Daily and Weekly Iron Supplementations to Improve Iron Status in Infants: A Randomized Controlled Trial

Background: Iron deficiency anemia screening and iron supplementation in infants aged 6 to12 months are recommended in the Guideline in Child Health Supervision. Objective: To evaluate the effectiveness of weekly iron supplementation compared with daily supplementation in improving the iron status in infants. Materials and Methods: A single-blind randomized controlled trial was conducted in infants aged 6 months visiting the Well Child Clinic between May 2019 and November 2020 at Burapha University Hospital, Chonburi, Thailand. The intervention consisted of either daily or weekly iron supplementation combined with iron-rich complementary food promotion for six months. The outcomes were the differences of serum ferritin and hematological variables before and after being iron supplemented. Results: Sixty-nine of the six-month-old healthy infants were randomized to receive either 10 mg Fe/day as the daily group or 30 mg Fe/week as the weekly group. Forty-five infants with 24 in the daily group and 21 in the weekly group completed the intervention. After the six-month period of iron supplementation, the average differences of serum ferritin in the daily and the weekly group were 10.85 (–13.19, 34.49) and –9.31 (–23.86, –2.30) ng/mL, respectively (p=0.012). The average differences of hemoglobin in the daily and the weekly group were 0.58±0.82 and 0.08±0.59 g/dL, respectively (95% CI 0.06 to 0.93; p=0.026). Conclusion: Daily iron supplementation of 10 mg/day is more effective than 30 mg weekly iron supplementation in improving iron status and hemoglobin level in the Thai infants. Keywords: Anemia; Ferritin; Infants; Iron deficiency; Iron supplementation

High-Ecological Cognitive Intervention to Improve Cognitive Skills and Cognitive–Functional Performance for Older Adults With Mild Cognitive Impairment

Importance: Evidence of the effectiveness of cognitive activity and preparatory tasks in improving the cognitive skills and functional performance of people with cognitive decline is limited. Objective: To examine the efficacy of a high-ecological cognitive intervention. Design: Quasi-experimental, pretest–posttest design with nonequivalent control. Setting: Community. Participants: Older adults with mild cognitive impairment from two senior centers. Intervention: Twelve 90-min weekly group sessions of a high-ecological cognitive intervention using simulated everyday cognitive tasks (experimental group) and of nutrition education (active control group). Outcomes and Measures: Cognitive skills were measured with the Color Trails Test (CTT), the Contextual Memory Test (CMT; Immediate Recall [CMT–Im] and Delayed Recall [CMT–De] tasks), and the Wechsler Adult Intelligence Scale–Fourth Edition Digit Span subtest (Digits Forward and Digits Backward). Cognitive–functional performance was measured with the Rivermead Behavioural Memory Test–Third Edition (RBMT–3; Immediate Recall [RBMT–3–Im] and Delayed Recall [RBMT–3–De] tasks) and the Cognitive Failures Questionnaire (CFQ). Results: Thirty-seven participants (M age = 70.84 yr; 70.3% women) met the inclusion criteria for analysis (20 participants in the intervention group, 17 participants in the control group). Multivariate linear regression showed that the intervention group improved significantly more than the control group on the CTT, CMT–Im, and RBMT–3–Im but not on the CMT–De, RBMT–3–De, and CFQ. Conclusions and Relevance: Twelve 90-min weekly group sessions of a high-ecological cognitive intervention improved attention, executive function, immediate memory, and objective cognitive–functional performance with immediate-memory task demands. What This Article Adds: Carefully designed and structured simulated everyday cognitive tasks can be used as a cognitive training agent to improve both cognitive skills and objective cognitive–functional performance. The effectiveness of group-based cognitive interventions depends on the skills of occupational therapy practitioners in activity analysis and grading.

