Standardized Clinical Pathway Research Articles

Evidence Review for the American College of Surgeons Quality Verification Part III: Standardization, Protocols, and Achieving Better Outcomes for Patient Care.

After decades of experience supporting surgical quality and safety by the American College of Surgeons, the ACS Quality Verification Program (ACS QVP) was developed to help hospitals improve surgical quality and safety. This review is the final installment of a three-part review aimed to synthesize evidence supporting the main principles of the ACS QVP. Evidence was systematically reviewed for three principles: standardized team-based care across five phases of surgical care, disease-based management, and external regulatory review. MEDLINE was searched for articles published from inception to January 2019 and two reviewers independently screened studies for inclusion in a hierarchical fashion, extracted data, and summarized results in a narrative fashion. A total of 5,237 studies across these three topics were identified. Studies were included if they evaluated the relationship between the standard of interest and patient-level or organization measures within the last twenty years. After applying inclusion criteria, a total of 150 studies in systematic reviews and primary studies were included for assessment. Despite institutional variation in standardized clinical pathways, evidence demonstrated improved outcomes such as reduced length of stay (LOS), costs, and complications. Evidence for multidisciplinary disease-based care protocols was mixed, though trended towards improving patient outcomes such as reduced LOS and readmissions. Similarly, the evidence for accreditation and adherence to external process measures was also mixed, though several studies demonstrated the benefit of accreditation programs on patient outcomes. The identified literature supports the importance of standardized multidisciplinary and disease-based processes and external regulatory systems to improve quality of care.

Identification and Application of Emerging Biomarkers in Treatment of Non-Small-Cell Lung Cancer: Systematic Review.

Non-small-cell lung cancer (NSCLC) comprises approximately 85% of all lung cancer cases, often diagnosed at advanced stages, which diminishes the effective treatment options and survival rates. This systematic review assesses the utility of emerging biomarkers-circulating tumor DNA (ctDNA), microRNAs (miRNAs), and the blood tumor mutational burden (bTMB)-enhanced by next-generation sequencing (NGS) to improve the diagnostic accuracy, prognostic evaluation, and treatment strategies in NSCLC. Analyzing data from 37 studies involving 10,332 patients from 2020 to 2024, the review highlights how biomarkers like ctDNA and PD-L1 expression critically inform the selection of personalized therapies, particularly beneficial in the advanced stages of NSCLC. These biomarkers are critical for prognostic assessments and in dynamically adapting treatment plans, where high PD-L1 expression and specific genetic mutations (e.g., ALK fusions, EGFR mutations) significantly guide the use of targeted therapies and immunotherapies. The findings recommend integrating these biomarkers into standardized clinical pathways to maximize their potential in enhancing the treatment precision, ultimately fostering significant advancements in oncology and improving patient outcomes and quality of life. This review substantiates the prognostic and predictive value of these biomarkers and emphasizes the need for ongoing innovation in biomarker research.

Abstract PO5-19-01: The HER2-RADiCAL study (Response ADaptive CAre pLan) – Tailoring treatment for HER2 positive early breast cancer

