Category: Statistics

JCO Glob Oncol. 2025 Apr;11:e2400255. doi: 10.1200/GO-24-00255. Epub 2025 Apr 11.

ABSTRACT

PURPOSE: In 2012, Kenya announced its commitment to prioritizing cervical cancer (CC) services with the National Cervical Cancer Prevention Program. However, gaps in implementation remain, causing suboptimal uptake. The goal of this study is to provide a situational analysis of 19 government health facilities in Kenya to assess facilities’ capacity to provide CC screening and treatment.

METHODS: We conducted a retrospective data review at 19 health facilities in Siaya and Busia counties of Kenya from September 2021 to September 2022 to assess availability and uptake of CC services. Key variables included hospital volume, positivity, and numbers of women screened, treated, and referred. Notes were taken to document challenges with service provision and data collection. The retrospective review informed site matching for a proposed cluster-randomized trial.

RESULTS: There were a total of 16,757 CC screenings or rescreenings documented across the 19 study sites during the study period. Across the 19 facilities, 10.8% of the women enrolled in care at the hospital were screened during the data collection period. The overall positivity was 3.8% but ranged from 0.7% to 16.7%. Of the 19 facilities offering CC screening, five lacked the required equipment to provide same-day treatment, and complex referral pathways were noted for women needing to seek care elsewhere. Challenges with documentation were noted at all stages of CC services.

CONCLUSION: Gaps noted were low screening rates, opportunities to improve the efficiency of CC services, structural limitations in implementing the screen-and-treat approach, and poor documentation of CC services and outcomes. Urgent action is needed to ensure that all facilities offering CC screening are equipped with the personnel, supplies, and equipment necessary to conduct guideline-adherent same-day cryotherapy or thermal ablation treatment and improve documentation at the facility level to track CC services across the cascade of care.

PMID:40215437 | DOI:10.1200/GO-24-00255

J Clin Oncol. 2025 Apr 11:JCO2402026. doi: 10.1200/JCO-24-02026. Online ahead of print.

ABSTRACT

In the phase III CodeBreaK 300 study, sotorasib 960 mg-panitumumab significantly prolonged progression-free survival (PFS) versus investigator’s choice (trifluridine/tipiracil or regorafenib) in patients with KRAS G12C-mutated chemorefractory metastatic colorectal cancer (mCRC). One hundred sixty patients were randomly assigned 1:1:1 to receive sotorasib 960 mg-panitumumab (n = 53), sotorasib 240 mg-panitumumab (n = 53), or investigator’s choice (n = 54; crossover permitted after primary analysis). Overall survival (OS) analysis, a key secondary end point, although not adequately powered, was prespecified at 50% maturity (after approximately 80 deaths). In this study, we report the OS, updated overall response rates (ORRs), and data for safety. After a median follow-up of 13.6 months, 24, 28, and 30 deaths occurred in the sotorasib 960 mg-panitumumab, sotorasib 240 mg-panitumumab, and investigator’s choice arms, respectively; updated objective response rates (ORRs; 95% CI) were 30.2% (95% CI, 18.3 to 44.3), 7.5% (95% CI, 2.1 to 18.2), and 1.9% (95% CI, 0.0 to 9.9), respectively. Compared with investigator’s choice, the hazard ratios (HRs [95% CI]) for OS were 0.70 (95% CI, 0.41 to 1.18; two-sided P = .20) with sotorasib 960 mg-panitumumab and 0.83 (95% CI, 0.49 to 1.39; two-sided P = .50) with sotorasib 240 mg-panitumumab. No new safety signals were observed. Although not statistically significant, the observed OS HR and ORR along with prior PFS and safety findings support sotorasib 960 mg-panitumumab as a standard of care in patients with chemorefractory KRAS G12C mCRC.

PMID:40215429 | DOI:10.1200/JCO-24-02026

J Int Med Res. 2025 Apr;53(4):3000605251328617. doi: 10.1177/03000605251328617. Epub 2025 Apr 11.

