Nevin Manimala

Int J Behav Med. 2022 Oct 25. doi: 10.1007/s12529-022-10131-4. Online ahead of print.

ABSTRACT

BACKGROUND: People with advanced cancer experience psychological distress due to physical symptoms, functional decline, and a limited prognosis. Difficult thoughts, feelings, and emotions may exacerbate distress and lead to avoidance of these experiences which is sometimes referred to as experiential avoidance (EA). Advanced cancer patients may be more likely to engage in EA especially when no obvious solutions to their problems exist. This study aims to examine the terms used to describe EA, the processes that might indicate EA, associations between EA and psychological distress, and to understand why individuals might engage in EA.

METHODS: A mixed-methods review. Literature search of Medline, Embase, Psych INFO, and CINAHL 1980-October 2019.

INCLUSION: adults ≥ 18 years; advanced cancer not amenable to cure.

EXCLUSION: no measures of EA or psychological distress. Risk of bias and study quality assessed. Evidence of statistical techniques collected. Themes coded, grouped, and developed based on meaning.

RESULTS: Nineteen studies identified, 13 quantitative studies and 6 qualitative. The quantitative of which 6 compared early-stage cancers with advanced cancers and examined subscales of EA alongside mood, quality of life, and psychological distress. EA covers a range or terms of which ‘avoidant coping’ is the commonest. EA is manifest as cognitive, behavioural, and emotional avoidance. A thematic synthesis suggests the function of EA is to protect people from distress, and from confronting or expressing difficult emotions by avoiding communication about cancer, controlling negative information, and maintaining normality and hope and optimism.

CONCLUSIONS: EA may be beneficial in the short term to alleviate distress, but in the longer term, it can impair function and limit engagement in life. Greater clinical awareness of the complexity of EA behaviours is needed. Clinicians and researchers should define EA precisely and be aware of the function it may serve in the short and longer term. Future research studies may consider using specific measures of EA as a primary outcome, to assess the impact of psychological interventions such as ACT.

PMID:36284042 | DOI:10.1007/s12529-022-10131-4

Cancer Causes Control. 2022 Oct 25. doi: 10.1007/s10552-022-01646-y. Online ahead of print.

ABSTRACT

PURPOSE: Clinical trials advance the standard of care for patients. Patients enrolled in trials should represent the population who would benefit from the intervention in clinical practice. The aim of this study was to assess whether clinical trials enrolling patients with gynecologic cancers report racial and ethnic participant composition and to examine the level of diversity in clinical trials.

METHODS: Using ClinicalTrials.gov, we identified clinical trials enrolling patients with ovarian, uterine/endometrial, cervical, vaginal, and vulvar cancers from 1988 to 2019. Race and ethnicity data were extracted from participant demographics. Descriptive statistics on race, ethnicity, cancer type, location, study status, and sponsor type were calculated. Among trials which reported race and/or ethnicity, sub-analyses were performed on composition of race and ethnicity by funding source, location, and completed study status.

RESULTS: A total of 1,882 trials met inclusion criteria; only 179 trials (9.5%) reported race information. Of these, the racial distribution of enrollees was 66.9% White, 8.6% Asian, 8.5% Black/African American, 0.4% Indian/Alaskan Native, 0.1% Native Hawaiian/Pacific Islander, 1.0% more than one race, and 14.5% unknown. Only 100 (5.3%) trials reported ethnicity. Except for trials enrolling patients with cervical cancer which enrolled 65.2% White and 62.1% Non-Hispanic/Latino/a patients, enrollees in trials for other gynecologic cancers were over 80% White and 88% Non-Hispanic/Latino/a. Industry funded trials enrolled higher proportions of White (68.4%) participants than non-industry funded trials (57.5%). Domestic trials report race (11.5%) and ethnicity (7.6%) at higher rates than international trials (6.9% and 2.3%, respectively). Reporting of race (1.7% vs. 13.9%) and ethnicity (1.7% vs. 11.1%) has increased over time for patients enrolled in 2000 vs. 2018.

CONCLUSION: Less than 10% of trials enrolling patients with gynecologic malignancies report racial/ethnic participant composition on ClinicalTrials.gov. Accurate reporting of participant race/ethnicity is imperative to ensuring minority representation in clinical trials.

PMID:36284031 | DOI:10.1007/s10552-022-01646-y

Res Synth Methods. 2022 Oct 25. doi: 10.1002/jrsm.1608. Online ahead of print.

ABSTRACT

OBJECTIVE: Effect modification (EM) may cause bias in network meta-analysis (NMA). Existing population adjustment NMA methods use individual patient data to adjust for EM but disregard available subgroup information from aggregated data in the evidence network. Additionally, these methods often rely on the shared effect modification (SEM) assumption. In this paper, we propose Network Meta-Interpolation (NMI): a method using subgroup analyses to adjust for EM that does not assume SEM.

