Tag: pubmed

JMIR Med Inform. 2022 Apr 20;10(4):e28696. doi: 10.2196/28696.

ABSTRACT

BACKGROUND: Clinical trials are the gold standard for advancing medical knowledge and improving patient outcomes. For their success, an appropriately sized cohort is required. However, patient recruitment remains one of the most challenging aspects of clinical trials. Information technology (IT) support systems-for instance, patient recruitment systems-may help overcome existing challenges and improve recruitment rates, when customized to the user needs and environment.

OBJECTIVE: The goal of our study is to describe the status quo of patient recruitment processes and to identify user requirements for the development of a patient recruitment system.

METHODS: We conducted a web-based survey with 56 participants as well as semistructured interviews with 33 participants from 10 German university hospitals.

RESULTS: We here report the recruitment procedures and challenges of 10 university hospitals. The recruitment process was influenced by diverse factors such as the ward, use of software, and the study inclusion criteria. Overall, clinical staff seemed more involved in patient identification, while the research staff focused on screening tasks. Ad hoc and planned screenings were common. Identifying eligible patients was still associated with significant manual efforts. The recruitment staff used Microsoft Office suite because tailored software were not available. To implement such software, data from disparate sources will need to be made available. We discussed concrete technical challenges concerning patient recruitment systems, including requirements for features, data, infrastructure, and workflow integration, and we contributed to the support of developing a successful system.

CONCLUSIONS: Identifying eligible patients is still associated with significant manual efforts. To fully make use of the high potential of IT in patient recruitment, many technical and process challenges have to be solved first. We contribute and discuss concrete technical challenges for patient recruitment systems, including requirements for features, data, infrastructure, and workflow integration.

PMID:35442203 | DOI:10.2196/28696

JMIR Med Inform. 2022 Apr 20;10(4):e33395. doi: 10.2196/33395.

ABSTRACT

BACKGROUND: As a major health hazard, the incidence of coronary heart disease has been increasing year by year. Although coronary revascularization, mainly percutaneous coronary intervention, has played an important role in the treatment of coronary heart disease, major adverse cardiovascular events (MACE) such as recurrent or persistent angina pectoris after coronary revascularization remain a very difficult problem in clinical practice.

OBJECTIVE: Given the high probability of MACE after coronary revascularization, the aim of this study was to develop and validate a predictive model for MACE occurrence within 6 months based on machine learning algorithms.

METHODS: A retrospective study was performed including 1004 patients who had undergone coronary revascularization at The People’s Hospital of Liaoning Province and Affiliated Hospital of Liaoning University of Traditional Chinese Medicine from June 2019 to December 2020. According to the characteristics of available data, an oversampling strategy was adopted for initial preprocessing. We then employed six machine learning algorithms, including decision tree, random forest, logistic regression, naïve Bayes, support vector machine, and extreme gradient boosting (XGBoost), to develop prediction models for MACE depending on clinical information and 6-month follow-up information. Among all samples, 70% were randomly selected for training and the remaining 30% were used for model validation. Model performance was assessed based on accuracy, precision, recall, F1-score, confusion matrix, area under the receiver operating characteristic (ROC) curve (AUC), and visualization of the ROC curve.

RESULTS: Univariate analysis showed that 21 patient characteristic variables were statistically significant (P<.05) between the groups without and with MACE. Coupled with these significant factors, among the six machine learning algorithms, XGBoost stood out with an accuracy of 0.7788, precision of 0.8058, recall of 0.7345, F1-score of 0.7685, and AUC of 0.8599. Further exploration of the models to identify factors affecting the occurrence of MACE revealed that use of anticoagulant drugs and course of the disease consistently ranked in the top two predictive factors in three developed models.

CONCLUSIONS: The machine learning risk models constructed in this study can achieve acceptable performance of MACE prediction, with XGBoost performing the best, providing a valuable reference for pointed intervention and clinical decision-making in MACE prevention.

PMID:35442202 | DOI:10.2196/33395

JMIR Aging. 2022 Apr 20;5(2):e35075. doi: 10.2196/35075.

