Non-compliant Group Research Articles

Risk factors for surgical compliance and impact on the survival of patients with glioma: a population-based propensity score-matched study.

To comprehensively analyze the impact of surgical compliance on the survival of patients with glioma and to explore the factors that influence surgical compliance. Clinical data of patients with glioma between 2004 and 2018 were collected from the Surveillance, Epidemiology, and End Results (SEER) database. Kaplan-Meier curves and Cox regression were used to analyze the effect of surgical compliance on overall survival (OS) and disease-specific survival (DSS). Multivariate Cox regression was used to select the prediction variables and construct the nomograms. The predictive power of these models was assessed using Harell's consistency index (C-index), decision curve analysis (DCA), receiver operating characteristic (ROC) curves, and calibration curves. Multivariate logistic regression was performed to analyze the related variables of surgical compliance, and 1:1 propensity score matching (PSM) was applied to evaluate the validity of the results of patients with favorable and poor surgical compliance. Among the 47,573 eligible glioma patients recommended for surgery, 46,380 (97.5%) were in the surgical compliance group, while 1193 (2.5%) were in the noncompliance group. Surgical compliance was an independent prognostic factor for glioma patients, as indicated by multivariate Cox regression analysis that patients with surgical compliance had worse OS (hazard ratio [HR] 1.924; 95% confidence interval [CI] 1.800-2.056, p < 0.001) and DSS (HR 1.718; 95% CI 1.592-1.853, p < 0.001) in comparison to those without surgical compliance. A nomogram was developed and internally validated to be able to predict glioma prognosis. The nomogram can well predict patients' OS (C-index: 0.745) and DSS (C-index: 0.744). ROC curve, DCA curve, and calibration curve were applied to further assess the accuracy of the nomogram. Poor surgical compliance was found to be related to older age, female gender, tumor diameter, grade II or higher, poor grading, tumor location in the cerebellum and brainstem, and low household income. Surgical compliance is an independent prognostic factor for predicting the OS and DSS of patients with glioma, and good surgical compliance was significantly related to good survival.

IRB 지속심사와 연구 미준수 연관성 분석

The continuing review of ongoing research approved by the Institutional Review Boards(IRB) is one of the ways to protect human subjects. Though the approval expiration date for new tasks depends on the risk assessment of said task, it is generally limited by law not to exceed a maximum of one year. Continuing review is required to extend the approval expiration date. Through continuing review, the IRB determines whether the research is conducted under the approved protocol, whether any side effects were reported timely, and whether the risk-to-benefit ratio remains favorable. This research used 784 cases of data reviewed by the C University Hospital's clinical research support system from 2019 to 2021 in a retrospective matter and analyzed the characteristics of research and researchers in non-compliance and compliance groups, and types of non-compliances, finding significant differences. Non-compliance groups were highly frequent in investigator initiated trials(IIT), non-clinical trials, and studies without clinical research coordinators, while compliance groups were more frequent in sponsor initiated trials(SIT), studies with co-investigator, and studies with clinical research coordinators. In addition, after analyzing the types of non-compliance, the non-compliance with the IRB reporting and non-compliance with the consent process were high in non-compliance groups. Therefore, we analyzed the relationship between non-compliance and compliance groups in continuing review to find a way to contribute for the ultimate purpose of IRB, protection of human subjects.

Role of compliance to dietary and physical activity recommendations for better quality of life in patients with chronic heart failure

Abstract Funding Acknowledgements Type of funding sources: Public Institution(s). Main funding source(s): Medical University of Varna, fund Science Background Diet and physical activity are important non-pharmacological determinants for the prognosis in patients with chronic heart failure (HF). The role of nurse in patient education and follow-up of these factors is of paramount importance for improvement the quality of life. Aim to determine the effect of adherence to life style recommendations for the better quality of life of patients in ambulatory HF program. Participants and methods: Overall, 72 patients with HF were included in a structured ambulatory program after hospital discharge, with the active participation of a nurse in it. After a 6-month follow-up, 61 finished the program. All patients were educated at the beginning and at the follow-up visits for their appropriate diet and physical activity by the health care practitioner. The adherence to the above mentioned life style measures was evaluated by asking the participants whether the follow the given recommendations. Quality of life was assessed by the change in NYHA class, 6-minute walking test (6MWT) distance, questionnaires (KCCQ, EQ-5) and self-assessment by visual analogue scale. For continuous variables, t-test and Mann-Whitney test was used depending on the normality of the distribution. For categorical variables, chi-square or Fisher’s exact test were applied where appropriate. Logistic regression was used to test the effect of adherence to advices for life- style parameters. Results There was no difference in age and sex distribution between the compliant (C) and non-compliant (NC) group (Table 1). All patients were medically treated according to the current guidelines. There was significant improvement in the functional capacity in adherent to treatment patients. The increase in 6MWT (Table 1) was on average 39.16 m more in the compliant group (p = 0.016). You have 6 times higher chance to improve your 6MWT performance if you are compliant – OR 6 (95%CI 1.02-31.11, p = 0.047). There was also slightly better improvement in NYHA class – mean change 0.9 vs 0.7, p = NS. The quality of life was also improved more significantly in the C than in NC group (Table 1). Clinically meaningful improvement in overall summary score (OSS) &amp;gt;5 points was observed in 92% in C vs 64% in NC (p = 0.0.029) and moderate to large improvement &amp;gt;10 points – in 82% vs 54.5% (p = 0.05). There was also a trend to better anxiety and depression attitudes at the end of the 6 months in the C than in NC patients. Conclusions The adherence to diet and physical activity advices improves the physical capacity and the quality of life in patients with HF even just after 6 months. In this respect, the role of the health care practitioner is of invaluable importance to promote the life style changes. This includes education and proper ambulatory follow-up by a trained nurse.Table 1

