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Nevin Manimala Statistics

Reporting and analysis of process-of-care time measures in clinical trials for hyperacute stroke interventions: a scoping review protocol

JBI Evid Synth. 2023 Dec 18. doi: 10.11124/JBIES-23-00136. Online ahead of print.

ABSTRACT

OBJECTIVE: The objective of this scoping review is to investigate the reporting and comparison of process-of-care time measures in hyperacute stroke trials and systematic reviews of trials (subsequently referred to as “studies”).

INTRODUCTION: Stroke is a leading cause of death and disability worldwide. A crucial factor in determining the effectiveness of stroke care in improving patient outcomes is time, and, therefore, time measures are frequently reported in studies of hyperacute stroke interventions. However, there is inconsistency in how these measures are reported and compared. Furthermore, there is a lack of clarity in how compatible the reporting methods are with the statistical analysis methods.

INCLUSION CRITERIA: This scoping review will include studies that report and/or compare time measures between key events of interest in the delivery of hyperacute stroke care. Studies of thrombolytic therapy and/or thrombectomy, as well as controlled trials of mobile stroke unit interventions, will be included.

METHODS: The scoping review will be conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) and the JBI methodology for scoping reviews. The search will be executed in MEDLINE (PubMed), Embase (Ovid), and clinical trials registries ANZCTR, ISRCTN, and ClinicalTrials.gov. Title and abstract screening will be followed by full-text screening and subsequent data extraction from eligible studies. The results from this scoping review will be presented in tables and narratively summarized.

REVIEW REGISTRATION: Open Science Framework osf.io/y98wz.

PMID:38099923 | DOI:10.11124/JBIES-23-00136

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The Impact of Making Proud Choices! on Youth’s Sexual Health Attitudes, Knowledge, and Behaviors

J Adolesc Health. 2023 Dec 13:S1054-139X(23)00582-7. doi: 10.1016/j.jadohealth.2023.10.031. Online ahead of print.

ABSTRACT

PURPOSE: To estimate the effect of the Making Proud Choices! (MPC) curriculum, one of the most popular evidence-based teen pregnancy prevention curricula being implemented nationwide.

METHODS: A cluster randomized trial was used to assign high schools to receive the MPC program or to serve as a standard care comparison group. The study took place in 15 schools in four cities in the United States. A total of 31 clusters and over 2,800 youth (predominantly in grades 9 and 10) were assigned to condition between 2016 and 2019. Student surveys administered at baseline and approximately 9 months after baseline were used to estimate the effects of MPC on risk and protective factors (knowledge, attitudes, self-efficacy) as well as sexual behavior outcomes.

RESULTS: The evaluation showed several large, statistically significant, and favorable impacts on nearly all of the risk and protective factors for risky sexual behavior. In addition, the study found a favorable effect of MPC on reducing the number of episodes of sex in the past 3 months.

DISCUSSION: The evaluation showed that MPC, as it is commonly implemented today, has evidence of effectiveness on improving both risk and protective factors, and sexual behavior outcomes. Based on these findings, MPC will continue to be seen as an evidence-based teen pregnancy prevention program for implementation through federal grant programs.

PMID:38099897 | DOI:10.1016/j.jadohealth.2023.10.031

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High health care use prior to elective surgery for osteoarthritis is associated with poor postoperative outcomes: A Canadian population-based cohort study

J Health Serv Res Policy. 2023 Dec 15:13558196231213298. doi: 10.1177/13558196231213298. Online ahead of print.

ABSTRACT

BACKGROUND: The characterization and influence of preoperative health care use on quality-of-care indicators (e.g., readmissions) has received limited attention in populations with musculoskeletal disorders. The purpose of this study was to characterize preoperative health care use and examine its effect on quality-of-care indicators among patients undergoing elective surgery for osteoarthritis.

METHODS: Data on health care use for 124,750 patients with elective surgery for osteoarthritis in Ontario, Canada, from April 1, 2015 to March 31, 2018 were linked across health administrative databases. Using total health care use one-year previous to surgery, patients were grouped from low to very high users. We used Poisson regression models to estimate rate ratios, while examining the relationship between preoperative health care use and quality-of-care indicators (e.g., extended length of stay, complications, and 90-day hospital readmissions). We controlled for covariates (age, sex, neighborhood income, rural/urban residence, comorbidities, and surgical anatomical site).

RESULTS: We found a statistically significant trend of increasing worse outcomes by health care use gradients that persisted after controlling for patient demographics and comorbidities. Findings were consistent across surgical anatomical sites. Moreover, very high users have relatively large numbers of visits to non-musculoskeletal specialists.

