Category: Statistics

J Natl Compr Canc Netw. 2023 Oct;21(10):1039-1049.e10. doi: 10.6004/jnccn.2023.7047.

ABSTRACT

BACKGROUND: Although VEGFR tyrosine kinase inhibitors (TKIs) are a preferred systemic treatment approach for patients with advanced renal cell carcinoma (RCC) and thyroid carcinoma (TC), treatment-related cardiovascular (CV) toxicity is an important contributor to morbidity. However, the clinical risk assessment and impact of CV toxicities, including early significant hypertension, among real-world advanced cancer populations receiving VEGFR TKI therapies remain understudied.

METHODS: In a multicenter, retrospective cohort study across 3 large and diverse US health systems, we characterized baseline hypertension and CV comorbidity in patients with RCC and those with TC who are newly initiating VEGFR TKI therapy. We also evaluated baseline patient-, treatment-, and disease-related factors associated with the risk for treatment-related early hypertension (within 6 weeks of TKI initiation) and major adverse CV events (MACE), accounting for the competing risk of death in an advanced cancer population, after VEGFR TKI initiation.

RESULTS: Between 2008 and 2020, 987 patients (80.3% with RCC, 19.7% with TC) initiated VEGFR TKI therapy. The baseline prevalence of hypertension was high (61.5% and 53.6% in patients with RCC and TC, respectively). Adverse CV events, including heart failure and cerebrovascular accident, were common (occurring in 14.9% of patients) and frequently occurred early (46.3% occurred within 1 year of VEGFR TKI initiation). Baseline hypertension and Black race were the primary clinical factors associated with increased acute hypertensive risk within 6 weeks of VEGFR TKI initiation. However, early significant “on-treatment” hypertension was not associated with MACE.

CONCLUSIONS: These multicenter, real-world findings indicate that hypertensive and CV morbidities are highly prevalent among patients initiating VEGFR TKI therapies, and baseline hypertension and Black race represent the primary clinical factors associated with VEGFR TKI-related early significant hypertension. However, early on-treatment hypertension was not associated with MACE, and cancer-specific CV risk algorithms may be warranted for patients initiating VEGFR TKIs.

PMID:37856199 | DOI:10.6004/jnccn.2023.7047

J Natl Compr Canc Netw. 2023 Oct;21(10):1011-1019.e6. doi: 10.6004/jnccn.2023.7048.

ABSTRACT

BACKGROUND: PREDICT is an online prognostication tool derived from breast cancer registry information on approximately 6,000 women treated in the United Kingdom that estimates the postsurgical treatment benefit of surgery alone, chemotherapy, trastuzumab, endocrine therapy, and/or adjuvant bisphosphonates in early-stage breast cancer. Our aim was to validate the PREDICT algorithm in predicting 5- and 10-year overall survival (OS) probabilities using real-world outcomes among US patients with breast cancer.

METHODS: A retrospective study was performed including women diagnosed with unilateral breast cancer in 2004 through 2012. Women with primary unilateral invasive breast cancer were included. Patients with bilateral or metastatic breast cancer, no breast surgery, or missing critical clinical information were excluded. Prognostic scores from PREDICT were calculated and external validity was approached by assessing statistical discrimination through area under time-dependent receiver-operator curves (AUC) and comparing the predicted survival to the observed OS in relevant subgroups.

RESULTS: We included 708,652 women, with a median age of 58 years. Most patients were White (85.4%), non-Hispanic (88.4%), and diagnosed with estrogen receptor-positive breast cancer (79.6%). Approximately 50% of patients received adjuvant chemotherapy, 67% received adjuvant endocrine therapy, 60% underwent a partial mastectomy, and 59% had 1 to 5 axillary sentinel nodes removed. Median follow-up time was 97.7 months. The population’s 5- and 10-year OS were 89.7% and 78.7%, respectively. Estimated 5- and 10-year median survival with PREDICT were 88.3% and 73.8%, and an AUC of 0.77 and 0.76, respectively. PREDICT performed most poorly in patients with high Charlson-Deyo comorbidity scores (2-3), where PREDICT overestimated OS. Sensitivity analysis by year of diagnosis and HER2 status showed similar results.

