Category: Statistics

Worldviews Evid Based Nurs. 2023 Jun 27. doi: 10.1111/wvn.12665. Online ahead of print.

ABSTRACT

BACKGROUND: Weight management is an important part of disease management in patients with heart failure. However, the effectiveness of reported weight management interventions is inconclusive.

AIMS: The aim of this systematic review and meta-analysis was to assess the effects of weight management on functional status, heart failure-related hospitalizations, and all-cause mortality in patients with heart failure.

METHODS: PubMed, Web of Science, Embase, and the Cochrane Library were searched on April 3, 2022. This study was registered with PROSPERO (CRD42021283817). Eligible studies assessed functional status, heart failure-related hospitalizations, and all-cause mortality in patients with heart failure. Two researchers independently screened the articles, extracted data, and evaluated the risk bias of each study. Dichotomous variables were presented as OR with a 95% confidence interval (CI). The data were analyzed using a fixed effect or random effect model, and heterogeneity was determined using I² statistics. All statistical analyses were conducted using RevMan 5.3.

RESULTS: Among 4279 studies screened, seven randomized controlled trials were included in this study. The results showed that weight management significantly improved functional status (OR = 0.15, 95% CI [0.07, 0.35], I² = 52%) and reduced the risk of all-cause mortality (OR = 0.54, 95% CI [0.34, 0.85], I² = 0%), but had no significant effect on heart failure-related hospitalizations (OR = 0.72, 95% CI [0.20, 2.66]).

LINKING EVIDENCE TO ACTION: Weight management has effects on improved functional status and reduced all-cause mortality in patients with heart failure. It is necessary to strengthen the weight management interventions of patients with heart failure to improve patients’ functional status and reduce all-cause mortality.

PMID:37368482 | DOI:10.1111/wvn.12665

JMIR Public Health Surveill. 2023 Jun 27;9:e42149. doi: 10.2196/42149.

ABSTRACT

BACKGROUND: Health advocates and the media often use the rankings of the leading causes of death (CODs) to draw attention to health issues with relatively high mortality burdens in a population. The National Center for Health Statistics (NCHS) publishes “Deaths: leading causes” annually. The ranking list used by the NCHS and statistical offices in several countries includes broad categories such as cancer, heart disease, and accidents. However, the list used by the World Health Organization (WHO) subdivides broad categories (17 for cancer, 8 for heart disease, and 6 for accidents) and classifies Alzheimer disease and related dementias and hypertensive diseases more comprehensively compared to the NCHS list. Regarding the data visualization of the rankings of leading CODs, the bar chart is the most commonly used graph; nevertheless, bar charts may not effectively reveal the changes in the rankings over time.

OBJECTIVE: The aim of this study is to use a dashboard with bump charts to visualize the changes in the rankings of the leading CODs in the United States by sex and age from 1999 to 2021, according to 2 lists (NCHS vs WHO).

METHODS: Data on the number of deaths in each category from each list for each year were obtained from the Wide-ranging Online Data for Epidemiologic Research system, maintained by the Center for Disease Control and Prevention. Rankings were based on the absolute number of deaths. The dashboard enables users to filter by list (NCHS or WHO) and demographic characteristics (sex and age) and highlight a particular COD.

RESULTS: Several CODs that were only on the WHO list, including brain, breast, colon, hematopoietic, lung, pancreas, prostate, and uterus cancer (all classified as cancer on the NCHS list); unintentional transport injury; poisoning; drowning; and falls (all classified as accidents on the NCHS list), were among the 10 leading CODs in several sex and age subgroups. In contrast, several CODs that appeared among the 10 leading CODs according to the NCHS list, such as pneumonia, kidney disease, cirrhosis, and sepsis, were excluded from the 10 leading CODs if the WHO list was used. The rank of Alzheimer disease and related dementias and hypertensive diseases according to the WHO list was higher than their ranks according to the NCHS list. A marked increase in the ranking of unintentional poisoning among men aged 45-64 years was noted from 2008 to 2021.

CONCLUSIONS: A dashboard with bump charts can be used to improve the visualization of the changes in the rankings of leading CODs according to the WHO and NCHS lists as well as demographic characteristics; the visualization can help users make informed decisions regarding the most appropriate ranking list for their needs.

