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The exploration of molecular characteristics has emerged as a prominent trend to advance precision medicine. The utilization of genetic testing to guide therapy is integral to precision medicine. This study aims to investigate the potential patient populations for the reimbursement of next-generation sequencing (NGS) and assess the budget impact from the perspective of Taiwan’s single insurer, the National Health Insurance Administration.
Methods
To comprehend the scope for medicines with companion diagnostics (CDx) involved, we analyze the U.S. Food and Drug Administration-approved/cleared diagnostic tests, conduct a literature review to identify medicines approved by the European Medicines Agency that require a CDx, and identify the medicines with CDx involved covered by the National Health Insurance (NHI) in Taiwan. Subsequently, we explore the potential reimbursement indications for NGS testing and conduct a budget impact analysis to evaluate the expected financial impact for the NHI over a five-year period. Furthermore, sensitivity analyses are conducted to deal with uncertainty.
Results
We have compiled 13 cancer types for which NGS can serve as a companion diagnostic. These encompass non-small-cell lung cancer, colorectal cancer, breast cancer, ovarian cancer, biliary tract cancer, acute myeloid leukemia, acute lymphoblastic leukemia, melanoma, cholangiocarcinoma, prostate cancer, pancreatic cancer, gastrointestinal stromal tumor, and thyroid cancer/medullary thyroid cancer. The implementation of NGS reimbursement in NHI will benefit 25,000 to 30,000 patients undergoing targeted therapies. The projected incremental budget impact ranges from TWD570 million to TWD650 million (USD19 million to USD22 million) over five years.
Conclusions
This study focuses on evaluating the financial impact of incorporating NGS testing into NHI reimbursement for relevant cancer drug indications. The findings can serve as references for the planning of reimbursement policies. However, with the advancement of precision medicine, it is foreseeable that there will be a broader range of applications for NGS, and its cost will gradually decrease.
Most studies on the impact of the COVID-19 pandemic on depression burden focused on the earlier pandemic phase specific to lockdowns, but the longer-term impact of the pandemic is less well studied. In this population-based cohort study with quasi-experimental design, we examined both the short-term and long-term impacts of COVID-19 on depression incidence and healthcare service use among patients with depression.
Methods
Using the territory-wide electronic medical records in Hong Kong, we identified patients with new diagnoses of depression from 2014 to 2022. An interrupted time-series (ITS) analysis examined changes in incidence of depression before and during the pandemic. We then divided patients into nine cohorts based on year of incidence and studied their initial and ongoing service use until December 2022. Generalized linear modeling compared the rates of healthcare service use in the year of diagnosis between patients newly diagnosed before and during the pandemic. A separate ITS analysis explored the pandemic impact on the ongoing service use among preexisting patients.
Results
There was an immediate increase in depression incidence (RR=1.21; 95% CI: 1.10, 1.33; p<0.001) in the population since the pandemic with a nonsignificant slope change, suggesting a sustained effect until the end of 2022. Subgroup analysis showed that increases in incidence were significant among adults and the older population, but not adolescents. Depression patients newly diagnosed during the pandemic used 11 percent fewer resources than the prepandemic patients in the first diagnosis year. Preexisting depression patients also had an immediate decrease of 16 percent in overall all-cause service use since the pandemic, with a positive slope change indicating a gradual rebound.
Conclusions
During the COVID-19 pandemic, service provision for depression was suboptimal in the face of greater demand generated by the increasing depression incidence. Our findings indicate the need to improve mental health resource planning preparedness for future public health crises.
We developed a real-world evidence (RWE) based Markov model to project the 10-year cost of care for patients with depression from the public payer’s perspective to inform early policy and resource planning in Hong Kong.
Methods
The model considered treatment-resistant depression (TRD) and development of comorbidities along the disease course. The outcomes included costs for all-cause and psychiatric care. From our territory-wide electronic medical records, we identified 25,190 patients with newly diagnosed depression during the period from 2014 to 2016, with follow-up until December 2020 for real-world time-to-event patterns. Costs and time varying transition inputs were derived using negative binomial and parametric survival modeling. The model is available as a closed cohort, which studies a fixed cohort of incident patients, or an open cohort that introduces new patients every year. Utilities values and the number of incident cases per year were derived from published sources.
