Research Register Research Articles

Factors associated with DPP4i or SGLT2i utilisation: a retrospective cohort study among people with type 2 diabetes mellitus

AbstractBackgroundDipeptidyl peptidase‐4 inhibitors (DPP4i) and sodium‐glucose co‐transporter 2 inhibitors (SGLT2i) are increasingly used as glucose‐lowering therapies in Malaysia.AimTo examine factors associated with the initiation of DPP4i or SGLT2i among people with type 2 diabetes mellitus (T2DM) in Malaysia.MethodA retrospective cohort study was conducted from 1 January 2012–30 December 2020 in two tertiary Malaysian hospitals. Multivariate logistic regression was used to assess the factors associated with DPP4i or SGLT2i initiation. The impact of treatment initiation on glycaemic control, anthropometric and lipid levels at 6 and 12 months were also measured. Ethical approval was granted by the Malaysian National Medical Research Register (Reference no: NMRR‐20‐662‐52570), the Monash University Human Research Ethics Committee (Reference no: 2020‐24900‐45575), the Ministry of Health Malaysia Medical Research and Ethics Committee, and the study conforms with the Declaration of Helsinki.ResultsThis study included 1628 patients. Patients with co‐existing dyslipidaemia (odds ratio [OR] 1.34, 95% confidence interval [CI] 1.04–1.73), cardiovascular disease (OR 1.43, 95% CI 1.1–1.87), and microalbuminuria (OR 2.47, 95% CI 1.42–4.3), with ≥5‐year history of T2DM (years of T2DM 5–14 OR 1.67, 95% CI1.18–2.38; years of T2DM ≥15 OR 2.07, 95% CI 1.39–3.07), who had a body weight of ≥100 kg (OR 1.75, 95% CI 1.26–2.45), and baseline use of three or more glucose‐lowering medicines (OR 2.92, 95% CI 1.74–4.91) had higher odds of being prescribed with SGLT2i. Patients aged ≥65 years old (OR 0.68, 95% CI 0.50–0.93), presented with a family history of diabetes (OR 0.64, 95% CI 0.47–0.89), an estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73 m2 (eGFR 60–89 mL/min/1.73 m2 OR 0.60, 95% CI 0.39–0.90; eGFR ≥90 mL/min/1.73 m2 OR 0.55, 95% CI 0.34–0.87), with serum creatinine ≥120 μmol/L (OR 0.31, 95% CI 0.17–0.58), and had baseline usage of sulfonylureas (OR 0.28, 95% CI 0.19–0.4) and insulin (OR 0.5, 95% CI 0.35–0.72) were more likely to receive DPP4i. Glycated haemoglobin of patients receiving these medicines reduced significantly at 6 months (DPP4i: −0.61%, p < 0.001; SGLT2i: −0.66%, p < 0.001) and 12 months (DPP4i: −0.62%, p < 0.001; SGLT2i: −0.74%, p < 0.001).ConclusionTreatment choice with pharmacotherapy was associated with many clinical risk factors presented by patients.

Enrollment in Alzheimer’s disease-focused research registries: altruistic and egocentric motivations

ABSTRACT The relative effectiveness of altruistic and egocentric persuasion messages is an important research question when voluntary participation in medical research is the target behavior. In the US, most participants in Alzheimer’s disease-focused research registries are White females, so increasing diversity in registry membership is a public health priority. We compared the association of two belief-based motivations – egocentric and altruistic – with intention to enroll in an Alzheimer’s research registry using a nationally representative theory-based survey of US adults 50 years of age or older while oversampling Black and Hispanic respondents. With the exception of Hispanic females, there were few respondent differences between individual motivational belief items and the correlations between the altruistic and egocentric indices were similar with independent effects on intention: the effects of the two motivations on intention were not redundant. Further analysis demonstrated that a moderation model was not superior to an additive model when both altruistic and egocentric indices simultaneously predicted intention. Registry recruitment messages should use both altruistic and egocentric persuasive message components to increase enrollment into Alzheimer’s research registries. Similar studies should determine if the additive effects of altruistic and egocentric motivations apply to other voluntary research participation contexts such as chronic diseases and mental illness.

