Version Of Criterion Research Articles

Low-dose nivolumab in advanced hepatocellular carcinoma

BackgroundThe approved dose of nivolumab is 3 mg/kg or a flat dose of 240 mg for indications. There is no dose-response relationship for nivolumab; therefore, a low-dose regimen may be an option to reduce financial toxicity. This study was designed to investigate the efficacy and safety of low-dose nivolumab in the management of hepatocellular carcinoma (HCC).MethodsWe retrospectively reviewed patients with HCC who received 20 or 100 mg of nivolumab intravenously every 2 weeks. The objective response rate was determined in accordance with the Response Evaluation Criteria in Solid Tumors criteria version 1.1. The Cox regression model and Kaplan–Meier method were used to analyze hazard factors, progression-free survival (PFS), and overall survival (OS). Adverse events (AEs) were assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.ResultsIn total, 78 patients were enrolled, including 49 with hepatitis B virus (HBV) and 23 with hepatitis C virus (HCV). All patients were staged as Barcelona Clinic Liver Cancer stage C, and 20 patients were classified as having Child–Pugh classification B (7). Nivolumab 20 mg was an independent prognostic factor for better PFS, and albumin-bilirubin grade 1 was the independent prognostic factor for superior OS in the multivariate analyses. Patients with better HBV (HBV DNA < 500 IU/ml) and HCV (HCV RNA undetectable) controls had superior OS. All AEs were grade 1–2 in severity, and all patients tolerated nivolumab without treatment interruption or dose adjustment. Additionally, 31 patients underwent subsequent therapy after nivolumab treatment.ConclusionLow-dose nivolumab may be effective with manageable toxicity and can be an alternative option to reduce financial toxicity in patients with advanced HCC who cannot afford the high cost of immune checkpoint inhibitors in real-world practice.

Robust design for 3-DoF anti-windup framework based on QFT

On the basis of the fact that all signals in the practical system are always bounded, this paper proposes a practical QFT-based approach for the synthesis of anti-windup compensation for uncertain LTI systems. Meanwhile, a modified version of the circle criterion is developed for saturated systems with parametric uncertainty to reduce the conservativeness of the anti-windup compensator design within the non-interfering anti-windup framework. In the context of QFT, it means enlarging the allowed zone of the compensator remarkably in the Nichols chart compare to the traditional version of the circle criterion. As a result, the less conservative stability boundary provides more room for the compensator synthesis, making the performance improvement possible. Numerical examples demonstrate the effectiveness and the performance improvement as expected of the proposed technique based on QFT for the anti-windup compensator design.

Web-Based Symptom Monitoring With Patient-Reported Outcomes During Definitive Radiation Therapy With Chemotherapy (SYMPATHY): A Prospective Single-Center Phase 1 Study

We evaluated the feasibility of patient symptom self-reporting using a web-based interface (WBI), with automated message alerts for severe and/or worsening symptoms, in patients undergoing definitive chemoradiation therapy (CRT). Patients receiving definitive CRT for gastrointestinal, lung, and head and neck cancers with access to a computer and/or mobile device were eligible. Symptom self-reporting was conducted via a WBI through surveys adapted from the patient-reported outcomes version of the Common Terminology Criteria for Adverse Events: 2 per week during CRT and 1 per week for 3 months after CRT. Nurses were alerted whenever a patient's symptom worsened by ≥2 points or reached a score of ≥3. Patient-Reported Outcomes Measurement Information System (PROMIS) surveys were conducted at baseline, end of CRT, and 3 months after CRT. Patients also completed exit surveys 3 months after CRT. Nineteen patients were enrolled with a median of 30 fractions (range, 28-33). The median survey completion rate was 26% (range, 0%-100%) during CRT and 33% (range, 0%-100%) during the first 3 months after CRT. Five (26%) had acute hospital encounters during CRT or within 3 months of CRT completion. Two patients (11%) experienced CRT treatment interruptions. During CRT, 70 of 81 surveys (86%) were flagged and 61 of 70 (87%) were acted upon by a nurse or physician within 4 days; during the first 3 months after CRT, 47 of 85 (55%) were flagged and 28 of 47 (60%) were acted upon within 7 days. Ninety-two percent of patients found it always easy to access the survey while 58% found the surveys too long or too frequent. None of the PROMIS domains had statistically significant changes during any time points. Symptom self-reporting via a WBI is feasible during definitive chemoradiation with high patient satisfaction. Survey fatigue is common and may be mitigated by improving the WBI to make it more patient-centered and allowing patients to choose which symptoms to report.

