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Hematopoietic stem cell transplantation therapy for refractory’ Crohn disease: A systematic review and meta-analysis

Medicine (Baltimore). 2024 Oct 18;103(42):e40144. doi: 10.1097/MD.0000000000040144.

ABSTRACT

BACKGROUND: Despite the availability of numerous treatments for Crohn disease, there are patients who do not respond to any therapy, thereby diminishing their quality of life. The aim of this review is to analyze the efficacy and safety of autologous hematopoietic stem cell transplantation therapy for refractory Crohn disease.

METHODS: This work is a systematic review with meta-analysis conducted in accordance with the guidelines of the Preferred Reporting Items for Systematic Review and Meta-Analyses. Electronic databases such as PubMed, Scopus, Web of Science, and ClinicalTrials were consulted. The searches were carried out in August 2024. To evaluate the efficacy of autologous hematopoietic stem cell transplantation in inducing remission, the mean and standard deviation of the Crohn’s Disease Activity Index pre- and post- treatment were used, and a fixed-effects meta-analysis was conducted. Additionally, to assess the efficacy in perianal fistulas, a random-effects meta-analysis was performed, collecting data on the number of subjects with fistulas at the beginning and end of the intervention. All 95% confidence intervals were calculated, and the I2 statistic was used to assess the heterogeneity of the outcome variables.

RESULTS: A total of 609 records were identified from databases, with 12 studies selected for inclusion in the review. Immediate intervention proved effective in inducing a decrease in the Crohn Disease Activity Index compared to late intervention with conventional therapies. Moreover, the meta-analysis demonstrated efficacy for Crohn disease and associated fistulas with a mean decrease in the CDAI of -217.53 ± 14.3. When evaluating the efficacy of the procedure in perianal fistulas, a risk ratio of 0.47 with a 95% CI of [0.26, 0.86] was obtained. However, the procedure showed adverse effects, such as infections, acute renal failure or deaths.

CONCLUSION: Systemic autologous hematopoietic stem cell transplantation has shown efficacy in patients who fail to achieve remission of their Crohn disease with conventional therapies. This procedure has also demonstrated efficacy in treating perianal fistulas. However, it is essential to carefully evaluate de implementation of this procedure due to the associated risks.

PMID:39432634 | DOI:10.1097/MD.0000000000040144

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Accessibility, Cost, and Quality of an Online Regular Follow-Up Visit Service at an Internet Hospital in China: Mixed Methods Study

J Med Internet Res. 2024 Oct 21;26:e54902. doi: 10.2196/54902.

ABSTRACT

BACKGROUND: Telemedicine provides remote health care services to overcome constraints of time and space in accessing medical care. Similarly, internet hospitals in China support and provide remote health care services. Due to the COVID-19 pandemic, there has been a proliferation of internet hospitals. Many new services, including online consultations and regular online follow-up visit services, can now be accessed via internet hospitals in China. However, the accessibility, cost, and quality advantages of regular online follow-up visit services remain unclear.

OBJECTIVE: This study aimed to evaluate the accessibility, costs, and quality of an online regular follow-up visit service provided by an internet hospital in China. By analyzing the accessibility, costs, and quality of this service from the supply and demand sides, we can summarize the practical and theoretical experiences.

METHODS: A mixed methods study was conducted using clinical records from 18,473 patients receiving 39,239 online regular follow-up visit services at an internet hospital in 2021, as well as interviews with 7 physicians, 2 head nurses, and 3 administrative staff members. The quantitative analysis examined patient demographics, diagnoses, prescriptions, geographic distribution, physician characteristics, accessibility (travel time and costs), and service hours. The qualitative analysis elucidated physician perspectives on ensuring the quality of online health care.

