Category: Statistics

J Am Acad Orthop Surg. 2021 Feb 22. doi: 10.5435/JAAOS-D-20-01270. Online ahead of print.

ABSTRACT

The interactions between physicians and industry are necessary for advancement of clinical practice and improvement in medical devices. Physician-industry relationships also introduces financial conflicts of interest into research publications. Payments to physicians do not inherently introduce bias in research, but failure to disclose potential conflicts of interest can negatively impact the perceived integrity of authors, editors, and journals. The conflict of interest disclosure statement in all articles published in the Journal of the American Academy of Orthopaedic Surgery between 2014 and 2018 were compared to the financial payments indexed in the Center for Open Payments Database. Payment type, magnitude, and payer were obtained for each payment meeting inclusion criteria. Statistical comparisons were made using Mann-Whitney comparisons due to non-normal distribution of payment amounts. 704 articles involving 2596 authors were reviewed, with 1268 authors meeting inclusion criteria. 634 authors had accurate disclosure statements. The total amount of disclosed payments was $169 million, whereas undisclosed payments were $14.2 million. The amount of disclosed payments on a per-author basis, $55,844 ($12,559, $186,129), was significantly greater than undisclosed payments, $2,171 ($568, $7,238). The lowest rates of correct disclosure were in education (29.2%), gifts (38.7%) and honoraria (57.8%). First and middle authors disclosed correctly at a significantly lower rate than last authors. The magnitude of undisclosed payments was significantly lower than disclosed payments, indicating that these payments do not register with authors as significant enough to disclose.

PMID:33620174 | DOI:10.5435/JAAOS-D-20-01270

Ann Noninvasive Electrocardiol. 2021 Feb 23:e12832. doi: 10.1111/anec.12832. Online ahead of print.

ABSTRACT

BACKGROUD: Present electrocardiogram (ECG) criteria for diagnosing left ventricular hypertrophy (LVH) usually have low sensitivity, while the newly proposed SD + SV4 criterion, namely the deepest S-wave amplitude in any lead (SD) plus SV4 amplitude, has been reported to have higher sensitivity and accuracy compared with other existing criteria. We aimed to further evaluate the diagnostic value of the SD + SV4 criterion in reference to the gold standard cardiac magnetic resonance imaging (CMR) in LVH diagnosis.

METHODS: This retrospective study enrolled 138 patients who received CMR examination-60 patients with reduced ejection fraction (EF) and 78 patients with preserved EF. The left ventricular mass index (LVMI) measured by CMR was used as the gold standard for diagnosing LVH.

RESULT: The diagnostic value of the SD + SV4 criterion was compared with other 4 commonly used criteria. By CMR, 29 out of 138 people (21%) were diagnosed with LVH in reference to CMR. The SD + SV4 criterion had markedly higher sensitivity in diagnosing LVH compared with other criteria, but no higher specificity. There was no significant difference in area under receiver operating characteristic (ROC) curve among these criteria. The SD + SV4 criterion was not markedly consistent with CMR in diagnosing LVH. Compared to the other criteria, the SD + SV4 criterion had the highest sensitivity in patients with reduced ejection fraction; however, the area under the curve (AUC) of the SD + SV4 criterion in patients with reduced EF was significantly lower than in patients with preserved EF.

CONCLUSION: The newly proposed SD + SV4 criterion did not have a better diagnostic value compared with other existing criteria, and the statistical power of the SD + SV4 criterion was influenced by EF.

PMID:33620147 | DOI:10.1111/anec.12832

Cancer Med. 2021 Feb 23. doi: 10.1002/cam4.3732. Online ahead of print.

ABSTRACT

PURPOSE: To date there has not been an extensive analysis of the outcomes of biomarker use in oncology.

METHODS: Data were pooled across four indications in oncology drawing upon trial outcomes from www.clinicaltrials.gov: breast cancer, non-small cell lung cancer (NSCLC), melanoma and colorectal cancer from 1998 to 2017. We compared the likelihood drugs would progress through the stages of clinical trial testing to approval based on biomarker status. This was done with multi-state Markov models, tools that describe the stochastic process in which subjects move among a finite number of states.