Web-Based Symptom Monitoring with Patient-Reported Outcomes during Definitive Radiation Therapy with Chemotherapy (SYMPATHY): A Prospective Single-Center Phase I Study

<h3>Purpose/Objective(s)</h3> We evaluated the feasibility of patient symptom self-reporting using a web-based interface (WBI), with automated message alerts for severe or worsening symptoms, in patients undergoing definitive chemoradiation therapy (CRT). <h3>Materials/Methods</h3> Patients receiving definitive CRT for gastrointestinal, lung, and head and neck cancer with access to a computer/mobile device were eligible. Symptom self-reporting was conducted via a WBI through surveys adapted from the patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE), 2/week during CRT and 1/week for 3 months post-CRT. Nurses were alerted whenever a patient's symptom worsened by ≥ 2 points or reached a score of ≥3. Patient-Reported Outcomes Measurement Information System (PROMIS) surveys were conducted at baseline, end of RT and 3 months post-RT. Patients also completed exit surveys 3 months post-CRT. <h3>Results</h3> Nineteen patients were enrolled with a median of 30 fractions (range 28-33). Median survey completion rate was 26% (range 0-100%) during CRT and 33% (range 0-100%) during the first 3 months post-CRT. Five (26%) patients had acute hospital encounters during CRT or within 3 months of CRT completion. Two patients (11%) experienced CRT treatment interruptions. During CRT, 70/81 (86%) of surveys were flagged and 61/70 (87%) were acted upon by a nurse or physician within 4 days of the survey; during the first 3 months post-CRT, 47/85 (55%) were flagged and 28/47 (60%) were acted upon within 7 days. 92% of patients found it always easy to access the survey while 58% found the surveys too long or too frequent. None of the PROMIS domains had statistically significant changes during any time points. <h3>Conclusion</h3> Symptom self-reporting via a WBI is feasible during definitive chemoradiation with high patient satisfaction. Survey fatigue is common and may be mitigated by improving the WBI to make it more patient-centered and allowing patients to choose which symptoms to report.

Pilot/Phase II Trial of Hypofractionated Radiation Therapy to the Whole Breast Alone Before Breast Conserving Surgery

PurposeOur purpose was to report the results of a phase II trial of patients with breast cancer treated with hypofractionated whole breast radiation therapy (RT) before breast-conserving surgery (BCS). Methods and MaterialsBetween 2019 and 2020, patients with cT0-T2, N0, M0 breast cancer were enrolled. Patients were treated with hypofractionated whole breast RT, 25 Gy in 5 fractions, 4 to 8 weeks before BCS. Pathologic assessment was performed using the residual cancer burden (RCB). Toxicities were assessed according to Common Terminology Criteria for Adverse Events (version 4). Quality of life was assessed with Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events, The Breast Cancer Treatment Outcome Scale, Linear Analogue Self-Assessment, and Patient-Reported Outcomes Measurement Information System. ResultsTwenty-two patients were enrolled. Median follow-up was 7.6 months (range, 0.2-16.8). Seven (32%) and 2 (9%) patients experienced grade 2+ or 3 toxicities, respectively. Overall quality of life Linear Analogue Self-Assessment and Patient-Reported Outcomes Measurement Information System did not change significantly from baseline (P = .21 and P = .72, respectively). There was no clinically significant change (≥1 point) in any of The Breast Cancer Treatment Outcome Scale domains. Only 1 (5%) patient experienced a clinical deterioration that corresponded to a “fair” outcome on the Harvard Cosmesis Scale. At pathologic evaluation, 14 (64%) patients had RCB-0 or RCB-I, including 3 (14%) patients with a pathologic complete response (RCB-0). Eight patients (36%) had RCB-II. No local or distant recurrences have been observed. ConclusionsExtremely hypofractionated whole breast RT before BCS is a feasible approach. There were low rates of toxicities and good cosmesis. Further investigation into this approach with RT before BCS is warranted.