ABSTRACT

BACKGROUND: eHealth technologies for self-management can improve quality of life, but little is known about whether the benefits gained outweigh their costs. The electronic patient-reported outcome (ePRO) mobile app and portal system supports patients with multiple chronic conditions to collaborate with primary health care providers to set and monitor health-related goals.

OBJECTIVE: This study aims to estimate the cost of ePRO and the cost utility of the ePRO intervention compared with usual care provided to patients with multiple chronic conditions and complex needs living in the community, from the perspective of the publicly funded health care payer in Ontario, Canada.

METHODS: We developed a decision tree model to estimate the incremental cost per quality-adjusted life year (QALY) gained for the ePRO tool versus usual care over a time horizon of 15 months. Resource utilization and effectiveness of the ePRO tool were drawn from a randomized clinical trial with 6 family health teams involving 45 participants. Unit costs associated with health care utilization (adjusted to 2020 Canadian dollars) were drawn from literature and publicly available sources. A series of sensitivity analyses were conducted to assess the robustness of the findings.

RESULTS: The total cost of the ePRO tool was CAD $79,467 (~US $ 63,581; CAD $1733 [~US $1386] per person). Compared with standard care, the ePRO intervention was associated with higher costs (CAD $1710 [~US $1368]) and fewer QALYs (-0.03). The findings were consistent with the clinical evidence, suggesting no statistical difference in health-related quality of life between ePRO and usual care groups. However, the tool would be considered a cost-effective option if it could improve by at least 0.03 QALYs. The probability that the ePRO is cost-effective was 17.3% at a willingness-to-pay (WTP) threshold of CAD $50,000 (~US $40,000)/QALY.

CONCLUSIONS: The ePRO tool is not a cost-effective technology at the commonly used WTP value of CAD $50,000 (~US $40,000)/QALY, but long-term and the societal impacts of ePRO were not included in this analysis. Further research is needed to better understand its impact on long-term outcomes and in real-world settings. The present findings add to the growing evidence about eHealth interventions’ capacity to respond to complex aging populations within finite-resourced health systems.

TRIAL REGISTRATION: ClinicalTrials.gov NCT02917954; https://clinicaltrials.gov/ct2/show/NCT02917954.

PMID:35442194 | DOI:10.2196/35075

JMIR Ment Health. 2022 Apr 20;9(4):e21208. doi: 10.2196/21208.

ABSTRACT

BACKGROUND: Patient-controlled granular information sharing (PC-GIS) allows a patient to select specific health information “granules,” such as diagnoses and medications; choose with whom the information is shared; and decide how the information can be used. Previous studies suggest that health professionals have mixed or concerned opinions about the process and impact of PC-GIS for care and research. Further understanding of behavioral health professionals’ views on PC-GIS are needed for successful implementation and use of this technology.

OBJECTIVE: The aim of this study was to evaluate changes in health professionals’ opinions on PC-GIS before and after a demonstrative case study.

METHODS: Four focus groups were conducted at two integrated health care facilities: one serious mental illness facility and one general behavioral health facility. A total of 28 participants were given access to outcomes of a previous study where patients had control over medical record sharing. Participants were surveyed before and after focus groups on their views about PC-GIS. Thematic analysis of focus group output was paired with descriptive statistics and exploratory factor analysis of surveys.

RESULTS: Behavioral health professionals showed a significant opinion shift toward concern after the focus group intervention, specifically on the topics of patient understanding (P=.001), authorized electronic health record access (P=.03), patient-professional relationship (P=.006), patient control acceptance (P<.001), and patient rights (P=.02). Qualitative methodology supported these results. The themes of professional considerations (2234/4025, 55.5% of codes) and necessity of health information (260/766, 33.9%) identified key aspects of PC-GIS concerns.

CONCLUSIONS: Behavioral health professionals agreed that a trusting patient-professional relationship is integral to the optimal implementation of PC-GIS, but were concerned about the potential negative impacts of PC-GIS on patient safety and quality of care.