CONCLUSIONS: In this prognostic study utilizing the National Cancer Database, the PREDICT tool accurately predicted 5- and 10-year OS in a contemporary and diverse population of US patients with nonmetastatic breast cancer.

PMID:37856198 | DOI:10.6004/jnccn.2023.7048

J Med Internet Res. 2023 Oct 19;25:e45764. doi: 10.2196/45764.

ABSTRACT

BACKGROUND: Ecological momentary assessments (EMAs) are short, repeated surveys designed to collect information on experiences in real-time, real-life contexts. Embedding periodic bursts of EMAs within cohort studies enables the study of experiences on multiple timescales and could greatly enhance the accuracy of self-reported information. However, the burden on participants may be high and should be minimized to optimize EMA response rates.

OBJECTIVE: We aimed to evaluate the effects of study design features on EMA response rates.

METHODS: Embedded within an ongoing cohort study (Health@NUS), 3 bursts of EMAs were implemented over a 7-month period (April to October 2021). The response rate (percentage of completed EMA surveys from all sent EMA surveys; 30-42 individual EMA surveys sent/burst) for each burst was examined. Following a low response rate in burst 1, changes were made to the subsequent implementation strategy (SMS text message announcements instead of emails). In addition, 2 consecutive randomized controlled trials were conducted to evaluate the efficacy of 4 different reward structures (with fixed and bonus components) and 2 different schedule lengths (7 or 14 d) on changes to the EMA response rate. Analyses were conducted from 2021 to 2022 using ANOVA and analysis of covariance to examine group differences and mixed models to assess changes across all 3 bursts.

RESULTS: Participants (N=384) were university students (n=232, 60.4% female; mean age 23, SD 1.3 y) in Singapore. Changing the reward structure did not significantly change the response rate (F_3,380=1.75; P=.16). Changing the schedule length did significantly change the response rate (F_1,382=6.23; P=.01); the response rate was higher for the longer schedule (14 d; mean 48.34%, SD 33.17%) than the shorter schedule (7 d; mean 38.52%, SD 33.44%). The average response rate was higher in burst 2 and burst 3 (mean 50.56, SD 33.61 and mean 48.34, SD 33.17, respectively) than in burst 1 (mean 25.78, SD 30.12), and the difference was statistically significant (F_2,766=93.83; P<.001).

CONCLUSIONS: Small changes to the implementation strategy (SMS text messages instead of emails) may have contributed to increasing the response rate over time. Changing the available rewards did not lead to a significant difference in the response rate, whereas changing the schedule length did lead to a significant difference in the response rate. Our study provides novel insights on how to implement EMA surveys in ongoing cohort studies. This knowledge is essential for conducting high-quality studies using EMA surveys.

TRIAL REGISTRATION: ClinicalTrials.gov NCT05154227; https://clinicaltrials.gov/ct2/show/NCT05154227.

PMID:37856188 | DOI:10.2196/45764

J Med Internet Res. 2023 Oct 19;25:e46189. doi: 10.2196/46189.

ABSTRACT

BACKGROUND: Head and neck cancers (HNCs) are very common malignancies, and treatment often requires multimodal approaches, including radiotherapy and chemotherapy. Patients with HNC often display a high symptom burden, both due to the disease itself and the adverse effects of the multimodal therapy. Close telemonitoring of symptoms and quality of life during the course of treatment may help to identify those patients requiring early medical support.

OBJECTIVE: The App-Controlled Treatment Monitoring and Support for Patients With Head and Neck Cancer (APCOT) trial aimed to investigate the feasibility of integrating electronic patient-reported outcomes (ePROs) in the treatment surveillance pathway of patients with HNC during the course of their radiotherapy. Additionally, the influence of app-based ePRO monitoring on global and disease-specific quality of life and patient satisfaction with treatment was assessed.

