Category: Statistics

Can J Anaesth. 2023 Aug 23. doi: 10.1007/s12630-023-02547-7. Online ahead of print.

ABSTRACT

PURPOSE: Limiting family presence runs counter to the family-centred values of Canadian pediatric intensive care units (PICUs). This study explores how implementing and enforcing COVID-19-related restricted family presence (RFP) policies impacted PICU clinicians nationally.

METHODS: We conducted a cross-sectional, online, self-administered survey of Canadian PICU clinicians to assess experience and opinions of restrictions, moral distress (Moral Distress Thermometer, range 0-10), and mental health impacts (Impact of Event Scale [IES], range 0-75 and attributable stress [five-point Likert scale]). For analysis, we used descriptive statistics, multivariate regression modelling, and a general inductive approach for free text.

RESULTS: Representing 17/19 Canadian PICUs, 368 of 388 respondents (94%) experienced RFP policies and were predominantly female (333/368, 91%), English speaking (338/368, 92%), and nurses (240/368, 65%). The mean (standard deviation [SD]) reported moral distress score was 4.5 (2.4) and was associated with perceived differential impact on families. The mean (SD) total IES score was 29.7 (10.5), suggesting moderate traumatic stress with 56% (176/317) reporting increased/significantly increased stress from restrictions related to separating families, denying access, and concern for family impacts. Incongruence between RFP policies/practices and PICU values was perceived by 66% of respondents (217/330). Most respondents (235/330, 71%) felt their opinions were not valued when implementing policies. Though respondents perceived that restrictions were implemented for the benefit of clinicians (252/332, 76%) and to protect families (236/315, 75%), 57% (188/332) disagreed that their RFP experience was mainly positive.

CONCLUSION: Pediatric intensive care unit-based RFP rules, largely designed and implemented without bedside clinician input, caused increased psychological burden for clinicians, characterized as moderate moral distress and trauma triggered by perceived impacts on families.

PMID:37610552 | DOI:10.1007/s12630-023-02547-7

Clin Pharmacokinet. 2023 Aug 23. doi: 10.1007/s40262-023-01281-z. Online ahead of print.

ABSTRACT

BACKGROUND AND OBJECTIVE: Mirikizumab is a humanized anti-interleukin-23-p19 monoclonal antibody being developed for ulcerative colitis and Crohn’s disease. This analysis characterized mirikizumab pharmacokinetics using phase II and III trial data from patients with moderately to severely active ulcerative colitis.

METHODS: Serum pharmacokinetic data in patients receiving mirikizumab 50-1000 mg intravenously every 4 weeks as induction treatment and mirikizumab 200 mg subcutaneously every 4 or 12 weeks as maintenance treatment across three trials (N = 1362) were analyzed using non-linear mixed-effects modeling. Covariate effects on mirikizumab exposure were evaluated using simulation-based estimations.

RESULTS: Mirikizumab pharmacokinetics was best described by a linear two-compartment model with first-order absorption. Clearance, volume of distribution for central and peripheral compartments, and half-life were estimated at approximately 0.022 L/h (linear), 3.11 L and 1.69 L, and 9.5 days, respectively. Statistically significant effects of body weight and serum albumin levels on clearance, body weight on central and peripheral volumes of distribution, and body mass index on bioavailability were observed but effects were small relative to random inter-individual variability (% coefficient of variation: 18-64%). The subcutaneous bioavailability of mirikizumab was 48%.

CONCLUSIONS: Mirikizumab displayed pharmacokinetic characteristics typical of a monoclonal antibody where clearance increased with body weight and decreased with the albumin level, and bioavailability decreased with body mass index. These effects were small relative to random variability, indicating that a dose adjustment for patient factors is not required.

CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov: NCT02589665 (28 October, 2015), NCT03518086 (8 May, 2018), NCT03524092 (14 May, 2018).

PMID:37610533 | DOI:10.1007/s40262-023-01281-z

Ann Surg Oncol. 2023 Aug 23. doi: 10.1245/s10434-023-14139-2. Online ahead of print.