Abstract 14: Barriers to Effective Safe Handling of Chemotherapeutic Drugs Among Healthcare Workers in Vietnam: Needs Assessment by Electronic Survey

Abstract Purpose: To identify barriers and facilitators of effective safe handling of chemotherapeutic drugs among healthcare workers in hospitals across Vietnam. Methods: We used Qualtrics to design a 45-question structured questionnaire in English and Vietnamese survey to assess the safe handling of chemotherapeutic drugs. This questionnaire was distributed as an anonymous online survey through the e-mail listserv of the Vietnam Pediatric Oncology Association in August 2022. Survey instruments included years of practice, types of prior training, knowledge, personal practice, and organizational factors. Respondents were asked whether they used specific personal protective equipment (PPE) in the steps of preparation, administration, and disposal of chemotherapeutic drugs. Results: The survey was distributed to 310 healthcare workers at 14 children’s hospitals. Sixty-two healthcare workers from 13 hospitals completed the survey (response rate 20%). Among those who completed the survey, diverse occupations were represented (39 nurses, 21 physicians, and 2 pharmacists). Forty-six had received prior training in the safe handling of chemotherapeutic drugs, and 25 had longer than ten years of practice. Forty-two workers reported involvement in the administration of chemotherapy, and 17 reported wearing chemotherapy gloves (compliant group) while 25 wore other types of gloves or no gloves at all (non-compliant group). Thirty-six workers (86%) reported the availability of chemotherapy gloves, and 38 (90%) were aware that not all gloves provide the same level of protection. In the compliant group, 71% (n = 12) were aware of institutional policies at their workplaces, while only 36% of the non-compliant group (n = 9) reported awareness of the institutional policies. When stratified according to the availability of institutional policy, long years of practice were more common in the compliant group. Conclusion: Overall, respondents reported having supplies of gloves and knowledge of glove use. Those who used chemotherapy gloves were generally aware of institutional policies and had longer years of practice. The next step will involve reviewing institutional policy at each institution and studying how long years of practice influence the practice of safe handling. Citation Format: Cham Nguyen, Linda Abramovitz, Kim Lien Nguyen, Bao Truong, Michelle Hermiston. Barriers to Effective Safe Handling of Chemotherapeutic Drugs Among Healthcare Workers in Vietnam: Needs Assessment by Electronic Survey [abstract]. In: Proceedings of the 11th Annual Symposium on Global Cancer Research; Closing the Research-to-Implementation Gap; 2023 Apr 4-6. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2023;32(6_Suppl):Abstract nr 14.

Poor Adherence to Self-Applied Topical Drug Treatment Is a Common Source of Low Lesion Clearance in Patients with Actinic Keratosis-A Cross-Sectional Study.

Many treatments for actinic keratosis (AK) have been proven efficient in clinical trials. However, patients with AK may still experience unsatisfactory therapeutic outcomes in clinical practice. To investigate patient adherence to self-applied topical interventions for AK and to explore factors associated with adherence in a real-world setting. A cross-sectional study was conducted. Patients presenting with AK were asked to complete a self-administered questionnaire about their last topical AK treatment. A total of 113 patients participated with a median age of 78.5 years (range 58-94). Fifty-four patients (47.8%) received topical diclofenac, ten (8.8%) imiquimod, nine (8%) 5-fluorouracil, nine (8%) 5-fluorouracil plus salicylic acid, and eight (7.1%) photodynamic therapy. The non-adherence rate was 46.9% (n = 53), and only 30.9% (n = 35) used the topical treatments according to the summary of product characteristics (SmPC). These subgroups were compared. Patients of the non-compliant group were significantly less informed about the application time of the specific topical intervention (p = 0.002) and adjusted the timeframe (p < 0.001) and application frequency of the therapy (p = 0.02) independently of their physician. Conversely, patients reporting a sufficient pre-treatment consultation (p = 0.019) generally complied with the SmPC compliance application. A thorough pre-treatment consultation can help to increase treatment adherence and ensure lesion clearance.

