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One obstacle to adopting instrumental variable (IV) methods in pharmacoepidemiology is their reliance on strong, unverifiable assumptions. We can falsify IV assumptions by leveraging the causal structure, which can strengthen or refute their plausibility and increase the validity of effect estimates. We illustrate a systematic approach to evaluate calendar time IV assumptions in estimating the known effect of thiazolidinediones on hospitalized heart failure. Using cohort entry time before and after 09/2010, when the U.S. Food and Drug Administration issued a safety communication as a proposed IV, we estimated IV and propensity score-weighted 2-year risk differences (RDs) using Medicare data (2008-2014). We (i) performed inequality tests, (ii) identified the negative control IV/outcome using causal assumptions, (iii) estimated RDs after narrowing the calendar time range and excluding patients likely associated with unmeasured confounding, (iv) derived bounds for RDs, and (v) estimated the proportion of compliers and their characteristics. The findings revealed that IV assumptions were violated and RDs were extreme, but the assumptions became more plausible upon narrowing the calendar time range and restricting the cohort by excluding prevalent heart failure (the strongest measured predictor of outcome). Systematically evaluating IV assumptions could help detect bias in IV estimators and increase their validity.

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In recent years the diagnostics of pulmonary artery embolisms (PE) has gained significance, with confirmation occurring in only about 15-25 % of suspected cases. Despite technological advances, radiological methods remain problematic due to radiation and contrast medium exposure. Clinical scores play a crucial role in the risk assessment of PE. High-risk situations call for specific measures, while negative D­dimers can help avoid overdiagnosis. Computed tomographic pulmonary angiography (CTPA) remains the gold standard with high sensitivity and specificity. Treatment requires an interdisciplinary team (pulmonary embolism response team, PERT). Anticoagulation is an option for stable patients, while in unstable or unsuccessful courses, thrombolysis or interventional procedures can be considered. Side effects, especially the risk of bleeding, need to be considered for both forms of treatment.

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BACKGROUND: Higher-level functional capacity (HLFC) is crucial for the independent living of older adults. While internet use positively impacts the health of older adults, its effect on HLFC and how this effect varies with educational attainment remains uncertain. OBJECTIVE: This longitudinal study aimed to investigate whether internet use could mitigate the risk of HLFC decline and if this benefit extends to older adults with lower levels of education. METHODS: The data were sourced from the Japan Gerontological Evaluation Study (JAGES), encompassing 8050 community-dwelling adults aged 65 years and older from 2016 to 2019. The study focused on those who remained self-sufficient from 2016 to 2019, identifying participants with independent HLFC in 2016. The Tokyo Metropolitan Institute of Gerontology Index of Competence defined HLFC operationally, consisting of 3 subscales, namely instrumental activities of daily living, intellectual activity, and social role. The primary variable was the frequency of internet use in 2016; participants who reported using the internet were classified as internet users, while those who answered "No" were identified as nonusers. The study compared the effects of internet use on HLFC decline across educational levels of ≤9 years, 10-12 years, and ≥13 years using Poisson regression analysis adjusted for robust SE to calculate the risk ratio (RR) and 95% CI for HLFC decline in 2019. RESULTS: After adjusting for demographic and health condition risk factors, internet use was significantly linked to a decreased risk of HLFC decline in older adults over 3 years, including those with lower educational levels. Internet users with ≤9 years of educational attainment experienced a suppressed decline in the total score (RR 0.57, 95% CI 0.43-0.76; P<.001); instrumental activities of daily living (RR 0.58, 95% CI 0.38-0.91; P=.02), intellectual activity (RR 0.60, 95% CI 0.41-0.89; P=.01), and social role (RR 0.74, 95% CI 0.56-0.97; P=.03) compared with nonusers. Participants with 10-12 years of education showed suppression rates of 0.78 (95% CI 0.63-0.98; P=.03), 0.59 (95% CI 0.39-0.90; P=.01), 0.91 (95% CI 0.63-1.31; P=.61), and 0.82 (95% CI 0.68-1.00; P=.05), respectively, and those with ≥13 years displayed suppression rates of 0.65 (95% CI 0.51-0.85; P=.001), 0.55 (95% CI 0.36-0.83; P=.01), 0.64 (95% CI 0.37-1.10; P=.11), and 0.83 (95% CI 0.64-1.08; P=.17), respectively. CONCLUSIONS: These findings indicate that internet use supports the maintenance of HLFC independence in older adults with higher education and those with lower educational levels. Encouraging internet use among older adults with lower levels of education through future policies could help narrow functional health disparities associated with educational attainment.

