Category: Nevin Manimala

PLoS One. 2023 Aug 1;18(8):e0289021. doi: 10.1371/journal.pone.0289021. eCollection 2023.

ABSTRACT

BACKGROUND: Ulcerative colitis (UC) is a manifestation of inflammatory bowel disease (IBD), which can cause inflammation of the intestinal tract. Ankylosing spondylitis (AS) is an inflammatory disease of the sacroiliac joints. Many studies have found that some UC patients progress to AS. In this study, we conducted a literature search and meta-analysis to investigate the prevalence of AS among UC patients during follow-up.

METHODS: The studies related to the AS among patients with UC were obtained from PubMed, Web of Science, Embase, and Cochrane Library databases since its inception-December 2022. The literature was screened strictly according to inclusion and exclusion criteria. Forest plots were used to detect the overall incidence of AS in UC and to compare the risk ratios for the development of AS in the UC. The heterogeneity of studies was assessed using I2 statistical methods.

RESULTS: 1) 17 studies with 98704 UC patients were included. 2)700 UC patients developed AS during follow-up (1.66%, 95% CI: 0.89-2.62%). Human leukocyte antigen B27 (HLA-B27) was reported in 3 studies. HLA-B27 positivity was significantly higher than the incidence of HLA-B27 negativity in AS patients (68.29% vs 31.71%, P < 0.0001). There was significantly increased risk of AS development in HLA-B27 positive IBD patients (RR: 22.17, 95% CI: 11.79-41.66, P < 0.0001). 3)The definite follow-up time was reported in 12 studies (range: 0.3-40 years). After follow-up for ≥5 years, the incidence of AS among patients with UC was 1.75% (95% CI: 0.62-3.37%). Meanwhile, after follow-up for <5 years, the incidence of AS among patients with UC was 1.41% (95% CI: 0.65-2.37%) which was significant.

CONCLUSION: Patients with UC are more likely to develop AS in the future. Furthermore, the IBD patients are at a higher risk of AS who have positive HLA-B27. The incidence of AS increased with longer follow-up time.

PMID:37527250 | DOI:10.1371/journal.pone.0289021

JMIR Public Health Surveill. 2023 Aug 1;9:e44822. doi: 10.2196/44822.

ABSTRACT

BACKGROUND: COVID-19 vaccine hesitancy reduces vaccination rates, which is detrimental to building herd immunity and halting the spread of COVID-19 and its variations. Most researches have simply identified the reasons affecting COVID-19 vaccination reluctance without delving into its dynamics, which makes forecasting future trends difficult.

OBJECTIVE: This study aimed to examine the current COVID-19 vaccine booster hesitancy rate in Chinese adults as well as the dynamics of vaccine hesitancy and its influencing factors. The results of this study will have practical implications for policy responses in mainland China, and effective COVID-19 booster vaccination in specific populations.

METHODS: The web-based survey was completed by creating questionnaires and using a stratified random sampling method to collect information from adults (≥18 years old) among 2556 households in 4 geographical regions of China. We collected sociodemographic information, health status, awareness of COVID-19 and its vaccine, self-perceptions, trust in medical staff and vaccine developers, and so on. The odds ratios and 95% CI for the statistical associations were estimated using logistic regression models.

RESULTS: Overall, 6659 participants (females: n=3540, 53.2%; males: n=3119, 46.8%) responded. In total, 533 (8%; 95% CI 7.4%-8.7%) participants presented a clear hesitancy in receiving the COVID-19 booster vaccination, while 736 (11.1%; 95% CI 10.3%-11.8%) expressed hesitancy in regular booster vaccination. A higher prevalence of vaccine hesitancy in both booster vaccination and regular booster vaccination was observed among participants with a history of allergies, experiencing chronic disease, lower levels of public health prevention measures or susceptibility or benefits or self-efficiency, higher levels of severity or barriers, and lower trust in both medical staff and vaccine developers (P<.05). The females and participants with higher education levels, higher levels of barriers, lower levels of susceptibility, and lower trust in vaccine developers preferred to have attitudinal changes from acceptance to hesitancy, while people with higher education levels, lower self-report health conditions, experiencing chronic disease, history of allergies, and lower trust in medical staff and developers were all positively associated with constant COVID-19 booster hesitancy.

