Categories
Nevin Manimala Statistics

PET/MRI for staging patients with Hodgkin lymphoma: equivalent results with PET/CT in a prospective trial

Ann Hematol. 2021 Apr 28. doi: 10.1007/s00277-021-04537-5. Online ahead of print.

ABSTRACT

To compare FDG-PET/unenhanced MRI and FDG-PET/diagnostic CT in detecting infiltration in patients with newly diagnosed Hodgkin lymphoma (HL). The endpoint was equivalence between PET/MRI and PET/CT in correctly defining the revised Ann Arbor staging system. Seventy consecutive patients with classical-HL were prospectively investigated for nodal and extra-nodal involvement during pretreatment staging with same-day PET/CT and PET/MRI. Findings indicative of malignancy with the imaging procedures were regarded as lymphoma infiltration; in case of discrepancy, positive-biopsy and/or response to treatment were evidenced as lymphoma. Sixty of the 70 (86%) patients were evaluable having completed the staging program. Disease staging based on either PET/MRI or PET/CT was correct for 54 of the 60 patients (90% vs. 90%), with difference between proportions of 0.0 (95% CI, -9 to 9%; P=0.034 for the equivalence test). As compared with reference standard, invasion of lymph nodes was identified with PET/MRI in 100% and with PET/CT in 100%, of the spleen with PET/MRI in 66% and PET/CT in 55%, of the lung with PET/MRI in 60% and PET/CT in 100%, of the liver with PET/MRI in 67% and PET/CT in 100%, and of the bone with PET/MRI in 100% and PET/CT in 50%. The only statistically significant difference between PET/MRI and PET/CT was observed in bony infiltration detection rates. For PET/CT, iodinate contrast medium infusions’ average was 86 mL, and exposure to ionizing radiation was estimated to be 4-fold higher than PET/MRI. PET/MRI is a promising safe new alternative in the care of patients with HL.

PMID:33909101 | DOI:10.1007/s00277-021-04537-5

Categories
Nevin Manimala Statistics

IMI 2021 Yearly Digest

Invest Ophthalmol Vis Sci. 2021 Apr 28;62(5):7. doi: 10.1167/iovs.62.5.7.

ABSTRACT

PURPOSE: The International Myopia Institute (IMI) Yearly Digest highlights new research considered to be of importance since the publication of the first series of IMI white papers.

METHODS: A literature search was conducted for articles on myopia between 2019 and mid-2020 to inform definitions and classifications, experimental models, genetics, interventions, clinical trials, and clinical management. Conference abstracts from key meetings in the same period were also considered.

RESULTS: One thousand articles on myopia have been published between 2019 and mid-2020. Key advances include the use of the definition of premyopia in studies currently under way to test interventions in myopia, new definitions in the field of pathologic myopia, the role of new pharmacologic treatments in experimental models such as intraocular pressure-lowering latanoprost, a large meta-analysis of refractive error identifying 336 new genetic loci, new clinical interventions such as the defocus incorporated multisegment spectacles and combination therapy with low-dose atropine and orthokeratology (OK), normative standards in refractive error, the ethical dilemma of a placebo control group when myopia control treatments are established, reporting the physical metric of myopia reduction versus a percentage reduction, comparison of the risk of pediatric OK wear with risk of vision impairment in myopia, the justification of preventing myopic and axial length increase versus quality of life, and future vision loss.

CONCLUSIONS: Large amounts of research in myopia have been published since the IMI 2019 white papers were released. The yearly digest serves to highlight the latest research and advances in myopia.

PMID:33909031 | DOI:10.1167/iovs.62.5.7

Categories
Nevin Manimala Statistics

IMI Risk Factors for Myopia

Invest Ophthalmol Vis Sci. 2021 Apr 28;62(5):3. doi: 10.1167/iovs.62.5.3.

ABSTRACT

Risk factor analysis provides an important basis for developing interventions for any condition. In the case of myopia, evidence for a large number of risk factors has been presented, but they have not been systematically tested for confounding. To be useful for designing preventive interventions, risk factor analysis ideally needs to be carried through to demonstration of a causal connection, with a defined mechanism. Statistical analysis is often complicated by covariation of variables, and demonstration of a causal relationship between a factor and myopia using Mendelian randomization or in a randomized clinical trial should be aimed for. When strict analysis of this kind is applied, associations between various measures of educational pressure and myopia are consistently observed. However, associations between more nearwork and more myopia are generally weak and inconsistent, but have been supported by meta-analysis. Associations between time outdoors and less myopia are stronger and more consistently observed, including by meta-analysis. Measurement of nearwork and time outdoors has traditionally been performed with questionnaires, but is increasingly being pursued with wearable objective devices. A causal link between increased years of education and more myopia has been confirmed by Mendelian randomization, whereas the protective effect of increased time outdoors from the development of myopia has been confirmed in randomized clinical trials. Other proposed risk factors need to be tested to see if they modulate these variables. The evidence linking increased screen time to myopia is weak and inconsistent, although limitations on screen time are increasingly under consideration as interventions to control the epidemic of myopia.

