OBJECTIVE: This study aims to explore the perceived benefits and challenges, needs and preferences, and willingness of patients with diabetes to use mHealth apps for self-management of diabetes.
METHODS: The study involved one-on-one semistructured online interviews with a total of 15 participants, all of whom were aged 18 years or older and had been diagnosed with diabetes for more than 6 months. An interview guide was developed based on the constructs of the Technology Acceptance Model (TAM), the Health Information Technology Acceptance Model (HITAM), and the aesthetics factor derived from the Mobile Application Rating Scale. All interviews were recorded in audio format and transcribed verbatim. The interview content was then organized and coded using ATLAS.ti version 8. Thematic analysis was conducted in accordance with the recommended guidelines for analyzing the data.
RESULTS: From the interviews with participants, 3 key themes emerged regarding the perceived benefits of using mHealth app support in diabetes self-management. These themes were the ability to track and monitor diabetes control, assistance in making lifestyle modifications, and the facilitation of more informed treatment decision-making for health care professionals. The interviews with participants revealed 4 prominent themes regarding the perceived barriers to using mHealth app support for diabetes self-management. These themes were a lack of awareness about the availability of mHealth support, insufficient support in using mHealth apps, the perception that current mHealth apps do not align with users' specific needs, and limited digital literacy among users. The interviews with participants unveiled 4 key themes related to their needs and preferences concerning mHealth app support for diabetes self-management. These themes were the desire for educational information, user-friendly design features, carbohydrate-counting functionality, and the ability to engage socially with both peers and health care professionals. The majority of participants expressed their willingness to use mHealth apps if they received recommendations and guidance from health care professionals.
CONCLUSIONS: Patients generally perceive mHealth app support as beneficial for diabetes self-management and are willing to use these apps, particularly if recommended by health care professionals. However, several barriers may hinder the utilization of mHealth apps, including a lack of awareness and recommendations regarding these apps from health care professionals. To ensure the effective development of mHealth app support systems for diabetes self-management, it is crucial to implement user-centered design processes that consider the specific needs and preferences of patients. This approach will help create apps that are tailored to the requirements of individuals managing diabetes.
METHODS: In this phase 3, international, randomized trial, we assigned in a 1:1 ratio patients with advanced NSCLC with EGFR exon 20 insertions who had not received previous systemic therapy to receive intravenous amivantamab plus chemotherapy (amivantamab-chemotherapy) or chemotherapy alone. The primary outcome was progression-free survival according to blinded independent central review. Patients in the chemotherapy group who had disease progression were allowed to cross over to receive amivantamab monotherapy.
RESULTS: A total of 308 patients underwent randomization (153 to receive amivantamab-chemotherapy and 155 to receive chemotherapy alone). Progression-free survival was significantly longer in the amivantamab-chemotherapy group than in the chemotherapy group (median, 11.4 months and 6.7 months, respectively; hazard ratio for disease progression or death, 0.40; 95% confidence interval [CI], 0.30 to 0.53; P<0.001). At 18 months, progression-free survival was reported in 31% of the patients in the amivantamab-chemotherapy group and in 3% in the chemotherapy group; a complete or partial response at data cutoff was reported in 73% and 47%, respectively (rate ratio, 1.50; 95% CI, 1.32 to 1.68; P<0.001). In the interim overall survival analysis (33% maturity), the hazard ratio for death for amivantamab-chemotherapy as compared with chemotherapy was 0.67 (95% CI, 0.42 to 1.09; P = 0.11). The predominant adverse events associated with amivantamab-chemotherapy were reversible hematologic and EGFR-related toxic effects; 7% of patients discontinued amivantamab owing to adverse reactions.
CONCLUSIONS: The use of amivantamab-chemotherapy resulted in superior efficacy as compared with chemotherapy alone as first-line treatment of patients with advanced NSCLC with EGFR exon 20 insertions. (Funded by Janssen Research and Development; PAPILLON ClinicalTrials.gov number, NCT04538664.).
METHODS: In the global, open-label, phase 3 IMbrave050 study, adult patients with high-risk surgically resected or ablated hepatocellular carcinoma were recruited from 134 hospitals and medical centres in 26 countries in four WHO regions (European region, region of the Americas, South-East Asia region, and Western Pacific region). Patients were randomly assigned in a 1:1 ratio via an interactive voice-web response system using permuted blocks, using a block size of 4, to receive intravenous 1200 mg atezolizumab plus 15 mg/kg bevacizumab every 3 weeks for 17 cycles (12 months) or to active surveillance. The primary endpoint was recurrence-free survival by independent review facility assessment in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, NCT04102098.