METHODS: NMI balances effect modifiers across studies by turning treatment effect (TE) estimates at the subgroup- and study level into TE and standard errors at EM values common to all studies. In an extensive simulation study, we simulate two evidence networks consisting of four treatments, and assess the impact of departure from the SEM assumption, variable EM correlation across trials, trial sample size and network size. NMI was compared to standard NMA, network meta-regression (NMR) and Multilevel NMR (ML-NMR) in terms of estimation accuracy and credible interval (CrI) coverage.

RESULTS: In the base case non-SEM dataset, NMI achieved the highest estimation accuracy with root mean squared error (RMSE) of 0.228, followed by standard NMA (0.241), ML-NMR (0.447) and NMR (0.541). In the SEM dataset, NMI was again the most accurate method with RMSE of 0.222, followed by ML-NMR (0.255). CrI coverage followed a similar pattern.

CONCLUSIONS: NMI’s dominance in terms of estimation accuracy and CrI coverage appeared to be consistent across all scenarios. NMI represents an effective option for NMA in the presence of study imbalance and available subgroup data. This article is protected by copyright. All rights reserved.

PMID:36283960 | DOI:10.1002/jrsm.1608

Ultrasound Med Biol. 2022 Oct 22:S0301-5629(22)00532-4. doi: 10.1016/j.ultrasmedbio.2022.08.007. Online ahead of print.

ABSTRACT

Ultrasound (US) is an increasingly prevalent and effective diagnostic modality for neuromuscular imaging. Gray-scale B-mode imaging has been the dominant US approach to evaluating nerves qualitatively or making morphometric measurements of nerves, providing important insights into pathological changes for conditions such as carpal tunnel syndrome. Among more recent ultrasound strategies, high-frequency ultrasound (often defined as >15 MHz for clinical applications), quantitative ultrasound and image textural analysis offer promising enhancements for improved and more objective approaches to nerve imaging. In this study, we evaluated the repeatability and reproducibility of backscatter coefficient (BSC) and imaging texture features extracted by gray-level co-occurrence matrices (GLCMs) in homogeneous tissue-mimicking reference phantoms and in median nerves in the wrists of healthy participants. We also investigated several practical sources of variability in the assessment of quantitative parameters, including influences of operators, and participant-to-participant variability. Overall, BSC- and GLCM-based outcomes are highly repeatable and reproducible after operator training, based on measurement of descriptive statistics, repeatability coefficient (RC) and reproducibility coefficient recommended by Quantitative Imaging Biomarker Alliance (QIBA RDC). GLCM parameters appear more reproducible and repeatable than BSC-based parameters in healthy participants in vivo. However, such variability noted here must be compared with the value ranges and variability of the results in pathological nerves, including median nerves afflicted by trauma, overuse syndromes such as carpal tunnel syndrome and after surgical repair.

PMID:36283940 | DOI:10.1016/j.ultrasmedbio.2022.08.007

Ultrasound Med Biol. 2022 Oct 23:S0301-5629(22)00578-6. doi: 10.1016/j.ultrasmedbio.2022.09.018. Online ahead of print.

ABSTRACT

In patients with breast cancer undergoing anthracycline-based chemotherapy, we investigated the deformational parameters of the left ventricle, right ventricle and left atrium, as well as the relationship between these parameters. Ninety-five patients with breast cancer who were treated with anthracycline-based chemotherapy were enrolled. The control group included 116 healthy female volunteers. Parameters including left ventricular global longitudinal strain (LV-GLS); right ventricular free wall longitudinal strain (RVFWSL) and global longitudinal strain (RV4CSL); and peak strain of the left atrium during LV systole (LASR), early LV diastole (LASCD) and late LV diastole (LASCT) were analyzed by speckle tacking echocardiography. LV-GLS, LASR, LASCD, RVFWSL and RV4CSL in the chemotherapy group decreased significantly by 15.6%, 13.8%, 19.8%, 21.8% and 13.2% (p < 0.05), respectively, when compared with the control group. LASCT was slightly increased in the chemotherapy group but the increase was not statistically significant (p > 0.05). Formulas for the influencing factors of LV-GLS were LV-GLS = -18.73738541 + 0.13961 × LVIDd + 0.09672 × LASCD + 0.18113 × RVFWSL in the control group and LV-GLS = -8.026302253 + 0.20811 × LASCD + 0.11084 × LASCT + 0.12153 × RVFWSL in the chemotherapy group. Both LV contraction and RV contraction were impaired after the completion of anthracycline-based therapy, and RVFWSL may be superior to LV-GLS in assessing cardiotoxicity. LA reserve and channel function were significantly reduced, while pump function was slightly increased. Compared with the results among healthy people, the influencing factor of LV-GLS varied after anthracycline treatment, and LA function had a greater impact on LV-GLS.