Results
There were 9,217 new patients with depression in 2023. Our closed cohort model projected that the cumulative cost of all-cause and psychiatric care for these patients would reach USD309 million and USD58 million by 2032, respectively. In our open cohort model, 55,849 to 57,896 active prevalent cases would cost more than USD322 million and USD61 million annually in all-cause and psychiatric care, respectively. Although less than 20 percent of patients would develop TRD or its associated comorbidities, they contribute 31 to 54 percent of the costs. The key cost drivers were the number of annual incident cases and the probability of developing TRD and associated comorbidities and of becoming a low-intensity service user. These factors are relevant to early disease stages.
Conclusions
A small proportion of patients with depression develop TRD, but they contribute to a high proportion of the care costs. Our projection also demonstrates the application of RWE to model the long-term costs of care, which can aid policymakers in anticipating foreseeable burden and undertaking budget planning to prepare for future care needs.
Latent class models for cognitive diagnosis often begin with specification of a matrix that indicates which attributes or skills are needed for each item. Then by imposing restrictions that take this into account, along with a theory governing how subjects interact with items, parametric formulations of item response functions are derived and fitted. Cluster analysis provides an alternative approach that does not require specifying an item response model, but does require an item-by-attribute matrix. After summarizing the data with a particular vector of sum-scores, K-means cluster analysis or hierarchical agglomerative cluster analysis can be applied with the purpose of clustering subjects who possess the same skills. Asymptotic classification accuracy results are given, along with simulations comparing effects of test length and method of clustering. An application to a language examination is provided to illustrate how the methods can be implemented in practice.
Although dietary factors have been examined as potential risk factors for liver cancer, the evidence is still inconclusive. Using a diet-wide association analysis, our research evaluated the associations of 126 foods and nutrients on the risk of liver cancer in a Chinese population. We obtained the diet consumption of 72,680 women in the Shanghai Women’s Health Study using baseline dietary questionnaires. The association between each food and nutrient and liver cancer risk was quantified by Cox regression model. A false discovery rate of 0.05 was used to determine the foods and nutrients which need to be verified. Totally 256 incident liver cancer cases were identified in 1,267,391 person-years during the follow-up duration. At the statistical significance level (P ≤ 0.05), higher intakes of cooked wheaten foods, pear, grape and copper were inversely associated with liver cancer risk, while spinach, leafy vegetables, eggplant and carrots showed the positive associations. After considering multiple comparisons, no dietary variable was associated with liver cancer risk. Similar findings were seen in the stratification, secondary and sensitivity analyses. Our findings observed no significant association between dietary factors and liver cancer risk after considering multiple comparisons in Chinese women. More evidence is needed to explore the associations between diet and female liver cancer occurrence.
Prior to the No Surprises Act (NSA), numerous states passed laws protecting patients from surprise medical bills from out-of-network (OON) hospital-based physicians supporting elective treatment in in-network hospitals. Even in non-emergency situations, patients have little ability to choose physicians such as anaesthesiologists, pathologists or radiologists. Using a comprehensive, multi-payer claims database, we estimated the effect of these laws on hospital-based physician reimbursement, charges, network participation and potential surprise billing episodes. Overall, the state laws were associated with a reduction in anaesthesiology prices and charges, but an increase in pathology and radiology prices. The price effects for each state exhibit substantial heterogeneity. California and New Jersey experienced increases in network participation by anaesthesiologists and pathologists and reductions in potential surprise billing episodes, but, overall, we find little evidence of changes in network participation across all of the states implementing surprise billing laws. Our results suggest that the effects of the NSA may vary across states.
This study examined the sour grapes/sweet lemons rationalization through 2 conditions: ‘attainable’ (sweet lemons) and ‘unattainable’ (sour grapes), reflecting China’s 2019-nCoV vaccination strategy. The aim was to find ways to change people’s beliefs and preferences regarding vaccines by easing their safety concerns and encouraging more willingness to get vaccinated. An online survey was conducted from January 22 to 27, 2021, with 3,123 residents across 30 provinces and municipalities in the Chinese mainland. The direction of belief and preference changed in line with the sour grapes/sweet lemons rationalization. Using hypothetical and real contrasts, we compared those for whom the vaccine was relatively unattainable (‘sour grapes’ condition) with those who could get the vaccine easily (‘sweet lemons’). Whether the vaccine was attainable was determined in the early stage of the vaccine roll-out by membership in a select group of workers that was supposed to be vaccinated to the greatest extent possible, or, by being in the second stage when the vaccine was available to all. The attainable conditions demonstrated higher evaluation in vaccine safety, higher willingness to be vaccinated, and lower willingness to wait and see. Hence, we propose that the manipulation of vaccine attainability, which formed the basis of the application of sour grapes/sweet lemons rationalization, can be utilized as a means to manipulate the choice architecture to nudge individuals to ease vaccine safety concerns, reducing wait-and-see tendencies, and enhancing vaccination willingness. This approach can expedite universal vaccination and its associated benefits in future scenarios resembling the 2019-nCoV vaccine rollout.