Prophylactic PICO◊ dressing shortens wound dressing requirements post emergency laparotomy (EL-PICO◊ trial)

BackgroundSurgical site infection (SSI) is a very common complication of emergency laparotomy and causes significant morbidity. The PICO◊ device delivers negative pressure wound therapy (NPWT) to closed incisions, with some studies suggesting a role for prevention of SSI in heterogenous surgical populations. We aimed to compare SSI rates between patients receiving PICO◊ versus conventional dressing post-emergency laparotomy. Secondary objectives were to observe seroma and dehiscence rates, length of stay, days on dressing and patients’ wound experience.MethodsThis double blinded randomized controlled trial was conducted in University Malaya Medical Centre between October 2019 and March 2022. Patients undergoing emergency laparotomy requiring incisions less than 35 cm were included. Statistical analysis was performed using χ2 test for categorical variables, independent T-test or Mann–Whitney U were used for parametric or non-parametric data respectively besides logistic regression. P values of < 0.05 were considered to be significant.ResultsNinety-six patients were analyzed (47 interventions, 49 controls). The duration on dressing was more consistent in the intervention arm (PICO◊) versus control arm [9.78 ± 10.20 vs 17.78 ± 16.46 days, P < 0.001]. There was a trend towards lower SSI [14.3 vs 4.3%, P = 0.09], dehiscence [27.1 vs 10.6%, P = 0.07] and seroma [40.8 vs 23.4%, P = 0.08] rates in the intervention arm but this did not reach statistical significance. Length of stay [9 (IQR: 6–14) vs 11 (IQR: 6–22.5) days, P = 0.18] was fairly similar between the two arms, but more patients were very satisfied with PICO◊ compared to the conventional dressing [80% vs 57.1%, P = 0.03].ConclusionThe use of NPWT in emergency laparotomy improves patients wound care experience, and was associated with trends towards fewer wound related complications. Cost effectiveness needs to be explored in order to further validate its use in the emergency setting, especially for patients with additional risk for SSI.Trial registrationNational Medical Research Registry (NMRR): NMRR-20-1975-55222.

Theory-Based Message Design for Recruitment of Underrepresented Racial/Ethnic Groups Into Alzheimer's-Focused Research Registries.

Alzheimer's disease (AD)-focused recruitment research registries can help identify eligible participants for AD studies, but registry participation is limited among racial and ethnic groups most at risk for AD. Using the Reasoned Action Approach (RAA), this study is part of a larger project to design theory-based persuasive recruitment messages that would encourage registry enrollment among underrepresented racial and ethnic groups. National survey data were collected in May/June 2021 from adults aged 50-80 years old living in the United States (n = 1,501) with oversamples of non-Hispanic Black (n = 334) and Hispanic (n = 309) adults for group comparisons. Regression analysis was used to estimate the relationship of the attitudes, norms, and perceived behavioral control on intention to sign up for an AD-focused research registry for each racial/ethnic and sex group (i.e., Black women, Black men, Hispanic female, Hispanic men, non-Hispanic White women, and non-Hispanic White men), followed by an audience segmentation analysis based on intender status. Across almost all target groups, attitudes were an important determinant of intention, and norms and capacity were secondary determinants for Black and Hispanic adults, respectively. There was considerable overlap in attitudinal beliefs most salient to the behavior which focused on benefits to society in some way, either generally (i.e., "helping others in the future"; "advancing science") or more specifically (i.e., "helping others like you"). Differences between groups were more apparent regarding norms and capacity. Targeted recruitment messages based on beliefs that were common across the groups could be an efficient way of recruiting people of color into AD research registries.

