Category: Statistics

Pain Physician. 2023 Jul;26(4):E329-E340.

ABSTRACT

BACKGROUND: A diseased shoulder due to pain, stiffness, or weakness negatively affects patients’ quality of life and their ability to carry out activities of daily living. Adhesive capsulitis is a disease characterized by shoulder pain and global limitation of movement in the shoulder joint. Many interventions have been proposed for the treatment of primary adhesive capsulitis. The current study compares the effect of ultrasound-guided intraarticular injection of ozone versus steroid versus intraarticular application of pulsed radiofrequency.

OBJECTIVES: The primary outcome of the current study was to compare the improvement in the Visual Analog Scale (VAS) after the 3 treatment modalities. The secondary outcomes included functional improvement measured by the Shoulder Pain and Disability Index (SPADI) and level of inflammatory biomarkers measured by serum intercellular adhesion molecule (ICAM-1) and high-sensitivity C-reactive protein(hs-CRP).

STUDY DESIGN: The current study is a prospective, double blinded, randomized controlled trial. We employed a double blinding technique for both the patients and the outcome assessors.

SETTING: Our study was carried out at the Medical Research Institute, Alexandria University, Egypt, after approval of the local ethical committee (IORG0008812). The study was registered in the “clinical trials library for protocol registration and results system” with number NCT04724317.The study included 45 patients with a diagnosis of primary adhesive capsulitis.

METHODS: Patients were randomly assigned to 3 equal groups: steroid group, ozone group, and pulsed radiofrequency group. Pain and global shoulder functions were assessed using the VAS at rest and with movement, range of motion (ROM), and the SPADI. Moreover, ICAM-1 and hs-CRP were measured as inflammatory markers.

RESULTS: The results of the current study reveal that all patients in all groups have had a statistically significant improvement after their intervention regarding pain, disability, ROM, and inflammatory markers. Pairwise comparisons revealed that improvement of the VAS during movement had a statistically significant improvement starting from the second week and continuing to the fourth and eighth week. VAS during rest had a significant improvement starting from follow-up week one in the steroid group. Moreover, improvement in the ROM and SPADI scores started from the second week follow-up. Percent improvement was calculated for each group and there was a statistically significant difference between groups in VAS at rest and ROM in the pulsed radiofrequency group compared to the steroid group.Regarding inflammatory markers, both ICAM-1 and hs-CRP had a significant improvement after all 3 interventions with no statistically significant difference among the groups.

LIMITATIONS: This study is a single-center study. A shortage of previously published data, and heterogeneity in the published methodology of the 3 interventions limited our discussion data for comparison with the previous literature.

CONCLUSION: Ultrasound-guided shoulder joint intraarticular injection of steroid, ozone, or pulsed radiofrequency application all result in a significant improvement in pain, disability, and ROM in primary adhesive capsulitis. They can be used as an effective treatment modality for this condition. Comparing groups statistically, the pulsed radiofrequency group had a more delayed, but statistically better long-term improvement compared to the other 2 groups.

PMID:37535775

Pain Physician. 2023 Jul;26(4):357-367.

ABSTRACT

BACKGROUND: Postoperative pain after hip arthroscopy remains a major cause of patient dissatisfaction in the immediate postoperative period. Adequate postoperative analgesia is associated with increased patient satisfaction, earlier mobilization, and decreased opioid consumption.

OBJECTIVES: Therefore, there is a need for safe, reliable, and opioid- and motor-sparing methods of achieving postoperative analgesia following hip arthroscopy. We evaluated the efficacy of pericapsular nerve group (PENG) block vs fascia iliaca block (FIB) in reducing postoperative pain and analgesic consumption in the first 24 hours following hip arthroscopy.

STUDY DESIGN: A prospective randomized double-blinded control clinical trial.

SETTING: At the arthroscopy unit of the orthopedic department of Assiut University Hospitals, Assiut, Egypt from 2019 to 2022.