This study aimed to investigate the effects of esketamine (Esk) combined with dexmedetomidine (Dex) on postoperative delirium (POD) and quality of recovery (QoR) in elderly patients undergoing thoracoscopic radical lung cancer surgery.
Methods
In this prospective, randomized, and controlled study, 172 elderly patients undergoing thoracoscopic radical lung cancer surgery were divided into two groups: the Esk + Dex group (n = 86) and the Dex group a (n = 86). The primary outcome was the incidence of POD within 7 days after surgery and the overall Quality of Recovery−15 (QoR − 15) scores within 3 days after surgery. Secondary outcomes included postoperative adverse reactions, extubation time, PACU stay, and hospitalization time. Serum levels of IL-6, IL-10, S100β protein, NSE, CD3+, CD4+, and CD8+ were detected from T0 to T5.
Results
Compared with the Dex group, the incidence of POD in the Esk + Dex group was significantly lower at 7 days after surgery (14.6% vs 30.9%; P = 0.013). The QoR − 15 score was significantly increased 3 days after surgery (P < 0.01). Levels of IL-6 and CD8+ were significantly decreased, and IL − 10 levels were significantly increased at T1-T2 (P < 0.05). At T1-T4, NSE levels were significantly decreased, while CD3+ and CD4+/CD8+ values were significantly increased (P < 0.01). At T1-T5, serum S100β protein concentration decreased significantly, and CD4+ value increased significantly (P < 0.01). The incidence of nausea/vomiting and hyperalgesia decreased significantly 48 hours after surgery (P < 0.01). The duration of extubation, PACU stay, and postoperative hospitalization were significantly shortened.
Conclusions
Esketamine combined with dexmedetomidine can significantly reduce the POD incidence and improve the QoR in patients undergoing thoracoscopic radical lung cancer surgery, which may be related to the improvement of cellular immune function.
Foodborne diseases are ongoing and significant public health concerns. This study analysed data obtained from the Foodborne Outbreaks Surveillance System of Wenzhou to comprehensively summarise the characteristics of foodborne outbreaks from 2012 to 2022. A total of 198 outbreaks were reported, resulting in 2,216 cases, 208 hospitalisations, and eight deaths over 11 years. The findings suggested that foodborne outbreaks were more prevalent in the third quarter, with most cases occurring in households (30.8%). Outbreaks were primarily associated with aquatic products (17.7%) as sources of contamination. The primary transmission pathways were accidental ingestion (20.2%) and multi-pathway transmission (12.1%). Microbiological aetiologies (46.0%), including Vibrio parahaemolyticus, Salmonella ssp., and Staphylococcus aureus, were identified as the main causes of foodborne outbreaks. Furthermore, mushroom toxins (75.0%), poisonous animals (12.5%), and poisonous plants (12.5%) were responsible for deaths from accidental ingestion. This study identified crucial settings and aetiologies that require the attention of both individuals and governments, thereby enabling the development of effective preventive measures to mitigate foodborne outbreaks, particularly in coastal cities.
Choline and betaine are important in the body, from cell membrane components to methyl donors. We aimed to investigate trends in dietary intake and food sources of total choline, individual choline forms and betaine in Chinese adults using data from the China Health and Nutrition Survey (CHNS) 1991–2011, a prospective cohort with a multistage, random cluster design. Dietary intake was estimated using three consecutive 24-h dietary recalls in combination with a household food inventory. Linear mixed-effect models were constructed using R software. A total of 11 188 men and 12 279 women aged 18 years or older were included. Between 1991 and 2011, total choline intake increased from 219·3 (95 % CI 215·1, 223·4) mg/d to 269·0 (95 % CI 265·6, 272·5) mg/d in men and from 195·6 (95 % CI 191·8, 199·4) mg/d to 240·4 (95 % CI 237·4, 243·5) mg/d in women (both P-trends < 0·001). Phosphatidylcholine was the major form of dietary choline, and its contribution to total choline increased from 46·9 % in 1991 to 58·8 % in 2011. Cereals were the primary food source of total choline before 2000, while eggs had ranked at the top since 2004. Dietary betaine intake was relatively steady over time with a range of 134·0–151·5 mg/d in men (P-trend < 0·001) and 111·7–125·3 mg/d in women (P-trend > 0·05). Chinese adults experienced a significant increase in dietary intake of choline, particularly phosphatidylcholine during 1991–2011 and animal-derived foods have replaced plant-based foods as the main food sources of choline. Betaine intake remained relatively stable over time. Future efforts should address the health effects of these changes.