Effects of the ABC pathway on clinical outcomes in a secondary prevention population of Chinese patients with atrial fibrillation: A report from the Optimal Thromboprophylaxis in Elderly Chinese Patients with Atrial Fibrillation (ChiOTEAF) registry.

The atrial fibrillation better care (ABC) pathway is a simple, comprehensive framework that facilitates provision of integrated care for atrial fibrillation (AF) patients. We evaluated management of AF patients in a secondary prevention cohort using the ABC pathway and examined the impact of ABC adherence on clinical outcomes. The Chinese Patients with Atrial Fibrillation registry is a prospective registry conducted in 44 sites across China between October 2014 and December 2018. The primary outcome was the composite of all-cause mortality/any thromboembolism (TE), all-cause death, any TE and major bleeding at 1 year. Of the 6420 patients, 1588 (24.7%) had a prior stroke or transient ischemic attack and were identified as the secondary prevention cohort. After excluding 793 patients due to insufficient data, 358 (22.5%) were ABC compliant and 437 (27.5%) ABC noncompliant. ABC adherence was associated with a significantly lower risk of the composite outcome of all-cause death/TE, odds ratio (OR) 0.28 (95% confidence interval [CI]: 0.11-0.71) and all-cause death, OR 0.29 (95% CI: 0.09-0.90). Significant differences were not observed for TE, OR 0.27 (95% CI: 0.06-1.27) and major bleeding, OR 2.09 (95% CI: 0.55-7.97). Age and prior major bleeding were significant predictors of ABC noncompliance. Health-related quality of life (QOL) was higher in the ABC compliant group versus the noncompliant group (EQ score 0.83 ± 0.17 vs. 0.78 ± 0.20; p = .004). ABC pathway adherence in secondary prevention AF patients was associated with a significantly lower risk of the composite outcome of all-cause death/TE and all-cause death, as well as better health-related QOL.

OUTCOME OF DEVELOPMENTAL THERAPY IN CHILDREN WITH CEREBRAL PALSY CHILDREN: A PROSPECTIVE COHORT

Introduction: Cerebral palsy (CP) is the non-progressive disorder of motor and posture with associated delayed development in areas of cognition, perception, behavior and sensation, due to insult to immature brain. Improvement in all developmental domains of CP patients depends upon early institution of rehabilitation programs involving all multidisciplinary approach. The portage early education program (PEEP) is a worldwide, effective and early interventional method, for developmentally delayed children. Objective: To determine the outcome of developmental therapy in children with CP by using PEEP. Study Design: Experimental research design (within group) Settings: The children hospital and the institute of child health Multan. Methodology: 156 patients of 2 to 10 years of age, both gender from January 2020 to December 2020, diagnosed as CP were enrolled for this study. All children were assessed by using PEEP and GMFM (Gross Motor Function Measure) twice 6 months apart. A trained clinical psychologist administered PEEP to all the children. All the Patients were advised regular weekly sessions at hospital by multidisciplinary team and at least 2 hours per day for continuation of these therapies at home. At the end of 6 months we found that all families had not followed this. The patient who visited &gt;2times/month were considered compliant and those visited &lt;2times/month were considered non-compliant. Data was analyzed by using SSPS version 16. Paired t test was used to compare the developmental outcome of compliant and non-compliant groups. Results: Out of 156 participants, 58(37%) were in compliant and 98(63%) non-compliant. Male subjects were prominent 42(72.41%) and 67(68.37%) respectively. Most of the participants belonged to 3-6 years of age in both groups28(48.29%) and 51(52.04%) respectively. Spastic quadriplegia (26(44.83%), 57 (58.16%)), and level 5 on GMFM 24(42.86) and 52(53.06%) respectively was commonly presents in both patient groups. The mean comparison of DQ of Compliant CP Children at initial stage and after six months in areas of GM, C, SH, S, L and GMFM was found statistically significant. Conclusion: CP children should be on regular follow up for developmental therapy for long time for better outcome. PEEP is an excellent system for the assessment, training and rehabilitation of children with delayed development.