PMID:37368475 | DOI:10.2196/42149

J Med Internet Res. 2023 Jun 27;25:e42175. doi: 10.2196/42175.

ABSTRACT

BACKGROUND: Clinical research associates (CRAs) monitor the progress of a trial, verify the data collected, and ensure that the trial is carried out and reported in accordance with the trial protocol, standard operating procedures, and relevant laws and regulations. In response to monitoring challenges during the COVID-19 pandemic, Peking University Cancer Hospital launched a remote monitoring system and established a monitoring model, combining on-site and remote monitoring of clinical trials. Considering the increasing digitization of clinical trials, it is important to determine the optimal monitoring model for the general benefit of centers conducting clinical trials worldwide.

OBJECTIVE: We sought to summarize our practical experience of a hybrid model of remote and on-site monitoring of clinical trials and provide guidance for clinical trial monitoring management.

METHODS: We evaluated 201 trials conducted by our hospital that used on-site monitoring alone or a hybrid monitoring model, of which 91 trials used on-site monitoring alone (arm A) and 110 used a hybrid model of remote and on-site monitoring (arm B). We reviewed trial monitoring reports from June 20, 2021, to June 20, 2022, and used a customized questionnaire to collect and compare the following information: monitoring cost of trials in the 2 models as a sum of the CRAs’ transportation (eg, taxi fare and air fare), accommodation, and meal costs; differences in monitoring frequency; the number of monitored documents; and monitoring duration.

RESULTS: From June 20, 2021, to June 20, 2022, a total of 320 CRAs representing 201 sponsors used the remote monitoring system for source data review and the verification of data from 3299 patients in 320 trials. Arm A trials were monitored 728 times and arm B trials were monitored 849 times. The hybrid model in arm B had 52.9% (449/849) remote visits and 48.1% (409/849) on-site visits. The number of patients’ visits that could be reviewed in the hybrid monitoring model increased by 34% (4.70/13.80; P=.004) compared with that in the traditional model, whereas the duration of monitoring decreased by 13.8% (3.96/28.61; P=.03) and the total cost of monitoring decreased by 46.2% (CNY ¥188.74/408.80; P<.001). These differences were shown by nonparametric testing to be statistically significant (P<.05).

CONCLUSIONS: The hybrid monitoring model can ensure timely detection of monitoring issues, improve monitoring efficiency, and reduce the cost of clinical trials and should therefore be applied more broadly in future clinical studies.

PMID:37368468 | DOI:10.2196/42175

J Med Internet Res. 2023 Jun 27;25:e43528. doi: 10.2196/43528.

ABSTRACT

BACKGROUND: Urinary incontinence (UI) is a highly prevalent health concern commonly observed during and after pregnancy that can substantially impact women’s physical and psychological well-being and quality of life. Owing to its numerous advantages, mobile health may be a promising solution; however, it is unclear whether the app-based intervention can effectively improve UI symptoms during and after pregnancy.

OBJECTIVE: This study aimed to evaluate the effectiveness of the Urinary Incontinence for Women (UIW) app-based intervention for UI symptom improvement among pregnant women in China.

METHODS: Singleton pregnant women without incontinence before pregnancy who were aged ≥18 years and between 24 and 28 weeks of gestation were recruited from a tertiary public hospital in China and were randomly allocated (1:1) to either an experimental group (n=63) or a control group (n=63). The experimental group received the UIW app intervention and oral pelvic floor muscle training (PFMT) instructions, whereas the control group received oral PFMT instructions alone. Neither the participants nor the researchers were blinded to the intervention. The primary outcome was UI severity. The secondary outcomes included quality of life, self-efficacy with PFMT, and knowledge of UI. All data were collected at baseline, 2 months after randomization, and 6 weeks post partum through electronic questionnaires or by checking the electronic medical record system. Data analysis followed the intention-to-treat principle. A linear mixed model was used to examine the intervention effect on primary and secondary outcomes.

