Category: Statistics

Cancer Res. 2022 Aug 16;82(16):2821-2823. doi: 10.1158/0008-5472.CAN-22-2124.

ABSTRACT

In 1988, Blot and colleagues reported results from a U.S. case-control study of oral cavity or pharyngeal (oropharyngeal and hypopharyngeal) cancers, with results showing independent associations of smoking and alcohol with increased risk, multiplicative interaction effects between smoking and alcohol, and that nearly three-quarters of these cancers are attributable to smoking and alcohol. The report by Blot and colleagues represents a landmark in oropharyngeal cancer epidemiology. This study, the largest at the time, introduced several novel concepts in oropharyngeal cancer epidemiology that remain relevant today-etiologic heterogeneity, statistical interaction effects, adjusted attributable fractions, and disparities by sex and race/ethnicity. Perhaps the most significant recognition in the field since 1988 is the etiologic association of human papillomavirus (HPV, primarily HPV16) with cancers arising in the oropharynx. Today, more than 80% of oropharyngeal cancers in the United States are caused by HPV while only approximately 3% of oral cavity cancers are caused by HPV. This etiologic heterogeneity across head and cancer subsites revealed by HPV is manifest at the genetic/genomic, epidemiologic, and clinical levels. Tobacco and alcohol remain the major etiologic factors for oral cavity cancers while HPV is the major cause of oropharyngeal cancers. Thus, tobacco and alcohol control and prophylactic HPV vaccination remain the most promising prevention tools for oral cavity and oropharyngeal cancers at this time. Importantly, the ever-emerging alternative tobacco products, such as smokeless tobacco/snus, hookah and water pipes, e-cigarettes, flavored cigars and cigarillos, and oral dissolvable products, represent a key public health concern and the carcinogenic effects of these products remains an active area of investigation. See related article by Blot and colleagues, Cancer Res 1988;48:3282-7.

PMID:35971675 | DOI:10.1158/0008-5472.CAN-22-2124

J Diabetes Sci Technol. 2022 Aug 16:19322968221116384. doi: 10.1177/19322968221116384. Online ahead of print.

ABSTRACT

BACKGROUND: A smartphone-based automated insulin delivery (AID) controller device can facilitate use of interoperable components and acceptance in adolescents and children.

METHODS: Pediatric participants (N = 20, 8F) with type 1 diabetes were enrolled in three sequential age-based cohorts: adolescents (12-<18 years, n = 8, 5F), school-age (8-<12 years, n = 7, 2F), and young children (2-<8 years, n = 5, 1F). Participants used the interoperable artificial pancreas system (iAPS) and zone model predictive control (MPC) on an unlocked smartphone for 48 hours, consumed unrestricted meals of their choice, and engaged in various unannounced exercises. Primary outcomes and stopping criteria were defined using fingerstick blood glucose (BG) data; secondary outcomes compared continuous glucose monitoring (CGM) data with preceding sensor augmented pump (SAP) therapy.

RESULTS: During AID, there was no more than one BG <50 mg/dL except in one young child participant; no instance of more than two episodes of BG ≥300 mg/dL lasting longer than 2 hours; and no adverse events. Despite large meals (total of 404.9 grams of carbs) and unannounced exercise (total of 182 minutes), overall CGM percent time in range (TIR) of 70 to 180 mg/dL during AID was statistically similar to SAP (63.5% vs 57.3%, respectively, P = .145). Overnight glucose standard deviation was 43 mg/dL (vs SAP 57.9 mg/dL, P = .009) and coefficient of variation was 25.7% (vs SAP 34.9%, P < .001). The percent time in closed-loop mode and connected to the CGM was 92.7% and 99.6%, respectively. Surveys indicated that participants and parents/guardians were satisfied with the system.

CONCLUSIONS: The smartphone-based AID was feasible and safe in sequentially younger cohorts of adolescents and children.

CLINICALTRIALS.GOV: NCT04255381 (https://clinicaltrials.gov/ct2/show/NCT04255381).

PMID:35971681 | DOI:10.1177/19322968221116384

Br J Haematol. 2022 Aug 15. doi: 10.1111/bjh.18431. Online ahead of print.