METHODS: Forty-three patients comprising 18 women and 25 men scheduled for hip arthroscopy were randomized to receive a preoperative block with PENG or FIB from March 2019 to March 2022. The mean age was 27.9 years (standard deviation [SD], 6.2 years; range, 18-42 years) and the mean body mass index was 25.13 kg/m2 (SD, 5.08 kg/m2). Patients were randomized into 2 groups: group A comprising 20 patients that received FIB; and group B comprising 23 patients that received PENG block. The efficacies of FIB and PENG block were evaluated using Visual Analog Scale scores.

RESULTS: Statistically significant differences in median pain scores and mean at rest pain scores were observed between the 2 groups at all measured time points following surgery (i.e., 6, 12, 18, and 24 hours). Further, dynamic pain scores (with hip flexion) scores significantly differed between the 2 groups at 24 hours postoperatively (P = 0.001). PENG block significantly decreased postoperative opioid use compared to FIB. Total opioid use in the 24-hour postoperative period was lower in the PENG group compared to the FIB group (16.5 ± 9.9 vs 27.5 ± 9.6; P < 005).

LIMITATIONS: Different hip pathologies and different interventions lead to different outcomes. Also, a larger sample size and longer follow-up duration are required.

CONCLUSIONS: PENG block may represent the ideal regional anesthesia modality for hip arthroscopy as an alternative to more conventional regional nerve blocks, such as FIB, femoral nerve block, and lumbar plexus block. PENG block is reproducible, easily performed in the preoperative setting, and appears to spare motor function while providing prolonged sensory analgesia.

PMID:37535774

Pain Physician. 2023 Jul;26(4):347-355.

ABSTRACT

BACKGROUND: The efficacy and its associated predictors of transforaminal epidural steroid injection (TFESI) in elderly patients with lumbar radiculopathy are unknown.

OBJECTIVE: The purpose of this retrospective study was to identify the efficacy of TFESI in elderly patients with lumbar radiculopathy and its associated predictors of long-term outcomes.

STUDY DESIGN: Retrospective study.

SETTING: Interventional pain clinics in West China Hospital of Sichuan University.

METHODS: In total, 294 elderly patients who were diagnosed with lumbar radiculopathy and underwent transforaminal epidural steroid injections from January 2019 through January 2022 were retrospectively analyzed. Demographic, clinical, magnetic resonance imaging, and TFESI-related information was collected to assess the predictive factors of long-term outcomes of the TFESI. Pain scores were assessed using the Numeric Rating Scale. Treatment success was defined as a >= 50% reduction in pain scores at 6 months.

RESULTS: Multivariate logistic regression analysis revealed that the duration of symptoms, immediate postoperative response, and neutrophilic granulocyte percentage were independently associated with a favorable response to TFESI. In addition, the level of pain at the initial visit and the number of TFESI performed were also associated with a good response in the multivariate regression analysis, even though the association was not statistically significant.

LIMITATIONS: Approximately 6% of the patients were lost to follow-up; therefore, selection bias may have slightly influenced our findings. In addition, our patients were not compared with a control population, and consequently, a placebo effect could not be assessed.

CONCLUSION: This study revealed that a short duration of symptoms, good immediate postoperative response and high neutrophilic granulocyte percentage were long-term predictors of a good response to TFESI in elderly patients with lumbar radiculopathy.

PMID:37535773

PLoS Comput Biol. 2023 Aug 3;19(8):e1011130. doi: 10.1371/journal.pcbi.1011130. eCollection 2023 Aug.

ABSTRACT

Over the past 40 years, there has been a strong focus on the development of mathematical models of angiogenesis, while developmental remodelling has received little such attention from the mathematical community. Sprouting angiogenesis can be seen as a very crude way of laying out a primitive vessel network (the raw material), while remodelling (understood as pruning of redundant vessels, diameter control, and the establishment of vessel identity and hierarchy) is the key to turning that primitive network into a functional network. This multiscale problem is of prime importance in the development of a functional vasculature. In addition, defective remodelling (either during developmental remodelling or due to a reactivation of the remodelling programme caused by an injury) is associated with a significant number of diseases. In this review, we discuss existing mathematical models of developmental remodelling and explore the important contributions that these models have made to the field of vascular development. These mathematical models are effectively used to investigate and predict vascular development and are able to reproduce experimentally observable results. Moreover, these models provide a useful means of hypothesis generation and can explain the underlying mechanisms driving the observed structural and functional network development. However, developmental vascular remodelling is still a relatively new area in mathematical biology, and many biological questions remain unanswered. In this review, we present the existing modelling paradigms and define the key challenges for the field.

