Category: Statistics

Clin Psychol Rev. 2024 Apr 7;110:102428. doi: 10.1016/j.cpr.2024.102428. Online ahead of print.

ABSTRACT

Cognitive reappraisal, an adaptive emotion regulation strategy that involves subjectively reinterpreting stressful and adverse experiences in a more positive manner, can enhance personal resilience. Personal resilience is a constellation of attributes that facilitate successful coping and an expeditious return to adaptive functioning after exposure to stress or adversity. This meta-analysis evaluated the association between cognitive reappraisal and personal resilience. A systematic and exhaustive search identified 64 independent samples from 55 studies (N = 29,824) that examined the correlation between cognitive reappraisal and personal resilience. A random-effects model revealed a positive summary effect (r = 0.47, p < .001), indicating that higher cognitive reappraisal was associated with higher personal resilience. Six potential meta-moderators were tested: culture, age, name of the cognitive reappraisal measure, name of the personal resilience measure, study design, and publication period. After two extreme effect size outliers were omitted, tests of publication bias did not reveal any publication bias in this line of research. This quantitative synthesis offers compelling evidence showing that cognitive reappraisal skills operate as a protective strategy against stress and adversity and, therefore, enhance personal resilience. The protective benefits of cognitive reappraisal in relation to personal resilience are relatively robust, as the correlations were statistically significant for all subgroups in the meta-moderation analyses.

PMID:38657292 | DOI:10.1016/j.cpr.2024.102428

N Engl J Med. 2024 Apr 25;390(16):1493-1504. doi: 10.1056/NEJMoa2313942.

ABSTRACT

BACKGROUND: Most moderate-to-late-preterm infants need nutritional support until they are feeding exclusively on their mother’s breast milk. Evidence to guide nutrition strategies for these infants is lacking.

METHODS: We conducted a multicenter, factorial, randomized trial involving infants born at 32 weeks 0 days’ to 35 weeks 6 days’ gestation who had intravenous access and whose mothers intended to breast-feed. Each infant was assigned to three interventions or their comparators: intravenous amino acid solution (parenteral nutrition) or dextrose solution until full feeding with milk was established; milk supplement given when maternal milk was insufficient or mother’s breast milk exclusively with no supplementation; and taste and smell exposure before gastric-tube feeding or no taste and smell exposure. The primary outcome for the parenteral nutrition and the milk supplement interventions was the body-fat percentage at 4 months of corrected gestational age, and the primary outcome for the taste and smell intervention was the time to full enteral feeding (150 ml per kilogram of body weight per day or exclusive breast-feeding).

RESULTS: A total of 532 infants (291 boys [55%]) were included in the trial. The mean (±SD) body-fat percentage at 4 months was similar among the infants who received parenteral nutrition and those who received dextrose solution (26.0±5.4% vs. 26.2±5.2%; adjusted mean difference, -0.20; 95% confidence interval [CI], -1.32 to 0.92; P = 0.72) and among the infants who received milk supplement and those who received mother’s breast milk exclusively (26.3±5.3% vs. 25.8±5.4%; adjusted mean difference, 0.65; 95% CI, -0.45 to 1.74; P = 0.25). The time to full enteral feeding was similar among the infants who were exposed to taste and smell and those who were not (5.8±1.5 vs. 5.7±1.9 days; P = 0.59). Secondary outcomes were similar across interventions. Serious adverse events occurred in one infant.

CONCLUSIONS: This trial of routine nutrition interventions to support moderate-to-late-preterm infants until full nutrition with mother’s breast milk was possible did not show any effects on the time to full enteral feeding or on body composition at 4 months of corrected gestational age. (Funded by the Health Research Council of New Zealand and others; DIAMOND Australian New Zealand Clinical Trials Registry number, ACTRN12616001199404.).

PMID:38657245 | DOI:10.1056/NEJMoa2313942

N Engl J Med. 2024 Apr 25;390(16):1467-1480. doi: 10.1056/NEJMoa2313812.

