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Improving Antibiotic Stewardship for Diarrheal Disease With Probability-Based Electronic Clinical Decision Support: A Randomized Crossover Trial

JAMA Pediatr. 2022 Aug 29. doi: 10.1001/jamapediatrics.2022.2535. Online ahead of print.

ABSTRACT

IMPORTANCE: Inappropriate use of antibiotics for diarrheal illness can result in adverse effects and increase in antimicrobial resistance.

OBJECTIVE: To determine whether the diarrheal etiology prediction (DEP) algorithm, which uses patient-specific and location-specific features to estimate the probability that diarrhea etiology is exclusively viral, impacts antibiotic prescriptions in patients with acute diarrhea.

DESIGN, SETTING, AND PARTICIPANTS: A randomized crossover study was conducted to evaluate the DEP incorporated into a smartphone-based electronic clinical decision-support (eCDS) tool. The DEP calculated the probability of viral etiology of diarrhea, based on dynamic patient-specific and location-specific features. Physicians were randomized in the first 4-week study period to the intervention arm (eCDS with the DEP) or control arm (eCDS without the DEP), followed by a 1-week washout period before a subsequent 4-week crossover period. The study was conducted at 3 sites in Bangladesh from November 17, 2021, to January 21, 2021, and at 4 sites in Mali from January 6, 2021, to March 5, 2021. Eligible physicians were those who treated children with diarrhea. Eligible patients were children between ages 2 and 59 months with acute diarrhea and household access to a cell phone for follow-up.

INTERVENTIONS: Use of the eCDS with the DEP (intervention arm) vs use of the eCDS without the DEP (control arm).

MAIN OUTCOMES AND MEASURES: The primary outcome was the proportion of children prescribed an antibiotic.

RESULTS: A total of 30 physician participants and 941 patient participants (57.1% male; median [IQR] age, 12 [8-18] months) were enrolled. There was no evidence of a difference in the proportion of children prescribed antibiotics by physicians using the DEP (risk difference [RD], -4.2%; 95% CI, -10.7% to 1.0%). In a post hoc analysis that accounted for the predicted probability of a viral-only etiology, there was a statistically significant difference in risk of antibiotic prescription between the DEP and control arms (RD, -0.056; 95% CI, -0.128 to -0.01). No known adverse effects of the DEP were detected at 10-day postdischarge.

CONCLUSIONS AND RELEVANCE: Use of a tool that provides an estimate of etiological likelihood did not result in a significant change in overall antibiotic prescriptions. Post hoc analysis suggests that a higher predicted probability of viral etiology was linked to reductions in antibiotic use.

TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT04602676.

PMID:36036920 | DOI:10.1001/jamapediatrics.2022.2535

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Changes in Health and Quality of Life in US Skilled Nursing Facilities by COVID-19 Exposure Status in 2020

JAMA. 2022 Aug 29. doi: 10.1001/jama.2022.15071. Online ahead of print.

ABSTRACT

IMPORTANCE: During the COVID-19 pandemic, the US federal government required that skilled nursing facilities (SNFs) close to visitors and eliminate communal activities. Although these policies were intended to protect residents, they may have had unintended negative effects.

OBJECTIVE: To assess health outcomes among SNFs with and without known COVID-19 cases.

DESIGN, SETTING, AND PARTICIPANTS: This retrospective observational study used US Medicare claims and Minimum Data Set 3.0 for January through November in each year beginning in 2018 and ending in 2020 including 15 477 US SNFs with 2 985 864 resident-years.

EXPOSURES: January through November of calendar years 2018, 2019, and 2020. COVID-19 diagnoses were used to assign SNFs into 2 mutually exclusive groups with varying membership by month in 2020: active COVID-19 (≥1 COVID-19 diagnosis in the current or past month) or no-known COVID-19 (no observed diagnosis by that month).

MAIN OUTCOMES AND MEASURES: Monthly rates of mortality, hospitalization, emergency department (ED) visits, and monthly changes in activities of daily living (ADLs), body weight, and depressive symptoms. Each SNF in 2018 and 2019 served as its own control for 2020.