CONCLUSIONS: Our findings highlight that information on patients’ preoperative health care use, together with other risk factors (such as comorbidities), could help decision-making when benchmarking or reimbursing hospitals caring for complex patients undergoing surgery for osteoarthritis.

PMID:38099445 | DOI:10.1177/13558196231213298

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Code ICH: A Call to Action

Stroke. 2023 Dec 15. doi: 10.1161/STROKEAHA.123.043033. Online ahead of print.

ABSTRACT

Intracerebral hemorrhage is the most serious type of stroke, leading to high rates of severe disability and mortality. Hematoma expansion is an independent predictor of poor functional outcome and is a compelling target for intervention. For decades, randomized trials aimed at decreasing hematoma expansion through single interventions have failed to meet their primary outcomes of statistically significant improvement in neurological outcomes. A wide range of evidence suggests that ultra-early bundled care, with multiple simultaneous interventions in the acute phase, offers the best hope of limiting hematoma expansion and improving functional recovery. Patients with intracerebral hemorrhage who fail to receive early aggressive care have worse outcomes, suggesting that an important treatment opportunity exists. This consensus statement puts forth a call to action to establish a protocol for Code ICH, similar to current strategies used for the management of acute ischemic stroke, through which early intervention, bundled care, and time-based metrics have substantially improved neurological outcomes. Based on current evidence, we advocate for the widespread adoption of an early bundle of care for patients with intracerebral hemorrhage focused on time-based metrics for blood pressure control and emergency reversal of anticoagulation, with the goal of optimizing the benefit of these already widely used interventions. We hope Code ICH will endure as a structural platform for continued innovation, standardization of best practices, and ongoing quality improvement for years to come.

PMID:38099439 | DOI:10.1161/STROKEAHA.123.043033

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Predictors of Surgical Site Infection in Contaminated Abdominal Surgical Wounds: Our Experience in Irrua Specialist Teaching Hospital

West Afr J Med. 2023 Nov 30;40(11):1223-1231.

ABSTRACT

BACKGROUND: Secondary peritonitis is a common emergency surgical condition with varying aetiologies managed by surgeons all over the world. One important morbidity associated with it is postoperative surgical site infection (SSI). A better prevention strategy can be instituted if this complication in patients can be correctly predicted. The study aimed to identify factors in patients with peritonitis that have a significant bearing on the development of postoperative SSI.

METHOD: A total of fifty patients operated on for peritonitis in a period of one year were studied. Factors including age, gender, comorbidities, presenting symptoms, time of presentation, time of intervention, intraoperative findings, duration of surgery, and postoperative SSI were noted. Chi-square, Fisher’s exact test and Student’s t-test were used to test for association where appropriate and a p-value of < 0.05 was considered statistically significant.

RESULTS: Peritonitis was most commonly due to a ruptured appendix (46%) followed by perforated peptic ulcer disease (42%). The incidence of SSI was 44%. For the patients that developed SSI, the lowest rate was observed in cases of ruptured appendix (39.1%) and the highest in perforated gastric ulcer (64.3%) which was closely followed by perforated duodenal ulcer (57.1%). The association between the time of presentation and the occurrence of SSI was statistically significant (p = 0.028).

CONCLUSION: The SSI rate (44%) from peritonitis in our centre was quite high and the time of presentation played a crucial role. Prevention strategies focusing on predictors of SSI is necessary to reduce the rate of SSI in our setting.

PMID:38099433

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Beyond mediators: A critical review and methodological path forward for studying mechanisms in alcohol use treatment research

Alcohol Clin Exp Res (Hoboken). 2023 Dec 15. doi: 10.1111/acer.15242. Online ahead of print.

ABSTRACT

BACKGROUND: Understanding how treatments for alcohol use disorder (AUD) facilitate behavior change has long been recognized as an important area of research for advancing clinical care. Even after decades of research, however, the specific mechanisms of change for most AUD treatments remain largely unknown because most prior work in the field has solely focused on statistical mediation. Statistical mediation is a necessary but not sufficient condition for establishing evidence for a mechanism of change. Mediators are intermediate variables that statistically account for the relationship between an independent and dependent variable whereas mechanisms provide more detailed explanations of how an intervention leads to a desired outcome. Thus, mediators and mechanisms are not equivalent.

METHODS: To advance mechanisms of behavior change research, this critical review provides an overview of methodological shortfalls of existing AUD treatment mechanisms research and introduces an etiologically informed precision medicine approach that facilitates testing mechanisms of behavior change rather than treatment mediators.