Culturally Tailored Messages and Trial Registry Enrollment

Marginalized populations have lower levels of clinical trial representation than other populations. Tailoring recruitment materials and providing incentives may improve representation. To determine whether culturally tailored video improves parents' decision to enroll (DTE) Black children in a research registry. A randomized clinical trial, using mixed methods and consecutive sampling, was conducted in an urban primary care pediatric clinic. A post hoc study assessed the association of a monetary incentive with DTE. Ninety-three parents were recruited before their child's scheduled clinic visit. Participants completed a survey during which they were randomly assigned to review a paragraph (control group), generic video, or tailored video and received a gift card. Video watchers completed questions about its effectiveness. All participants were invited to join the registry. In the post hoc study, consenting participants followed the control group protocol and the coordinator promised them an ink pen for participating. The study was conducted between November 15, 2022, and August 29, 2023. A survey regarding the importance of being included in research studies was administered after participants watched a culturally tailored video. The primary outcome was DTE. Covariates were message effectiveness, clinical trial knowledge, and trust. Intention-to-treat analysis was performed. A total of 125 individuals were included. All groups had similar mean (SD) parent age (overall, 32.6 [7.35] years), gender (110 [88.0%] women), and race (116 [92.8%] Black or African American). There was no significant difference in the odds of DTE between the appeal video and control (odds ratio [OR], 1.19; 95% CI, 0.38-3.72) or between the generic video and control (OR, 1.91; 95% CI, 0.54-6.71). However, DTE was higher for all 3 gift card groups vs the ink pen incentive group (eg, control vs ink pen incentive: OR, 5.01; 95% CI, 1.68-14.95). After adjusting for trust, monetary incentives were associated with higher odds of DTE (adjusted OR, 5.92; 95% CI, 2.44-14.39). In this randomized clinical trial, targeted messaging was not associated with a higher decision to enroll in a pediatric clinical trial registry. There may be a role for combining holistic messaging with monetary incentives to improve enrollment. ClinicalTrials.gov Identifier: NCT06138145.

Outcomes of emergency colorectal surgery within a non-colorectal split site service-a retrospective cohort study.

Emergency colorectal surgery carries a high risk of morbidity and mortality. Subspecialisation and split-site geographically distinct services may lead to critically unwell patients presenting to a non-colorectal specialist centre requiring urgent on-site intervention. This study aims to determine outcomes of this high-risk patient cohort. An observational retrospective study of emergency colorectal laparotomies at the Royal Infirmary of Edinburgh (RIE) between January 2016 and August 2020 was performed. The primary outcome was 30-day mortality. Secondary outcomes included rate of primary anastomosis, complications and overall mortality. Subgroup analysis of the vascular ischaemia cohort and colorectal surgeon involvement was performed. One hundred and eighteen patients were included. The median NELA (National Emergency Laparotomy Audit) score was 6.4% (IQR 2.5%-16.7%) and the 30-day mortality rate was 22% (26/118). The rate of primary anastomosis was 24.6%. Twenty-five patients had a vascular ischaemic pathology demonstrating a higher median NELA score (14.3%, IQR 5-22.4% vs. non-ischaemic group 5.7%, IQR 1.7-14.2%, p = 0.013) and thirty-day mortality (44%, 11/25 vs. 16.1%, 15/93, p = 0.006) than those without ischaemic pathology. Colorectal surgeon involvement in cases without ischaemia (23/93) was associated with a similar 30-day mortality (13.1% colorectal surgeon vs. 17.1% non-colorectal specialist surgeon, p = 0.755) and rate of primary anastomosis (30.4% colorectal surgeon vs. 31.8% non-colorectal specialist surgeon, p = 1). The high mortality rate described highlights a specific group of unwell patients unfit for transfer. Research registration number: researchregistry7101.

The effect of the great Kermanshah earthquake on the tuberculosis infection trend: interrupted time series analysis