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Three experiments with rats examined the impact of a retrieval-extinction procedure on ABA and AAB renewal of instrumental learning. In all experiments, rats were trained to run down an alley for alcoholic beer in Context A. Then, the instrumental response underwent extinction, which was conducted in Context B for Experiments 1 and 2, and in Context A for Experiment 3. In each experiment, one group of animals received a brief exposure to the beer prior to each extinction session, whereas this beer exposure was omitted for a second group. Moreover, Experiment 2 comprised a third group that was exposed to non-alcoholic beer before each extinction session. Finally, all rats were tested in their extinction context and in a second context, which was Context A for Experiments 1 and 2, and Context B for Experiment 3. We found ABA (Experiments 1 and 2) and AAB (Experiment 3) renewal of beer seeking in those animals for which beer exposure prior to extinction was omitted. However, response recovery was not evident when animals received exposure to beer before extinction, regardless of whether alcoholic or non-alcoholic beer was used. Our results suggest that the renewal of alcohol seeking can be prevented by means of the retrieval-extinction paradigm.

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BACKGROUND: Schizophrenia is a disorder associated with neurocognitive deficits that adversely affect daily functioning and impose an economic burden. Cognitive rehabilitation interventions, particularly during the early phases of illness, have been shown to improve cognition, functionality, and quality of life. The Feuerstein Instrumental Enrichment (FIE) program, based on the Mediated Learning Experience and the Structural Cognitive Modifiability theory, has been applied in various disorders, but its applicability in schizophrenia has not yet been clarified. OBJECTIVE: This study aims to investigate the effects of the FIE program on the functionality of patients with first-episode schizophrenia. METHODS: In total, 17 patients will be recruited for an open-label intervention consisting of twice-weekly sessions for 10 weeks. The primary outcome measure will be changes in the Goal Achievement Scale score. Maze task performance from the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) battery will serve as a secondary outcome measure. At the same time, changes in Positive and Negative Syndrome Scale scores and other MATRICS domains will be analyzed as exploratory outcomes. Assessments will be administered before and after the intervention, with a follow-up period of 6 months. RESULTS: This trial was preregistered in The Brazilian Registry of Clinical Trials (RBR-4gzhy4s). By February 2024, 11 participants were enrolled in the training. Recruitment is expected to be completed by May 2024. Data analysis will be conducted between May and September 2024. The results are expected to be published in January 2025. CONCLUSIONS: This study may establish a protocol for the FIE program that uses mediation techniques for individuals in the early stages of schizophrenia. The results will add to the knowledge about strategies to promote cognitive skills and functional impairment in daily life. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/57031.

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INTRODUCTION AND HYPOTHESIS: Guidelines recommend episiotomy for instrumental vaginal delivery with an optimal incision angle of 60° to protect the anal sphincter. The "Episiometer" is a new device promising a 60° incision angle. We compared the incidence of obstetric anal sphincter injury (OASI) and post-repair suture angle of episiotomies made with conventional "eyeballing" versus Episiometer guided during instrumental delivery. METHODS: We conducted this randomized controlled trial in a tertiary care teaching institute in southern India after ethical committee approval, trial registration, and informed consent. We randomized (block) 328 pregnant women aged 18 years and above with term, singleton fetuses delivered by instruments into Episiometer-guided (164) or conventional episiotomy (164) groups (allocation concealed). We compared the OASI (identified clinically) and the suture angle measured from the midline (assessor blinded) in the two groups. We followed up on the subjects at 6 and 12 weeks to assess perineal pain and fecal/flatus incontinence. RESULTS: The incidence of OASI of 0.61% in the Episiometer group was significantly lower compared with 4.88% in the eyeballing group (Chi-squared = 5.6; p = 0.02; adjusted risk ratio = 5.9; CI 0.7-46.1; p = 0.09). A significantly higher proportion of subjects (59.1%) in the Episometer group had a post-suture angle between 36 and 40° compared with 36.6% in the eyeballing group (Chi-squared = 21.8, p < 0.001). We found no significant difference in the perineal pain or Wexner score during follow-up. CONCLUSION: The Episiometer-guided episiotomy during instrumental delivery resulted in a significantly higher suture angle and lower obstetric anal sphincter injuries than with conventional eyeballing.