Yoga, cognitive–behavioural therapy versus education to improve quality of life and reduce healthcare costs in people with endometriosis: a randomised controlled trial

IntroductionEndometriosis is a debilitating chronic inflammatory condition highly burdensome to the healthcare system. The present trial will establish the efficacy of (1) yoga and (2) cognitive–behavioural therapy (CBT), above (3) education, on quality of life, biopsychosocial outcomes and cost-effectiveness.Methods and analysisThis study is a parallel randomised controlled trial. Participants will be randomly allocated to yoga, CBT or education. Participants will be English-speaking adults, have a diagnosis of endometriosis by a qualified physician, with pain for at least 6 months, and access to internet. Participants will attend 8 weekly group CBT sessions of 120 min; or 8 weekly group yoga sessions of 60 min; or receive weekly educational handouts on endometriosis. The primary outcome measure is quality of life. The analysis will include mixed-effects analysis of variance and linear models, cost–utility analysis from a societal and health system perspective and qualitative thematic analysis.Ethics and disseminationEnrolment in the study is voluntary and participants can withdraw at any time. Participants will be given the option to discuss the study with their next of kin/treating physician. Findings will be disseminated via publications, conferences and briefs to professional organisations. The University’s media team will also be used to further disseminate via lay person articles and media releases.Trial registration numberACTRN12620000756921p; Pre-results.

Weekly chemotherapy as first line treatment in frail head and neck cancer patients in the immunotherapy era

Objective First-line therapy for metastatic squamous cell carcinoma of the head and neck (R/M HNSCC) has been revolutionized by the introduction of anti-checkpoint monoclonal antibodies, which have shown a significant improvement in overall survival (OS) gaining approval in a first line setting. Efficacy and safety of first-line weekly chemotherapy, compared to 3-weeks treatment, was retrospectively evaluated in a frail patient population with R/M HNSCC with the aim to evaluate its role as part of a personalized first-line approach. Methods A total of 124 patients with locally incurable R/M HNSCC receiving weekly (21) or three-weekly (103) chemotherapy plus cetuximab in a first line setting from December 2010 to September 2020 were retrospectively reviewed. Treatment outcomes in terms of objective response rate (ORR), progression-free survival (PFS), overall survival (OS) and toxicities were analysed. Results Patients in the three-week subgroup were ECOG PS 0 (39) and 1 (64) while patients in weekly group (21) were all PS 2. No significant differences were reported in terms of age, sex, smoking and previous alcohol abuse considering the two distinct subgroups. Moreover, no statistically significant difference was found in PFS and OS between the two treatment subgroups. The response rate was 35% (36 patients) and 34% (7 patients) in three-week and weekly treatment group, respectively. Seventy patients (68%) in the three-week group experienced chemotherapy-related toxicities, predominantly G3. In the weekly group a predominantly low-grade toxicity was found in a lower number of patients (52%). Conclusion The weekly schedule appears to be an active and safe strategy in frail patients with R/M HNSCC. Based on these data, a weekly schedule could be considered as a first line treatment in all frail patients excluded from pembrolizumab treatment and a study on the combination of weekly chemotherapy and immunotherapy should be performed.

Group Support for Smoking Cessation: Importance of the Smoker's Choice for Better Outcomes

Smoking cessation method effectiveness is discussed among socially disadvantaged smokers. Our aim was to measure real-life effectiveness of the choice of a multi-component group intervention in comparison with individual usual care. We report an observational study (N = 100). Disadvantaged smokers were screened with a validated tool. We designed a multi-component structured behavioural group intervention, delivered in weekly group sessions during 6 weeks. Usual care consisted of individual visits. Both groups received free nicotine replacement therapy. We observed 33 smokers participating in the group intervention, while 67 received usual care. Abstinence at 6 weeks was 24.2% (n = 8) in the group intervention versus 11.9% (n = 8) in usual care (p = .115). Also, 36.4% (n = 12) of group intervention patients had reduced their cigarette consumption versus 16.4% (n = 11) in usual care (p = .026). In addition, 6.1% (n = 2) dropped out of group versus 31.3% (n = 21) in usual care (p = .005). Finally, 6 months after their first visit, 15.2% (n = 5) of group intervention patients and 4.5% (n = 3) in usual care were abstinent (p = .111). Group intervention choice versus usual care might facilitate smoking abstinence, reduction, and follow-up adherence.

