Standard Care Group Research Articles

The effect of prehabilitation on long-term survival and hospital admissions in older patients undergoing elective colorectal cancer surgery

IntroductionThere is a growing body of evidence for a beneficial effect of prehabilitation on short-term outcomes after colorectal cancer (CRC) surgery in older patients. However, long-term effects on survival or hospital admissions have not been investigated. This study reports these long-term outcomes from a previously published observational cohort study. MethodsWe compared patients ≥75 years who received elective CRC surgery in Reinier de Graaf Hospital before (2010–2013: standard care) and after implementation of a multimodal prehabilitation program (2014–2015; prehabilitation). With a six-year follow-up period, we analyzed survival using the Kaplan-Meier method and the occurrence of one or more hospital admissions using logistic regression analyses. ResultsOverall, 137 patients were included in the standard care group and 86 patients in the prehabilitation group. There were no differences in patients, tumor and treatment characteristics. After six years, 51.1% in the standard care group and 59.3% in the prehabilitation group (p = 0.167) were still alive. When corrected for confounders in the prehabilitation group less patients had one or more hospital admissions during follow-up (odds ratio (OR) 0.43 (95% CI 0.24–0.77). ConclusionsUnfortunately these limited historical cohorts did not allow for strong conclusions concerning long-time survival. However, after prehabilitation less patients had hospital admissions during follow up. Hopefully, this first study into the long-term effects of multimodal prehabilitation will trigger more future research.

Comparison of Vaginal Pessaries to Standard Care or Pelvic Floor Muscle Training for Treating Postpartum Urinary Incontinence: a Pragmatic Randomized Controlled Trial.

To compare three conservative treatment options, standard care, pelvic floor muscle training (PFMT), and vaginal pessaries, for postpartum urinary incontinence (UI) that are accessible to most patients and practitioners in a generalizable cohort. A multicenter, open-label, parallel group, pragmatic randomized controlled clinical trial comparing standard care, PFMT, and vaginal cube pessary for postpartum urinary incontinence was conducted in six outpatient clinics. Sample size was based on large treatment effects (Cramers' V>0.35) with a power of 80% and an alpha of 0.05 for a 3×3 contingency table, 44 patients needed to be included in the trial. Outcomes were analyzed according to the intention-to-treat principle. Group comparisons were made using analysis of variance (ANOVA), Kruskal-Wallis, and chi-square test as appropriate. P<0.05 was considered statistically significant. Of the 516 women screened, 111 presented with postpartum UI. Of these, 52 were randomized to one of three treatment groups: standard care (n=17), pelvic floor muscle training (n=17), or vaginal cube pessary (n=18). After 12 weeks of treatment, treatment success, as measured by patient satisfaction, was significantly higher in the vaginal pessary group (77.8%, n=14/18), compared to the standard care group (41.2%, n=7/17), and the PFMT (23.5%, n=4/17; χ 2 2,n=52 =14.55; p=0.006, Cramer-V=0.374). No adverse events were reported. SUI and MUI accounted for 88.4% of postpartum UI. Vaginal pessaries were superior to standard care or PFMT to satisfyingly reduce postpartum UI symptoms. No complications were found.

Enhanced recovery protocols after surgery: A systematic review and meta-analysis of randomized trials in cardiac surgery.

Previous meta-analyses combining randomized and observational evidence in cardiac surgery have shown positive impact of enhanced recovery protocols after surgery (ERAS) on postoperative outcomes. However, definitive data based on randomized studies are missing, and the entirety of the ERAS measures and pathway, as recently systematized in guidelines and consensus statements, have not been captured in the published studies. The available literature actually focuses on "ERAS-like" protocols or only limited number of ERAS measures. This study aims at analyzing all randomized studies applying ERAS-like protocols in cardiac surgery for perioperative outcomes. A meta-analysis of randomized controlled trials (RCTs) comparing ERAS-like with standard protocols of perioperative care was performed (PROSPERO registration CRD42021283765). PRISMA guidelines were used for abstracting and assessing data. Thirteen single center RCTs (N=1704, 850 in ERAS-like protocol and 854 in the standard care group) were selected. The most common procedures were surgical revascularization (66.3%) and valvular surgery (24.9%). No difference was found in the incidence of inhospital mortality between the ERAS and standard treatment group (risk ratio [RR] 0.61 [0.31; 1.20], p=0.15). ERAS was associated with reduced intensive care unit (standardized mean difference [SMD] -0.57, p<0.01) and hospital stay (SMD -0.23, p<0.01) and reduced rates of overall complications when compared to the standard protocol (RR 0.60, p<0.01) driven by the reduction in stroke (RR 0.29 [0.13; 0.62], p<0.01). A significant heterogeneity in terms of the elements of the ERAS protocol included in the studies was observed. ERAS-like protocols have no impact on short-term survival after cardiac surgery but allows for a faster hospital discharge while potentially reducing surgical complications. However, this study highlights a significant nonadherence and heterogeneity to the entirety of ERAS protocols warranting further RCTs in this field including a greater number of elements of the framework.