CONCLUSIONS: The prevalence of COVID-19 vaccine booster hesitancy is not high in mainland China. However, there is a slight increment in hesitancy on regular booster vaccination. Conducting targeted information guidance for people with higher education levels and chronic diseases, as well as improving accessibility to booster vaccination and increasing trust in medical staff and vaccine producers may be highly effective in reducing vaccine hesitancy.

PMID:37526963 | DOI:10.2196/44822

JAMA Netw Open. 2023 Aug 1;6(8):e2326546. doi: 10.1001/jamanetworkopen.2023.26546.

ABSTRACT

IMPORTANCE: Black patients present with more aggressive disease and experience higher mortality than White patients with prostate cancer. Race and social determinants of health influence prostate cancer-specific mortality and overall survival (OS); however, in a previous trial, Black patients did not have inferior outcomes compared with White patients, possibly because of equitable access to care available in a clinical trial setting.

OBJECTIVE: To compare differences in survival outcomes of patients with metastatic castration-sensitive prostate cancer (mCSPC) by race in a phase 3 trial with a large proportion of Black patients.

DESIGN, SETTING, AND PARTICIPANTS: This secondary analysis of patient-level data of a prospective phase 3 randomized clinical trial included patients with newly diagnosed mCSPC enrolled between March 1, 2013, and July 15, 2017. Analysis was conducted between December 2022 and February 2023.

INTERVENTIONS: Patients receiving androgen deprivation therapy were randomized (1:1) to receive either orteronel 300 mg orally twice daily (experimental group) or bicalutamide 50 mg orally daily (control group).

MAIN OUTCOMES AND MEASURES: OS, with progression-free survival (PFS) as a secondary end point.

RESULTS: Among 1313 participants, 135 (10%) identified as Black and 1077 (82%) as White, with an equal racial distribution between groups. Black patients were younger (median [IQR] age, 65.8 [60-70] vs 68.4 [62.5-74.1] years; P = .001) and had a higher median (IQR) baseline prostate-specific antigen response rate than White patients (54.7 [19.8-222.0] vs 26.7 [9.2-96.0] ng/mL; P < .001). At a median follow-up of 4.9 years, Black and White patients had similar median PFS (2.3 years; 95% CI, 1.8-1.4 years vs 2.9 years; 95% CI, 2.5-3.3 years; P = .71) and OS (5.5 years; 95% CI, 4.8-NR vs 6.3 years; 95% CI, 5.7-NR; P = .65). The multivariable analysis confirmed similar PFS and OS after adjusting for known prognostic factors. No interaction between race and treatment was observed.

CONCLUSIONS AND RELEVANCE: In this secondary analysis of a randomized clinical trial studying androgen deprivation therapy with first- or second-generation androgen receptor pathway inhibitors, both Black and White patients demonstrated similar OS and PFS. Equitable access to care may reduce historical differences in outcomes between Black and White patients with advanced prostate cancer.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01809691.

PMID:37526936 | DOI:10.1001/jamanetworkopen.2023.26546

JAMA Netw Open. 2023 Aug 1;6(8):e2326654. doi: 10.1001/jamanetworkopen.2023.26654.

ABSTRACT

IMPORTANCE: Patients with head and neck squamous cell carcinoma (HNSCC) have a significant risk of locoregional recurrence within the first 2 years, with approximately two-thirds of patients experiencing such recurrence. While early recurrence detection may be associated with improved patient outcomes, the association of such detection with survival remains uncertain.

OBJECTIVE: To investigate the association of an intensive posttreatment follow-up strategy using 18F-fludeoxyglucose-positron emission tomography with computed tomography (18FDG-PET/CT) with survival among patients with HNSCC.

DESIGN, SETTING, AND PARTICIPANTS: This case-control study was conducted among patients treated at 1 of 3 locations in Brest, France (University Hospital, Military Hospital, or Pasteur Clinic). The statistical analysis was conducted from January to June 2023. All adults with histologically proven HNSCC who were treated with curative intent between January 1, 2006, and December 31, 2019, and achieved a complete response on imaging at 3 to 6 months were included. They had a minimum of 3 years of follow-up.