To investigate the associations between dietary patterns and biological ageing, identify the most recommended dietary pattern for ageing and explore the potential mediating role of gut microbiota in less-developed ethnic minority regions (LEMRs). This prospective cohort study included 8288 participants aged 30–79 years from the China Multi-Ethnic Cohort study. Anthropometric measurements and clinical biomarkers were utilised to construct biological age based on Klemera and Doubal’s method (KDM-BA) and KDM-BA acceleration (KDM-AA). Dietary information was obtained through the baseline FFQ. Six dietary patterns were constructed: plant-based diet index, healthful plant-based diet index, unhealthful plant-based diet index, healthy diet score, Dietary Approaches to Stop Hypertension (DASH), and alternative Mediterranean diets. Follow-up adjusted for baseline analysis assessed the associations between dietary patterns and KDM-AA. Additionally, quantile G-computation identified significant beneficial and harmful food groups. In the subsample of 764 participants, we used causal mediation model to explore the mediating role of gut microbiota in these associations. The results showed that all dietary patterns were associated with KDM-AA, with DASH exhibiting the strongest negative association (β = −0·91, 95 % CI (–1·19, −0·63)). The component analyses revealed that beneficial food groups primarily included tea and soy products, whereas harmful groups mainly comprised salt and processed vegetables. In mediation analysis, the Synergistetes and Pyramidobacter possibly mediated the negative associations between plant-based diets and KDM-AA (5·61–9·19 %). Overall, healthy dietary patterns, especially DASH, are negatively associated with biological ageing in LEMRs, indicating that Synergistetes and Pyramidobacter may be potential mediators. Developing appropriate strategies may promote healthy ageing in LEMRs.
Purple nutsedge (Cyperus rotundus L.) is one of the world’s resilient upland weeds, primarily spreading through its tubers. Its emergence in rice (Oryza sativa L.) fields has been increasing, likely due to changing paddy-farming practices. This study aimed to investigate how C. rotundus, an upland weed, can withstand soil flooding and become a problematic weed in rice fields. The first comparative analysis focused on the survival and recovery characteristics of growing and mature tubers of C. rotundus exposed to soil-flooding conditions. Notably, mature tubers exhibited significant survival and recovery abilities in these environments. Based on this observation, further investigation was carried out to explore the morphological structure, nonstructural carbohydrates, and respiratory mechanisms of mature tubers in response to prolonged soil flooding. Over time, the mature tubers did not form aerenchyma but instead gradually accumulated lignified sclerenchymal fibers, with lignin content also increasing. After 90 d, the lignified sclerenchymal fibers and lignin contents were 4.0 and 1.1 times higher than those in the no soil-flooding treatment. Concurrently, soluble sugar content decreased while starch content increased, providing energy storage, and alcohol dehydrogenase activity rose to support anaerobic respiration via alcohol fermentation. These results indicated that mature tubers survived in soil-flooding conditions by adopting a low-oxygen quiescence strategy, which involves morphological adaptations through the development of lignified sclerenchymal fibers, increased starch reserves for energy storage, and enhanced anaerobic respiration. This mechanism likely underpins the flooding tolerance of mature C. rotundus tubers, allowing them to endure unfavorable conditions and subsequently germinate and grow once flooding subsides. This study provides a preliminary explanation of the mechanism by which mature tubers of C. rotundus from the upland areas confer flooding tolerance, shedding light on the reasons behind this weed’s increasing presence in rice fields.