Cough, Cough-Induced, and Primary Cough Headache

Dear Editor, We read the article entitled “Magnetic Resonance Imaging of Leptomeningeal Cyst with Atypical Presentation: Cough-Induced Headache” on the esteemed “Matrix Science Medica” with great interest. Dar et al. presented two adult patients with posttraumatic leptomeningeal cysts presenting as cough-induced headache. The headache worsened on forceful coughing in both individuals. In this context, the presence of growing skull fractures with headache and cough highlights the possible association between this type of headache and cerebrospinal fluid dynamic.[1] Headache associated with coughing is characterized by headaches triggered by a rapid increase in intra-abdominal pressure caused by coughing, sneezing, or straining. It is an uncommon finding with a lifetime prevalence of <1%. Interestingly, the syndrome of cough headache is symptomatic in about 40% of cases, and the majority of these patients have Arnold–Chiari malformation Type I.[2] Herein, we would like to discuss recent studies about this rare condition. Four main mechanisms could explain headaches triggered by cough, which are jugular vein stenosis, cerebrospinal fluid hypervolemia, infection altering vascular tone, and crowdedness of the posterior cranial fossa [Figure 1]. We believe that these mechanisms combined lead to the development of headaches, instead of being separated pathways.Figure 1: Pathophysiological mechanisms related to headache associated with cough. There are four main pathways that are jugular vein stenosis, cerebrospinal fluid hypervolemia, infection alters vascular tone, and crowdedness of posterior cranial fossa. The third version of the diagnostic criteria for primary cough headache of the international classification of headache disordersTakizawa et al. reported a case of an individual presenting with both primary cough headache and headache attributed to temporomandibular disorder. Their report was interesting because headaches associated with referred pain exhibit secondary central nervous system effects that can easily confound clinicians. It is worthy of mentioning that involuntary nonfunctional tooth contact is believed to be an important cause of both types of headaches.[2] Primary cough headaches are mainly observed in adult patients, but cough-induced headaches are potentially symptomatic in the pediatric population. Omata et al. described a 7-year-old boy presenting with powerful cough-induced headaches. Echo examination confirmed right internal jugular vein dilatation during a Valsalva maneuver, and the individual was diagnosed with primary cough headache with internal jugular phlebectasia. Their report brings a new idea about the pathophysiology of this type of headache, which may be associated with the morphology and function of the internal jugular vein.[3] Moreno-Ajona et al. reported a 53-year-old male diagnosed with primary cough headache using indomethacin, which was stopped due to gastroesophageal reflux disease. He was started on noninvasive vagal nerve stimulation (nVNS) using the gammaCore™ device. The individual showed improvement in his symptoms with nVNS, in particular, the parasympathetic reflex arc. This approach has advantages when compared to indomethacin such as good tolerability and safety of neuromodulation.[4] In a recent Chinese respiratory clinic, it was assessed the prevalence, predictive factors, and clinical characteristics of cough headache in 679 patients. The prevalence of cough headache was 18.0% in these coughing patients. The main risk factor for the development of cough headache was age between 31 and 50 years (odds ratio 2.0). Furthermore, cough headache was associated with cough severity. It is noteworthy that headache severity had a positive correlation with cough severity, age, and headache duration.[5] In sum, primary cough headaches are related to a mixture of pathological mechanisms. They are probably more common than we first believed. Moreover, when present in the pediatric population, further evaluation is needed. Declaration of patient consent The authors certify that they have obtained all appropriate patient consent forms. In the form the patient (s) has/have given his/her/their consent for his/her/their images and other clinical information to be reported in the journal. The patients understand that their names and initial s will not be published and due efforts will be made to conceal their identity, but anonymity cannot be guaranteed. Financial support and sponsorship Nil. Conflicts of interest There are no conflicts of interest.