Abstract Background The presence or absence of residual disease following neoadjuvant systemic anti-cancer therapy (neoSACT) for HER2-positive early breast cancer (HER2+ EBC) provides powerful prognostic information. Pathological complete response (pCR) following neoSACT, particularly in patients with earlier clinical TNM stage at diagnosis, identifies a population with excellent survival outcomes in whom the balance of toxicity associated with the current treatment pathway may be disproportionate to absolute clinical benefit. Aims >HER2-RADiCAL seeks to reduce the treatment burden and healthcare costs of treating HER2+ EBC by testing the hypothesis that pCR can be used as a functional response biomarker to select patients who can safely receive less systemic therapy with minimal/no loss of efficacy. Trial design and eligibility criteria HER2-RADiCAL is a response-directed interventional cohort/threshold-crossing design study embedded within a real-world data-driven clinical pathway model. Patients with ER-positive or negative HER2+ EBC with cT1N1 or cT2N0-1 stage at diagnosis are eligible after completion of standard of care neoSACT and locally determined pCR (ypT0/Tis ypN0). Patients with pathological features consistent with previous malignant involvement in >4 nodes are not eligible. Adjuvant trastuzumab +/- pertuzumab may have continued prior to study entry provided no more than 9 cycles of trastuzumab are received. After registration all participants receive a total of 9 cycles of trastuzumab including those administered prior to study entry. Participants receive no further pertuzumab and no adjuvant chemotherapy. Adjuvant endocrine therapy and radiotherapy are given as per standard of care. Central pathology review of pCR status will be conducted in a subset of cases. A Study Within a Trial (SWAT) will explore identification of factors influencing patient decision-making for participation in studies of response-adapted treatment. Statistical methods The primary endpoint is relapse-free interval. Recruitment of 720 participants over 3.5 years will provide 90% power to exclude an event rate >6.5% at 3 years (expected event rate ≤4%). Secondary endpoints include relapse-free survival, invasive breast cancer-free survival, invasive disease-free survival, distant recurrence-free interval, breast cancer-free interval, overall survival, treatment pathway adherence and cost-effectiveness. An interventional cohort is preferred to a randomised non-inferiority trial based on the known event rate in this population which is sufficiently low such that any deviation from this expected event rate would indicate failure of the reduced therapy strategy. Real-world data driven clinical pathway model Health economic modelling will compare the protocol-driven study cohort with two comparator pathways: a non-response adapted maximum therapy pathway (the standard clinical pathway prior to the study) and a real-world representative pathway derived from anonymised data for all patients treated for HER2+ EBC within the UK NHS. Patient and public involvement Our PPI partners continue to shape this research, holding key roles as trial management group members, overseeing progress of the study, contributing to protocol amendment development, and design and implementation of the SWAT. Current status The first patient was enrolled in December 2021. At 10th July 2023, 25 research sites have opened with 39 participants recruited. Site opening continues with a minimum target of 40. Responding to continued use of anthracycline-based regimens in UK practice, eligibility criteria have recently been extended to permit entry of patients who have received anthracycline-containing neoSACT. For further information contact her2radical-icrctsu@icr.ac.uk. Citation Format: Iain Macpherson, Stuart McIntosh, Lucy Kilburn, Holly Tovey, Laura Moretti, Katie Goddard, Indrani Bhattacharya, Clinton Boyd, Cliona Kirwan, Ciara O'Brien, Duncan Wheatley, Jennifer Glendenning, Mairead MacKenzie, Hilary Stobart, Claire Snowdon, Andrew Wardley, Abeer Shaaban, Peter Hall, David Cameron, Judith Bliss. The HER2-RADiCAL study (Response ADaptive CAre pLan) – Tailoring treatment for HER2 positive early breast cancer [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO5-19-01.

Pediatricians' Perspectives on Introducing Transitional Care into Handover Between Pediatric Intensive Care Units and General Wards.

Despite the availability of a considerable number of studies on transitional care, few qualitative studies have synthesized physicians' perspectives on PICU-to-ward transition to develop a comprehensive transitional care curriculum. The aim of this study is to explore physicians' perceptions and management of the transition of critically ill children from the PICU to the general ward, with the aim of providing an evidence-based curriculum. A qualitative study was conducted between July and August 2022. The study involved semi-structured interviews with 11 participants, and data analysis was carried out using NVivo 12.0 software through thematic analysis method. Based on the data analysis, three main themes were identified: recognition of professional roles during transition, difficulties during implementation transitional care and suggestions for improving transitional care. The insights of doctors can be valuable in improving transitional care for critically ill children during PICU-to-Ward transition and in developing relevant curricula. It is essential to introduce standardized clinical pathways and strengthen curricula on critical elements, including communication and follow-up.

Consensus for a primary care clinical decision-making tool for assessing, diagnosing, and managing low back pain in Alberta, Canada.

Low back pain (LBP) is a common condition causing disability and high healthcare costs. Alberta faces challenges with unnecessary referrals to specialists and long wait times. A province-wide standardized clinical care pathway based on evidence-based best practices can improve efficiency, reduce wait times, and enhance patient outcomes. Implementing such pathways has shown success in other areas of healthcare in Alberta. This study developed a clinical decision-making pathway to standardize care and minimize uncertainty in assessment, diagnosis, and management. A systematic rapid review identified existing tools and evidence that could support a comprehensive LBP clinical decision-making tool. Forty-seven healthcare professionals participated in four rounds of a modified Delphi approach to reach consensus on the assessment, diagnosis, and management of patients presenting to primary care with LBP in Alberta, Canada. This project was a collaborative effort between Alberta Health Services' Bone and Joint Health Strategic Clinical Network (BJHSCN) and the Alberta Bone and Joint Health Institute (ABJHI). A province-wide expert panel consisting of professionals from different health disciplines and regions collaborated to develop an LBP clinical decision-making tool. This tool presents clinical care pathways for acute, subacute, and chronic LBP. It also provides guidance for history-taking, physical examination, patient education, and management. This clinical decision-making tool will help to standardize care, provide guidance on the diagnosis and management of LBP, and assist in clinical decision-making for primary care providers in both public and private sectors.

