Interim Visits Research Articles

HPV infection and its correlation with p53 and Bcl-2 among pregnant mothers and their infants.

The investigation of perinatal transmission of HPV is vital for early screening of cervical/oral cancers. Here, transmission of HPV from the pregnant women to their infants was studied. p53 and Bcl-2 expressions and their correlations with HPV infection were examined. HPV infection was detected in the cervical and oral swabs of 135 mother-baby pairs employing both PCR and HC-II methods. 1year follow-up with an interim visit at 3months for mothers and 6months for babies was performed. Immunocytochemistry of p53 and Bcl-2 using the streptavidin-biotin peroxidase method was performed. Prevalence of HPV infection in the mothers was 28.14%, (38/135) and 30.37% (41/135) determined by the PCR and HC-II methods respectively. HPV 16 and/or 18 was identified in 81.57% (31/38) and 82.92% (34/41) of the HPV + women estimated by PCR and HC-II methods respectively. Prevalence rate of HPV 16 among the HPV + pregnant women was 63.15% (24/38) and 65.85% (27/41) determined by PCR and HC-II methods respectively. The frequency of perinatal transmission was 21.05% (8/38) and 21.95% (9/41) determined by PCR and HC-II methods respectively at birth. The HPV + infants in the follow up study cleared the infection within 6weeks. An abnormal nuclear expression of p53 and cytoplasmic expression of Bcl-2 were observed in the HPV + mother-baby pairs. Cesarean section did not protect the infants against perinatal HPV transmission. The detection of p53 and Bcl-2 proteins in the HPV + mother-baby pairs suggests that these biomarkers may be important in the early screening of oral/cervix cancers in positive cases.

Utility of Follow-up Radiographs in Type 1 Supracondylar Humerus Fractures.

Supracondylar humerus (SCH) fractures are common among pediatric patients, with the severity categorized using the Gartland classification system. Type 1 SCH fractures are nondisplaced and treated with immobilization, while more displaced fractures require surgery. The need for follow-up radiographs, particularly for type 1 fractures, is an area where evidence is lacking. This study investigates the clinical value and financial implications of follow-up radiographs for type 1 SCH fractures, hypothesizing that they do not alter clinical management and, therefore, represent an unnecessary expense. This retrospective cohort study, approved by the Institutional Review Board, focused on patients under 18 with nondisplaced SCH fractures treated nonoperatively. One hundred one type 1 SCH fractures, in which the fracture was visible on presenting radiographs, were chosen from patients presenting between January 2021 and December 2022. Charts were reviewed for demographic information, time of cast removal, and complications. A pediatric orthopaedic surgeon and orthopaedic resident reviewed the radiographs to confirm the injury to be a type 1 SCH fracture. Among the 101 patients, after the initial presentation, 79 attended an interim visit and 101 attended a "3-week follow-up" at an average of 23 days postinjury. All patients underwent radiographs during these visits for a total of 180 radiographs after confirmation of type 1 SCH fracture. No changes in management resulted from follow-up radiographs. One instance of refracture was noted ~3 months after cast removal. There were 180 superfluous follow-up radiographs taken at subsequent clinic visits. The total charge for these radiographs was $76,001.40, averaging $752.49 per patient. Follow-up radiographs for type 1 SCH fractures did not lead to changes in clinical management, aligning with previous findings in more severe SCH fractures. This approach can reduce costs, radiation exposure, and clinic time without compromising patient care. The study can reassure providers and parents about the lack of necessity for follow-up radiographs to document healing. Level-IV.

Impact of Iron Supplementation in Anemic Voluntary First-Time Blood Donors-Results of a Pilot Trial in Ghana