RESULTS: Participants in the experimental and control groups were comparable at baseline. Of the 126 overall participants, 117 (92.9%) and 103 (81.7%) women completed follow-up visits at 2 months after randomization and 6 weeks after delivery, respectively. A statistically significant difference in UI symptom severity was observed between the experimental group and control group (2 months after randomization: mean difference -2.86, 95% CI -4.09 to -1.64, P<.001; 6 weeks post partum: mean difference -2.68, 95% CI -3.87 to -1.49, P<.001). For the secondary outcomes, a statistically significant intervention effect on the quality of life, self-efficacy, and UI knowledge was found at the 2-month follow-up (all P<.05) and 6 weeks post partum (all P<.001).

CONCLUSIONS: The app-based UI self-management intervention (UIW) effectively improved UI symptom severity, quality of life, self-efficacy with PFMT, and knowledge of UI during the late pregnancy and early postnatal periods. Larger multicenter studies with a longer postpartum follow-up are required to further extend these findings.

TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR1800016171; http://www.chictr.org.cn/showproj.aspx?proj=27455.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/22771.

PMID:37368465 | DOI:10.2196/43528

Paediatr Anaesth. 2023 Jun 27. doi: 10.1111/pan.14715. Online ahead of print.

ABSTRACT

BACKGROUND: Neonates undergoing surgery are at greater risk of requiring packed red blood cell transfusion. Pediatric transfusion practices vary widely between countries and institutions, especially in the management of neonates.

AIMS: The aim of this study was to describe the use of intraoperative blood product transfusion during neonatal surgery in current clinical practice at our institution.

METHODS: A retrospective contextual, descriptive, and comparative study was conducted at Chris Hani Baragwanath Academic Hospital. A total of 1078 anesthetic records of neonates who underwent surgery from January 1, 2015 to December 31, 2019 were reviewed. Descriptive and inferential statistics were used to analyze the data.

RESULTS: Blood products were transfused during 374 (34.7%) neonatal surgeries. Packed red blood cells, platelet concentrate, and fresh frozen plasma were administered during 327 (30.3%), 133 (12.3%), and 85 (7.9%) of the total 1078 surgeries, respectively. The median (interquartile range) volume of packed red blood cells, fresh frozen plasma, platelets, and clear fluid administered was 15 (10-21.8) mL/kg, 12.3 (10-23.5) mL/kg, 13.6 (10-20.5) mL/kg, and 19 (9.1-28.8) mL/kg, respectively. Very low weight, low preoperative hemoglobin, long total anesthetic time, emergency surgery, and major surgery were independently associated with blood product transfusion. Gestational age at birth, blood product transfusion, emergency surgery, and major surgery were independently associated with the composite adverse outcomes. The median preoperative hemoglobin was 11.8 g/dL.

CONCLUSIONS: Intraoperative blood product transfusion occurred at a much higher rate with a high median pre-transfusion hemoglobin compared to other studies.

PMID:37368461 | DOI:10.1111/pan.14715

Plant Dis. 2023 Jun 27. doi: 10.1094/PDIS-02-23-0255-RE. Online ahead of print.

ABSTRACT

Bacteriophages are biocontrol agents used to manage bacterial diseases. They have long been used against plant pathogenic bacteria; however, several factors impede its use as a reliable disease management strategy. Short-lived persistence on plant surfaces under field conditions results mainly from rapid degradation by exposure to ultraviolet light (UV). Currently, there are no effective commercial formulations that protect phage from UV. Phage ΦXp06-02, which lyses strains of the bacterial spot of tomato pathogen Xanthomonas perforans (Xp), was mixed with different concentrations of the nanomaterial N-acetyl cysteine surface-coated manganese-doped zinc sulfide (NAC-ZnS; 3.5 nm). In vitro, NAC-ZnS at 1,000 µg/ml formulated phage, when exposed to UV for 1 min, provided statistically equivalent PFU/ml recovery as phage not exposed to UV. NAC-ZnS had no negative effect on phage ability to lyse bacterial cells under in vitro conditions. NAC-ZnS reduced phage degradation over time in comparison to the non-treated control. The nanomaterial-phage mixture did not cause any phytotoxicity when applied to tomato plants. Following exposure to sunlight, NAC-ZnS formulation improved phage persistence in the phyllosphere by 15 times compared to non-formulated phage. Phage populations with NAC-ZnO formulation were undetectable within 32 h while NAC-ZnS formulated phage populations were detected at 103 PFU/g. At 4 h of sunlight exposure, NAC-ZnS formulated phage at 1,000 µg/ml significantly reduced bacterial spot of tomato disease severity compared to non-formulated phage. These results suggest that NAC-ZnS can be used to improve phage efficacy for bacterial disease.