Correlation between a Compliance of Using Double-Gloving Bundle during Endotracheal Intubation and the Surgical Site Infection

Background: Surgical site infections (SSI) represent severe postoperative adverse events. Contamination of operating room (OR) environment with oral bacteria and bloodborne pathogens poses an additional risk of infection. Studies have demonstrated that anesthesia providers’ use of double-gloving care bundle reduce operating room contamination as intubator wears two sets of gloves, sheaths the laryngoscope blade after use with endotracheal tube packaging and removes the outer glove after intubation. Materials and Methods: The authors conducted a prospective, single-center quality improvement project to increase anesthesia provider compliance with a double-gloving care bundle between January and December 2019. The primary measure was the percentage of anesthesia providers’ compliance with the double-gloving care bundle as compared to baseline. The secondary measure was the correlation between compliance with the use of the double-gloving bundle and SSIs. Results: The authors assessed 307 surgeries with 280 that had adequate data for analyses. The initial compliance rate was 38% before the quality improvement initiative. There was no change in the median compliance rate following the initiative. There was no difference in demographic data between the compliance and the non-compliance providers. Three patients (1.07%) developed SSIs, one patient in compliance group and two patients in the non-compliance group. There was no correlation between double-glove care bundle compliance and SSIs. Conclusion: The present study quality improvement initiative study did not increase anesthesia providers’ compliance with the double-gloving care bundle. There was no correlation between compliance and SSIs due to small sample size. However, double-gloving and laryngoscope sheathing by anesthesia providers do improve the standard of care and reduce contamination in the operating room setting. We will continue efforts to increase compliance. Keywords: Double-gloving; Laryngoscope sheathing; Surgical site infection; Anesthesia provider; Operating room contamination

Comparison of the Effectiveness of Liposuction for Lower Limb versus Upper Limb Lymphedema

Liposuction is the most frequently performed debulking procedure in patients with lymphedema. However, it remains uncertain whether liposuction is equally effective for upper extremity lymphedema (UEL) and lower extremity lymphedema (LEL). In this study, we retrospectively compared the effectiveness of liposuction according to whether it was performed for LEL or UEL, and identified factors associated with outcomes. All patients had been treated at least once by lymphovenous anastomosis or vascularized lymphatic transplant before liposuction but without sufficient volume reduction. The patients were divided into an LEL group and a UEL group, and then subdivided further according to whether they completed their planned compression therapy into an LEL compliance group, an LEL non-compliance group, a UEL compliance group, and a UEL non-compliance group. The reduction rates in LEL (REL) and in UEL (REU) were compared between the groups. In total, 28 patients with unilateral lymphedema were enrolled (LEL compliance group, n = 12; LEL non-compliance group, n = 6; UEL compliance group, n = 10; UEL non-compliance group, n = 0). The non-compliance rate was significantly higher in the LEL group than in the UEL group (p = 0.04). REU was significantly higher than REL (100.1 ± 37.3% vs. 59.3 ± 49.4%; p = 0.03); however, there was no significant difference between REL in the LEL compliance group (86 ± 31%) and REU in the UEL group (101 ± 37%) (p = 0.32). Liposuction seems to be more effective in UEL than in LEL, probably because the compression therapy required for management after liposuction is easier to implement for UEL. The lower pressure and smaller coverage area required for postoperative management after liposuction in the upper limb may explain why liposuction is more effective in UEL than in LEL.

Factors of Non-Compliance with a Protocol for Oral Administration of Misoprostol (Angusta®) 25 Micrograms to Induce Labor: An Observational Study.

We set out to identify factors of non-compliance with a protocol for the oral administration of misoprostol 25 µg (Angusta®) every 2 h (up to eight tablets), for the induction of labor (IOL). We conducted a retrospective study on IOL at term, on singleton pregnancies from 2019 to 2021, in a university hospital. The study included 195 patients, comprising 144 compliant protocols. Pain was statistically more frequent in the non-compliance group (92.2% vs. 62.5%, p < 0.001), and when a midwife was unavailable (15.7% vs. 0.7%, p < 0.001). A multivariable analysis found factors of good response (defined as going into labor before the administration of the median number of tablets, i.e., six) to be an indication for PROM (OR: 12.03, 95% CI: 5.42-26.71), and gestational age at induction (OR: 1.54, 95% CI: 1.19-2.01), independently of BMI, initial Bishop score, and parity. Patients with pain who were able to follow the protocol delivered 9 h earlier than patients with pain who interrupted the protocol and 16 h earlier than patients who experienced no pain. We identified two key elements that favored compliance: (i) providing the next tablet in advance; and (ii) offering patients early epidural analgesia when in pain in order to continue the protocol and go into labor promptly.

A panoramic view of a cohort of obstructive sleep apnea patients on positive airway pressure therapy using cloud based telemonitoring devices.