PMID:37535698 | DOI:10.1371/journal.pcbi.1011130

PLoS One. 2023 Aug 3;18(8):e0289557. doi: 10.1371/journal.pone.0289557. eCollection 2023.

ABSTRACT

INTRODUCTION: Several important human pathogens that cause life-threatening infections are asymptomatically carried in the Nasopharynx/Oropharynx (NP/OP). DNA extraction is a prerequisite for most culture-independent techniques used to identify pathogens in the NP/OP. However, components of DNA extraction kits differ thereby giving rise to differences in performance. We compared the DNA concentration and the detection of three pathogens in the NP/OP using the discontinued DNeasy PowerSoil Kit (Kit DP) and the DNeasy PowerLyzer PowerSoil Kit (Kit DPP).

METHODS: DNA was extracted from the same set of 103 NP/OP samples using the two kits. DNA concentration was measured using the Qubit 2.0 Fluorometer. Real-time Polymerase Chain reaction (RT-PCR) was done using the QuantStudio 7-flex system to detect three pathogens: S. pneumoniae, H. influenzae, and N. meningitidis. Bland-Altman statistics and plots were used to determine the threshold cycle (Ct) value agreement for the two kits.

RESULTS: The average DNA concentration from kit DPP was higher than Kit DP; 1235.6 ng/ml (SD = 1368.3) vs 884.9 ng/ml (SD = 1095.3), p = 0.002. Using a Ct value cutoff of 40 for positivity, the concordance for the presence of S. pneumoniae was 82% (84/102); 94%(96/103) for N. meningitidis and 92%(95/103) for H. influenzae. Kit DP proportionately resulted in higher Ct values than Kit DPP for all pathogens. The Ct value bias of measurement for S. pneumoniae was +2.4 (95% CI, 1.9-3.0), +1.4 (95% CI, 0.9-1.9) for N. meningitidis and +1.4 (95% CI, 0.2-2.5) for H. influenzae.

CONCLUSION: The higher DNA concentration obtained using kit DPP could increase the chances of recovering low abundant bacteria. The PCR results were reproducible for more than 90% of the samples for the gram-negative H. influenzae and N. meningitidis. Ct value variations of the kits must be taken into consideration when comparing studies that have used the two kits.

PMID:37535692 | DOI:10.1371/journal.pone.0289557

PLoS One. 2023 Aug 3;18(8):e0288203. doi: 10.1371/journal.pone.0288203. eCollection 2023.

ABSTRACT

AIM: We aimed to perform a meta-analysis to find out whether PCT and MDW could be used as accurate diagnostic markers for sepsis.

METHODS: We searched PUBMED, WOS, and SCOPUS databases. Inclusion criteria were any observational or clinical trials that compared monocyte Distribution Width [MDW] with Procalcitonin [PCT] as diagnostic markers in a patient with sepsis. Case reports, editorials, conference abstracts, and animal studies were excluded. RevMan software [5.4] was used to perform the meta-analysis.

RESULTS: After the complete screening, 5 observational studies were included in the meta-analysis. The total number of patients included in the meta-analysis in the sepsis group is 565 and 781 in the control group. The pooled analysis between the sepsis group and controls showed a statistically significant association between sepsis and increased levels of MDW and PCT [MD = 3.94, 95% CI = 2.53 to 5.36, p-value < 0.00001] and [MD = 9.29, 95% CI = 0.67 to 17.91, p-value = 0.03] respectively. Moreover, the subgroup analysis showed that the p-value of MDW levels [< 0.00001] is more significant than the p-value of PCT levels = 0.03, the p-value between the two subgroups [< 0.00001]. Additionally, the overall ROC Area for MDW [0.790] > the overall ROC Area for PCT [0.760].

CONCLUSION: Our study revealed a statistically significant association between sepsis and increased MDW and PCT levels compared with controls and the overall ROC Area for MDW is higher than the overall ROC Area for PCT, indicating that the diagnostic accuracy of MDW is higher than PCT.MDW can be used as a diagnostic marker for sepsis patients in the emergency department. More multicenter studies are needed to support our findings.