Introduction : Blood transfusion is a major developmental challenge in sub-Saharan Africa due to chronic inadequacy and shortage of major blood products. In Ghana, deferral of potential blood donors has been identified as a significant challenge. Anemia, accounts for nearly half of ineligible blood donors. The estimated prevalence of anemia is 42.4% in women of reproductive age and 18.8% among peri-urban men ( Spring and Ghana Health service 2016). Thus, a high prevalence of anemia accounting for nearly half of voluntary blood donor deferrals, may contribute to the country's poor availability of safe blood for transfusion. No prior investigation had been carried out in Ghana on whether potential blood donors, deferred due to anemia, would consider donating blood after receiving counselling and appropriate treatment. This study tested the hypothesis that low-dose iron supplementation will increase hemoglobin levels sufficiently among anemic individuals to make them eligible to donate blood. Data from this trial informed the design of a larger randomized control type 1 pragmatic effectiveness implementation hybrid trial. Methods:This was a longitudinal two-arm parallel-group trial (participants aged 18 - 60 years). We compared the hemoglobin levels among those with anemia, iron deficiency (ID) or iron deficiency anemia (IDA) who received iron supplementation to donors without ID or IDA (Control group) in a non-inferiority design(NCT04949165). Anemia, IDA and ID were defined and determined using World Health Organization cut-off values (WHO, 2011). Potential blood donors with hemoglobin values less than 10 g/dl were excluded from the study. Participants in the iron supplementation arm were given low-dose iron (65 mg elemental iron) three times weekly for four months while the control arm received the standard nutritional counselling practice. In-person visits occurred at two, four and six months and included blood draws for full blood count, peripheral blood film smear, malaria rapid test and serum ferritin. The primary outcome was hemoglobin level after four months. A structured questionnaire assessed adherence, nutritional counselling and adverse events every two weeks via phone. Results: Two hundred and twenty-three first-time voluntary blood donors consented and passed pre-screening donation requirements (105 in iron supplementation arm vs. 118 in the control arm). The mean ages were similar between the iron supplementation and control groups (19.7±2.5 vs. 20.1±3.1 years). In both groups, there were more females than males (iron: 75.2%; control: 51.7%). At screening, 43.9% (98/223) had anemia while 3.1% (7/223) had ID. Of those who had anemia, 84.7% (83/98) had ferritin at least 15 g/l while 15.3% (15/98) had IDA. Among controls who donated blood at screening with an interim 1 visit, 42.6% (20/47) of females and 20.9% (9/43) of males were anemic. Only 23.4% (11/47) of females but no male was ID after one blood donation. Among participants assigned to iron supplementation who were anemic at screening, 31.7% (20/63) of females and 28.6% (6/21) of males were no longer anemic at interim visit 1. Among iron participants who were ID at screening 53.3% (8/15) of females and no male (0/2) were iron replete at interim visit 1. Only half of the participants receiving iron supplementation self-reported perfect adherence at the first and second interim visits (end of iron supplementation). A small proportion of participants reported side effects of dark stools and abdominal pain. We did not observe bacterial infections or increased malaria incidence. The mean hemoglobin values decreased over time from baseline to month four in the control group (screening: N=118, 13.4±1.3 g/dl; interim visit 2: N=74, 12.3±1.5 g/dl) and increased in the iron supplementation group (screening: N=105, 11.3±0.9 g/dl; interim visit 2: N=56, 11.4±1.3 g/dl). However, the primary comparison, mean hemoglobin difference between the iron supplementation and control arm at four months, did not meet the threshold to reject the inferiority hypothesis. Conclusion: The prevalence of ID and IDA among voluntary first-time blood donors was lower than previously published estimates. Adherence to low-dose iron supplementation three times a week was poor. Hemoglobin levels in the iron supplementation arm were not close enough to those in the control group after four months of iron supplementation to declare non-inferiority.

Suitability of the Respicheck questionnaire and Epworth sleepiness scale for therapy monitoring in myotonic dystrophy type 1

Myotonic dystrophy type 1 (DM1) is an autosomal dominant trinucleotide disorder that often leads to respiratory dysfunction resulting in hypoventilation symptoms, reduced quality of life and causing premature death if untreated. To early identify symptoms of hypoventilation, the Respicheck questionnaire was developed as a screening tool. Symptomatic therapies like inspiratory muscle training (IMT) are recommended to strengthen respiratory muscles and reduce or even prevent hypoventilation symptoms.Our study aimed to evaluate the Respicheck questionnaire's suitablility to monitor the efficacy of IMT. Patients with genetically confirmed DM1 were randomly assigned to either IMT – endurance or strength training, or control group. At baseline, end of study and four interim visits, pulmonary function tests, Respicheck questionnaire and Epworth sleepiness scale were assessed. While patients in training groups achieved a substantial improvement after nine months of regular IMT in pulmonary function tests, the Respicheck score did not improve likewise. Similarly, the ESS score did not change significantly in both training and control groups. Consequently, we conclude that either improvement of respiratory function is not necessarily associated with clinical improvement, or respiratory muscle weakness was not the only reason for hypoventilation syndrome, or both questionnaires are not sensitive enough to detect slight clinical changes.

Association of the Hydronephrosis Severity Score With Likelihood of Pyeloplasty: A Large Prospective Database Analysis

To apply and reproduce this scoring system in our prenatal hydronephrosis population with ureteropelvic junction obstruction (UPJO)-like hydronephrosis (HN), specifically looking at determining better HHS cutoffs that would allow for stratification into three risk categories: spontaneous HN resolution, observation, and surgery. A prospectively collected prenatal hydronephrosis database was reviewed to extract UPJO-like HN patients. Children with vesicoureteral reflux, primary megaureter, bilateral HN, and other associated anomalies were excluded. Only patients who had an ultrasound and mercaptoacetyltriglycine renal scan at a minimum of 2-time points were included. Hydronephrosis Severity Score was calculated at the initial, interim, and last follow-up clinic visits. Scores were analyzed regarding its usefulness to determine which patients would have been more likely to undergo pyeloplasty. Of 167 patients, 131 (78%) were male, 119 (71%) had left UPJO-like, and 113 (67%) had a pyeloplasty. The median age at baseline was 2months (interquartile range 1-4). According to initial (first clinic visit) Hydronephrosis Severity Score, 5/36 (14%) patients with a 0-4 score, 93/116 (80%) with a 5-8 score, and 15/15 (100%) with a 9-12 score underwent pyeloplasty, respectively (P<.01). The proposed HHS system for UPJO-like HN patients is reproducible, however, cut-off values need to be reassessed to accurately reflect true risk categories, as the purpose of this system is to differentiate those who have HN severe enough to require intervention from those who can be managed nonsurgically. Changing risk groups to mild (0-3), moderate (4-6), and severe (7-12) allowed for better discrimination between patients who underwent surgical intervention from those who did not in our dataset.

