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Nevin Manimala Statistics

Methodology for Determining Minimally Clinically Important Differences in Acute Pain Intensity with the Double Stopwatch Technique

J Pain. 2024 Dec 15:104759. doi: 10.1016/j.jpain.2024.104759. Online ahead of print.

ABSTRACT

Minimum clinically important differences (MCIDs) in acute pain intensity have not been well established. Conventional approaches for estimating MCIDs require an independent reference scale, with a threshold that must be presumed to accurately classify meaningful change in pain for all study participants, to serve as an anchor. The double stopwatch technique is the gold standard for measuring the time to meaningful relief, where participants actively press the second stopwatch when they experience pain relief that is meaningful to them. This technique eliminates the problem of misclassification with arbitrary anchors at a single time point, but the censored nature of the data is not amenable for determining MCIDs using standard methods. We propose a stopwatch-based MCID methodology that employs the double stopwatch technique to identify individualized thresholds for meaningful change in pain. This approach enables direct classification of changes in pain for each participant based on whether they perceived the change as meaningful and whether it exceeded the study cut-off being tested. Pain values of participants who do not achieve meaningful relief are incorporated into the analysis to address censoring and avoid bias. The performance (e.g., sensitivity, specificity) of different thresholds to serve as an MCID can be estimated using standard approaches with variance estimates derived by cluster bootstrapping. The advantages of the stopwatch-based MCID methodology are illustrated relative to a conventional approach using data from a randomized trial in third molar extraction. PERSPECTIVE: This article describes a methodology for determining MCIDs using the double stopwatch technique, the gold standard for assessing meaningful changes in acute pain. This methodology can be used to establish MCIDs in different acute pain settings, providing a useful basis to evaluate the meaningfulness of clinical trial results. DATA AVAILABILITY: The participant-level data included in this study as an illustrative example were submitted to the FDA by an industry sponsor and may not be publicly released. R statistical code is provided for a simulated dataset to illustrate the proposed method as a supplementary appendix.

PMID:39689766 | DOI:10.1016/j.jpain.2024.104759

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Identification and quantitation of multiplex camellia oil adulteration based on 11 characteristic lipids using UPLC-Q-Orbitrap-MS

Food Chem. 2024 Dec 6;468:142370. doi: 10.1016/j.foodchem.2024.142370. Online ahead of print.

ABSTRACT

Currently, the identification and quantification of complex adulteration of high-value vegetable oils are still challenging. In this study, the extreme vertex design method was adopted to design representative multivariate adulterated camellia oil samples. Thereafter, 11 characteristic lipid species were identified by considering the statistically significant difference and categorical contribution. A discriminant method and linear regression model were established based on 11 key lipids. The accuracy rate of the model was 100 %, which could correctly discriminate the camellia oil with an adulteration ratio as low as 2.5 %. The root mean square error (RMSE) of the regression equation was close to 0, and the coefficient of determination (R2P) was 0.9054. This method has been successfully applied to commercially available samples for validation purposes, detecting 27.3 % of camellia oil adulteration. Overall, the results indicate that the discriminating method and content prediction model can provide a potential strategy for authentication of multivariate vegetable oils.

PMID:39689496 | DOI:10.1016/j.foodchem.2024.142370

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Dietary supplementation with Jasminum sambac leaf powder: Effects on growth, hematology, and immune parameters in broiler chickens

Poult Sci. 2024 Dec 5;104(1):104645. doi: 10.1016/j.psj.2024.104645. Online ahead of print.