RESULTS: Patients were predominantly middle-aged men with chronic diseases like viral hepatitis who were located near the hospital. The vast majority were from Guangdong province where the hospital is based, especially concentrated in Guangzhou city. The online regular follow-up visit service reduced travel time by 1 hour to 9 hours and costs by ¥6 to ¥991 (US $0.86-$141.32) depending on proximity, with greater savings for patients farther from the hospital. Consultation times were roughly equivalent between online and in-person visits. Physicians provided most online services during lunch breaks (12 PM to 2 PM) or after work hours (7 PM to 11 PM), indicating increased workload. The top departments providing online regular follow-up visit services were Infectious Diseases, Rheumatology, and Dermatology. The most commonly prescribed medications aligned with the prevalent chronic diagnoses. To ensure quality, physicians conducted initial in-person consultations to fully evaluate patients before allowing online regular follow-up visits, during which they communicated with patients to assess conditions and determine if in-person care was warranted. They also periodically reminded patients to come in person for more comprehensive evaluations. However, they acknowledged online visits cannot fully replace face-to-face care.

CONCLUSIONS: Telemedicine services such as online regular follow-up visit services provided by internet hospitals must strictly adhere to fundamental medical principles of diagnosis, prescription, and treatment. For patients with chronic diseases, online regular follow-up visit services improve accessibility and reduce cost but cannot fully replace in-person evaluations. Physicians leverage various strategies to ensure the quality of online care.

PMID:39432365 | DOI:10.2196/54902

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Bouncing back from life’s perturbations: Formalizing psychological resilience from a complex systems perspective

Psychol Rev. 2024 Oct 21. doi: 10.1037/rev0000497. Online ahead of print.

ABSTRACT

Experiencing stressful or traumatic events can lead to a range of responses, from mild disruptions to severe and persistent mental health issues. Understanding the various trajectories of response to adversity is crucial for developing effective interventions and support systems. Researchers have identified four commonly observed response trajectories to adversity, from which the resilient is the most common one. Resilience refers to the maintenance of healthy psychological functioning despite facing adversity. However, it remains an open question how to understand and anticipate resilience, due to its dynamic and multifactorial nature. This article presents a novel formalized framework to conceptualize resilience from a complex systems perspective. We use the network theory of psychopathology, which states that mental disorders are self-sustaining endpoints of direct symptom-symptom interactions organized in a network system. The internal structure of the network determines the most likely trajectory of symptom development. We introduce the resilience quadrant, which organizes the state of symptom networks on two domains: (1) healthy versus dysfunctional and (2) stable versus unstable. The quadrant captures the four commonly observed response trajectories to adversity along those dimensions: resilient trajectories in the face of adversity, as well as persistent symptoms despite treatment interventions. Subsequently, an empirical illustration, by means of a proof-of-principle, shows how simulated observations from four different network architectures lead to the four commonly observed responses to adversity. As such, we present a novel outlook on resilience by combining existing statistical symptom network models with simulation techniques. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

PMID:39432353 | DOI:10.1037/rev0000497

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A review of general cognitive-behavioral programs in English and Welsh prisons and probation services: Three decades of quasi-experimental evaluations

Am Psychol. 2024 Oct 21. doi: 10.1037/amp0001405. Online ahead of print.

ABSTRACT

For over 30 years, general cognitive-behavioral programs have contributed to the rehabilitation services offered within His Majesty’s Prison and Probation Service in England and Wales. There is an extensive body of international evidence that demonstrates the effectiveness of such interventions as a correctional strategy. However, there is widespread variability of program effects associated with the standards of implementation. Over the last 3 decades, British researchers have produced a steady output of quasi-experimental program evaluations that have contributed to the evidence base. The most recent additions are some of the largest and most rigorous available worldwide. This review documents those evaluations and provides a meta-analysis that statistically aggregates the effects of programs delivered in His Majesty’s prisons in England and Wales. We suggest there is sufficient evidence from evaluations of acceptable scientific rigor to conclude that general cognitive-behavioral programs delivered in prisons during the last decade and a half (circa 2006 to 2019) have had a small statistically significant mean reductive effect on general reoffending (odds ratio = 0.91). Program characteristics and implementation factors, including program dose, the scale of service delivery and program integrity, are discussed as possible factors associated with the size of the effect. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

PMID:39432335 | DOI:10.1037/amp0001405

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Communities That HEAL Intervention and Mortality Including Polysubstance Overdose Deaths: A Randomized Clinical Trial

JAMA Netw Open. 2024 Oct 1;7(10):e2440006. doi: 10.1001/jamanetworkopen.2024.40006.