ObjectivesTuberculosis (TB) presents a substantial danger to populations experiencing crises like earthquakes. This study aims to explore the effect of the Kermanshah earthquake on the trend of TB.MethodsThis cross-sectional study examined tuberculosis data from 2009 to 2020, using monthly diagnoses. Data was collected from the TB research office and registration system. The study employed interrupted time series (ITS) analysis to assess both the immediate and long-term impacts of the earthquake on TB cases.ResultsIn Sarpol-e Zahab, TB cases initially surged after the earthquake, indicating an immediate effect, but then significantly declined compared to pre-earthquake levels, reflecting an effect over time (β0 = 1.39, β1=-0.004, β2 = 0.11 and β3=-0.01, P = 0.001 and Post-intervention linear trend= -0.015, P < 0.001). In Ghasr-e Shirin, the average number of TB cases prior to the earthquake was estimated at 0.58 cases, with a significant monthly decrease of 0.005 cases leading up to the earthquake (P = 0.001). There was no significant immediate change in TB cases during the first month after the earthquake (β2 = 0.008, P = 0.680). Post-earthquake, TB cases dramatically increased (β3 = 0.008, P = 0.001). The monthly trend of TB cases rose significantly by 0.002 (P = 0.001), indicating an effect over time. In Salas-e Babajani, there was no immediate change in TB cases, but there was a significant long-term decline compared to the period before the earthquake (P = 0.001).ConclusionsEarthquake is one of the natural crises that provide the conditions for the increase of TB. Local health policymakers must make plans in these areas to contain TB after the earthquake.

Vitamin D levels do not correlate with severity of idiopathic peripheral neuropathy.

Peripheral neuropathy (PN) is a common neurological condition in elderly adults. Vitamin D deficiency has been associated with diabetic and chemotherapy-induced neuropathy, but its role in idiopathic PN, in which no underlying cause of neuropathy can be identified, has not been investigated. Two hundred thirty patients with idiopathic PN enrolled in the Peripheral Neuropathy Research Registry (PNRR) at Johns Hopkins University School of Medicine had vitamin D testing information on record. Linear and logistic regressions were used to investigate the relationship between absolute vitamin D level or vitamin D insufficiency (<20 ng/mL) and both the severity of neuropathy as measured by the reduced total neuropathy score (TNSr) and severity of neuropathic pain. Sixteen (7%) patients were vitamin D insufficient (<20 ng/mL). Controlling for factors known to correlate with severity of neuropathy, there was no correlation between absolute vitamin D levels and TNSr (correlation coefficient 0.01, 95% CI -0.03 to 0.07, p = .59) and no association between vitamin D insufficiency and TNSr (correlation coefficient 0.3, 95% CI -2.8 to 3.4, p = .86). Vitamin D insufficiency was not associated with the presence of neuropathic pain (OR 4.1, 95% CI 0.6-26.0, p = .13), and there was no correlation between vitamin D levels and pain score (correlation coefficient 0.01, 95% CI -0.02 to 0.03, p = .59). In a single-center cohort of patients with idiopathic PN, there was no correlation between vitamin D levels and the severity of neuropathy or neuropathic pain.

Efficacy and Safety of Tisagenlecleucel in Patients with Relapsed/Refractory Follicular Lymphoma: A Real-World Analysis from the Center for Blood and Marrow Transplant Research (CIBMTR) Registry

Efficacy and Safety of Tisagenlecleucel in Patients with Relapsed/Refractory Follicular Lymphoma: A Real-World Analysis from the Center for Blood and Marrow Transplant Research (CIBMTR) Registry

Randomised controlled trial of HOYA one-day multifocal contact lenses: The HOMCL trial

Trial designDouble-masked crossover RCT (Research Registry: #8136) comparison of a new HOYA one-day disposable multifocal contact lens (HOMCL) with Alcon DAILIES TOTAL1® Multifocal (ADT1). MethodsSixty presbyopic participants from three countries attended for baseline measurements and fitting of both lens types and then for a fortnight completed daily diaries of symptoms with habitual optical correction, and VF-14 questionnaire. Participants collected either HOMCL or ADT1, when the vision was measured again, and they wore this product for a fortnight, completing daily diaries and VF-14. Participants then collected the other type and had vision and symptoms recorded in the same way. ResultsThere were no serious adverse events. Primary outcomes were no significant differences between the lens types in willingness to purchase nor stated preference; no significant differences in the daily symptom ratings of comfort; statistically significant findings with the daily symptom ratings and VF-14 of better near vision with HOMCL and better distance vision with ADT1. Secondary outcomes were better high contrast distance visual acuity with ADT1 (<1 line), better low contrast distance visual acuity with ADT1; faster Wilkins rate of reading test with HOMCL; no significant differences in near visual acuity, wearing time, or number of lenses required during fitting process. Exploratory analyses were better handling scores with ADT1; and some, but not all of the dry eye data indicating better acceptance of HOMCL by patients with relatively dry eyes. For all measures, there were some participants who preferred/performed better with each lens type. ConclusionsThe differences between the performance of the two products were small. There was a trend in some clinical measurements and the daily diary data and VF-14 questionnaire, for HOMCL to outperform ADT1 for near vision and vice versa for distance vision.

