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Nevin Manimala Statistics

How accurate are the longer-term projections of overall survival for cancer immunotherapy for standard versus more flexible parametric extrapolation methods?

J Med Econ. 2022 Jan 21:1-41. doi: 10.1080/13696998.2022.2030599. Online ahead of print.

ABSTRACT

Aims To assess the accuracy of standard parametric survival models, spline models, and mixture cure models (MCMs) fitted to overall survival (OS) data available at the time of submission in the NICE HTA process compared with data subsequently made available.Methods Standard parametric distributions, spline models, and MCMs were fitted to OS data presented in single technology appraisals (TAs) for immune-checkpoint inhibitors (ICIs) in cancer. For each TA, the estimated survival from the fitted models was compared with Kaplan-Meier (KM) data that were made available following the HTA submission using differences between point estimates and restricted area under the curve (AUC) at both the midpoint and the end of additional follow-up. Differences in interval AUC values (calculated for each 6-month period) were also assessed.Results Standard parametric survival models and spline models were more likely to underestimate longer-term survival, irrespective of the measure used to assess model accuracy. MCMs were more likely to over-estimate survival; however, this was improved in some cases by applying an additional hazard of mortality for ‘statistically cured’ patients.Limitations The accuracy of the models was assessed based on much shorter OS data than the period for which extrapolation is needed, which may impact conclusions regarding the most accurate models. The most recent TAs for ICIs have not been captured.Conclusions There are no definitive findings that unquestionably support the use of one specific extrapolation technique. Rather, each has the potential to provide accurate or inaccurate extrapolation to longer-term data in certain circumstances, but the added flexibility of more complex models can be justified for treatments, like ICIs, that have extended survival for patients across disease areas. The use of mortality adjustments for ‘statistically cured’ patients allows decision makers to explore more conservative scenarios in the face of high decision uncertainty.

PMID:35060433 | DOI:10.1080/13696998.2022.2030599

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Nevin Manimala Statistics

Prevalence and Correlates of Physical-mental Multimorbidity in Outpatient Children From a Pediatric Hospital in Canada

Can J Psychiatry. 2022 Jan 21:7067437221074430. doi: 10.1177/07067437221074430. Online ahead of print.

ABSTRACT

OBJECTIVE: The aim of this study was to estimate the six-month prevalence of mental illness in children with chronic physical illness (multimorbidity), examine agreement between parent and child reports of multimorbidity, and identify factors associated with child multimorbidity.

METHOD: The sample included 263 children aged 2-16 years with a physician-diagnosed chronic physical illness recruited from the outpatient clinics at a pediatric hospital. Children were categorized by physical illness according to the International Statistical Classification of Diseases and Related Health Problems (ICD)-10. Parent and child-reported six-month mental illness was based on the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID).

RESULTS: Overall, 101 (38%) of children had a parent-reported mental illness; 29 (25%) children self-reported mental illness. There were no differences in prevalence across ICD-10 classifications. Parent-child agreement on the MINI-KID was low (κ = 0.18), ranging from κ = 0.24 for specific phobia to κ = 0.03 for attention-deficit hyperactivity. From logistic regression modeling (odds ratio [OR] and 95% confidence interval), factors associated with multimorbidity were: child age (OR = 1.16 [1.04, 1.31]), male (OR = 3.76 [1.54, 9.22]), ≥$90,000 household income (OR = 2.57 [1.08, 6.22]), parental symptoms of depression (OR = 1.09 [1.03, 1.14]), and child disability (OR = 1.21 [1.13, 1.30]). Similar results were obtained when modeling number of mental illnesses.

CONCLUSIONS: Findings suggest that six-month multimorbidity is common and similar across different physical illnesses. Level of disability is a robust, potentially modifiable correlate of multimorbidity that can be assessed routinely by health professionals in the pediatric setting to initiate early mental health intervention to reduce the incidence of multimorbidity in children.

PMID:35060408 | DOI:10.1177/07067437221074430

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Nevin Manimala Statistics

A simplified procedure of nerve-sparing radical hysterectomy

J Obstet Gynaecol Res. 2022 Jan 20. doi: 10.1111/jog.15154. Online ahead of print.

ABSTRACT

AIM: We devised a simplified nerve-sparing radical hysterectomy that is simpler than commonly used procedures.

METHODS: We retrospectively examined 16 cases of classical non-nerve-sparing radical hysterectomy (non-nerve-sparing group) and 16 cases of simplified nerve-sparing radical hysterectomy (nerve-sparing group) performed between 2019 and 2020. We examined and compared the duration of surgery, blood loss, perioperative complications, postoperative urinary function (presence or absence of urinary sensation, number of days with residual urine measurement, and frequency and duration of oral sustained release urapidil capsules and self-catheterization), and short-term prognosis between the two groups.

