Historical Control Cohort Research Articles

4R program results: What is the impact of 4R care delivery model on patient self-management and which patients benefited?

139 Background: We previously proposed a 4R model of teamwork and patient self-management (pSM) in cancer care (NCI ASCO Teams Project, Trosman JOP 2016). 4R (Right Info/Care/Patient/Time) enables patient and care team to manage complex care with an innovative 4R Care Sequence plan, including a novel visual feature describing timing and sequence of care. We report final results of a program which tested 4R at 5 safety net and 5 non safety net US centers from 2016 to 2019. Methods: Patients with stage 0-III breast cancer received 4R plans (4R Cohort). We surveyed 4R cohort and a historical control cohort of patients receiving care at same centers pre-4R. We assessed the usefulness of 4R to the 4R cohort and the impact on pSM in 4R cohort compared to historical cohort. Results: Survey response rates: 63%, 422/670 (4R cohort); 47%, 466/992 (control). 4R significantly increased the composite pSM score and 5 of 7 pSM metrics vs control (Table). The increase was not influenced by patient age, stage or whether treated at safety net site. pSM scores increased in 4R vs control cohort to a similar extent for patients < 65 years old (74% vs 51%, p = .0001) as for patients ≥ 65 years old (78% vs 57%, p = .0002). pSM improved similarly for patients with stage 0 or I breast cancer (77% vs 56%, p = .0001) as for patients with stage II or III breast cancer (72% vs 54%, p = .0001). Safety net patients showed pSM increase (77% vs 51%, p = .0001) similar to non safety net patients (74% vs 58%, p = .0002). Within the 4R cohort, 80% found 4R useful for organizing care and 70% found the novel visual feature useful to manage care timing and sequence. Usefulness was similar for age groups and stages, but higher for safety net than non safety net patients (88% vs 74%, p = .0008). Conclusions: 4R markedly improved patient self-management in early breast cancer across age groups and cancer stages, but further enhancements are needed to benefit as many patients as possible. 4R benefits in safety net setting indicate that 4R may reduce disparities. [Table: see text]

4R program results in breast cancer: The impact of 4R Care Delivery Model on timing and sequence of guideline recommended care.

15 Background: We previously proposed a 4R care delivery model which enables patients and care teams to manage timing and sequence of interdependent, time sensitive care with a novel multimodality 4R Care Sequence plan (NCI ASCO Teams Project; Trosman, JOP 2016). We report final results of a program which tested 4R at 10 US centers (4 academic and 6 non-academic) from 2016 to 2019. Methods: 4R Sequences were provided to stage 0-III breast cancer patients (4R cohort, N = 422) at participating centers. Analyses of clinical and patient-reported data compared the 4R cohort to a historical control cohort of patients who received care pre-4R at the same centers (N = 466). Results: We significantly improved 5 guideline recommended referral metrics and 4 referral completion metrics indicating receipt of care by patients who were referred (Table). Although significantly increased, referrals to dental visit and smoking cessation before treatment remained low (< 20% and < 10% respectively). Patient survey comments indicated that insufficient lead time to quit smoking or obtain fertility consult before cancer treatment was a key barrier for completing these referrals. Conclusions: 4R markedly improved referral and receipt of interdependent guideline recommended breast cancer care for most metrics. Future 4R program should optimize the timing of referrals within the 4R Care Sequence to allow sufficient time for smoking cessation and fertility care before treatment initiation. [Table: see text]

Treatment outcomes in patients with drug-resistant TB-HIV co-infection treated with bedaquiline and linezolid.

BACKGROUND: Bedaquiline (BDQ) has not been extensively studied among patients co-infected with HIV drug-resistant tuberculosis (DR-TB). We compared treatment outcomes in DR-TB patients treated with BDQ- and linezolid (LZD) containing regimens to historic controls treated with second-line injectable-containing regimens.METHODS: Retrospective cohort study of consecutive DR-TB patients initiated on BDQ- and LZD-containing regimens at a TB referral hospital in KwaZulu-Natal, South Africa. Participants were prospectively followed through 24 months for treatment outcome and adverse events. Outcomes were compared to a historic control cohort of DR-TB HIV patients enrolled at the same facility prior to BDQ introduction.RESULTS: Adult DR-TB patients initiating BDQ between January 2014 and November 2015 were enrolled (n = 151). The majority of patients were female (52%), HIV co-infected (77%) and on antiretroviral therapy (100%). End of treatment outcomes included cure (63%), TB culture conversion (83%), completion (0.7%), loss to follow-up (15%), treatment failure (5%), and death (17%). Compared to historic controls (n = 105), patients treated with BDQ experienced significantly higher TB culture conversion and cure, with significantly lower mortality. Adverse effects were common (92%), and most frequently attributed to LZD (24.1%). QT segment prolongation was common but without clinical sequelae.CONCLUSION: Treatment with BDQ- and LZD-containing regimens was associated with improved treatment outcomes and survival in DR-TB HIV patients.