The PD-Ballet study: study protocol for a randomised controlled single-blind hybrid type 2 clinical trial evaluating the effects of ballet dancing on motor and non-motor symptoms in Parkinson’s disease

BackgroundTo date, beneficial effects of multimodal exercise programmes on Parkinson’s disease (PD) have focused on motor symptoms and little attention has been paid to the potential effects of such programmes on the non-motor symptoms of PD, which are now universally known as one of the key drivers of quality of life and a key unmet need. We aim to explore clinical effectiveness of a ballet-based dance programme in addressing non-motor and motor symptoms of Parkinson’s disease across all stages of progression.MethodsA randomised, single-blind, controlled trial of 160 people with Parkinson’s across all motor stages (Participants will be stratified into three groups of motor advancement: Hoehn and Yahr (HY) stages I and II being Mild Group, HY Stage III being Moderate Group and HY Stages IV and V being Severe Group) will be randomly allocated to either an intervention or a control group using an independent randomisation body. The primary outcome is an improvement in non-motor symptoms as measured by the Movement Disorders Society Non-Motor Scale (MDS-NMS). The intervention protocol consists of 12 one-weekly dance sessions led by English National Ballet. Each session is followed by a ‘tea and biscuit’ social time. Control group follows standard clinical pathway and joins the ‘tea and biscuit’ to control for any positive effects of social interactions. All participants are assessed at baseline, immediately after completion of the intervention and 3–6 months later to explore any potential longitudinal effects.DiscussionTo our knowledge, no adequately powered study has explored the effects of a dance-based intervention on non-motor symptoms of Parkinson’s disease, assessing these on both holistic and granular levels. We also aim to stratify participants in accordance with their motor state as assessed by.HY staging to explore specific effects on the symptoms at the initial, moderate and complex stages of the disease. If successful, this trial provides first evidence on clinical effectiveness of a ballet-based dance intervention for symptoms of Parkinson’s disease, assessed in a robust, rigorous manner.Trial registrationNCT04719468.

A quality perspective on the ideal of coherent care pathways for patients with complex, long-term healthcare needs. A policy document analysis

Background: Policy documents’ rhetoric emphasize coherent care pathways as an expression of integrated and person-centred care in healthcare services for persons with complex long-term needs. Various measures are introduced to achieve these ideals. Norwegian policy highlights personal responsibility for one professional as a coordinator, cross-sectional individual care plans, services provided by multidisciplinary teams, formal collaboration structures between primary and specialized care, and implementation of different types of pathway organization. Policy documents rarely specify how quality in terms of goal achievement is to be understood, assessed, or evaluated. It has proved difficult to show outcomes of the measures as well as whether they contribute to achievement of the ideals. 
 Theoretical framework: Four quality paradigms have been demonstrated as a common basis for assessing quality in integrated care: the empirical paradigm which focus on measuring reality, the reference paradigm where care is evaluated according to models or frameworks, the reflective paradigm where quality cannot be defined, just discussed. And finally, the emergence paradigm where all stakeholders explore and co-create new solutions together.
 Aim: To analyse how ideals of coherent care pathways are described in policy documents, and how they resonate with different quality paradigms. 
 Methods: An analysis of two central Norwegian policy documents is in process. The meaning of ‘care pathway’ is interpreted in the context of each paragraph, and categorized according to which quality paradigm(s) is considered relevant. 
 Preliminary results and discussion: The concept ‘coherent care pathways’ is used as an expression of, and as an argument for, a variety of models, care organization, care values, and desirable patient experiences related to process-oriented care. Achievement of coherent care pathways for persons with long-term complex healthcare needs, can therefore imply different types of “success”. 
 One type of model is standardized clinical pathways. Here quality is defined as timely accomplishments of defined tasks. This is in accordance with the empirical paradigm. In the Norwegian coordination reform, care pathways is defined as the chronological chain of events that make up the patient's encounters with various parts of the health and care services. In good pathways these events are put together in a rational and coordinated way to meet the patient's various needs. Pathway in this meaning must be evaluated in perspective of the individual patient’s situation, considering the degree of predictability and the prerequisites for planning during the process. This in accordance with the emergence paradigm.
 Van Kemenade, van der Vlegel et al. (2019, 2020, 2021, 2022) have introduced the quality paradigms in analysis of, and recommendations for, integrated care research, to show different understandings and values at play in a patient case, and to propose a new definition of integrated care. In this paper we intend to discuss how conceptualizations of coherent care pathways in policy documents has consequences for how quality can be understood and evaluated. And further, that we can draw relevant knowledge from this of benefit to discussions and plans for realizing the measures and the ideals of integrated person-centred care. 
 Keywords: Care pathways, integrated care, person-centred care, quality paradigms.

