Category: Statistics

Front Med. 2021 Mar 9. doi: 10.1007/s11684-020-0824-3. Online ahead of print.

ABSTRACT

Tocilizumab has been reported to attenuate the “cytokine storm” in COVID-19 patients. We attempted to verify the effectiveness and safety of tocilizumab therapy in COVID-19 and identify patients most likely to benefit from this treatment. We conducted a randomized, controlled, open-label multicenter trial among COVID-19 patients. The patients were randomly assigned in a 1:1 ratio to receive either tocilizumab in addition to standard care or standard care alone. The cure rate, changes of oxygen saturation and interference, and inflammation biomarkers were observed. Thirty-three patients were randomized to the tocilizumab group, and 32 patients to the control group. The cure rate in the tocilizumab group was higher than that in the control group, but the difference was not statistically significant (94.12% vs. 87.10%, rate difference 95% CI-7.19%-21.23%, P = 0.4133). The improvement in hypoxia for the tocilizumab group was higher from day 4 onward and statistically significant from day 12 (P = 0.0359). In moderate disease patients with bilateral pulmonary lesions, the hypoxia ameliorated earlier after tocilizumab treatment, and less patients (1/12, 8.33%) needed an increase of inhaled oxygen concentration compared with the controls (4/6, 66.67%; rate difference 95% CI-99.17% to-17.50%, P = 0.0217). No severe adverse events occurred. More mild temporary adverse events were recorded in tocilizumab recipients (20/34, 58.82%) than the controls (4/31, 12.90%). Tocilizumab can improve hypoxia without unacceptable side effect profile and significant influences on the time virus load becomes negative. For patients with bilateral pulmonary lesions and elevated IL-6 levels, tocilizumab could be recommended to improve outcome.

PMID:33687643 | DOI:10.1007/s11684-020-0824-3

Int Arch Occup Environ Health. 2021 Mar 9. doi: 10.1007/s00420-021-01678-y. Online ahead of print.

ABSTRACT

PURPOSE: This study was conducted to evaluate the depression, anxiety and stress status of health sector and community service workers who were actively working during the pandemic period.

METHODS: This is a descriptive study. A total of 735 people consisting of 426 health sector employees and 309 service sector employees, constituted the study sample. In this study, the data were collected using the personal information form and the Depression Anxiety Stress Scales-21 (DASS-21). A regression model was established to test the effect of socio-demographic characteristics on depression, anxiety, and stress levels during the COVID-19 pandemic.

RESULTS: While there was no difference in working a second job across different sectors (p = 0.450), the household income (p < 0.001) and the increase in expenditures during the COVID-19 pandemic (p < 0.001) were different across the sectors. The scores of the overall scale and its sub-dimensions were significantly different across the sectors (p < 0.001). The DASS-21 scores were higher in the participants, who started to smoke more and who had their sleep duration decreased (p < 0.001). There is a statistically significant difference between social media use and the DASS-21 score (p < 0.001). There is a significant difference across all DASS-21 subgroups by the daily working hours in the health sector (p < 0.001).

CONCLUSION: Our study provides significant findings regarding the mental health of individuals who continued working during the pandemic. To implement effective mental health interventions to risk groups and affected people in the COVID-19 pandemic, the recommendations of leading organizations, including WHO and ILO, should be implemented effectively concerning occupational health.

PMID:33687541 | DOI:10.1007/s00420-021-01678-y

Clin Oral Investig. 2021 Mar 9. doi: 10.1007/s00784-021-03841-8. Online ahead of print.

ABSTRACT

BACKGROUND: The mechanical disruption and removal of the subgingival biofilm represent the most important step in the treatment of periodontitis. However, in deep periodontal pockets, mechanical removal of the subgingival biofilm is difficult and frequently incomplete. Preliminary findings indicate that the use of amino acid buffered sodium hypochlorite (NaOCl) gel may chemically destroy the bacterial biofilm and facilitate its mechanical removal.

OBJECTIVES: To clinically evaluate the efficacy of minimally invasive nonsurgical therapy (MINST) of periodontal pockets with or without local application of an amino acid buffered sodium hypochlorite (NaOCl) gel.