PMID:35442199 | DOI:10.2196/21208

Microb Genom. 2022 Apr;8(4). doi: 10.1099/mgen.0.000675.

ABSTRACT

A hospital outbreak of carbapenem-resistant Enterobacterales was detected by routine surveillance. Whole genome sequencing and subsequent analysis revealed a conserved promiscuous bla _OXA-48 carrying plasmid as the defining factor within this outbreak. Four different species of Enterobacterales were involved in the outbreak. Escherichia coli ST399 accounted for 35 of all the 55 isolates. Comparative genomics analysis using publicly available E. coli ST399 genomes showed that the outbreak E. coli ST399 isolates formed a unique clade. We developed a mathematical model of pOXA-48-like plasmid transmission between host lineages and used it to estimate its conjugation rate, giving a lower bound of 0.23 conjugation events per lineage per year. Our analysis suggests that co-evolution between the pOXA-48-like plasmid and E. coli ST399 could have played a role in the outbreak. This is the first study to report carbapenem-resistant E. coli ST399 carrying blaOXA-48 as the main cause of a plasmid-borne outbreak within a hospital setting. Our findings suggest complementary roles for both plasmid conjugation and clonal expansion in the emergence of this outbreak.

PMID:35442183 | DOI:10.1099/mgen.0.000675

Hemodial Int. 2022 Apr 19. doi: 10.1111/hdi.13014. Online ahead of print.

ABSTRACT

BACKGROUND: Home hemodialysis (HHD) remains underused in patients with kidney failure. Current literature on HHD mostly originates from non-European countries, making generalization difficult. The present study describes patients’ profile and practice patterns from a Belgian HHD center, and assesses patient and technique survival and complications associated with HHD.

METHODS: We analyzed data from all our incident patients during a 6-year period. The patient’s characteristics were summarized using descriptive statistics. Transition to another therapeutic modality, estimated using a risk model with death and transplantation as competing events, episodes of respite cares and hospitalizations, and access complications were analyzed.

RESULTS: Eighty patients (mean age: 47 years; male: 64%) met the inclusion criteria. Fifty-one percent of patients initiated dialysis with a central venous catheter (CVC) and 96% were not assisted. Arterio-venous fistula (AVF) cannulation was performed using buttonhole technique. Standard-frequent HD (47%) and short-frequent low-flow dialysate HD (34%) were mostly used at HHD initiation. Cumulative incidences of technique failure and death were 15%, 24%, and 32% at 1, 2, and 5 years. Incidence rates for respite dialysis and hospitalizations were 2.39 and 0.54 per patient-year of HHD. In comparison with AVF, incidence rate ratios of overall access complications and access-related infections for CVC were 4.3 (95% CI: 3.1-6, p < 0.01) and 4.4 (95% CI: 2.1-10, p < 0.01), respectively. Buttonhole cannulation was complicated by 0.26 (95% CI: 0.15-0.46) infections per 1000 AVF-days.

CONCLUSIONS: This present study provides important information about patient’s profile and practice patterns and safety in a cohort of 80 incident Belgian HHD patients, with encouraging techniques and patient survival.

PMID:35441473 | DOI:10.1111/hdi.13014

J Int AIDS Soc. 2022 Apr;25(4):e25895. doi: 10.1002/jia2.25895.

ABSTRACT

INTRODUCTION: HIV reservoirs and infected cells may persist in tissues with low concentrations of antiretrovirals (ARVs). Traditional pharmacology methods cannot assess variability in ARV concentrations within morphologically complex tissues, such as lymph nodes (LNs). We evaluated the distribution of six ARVs into LNs and the proximity of these ARVs to CD4⁺ T cells and cell-associated RT-SHIV viral RNA.

METHODS: Between December 2014 and April 2017, RT-SHIV infected (SHIV+; N = 6) and healthy (SHIV-; N = 6) male rhesus macaques received two selected four-drug combinations of six ARVs over 10 days to attain steady-state conditions. Serial cryosections of axillary LN were analysed by a multimodal imaging approach that combined mass spectrometry imaging (MSI) for ARV disposition, RNAscope in situ hybridization for viral RNA (vRNA) and immunohistochemistry for CD4⁺ T cell and collagen expression. Spatial relationships across these four imaging domains were investigated by nearest neighbour search on co-registered images using MATLAB.

