Category: Nevin Manimala

J Diabetes Sci Technol. 2021 Dec 31:19322968211067511. doi: 10.1177/19322968211067511. Online ahead of print.

ABSTRACT

On March 23, 2020, all insulin products were reclassified as biologics instead of drugs under the Biological Price Competition and Innovation (BPCI) Act of 2009. This allows biosimilar insulin products to be manufactured when the patent expires for the reference biologic, sometimes called the originator or brand name product. A biosimilar product may not be substituted for the reference biologic at the pharmacy counter unless the biosimilar undergoes further switch trials to earn the designation as an interchangeable biosimilar. Insulin glargine-yfgn 100 units/mL is the first biosimilar insulin to attain interchangeable status with the reference insulin glargine. In the INSTRIDE 1 and INSTRIDE 2 trials, insulin glargine-yfgn has proven noninferiority regarding blood glucose reduction and adverse effect profile versus reference insulin glargine; even in the INSTRIDE 3 trial in which treatment of diabetes was switched between insulin glargine-yfgn and reference insulin glargine throughout the trial without statistically significant changes to glucose levels or adverse effects. Insulin glargine-yfgn may be substituted at the pharmacy counter without consultation with the prescriber, in accordance with state laws. In suit with other biosimilars, insulin glargine-yfgn’s list price is significantly lower than other insulin glargine products. This increases market competition leading to decreases in costs of other insulin glargine products. Many patients who could not previously afford insulin therapy may now have significantly improved access to treatment. Providers will need education to increase awareness of these new biosimilars and interchangeable biosimilar insulin products, cost benefits, and substitution allowances.

PMID:34971335 | DOI:10.1177/19322968211067511

Mod Rheumatol. 2021 Dec 31:roab119. doi: 10.1093/mr/roab119. Online ahead of print.

ABSTRACT

OBJECTIVES: To evaluate the safety and efficacy of tocilizumab (TCZ) on refractory macrophage activation syndrome (rMAS) associated with systemic juvenile idiopathic arthritis (sJIA-rMAS).

METHODS: We retrospectively reviewed the charts of 14 patients diagnosed with sJIA-rMAS, who were treated with TCZ after failing conventional therapies at three hospital centers from Jan 2016 to Dec 2020. Demographic, clinical, and laboratory characteristics were recorded at the onset of MAS, before TCZ (pre-TCZ) and 14 days after TCZ (post-TCZ).

RESULTS: The clinical manifestation of sJIA-rMAS included fever (100%), skin rashes (35.7%), lymphadenomegaly (42.9%), hepatomegaly (57.1%), splenomegaly (7.1%), gastrointestinal symptoms (28.6%), arthritis (14.3%), myalgia (28.6%) and polyserositis (14.3%). After TCZ treatment, fever (100%, 14/14), gastrointestinal symptoms (100%, 4/4) and myalgia (100%, 4/4) were significantly improved after one week (p< 0.05). Skin rashes, lymphadenomegaly and arthritis also improved in many patients but these parameters did not reach statistical significance. In post-TCZ group, decreases in levels of c-reactive protein, erythrocyte sedimentation rate and serum ferritin of sJIA-rMAS were observed compared with pre-TCZ (p< 0.05). Although not statistically significant, post-TCZ group showed normalization of white blood cell, platelet count, alanine aminotransferase, aspartate aminotransferase, lactic dehydrogenase and triglyceride levels compared with pre-TCZ. No disease relapse or fatality was recorded during the follow-up (25 months, range 3-60 months).

CONCLUSIONS: TCZ is safe and effective for the treatment of sJIA-rMAS after failure of conventional therapies.

PMID:34971386 | DOI:10.1093/mr/roab119

OTJR (Thorofare N J). 2021 Dec 31:15394492211060877. doi: 10.1177/15394492211060877. Online ahead of print.

ABSTRACT

This study evaluated the psychometric properties of the Relative Mastery Scale (RMS). Valid and reliable client-centered instruments support practice in value-based health care and community-based settings. Participants were 368 community-dwelling adults aged 18 to 95 years. Researchers conducted validity and reliability examinations of the RMS using classical test theory and Rasch measurement model. A partial credit model allowed exploration of individual scale properties. Spearman’s correlation coefficients between items were statistically significant at the .01 level. Cronbach’s alpha coefficient was .94 showing strong internal consistency. In exploratory factor analysis, Factor 1 accounted for 71% of variance with an eigenvalue of 4.26. In Rasch analysis, the 5-point rating scale demonstrated adequate functioning, confirmed unidimensionality, and person/item separation. The RMS instrument demonstrates sound psychometric characteristics. A valid and reliable measure of internal occupational adaptation supports application to monitor progress of internal occupational adaptation across a variety of individuals.