PMID:33909035 | DOI:10.1167/iovs.62.5.3

Categories
Nevin Manimala Statistics

Racial/Ethnic Disparities in the Performance of Prediction Models for Death by Suicide After Mental Health Visits

JAMA Psychiatry. 2021 Apr 28. doi: 10.1001/jamapsychiatry.2021.0493. Online ahead of print.

ABSTRACT

IMPORTANCE: Clinical prediction models estimated with health records data may perpetuate inequities.

OBJECTIVE: To evaluate racial/ethnic differences in the performance of statistical models that predict suicide.

DESIGN, SETTING, AND PARTICIPANTS: In this diagnostic/prognostic study, performed from January 1, 2009, to September 30, 2017, with follow-up through December 31, 2017, all outpatient mental health visits to 7 large integrated health care systems by patients 13 years or older were evaluated. Prediction models were estimated using logistic regression with LASSO variable selection and random forest in a training set that contained all visits from a 50% random sample of patients (6 984 184 visits). Performance was evaluated in the remaining 6 996 386 visits, including visits from White (4 031 135 visits), Hispanic (1 664 166 visits), Black (578 508 visits), Asian (313 011 visits), and American Indian/Alaskan Native (48 025 visits) patients and patients without race/ethnicity recorded (274 702 visits). Data analysis was performed from January 1, 2019, to February 1, 2021.

EXPOSURES: Demographic, diagnosis, prescription, and utilization variables and Patient Health Questionnaire 9 responses.

MAIN OUTCOMES AND MEASURES: Suicide death in the 90 days after a visit.

RESULTS: This study included 13 980 570 visits by 1 433 543 patients (64% female; mean [SD] age, 42 [18] years. A total of 768 suicide deaths were observed within 90 days after 3143 visits. Suicide rates were highest for visits by patients with no race/ethnicity recorded (n = 313 visits followed by suicide within 90 days, rate = 5.71 per 10 000 visits), followed by visits by Asian (n = 187 visits followed by suicide within 90 days, rate = 2.99 per 10 000 visits), White (n = 2134 visits followed by suicide within 90 days, rate = 2.65 per 10 000 visits), American Indian/Alaskan Native (n = 21 visits followed by suicide within 90 days, rate = 2.18 per 10 000 visits), Hispanic (n = 392 visits followed by suicide within 90 days, rate = 1.18 per 10 000 visits), and Black (n = 65 visits followed by suicide within 90 days, rate = 0.56 per 10 000 visits) patients. The area under the curve (AUC) and sensitivity of both models were high for White, Hispanic, and Asian patients and poor for Black and American Indian/Alaskan Native patients and patients without race/ethnicity recorded. For example, the AUC for the logistic regression model was 0.828 (95% CI, 0.815-0.840) for White patients compared with 0.640 (95% CI, 0.598-0.681) for patients with unrecorded race/ethnicity and 0.599 (95% CI, 0.513-0.686) for American Indian/Alaskan Native patients. Sensitivity at the 90th percentile was 62.2% (95% CI, 59.2%-65.0%) for White patients compared with 27.5% (95% CI, 21.0%-34.7%) for patients with unrecorded race/ethnicity and 10.0% (95% CI, 0%-23.0%) for Black patients. Results were similar for random forest models, with an AUC of 0.812 (95% CI, 0.800-0.826) for White patients compared with 0.676 (95% CI, 0.638-0.714) for patients with unrecorded race/ethnicity and 0.642 (95% CI, 0.579-0.710) for American Indian/Alaskan Native patients and sensitivities at the 90th percentile of 52.8% (95% CI, 50.0%-55.8%) for White patients, 29.3% (95% CI, 22.8%-36.5%) for patients with unrecorded race/ethnicity, and 6.7% (95% CI, 0%-16.7%) for Black patients.

CONCLUSIONS AND RELEVANCE: These suicide prediction models may provide fewer benefits and more potential harms to American Indian/Alaskan Native or Black patients or those with undrecorded race/ethnicity compared with White, Hispanic, and Asian patients. Improving predictive performance in disadvantaged populations should be prioritized to improve, rather than exacerbate, health disparities.