ABSTRACT

IMPORTANCE: The HEALing Communities Study (HCS) evaluated the effectiveness of the Communities That HEAL (CTH) intervention in preventing fatal overdoses amidst the US opioid epidemic.

OBJECTIVE: To evaluate the impact of the CTH intervention on total drug overdose deaths and overdose deaths involving combinations of opioids with psychostimulants or benzodiazepines.

DESIGN, SETTING, AND PARTICIPANTS: This randomized clinical trial was a parallel-arm, multisite, community-randomized, open, and waitlisted controlled comparison trial of communities in 4 US states between 2020 and 2023. Eligible communities were those reporting high opioid overdose fatality rates in Kentucky, Massachusetts, New York, and Ohio. Covariate constrained randomization stratified by state allocated communities to the intervention or control group. Trial groups were balanced by urban or rural classification, 2016-2017 fatal opioid overdose rate, and community population. Data analysis was completed by December 2023.

INTERVENTION: Increased overdose education and naloxone distribution, treatment with medications for opioid use disorder, safer opioid prescribing practices, and communication campaigns to mitigate stigma and drive demand for evidence-based interventions.

MAIN OUTCOMES AND MEASURES: The primary outcome was the number of drug overdose deaths among adults (aged 18 years or older), with secondary outcomes of overdose deaths involving specific opioid-involved drug combinations from death certificates. Rates of overdose deaths per 100 000 adult community residents in intervention and control communities from July 2021 to June 2022 were compared with analyses performed in 2023.

RESULTS: In 67 participating communities (34 in the intervention group, 33 in the control group) and including 8 211 506 participants (4 251 903 female [51.8%]; 1 273 394 Black [15.5%], 603 983 Hispanic [7.4%], 5 979 602 White [72.8%], 354 527 other [4.3%]), the average rate of overdose deaths involving all substances was 57.6 per 100 000 population in the intervention group and 61.2 per 100 000 population in the control group. This was not a statistically significant difference (adjusted rate ratio [aRR], 0.92; 95% CI, 0.78-1.07; P = .26). There was a statistically significant 37% reduction (aRR, 0.63; 95% CI, 0.44-0.91; P = .02) in death rates involving an opioid and psychostimulants (other than cocaine), and nonsignificant reductions in overdose deaths for an opioid with cocaine (6%) and an opioid with benzodiazepine (1%).

CONCLUSION AND RELEVANCE: In this clinical trial of the CTH intervention, death rates involving an opioid and noncocaine psychostimulant were reduced; total deaths did not differ statistically. Community-focused data-driven interventions that scale up evidence-based practices with communications campaigns may effectively reduce some opioid-involved polysubstance overdose deaths.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04111939.

PMID:39432308 | DOI:10.1001/jamanetworkopen.2024.40006

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Trends in Cancer Incidence and Potential Associated Factors in China

JAMA Netw Open. 2024 Oct 1;7(10):e2440381. doi: 10.1001/jamanetworkopen.2024.40381.

ABSTRACT

IMPORTANCE: Timely analysis of cancer incidence trends is crucial for cancer prevention and control, which is a public health priority in China.

OBJECTIVE: To estimate incidence trends for 32 cancers in China from 1983 to 2017 and project changes to 2032, assessing distinct changes due to risk factors and an aging population.

DESIGN, SETTING, AND PARTICIPANTS: This population-based cohort study used data from the Cancer Incidence in Five Continents database (1983-2017). New cases of 32 cancers were collected. Data were analyzed from October 15, 2023, to May 23, 2024.

MAIN OUTCOMES AND MEASURES: Age-standardized incidence rate (AIR) standardized to the World Health Organization World Standard Population, average annual percentage changes (AAPC) using joinpoint regression, and percentage change due to aging and risk factors, using Møller decomposition analysis, stratified by cancer and sex.