Continued attendance in a PrEP program despite low adherence and non-protective drug levels among adolescent girls and young women in Kenya: Results from a prospective cohort study.

In sub-Saharan Africa (SSA), adolescent girls and young women (AGYW) ages 15 to 24 years represent <10% of the population yet account for 1 in 5 new HIV infections. Although oral pre-exposure prophylaxis (PrEP) with tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) can be highly effective, low persistence in PrEP programs and poor adherence have limited its ability to reduce HIV incidence among women. A total of 336 AGYW participating in the PEPFAR-funded DREAMS PrEP program in western Kenya were enrolled into a study of PrEP use conducted between 6/2019 to 1/2020. AGYW, who used daily oral TDF/FTC, completed interviews and provided dried blood spots (DBS) for measurement of tenofovir-diphosphate (TFV-DP) concentrations at enrollment and 3 months later, and 176/302 (58.3%, 95% confidence interval [95% CI 52.3 to 63.8]) met our definition of PrEP persistence: having expressed intention to use PrEP and attended both the second interview and an interim refill visit. Among AGYW with DBS taken at the second interview, only 9/197 (4.6%, [95% CI 1.6 to 7.5]) had protective TFV-DP levels (≥700 fmol/punch) and 163/197 (82.7%, [95% CI 77.5 to 88]) had levels consistent with no recent PrEP use (<10 fmol/punch). Perception of being at moderate-to-high risk for HIV if not taking PrEP was associated with persistence (adjusted odds ratio, 10.17 [95% CI 5.14 to 20.13], p < 0.001) in a model accounting for county of residence and variables that had p-value <0.1 in unadjusted analysis (age, being in school, initiated PrEP 2 to 3 months before the first interview, still active in DREAMS, having children, having multiple sex partners, partner aware of PrEP use, partner very supportive of PrEP use, partner has other partners, AGYW believes that a partner puts her at risk, male condom use, injectable contraceptive use, and implant contraceptive use). Among AGYW who reported continuing PrEP, >90% indicated they were using PrEP to prevent HIV, although almost all had non-protective TFV-DP levels. Limitations included short study duration and inclusion of only DREAMS participants. Many AGYW persisted in the PrEP program without taking PrEP frequently enough to receive benefit. Notably, AGYW who persisted had a higher self-perceived risk of HIV infection. These AGYW may be optimal candidates for long-acting PrEP.

Treatment of Mechanical Corneal Wounds Emergencies during the COVID-19 Pandemic: Absorbable 10-0 Vicryl (Polyglactin 910) Sutures as a Suitable Strategy.

Background—The COVID-19 pandemic has changed our standard practices: operating rooms were only available for functional emergencies and outpatient visits were drastically reduced in favor of telemedicine. Aim: To report the personalized “one-shot” surgery using absorbable 10-0 Vicryl (V10-0) or polyglactin 910 monofilament in mechanical corneal injuries from February 2020 to December 2021. Methods—Prospective case series with at least 12-months’ follow-up, in a French university hospital. Among the overall population of open or closed-globe emergencies (n = 40), non-penetrating corneal lamellar lacerations (long axis > 2 mm) in zone 1 (OTC group) were treated with V10-0 suture(s) (n = 10), replacing traditional non-absorbable 10-0 nylon suture(s) or medical options in first line. The outpatient visits were performed on day (D)10, month (M)2, M6 then every six months. One interim visit by phone teleconsultation was scheduled between D10 and M2, and other(s) as needed. The main outcome was best-corrected visual acuity (BCVA) at M6. Secondary outcomes included mainly corneal astigmatism (CA) at M6 complications. Results—Among the ten corneal wounds, there were three children (30%), eight domestic accidents (80%), three eyes with metallic foreign bodies (30%), four open-globe injuries (40%), and nine eyes that received high-speed projectiles or sharp objects (90%). The complete V10-0 suture(s) absorption occurred in all eyes between D10 and M2. At M6, mean far and near BCVA decreased from 0.680 ± 0.753 and 0.490 ± 0.338 preoperatively to 0.050 ± 0.071 and 0.220 ± 0.063 logMAR (p = 0.019 and p = 0.025 respectively), mean CA decreased from 4.82 ± 3.86 preoperatively to 1.15 ± 0.66 diopters (p = 0.008). BCVA and CA were unchanged thereafter. No serious adverse event nor repeated surgery occurred. The mean number of teleconsultations was 1.20 ± 0.63 without an additional nonscheduled outpatient visit. Conclusions—The absorbable V10-0 sutures might be a safe and effective alternative for eligible corneal wounds, while reducing the number of outpatient visits, especially for children (no suture removal). The COVID-19 pandemic highlighted that they are ideally suited to logistical challenges.