ABSTRACT

BACKGROUND: This study aimed to systematically evaluate the effect of early oral feeding (EOF) versus late oral feeding (LOF) on postoperative complications and rehabilitation outcomes for patients with esophageal cancer.

METHODS: This study searched relevant literature published up to March 2023 by computer retrieval of PubMed, Embase, The Cochrane Library, and Web of Science. A meta-analysis was performed using Review Manager 5.4 software to compare the effects of EOF and LOF on postoperative complications and recovery outcomes of patients with esophageal cancer.

RESULTS: The study included 14 articles, including 9 retrospective studies, 4 randomized controlled trials (RCTs), and 1 prospective study. The 2555 patients included in the study comprised 1321 patients who received EOF and 1234 patients who received LOF. The results of the meta-analysis showed that compared with the LOF group, the EOF group has a shorter time to the first flatus postoperatively (mean difference [MD], – 1.12; 95% confidence interval [CI], (- 1.25 to – 1.00; P < 0.00001), a shorter time to the first defecation postoperatively (MD, – 1.31; 95% CI, – 1.67 to – 0.95;, P < 0.00001], and a shorter hospital stay postoperatively (MD, – 2.87; 95% CI, – 3.84 to – 1.90; P < 0.00001). The two groups did not differ significantly statistically in terms of postoperative anastomotic leakage rate (P = 0.10), postoperative chyle leakage rate (P = 0.10), or postoperative pneumonia rate (P = 0.15).

CONCLUSION: Early oral feeding after esophageal cancer surgery can shorten the time to the first flatus and the first defecation postoperatively, shorten the hospital stay, and promote the recovery of patients. Moreover, it has no significant effect on the incidence of postoperative complications.

PMID:37610489 | DOI:10.1245/s10434-023-14139-2

J Cancer Surviv. 2023 Aug 23. doi: 10.1007/s11764-023-01446-6. Online ahead of print.

ABSTRACT

PURPOSE: The objective of this study is to evaluate whether the presence of a cancer history constitutes a risk for encountering unfavourable health outcomes and functional limitations. Moreover, the study also aims to identify specific attributes of cancer survivors that are associated with an increased risk of experiencing poor health and disability.

METHODS: This study has utilized data from Longitudinal Ageing Study in India (LASI) conducted in 2017-18. The analytical sample size for this study was 65,562 older individuals of age 45 years and above. We have focused on individuals diagnosed with cancer, i.e., cancer survivors, and compared their health outcomes to those of a similar group (without a cancer history) with similar socioeconomic and demographic features. Descriptive statistics and logistic regression models were used to assess the adjusted effect of explanatory variables on cancer survivors.

RESULTS: The result shows that the overall number of cancer survivors is 673 per 100.000 older adults and is higher in Urban areas (874 per 100.000) than in rural areas (535 per 100.000). 43.7% of the survivors reported poor self-rated health, and around 34.0% of cancer survivors reported depression, while this prevalence was much lower among older adults without a cancer history. Individuals who were diagnosed with cancer a long time ago have a significantly lower likelihood of experiencing poor SRH, depression, and diminished life satisfaction in comparison to those diagnosed more recently.

CONCLUSION: The study highlights the importance of factors such as time since diagnosis and the number of cancer sites in influencing health outcomes among survivors. Additionally, socioeconomic factors, such as wealth and access to health insurance, appear to play a role in the health status of cancer survivors.

IMPLICATIONS FOR CANCER SURVIVORS: Healthcare policies should recognize the long-term impact of cancer and prioritize the provision of long-term survivorship care. This may involve establishing survivorship clinics or dedicated healthcare centres that provide specialized care for cancer survivors, addressing their unique needs throughout the survivorship continuum.

PMID:37610478 | DOI:10.1007/s11764-023-01446-6

Biom J. 2023 Aug 23:e2200370. doi: 10.1002/bimj.202200370. Online ahead of print.