MATERIALS AND METHODS: Forty untreated patients diagnosed with severe/advanced periodontitis (i.e. stage III/IV) with a slow/moderate rate of progression (i.e. grade A/B) were randomly allocated in two treatment groups. In the test group, the periodontal pockets were treated by means of MINST and NaOCl gel application, while in the control group, treatment consisted of MINST alone. Full-mouth plaque scores (FMPS), full-mouth bleeding scores (FMBS), probing depths (PD), clinical attachment levels (CAL) and gingival recessions (GR) were assessed at baseline and at 6 months following therapy. The primary outcome variable was PD reduction at sites with PD ≥ 5 mm at baseline.

RESULTS: At 6 months, statistically significant differences between the two groups were found (p = 0.001) in terms of PD and CAL change. No statistically significant differences were found in terms of GR (p = 0.81). The number of sites with PD ≥ 5 mm and BOP (+) decreased statistically significantly (p = 0.001), i.e. from 85.3 to 2.2% in the test group and from 81.6 to 7.3% in the control group, respectively. Statistically significant differences between test and control groups were recorded at 6 months (p = 0.001). MINST + NaOCl compared to MINST alone decreased statistically significantly (p = 0.001) the probability of residual PDs ≥ 5 mm with BOP- (14.5% vs 18.3%) and BOP+ (2.2% vs. 7.2%).

CONCLUSIONS: Within their limits, the present results indicate that (a) the use of MINST may represent a clinically valuable approach for nonsurgical therapy and (b) the application of NaOCl gel in conjunction with MINST may additionally improve the clinical outcomes compared to the use of MINST alone.

CLINICAL RELEVANCE: In patients with untreated periodontitis, treatment of deep pockets by means of MINST in conjunction with a NaOCl gel may represent a valuable approach to additionally improve the clinical outcomes obtained with MINST alone.

PMID:33687555 | DOI:10.1007/s00784-021-03841-8

Wien Klin Wochenschr. 2021 Mar 9. doi: 10.1007/s00508-021-01831-0. Online ahead of print.

ABSTRACT

BACKGROUND: Performing cardiopulmonary resuscitation (CPR) and postresuscitation care in the intensive care unit (ICU) are standardized procedures; however, there is evidence suggesting sex-dependent differences in clinical management and outcome variables after cardiac arrest (CA).

METHODS: A prospective analysis of patients who were hospitalized at a medical ICU after CPR between December 2018 and March 2020 was conducted. Exclusion criteria were age < 18 years, hospital length of stay < 24 h and traumatic CA. The primary study endpoint was mortality after 6 months and the secondary endpoint neurological outcome assessed by cerebral performance category (CPC). Differences between groups were calculated by using U‑tests and χ²-tests, for survival analysis both univariate and multivariable Cox regression were fitted.

RESULTS: A total of 106 patients were included and the majority were male (71.7%). No statistically significant difference regarding 6‑month mortality between sexes could be shown (hazard risk, HR 0.68, 95% confidence interval, CI 0.35-1.34; p = 0.27). Neurological outcome was also similar between both groups (CPC 1 88% in both sexes after 6 months; p = 1.000). There were no statistically significant differences regarding general characteristics, pre-existing diseases, as well as the majority of clinical and laboratory parameters or measures performed on the ICU.

CONCLUSION: In a single center CPR database no statistically significant sex-specific differences regarding post-resuscitation care, survival and neurological outcome after 6 months were observed.

PMID:33687563 | DOI:10.1007/s00508-021-01831-0

Arch Dermatol Res. 2021 Mar 9. doi: 10.1007/s00403-021-02211-4. Online ahead of print.

ABSTRACT

The association between bullous pemphigoid (BP) and melanoma is yet to be investigated. We aimed to assess assess the bidirectional association between BP and melanoma and to delineate the epidemiological features of patients with both diagnoses. A population-based cohort study was performed comparing BP patients (n = 3924) with age-, sex- and ethnicity-matched control subjects (n = 19,280) with regard to incident cases of melanoma. A case-control design was additionally adopted to estimate the risk of BP in individuals with a preexisting diagnosis of melanoma. The prevalence of preexisting melanoma was higher in patients with BP than in control subjects (1.5% vs. 1.0%, respectively; P = 0.004). A history of melanoma confers a 50% increase in the risk of subsequent BP (OR 1.53; 95% CI 1.14-2.06). This risk was higher among males (OR 1.66; 95% CI 1.09-2.54) and individuals older than 80 years (OR 1.63; 95% CI 1.11-2.38), and persisted after adjustment for multiple putative confounders including PD-1/PDL-1 antagonists (adjusted OR 1.53; 95% CI 1.14-2.06). Conversely, the risk of melanoma among patients with BP was slightly elevated, but did not reach the level of statistical significance (adjusted HR 1.13; 95% CI 0.73-1.74). Patients with a dual diagnosis of BP and melanoma were older at the onset of BP and had lower body mass index. A history of melanoma is associated with a 50% increase in the incidence of subsequent BP. Physicians managing patients with both conditions should be aware of this association. Further research is warranted to reveal the underlying mechanism of these findings.

