Nevin Manimala

J Patient Rep Outcomes. 2022 Dec 23;6(1):129. doi: 10.1186/s41687-022-00534-y.

ABSTRACT

BACKGROUND: The Primary Mitochondrial Myopathy Symptom Assessment (PMMSA) is a 10-item patient-reported outcome (PRO) measure designed to assess the severity of mitochondrial disease symptoms. Analyses of data from a clinical trial with PMM patients were conducted to evaluate the psychometric properties of the PMMSA and to provide score interpretation guidelines for the measure.

METHODS: The PMMSA was completed as a daily diary for approximately 14 weeks by individuals in a Phase 2 randomized, placebo-controlled crossover trial evaluating the safety, tolerability, and efficacy of subcutaneous injections of elamipretide in patents with mitochondrial disease. In addition to the PMMSA, performance-based assessments, clinician ratings, and other PRO measures were also completed. Descriptive statistics, psychometric analyses, and score interpretation guidelines were evaluated for the PMMSA.

RESULTS: Participants (N = 30) had a mean age of 45.3 years, with the majority of the sample being female (n = 25, 83.3%) and non-Hispanic white (n = 29, 96.6%). The 10 PMMSA items assessing a diverse symptomology were not found to form a single underlying construct. However, four items assessing tiredness and muscle weakness were grouped into a “general fatigue” domain score. The PMMSA Fatigue 4 summary score (4FS) demonstrated stable test-retest scores, internal consistency, correlations with the scores produced by reference measures, and the ability to differentiate between different global health levels. Changes on the PMMSA 4FS were also related to change scores produced by the reference measures. PMMSA severity scores were higher for the symptom rated as “most bothersome” by each subject relative to the remaining nine PMMSA items (most bothersome symptom mean = 2.88 vs. 2.18 for other items). Distribution- and anchor-based evaluations suggested that reduction in weekly scores between 0.79 and 2.14 (scale range: 4-16) may represent a meaningful change on the PMMSA 4FS and reduction in weekly scores between 0.03 and 0.61 may represent a responder for each of the remaining six non-fatigue items, scored independently.

CONCLUSIONS: Upon evaluation of its psychometric properties, the PMMSA, specifically the 4FS domain, demonstrated strong reliability and construct-related validity. The PMMSA can be used to evaluate treatment benefit in clinical trials with individuals with PMM. Trial registration ClinicalTrials.gov identifier, NCT02805790; registered June 20, 2016; https://clinicaltrials.gov/ct2/show/NCT02805790 .

PMID:36562873 | DOI:10.1186/s41687-022-00534-y

Cell Tissue Res. 2022 Dec 23. doi: 10.1007/s00441-022-03732-8. Online ahead of print.

ABSTRACT

In this study, a biological conduit, consisting of an adipocyte-derived mesenchymal stem cell (AdMSCs) sheet and amniotic membrane (AM), was designed for the reconstruction of peripheral nerve defects. To evaluate the effect of the produced conduit on neural regeneration, a 10-mm sciatic nerve defect was created in rats, and experiments were carried out on six groups, i.e., sham control group (SC), negative control group (NC), nerve autograft group (NG), the biological conduit (AdMSCs + AM) group, the commercial PGA tube conduit (PGA) group, and the conduit only consisting of AM (AM) group. The effects of different nerve repair methods on the peripheral nerve and gastrocnemius muscle were evaluated by functional, histological, and immunohistochemical tests. When the number of myelinated axons was compared between the groups of AdMSCs + AM and PGA, it was higher in the AdMSCs + AM group (p < 0.05). The percentage of gastrocnemius collagen bundle area of AdMSCs + AM group was found to be statistically lower than the PGA group (p < 0.05). The muscle fiber diameter of AdMSCs + AM group was lower than that of the NG group, but significantly higher than that of the PGA group and the AM group (p < 0.001). Muscle weight index was significantly higher in the AdMSCs + AM group compared to the PGA group (p < 0.05). It was observed that nerve regeneration was faster in the AdMSCs + AM group, and there was an earlier improvement in pin-prick score and sciatic functional index compared to the PGA group and the AM group. In conclusion, the biological conduit prepared from the AdMSCs sheet and AM is regarded as a new biological conduit that can be used as an alternative treatment method to nerve autograft in clinical applications.