PMID:34971325 | DOI:10.1177/15394492211060877

Alzheimers Dement. 2021 Dec;17 Suppl 8:e057766. doi: 10.1002/alz.057766.

ABSTRACT

BACKGROUND: Hallucinations and delusions associated with dementia-related psychosis (DRP) can occur in persons with dementia-however, quickly screening for these symptoms in busy clinical settings can be challenging. We developed the DRP3 Screen, a novel tool to screen for psychosis in clinical settings; performed an Alignment Exercise to determine association of the DRP3 Screen with established psychosis/DRP reference assessments; and retrospectively assessed the ability of the DRP3 Screen to detect patients with DRP enrolled in a clinical trial (HARMONY, NCT03325556).

METHODS: The DRP3 Screen comprises 3 yes/no questions and was developed by Acadia Pharmaceuticals Inc. in collaboration with an international team of six subject matter experts (SMEs). Through facilitated discussions, the panel developed questions addressing key aspects of psychosis in dementia. SMEs independently rated level of alignment (Table) of the questions with current reference assessments (SAPS-H+D, NPI-Q, IPA Criteria) to determine if the symptoms itemized in those assessments would be captured by ≥1 DRP3 Screen question. Criteria for association with a reference assessment item was mean rating ≥2.0 for at least one DRP3 Screen question (95% CI, lower limit ≥1.3). Inter-rater reliability of the Alignment Exercise for individual reference assessments was assessed using Fleiss’ kappa statistic. For retrospective application of the DRP3 Screen to HARMONY, patients were considered likely to have been identified by the DRP3 Screen if they were positive (score ≥2) on ≥1 SAPS-H+D items that were positively associated with the DRP3 Screen.

RESULTS: All items across 3 reference assessments (except SAPS-H+D D6, somatic delusions) were associated with the DRP3 Screen. Mean level of alignment segregated to none/some (0.3-1.8) and most/all (2.3-3.0) with significant inter-rater agreement of the DRP3 Screen with the SAPS-H+D, NPI-Q and IPA Criteria, (kappa values: 0.37, 0.26, and 0.45, respectively; p<.0001). Retrospective application of the DRP3 Screen to HARMONY identified all trial enrollees.

CONCLUSIONS: The novel DRP3 Screen is a brief tool designed to assess the presence of hallucinations and delusions in persons with dementia. Potential for its clinical application has been established through association with current reference assessments, with significant agreement among raters; and through successful retrospective application to an existing trial population.

PMID:34971295 | DOI:10.1002/alz.057766

Dent Med Probl. 2021 Dec 31. doi: 10.17219/dmp/133664. Online ahead of print.

ABSTRACT

BACKGROUND: Postoperative pain is one of the main complications following impacted mandibular third molar (IMTM) surgery.

OBJECTIVES: The aim of this study was to assess the effect of the local application of bupivacaine on reducing early postoperative pain following IMTM surgery.

MATERIAL AND METHODS: A prospective, single-blinded, randomized controlled study was conducted on 40 patients who had undergone the surgical removal of an IMTM under local anesthesia. In the study group (n = 20), absorbable gelatin sponge (AGS) soaked in 3 mL of 0.5% plain bupivacaine hydrochloride was locally applied in the post-extraction socket. In the control group (n = 20), AGS soaked in 3 mL of normal saline was used. Pain intensity was assessed using a pain numerical rating scale (NRS) 4 and 12 h postoperatively. The variables were compared between the 2 groups and probability values <0.05 were considered statistically significant.

RESULTS: The pain scores in the study group were significantly lower than those recorded in the control group at 4 h postoperatively (p = 0.003), whereas the difference in the pain scores between the 2 groups 12 h after surgery was not statistically significant (p = 0.443).

CONCLUSIONS: The local application of bupivacaine is effective in reducing postoperative pain 4 h after the surgical extraction of IMTMs without any significant complications.

PMID:34971304 | DOI:10.17219/dmp/133664

Alzheimers Dement. 2021 Dec;17 Suppl 8:e053406. doi: 10.1002/alz.053406.

ABSTRACT

BACKGROUND: The COVID-19 pandemic has made it necessity that rehabilitation services are provided remotely to patients. These process required a transformation in healthcare. The aim of this study was investigate the effectiveness of the home-based online supervised exercise program in Alzheimer’s disease (AD). To our knowledge, this is the first study to report the results of real-time supervised physical exercise telerehabilitation program in AD.