PMID:36283937 | DOI:10.1016/j.ultrasmedbio.2022.09.018

Reprod Biomed Online. 2022 Sep 21:S1472-6483(22)00709-X. doi: 10.1016/j.rbmo.2022.09.015. Online ahead of print.

ABSTRACT

RESEARCH QUESTION: Do internal levels of persistent organic pollutants (POP) in serum and follicular fluid affect ovarian function of women attending IVF?

DESIGN: This cohort study included 136 women undergoing IVF in the assisted reproductive technology (ART) service of University Hospital from Nantes (France). Representative POP were measured using gas and liquid chromatography coupled with tandem mass spectrometry. Polyfluoroalkylated and perfluoroalkylated substances were measured in serum and polychlorinated biphenyls and organochlorinated pesticides in follicular fluid. Statistical associations between POP and ovarian reserve markers (anti-Müllerian Hormone [AMH] and antral follicle count [AFC], and ovarian responsiveness markers (Ovarian Sensitivity Index [OSI] and Follicular Output RaTe [FORT]), were explored in single and multipollutant regression models.

RESULTS: Twenty-seven out of 53 POP congeners were frequently detected in almost all women attending IVF. Adjusted models did not show statistically significant associations between POP and ovarian reserve markers. Positive associations were found between some POP, i.e. hexachlorobenzene with FORT (β 0.42, 95% CI 0.13 to 0.71, P = 0.005) or PCB52 with Ovarian Sensitivity Index (β 0.22; 95% CI, 0.07 to 0.38, P = 0.005). Negative associations between some polyfluoroalkylated and perfluoroalkylated substances, PCB189 and trans-nonachlor with AFC and AMH were found among current smokers.

CONCLUSIONS: Globally, associations between POP and the markers of ovarian function or responsiveness were lacking. Nonetheless, the stratification analysis suggested that current smoking could be a risk modifier, and extension of the study to a larger population sample size is needed.

PMID:36283934 | DOI:10.1016/j.rbmo.2022.09.015

J Surg Educ. 2022 Oct 23:S1931-7204(22)00249-5. doi: 10.1016/j.jsurg.2022.09.014. Online ahead of print.

ABSTRACT

OBJECTIVE: The purpose of this study was to examine the mortality difference and other outcome measures amongst trauma patients with residents involved in the initial management versus those that were managed by attending physicians only without resident involvement.

DESIGN: Retrospective review. Chi-square, Fisher’s tests were used to analyze the outcomes, diagnostics, and interventions using the presence of residents in the initial care of patients as an independent variable. Linear and logistic regression were used to estimate adjusted outcomes.

SETTING: Riverside Community Hospital, Riverside California (State-designated level I trauma center) PARTICIPANTS: Data on all trauma patients ≥18 years old that were admitted between July 1, 2018 and June 30, 2020 was collected retrospectively (total 2644 trauma patients). Trauma patients that were transferred from outside facilities were excluded from the study.

RESULTS: There was no significant difference in mortality associated with resident involvement in both unadjusted and adjusted analysis. Patients treated by residents, however, had more comorbidities (higher CCI) and were more severely injured (higher ISS). On adjusted analysis, higher ISS was independently associated with resident presence. There was also a statistically significant increase in the use of diagnostic studies and therapeutic interventions in the resident-present group.

CONCLUSIONS: Involvement of residents in the initial management of our trauma patient population was associated with no difference in overall mortality or morbidity, despite higher injury severity in the resident treated patient group.

PMID:36283922 | DOI:10.1016/j.jsurg.2022.09.014

Oral Surg Oral Med Oral Pathol Oral Radiol. 2022 Aug 31:S2212-4403(22)01117-8. doi: 10.1016/j.oooo.2022.08.012. Online ahead of print.

ABSTRACT

PURPOSE: To investigate the efficacy and stability of temporomandibular joint disk repositioning by suturing through an open incision in adolescents with anterior disk displacement (ADD).

METHODS: Patients (aged 10-18 years) diagnosed with ADD and operated for disc repositioning between June 2019 and January 2021 were included in this study. Magnetic resonance imaging (MRI) and cephalometric films before and 1 year after surgery were collected from all patients. The surgical success rate was defined as the primary outcome variable. Changes of condylar height, mandibular asymmetry, and retrognathia were defined as the secondary outcome variables.

RESULTS: One hundred and four patients (167 joints) with a mean age of 14.6 ± 1.81 years were included in this study. Postoperative MRIs showed that all disks had been repositioned with an overall success rate of 94%. Statistically significant differences were found in the improvement of condylar height (P < .001), mandibular asymmetry (P < .001), and retrognathia (P < .001) after 1 year of follow-up. The relapse rate in patients <15 years (8.57%) was higher than that of patients older than 15 years (4.12%), although this was not statistically significant (P = .387).