RESULTS: Over 10000 trials were screened, which yielded 745 drugs. The inclusion of biomarker status as a covariate significantly improved the fit of the Markov model in describing the drug trajectories through clinical trial testing stages. Hazard ratios based on the Markov models revealed the likelihood of drug approval with biomarkers having nearly a fivefold increase for all indications combined. A 12, 8 and 7-fold hazard ratio was observed for breast cancer, melanoma and NSCLC, respectively. Markov models with exploratory biomarkers outperformed Markov models with no biomarkers.

CONCLUSION: This is the first systematic statistical evidence that biomarkers clearly increase clinical trial success rates in three different indications in oncology. Also, exploratory biomarkers, long before they are properly validated, appear to improve success rates in oncology. This supports early and aggressive adoption of biomarkers in oncology clinical trials.

PMID:33620160 | DOI:10.1002/cam4.3732

Infect Dis (Lond). 2021 Feb 23:1-12. doi: 10.1080/23744235.2021.1884286. Online ahead of print.

ABSTRACT

BACKGROUND: There is an urgent need to reduce mortality of COVID-19. We examined if corticosteroids and tocilizumab reduce risk for death in patients with severe pneumonia caused by SARS-CoV-2.

METHODS: A retrospective cohort study was performed in a single university hospital. All adult patients admitted with confirmed severe COVID-19 pneumonia from 9 March to 9 April 2020 were included. Severe pneumonia was defined as multi-lobar or bilateral pneumonia and a ratio of oxygen saturation by pulse oximetry to the fraction of inspired oxygen (SpFi)<315. All patients received antiviral and antibiotic treatment. From March 26, patients also received immunomodulatory treatment with corticosteroids (methylprednisolone 250 mg/day for 3 days), or tocilizumab or both. In-hospital mortality in the entire cohort and in a 1:1 matched cohort sub-analysis was evaluated.

RESULTS: 255 patients were included, 118 received only antiviral and antibiotic treatment while 137, admitted after March 26, also received immunomodulators. In-hospital mortality of patients on immunomodulatory treatment was significantly lower than in those without [47/137(34.3%) vs. 69/118(58.5%), (p < .001)]. The risk of death was 0.44 (CI, 0.26-0.76) in patients receiving corticosteroids alone and 0.292 (CI, 0.18-0.47) in those treated with corticosteroids and tocilizumab. In the sub-analysis with 202 matched patients, the risk of death was 0.356 (CI 0.179-0.707) in patients receiving corticosteroids alone and 0.233 (0.124-0.436) in those treated with the combination.

CONCLUSIONS: Combined treatment with corticosteroids and tocilizumab reduced mortality with about 25% in patients with severe COVID-19 pneumonia. Corticosteroids alone also resulted in lower in-hospital mortality rate compared to patients receiving only antiviral and antibiotic treatment. Corticosteroids alone or combined with tocilizumab may be considered in patients with severe COVID-19 pneumonia.

PMID:33620019 | DOI:10.1080/23744235.2021.1884286

Ther Adv Respir Dis. 2021 Jan-Dec;15:1753466621995040. doi: 10.1177/1753466621995040.

ABSTRACT

BACKGROUND: The clinical and economic burden of pulmonary arterial hypertension (PAH) is poorly understood outside the United States. This retrospective database study describes the characteristics of patients with PAH in England, including their healthcare resource utilisation (HCRU) and associated costs.

METHODS: Data from 1 April 2012 to 31 March 2018 were obtained from the National Health Service (NHS) Digital Hospital Episode Statistics database, which provides full coverage of patient events occurring in NHS England hospitals. An adult patient cohort was defined using an algorithm incorporating pulmonary hypertension (PH) diagnosis codes, PAH-associated procedures, PH specialist centre visits and PAH-specific medications. HCRU included inpatient admissions, outpatient visits and Accident and Emergency (A&E) attendances. Associated costs, calculated using national tariffs inflation-adjusted to 2017, did not include PAH-specific drugs on the High Cost Drugs list.

RESULTS: The analysis cohort included 2527 patients (68.4% female; 63.6% aged ⩾50 years). Mean annual HCRU rates ranged from 2.9 to 3.2 for admissions (21-25% of patients had ⩾5 admissions), 9.4-10.3 for outpatient visits and 0.8-0.9 for A&E attendances. Costs from 2013 to 2017 totalled £43.2M (£33.9M admissions, £8.3M outpatient visits and £0.9M A&E attendances). From 2013 to 2017, mean cost per patient decreased 13% (from £4400 to £3833) for admissions and 13% (from £1031 to £896) for outpatient visits, but increased 52% (from £81 to £123) for A&E attendances.