METHOD: Eighteen subjects with early-middle stage of AD were randomised into 2 group as telerehabilitation group (TG; mean age: 77.7 ± 5.29 years; 7 Female, 3 Male) and control group (CG; mean age: 78.5 ± 7.07 years; 5 Female, 3 Male). Our primary outcome was Mini-Mental State Examination (MMSE), seconder outcomes were Timed Up&Go (TUG), One-leg Balance Test (OLBT), Functional Independence Measure (FIM), Geriatric Depression Scale-Short Form (GDS). The 6-week motor-cognitive dual-task exercise training was performed online and under the supervision of physiotherapist through videoconference. No physical or cognitive intervention was applied to the control group for 6 weeks. Subjects were assessed before and after the treatment. In statistical analysis, the change in the outcome scores was calculated (∆ = last measurement-first measurement), the difference between the groups was performed with the Mann Whitney-U Test in SPSS 22.0. Trial’s protocol is registered with Clinicaltrials.gov under number NCT04606251.

RESULT: There was a significant difference between TG and CG in favor of TG in MMSE, TUG, FIM and GDS (p<0,05); There was no significant difference between groups in OLBT (p>0,05). Statistical results have been showed in Table 1. No safety problem was observed during the treatment. All subjects were completed the study, there was a high adherence to treatment.

CONCLUSION: Physical exercise treatment with telerehabilitation was feasible, safe and well-accepted by people with early-middle stage of AD. Online-supervised exercise program can improve cognitive function, functional mobility, independence and reduce depressive symptoms.

PMID:34971285 | DOI:10.1002/alz.053406

Alzheimers Dement. 2021 Dec;17 Suppl 8:e054804. doi: 10.1002/alz.054804.

ABSTRACT

BACKGROUND: The uniform standardized neuro-cognitive test is a challenge for the primary care physician due to time constraints, interpretation, and clinical use in the daily practice for dementia care.

METHOD: The DMAC was given to 318 patients presenting with memory loss in the disease group and 33 patients in the control group. The DMAC was given between 35-55 minutes after the pre-screening test. Each domain test was bundled to give a comprehensive average score of each domain in percentage: as the person’s ability to recruit neurons in the neural circuit to perform the cognitive task. The test was given individually. The domains tested include visual, auditory, delayed recall, attention, executive, number recall, disinhibition, and working memory.

RESULTS: Statistical analysis with a series of t-Tests showed the diseased group (n-318) had significantly lower scores than the control group (c-33) with confidence interval of 95% in the following domains: visual (p < 0.001), auditory (p < 0.001), delayed recall ( p < 0.001), disinhibition (p < 0.001), attention (p < 0.001), executive function (p < 0.001), numerical recall ( p < 0.001), and working memory (p < 0.001). The average sensitivity of the DMAC across these eight domains was 84.75% while the average specificity was 59.56%.

DISCUSSION: Neuropsychological test batteries have limitations as it takes 4 to 6 hours, which is not possible for the dementia group due to a short attention span and score interpretation is a challenge due to t-score and z-score reporting and selection bias of test battery. In an effort to create a comprehensive, reliable, and simple test for cognitive evaluation by a primary care physician under a controlled environment, we have created a digital mobile cognitive assessment test (DMAC) for memory loss patients with 8 common domains with simple interpretation and guidance to cognitive therapy within one software package. The DMAC has an inbuilt prescreening questionnaire to eliminate and standardize the patient selection.

CONCLUSION: The DMAC is an ideal cognitive test in an outpatient primary care setting as the results are also translated into cognitive therapy & training in simple digital media.

PMID:34971268 | DOI:10.1002/alz.054804

Alzheimers Dement. 2021 Dec;17 Suppl 8:e052545. doi: 10.1002/alz.052545.

ABSTRACT

BACKGROUND: Despite the rapidly rising incidence of cognitive impairment, no current medications have proven effective for mild cognitive impairment (MCI). The Integrated dementia clinic at Dongguk University Ilsan Hospital is a nationally recognized Korean-Western (KW) clinic that provides the integrated medical service via co-consultation by both neurologists and Korean medicine neuropsychologists.

OBJECTIVE: The purpose of this study is to examine whether the integrated KW treatment prevents cognitive decline in patients with MCI as measured by changes in the Mini Mental State Examination (MMSE) scores over time.

METHOD: We retrospectively examined the medical records of patients from May 2015 to June 2020. Of 19 patients who were diagnosed as MCI, twelve MCI patients underwent MMSE at their initial visit to the clinic and at least once more over a period of up to 5 years. These twelve MCI patients divided into two groups: MMSE improvement group vs. MMSE worsening group. We performed the Wilcoxon rank sum test to compare the group achieving improvement in MMSE to decrease in MMSE. We also used the same test to assess the difference in the median length of follow-up between the two groups.

RESULT: The prevalence of MCI seen during the review period was 23% (19/82). The baseline characteristics of patients with MCI were shown in Table 1. Among those twelve MCI patients who received integrated KW treatment, 67 % (8/12) of them achieved improvement in MMSE score, which was statistically significant (p-value = 0.008) compared to those showing a decrease in MMSE score while the length of follow-up was not significantly different between the two groups. The detailed treatment and changes in MMSE presented in Table 2. For treatment from Western medicine, anticonvulsants were most commonly prescribed, and donepezil was given to 63%. Acupuncture (100%), Moxibustion (100%), and herbal medicine (Gagam-sohabhwangwon: 6/8,62.5 %) were most prescribed Korean medicine.