ABSTRACT

Food production needs to expand by 70% to keep up with the expected considerable increase in the world population by 2050. As a major source of high-quality protein, poultry products are essential to the world’s food supply. Nonetheless, problems with industrial mechanization, pollution, animal welfare, and antibiotic resistance affect the poultry industry. The objective of this study was to assess the impact of adding Jasminum sambac leaf powder (JSLP) to the feed of broiler chickens on their growth performance, coliform bacterial levels, and immunological function. During a 42-day period, 100 day-old Ross broiler chicks were randomly allocated to one of four treatment groups, each consisting of 25 replicates: T0 (control) with no additives, T1 supplemented with 3% JSLP, T2 with 6% JSLP, and T3 with 9% JSLP. One-way ANOVA was used to determine statistical inference among groups. Feeding JSLP resulted in a significant increase in body weight (BW), body weight gain (BWG), and feed intake (P<0.05), while faecal coliforms were significantly reduced (P<0.01). Further, haemoglobin concentration and red blood cell counts (RBC) on days 14, 28, and 42, were significantly increased(P<0.01). Additionally, significant differences in differential leucocyte counts (DLC) were observed between the JSLP-treated groups (P<0.001). Overall, JSLP supplementation positively influenced broiler chicken growth indices and haematological profiles, though its impact on immunological parameters warrants further investigation.

PMID:39689481 | DOI:10.1016/j.psj.2024.104645

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Are clinical decision support systems seen as helpful to First Contact Practitioners (FCPs) working in musculoskeletal health?

Physiotherapy. 2024 Oct 29;126:101445. doi: 10.1016/j.physio.2024.101445. Online ahead of print.

ABSTRACT

BACKGROUND: There is increasing burden on musculoskeletal (MSK) First Contact Practitioners (FCPs) working in primary care. One possible solution is to use digital technologies such as clinical decision support systems (CDSS). The primary objective of this study was to understand the potential for MSK FCPs to use a CDSS to support their practice in the United Kingdom.

DESIGN: An exploratory sequential mixed methods design, using a cross sectional survey questionnaire and a subsequent focus group. Following ethical approval responders were recruited via professional networks to complete an online survey. A subsequent focus group enabled an in-depth exploration of survey results. Descriptive statistics were used to summarise survey data and thematic analysis with normalisation process theory used to describe findings.

METHODS: A snowball sampling method was used to invite MSK FCPs to complete the survey, using email, adverts and social media. The questionnaire captured responders’ demographic and professional practice characteristics, their knowledge and use of CDSS and their views and experiences regarding CDSS in MSK practice.

RESULTS: There were 75 responders to the survey and six participants in the focus group. The majority of responders 67% (n = 50/75) reported to be in favour of integrating a CDSS into their practice. Three themes were: 1) ensuring CDSS address efficiency concerns, 2) using CDSS to reduce unwarranted variation in practice, and 3) ensuring CDSS sustainability.

CONCLUSIONS: CDSSs have potential value for FCPs working in MSK primary care settings. Eight summary recommendations advise future developments of CDSS for FCPs working in MSK primary care practice. CONTRIBUTION OF THE PAPER.

PMID:39689409 | DOI:10.1016/j.physio.2024.101445

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Detection of Enterococcus faecalis and the red complex bacteria analyzed by the Checkerboard technique for DNA-DNA hybridization in endodontic infections: A systematic review and meta-analysis

Diagn Microbiol Infect Dis. 2024 Dec 9;111(3):116654. doi: 10.1016/j.diagmicrobio.2024.116654. Online ahead of print.

ABSTRACT

Endodontic infections include conditions such as pulp necrosis, apical periodontitis, abscesses, granulomas, and periapical cysts. Detection of pathogenic microorganisms responsible for these diseases is essential for accurate diagnosis and future therapy. Enterococcus faecalis, Porphyromonas gingivalis, Tannerella forsythia, and Treponema denticola were analyzed qualitatively and quantitatively using the Checkerboard methodology for DNA-DNA hybridizations as a bacterial identification tool. Clinical investigations have shown a significant frequency of these microorganisms. The present systematic review and meta-analysis aimed to determine the prevalence of E. faecalis and red complex bacteria (RCB) (P. gingivalis, T. forsythia, and T. denticola) analyzed by the Checkerboard DNA-DNA hybridization technique in endodontic infections. This systematic literature review followed the Preferred Reporting Items for Systematic Reviews and Meta-analysis (PRISMA) guidelines-electronic databases: PubMed, Scopus, ScienceDirect, Web of Science, and Google Scholar. Statistical analysis was performed using STATA V.15 software. Seventeen articles were included, of which a total of 620 samples were evaluated. Five hundred sixty-seven samples were taken from infected root canals, 34 samples from periradicular tissues, and 27 samples from periapical abscesses of infected teeth. The prevalence of E. faecalis in endodontic infections in all studies was 74 %, of P. gingivalis was 63 %, of T. forsythia 46 %, and of T. denticola 58 %. The presence of bacteria such as E. faecalis reduces the efficiency of endodontic therapy and leads to recurring infections. It is recognized that “RCB” can be identified in endodontic lesions; however, they are not usually prominent. The DNA-DNA hybridization approach is critical for identifying bacteria and detecting difficult-to-culture microorganisms, making it a helpful and cost-effective tool for directing personalized endodontic treatments.