Leveraging digital tools to enhance diversity and inclusion in clinical trial recruitment.

Clinical research is pivotal in assessing the safety and efficacy of new treatments in healthcare. However, the success of such research depends on the inclusion of a diverse and representative participant sample, which is currently lacking. This lack of diversity in biomedical research participants has significant repercussions, limiting the real-world applicability and accessibility of medical interventions, especially for underrepresented groups. Barriers to diverse participation include historical mistrust, logistical challenges, and financial constraints. Recent guidelines by government agencies and funding bodies emphasize the need for diversity in clinical trials, but specific strategies for inclusive recruitment are often lacking. This paper explores the use of digital methods to enhance diversity and inclusion in research recruitment. Digital tools, such as electronic medical records, social media, research registries, and mobile applications, offer promising opportunities for reaching diverse populations. Strategies include culturally tailored messaging, collaborations with community organizations, and the use of SEO to improve visibility and engagement. However, challenges such as privacy concerns, digital literacy gaps, and ethical considerations must be addressed. The promotion of diversity in clinical research recruitment is crucial for advancing health equity. By leveraging digital tools and adopting inclusive strategies, study teams can improve the diversity of study participants, ultimately leading to more applicable and equitable healthcare outcomes.

Assessment of enoxaparin‐related knowledge, administration technique, and self‐reported adherence among women after caesarean section delivery

AbstractBackgroundVenous thromboembolism is among the main causes of maternal morbidity and mortality, with caesarean section (CS) delivery carrying greater risk. Outpatient thromboprophylaxis, such as enoxaparin, is administered subcutaneously and prescribed as an outpatient; raising the issue of medication adherence.AimThis study aimed to evaluate women's adherence to enoxaparin administration after CS delivery, explore the reasons for non‐adherence, and assess the factors associated with patients' adherence to enoxaparin.MethodWomen after CS delivery, who had been given enoxaparin at discharge were included in the study. Eligible patients were contacted via telephone at the middle and the end of the enoxaparin treatment. Syringe count determined the main outcome of adherence during direct telephone interviews with the patient. Optimal adherence was defined as all the doses of enoxaparin being administered and suboptimal adherence was at least one dose not administered. Ethical approval was granted by the Malaysian Registry Ethics Committee belonging to National Medical Research Registry (Reference no: NMRR ID‐22‐02859‐P41) and the study conforms with the Declaration of Helsinki. Informed consent was obtained from all participants through completion of written consent forms, after an explanation of the study was provided by investigators.ResultsOut of 201 women included, the majority (91.5%) were fully adherent to enoxaparin, while 8.5% missed at least one dose. Most patients administering at home missed the dose due to reporting they were unwell (n = 6), busy (n = 4), or forgot to administer (n = 2). Among missed doses in patients administered in a healthcare setting, all participants (n = 5) forgot to bring their medication to the appointment. Only medication knowledge had a significant association with adherence to enoxaparin administration (p = 0.008).ConclusionThe study raised concern about the substantial percentage of patients missing at least one dose of enoxaparin, particularly among patients injecting at home. Initiatives should focus on customised enoxaparin administration counselling and providing educational materials.

The Role of Intravascular Ultrasound in Limb Salvage: A Systematic Review and Meta-Analysis.