RESULTS: Compared to conventional non-nerve-sparing radical hysterectomy, the duration of surgery for nerve-sparing radical hysterectomy was significantly shorter (407 [339-555] min vs. 212 [180-356] min; p < 0.001), and blood loss was significantly less. Compared to the nerve-sparing group, the non-nerve-sparing group had more cases of oral urapidil use and a higher frequency of clean intermittent catheterization. Clean intermittent catheterization was required in two cases in the nerve-sparing group; however, it was withdrawn at 180 and 240 days. Conversely, clean intermittent catheterization was still required in three cases in the non-nerve-sparing group. There were no statistically significant differences in progression-free survival and overall survival between the two groups.

CONCLUSION: The simple nerve-sparing radical hysterectomy resulted in shorter duration of surgery and less blood loss as well as in a clear improvement in the postoperative urinary status and short-term prognosis. This technique simplifies nerve-sparing radical hysterectomy, which is commonly thought to be complicated, making it easier to understand.

PMID:35052017 | DOI:10.1111/jog.15154

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Nevin Manimala Statistics

Trends in the amyloidosis mortality rate in Japan: A nationwide observational study from 1998 to 2019

Geriatr Gerontol Int. 2022 Jan 20. doi: 10.1111/ggi.14348. Online ahead of print.

ABSTRACT

AIM: Despite the increasing attention that has been paid to amyloidosis in recent years, there have been few reports on amyloidosis mortality and its trends worldwide. This study aimed to evaluate the trends in crude and age-adjusted amyloidosis-associated mortality rates in Japan from 1998 to 2019.

METHODS: We used national Vital Statistics data among older adults aged over 50 years. The data were analyzed using the joinpoint regression program to estimate the long-term trends and average annual percentage changes (AAPCs).

RESULTS: A total of 9158 amyloidosis-associated deaths were recorded from 1998 to 2019, of which 56.1% were in men. The crude mortality rate per 1 000 000 older adults aged over 80 years increased from 9.65 to 54.3 among men and from 7.02 to 22.1 among women during the study period. Overall, the AAPCs of age-adjusted amyloidosis-associated mortality rates increased significantly over the study period (1.8%, 95% confidence interval [CI], 1.0-2.7%). While the annual percentage change (APC) of age-adjusted mortality rates in women showed no significant change over the study period, the APC in men markedly increased in the 2013-2019 period (8.2%, 95% CI: 6.0-10.4%).

CONCLUSIONS: This study revealed an increasing trend in mortality associated with amyloidosis, and in particular a marked increase in mortality among men over the past 6 years. Considering its high mortality rate and susceptibility to the effects of an increasing population of older adults, amyloidosis deserves more attention from healthcare providers to improve the understanding of diagnosis, clinical treatment, and healthcare planning. Geriatr Gerontol Int 2022; ••: ••-••.

PMID:35052016 | DOI:10.1111/ggi.14348

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Nevin Manimala Statistics

Management Strategies Following Slightly Out of Range INRs: Watchful Waiting vs. Dose Changes

Blood Adv. 2022 Jan 20:bloodadvances.2021006454. doi: 10.1182/bloodadvances.2021006454. Online ahead of print.

ABSTRACT

Patients’ international normalized ratios (INRs) often fall slightly out of range. In these cases, the American College of Chest Physician (ACCP) guidelines suggest maintaining the current warfarin dose and retesting the INR within the following two weeks (watchful waiting). We sought to determine whether watchful waiting or dose changes for slightly out of range INRs is more effective in obtaining in-range INRs at follow-up. INRs and management strategies of warfarin-treated patients within the Michigan Anticoagulation Quality Improvement Initiative (MAQI²) registry were analyzed. Management strategies included watchful waiting or dose changes. INRs slightly out of range (target range 2.0-3.0) and their associated management were identified. Multilevel mixed-effects logistic regression was used to estimate the probability of the next INR being in range adjusted for clustering due to multiple out of range INRs per patient. A total of 45,351 slightly out of range INRs (ranging 1.50-1.99 and 3.01-3.49) from 8,288 patients were identified. The next INR was slightly less likely to be in range with watchful waiting than with a dose change (Predicted Probabilities 58.9% vs. 60.0%, P-value = 0.024). Although a significant statistical difference was detected in the probabilities of the next INR being back in range when managed by a dose change compared to watchful waiting following a slightly out of range INR, the magnitude of the difference was small and unlikely to represent clinical importance. Our study supports the current guideline recommendations for watchful waiting in cases of slightly out of range INRs values.

PMID:35052000 | DOI:10.1182/bloodadvances.2021006454

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Nevin Manimala Statistics

Exposure Determinants in the French Database COLCHIC (1987-2019): Statistical Modeling across 77 Chemicals

Ann Work Expo Health. 2021 Nov 23:wxab104. doi: 10.1093/annweh/wxab104. Online ahead of print.