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INTRODUCTION: Cervical laceration is an obstetric injury associated with severe postpartum hemorrhage and subsequent spontaneous preterm birth. While operative vaginal delivery is a known risk factor for cervical laceration, it is unclear whether forceps and vacuum deliveries incur the same risk. The aim of this systematic review was to compare the risk of cervical laceration between operative instruments (forceps vs vacuum). MATERIAL AND METHODS: Medline, Embase, Global Health, CENTRAL, Emcare, and Web of Science were searched from inception until August 2024 with terms related to operative vaginal delivery and cervical laceration. Studies comparing the risk of cervical laceration in individuals undergoing forceps or vacuum delivery were included. Two authors conducted screening, data extraction, and quality assessment of all studies. Random-effects models were used to pool risk ratios across studies and certainty of evidence was assessed using Cochrane methods and the GRADE approach. PROSPERO Registration Number CRD42023421890. RESULTS: Thirteen studies were eligible for inclusion, 3 randomized controlled trials (RCTs) and 10 observational studies. The overall rate of cervical laceration was 0.35% (990/284218 births) where 1.04% of forceps deliveries (456/43817) were complicated by cervical laceration compared to 0.22% of vacuum deliveries (534/240401). The risk of cervical laceration was 2-5 fold greater in forceps deliveries than in vacuum deliveries: pooled unadjusted risk ratio [RR] 4.83, 95% confidence interval [CI] 1.56-14.98 among RCTs and pooled unadjusted RR 1.89, 95% CI 1.59-2.24 among observational studies. The overall quality of evidence was low to moderate mainly due to the lack of attention to confounding in the included literature. The GRADE assessment indicated that the certainty of evidence was very low for observational studies and moderate for RCTs. CONCLUSIONS: Low certainty of evidence indicates that forceps deliveries may be associated with an increased risk of cervical laceration compared to vacuum deliveries.

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The storage duration of fresh meat products is a contributing factor leading to increased waste and loss at the retail counter. Losses of fresh pork can be linked to packaging methods that do not protect the attributes of color, taste, and odors consumers use in determining wholesome meat. Boneless pork loins (N = 63) were fabricated into 2.54-cm-thick chops and assigned to one of three vacuum treatments (VacA, VacB, VacC) or a fourth polyvinyl chloride overwrap (PVC) treatment to assess objective fresh color, cook loss, Warner-Bratzler shear force (WBSF), and lipid oxidation. Pork chops (n = 882) were evaluated at 5-day intervals (D 0, 5, 10, 15) in a randomized complete block design. Pork chop surface color was lighter (L*; p < 0.0001) when stored in a vacuum compared to PVC-packaged loin chops, regardless of storage duration. Redness (a*) values were greater (p < 0.0001) for loin chops stored in PVC than all other vacuum packaging treatments throughout the entire 15-day display period. Relative values for chroma on PVC-packaged loin chops were greater (p < 0.0001) throughout the simulated retail display period. An interaction of day and packaging treatment (p < 0.0343) occurred for WBSF. Lipid oxidation for pork chops packaged using PVC was significantly greater (p < 0.0001) from Day 10 through the completion of the storage period. Results indicate that vacuum packaging limits the deterioration of fresh pork loin chops, whereas traditional overwrapping expedites the color and lipid oxidation during refrigerated storage.