Positive airway pressure therapy is mainstay of treatment of obstructive sleep apnea (OSA). But long-term compliance with is poor with such therapy. A proactive and vigilant management may improve the PAP therapy usage. Cloud-based telemonitoring PAP devices offer an opportunity for proactive monitoring and prompt interventions related to PAP troubleshooting. This technology is also used in India for adult OSA patients. But we lack our own data on behavior of Indian patients as a cohort on PAP therapy. The present study is an attempt to look at the behavior a cohort of PAP users in OSA. This study was planned as a retrospective analysis of data of OSA patients who were using a cloud-based PAP devices. First 100 patients were chosen for data retrieval that who was on this therapy. The data was obtained for those patients who were on PAP for at least 7 days and maximum follow-up was available up to 390 days. Descriptive statistical analysis has been carried out in the present study. The number of male and female patients was 75 and 25, respectively. Overall good compliance was present in 66% of patients. 34% of patients were not compliant with PAP during follow-up. The compliance was statistically same in both the sexes (P = 0.8088). Incomplete data recovery was present in 17 patients and 11 (64.70%) were non-compliant among them. In the initial, 60 days non-compliant patients were more than compliant patients. The difference was lost in 60 to 90 days of use. The air leak was present more in the compliant group than non-compliant group (P = 0.0239). 75.75% of compliant patients had achieved AHI control, whereas 35.29% of non-compliant patients also achieved AHI control. But overall, AHI control was poor in non-compliant patients and 61.76% of non-compliant patients had an AHI uncontrolled. We conclude that 3/4th of the compliant patients achieve AHI control while 1/4th didn't. This 1/4th population needs further exploration to determine the causes of poor AHI control. Cloud-based PAP devices give an easy opportunity to monitor patients of OSA. It gives an instant panoramic view of behavior of OSA patients on PAP therapy. The compliant patients can be tracked, and non-compliant patients can be segregated quickly.

Assessment of the attitude toward medication and reasons for drug compliance among schizophrenic patients attending the tertiary care hospital

Abstract Introduction: Medication compliance is one of the most difficult challenges in the management of schizophrenia in India. Compliance broadly means the extent to which a person’s behavior, in terms of taking medications, following diets and executing lifestyle changes, visiting for follow-up, etc., coincides with medical and health advice. The current study has tried to assess the attitudes and reasons for compliance as well as noncompliance among patients with schizophrenia, which can provide the basis for planning effective interventional strategies for the mental health professionals for improving compliance of the patient in the future. Methodology: A hospital-based noninterventional cross-sectional study was done on 135 schizophrenic patients attending the outpatient services in the Department of Psychiatry, Government General Hospital, Kurnool, hospital by convenient sampling method for 6 months from October 2021 to March 2022, after obtaining approval from the institutional ethical committee. Data were collected and entered in Microsoft Excel and analyzed using the Statistical Package for Social Sciences (SPSS) 16 version software. Results: The prevalence observed in the present study, 75 (55.56%) participants were compliant, i.e., had a positive attitude toward medication and 60 (44.44%) participants were noncompliant toward medication. Higher mean scores for the Positive and Negative Syndrome Scale score were seen in the compliant group (101.25 ± 19.27) than the noncompliant group (100.98 ± 22.51). Conclusion: Main reasons for drug noncompliance identified in the present study were financial difficulty, distance from the hospital, improvement or no improvement in symptoms, side effects, lack of insight into the mental illness, and lack of awareness about the need for long-term medication.

Interaction between Health and Financial Status on Coping Behaviors during the COVID-19 Pandemic.

Background: The year 2022 started with protests against COVID-19 restrictions throughout North America. These events manifest the fact that some segments of the population are not compliant with the preventive measures of COVID-19, and the reasons of the disobedience against public health regulation remain unclear. The current paper examined the joint effect of financial and health status on people’s likelihood of pursuing active coping efforts (i.e., following preventive measures) and giving up coping with the COVID-19 pandemic. Method: We conducted a large-scale survey study in China (N = 3834) in May 2020. Results: Our results showed that people with low financial status were less likely to manifest active coping behavior and more likely to give up coping with the pandemic. People’s self-confidence in coping with the pandemic mediated this effect. We showed that one’s health status could interact with their financial status in a way that healthy people with low financial status would have less confidence in their coping abilities and thus become less likely to pursue active coping efforts and more likely to give up coping with the pandemic. Conclusions: Our results call for policymakers to find more effective solutions for noncompliant groups so that they can abide by the general guidelines in the COVID-19 context and other social crises that may emerge in the future. We suggest that governments should concentrate their support efforts on healthy populations of low financial segments to prevent COVID-19 and other infectious diseases in the future from spreading further.

Effect of Precision Health Education on Compliance Behavior after Extracorporeal Shock Wave Lithotripsy.