PMID:36562866 | DOI:10.1007/s00441-022-03732-8

Pediatr Surg Int. 2022 Dec 23;39(1):60. doi: 10.1007/s00383-022-05344-3.

ABSTRACT

BACKGROUND: Our study aimed to compare the clinical outcomes and cost-efficiency of antibiotic management versus laparoscopic appendectomy for acute uncomplicated appendicitis (AUA) in children during the COVID-19 pandemic when resources were limited and transmission risks uncertain.

METHOD: In this prospective comparative cohort study, we analyzed the data of 139 children diagnosed with AUA meeting the following inclusion criteria: 5-18 years of age, symptoms duration of ≤ 48 h, appendix diameter ≤ 11 mm and no appendicolith. Treatment outcomes between non-operative management group (78/139) and upfront laparoscopic appendectomy group (61/139) were compared. Antibiotic regimes were intravenous ceftriaxone/metronidazole or amoxicillin/clavulanic acid for 48 h, followed by oral antibiotics to complete total 10-days course.

RESULTS: 8/78 (10.3%) children had early failure (within 48 h) requiring appendectomy. 17/70 (24.3%) patients experienced late recurrence within mean follow-up time of 16.2 ± 4.7 months. There were no statistical differences in peri-operative complications, negative appendicectomy rate, and incidence of perforation and hospitalization duration between antibiotic and surgical treatment groups. Cost per patient in upfront surgical group was significantly higher ($6208.5 ± 5284.0) than antibiotic group ($3588.6 ± 3829.8; p = 0.001).

CONCLUSION: Despite 24.3% risk of recurrence of appendicitis in 16.2 ± 4.7 months, antibiotic therapy for AUA appears to be a safe and cost-effective alternative to upfront appendectomy.

PMID:36562855 | DOI:10.1007/s00383-022-05344-3

J Exp Orthop. 2022 Dec 23;9(1):123. doi: 10.1186/s40634-022-00559-8.

ABSTRACT

PURPOSE: Knee osteoarthritis (OA) is the most common form of clinical arthritis in middle-aged and older individuals. Undenatured or native type II (TII) collagen derived from the chicken sternum has a good therapeutic effect on relieving severe pain of OA. Hence, the present study aimed to investigate the efficacy and safety of TII collagen (Native CT-II®) in individuals with knee OA.

METHODS: We conducted a 12-week randomised, double-blind, placebo-controlled, parallel-group study on 101 participants aged 40-65 years with knee OA. The participants were randomised to receive either TII collagen, glucosamine hydrochloride + chondroitin sulfate (G + C) or a placebo. The primary outcome was an improvement in the joint health of the participants assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) compared to G + C and placebo.

RESULTS: Compared with the placebo group (n = 27), the TII collagen group (n = 29) and G + C group (n = 29) significantly improved the overall joint health measured by the change in WOMAC total score (week 12: TII collagen = -32.47 ± 19.51 and G + C = -33.74 ± 24.64 vs. placebo = -13.84 ± 17.61; p < 0.05) and relieved knee joint pain (week 12: TII collagen = -5.69 ± 3.66 and G + C = -6.03 ± 4.72 vs. placebo = -2.71 ± 3.95; p < 0.05). The statistically significant effect was observed as early as 4 weeks after the investigational product administration. Additionally, the TII collagen was more effective in improving the quality of life than the G + C.

CONCLUSION: TII collagen not only has a significantly better effect and high safety profile for OA but also improves the quality of life of patients.

LEVEL OF EVIDENCE: Level 1 – Randomized Controlled Trial.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04470336 ; First submitted date: July 08, 2020; First posted date: July 14, 2020.

PMID:36562843 | DOI:10.1186/s40634-022-00559-8

J Med Philos. 2022 Dec 23;47(6):711-722. doi: 10.1093/jmp/jhac027.