Effect of virtual reality hypnosis on intraoperative sedation needs and functional recovery in knee arthroplasty: a prospective randomized clinical trial

Background and objectivesPerioperative psychological stress and pharmacological anxiolysis can negatively affect the quality of recovery after total knee arthroplasty. We aimed to assess whether hypnosis combined with virtual reality could...

Liberating Electrophysiology Preprocedure NPO Status

BackgroundFasting at midnight is standard practice for patients undergoing inpatient electrophysiological (EP) procedures, creating discomfort and dissatisfaction. MethodsThis single-center, cross-sectional observational study utilized a standard-of-care (SOC) group who remained nil per os at midnight and an evidence-based (EB) group who received clear liquids up to 2 hours before their procedure. Each participant completed a Likert scale survey assessing fasting satisfaction and a retrospective chart review was completed to assess adverse outcomes. ResultsSubjects’ hunger in the SOC group (M = 4.067) differed significantly from the EB group (M = 3.167), U = 254.5, z = 2.883, p = .004, r = 0.372. Subjects' thirst in the SOC group (M = 4.367) differed significantly from the EB group (M = 3.1), U = 186, z = 3.896, p = <.001, r = 0.503. Hypoglycemia in the SOC group was statistically significant from the EB group. ConclusionAllowing clear liquids 2 hours before EP procedures reduced patient thirst and hunger without adverse outcomes.

Effectiveness and safety of dermal matrix used for diabetic foot ulcer: a systematic review and meta-analysis of randomized controlled trials

BackgroundDiabetic foot ulcers (DFUs) have become a global health concern, which can lead to diabetic foot infection (DFI), lower leg amputation, and even mortality. Though the standard of care (SOC) practices have been recognized as the “gold standard” for DFU care, SOC alone may not be adequate to heal all DFUs and prevent their recurrence. The use of dermal matrix has emerged as an adjuvant treatment to enhance DFU healing. The current study aimed to evaluate the effectiveness and safety of dermal matrix application as an adjuvant treatment to the SOC.MethodsThe databases of PubMed, Embase and CENTRAL were independently searched by two authors, with the following key terms: “diabetic foot ulcer”, “acellular dermal matrix”, “wound healing”, and so on. Randomized controlled trials (RCTs) evaluated the efficacy and safety of dermal matrix in the treatment of DFUs were eligible for inclusion. The primary outcomes analyzed included time to complete healing and complete healing rate at the final follow-up, while secondary outcomes included wound area, ulcer recurrence rate, amputation risk and complication risk. Meta-analyses were performed using random-effect or fixed-effect models, based on the heterogeneity test.ResultsThis study included a total of 15 RCTs with a total of 1524 subjects. Of these, 689 patients were treated with SOC alone, while 835 patients received SOC plus dermal matrix. Compared to the SOC group, significantly shorter time (MD = 2.84, 95%CI: 1.37 ~ 4.32, p < 0.001***) was required to achieve complete healing in dermal matrix group. Significantly higher complete healing rate (OR = 0.40, 95%CI: 0.33 ~ 0.49, p < 0.001***) and lower overall (RR = 1.83, 95%CI: 1.15 ~ 2.93, p = 0.011*) and major (RR = 2.64, 95%CI: 1.30 ~ 5.36, p = 0.007**) amputation risks were achieved in dermal matrix group compared to SOC group. No significant difference was found in the wound area, ulcer recurrence rate, and complication risk between the two groups.ConclusionsThe application of dermal matrix as an adjuvant therapy in conjunction with SOC effectively improved the healing process of DFUs and reduced the amputation risk when compared to SOC alone. Furthermore, dermal matrix application was well tolerated by the subjects with no added complication risk.