The purpose of this study was to review the current literature of intravascular ultrasound (IVUS) use in real world cohorts inclusive of chronic limb threatening ischemia (CLTI) patients and compare the outcomes to patients imaged by angiography alone. The systematic review was registered in Research Registry. A literature search was performed across 4 databases: PubMed, Medline/Embase, Cochrane Review, and Web of Science for eligible comparative studies. The primary outcomes examined were clinically driven target lesion revascularization (CD-TLR), amputation (including minor below the ankle and major above the ankle), all-cause mortality, limb salvage and mean balloon dilation. A random effects model was used when pooling outcomes to account for heterogeneity. Publication bias was determined using eggers test and illustrated on a funnel plot. Six studies were included in this review, with a total of 1883 subjects with Rutherford 1-6. Among the 1883 subjects, 940 had Rutherford 4-6. IVUS was used in 1294 subjects and angiography alone was used in 589 subjects. Pooled analysis determined no significant association in IVUS + angiography with CD-TLR (O.R = 1.43 [CI: 0.80, 2.58]), all-cause amputation (O.R = 0.63 [CI: 0.34, 1.17]), and all-cause mortality (O.R = 0.63 [CI: 0.34, 1.17]). Sub analysis of subjects with CLTI, Rutherford classes 4-6 showed an association between IVUS + angiography use with limb salvage at 1 year, O.R = 2.22 [1.24, 3.97]. The use of IVUS + angiography compared to angiography alone showed larger reference vessel diameter in both all-inclusive Rutherford classifications and the CLTI subset. The use of IVUS + angiography compared to angiography alone showed no difference in CD-TLR at 12 months, lower extremity amputation, and all-cause mortality for Rutherford 1-6. The use of IVUS + angiography compared to angiography alone in the CLTI subset analysis improved limb salvage.

Patient-reported outcomes in cancer survivorship: insights from two decades of population-based PROFILES registry research.

When the field of cancer survivorship research was in its infancy, the PROFILES registry was set up in 2004 to monitor patient-reported outcomes (PROs) in survivors and a normative population. This scoping review aims to summarize lessons learned from developing a population-based PRO registry, focusing on study methodologies, data collection shifts, data utilization, multidisciplinary collaboration, societal impact, and data sharing. A systematic computerized literature search through PubMed was performed to collect all publications using data from the PROFILES registry between January 1, 2004, and December 31, 2023. The PROFILES registry's research today encompassed 249 papers from 35 studies. Key insights include the importance of multi-hospital collaboration, which enhances participant inclusion and result generalizability. Optimizing response rates and patient inclusion is achieved through proactive data collection methods such as inclusion by health care professionals, and using both web-based and paper questionnaires. Longitudinal studies, despite their intensive data collection efforts, provide critical insights into the consequences of cancer and its treatment on patient-reported outcomes (PROs) from diagnosis through survivorship. Combining PRO data with comprehensive clinical registry data ensures reliable datasets, crucial for drawing meaningful conclusions. The shift towards multidisciplinary collaboration, open-access publishing, and data sharing all contribute to accessible and impactful research. This review highlights key insights from the PROFILES registry, emphasizing multi-hospital collaboration, proactive data collection, and the integration of PROs with clinical data. These lessons can guide future research on cancer survivorship, improving methodologies to enhance survivorship care and quality of life through multidisciplinary collaboration and data sharing.

Communication and empathy within the patient-physician relationship among patients with and without chronic pain.