RESULTS: Through MSI, ARV-dependent, heterogeneous concentrations were observed in different morphological LN regions, such as the follicles and medullary sinuses. After 5-6 weeks of infection, more limited ARV penetration into LN tissue relative to the blood marker heme was found in SHIV+ animals (SHIV+: 0.7 [0.2-1.4] mm; SHIV-: 1.3 [0.5-1.7] mm), suggesting alterations in the microcirculation. However, we found no detectable increase in collagen deposition. Regimen-wide maps of composite ARV distribution indicated that up to 27% of SHIV+ LN tissue area was not exposed to detectable ARVs. Regions associated with B cell follicles had median 1.15 [0.94-2.69] -fold reduction in areas with measurable drug, though differences were only statistically significant for tenofovir (p = 0.03). Median co-localization of drug with CD4⁺ target cells and vRNA varied widely by ARV (5.1-100%), but nearest neighbour analysis indicated that up to 10% of target cells and cell-associated vRNA were not directly contiguous to at least one drug at concentrations greater than the IC50 value.

CONCLUSIONS: Our investigation of the spatial distributions of drug, virus and target cells underscores the influence of location and microenvironment within LN, where a small population of T cells may remain vulnerable to infection and low-level viral replication during suppressive ART.

PMID:35441468 | DOI:10.1002/jia2.25895

Pediatr Blood Cancer. 2022 Apr 19:e29691. doi: 10.1002/pbc.29691. Online ahead of print.

ABSTRACT

BACKGROUND: CWS/RMS-96 was an international multicenter trial with randomization between two therapy arms of the standard four-drug therapy (vincristine, ifosfamide, adriamycin, dactinomycin [VAIA]) versus an intensified six-drug regimen (carboplatin, epirubicin, vincristine, dactinomycin, ifosfamide, and etoposide [CEVAIE]) for high-risk rhabdomyosarcoma (RMS), extraskeletal Ewing sarcoma (EES), and undifferentiated sarcoma (UDS) in children, adolescents, and young adults aiming to improve their survival. Intensified chemotherapy with CEVAIE did not improve outcome.

METHODS: Patients younger than 21 years with a previously untreated localized HR-RMS, EES, and UDS were enrolled from Cooperative Weichteilsarkom Studiengruppe (CWS) centers in Germany, Austria, Poland, Switzerland, and from Italian Soft Tissue Sarcoma Committee (STSC) centers. Randomization (1:1) to receive either 9 × 21 days cycles of VAIA or CEVAIE was performed separately in CWS and STSC. Hyperfractionated accelerated radiotherapy (32-44.8 Gy) was added at week 9-12 according to histology and response to chemotherapy. A secondary microscopically complete nonmutilating resection was performed if possible. Primary endpoints were response to chemotherapy, event-free (EFS) and overall survival (OS).

RESULTS: Five hundred fifty-seven patients (HR-RMS: n = 416, EES and UDS: n = 141) underwent randomization: VAIA (n = 273) or CEVAIE (n = 284). Radiotherapy was given to 70% of patients in both groups. A secondary resection was performed in 47% and 48% patients, respectively. The 5-year EFS and OS for the VAIA and CEVAIE treatment arms were 59.8% and 60.8% (p = .89), and 74.2% and 68.3% (p = .16), respectively. No differences in response, toxicity, or second malignancies emerged in the two groups.

CONCLUSION: The use of an intensified regimen failed to show a significant improvement in tumor response and outcome of patients with localized HR-RMS, EES, and UDS.

PMID:35441463 | DOI:10.1002/pbc.29691

Orthop Surg. 2022 Apr 19. doi: 10.1111/os.13237. Online ahead of print.

ABSTRACT

OBJECTIVE: To compare the clinical efficacy of posterior percutaneous endoscopic unilateral laminotomy (PPEUL) and anterior cervical decompression and fusion (ACDF) in the treatment of single-segment spondylotic myelopathy (CSM).