RESULTS: A total of 3 677 027 new cancer cases (54.9% male, 45.1% female) were included in the analysis. Increased AIRS were observed for 11 cancers in males and 14 in females from 1983 to 2017, with trends expected to continue until 2032. Thyroid cancer showed the highest increase (AAPC: 7.82% in males; 95% CI, 6.92%-10.38%; 8.59% in females; 95% CI, 7.84%-10.42%), followed by prostate (4.71%; 95% CI, 3.12%-9.95%) and kidney (3.61%; 95% CI, 3.11%-5.82%) cancers in males, and cervical (4.43%; 95% CI, 3.36%-9.44%) and kidney (3.66%; 95% CI, 2.98%-6.86%) cancers in females. The AIRs of lung cancer tended to decrease in males but increase in females during 1983-2017. In contrast, the AIRs of stomach, liver, larynx, and nose and sinuses cancers decreased from 1983 to 2032. From 2018 to 2032, cancer cases were projected to increase primarily due to risk factors for 18 cancers in males and 11 in females, while aging would be associated with the increase in other cancers.

CONCLUSIONS AND RELEVANCE: In this population-based cohort study of incident cancer in the general population, the cancer landscape in China is evolving, with an increasing incidence primarily due to risk factors in 20 cancers and aging in others. Primary prevention efforts to reduce risk exposure are crucial, and further basic research is needed. Additionally, second prevention efforts are imperative to improve cancer survival, particularly among older individuals.

PMID:39432306 | DOI:10.1001/jamanetworkopen.2024.40381

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Three vs 6 Cycles of Chemotherapy for High-Risk Retinoblastoma: A Randomized Clinical Trial

JAMA. 2024 Oct 21. doi: 10.1001/jama.2024.19981. Online ahead of print.

ABSTRACT

IMPORTANCE: Adjuvant therapy is an important and effective treatment for retinoblastoma. However, there is a lack of head-to-head clinical trials comparing 3 vs 6 cycles of CEV chemotherapy (carboplatin, etoposide, and vincristine) for enucleated unilateral retinoblastoma with high-risk pathological features.

OBJECTIVE: To assess whether 3 cycles of CEV chemotherapy is noninferior to 6 cycles for enucleated unilateral retinoblastoma with high-risk pathological features.

DESIGN, SETTING, AND PARTICIPANTS: This double-center, randomized, open-label, noninferiority trial was conducted at 2 premier eye centers in China and included 187 patients who had undergone enucleation for unilateral retinoblastoma with high-risk pathological features (massive choroidal infiltration, retrolaminar optic nerve invasion, or scleral infiltration) between August 2013 and March 2024. The final date of follow-up was March 21, 2024.

INTERVENTIONS: Patients were randomly assigned to receive either 3 (n = 94) or 6 (n = 93) cycles of CEV chemotherapy regimen after enucleation.

MAIN OUTCOMES AND MEASURES: The primary end point was disease-free survival, with a noninferiority margin of 12%. Secondary end points encompassed overall survival, safety, economic burden, and the quality of life of children.

RESULTS: All 187 patients (median [IQR] age, 25.0 [20.0-37.0] months; 83 [44.4%] female) completed the trial. Median (IQR) follow-up was 79.0 (65.5-102.5) months. Five-year disease-free survival was 90.4% for the 3-cycle group vs 89.2% for the 6-cycle group (difference, 1.2% [95% CI, -7.5% to 9.8%]), which met the noninferiority criterion (P = .003 for noninferiority). The 6-cycle group experienced a higher frequency of adverse events, greater reduction in quality of life scores, and increased costs compared with the 3-cycle group.

CONCLUSIONS AND RELEVANCE: Among patients with unilateral pathologic high-risk retinoblastoma, 3 cycles of CEV chemotherapy resulted in 5-year disease-free survival that was noninferior to 6 cycles of CEV chemotherapy.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01906814.

PMID:39432296 | DOI:10.1001/jama.2024.19981

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Community Health Workers Linking Clinics and Schools and Asthma Control: A Randomized Clinical Trial

JAMA Pediatr. 2024 Oct 21. doi: 10.1001/jamapediatrics.2024.3967. Online ahead of print.

