Category: Nevin Manimala

BMC Med Res Methodol. 2023 Jun 24;23(1):147. doi: 10.1186/s12874-023-01967-9.

ABSTRACT

BACKGROUND: To produce quality data that informs valid clinical trial results and withstands regulatory inspection, trial sites should adhere to many complex and dynamic requirements. Understanding non-conformance to requirements informs the emerging field of improvement science. We describe protocol deviations in South Africa’s largest HIV vaccine efficacy trial.

METHODS: We analysed data from the HVTN 702 trial using mixed methods. We obtained descriptive statistics, from protocol deviation case report forms collected from 2016-2022, of deviation by participant, trial site, and time to site awareness. We thematically analysed text narratives of deviation descriptions, corrective and preventive actions, generating categories, codes and themes which emerged from the data.

RESULTS: For 5407 enrollments, 4074 protocol deviations were reported (75 [95% CI: 73.0-77.6] deviations per 100 enrolments). There was a median of 1 protocol deviation per participant (IQR 1-2). Median time from deviation to site awareness was 31 days (IQR 0-146). The most common category of deviation type was omitted data and/or procedures (69%), and 54% of these omissions were stated to have arisen because of the national lockdown at the beginning of the COVID-19 pandemic. The ratio of protocol deviations to cumulative enrolments was highest in the year 2020 (0.34). Major themes of deviations were: COVID-19 and climate disasters giving rise to deviation trends, subroutines introducing an opportunity for deviation, and document fragmentation (such as requirements dispersed across multiple guidance documents) as an obstacle. Preventive action categories were: no preventive measures; discipline, training and/or awareness; quality review, checking and verifying and changing the process and/or implementation tools. Major themes of preventive actions were that systems-based actions are unusual, with people-based actions dominating, and that root cause analysis was rarely mentioned.

CONCLUSIONS: In the age of infectious and climate disaster risks, trials may benefit from simple study designs and trial-related documents. To optimise protocol adherence, sponsors and sites should consider ongoing training, and routinely review deviation reports with a view to adjusting processes. These data quality lessons may inform future trial design, training and implementation.

TRIAL REGISTRATION: HVTN 702 was registered with the South African National Clinical Trials Register (DOH-27-0916-5327) and ClinicalTrials.gov ( NCT02968849 ).

PMID:37355583 | DOI:10.1186/s12874-023-01967-9

BMC Pediatr. 2023 Jun 24;23(1):323. doi: 10.1186/s12887-023-04125-8.

ABSTRACT

BACKGROUND/AIMS: To investigate the clinical situation, treatment methods, and clinical predictors of surgical intervention in children with magnetic foreign bodies in the digestive tract.

MATERIALS AND METHODS: From January 2019 to June 2022, we retrospectively analyzed the clinical data of 72 children who ingested magnetic foreign bodies inadvertently in our hospital, including their general information, admissions, clinical manifestations, and treatment methods, as well as pertinent literature and statistical data. Following software processing, univariate and multivariate logistic regression analyses were conducted to determine the independent risk factors of this study.

RESULTS: In this study, 16 patients (22.2%) were discharged smoothly following conservative treatment and 19 patients (26.4%) were cured by gastroscopy. The remaining 37 patients (51.4%) were underwent surgery, in which 26 cases developed gastrointestinal perforation. There were statistical differences between surgery group and non- surgery group in the days of eating by mistake, clinical manifestations (nausea and vomiting, intermittent abdominal pain, abdominal muscle tension) and movement trajectory by every 24-h radiograph (P < 0.01). Logistic regression analysis showed that intermittent abdominal pain and abdominal muscle tension were independent risk factors for surgical treatment.

CONCLUSION: Magnetic foreign bodies seriously endanger children’s health. This study offers a single-center basis for the choice of surgical opportunity for intestinal obstruction or perforation caused by magnetic foreign bodies. Clinicians need immediate surgical intervention if the child shows symptoms of abdominal pain or abdominal tension.

PMID:37355569 | DOI:10.1186/s12887-023-04125-8

Integr Environ Assess Manag. 2023 Jun 24. doi: 10.1002/ieam.4800. Online ahead of print.