CONCLUSIONS: This study demonstrates, for the first time, that integrated KW treatment positively affects cognitive function in MCI patients with increases in MMSE scores over time. Further research with a larger data set, needs to be conducted to validate the effectiveness of integrative approach.

PMID:34971275 | DOI:10.1002/alz.052545

Alzheimers Dement. 2021 Dec;17 Suppl 8:e054527. doi: 10.1002/alz.054527.

ABSTRACT

BACKGROUND: It is estimated that up to 40% of Alzheimer’s Disease and Related Dementias cases can be prevented or delayed by addressing modifiable factors including those that influence vascular risk (hypertension, obesity, smoking, physical activity, diabetes). Prevention may be particularly important in the vascular dementia subtypes. Despite the supporting evidence, the rates of medical therapy to reduce vascular risk are not well described.

METHOD: We assessed the utilization of statins, aspirin, and blood pressure (BP) medications in adults age ≥65 years cared for at NYU Langone Health, as recorded in the electronic health record. We included two cohorts: cohort 1 included patients who were diagnosed with vascular dementia (VaD) at NYU Langone Barlow Center for Memory Evaluation between January 1, 2015 and June 24, 2019. Cohort 2 extended the inclusion to seniors with VD diagnosis by any NYU Langone physician. Definitions for vascular dementia, the covariates assessed, and medications that we included in each category are shown in Tables 1-3.

RESULT: We included 419 and 3745 patients in cohort 1 and cohort 2, respectively. Table 4 shows the characteristics and medication adherence in cohorts 1 and 2. In cohort 1, the prescription rates for statins, aspirin, and BP medications were 66%, 66%, 70%. In cohort 2, the rates for statin, aspirin, and BP medications were 56%, 46%, and 65%, respectively. The differences between prescription rates in cohort 1 and 2 for the three medication groups were statistically significant (p<0.05).

CONCLUSION: Our analysis of the utilization of cardiovascular medications among patients with vascular dementia illuminates potential gaps both among patients who receive care at specialty clinics, as well as the overall population with vascular dementia. The rates of medication utilization are higher for patients under the care of cognitive neurologists. Electronic health records can help identify large cohorts of patients who may benefit from improved access to preventative measures including cardiovascular medications.

PMID:34971267 | DOI:10.1002/alz.054527

Alzheimers Dement. 2021 Dec;17 Suppl 8:e053351. doi: 10.1002/alz.053351.

ABSTRACT

INTRODUCTION: Neuroplasticity can only occur in an ideal body condition and establish a new synaptic connection with repeated stimulations in weak cognitive domains or circuits.

METHOD: A Two-phase study was planned as a course of memory loss treatment in an outpatient clinic for a period of 3 years. 49 of 72 acquired brain injury and dementia patients completed X≥14 sessions of cognitive therapy intervention within the period of 2-4 months. Patients selected for intervention had mild severe memory loss on MoCA Score [(9-24)/30]. The first phase of intervention was the correction of nutraceutical status and sleep optimization. The second phase of the intervention was individualized cognitive therapy (CT) by trained cognitive therapists after the Digital Mobile Assessment of Cognitive test (DMAC) was given before and after an intervention. The domains included visual, auditory, delayed recall, attention, executive, number recall, disinhibition, language, and working memory.

RESULTS: Statistical analysis of n-49 with confidence interval 95%, series paired t-tests showed in the post-intervention group, on average, scores were higher as follows: Visual domain 4.89% to 13.74% (p < 0.001), Auditory domain 8.35% to 19.72% (p < 0.001), Delayed recall 21.34% to 33.95% (p < 0.001), Disinhibition Frontal domain 6.89% to 21.80% (p < 0.001), Attention domain 9.33%, 26.12% (p < 0.001 ), Executive domain 9.81%, 23.06% ( p < 0.001), Number domain 5.22% to 17.91% (p < 0.001), and Working memory 2.96%, 29.85% (p = 0.01).

DISCUSSION: Dr. Eric Kandel, Nobel Laureate, showed that damaged neurons can synapse after repeated neuron stimulation. Physical therapy is a standard of practice after acquired brain injury, but cognitive impairment evaluation is often ignored. The systematic approach to body optimization for learning and cognitive therapy can change the course of cognitive decline in dementia or acquired brain injury.

CONCLUSION: The significant improvement in mild to severe dementia in short-term memory or patients’ ability of memory retention improved 22% to 34% in the intervention group provides statistically significant evidence that a systematic approach to cognitive therapy can reverse the course of cognitive decline.

PMID:34971240 | DOI:10.1002/alz.053351