PMID:33687539 | DOI:10.1007/s00403-021-02211-4

Int Arch Occup Environ Health. 2021 Mar 8. doi: 10.1007/s00420-021-01681-3. Online ahead of print.

ABSTRACT

PURPOSE: To identify the factors affecting teachers’ vocal acoustic parameters, with the aim of detecting individuals at risk of phonotrauma.

METHOD: The voicing time, voice sound pressure level [SPL] and fundamental frequency [f_o] of 87 teachers were measured during one workweek using a voice dosimeter. We retrospectively investigated the impact of 10 factors (gender, age, teaching experience, teaching level, tobacco, gastro-esophageal problems, nonoccupational voice activity, voice education, past voice problems, and biopsychosocial impact of voice problems measured using the Voice Handicap Index [VHI]) on each voice parameter.

RESULTS: None of the above factors affected voicing time or SPL. f_o depended significantly on gender, teaching level, nonoccupational voice activity and VHI score. Specifically, f_o was higher in women (Δ = 69 Hz), in individuals without nonoccupational voice activities (Δ = 11 Hz), and in individuals with a lower VHI score (increase of 0.7 Hz for each additional point). For females, post hoc comparisons revealed a substantial impact of teaching level on f_o: university instructors had deeper voices than kindergarten (Δ = 66 Hz), elementary (Δ = 52 Hz), or secondary teachers (Δ = 41 Hz).

CONCLUSIONS: Since higher f_o increases the mechanical stress related to vocal fold vibration, the screening and prevention of phonotrauma should focus primarily on women, particularly those who teach at lower levels, and teachers with more self-rated voice problems. The lower f_o of teachers who engage in nonprofessional voice activities may suggest acute inflammation or muscle fatigue due to voice overload.

PMID:33686473 | DOI:10.1007/s00420-021-01681-3

Diabetologia. 2021 Mar 8. doi: 10.1007/s00125-021-05413-7. Online ahead of print.

ABSTRACT

AIMS/HYPOTHESIS: Our aim was to assess the use of continuous subcutaneous insulin infusion (CSII) in people with type 1 diabetes in Scotland and its association with glycaemic control, as measured by HbA_1c levels, frequency of diabetic ketoacidosis (DKA) and severe hospitalised hypoglycaemia (SHH), overall and stratified by baseline HbA_1c.

METHODS: We included 4684 individuals with type 1 diabetes from the national Scottish register, who commenced CSII between 2004 and 2019. We presented crude within-person differences from baseline HbA_1c over time since initiation, crude DKA and SHH event-rates pre-/post-CSII exposure. We then used mixed models to assess the significance of CSII exposure, taking into account: (1) the diffuse nature of the intervention (i.e. structured education often precedes initiation); (2) repeated within-person measurements; and (3) background time-trends occurring pre-intervention.

RESULTS: HbA_1c decreased after CSII initiation, with a median within-person change of -5.5 mmol/mol (IQR -12.0, 0.0) (-0.5% [IQR -1.1, 0.0]). Within-person changes were most substantial in those with the highest baseline HbA_1c, with median -21.0 mmol/mol (-30.0, -11.0) (-1.9% [-2.7, -1.0]) change in those with a baseline >84 mmol/mol (9.8%) within a year of exposure, that was sustained: -19.0 mmol/mol (-27.6, -6.5) (-1.7% [-2.5, -0.6]) at ≥5 years. Statistical significance and magnitude of change were supported by the mixed models results. The crude DKA event-rate was significantly lower in post-CSII person-time compared with pre-CSII person-time: 49.6 events (95% CI 46.3, 53.1) per 1000 person-years vs 67.9 (64.1, 71.9); rate ratio from Bayesian mixed models adjusting for pre-exposure trend: 0.61 (95% credible interval [CrI] 0.47, 0.77; posterior probability of reduction pp = 1.00). The crude overall SHH event-rate in post-CSII vs pre-CSII person-time was also lower: 17.8 events (95% CI 15.8, 19.9) per 1000 person-years post-exposure vs 25.8 (23.5, 28.3) pre-exposure; rate ratio from Bayesian mixed models adjusting for pre-exposure trend: 0.67 (95% CrI 0.45, 1.01; pp = 0.97).