Bestvina–Brady discrete Morse theory and Vietoris–Rips complexes

We inspect Vietoris--Rips complexes ${\cal{VR}}_t(X)$ of certain metric spaces $X$ using a new generalization of Bestvina--Brady discrete Morse theory. Our main result is a pair of metric criteria on $X$, called the {\it Morse Criterion} and {\it Link Criterion}, that allow us to deduce information about the homotopy types of certain ${\cal{VR}}_t(X)$. One application is to topological data analysis, specifically persistence of homotopy type for certain Vietoris--Rips complexes. For example we recover some results of Adamaszek--Adams and Hausmann regarding homotopy types of ${\cal{VR}}_t(S^n)$. Another application is to geometric group theory; we prove that any group acting geometrically on a metric space satisfying a version of the Link Criterion admits a geometric action on a contractible simplicial complex, which has implications for the finiteness properties of the group. This applies for example to asymptotically ${\rm CAT}(0)$ groups. We also prove that any group with a word metric satisfying the Link Criterion in an appropriate range has a contractible Vietoris--Rips complex, and use combings to exhibit a family of groups with this property.

The Hindi Version of International Consensus Criteria: A Cross-cultural Adaptation and Validation Study for Myalgic Encephalomyelitis in Post-COVID Patients.

Fatigue is the most prominent feature of long COVID. With the increasing burden of long COVID cases post-acute phase of illness after recurrent waves of the pandemic, understanding its pathophysiology is of paramount importance. Such fatigue and post-viral illness could be associated with features of neuroimmune exhaustion and thus be a part of a larger syndrome such as myalgic encephalomyelitis (ME). Identifying the proportion of patients having ME from those experiencing fatigue would bring us one step closer to understanding the pathophysiology. International consensus criteria (ICC) originally published in English (ICC-E) is a valid and reliable tool for identifying cases of ME. However, a validated Hindi version of ICC-E is not available. : To develop and validate an equivalent version of ICC-E in the native Hindi language (ICC-H) to suit Indian patients and health care workers even at peripheries and to make conducting large scales surveys more feasible. Once permission from the ethics board was granted, guidelines given by MAPI Research Trust were followed and ICC-H was developed from ICC-E, in the following steps: (a) translation to Hindi, (b) back translation, (c) comparison between the translated and back-translated version performed by experts, and (d) pre-pilot test in the intended population. The ICC-H was applied to 53 bilingual individuals knowing both Hindi and English. The distribution of Hindi and English questionnaires was analyzed using the Chi-square test and Spearman's correlation coefficient was used for correlation between answers of each question. The score of individual items and its global score was highly correlated with each other (p&lt;0.001). The scores of individual components and global scores of ICC-H at baseline and original ICC-E after 4 weeks did not differ significantly. This study shows that the ICC-H is a valid and reliable instrument for the assessment of ME. ICC-H can be used for Hindi speaking population for identifying cases of ME. Key Messages There is a significant overlap in symptoms of long COVID and ME, with fatigue being a major component in both. Understanding the prevalence of ME in the post-acute phase of COVID illness can bring us a step closer to understanding its pathophysiology. In a multilingual country like ours, regionally translated criteria are a must for conducting large-scale surveys.

The GA2LEN survey for chronic rhinosinusitis prevalence studies: Arabic translation, cultural adaptation, and validation