ABSTRACT

Lung damage caused by SARS-Cov-2 virus results in marked arterial hypoxia, accompanied in many cases by hypocapnia. The literature is inconclusive as to whether these conditions induce alteration of the affinity of haemoglobin for oxygen. We studied the oxyhaemoglobin dissociation curves (ODCs) of 517 patients hospitalized with coronavirus disease 2019 (COVID-19) for whom arterial blood gas analysis (BGA) was performed upon hospitalization, i.e. before treatment. With respect to a conventional normal p50 (pO₂ at 50% saturation of haemoglobin) of 27 mmHg, 76% had a lower standardized p50 (p50s) and 85% a lower “in vivo” p50 (p50i). In a 33-patient subgroup with follow-up BGAs after 3, 6, 9, 12, 15 and 18 days’ treatment, p50s and p50i exhibited statistically significant differences between baseline values and values recorded at all these time points. The 30-day Kaplan-Meier survival curves of COVID-19 patients stratified by p50i level show a higher probability of survival among patients who at admission had p50 values below 27 mmHg (P = 0.012). Whether the observed alteration of the affinity of haemoglobin for oxygen in COVID-19 patients is a direct or indirect effect of the virus on haemoglobin is unknown.

PMID:35971642 | DOI:10.1111/bjh.18431

Thorac Cancer. 2022 Aug 15. doi: 10.1111/1759-7714.14531. Online ahead of print.

ABSTRACT

BACKGROUND: The monoclonal antibody durvalumab, an immune-checkpoint inhibitor (ICI) antiprogrammed death ligand 1 (PD-L1), is available for unresectable stage III NSCLC patients as consolidation therapy following induction chemoradiotherapy, with very promising overall survival (OS) and progression-free survial (PFS) results in registration trials. The purpose of this study was to provide policymakers with an estimate of the cost-effectiveness of durvalumab in the treatment of non-small cell lung cancer (NSCLC).

METHODS: The study developed a Markov model covering a 5-year period to compare costs and outcomes of treating PD-L1 positive patients with or without durvalumab. We conducted a series of sensitivity analyses (Tornado analysis and Monte Carlo simulation) by varying some parameters to assess the robustness of our model and identify the parameters with the greatest impact on cost-effectiveness.

RESULTS: Prior to the release of durvalumab, the management of NSCLC over a 5-year period cost €33 317 per patient, with an average life expectancy of 2.01 years. After the introduction of the drug, this increased to €37 317 per patient, with an average life expectancy of 2.13 years. Treatment with durvalumab led to an incremental cost-effectiveness ratio (ICER) of €35 526 per year. OS is the variable that contributes the most to the variability of the ICER.

CONCLUSIONS: The study observed that durvalumab is a cost-effective treatment option for patients with unresectable stage III NSCLC.

PMID:35971638 | DOI:10.1111/1759-7714.14531

Clin Shoulder Elb. 2022 Jul 22. doi: 10.5397/cise.2022.00871. Online ahead of print.

ABSTRACT

BACKGROUND: Most acromioclavicular joint (ACJ) injuries are caused by direct trauma to the shoulders, and various methods and techniques are used to treat them; however, none of the options can be considered the gold standard. This study examines the horizontal stability of the ACJ after a complete dislocation was repaired using one of two Ethibond suture techniques, the loop technique and the two holes in the clavicle technique.

METHODS: In this single-blind, randomized clinical trial, 104 patients diagnosed with complete ACJ dislocation type V were treated using Ethibond sutures with either the loop technique or the two holes in the clavicle technique. Horizontal changes in the ACJ were radiographically assessed in the lateral axial view, and shoulder function was evaluated by the Constant (CS) and Taft (TS) scores at intervals of 3, 6, and 12 months after surgery.

RESULTS: The horizontal stability of the ACJ was better with the two-hole technique than the loop technique at all measurement times. CS and TS changes showed a significant upward trend over time with both techniques. The mean CS and TS at the final visit were 95.2 and 11.6 with the loop technique and 94 and 11.9 with the two-hole technique, respectively. The incidence of superficial infections caused by the subcutaneous pins was the same in the two groups.

CONCLUSIONS: Due to the improved ACJ stability with the two-hole technique, it appears to be a more suitable option than the loop technique for AC joint reduction.

PMID:35971605 | DOI:10.5397/cise.2022.00871

Clin Transl Sci. 2022 Aug 15. doi: 10.1111/cts.13377. Online ahead of print.