Morbidity of Transrectal MRI-Fusion Targeted Prostate Biopsy at a Tertiary Referral Academic Centre: An Audit to Guide the Transition to the Transperineal Approach.

Despite transrectal prostate biopsy (TRPB) being still widespread globally, the EAU Guidelines strongly recommend the transperineal approach, due to the reported lower infectious risk. Our study aims to evaluate the impact of a standardized clinical pathway for TRPB on post-operative complications. We prospectively collected data from all patients undergoing mpMRI-targeted TRPB at our Academic Centre from January 2020 to December 2022. All patients followed a standardized, structured multistep pathway. Post-procedural complications were collected and classified according to the Clavien-Dindo (CD) Classification. Among 458 patients, post-procedural adverse events were reported by 203 (44.3%), of which 161 (35.2%) experienced CD grade 1 complications (hematuria [124, 27.1%], hematochezia [22, 4.8%], hematospermia [14, 3.1%], or a combination [20, 4.4%]), and 45 (9.0%) reported CD grade 2 complications (acute urinary retention or hematuria needing catheterization, as well as urinary tract infections, of which 2 cases required hospitalization). No major complications, including sepsis, were observed. At uni- and multivariable analysis, age > 70 years and BMI > 25 kg/ m2 for patients were identified as predictors of post-operative complications. The results of our study confirm that TRPB is a safe and cost-effective procedure with a low risk of severe adverse events in experienced hands and following a standardized pathway.

Hypertension in children with congenital anomalies of the kidney and urinary tract.

Congenital anomalies of the kidney and urinary tract (CAKUT) are the most common cause of childhood chronic kidney disease (CKD). We hypothesized that hypertension varies across CAKUT categories and increases the risk of CKD. This was a retrospective cohort study and included cases with a multicystic dysplastic kidney (MCDK, n = 81), unilateral kidney agenesis (UKA, n = 47), kidney hypoplasia (KH, n = 130), and posterior urethral valves (PUV, n = 75). Hypertension was defined as systolic or diastolic blood pressure ≥ 95th percentile for age, sex and height, and CKD as an estimated glomerular filtration rate < 60ml/min/1.73 m2, both at 2 consecutive clinic visits at least 3months apart. Sixty-two (19%) out of 333 cases developed hypertension, with significant difference according to CAKUT type. Patients with smaller kidney size (7.7 vs. 8.3, p = 0.045), kidney anomalies in addition to the primary diagnosis (aCAKUT) (53 vs. 38%, p = 0.03), proteinuria (46 vs. 12%, p < 0.001), and CKD (51 vs. 23%, p < 0.001) were more likely to develop hypertension. When adjusted for kidney size, the diagnoses of PUV (OR 10.9, 95%CI 3.0, 40.5), UKA (OR 6.4, 95%CI 1.6, 24.9) and KH (OR 4.2, 95%CI 1.1, 16.1), and aCAKUT (OR 2.1, 95%CI 1.2, 3.9) were independent risk factors for hypertension. Hypertension increased the risk of developing CKD by twofold (HR 1.9, 95%CI 1.19, 2.94). Hypertension is common in children with CAKUT and increases the risk of CKD. These findings will aid in the development of a standardized clinical pathway for the care of hypertensive children with CAKUT.

THU423 Recognizing Secondary Contributors Of Osteoporosis In A Hip Fracture Cohort In Singapore