The efficacy and safety of pre-hospital plasma in patients at risk for hemorrhagic shock: an updated systematic review and meta-analysis of randomized controlled trials.

Plasma is a critical element in hemostatic resuscitation post-injury, and its prompt administration within the prehospital setting may reduce the complications resulting from hemorrhage and shock. Our objective is to assess the efficacy and safety of prehospital plasma infusion in patients susceptible to hemorrhagic shock. We conducted our study by aggregating randomized controlled trials (RCTs) sourced from PubMed, EMBASE, Scopus, Web of Science, and Cochrane CENTRAL up to January 29, 2023. Quality assessment was implemented using the Cochrane RoB 2 tool. Our study protocol is registered in PROSPERO under ID: CRD42023397325. Three RCTs with 760 individuals were included. There was no difference between plasma infusion and standard care groups in 24-h mortality (P = 0.11), 30-day mortality (P = 0.12), and multiple organ failure incidences (P = 0.20). Plasma infusion was significantly better in the total 24-h volume of PRBC units (P = 0.03) and INR on arrival (P = 0.009). For all other secondary outcomes evaluated (total 24-h volume of packed FFP units, total 24-h volume of platelets units, massive transfusion, vasopressor need during the first 24h, any adverse event, acute lung injury, transfusion reaction, and sepsis), no significant differences were observed between the two groups. Plasma infusion in trauma patients at risk of hemorrhagic shock does not significantly affect mortality or the incidence of multiple organ failure. However, it may lead to reduced packed red blood cell transfusions and increased INR at hospital arrival.

Cyclosporine A in hospitalized COVID-19 pneumonia patients to prevent the development of interstitial lung disease: a pilot randomized clinical trial

Post-COVID-19 interstitial lung disease (ILD) is a new entity that frequently causes pulmonary fibrosis and can become chronic. We performed a single-center parallel-group open-label pilot randomized clinical trial to investigate the efficacy and safety of cyclosporine A (CsA) in the development of ILD in the medium term among patients hospitalized with COVID-19 pneumonia. Patients were randomized 1:1 to receive CsA plus standard of care or standard of care alone. The primary composite outcome was the percentage of patients without ILD 3 months after diagnosis of pneumonia and not requiring invasive mechanical ventilation (IMV) (response without requiring IMV). The key secondary composite outcomes were the percentage of patients who achieve a response requiring IMV or irrespective of the need for IMV, and adverse events. A total of 33 patients received at least one dose of CsA plus standard of care (n = 17) or standard of care alone (n = 16). No differences were found between the groups in the percentage of patients who achieved a response without requiring IMV or a response requiring IMV. A higher percentage of patients achieved a response irrespective of the need for IMV in the CsA plus standard of care group although the RR was almost significant 2.833 (95% CI, 0.908–8.840; p = 0.057). No differences were found between the groups for adverse events. In hospitalized patients with COVID-19 pneumonia, we were unable to demonstrate that CsA achieved a significant effect in preventing the development of ILD. (EU Clinical Trials Register; EudraCT Number: 2020-002123-11; registration date: 08/05/2020).

Digital Health Interventions for Hypertension Management in US Populations Experiencing Health Disparities