ABSTRACT

BACKGROUND: Patients with relapsed or refractory hematologic cancers have a poor prognosis. Chimeric antigen receptor (CAR) T-cell therapy as a bridge to allogeneic hematopoietic stem-cell transplantation (HSCT) has the potential for long-term tumor elimination. However, pre-HSCT myeloablation and graft-versus-host disease (GVHD) prophylaxis agents have toxic effects and could eradicate residual CAR T cells and compromise antitumor effects. Whether the integration of CAR T-cell therapy and allogeneic HSCT can preserve CAR T-cell function and improve tumor control is unclear.

METHODS: We tested a novel “all-in-one” strategy consisting of sequential CD7 CAR T-cell therapy and haploidentical HSCT in 10 patients with relapsed or refractory CD7-positive leukemia or lymphoma. After CAR T-cell therapy led to complete remission with incomplete hematologic recovery, patients received haploidentical HSCT without pharmacologic myeloablation or GVHD prophylaxis drugs. Toxic effects and efficacy were closely monitored.

RESULTS: After CAR T-cell therapy, all 10 patients had complete remission with incomplete hematologic recovery and grade 4 pancytopenia. After haploidentical HSCT, 1 patient died on day 13 of septic shock and encephalitis, 8 patients had full donor chimerism, and 1 patient had autologous hematopoiesis. Three patients had grade 2 HSCT-associated acute GVHD. The median follow-up was 15.1 months (range, 3.1 to 24.0) after CAR T-cell therapy. Six patients remained in minimal residual disease-negative complete remission, 2 had a relapse of CD7-negative leukemia, and 1 died of septic shock at 3.7 months. The estimated 1-year overall survival was 68% (95% confidence interval [CI], 43 to 100), and the estimated 1-year disease-free survival was 54% (95% CI, 29 to 100).

CONCLUSIONS: Our findings suggest that sequential CD7 CAR T-cell therapy and haploidentical HSCT is safe and effective, with remission and serious but reversible adverse events. This strategy offers a feasible approach for patients with CD7-positive tumors who are ineligible for conventional allogeneic HSCT. (Funded by the National Natural Science Foundation of China and the Key Project of Science and Technology Department of Zhejiang Province; ClinicalTrials.gov numbers, NCT04599556 and NCT04538599.).

PMID:38657244 | DOI:10.1056/NEJMoa2313812

JMIR Res Protoc. 2024 Apr 24;13:e54041. doi: 10.2196/54041.

ABSTRACT

BACKGROUND: In the last few years, several nicotine products have become available as alternatives to smoking tobacco. While laboratory and limited clinical studies suggest that these devices are less toxic compared to classic tobacco cigarettes, very little is known about their epidemiological impact. Visiting the emergency department (ED) often represents the first or even the only contact of patients with the health care system. Therefore, a study conducted at the ED to assess the impact of these products on health can be reliable and reflect a real-life setting.

OBJECTIVE: The aim of this noninterventional observational study (SMOPHED study) is to analyze the association between the severity of clinical presentation observed during ED visits among patients using various nicotine products and the subsequent outcomes, specifically hospitalization and mortality.

METHODS: Outcomes (hospitalization and mortality in the ED) will be examined in relation to various patterns of nicotine products use. We plan to enroll approximately 2000 participants during triage at the ED. These individuals will be characterized based on their patterns of tobacco and nicotine consumption, identified through a specific questionnaire. This categorization will allow for a detailed analysis of how different usage patterns of nicotine products correlate with the clinical diagnosis made during the ED visits and the consequent outcomes.

RESULTS: Enrollment into the study started in March 2024. We enrolled a total of 901 participants in 1 month (approximately 300 potential participants did not provide the informed consent to participate). The data will be analyzed by a statistician as soon as the database is completed. Full data will be published by December 2024.