CONCLUSION: PAH incurs a heavy economic burden on a per-patient basis, highlighting the need for improved treatment strategies able to reduce disease progression and hospitalisations.The reviews of this paper are available via the supplemental material section.

PMID:33620026 | DOI:10.1177/1753466621995040

Indoor Air. 2021 Feb 23. doi: 10.1111/ina.12809. Online ahead of print.

ABSTRACT

This field study aimed to investigate naturally ventilated bedroom environment and its effects on subjective perception and sleep quality. Totally, 104 healthy subjects living in urban areas of Beijing participated in the study for one night during transition seasons. Bedroom environment parameters, including temperature, relative humidity, and CO₂ concentration, were recorded before and during sleep. Objective sleep quality was measured by Fitbit Alta 2, a wrist-type actigraphy sensor. Subjective assessments were collected by paper-based questionnaires on sleep quality and environmental perceptions. The results showed that neutral temperature for waking state (before sleep) was estimated to be 23.8°C while for sleep state it was 26.5°C. Furthermore, pre-sleep thermal sensation vote was found to be positively correlated with deep sleep percentage. Indoor air quality was correlated with sleep quality as indicated by statistically significant correlations between odor intensity assessment, air quality acceptability, average nightly CO₂ concentration, and measures of sleep quality. For naturally ventilated bedrooms during transition seasons with a mild outdoor climate, present findings suggest that a bedroom with slightly warm pre-sleep environment than neutral, and with high ventilation as indicated by low indoor CO₂ concentration, could be beneficial for sleep quality of residents.

PMID:33620120 | DOI:10.1111/ina.12809

J Endourol. 2021 Feb 23. doi: 10.1089/end.2020.1059. Online ahead of print.

ABSTRACT

BACKGROUND: Suction during robotic surgery has traditionally been performed by a bedside assistant. Adequately-skilled assistants are not always available. We assessed a purpose-designed, robotic surgeon-controlled suction catheter for efficiency and safety by comparing with historic cases of suction controlled by a dedicated bedside assistant using standard rigid laparoscopic suction.

METHODS: Beginning in February 2019, the Remotely Operated Suction Irrigation (ROSI) device was used in all robotic prostatectomy (RP) procedures, which is a flexible suction catheter manipulated by the surgeon such that a bedside assistant is never required for suction. The initial 300 consecutive cases performed with ROSI were compared with the 300 immediately previous procedures using bedside-assistant suctioning.

RESULTS: There were no statistically-significant differences between groups in age, BMI, ASA score, PSA or pathological stage. Lymph node dissection was performed in all 600 patients. All 300 ROSI cases were completed without requiring switching to bedside-assistant suctioning. Estimated blood loss (102.7cc vs 120.2cc, p=0.001) and operative time (156.1min vs 149.3min, p<0.001) were slightly lower in the ROSI group. There was no statistical difference in the 90-day complication rate (Clavien ≥III) between groups, with both having 3% of patients readmitted or seen in the emergency department within 90 days of surgery.

CONCLUSION: Surgeon-controlled suction allowed more surgeon autonomy without a negative impact on efficiency or safety issues requiring “bailout” suctioning by the bedside assistant whether urgent or otherwise. Robotic surgeons without access to skilled bedside assistants should consider suctioning for themselves not unlike the norm for many laparoscopic surgeons.

PMID:33619992 | DOI:10.1089/end.2020.1059

J Am Heart Assoc. 2021 Feb 23:e019217. doi: 10.1161/JAHA.120.019217. Online ahead of print.

ABSTRACT

Background The current American College of Cardiology/American Heart Association women cardiovascular disease (CVD) risk score suboptimally estimates CVD risk for young and minority women in the military. The current study developed an internally validated CVD risk score for women military service members and veterans using the Veterans Affairs (VA) national electronic health records data. Methods and Results The study cohort included 69 574 White, Black, and Hispanic women service members and veterans aged 30 to 79 years in 2007 treated in the VA Health Care System between January 1, 2007 and December 31, 2017 (henceforth, VA women). Stratified by race and ethnicity, the new VA women CVD risk model estimated risk coefficients and 10-year CVD risk using a time-variant covariate Cox model. Harrell C-statistics, calibration plots, and net classification index were used to assess accuracy and prognostic performance of the new VA women CVD risk model. The new internally validated VA women CVD risk score performed better in predicting VA women 10-year atherosclerosis cardiovascular disease risk than the pooled cohort American College of Cardiology/American Heart Association risk score in both accuracy (White Harrell C-statistics, 70% versus 61%; Black, 68% versus 63%) and prognostic performance (White net classification index, 0.31; 95% CI, 0.26-0.33; Black net classification index, 0.06; 95% CI, 0.03-0.09). Conclusions The proposed VA women CVD risk score improves accuracy of the existing American College of Cardiology/American Heart Association CVD risk assessment tool in predicting long-term CVD risk for VA women, particularly in young and racial/ethnic minority women.