RESULTS: In 2018-2019, mean monthly mortality was 2.2%, hospitalization 3.0%, and ED visit rate 2.9% overall. In 2020, among active COVID-19 SNFs compared with their own 2018-2019 baseline, mortality increased by 1.60% (95% CI, 1.58% to 1.62%), hospitalizations decreased by 0.10% (95% CI, -0.12% to -0.09%), and ED visit rates decreased by 0.57% (95% CI, -0.59% to -0.55%). Among no-known COVID-19 SNFs, mortality decreased by 0.15% (95% CI, -0.16% to -0.13%), hospitalizations by 0.83% (95% CI, -0.85% to -0.81%), and ED visits by 0.79% (95% CI, -0.81% to -0.77%). All changes were statistically significant. In 2018-2019, across all SNFs, residents required assistance with an additional 0.89 ADLs between January and November, and lost 1.9 lb; 27.1% had worsened depressive symptoms. In 2020, residents in active COVID-19 SNFs required assistance with an additional 0.36 ADLs (95% CI, 0.34 to 0.38), lost 3.1 lb (95% CI, -3.2 to -3.0 lb) more weight, and were 4.4% (95% CI, 4.1% to 4.7%) more likely to have worsened depressive symptoms, all statistically significant changes. In 2020, residents in no-known COVID-19 SNFs had no significant change in ADLs (-0.06 [95% CI, -0.12 to 0.01]), but lost 1.8 lb (95% CI, -2.1 to -1.5 lb) more weight and were 3.2% more likely (95% CI, 2.3% to 4.1%) to have worsened depressive symptoms, both statistically significant changes.

CONCLUSIONS AND RELEVANCE: Among skilled nursing facilities in the US during the first year of the COVID-19 pandemic and prior to the availability of COVID-19 vaccination, mortality and functional decline significantly increased at facilities with active COVID-19 cases compared with the prepandemic period, while a modest statistically significant decrease in mortality was observed at facilities that had never had a known COVID-19 case. Weight loss and depressive symptoms significantly increased in skilled nursing facilities in the first year of the pandemic, regardless of COVID-19 status.

PMID:36036916 | DOI:10.1001/jama.2022.15071

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Estimating individualized treatment effects using a risk-modeling approach: an application to epidural steroid injections for lumbar spinal stenosis

Pain. 2022 Aug 26. doi: 10.1097/j.pain.0000000000002768. Online ahead of print.

ABSTRACT

Conventional “1-variable-at-a-time” analyses to identify treatment effect modifiers are often underpowered and prone to false positive results. This study used a “risk-modeling” approach guided by the Predictive Approaches to Treatment effect Heterogeneity (PATH) Statement framework: (1) developing and validating a multivariable model to estimate predicted future back-related functional limitations as measured by the Roland-Morris Disability Questionnaire (RMDQ); and (2) stratifying patients from a randomized controlled trial (RCT) of lumbar epidural steroid injections (LESI) for the treatment of lumbar spinal stenosis into subgroups with different individualized treatment effects on RMDQ scores at 3-week follow-up. Model development and validation was conducted in a cohort (n=3259) randomly split into training and testing sets in a 4:1 ratio. The model was developed in the testing set using linear regression with least absolute shrinkage and selection regularization and 5-fold cross-validation. The model was then applied in the testing set, and subsequently in patients receiving the control treatment in the RCT of LESI. R2 values in the training set, testing set and RCT were 0.38, 0.32, and 0.34, respectively. There was statistically significant modification (p=0.03) of the LESI treatment effect according to predicted risk quartile, with clinically relevant LESI treatment effect point estimates in the two quartiles with greatest predicted risk (-3.7 and -3.3 RMDQ points) and no effect in the lowest two quartiles. A multivariable risk-modeling approach identified subgroups of patients with lumbar spinal stenosis with a clinically relevant treatment effect of LESI on back-related functional limitations.

PMID:36036907 | DOI:10.1097/j.pain.0000000000002768

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A Deception Study to Avoid Recall Bias Confirms Similar Scores for 3 Validated Questionnaires in the Office or over the Phone in Women with or without Urinary Incontinence

J Urol. 2022 Aug 29:101097JU0000000000002891. doi: 10.1097/JU.0000000000002891. Online ahead of print.

ABSTRACT

INTRODUCTION/BACKGROUND: With increasing telehealth technology, confirming the validity of non-office administration of questionnaires intended for office use only is important. We studied three validated questionnaires: Urinary Distress Inventory 6-Short Form (UDI-6), International Incontinence 7- Short Form (IIQ-7), and one Quality of Life Survey (QoL) using a deception model.

METHODS/MATERIALS: Following IRB approval and power calculations, these 3 questionnaires were prospectively administered in women with and without incontinence by phone and then again in person about 2 weeks later. To avoid recall bias, participants were not informed of the study over the phone. After completing their office visit questionnaire scores, they were told about the study and invited to consent for comparison of their phone and in-person questionnaire scores. Non-English speakers and those with an active urinary tract infection, impaired mental competency, or on fluid diets were excluded.