METHODS: Patients undergoing radiotherapy for histologically proven HNCs at the Department of Radiation Oncology, University Medical Center Freiburg, Germany, were enrolled in this trial and monitored by weekly physician appointments. Patients were randomized between additional ePRO monitoring on each treatment day or standard-of-care monitoring. Feasibility of ePRO monitoring was defined as ≥80% of enrolled patients answering ≥80% of their daily app-based questions. Quality of life and patient satisfaction were assessed by the European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire (QLQ-C30), the head and neck cancer module (H&N35), and the validated Patient Satisfaction Questionnaire Short Form (PSQ-18) at the completion of treatment and compared between trial arms.

RESULTS: A total of 100 patients were enrolled in this trial, and 93 patients were evaluable. All patients (100%) in the experimental arm answered ≥80% of the ePRO questions during treatment, reaching the predefined threshold for the feasibility of ePRO monitoring (P<.001 in the binomial test). No clinical or patient-specific factor was found to influence feasibility. Global health and most domains of the general quality of life were comparable between trial arms, but an increased HNC-specific symptom burden was reported by patients undergoing ePRO surveillance. ePRO monitoring resulted in improved patient satisfaction regarding interpersonal manners (P=.01), financial aspects (P=.01), and time spent with a doctor (P=.01).

CONCLUSIONS: This trial demonstrated the feasibility of incorporating daily app-based ePRO surveillance for patients with HNC undergoing radiotherapy. Our data, for the first time, demonstrate that telemonitoring in this setting led to increased reporting of HNC-specific symptom burden and significantly improved several domains of patient satisfaction. Further analyses are needed to assess whether our findings hold true outside the context of a clinical trial.

TRIAL REGISTRATION: German Clinical Trials Register DRKS00020491; https://drks.de/search/en/trial/DRKS00020491.

PMID:37856185 | DOI:10.2196/46189

JMIR Serious Games. 2023 Oct 19;11:e49080. doi: 10.2196/49080.

ABSTRACT

BACKGROUND: This study explored the use of virtual reality (VR) technology to enhance the effectiveness and duration of low-intensity movements and postures in Pilates-derived exercises. We postulate that by leveraging the flow state in VR, individuals can engage in these exercises for longer periods while maintaining a high level of flow.

OBJECTIVE: The purpose of this study was to compare differences in posture maintenance and flow between VR Pilates training and conventional Pilates training, and the correlation between the 2 factors.

METHODS: The 18 participants in each group received either VR training or conventional training and were switched to the other training type after a 2-day wash-out period. Each group performed Pilates movements in a VR environment and a conventional environment, divided into 4 types. After training sessions, participants were evaluated for flow using a self-report questionnaire. In addition, a sports video analysis program was used to measure the duration of posture maintenance in 2 video-recorded sessions. Repeated-measures ANOVA and correlation analysis were performed on the measured duration of posture maintenance and flow scores. In all cases, the statistical significance level was set at P<.05.

RESULTS: Results for the duration of posture maintenance verification by type showed that simple behavior (F_1,16=17.631; P<.001), upper body-arm coordination behavior (F_1,16=6.083; P=.04), upper body-leg coordination behavior (F_1,16=8.359; P<.001), and whole-body coordination behavior (F_1,16=8.426; P<.001) all showed an interaction effect at P<.05. Flow (F_1,16=15.250; P<.001) also showed an interaction effect. In addition, significant correlations were determined between duration of all types of posture maintenance and flow in the VR training group at P<.05.

CONCLUSIONS: Our results indicate that VR Pilates training may be more useful than conventional Pilates training in improving the duration of posture maintenance and that it promotes a significantly higher degree of flow when compared with conventional Pilates training.

PMID:37856178 | DOI:10.2196/49080

Surg Infect (Larchmt). 2023 Oct 19. doi: 10.1089/sur.2023.191. Online ahead of print.