Background: Chronic rhinosinusitis (CRS) is a common disease that significantly impacts quality of life. Its prevalence varies between different geographical areas. This study aimed to validate the Arabic version of the EPOS criteria in the GA2LEN questionnaire to use it as a tool to estimate the prevalence of CRS in Arab countries. Methods: This is multicentric cross-sectional validation study. The original English EPOS criteria used in the GA2LEN survey (four main questions and two additional questions) were translated into Arabic. The study was conducted at King Abdulaziz University Hospital – Riyadh and Qatif Central Hospital – Qatif in the period between October 2020 and August 2021. Groups of CRS and non-CRS patients were selected randomly from databases of the hospital and asked to participate in the study through phone calls. Sensitivity, specificity, positive, and negative predictive values were calculated for the Arabic questionnaire. Results: Of 200 subjects contacted to complete the questionnaire, 128 agreed to participate and completed the survey. The Arabic version of the GA2LEN questionnaire was found to be reliable with high sensitivity and specificity. The reliability of the questionnaire increased when we added the question, “Has a doctor ever told you that you have chronic sinusitis?” to the main four questions. The sensitivity, specificity, and positive and negative predictive values were 93.9%, 59.6%, 71.25%, and 90.2%, respectively. Conclusions: The Arabic version of the EPOS criteria in the GA2LEN questionnaire is a valid and reliable tool for epidemiological studies to estimate the prevalence of CRS.

Potentially Inappropriate Medication Use among Nursing Home Residents: Medication Errors Associated with Pro re nata Medications and the Importance of Pill Burden.

BackgroundThe use of potentially inappropriate medications (PIM) has become more common among nursing home residents (NHR). This study focused on drugs initially prescribed as pro re nata (PRN) medications and pill burden in association with PIM among NHR.MethodsThis observational cross-sectional study was conducted between March and April 2019 on 225 adult NHR aged ≥60 years.ResultsThe prevalence of PIM was 47.6% among NHR according to the Screening Tool of Older Persons' Prescriptions (STOPP) criteria version 2. The most frequent PIM was the use of any drug prescribed without evidence-based clinical indication; most medication errors were associated with PRN medications. The prevalence rates of PRN in non-PIM and PIM users were 12% and 62.4%, respectively. PRN medications that most commonly caused PIM were non-steroidal anti-inflammatory drugs and proton pump inhibitors. The cut-off value for both medications and pills to correctly identify participants with PIM was 5.5. Pill burden had a similar sensitivity to polypharmacy in identifying individuals with PIM.ConclusionMedication errors associated with PRN medications were overlooked as factors that increased the risk of PIMs. The most common error related to PRN medications was the continued daily use despite symptom resolution.

Longitudinal use of patient reported outcomes in pediatric leukemia and lymphoma reveals clinically relevant symptomatic adverse events.

Leukemia and lymphoma (LL) are the most common cancer diagnoses of childhood with high survival rates, but not without impact on the child's functioning and quality of life. This study aimed to use patient-reported data to describe the symptomatic adverse event (AE) experiences among children with LL diagnoses. Two hundred and fifty seven children and adolescents aged 7-18 years with a first LL diagnosis completed the Pediatric Patient-Reported version of the Common Terminology Criteria for Adverse Events (Ped-PRO-CTCAE) and Patient-Reported Outcome Measurement Information System (PROMIS) Pediatric measures before starting a treatment course (T1) and after the treatment (T2). Fatigue was the most severe AE (68.1% at T1; 67% at T2) and caused the most interference over time. Gastrointestinal AEs were also quite common (e.g., nausea 46.3% at T1 and 48.9% at T2; abdominal pain 42.4% at T1; 46.5% at T2). In general, symptoms were present both at T1 and T2 and did not change significantly in severity or interference. The prevalence of AEs varied by LL disease group (e.g., nausea was most common in acute lymphoblastic leukemia (ALL), fatigue was most severe in ALL and Hodgkin Lymphoma (HL), acute myeloid leukemia had the fewest AEs). Despite current supportive care regimens, many children with LL continue to report fatigue, pain, insomnia, and gastrointestinal symptoms as the most frequent or severe symptoms during therapy.