CONCLUSIONS: For juvenile patients, disk repositioning by suturing through an open incision was an effective treatment. Early surgery can promote condylar regeneration and alleviate maxillofacial deformity in juvenile patients.

PMID:36283917 | DOI:10.1016/j.oooo.2022.08.012

Vaccine. 2022 Oct 22:S0264-410X(22)01281-6. doi: 10.1016/j.vaccine.2022.10.022. Online ahead of print.

ABSTRACT

BACKGROUND: Human papillomavirus (HPV) infections were the main cause of anogenital cancers and warts. HPV 6/11/16/18 vaccines provide protection against the high-risk types of HPV responsible for 70% of cervical cancers and 90% of genital warts. This randomized, blinded, non-inferiority phase III trial was to determine whether immunogenicity and tolerability would be non-inferior among women after receiving two novel 4- and 9-valent HPV vaccines (4vHPV, HPV 6/11/16/18; 9vHPV, HPV 6/11/16/18/31/33/45/52/58) compared with those receiving Gardasil 4 (4-valent).

METHODS: 1680 females between 20 and 45 years were randomized in a 2:1:1 ratio to 20-26, 27-35, or 36-45 y groups. Subjects then equally assigned to receive 4vHPV, 9vHPV or Gardasil 4 (control) vaccine at months 0, 2, and 6. End points included non-inferiority of HPV-6/11/16/18 antibodies for 4vHPV versus control, and 9vHPV versus control and safety. The immunogenicity non-inferiority was pre-defined as the lower bound of 95% confidence interval (CI) of seroconversion rate (SCR) difference > -10% and the lower bound of 95% CI of geometric mean antibody titer (GMT) ratio > 0.5.

RESULTS: Among the three vaccine groups, more than 99% of the participants seroconverted to all 4 HPV types. The pre-specified statistical non-inferiority criterion for the immunogenicity hypothesis was met: all the lower bounds of 95% CIs on SCR differences exceeded -10% for each vaccine HPV type and the corresponding lower bounds of 95% CIs for GMT ratios > 0.5. Across vaccination groups, the most common vaccination reaction were injection-site adverse events (AEs), including pain, swelling, and redness. General and serious AEs were similar in the three groups. There were no deaths.

CONCLUSIONS: This study demonstrated that the novel 4- and 9-valent HPV vaccination was highly immunogenic and generally well tolerated, both of which were non-inferior to Gardasil 4 in immunogenicity and safety.

PMID:36283897 | DOI:10.1016/j.vaccine.2022.10.022

Injury. 2022 Oct 2:S0020-1383(22)00732-X. doi: 10.1016/j.injury.2022.09.064. Online ahead of print.

ABSTRACT

BACKGROUND: Surgical stabilization of rib fractures (SSRF) is being done with increased frequency and new advances. Intrathoracic SSRF is a new less invasive approach compared to the traditional extrathoracic plating procedure. Educational assessment can be done through descriptive analysis of learning curves with operation time used as a proxy measurement for learning. The objective of this level 3 observational cohort study is to assess the learning curve of introducing the intrathoracic method of plating at a large academic medical institution.

METHODS: Intrathoracic surgical stabilization of rib fractures was introduced at a tertiary trauma center in March of 2019. All patients that received SSRF beginning 11/2017 were included. Patients with abbreviated injury scale score of the head, abdomen, extremity, or face greater than three and days from injury to SSRF greater than 4 were excluded. Operation time was determined from time of incision to completion of skin closure. Time per fracture and time per plate were calculated using total operation time. Learning curves and CUSUM graphs for individual surgeons that had completed in more than 3 SSRF cases were generated using and trended for statistical significance.

RESULTS: After exclusions, there were 38 patients with extrathoracic SSRF between November 2017-September 2021 and 24 patients with intrathoracic plating between March 2019-Sept. 2021. There were 5 fellows and 6 residents that performed extrathoracic SSRF. Four fellows and 2 residents performed intrathoracic SSRF. Graphs of time per fracture and time per plate over time produced learning curves without an inflection point for extrathoracic or intrathoracic SSRF in any of the following categories: all surgeries (Figs. 1 and 2), academic year (July to June), individual attending surgeons, fellows, or residents.

CONCLUSION: There was no discernible inflection point on the generated learning curves. Time per plate and time per fracture did not decrease as surgeons gained more experience. Introducing intrathoracic SSRF in a large academic hospital may not need to account for a learning curve adjustment period.

PMID:36283879 | DOI:10.1016/j.injury.2022.09.064