Anakinra for severe forms of COVID-19 - Authors' reply.

Anakinra for severe forms of COVID-19 - Authors' reply.

Five-year Estimated Glomerular Filtration Rate in Patients With Hypoparathyroidism Treated With and Without rhPTH(1–84)

ContextChronic hypoparathyroidism (HypoPT) is conventionally managed with oral calcium and active vitamin D. Recombinant human parathyroid hormone (1–84) (rhPTH[1–84]) is a therapy targeting the pathophysiology of HypoPT by replacing parathyroid hormone.ObjectiveTo compare changes in the estimated glomerular filtration rate (eGFR) in patients with chronic HypoPT receiving or not receiving rhPTH(1–84) during a 5-year period.Design/SettingA retrospective analysis of patients with chronic HypoPT treated with or without rhPTH(1–84).PatientsSixty-nine patients with chronic HypoPT from 4 open-label, long-term trials (NCT00732615, NCT01268098, NCT01297309, and NCT02910466) composed the rhPTH(1–84) cohort and 53 patients with chronic HypoPT not receiving rhPTH(1–84) from the Geisinger Healthcare Database (01/2004–06/2016) composed the historical control cohort.InterventionsThe rhPTH(1–84) cohort (N = 69) received rhPTH(1–84) therapy; the historical control cohort (N = 53) did not receive rhPTH(1–84).Main Outcome MeasuresChanges in eGFR from baseline during a 5-year follow-up were examined in multivariate regression analyses.ResultsAt baseline, demographic characteristics and eGFR were similar between cohorts, though the proportions with diabetes and cardiac disorders were lower in the rhPTH(1–84) cohort. At the end of follow-up, mean eGFR increased by 2.8 mL/min/1.73 m2 in the rhPTH(1–84) cohort, while mean eGFR fell by 8.0 mL/min/1.73 m2 in the control cohort. In the adjusted model, the difference in the annual eGFR change between the rhPTH(1–84) cohort and the control cohort was 1.7 mL/min/1.73 m2 per year (P = 0.009).ConclusionsEstimated glomerular filtration rate was preserved for over 5 years among patients with chronic HypoPT receiving rhPTH(1–84) treatment, contrasting with an eGFR decline among those not receiving rhPTH(1–84).

Standardized Glycemic Management versus Conventional Glycemic Management and Postoperative Outcomes in Type 2 Diabetes Patients Undergoing Elective Surgery.

PurposeOptimized postoperative blood glucose control can minimize postoperative complications. Conventional perioperative glycemic control protocol (CG), which has been routinely used in our institution, lacks detailed perioperative glycemic management. A new standardized glycemic control protocol (SG) was designed which employs frequent postoperative monitoring of blood glucose, more tightly targeted blood glucose control, and adjustment of insulin dosage prior to surgery. This study compared the efficacy of postoperative glycemic control and complications with the two protocols, CG and SG.Patients and MethodsThree hundred and eighty type 2 diabetes patients who underwent elective surgeries were included in the study. Of those, 182 patients with CG were identified retrospectively as a historical control cohort. Additional 198 patients with SG were prospectively enrolled. Covariate imbalance was controlled using propensity score matching. Outcomes were evaluated using regression analysis clustered by type of surgery.ResultsThe SG group had lower mean levels of postoperative 24-hr blood glucose than the CG group (β =−8.6 mg/dL; 95% CI (−16.5 to −7.9), p=0.042). In SG group, the incidence of ICU admission and of acute kidney injury after surgery was lower than in the CG group (OR 0.36; 95% CI (0.18–0.74), p=0.005 and OR=0.59; 95% CI (0.41–0.85), p=0.005, respectively). There was no significant difference in postoperative hypoglycemia, infection, cardiovascular complications, stroke, or mortality rate between the two groups.ConclusionFor type 2 diabetes patients undergoing elective surgery, the SG protocol is more effective in controlling blood glucose. The protocol can also reduce the incidence of some postoperative complications compared to CG with no increased risk of hypoglycemia.