Chronic pain may affect the relationship between patients and their treating physicians. This study was designed to compare four aspects of physician communication and physician empathy reported by patients with chronic pain and in chronic pain-free controls. A cross-sectional study was conducted within a national pain research registry from July 2020 through January 2024. Patients with chronic low back pain of greater than 3months duration were matched to chronic pain-free controls utilizing propensity scores derived froma logistic regression model based on 11 variables thatincluded sociodemographic characteristics, cigarette smoking status, history of comorbid medical conditions, and duration of the current patient-physician relationship. Patients reported on the primary outcomes of physician communication utilizing the Communication Behavior Questionnaire (CBQ) and physician empathy utilizing the Consultation and Relational Empathy (CARE) measure. Group means were compared for each aspect of physician communication (patient participation and patient orientation, effective and open communication, emotionally supportive communication, and communication about personal circumstances) and physician empathy, and Cohen's d statistic was utilized to assess the clinical relevance of between-group differences. Secondary exploratory analyses were also performed to compare patients treated by osteopathic physicians vs. allopathic physicians and to determine whether study group X physician type interaction effects were present. The 387 patients in each study group were matched within a caliper width of 0.001 on the propensity score. Overall, patients ranged from 21 to 79 years of age (mean, 50.7 years; standard deviation [SD], 15.1 years), and 617 (79.7 %) of them were female. Patients in the chronic pain group reported poorer scores for all aspects of physician communication and physician empathy than the chronic pain-free controls. All between-group differences were clinically relevant. There were no differences in physician communication or physician empathy according to physician type in the exploratory analyses, and study group X physician type interaction effects were not observed. In this cross-sectional study, patients with chronic pain reported having physicians with poorer communication and less empathy than chronic pain-free controls. Longitudinal research is needed to more clearly determine the temporal relationship between patients' chronic pain and physician communication and physician empathy during medical encounters.

Estimating the prevalence of Sjogren’s syndrome in the world using systematic review and meta-analysis

Introduction: Sjogren’s syndrome is an autoimmune disorder with variable prevalence in different parts of the world. This study aims to estimate the prevalence of Sjogren’s syndrome worldwide using a systematic review and meta-analysis. Materials and Methods: For this study, we searched the databases of PubMed, ProQuest, Cochrane, Web of Science, and the Google Scholar search engine without any time limit until February 17, 2024. We used STATA 14 software for data analysis, and the significance level was set at P&lt;0.05. Results: Combining the findings of 24 observational studies with a total of 211349 participants, we concluded that the overall prevalence of Sjogren’s syndrome in the world and the female population was (13%; [95% CI: 10%, 16%]) and (15% [95% CI: 4%, 26%]), respectively. The worldwide prevalence of Sjogren’s syndrome in cohort studies and cross-sectional studies was (14% [95% CI: 10%, 19%]) and (10% [95% CI: 7%, 14%]), respectively. However, the prevalence of primary Sjogren’s syndrome was (7% [95% CI: 5%, 9%]) and the prevalence of secondary Sjogren syndrome was (9% [95% CI: 6%, 13%]). Additionally, the prevalence of Sjogren’s syndrome among the age groups of 20-29, 30-39, 40-49, 50-59, 60-69, and 70-79 years was (31% [95% CI: 30%, 42%]), (4% [95% CI: 1%, 6%]), (7% [95% CI: 5%, 10%]), (24% [95% CI: 15%, 33%]), (22% [95% CI: 2%, 42%]), and (5% [95% CI: 1%, 9%]), respectively. Conclusion: Sjogren’s syndrome has a high overall prevalence in the world, and considering the adverse outcomes of this disease, there should be measures taken to control and screen the prevalence of Sjogren’s disease. Registration: This study has been compiled based on the PRISMA checklist, and its protocol was registered on the PROSPERO (ID: CRD42024513783) and Research Registry (UIN: reviewregistry1793) website.

Investigating the effect of adding silymarin to the standard treatment of naloxone in methadone intoxication; a double-blind clinical trial