Objective The aim of this study was to investigate the effects of precision health education on patients' compliance behavior and lithotripsy efficacy after extracorporeal shock wave lithotripsy (ESWL). Methods From June 2018 to September 2018, 104 patients with upper urinary tract calculi who underwent ESWL at Anhui No.2 Provincial People's Hospital were randomly divided into two groups. The observation group (n = 53) was given precision health education guidance after ESWL treatment, while the control group (n = 51) was only informed of precautions after lithotripsy. Postoperative compliance behavior, stone expulsion time, and complications were recorded in both groups. Results The clinical baseline data of the two groups were similar in age, gender, number of stones, size of stones, location of stones, complications, number of lithotripsies, and voltage of lithotripsy between the two groups (P > 0.05). However, compared with the control group, the observation group had better compliance behavior of patients. Furthermore, we divided the patients into three groups based on whether they complied with medical advice. Compared with the noncompliance group (n = 17) and the partial compliance group (n = 23), the stone expulsion time in the complete compliance group (n = 64) was significantly shorter. Also, the number of patients with nausea and vomiting, lacrimation, and cold sweat in the complete compliance group was significantly lower than that in the other groups. Conclusion Precision health education for patients treated with ESWL can significantly enhance the compliance behavior of patients, thereby accelerating the expulsion of stones, improving the efficacy and relieving pain. Precision health education and good compliance behavior complement and reinforce each other.

Group B Streptococcus Screening and Treatment Adherence in Pregnancy: A Retrospective Cohort Study and Opportunities for Improvement

Pregnancy is a time of increased healthcare screening, and past adherence to evolving guidelines informs best practices. Although studies of Group B Streptococcus guideline adherence have focused primarily on treatment of Group B Streptococcus carriers, this study broadly evaluated long-term adherence to both Group B Streptococcus screening and treatment guidelines. Adherence was evaluated across provider types (obstetrics and gynecology, certified nurse midwives, and family medicine). We conducted a retrospective cohort study. Demographic and clinical information were extracted from all prenatal care and delivery patients at a single institution in a single year. Vancomycin prescriptions in pregnancy were tracked for 10 years to determine long-term adherence. Adherence was defined as no deviation from 2010 Group B Streptococcus screening and treatment guidelines. Adherence occurred in 89% (1,610/1,810) of patients. Reasons for deviations from guidelines could not always be determined. There was no significant difference in maternal age, race, prenatal provider type, provider type at delivery, gestational age at delivery, delivery mode, or whether antibiotic sensitivities were performed between compliant and noncompliant groups. Significant differences in adherence were found between obstetric clinics (high-risk obstetrics clinic, maternal‒fetal medicine fellows clinic, continuity of care clinic, and faculty private clinic) (p<0.0001) and between the faculty family medicine clinic and resident family medicine clinic (p=0.001). Vancomycin prescription practice did not change significantly over the10-year period. High rates of adherence to Group B Streptococcus screening and treatment guidelines in pregnancy have positive implications for reducing antibiotic resistance. Given evolving guidelines, there is a need to periodically evaluate adherence and to re-educate providers about standard practices and best documentation practices.

Implementation of enhanced recovery protocols reduces opioid use in pediatric laparoscopic cholecystectomy surgery.

Enhanced recovery protocols [ERPs] standardize care and have been demonstrated to improve surgical quality in adults. We retrospectively compared outcomes before and after implementation of ERPs in children undergoing elective laparoscopic cholecystectomy [ELC] surgery. A pediatric-specific ERP was implemented for children undergoing ELC at one [C1] of the two Pediatric Surgical Centers in July 2016. We retrospectively reviewed 606 patients undergoing ELC between July 2014 and December 2019. Of these, 206 patients underwent ELC prior to ERP implementation [Pre-ERP] were compared to 400 patients undergoing ELC managed in the post-ERP implementation period (between January 2017 and December 2019), 21 of which were managed by enhanced recovery protocol. Primary Outcomes included immediate peri-operative and post-operative narcotic use in mean morphine equivalents [MME], narcotics at discharge, complications, nurse calls and returns to system [RTS]. There was a significant decrease in opioid use both post-operatively and at time of discharge in the ERP managed cohort. The MME use during the post-operative period was 0.85 in the in ERP-compliant patients compared to 6.40 in the non-compliant group (p < 0.027). Eighty-six percent of ERP-compliant patients in the study required no narcotics at discharge, which was statistically significant when compared to ERP non-compliant cohort (p < 0.0001). There was also no change in RTS, nurse calls or complications. In addition, in the post-ERP period (2017-2019), a dominant proportion of patients at C1 partially complied with the ERP, resulting in a statistically significantly decrease of opioid use between sites in the post-op period (6.54 vs 10.57 MME) post-ERP (p < 0.001). Similar effects were noted in discharge narcotics. The use of pediatric-specific ERP in children undergoing ELC is safe, effective, and provides compassionate pain control while leading to a reduction in opioid use peri-operatively and at discharge. This improvement occurred without changes in RTS, nursing calls or complications. Level III; Retrospective study.