ABSTRACT

Decentralized clinical trials (DCTs), that is, studies integrating elements of telemedicine and mobile/local healthcare providers allowing for home-based assessments, are an important concept to make studies more resilient and more patient-centric by taking into consideration participant’s views and shifting trial activities to better meet the needs of trial participants. There are however, not only advantages but also challenges associated with DCTs. An area to be addressed by appropriate statistical methodology is the integration of data resulting from a possible mix of home and clinic assessments at different visits for the same variable, especially in adjusting for sources of possible systematic differences. One source of systematic bias may be how a participant perceives their disease and treatment in their home versus in a clinical setting. In this paper, we will discuss these issues with a focus on Neuroscience when participants have the choice between home and clinic assessments to illustrate how to identify systematic biases and describe appropriate approaches to maintain clinical trial scientific rigor. We will describe the benefits and challenges of DCTs in Neuroscience and then describe the relevance of home versus clinic assessments using the estimand framework. We outline several options to enable home assessments in a study. Results of simulations will be presented to help deciding between design and analysis options in a simple scenario where there might be differences in response between clinic and home assessments.

PMID:37609878 | DOI:10.1002/bimj.202200370

Disaster Med Public Health Prep. 2023 Aug 23;17:e459. doi: 10.1017/dmp.2023.110.

ABSTRACT

OBJECTIVE: The aim of this study was to investigate the occurrence of the disease and research risk factors through sociodemographic data of children aged 0 to 15 years, with symptoms suggestive of COVID-19 in 3 Brazilian municipalities in an international border region.

METHODS: Epidemiological and RT-PCR test results were collected from the COVID-19 notification records in suspected children and adolescents from March 1 to August 31, 2020, in municipalities (Assis Chateaubriand, Tupãssi, and Formosa do Oeste) located in an international border region. The results obtained and the variables associated were subjected to statistical analysis using the Chi-Square Test (x²) or Fisher’s Exact Test, using the statistical program SPSS v. 21.0 (IBM Corp., Armonk, New York, USA) at the 5% significance level.

RESULTS: Among the 147 children from the 3 municipalities, 20 (13.60%) were diagnosed as positive. The predominance of cases was in male children (60.00%) and in children living in urban areas (80%). The most frequent symptoms observed in children were fever (65.00% of the cases), followed by headache (60.00%), cough (55.00%), and nasal congestion, as well as sore throat, both found in 35.00% of the cases.

CONCLUSION: All these data highlight the importance and the need for more epidemiological studies, especially in children and adolescents, as COVID-19 becomes part of the child health panorama worldwide, with serious direct and indirect impacts for humans, animals, and the environment.

PMID:37609851 | DOI:10.1017/dmp.2023.110

J Perinat Med. 2023 Aug 23. doi: 10.1515/jpm-2023-0234. Online ahead of print.

ABSTRACT

OBJECTIVES: To evaluate the impact of an Enhanced Recovery After Cesarean (ERAC) protocol on the post-cesarean recovery experience using a validated ten-item questionnaire (ERAC-Q).

METHODS: This is a prospective cohort study of patients completing ERAC quality-of-life questionnaires (ERAC-Q) during inpatient recovery after cesarean delivery (CD) between October 2019 and September 2020, before and after the implementation of our ERAC protocol. Patients with non-Pfannenstiel incision, ICU admission, massive transfusion, bowel injury, existing chronic pain disorders, acute postpartum depression, or neonatal demise were excluded. The ERAC-Q was administered on postoperative day one and day of discharge to the pre- and post-ERAC implementation cohorts, rating aspects of their recovery experience on a scale of 0 (best) to 10 (worst). The primary outcome was ERAC-Q scores. Statistical analysis was performed with SAS software.

RESULTS: There were 196 and 112 patients in the pre- and post-ERAC cohorts, respectively. The post-ERAC group reported significantly lower total ERAC-Q scores compared to the pre-ERAC group, reflecting fewer adverse symptoms and greater perceived recovery on postoperative day one (1.6 [0.7, 2.8] vs. 2.7 [1.6, 4.3]) and day of discharge (0.8 [0.3, 1.5] vs. 1.4 [0.7, 2.2]) (p<0.001). ERAC-Q responses did not predict the time to achieve objective postoperative milestones. However, worse ERAC-Q pain and total scores were associated with higher inpatient opiate use.