PMID:39689402 | DOI:10.1016/j.diagmicrobio.2024.116654

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Serial intrapartum ultrasound to predict vaginal delivery using angle of progression and head- progression distance in term nulliparous women

Eur J Obstet Gynecol Reprod Biol. 2024 Dec 10;305:125-131. doi: 10.1016/j.ejogrb.2024.12.014. Online ahead of print.

ABSTRACT

INTRODUCTION: Over the past decade, intrapartum ultrasound (ITU) has been in the global limelight for labour monitoring. The use of the same in clinical settings of low- and middle-income countries (LMIC’s) however, is limited. Till date, angle of progression (AOP) stands as the most studied parameter. Very few studies, most from developed countries, have shown that other ITU measurements could also hold relevance to labour and delivery. In recent times, serial ITU has also garnered some attention and could possibly be a better predictor of labour outcome.

AIMS: This study aimed to compare the predictive accuracies of AOP and head PD for vaginal delivery and to investigate whether the rate of change of serially measured AOP and head PD in the first stage is predictive of vaginal delivery.

METHODS: A prospective observational study was conducted on 90 nulliparous women between April 2023 and July 2024 at a tertiary teaching hospital in South India. Participants had singleton pregnancies in cephalic presentation between 37-40 weeks with regular contractions, and cervical dilation ≥ 3 cm. Exclusion criteria included prior LSCS and abnormal cardiotocography. Intrapartum ultrasound was performed twice, once at recruitment and 3-5 h apart, to measure AOP and PD. Statistical analysis included ROC curve plotting for diagnostic accuracy of AOP and PD in predicting vaginal delivery.

RESULTS: Of the 90 participants, 71 (78.9 %) delivered vaginally and 19 (21.1 %) had caesarean sections. AOP ≥ 120° and PD ≥ 2.7 cm at ≥ 6 cm cervical dilation showed a strong correlation with vaginal delivery, with sensitivity and specificity of 70.4 % and 94.7 %, and 63.4 % and 89.5 % respectively. Change (delta) in AOP > 10° had the highest diagnostic accuracy (81 %), with a positive predictive value of 92.2 %.

CONCLUSION: ITU offers valuable insights into labour progression. AOP and PD, particularly at cervical dilation of ≥ 6 cm, are predictive of vaginal delivery. Delta AOP serves as the most accurate predictor. Incorporating ITU into routine labour management enhances clinical decision-making, helping reduce unnecessary interventions and caesarean deliveries.

PMID:39689388 | DOI:10.1016/j.ejogrb.2024.12.014

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Placenta-derived biomaterials vs. standard care in chronic diabetic foot ulcer healing: A systematic review and meta-analysis

Diabetes Metab Syndr. 2024 Dec 10;19(1):103170. doi: 10.1016/j.dsx.2024.103170. Online ahead of print.

ABSTRACT

INTRODUCTION: This study explored the effectiveness of current placenta-derived biomaterials therapies in ulcer healing in DFU compared to standard of care (SOC).

METHODS: The systematic review and meta-analysis were performed following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) standard. The electronic databases of PubMed, EMBASE, and Web of Science (WoS) internet were searched for the outcome rate of complete ulcer healing. The risk of bias assessment was conducted using the tool recommended by the Cochrane Collaboration. Statistical analysis included the individual and combined result of the studies, heterogeneity test, the effect size, sensitivity analysis, and publication bias tests.