ABSTRACT

IntroductionClavicular fractures, particularly comminuted fractures, are common injuries that can affect shoulder function and upper limb mobility. The management of these fractures, especially using surgical approaches and fixation methods, remains a key area of clinical focus. Preserving the periosteum during surgery may improve fracture healing and reduce complications. This study explored the clinical efficacy of a periosteum-preserving surgical technique combined with a Nice knot-assisted locking plate for treating comminuted clavicular fractures.MethodsA total of 85 patients with comminuted clavicular fractures were included in this retrospective study. According to the Allman classification, 56 (65.9%) cases were type IC, 19 (22.4%) were type II, 9 (10.9%) were type III, and 1 (1.1%) involved comminuted fractures across the entire clavicle. All patients underwent surgical treatment using a periosteum-preserving approach combined with a Nice knot-assisted locking plate. Fracture healing time, upper limb function (measured via Constant-Murley score and disabilities of the arm, shoulder, and hand questionnaire), and postoperative complications were assessed 6 and 12 months postoperatively.ResultsThe median healing time was 13 weeks, with no cases of nonunion reported. At 6 months postoperatively, the Constant-Murley and disabilities of the arm, shoulder, and hand scores were excellent. Although a statistically significant difference (P < 0.05) was observed in these scores between 6 and 12 months, all patients reported satisfactory recovery of shoulder function and upper limb mobility. No significant differences (P > 0.05) in fracture healing time or upper limb function recovery were observed across different types of clavicular fractures. Six (7.1%) patients experienced temporary numbness in the subclavian region, which gradually resolved by the final follow-up.ConclusionThe periosteum-preserving approach with Nice knot-assisted locking plate fixation proved to be an effective and reliable treatment for comminuted clavicular fractures. The technique was associated with favorable healing times, excellent functional outcomes, and low complication rates. Preservation of the periosteum and soft tissue during surgery may considerably reduce intraoperative trauma and improve postsurgical recovery. Further studies with larger sample sizes and longer follow-up periods are needed to confirm the long-term benefits of this approach.

PMID:40215412 | DOI:10.1177/03000605251328617

J Int Med Res. 2025 Apr;53(4):3000605251328608. doi: 10.1177/03000605251328608. Epub 2025 Apr 11.

ABSTRACT

BackgroundWhite spot lesion formation around orthodontic brackets is a major complication associated with fixed orthodontic treatment.ObjectiveThis review aimed to evaluate the current evidence regarding the differences in white spot lesion formation between self-ligating and conventional ligating brackets.MethodsEleven bibliographic databases were searched until January 2025. This review covered parallel-group and split-mouth randomized controlled trials, controlled clinical trials, and cross-sectional studies that investigated the differences in white spot lesion formation between self-ligating and conventional ligating brackets.ResultsThree randomized controlled trials, one controlled clinical trial, and one cross-sectional study were included in this systematic review. Among these, three studies were classified as having a low risk of bias. Four of the five included studies showed no statistically significant difference in white spot lesion formation between the two types of bracket systems (p < 0.05).ConclusionThere are no potential differences in white spot lesion formation between self-ligating and conventional ligating bracket systems. However, orthodontists must be aware of the other factors affecting white spot lesion formation, with oral hygiene being the most critical factor.Registration: The protocol was registered in the PROSPERO database (CRD42022353478) on 25 August 2022.

PMID:40215411 | DOI:10.1177/03000605251328608

J Int Med Res. 2025 Apr;53(4):3000605251328245. doi: 10.1177/03000605251328245. Epub 2025 Apr 11.

ABSTRACT

ObjectivesThis study aimed to identify risk factors for postoperative recurrence in patients with perianal fistulizing Crohn’s disease and assess the predictive value of fecal calprotectin and serum miRNA6086.MethodsFrom 105 patients with perianal fistulizing Crohn’s disease, blood and fecal samples as well as clinical data were collected. Analysis of blood tests, C-reactive protein, miRNA6086, and fecal calprotectin revealed postoperative recurrence risk factors. Receiver operating characteristic curve analysis assessed the predictive accuracy of miRNA6086 and fecal calprotectin for perianal fistulizing Crohn’s disease recurrence and determined their optimal cutoff values, sensitivity, and specificity.ResultsOf the 105 patients with perianal fistulizing Crohn’s disease, 33 (31.4%) experienced recurrence. Anal fistula type, preoperative miRNA6086, and fecal calprotectin levels were identified as independent risk factors for postoperative recurrence. Receiver operating characteristic curve analysis revealed that miRNA6086 had a cutoff value of 0.3195, sensitivity of 65.28%, specificity of 66.67%, and area under curve value of 0.6589 (95% confidence interval, 0.5503-0.7674). Fecal calprotectin had a cutoff value of 0.6073, sensitivity of 81.94%, specificity of 78.79%, and area under curve value of 0.8224 (95% confidence interval, 0.5503-0.7674). Combined miRNA6086 and fecal calprotectin detection had a cutoff value of 0.7121, sensitivity of 83.33%, specificity of 87.88%, and area under curve value of 0.9146 (95% confidence interval, 0.8547-0.9744).ConclusionAnal fistula type, preoperative miRNA6086, and fecal calprotectin levels are independent risk factors for perianal fistulizing Crohn’s disease recurrence. Combined detection of miRNA6086 and fecal calprotectin levels enhances predictive accuracy for postoperative recurrence.