Abstract Disclosure: W. Tay: None. T.Y. Donovan: None. Osteoporotic fractures pose a considerable burden on a country’s healthcare system. Identifying and managing secondary contributors is essential in optimizing the response to osteoporosis treatment. The reported prevalence of secondary osteoporosis is heterogeneous and maybe country-specific and recommendations on screening for these contributors in guidelines are variable. Knowing the frequency of underlying disorders can facilitate development of suitable and cost-effective recommendations specific to a population. We aimed to examine the prevalence of secondary contributors of osteoporosis in a multi-ethnic cohort of Singaporean women and men presenting with hip fracture and to also identify the extent of treatment gap. A retrospective cohort study of 493 consecutive adult patients admitted to a regional hospital in Singapore for a hip fracture were evaluated for secondary contributors. All patients were enrolled in a standard electronic hip fracture clinical pathway. Laboratory investigations were standardised. Deidentified data was extracted from the electronic health intelligence system (eHINTS) using the Oracle Business Intelligence and Enterprise Edition (OBIEE) software. The eHINTS is a data repository that consolidates healthcare, operational and finance data from multiple healthcare system uploaded on the web-based business intelligence software. Demographics, clinical data and laboratory investigations, bone mineral density and current medication were extracted. Approval was obtained from the centralized institutional board of our institution. The mean age of the cohort was 78 ±11 years. The majority (67.3%) of the cohort were female. Mean BMI was 22.3± 9.2 kg/m2. The mean T score at the lumbar spine was -1.87± 1.55; total hip -2.32±1.42; femoral neck -2.50 ± 1.28. 45.2% of the cohort had at least a secondary contributor of osteoporosis. 30.6% had vitamin deficiency (25OHD &amp;lt;20µg/L). 12.2% were on at least 1 medication implicated in the pathogenesis of osteoporosis such as aromatase inhibitors, glucocorticoids, anti-epileptics, levothyroxine, anti-depressants, warfarin, gonadotropin-releasing hormone (GnRH) therapy. 6.9% had primary hyperparathyroidism. 2.6% had primary hyperthyroidism. In male patients, 2.5% had hypogonadism. 1 patient had hypercalciuria. 13.6% had a BMD done prior to the hip fracture admission and only 11.8% of patients were on osteoporosis treatment prior to admission. Secondary contributors to osteoporosis are common and this should be considered in the evaluation of patients presenting with hip fractures. A significant treatment gap still exists and future studies should address the reasons behind the treatment inertia. Presentation: Thursday, June 15, 2023

Immunological effects and safety of live rotavirus vaccination after antenatal exposure to immunomodulatory biologic agents: a prospective cohort study from the Canadian Immunization Research Network.

People with inflammatory or autoimmune diseases are recommended to continue immunomodulatory biologic agents throughout pregnancy. However, concerns regarding potential immunosuppression in infants exposed to biologic agents have led to recommendations to avoid live vaccines in the first 6-12 months of life. We aimed to examine whether live rotavirus vaccine could be administered safely to infants exposed to biologic agents, assessed in the Canadian Special Immunization Clinic (SIC) Network. In this prospective cohort study, infants exposed to biologic agents in utero were referred to one of six SIC sites in Canada for rotavirus vaccination recommendations. Children with other contraindications to rotavirus vaccination or older than 15 weeks were excluded. Clinical and laboratory evaluations were conducted according to a standard clinical pathway. Data were collected for relevant medical history, pregnancy outcomes, biologic agent exposure history, physical examination, laboratory results of the child, SIC recommendations for rotavirus vaccination, rotavirus vaccine series completion, and adverse events after immunisation. After parental consent, deidentified data were transferred to a central database for analysis. Children recommended for rotavirus vaccination were followed up for 8 months after series initiation to ascertain severe and serious adverse events, including severe diarrhoea, vomiting, and intussusception. Between May 1, 2017, and Dec 31, 2021, 202 infants were assessed and 191 eligible infants were enrolled (97 [51%] were female and 94 [49%] were male). When including those exposed to multiple agents, the most common biologic agents to which infants were exposed were infliximab (67 [35%] of 191), adalimumab (49 [26%]), ustekinumab (18 [9%]), and vedolizumab (17 [9%]). Biologic agent exposure continued into the third trimester for 178 (93%) infants. No clinically significant abnormalities in lymphocyte subsets, quantitative immunoglobulins, or mitogen responses were detected. After SIC assessment, rotavirus vaccination was recommended for 187 (98%) of 191 infants, all of whom were followed up. By end of follow-up on Aug 19, 2022, 168 (90%) infants had initiated rotavirus vaccination; 150 (80%) completed the series. No serious adverse events after immunisation were reported, but three (2%) infants required medical attention, one for vomiting and change in stools who was subsequently diagnosed with gastroesophageal reflux disease, one for rash on labia unrelated to vaccination, and one for vomiting and diarrhoea associated with a milk allergy. Findings from this study suggest that lymphocyte subsets and the safety of live rotavirus vaccination are generally not affected by in-utero exposure to biologic agents. Rotavirus vaccination can be offered to infants exposed to anti-TNF agents in utero. Public Health Agency of Canada and Canadian Institutes of Health Research through the Canadian Immunization Research Network.

The Impact of an Emergency Department Bruising Pathway on Disparities in Child Abuse Evaluation.