CONCLUSIONS/INTERPRETATION: CSII therapy was associated with marked falls in HbA_1c especially in those with high baseline HbA_1c. CSII was independently associated with reduced DKA and SHH rates. CSII appears to be an effective option for intensive insulin therapy in people with diabetes for improving suboptimal glycaemic control.

PMID:33686483 | DOI:10.1007/s00125-021-05413-7

Hum Reprod. 2021 Mar 4:deab031. doi: 10.1093/humrep/deab031. Online ahead of print.

ABSTRACT

STUDY QUESTION: Does an individualised luteal phase support (iLPS), according to serum progesterone (P4) level the day prior to euploid frozen embryo transfer (FET), improve pregnancy outcomes when started on the day previous to embryo transfer?

SUMMARY ANSWER: Patients with low serum P4 the day prior to euploid FET can benefit from the addition of daily subcutaneous P4 injections (Psc), when started the day prior to FET, and achieve similar reproductive outcomes compared to those with initial adequate P4 levels.

WHAT IS KNOWN ALREADY: The ratio between FET/IVF has spectacularly increased in the last years mainly thanks to the pursuit of an ovarian hyperstimulation syndrome free clinic and the development of preimplantation genetic testing (PGT). There is currently a big concern regarding the endometrial preparation for FET, especially in relation to serum P4 levels around the time of embryo transfer. Several studies have described impaired pregnancy outcomes in those patients with low P4 levels around the time of FET, considering 10 ng/ml as one of the most accepted reference values. To date, no prospective study has been designed to compare the reproductive outcomes between patients with adequate P4 the day previous to euploid FET and those with low, but restored P4 levels on the transfer day after iLPS through daily Psc started on the day previous to FET.

STUDY DESIGN, SIZE, DURATION: A prospective observational study was conducted at a university-affiliated fertility centre between November 2018 and January 2020 in patients undergoing PGT for aneuploidies (PGT-A) IVF cycles and a subsequent FET under hormone replacement treatment (HRT). A total of 574 cycles (453 patients) were analysed: 348 cycles (leading to 342 euploid FET) with adequate P4 on the day previous to FET, and 226 cycles (leading to 220 euploid FET) under iLPS after low P4 on the previous day to FET, but restored P4 levels on the transfer day.

PARTICIPANTS/MATERIALS, SETTING, METHODS: Overall we included 574 HRT FET cycles (453 patients). Standard HRT was used for endometrial preparation. P4 levels were measured the day previous to euploid FET. P4 > 10.6 ng/ml was considered as adequate and euploid FET was performed on the following day (FET Group 1). P4 < 10.6 ng/ml was considered as low, iLPS was added in the form of daily Psc injections, and a new P4 analysis was performed on the following day. FET was only performed on the same day when a restored P4 > 10.6 ng/ml was achieved (98.2% of cases) (FET Group 2).

MAIN RESULTS AND THE ROLE OF CHANCE: Patient’s demographics and cycle parameters were comparable between both euploid FET groups (FET Group 1 and FET Group 2) in terms of age, weight, oestradiol and P4 levels and number of embryos transferred. No statistically significant differences were found in terms of clinical pregnancy rate (56.4% vs 59.1%: rate difference (RD) -2.7%, 95% CI [-11.4; 6.0]), ongoing pregnancy rate (49.4% vs 53.6%: RD -4.2%, 95% CI [-13.1; 4.7]) or live birth rate (49.1% vs 52.3%: RD -3.2%, 95% CI [-12; 5.7]). No significant differences were also found according to miscarriage rate (12.4% vs 9.2%: RD 3.2%, 95% CI [-4.3; 10.7]).

LIMITATIONS, REASONS FOR CAUTION: Only iLPS through daily Psc was evaluated. The time for Psc injection was not stated and no serum P4 determinations were performed once the pregnancy was achieved.

