, which aim to reduce the severity and impact of these difficulties. However, most parenting interventions in the UK focus on early childhood (0-10 years) and often fail to engage families from ethnic minority groups and those living in poverty. Strengthening Families, Strengthening Communities (SFSC) is a parenting programme designed by the Race Equality Foundation, which aims to address this gap. Evidence from preliminary studies is encouraging, but no randomised controlled trials have been undertaken so far. METHODS/DESIGN: The TOGETHER study is a multi-centre, waiting list controlled, randomised trial, which aims to test the effectiveness of SFSC in families with children aged 3-18 across seven urban areas in England with ethnically and socially diverse populations. The primary outcome is parental mental well-being (assessed by the Warwick-Edinburgh Mental Well-Being Scale). Secondary outcomes include child socio-emotional well-being, parenting practices, family relationships, self-efficacy, quality of life, and community engagement. Outcomes are assessed at baseline, post intervention, three- and six-months post intervention. Cost effectiveness will be estimated using a cost-utility analysis and cost-consequences analysis. The study is conducted in two stages. Stage 1 comprised a 6-month internal pilot to determine the feasibility of the trial. A set of progression criteria were developed to determine whether the stage 2 main trial should proceed. An embedded process evaluation will assess the fidelity and acceptability of the intervention. DISCUSSION: In this paper we provide details of the study protocol for this trial. We also describe challenges to implementing the protocol and how these were addressed. Once completed, if beneficial effects on both parental and child outcomes are found, the impact, both immediate and longer term, are potentially significant. As the intervention focuses on supporting families living in poverty and those from minority ethnic communities, the intervention should also ultimately have a beneficial impact on reducing health inequalities. TRIAL REGISTRATION: Prospectively registered Randomised Controlled Trial ISRCTN15194500 .