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Storing ground beef at frozen temperatures prior to refrigerated display when using thermoforming vacuum packaging is not a common manufacturing practice. However, limited data on thermoforming packaging film and its interaction with meat quality suggests that more information is needed. The current study aimed to identify the influences of thermoforming packaging on the surface color and lipid oxidation of ground beef. Ground beef was portioned into 454 g bricks and packaged into one of three thermoforming films: T1 (150 µ polyethylene/EVOH/polyethylene coextrusion), T2 (175 µ polyethylene /EVOH/polyethylene coextrusion), and T3 (200 µ polyethylene/EVOH/polyethylene coextrusion), stored for 21 days at -20.83 °C (±1.50 °C), and displayed for 42 days at 3.0 °C ± 1.5 °C. There were no statistical differences for the packaging treatment of lipid oxidation (p = 0.0744), but oxidation increased throughout storage day (p < 0.0001). The main effects of treatment and day resulted in altered (p < 0.05) surface lightness (L*), redness (a*), yellowness, hue angle (°), red-to-brown (RTB), and relative myoglobin for met-myoglobin (MET), deoxymyoglobin (DMB), and oxymyoglobin (OMB). Surprisingly, there was an interaction between treatment and day for the calculated relative values of chroma (p = 0.0321), Delta E (p = 0.0155), and the ratio of a*:b* (p < 0.0001). These results indicate that thermoforming vacuum packaging can reduce the rate of deterioration that occurs to ground beef color and the rate of oxidation.

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BACKGROUND: Genome-wide association studies have enabled Mendelian randomization analyses to be performed at an industrial scale. Two-sample summary data Mendelian randomization analyses can be performed using publicly available data by anyone who has access to the internet. While this has led to many insightful papers, it has also fuelled an explosion of poor-quality Mendelian randomization publications, which threatens to undermine the credibility of the whole approach. FINDINGS: We detail five pitfalls in conducting a reliable Mendelian randomization investigation: (1) inappropriate research question, (2) inappropriate choice of variants as instruments, (3) insufficient interrogation of findings, (4) inappropriate interpretation of findings, and (5) lack of engagement with previous work. We have provided a brief checklist of key points to consider when performing a Mendelian randomization investigation; this does not replace previous guidance, but highlights critical analysis choices. Journal editors should be able to identify many low-quality submissions and reject papers without requiring peer review. Peer reviewers should focus initially on key indicators of validity; if a paper does not satisfy these, then the paper may be meaningless even if it is technically flawless. CONCLUSIONS: Performing an informative Mendelian randomization investigation requires critical thought and collaboration between different specialties and fields of research.

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Background: An escalating body of clinical trials and observational studies hints at a plausible link between gut flora and postpartum depression (PPD). The definitive causal dynamics between these two entities remain shrouded in ambiguity. Therefore, in this study, we employed the two-sample Mendelian randomization approach to ascertain the causal link between gut microbiota and PPD. Methods: Summary-level GWAS data related to the human gut microbiota were obtained from the international consortium MiBioGen and the Dutch Microbiome Project (species). For PPD, GWAS data were derived from the FinnGen biobank, consisting 57,604 cases and 596,601 controls. The inverse variance weighted method (IVW) as the cornerstone of our analytical approach. Subsequent to this, a comprehensive suite of tests for pleiotropy and heterogeneity were conducted to ensure the reliability and robustness of our findings. Results: We identified 12 bacterial taxa associated with the risk of PPD. Veillonellaceae, Ruminococcaceae UCG 011, Bifidobacterium adolescentis, Paraprevotella clara, Clostridium leptum, Eubacterium siraeum, Coprococcus catus exhibited an inversely associated with the risk of PPD. Alphaproteobacteria, Roseburia, FamilyXIIIAD3011group, Alistipes onderdonkii, Bilophila wadsworthia showed a positive correlation with the risk of PPD. Limitations: The GWAS data derived from the MiBioGen consortium, DMP, and FinnGen consortium, may introduce selection bias. Moreover, the data primarily originates from European populations, hence extrapolating these results to diverse populations should be approached with caution. The etiological factors behind PPD remain enigmatic, alluding to the existence of potential undisclosed confounders. Conclusion: Based on this MR analysis, we found a causal relationship between certain gut microbial communities and PPD. Future clinical studies can further explore the treatment of PPD through the combined use of microorganisms. This not only offers insights into the pathogenesis of PPD but also lays the foundation for utilizing gut microbiota as biotherapeutics in treating neurological disorders.