PMID:33909019 | DOI:10.1001/jamapsychiatry.2021.0493

Categories
Nevin Manimala Statistics

Impact of photobiomodulation and low-intensity pulsed ultrasound adjunctive interventions on orthodontic treatment duration during clear aligner therapy: A retrospective study

Angle Orthod. 2021 Apr 28. doi: 10.2319/112420-956.1. Online ahead of print.

ABSTRACT

OBJECTIVE: To assess the efficiency of low-intensity pulsed ultrasound (LIPUS) and photobiomodulation (PBM) interventions in accelerating orthodontic tooth movement during clear aligner therapy (CAT).

MATERIALS AND METHODS: This retrospective study was carried out on the records of 84 subjects who were treated using CAT. Twenty-eight patients were treated using CAT with a daily use of LIPUS for 20 minutes, 28 patients were treated using CAT with a daily use of PBM for 10 minutes, and 28 patients were treated using CAT alone. The total duration of treatment was recorded for all patients. One-way analysis of variance and post hoc Tukey test were used to assess whether there was any significant difference in total treatment duration among the three groups (P < .05).

RESULTS: The mean treatment durations in days were 719 ± 220, 533 ± 242, and 528 ± 323 for the control, LIPUS, and PBM groups, respectively. The LIPUS group showed a 26% reduction, on average, in treatment duration when compared with the control group, whereas the PBM group showed an average 26.6% reduction in the treatment duration when compared with the control group. The results showed that there were statistically significant differences among the groups (P = .011). Treatment durations were significantly reduced in the LIPUS and PBM groups as compared with the control (P = .027 and P = .023, respectively), with no statistically significant differences between the LIPUS and PBM groups (P = .998).

CONCLUSIONS: Daily use of LIPUS or PBM as adjunctive interventions during CAT could reduce the duration of orthodontic treatment.

PMID:33909012 | DOI:10.2319/112420-956.1

Categories
Nevin Manimala Statistics

Differences in hypertension prevalence and hypertension control by urbanization among adults in the United States, 2013-2018

Am J Hypertens. 2021 Apr 28:hpab067. doi: 10.1093/ajh/hpab067. Online ahead of print.

ABSTRACT

OBJECTIVE: To examine the associations between urbanization and hypertension, stage II hypertension, and hypertension control.

METHODS: Data on 16,360 U.S. adults aged 18 years or older from the 2013-2018 National Health and Nutrition Examination Survey (NHANES) were used to estimate the prevalence of hypertension (blood pressure (BP) ≥130/80 mm Hg or use of medication for hypertension), stage II hypertension (BP ≥140/90 mm Hg), and hypertension control (BP < 130/80 mm Hg among hypertensives) by urbanization, classified by levels of metropolitan statistical areas as large MSAs (population ≥ 1,000,000), medium to small MSAs (population 50,000-999,999), and non-MSAs (population <50,000)).

RESULTS: All prevalence ratios (PRs) were compared with large MSAs and adjusted for demographics and risk factors. The PRs of hypertension were 1.07 (95% CI= 0.99-1.14) for adults residing in medium to small MSAs and 1.06 (95% CI=0.99- 1.13) for adults residing in non-MSAs, For stage II hypertension, the PRs were higher for adults residing in medium to small MSAs 1.21 (95% CI =1.06-1.36) but not for adults residing in non-MSAs 1.06 (95% CI= 0.88-1.29). For hypertension control, the PRs were 0.96 (95% CI=0.91-1.01) for adults residing in medium to small MSAs and 1.00 (95% CI=0.93-1.06) for adults residing in non-MSAs.

CONCLUSION: Among U.S. adults, urbanization was associated with stage II hypertension.

PMID:33909014 | DOI:10.1093/ajh/hpab067

Categories
Nevin Manimala Statistics

Performance of the American Heart Association/American College of Cardiology Pooled Cohort Equations to Estimate Atherosclerotic Cardiovascular Disease Risk by Self-reported Physical Activity Levels

JAMA Cardiol. 2021 Apr 28. doi: 10.1001/jamacardio.2021.0948. Online ahead of print.

ABSTRACT

IMPORTANCE: The American Heart Association/American College of Cardiology pooled cohort equations (PCEs) are used for predicting 10-year atherosclerotic cardiovascular disease (ASCVD) risk. Pooled cohort equation risk prediction capabilities across self-reported leisure-time physical activity (LTPA) levels and the change in model performance with addition of LTPA to the PCE are unclear.

OBJECTIVE: To evaluate PCE risk prediction performance across self-reported LTPA levels and the change in model performance by adding LTPA to the existing PCE model.