PMID:37535683 | DOI:10.1371/journal.pone.0288203

PLoS Med. 2023 Aug 3;20(8):e1004266. doi: 10.1371/journal.pmed.1004266. Online ahead of print.

ABSTRACT

BACKGROUND: The optimal approach to prevent preterm birth (PTB) in twins has not been fully established yet. Recent evidence suggests that placement of cervical cerclage in twin pregnancies with short cervical length at ultrasound or cervical dilatation at physical examination might be associated with a reduced risk of PTB. However, such evidence is based mainly on small studies thus questioning the robustness of these findings. The aim of this systematic review was to determine the role of cervical cerclage in preventing PTB and adverse maternal or perinatal outcomes in twin pregnancies.

METHODS AND FINDINGS: Key databases searched and date of last search: MEDLINE, Embase, and CINAHL were searched electronically on 20 April 2023. Eligibility criteria: Inclusion criteria were observational studies assessing the risk of PTB among twin pregnancies undergoing cerclage versus no cerclage and randomized trials in which twin pregnancies were allocated to cerclage for the prevention of PTB or to a control group (e.g., placebo or treatment as usual). The primary outcome was PTB <34 weeks of gestation. The secondary outcomes were PTB <37, 32, 28, 24 weeks of gestation, gestational age at birth, the interval between diagnosis and birth, preterm prelabor rupture of the membranes (pPROM), chorioamnionitis, perinatal loss, and perinatal morbidity. Subgroup analyses according to the indication for cerclage (short cervical length or cervical dilatation) were also performed. Risk of bias assessment: The risk of bias of the included randomized controlled trials (RCTs) was assessed using the Revised Cochrane risk-of-bias tool for randomized trials, while that of the observational studies using the Newcastle-Ottawa scale (NOS). Statistical analysis: Summary risk ratios (RRs) of the likelihood of detecting each categorical outcome in exposed versus unexposed women, and (b) summary mean differences (MDs) between exposed and unexposed women (for each continuous outcome), with their 95% confidence intervals (CIs) were computed using head-to-head meta-analyses. Synthesis of the results: Eighteen studies (1,465 twin pregnancies) were included. Placement of cervical cerclage in women with a twin pregnancy with a short cervix at ultrasound or cervical dilatation at physical examination was associated with a reduced risk of PTB <34 weeks of gestation (RR: 0.73, 95% CI [0.59, 0.91], p = 0.005 corresponding to a 16% difference in the absolute risk, AR), <32 (RR: 0.69, 95% CI [0.57, 0.84], p < 0.001; AR: 16.92%), <28 (RR: 0.54, 95% [CI 0.43, 0.67], 0.001; AR: 18.29%), and <24 (RR: 0.48, 95% CI [0.23, 0.97], p = 0.04; AR: 15.57%) weeks of gestation and a prolonged gestational age at birth (MD: 2.32 weeks, 95% [CI 0.99, 3.66], p < 0.001). Cerclage in twin pregnancy with short cervical length or cervical dilatation was also associated with a reduced risk of perinatal loss (RR: 0.38, 95% CI [0.25, 0.60], p < 0.001; AR: 19.62%) and composite adverse outcome (RR: 0.69, 95% CI [0.53, 0.90], p = 0.007; AR: 11.75%). Cervical cerclage was associated with a reduced risk of PTB <34 weeks both in women with cervical length <15 mm (RR: 0.74, 95% CI [0.58, 0.95], p = 0.02; AR: 29.17%) and in those with cervical dilatation (RR: 0.68, 95% CI [0.57, 0.80], p < 0.001; AR: 35.02%). The association between cerclage and prevention of PTB and adverse perinatal outcomes was exclusively due to the inclusion of observational studies. The quality of retrieved evidence at GRADE assessment was low.

CONCLUSIONS: Emergency cerclage for cervical dilation or short cervical length <15 mm may be potentially associated with a reduction in PTB and improved perinatal outcomes. However, these findings are mainly based upon observational studies and require confirmation in large and adequately powered RCTs.