CONCLUSIONS: There is substantial debate about the harm reduction potential of alternative nicotine products in terms of their smoking-cessation and risk-reduction potential. This study represents an opportunity to document epidemiological data on the link between the use of different types of nicotine products and disease diagnosis and severity during an ED visit, and thus evaluate the harm reduction potential claims for these products.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/54041.

PMID:38657239 | DOI:10.2196/54041

JMIR Res Protoc. 2024 Apr 24;13:e51540. doi: 10.2196/51540.

ABSTRACT

BACKGROUND: Understanding a student’s depressive symptoms could facilitate significantly more precise diagnosis and treatment. However, few studies have focused on depressive symptom prediction through unobtrusive systems, and these studies are limited by small sample sizes, low performance, and the requirement for higher resources. In addition, research has not explored whether statistically significant rhythms based on different app usage behavioral markers (eg, app usage sessions) exist that could be useful in finding subtle differences to predict with higher accuracy like the models based on rhythms of physiological data.

OBJECTIVE: The main objective of this study is to explore whether there exist statistically significant rhythms in resource-insensitive app usage behavioral markers and predict depressive symptoms through these marker-based rhythmic features. Another objective of this study is to understand whether there is a potential link between rhythmic features and depressive symptoms.

METHODS: Through a countrywide study, we collected 2952 students’ raw app usage behavioral data and responses to the 9 depressive symptoms in the 9-item Patient Health Questionnaire (PHQ-9). The behavioral data were retrieved through our developed app, which was previously used in our pilot studies in Bangladesh on different research problems. To explore whether there is a rhythm based on app usage data, we will conduct a zero-amplitude test. In addition, we will develop a cosinor model for each participant to extract rhythmic parameters (eg, acrophase). In addition, to obtain a comprehensive picture of the rhythms, we will explore nonparametric rhythmic features (eg, interdaily stability). Furthermore, we will conduct regression analysis to understand the association of rhythmic features with depressive symptoms. Finally, we will develop a personalized multitask learning (MTL) framework to predict symptoms through rhythmic features.

RESULTS: After applying inclusion criteria (eg, having app usage data of at least 2 days to explore rhythmicity), we kept the data of 2902 (98.31%) students for analysis, with 24.48 million app usage events, and 7 days’ app usage of 2849 (98.17%) students. The students are from all 8 divisions of Bangladesh, both public and private universities (19 different universities and 52 different departments). We are analyzing the data and will publish the findings in a peer-reviewed publication.

CONCLUSIONS: Having an in-depth understanding of app usage rhythms and their connection with depressive symptoms through a countrywide study can significantly help health care professionals and researchers better understand depressed students and may create possibilities for using app usage-based rhythms for intervention. In addition, the MTL framework based on app usage rhythmic features may more accurately predict depressive symptoms due to the rhythms’ capability to find subtle differences.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/51540.

PMID:38657238 | DOI:10.2196/51540

JMIR Form Res. 2024 Apr 24;8:e54326. doi: 10.2196/54326.

ABSTRACT

BACKGROUND: Tinnitus is a complex and heterogeneous disease that has been identified as a common manifestation of COVID-19. To gain a comprehensive understanding of tinnitus symptoms in individuals following COVID-19 infection, we conducted an online survey called the China Ear Nose and Throat Symptom Survey in the COVID-19 Pandemic (CENTSS) among the Chinese population.

OBJECTIVE: Our objective was to investigate tinnitus and ear-related symptoms after COVID-19 infection in the Chinese population, with the aim of providing a solid empirical foundation for improved health care. The findings from CENTSS can contribute to the development of enhanced management strategies for tinnitus in the context of long COVID. By gaining a better understanding of the factors contributing to tinnitus in individuals with COVID-19, health care providers can tailor interventions to address the specific needs of affected patients. Furthermore, this study serves as a basis for research on the long-term consequences of COVID-19 infection and its associated tinnitus symptoms.