PMID:33619994 | DOI:10.1161/JAHA.120.019217

Clin Toxicol (Phila). 2021 Feb 23:1-8. doi: 10.1080/15563650.2021.1887493. Online ahead of print.

ABSTRACT

BACKGROUND: Recent recognition of “massive” acetaminophen (APAP) overdoses has led to the question of whether standard dosing of N-acetylcysteine (NAC) is adequate to prevent hepatoxicity in these patients. The primary aim of this study was to evaluate the clinical outcome for patients with massive APAP overdose who received standard intravenous NAC dosing of 300 mg/kg over 21 h.

METHODS: This was a single-center retrospective cohort study conducted by chart review of APAP overdoses reported to a regional poison center from 1 January 2010 to 31 December 2019. Massive APAP overdose was defined by single, acute overdose resulting in an APAP concentration exceeding 300 mcg/mL at 4 h post-ingestion. Standard univariate statistical analysis was conducted to describe the cohort, and a multivariate logistic model was utilized to calculate adjusted odds ratios for risk of hepatoxicity.

RESULTS: 1425 cases of APAP overdose were reviewed. 104 cases met the inclusion criteria of massive APAP overdose. Overall, 79 cases (76%) had no acute liver injury or hepatotoxicity, and 25 (24%) developed hepatoxicity. Nine percent (n = 4) of cases receiving NAC within 8 h developed hepatotoxicity. Crude odds for hepatoxicity was 5.5-fold higher for cases who received NAC after 8 h.

CONCLUSIONS: Standard NAC dosing received within 8 h prevented hepatoxicity in 91% (n = 40) of cases in our series of massive APAP overdoses. Additional data is needed to determine the clinical outcomes of massive APAP overdose using current intravenous NAC dosing.

PMID:33620007 | DOI:10.1080/15563650.2021.1887493

Scand J Urol. 2021 Feb 23:1-7. doi: 10.1080/21681805.2021.1889026. Online ahead of print.

ABSTRACT

INTRODUCTION AND AIM: Speedy diagnosis are mandatory in testicular torsion, nevertheless some cases of irreversible ischemia still occur. In this study we analysed the results of patients undergoing surgical exploration for acute scrotum.

MATERIALS AND METHODS: A multicentric retrospective clinical evaluation was carried out on patients who underwent urgent scrotal exploration at 12 different departments in North-Eastern Italy. Data included complete anagraphic information, clinical presentation, numeric pain rating scale, previous testicular surgery, Doppler serial ultrasonography (US) evaluation and concordance with surgical findings, testicular mobility, surgical treatment, staged or concurrent treatment of the contralateral gonad. Statistical analysis was conducted both for descriptive and inferential statistics with SPSS v26.

RESULTS: Three hundred and sixty-eight cases were collected between January 2010 and June 2019. The time between symptom onset and ER access time was within 6 h in majority of patients. However, 17.4% of subject presented after more than 12 h. In patients undergoing US, this showed signs of ischemia in 237 patients (77.2%) and normal vascularisation in 70 (22.8%) of whom 26 had signs of testicular torsion at surgical exploration. Overall, the US data were concordant with the surgical findings in 254 cases (82.7%). A significant association was found between time-to-evaluation and time-to-treatment and the need for orchiectomy (p < 0.01).

CONCLUSION: Testicular torsion management is still challenging in terms of time-saving decision making. Scrotal US is helpful, but even in the contemporary its sensitivity is low era in a non-neglectable number of cases, therefore surgical exploration is warranted in acute scrotum when torsion cannot be ruled out, even when US shows vascularisation.

PMID:33620015 | DOI:10.1080/21681805.2021.1889026