EXPOSURES: Patients undergoing an intensive posttreatment follow-up strategy had 18FDG-PET/CT (PET/CT group) at months 12, 24, and 36, chosen at the discretion of ear, nose, and throat surgeons.

MAIN OUTCOMES AND MEASURES: Overall survival (OS) at 3 years.

RESULTS: Among 782 patients with HNSCC (642 males [82.1%]; median [IQR] age, 61 [56-68] years), 497 patients had 18FDG-PET/CT during follow-up and 285 patients had conventional follow-up (CFU group). Cox regression analysis showed an association between undergoing 18FDG-PET/CT and lower risk of death (odds ratio, 0.71; 95% CI, 0.57-0.88; P = .002) after adjustment for covariates (age, sex, comorbidities, primary location, stage, surgeon, year of treatment, and treatment). The mean (SD) 3-year OS was significantly better in the PET/CT vs CFU group (72.5% [2.0%] vs 64.3% [2.9%]; P = .002). Analysis based on American Joint Committee on Cancer stage showed significantly better mean (SD) 3-year OS for advanced stages III and IV in the PET/CT group (373 patients) vs CFU group (180 patients; 68.5% [2.4%] vs 55.4% [3.8%]; P < .001), while no significant difference was observed between patients with stage I or II HNSCC. Analysis based on primary tumor site revealed significantly longer mean (SD) 3-year OS for oropharyngeal tumor in the PET/CT group (176 patients) than the CFU group (100 patients; 69.9% [3.5%] vs 60.5% [5.0%]; P = .04).

CONCLUSIONS AND RELEVANCE: This case-control study found that use of 18FDG-PET/CT in the standard annual CFU of HNSCC was associated with a 3-year survival benefit, with a larger benefit for patients with advanced initial tumor stage (III-IV) and oropharyngeal disease.

PMID:37526935 | DOI:10.1001/jamanetworkopen.2023.26654

Lab Anim. 2023 Aug 1:236772231191879. doi: 10.1177/00236772231191879. Online ahead of print.

NO ABSTRACT

PMID:37526929 | DOI:10.1177/00236772231191879

Eur Arch Paediatr Dent. 2023 Aug 1. doi: 10.1007/s40368-023-00827-w. Online ahead of print.

ABSTRACT

PURPOSE: The current study compares articaine 4% with lidocaine 2% in terms of injection pain and effectiveness of anesthesia when treating permanent mandibular first molars (PMFMs) affected by molar incisor hypomineralization (MIH). In addition to comparing the complications of local anesthesia for both solutions.

METHODS: The sample included 20 children. Each child was randomly assigned to either articaine 4% or lidocaine 2% in their first session with the other solution being used at the subsequent session. Injection pain and the effectiveness of anesthesia were assessed using the Wong-Baker Faces® Pain Rating Scale and the Face, Legs, Activity, Cry, and Consolability (FLACC) scale. Parents were asked to report any complications of local anesthesia. The Wilcoxon-matched pairs signed-rank test was used to analyze the data.

RESULTS: Patients experienced greater pain when receiving articaine 4% injections according to both scales, differences were statistically significant when using the Wong-Baker Faces® Pain Rating scale (p < 0.05). Whereas, the FLACC scale did not show such differences (P > 0.05). Although there were no significant differences between the two solutions regarding the effectiveness of local anesthesia according to both scales (P > 0.05), articaine 4% was clinically found to be more effective than lidocaine 2%. No complications of local anesthesia were reported.

CONCLUSIONS: Articaine 4% injection was more painful than lidocaine 2%. However, both solutions were effective in anesthetizing PMFMs affected by MIH and without anesthetic complications in the studied sample.

TRIAL REGISTRATION: Clinical trial, NCT05200884, ( https://clinicaltrials.gov/ct2/show/NCT05200884 ).

PMID:37526883 | DOI:10.1007/s40368-023-00827-w

J Cancer Surviv. 2023 Aug 1. doi: 10.1007/s11764-023-01423-z. Online ahead of print.