Hypertension remains a leading factor associated with cardiovascular disease, and demographic and socioeconomic disparities in blood pressure (BP) control persist. While advances in digital health technologies have increased individuals' access to care for hypertension, few studies have analyzed the use of digital health interventions in vulnerable populations. To assess the association between digital health interventions and changes in BP and to characterize tailored strategies for populations experiencing health disparities. In this systematic review and meta-analysis, a systematic search identified studies evaluating digital health interventions for BP management in the Cochrane Library, Ovid Embase, Google Scholar, Ovid MEDLINE, PubMed, Scopus, and Web of Science databases from inception until October 30, 2023. Included studies were randomized clinical trials or cohort studies that investigated digital health interventions for managing hypertension in adults; presented change in systolic BP (SBP) or baseline and follow-up SBP levels; and emphasized social determinants of health and/or health disparities, including a focus on marginalized populations that have historically been underserved or digital health interventions that were culturally or linguistically tailored to a population with health disparities. The study followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guideline. Two reviewers extracted and verified data. Mean differences in BP between treatment and control groups were analyzed using a random-effects model. Primary outcomes included mean differences (95% CIs) in SBP and diastolic BP (DBP) from baseline to 6 and 12 months of follow-up between digital health intervention and control groups. Shorter- and longer-term follow-up durations were also assessed, and sensitivity analyses accounted for baseline BP levels. A total of 28 studies (representing 8257 participants) were included (overall mean participant age, 57.4 years [range, 46-71 years]; 4962 [60.1%], female). Most studies examined multicomponent digital health interventions incorporating remote BP monitoring (18 [64.3%]), community health workers or skilled nurses (13 [46.4%]), and/or cultural tailoring (21 [75.0%]). Sociodemographic characteristics were similar between intervention and control groups. Between the intervention and control groups, there were statistically significant mean differences in SBP at 6 months (-4.24 mm Hg; 95% CI, -7.33 to -1.14 mm Hg; P = .01) and SBP changes at 12 months (-4.30 mm Hg; 95% CI, -8.38 to -0.23 mm Hg; P = .04). Few studies (4 [14.3%]) reported BP changes and hypertension control beyond 1 year. In this systematic review and meta-analysis of digital health interventions for hypertension management in populations experiencing health disparities, BP reductions were greater in the intervention groups compared with the standard care groups. The findings suggest that tailored initiatives that leverage digital health may have the potential to advance equity in hypertension outcomes.

Nudging towards COVID-19 and influenza vaccination uptake in medically at-risk children: EPIC study protocol of randomised controlled trials in Australian paediatric outpatient clinics

IntroductionChildren with chronic medical diseases are at an unacceptable risk of hospitalisation and death from influenza and SARS-CoV-2 infections. Over the past two decades, behavioural scientists have learnt how to...

The efficacy of sacral foam dressing in preventing sacral pressure injury: A systematic review and meta‐analysis

AbstractPurposeWe aim to evaluate the efficacy of sacral foam dressings in preventing sacral pressure injury.MethodsThe PubMed, Embase and Web of Science databases were searched for relevant publications until October 2023. All studies evaluating the efficacy of sacral foam dressings in preventing sacral pressure injury were included. We calculated pooled risk ratio (RR) with 95% confidence intervals (CIs) for binary outcomes. The Cochrane's Risk of Bias Tool were used to evaluate the quality of studies.ResultsA total of 9 randomized controlled studies with 3972 patients were included in this analysis. Sacral pressure injury rate was significantly lower in the sacral foam dressing group compared with the standard care group (RR: 0.37, 95% CI: 0.17–0.82). Furthermore, the rate of ≥stage II sacral pressure injury was also significantly reduced (RR: 0.56, 95% CI: 0.37–0.83), along with a lower blanching erythema rate (RR: 0.64, 95% CI: 0.42–0.97). No obvious publication bias was observed in the funnel plot (Egger's p values = 0.91).ConclusionsSacral foam dressing significantly reduced the incidence of sacral pressure injuries, including those of stage II or higher, and blanching erythema when compared to standard care without sacral foam dressing. However, the results should be interpreted with cautious because of the observed heterogeneity and the diverse patient population. Further larger, well‐designed randomized control studies are needed.

Telemedicine Plus Standard Care Versus Standard Care Only in Specialized Outpatient Palliative Care: A Randomized Controlled Noninferiority Trial.