ABSTRACT

Opponents of the provision of therapeutic, healthy limb amputation in Body Integrity Identity Disorder cases argue that such surgeries stand in contrast to the goal of medical practice – that of health restoration and maintenance. This paper refutes such a conclusion via an appeal to the nuanced and reflective model of health proposed by Georges Canguilhem. The paper examines the conceptual entanglement of the statistically common with the normatively desirable, arguing that a healthy body can take multiple forms, including that of an amputee, provided that such a form enables the continuing ability to initiate new norms of existence. It concludes that the practice of healthy limb amputation in cases of Body Integrity Identity Disorder is not only compatible with the goal of medicine but is potentially the only method of achieving this goal in the face of a complex and often mischaracterized disorder.

PMID:36562839 | DOI:10.1093/jmp/jhac027

Eur J Pediatr. 2022 Dec 23. doi: 10.1007/s00431-022-04765-5. Online ahead of print.

ABSTRACT

Non-operative reduction has emerged as first line in the management of uncomplicated intussusception. The aim of this study was to compare the outcome of ultrasound-guided saline hydrostatic reduction and ultrasound-guided pneumatic reduction of intussusception in infants. This is a prospective study of infants with uncomplicated intussusception confirmed by ultrasound over a period of 21 months from December 2018 to August 2020. Fifty-two (69.3%) out of seventy-five infants were eligible and randomized based on simple random sampling technique into two groups: Group A included patients who had ultrasound-guided hydrostatic (saline) reduction; Group B included patients who had ultrasound-guided pneumatic (air) reduction. The success rates, time to reduction and complication rates were assessed. The success rates, between the saline hydrostatic reduction group and pneumatic reduction group, were comparable [17 (65.4%) versus 19 (73.1%); relative risk (RR) 0.8; 95% confidence interval (CI) 0.6-1.2; p = 0.54]. The mean time to reduction was higher in the saline hydrostatic reduction group (15.4 ± 5.1 min versus 10.8 ± 4.1 min; p = 0.003). There was no statistically significant difference in the perforation and recurrence rates between the two groups.

CONCLUSION: Saline hydrostatic reduction and pneumatic reduction of uncomplicated intussusception under ultrasound guidance in infants might have comparable outcomes. However, pneumatic reduction may be faster.

WHAT IS KNOWN: • Ileocolic intussusception is the most common cause of intestinal obstruction in infants. • Ultrasonography is useful in the diagnosis and non-operative treatment of ileocolic intussusception.

WHAT IS NEW: • Ultrasound-guided hydrostatic enema and ultrasound-guided pneumatic enema are similarly effective and safe techniques in the reduction of ileocolic intussusception. • Reduction of ileocolic intussusception under ultrasound guidance is a great technique that may prove useful in the developing world due to lower cost of required equipment.

PMID:36562833 | DOI:10.1007/s00431-022-04765-5

Lasers Med Sci. 2022 Dec 23;38(1):16. doi: 10.1007/s10103-022-03686-x.

ABSTRACT

To examine the effects of photobiomodulation (PBM) in healthy volunteers using photonic stimulation of acupuncture points on conditioned pain modulation (CPM), temporal summation of pain (TSP), and offset analgesia (OA), which reflect some aspects of endogenous pain modulation. We included 15 men and 15 women (age, 31.5 [27.3-37.0], body mass index, 25.7 [24.4-27.1], Fitzpatrick skin typing, II: 20, III: 8, IV: 2). CPM, TSP, and OA were evaluated after a sham procedure (control session) and after acupuncture point stimulation (LI4 and LI10 on the non-dominant forearm) using linear polarized near-infrared light irradiation (LPNILI; wavelengths peaked at approximately 1000 nm, output: 1.4 W/cm², spot diameter: 10 mm, spot size: 1.02 cm², maximum temperature: 40.5 °C, pulse width: 1 s, frequency: 0.2 Hz) (PBM session). Differences in CPM, TSP, and OA between the two sessions were evaluated by the paired t-test and Fisher’s exact test (statistical significance: p < 0.05). Values indicate median [interquartile range]. LPNILI significantly increased CPM in all participants (control session: 12.1 [-4.5-37.4], PBM session: 23.9 [8.3-44.8], p < 0.05) and women (control session: 16.7 [-3.4-36.6], PBM session: 38.7 [24.6-52.1], p < 0.05). The CPM effect increment was significantly higher in women than in men (p = 0.0253). LPNILI decreased TSP in participants with higher TSP ratios (p = 0.0219) and increased OA in participants with lower OA scores (p = 0.0021). LPNILI enhanced endogenous pain modulation in healthy volunteers, particularly in women, as evaluated using CPM. CPM, TSP, and OA evaluations are potentially useful for discriminating PBM responders from non-responders.