ABSTRACT

PURPOSE: To investigate the extent to which three systematic approaches for prioritizing symptoms lead to similar treatment advices in cancer survivors with co-occurring fear of cancer recurrence, depressive symptoms, and/or cancer-related fatigue.

METHODS: Psychological treatment advices were was based on three approaches: patient preference, symptom severity, and temporal precedence of symptoms based on ecological momentary assessments. The level of agreement was calculated according to the Kappa statistic.

RESULTS: Overall, we found limited agreement between the three approaches. Pairwise comparison showed moderate agreement between patient preference and symptom severity. Most patients preferred treatment for fatigue. Treatment for fear of cancer recurrence was mostly indicated when based on symptom severity. Agreement between temporal precedence and the other approaches was slight. A clear treatment advice based on temporal precedence was possible in 57% of cases. In cases where it was possible, all symptoms were about equally likely to be indicated.

CONCLUSIONS: The three approaches lead to different treatment advices. Future research should determine how the approaches are related to treatment outcome. We propose to discuss the results of each approach in a shared decision-making process to make a well-informed and personalized decision with regard to which symptom to target in psychological treatment.

IMPLICATIONS FOR CANCER SURVIVORS: This study contributes to the development of systematic approaches for selecting the focus of psychological treatment in cancer survivors with co-occurring symptoms by providing and comparing three different systematic approaches for prioritizing symptoms.

PMID:37526860 | DOI:10.1007/s11764-023-01423-z

Adv Exp Med Biol. 2023;1430:41-58. doi: 10.1007/978-3-031-34567-8_3.

ABSTRACT

This chapter describes the regulation of cell and gene therapy products (CGTPs) in Switzerland and its legal basis. The Swiss Agency for Therapeutic Products, Swissmedic, is the lead Regulatory Authority and its ATMP Division is responsible for the regulation of these products at the level of clinical trials and marketing authorization. CGTPs are regulated similarly to medicinal products. The legal basis is set by the Therapeutic Product Act, the Transplantation Act, the Human Research Act, and associated ordinances. The ATMP Division is involved in processes such as scientific advice meetings, presubmission advice meetings, pharmacovigilance, market surveillance, import/export approvals, manufacturing license approval, and inspections. In Switzerland, guidance documents relevant for cell and gene therapy provided by PIC/S, OECD, ICH, Ph.Eur., EMA, or FDA are considered. In order to harmonize requirements for CGTPs, the ATMP Division is in constant exchange of information with foreign Regulatory Authorities and part of working groups of ICH, IPRP, and Ph.Eur. As CGTPs are biologically and technically complex, a risk-based approach is applied on a case-by-case basis for the evaluation of clinical trial and marketing applications. A substantial part of this chapter will provide requirements with respect to the manufacturing and quality, nonclinical and clinical evaluation of CGTPs. Furthermore, information will be provided regarding the use of real-world evidence in evaluation of clinical long-term efficacy and safety in case of rare diseases where the numbers of patients are too small for statistically meaningful analysis during clinical trials. Finally, the chapter will provide information on a health technology assessment (HTA) program that was launched in 2015 in Switzerland by the federal authorities.

PMID:37526841 | DOI:10.1007/978-3-031-34567-8_3

J Gen Intern Med. 2023 Aug 1. doi: 10.1007/s11606-023-08328-8. Online ahead of print.

ABSTRACT

BACKGROUND: High-need, high-cost Medicare patients can have difficulties accessing office-based primary care. Home-based primary care (HBPC) can reduce access barriers and allow a clinician to obtain valuable information not obtained during office visit, possibly leading to reductions in hospital use.

OBJECTIVE: To determine whether HBPC for high-need, high-cost patients reduces hospitalizations and Medicare inpatient expenditures.

DESIGN: We conducted a matched retrospective cohort study using a difference-in-differences analysis to examine patients 2 years before and 2 years after their first home visit (HBPC group).

PARTICIPANTS: The study included high-need, high-cost fee-for-service Medicare patients without prior HBPC use, of which 55,303 were new HBPC recipients and 156,142 were matched comparison patients.