Introduction: In cases of methadone intoxication, the drug is mainly processed by the liver, however, its elimination through the kidneys is also crucial. On the other hand, naloxone therapy is a gold standard treatment for opioid intoxication, the addition of other drugs can improve its benefits and reduce side effects. Objectives: This study aimed to assess the effectiveness of adding silymarin to the standard treatment of naloxone in patients with methadone intoxication, to improve patient outcomes and reduce the risk of complications associated with alone naloxone therapy. Patients and Methods: This clinical trial study aimed to investigate the efficacy of silymarin in combination with standard treatment for methadone intoxication patients. The study employed a control group, which received standard treatment with naloxone, and an intervention group, which received both naloxone and silymarin. Liver functional tests (LFTs), kidney functional tests, malondialdehyde (MDA), and ferric-reducing ability of plasma (FRAP) were measured at admission and post-intervention times to compare the outcomes between the two groups. Statistical analyses, including chi-square, independent and paired t tests, Wilcoxon, and Mann-Whitney tests were conducted to identify significant differences between the groups. Results: Results indicated that 32 and 33 patients were included in the naloxone and naloxone + silymarin groups, respectively. The results showed that the changes in kidney functional tests such as blood urea nitrogen (BUN) and creatinine (Cr), MDA, and FRAP were not statistically significant between the two groups. However, the changes in LFTs, including, aspartate transaminase (AST), alanine transaminase (ALT), and alkaline phosphatase (ALP), were statistically significant. Notably, the LFT changes were more pronounced in the group receiving both naloxone and silymarin, indicating a greater reduction in liver enzymes in this combined treatment group. Conclusion: The addition of silymarin to standard naloxone treatment for methadone intoxication patients could improve liver function, as the combined therapy showed a more pronounced reduction in liver enzyme levels compared to standard treatment alone; however, this combination treatment could not change the kidney function and oxidative stress markers. Trial Registration: The trial protocol was approved by the Iranian Registry of Clinical Trials (identifier: IRCT20210216050377N1; ethical code from Shahrekord University of Medical Sciences; IR.SKUMS.REC.1400.048). This study was also registered in Research Registry website with Unique Identifying Number (UIN) of researchregistry10395.

Statins and the risk of colorectal cancer; a systematic review and meta-analysis of cohort and case-control studies

Introduction: Colorectal malignancy is the third furthermost frequent malignancy in the world, and approximately 80% of the cases are related to nongenetic causes, including high cholesterol levels. Accordingly, the present systematic review and meta-analysis aimed to investigate the relationship between statin treatment and the risk of colorectal cancer. Materials and Methods: The current study was a systematic review and meta-analysis designed based on PRISMA. International databases, including PubMed, Scopus, Web of Science, Cochrane, and Google Scholar search engine, were used to search for studies published until July 7, 2023. Data analysis was directed by STATA software version 14, and P values below than 0.05 (P&lt;0.05) indicated the significance of statistical tests. Results: The results obtained from a combination of 30 studies with 2436650 samples indicated that statin use increased the risk of colorectal malignancy by 11% (OR: 0.89; 95% CI: 0.84, 0.95) and reduced the risk of rectal cancer by 16% (R: 0.84; 95% CI: 0.74, 0.94). Instead, statin administration reduced the hazard of colorectal cancer in individuals aged 50 to 59 by 22% (R: 0.78; 95% CI: 0.63, 0.95), 60 to 69 by 14% (OR: 0.86; 95% CI: 0.75, 0.98), and 70 to 79 by 8% (OR: 0.92; 95% CI: 0.87, 0.98). Utilization of statin in male (OR: 0.71; 95% CI: 0.58, 0.87) and female (OR: 0.84; 95% CI: 0.77, 0.92) patients reduced the risk of colorectal cancer by 29% and 16%, respectively. Furthermore, statin use in men (OR: 0.41; 95% CI: 0.26, 0.67) and women (OR: 0.64; 95% CI: 0.42, 0.97) reduced the risk of colon cancer by 59% and 36%, respectively. Conclusion: Statin administration reduced the risk of colorectal cancer, and the possibility of reduction in risk of colorectal cancer at lower ages was higher than in older adults and also higher in males compared with females. Registration: This study has been compiled based on the PRISMA checklist, and its protocol was registered on the PROSPERO (CRD42023450984) and Research Registry (UIN: reviewregistry1779) website.

S1142 Recurrence Patterns in Crohn's Disease Patients With End Ostomies: Insights From the Cleveland Clinic IBD Ostomy Research Registry

S1142 Recurrence Patterns in Crohn's Disease Patients With End Ostomies: Insights From the Cleveland Clinic IBD Ostomy Research Registry

S1143 End Ostomy in Crohn's Disease: Insights From the Cleveland Clinic Inflammatory Bowel Disease Ostomy Research Registry

S1143 End Ostomy in Crohn's Disease: Insights From the Cleveland Clinic Inflammatory Bowel Disease Ostomy Research Registry