PMID:40215410 | DOI:10.1177/03000605251328245

JMIR Form Res. 2025 Apr 11;9:e65188. doi: 10.2196/65188.

ABSTRACT

BACKGROUND: Allogeneic hematopoietic stem cell transplantation (allo-SCT) is an effective treatment for various hematologic cancers, though it often results in severe side effects and psychological distress, which can negatively impact health outcomes. Integrative therapies like mindfulness-based stress reduction (MBSR), mindfulness meditation (MM), and music therapy (MT) yield promising results in enhancing both psychosocial outcomes (eg, reducing anxiety and depression) and physiological adaptation (eg, decreasing inflammation) in cancer patients.

OBJECTIVE: We developed and refined, using focus groups and environmental and field testing, an eHealth-delivered mindfulness-based music therapy (eMBMT) intervention aimed at improving health-related quality of life, symptom burden (ie, pain, fatigue, and sleep), disease activity (ie, chronic graft-versus-host disease, cytomegalovirus activation, and infections) and psychosocial (ie, depression, anxiety, and cancer-specific distress) and physiological adaptation (ie, inflammation and immune reconstitution) tailored to adults receiving allo-SCT.

METHODS: eMBMT intervention content is grounded in MT, MM, and MBSR, developed by a multidisciplinary team, and adapted for adults undergoing allo-SCT. eMBMT content was refined through focus groups and usability and field testing. Focus groups used a semistructured interview guide, while field testing used the “think aloud” method. Usability was evaluated using the 30-item Usefulness, Satisfaction, and Ease of Use (USE) questionnaire. Descriptive statistics analyzed the USE questionnaire and participant characteristics, while rapid qualitative analysis was applied to focus groups and field-testing sessions. Survivors eligible to participate in the focus groups and usability and field testing were adults (>18 years old) who received an allo-SCT (<36 months) for myelodysplastic syndrome, acute myeloid leukemia, or chronic myeloid leukemia, and were in remission for greater than 3 months.

RESULTS: During the focus groups, participants (n=11; mean age 43.6, SD 17.8 years) provided qualitative feedback highlighting the shock of diagnosis, challenges during hospitalization, and coping strategies posttreatment. The eMBMT platform received positive evaluations for usefulness (mean 6.47, SD 0.29), ease of use (mean 6.92, SD 0.60), and satisfaction (mean 6.16, SD 0.82). Key themes from field testing highlighted the significance of social support, hope, and maintaining an active lifestyle. Suggestions for improvement included incorporating more representative content, reducing text, enhancing guidance, offering diverse music options, and streamlining blood sample collection.

CONCLUSIONS: The eMBMT intervention is a comprehensive, user-friendly eHealth tool tailored to the unique needs of allo-SCT patients. The positive feedback and identified areas for improvement underscore its potential to enhance well-being, symptom management, and overall quality of life for cancer survivors. A future pilot randomized controlled trial will further evaluate the feasibility, acceptability, and preliminary efficacy of the eMBMT intervention in improving health-related quality of life, symptom burden, disease activity, and psychosocial and physiological adaptation.

PMID:40215402 | DOI:10.2196/65188

JMIR Form Res. 2025 Apr 11;9:e67275. doi: 10.2196/67275.