Background: Patients suffering from incurable diseases are more likely to die in the hospital than at home. Specialized outpatient palliative care (PC) may be able to counteract this tendency. Similarly, potential benefits of telemedicine in health care were scientifically reported. The aim of this research was to compare patients receiving specialized outpatient PC plus telemedicine with those receiving standard specialized outpatient PC only. In this study, telemedicine is assumed to decrease the number of home visits and therefore should not be considered a mere add-on. Methods: This is a randomized controlled noninferiority trial. Recruitment lasted between January 2020 and October 2021. Quality of care was evaluated using the Integrated Palliative Care Outcome Scale (IPOS) at day 0, 7, and 14 after randomization. Change from day 0 to 7 was defined as the primary outcome (noninferiority margin = 4 points). This study was conducted in an urban setting in collaboration with a university hospital and a local specialized outpatient PC service. Results: A total of 196 patients were screened with 34 patients included (18 telemedicine/16 standard care). The mean change in the total score of the IPOS from day 0 to 7 amounted to -1.8 ± 3.9 (telemedicine) versus 1.2 ± 5.7 (standard care). The telemedicine group was statistically not relevantly inferior to the standard care group (t-test for noninferiority, p = 0.005). Conclusions: Although, due to COVID-19, the sample size remained rather small, our findings indicate that telemedical approaches offer a promising and equally effective option to provide specialized outpatient PC. Clinical Trial Registration Number: NCT06054048.

Effects of enhanced recovery after surgery nursing program on the surgical site wound infection and postoperative complications in patients of gastric cancer: A meta‐analysis

AbstractThis meta‐analysis systematically evaluates the impact of the enhanced recovery after surgery (ERAS) concept on surgical site wound infections and postoperative complications in gastric cancer patients. A comprehensive computerized search was conducted in PubMed, Embase, Google Scholar, Cochrane Library, China National Knowledge Infrastructure and Wanfang databases for randomized controlled trials (RCTs), from database inception to November 2023, exploring the application of the ERAS concept in the perioperative period of gastric cancer surgery. Two researchers independently screened the literature, extracted data, and conducted quality assessments based on inclusion and exclusion criteria. Data analysis was performed using Stata 17.0 software. A total of 24 RCTs involving 2050 gastric cancer patients were included. The analysis revealed a significantly lower incidence of wound infections (OR = 0.23, 95% CI: 0.14–0.40, p &lt; 0.001) and postoperative complications (OR = 0.20, 95% CI: 0.15–0.27, p &lt; 0.001) in the ERAS group compared to the standard care group. This study demonstrates that the application of the ERAS concept during the perioperative period in gastric cancer surgery can effectively reduce the occurrence of wound infections and complications, thereby facilitating postoperative recovery.

Efficacy and safety of acupuncture in treating low back and pelvic girdle pain during pregnancy: a systematic review and meta-analysis of randomized controlled trials

Objectives: Low back and pelvic girdle pain (LBPGP) is common during pregnancy. Acupuncture is an effective and safe therapy for pain relief. However, further evidence is required to confirm the efficacy and safety of acupuncture in treating LBPGP during pregnancy. This study aimed to systematically review and investigate the clinical efficacy and safety of acupuncture for the treatment of pregnancy-related LBPGP. Methods: The PubMed, EMBASE, Cochrane Library, CNKI, VIP, and WanFang databases were searched from January 2000 to August 2023. Only the randomized controlled trials (RCTs) involving pregnant women between 16 and 34 weeks of gestation diagnosed with LBPGP were included in the study. A meta-analysis was conducted and pooled risk ratios (RRs) or mean differences (MDs) with 95% confidence intervals (CIs) were compared. Results: Meta-analysis included 12 RCTs involving 1,641 participants. Eleven trials compared acupuncture alone or acupuncture combined with standard care (SC), of which three trials also used non-penetrating or placebo acupuncture as the control group. One trial compared acupuncture alone with non-penetrating acupuncture. Compared with SC, acupuncture combined with SC group significantly decreased visual analog scale score (mean difference (MD) = −2.83, 95% CI = −3.41 to −2.26, P &lt; 0.00001), cesarean section rate (RR = 0.69, 95% CI = 0.49–0.97, P = 0.03), preterm birth rate (RR = 0.42, 95% CI = 0.27–0.65, P &lt; 0.0001), labor duration (MD = −1.97, 95% CI = −2.73 to −1.20, P &lt; 0.0001), and Oswestry disability index score (MD = −9.14, 95% CI = −15.68 to −2.42, P = 0.008). In addition, acupuncture combined with SC significantly improved 12-Items Short Form Health Survey of physical component summaries (SF12-PCS). No significant differences were observed in the spontaneous delivery rate, newborn weight, drowsiness, and 12-Items Short Form Health Survey of mental component summaries (SF12-MCS) between the two groups. Adverse events such as needle pain and needle bleeding were aggravated in both the SC and acupuncture treatment groups but none were associated with acupuncture during or after the treatment period. Conclusions: Meta-analysis showed that acupuncture combined with SC had better efficacy than SC alone and could be a potential therapy for LBPGP during pregnancy. The safety results imply that acupuncture caused few adverse reactions; however, more evidence is required for further confirmation.