RESULTS: Twelve randomized controlled trials (RCTs) with a total of 833 patients were included in this study. This meta-analysis showed a higher rate of complete ulcer healing in groups receiving placenta-derived biomaterials therapies (OR = 6.247 [4.425, 8.819], p < 0.01, I2 = 41 %) compared to control groups.

CONCLUSION: Placenta-derived biomaterials therapies have been shown to be more effective for achieving complete ulcer healing compared to current conventional treatments in DFU.

IMPLICATIONS FOR CLINICAL PRACTICE: The utilization of placenta-derived biomaterials in therapies for wound healing, particularly in chronic DFU, presents promising implications for clinical practice. These biomaterials offer a rich source of growth factors, cytokines, and extracellular matrix components, which can stimulate tissue regeneration and angiogenesis. Incorporating such therapies into clinical practice holds the potential to accelerate wound closure, reduce infection rates, and improve overall healing outcomes in people with diabetic chronic foot ulcers. Furthermore, the availability of these biomaterials can offer clinicians a readily-accessible and cost-effective alternative to traditional wound care approaches, ultimately enhancing patient care and quality of life. This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

PMID:39689387 | DOI:10.1016/j.dsx.2024.103170

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Insights and Trends in Open Note Access: Retrospective Observational Study

J Med Internet Res. 2024 Dec 17;26:e55982. doi: 10.2196/55982.

ABSTRACT

BACKGROUND: As of 2021, at least 4 out of every 5 hospitals offered patients access to clinical notes via a web-based patient portal, a number that is expected to grow because of the 21st Century Cures Act. There is limited data on how open note use may have evolved over time or which types of clinical interactions were viewed most in the outpatient setting.

OBJECTIVE: This study aims to analyze trends in outpatient open note access over time; characterize usage in terms of age, sex, and clinical interaction type; and assess the method of access to help uncover areas of improvement in patient engagement and identify further areas of research.

METHODS: A retrospective observational study was conducted at Erie County Medical Center from November 1, 2021, to December 31, 2022, to coincide with the time that open notes went live. Outpatient note access and account logs were downloaded from the portal and combined into a single dataset consisting of 18,384 note accesses by 4615 users, with column headings of the patient index, sex, age, note title that was accessed, clinical interaction type, time stamp of note creation, time stamp of access, and method of access (web vs mobile). A separate table was created with sex data for all 35,273 portal accounts. Microsoft Excel and Microsoft Power Query were used to combine and analyze the data.

RESULTS: During the study period, 4615 portal users viewed 12,150 documents for a total of 18,384 times, averaging 2.6 notes per patient viewed 4 times. Only 13.1% (4615/35,273) of all portal inpatient and outpatient registrants viewed their outpatient notes. There was a female predominance in those who viewed notes (2926/4615, 63.4%; P<.001), while 56.8% (20,047/35,273) of all portal registrants were female. Users in their 30s and 50s accessed more notes than other age groups. The ratio of mobile-to-web access of notes tended to decrease as a function of increasing age, which was not observed in those aged ≥90 years. Notes regarding COVID-19 assessments were the most accessed among all clinical interactions (4725/12,150, 38.9%). Overall, the number of users accessing notes reached a maximum of 1968 before declining to 1027 by the end of the study period.

CONCLUSIONS: Open note access was largely dominated by COVID-19 assessments, and the number of users viewing their notes has declined over time as the pandemic subsided. Furthermore, female patients and those aged in their 30s as well as 50s viewed more notes than other groups. Finally, the percentage of notes viewed via a mobile device tended to decrease as a function of increasing age, showing that web-based access of open notes is an important modality for older patients.

PMID:39689311 | DOI:10.2196/55982

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Heuristics Identified in Health Data-Sharing Preferences of Patients With Cancer: Qualitative Focus Group Study

J Med Internet Res. 2024 Dec 17;26:e63155. doi: 10.2196/63155.