Achievement of nutritional goals after a pediatric intensive care unit nutrition support guideline implementation.

A nutrition support guideline was developed and implemented in a pediatric intensive care unit (PICU) to improve the nutritional management of patients. This study aimed to evaluate the impact of this guideline on achieving energy and protein delivery goals. Medical records of the patients admitted in the PICU from August 2015 to April 2017 were retrospectively reviewed. Patients who stayed in the PICU for less than 24h or had an inborn error of metabolism were excluded. Achievement of nutritional goals was compared between the patients during the pre-implementation period (August to October 2015) and post-implementation period (November 2015 to April 2017) of the guideline. Subgroup analysis by protocol compliance was conducted in the post-implementation group. A total of 215 patients were included in the study (53 pre-implementation, 162 post-implementation). There were no differences between the two groups in patient characteristics, time to start enteral nutrition, time to reach the energy delivery goal, time to reach the protein delivery goal, and proportion of the patients who reached each goal. In the post-implementation group, parenteral nutrition was delayed to three days compared with one day in pre-implementation (p=0.027) and the proportion of patients who did not receive nutrition support was lower (3.1% vs 9.4% pre-implementation, p=0.043). Subgroup analysis in the post-implementation group showed that 69.7% of the patients were protocol compliant, of which the time to reach the energy delivery goal (59 vs 103h, p<0.001) and protein delivery goal (64 vs 135h, p=0.02) were significantly shorter compared with the non-compliant group. Moreover, the proportion of the patients who reached the energy delivery goal (75.2% vs 24.5%, p<0.001) and protein delivery goal (56.6% vs 12.2%, p<0.001) were higher in the compliant group. Compliance with the nutrition support guideline significantly improved the achievements in delivering energy and protein to patients in PICU. Increasing compliance with the guideline may improve clinical outcomes in PICU patients.

Effect of Condom Use after CIN Treatment on Cervical HPV Biomarkers Positivity: Prolonged Follow Up Study.

Simple SummaryThe definite effects of consistent condom use following cervical local excisional procedures on preventing recurrent preinvasive disease as well as in biomarkers of HPV expression have not been studied so far. We embarked on a prospective observational study enrolling over 200 individuals who received strong advice for consistent condom use after undergoing local surgical CIN treatment. We assessed in the mid and long term (six and twenty-four-month post-op intervals, respectively) rates of CIN recurrence and the expression of HPV dependent and other biomarkers (HPV DNA, HPV mRNA E6 & E7, p16) in correlation with consistency of use. A favorable effect of routine condom use in rates of CIN relapse and biomarker expression was evident at the 6-month follow up; this was more pronounced at the 2-year assessment. In conclusion, consistent condom use following cervical local excisional treatment might influence favorably rates of CIN recurrence and biomarkers of HPV expression.Background: Several factors contribute in the cervical healing process following local surgical treatment; in a previous work our group has documented a beneficial mid-term role of regular condom use immediately postoperatively in terms of CIN relapse prevention and expression of active viral biomarkers. Materials and Methods: Aiming to investigate whether the favorable contribution of consistent condom use could be extrapolated in the longer term, we conducted a prospective single center observational study including women scheduled to undergo conservative excisional treatment for CIN (LLETZ procedure). In all women a strong recommendation for consistent use for the first 6 months was given. For 204 women who underwent the procedure and completed successfully the two-year follow up a complete dataset of HPV biomarkers’ results obtained six months and two years postoperatively was available. Patients were asked to complete a questionnaire to assess condom use compliance. A 90% compliance rate represented the threshold for consistent use. An LBC sample was obtained and tested for HPV genotyping, E6 & E7 mRNA by NASBA technique as well as flow cytometry, and p16 at 0 (pre-treatment), 6 and 24 months. HPV DNA and other related biomarkers status at 6 and 24 months, treatment failures at 24 months and condom use compliance rates represented study outcomes. Results: Six months post-operatively we documented a reduction in the rates of HPV DNA positivity, which was detected in only 23.2% of compliant condom users in comparison to 61.9% in the non-compliant group (p < 0.001, OR: 0.19, 95%CI: 0.1–0.36). For the HPV mRNA test, either assessed with the NASBA method or with flow cytometry, reduced positivity percentages were observed in the compliant group, in particular 1.6% vs. 8% for NASBA and 7.1% vs. 16.4% using flow cytometry, although these differences were not statistically significant (p = 0.1039 and 0.0791, respectively). Finally, reduced p16 positivity rates were documented in the compliant group. At the two year follow up, a more pronounced difference in HPV DNA positivity rates was observed, specifically only 13% positivity among the compliant women compared with 71% of the non-compliant (p < 0.0001); this illustrates a further decreasing trend compared with the 6th month in the compliant group as opposed to an increasing tendency in the non-compliant group, respectively (difference: 9.0%, 95% CI: 0% to 20.6%, p = 0.1523). At that time, 80% of the failed treatments were HPV mRNA positive compared to 10% positivity for the cases treated successfully (OR: 34, 95%CI: 6.8–173, p < 0.0001), a finding indicative that HPV mRNA E6 & E7 positivity accurately predicts treatment failure; p16 positivity was also observed at higher rates in cases with treatment failure. Conclusions: Consistent condom use following conservative excisional CIN treatment appears to significantly reduce rates of CIN recurrence and biomarkers of HPV expression. Additional HPV vaccination at the time of treatment could further enhance the positive effect of consistent condom use.