P692 An IBD nurse-led educational programme on safety and efficacy of adjuvated recombinant zoster vaccine can improve vaccine uptake in IBD patients on immunosuppressive treatment

Abstract Background Herpes Zoster (HZ) represents one of the most frequent opportunistic infections in IBD patients under immunosoppressive treatment and can be prevented by vaccination. Adjuvated recombinant zoster vaccine (RZV) is the first HZ vaccine approved for immunocompromised persons. IBD patients are less likely to receive appropriate vaccinations compared to the general population. IBD nurses operate as the primary point of contact for patients and this unique position provides a suitable opportunity to positively impact patient care and encourage vaccination. We aimed to improve RZV vaccination rates by a nurse-led education intervention within an on-site RZV vaccination programme. Methods IBD patients on immunosuppressive therapies were actively recruited by phone contact, mail and during outpatient clinic or infusion centre attendance. Prior immunization to VZV was collected from medical records. Patients were randomly assigned to receive either standard explanation on the importance of HZ vaccination by the IBD attending physician (group P) or additional education by an IBD nurse (group N). Patients in group N were referred to an IBD nurse for an individual 15 minutes nurse–patient interview. During the interview, disease activity and current treatment, previous immunization to VZV and history of HZ were reviewed; the importance, benefits and safety of HZ vaccination with RZV were discussed with the patient. Patients were then referred to dedicated on-site vaccination clinics where vaccine administration was provided by the IBD nurses running the infusion centre. Reasons for vaccine refusal was also recorded. Results From February to April 2022, 164 (80%) out of 205 eligible patients were enrolled (median age 48.5 years, 54.1% male; 48.7% UC, 51.3% CD); 65 patients (39.6%) were randomized to group P and 99 patients (60.4%) to group N. Six months after randomization, 112 (68.2%) had received at least 1 RZV vaccine dose whereas vaccination was completed in 110 patients (67%). Vaccination rate was significantly higher in the nurse-led education intervention group compared to standard clinical care (group N 75.7% vs group P 56.9%,p&amp;lt;0.05). Most common reasons for vaccine hesitancy were concerns about side effects (40.9%), fear of vaccine aggravating the disease (14.7%), considering themselves not at risk (13.3%) and objection to the administration of vaccine (10.1%). Conclusion Vaccination recommendations should be responsibility of the IBD patient care team and efforts should be made to reduce vaccine hesitancy. We showed that a simple nurse-led educational intervention on vaccine safety and efficacy was able to improve RVZ vaccination rates in IBD patients on immunosuppressive treatment.

DOP29 Capsule endoscopy-guided proactive treatment versus standard treatment of patients with quiescent Crohn’s Disease: The CURE-CD randomized controlled trial