Previous research has shown racial, ethnic, and socioeconomic disparities in provider medical evaluations and reporting to child protective services (CPS) and law enforcement (LE) for cases of suspected child physical abuse. Our hospital standardized evaluation and reporting of high-risk bruising using a clinical pathway. We aimed to assess whether standardization impacted disparity. We performed a retrospective observational study including children evaluated in the emergency department who had a social work consult for concern for child abuse or neglect between June 2012 and December 2019. From this group, we identified children with high-risk bruising. We compared outcomes (receipt of skeletal survey, CPS report, or LE report) before and after implementation of a standard bruising evaluation pathway to determine how the intervention changed practice among various racial, ethnic, and socioeconomic groups. During the study period, 2129 children presented to the ED and received a social work consult for child abuse or neglect. Of these, 333 had high-risk bruising. Children without private insurance had a higher risk of having a CPS (adjusted relative risk, 1.32; 95% confidence interval, 1.09-1.60) or LE (adjusted relative risk, 1.48; 95% confidence interval, 1.11-1.97) report prepathway, but not after pathway implementation. No significant associations were seen for race or ethnicity. A standardized clinical pathway for identification and evaluation of high-risk bruising may help to decrease socioeconomic disparities in reporting high-risk bruising. Larger studies are needed to fully evaluate disparities in assessment and reporting of child abuse.

Implementation of a standardized clinical pathway in a dedicated posterior urethral valves clinic: short-term outcomes.

To determine if the implementation of a posterior urethral valves (PUV) clinic and standardized management pathway improves the short-term kidney outcomes of infants with PUV. From 2016-2022, 50 consecutive patients were divided into groups after the implementation of the clinic (APUV, n = 29) and before (BPUV, n = 21) during a comparable timeframe. Assessed data included age at initial visit, timing and type of surgery, frequency of follow-up visits, medications, nadir creatinine, and development of CKD/kidney failure. Data are shown as median with interquartile range (IQR) and odds ratios (OR) with 95% confidence interval (CI). APUV had higher rates of prenatal diagnoses (12/29 vs. 1/21; p = 0.0037), earlier initial surgical intervention (8days; IQR 0, 105 vs. 33days; IQR 4, 603; p < 0.0001), and higher rates of primary diversions (10/29 vs. 0/21; p = 0.0028). Standardized management led to earlier initiation of alpha blockers (326days; IQR 6, 860 vs. 991; IQR 149, 1634; p = 0.0019) and anticholinergics(57days; IQR 3, 860 vs. 1283days; IQR 477, 1718; p < 0.0001). Nadir creatinine was reached at earlier ages in APUV (105days; IQR 2, 303 vs. 164days; IQR 21, 447; p = 0.0192 BPUV). One patient progressed to CKD5 in APUV compared to CKD3, CKD5 and one transplant in BPUV. Implementing the PUV clinic with standardized treatment expedited postnatal management and resulted in a higher number of cases detected prenatally, a shift in primary treatment, younger ages at initial treatment, reduced time to nadir creatinine, and timely initiation of supportive medications. A higher resolution version of the Graphical abstract is available as Supplementary information.

Advantages of routine next-generation sequencing over standard genetic testing in the amyotrophic lateral sclerosis clinic.

Next-generation sequencing has enhanced our understanding of amyotrophic lateral sclerosis (ALS) and its genetic epidemiology. Outside the research setting, testing is often restricted to those who report a family history. The aim of this study was to explore the added benefit of offering routine genetic testing to all patients in a regional ALS centre. C9ORF72 expansion testing and exome sequencing was offered to consecutive patients (150 with ALS and 12 with primary lateral sclerosis [PLS]) attending the Oxford Motor Neuron Disease Clinic within a defined time period. A total of 17 (11.3%) highly penetrant pathogenic variants in C9ORF72, SOD1, TARDBP, FUS and TBK1 were detected, of which 10 were also found through standard clinical genetic testing pathways. The systematic approach resulted in five additional diagnoses of a C9ORF72 expansion (number needed to test [NNT] = 28), and two further missense variants in TARDBP and SOD1 (NNT = 69). Additionally, 3 patients were found to carry pathogenic risk variants in NEK1, and 13 patients harboured common missense variants in CFAP410 and KIF5A, also associated with an increased risk of ALS. We report two novel non-coding loss-of-function splice variants in TBK1 and OPTN. No relevant variants were found in the PLS patients. Patients were offered double-blinded participation, but >80% requested disclosure of the results. This study provides evidence that expanding genetic testing to all patients with a clinical diagnosis of ALS enhances the potential for recruitment to clinical trials, but will have direct resource implications for genetic counselling.