Impact of switching from triple therapy to dual bronchodilation in COPD: the DACCORD \u2018real world\u2019 study

IntroductionChronic obstructive pulmonary disease (COPD) guidelines recommend reserving triple therapy of inhaled corticosteroid (ICS), long-acting β2-agonist (LABA) and long-acting muscarinic antagonist (LAMA) for patients with exacerbations despite dual therapy. However, many patients receive triple therapy without a clear indication. For these patients, it would be useful to know whether ICS can be withdrawn.MethodsDACCORD was a longitudinal, non-interventional ‘real-world’ study in three cohorts. This manuscript describes the results of Cohort 3, which recruited patients with COPD who had received triple therapy for ≥ 6 months. Prior to entry, each patient’s physician decided to continue triple therapy, or switch to a LABA/LAMA; patients were then followed for 12 months, with exacerbations and COPD Assessment Test (CAT) data recorded every 3 months. The primary endpoint was the time until COPD worsening, defined as the occurrence of a moderate/severe exacerbation or clinically relevant CAT worsening.ResultsOf the 1192 patients recruited into the study, 967 completed the end-of-study visit and ≥ 2 of the three interim visits, 292 and 675 receiving LABA/LAMA and triple therapy, respectively. Most baseline demographics were similar between the two groups. A lower proportion of patients in the LABA/LAMA group had COPD worsening than with triple therapy (32.5% vs 55.7% at 12 months), with the time to worsening extended in the LABA/LAMA group (hazard ratio 2.004, p < 0.001). In addition, a significantly lower proportion of patients in the LABA/LAMA group exacerbated (18.5% vs 28.7%; p < 0.001), accompanied by a greater improvement from baseline in CAT total score. Overall, fewer patients in the LABA/LAMA group reported adverse events than in the triple therapy group (12.9% vs 15.1%).ConclusionsThese results suggest that in a real world setting physicians are able to identify patients who can be ‘stepped down’ from triple therapy to LABA/LAMA. Following step down, there was no overall decline in COPD—indeed, some patients had better outcomes.

Corneal wounds repair emergencies during COVID‐19: 10/0 absorbable polyglactin sutures as a valuable strategy

AbstractPurposeThe aim of this study is to report the use of Vicryl 10‐0 (polyglactin 910) resorbable monofilament in corneal trauma during COVID‐19 pandemic: structural and functional results, and follow‐up adaptation during health crisis.MethodsDuring the COVID‐19 pandemic, nine patients were selected from the overall population of open or closed globe surgical emergencies (n = 37) in a french University Hospital. Selected patients were eligible for corneal sutures with Vicryl 10‐0, thus replacing the traditional 10‐0 nonabsorbable monofilament nylon suture. Postoperative treatment combined anti‐inflammatory drugs, topical antibiotics and lubricating drops. Outpatient visits were performed at D10, M2, M6 then every six month. Interim visits were performed if needed between D10 and M2 by teleconsultation. Patients received complete examination including different imaging. The main outcome was best corrected visual acuity. Secondary outcomes included average corneal astigmatism and the occurrence of complications.ResultsMean distance and near acuity improved from 0.711 ± 0.805 &amp; 0.556 ± 0.305 logMAR preoperatively to 0.056 ± 0.073 &amp; 0.333 ± 0.100 logMAR postoperatively (p = 0.032 and p = 0.043 respectively). Mean astigmatism decreased from 4.91 ± 4.21 diopters preoperatively to 0.99 ± 0.57 after suture resorption (p = 0.020). There were no serious adverse events or repeated surgery.ConclusionsPolyglactin 910 10‐0 could provide a maximum infectious risk reduction; a shorter topical treatment and antibiotic prophylaxis. The absorbable nature of the sutures simplifies logistics by reducing the number of early outpatient visits before M2. It avoids suture removal, especially for the pediatric population. Interim teleconsultation(s) on demand are interesting to evaluate the need for an additional face‐to‐face consultation. Vicryl 10‐0 sutures are ideally suited to the COVID‐19 pandemic logistical constraints, as a safe and effective alternative to nylon 10‐0 for the management of eligible corneal wounds.

373. Household transmission of SARS-CoV-2 B.1.1.7 lineage –2 U.S. States, 2021

BackgroundIn December 2020, B.1.1.7 lineage of SARS-CoV-2 was first detected in the United States and has since become the dominant lineage. Previous investigations involving B.1.1.7 suggested higher rates of transmission relative to non-B.1.1.7 lineages. We conducted a household transmission investigation to determine the secondary infection rates (SIR) of B.1.1.7 and non-B.1.1.7 SARS-CoV-2 lineages. MethodsFrom January–April 2021, we enrolled members of households in San Diego County, CA, and Denver, CO metropolitan area (Tri-County), with a confirmed SARS-CoV-2 infection in a household member with illness onset date in the previous 10 days. CDC investigators visited households at enrollment and 14 days later at closeout to obtain demographic and clinical data and nasopharyngeal (NP) samples on all consenting household members. Interim visits, with collection of NP swabs, occurred if a participant became symptomatic during follow-up. NP samples were tested for SARS-CoV-2 using TaqPath™ RT-PCR test, where failure to amplify the spike protein results in S-Gene target failure (SGTF) may indicate B.1.1.7 lineage. Demographic characteristics and SIR were compared among SGTF and non-SGTF households using two-sided p-values with chi-square tests; 95% confidence intervals (CI) were calculated with Wilson score intervals.Results552 persons from 151 households were enrolled. 91 (60%) households were classified as SGTF, 57 (38%) non-SGTF, and 3 (2%) indeterminant. SGTF and non-SGTF households had similar sex distribution (49% female and 52% female, respectively; P=0.54) and age (median 30 years, interquartile range (IQR 14–47) and 31 years (IQR 15–45), respectively). Hispanic people accounted for 24% and 32% of enrolled members of SGTF and non-SGTF households, respectively (p=0.04). At least one secondary case occurred in 61% of SGTF and 58% of non-SGTF households (P=0.66). SIR was 52% (95%[CI] 46%-59%) for SGTF and 45% (95% CI 37%-53%) for non-SGTF households (P=0.18). ConclusionSIRs were high in both SGTF and non-SGTF households; our findings did not support an increase in SIR for SGTF relative to non-SGTF households in this setting. Sequence confirmed SARS-CoV-2 samples will provide further information on lineage specific SIRs.Disclosures All Authors: No reported disclosures