Preoperative nutrition-enhanced recovery after surgery protocol for thoracic neoplasms

ObjectivesBecause patients' preoperative nutritional status influences the outcomes, we have used a preoperative nutrition program for surgical patients for a 2-year period and compared the results with those from a cohort treated in the previous 2 years. MethodsWe retrospectively reviewed curative thoracic neoplasm resections from July 15, 2016, to July 15, 2018, in patients who had received a preoperative nutritional-enhanced recovery after surgery (N-ERAS) protocol. The protocol consisted of 5 days of an oral immunonutrition drink 3 times daily, daily receipt of probiotics, and a carbohydrate-loading drink the night before surgery. The historical control cohort (standard group) included those patients who had undergone surgery by the same surgeon during the previous 24 months. We excluded patients who had undergone esophageal, diagnostic, benign, emergency, or palliative procedures. Nonparametric and parametric statistical tests were used to analyze the data. ResultsThe data from 462 patients were analyzed: 229 N-ERAS patients and 233 standard patients. No significant demographic or caseload differences were found between the 2 groups. The major significant outcome differences included fewer postoperative complications (30 [13.1%] in the N-ERAS group vs 60 [25.8%] in the standard group; P < .001) and shorter hospital stays (3.8 ± 1.9 days for the N-ERAS group vs 4.4 ± 2.6 days for the standard group; P = .001). Use of the N-ERAS protocol resulted in a 16% reduction ($2198; P < .001) in the mean direct hospital costs/patient. Consequently, for the N-ERAS cohort, the hospital was likely saved $503,342 during the 2-year period for the 229 patients just by using the N-ERAS protocol. ConclusionsThoracic surgeons should consider using the nontoxic, patient-compliant N-ERAS protocol for their patients, with an expectation of improved clinical results at lower hospital costs—an important consideration when exploring methods to decrease costs because hospitals are increasingly being paid by a negotiated prospective bundled payment reimbursement model.

Introducing the "hip call" to facilitate early surgical treatment of hip fractures: A feasibility study.

Surgical treatment of hip fractures within 24-48hours decreases morbidity and mortality, but goals for early surgery have not been widely achieved so far. The primary aim of this study was to investigate the feasibility of implementation of a hip call, and the secondary aim was to investigate the effect of the hip call on time for pre-operative preparation and surgery compared to a historical control cohort. From March 4, 2019 until June 30, 2019, admission of patients at Copenhagen University Hospital, Bispebjerg, Denmark, with a suspected hip fracture triggered an acute hip call. Key personnel are summoned to secure rapid pre-operative preparation and surgery. The implementation was defined feasible, if≥75% of the patients were ready for surgery within 4hours and had surgery initiated within 24hours of hospital arrival. The historical control cohort was patients with hip fractures in the same period in 2018. A total of 128 patients were included in 2019, and 99 in 2018. After implementation of hip call, 83% of patients were ready for surgery within 4hours. After vs before hip call, 88% vs 51% were operated within 24hours and 96% vs 79% within 36hours. Time from admission to surgery (hh:mm) was reduced by mean 10:33 (CI 07:46-13:20), P<.001. The implementation of a hip call was feasible with 83% of patients being ready for surgery within 4hours, and 88% being operated within 24hours. Future large-scale studies should clarify potential benefits on clinical outcome.

Anakinra for severe forms of COVID-19: a cohort study.