ABSTRACT

IMPORTANCE: Childhood asthma is characterized by pervasive disparities, including 3-fold higher hospitalization rates and 7-fold higher death rates for Black children compared with White children. To address asthma disparities, one must intervene in all lived environments.

OBJECTIVE: To determine if a community health worker (CHW) intervention to connect the primary care, home, and school for low-income minoritized school-aged children with asthma and their caregivers improves asthma control.

DESIGN, SETTING, AND PARTICIPANTS: This study was a hybrid effectiveness/implementation trial using a 2 × 2 factorial, cluster randomized clinical trial design of 36 schools crossed with participant-level randomization into a clinic-based CHW intervention. The study was conducted from May 2018 to June 2022. The intervention took place in primary care offices, homes, and 36 West Philadelphia, Pennsylvania, public and charter schools. Children aged 5 to 13 years with uncontrolled asthma were recruited from local primary care practices.

INTERVENTIONS: Asthma management, trigger remediation, and care coordination occurred in school, home, and primary care settings. Children were followed up for 12 months. The Yes We Can Children’s Asthma Program, Open Airways For Schools Plus, and school-based asthma therapy were implemented.

MAIN OUTCOMES AND MEASURES: Improvement in asthma control, as measured by the Asthma Control Questionnaire, comparing the mean difference between groups 1 year after randomization with their baseline (difference in differences). Both primary care and school interventions were dramatically disrupted by the COVID-19 pandemic; therefore, stratified analyses were performed to assess per-protocol intervention efficacy before the pandemic disruptions.

RESULTS: A total of 1875 participants were approached, 1248 were excluded, and 1 was withdrawn. The 626 analyzed study participants (mean [SD] age, 8.7 [2.4] years; 363 male [58%]) self-identified as Black race (96%) and non-Hispanic ethnicity (98%). Although all groups had statistically significant improvements in asthma control from baseline to 12 months (P- group: -0.46; 95% CI, -0.58 to -0.33; P+ group: -0.57; 95% CI, -0.74 to -0.44; S- group: -0.47; 95% CI, -0.58 to -0.35; S+ group: -0.59; 95% CI, -0.74 to -0.44), none of the difference-in-differences estimates from the primary prespecified models showed a clinically meaningful improvement in asthma control. Analysis from the prepandemic interval, however, demonstrated that children in the combined clinic-school intervention had a statistically significant improvement in asthma control scores compared with control (-0.79; 95% CI, -1.40 to -0.18).

CONCLUSIONS AND RELEVANCE: This randomized clinical trial provides preliminary evidence that connecting all lived environments for care of children can be accomplished through linkages with CHWs.

PMID:39432292 | DOI:10.1001/jamapediatrics.2024.3967

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Development and Validation of a Clinical Score to Predict Epilepsy After Cerebral Venous Thrombosis

JAMA Neurol. 2024 Oct 21. doi: 10.1001/jamaneurol.2024.3481. Online ahead of print.

ABSTRACT

IMPORTANCE: One of 10 patients develop epilepsy in the late phase after cerebral venous thrombosis (CVT) diagnosis but predicting the individual risk is difficult.

OBJECTIVE: To develop and externally validate a prognostic score to estimate the individual risk of post-CVT epilepsy.

DESIGN, SETTING, AND PARTICIPANTS: This observational cohort study included both retrospective and prospective patients enrolled from 1994 through 2022. For development of the DIAS3 score, data from the International CVT Consortium (n = 1128), a large international hospital-based multicenter CVT cohort, were used. For validation, data from 2 independent multicenter cohorts, the ACTION-CVT (n = 543) and the Israel CVT study (n = 556), were used. Of 2937 eligible, consecutively enrolled adult patients with radiologically verified CVT, 710 patients with a history of epilepsy prior to CVT, follow-up less than 8 days, and missing late seizure status were excluded.