Weekly Chemotherapy as First Line Treatment in Frail Head and Neck Cancer Patients in the Immunotherapy Era

Objective: First-line therapy for metastatic squamous cell carcinoma of the head and neck (R/M HNSCC) has been revolutionized by the introduction of anti-checkpoint monoclonal antibodies, that have shown a significant improvement in overall survival (OS) gaining the approval in first line setting. Efficacy and safety of first-line weekly chemotherapy, compared to three-weeks treatment, was retrospectively evaluated in frail patients’ population with R/M HNSCC with the aim to evaluate its role as part of a personalized first-line approach.Methods: A total of 124 patients with locally incurable R/M HNSCC receiving weekly (21) or three-weekly (103) chemotherapy plus cetuximab in first line setting from December 2010 to September 2020 were retrospectively reviewed. Treatment outcomes in terms of objective response rate (ORR), progression-free survival (PFS), OS and toxicities were analyzed.Results: Patients in the three-week subgroup were ECOG PS 0 (39) and 1 (64) while patients (21) in weekly group were all PS 2. No significant differences were reported in terms of age, sex, smoking and previous alcohol abuse considering the two distinct subgroups. Moreover, no statistically significant difference was found in PFS and OS between the two treatment subgroups. The response rate was 35 % (36 patients) and 34 % (7 patients) in three-week and weekly treatment group, respectively. Seventy patients (68%) in the three-week group experienced chemotherapy-related toxicities, predominantly G3. In the weekly group a predominantly low-grade toxicity was found in a lower number of patients (52%).Conclusion: The weekly schedule appears an active and safe strategy in frail patients with R/M HNSCC. Based on our data, the weekly schedule could currently be considered in all frail patients and study of combination of weekly chemotherapy and immunotherapy should be performed.

Cost-Effectiveness Analysis of 12-Versus 4-Weekly Administration of Bone-Targeted Agents in Patients with Bone Metastases from Breast and Castration-Resistant Prostate Cancer

A cost–utility analysis was performed based on the Rethinking Clinical Trials (REaCT) bone-targeted agents (BTA) clinical trial that compared 12-weekly (once every 12 weeks) (n = 130) versus 4-weekly (once every 4 weeks) (n = 133) BTA dosing for metastatic breast and castration-resistant prostate (CRPC) cancer. Using a decision tree model, we calculated treatment and symptomatic skeletal event (SSE) costs as well as quality-adjusted life-years (QALYs) for each treatment option. Deterministic and probabilistic sensitivity analyses were performed to assess the robustness of the study findings. The total cost of BTA treatment in Canadian dollars (C$) and estimated QALYs was C$8965.03 and 0.605 QALY in the 4-weekly group versus C$5669.95 and 0.612 QALY in the 12-weekly group, respectively. De-escalation from 4-weekly to 12-weekly BTA reduces cost (C$3293.75) and improves QALYs by 0.008 unit, suggesting that 12-weekly BTA dominates 4-weekly BTA in breast and CRPC patients with bone metastases. Sensitivity analysis suggests high levels of uncertainty in the cost-effectiveness findings. De-escalation of bone-targeted agents is cost-effective from the Canadian public payer’s perspective.

A Randomized Controlled Trial of Daily and Weekly Iron Supplementations for Improving Iron Status in the Infants

Background: Iron deficiency anemia screening and iron supplementation in infants aged 6-12 months are recommended in the Guideline in Child Health Supervision. This study aims to evaluate the effectiveness of weekly iron supplementation compared with daily supplementation in improving the iron status in infants.Methods: A single-blind randomized controlled trial was conducted in infants aged 6 months visiting the Well Child Clinic between May 2019 and November 2020 at Burapha University Hospital, Chonburi, Thailand. The intervention consisted of either daily or weekly iron supplementation combined with iron-rich complementary food promotion for six months. The outcomes were the differences of serum ferritin and hematological variables before and after being iron supplemented. Results: Sixty-nine six-month-old healthy infants were randomized to receive either 10 mg Fe/day (daily group) or 30 mg Fe/week (weekly group). Forty-five infants (daily group; n = 24 and weekly group; n = 21) completed the intervention. After the six-month period of iron supplementation, the mean differences of serum ferritin in the daily and the weekly group were 8.78±37.21 and -13.05 ±17.53 ng/mL, respectively (95%CI: 4.54, 39.12; P=0.015). The mean differences of hemoglobin in the daily and the weekly group were 0.58±0.82 and 0.08±0.59 g/dL, respectively (95%CI: 0.06, 0.93; P=0.026). Daily supplementation could prevent iron deficiency more than weekly supplementation significantly (P=0.029), particularly in the exclusive breastfeeding subgroup (P=0.032).Conclusions: Daily iron supplementation is more effective than weekly iron supplementation in improving iron status and hemoglobin level in infants, especially in the exclusively breast-feds.Trial registration: TCTR20191107001, November 7th, 2019. Retrospectively registered, http://www.thaiclinicaltrials.org