SummaryBackgroundCoronaviruses can induce the production of interleukin (IL)-1β, IL-6, tumour necrosis factor, and other cytokines implicated in autoinflammatory disorders. It has been postulated that anakinra, a recombinant IL-1 receptor antagonist, might help to neutralise the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-related hyperinflammatory state, which is considered to be one cause of acute respiratory distress among patients with COVID-19. We aimed to assess the off-label use of anakinra in patients who were admitted to hospital for severe forms of COVID-19 with symptoms indicative of worsening respiratory function.MethodsThe Ana-COVID study included a prospective cohort from Groupe Hospitalier Paris Saint-Joseph (Paris, France) and a historical control cohort retrospectively selected from the Groupe Hospitalier Paris Saint-Joseph COVID cohort, which began on March 18, 2020. Patients were included in the prospective cohort if they were aged 18 years or older and admitted to Groupe Hospitalier Paris Saint-Joseph with severe COVID-19-related bilateral pneumonia on chest x-ray or lung CT scan. The other inclusion criteria were either laboratory-confirmed SARS-CoV-2 or typical lung infiltrates on a lung CT scan, and either an oxygen saturation of 93% or less under oxygen 6 L/min or more, or aggravation (saturation ≤93% under oxygen 3 L/min) with a loss of 3% of oxygen saturation in ambient air over the previous 24 h. The historical control group of patients had the same inclusion criteria. Patients in the anakinra group were treated with subcutaneous anakinra (100 mg twice a day for 72 h, then 100 mg daily for 7 days) as well as the standard treatments at the institution at the time. Patients in the historical group received standard treatments and supportive care. The main outcome was a composite of either admission to the intensive care unit (ICU) for invasive mechanical ventilation or death. The main analysis was done on an intention-to-treat basis (including all patients in the anakinra group who received at least one injection of anakinra).FindingsFrom March 24 to April 6, 2020, 52 consecutive patients were included in the anakinra group and 44 historical patients were identified in the Groupe Hospitalier Paris Saint-Joseph COVID cohort study. Admission to the ICU for invasive mechanical ventilation or death occurred in 13 (25%) patients in the anakinra group and 32 (73%) patients in the historical group (hazard ratio [HR] 0·22 [95% CI 0·11–0·41; p<0·0001). The treatment effect of anakinra remained significant in the multivariate analysis (HR 0·22 [95% CI 0·10–0·49]; p=0·0002). An increase in liver aminotransferases occurred in seven (13%) patients in the anakinra group and four (9%) patients in the historical group.InterpretationAnakinra reduced both need for invasive mechanical ventilation in the ICU and mortality among patients with severe forms of COVID-19, without serious side-effects. Confirmation of efficacy will require controlled trials.FundingGroupe Hospitalier Paris Saint-Joseph.

4R Care Delivery Program results: Impact of implementation metrics on patient self-management and 4R usefulness.

e14039 Background: We previously proposed a 4R care delivery model that facilitates teamwork and patient self-management (pSM) in cancer care (NCI ASCO Teams Project, Trosman JOP 2016). 4R (Right Info / Care / Patient / Time) enables patient and care team to manage complex care with an innovative 4R Care Sequence. We tested 4R at 10 US sites in a stepwise mode 2016-2019. Methods: Step 1 included 1 academic and 2 nonacademic sites; step 2 included 3 academic and 4 nonacademic sites. Patients with stage 0-III breast cancer received 4R Sequences (4R Cohort). We surveyed 4R and historical control cohorts of patients treated at the same sites pre-4R. We assessed the impact of implementation metrics on usefulness of 4R to the 4R cohort and on improvement of pSM in 4R cohort vs historical control cohort. Results: Survey response rates: 63%, 422/670 (4R cohort); 47%, 466/992 (control cohort). Three of the five implementation metrics significantly impacted patient usefulness of 4R (Table). Patients at step 2 sites; sites with a systematic care process; and sites with small practices reported significantly higher 4R usefulness than patients in the comparison subgroup within respective metrics. 4R usefulness was not affected by practice setting or availability of patient navigators. pSM was significantly improved between control and 4R cohorts along all implementation metrics (p &lt; .001), but the magnitude of incremental improvement between comparison subgroups varied across metrics (Table), with the largest increment associated with the program step metric. Conclusions: 4R is useful to patients across settings, with or without patient navigators. Stepwise design is effective in increasing 4R impact overtime. Future 4R Program will investigate an expanded array of implementation metrics and their influence on 4R outcomes. [Table: see text]

4R Program results: What is the impact of 4R care delivery model on patient self-management and which patients benefited?