Factors associated with the follow-up of high risk infants discharged from a neonatal intensive care unit.

The study aimed to identify factors associated with compliance to follow-up (FU) appointments among infants following their discharge from the neonatal intensive care unit (NICU). This retrospective cohort study reviewed 657 infants (birth weight <1500g or gestational age [GA] <32 weeks), born between 2011 and 2015. A total of 525 eligible infants were classified into two groups: the compliant group (n=360), who attended clinics from 18 to 24 months, and the non-compliant group (n=165), who were lost to FU before 18 months. The non-compliant group was more likely to have higher usage rate of assisted reproductive technology (p=0.023), GA (p<0.001), weight (p<0.001), height (p<0.001), and head circumference (p<0.001) at birth. The sibling number was higher in the non-compliant group (p=0.011). Moreover, the non-compliant group demonstrated higher Apgar scores at 1min and 5min (p=0.002 and p=0.031, respectively). The compliant group was more likely to live in metropolitan or larger cities with a borderline significance (p=0.056). Furthermore, the non-compliant group was less likely to suffer from respiratory distress syndrome (p<0.001), patent ductus arteriosus (p=0.002), retinopathy of prematurity (p=0.007), necrotizing enterocolitis (p=0.019), and bronchopulmonary dysplasia (p<0.001). Moreover, it demonstrated lower postmenstrual age at discharge (p=0.005) and a shorter length of stay in the NICU (p<0.001). The compliance with FU appointment varied with the assigned doctor (p<0.001). The multivariate regression analysis mentioned that the birth weight (OR=0.903), residence in metropolitan or larger cities (OR=1.495), and an experience of magnetic resonance imaging (OR=1.920) were associated with compliance. The compliance to FU appointments was different according to the assigned doctor at admission (OR=0.357). The birth weight, residence in metropolitan or larger cities, an experience of MRI, and the assigned doctors were associated with compliance to FU at a corrected age of 18-24 months.

Efficacy of the Diabetes Prevention Program Group Lifestyle Balance Program Modified for Individuals with TBI (GLB-TBI): Results from a 12-month Randomized Controlled Trial.

Obesity after traumatic brain injury (TBI) is a public health issue and no evidence-based weight loss interventions exist to meet the unique needs of individuals after TBI. To (a) examine the efficacy of the Diabetes Prevention Program Group Lifestyle Balance for TBI (GLB-TBI) weight-loss intervention compared to an attention control for primary (weight-loss) and secondary health outcomes; (b) determine participant compliance with the GLB-TBI; and (c) determine if compliance is associated with improved outcomes. Individuals with moderate to severe TBI, age 18-64 years, ≥6 months postinjury, and body mass index of ≥25 kg/m2 were randomized to a 12-month, 22-session GLB-TBI intervention or attention control condition. Weight-loss (lbs.), anthropometric, biomarkers, and patient-reported outcomes were collected at baseline, 3, 6, and 12 months. The GLB-TBI group (n = 27) lost 17.8 ± 41.4lbs (7.9%) over the 12-month program and the attention control group (n = 27) lost 0 ± 55.4lbs (0%). The GLB-TBI group had significant improvements in diastolic blood pressure, triglycerides, and HDL cholesterol. GLB-TBI attendance was 89.6% and weekly self-monitoring of diet and activity was 68.8%. Relative to baseline, the GLB-TBI compliant group (≥80% attendance; ≥85% self-monitoring; n = 10) had a statistically significant decrease in weight at each assessment, the noncompliant group had a significant decrease between 6 and 12 months (n = 17), with no change in weight in the attention control group (n = 27). Findings suggest for adults with TBI who are overweight or obese, participation in the GLB-TBI can significantly reduce weight and metabolic risk factors and increase self-reported habits for diet and exercise.