This study aimed to understand the potassium voltage-gated channel KQT-like subfamily, member 1 gene polymorphism in a rural elderly population in a county in Guangxi and to explore the possible relationship between its gene polymorphism and blood sugar. The 6 SNP loci of blood DNA samples from 4355 individuals were typed using the imLDRTM Multiple SNP Typing Kit from Shanghai Tianhao Biotechnology Co. The data combining epidemiological information (baseline questionnaire and physical examination results) and genotyping results were statistically analyzed using GMDR0.9 software and SPSS22.0 software. A total of 4355 elderly people aged 60 years and above were surveyed in this survey, and the total abnormal rate of glucose metabolism was 16·11 % (699/4355). Among them, male:female ratio was 1:1·48; the age group of 60–69 years old accounted for the highest proportion, with 2337 people, accounting for 53·66 % (2337/4355). The results of multivariate analysis showed that usually not doing farm work (OR 1·26; 95 % CI 1·06, 1·50), TAG ≥ 1·70 mmol/l (OR 1·19; 95 % CI 1·11, 1·27), hyperuricaemia (OR 1·034; 95 % CI 1·01, 1·66) and BMI ≥ 24 kg/m2 (OR 1·06; 95 % CI 1·03, 1·09) may be risk factors for abnormal glucose metabolism. Among all participants, rs151290 locus AA genotype, A allele carriers (AA+AC) were 0.70 times more likely (0.54 to 0.91) and 0.82 times more likely (0.70 to 0.97) to develop abnormal glucose metabolism than CC genotype carriers, respectively. Carriers of the T allele at the rs2237892 locus (CT+TT) were 0.85 times more likely to have abnormal glucose metabolism than carriers of the CC genotype (0.72 to 0.99); rs2237897 locus CT gene. The possibility of abnormal glucose metabolism in the carriers of CC genotype, TT genotype and T allele (CT + TT) is 0·79 times (0·67–0·94), 0·74 times (0·55–0·99) and 0·78 times (0·66, 0·92). The results of multifactor dimensionality reduction showed that the optimal interaction model was a three-factor model consisting of farm work, TAG and rs2237897. The best model dendrogram found that the interaction between TAG and rs2237897 had the strongest effect on fasting blood glucose in the elderly in rural areas, and they were mutually antagonistic. Environment–gene interaction is an important factor affecting abnormal glucose metabolism in the elderly of a county in Hechi City, Guangxi.
The Indo-Pacific Warm Pool (IPWP) significantly influences the global hydrological cycle through its impact on atmospheric-oceanic circulation. However, gaining a comprehensive understanding of the hydrologic climate dynamics within the IPWP and its broader effects on the global climate have been hindered by spatial and temporal limitations in paleoclimate records on orbital timescales. In this study, we reconstructed precipitation records (approximated from δ18Osw-ivc) over the past 450 kyr, based on planktonic foraminiferal Mg/Ca and δ18O data obtained from International Ocean Discovery Program Site U1486 in the western tropical Pacific. The δ18Osw-ivc record revealed a generally consistent pattern with precession variations over the past 450 kyr, closely corresponding to changes in boreal summer insolation at the equator. The δ18Osw-ivc record displayed an anti-phased relationship with Chinese speleothem δ18O records on the precession band, with lower precipitation in the western tropical Pacific and higher precipitation in the East Asia summer monsoon region during periods of high Northern Hemisphere summer insolation. This anti-phased correlation primarily resulted from the north-south migration of the Intertropical Convergence Zone (ITCZ), influenced by the interhemispheric insolation contrast. By considering additional δ18Osw-ivc records from various locations within the IPWP region, we identified synchronous precipitation changes within the IPWP on the precession band. The synchronization of precipitation on both margins of the ITCZ’s seasonal range and differences between central and marginal regions of the ITCZ within the IPWP revealed the expansion and contraction of the ITCZ on precession band.
Preoperative pneumonia in children with CHD may lead to longer stays in the ICU after surgery. However, research on the associated risk factors is limited. This study aims to evaluate the pre-, intra-, and postoperative risk factors contributing to extended ICU stays in these children.
Methods:
This retrospective cohort study collected data from 496 children with CHD complicated by preoperative pneumonia who underwent cardiac surgery following medical treatment at a single centre from 2017 to 2022. We compared the clinical outcomes of patients with varying ICU stays and utilised multivariate logistic regression analysis and multiple linear regression analyses to evaluate the risk factors for prolonged ICU stays.
Results:
The median ICU stay for the 496 children was 7 days. Bacterial infection, severe pneumonia, and Risk Adjustment for Congenital Heart Surgery-1 were independent risk factors for prolonged ICU stays following cardiac surgery (P < 0.05).
Conclusion:
CHD complicated by pneumonia presents a significant treatment challenge. Better identification of the risk factors associated with long-term postoperative ICU stays in these children, along with timely diagnosis and treatment of respiratory infections in high-risk populations, can effectively reduce ICU stays and improve resource utilisation.