FINDINGS: The intention-to-treat population included 668 patients randomly assigned between Dec 31, 2019, and Nov 25, 2021, to either atezolizumab plus bevacizumab (n=334) or to active surveillance (n=334). At the prespecified interim analysis (Oct 21, 2022), median duration of follow-up was 17·4 months (IQR 13·9-22·1). Adjuvant atezolizumab plus bevacizumab was associated with significantly improved recurrence-free survival (median, not evaluable [NE]; [95% CI 22·1-NE]) compared with active surveillance (median, NE [21·4-NE]; hazard ratio, 0·72 [adjusted 95% CI 0·53-0·98]; p=0·012). Grade 3 or 4 adverse events occurred in 136 (41%) of 332 patients who received atezolizumab plus bevacizumab and 44 (13%) of 330 patients in the active surveillance group. Grade 5 adverse events occurred in six patients (2%, two of which were treatment related) in the atezolizumab plus bevacizumab group, and one patient (<1%) in the active surveillance group. Both atezolizumab and bevacizumab were discontinued because of adverse events in 29 patients (9%) who received atezolizumab plus bevacizumab.
INTERPRETATION: Among patients at high risk of hepatocellular carcinoma recurrence following curative-intent resection or ablation, recurrence-free survival was improved in those who received atezolizumab plus bevacizumab versus active surveillance. To our knowledge, IMbrave050 is the first phase 3 study of adjuvant treatment for hepatocellular carcinoma to report positive results. However, longer follow-up for both recurrence-free and overall survival is needed to assess the benefit-risk profile more fully.
FUNDING: F Hoffmann-La Roche/Genentech.
OBJECTIVE: Thus, we aimed to determine the impacts of protein supplementation and exercise in older adults with sarcopenic obesity.
METHOD: A systematic database search was conducted for randomised controlled trials, quasi experimental study and pre-post study design addressing the effects of protein supplementation in improving sarcopenic obesity among older adults. This scoping review was conducted based on PRISMA-Scr guidelines across PubMed, Embase, Web of Science and Cochrane Library databases. To assess record eligibility, two independent reviewers performed a rigorous systematic screening process.
RESULTS: Of the 1,811 citations identified, 7 papers met the inclusion criteria. Six studies were randomised controlled trials and one study was a pre-post test study design. The majority of studies discussed the use of both protein supplements and exercise training. The included studies prescribed protein intake ranging from 1.0 to 1.8 g/kg/BW/day for the intervention group, while the duration of exercise performed ranged from 2 to 3 times per week, with each session lasting for 1 hour. Whey protein supplementation has been shown to be effective in improving sarcopenic conditions and weight status in SO individuals. The combination of exercise training especially resistance training and the used of protein supplement provided additional benefits in terms of lean muscle mass as well as biomarkers. The study also revealed a lack of consistency in exercise design among interventions for sarcopenic obesity.
CONCLUSION: Overall, it appears to be a promising option for SO individuals to improve their sarcopenic condition and weight status through the combination of resistance exercise and whey protein supplementation. However, it also highlights the need for caution when it comes to high amounts of protein intake prescription. Future research is warranted to investigate the optimal exercise design for this population, given the limited research conducted in this specific area.
METHODS: Treatment-naive patients with EGFR-mutated advanced NSCLC were randomized one-to-one to lazertinib (240 mg/d) or gefitinib (250 mg/d). Patients with asymptomatic or stable CNS metastases were included if any planned radiation, surgery, or steroids were completed more than 2 weeks before randomization. For patients with CNS metastases confirmed at screening or subsequently suspected, CNS imaging was performed every 6 weeks for 18 months, then every 12 weeks. End points assessed by blinded independent central review and Response Evaluation Criteria in Solid Tumors version 1.1 included intracranial progression-free survival, intracranial objective response rate, and intracranial duration of response.
RESULTS: Of the 393 patients enrolled in LASER301, 86 (lazertinib, n = 45; gefitinib, n = 41) had measurable and or non-measurable baseline CNS metastases. The median intracranial progression-free survival in the lazertinib group was 28.2 months (95% confidence interval [CI]: 14.8-28.2) versus 8.4 months (95% CI: 6.7-not reached [NR]) in the gefitinib group (hazard ratio = 0.42, 95% CI: 0.20-0.89, p = 0.02). Among patients with measurable CNS lesions, the intracranial objective response rate was numerically higher with lazertinib (94%; n = 17) versus gefitinib (73%; n = 11, p = 0.124). The median intracranial duration of response with lazertinib was NR (8.3-NR) versus 6.3 months (2.8-NR) with gefitinib. Tolerability was similar to the overall LASER301 population.
CONCLUSIONS: In patients with CNS metastases, lazertinib significantly improved intracranial progression-free survival compared with gefitinib, with more durable responses.