ABSTRACT

The nexus between food production $\left(\mathrm{FP}\right),$ energy consumption $\left(\mathrm{EC}\right),$ institutional quality $\left(\mathrm{IQ}\right),$ and ecological degradation $\left(\mathrm{ED}\right)$ has significant implications for environmental sustainability. Nevertheless, environmental degradation caused by $\mathrm{FP}$ activities is a widely ignored topic, especially in Pakistan. To fill this void, we investigated the impact of energy use, food production, and institutional quality on Pakistan’s environmental degradation between 1990 and 2021. It also explores the moderating influence of $\mathrm{IQ}$ on $\mathrm{ED}.$ To evaluate this influence, we use the autoregressive distributed lag $\left(\mathrm{ARDL}\right)$ method for cointegration and the fully modified ordinary least squares $\left(\mathrm{FMOLS}\right)$ method for robustness estimation. Our empirical results show that whereas $\mathrm{FP}$ and $\mathrm{EC}$ contribute to pollution, $\mathrm{IQ}$ reduces the pace of environmental degradation. Furthermore, the presence of a strong $\mathrm{IQ}$ mitigates the harmful ecological effects of $\mathrm{FP}$ and $\mathrm{EC}$ . Moreover, the results revealed that unbiased domestic $\mathrm{IQ}$ is crucial to boosting energy and agricultural efficiency while reducing ${\mathrm{CO}}_2$ emissions. Our findings might be considered while developing public policies to reduce carbon emissions while increasing food production in a healthy environment.

PMID:37354032 | DOI:10.1002/ieam.4800

Paediatr Perinat Epidemiol. 2023 Jun 24. doi: 10.1111/ppe.12993. Online ahead of print.

ABSTRACT

BACKGROUND: Survival analysis methods are increasingly used to model the gestational age-specific risk of perinatal phenomena such as stillbirth.

OBJECTIVES: To compare two types of survival analysis models, and highlight differences by estimating the relationships between pre-pregnancy BMI and gestational age-specific rates of stillbirth.

METHODS: The study was based on singleton live births and stillbirths in the United States in 2016-2017, with data obtained from the natality and fetal death files of the National Center for Health Statistics. We compared Cox regression versus piecewise exponential additive mixed models (PAMMs) for modelling the relationship between BMI and stillbirth across gestational age. In a second analysis, we illustrated the performance of both models for assessing the relationship between the trimester-specific number of cigarettes smoked, a time-dependent covariate, and stillbirth.

RESULTS: The study population included 7,567,316 births, of which 42,739 were stillbirths (5.6 per 1000 total births). Stillbirth rates increased with increasing pre-pregnancy BMI and increasing gestational age. In analyses with BMI as a categorical variable, the Cox model and PAMM models yielded similar results. Analyses of BMI as a continuous variable also showed similar results when BMI associations were assumed to be linear, and the changes in gestational age-specific rates were modelled parametrically. However, results differed slightly when PAMMs, modelled with data-driven approaches, were used to estimate changes in BMI effects across gestational age; PAMMs provided a more nuanced modelling of time-varying effects. PAMM models showed an approximately linear increase in the effect of smoking on stillbirth with increasing gestational age.

CONCLUSIONS: For survival analyses using the foetuses-at-risk approach, PAMMs provide a valuable alternative to the traditional Cox model, with increased modelling flexibility when proportional hazards assumptions are violated.

PMID:37354020 | DOI:10.1111/ppe.12993

Urologia. 2023 Jun 24:3915603231183478. doi: 10.1177/03915603231183478. Online ahead of print.

ABSTRACT

OBJECTIVE: To study and analyze any correlations between positive surgical margins after RARP and biochemical recurrence.

METHODS: We enrolled 105 patients who underwent robot-assisted radical prostatectomy (RARP) from 2016-2020 with PSMs on final pathology, all performed or supervised by a senior surgeon in two tertiary referral center. Pathology has been described indicating also the area (apical, base, mediolateral, anterior, or multiple) and the extent of PSMs: focal (≤3 mm) or extensive (>3 mm). Cox univariable and multi-variable regression models were used to find the correlation between clinico-pathologic factors: age, local staging, PSA, grading, area, and size of PSMs).