Characterised by the extensive use of obsidian, a blade-based tool inventory and microblade technology, the late Upper Palaeolithic lithic assemblages of the Changbaishan Mountains are associated with the increasingly cold climatic conditions of Marine Isotope Stage 2, yet most remain poorly dated. Here, the authors present new radiocarbon dates associated with evolving blade and microblade toolkits at Helong Dadong, north-east China. At 27 300–24 100 BP, the lower cultural layers contain some of the earliest microblade technology in north-east Asia and highlight the importance of the Changbaishan Mountains in understanding changing hunter-gatherer lifeways in this region during MIS 2.
Coronavirus disease 2019 (COVID-19) has caused psychological distress among health-care professionals (HCP) worldwide, suggesting that morale could also be affected. This warrants further investigation as HCPs’ morale directly impacts delivery of quality care and work productivity. This study aims to explore the experiences of HCPs who served migrant workers in a local COVID-19 hotspot in Singapore and the impact on their morale.
Methods
Eleven volunteer HCPs from a regional hospital in Singapore who served migrant workers in a local COVID-19 hotspot were recruited. Semi-structured face-to-face interviews were conducted, and recordings were transcribed verbatim. Transcripts were analyzed using thematic analysis. Morale of HCPs was evaluated based on responses.
Results
Four main themes emerged: motivators, challenges, support, and leadership. Motivators or factors that drove HCPs to serve include varying personal reasons and a sense of duty to do good. Challenges faced by HCPs include a language barrier, keeping up with rapidly changing workflows, fear of contagion, and coping with emotions. Support and leadership were revealed to have boosted HCPs’ morale.
Conclusions
Peer and social support and effective leadership have potential protective effects on HCPs’ morale against negative experiences faced during the COVID-19 pandemic.
The femtosecond laser filament-induced air laser plays a significant role for the remote sensing of air pollutants. The spatial distributions of air laser intensity were investigated experimentally in previous studies. However, the mechanism of the air laser propagation properties inside the filament plasma has not been quite clear yet. Moreover, few studies have been dedicated to the reproduction of the air laser profile from nitrogen molecules propagating in the filament plasma based on the numerical simulation method. In this study, the lasing action of the air laser from the transition of the first negative (0,0) band of nitrogen ions at 391 nm was simulated during the femtosecond laser filamentation. The beam profile of the air laser changes from a Gaussian or super-Gaussian shape to an outer ring structure by increasing the filament length or nitrogen ion density, which is in accord with the previous experimental result. A multiple-diffraction effect has been proposed to clarify the mechanism of the outer rings beam pattern formation, which is induced by the dynamical interaction between the lasing effect and diffraction effect of the air laser propagating inside the filament plasma. In addition, the amplified air laser power as a function of both the filament length and nitrogen ion density was investigated. Our study would pave the way to improve the energy conversion efficiency and directivity of remote air lasers, which would be significant for remote sensing applications.
The right inferior frontal gyrus (RIFG) is a potential beneficial brain stimulation target for autism. This randomized, double-blind, two-arm, parallel-group, sham-controlled clinical trial assessed the efficacy of intermittent theta burst stimulation (iTBS) over the RIFG in reducing autistic symptoms (NCT04987749).
Methods
Conducted at a single medical center, the trial enrolled 60 intellectually able autistic individuals (aged 8–30 years; 30 active iTBS). The intervention comprised 16 sessions (two stimulations per week for eight weeks) of neuro-navigated iTBS or sham over the RIFG. Fifty-seven participants (28 active) completed the intervention and assessments at Week 8 (the primary endpoint) and follow-up at Week 12.
Results
Autistic symptoms (primary outcome) based on the Social Responsiveness Scale decreased in both groups (significant time effect), but there was no significant difference between groups (null time-by-treatment interaction). Likewise, there was no significant between-group difference in changes in repetitive behaviors and exploratory outcomes of adaptive function and emotion dysregulation. Changes in social cognition (secondary outcome) differed between groups in feeling scores on the Frith-Happe Animations (Week 8, p = 0.026; Week 12, p = 0.025). Post-hoc analysis showed that the active group improved better on this social cognition than the sham group. Dropout rates did not vary between groups; the most common adverse event in both groups was local pain. Notably, our findings would not survive stringent multiple comparison corrections.
Conclusions
Our findings suggest that iTBS over the RIFG is not different from sham in reducing autistic symptoms and emotion dysregulation. Nonetheless, RIFG iTBS may improve social cognition of mentalizing others' feelings in autistic individuals.