METHODS: This is a retrospective research, from January 2017 to December 2019, 30 cases were included in the PPEUL group and 32 cases were included in the ACDF group. The operative duration, blood loss, length of stay, complications, Japanese Orthopaedic Association (JOA) score, visual analogue scale (VAS) score, MacNab classification and imaging data were collected preoperatively, postoperative 1-week, final follow-up and statistically analyzed.

RESULTS: The surgery was completed successfully on all patients, and there were no serious complications, such as nerve or spinal cord injury or infection. In the PPEUL and ACDF groups, the operative duration were 56.63 ± 1.40 and 65.21 ± 2.45 min, the intraoperative blood loss were 51.69 ± 3.23 and 50.51 ± 5.48 mL, and the hospitalization duration was 5.75 ± 1.43 and 6.38 ± 2.16 days. The follow-up period in the PPEUL and ACDF groups was 24.96 ± 1.12 months and 25.65 ± 1.45 months, respectively. There was no significant difference in intraoperative blood loss between the two groups, but the hospitalization and operative durations in the PPEUL group were significantly shorter than those in the ACDF group (P < 0.05). The VAS scores at postoperative 1 week and final follow-up were significantly improved compared with those before surgery. The JOA scores at postoperative 1 week and final follow-up were significantly improved compared with those before surgery, but there was no significant difference between the two groups at the last follow-up. The intervertebral disc height of the adjacent segment at the last follow-up was significantly lower in the ACDF group than in the PPEUL group (P < 0.05), but there was no significant difference between the two groups in the intervertebral disc height of the surgical segment (P > 0.05). The rate of excellent and good results was 90.0% and 87.5%, respectively. Postoperative cervical CT and MRI showed that the spinal canal was fully decompressed and spinal cord compression was relieved.

CONCLUSION: PPEUL has the advantages of reduced trauma, rapid recovery and remarkable curative efficacy, so it is a new choice for the treatment of CSM.

PMID:35441460 | DOI:10.1111/os.13237

Ecol Appl. 2022 Apr 19:e2638. doi: 10.1002/eap.2638. Online ahead of print.

ABSTRACT

Information about how animal abundance varies across landscapes is needed to inform management action but is costly and time-consuming to obtain; surveys of a single population distributed over a large area can take years to complete. Surveys employing small, spatially replicated sampling units improve efficiency, but statistical estimators rely on assumptions that constrain survey design or become less reasonable as larger areas are sampled. Efficient methods that avoid assumptions about similarity of detectability or density among replicates are therefore appealing. Using simulations and data from >3500 black bears sampled on 73 independent study areas in Ontario, Canada, we (1) quantified bias induced by unmodelled spatial heterogeneity in detectability and density, (2) evaluated novel, design-based estimators of average density across replicate study areas, and (3) evaluated two estimators of the variance of average density across study areas: an analytic estimator that assumed an underlying homogeneous spatial Poisson point process for the distribution of animals’ activity centers, and an empirical estimator of variance across study areas. In simulations where detectability varied in space, assuming spatially constant detectability yielded density estimates that were negatively biased by 20 to 30%; estimating local detectability and density from local data and treating study areas as independent, equal replicates when estimating average density across study areas using the design-based estimator yielded unbiased estimates at local and landscape scales. Similarly, detectability of black bears varied among study areas and estimates of bear density at landscape scales were higher when no information was shared across study areas when estimating detectability. This approach also maximized precision (relative standard errors of estimates of average black bear density ranged from 7 to 18%) and computational efficiency. In simulations, the analytic variance estimator was robust to threefold variation in local densities but the empirical estimator performed poorly. Conducting multiple, similar SECR surveys and treating them as independent replicates during analyses allowed us to efficiently estimate density at multiple scales and extents while avoiding biases caused by pooling spatially heterogeneous data. This approach enables researchers to address a wide range of ecological or management-related questions and is applicable with most types of SECR data.

PMID:35441452 | DOI:10.1002/eap.2638