ABSTRACT

Background: Circumferential subcuticular wound approximation (CSWA) of round shaped skin wounds after ileostomy take down is believed to lower the rates of surgical site infection (SSI). We performed this randomized trial to compare the rates of SSI and other short-term outcomes among primary linear skin closure (PC) and CSWA groups of patients. Patients and Methods: All patients undergoing ileostomy reversal during the study period were randomly assigned to either PC or CSWA. The primary outcome was the incidence of SSI as assessed by ASEPSIS scoring system. The secondary outcomes included healing time, length of post-operative hospital stay, and patients’ satisfaction regarding cosmetic outcome, expectations, pain, time of healing, wound care, and activity on a five-point Likert scale. Results: Thirty-one patients (PC = 15; CSWA = 16) underwent ileostomy reversal during the study period. There was no SSI in the PC group whereas three patients developed SSI in the CSWA group but the result was not statistically significant (p = 0.23). The scores for time of healing (p < 0.001), wound care (p = 0.007), and activity (p < 0.001) were significantly better for PC compared with CSWA whereas there was no significant difference in the scores for cosmetic outcome, expectations, and pain. Healing time was shorter in the PC group (6.7 vs. 34.2 days; p < 0.001) whereas the post-operative length of stay was comparable (6.3 vs. 7 days; p = 0.27). Conclusions: Although there was no difference in the incidence of SSI among the two groups, the PC group fared better in terms of mean time to healing and requirement of wound care.

PMID:37856166 | DOI:10.1089/sur.2023.191

J Womens Health (Larchmt). 2023 Oct 19. doi: 10.1089/jwh.2023.0091. Online ahead of print.

ABSTRACT

Background: Endometriosis is a common disease affecting 10% of reproductive-age women globally and is associated with chronic systemic inflammation. Some studies suggest that women with endometriosis have a higher risk of cardiovascular disease, whereas others have conflicting findings. This study aims to further investigate the association between endometriosis and cardiovascular disease. Methods: A systematic review was conducted using the EMBASE and MEDLINE databases from inception to October 2022. The search strategy comprised terms for “endometriosis” and “cardiovascular disease.” Eligible studies had to include one group of patients with endometriosis and another group of individuals without endometriosis. The study must then compare the incidence or prevalence of cardiovascular disease (major adverse cardiovascular events [MACE], ischemic heart disease [IHD], cerebrovascular accident [CVA], or peripheral artery disease [PAD]). Results: A total of 5,401 articles were identified, and 9 studies were eligible for meta-analysis. Pooled analysis showed an increased prevalence of IHD (pooled odds ratio [OR]: 1.22; 95% confidence interval [95% CI]: 0.74-2.02), CVA (pooled OR: 1.28; 95% CI: 1.07-1.53), and PAD (pooled OR: 1.55; 95% CI: 1.35-1.78). Pooled analysis showed an increased incidence of MACE (pooled hazard ratio [HR]: 1.23; 95% CI: 1.14-1.33), IHD (pooled HR: 1.43; 95% CI: 1.28-1.59), and CVA (pooled HR: 1.20; 95% CI: 1.11-1.30). Conclusions: This systematic review and meta-analysis found a statistically significant association between endometriosis and increased risk of cardiovascular disease (MACE, IHD, CVA, PAD).

PMID:37856152 | DOI:10.1089/jwh.2023.0091

JAMA Netw Open. 2023 Oct 2;6(10):e2338224. doi: 10.1001/jamanetworkopen.2023.38224.

ABSTRACT

IMPORTANCE: Rates of alcohol-associated deaths increased over the past 20 years, markedly between 2019 and 2020. The highest rates are among individuals aged 55 to 64 years, primarily attributable to alcoholic liver disease and psychiatric disorders due to use of alcohol. This study investigates potential geographic disparities in documentation of alcohol-related problems in primary care electronic health records, which could lead to undertreatment of alcohol use disorder.

OBJECTIVE: To identify disparities in documentation of alcohol-related problems by practice-level social deprivation.