METHODS: A quantitative, online, cross-sectional survey study design was used to explore the impact of the COVID-19 pandemic on experiences with tinnitus in China. Data were collected through an online questionnaire designed to identify the presence of tinnitus and its impacts. Descriptive statistics were used to analyze individuals’ demographic characteristics, COVID-19 infection-related ear symptoms, and the cognitive and emotional implications of tinnitus. Univariable and multivariable logistic regression analyses were used to model the cross-sectional baseline associations between demographic characteristics, noise exposure, educational level, health and lifestyle factors, and the occurrence of tinnitus.

RESULTS: Between December 19, 2022, and February 1, 2023, we obtained responses from 1262 Chinese participants representing 24 regions, with an average age of 37 years. Among them, 540 patients (42.8%) reported experiencing ear-related symptoms after COVID-19 infection. Only 114 (9%) of these patients sought medical attention specifically for their ear symptoms, while 426 (33.8%) did not seek hospital care. Tinnitus emerged as the most prevalent and impactful symptom among all ear-related symptoms experienced after COVID-19 infection. Of the respondents, female participants (688/888, 77.78%), younger individuals (<30 years), individuals with lower education levels, participants residing in western China, and those with a history of otolaryngology diseases were more likely to develop tinnitus following COVID-19 infection.

CONCLUSIONS: In summary, tinnitus was identified as the most common ear-related symptom during COVID-19 infection. Individuals experiencing tinnitus after COVID-19 infection were found to have poorer cognitive and emotional well-being. Different ear-related symptoms in patients post-COVID-19 infection may suggest viral invasion of various parts of the ear. It is therefore crucial to monitor and manage hearing-related changes resulting from COVID-19 as clinical services resume.

PMID:38657236 | DOI:10.2196/54326

JMIR Form Res. 2024 Apr 24;8:e53668. doi: 10.2196/53668.

ABSTRACT

BACKGROUND: Cancer is the leading cause of death in Canada, and living with cancer generates psychological demands, including depression and anxiety among cancer survivors and caregivers. Text4Hope-Cancer Care SMS text messaging-based service was provided to people with cancer and caregivers during the COVID-19 pandemic to support their mental health.

OBJECTIVE: The aim of this study is to examine the clinical effectiveness of and satisfaction with Text4Hope-Cancer Care in addressing mental health conditions among people living with cancer and caregivers.

METHODS: The study was conducted in Alberta, Canada. People who were diagnosed or receiving cancer treatment and caregivers self-subscribed to receive 3-months daily supportive cognitive behavioral therapy-based SMS text messages and a web-based survey was sent at designated time points to collect clinical and nonclinical data. The Hospital Anxiety and Depression scale (HADS) was used to examine changes in anxiety and depression symptoms after receiving the service. Satisfaction with the service was assessed using a survey with a Likert scale. Descriptive and inferential statistics were used, and test significance was considered with P≤.05.

RESULTS: Overall, 107 individuals subscribed to the service, and 93 completed the program (completion rate 93/107, 86.9%). A significant improvement in the anxiety symptoms (HADS-Anxiety [HADS-A] subscale) was reported after 3 months of Text4Hope-Cancer Care (t₁₁=2.62; P=.02), with medium effect size (Hedges g=0.7), but not depression symptoms (HADS-Depression [HADS-D] subscale). Subscribers expressed high satisfaction and agreed that the service has helped them to cope with mental health symptoms and improve their quality of life. Most subscribers read the SMS text messages more than once (30/30, 100%); took time to reflect or took a beneficial action after reading the messages (27/30, 90%); and highly agreed (27/30, >80%) with the value of the received supportive SMS text messages as being relevant, succinct, affirmative, and positive. All subscribers recommended SMS text messaging for stress, anxiety, and depression and for cancer care support (30/30, 100%).