Influence of Postponed Follow-Up after Cochlear Implant Activation during the COVID-19 Pandemic on Aided Sound Field Detection and Speech Recognition

Introduction: The objective of this study was to assess the influence of postponing the first post-activation follow-up due to the COVID-19 pandemic on the aided sound field detection thresholds and speech recognition of cochlear implant (CI) users. Methods: A retrospective review was performed at a tertiary referral center. Two groups of adult CI recipients were evaluated: (1) patients whose first post-activation follow-up was postponed due to COVID-19 closures (postponed group; n = 10) and (2) a control group that attended recommended post-activation follow-ups prior to the COVID-19 pandemic (control group; n = 18). For both groups, electric thresholds were estimated at initial activation based on comfort levels and were measured behaviorally at subsequent post-activation follow-ups. For the control group, behavioral thresholds were measured at the 1-month follow-up. For the postponed group, behavioral thresholds were not measured until 3 months post-activation since the 1-month follow-up was postponed. The aided pure-tone average (PTA) and word recognition results were compared between groups at the 3-month follow-up and at an interim visit 2–9 weeks later. Results: At the 3-month follow-up, the postponed group had significantly poorer word recognition (23 vs. 42%, p = 0.027) and aided PTA (42 vs. 37 dB HL, p = 0.041) than the control group. No significant differences were observed between 3-month data from the control group and interim data from the postponed group. Conclusions: The postponed follow-up after CI activation was associated with poorer outcomes, both in terms of speech recognition and aided audibility. However, these detrimental effects were reversed following provision of an individualized map, with behaviorally measured electric threshold and comfort levels. While adult CI recipients demonstrate an improvement in speech recognition with estimated electric thresholds, the present results suggest that behavioral mapping within the initial weeks of device use may support optimal outcomes.

The Relationship of the Therapeutic Alliance to Patient Characteristics and Functional Outcome During an Episode of Physical Therapy Care for Patients With Low Back Pain: An Observational Study

Research supports the relevance of the therapeutic alliance (TA) between patients and physical therapists on outcomes, but the impact of TA during routine physical therapist practice has not been quantified. The primary objective of this study was to examine the relationship between TA assessed during a physical therapy episode of care for patients with low back pain and functional outcome at the conclusion of care. The secondary objective was to examine psychometric properties of the Working Alliance Inventory-Short Revised (WAI-SR) form, a patient-reported TA measure. This study was a retrospective analysis of prospectively collected data from 676 patients (mean [SD] age=55.6 [16.1] y; 55.9% female) receiving physical therapy for low back pain in 45 outpatient clinics from 1 health system in the United States. Participating clinics routinely collect patient-reported data at initial, interim, and final visits. The lumbar computer-adapted test (LCAT) was used to evaluate functional outcome. The TA was assessed from the patient's perspective at interim assessments using the WAI-SR, bivariate correlations were examined, and regression models were examined if interim WAI-SR scores explained outcome variance beyond a previously validated multivariate prediction model. Internal consistency and ceiling effects for the WAI-SR were examined. Interim WAI-SR scores were not correlated with patient characteristics or initial LCAT, but they were correlated with final LCAT and LCAT change from initial to final assessment. WAI-SR total score (adjusted R2=0.36), and Task (adjusted R2=0.38) and Goal subscales (adjusted R2=0.35) explained additional variance in outcome beyond the base model (adjusted R2=0.33). Internal consistency was higher for WAI-SR total score (α=.88) than for subscales (α=.76-.82). Substantial ceiling effects were observed for all WAI-SR scores (27.2%-63.6%). Findings support the importance of TA in physical therapist practice. Measurement challenges were identified, most notably ceiling effects. This study supports the impact of the patient-physical therapist alliance on functional outcome. Results extend similar findings from controlled studies into a typical physical therapist practice setting. Better understanding of the role of contextual factors including the therapeutic alliance might be key to improving the magnitude of treatment effect for discrete physical therapist interventions and enhancing clinical outcomes of physical therapy episodes of care.