RESULTS: From June to September 2021, 86 women, including 40 incontinent (30-85) and 46 control (30-85), with similar demographic parameters, met all study criteria. Of the 14 questions studied, only two, the UDI6: Q1 (p=0.033) and IIQ-7: Q7 (p=0.036), showed rather minimal but statistically significant differences in scores. For incontinent women, only the IIQ-7: Q7 (p=0.012) showed a significant score difference.

CONCLUSIONS: The three questionnaire scores were overall comparable when obtained over the phone or during office visit. Women with incontinence, who may otherwise be lost to follow-up or only reachable by telehealth calls, can benefit from the remote administration of these 3 questionnaires.

PMID:36036901 | DOI:10.1097/JU.0000000000002891

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Cytoplasmic WT1 in IgA nephropathy, an indicator of poor prognosis associated with mesangial/peri-mesangial C4d

Int Urol Nephrol. 2022 Aug 29. doi: 10.1007/s11255-022-03357-4. Online ahead of print.

ABSTRACT

BACKGROUND: We aimed to investigate the immuno-histochemical expression of C4d, ADAM10 and WT1 in kidney biopsies of immunoglobulin A nephropathy (IgAN) patients and correlate the findings with clinical, laboratory and histopathologic features in the hope of defining new parameters to better understand the pathogenesis of the disease, and predict prognosis.

MATERIALS AND METHODS: Paraffin-embedded kidney biopsy samples of 128 IgAN patients were immuno-histochemically treated with C4d and ADAM10/WT1 dual stain. Results were evaluated according to Oxford classification parameters, epidemiologic features, laboratory findings at presentation and clinical follow-up.

RESULTS: We observed C4d positivity in 40.6% of our patients, 25% of which was mesangial/peri-mesangial (m/pm) staining. Only m/pmC4d positivity statistically correlated with progression to end-stage renal disease (ESRD). M/pmC4d positive patients had statistically significantly higher baseline proteinuria levels, presence of crescents and > 25% segmental sclerosis of glomeruli. There was cytoplasmic staining of WT1 in 11.2% of cases. Presence of cWT1 correlated with m/pmC4d positivity and progression to ESRD. There was no glomerular ADAM10 detected and tubular expression of this protein did not relate to amount of tubular damage or other parameters.

CONCLUSION: This study is the first to show that cWT1is involved in IgAN and appears as an independent variable for worse prognosis.

PMID:36036855 | DOI:10.1007/s11255-022-03357-4

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The Fibromyalgia Transcutaneous Electrical Nerve Stimulation in Physical Therapy Study (FM-TIPS) Protocol: A Multisite Embedded Pragmatic Trial

Phys Ther. 2022 Aug 29:pzac116. doi: 10.1093/ptj/pzac116. Online ahead of print.

ABSTRACT

OBJECTIVES: Transcutaneous electrical nerve stimulation (TENS) is a nonpharmacological intervention that provides an electrical current through the skin to produce analgesia. The primary purpose of this study is to examine if the addition of TENS to routine physical therapy improves movement-evoked pain in individuals with fibromyalgia in a physical therapy clinical setting.

METHODS: FM-TIPS is a phase III embedded pragmatic clinical trial funded through the National Institutes of Health Helping to End Addiction Long-Term (HEAL) Initiative. This trial will utilize a randomized cluster design that includes more than 110 physical therapists in 24 to 30 physical therapy clinics within 6 health care systems and 7 states. Clinics will be randomized to TENS or No-TENS, stratified by health care system and clinic size. The plan is to enroll 600 participants, with all participants completing physical therapy as prescribed by their physical therapist. Participants at TENS clinics will utilize TENS for a minimum of 2-hour per day while at the physical therapy clinic and at home when active. The primary outcome is reduction in movement-evoked pain from baseline to Day 60 on an 11-point numeric rating scale when participants sit and stand five times (Sit and Stand Test) Secondary outcomes include resting pain and fatigue, pain interference, fibromyalgia disease activity, movement-evoked fatigue, multidimensional assessment of fatigue, rapid assessment of physical activity, patient global impression of change, and common data elements shared across studies supported through the HEAL Initiative.

PMID:36036838 | DOI:10.1093/ptj/pzac116

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Association between prehospital FPS and ROSC in adults with OHCA : A retrospective multicenter study using the German Resuscitation Registry and Intubation Registry (FiPS-CPR)

Anaesthesiologie. 2022 Aug 29. doi: 10.1007/s00101-022-01193-w. Online ahead of print.