ABSTRACT

BACKGROUND: Evidence-based guidelines support the use of structured exercise to facilitate concussion recovery. Despite the growing number of mobile health (mHealth) apps aimed at managing concussions, few focus on delivering exercise rehabilitation protocols. Therefore, a mobile app was developed to provide personalized rehabilitation programs based on evidence-based exercise principles designed to cater to individuals recovering from concussions.

OBJECTIVE: This study aimed to evaluate the usability and user experience of a mobile app designed to deliver an evidence-based rehabilitation program to individuals recovering from concussions.

METHODS: A two-week prospective single-arm pilot study was conducted among adults with a physician-diagnosed concussion. Participants engaged in home-based rehabilitation exercises through a mobile app. Usability was assessed using a combination of the mHealth App Usability Questionnaire (MAUQ) and five custom questions evaluating confidence in recommendations, exercise flow, clarity of voice commands, and usability of the exercise report feature. Following the two-week period, participants rated each question on a 7-point Likert scale ranging from “strongly agree” to “strongly disagree”.

RESULTS: Twenty-six participants consented and were enrolled in the study, with 23 participants (82%) completing all study components at the end of two weeks. The majority of participants were women, aged 26-38 years, and on average, approximately at three months postconcussion. Responses to both the MAUQ and custom questions were overwhelmingly positive. Overall, seven MAUQ questions received 100% positive responses, with no single question scoring below 83% positive responses. In the “ease of use and satisfaction” category, 100% of users responded positively to questions on ease of learning, usability, interface likeness, and comfort in social settings, while 83%-96% (19-22) of users responded positively to the remaining four questions. In the “system information arrangement” category, 100% (N=23) of users rated screen navigation, function usability, and health care service acceptability positively, with 87%-96% of users approving action acknowledgment, error recovery, and expected functions. Under the “usefulness” category, 96% (n=22) of users found the app beneficial for health and well-being, and 91% (n=21) users felt it effectively managed their health. For the five custom questions, 100% (N=23) users responded positively to voice command clarity, exercise awareness, ease of following exercises, and report understandability, with a single unfavorable response noted for confidence in app recommendations.

CONCLUSIONS: The findings of this study indicate that the mobile app is a user-friendly platform for delivering evidence-based exercise rehabilitation to individuals recovering from concussions. Positive user feedback, particularly in the areas of recommendation confidence, ease of exercise flow, and clarity of voice commands, highlights the app’s potential to support concussion recovery. Future iterations of the app will aim to improve time efficiency and streamline error recovery processes to further enhance the user experience.

PMID:40215401 | DOI:10.2196/67275

J Clin Psychiatry. 2025 Apr 2;86(2):24m15516. doi: 10.4088/JCP.24m15516.

ABSTRACT

Objectives: To describe the characteristics, clinical trajectories, and disposition of older adults consulting in the emergency department (ED) for mental health issues. The secondary objective was to explore the impact of age, sex, and living environment on those patients’ clinical care and disposition.

Methods: This registry study included data from 5 Canadian EDs. Patients were included if they were aged ≥65 years and consulting in the ED between March 1, 2020, and March 31, 2021, for mental health issues. Relative risks (RRs) were obtained using a modified Poisson regression model, and 95% confidence intervals (CIs) were estimated with a robust variance estimator.

Results: 1,673 patients were included. The mean ±SD age was 75.2±8.1 years; 58.8% were female, and 87.4% had a prior history of mental health issues. Suicidal ideations (40.8%) and neurocognitive disorders (31.8%) were the most frequent diagnostic impressions. 52.0% were assessed by a psychiatrist, and 49.9% were discharged from the ED. Males were at higher risk of neurocognitive (RR: 1.16 [95% CI, 1.01-1.32]) and substance use disorders (RR: 1.54 [95% CI, 1.19-1.99]). Patients aged ≥85 were more likely to be physically/chemically restrained and less likely to be assessed by psychiatry and hospitalized (RR: 1.69 [95% CI, 1.14-2.50], RR: 0.62 [95% CI, 0.52-0.74], RR: 0.73 [95% CI, 0.57-0.95]).

Conclusion: This study highlights that most older ED patients consulting for mental health issues had a prior history of such issues. A psychiatrist assessed most patients, but those aged ≥85 were less likely to be assessed or hospitalized, yet more likely to be restrained. These results should be considered when designing targeted investigations to meet the complex needs of this population.