DESIGN, SETTING, AND PARTICIPANTS: A cross-sectional study using secondary data from the Integrating Behavioral Health and Primary Care clinical trial (September 21, 2017, to January 8, 2021) was performed. A national sample of 44 primary care practices with co-located behavioral health services was included in the analysis. Patients with 2 primary care visits within 2 years and at least 1 chronic medical condition and 1 behavioral health condition or at least 3 chronic medical conditions were included.

EXPOSURE: The primary exposure was practice-level Social Deprivation Index (SDI), a composite measure based on county income, educational level, employment, housing, single-parent households, and access to transportation (scores range from 0 to 100; 0 indicates affluent counties and 100 indicates disadvantaged counties).

MAIN OUTCOMES AND MEASURES: Documentation of an alcohol-related problem in the electronic health record was determined by International Classification of Diseases, 9th Revision, Clinical Modification and International Statistical Classification of Diseases and Related Health Problems, Tenth Revision, Clinical Modification codes or use of medications for alcohol use disorder in past 2 years. Multivariable models adjusted for alcohol consumption, screening for a substance use disorder, urban residence, age, sex, race and ethnicity, income, educational level, and number of chronic health conditions.

RESULTS: A total of 3105 participants (mean [SD] age, 63.7 [13.0] years; 64.1% female; 11.5% Black, 7.0% Hispanic, 76.7% White, and 11.9% other race or chose not to disclose; 47.8% household income <$30 000; and 80.7% urban residence). Participants had a mean (SD) of 4.0 (1.7) chronic conditions, 9.1% reported higher-risk alcohol consumption, 4% screened positive for substance use disorder, and 6% had a documented alcohol-related problem in the electronic health record. Mean (SD) practice-level SDI score was 45.1 (20.9). In analyses adjusted for individual-level alcohol use, demographic characteristics, and health status, practice-level SDI was inversely associated with the odds of documentation (odds ratio for each 10-unit increase in SDI, 0.89; 95% CI, 0.80 to 0.99; P = .03).

CONCLUSIONS AND RELEVANCE: In this study, higher practice-level SDI was associated with lower odds of documentation of alcohol-related problems, after adjusting for individual-level covariates. These findings reinforce the need to address primary care practice-level barriers to diagnosis and documentation of alcohol-related problems. Practices located in high need areas may require more specialized training, resources, and practical evidence-based tools that are useful in settings where time is especially limited and patients are complex.

PMID:37856124 | DOI:10.1001/jamanetworkopen.2023.38224

JAMA Netw Open. 2023 Oct 2;6(10):e2338534. doi: 10.1001/jamanetworkopen.2023.38534.

ABSTRACT

IMPORTANCE: Motoric cognitive risk (MCR) is a novel predementia syndrome; however, whether it can estimate dementia in a nationwide population or has additive estimation validity over cognitive or motoric components alone remains unknown.

OBJECTIVE: To examine whether modified MCR, which incorporates the timed-up-and-go and one-leg-standing tests, improves estimation validity for incident dementia over using cognitive or motoric components alone.

DESIGN, SETTING, AND PARTICIPANTS: This nationwide cohort study evaluated data from individuals aged 66 years who participated in the National Screening Program for Transitional Ages in Korea from January 1, 2009, to December 31, 2013, and examined the association between MCR and incident dementia using Cox proportional hazards regression analysis. Data were collected from the index date (the date on which the participant had the screening) until dementia onset, death, or the end of the follow-up period, whichever came first. The 2 subtypes were defined as subjective cognitive declines with timed-up-and-go impairment or one-leg-standing impairment. The data set was generated with permission from the Korean National Health Insurance Service, and data analysis was conducted from August 2, 2021, to January 31, 2022. Individuals diagnosed with dementia or psychotic disorders or those who had a documented history of dementia medication use before the index date were excluded.

MAIN OUTCOMES AND MEASURES: The main outcome was incidence of dementia, defined as an individual receiving their first dementia medication with the relevant International Statistical Classification of Diseases and Related Health Problems, Tenth Revision, codes after the index date.

