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Nevin Manimala Statistics

Pain self-management plus activity tracking and nurse-led support in adults with chronic low back pain: feasibility and acceptability of the problem-solving pain to enhance living well (PROPEL) intervention

BMC Nurs. 2023 Jun 25;22(1):217. doi: 10.1186/s12912-023-01365-y.

ABSTRACT

BACKGROUND: Chronic low back pain can lead to individual suffering, high medical expenditures, and impaired social well-being. Although the role of physical activity in pain management is well established, the underlying mechanisms of biological and clinical outcomes are unknown. This study aimed to assess the feasibility and acceptability of a pain self-management intervention, Problem-Solving Pain to Enhance Living Well, which employs wearable activity tracking technology and nurse consultations for people with chronic low back pain.

METHODS: This one-arm longitudinal study recruited 40 adults aged 18-60 years with chronic low back pain. Over 12 weeks, participants watched 10 short video modules, wore activity trackers, and participated in nurse consultations every 2 weeks. At baseline and the 12-week follow-up, they completed study questionnaires, quantitative sensory testing, and blood sample collection.

RESULTS: Forty participants were recruited, and their mean age was 29.8. Thirty-two participants completed the survey questionnaire, quantitative sensory testing, Fitbit activity tracker, and bi-weekly nurse consultation, and 25 completed the evaluation of biological markers. The overall satisfaction with the Problem-Solving Pain to Enhance Living Well video modules, nurse consultations, and Fitbit in pain management was rated as excellent. No adverse events were reported. Between the baseline and 12-week follow-up, there was a significant decrease in pain intensity and interference and an increase in the warm detection threshold at the pain site.

CONCLUSIONS: Despite concerns about the participant burden due to multidimensional assessment and intensive education, the feasibility of the Problem-Solving Pain to Enhance Living Well intervention was favorable. Technology-based self-management interventions can offer personalized strategies by integrating pain phenotypes, genetic markers, and physical activity types affecting pain conditions.

TRIAL REGISTRATION: This pilot study was registered with ClinicalTrials.gov [NCT03637998, August 20, 2018]. The first participant was enrolled on September 21, 2018.

PMID:37355622 | DOI:10.1186/s12912-023-01365-y

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Nevin Manimala Statistics

Intersections between syndemic conditions and stages along the continuum of overdose risk among women who inject drugs in Mexicali, Mexico

Harm Reduct J. 2023 Jun 24;20(1):79. doi: 10.1186/s12954-023-00815-9.

ABSTRACT

BACKGROUND: Research on women who inject drugs is scarce in low- and middle-income countries. Women experience unique harms such as sexism and sexual violence which translate into negative health outcomes. The present work aims to provide insight into the experiences of women who inject drugs at the US-Mexico border to identify social and health-related risk factors for overdose to guide harm reduction interventions across the Global South.

METHODS: We recruited 25 women ≥ 18 years of age accessing harm reduction and sexual health services at a non-governmental harm reduction organization, “Verter”, in Mexicali, Mexico. We employed purposeful sampling to recruit women who inject drugs who met eligibility criteria. We collected quantitative survey data and in-depth interview data. Analyses of both data sources involved the examination of descriptive statistics and thematic analysis, respectively, and were guided by the syndemic and continuum of overdose risk frameworks.

RESULTS: Survey data demonstrated reports of initiating injection drug use at a young age, experiencing homelessness, engaging in sex work, being rejected by family members, experiencing physical violence, injecting in public spaces, and experiencing repeated overdose events. Interview data provided evidence of stigma and discrimination toward women, a lack of safe spaces and support systems, risk of overdose-related harms, sexual violence, and the overall need for harm reduction services.

CONCLUSION: Women who inject drugs in Mexicali describe experiences of violence, overdose, and public injecting. Women are particularly vulnerable in the Mexicali context, as this area faces a noticeable lack of health and social services. Evidenced-based harm reduction strategies such as safe consumption sites and overdose prevention strategies (e.g., naloxone distribution and training) may benefit this population. Evidence from local organizations could help close the gap in service provision in low-resource settings like Mexico, where government action is almost nonexistent.

PMID:37355611 | DOI:10.1186/s12954-023-00815-9

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Nevin Manimala Statistics

Validation of the German version of the pregnancy-related anxiety scale (PrAS): psychometric properties across all trimesters of pregnancy

BMC Pregnancy Childbirth. 2023 Jun 24;23(1):472. doi: 10.1186/s12884-023-05787-z.

ABSTRACT

BACKGROUND: Pregnancy-related anxiety has received greater research attention recently given its association with adverse outcomes (e.g., negative birth experiences). The Pregnancy-related Anxiety Scale (PrAS) offers the possibility to assess pregnancy-related anxiety, but no German version is available. Therefore, the aim of this study was to validate a German version of the PrAS, a comprehensive measure with eight dimensions.