Partner Involvement Reduces Postoperative Care Burden Following Penile Prosthesis Placement

To determine whether preoperative partner involvement at clinic appointments is associated with deviation from a standardized postoperative care pathway for patients undergoing an inflatable penile prosthesis placement. This is a retrospective study of 170 patients undergoing primary inflatable penile prosthesis placement performed by a single surgeon between 2017 and 2020. A standardized postoperative clinical pathway was used, including planned follow-up visits at 2 weeks (for wound check and device deflation) and 6 weeks (for device teaching). Patient characteristics, including demographics, partner involvement, and the number of follow-up visits were obtained from the medical record. Logistic regression modeling was performed to determine whether partner involvement was associated with unanticipated follow-up visits. Partners were involved in preoperative visits for 92 patients (54%). Additional unplanned follow-up visits were observed for 58 patients (34%) between 0 and 6 weeks and for 28 patients (16%) after 6 weeks from surgery. Partner involvement was associated with reduced odds of unanticipated follow-up visits, both between 0 and 6 weeks (odds ratios 0.37, 95% CI 0.18-0.75) and after 6 weeks (odds ratios 0.33, 95% CI 0.13-0.81) in adjusted models. Having a patient's partner involved during the preoperative period is associated with a significant reduction in unanticipated follow-up. We would recommend that urologists routinely encourage patients considering the insertion of a penile prosthesis to involve their partners in perioperative visits. Further research needed is needed to determine how to best support patients during surgical decision-making and through the postoperative period.

A standardized clinical pathway for hip fracture patients is associated with reduced mortality: data from the Norwegian Hip Fracture Register

Key summary pointsAimTo survey standardization of treatment in Norwegian hospitals and to investigate whether this affected 30-day mortality and quality of life after hip fracture surgery.FindingsOnly two out of three hospitals had a standardized clinical pathway for hip fracture patients. A standardized clinical pathway for hip fracture patients was associated with reduced 30-day mortality and higher functional level.MessageA standardized clinical pathway should be implemented at all hospitals treating hip fracture patients.

The ANZ hernia repair practices study: low consensus on inguinal and small ventral hernia management and infrequent long-term follow-up.

The ANZ hernia repair practices study: low consensus on inguinal and small ventral hernia management and infrequent long-term follow-up.

Standardizing the Diagnostic and Therapeutic Approach to Newly Diagnosed Children with ITP: Prospective Data from the ITP Consortium of North America (ICON) Quality Improvement Initiative

Background Pediatric immune thrombocytopenia (ITP) is an acquired autoimmune disorder which leads to a low platelet count and increased risk of bleeding. Despite published treatment guidelines, there is practice variation among clinicians and institutions due to the low grade of available evidence. The recommended management of newly diagnosed children at low risk of serious bleeding is observation; despite this, these patients are often treated with medication. These medications are only transiently effective with potential for side effects and excess lab monitoring as well as associated with increased costs and overuse of healthcare resources due to hospital admissions and encounters for medication-related side effects. Our objective is to report prospective data from a quality improvement (QI) project of the Pediatric ITP Consortium of North America (ICON) that was initiated in 2020 to improve consistency in clinical practice using national ITP guidelines. DESIGN/METHODS Within the ICON QI subcommittee, a standardized clinical care pathway for newly diagnosed childhood ITP was developed based on the American Society of Hematology (ASH) 2019 guidelines. Sites initially completed a retrospective analysis documenting the pre-QI pathway management of children, ages 1-16 years, diagnosed with ITP from January to December 2019. After local dissemination of the clinical care pathway, clinicians at all participating sites reviewed the pathway at the time of managing newly diagnosed children and completed a short survey documenting a modified Buchanan-Adix bleeding score and management decisions. Chart review was completed six months following ITP diagnosis to collect data regarding additional treatment or hospitalization. For retrospective data, total patients include those with available data. Results Retrospective data were collected from 7 centers for 205 patients managed for newly diagnosed ITP. In this pre-intervention cohort, 0.5% of patients (1/204) had a bleeding score documented at their initial visit. Most patients (63%,129/204) received initial medication treatment including intravenous immunoglobulin (54%), corticosteroids (9%), and anti-D/other (3%); 37% (75/204) were initially observed. In the 6 months after diagnosis, 11% (23/205) were admitted to the hospital for management of ITP. The ITP QI pathway was implemented prospectively in the care of 126 patients from 7 centers between November 2020 and July 2022. Of these patients,100% (126/126) had a bleeding score documented at their initial visit [Grade 0 (2%), Grade 1 (26%), Grade 2 (27%), Grade 3 (45%), Grade 4 (0%)]. Initial treatment included close observation in the majority (63%, 79/125) and medication treatment in 37% [corticosteroids (22%, 28/125) and IVIG/anti-D (14%, 18/125)] (Figure 1). Most patients were managed per the pathway according to their bleeding score (80%, 93/117). The most common reasons that providers deviated from the pathway were parent preference (50%, 12/24) and provider concern about bleeding risk (29%, 7/24). Of those with low level grade 3 bleeding, in whom the pathway suggested close observation, 62% (21/34) were observed and 38% of patients (13/34) were treated with medication (Figure 2). For patients with high level grade 3 bleeding, in whom the pathway suggested medication treatment, all patients except one were treated with medication. Of the 66 patients with 6 month follow up data, only 2 patients (3%, 2/66) were admitted to the hospital. DISCUSSION For children with newly diagnosed ITP and a platelet count <20 x 109/L who have no or mild bleeding, ASH guidelines suggest observation rather than treatment with corticosteroids. Implementation of an ITP clinical care pathway based on bleeding score led to an increase in the number of children observed. In contrast to the pre-intervention cohort, most patients treated with medication received corticosteroids rather than IVIG as per ASH guidelines. Despite the increase in patients managed with close observation, just 3% were admitted to the hospital within the first 6 months of diagnosis compared to 11% of the retrospective cohort. Our findings suggest that the use of a clinical care pathway based on objective assessment of bleeding symptoms increases management with close observation when indicated in the treatment of childhood ITP without a subsequent increase in hospitalization and increases adherence to national guidelines. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