RESULTS: We propose a framework for studying mechanisms in alcohol treatment research that holds promise for facilitating our understanding of behavior change and precision medicine (i.e., for whom a given mechanisms of behavior change operates under what conditions). The framework forwarded in this review has several overarching goals including providing a methodological roadmap for testing AUD recovery mechanisms. We provide two examples of our framework, one pharmacological and one behavioral, to facilitate future efforts to implement this methodological approach to mechanisms research.

CONCLUSIONS: The framework proposed in this critical review facilitates the alignment of AUD treatment mechanisms research with current theories of etiologic mechanisms, precision medicine efforts, and cross-disciplinary approaches to testing mechanisms. Although no framework can resolve all the challenges related to mechanisms research, our goal is to help facilitate a shift towards more rigorous and falsifiable behavior change research.

PMID:38099412 | DOI:10.1111/acer.15242

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Clinical spectrum and clinicopathological correlation of pediatric orbital tumors: 20 years’ experience from a tertiary eye care center

Indian J Ophthalmol. 2023 Dec 15. doi: 10.4103/IJO.IJO_495_23. Online ahead of print.

ABSTRACT

PURPOSE: To study the epidemiological profile of various pediatric orbital tumors and determine their clinicopathological correlation over 20 years.

METHODS: A retrospective analysis of all pediatric patients with orbital tumors from the medical records between 1995 and 2015 was done. Tumors were categorized based on their cellular origin. Demographic details, clinical and histopathological diagnoses, frequency, and clinicopathological correlation were studied.

RESULTS: A total of 265 pediatric patients with orbital tumors were analyzed, of which 145 (54.7%) patients were males and 120 (45.3%) were females. The mean age was 7 years (median: 6 years; range: 10 days-16 years).The distribution of lesions in each group was as follows: vasculogenic, 76 (28.7%); lipogenic and myxoid, 66 (25%); myogenic, 31 (11.7%); optic nerve and meningeal, 22 (8.3%); lymphoid and lymphoproliferative, 18 (6.8%); secondary orbital tumors, 14 (5.2%); histiocytic, 9 (3.4%); miscellaneous, 9 (3.4%), lacrimal gland, 8 (3%); mesenchymal with neural differentiation, 6 (2%); osseous, 4 (1.5%), and fibrocystic, 2 (0.8%). The most common benign and malignant pediatric orbital tumors were dermoid cysts (65, 24.5%) and rhabdomyosarcoma (31, 11.7%). A statistically significant (P < 0.0001) clinicopathological correlation was observed in 208 (83.2%) out of 250 biopsy-proven cases.

CONCLUSION: Pediatric orbital neoplasms include a broad spectrum of benign and malignant lesions. Vasculogenic tumors constitute the majority of them, followed by lipogenic and myxoid tumors. A thorough knowledge of the incidence, clinical profile, imaging features, and histopathology of specific orbital tumors aids in accurate diagnosis and their successful management.

PMID:38099389 | DOI:10.4103/IJO.IJO_495_23

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Bedside assessment of ophthalmic manifestations in neurocritical care: A study in Southern India

Indian J Ophthalmol. 2023 Dec 15. doi: 10.4103/IJO.IJO_2878_22. Online ahead of print.

ABSTRACT

PURPOSE: This study aimed to investigate the incidence of Ocular Surface Disorders (OSDs), including Dry Eye Disease, Chemosis, and Exposure Keratitis, among patients admitted to the Neurocritical Care Unit (NCC). Additionally, we sought to assess the correlation between these OSDs, the length of hospitalization at NCC, and the Glasgow Coma Score (GCS). The heightened risk of OSD development in the NCC environment, coupled with pre-existing neurological impairments, can lead to conditions like dry eye disease, chemosis, corneal abrasions, and infectious keratitis, ultimately resulting in corneal opacities and perforations that significantly impact visual acuity and overall quality of life.

METHODS: In this observational cross-sectional study, we examined the ocular health of all patients admitted to an NCC unit from February to May 2022. We assessed the presence of Conjunctivitis, chemosis, Keratitis, and Dry Eyes in relation to the duration of stay at NCC, GCS, lagophthalmos, adherence to the prescribed eye care protocol in NCC, and the use of mechanical ventilation. Our study comprised one hundred subjects over a four-month period, with a mean age of 51.92 ± 18.73 years (ranging from 17 to 89), including 70% males and 30% females (gender ratio of 2.33).