e19211 Background: We previously proposed a 4R model of teamwork and patient self-management (pSM) in cancer care (NCI ASCO Teams Project, Trosman JOP 2016). 4R (Right Info / Care / Patient / Time) enables patient and care team to manage complex care with an innovative 4R Care Sequence plan, including a novel visual feature describing timing and sequence of care. We report final results of a program which tested 4R at 5 safety net and 5 non safety net US centers from 2016 to 2019. Methods: Patients with stage 0-III breast cancer received 4R plans (4R Cohort). We surveyed 4R cohort and a historical control cohort of patients receiving care at same centers pre-4R. We assessed the usefulness of 4R to the 4R cohort and the impact on pSM in 4R cohort compared to historical cohort. Results: Survey response rates: 63%, 422/670 (4R cohort); 47%, 466/992 (control). 4R significantly increased the composite pSM score and 5 of 7 pSM metrics vs control (Table). The increase was not influenced by patient age, stage or whether treated at safety net site. pSM scores increased in 4R vs control cohort to a similar extent for patients &lt; 65 years old (74% vs 51%, p = .0001) as for patients ≥ 65 years old (78% vs 57%, p = .0002). pSM improved similarly for patients with stage 0 or I breast cancer (77% vs 56%, p = .0001) as for patients with stage II or III breast cancer (72% vs 54%, p = .0001). Safety net patients showed pSM increase (77% vs 51%, p = .0001) similar to non safety net patients (74% vs 58%, p = .0002). Within the 4R cohort, 80% found 4R useful for organizing care and 70% found the novel visual feature useful to manage care timing and sequence. Usefulness was similar for age groups and stages, but higher for safety net than non safety net patients (88% vs 74%, p = .0008). Conclusions: 4R markedly improved patient self-management in early breast cancer across age groups and cancer stages, but further enhancements are needed to benefit as many patients as possible. 4R benefits in safety net setting indicate that 4R may reduce disparities. [Table: see text]

4R Program results in breast cancer: the impact of 4R Care Delivery Model on timing and sequence of guideline recommended care.

573 Background: We previously proposed a 4R care delivery model which enables patients and care teams to manage timing and sequence of interdependent, time sensitive care with a novel multimodality 4R Care Sequence plan (NCI ASCO Teams Project; Trosman, JOP 2016). We report final results of a program which tested 4R at 10 US centers (4 academic and 6 non-academic) from 2016 to 2019. Methods: 4R Sequences were provided to stage 0-III breast cancer patients (4R cohort, N = 422) at participating centers. Analyses of clinical and patient-reported data compared the 4R cohort to a historical control cohort of patients who received care pre-4R at the same centers (N = 466). Results: We significantly improved 5 guideline recommended referral metrics and 4 referral completion metrics indicating receipt of care by patients who were referred (Table). Although significantly increased, referrals to dental visit and smoking cessation before treatment remained low (&lt; 20% and &lt; 10% respectively). Patient survey comments indicated that insufficient lead time to quit smoking or obtain fertility consult before cancer treatment was a key barrier for completing these referrals. Conclusions: 4R markedly improved referral and receipt of interdependent guideline recommended breast cancer care for most metrics. Future 4R program should optimize the timing of referrals within the 4R Care Sequence to allow sufficient time for smoking cessation and fertility care before treatment initiation. [Table: see text]

Derivation and Validation of a Diagnostic Prediction Tool for Interstitial Lung Disease

Interstitial lung disease (ILD) results in high morbidity and health-care utilization. Diagnostic delays remain common and often occur in nonpulmonology settings. Screening for ILD in these settings has the potential to reduce diagnostic delays and improve patient outcomes. This study sought to determine whether a pulmonary function test (PFT)-derived diagnostic prediction tool (ILD-Screen) could accurately identify incident ILD cases in patients undergoing PFT in nonpulmonology settings. Clinical and physiologic PFT variables predictive of ILD were identified by using iterative multivariable logistic regression models. ILD status was determined by using a multi-reader approach. An ILD-Screen score was generated by using final regression model coefficients, with a score≥ 8 considered positive. ILD-Screen test performance was validated in an independent external cohort and applied prospectively to PFTs over 1 year to identify incident ILD cases at our institution. Variables comprising the ILD-Screen were age, height, total lung capacity, FEV1, diffusion capacity, and PFT indication. The ILD-Screen showed consistent test performance across cohorts, with a sensitivity of 0.79 and a specificity of 0.83 when applied prospectively. A positive ILD-Screen strongly predicted ILD (OR, 18.6; 95%CI, 9.4-36.9) and outperformed common ILD clinical features, including cough, dyspnea, lung crackles, and restrictive lung physiology. Prospective ILD-Screen application resulted in a higher proportion of patients undergoing chest CT imaging compared with a historical control cohort (74%vs56%, respectively; P= .003), with a significantly shorter median time to chest CT imaging (5.6 vs21.1months; P< .001). The ILD-Screen showed good test performance in predicting ILD across diverse geographic settings and when applied prospectively. Systematic ILD-Screen application has the potential to reduce diagnostic delays and facilitate earlier intervention in patients with ILD.