Comparison of Clinical and Economic Outcomes of an Optimized Lean Versus a Standard Transcatheter Aortic Valve Implantation Program (from SOLAR [Safe Outcomes Lean And Resourceful] Study)

The increasing prevalence of aortic stenosis (AS) and the increasing number of patients indicated for transcatheter aortic valve implantation (TAVI) can lead to increased hospital constraints. This study aimed to compare, from the hospital perspective, the costs, resource use, and 30-day clinical outcomes of patients who underwent TAVI under an optimized or standard clinical pathway. A single-center, retrospective study was conducted among patients with native AS who underwent TAVI between January 2018 and March 2021. Patients who underwent optimized lean TAVI were propensity-score matched 1:1 to those who underwent standard TAVI. In-hospital costs and 30-day clinical outcomes were compared between the 2 groups. A total of 182 patients (91 in each group) were included in the final analysis. Baseline covariates were well balanced after matching. Patients who underwent lean TAVI had shorter length of stay (median [interquartile range] 3.0 days [2.0 to 6.0] vs 6.0 days [5.0 to 9.0], p <0.001). Patients in the lean TAVI group incurred lower total costs than did those in the standard TAVI group (mean ± SD: $41,346 ± 10,062 vs $50,471 ± 15,115, p=0.002). There was no between-group difference in 30-day all-cause mortality (2.2% vs 1.1%, p=0.573) and pacemaker implantations (5.5% vs 6.6%, p=0.788). Rates of procedural complications were comparable between groups. In conclusion, lean TAVI leads to hospital efficiencies without compromising patient safety. Efforts to streamline the TAVI procedure should be encouraged to improve access to TAVI for patients with AS, amid resource constraints.

ERAS guidelines-driven upper gastrointestinal contrast study after esophagectomy can detect delayed gastric conduit emptying and improve outcomes

BackgroundDelayed gastric conduit emptying can occur after esophagectomy and has been shown to be associated with increased risk for postoperative complications. Application of a standardized clinical protocol after esophagectomy including an upper gastrointestinal contrast study has the potential to improve postoperative outcomes.MethodsProspective cohort including all patients operated with esophagectomy at two high-volume centers for esophageal surgery. The standardized clinical protocol included an upper gastrointestinal contrast study on day 2 or 3 after surgery. All images were compiled and evaluated for the purpose of the study. Clinical data was collected in IRB approved institutional databases at the participating centers.ResultsThe study included 119 patients treated with esophagectomy of whom 112 (94.1%) completed an upper gastrointestinal contrast study. The results showed that 8 (7.1%) patients had radiological delayed gastric conduit emptying defined as no emptying of contrast through the pylorus. Partial conduit emptying was seen in 34 (30.4%) patients, and 70 (62.5%) patients had complete conduit emptying. Complete or partial emptying was associated with significantly earlier nasogastric tube removal (3 vs. 6 days) and hospital discharge 8 vs. 17 days, P < 0.001). Radiological signs of delayed gastric conduit emptying were shown to be associated with increased risk of postoperative complications. There was, however, no association with severe postoperative complications according to Clavien–Dindo score, pulmonary complications, anastomotic leak or need for intensive care.ConclusionThe results of the study demonstrate that postoperative upper gastrointestinal contrast studies can be used to assess the level of emptying of the gastric conduit after esophagectomy. Application of upper gastrointestinal contrast study in the ERAS guidelines-driven standardized clinical pathway after esophagectomy has the potential to improve postoperative outcomes.