RESULTS: Our findings revealed that 26 eyes (13%) exhibited Conjunctival Hyperemia, 23 eyes (11.5%) displayed Chemosis, and severe dry eye was prevalent in 41 (20.5%) eyes. A statistically significant association was observed between GCS (p-value <0.001) and Keratitis (p-value 0.0035) with dry eyes (Chi-Square Test). Notably, the incidence of dry eyes was significantly higher among patients with a prolonged stay of ≥10 days (p-value 0.003).

CONCLUSIONS: Patients admitted to Neurocritical Care Units necessitate meticulous eye care and structured protocols to mitigate the risk of long-term ocular complications such as exposure keratitis. Given their heightened susceptibility to these conditions, proactive measures are imperative to ensure optimal ocular health among NCC patients.

PMID:38099377 | DOI:10.4103/IJO.IJO_2878_22

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A meta-analysis of randomized controlled trials evaluating the effectiveness and safety of the repeated low-level red light therapy in slowing the progression of myopia in children and adolescents

Indian J Ophthalmol. 2023 Dec 15. doi: 10.4103/IJO.IJO_1037_23. Online ahead of print.

ABSTRACT

PURPOSE: The aim of this study was to evaluate the effectiveness and safety of repeated low-level red light (RLRL) therapy in controlling myopia progression in children through a meta-analysis.

METHODS: We searched several databases including PubMed, Embase, The Cochrane Library, Web of Science, CNKI, WANFANG, CBM, and VIP with languages restricted to both Chinese and English. The search was conducted from the establishment of the databases to March 23, 2023. We collected randomized controlled trials and controlled experiments to evaluate changes in axial length (AL) and spherical equivalent (SE) before and after RLRL intervention. Two researchers performed literature screening and data extraction, and RevMan software (Ver 5.3) and StataMP 17.0 were used for meta-analysis.

RESULTS: A total of 141 articles were retrieved, and finally, six randomized controlled trials met the inclusion and exclusion criteria, including 820 eyes (RLRL group: 411 eyes, control group: 409 eyes). The meta-analysis results showed that the RLRL group was significantly better than the control group in controlling AL, and the difference between the two groups was statistically significant (mean difference [MD] = -0.22, 95% confidence interval [CI] [ – 0.28, -0.16]; P < 0.001). The RLRL group was also better than the control group in terms of SE, and the difference between the two groups was statistically significant (MD = 0.46, 95% CI [0.32, 0.6]; P < 0.001). Five studies reported adverse reactions in the RLRL group, and two cases stopped treatment due to the feeling of too bright light, while the others had no significant side effects in the short term.

CONCLUSION: RLRL therapy is a safe and effective method for controlling myopia, which can inhibit the growth of AL and slow down the progression of myopia. However, further research and validation are needed to determine its treatment efficacy and course.

PMID:38099371 | DOI:10.4103/IJO.IJO_1037_23

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Factors affecting adherence to glaucoma medication: Patient perspective from North India

Indian J Ophthalmol. 2023 Dec 15. doi: 10.4103/IJO.IJO_806_23. Online ahead of print.

ABSTRACT

PURPOSE: Adherence to glaucoma medical therapy is a key factor in achieving target intraocular pressure to prevent glaucoma progression. To determine factors affecting medication adherence in glaucoma patients in an urban population belonging to poor socioeconomic status.

METHODS: A cross-sectional study was conducted on 200 patients attending glaucoma services in a tertiary referral hospital of North India. Adherence to medication was determined subjectively by questionnaire and objectively by counting the number of used bottles at the end of a month or during refill, whichever was earlier. Patient-related parameters in adherence toward glaucoma medication were studied based on demography, knowledge, attitudes, and practices (KAP). The statistical techniques of bivariate and multivariate logistic regression were adopted to test the objective.

RESULTS: The population was statistically homogeneous based on gender and income in both groups. A large proportion of patients had bilateral disease (87%) and were on two or more medications (62.5%). Adherence to glaucoma medical therapy was seen in 68% of patients, with knowledge about glaucoma present in 58% of patients. Deterrents to drug adherence were identified as forgetfulness (71%), unavailability of drugs (19%) or funds to purchase the same (26%), polypharmacy (21%), and side effects (5%). Dependence on an escort by 44% and dependence on hospital supply of medications by 60% emerged as the contextual factors requiring scrutiny while prescribing lifelong glaucoma medications. Disease misconceptions (53%) were prevalent and drug instillation practices were unsatisfactory (57%).

CONCLUSION: The study offers insight into patients’ perspectives regarding the lifetime use of antiglaucoma medications and focuses on key issues linked to drug nonadherence.

PMID:38099369 | DOI:10.4103/IJO.IJO_806_23