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INTRODUCTION: Among older adults without cancer, living alone is associated with poor health outcomes. However, among older adults with non-small cell lung cancer (NSCLC) who live alone, data on function, cognition, and quality of life (QOL) during systemic treatment remain limited. MATERIALS AND METHODS: We enrolled adults aged ≥65 with advanced NSCLC starting a new chemotherapy, immunotherapy, and/or targeted therapy regimen with non-curative intent. Patients completed geriatric assessments including instrumental activities of daily living (IADL), Montreal Cognitive Assessment, and QOL pretreatment and at 1, 2, 4, and 6 months, or until treatment discontinuation, whichever occurred earlier. We categorized change in IADL, cognition, and QOL as stable/improved, declined with recovery, or declined without recovery using clinically meaningful definitions of change. We used multinomial logistic regression to compare change between patients who lived alone versus with others. RESULTS: Among 149 patients, median age was 73; 21% lived alone. Pretreatment IADL, cognition, and QOL scores were similar between older adults who lived alone versus with others. During NSCLC treatment, older adults who lived alone had similar trajectories of function (52% functional decline vs 38%), cognition (43% cognitive decline vs 50%), and QOL (45% QOL decline vs 44%) compared with those who lived with others. In unadjusted analyses, patients who lived alone were more likely to develop functional decline with recovery (reference category: stable/improved function) than those who lived with others (relative risk ratio 4.07, 95% CI 1.14-14.6, p = 0.03). However, this association was not observed after adjusting for age, race, prior NSCLC treatment, current treatment group, and pretreatment geriatric assessment differences. There were no differences in cognitive or QOL trajectories in unadjusted or adjusted analyses. DISCUSSION: Approximately half of older adults with advanced NSCLC who lived alone were able to maintain their function, cognition, and QOL during NSCLC treatment, which was similar to older adults who lived with others. Many older adults with advanced NSCLC who live alone can receive systemic treatment with individualized supportive care.

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Functional limitations refer to the dependency to perform activities of daily living. Increasing evidence has demonstrated a bidirectional association between functional limitations and cognitive functioning, although the exact mechanism remains unclear. This study investigated whether social participation bidirectionally mediates the association between functional limitations and cognitive decline. We analyzed a sample of 16,385 middle-aged and older adults (aged over 50 years) using longitudinal data from the China Health and Retirement Longitudinal Study (CHARLS; Waves 1-4). We utilized a cross-lagged panel model to examine the bidirectional mediation of social participation between functional limitations and cognitive functioning over a span of eight years. The results indicated that social participation bidirectionally and partially mediated the relationship between the onset of functional limitations and cognitive decline, indicating that social participation may play an important role in mitigating the disablement process.

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Mendelian randomization (MR) addresses causal questions using genetic variants as instrumental variables. We propose a new MR method, G-Estimation under No Interaction with Unmeasured Selection (GENIUS)-MAny Weak Invalid IV, which simultaneously addresses the 2 salient challenges in MR: many weak instruments and widespread horizontal pleiotropy. Similar to MR-GENIUS, we use heteroscedasticity of the exposure to identify the treatment effect. We derive influence functions of the treatment effect, and then we construct a continuous updating estimator and establish its asymptotic properties under a many weak invalid instruments asymptotic regime by developing novel semiparametric theory. We also provide a measure of weak identification, an overidentification test, and a graphical diagnostic tool.

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BACKGROUND: Previous observational studies have hinted at a potential correlation between aplastic anemia (AA) and the gut microbiome. However, the precise nature of this bidirectional causal relationship remains uncertain. METHODS: We conducted a bidirectional two-sample Mendelian randomization (MR) study to investigate the potential causal link between the gut microbiome and AA. Statistical analysis of the gut microbiome was based on data from an extensive meta-analysis (genome-wide association study) conducted by the MiBioGen Alliance, involving 18,340 samples. Summary statistical data for AA were obtained from the Integrative Epidemiology Unit database. Single -nucleotide polymorphisms (SNPs) were estimated and summarized using inverse variance weighted (IVW), MR Egger, and weighted median methods in the bidirectional MR analysis. Cochran's Q test, MR Egger intercept test, and sensitivity analysis were employed to assess SNP heterogeneity, horizontal pleiotropy, and stability. RESULTS: The IVW analysis revealed a significant correlation between AA and 10 bacterial taxa. However, there is currently insufficient evidence to support a causal relationship between AA and the composition of gut microbiome. CONCLUSION: This study suggests a causal connection between the prevalence of specific gut microbiome and AA. Further investigation into the interaction between particular bacterial communities and AA could enhance efforts in prevention, monitoring, and treatment of the condition.