PMID:40215386 | DOI:10.4088/JCP.24m15516

J Clin Psychiatry. 2025 Mar 31;86(2):24m15476. doi: 10.4088/JCP.24m15476.

ABSTRACT

Background: Major depressive disorder (MDD) has been associated with both all cause and suicide mortality in young adults. However, the effects of parental severe mental disorders (SMDs), such as schizophrenia, bipolar disorder, MDD, alcohol use disorder (AUD), and substance use disorder, on the risks of all-cause and suicide mortality in adolescents and young adults with MDD remain unclear.

Methods: We retrospectively evaluated the incidence of all-cause and suicide mortality (2001-2011) in 196,000 adolescents (age: 10-17 years) and young adults (age: 18-29 years) with MDD. We investigated associations between parental SMDs and all-cause and suicide mortality among patients with MDD using Cox regression analyses. In addition, we assessed the additive effects of paternal and maternal SMDs on the mortality risk of depressed offspring.

Results: Our findings revealed that all cause mortality in offspring was associated with paternal AUD (hazard ratio [HR]: 1.66) as well as maternal schizophrenia (HR: 2.77), bipolar disorder (HR: 1.99), and MDD (HR: 1.25). Furthermore, suicide mortality in offspring was associated with maternal schizophrenia (HR: 4.36) and bipolar disorder (HR: 4.01). Notably, the risk of suicide mortality was the highest in offspring with paternal bipolar disorder and maternal MDD (HR: 7.31).

Conclusion: Parental SMDs such as schizophrenia, bipolar disorder, MDD, and AUD are associated with all-cause and suicide mortality in adolescents and young adults with MDD. Optimizing support systems and prioritizing early interventions for parental mental health problems may help reduce the risks of suicide and premature death in young patients with MDD.

PMID:40215383 | DOI:10.4088/JCP.24m15476

JMIR Form Res. 2025 Apr 11;9:e63700. doi: 10.2196/63700.

ABSTRACT

BACKGROUND: Dependent older people or those losing their autonomy are at risk of emergency hospitalization. Digital systems that monitor health remotely could be useful in reducing these visits by detecting worsening health conditions earlier. However, few studies have assessed the medico-economic impact of these systems, particularly for older people.

OBJECTIVE: The objective of this study was to compare the clinical and economic impacts of an eHealth device in real life compared with the usual monitoring of older people living at home.

METHODS: This study was a comparative, retrospective, and controlled trial on data collected between May 31, 2021, and May 31, 2022, in one health care and home nursing center located in Brittany, France. Participants had to be aged >75 years, living at home, and receiving assistance from the home care service for at least 1 month. We implemented among the intervention group an eHealth system that produces an alert for a high risk of emergency department visits or hospitalizations. After each home visit, the home care aides completed a questionnaire on participants’ functional status using a smartphone app, and the information was processed in real time by a previously developed machine learning algorithm that identifies patients at risk of an emergency visit within 7 to 14 days. In the case of predicted risk, the eHealth system alerted a coordinating nurse who could then inform the family carer and the patient’s nurses or general practitioner.

RESULTS: A total of 120 patients were included in the study, with 60 in the control group and 60 in the intervention group. Among the 726 visits from the intervention group that were not followed by an alert, only 4 (0.6%) resulted in hospitalizations (P<.001), confirming the relevance of the system’s alerts. Over the course of the study, 37 hospitalizations were recorded for 25 (20.8%) of the 120 patients. Additionally, of the 120 patients, 9 (7.5%) were admitted to a nursing home, and 7 (5.8%) died. Patients in the intervention group (56/60, 93%) remained at home significantly more often than those in the control group (48/60, 80%; P=.03). The total cost of primary care and hospitalization during the study was €167,000 (€1=US $1.09), with €108,000 (64.81%) attributed to the intervention group (P=.20).

CONCLUSIONS: This study presents encouraging results on the impact of a remote medical monitoring system for older adults, demonstrating a reduction in both emergency department visits and hospitalization costs.

TRIAL REGISTRATION: ClinicalTrials.gov NCT05221697; https://clinicaltrials.gov/study/NCT05221697.

PMID:40215100 | DOI:10.2196/63700