INTERVENTION: Receipt of at least two HBPC visits and, within 6 months of the index HBPC visit, a majority of a patient’s primary care visits in the home.

MAIN MEASURES: Total and potentially avoidable hospitalizations and Medicare inpatient expenditures.

KEY RESULTS: HBPC reduced total hospitalization rates, but the marginal effects were not statistically significant: a reduction of 11 total hospitalizations per 1000 patients in the first year (- 0.6%, p = 0.19) and 14 in the second year (- 0.7%, p = 0.16). However, HBPC reduced potentially avoidable hospitalization rates in the second year. The estimated marginal effect was a reduction of 6 potentially avoidable hospitalizations per 1000 patients in the first year (- 1.6%, p = 0.16) and 11 in the second (- 3.1%, p = 0.01). The estimated effect of HBPC was a small decrease in inpatient expenditures of $24 per patient per month (- 1.1%, p = 0.10) in the first year and $0 (0.0%, p = 0.99) in the second.

CONCLUSIONS: After high-need, high-cost patients started receiving HBPC, they did not experience fewer total hospitalizations or lower inpatient spending but may have had lower rates of potentially avoidable hospitalizations after 2 years.

PMID:37526814 | DOI:10.1007/s11606-023-08328-8

Sports Med. 2023 Aug 1. doi: 10.1007/s40279-023-01892-3. Online ahead of print.

ABSTRACT

BACKGROUND: Hyperthermia (and associated health and performance implications) can be a significant problem for athletes and teams involved in intermittent sports. Quantifying the highest thermal strain (i.e. peak core body temperature [peak T_c]) from a range of intermittent sports would enhance our understanding of the thermal requirements of sport and assist in making informed decisions about training or match-day interventions to reduce thermally induced harm and/or performance decline.

OBJECTIVE: The objective of this systematic review was to synthesise and characterise the available thermal strain data collected in competition from intermittent sport athletes.

METHODS: A systematic literature search was performed on Web of Science, MEDLINE, and SPORTDiscus to identify studies up to 17 April 2023. Electronic databases were searched using a text mining method to provide a partially automated and systematic search strategy retrieving terms related to core body temperature measurement and intermittent sport. Records were eligible if they included core body temperature measurement during competition, without experimental intervention that may influence thermal strain (e.g. cooling), in healthy, adult, intermittent sport athletes at any level. Due to the lack of an available tool that specifically includes potential sources of bias for physiological responses in descriptive studies, a methodological evaluation checklist was developed and used to document important methodological considerations. Data were not meta-analysed given the methodological heterogeneity between studies and therefore were presented descriptively in tabular and graphical format.

RESULTS: A total of 34 studies were selected for review; 27 were observational, 5 were experimental (2 parallel group and 3 repeated measures randomised controlled trials), and 2 were quasi-experimental (1 parallel group and 1 repeated measures non-randomised controlled trial). Across all included studies, 386 participants (plus participant numbers not reported in two studies) were recruited after accounting for shared data between studies. A total of 4 studies (~ 12%) found no evidence of hyperthermia, 24 (~ 71%) found evidence of ‘modest’ hyperthermia (peak T_c between 38.5 and 39.5 °C), and 6 (~ 18%) found evidence of ‘marked’ hyperthermia (peak T_c of 39.5 °C or greater) during intermittent sports competition.

CONCLUSIONS: Practitioners and coaches supporting intermittent sport athletes are justified to seek interventions aimed at mitigating the high heat strain observed in competition. More research is required to determine the most effective interventions for this population that are practically viable in intermittent sports settings (often constrained by many competing demands). Greater statistical power and homogeneity among studies are required to quantify the independent effects of wet bulb globe temperature, competition duration, sport and level of competition on peak T_c, all of which are likely to be key modulators of the thermal strain experienced by competing athletes.

REGISTRATION: This systematic review was registered on the Open Science Framework ( https://osf.io/vfb4s ; https://doi.org/10.17605/OSF.IO/EZYFA , 4 January 2021).

PMID:37526813 | DOI:10.1007/s40279-023-01892-3