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OBJECTIVE: Observational studies have established a connection between gut microbiota and ankylosing spondylitis (AS) risk; however, whether the observed associations are causal remains unclear. Therefore, we conducted a two-sample Mendelian randomization (MR) analysis to assess the potential causal associations of gut microbiota with AS risk. METHODS: Instrumental variants of gut microbiota were obtained from the MiBioGen consortium (n = 18,340) and the Dutch Microbiome Project (n = 7738). The FinnGen consortium provided genetic association summary statistics for AS, encompassing 2860 cases and 270,964 controls. We used the inverse-variance weighted (IVW) method as the primary analysis, supplemented with the weighted median method, maximum likelihood-based method, MR pleiotropy residual sum and outlier test, and MR-Egger regression. In addition, we conducted a reverse MR analysis to assess the likelihood of reverse causality. RESULTS: After the Bonferroni correction, species Bacteroides vulgatus remained statistically significantly associated with AS risk (odds ratio (OR) 1.55, 95% confidence interval (CI) 1.22-1.95, P = 2.55 × 10-4). Suggestive evidence of associations of eleven bacterial traits with AS risk was also observed (P < 0.05 by IVW). Among them, eight were associated with an elevated AS risk (OR 1.37, 95% CI 1.07-1.74, P = 0.011 for phylum Verrucomicrobia; OR 1.31, 95% CI 1.03-1.65, P = 0.026 for class Verrucomicrobiae; OR 1.17, 95% CI 1.01-1.36, P = 0.035 for order Bacillales; OR 1.31, 95% CI 1.03-1.65, P = 0.026 for order Verrucomicrobiales; OR 1.43, 95% CI 1.13-1.82, P = 0.003 for family Alcaligenaceae; OR 1.31, 95% CI 1.03-1.65, P = 0.026 for family Verrucomicrobiaceae; OR 1.31, 95% CI 1.03-1.65, P = 0.026 for genus Akkermansia; OR 1.55, 95% CI 1.19-2.02, P = 0.001 for species Sutterella wadsworthensis). Three traits exhibited a negative association with AS risk (OR 0.68, 95% CI 0.53-0.88, P = 0.003 for genus Dialister; OR 0.84, 95% CI 0.72-0.97, P = 0.020 for genus Howardella; OR 0.75, 95% CI 0.59-0.97, P = 0.026 for genus Oscillospira). Consistent associations were observed when employing alternate MR methods. In the reverse MR, no statistically significant correlations were detected between AS and these bacterial traits. CONCLUSION: Our results revealed the associations of several gut bacterial traits with AS risk, suggesting a potential causal role of gut microbiota in AS development. Nevertheless, additional research is required to clarify the mechanisms by which these bacteria influence AS risk. Key Points • The association of gut microbiota with AS risk in observational studies is unclear. • This MR analysis revealed associations of 12 gut bacterial traits with AS risk.

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Texture and sensory studies at various temperatures are important in evaluating and improving the functionality of butter. While literature is scarce, we evaluated and compared the effect of temperature (5-25°C) on the texture, rheological and sensory properties of commercial butter samples (salted, unsalted, cultured, and spreadable) from the New Zealand market. In addition, the instrumental analyses were compared with the sensory evaluation, to understand the possibility of using instrumental analysis to evaluate consumer liking for different butters. Butter type, temperature, and their type-temperature interaction exhibited significant differences for all instrumental textural parameters. As expected, higher temperature produced softer butter that was more spreadable, liquid-like, less adhesive, less cohesive, had lower storage modulus (G') and lower loss modulus (G″) with the melting of milk fat crystals; however, the rate of change varied for the different butter samples. We have established meltability as the parameter for evaluating butter selection for different applications. The spreadable butter sample exhibited the lowest hardness and G', and highest spreadability (p < .05) at all temperatures, owing to its low solid fat content and the abundance of low-melting triglycerides. The cultured butter sample had the highest melting point, owing to compositional differences. The instrumental and sensory texture analyses were highly correlated, indicating the comparative effectiveness of both approaches for studying the effects of different temperatures on butter textural properties. Overall, our findings provide detailed reference to the dairy industry for butter manufacture, considering variation in fatty acid composition, texture analysis, rheology, and sensory analysis, over the range of storage/usage temperatures.