PMID:37368450 | DOI:10.1094/PDIS-02-23-0255-RE

Health Serv Manage Res. 2023 Jun 27:9514848231179182. doi: 10.1177/09514848231179182. Online ahead of print.

ABSTRACT

This study aimed to use national data to examine the relationship between staff and inpatient survey results (National Health Service (NHS) Friends and Family Test (FFT)) and assess how these align with more traditional measurements of hospital quality as captured by the summary hospital mortality indicator (SHMI). Provider level FFT responses were obtained for 128 English non-specialist acute providers for staff and inpatients between April 2016 and March 2019. Multilevel linear regression models assessed the relationship between staff and patient FFT recommendations, and separately how SHMI related to each of staff and patient FFT recommendations. A total of 1,536 observations were recorded across all providers and financial quarters. Patients were more likely to recommend their provider (95.5%) than staff (76.8%). In multivariable regression, a statistically significant association was observed between staff and patient FFT recommendations. A statistically significant negative relationship was also observed between staff FFT recommendations and SHMI. The association between SHMI and staff FFT recommendations suggests that staff feedback tools may provide a useful analogue for providers in potential need of intervention and improvement in care. For patients meanwhile, qualitative approaches and hospital organisations working in partnership with patients may provide better opportunities for patients to drive improvement.

PMID:37368436 | DOI:10.1177/09514848231179182

Pharmacy (Basel). 2023 Jun 8;11(3):96. doi: 10.3390/pharmacy11030096.

ABSTRACT

We aimed to collect parallel perspectives from pharmacists and pharmacy students on their use, knowledge, attitudes, and perceptions about herbal supplements/natural products. Two cross-sectional descriptive survey questionnaires-one focusing on pharmacists and the other focusing on pharmacy students-were administered from March to June 2021 via Qualtrics. The surveys were sent out to preceptor pharmacists and pharmacy students currently enrolled at a single U.S. school of pharmacy. The questionnaires were composed of five main sections, including (1) demographics; (2) attitudes/perceptions; (3) educational experience; (4) resource availability; and (5) objective knowledge of herbal supplements/natural products. Data analysis primarily utilized descriptive statistics with relevant comparisons across domains. A total of 73 pharmacists and 92 pharmacy students participated, with response rates of 8.8% and 19.3%, respectively. A total of 59.2% of pharmacists and 50% of pharmacy students stated they personally used herbal supplements/natural products. Most respondents (>95% for both groups) considered vitamins/minerals safe, although a lower percentage agreed on this for herbal supplements/natural products (60% and 79.3% for pharmacists and pharmacy students, respectively). Patient inquiries in the pharmacy setting were most seen for vitamin D, zinc, cannabidiol, and omega-3. A total of 34.2% of pharmacists reported having training in herbal supplements/natural products as a required part of their Pharm.D. training, and 89.1% of pharmacy students desired to learn more. The median score on the objective knowledge quiz was 50% for pharmacists and 45% for pharmacy students. Ultimately, herbal supplements/natural products are recognized by pharmacists/pharmacy students as a consistent and embedded part of pharmacy practice, although there is a need to enhance knowledge and skills in this area.

PMID:37368422 | DOI:10.3390/pharmacy11030096

Pharmacy (Basel). 2023 Jun 4;11(3):94. doi: 10.3390/pharmacy11030094.

ABSTRACT

BACKGROUND: The INhaler Compliance Assessment (INCA^TM) device is an electronic monitoring device (EMD) that assesses both patient’s adherence and inhaler technique (IT). This study aimed, first, to assess the value of using the INCA^TM device as an objective measure during medicine use review (MUR) consultations provided by community pharmacists (CPs) on patients’ adherence and IT. Second, we aimed to explore patients’ perceptions about the INCA^TM device.

METHODS: A mixed methods approach was used, involving two phases. Phase one was a service evaluation in independent community pharmacies in London with a before-and-after study design. The service included provision of an MUR consultation to asthma and COPD patients using objective feedback about adherence and IT generated with the INCA^TM device. Descriptive and inferential statistics were performed using SPSS. Phase two involved semi-structured interviews with respiratory patients. Thematic analysis was performed to generate key findings.