Abstract Background Optimal strategies for treat-to-target in Crohn’s disease (CD) are still being sought. We aimed to examine the value of capsule endoscopy (CE) to guide proactive treatment optimization in patients with CD Methods A prospective randomized controlled clinical trial with temporally-restricted blinding. Patients with CD involving the small bowel who were in clinical remission (CDAI&amp;lt;150) for over three months were enrolled. Baseline clinical, biomarker, imaging, patency capsule and CE assessments were performed. ‘High risk’ patients, defined as CE Lewis score ≥350 were randomized to either proactive treatment optimization or continued standard care for 24 months. ‘Low risk’ patients with Lewis score&amp;lt;350 continued their standard care. All patients repeated CE every six months for 24 months. Primary outcome was the rate of clinical exacerbation (CDAI increase&amp;gt;70 points and CDAI&amp;gt;150 or hospitalization/surgery) in the standard-care versus the proactive-care sub-groups of high-risk patients, at 24 months. Secondary outcomes included risk of flare in the low-risk versus the standard-care high-risk arms, and predictive profiles for flare of calprotectin, MRI, intestinal ultrasound and Lewis score. Results Out of 118 screened patients, 60 were enrolled (20 in each of the three arms). Treatment intensification in CE-determined high-risk group, who were allocated to proactive treatment, comprised biologic dose-escalation (n=11/20), starting a biologic (8/20) or swapping a biologic (1/20) at study entry. Notably, 9/20 proactive-group patients underwent a second optimization following detected inflammation on subsequent semi-annual CE studies. Clinical exacerbation by 24 months (primary outcome) occurred in 5/20 (25%) of the high-risk proactive-treatment group versus 14/20 (70%) of the high-risk standard-care group (OR=0.14, 95%CI 0.04-0.57, p=0.006). For secondary outcomes, the rate of clinical flare in the standard-care low-risk group was numerically but not significantly lower than in standard-care high-risk group (9/20 versus 14/20, respectively, OR 0.3, 0.1-1.3, P=0.11). Among all patients continuing standard care, baseline CE Lewis score was higher among relapsers versus non-relapsers (median 450, IQR [225-900] versus 225, [135-600], respectively, p=0.03). Of 251 CE ingested, there was a single (0.4%) temporarily-retained CE, which resolved spontaneously. Conclusion In a randomized strategy-finding controlled trial, proactive treatment optimization based on CE findings in patients with CD in remission, proved safe and superior for prevention of disease exacerbation compared with continued standard care. NCT03555058

Dialysis and Nutrition: Optimizing Dietary Support for Patients Undergoing Blood Purification

This study evaluated the effectiveness of individualized dietary interventions in improving the nutritional status and general health of individuals undergoing dialysis. A total of 120 patients undergoing dialysis were equally allocated to the Standard Care Group and Intervention Group. The recipients of individualized dietary counseling had their plans modified monthly in accordance with their nutritional needs, personal preferences, and clinical circumstances. Nutritional adherence, biochemical parameters, clinical outcomes, and quality of life were evaluated and compared between groups. At baseline, both groups exhibited comparable demographic characteristics. Compared to baseline values, the Intervention Group showed substantial enhancements in albumin, hemoglobin, potassium, and phosphorus levels after six months (P &lt; 0.05). The Intervention Group had a considerably higher rate of adherence to dietary recommendations than the Standard Care Group (92% vs. 75%, P &lt; 0.01). Nutritional intake analyses revealed a noteworthy enhancement in energy and protein consumption, while sodium, potassium, and phosphorus intake decreased (P &lt; 0.05). The results of the quality-of-life evaluation demonstrated notable improvements in physical, emotional, social, and overall health perception scores (P &lt; 0.05). Thus, personalized dietary interventions substantially improve the nutritional status, biochemical profile, and overall quality of life of patients undergoing dialysis.

Default Palliative Care Consultation for Seriously Ill Hospitalized Patients

Increasing inpatient palliative care delivery is prioritized, but large-scale, experimental evidence of its effectiveness is lacking. To determine whether ordering palliative care consultation by default for seriously ill hospitalized patients without requiring greater palliative care staffing increased consultations and improved outcomes. A pragmatic, stepped-wedge, cluster randomized trial was conducted among patients 65 years or older with advanced chronic obstructive pulmonary disease, dementia, or kidney failure admitted from March 21, 2016, through November 14, 2018, to 11 US hospitals. Outcome data collection ended on January 31, 2019. Ordering palliative care consultation by default for eligible patients, while allowing clinicians to opt-out, was compared with usual care, in which clinicians could choose to order palliative care. The primary outcome was hospital length of stay, with deaths coded as the longest length of stay, and secondary end points included palliative care consult rate, discharge to hospice, do-not-resuscitate orders, and in-hospital mortality. Of 34 239 patients enrolled, 24 065 had lengths of stay of at least 72 hours and were included in the primary analytic sample (10 313 in the default order group and 13 752 in the usual care group; 13 338 [55.4%] women; mean age, 77.9 years). A higher percentage of patients in the default order group received palliative care consultation than in the standard care group (43.9% vs 16.6%; adjusted odds ratio [aOR], 5.17 [95% CI, 4.59-5.81]) and received consultation earlier (mean [SD] of 3.4 [2.6] days after admission vs 4.6 [4.8] days; P < .001). Length of stay did not differ between the default order and usual care groups (percent difference in median length of stay, -0.53% [95% CI, -3.51% to 2.53%]). Patients in the default order group had higher rates of do-not-resuscitate orders at discharge (aOR, 1.40 [95% CI, 1.21-1.63]) and discharge to hospice (aOR, 1.30 [95% CI, 1.07-1.57]) than the usual care group, and similar in-hospital mortality (4.7% vs 4.2%; aOR, 0.86 [95% CI, 0.68-1.08]). Default palliative care consult orders did not reduce length of stay for older, hospitalized patients with advanced chronic illnesses, but did improve the rate and timing of consultation and some end-of-life care processes. ClinicalTrials.gov Identifier: NCT02505035.