Multimorbidity, polypharmacy and inappropriate prescribing in elderly patients with atrial fibrillation: A report from the China Atrial Fibrillation Registry Study

BackgroundMultimorbidity, polypharmacy and inappropriate prescribing is common in elderly patients worldwide. We aimed to explore the current status of multimorbidity, polypharmacy and the appropriateness of pharmacological therapy among elderly patients with atrial fibrillation (AF) in China.Materials and methodsWe randomly selected 500 patients aged 65 years or older from the China AF Registry study. Multimorbidity was defined as ≥2 comorbidities and polypharmacy was defined as ≥5 long-term prescribed drugs. Appropriateness of prescribing was evaluated using the Screening Tool of Older People’s Prescriptions/Screening Tool to Alert to Right Treatment (STOPP/START) criteria version 2. Patients’ attitudes toward polypharmacy were evaluated by the Patients’ Attitudes Towards Deprescribing (PATD) questionnaire.ResultsAmong the 500 patients included (mean age 75.2 ± 6.7 years, 49.0% male), 98.0% had multimorbidity and 49.4% had polypharmacy. The prevalence of potentially inappropriate medications (PIMs) and potential prescribing omissions (PPOs) was 43.6% (n = 218) and 71.6% (n = 358), respectively. Traditional Chinese medicine attributed largely to PIMs. Anticoagulants were the most common PPOs. Many clinical factors increased the risk of PIMs and PPOs. However, polypharmacy increased the risk of PIMs (OR 2.70, 95%CI 1.78–4.11; p < 0.0001), but not PPOs. In addition, 73.7% patients with polypharmacy were willing to have one or more of their medications prescribed if advised by their doctor.ConclusionMultimorbidity and polypharmacy were highly prevalent in elderly patients with AF in China. A high prevalence of inappropriate prescribing was also observed. Therefore, much more attention should be paid to the serious health problem in the elderly population.

Evaluating Inappropriate Medication Prescribing Among Elderly Patients in Palestine Using the STOPP/ START Criteria.

BackgroundElderly patients suffer from chronic diseases and are prone to polypharmacy and potentially inappropriate prescribing (PIP). This study aimed to identify potentially inappropriate medications (PIMs) and potential prescribing omissions (PPOs) among elderly patients in a tertiary care hospital setting and to estimate the prevalence of polypharmacy.MethodsThis multicenter retrospective observational study reviewed patient data from two major Palestinian hospitals. The collected data included patient demographics, comorbidities, and medications administered during hospitalization and discharge. The study included 247 patients aged ≥ 65 years hospitalized between January 2019 and December 2019. The STOPP/START criteria version 2 was used to identify the prevalence of PIMs and PPOs. Clinical pharmacists verified the data, and SPSS was used for data analysis. Descriptive statistics, one-tailed bivariate correlations, and Pearson’s test were applied to the variables of interest to examine their association with the STOPP/START criteria.ResultsA total of 247 patients were included in the study, and 50.2% were females. As a result, 165 (66.8%) participants were identified with PIPs, including 30 patients with PPOs, 91 with PIMs, and 44 with both. Furthermore, the prevalence of PIP during hospitalization and discharge was 56.29% and 64.39%, respectively. Polypharmacy (5–9 medications) was 44.5% and 52.1% during hospitalization and discharge, respectively, and excessive polypharmacy (ten medications or more) was 33.6% and 16.4% during hospitalization and discharge, respectively. Moreover, 47.3% of the patients had a comorbidity index of ≥ 5.ConclusionThis study identified a high prevalence of PIPs among elderly patients during hospital admission and discharge. In addition, more than half of the geriatric patients in this study had PIP and a high prevalence of polypharmacy. Therefore, this study emphasizes the importance of adapting evidence-based tools, such as the STOPP/START criteria, to optimize patient medication therapy and guide prescribers in identifying and resolving PIMs and PPOs.

Utility of the ACR-1997, SLICC-2012 and EULAR/ACR-2019 classification criteria for systemic lupus erythematosus: a single-centre retrospective study

Background and aimsSeveral different versions of classification criteria, including the American College of Rheumatology (ACR)-1997, Systemic Lupus International Collaborating Clinics (SLICC)-2012 and European Alliance of Associations for Rheumatology (EULAR)/ACR-2019 classification...

Effects of a home-based Radio-Taiso exercise programme on health-related quality of life in older adults with frailty: protocol for an assessor-blind randomised controlled trial

IntroductionFew clinical trials have examined the effects of home-based exercise programmes on health-related quality of life (HR-QoL) in older adults with frailty. Radio-Taiso is the most famous exercise programme in...