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Recently, a bespoke instrumental variable method was proposed, which, under certain assumptions, can eliminate bias due to unmeasured confounding when estimating the causal exposure effect among the exposed. This method uses data from both the study population of interest, and a reference population in which the exposure is completely absent. In this paper, we extend the bespoke instrumental variable method to allow for a non-ideal reference population that may include exposed subjects. Such an extension is particularly important in randomized trials with nonadherence, where even subjects in the control arm may have access to the treatment under investigation. We further scrutinize the assumptions underlying the bespoke instrumental method, and caution the reader about the potential non-robustness of the method to these assumptions.

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INTRODUCTION AND AIMS: Gastroesophageal reflux disease (GERD) and temporomandibular joint disorder (TMD) are relatively common conditions with a potential causal relationship. This study aims to investigate the possible causal relationship between GERD and TMD through bidirectional Mendelian randomization analysis. METHODS: Using data from large GWAS databases, we conducted bidirectional Mendelian randomization analyses to investigate the potential causal link between GERD and TMD. Instrumental variables were selected from the IEU platform, comprising 129,080 GERD cases and 473,524 controls from the UK Biobank. TMD data from the FinnGen project included 6,314 cases and 222,498 controls. RESULTS: The forward MR analysis suggested that GERD may increase the risk of TMD (OR = 1.47, 95% CI: 1.20-1.81, P = 2e-4). The Weighted Median method also yielded significant results (OR = 1.53, 95% CI: 1.14-2.04, P = 4.1e-3). However, the reverse MR analysis did not reveal a significant association between TMD and GERD (OR = 1.02, 95% CI: 0.98-1.05, P = .33). CONCLUSION: This study, employing MR analysis, provides initial evidence supporting a potential causal relationship between GERD and TMD. The findings contribute to a better understanding of the relationship between these two conditions and offer insights for future clinical investigations. CLINICAL RELEVANCE: The findings of this study hold potential clinical significance in guiding early management strategies for GERD, reducing the incidence of TMD, and optimizing healthcare resource allocation, thereby improving patient quality of life. Further clinical studies are warranted to validate these findings and explore underlying mechanisms.

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BACKGROUND: PM2.5 can induce and aggravate the occurrence and development of cardiovascular diseases (CVDs). The objective of our study is to estimate the causal effect of PM2.5 on mortality rates associated with CVDs using the instrumental variables (IVs) method. METHODS: We extracted daily meteorological, PM2.5 and CVDs death data from 2016 to 2020 in Binzhou. Subsequently, we employed the general additive model (GAM), two-stage predictor substitution (2SPS), and control function (CFN) to analyze the association between PM2.5 and daily CVDs mortality. RESULTS: The 2SPS estimated the association between PM2.5 and daily CVDs mortality as 1.14% (95% CI: 1.04%, 1.14%) for every 10 µg/m3 increase in PM2.5. Meanwhile, the CFN estimated this association to be 1.05% (95% CI: 1.02%, 1.10%). The GAM estimated it as 0.85% (95% CI: 0.77%, 1.05%). PM2.5 also exhibited a statistically significant effect on the mortality rate of patients with ischaemic heart disease, myocardial infarction, or cerebrovascular accidents (P < 0.05). However, no significant association was observed between PM2.5 and hypertension. CONCLUSION: PM2.5 was significantly associated with daily CVDs deaths (excluding hypertension). The estimates from the IVs method were slightly higher than those from the GAM. Previous studies based on GAM may have underestimated the impact of PM2.5 on CVDs.

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