ABSTRACT

This phase Ib study compared the effects of AZD9977, a selective mineralocorticoid receptor modulator with predicted low hyperkalemia risk, with spironolactone on serum potassium (sK⁺ ) in patients with heart failure (HF) with preserved or mildly reduced EF (≥ 40%), and renal impairment. HF patients with EF ≥ 40% and estimated glomerular filtration rate of 40-70 mL/min/1.73 m² were randomized to once-daily AZD9977 100 mg or spironolactone 25 mg for 14 days, up-titrated to AZD9977 200 mg or spironolactone 50 mg for another 14 days. Primary endpoint was relative change (%) in sK⁺ for AZD9977 versus spironolactone (baseline to Day 28). Serum/urinary electrolytes, fractional excretion (FE) of Na⁺ /K⁺ , plasma aldosterone, cortisol and renin, and safety were also assessed. Sixty-eight patients were randomized (AZD9977, n = 33; spironolactone, n = 35). Mean (SD) age was 73.0 (8.5) years, 51.5% male. Mean sK⁺ change from baseline to Day 28 was 5.7% (AZD9977) and 4.2% (spironolactone), and 1.5% and 4.2% at Day 14. Relative change (95% CI) in sK⁺ with AZD9977 versus spironolactone was -0.3% (-5.3% – 4.4%; Day 28), and 3.4% (-0.8% – 7.5%; Day 14). Median increase from baseline in plasma aldosterone at Day 28 was 89.8 pmol/L for AZD9977 and 67.4 pmol/L for spironolactone. Median FE of K⁺ was 12.9% (AZD9977) and 10.1% (spironolactone). AZD9977 was well tolerated. No discontinuations due to hyperkalemia occurred with either treatment. Evidence of target engagement for AZD9977 with a favorable safety profile, supports further evaluation of AZD9977 in patients with HF and renal impairment.

PMID:35971596 | DOI:10.1111/cts.13377

Health Inf Manag. 2022 Aug 15:18333583221115898. doi: 10.1177/18333583221115898. Online ahead of print.

ABSTRACT

BACKGROUND: The professional identity and motivation of qualified health information managers (HIMs) is largely unexplored.

OBJECTIVES: A larger study has investigated the motivators of HIMs in the construction of their professional identity and associated relationships to job satisfaction and engagement with their profession. The aims of this component of the study were to: (i) identify and analyse the characteristics of members of the profession who have different motivation profiles; (ii) obtain HIMs’ perspectives on their professional identity; and (iii) measure correlation between HIMs’ professional identity and different motivating factors. Method: A cross-sectional study design, with a convergent mixed-methods approach to data collection was employed. An online survey was administered to the 1985, 1995, 2005 and 2015 Australian health information management and medical record administration graduate cohorts from one university in Victoria.

RESULTS: Response rate: 72.7% (n = 72). There were no statistically significant correlations between the HIMs’ motivation profile and professional identity. The HIMs were largely motivated by a need for achievement (striving for excellence) and continuous improvement; maintained high standards of work quality (95.8%); valued their work (94.4%) and work collaborations (84.7%); satisfactorily applied skills-knowledge (94%); demonstrated a very strong professional association (92% were proud to belong to the profession). Key factors in motivation that were consistently reported by members of all cohorts in the open-ended questions were as follows: intrinsic motivation; colleagues and teamwork; the variety of work performed; and contribution to the bigger picture. Overall, and notwithstanding between-cohort differences: 65.3% confidently directed others, 45.8% aspired to leadership and 38% actively networked. They related difficulty in explaining the profession to outsiders.

CONCLUSION: There was no correlation between motivation profile and professional identity. Significantly, the HIMs demonstrated exceptionally strong positive professional identity, reflected particularly in pride in membership of the profession and their belief in the importance of their professional work.

PMID:35971595 | DOI:10.1177/18333583221115898

Scand J Urol. 2022 Aug 15:1-7. doi: 10.1080/21681805.2022.2107065. Online ahead of print.

ABSTRACT

OBJECTIVES: To evaluate S-phase fraction as a predictor of invasiveness and cancer-specific survival in upper tract urothelial carcinoma (UTUC).

PATIENTS AND METHODS: One hundred and fifteen patients having undergone radical nephroureterectomy were analysed with histology in radical nephroureterectomy specimens as reference test and S-phase fraction as index test. Ploidy and S-phase were determined using flow cytometry. Differences in S-phase fraction were calculated between stages, grades (WHO 1999 and 2004 classifications), ploidy and patients that died of UTUC and those who did not. Five- and 10-year-cancer-specific survivals were calculated. Areas under the ROC curve (AUCs) of S-phase fraction in relation to tumour stage and to death from UTUC were measured. Multiple Cox regression was performed.