Baseline characteristics as 3-year predictors of tooth fracture and crack progression: Findings from The National Dental Practice-Based Research Network

BackgroundThe authors of this practice-based study estimated the risk of experiencing tooth fractures and crack progression over 3 years and correlated baseline patient-, tooth-, and crack-level characteristics with these outcomes. MethodsTwo-hundred-and-nine National Dental Practice-Based Research Network dentists enrolled a convenience sample of 2,601 participants with a cracked vital posterior tooth that had been examined for at least 1 recall visit over 3 years. Data were collected at the patient, tooth, and crack levels at baseline, annual follow-up visits, and any interim visits. Associations between these characteristics and the subsequent same-tooth fractures and crack progression were quantified. ResultsOf the 2,601 teeth with a crack or cracks at baseline, 78 (3.0%; 95% confidence interval, 2.4% to 3.7%) subsequently developed a fracture. Of the 1,889 patients untreated before year 1, 232 (12.3%; 95% confidence interval, 10.9% to 13.8%) had some type of crack progression. Baseline tooth-level characteristics associated with tooth fracture were the tooth was maxillary and had a wear facet through enamel and a crack was detectable with an explorer, on the facial surface, and in a horizontal direction. Crack progression was associated with males and teeth with multiple cracks at baseline; teeth with a baseline facial crack were less likely to show crack progression. There was no commonality between characteristics associated with tooth fracture and those associated with crack progression. ConclusionsDevelopment of tooth fractures and crack progression over 3 years were rare occurrences. Specific characteristics were associated with the development of tooth fracture and crack progression, although none were common to both. Practical ImplicationsThis information can aid dentists in assessing factors that place posterior cracked teeth at risk of experiencing adverse outcomes.

A Culturally Adapted SMS Text Messaging Intervention to Promote Antiretroviral Therapy Adherence Among African Americans: Protocol for a Single-Arm Trial.

BackgroundAfrican Americans are disproportionally affected by HIV and have poorer rates of antiretroviral therapy (ART) adherence compared to other racial or ethnic groups in the United States. Factors associated with poor HIV disease outcomes are commonly associated with sociostructural barriers that prevent engagement with and retention in HIV care. SMS text messaging interventions to promote ART adherence among predominantly non-Hispanic White persons with HIV (PWH) have been shown to be efficacious; however, limited research has been devoted to culturally tailoring interventions for underrepresented racial/ethnic groups. Considering African Americans show poorer engagement along the HIV care continuum, we developed an individualized and culturally tailored two-way SMS text messaging intervention to improve ART adherence and associated virologic suppression among African American PWH.ObjectiveIn this paper we describe the protocol of a culturally tailored individualized Texting for Adherence Building (iTAB) intervention in a 24- to 48-week, single-arm study.MethodsWe developed a culturally tailored iTAB intervention, which we are implementing in a 24- to 48-week, single-arm study. Participants were recruited from the Family Health Centers of San Diego (FHCSD), a federally qualified health center. Patient inclusion criteria were (1) receiving care at the FHCSD, (2) living with HIV, (3) self-identification as Black, African American, or of African ancestry, (4) English speaking, (5) age 18 or older, (6) currently on ART, and (7) able to provide informed consent. Study enrollment began in November 2017 and closed in July 2019. A total of 90 participants from the FHCSD enrolled in the iTAB intervention, and we anticipate completing data collection in July 2020. Participants were assisted in individualizing and customizing their SMS text message preferences at the baseline study visit. Self-assessment measures are collected at baseline, interim, and final study visits. Problems related to sending/receiving SMS text messages and barriers to ART adherence are assessed at each interim study visit. The FHCSD staff monitors and tracks participants’ daily SMS text message responses to ART adherence reminders using a clinical dashboard.ResultsWe hypothesize that the proportion of individuals achieving HIV virologic suppression (viral load <40 copies/mL) will be greater at the end of the intervention period compared to the proportion prior to study implementation. Additionally, we anticipate that rates of virologic suppression at the end of the intervention among participants receiving iTAB will be comparable to those among the general FHCSD non-African American population who did not receive iTAB. Finally, we anticipate a high response rate to iTAB SMS text messages as well as positive participant feedback at the end of the intervention with regard to the acceptability of, satisfaction with, and perceived efficacy of iTAB.ConclusionsThe iTAB intervention is a novel individualized two-way SMS text messaging intervention that has been culturally tailored for use among African Americans with HIV. We anticipate that iTAB will demonstrate efficacy in future randomized control trials and will be supportive of medication adherence among other populations facing health disparities.International Registered Report Identifier (IRRID)DERR1-10.2196/21592

Demonstrate change

Jo Caswell explains what to expect from Ofsted's ‘interim visits’ which will focus strongly on your setting's safeguarding arrangements. Be ready to show how you are supporting and reassessing the needs of vulnerable children.

Digital Diabetes Care System Observations from a Pilot Evaluation Study in Vietnam.