DESIGN, SETTING, AND PARTICIPANTS: Individual-level pooling of data from 3 longitudinal cohort studies-Atherosclerosis Risk in Communities, Multi-Ethnic Study of Atherosclerosis, and Cardiovascular Health Study-was performed. A total of 18 824 participants were stratified into 4 groups based on self-reported LTPA levels: inactive (0 metabolic equivalent of task [MET]-min/wk), less than guideline-recommended (<500 MET-min/wk), guideline-recommended (500-1000 MET-min/week), and greater than guideline-recommended (>1000 MET-min/wk). Pooled cohort equation risk discrimination was studied using the C statistic and reclassification capabilities were studied using the Greenwood Nam-D’Agostino χ2 goodness-of-fit test. Change in risk discrimination and reclassification on adding LTPA to PCEs was evaluated using change in C statistic, integrated discrimination index, and categorical net reclassification index.

MAIN OUTCOMES AND MEASURES: Adjudicated ASCVD events during 10-year follow-up.

RESULTS: Among 18 824 participants studied, 10 302 were women (54.7%); mean (SD) age was 57.6 (8.2) years. A total of 5868 participants (31.2%) were inactive, 3849 (20.4%) had less than guideline-recommended LTPA, 3372 (17.9%) had guideline-recommended LTPA, and 5735 (30.5%) had greater than guideline-recommended LTPA level. Higher LTPA levels were associated with a lower risk of ASCVD after adjustment for risk factors (hazard ratio [HR] per 1-SD higher LTPA, 0.91; 95% CI, 0.86-0.96). Across LTPA groups, PCE risk discrimination (C statistic, 0.76-0.78) and risk calibration (all χ2 P > .10) was similar. Addition of LTPA to the PCE model resulted in no significant change in the C statistic (0.0005; 95% CI, -0.0004 to 0.0015; P = .28) and categorical net reclassification index (-0.003; 95% CI, -0.010 to 0.010; P = .95), but a minimal improvement in the integrated discrimination index (0.0008; 95% CI, 0.0002-0.0013; P = .005) was observed. Similar results were noted when cohort-specific coefficients were used for creating the baseline model.

CONCLUSIONS AND RELEVANCE: Higher self-reported LTPA levels appear to be associated with lower ASCVD risk and increasing LTPA promotes cardiovascular wellness. These findings suggest the American Heart Association/American College of Cardiology PCEs are accurate at estimating the probability of 10-year ASCVD risk regardless of LTPA level. The addition of self-reported LTPA to PCEs does not appear to be associated with improvement in risk prediction model performance.

PMID:33909016 | DOI:10.1001/jamacardio.2021.0948

Categories
Nevin Manimala Statistics

Acute dental pain elevates salivary oxytocin in women: a risk factor during pregnancy

Gen Dent. 2021 May-Jun;69(3):73-77.

ABSTRACT

Irreversible pulpitis is an acute, brief, and painful condition. Oxytocin, cortisol, and secretory immunoglobulin A (sIgA) are released by the body in response to pain and emotional stress. The aim of this study was to investigate the expression of salivary cortisol, sIgA, and oxytocin among patients with irreversible pulpitis. This was an ethically approved case-control study comparing 90 cases of irreversible pulpitis and 40 healthy individuals. Five study groups were established: nonpregnant female pulpitis, pregnant female pulpitis, male pulpitis, healthy (nonpregnant) female control, and healthy male control. Pregnant women in the first trimester were enrolled in the study. Participants received both clinical and radiographic examinations, completed a simple questionnaire related to food intake, habits, and anxiety, and their pain levels were recorded on a visual analog scale in which 0 represented no pain and 10 represented the worst possible pain. Unstimulated saliva samples were collected to measure oxytocin, sIgA, and cortisol levels. Dental pulp specimens were obtained and stained with hematoxylin and eosin to evaluate the agreement between clinical and histologic pulpal diagnoses. The statistical analysis included analysis of variance and Tukey tests. The majority of patients (37%) recorded a score of 8 (severe pain) on the visual analog scale, while a score of 10 (worst possible pain) was recorded only by pregnant women (3%). There was no statistically significant difference among healthy subjects for all salivary samples. Oxytocin levels increased significantly in nonpregnant (P < 0.5) and pregnant (P < 0.001) women with pulpitis. Cortisol (P < 0.01) and sIgA (P < 0.001) levels were significantly elevated only in pregnant women with pulpitis. The results of the present study indicate that acute dental pain during pregnancy can be considered as a pregnancy risk factor because of the resulting elevated oxytocin and cortisol levels.