PMID:36562828 | DOI:10.1007/s10103-022-03686-x

Support Care Cancer. 2022 Dec 23;31(1):78. doi: 10.1007/s00520-022-07544-y.

ABSTRACT

PURPOSE: Care for older adults with cancer became more challenging during the COVID-19 pandemic, particularly in urban hotspots. This study examined the potential differences in healthcare providers’ provision of as well as barriers to cancer care for older adults with cancer between urban and suburban/rural settings.

METHODS: Members of the Advocacy Committee of the Cancer and Aging Research Group, with the Association of Community Cancer Centers, surveyed multidisciplinary healthcare providers responsible for the direct care of patients with cancer. Respondents were recruited through organizational listservs, email blasts, and social media messages. Descriptive statistics and chi-square tests were used.

RESULTS: Complete data was available from 271 respondents (urban (n = 144), suburban/rural (n = 127)). Most respondents were social workers (42, 44%) or medical doctors/advanced practice providers (34, 13%) in urban and suburban/rural settings, respectively. Twenty-four percent and 32.4% of urban-based providers reported “strongly considering” treatment delays among adults aged 76-85 and > 85, respectively, compared to 13% and 15.4% of suburban/rural providers (Ps = 0.048, 0.013). More urban-based providers reported they were inclined to prioritize treatment for younger adults over older adults than suburban/rural providers (10.4% vs. 3.1%, p = 0.04) during the pandemic. The top concerns reported were similar between the groups and related to patient safety, treatment delays, personal safety, and healthcare provider mental health.

CONCLUSION: These findings demonstrate location-based differences in providers’ attitudes regarding care provision for older adults with cancer during the COVID-19 pandemic.

PMID:36562819 | DOI:10.1007/s00520-022-07544-y

Anal Bioanal Chem. 2022 Dec 23. doi: 10.1007/s00216-022-04472-y. Online ahead of print.

ABSTRACT

Urine albumin concentration and albumin-creatinine ratio are important for the screening of early-stage kidney damage. Commutable urine certified reference materials (CRMs) for albumin and creatinine are necessary for standardization of urine albumin and accurate measurement of albumin-urine ratio. Two urine CRMs for albumin and creatinine with certified values determined using higher-order reference measurement procedures were evaluated for their commutability on five brands/models of clinical analyzers where different reagent kits were used, including Roche Cobas c702, Roche Cobas c311, Siemens Atellica CH, Beckman Coulter AU5800, and Abbott Architect c16000. The commutability study was conducted by measuring at least 26 authentic patient urine samples and the human urine CRMs using both reference measurement procedures and the routine methods. Both the linear regression model suggested by the Clinical and Laboratory Standard Institute (CLSI) guidelines and log-transformed model recommended by the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Commutability Working Group were used to evaluate the commutability of the human urine CRMs. The commutability of the human urine CRMs was found to be generally satisfactory on all five clinical analyzers for both albumin and creatinine, suggesting that they are suitable to be used routinely by clinical laboratories as quality control or for method validation of urine albumin and creatinine measurements.

PMID:36562812 | DOI:10.1007/s00216-022-04472-y

Stomatologiia (Mosk). 2022;101(6):62-68. doi: 10.17116/stomat202210106162.

NO ABSTRACT

PMID:36562369 | DOI:10.17116/stomat202210106162