RESULTS: We found a good correlation between PSA and grading and between PSA and local staging (T) (p < 0.001). There was no clear correlation between the PSM area with grading nor with T staging. There is a statistically significant correlation between extensive PSM and the worsening of grading and local staging (p < 0.001). BCR rate also has a strong correlation with the worsening of grading and local staging (T) (p < 0.001). A relevant fact is the difference between the BCR rate in the apical and base PSM (34.88%vs 62.5%; p < 0.001) which are the most frequent locations of PSMs.

DISCUSSION: PSMs remain a predictor of BCR but which may have controversial significance. The likelihood of BCR increases as grading or local staging gets worse. However, apical PSM is a relatively less powerful predictor of postoperative BCR. This can help to better select patients for subsequent RT, which still causes important side effects.

PMID:37354007 | DOI:10.1177/03915603231183478

Cancer Med. 2023 Jun 24. doi: 10.1002/cam4.6278. Online ahead of print.

ABSTRACT

BACKGROUND: Positron emission tomography (PET) images of head and neck squamous cell carcinoma (HNSCC) patients can assess the functional and biochemical processes at cellular levels. Therefore, PET radiomics-based prediction and prognostic models have the potentials to understand tumour heterogeneity and assist clinicians with diagnosis, prognosis and management of the disease. We conducted a systematic review of published modelling information to evaluate the usefulness of PET radiomics in the prediction and prognosis of HNSCC patients.

METHODS: We searched bibliographic databases (MEDLINE, Embase, Web of Science) from 2010 to 2021 and considered 31 studies with pre-defined inclusion criteria. We followed the CHARMS checklist for data extraction and performed quality assessment using the PROBAST tool. We conducted a meta-analysis to estimate the accuracy of the prediction and prognostic models using the diagnostic odds ratio (DOR) and average C-statistic, respectively.

RESULTS: Manual segmentation method followed by 40% of the maximum standardised uptake value (SUV_max ) thresholding is a commonly used approach. The area under the receiver operating curves of externally validated prediction models ranged between 0.60-0.87, 0.65-0.86 and 0.62-0.75 for overall survival, distant metastasis and recurrence, respectively. Most studies highlighted an overall high risk of bias (outcome definition, statistical methodologies and external validation of models) and high unclear concern in terms of applicability. The meta-analysis showed the estimated pooled DOR of 6.75 (95% CI: 4.45, 10.23) for prediction models and the C-statistic of 0.71 (95% CI: 0.67, 0.74) for prognostic models.

CONCLUSIONS: Both prediction and prognostic models using clinical variables and PET radiomics demonstrated reliable accuracy for detecting adverse outcomes in HNSCC, suggesting the prospect of PET radiomics in clinical settings for diagnosis, prognosis and management of HNSCC patients. Future studies of prediction and prognostic models should emphasise the quality of reporting, external model validation, generalisability to real clinical scenarios and enhanced reproducibility of results.

PMID:37353996 | DOI:10.1002/cam4.6278

Eur J Dent Educ. 2023 Jun 23. doi: 10.1111/eje.12931. Online ahead of print.

ABSTRACT

INTRODUCTION: Dental sleep medicine (DSM) is an emerging discipline that studies the oral and maxillofacial causes and consequences of sleep-related problems. DSM is of upmost importance given the major medical challenge it represents. Therefore, to verify whether the future generation of dentists would be ready to face this challenge, the main objective of this study was to assess the degree of involvement of the French dental schools in teaching DSM at the undergraduate level.

MATERIALS AND METHODS: All 16 dental schools in France were asked to participate in the study by answering to an online survey concerning the DSM curriculum during the 2018-2019 academic year. The survey was addressed to the head of the dental school and/or to relevant course coordinators and contained 10 questions related to the type, content and amount of DSM teaching to undergraduate dental students.