A rapid monitoring plan following a shift in coverage from brand name to biosimilar drugs for rheumatoid arthritis in British Columbia.

To describe a rapid monitoring plan to assess the impacts of a shift in drug coverage for biosimilar drugs in British Columbia following the introduction of a new policy on 27 May 2019. The Biosimilars Initiative requires users of originator infliximab or etanercept to switch to biosimilar versions of those drugs to maintain coverage. We propose a signal-detection method to provide near-real-time information to policymakers on the impacts of the policy change. The exposure will be the Biosimilars Initiative, a policy affecting patients using originator infliximab (Remicade) and etanercept (Enbrel) for approved rheumatologic or dermatologic indications. Two policy cohorts and six historical control cohorts of patients using originator infliximab or etanercept will be assembled using linked and de-identified data from the British Columbia Ministry of Health. Patients will be identified during the 6-month period before the policy anniversary. Outcomes will include medication refills and switching, hospital admissions, emergency department visits, and physician visits. Summary outcome measures, such as cumulative incidence or average quantity as applicable, will be examined daily and reported monthly for 1 year. Outcomes in the policy cohorts will be compared with historical controls using likelihood ratios. The results of this rapid monitoring plan will be based on analyses involving approximately 9000 patients: four infliximab cohorts of approximately 430 patients and four etanercept cohorts of approximately 1800 patients. Rapid monitoring results will inform ongoing policy decisions related to the Biosimilars Initiative, in terms of impacts on both patient health and health services utilization.

Changes in labor outcomes after implementing structured use of oxytocin augmentation with a 4-hour action line

Introduction Oxytocin augmentation is essential in labor management, but how to optimize its use is still debated. Joint international guidelines regarding prolonged labor and the use of oxytocin augmentation are still not available. Due to its potential harmful side effects, a decreased use of oxytocin is encouraged. We aimed to implement a structured protocol on the use of oxytocin augmentation and to observe changes in labor outcomes. Materials and methods The protocol was implemented at the Obstetric Department of Sørlandet Hospital, Kristiansand, Norway on 1 January 2012; therefore, data from the hospital were collected prospectively and compared for two time-period cohorts: the historic control cohort (2009–2010) and the study period cohort (2012–2013). The structured protocol instructs, and restricts, the birth attendants to diagnose prolonged labor, by protocol definition only, before commencing oxytocin infusion for augmentation. Nulliparous women with singleton, term deliveries (≥37 weeks), cephalic presentation, and spontaneous onset of labor (Ten-Group Classification System (TGCS) group 1) were included in the analysis. The main outcome was use of oxytocin augmentation. Results The study cohort and control cohort comprised 1103 (26.2%) and 1399 (33.1%) of all laboring women, respectively (p < .01). The protocol was followed satisfactorily in 78% of the study cohort. The use of oxytocin augmentation was reduced in the study cohort versus the control cohort; 41.3 versus 48.9% (p < .01); mean oxytocin infusion duration was shorter (100 versus 123 min; p < .01); and mean total oxytocin dose decreased (1009 versus 1293 mU; p < .01). The cesarean section rate was 5.9% in the study cohort versus 8.0% in the control cohort (p = .04). The estimated mean duration of the active phase of labor increased by 47 min (p < .01) after the implementation. The frequency of estimated postpartum hemorrhage >1000 ml was higher, 4.9 versus 2.0% (p < .01), but the use of blood transfusions remained stable, 2.5 versus 2.7% (p = .78), the study cohort versus control cohort, respectively. Conclusions Implementation of a protocol of structured use of oxytocin augmentation reduced the frequency, dosage, and duration of oxytocin without increasing the cesarean section rate in TGCS group 1.