ABSTRACT

BACKGROUND: Advanced airway management (AAM) is part of the standard treatment during advanced cardiac life support (ACLS). Current studies underline the importance of a first-pass intubation success (FPS) during in-hospital ACLS. It was shown that a failed initial intubation attempt in out-of-hospital cardiac arrest (OHCA) patients in the emergency department is an independent risk factor for the decreased effectiveness of ACLS measured by the return of spontaneous circulation (ROSC).

OBJECTIVE: This study first examines the association between prehospital FPS and ROSC in adults with OHCA and second identifies factors associated with FPS and ROSC. The initial hypothesis was that FPS would increase the probability of ROSC as well as decrease the time to ROSC.

MATERIAL AND METHODS: A retrospective multicenter analysis of 180 adult non-traumatic OHCA patients on whom advanced airway management (AAM) was performed between July 2017 and December 2018 in five different German physician-staffed ambulance stations. For information on FPS the Intubation Registry, and for information on ROSC the German Resuscitation Registry were used. In addition to yes/no questions, multiple answers and free text answers are possible in those questionnaires. The main outcome variables were ‘FPS’, ‘ROSC’ and ‘time to ROSC’. Mann-Whitney tests, χ2-tests, Fisher’s exact tests and multivariate binary logistic regressions were used for the statistical evaluation. Demographic factors, characteristics of the performer, selected equipment, laryngoscopy type, intubation method, medications, verification of tube position, respiratory evaluation, complications and time to ROSC were examined with respect to the influence on FPS. Concerning ROSC, the following factors were examined: demographic factors, initial heart rhythm, initial breathing, medications, defibrillation and AAM.

RESULTS: An FPS was recorded in 150 patients (83.3%), and ROSC was achieved in 82 patients (45.5%) after an average time of 22.16 min. There was a positive association between FPS and ROSC (p = 0.027). In patients with FPS, a trend for shorter time to ROSC was observed (p = 0.059; FPS 18 min; no FPS 28 min). The use of capnography (odds ratio, OR = 7.384, 95% confidence interval, CI 1.886-28.917) and complications during AAM (OR = 0.033, 95% CI: 0.007-0.153) were independently associated with FPS. The independent factor associated with ROSC was FPS (OR = 5.281, 95% CI: 1.800-15.494).

CONCLUSION: In prehospitally resuscitated adult OHCA patients with AAM, FPS is associated with a higher chance of ROSC.

PMID:36036834 | DOI:10.1007/s00101-022-01193-w

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Impact of rs11024102 PLEKHA7, rs3753841 COL11A1 single nucleotide polymorphisms, and serum levels of oxidative stress markers on the risk of primary angle-closure glaucoma in Egyptians

J Genet Eng Biotechnol. 2022 Aug 29;20(1):126. doi: 10.1186/s43141-022-00400-w.

ABSTRACT

BACKGROUND: Primary angle-closure glaucoma (PACG) is one of the major causes of blindness in the Middle East with genetic loci and systemic oxidative stress as potential risk factors. The current case-control study aimed to investigate the associations of rs11024102 in Pleckstrin homology domain-containing family A member 7 (PLEKHA7), rs3753841 in collagen 11 A1 (COL11A1), and the systemic oxidative stress markers with PACG in Egyptian patients. Thirty-five control subjects and 64 PACG patients were enrolled in this study. The polymorphisms in PLEKHA7 and COL11A1 were analyzed using quantitative PCR, and their associations were statistically tested with PACG at homozygous, heterozygous, dominant, and recessive genetic models. The levels of malondialdehyde (MDA), advanced glycation-end product (AOPP), protein carbonyl (PC), and ischemia modified albumin (IMA) were quantitated colorimetrically, and their associations with PACG were analyzed statistically. The associations of MDA, AOPP, PC, and IMA with elevated intraocular pressure (IOP) were statistically tested.

RESULTS: Neither significant difference in the genotype distribution nor allele frequency of PLEKHA7 11024102 T>C (p = 0.425 and 0.517, respectively) and COL11A1 rs3753841 G>A (p = 0.600 and 0.473, respectively) were recorded under any of the tested genetic models. Either rs11024102 PLEKHA7 or rs3753841 COL11A1 was not significantly (p > 0.025 after Bonferroni correction) associated with an increased risk of PACG in Egyptians. Egyptian patients with PACG showed significant elevations in the serum levels of MDA, AOPP, and PC either in patients with or without cases with diabetes mellites, hypertension, coronary vascular diseases, and smoking. Serum levels of MDA, AOPP, and PC were significantly associated with PACG in Egyptians (p < 0.013 after Bonferroni correction). However, MDA and PC only showed significant associations with the elevation in the IOP (p = 0.007 and 0.045, respectively) in PACG patients.