EXPOSURE: The prediction score (DIAS3) was developed based on available literature and clinical plausibility and consisted of 6 readily available clinical variables collected during the acute phase: decompressive hemicraniectomy, intracerebral hemorrhage at presentation, age, seizure(s) in the acute phase (excluding status epilepticus), status epilepticus in the acute phase, and subdural hematoma at presentation.

MAIN OUTCOME AND MEASURE: Time to a first late seizure, defined as occurring more than 7 days after diagnosis of CVT.

RESULTS: Of 1128 patients included in the derivation cohort (median age, 41 [IQR, 30-53] years; 805 women [71%]), 128 (11%) developed post-CVT epilepsy during a median follow-up of 12 (IQR, 3-26) months. According to the DIAS3 score, the predicted 1-year and 3-year risk of epilepsy in individual patients ranged from 7% to 68% and 10% to 83%, respectively. Internal and external validation showed adequate discrimination in the derivation cohort (1 year and 3 years: C statistic, 0.74; 95% CI, 0.70-0.79) and the 2 independent validation cohorts, (ACTION-CVT) 1 year: C statistic, 0.76; 95% CI, 0.67-0.84; 3 years: C statistic, 0.77; 95% CI, 0.66-0.84; and Israel CVT study 1 year: C statistic, 0.80; 95% CI, 0.75-0.86. Calibration plots indicated adequate agreement between predicted and observed risks.

CONCLUSIONS AND RELEVANCE: The DIAS3 score (freely available online) is a simple tool that can help predict the risk of post-CVT epilepsy in individual patients. The model can improve opportunities for personalized medicine and may aid in decision-making regarding antiseizure medication, patient counseling, and facilitation of research on epileptogenesis in CVT.

PMID:39432281 | DOI:10.1001/jamaneurol.2024.3481

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Hearing outcomes in subtotal facial nerve decompression with preserving ossicular chain intact

Acta Otolaryngol. 2024 Oct 21:1-6. doi: 10.1080/00016489.2024.2415493. Online ahead of print.

ABSTRACT

BACKGROUND: Facial paralysis patients with normal hearing often require ossicular chain dislocation throughout the entire process of facial nerve decompression surgery, and their hearing tends to be slightly impaired after surgery. There is not detailed explanation of hearing changes after facial nerve decompression with preserving intact ossicular chain.

PURPOSE: This study aimed to determine the efficacy and hearing outcomes of facial nerve decompression with preserving ossicular chain intact transmastoid supralabyrinthine recess pathway in Bell’s palsy.

METHODS: A retrospective study comparing the pre- and post-operative facial nerve HB functional grades and hearing results of 12 patients with Bell’s palsy who underwent facial nerve decompression.

RESULTS: Preoperative and postoperative mean House-Brackmann (HB) scores respectively were 4.41 ± 0.67 and 1.58 ± 0.79 grades; The recovery rate to HB grade I, II was 100% or to grade III or lower was 83.3% (10/12). The pre- and post-operative mean PTAs (0.125, 0.25, 0.5, 1, 2, 4, 8KHz) were 19.1 ± 1.9 dB and 36.8 ± 4.1 dB; The pre- and postoperative low frequencies (0.125, 0.25KHz) were 18.5 ± 2.3 dB and 26 ± 3.8 dB; The pre- and postoperative speech frequencies (0.5, 1, 2KHz) mean PTAs were 18.5 ± 1.9 dB and 21.5 ± 2.9 dB; Comparison of pre- and post-operative hearing outcomes at all frequencies, low frequencies, and speech frequencies showed no statistically significant differences (p < 0.05); The pre- and postoperative high frequencies (4, 8KHz) were 20.6 ± 4.7 dB and 70.4 ± 11.6 dB and the hearing outcomes were statistically significant (p >0.05).

CONCLUSION: Subtotal facial nerve decompression with preserving ossicular chain intact transmastoid supralabyrinthine recess pathway does not cause the verbal frequency hearing loss of Bell’s palsy, but it has high frequency sensorineural hearing loss, which tend to be unavoidable and independent of the skill of the surgical operator.

PMID:39432250 | DOI:10.1080/00016489.2024.2415493