CONCLUSIONS: Text4Hope-Cancer Care was well-perceived and effectively addressed anxiety symptoms among people living with cancer and caregivers during the peak of the COVID-19 pandemic. This study provides evidence-based support and insight for policy and stakeholders to implement similar convenient, economic, and accessible mental health services that support vulnerable populations during crises.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/20240.

PMID:38657234 | DOI:10.2196/53668

J Med Internet Res. 2024 Apr 24;26:e49445. doi: 10.2196/49445.

ABSTRACT

BACKGROUND: Sharing data from clinical studies can accelerate scientific progress, improve transparency, and increase the potential for innovation and collaboration. However, privacy concerns remain a barrier to data sharing. Certain concerns, such as reidentification risk, can be addressed through the application of anonymization algorithms, whereby data are altered so that it is no longer reasonably related to a person. Yet, such alterations have the potential to influence the data set’s statistical properties, such that the privacy-utility trade-off must be considered. This has been studied in theory, but evidence based on real-world individual-level clinical data is rare, and anonymization has not broadly been adopted in clinical practice.

OBJECTIVE: The goal of this study is to contribute to a better understanding of anonymization in the real world by comprehensively evaluating the privacy-utility trade-off of differently anonymized data using data and scientific results from the German Chronic Kidney Disease (GCKD) study.

METHODS: The GCKD data set extracted for this study consists of 5217 records and 70 variables. A 2-step procedure was followed to determine which variables constituted reidentification risks. To capture a large portion of the risk-utility space, we decided on risk thresholds ranging from 0.02 to 1. The data were then transformed via generalization and suppression, and the anonymization process was varied using a generic and a use case-specific configuration. To assess the utility of the anonymized GCKD data, general-purpose metrics (ie, data granularity and entropy), as well as use case-specific metrics (ie, reproducibility), were applied. Reproducibility was assessed by measuring the overlap of the 95% CI lengths between anonymized and original results.

RESULTS: Reproducibility measured by 95% CI overlap was higher than utility obtained from general-purpose metrics. For example, granularity varied between 68.2% and 87.6%, and entropy varied between 25.5% and 46.2%, whereas the average 95% CI overlap was above 90% for all risk thresholds applied. A nonoverlapping 95% CI was detected in 6 estimates across all analyses, but the overwhelming majority of estimates exhibited an overlap over 50%. The use case-specific configuration outperformed the generic one in terms of actual utility (ie, reproducibility) at the same level of privacy.

CONCLUSIONS: Our results illustrate the challenges that anonymization faces when aiming to support multiple likely and possibly competing uses, while use case-specific anonymization can provide greater utility. This aspect should be taken into account when evaluating the associated costs of anonymized data and attempting to maintain sufficiently high levels of privacy for anonymized data.

TRIAL REGISTRATION: German Clinical Trials Register DRKS00003971; https://drks.de/search/en/trial/DRKS00003971.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1093/ndt/gfr456.

PMID:38657232 | DOI:10.2196/49445

JMIR Res Protoc. 2024 Apr 24;13:e49861. doi: 10.2196/49861.

ABSTRACT

BACKGROUND: Multiple myeloma (MM) is the second-most common cancer among hematological malignancies. Patients with active disease may experience several comorbidities, including renal insufficiency and asthma, which may lead to treatment failure. The treatment of relapsed or refractory MM (RRMM) has been associated with multiple factors, causing a decline in progression-free survival as well as overall survival with subsequent lines of therapy. Data about the characteristics of this group of patients in the Greater Gulf region are lacking.

OBJECTIVE: The primary objective of this study is to describe the disease characteristics and various treatment approaches or regimens used in the management of patients with RRMM in the Greater Gulf region.