CONCLUSION: Both rs11024102 and rs3753841 could not be considered as potential gene-dependent risk factors for PACG pathogenesis in Egyptians. On the other hand, serum levels of MDA, AOPP, and PC might be considered risk factors for PACG. Moreover, MDA and PC could serve as good predictors for the elevation of the IOP in PACG disease.

PMID:36036827 | DOI:10.1186/s43141-022-00400-w

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Predictors of low and high opioid tablet consumption after inguinal hernia repair: an ACHQC opioid reduction task force analysis

Hernia. 2022 Aug 29. doi: 10.1007/s10029-022-02661-3. Online ahead of print.

ABSTRACT

PURPOSE: Prescribing and consumption of opioids remain highly variable. Using a national hernia registry, we aimed to identify patient and surgery specific factors associated with low and high opioid tablet consumption after inguinal hernia repair.

METHODS: This was a retrospective cross-sectional study evaluating patients undergoing elective inguinal hernia repair with 30-day follow-up and patient-reported opioid consumption from March 2019 to March 2021 using the Abdominal Core Health Quality Collaborative. Clinically significant patient demographics, comorbidities, operative details, quality-of-life measurements, and surgeon prescribing data were entered into a multivariable logistic regression model to identify statistically significant predictors of patients who took no opioid tablets or >10 tablets.

RESULTS: A total of 1937 patients were analyzed. Operations included 59% laparoscopic or robotic, 35% open mesh, and 6% open non-mesh repairs. Of these patients, 50% reported taking zero, 42% took 1-10, and 8% took ≥10 opioid tablets at 30-day follow-up. Patients who were older (OR 1.55, 95% CI 1.34-1.79, p-value <0.001), ASA ≤ 2 (OR 1.56, 95% CI 1.2-2.01, p-value <0.001), had no preoperative opioid use at baseline (OR 2.29, 95% CI 1.31-4.03, p-value = 0.004), had local anesthetic with general anesthesia (OR 1.39, 95% CI 1.0.5-1.85, p-value = 0.022), or prescribed <7 opioid tablets (OR 2.27, 95% CI 1.96-2.62, p-value <0.001) were more likely to take no opioid tablets.

CONCLUSION: Older, healthier, opioid naïve patients with local anesthetic administered during elective inguinal hernia repair are most likely to not require opioids. Surgeon prescribing-arguably the most modifiable factor-independently correlates with both low and high opioid consumption.

PMID:36036822 | DOI:10.1007/s10029-022-02661-3

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Acute clavicle fixation after blunt chest trauma: effect on pulmonary outcomes and patient disposition

Eur J Orthop Surg Traumatol. 2022 Aug 29. doi: 10.1007/s00590-022-03368-y. Online ahead of print.

ABSTRACT

PURPOSE: Clavicle fractures are common in patients who sustain blunt chest trauma (BCT). Recently, surgical fixation of rib fractures in patients with BCT has been shown to improve pulmonary and clinical outcomes. Therefore, the purpose of this study is to assess the role of early clavicle fixation (ECF) versus non-operative (NO) treatment for midshaft clavicle fractures in this same population.

METHODS: A retrospective chart review was performed in patients with midshaft clavicle fractures and BCT at a Level I Trauma Center between 2007 and 2017. Patients with pre-existing pulmonary conditions and head injuries necessitating mechanical ventilation were excluded. Demographic data, injury mechanisms, and Thoracic Trauma Severity Scores (TTS) were analyzed. Inpatient pulmonary outcomes were assessed with serial vital capacity (VC) measurements, intubation, mechanical ventilation, and pulmonary complications data. In addition, intensive care unit (ICU) and hospital length of stay (LOS), mortality, discharge location, and incidence of postoperative complications in the ECF group were also measured.

RESULTS: Thirty-six patients underwent ECF, and 24 underwent NO treatment. The ECF cohort was statistically younger and had a greater incidence of clavicle fracture shortening than the NO group. There was no difference in pulmonary outcomes, ICU or hospital LOS, or mortality between groups. There were no complications associated with ECF. Patients who underwent ECF were more likely to discharge to home. There were no postoperative complications associated with ECF.

CONCLUSION: ECF of midshaft clavicle fractures does not improve pulmonary outcomes in patients with BCT. However, despite the lack of pulmonary benefit, there appears to be no added risk of harm. Therefore, ECF is a reasonable consideration in this patient population who otherwise meet clavicle fracture operative indications.

PMID:36036820 | DOI:10.1007/s00590-022-03368-y