METHODS: Pregnant women of any parity or gestation completed an online survey consisting of the PrAS, PRAQ-R2, and measures of anxiety, depression, and resilience. The PrAS was translated into German (PrAS-G) using the back-translation method. Data were subjected to confirmatory factor analysis and inferential statistics.

RESULTS: Complete data were provided by 443 women. Participants were predominantly German nationals, partnered, and well-educated with a planned pregnancy. Approximately half were nulliparous. The eight-factor model was well fitting and consistent with the development of the original PrAS. Criterion-related validity was demonstrated by strong correlations with similar measures (PRAQ-R2, anxiety, and depression) and lower correlations with resilience scores. Predictive validity was shown by group comparisons for: planned versus unplanned pregnancy, trimester, and parity.

CONCLUSIONS: The PrAS-G provides a broader assessment of pregnancy-related anxiety than existing measures. Initial evaluation has demonstrated convergent, divergent, and predictive validity, excellent internal consistency, and good model fit indicating promising psychometric properties. The PrAS-G offers a comprehensive assessment of pregnancy-related anxiety which will enable tailored interventions aiming to improve birth experience and well-being of expectant mothers.

PMID:37355600 | DOI:10.1186/s12884-023-05787-z

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Nevin Manimala Statistics

Prevalence of uncontrolled hypertension and its associated factors in 50-74 years old Iranian adults: a population-based study

BMC Cardiovasc Disord. 2023 Jun 24;23(1):318. doi: 10.1186/s12872-023-03357-x.

ABSTRACT

BACKGROUND: By the lengthening of life span, the incidence of chronic diseases such as hypertension and uncontrolled hypertension has increased. This study aims to determine the prevalence of uncontrolled hypertension and its related factors in the age group of 50-74 years in Shahroud, northeast Iran.

METHODS: The data of the third phase of the Shahroud Eye Cohort Study were used in this study. This phase of the cohort study included 4394 participants aged 50 to 74 years from the previous phases. In addition to ophthalmological and optometric examinations, demographic characteristics, blood biochemistry tests, and blood pressure measurements were performed in this phase. Individuals with a blood pressure ≥ 140/90 mm/Hg (being treated or not treated with antihypertensive medicines) were defined as uncontrolled hypertension. In patients with diabetes and chronic kidney disease, blood pressure equal to or higher than 130/80 mm/Hg was considered uncontrolled hypertension. Descriptive statistics and multiple logistic regression were used to analyze the data.

FINDINGS: Overall, the prevalence of uncontrolled hypertension out of all the participants was 61.7% (95% CI: 60.3-63.2). Multiple regression results showed that the male gender (OR: 2.1, 95% CI: 1.5-2.9), patients with diabetes (OR:3.2, 95% CI: 2.4-4.3), and patients with chronic kidney disease (CKD) (OR: 3.2, 95% CI: 2.5-4.1) increased the risk of uncontrolled hypertension while in patients with cardiovascular disease (OR: 0.6, 95% CI: 0.4-0.8) and polypharmacy (OR: 0.2, 95% CI: 0.1-0.2) reduced the risk of uncontrolled hypertension.

CONCLUSION: The present study showed that uncontrolled hypertension has a high prevalence, and factors such as male gender, diabetes, and CKD are associated with this disorder. So, it is recommended to take the necessary measures to formulate and implement immediate actions to prevent or control hypertension.

PMID:37355590 | DOI:10.1186/s12872-023-03357-x

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Nevin Manimala Statistics

Data quality in an HIV vaccine efficacy clinical trial in South Africa: through natural disasters and with discipline

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

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Nevin Manimala Statistics

Clinical predictors of surgical intervention for gastrointestinal magnetic foreign bodies in children

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

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Nevin Manimala Statistics

Assessing the effect of energy consumption and food production from agriculture on environmental degradation in Pakistan: Does institutional quality matter?

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

ABSTRACT

The nexus between food production ( FP ) , energy consumption ( EC ) , institutional quality ( IQ ) , and ecological degradation ( ED ) has significant implications for environmental sustainability. Nevertheless, environmental degradation caused by 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 IQ on ED . To evaluate this influence, we use the autoregressive distributed lag ( ARDL ) method for cointegration and the fully modified ordinary least squares ( FMOLS ) method for robustness estimation. Our empirical results show that whereas FP and EC contribute to pollution, IQ reduces the pace of environmental degradation. Furthermore, the presence of a strong IQ mitigates the harmful ecological effects of FP and EC . Moreover, the results revealed that unbiased domestic IQ is crucial to boosting energy and agricultural efficiency while reducing 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

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A flexible approach to modelling stillbirths using the foetuses at risk approach

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

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Nevin Manimala Statistics

Impact of positive surgical margins (PSMs) after robotic prostatectomy on biochemical recurrence (BCR): Multicenter analysis

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

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Nevin Manimala Statistics

A systematic review and meta-analysis of predictive and prognostic models for outcome prediction using positron emission tomography radiomics in head and neck squamous cell carcinoma patients

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 (SUVmax ) 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