RESULTS: Nine of the 16 (56.2%) French dental schools responded to the questionnaire. All these nine reported the inclusion of DSM in their undergraduate curriculum. The total average hours dedicated to teaching DSM was 5.6 h (SD 4.2; range 1-15 h). Seven of the 9 dental schools spent most of their DSM curriculum teaching time in the fifth year. All of them reviewed obstructive sleep apnoea and sleep-related bruxism and covered some topics related to therapies for sleep-related breathing disorders, such as the use of oral appliance.

CONCLUSION: The results of this survey showed that, although the average hourly volume is relatively high, the DSM teaching in French dental schools appeared to be non-standardised, heterogeneous and often lacunar. It is therefore essential to develop a common curriculum and implement it in all dental schools to provide undergraduate students a comprehensive and updated teaching in DSM.

PMID:37353975 | DOI:10.1111/eje.12931

Aust N Z J Psychiatry. 2023 Jun 23:48674231181039. doi: 10.1177/00048674231181039. Online ahead of print.

ABSTRACT

OBJECTIVE: The aim of this study was to test the effectiveness of a tailored quitline tobacco treatment (‘Quitlink’) among people receiving support for mental health conditions.

METHODS: We employed a prospective, cluster-randomised, open, blinded endpoint design to compare a control condition to our ‘Quitlink’ intervention. Both conditions received a brief intervention delivered by a peer researcher. Control participants received no further intervention. Quitlink participants were referred to a tailored 8-week quitline intervention delivered by dedicated Quitline counsellors plus combination nicotine replacement therapy. The primary outcome was self-reported 6 months continuous abstinence from end of treatment (8 months from baseline). Secondary outcomes included additional smoking outcomes, mental health symptoms, substance use and quality of life. A within-trial economic evaluation was conducted.

RESULTS: In total, 110 participants were recruited over 26 months and 91 had confirmed outcomes at 8 months post baseline. There was a difference in self-reported prolonged abstinence at 8-month follow-up between Quitlink (16%, n = 6) and control (2%, n = 1) conditions, which was not statistically significant (OR = 8.33 [0.52, 132.09] p = 0.131 available case). There was a significant difference in favour of the Quitlink condition on 7-day point prevalence at 2 months (OR = 8.06 [1.27, 51.00] p = 0.027 available case). Quitlink costs AU$9231 per additional quit achieved.

CONCLUSION: The Quitlink intervention did not result in significantly higher rates of prolonged abstinence at 8 months post baseline. However, engagement rates and satisfaction with the ‘Quitlink’ intervention were high. While underpowered, the Quitlink intervention shows promise. A powered trial to determine its effectiveness for improving long-term cessation is warranted.

PMID:37353970 | DOI:10.1177/00048674231181039

Blood Press. 2023 Dec;32(1):2226736. doi: 10.1080/08037051.2023.2226736.

ABSTRACT

PURPOSE: Hypertension is a major global health concern. Despite of efficient antihypertensive medications a low percentage of patients reach a blood pressure (BP) of <140/90. Nonadherence is a great concern in hypertension treatment and patients’ beliefs about medications has been shown to have a strong impact on adherence. The objective of this study is to examine beliefs about medications and its impact on BP treatment in a group of Swedish primary healthcare patients treated for hypertension with or without an E-health platform.

MATERIALS AND METHOD: In a randomised unblinded controlled trial, 949 patients with hypertension from Swedish primary health care centres were included. The intervention group used a web-based system to support self-management of hypertension for eight weeks. Beliefs about medication questionnaire (BMQ) were administered to all patients at inclusion, 8-week follow up and 1-year follow up.

RESULTS: Data were collected from the 862 patients who completed the trial. No statistically significant difference was found in BMQ-scores between the intervention and the control group. An association between lower scores in the BMQ subsection ‘General-Harm’ and achieving target BP of <140/90 mmHg were noted (p = 0.021).

CONCLUSION: This study shows a significant association between beliefs about medication and BP levels, on hypertensive patients in the Swedish primary care setting, in only one out of four subsections of the BMQ. The intervention did not have a significant effect on changing patients’ beliefs about medication. Further emphasis on patients’ beliefs about medications could be useful in the clinical setting.

PMID:37353959 | DOI:10.1080/08037051.2023.2226736