CONCLUSIONS: ERAC implementation positively impacts patient recovery experience. The administration of ERAC-Q can provide real-time feedback on patient-perceived recovery quality and how healthcare protocol changes may impact their experience.

PMID:37609844 | DOI:10.1515/jpm-2023-0234

Infect Control Hosp Epidemiol. 2023 Aug 23:1-6. doi: 10.1017/ice.2023.130. Online ahead of print.

ABSTRACT

BACKGROUND: Patients diagnosed with coronavirus disease 2019 (COVID-19) aerosolize severe acute respiratory coronavirus virus 2 (SARS-CoV-2) via respiratory efforts, expose, and possibly infect healthcare personnel (HCP). To prevent transmission of SARS-CoV-2 HCP have been required to wear personal protective equipment (PPE) during patient care. Early in the COVID-19 pandemic, face shields were used as an approach to control HCP exposure to SARS-CoV-2, including eye protection.

METHODS: An MS2 bacteriophage was used as a surrogate for SARS-CoV-2 and was aerosolized using a coughing machine. A simulated HCP wearing a disposable plastic face shield was placed 0.41 m (16 inches) away from the coughing machine. The aerosolized virus was sampled using SKC biosamplers on the inside (near the mouth of the simulated HCP) and the outside of the face shield. The aerosolized virus collected by the SKC Biosampler was analyzed using a viability assay. Optical particle counters (OPCs) were placed next to the biosamplers to measure the particle concentration.

RESULTS: There was a statistically significant reduction (P < .0006) in viable virus concentration on the inside of the face shield compared to the outside of the face shield. The particle concentration was significantly lower on the inside of the face shield compared to the outside of the face shield for 12 of the 16 particle sizes measured (P < .05).

CONCLUSIONS: Reductions in virus and particle concentrations were observed on the inside of the face shield; however, viable virus was measured on the inside of the face shield, in the breathing zone of the HCP. Therefore, other exposure control methods need to be used to prevent transmission from virus aerosol.

PMID:37609833 | DOI:10.1017/ice.2023.130

Psychol Med. 2023 Aug 23:1-3. doi: 10.1017/S0033291723002490. Online ahead of print.

NO ABSTRACT

PMID:37609792 | DOI:10.1017/S0033291723002490

Histopathology. 2023 Aug 23. doi: 10.1111/his.15032. Online ahead of print.

ABSTRACT

AIMS: The LUMINA trial demonstrated a very low local recurrence rate in women ≥55 years with low-risk luminal A breast cancer (defined as grade I-II, T1N0, hormone receptor positive, HER2 negative and Ki67 index ≤13.25%) treated with breast-conserving surgery and endocrine therapy (but no other systemic therapy), supporting the safe omission of radiation in these women. Here we describe the protocol for Ki67 assessment, the companion diagnostic used to guide omission of adjuvant radiotherapy.

METHODS: Ki67 immunohistochemistry was performed on full-face sections at one of three regional labs. Pathologists trained in the International Ki67 in Breast Cancer Working Group (IKWG) method demarcated tumour areas on scanned slides and scored 100 nuclei from each of at least five randomly selected 1-mm fields. For cases with high Ki67 heterogeneity, further virtual cores were selected and scored in order to confidently assign a case as luminal A (≤13.25%) or B (>13.25%). Interlaboratory variability was assessed through an annual quality assurance programme during the study period.

RESULTS: From the quality assurance programme, the mean Ki67 index across all cases/labs was 13%. The observed intraclass correlation coefficient (ICC) and kappa statistics were ≥0.9 and ≥0.7, respectively, indicating a substantial level of agreement. Median scoring time was 4 min per case. The IKWG-recommended scoring method, performed directly from slides, requiring up to four scored fields, is concordant with the LUMINA scoring method (ICC ≥ 0.9).

CONCLUSION: Ki67 is a practical, reproducible, and inexpensive biomarker that can identify low-risk luminal A breast cancers as potential candidates for radiation de-escalation.

CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov number, NCT01791829.

PMID:37609778 | DOI:10.1111/his.15032