Patient-reported outcomes for patients with breast cancer undergoing radiotherapy: A single-center registry experience.

BackgroundWe present Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) for patients undergoing adjuvant radiotherapy for breast cancer with curative intent. We describe the frequency and severity of PRO-CTCAE and analyze them with respect to dose fractionation.MethodsPatients were included in this study if they were treated with curative intent for breast cancer and enrolled on a prospective registry. Patients must have completed at least one baseline and one post-radiation survey that addressed PRO-CTCAE. For univariate and multivariate analysis, categorical variables were analyzed by Fisher’s exact test and continuous variables by Wilcoxon rank sum test. PRO-CTCAE items graded ≥2 and ≥3 were analyzed between patients who received hypofractionation (HF) versus standard conventional fractionation (CF) therapy by the Chi-square test.ResultsThree hundred thirty-one patients met inclusion criteria. Pathologic tumor stage was T1–T2 in 309 (94%) patients. Eighty-seven (29%) patients were node positive. Two hundred forty-seven patients (75%) experienced any PRO-CTCAE grade ≥2, and 92 (28%) patients experienced any PRO-CTCAE grade ≥3. CF was found to be associated with an increased risk of grade ≥3 skin toxicity, swallowing, and nausea (all p < 0.01). HF (OR 0.48, p < 0.01) was significant in the multivariate model for decreased risk of any occurrence of PRO-CTCAE ≥3.ConclusionsOur study reports one of the first clinical experiences utilizing multiple PRO-CTCAE items for patients with breast cancer undergoing radiation therapy with curative intent. Compared with CF, HF was associated with a significant decrease in any PRO-CTCAE ≥3 after multivariate analysis.

Arterial Stiffness Assessment by Pulse Wave Velocity in Patients with Metabolic Syndrome and Its Components: Is It a Useful Tool in Clinical Practice?

Metabolic syndrome (MS) is not a single disease but a cluster of metabolic disorders associated with increased risk for development of diabetes mellitus and its complications. Currently, the definition of MS published in 2009 is widely used, but there are more versions of the diagnostic criteria, making it difficult to conduct scientific discourse in this area. Increased arterial stiffness (AS) can predict the development of cardiovascular disease both in the general population and in patients with MS. Pulse wave velocity (PWV), as a standard method to assess AS, may point out subclinical organ damage in patients with hypertension. The decrease in PWV level during antihypertensive therapy can identify a group of patients with better outcomes independently of their reduction in blood pressure. The adverse effect of metabolic disturbances on arterial function can be offset by an adequate program of exercises, which includes mainly aerobic physical training. Non-insulin-based insulin resistance index can predict AS due to a strong positive correlation with PWV. The purpose of this paper is to present the results of the review of the literature concerning the relationship between MS and its components, and AS assessed by PWV, including clinical usefulness of PWV measurement in patients with MS and its components.

Physical Frailty and Hemoglobin-to-Red Cell Distribution Width Ratio in Japanese Older Outpatients

The Frailty screening should be widely performed; however, simple and inexpensive biomarkers are missing. Biomarkers that can be routinely assessed in many patients are desirable. Recently, the hemoglobin-to-red cell distribution width ratio (Hb/RDW, HRR) has been suggested as a new prognostic marker and has been reported to be associated with inflammation, one of the factors contributing to frailty. Therefore, we aimed to address the role of HRR in frailty among 557 older outpatients (aged 65–96 years). Frailty was assessed using the Japanese version of the Cardiovascular Health Study criteria, and HRR was calculated from clinical records. Participants were classified into five groups based on a sex-stratified quintile of HRR (Q1–Q5). Of the participants, 20.3% were frail. Using multiple logistic regression models with the Q5 group as a reference, after adjusting for sex, age, body mass index, polypharmacy, pre-orthopedic surgery, and the use of iron medications, the multivariable-adjusted odds ratios (95% confidence intervals) of the Q4 to Q1 groups were 0.92 (0.58–1.47), 1.04 (0.67–1.61), 1.29 (0.84–1.96), and 1.85 (1.22–2.82), respectively, indicating that a lower HRR was significantly associated with frailty. The robustness of these results was also shown in the multiple imputation analysis. The results suggest that HRR measurement may be one of the indicators to identify frail older adults in routine practice.