METHODS: We will conduct a regional, retrospective study collecting real-world and epidemiological data on patients with MM in countries of the Greater Gulf region. Medical records will be used to obtain the required data. Around 150 to 170 patients’ records are planned to be retrospectively reviewed over 6 months without any cross-sectional or prospective intervention. Cases will be collected from Saudi Arabia, the United Arab Emirates, Kuwait, Oman, and Qatar. Descriptive as well as analytical statistics will be performed on the extracted data. The calculated sample size will allow us to estimate the percentages of RRMM cases with acceptable precision while complying with the challenges in light of data scarcity. We will obtain a comprehensive description of the demographic profile of patients with MM; treatment outcomes; the proportion of patients with MM with renal impairment and asthma, chronic obstructive pulmonary disease, or both at the time of diagnosis and any subsequent point; and data related to treatment lines, regimens, and MM-associated morbidities.

RESULTS: Patient medical records were reviewed between June 2022 and January 2023 for eligibility and data extraction. A total of 148 patients were eligible for study inclusion, of whom 64.2% (n=95) were male and 35.8% (n=53) were female. The study is currently in its final stages of data analysis. The final manuscript is expected to be published in 2024.

CONCLUSIONS: Although MM is a predominant hematological disease, data on its prevalence and patients’ characteristics in the Greater Gulf region are scarce. Therefore, this study will give us real-world insights into disease characteristics and various management approaches of patients with MM in the Greater Gulf region.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/49861.

PMID:38657230 | DOI:10.2196/49861

J Med Internet Res. 2024 Apr 24;26:e54645. doi: 10.2196/54645.

ABSTRACT

BACKGROUND: Understanding patient preference regarding taking tablet or capsule formulations plays a pivotal role in treatment efficacy and adherence. Therefore, these preferences should be taken into account when designing formulations and prescriptions.

OBJECTIVE: This study investigates the factors affecting patient preference in patients who have difficulties swallowing large tablets or capsules and aims to identify appropriate sizes for tablets and capsules.

METHODS: A robust data set was developed based on a questionnaire survey conducted from December 1, 2022, to December 7, 2022, using the harmo smartphone app operated by harmo Co, Ltd. The data set included patient input regarding their tablet and capsule preferences, personal health records (including dispensing history), and drug formulation information (available from package inserts). Based on the medication formulation information, 6 indices were set for each of the tablets or capsules that were considered difficult to swallow owing to their large size and concomitant tablets or capsules (used as controls). Receiver operating characteristic (ROC) analysis was used to evaluate the performance of each index. The index demonstrating the highest area under the curve of the ROC was selected as the best index to determine the tablet or capsule size that leads to swallowing difficulties. From the generated ROCs, the point with the highest discriminative performance that maximized the Youden index was identified, and the optimal threshold for each index was calculated. Multivariate logistic regression analysis was performed to identify the risk factors contributing to difficulty in swallowing oversized tablets or capsules. Additionally, decision tree analysis was performed to estimate the combined risk from several factors, using risk factors that were significant in the multivariate logistic regression analysis.

RESULTS: This study analyzed 147 large tablets or capsules and 624 control tablets or capsules. The “long diameter + short diameter + thickness” index (with a 21.5 mm threshold) was identified as the best indicator for causing swallowing difficulties in patients. The multivariate logistic regression analysis (including 132 patients with swallowing difficulties and 1283 patients without) results identified the following contributory risk factors: aged <50 years (odds ratio [OR] 1.59, 95% CI 1.03-2.44), female (OR 2.54, 95% CI 1.70-3.78), dysphagia (OR 3.54, 95% CI 2.22-5.65), and taking large tablets or capsules (OR 9.74, 95% CI 5.19-18.29). The decision tree analysis results suggested an elevated risk of swallowing difficulties for patients with taking large tablets or capsules.

CONCLUSIONS: This study identified the most appropriate index and threshold for indicating that a given tablet or capsule size will cause swallowing difficulties, as well as the contributory risk factors. Although some sampling biases (eg, only including smartphone users) may exist, our results can guide the design of patient-friendly formulations and prescriptions, promoting better medication adherence.

PMID:38657229 | DOI:10.2196/54645