Individualized clinical management of patients at risk for Alzheimer's dementia

IntroductionMultidomain intervention for Alzheimer's disease (AD) risk reduction is an emerging therapeutic paradigm. MethodsPatients were prescribed individually tailored interventions (education/pharmacologic/nonpharmacologic) and rated on compliance. Normal cognition/subjective cognitive decline/preclinical AD was classified as Prevention. Mild cognitive impairment due to AD/mild-AD was classified as Early Treatment. Change from baseline to 18 months on the modified Alzheimer's Prevention Cognitive Composite (primary outcome) was compared against matched historical control cohorts. Cognitive aging composite (CogAging), AD/cardiovascular risk scales, and serum biomarkers were secondary outcomes. ResultsOne hundred seventy-four were assigned interventions (age 25–86). Higher-compliance Prevention improved more than both historical cohorts (P = .0012, P < .0001). Lower-compliance Prevention also improved more than both historical cohorts (P = .0088, P < .0055). Higher-compliance Early Treatment improved more than lower compliance (P = .0007). Higher-compliance Early Treatment improved more than historical cohorts (P < .0001, P = .0428). Lower-compliance Early Treatment did not differ (P = .9820, P = .1115). Similar effects occurred for CogAging. AD/cardiovascular risk scales and serum biomarkers improved. DiscussionIndividualized multidomain interventions may improve cognition and reduce AD/cardiovascular risk scores in patients at-risk for AD dementia.

A standardized technique of laparoscopic placement of peritoneal dialysis catheter with omentectomy and closure of patent processus vaginalis: A 3-in-1 minimally invasive surgical approach in children

BackgroundOmental wrapping is a common cause for catheter failure in children on peritoneal dialysis (PD). Previous studies are conflicting in the benefits of omentectomy. MethodsWe conducted a retrospective study comparing children who underwent PD catheter placement by a standardized laparoscopic three-in-one technique (lap3-in-1) from 2013 to 2018 versus a historical control cohort by open surgery without omentectomy. Lap3-in-1technique combined catheter placement with well-defined indication and extent of omentectomy, and closure of any patent processus vaginalis (PPV). ResultsThere were 33 and 32 children in the lap3-in-1 and control cohorts respectively. 4/33(12.1%) in lap3-in-1 had reoperations for catheter failures which equated 1 reoperation per 144 catheter months. No reoperations were performed in lap3-in-1 cohort for omental wrapping or inguinal hernia, compared with 13/32 (41%; p < 0.001) and 5/32 (16%; p = 0.02) in the control cohort. Kaplan Meier survival curves showed significantly longer catheter life in the lap3-in-1 cohort (p < 0.001). In multivariate analysis by the COX proportional hazards model, the lap3-in-1 approach had significantly reduced risk of reoperation for catheter failure (HR 0.11; 95% CI: 0.04–0.31; p < 0.001). ConclusionsThe lap3-in-1 technique is effective in selecting those children who would benefit from omentectomy, and avoiding a second operation for inguinal hernia which develops after PD. Level of evidenceTreatment study, level III

LB5. A Long-Time Coming: Final 2-year Analysis of Efficacy, Durability, and Microbiome Changes in a Controlled Open-Label Trial of Investigational Microbiota-Based Drug RBX2660 for Recurrent Clostridioides difficile Infections

BackgroundRecurrent Clostridioides difficile infection (rCDI) is an urgent public health threat associated with significant mortality and medical cost. Microbiota therapy is gaining acceptance as a strategy to reduce rCDI recurrence. We present the final 24-month analysis of clinical safety, efficacy, and microbiome restoration from a Phase 2 open-label trial of RBX2660 for prevention of CDI recurrence.MethodsParticipants with multi-recurrent CDI received <2 doses of RBX2660 delivered via enema 7 days apart in this multicenter, open-label Phase 2 study. Efficacy was defined as the absence of CDI recurrence through 56 days after the last dose and was compared with 8-week recurrence-free rates for a historical control cohort that received standard-of-care antibiotic therapy. Fisher exact test compared the proportion of treatment participants who were CDI-free by age and sex. Durability was defined as continued absence of CDI episodes beyond 8 weeks. Safety and durability assessments occurred at 3, 6, 12, and 24 months. Participant stool samples were collected prior to and for up to 720 days after treatment, and microbiome changes were assessed by shallow shotgun sequencing.ResultsThe efficacy of RBX2660 to prevent rCDI at 8 weeks (78.9%; 112/142) was higher than the CDI-free rate in the historical control group (30.7%, 23/75; P < 0.0001). Age and sex did not impact efficacy. Among participants who achieved treatment success at 8 weeks and were evaluable for long-term durability (n = 95), 8 experienced a new CDI episode by the 24-month follow-up for an overall durability of 91.6%. The safety profile was consistent with previous reports for RBX2660. In total, 503 stool samples from 110 treatment responders were analyzed. Within 7 days of treatment, the relative abundance of Bacteroidia and Clostridia remained shifted higher than pre-treatment levels while Gammaproteobacteria and Bacilli declined sharply after treatment, and these changes persisted to at least 24 months.ConclusionRBX2660, a microbiota-based drug, was safe and efficacious for preventing rCDI with clinical durability to 24 months after treatment, independent of age or sex, and RBX2660 durability associated with durable microbiome shifts from pre-treatment to a healthier composition. DisclosuresRobert Orenstein, DO, Rebiotix Inc. (Advisor or Review Panel member), Sarah Mische, PhD, Rebiotix Inc. (Employee), Ken Blount, PhD, Rebiotix Inc. (Employee), Lindy Bancke, PharmD, Rebiotix Inc. (Employee), Xin Su, MD, MSci, Rebiotix Inc. (Employee), Dana Walsh, PhD, Rebiotix Inc. (Employee), Adam Harvey, PhD, Rebiotix Inc. (Employee), Carlos Gonzalez, MS, Rebiotix Inc. (Consultant), Dale N. Gerding, MD, Rebiotix Inc. (Board Member).