PMID:37535682 | DOI:10.1371/journal.pmed.1004266

JMIR Hum Factors. 2023 Aug 3;10:e48270. doi: 10.2196/48270.

ABSTRACT

BACKGROUND: Mobility is a meaningful aspect of an individual’s health whose quantification can provide clinical insights. Wearable sensor technology can quantify walking behaviors (a key aspect of mobility) through continuous passive monitoring.

OBJECTIVE: Our objective was to characterize the analytical performance (accuracy and reliability) of a suite of digital measures of walking behaviors as critical aspects in the practical implementation of digital measures into clinical studies.

METHODS: We collected data from a wrist-worn device (the Verily Study Watch) worn for multiple days by a cohort of volunteer participants without a history of gait or walking impairment in a real-world setting. On the basis of step measurements computed in 10-second epochs from sensor data, we generated individual daily aggregates (participant-days) to derive a suite of measures of walking: step count, walking bout duration, number of total walking bouts, number of long walking bouts, number of short walking bouts, peak 30-minute walking cadence, and peak 30-minute walking pace. To characterize the accuracy of the measures, we examined agreement with truth labels generated by a concurrent, ankle-worn, reference device (Modus StepWatch 4) with known low error, calculating the following metrics: intraclass correlation coefficient (ICC), Pearson r coefficient, mean error, and mean absolute error. To characterize the reliability, we developed a novel approach to identify the time to reach a reliable readout (time to reliability) for each measure. This was accomplished by computing mean values over aggregation scopes ranging from 1 to 30 days and analyzing test-retest reliability based on ICCs between adjacent (nonoverlapping) time windows for each measure.

RESULTS: In the accuracy characterization, we collected data for a total of 162 participant-days from a testing cohort (n=35 participants; median observation time 5 days). Agreement with the reference device-based readouts in the testing subcohort (n=35) for the 8 measurements under evaluation, as reflected by ICCs, ranged between 0.7 and 0.9; Pearson r values were all greater than 0.75, and all reached statistical significance (P<.001). For the time-to-reliability characterization, we collected data for a total of 15,120 participant-days (overall cohort N=234; median observation time 119 days). All digital measures achieved an ICC between adjacent readouts of >0.75 by 16 days of wear time.

CONCLUSIONS: We characterized the accuracy and reliability of a suite of digital measures that provides comprehensive information about walking behaviors in real-world settings. These results, which report the level of agreement with high-accuracy reference labels and the time duration required to establish reliable measure readouts, can guide the practical implementation of these measures into clinical studies. Well-characterized tools to quantify walking behaviors in research contexts can provide valuable clinical information about general population cohorts and patients with specific conditions.

PMID:37535417 | DOI:10.2196/48270

JMIR Res Protoc. 2023 Aug 3;12:e48128. doi: 10.2196/48128.

ABSTRACT

BACKGROUND: Emergency department (ED) providers are important collaborators in preventing falls for older adults because they are often the first health care providers to see a patient after a fall and because at-home falls are often preceded by previous ED visits. Previous work has shown that ED referrals to falls interventions can reduce the risk of an at-home fall by 38%. Screening patients at risk for a fall can be time-consuming and difficult to implement in the ED setting. Machine learning (ML) and clinical decision support (CDS) offer the potential of automating the screening process. However, it remains unclear whether automation of screening and referrals can reduce the risk of future falls among older patients.

OBJECTIVE: The goal of this paper is to describe a research protocol for evaluating the effectiveness of an automated screening and referral intervention. These findings will inform ongoing discussions about the use of ML and artificial intelligence to augment medical decision-making.

METHODS: To assess the effectiveness of our program for patients receiving the falls risk intervention, our primary analysis will be to obtain referral completion rates at 3 different EDs. We will use a quasi-experimental design known as a sharp regression discontinuity with regard to intent-to-treat, since the intervention is administered to patients whose risk score falls above a threshold. A conditional logistic regression model will be built to describe 6-month fall risk at each site as a function of the intervention, patient demographics, and risk score. The odds ratio of a return visit for a fall and the 95% CI will be estimated by comparing those identified as high risk by the ML-based CDS (ML-CDS) and those who were not but had a similar risk profile.