RESULTS: Independent prognostic markers of death from UTUC were S-phase fraction and stage. Correlation between S-phase fraction and risk of dying from UTUC was strong, with a 17% greater risk of death from UTUC with every 1% increase in S-phase fraction, hazard ratio = 1.17, 95% CI = 1.10-1.25, p < 0.001, Spearman’s rho ρ = 0.65. AUCs for S-phase fraction as predictors of stage and death from UTUC were 0.8 (95% CI = 0.705-0.894) and 0.77 (95% CI = 0.67-0.87), respectively. Cancer-specific survival was statistically significantly different between stages, ploidy and WHO 1999 grades, but not between WHO 2004 grades. This was also reflected in S-phase fraction, which differed in LG-G1 compared with LG-G2 and in HG-G2 compared with HG-G3.

CONCLUSION: S-phase fraction was a good test for predicting both invasiveness and cancer-specific survival. Using both WHO 1999 and 2004 classifications, rather than one system alone, had a higher predictive value of cancer-specific survival.

PMID:35971571 | DOI:10.1080/21681805.2022.2107065

JBI Evid Synth. 2022 Aug 1;20(8):2055-2063. doi: 10.11124/JBIES-21-00404.

ABSTRACT

OBJECTIVE: This systematic review will evaluate the effectiveness of nutrition care interventions delivered by general practitioners versus usual care or no care on dietary and health outcomes in adults with diet-related chronic conditions or risk states.

INTRODUCTION: General practitioners are usually the first contacts in the health care system for patients with diet-related chronic conditions. While there is some evidence that general practitioners can be effective in delivering nutrition care for a number of outcomes, to inform future care, an update of the evidence is required as well as an examination of which components are associated with positive outcomes.

INCLUSION CRITERIA: Published studies will be included if they report on adults with or at risk of diet-related chronic conditions; one-on-one nutrition care interventions individually delivered by general practitioners during primary care consultations; usual or no care as comparators; dietary and/or health outcomes with a minimum three-month follow-up; and randomized controlled trials. Included studies will be available in, or able to be translated into, English and will have no date restrictions.

METHODS: The databases to be searched will include CINAHL, Embase, MEDLINE, and ProQuest Nursing and Allied Health. Following deduplication, two reviewers will independently screen the titles and abstracts in Covidence, followed by the full texts of potentially relevant studies. Disagreements will be resolved through discussion or with a third reviewer. Included studies will be critically appraised and data will be extracted using a modified JBI tool. Findings will be reported in tables and narrative synthesis, and pooled with statistical meta-analysis, where possible.

SYSTEMATIC REVIEW REGISTRATION NUMBER: PROSPERO CRD42021289011.

PMID:35971203 | DOI:10.11124/JBIES-21-00404

JBI Evid Synth. 2022 Aug 1;20(8):2032-2039. doi: 10.11124/JBIES-21-00332.

ABSTRACT

OBJECTIVE: This review will evaluate the effectiveness of microsurgical clipping versus endovascular treatment of ruptured anterior communicating artery aneurysms in adults.

INTRODUCTION: Subarachnoid hemorrhage secondary to anterior communicating artery aneurysm rupture is a catastrophic event leading to significant neurological morbidity and mortality. The clinical outcomes of microsurgical clipping versus endovascular coiling have been reported in systematic reviews for other intracranial aneurysm locations, including middle cerebral artery and posterior communicating artery aneurysms. A systematic review is necessary to evaluate the functional, angiographic, and safety outcomes of endovascular management versus microsurgical clipping for treatment guidance.

INCLUSION CRITERIA: Patients aged 18 years and over with a ruptured anterior communicating artery aneurysm will be included. Patients may have intracranial aneurysms in other locations; however, they will only be included if a ruptured anterior communicating artery aneurysm has occurred and only if that aneurysm has been treated. Interventions of interest are microsurgical clipping compared to endovascular treatment.

METHODS: The following databases will be searched: PubMed, Embase, Scopus, and Cochrane Central Register of Controlled Trials. Experimental, quasi-experimental, and analytical observational studies will be considered. Studies in all languages will be included if they can be translated. Two independent reviewers will retrieve and assess relevant studies using JBI’s standardized critical appraisal instruments. Extracted data will include Glasgow Outcome Scale/Modified Rankin Score, angiographic occlusion, aneurysm recurrence, intra-operative thromboembolic event rates, post-operative complications, and post-operative aneurysm recurrence rates. Studies will, where possible, be pooled using statistical meta-analysis. Outcomes assessed will include functional status, angiographic occlusion rates, incidence of aneurysm recurrence, and safety of treatment.

PMID:35971201 | DOI:10.11124/JBIES-21-00332