RESULTS: Among the 1 137 530 participants (53.7% women), 15 380 (1.4%) met the MCR criteria for the timed-up-and-go subtype, and 32 910 (2.9%) met the criteria for the one-leg-standing subtype. The mean (SD) follow-up period was 7.02 (1.38) years. Participants with MCR demonstrated an approximately 2-fold higher risk of incident dementia than those without MCR (timed-up-and-go subtype, adjusted hazard ratio, 2.03; 95% CI, 1.94-2.13; one-leg-standing subtype, adjusted hazard ratio, 2.05; 95% CI, 1.98-2.12).

CONCLUSIONS AND RELEVANCE: In this cohort study of participants aged 66 years of the National Screening Program for Transitional Ages, modified motoric cognitive risk had higher adjusted hazard ratios of incident dementia than individual cognitive or motoric components. Motoric cognitive risk may be a practical screening tool for estimating dementia among individuals in their mid-60s ; however, further investigation of the clinical and neurobiological aspects is necessary.

PMID:37856120 | DOI:10.1001/jamanetworkopen.2023.38534

JAMA Netw Open. 2023 Oct 2;6(10):e2338604. doi: 10.1001/jamanetworkopen.2023.38604.

ABSTRACT

IMPORTANCE: Cesarean birth rate among nulliparous, term, singleton, vertex (NTSV) pregnancies is a standard quality measure in obstetrical care. There are limited data on how the number and type of preexisting conditions affect mode of delivery among primigravidae, and it is also uncertain how maternal comorbidity burden differs across racial and ethnic groups and whether this helps to explain disparities in the NTSV cesarean birth rate.

OBJECTIVE: To determine the association between obstetric comorbidity index (OB-CMI) score and cesarean delivery among NTSV pregnancies and to evaluate whether disparities in mode of delivery exist based on race and ethnicity group after adjusting for covariate factors.

DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional study of deliveries between January 2019 and December 2021 took place across 7 hospitals within a large academic health system in New York and included all NTSV pregnancies identified in the electronic medical record system. Exclusion criteria were fetal demise and contraindication to labor.

EXPOSURE: The OB-CMI score. Covariate factors assessed included race and ethnicity group (American Indian or Alaska Native, Asian or Pacific Islander, Hispanic, non-Hispanic Black, non-Hispanic White, other or multiracial, and declined or unknown), public health insurance, and preferred language.

MAIN OUTCOME AND MEASURES: Cesarean delivery.

RESULTS: A total of 30 253 patients (mean [SD] age, 29.8 [5.4] years; 100% female) were included. Non-Hispanic White patients constituted the largest race and ethnicity group (43.7%), followed by Hispanic patients (16.2%), Asian or Pacific Islander patients (14.6%), and non-Hispanic Black patients (12.2%). The overall NTSV cesarean birth rate was 28.5% (n = 8632); the rate increased from 22.1% among patients with an OB-CMI score of 0 to greater than 55.0% when OB-CMI scores were 7 or higher. On multivariable mixed-effects logistic regression modeling, there was a statistically significant association between OB-CMI score group and cesarean delivery; each successive OB-CMI score group had an increased risk. Patients with an OB-CMI score of 4 or higher had more than 3 times greater odds of a cesarean birth (adjusted odds ratio, 3.14; 95% CI, 2.90-3.40) than those with an OB-CMI score of 0. Compared with non-Hispanic White patients, nearly all other race and ethnicity groups were at increased risk for cesarean delivery, and non-Hispanic Black patients were at highest risk (adjusted odds ratio, 1.43; 95% CI, 1.31-1.55).

CONCLUSIONS AND RELEVANCE: In this cross-sectional study of patients with NTSV pregnancies, OB-CMI score was positively associated with cesarean birth. Racial and ethnic disparities in this metric were observed. Although differences in the prevalence of preexisting conditions were seen across groups, this did not fully explain variation in cesarean delivery rates, suggesting that unmeasured clinical or nonclinical factors may have influenced the outcome.

PMID:37856118 | DOI:10.1001/jamanetworkopen.2023.38604