Digital technologies are gaining an important role in the management of patients with diabetes. We assessed clinical outcomes and user satisfaction of incorporating a digital diabetes care system in diabetes clinics of a developing country. The system integrated a wireless blood glucose monitor that communicates data to any smartphone utilizing a patented acoustic data transfer method, a mobile-app, and cloud-based software that stores, analyzes, and presents data. Five hospital endocrinology clinics in Vietnam sequentially recruited all patients willing to join the study, providing they had a smartphone and access to internet connectivity. Face-to-face visits were conducted at baseline and at 12 weeks, with monthly digital visits scheduled in the interim and additional digital visits performed as needed. HbA1c levels were measured at baseline and at 12 weeks (±20 days). The study included 300 patients of whom 279 completed the evaluation. Average glucose levels declined from 170.4 ± 64.6 mg/dL in the first 2 weeks to 150.8 ± 53.2 mg/dL in the last 2 weeks (n = 221; p < 0.001). HbA1c levels at baseline and 12 weeks declined from 8.3% ± 1.9% to 7.6% ± 1.3% (n = 126; p < 0.001). The digital solution was broadly accepted by both patients and healthcare professionals and improved glycemic outcomes. The durability, scalability, and cost-effectiveness of this approach merits further study.

Symptom changes and crack progression in untreated cracked teeth: One-year findings from the National Dental Practice-Based Research Network

ObjectivesThe study objective was to: (1) quantify symptom (pain) and crack changes during one year of follow-up, among teeth that had at least one visible crack at baseline but which did not receive treatment for those cracks; (2) identify any patient traits/behaviors and external tooth/crack characteristics correlated with these changes. MethodsIn this observational study, 209 National Dental Practice-Based Research Network dentists enrolled a convenience sample of 2858 subjects, each with a single, vital posterior tooth with at least one observed external crack; 1850 teeth remained untreated after one year of follow-up and were the cohort for analyses. Data were collected at the patient-, tooth-, and crack-level at baseline, one-year follow up (Y1), and interim visits. Associations between changes in symptoms and cracks were identified, as were changes in symptoms associated with baseline treatment recommendations. ResultsChanges in pain symptoms were observed in 32% of patients; decreases were twice as common as increases (23% vs. 10%). More changes were observed in cold pain than in biting pain and spontaneous pain combined; 2% had increases in biting pain and 2% in spontaneous pain. Only 6% had an increase in the number of cracks. Changes in pain symptoms were not associated with an increase in the number of cracks, but were associated with baseline treatment recommendations. Specifically, pain symptom changes (especially decreases) were more common when the tooth was recommended for treatment at baseline. ConclusionsCracked teeth that have not received treatment one year after baseline do not show meaningful progression as measured by increased symptoms or number of cracks during follow-up. Clinical SignificanceUntreated cracked teeth, most of which were recommended for monitoring at baseline and some of which were recommended for treatment but did not receive treatment, remained relatively stable for one year with little progression of cracks or symptoms.

Benefits of LYM-X-SORB, a Highly Absorbed Structured Lipid Compound, in Children with Cystic Fibrosis and Pancreatic Insufficiency with Varying Degrees of Malabsorption (P08-125-19)

ObjectivesThe treatment of fat malabsorption and optimizing growth and nutritional status in patients with cystic fibrosis (CF) and pancreatic insufficiency (PI) is a challenge. A readily absorbable structured lipid (LYM-X-SORB™ [LXS]) improved fat absorption, growth, choline and essential fatty acid (EFA) status in children with CF and PI. Our objective in this secondary analysis is to determine if subjects with varying degrees of fat malabsorption show greater improvements with 3-month LXS treatment. MethodsSubjects with CF and PI (5–17yrs) participated in a 12-month double-blind randomized placebo-controlled LXS trial with a 3-month interim visit. LXS and placebo had similar calorie (303 or 456 kcal/d) and fat content (11 or 18 g/d), and LXS had 7-fold greater choline; dose depended on age. CFA was assessed with 72-hour stool and 3-day weighed food records. Height, weight and BMI Z-scores were calculated. Plasma linoleic and α-linolenic acid were assessed. Secondary analyses were restricted to children with baseline CFA who completed 3-month treatment (n = 66, 10.5 ± 3.0 yrs, 40% female). Subjects were divided into two groups at baseline: those with lower CFA (≤87.8%, median) and higher CFA (above median). ResultsIn those with lower baseline CFA, 3-month LXS treatment improved CFA significantly (8.7%, from 77.4 to 86.0%, P < 0.01), with a significant drop in stool fat loss (−6.6 g/24 hours) and no change in dietary fat intake. This was accompanied by significantly increased (P < 0.01) linoleic acid (434 nmol/L, 19% increase) and α-linolenic acid (25 nmol/L, 53% increase). Both weight and BMI Z scores increased ≥0.16 (P < 0.01). With placebo treatment, CFA did not change (72.5 to 71.1%), nor did EFA status, and growth status improved less (≤0.14, P < 0.05). For subjects with higher CFA at baseline, CFA did not change (92.1 to 90.1%) with either treatment, although EFA and growth status improved somewhat, with greater improvement evident in the LXS group. ConclusionsSubjects with CF and PI at higher risk for fat malabsorption had a dramatic improvement in CFA with LXS treatment, accompanied by improved EFA and growth status. This suggests that LXS may help those with CF and other pancreatic diagnoses in need of optimizing nutritional status and avoiding unintentional weight loss. Funding SourcesSupported by NIH.