RESULTS: The ML-CDS tool under study has been implemented at 2 of the 3 EDs in our study. As of April 2023, a total of 1326 patient encounters have been flagged for providers, and 339 unique patients have been referred to the mobility and falls clinic. To date, 15% (45/339) of patients have scheduled an appointment with the clinic.

CONCLUSIONS: This study seeks to quantify the impact of an ML-CDS intervention on patient behavior and outcomes. Our end-to-end data set allows for a more meaningful analysis of patient outcomes than other studies focused on interim outcomes, and our multisite implementation plan will demonstrate applicability to a broad population and the possibility to adapt the intervention to other EDs and achieve similar results. Our statistical methodology, regression discontinuity design, allows for causal inference from observational data and a staggered implementation strategy allows for the identification of secular trends that could affect causal associations and allow mitigation as necessary.

TRIAL REGISTRATION: ClinicalTrials.gov NCT05810064; https://www.clinicaltrials.gov/study/NCT05810064.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/48128.

PMID:37535416 | DOI:10.2196/48128

JAMA Otolaryngol Head Neck Surg. 2023 Aug 3. doi: 10.1001/jamaoto.2023.1939. Online ahead of print.

ABSTRACT

IMPORTANCE: Current olfactory neuroblastoma (ONB) staging systems inadequately delineate locally advanced tumors, do not incorporate tumor grade, and poorly estimate survival and recurrence.

OBJECTIVE: The primary aims of this study were to (1) examine the clinical covariates associated with survival and recurrence of ONB in a modern-era multicenter cohort and (2) incorporate Hyams tumor grade into existing staging systems to assess its ability to estimate survival and recurrence.

DESIGN, SETTING, AND PARTICIPANTS: This retrospective, multicenter, case-control study included patients with ONB who underwent treatment between January 1, 2005, and December 31, 2021, at 9 North American academic medical centers.

INTERVENTION: Standard-of-care ONB treatment.

MAIN OUTCOME AND MEASURES: The main outcomes were overall survival (OS), disease-free survival (DFS), and disease-specific survival (DSS) as C statistics for model prediction.

RESULTS: A total of 256 patients with ONB (mean [SD] age, 52.0 [15.6] years; 115 female [44.9%]; 141 male [55.1%]) were included. The 5-year rate for OS was 83.5% (95% CI, 78.3%-89.1%); for DFS, 70.8% (95% CI, 64.3%-78.0%); and for DSS, 94.1% (95% CI, 90.5%-97.8%). On multivariable analysis, age, American Joint Committee on Cancer (AJCC) stage, involvement of bilateral maxillary sinuses, and positive margins were associated with OS. Only AJCC stage was associated with DFS. Only N stage was associated with DSS. When assessing the ability of staging systems to estimate OS, the best-performing model was the novel modification of the Dulguerov system (C statistic, 0.66; 95% CI, 0.59-0.76), and the Kadish system performed most poorly (C statistic, 0.57; 95% CI, 0.50-0.63). Regarding estimation of DFS, the modified Kadish system performed most poorly (C statistic, 0.55; 95% CI, 0.51-0.66), while the novel modification of the AJCC system performed the best (C statistic, 0.70; 95% CI, 0.66-0.80). Regarding estimation of DSS, the modified Kadish system was the best-performing model (C statistic, 0.79; 95% CI, 0.70-0.94), and the unmodified Kadish performed the worst (C statistic, 0.56; 95% CI, 0.51-0.68). The ability for novel ONB staging systems to estimate disease progression across stages was also assessed. In the novel Kadish staging system, patients with stage VI disease were approximately 7 times as likely to experience disease progression as patients with stage I disease (hazard ratio [HR], 6.84; 95% CI, 1.60-29.20). Results were similar for the novel modified Kadish system (HR, 8.99; 95% CI, 1.62-49.85) and the novel Dulguerov system (HR, 6.86; 95% CI, 2.74-17.18).

CONCLUSIONS AND RELEVANCE: The study findings indicate that 5-year OS for ONB is favorable and that incorporation of Hyams grade into traditional ONB staging systems is associated with improved estimation of disease progression.

PMID:37535372 | DOI:10.1001/jamaoto.2023.1939