Enhanced recovery after surgery (ERAS) protocol reduces perioperative narcotic requirement and length of stay in patients undergoing mastectomy with implant-based reconstruction

IntroductionEnhanced Recovery after Surgery (ERAS) protocols have contributed to shortened hospital stays and reduced narcotic use after common surgical procedures. Though ERAS protocols exist for breast surgery, they have not been studied for implant-based reconstruction after mastectomy. MethodsTwenty-three consecutive patients undergoing mastectomy with implant-based reconstruction were treated with perioperative gabapentin, acetaminophen, and NSAIDs. Data regarding clinical course and medication requirement were compared to a historical control cohort (n = 23) receiving usual care after mastectomy. Opioid analgesics were converted to oral morphine equivalents (OMEs) for comparison between groups. ResultsPatients treated with the ERAS protocol required significantly fewer narcotics as measured in OMEs over postoperative days 0–2. Patient reported pain scores were equivalent between groups, as were postoperative complication rates of nausea, hematoma, and infection. Additionally, ERAS patients had significantly shorter mean length of hospital stay (1.3 vs. 2.5 days, p = 0.037). ConclusionsPatients receiving perioperative gabapentin, acetaminophen, and NSAIDs under an ERAS protocol required significantly fewer narcotics and shorter length of stay. This protocol may merit consideration for use at other centers.

New Concept Air Conditioning System for the Operating Room to Minimize Patient Cooling and Surgeon Heating: A Historical Control Cohort Study

BackgroundIntraoperative hypothermia is a common adverse event. For avoiding the complication due to hypothermia, many warming devices and methods have been used in perioperative period. It has been reported that more patients undergoing laparoscopic surgery tend to have hypothermia than with open surgery. To avoid intraoperative hypothermia, many kinds of warming tools have been used. But, it was also reported that some warming methods increased perceptions of distraction and physical demand.MethodsTo achieve both patients’ normothermia and surgeons’ comfort, new air conditioning (AC) system was designed with considering the characteristics of laparoscopic surgery. The temperature of the airflows to the patient and to the surgeons can be adjusted independently in this new system. The new system has two parts. One controls the temperature of the central area over the operation table. The air from this part falls on the patients. The other part is the lateral area beside the operating table; the air from this part falls on the surgeons. The subjects of this study were 160 gastric cancer patients and 316 colorectal cancer patients undergoing laparoscopic surgery. The temperature of the central flow was set 23.5 °C, and the temperature of the lateral flow was set 22 °C just after the anesthesia. The number of timepoints the patient spent in hypothermic state, defined as a temperature cooler by 0.5 °C or more than that at the starting point of surgery, was determined in each patient.ResultsIn the results, the rate of hypothermic state in old operation rooms was 23.8% and that in new operation rooms was 2.7% in male gastric cancer patients (p < 0.01). And those were 37.1% in old operation rooms and 0.9% in new operation rooms in female gastric cancer patients (p < 0.01). The rate of hypothermic state in old operation rooms was 30.0% and that in new operation rooms was 9.5% in male colorectal cancer patients (p < 0.01). And those were 41.6% in old operation rooms and 8.9% in new operation rooms in female colorectal cancer patients (p < 0.01). The similar results were showed in the study, which subjects were limited the patients undergoing surgery in 2015 and 2016; which were the last year the old operation rooms were used and the first year the new operation rooms were used.ConclusionsThus, the usefulness of the new air conditioning system for achieving both patients’ normothermia and comfort of surgeons could be verified in this study.