PMID:33908883

Categories
Nevin Manimala Statistics

Impact of Mobile Health Devices for the Detection of Atrial Fibrillation: Systematic Review

JMIR Mhealth Uhealth. 2021 Apr 28;9(4):e26161. doi: 10.2196/26161.

ABSTRACT

BACKGROUND: Atrial fibrillation (AF) is the most common arrhythmia, and its prevalence is increasing. Early diagnosis is important to reduce the risk of stroke. Mobile health (mHealth) devices, such as single-lead electrocardiogram (ECG) devices, have been introduced to the worldwide consumer market over the past decade. Recent studies have assessed the usability of these devices for detection of AF, but it remains unclear if the use of mHealth devices leads to a higher AF detection rate.

OBJECTIVE: The goal of the research was to conduct a systematic review of the diagnostic detection rate of AF by mHealth devices compared with traditional outpatient follow-up. Study participants were aged 16 years or older and had an increased risk for an arrhythmia and an indication for ECG follow-up-for instance, after catheter ablation or presentation to the emergency department with palpitations or (near) syncope. The intervention was the use of an mHealth device, defined as a novel device for the diagnosis of rhythm disturbances, either a handheld electronic device or a patch-like device worn on the patient’s chest. Control was standard (traditional) outpatient care, defined as follow-up via general practitioner or regular outpatient clinic visits with a standard 12-lead ECG or Holter monitoring. The main outcome measures were the odds ratio (OR) of AF detection rates.

METHODS: Two reviewers screened the search results, extracted data, and performed a risk of bias assessment. A heterogeneity analysis was performed, forest plot made to summarize the results of the individual studies, and albatross plot made to allow the P values to be interpreted in the context of the study sample size.

RESULTS: A total of 3384 articles were identified after a database search, and 14 studies with a 4617 study participants were selected. All studies but one showed a higher AF detection rate in the mHealth group compared with the control group (OR 1.00-35.71), with all RCTs showing statistically significant increases of AF detection (OR 1.54-19.16). Statistical heterogeneity between studies was considerable, with a Q of 34.1 and an I2 of 61.9, and therefore it was decided to not pool the results into a meta-analysis.

CONCLUSIONS: Although the results of 13 of 14 studies support the effectiveness of mHealth interventions compared with standard care, study results could not be pooled due to considerable clinical and statistical heterogeneity. However, smartphone-connectable ECG devices provide patients with the ability to document a rhythm disturbance more easily than with standard care, which may increase empowerment and engagement with regard to their illness. Clinicians must beware of overdiagnosis of AF, as it is not yet clear when an mHealth-detected episode of AF must be deemed significant.

PMID:33908885 | DOI:10.2196/26161

Categories
Nevin Manimala Statistics

Fast Healthcare Interoperability Resources (FHIR)-Based Quality Information Exchange for Clinical Next-Generation Sequencing Genomic Testing: Implementation Study

J Med Internet Res. 2021 Apr 28;23(4):e26261. doi: 10.2196/26261.

ABSTRACT

BACKGROUND: Next-generation sequencing (NGS) technology has been rapidly adopted in clinical practice, with the scope extended to early diagnosis, disease classification, and treatment planning. As the number of requests for NGS genomic testing increases, substantial efforts have been made to deliver the testing results clearly and unambiguously. For the legitimacy of clinical NGS genomic testing, quality information from the process of producing genomic data should be included within the results. However, most reports provide insufficient quality information to confirm the reliability of genomic testing owing to the complexity of the NGS process.

OBJECTIVE: The goal of this study was to develop a Fast Healthcare Interoperability Resources (FHIR)-based web app, NGS Quality Reporting (NGS-QR), to report and manage the quality of the information obtained from clinical NGS genomic tests.

METHODS: We defined data elements for the exchange of quality information from clinical NGS genomic tests, and profiled a FHIR genomic resource to enable information exchange in a standardized format. We then developed the FHIR-based web app and FHIR server to exchange quality information, along with statistical analysis tools implemented with the R Shiny server.

RESULTS: Approximately 1000 experimental data entries collected from the targeted sequencing pipeline CancerSCAN designed by Samsung Medical Center were used to validate implementation of the NGS-QR app using real-world data. The user can share the quality information of NGS genomic testing and verify the quality status of individual samples in the overall distribution.

CONCLUSIONS: This study successfully demonstrated how quality information of clinical NGS genomic testing can be exchanged in a standardized format. As the demand for NGS genomic testing in clinical settings increases and genomic data accumulate, quality information can be used as reference material to improve the quality of testing. This app could also motivate laboratories to perform diagnostic tests to provide high-quality genomic data.

PMID:33908889 | DOI:10.2196/26261