SAT-LB004 Therapeutic Potential of LPCN 1144 in NAFLD and NASH

Background & Aims Male hypogonadism is an underappreciated comorbidity in non-alcoholic fatty liver disease (NAFLD)/ steatohepatitis (NASH). A significant overlap of comorbidities such as obesity, hypertension, hypertriglyceridemia, type 2 diabetes, and metabolic syndrome, exists between hypogonadism and NAFLD/NASH. Herein we report the prevalence of NAFLD in hypogonadal patients and the potential utility of orally bioavailable prodrug of bioidentical testosterone (LPCN1144), delivered lymphatically, in NAFLD/NASH. Method The Liver Fat Study (LFS) is a 16-week open-label, multi-center, single arm study with LPCN 1144 treatment in subjects (N=36) assessing potential NAFLD/NASH prevalence and liver fat (LF) changes. The Study of Androgen Replacement (SOAR) trial was an active controlled (topical testosterone gel) randomized multicenter 52-week study with LPCN 1144. Results In the LFS, about 58 % of hypogonadal patients were identified as having NAFLD. Among the patients with NAFLD, obesity was the most prevalent comorbidity. NAFLD was about 2-fold overrepresented in hypogonadal patients compared to US general population. At interim visit (8 weeks) mean absolute and relative liver fat reduction in patients with LF ≥ 10 % at baseline were 7.6% and 38%, respectively. 28% of NAFLD (LF ≥ 5 %) confirmed subjects experienced NAFLD resolution with LPCN 1144. In the SOAR trial, subjects with elevated baseline serum liver enzymes (ALT, GGT) and cardiovascular risk markers (TG, Lp-PLA2, LDL-C) experienced significant reductions. Significant rates of patients with above-normal levels of liver enzymes and lipids at BL ended with normal levels post LPCN 1144 therapy: ALT = 52%, GGT = 31%, TG = 34%, and LDL-C = 56%. Changes of TG for patients with above-normal levels at BL were reduced with oral LPCN 1144 compared with topical T gel: -64 mg/dL vs. +13 mg/dL, respectively. SHBG change for all patients with oral LPCN 1144 and Topical T gel: -19.5% vs. +8.3%, respectively. Greater reductions of TG and ALP were observed with oral LPCN 1144 as in patients key comorbidities compared with topical T gel. LPCN 1144, with up to 52 weeks exposure, exhibited no adverse drug reaction in the Hepatobilliary System Organ Class (e.g., peliosis hepatitis, hepatic neoplasms, cholestatic hepatitis and jaundice), no major adverse cardiac events (MACE), no signs of increased skeletal fragility or nephrotoxicity, and good gastrointestinal tolerability. Conclusion Evaluation of NAFLD/NASH should be considered in hypogonadal males. LPCN 1144 therapy meaningfully reduces liver fat in hypogonadal males, suggesting utility as a NAFLD/NASH therapy. Biomarker data support unique benefits of oral over topical testosterone options. Unless otherwise noted, all abstracts presented at ENDO are embargoed until the date and time of presentation. For oral presentations, the abstracts are embargoed until the session begins. s presented at a news conference are embargoed until the date and time of the news conference. The Endocrine Society reserves the right to lift the embargo on specific abstracts that are selected for promotion prior to or during ENDO.

A customized approach for arm fat reduction using cryolipolysis.

Cryolipolysis of the arms has been demonstrated to be an effective treatment for non-invasive reduction of subcutaneous fat. This study evaluated the safety and efficacy of the concurrent use of a new commercially-available small applicator in conjunction with an existing medium sized applicator for the customized treatment of arm fat. Bilateral arms of 15 eligible subjects were simultaneously treated using one or two vacuum applicators with flat contours. Either a medium or small cryolipolysis applicator with an oblong cup-shaped cooling surface was selected to treat upper arm fat. The shape of the fat bulge in each subject's arm was assessed and up to two treatment cycles (-11°C for 35 minutes each) were delivered to each arm in one session, based upon investigator discretion. Throughout the procedure and at the completion of each treatment cycle, investigators assessed the subject's level of comfort, as well as sensory and motor nerve effects. Post-treatment manual massage was performed, and clinical assessments of each treatment site were recorded. Adverse events were recorded to monitor procedural safety. Baseline and 12 weeks post-treatment photographs and ultrasound measurements were taken to assess efficacy. Subject questionnaires were administered to evaluate satisfaction. Fifteen female subjects (mean age of 51.1, mean BMI of 26.8) completed the study. Ultrasound imaging revealed statistically significant fat layer reduction of 2.5 mm (SD ± 2.4 mm, 95%CI 1.6-3.3). Subject surveys administered 12 weeks post-treatment demonstrated 87% satisfaction with the arm cryolipolysis procedure. A panel of blinded, independent physicians correctly identified 83% of the before and after photos. Clinical assessments found adverse events were mild and included erythema and mild swelling that resolved without intervention. Mild treatment area numbness was reported by 73% of subjects at the 4-week interim visit and fully resolved at the 12-week visit. This study documents the first reported customized approach for assessment and treatment of arm fat using a small or medium cup applicator with varied applicator placement. By incorporating one or two treatment cycles per arm in a single session, the issue of variable fat distribution in people's arms can be addressed. This approach was shown to be a safe and effective way to reduce unwanted arm fat with high patient satisfaction. Lasers Surg. Med. © 2018 Wiley Periodicals, Inc.