ABSTRACT

OBJECTIVES: The COLCHIC database contains workplace exposure results of chemical samples collected by the French prevention network since 1987. We aimed to investigate potential associations between exposure levels and ancillary variables in COLCHIC across a broad range of chemical agents in order to provide insight into how to best interpret and exploit the information in this national database.

METHODS: We selected personal and area measurements in COLCHIC and collected outside respiratory personal protective equipment (PPE), restricted to chemical agents that had at least 1000 samples available. We used Tobit models to estimate associations between exposure concentrations and sample year, sampling duration, PPE, workforce size, collective protective equipment, origin of request, and reason for request for each chemical agent for the period 1987-2019. Models for period 2002-2019 also included type of process (open/closed) and exposure frequency. We used separate models for each combination of agent, period, and personal or area samples. We then applied Bayesian meta-analytical methods to assess average effects and effect heterogeneity of exposure factors across agents.

RESULTS: COLCHIC contained 720 282 exposure results (62% personal and 38% area samples) to 77 agents, including 346 766 results for the more recent period 2002-2019 (67% personal and 33% area samples). Sample year and duration, PPE, and process type had the strongest and most consistent associations with exposure levels across agents. Personal and area exposure levels decreased yearly (6% for the entire period and 9% since 2002), and 30-min samples were approximately twice as high as 240-min samples. Workers wearing PPE were exposed to levels 1.7 times higher on average than those without PPE for both area and personal samples. Personal exposure levels associated with enclosed or semi-enclosed processes were approximately 20-30% lower compared with open processes. The associations for the other exposure variables were weaker and more inconsistent between agents. Between-agent heterogeneity of estimated effects, based on 80% prediction intervals, was lowest for sampling duration, time trends, and the presence of PPE.

CONCLUSIONS: Sampling duration, time trends, and the presence of PPE are important factors to take into account when analyzing COLCHIC and had similar associations with exposure levels across agents. Other variables generally showed weaker associations or variable effects. These results will be used to adjust exposure estimates for the French working population from measurements stored in COLCHIC.

PMID:35051995 | DOI:10.1093/annweh/wxab104

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Nevin Manimala Statistics

Measurement of Diacetyl and Related Compounds in Coffee Roasteries and Breweries

Ann Work Expo Health. 2021 Nov 23:wxab101. doi: 10.1093/annweh/wxab101. Online ahead of print.

ABSTRACT

α-Diketones such as diacetyl (2,3-butanedione) and 2,3-pentanedione are generated during the roasting and fermentation of foods and are also used as flavoring compounds. Exposure to these compounds has been associated with obliterative bronchiolitis in workers. We report indoor air concentrations of diacetyl and 2,3-pentanedione, as well as acetoin (3-hydroxy-2-butanone), in several small coffee roasteries and breweries using standard integrated air sampling sorbent tubes followed by gas chromatography tandem mass spectrometry as well as the first use of on-site continuous real-time proton-transfer reaction time-of-flight mass spectrometry (PTR-ToF-MS). Diacetyl and 2,3-pentanedione were detected in most of the sorbent samples at concentrations between 0.02 and 8 ppbv, and in general were higher in coffee roasteries compared with breweries. Three integrated air samples, all from the barista area at one facility, exceeded the NIOSH recommended exposure limit (REL) of 5 ppbv for diacetyl. 2,3-Pentanedione concentrations in these three samples were greater than 50% of its REL, but did not exceed it. Acetoin, a precursor to diacetyl, was also detected at concentrations between 0.03 and 5 ppbv in most sorbent tube samples, with concentrations generally higher in breweries. PTR-ToF-MS measurements exhibited similar trends and provided continuous real-time volatile organic compound data that showed episodic excursions with peak concentrations of diacetyl and 2,3-pentanedione between 15 and 20 ppbv. Examination of the time series data identified specific activities associated with peak diketone emissions, including transfer of freshly roasted coffee beans to the cooling tray, or the opening of a brew kettle. Additional indoor air quality parameters including CO2, NO2, and PM2.5 were also assessed on-site. Airway inflammation was assessed in 19 workers before and after each work shift using online measurements of fractional exhaled nitric oxide (FENO). The pre-shift mean FENO was 3.7 (95% confidence interval: -3.6, 11.0) ppbv higher and the post-shift FENO was 7.1 (-1.9, 16.1) ppbv higher for workers at coffee roasteries compared with breweries. The cross-shift change in FENO was 3.4 (-2.8, 9.6) ppbv higher for workers at coffee roasteries compared with breweries. However, none of these differences were statistically significant, and the cross-shift change in FENO was not statistically different from zero for either group of workers. The findings from this pilot study demonstrate that α-diketones and related compounds are present in the indoor air of both breweries and coffee roasteries and may exceed health protective guidelines in coffee roasteries. Additional studies are required to fully characterize worker exposures in these settings and to identify specific work activities and processes associated with high exposures. Engineering controls, including targeted exhaust ventilation and the use of low-cost sensors, are recommended as an approach to protect workers from exposure to hazardous levels of α-diketones.