Under-prescription of medications in older adults according to START criteria: A cross-sectional study in Lebanon.

Background and AimsUnder‐prescription is defined as the exclusion of medications indicated for the treatment of certain conditions without any rationale for not prescribing them. The under‐prescription of medications is highly prevalent among older adults (≥65 years) receiving polypharmacy. This study aimed to assess the prevalence of the under‐prescription of medications using the Screening Tool to Alert to Right Treatment (START) criteria version 2 and to identify the predictors of having potential prescribing omissions (PPOs).MethodsThis cross‐sectional, face‐to‐face interview study was carried out between September 2021 and February 2022. The study comprised community‐dwelling older adults taking at least one medication on a regular basis. The study questionnaire included the patients' demographics, clinical data, and comorbidities. PPOs were identified using the START criteria. The χ 2 test was used to assess the association between under‐prescription of medication and the demographic/clinical variables. Multivariable logistic regression was performed to explore factors associated with under‐prescription of medications as the dependent variable and taking all variables that showed a p < 0.05 in the bivariate analysis as independent.ResultsA total of 444 older adults agreed to participate in this study. The mean age of participants was 71 ± 8.6; the majority of them, 305 (68.7%), were men. Polypharmacy was present in 261 patients (58.8%) and underprescribing of medications in 260 patients (58.6%). The highest percentage of under‐prescribing of medications was reported with statins in 115 patients (44.2%) followed by aspirin in 93 (35.7%), and angiotensin‐converting enzyme inhibitors in 61 (23.4%). The results of the multivariable analysis showed that patients with underprescribed medications had higher odds of polypharmacy (odds ratio [OR]: 2.015, confidence interval [CI] 95% 1.362–2.980, p < 0.001) and higher Charlson Comorbidity Index (OR 2.807, CI 95% 1.463–5.85, p = 0.02).ConclusionThe present findings highlight that PPOs are highly prevalent among community‐dwelling older adults in Lebanon. Multimorbidity and polypharmacy were the identified predictors for under‐prescription of medications in this population.

Effect of Mirogabalin on Chemotherapy-Induced Peripheral Neuropathy Caused by Gemcitabine plus Nab-Paclitaxel Therapy in Pancreatic Cancer Patients: A Pilot Study

Background: Gemcitabine/nab-paclitaxel therapy (GnP) is widely used to treat pancreatic cancer (PC), but chemotherapy-induced peripheral neuropathy (CIPN) is common. The CIPN is also reported to be related by microvascular damage as the basis for toxic neuropathy. However, no sufficient treatment options are available for CIPN. Mirogabalin is a novel drug for treating peripheral neuropathy. We investigated the effects of mirogabalin on CIPN due to GnP. Methods: Patients who had received GnP for PC and had taken mirogabalin for CIPN, were included. Patients completed a questionnaire about their symptoms before and after taking mirogabalin. The outcome was the change in numbness and tingling scores on the patient-reported outcomes version of the Common Terminology Criteria for Adverse Events, the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire–Chemotherapy-Induced Peripheral Neuropathy (EORTC-QLQ-CIPN20), numerical rating scale, and adverse events (AEs). Results: Increased numbness and tingling severity (1.84 vs. 1.76; p = 0.63) and interference (1.42 vs. 1.44; p = 0.80) were not seen in any of the 25 enrolled patients. The scores on the sensory subscale of the EORTC-QLQ-CIPN improved significantly after treatment (17.5 vs. 15.7; p = 0.02). Adverse events occurred in 22 patients (88%), but there were no serious AEs (≥grade 3). Conclusions: Mirogabalin may control the progression of CIPN caused by GnP and significantly improved sensory neuropathy. However, as the incidence of AEs is high, mirogabalin should be used with caution. (UMIN:R000044039).