MAIN FINDINGS: Eighteen patients participated in the study (12 COPD and 6 asthma). The results showed significant improvement in the INCA^TM actual adherence from 30% to 68% (p = 0.001) and significant reduction in IT error rate from 51% to 12% (p = 0.002) after conducting the service. Analysis of the interviews revealed patients’ positive attitudes in terms of the perceived benefits of the technology and a desire for future use and recommendation for others. Patients had also positive attitudes towards the consultations provided.

CONCLUSION: Embedding an objective measure about adherence and IT during CPs’ consultations showed a significant improvement in patients’ adherence and IT and was accepted by patients as well.

PMID:37368420 | DOI:10.3390/pharmacy11030094

JAMA Netw Open. 2023 Jun 1;6(6):e2320513. doi: 10.1001/jamanetworkopen.2023.20513.

ABSTRACT

IMPORTANCE: Combined modality therapy, such as chemoradiotherapy, often results in significant morbidity among patients with head and neck cancer. Although the role of body mass index (BMI) varies based on cancer subtypes, its association with treatment response, tumor recurrence, and survival outcomes among patients with head and neck cancer remains unclear.

OBJECTIVE: To evaluate the role of BMI in treatment response, tumor recurrence, and survival outcomes among patients with head and neck cancer undergoing chemoradiotherapy.

DESIGN, SETTING, AND PARTICIPANTS: This retrospective, observational, single-institution cohort study conducted at a comprehensive cancer center included 445 patients with nonmetastatic head and neck cancer who underwent chemoradiotherapy from January 1, 2005, to January 31, 2021.

EXPOSURE: Normal vs overweight or obese BMI.

MAIN OUTCOMES AND MEASURES: Metabolic response after chemoradiotherapy, locoregional failure (LRF), distant failure (DF), overall survival (OS), and progression-free survival (PFS), with Bonferroni correction used to adjust for multiple comparisons and P < .025 being considered statistically significant.

RESULTS: A total of 445 patients (373 men [83.8%]; median age, 61 years [IQR, 55-66 years]; 107 [24.0%] with normal BMI, 179 [40.2%] with overweight BMI, and 159 [35.7%] with obese BMI) were included for analysis. Median follow-up was 48.1 months (IQR, 24.7-74.9 months). On Cox proportional hazards regression multivariable analysis, only overweight BMI was associated with improved OS (5-year OS, 71.5% vs 58.4%; adjusted hazard ratio [AHR], 0.59 [95% CI, 0.39-0.91]; P = .02) and PFS (5-year PFS, 68.3% vs 50.8%; AHR, 0.51 [95% CI, 0.34-0.75]; P < .001). On logistic multivariable analysis, overweight BMI (91.6% vs 73.8%; adjusted odds ratio [AOR], 0.86 [95% CI, 0.80-0.93]; P < .001) and obese BMI (90.6% vs 73.8%; AOR, 0.89 [95% CI, 0.81-0.96]; P = .005) were associated with complete metabolic response on follow-up positron emission tomography-computed tomography after treatments. On Fine-Gray multivariable analysis, overweight BMI was associated with reduction in LRF (5-year LRF, 7.0% vs 25.9%; AHR, 0.30 [95% CI, 0.12-0.71]; P = .01), but not DF (5-year DF, 17.4% vs 21.5%; AHR, 0.92 [95% CI, 0.47-1.77]; P = .79). Obese BMI was not associated with LRF (5-year LRF, 10.4% vs 25.9%; AHR, 0.63 [95% CI, 0.29-1.37]; P = .24) or DF (5-year DF, 15.0% vs 21.5%; AHR, 0.70 [95% CI, 0.35-1.38]; P = .30).

CONCLUSION: In this cohort study of patients with head and neck cancer, when compared with normal BMI, overweight BMI was an independent factor favorably associated with complete response after treatments, OS, PFS, and LRF. Further investigations are warranted to improve understanding on the role of BMI among patients with head and neck cancer.

PMID:37368400 | DOI:10.1001/jamanetworkopen.2023.20513