PMID:35051991 | DOI:10.1093/annweh/wxab101

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Nevin Manimala Statistics

Reducing Opioid-Induced Constipation Post-Cardiac Surgery: An Improvement Project in a Pediatric Cardiac Intensive Care Unit

J Nurs Care Qual. 2022 Jan 19. doi: 10.1097/NCQ.0000000000000616. Online ahead of print.

ABSTRACT

BACKGROUND: Pain management with opioids and underutilization of prophylaxis for constipation can prolong a patient’s hospital length of stay and impede pain management efforts.

PROBLEM: In pediatric postoperative cardiac patients, opioid therapy is a common approach to pain management but often places them at greater risk for constipation due to anatomy and age.

METHODS: A retrospective review of 50 patients’ medical records for baseline data was conducted, and a survey evaluated providers’ current knowledge and practice.

INTERVENTIONS: The intervention was an electronic order set that provided decision support. Additionally, prophylactic measures were supported by a validated assessment tool that created a common language to report constipation risk.

RESULTS: Although not statistically significant, postintervention data demonstrated a 21.5% decrease in postoperative constipation and a 57% increase in ordered bowel regimens.

CONCLUSION: More focus is needed toward prophylactic bowel regimens to reduce the risk in this already high-risk population.

PMID:35051979 | DOI:10.1097/NCQ.0000000000000616

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The Relation of End-tidal CO2 Values With Infarct Volume and Early Prognosis in Patients With Acute Ischemic Stroke

Neurologist. 2022 Jan 20. doi: 10.1097/NRL.0000000000000418. Online ahead of print.

ABSTRACT

BACKGROUND: The aim of this study is to reveal the relationship between end-tidal CO2 (EtCO2) values with infarct volume and early prognosis in patients diagnosed with acute ischemic stroke in the emergency department.

MATERIALS AND METHODS: This prospective cross-sectional study was conducted in a tertiary hospital. The demographics, characteristics, EtCO2, volume of the stroke area on diffusion-weighted magnetic resonance imaging and the modified Rankin Scale (mRS) of the patients were recorded. The values calculated at admission and at discharge were labeled as “mRS-1” and “mRS-2”, respectively, and the mRS-2 measurement was used as a prognostic indicator. The “good” and the “poor” functional outcomes were defined as mRS ≤2 and mRS >2, respectively. Correlations between levels of EtCO2 and infarct volume, mRS were calculated.

RESULTS: In total, 44 patients were included in the study. The median age of the patients was 69 years (interquartile range; 16; min-max: 35 to 88 y) and 68.2% of them were male. In the univariate logistic regression models of the mRS-2 [0 to 2 (0) and 3 to 6 (1)], all variables were not statistically significant to predict mRS-2 group. There were statistically significant differences in EtCO2 values between mRS-1 (P=0.03) and mRS-2 (P=0.04). A negative moderate correlation was found between EtCO2 and mRS-2 (r=-0.410; P=0.006). The correlation between EtCO2 and infarct volume was not statistically significant (r=-0.256; P=0.093).

CONCLUSIONS: This study highlights the importance of capnography follow-up of patients with acute ischemic stroke. In patients with acute ischemic stroke, the EtCO2 value measured at the time of admission is lower in the group with high mRS at both admission and discharge.

PMID:35051967 | DOI:10.1097/NRL.0000000000000418

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Mental Health Disorders and Suicidal Behaviors Among Provincial Correctional Workers

J Occup Environ Med. 2022 Jan 19. doi: 10.1097/JOM.0000000000002488. Online ahead of print.

ABSTRACT

OBJECTIVE: We examined the prevalence of mental health disorders and suicidal behaviours (ideation, planning and attempts) among a sample of provincial correctional workers in Manitoba.

METHODS: Self-reported mental health data from a survey on correctional worker mental health and well-being were analyzed for 491 correctional workers.

RESULTS: Over half (57%) of respondents screened positive for mental health disorder, most commonly Major Depressive Disorder, and over one-third of respondents (37%) screened positive for more than one disorder. Positive mental health screens for all mental health disorders were associated with statistically significantly increased odds of lifetime suicidal ideation, and positive screens for most disorders were associated with past year suicidal ideation.

CONCLUSIONS: Relative to other public safety personnel and the general public, correctional workers appear have a higher prevalence of mental health disorders and suicidal behaviours. The association between positive screens for mental health disorders and suicidal behaviours highlights the vulnerability of correctional workers in regards to mental well-being.

PMID:35051959 | DOI:10.1097/JOM.0000000000002488