The Delivery Room Resuscitation of Infants with Congenital Diaphragmatic Hernia Treated with Fetoscopic Endoluminal Tracheal Occlusion: Beyond the Balloon

Introduction: Randomized controlled trials found that fetoscopic endoluminal tracheal occlusion (FETO) resulted in increased fetal lung volume and improved survival for infants with isolated, severe left-sided congenital diaphragmatic hernia (CDH). The delivery room resuscitation of these infants is particularly unique, and the specific delivery room events are largely unknown. The objective of this study was to compare the delivery room resuscitation of infants treated with FETO to standard of care (SOC) and describe lessons learned. Methods: Retrospective single-center cohort study of infants treated with FETO compared to infants who met FETO criteria during the same period but who received SOC. Results: FETO infants were more likely to be born prematurely with 8/12 infants born <35 weeks gestational age compared to 3/35 SOC infants. There were 5 infants who required emergent balloon removal (2 ex utero intrapartum treatment and 3 tracheoscopic removal on placental bypass with delayed cord clamping) and 7 with prenatal balloon removal. Surfactant was administered in 6/12 FETO (50%) infants compared to 2/35 (6%) in the SOC group. Extracorporeal membrane oxygenation use was lower at 25% and survival was higher at 92% compared to 60% and 71% in the SOC infants, respectively. Conclusion: The delivery room resuscitation of infants treated with FETO requires thoughtful preparation with an experienced multidisciplinary team. Given increased survival, FETO should be offered to infants with severe isolated left-sided CDH, but only in high-volume centers with the experience and capability of removing the balloon, emergently if needed. The neonatal clinical team must be skilled in managing the unique postnatal physiology inherent to FETO where effective interdisciplinary teamwork is essential. Empiric and immediate surfactant administration should be considered in all FETO infants to lavage thick airway secretions, particularly those delivered <48 h after balloon removal.

The Impact of Breast Crawl on the Effectiveness of Breastfeeding in the First 48 Hours: A Quasi-experimental Study

Background Breast crawl is known to be the most natural, spontaneous, and logical method of initiating breastfeeding; however, not practiced routinely in many labor rooms. Objective The study’s primary objective was to examine the effect of breast crawl on breastfeeding in the first 48 hours. Method 60 mother-infant dyads were included. Thirty infants were assigned to either Group 1 (breast crawl) or Group 2 (standard care) using a quasi-experimental design. All babies were observed for 1 hour. A blinded investigator did the LATCH (Latch Audible Swallowing Type of Nipple Comfort Hold) score and IBFAT (Infant Breast Feeding Assessment Tool) score at 24 and 48 hours. Result Out of 30 babies in the breast crawl group, 25 (83.3%) successfully completed breast crawl. 20 (80%) of 25 babies completed breast crawl within 45 minutes, and 5 (20%) completed within 60 minutes. LATCH and IBFAT scores were significantly higher in the breast crawl group than in the standard care group at 24 and 48 hours ( p &gt; .01). Scores were significantly higher after 48 hours compared to 24 hours in both groups ( p &gt; .01). Conclusion Most babies in the study successfully crawled the breast and took their first feed within 60 minutes. The breast crawl group had better LATCH and IBFAT scores, indicating a positive impact in the early postnatal period.