WIDER IMPLICATIONS OF THE FINDINGS: Our study provides information regarding an ‘opportunity window’ for improved ongoing pregnancy rates and miscarriage rates through a daily Psc injection in cases of inadequate P4 levels the day previous to FET (P4 < 10.6 ng/ml) and restored values the day of FET (P4 > 10.6 ng/ml). Only euploid FET under HRT were considered, avoiding one of the main reasons of miscarriage and implantation failure and overcoming confounding factors such as female age, embryo quality or ovarian stimulation protocols.

STUDY FUNDING/COMPETING INTEREST(S): No external funding was received. B.C. reports personal fees from MSD, Merck Serono, Ferring Pharmaceuticals, IBSA and Gedeon Richter outside the submitted work. N.P. reports grants and personal fees from MSD, Merck Serono, Ferring Pharmaceuticals, Theramex and Besins International and personal fees from IBSA and Gedeon Richter outside the submitted work. The remaining authors have no conflicts of interest to declare.

TRIAL REGISTRATION NUMBER: NCT03740568.

PMID:33686413 | DOI:10.1093/humrep/deab031

J Insect Sci. 2021 Mar 1;21(2):2. doi: 10.1093/jisesa/ieaa149.

ABSTRACT

Insecticide exposure has been identified as a contributing stressor to the decline in the North American monarch butterfly Danaus plexippus L. (Lepidoptera: Nymphalidae) population. Monarch toxicity data are currently limited and available data focuses on lethal endpoints. This study examined the 72-h toxicity of two pyrethroid insecticides, bifenthrin and β-cyfluthrin, and their effects on growth and diet consumption. The toxicity of bifenthrin to caterpillars was lower than β-cyfluthrin after 72 h. Survival was the most sensitive endpoint for bifenthrin, but diet consumption and caterpillar growth were significantly reduced at sublethal levels of β-cyfluthrin. Using AgDRIFT spray drift assessment, the aerial application of bifenthrin or β-cyfluthrin is predicted to pose the greatest risk to fifth-instar caterpillars, with lethal insecticide deposition up to 28 m for bifenthrin and up to 23 m for β-cyfluthrin from treated edges of fields. Low boom ground applications are predicted to reduce distances of lethal insecticide exposure to 2 m from the treated field edge for bifenthrin and β-cyfluthrin. Growth and survival of fifth-instar monarch caterpillars developing within the margins of a treated field may be significantly impacted following foliar applications of bifenthrin or β-cyfluthrin. These findings provide evidence that pyrethroid insecticides commonly used for soybean pest control are a potential risk to monarch caterpillars in agricultural landscapes.

PMID:33686432 | DOI:10.1093/jisesa/ieaa149

Phys Ther. 2021 Mar 3:pzab078. doi: 10.1093/ptj/pzab078. Online ahead of print.

ABSTRACT

OBJECTIVE: The purpose of this study is to explore academic faculty, employer, and recent graduate perspectives of the work-readiness of Australian new graduate physical therapists for private practice and factors that influence new graduate preparation and transition to private practice.

METHODS: This study used a mixed-methods design with 3 surveys and 12 focus groups. One hundred and twelve participants completed a survey and 52 participated in focus groups. Descriptive statistics were utilized to summarize the quantitative data and thematic analysis was used to analyze the qualitative data. Triangulation across participant groups and data sources was undertaken.

RESULTS: Australian new graduate physical therapists were perceived to be “somewhat ready” for private practice and “ready” by their third year of employment. Participants proposed that new graduates bring enthusiasm, readiness to learn, and contemporary, research-informed knowledge. New graduates were also perceived to find autonomous clinical reasoning and timely caseload management difficult; to have limited business, marketing and administration knowledge and skills; and to present with underdeveloped confidence, communication, and interpersonal skills. Factors perceived to influence graduate transition included private practice experience, such as clinical placements and employment; employer and client expectations of graduate capabilities; workplace support; university academic preparation and continuing education; and individual graduate attributes and skills.

CONCLUSION: Australian new graduate physical therapists have strengths and limitations in relation to clinical, business, and employability knowledge and skills. New graduate work-readiness and transition may be enhanced by additional private practice experience, employer and client expectation management, provision of workplace support, and tailored university and continuing education.

IMPACT: The number of new graduate physical therapists employed in private practice in Australia is increasing; however, until this study, their work-readiness for this setting was unknown. This exploration of new graduate performance in private practice and transition can help to increase understanding and enhancement of work-readiness.

PMID:33686439 | DOI:10.1093/ptj/pzab078