ABSTRACT

BACKGROUND: Evaluating precision oncology outcomes requires access to real-world and clinical trial data. Access is based on consent, and consent is based on patients’ informed preferences when deciding to share their data. Decision-making is often modeled using utility theory, but a complex decision context calls for a consideration of how heuristic, intuitive thought processes interact with rational utility maximization. Data-sharing decision-making has been studied using heuristic theory, but almost no heuristic research exists in the health data context. This study explores this evidence gap, applying a qualitative approach to probe for evidence of heuristic mechanisms behind the health data-sharing preferences of those who have experienced cancer. Exploring qualitative decision-making reveals the types of heuristics used and how they are related to the process of decision-making to better understand whether consent mechanisms should consider nonrational processes to better serve patient decision-making.

OBJECTIVE: This study aimed to explore how patients with cancer use heuristics when deciding whether to share their data for research.

METHODS: The researchers conducted a focus group study of Canadians who have experienced cancer. We recruited participants through an online advertisement, screening individuals based on their ability to increase demographic diversity in the sample. We reviewed the literature on data-sharing platforms to develop a semistructured topic guide on concerns about data sharing, incentives to share, and consent and control. Focus group facilitators led the open-ended discussions about data-sharing preferences that revealed underlying heuristics. Two qualitative analysts coded transcripts using a heuristic framework developed from a review of the literature. Transcripts were analyzed for heuristic instances which were grouped according to sociocultural categories. Using thematic analysis, the analysts generated reflexive themes through norming sessions and consultations.

RESULTS: A total of 3 focus groups were held with 19 participants in total. The analysis identified 12 heuristics underlying intentions to share data. From the thematic analysis, we identified how the heuristics of social norms and community building were expressed through altruism; the recognition, reputation, and authority heuristics led to (dis)trust in certain institutions; the need for security prompted the illusion of control and transparency heuristics; and the availability and affect heuristics influenced attitudes around risk and benefit. These thematic relationships all had impacts on the participants’ intentions to share their health data.

CONCLUSIONS: The findings provide a novel qualitative understanding of how health data-sharing decisions and preferences may be based on heuristic processing. As patients consider the extent of risks and benefits, heuristic processes influence their assessment of anticipated outcomes, which may not result in rational, truly informed consent. This study shows how considering heuristic processing when designing current consent mechanisms opens up the opportunity for more meaningful and realistic interactions with the complex decision-making context.

PMID:39689309 | DOI:10.2196/63155

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Hepatitis B Virus Exposure, Seroprotection Status, and Susceptibility in Health Care Workers From Lao People’s Democratic Republic: Cross-Sectional Study

JMIR Public Health Surveill. 2024 Dec 17;10:e65093. doi: 10.2196/65093.

ABSTRACT

BACKGROUND: Despite the high prevalence of chronic hepatitis B virus (HBV) infection in adults in Lao People’s Democratic Republic (Lao PDR), Lao health care workers (HCWs) have previously been shown to have low levels of protection against infection. Furthermore, the prevalence of hepatitis D virus (HDV), which increases disease severity in individuals infected with HBV, is not known in Lao PDR.

OBJECTIVE: This study aimed to estimate the exposure and seroprotection against HBV, as well as exposure to HDV, in Lao HCWs from 5 provinces.

METHODS: In 2020, a total of 666 HCWs aged 20 to 65 years from 5 provinces of Lao PDR were recruited, and their sera were tested by enzyme-linked immunosorbent assay to determine their HBV and HDV coinfection status.

RESULTS: HBV exposure, as indicated by the presence of anti-hepatitis B core antibodies, was 40.1% (267/666) overall and significantly higher for HCWs from Oudomxay province (21/31, 67.7%; adjusted odds ratio 3.69, 95% CI 1.68-8.12; P=.001). The prevalence of hepatitis B surface antigen was 5.4% (36/666) overall and increased with age, from 3.6% (9/248) in those aged ≤30 years to 6.8% (8/118) in those aged ≥50 years. Only 28.7% (191/666) of participants had serological indication of immunization. We could find no evidence for HDV exposure in this study.

CONCLUSIONS: The study found intermediate hepatitis B surface antigen prevalence among HCWs in Lao PDR, with no evidence of HDV coinfection. Notably, a significant proportion of HCWs remains susceptible to HBV, indicating a substantial gap in seroprotection against the disease.

PMID:39689257 | DOI:10.2196/65093