OBJECTIVE: To assess the impact of digital picture books on preoperative anxiety, pain and sleep quality in young children undergoing cardiac catheterisation and the anxiety of their family caregivers.
METHODS: A randomised, single-blinded, two-arm, parallel-group controlled trial.
METHODS: Participants are young children aged 2-7 years with congenital heart disease scheduled for cardiac catheterisation and their family caregivers. They were enrolled at Fujian Medical University Union Hospital between September 2022 and July 2023. They were randomised to either a control group receiving usual care or an intervention group receiving digital picture book sessions. Anxiety and pain levels were assessed using standardised scales, and sleep quality was measured using actigraphy.
RESULTS: The study included 64 pairs of young children and family caregivers. Digital picture books significantly reduced preoperative anxiety and bandage removal pain in children and anxiety in family caregivers. However, there was no statistical difference in sleep quality between the intervention group and the control group.
CONCLUSIONS: Digital picture books prove to be an effective intervention for reducing anxiety and pain in paediatric cardiac catheterisation patients and anxiety of their family caregivers. The intervention did not affect sleep quality, suggesting the need for additional strategies to address this aspect of the hospital experience.
UNASSIGNED: This study demonstrated the effectiveness of digitally illustrated books in reducing preoperative anxiety and pain in young children and anxiety in family caregivers. Digital picture books offer a creative and engaging way to help children and their families cope with the stress and anxiety associated with medical procedures. Further research in this area may lead to the development of more innovative and effective interventions for paediatric patients and their family caregivers.
CONCLUSIONS: The study\'s impact lies in its innovative approach to addressing the psychological and emotional challenges faced by young children and their family caregivers during the stressful experience of cardiac catheterisation. By demonstrating the efficacy of digital picture books in significantly reducing preoperative anxiety and postoperative pain, the research presents a non-pharmacological, accessible and engaging intervention that can be seamlessly integrated into existing healthcare practices. The findings have the potential to transform paediatric care by offering a safe, developmentally appropriate and cost-effective method to support the emotional well-being of children and their families, thereby enhancing the overall patient experience and clinical outcomes. Moreover, the study\'s emphasis on family caregiver involvement underscores the importance of a holistic approach to care that considers the needs of both the patient and their support system.
UNASSIGNED: Children and their family caregivers were invited to provide valuable input which has been critical to the development of the intervention. The participant information sheet and consent form, as well as the consent/recruitment process, were reviewed by a consumer advisor advocate from the pilot study.
UNASSIGNED: CONSORT.
BACKGROUND: Chinese clinical trial registry: ChiCTR2200063973. Registered on 22 September 2022, https://www.chictr.org.cn/showproj.html?proj=132833.

暂无摘要。

UNASSIGNED: There is currently no self-management package designed to meet the needs of people with pulmonary fibrosis (PF). This study evaluated the feasibility and acceptability of a PF-specific self-management package.
UNASSIGNED: Adults with PF were randomly allocated (1:1) to either receive the self-management package with healthcare professional (HCP) support or standardised PF information. Primary outcomes were feasibility and acceptability of the intervention. Secondary outcomes included health-related quality of life, self-efficacy, breathlessness, daily steps, use of PF-related treatments, and healthcare utilisation. Participants\' experiences of using the package were explored using qualitative interviews.
UNASSIGNED: Thirty participants were included. Recruitment rate was 91% and 100% of those recruited were randomised. Eighty-seven percent of participants who received the package read ≥1 module and set a goal. Secondary outcomes were feasible to collect with high assessment completion rates (87%). Most participants reported the package was easy to use and enhanced knowledge, but suggested some improvements, while HCP support was highly valued.
UNASSIGNED: A PF-specific self-management package was feasible to deliver and requires further testing in a trial powered to detect changes in clinical outcomes.
UNASSIGNED: This is the first self-management package designed specifically for people with PF, informed by patient experience and expert consensus.

Purpose Video laryngoscopes were being used more often in cases of potentially difficult airways. The Karl Storz video stylet offered clear advantages over conventional laryngoscopes for patients with cervical spine fractures. This study aimed to compare the performance of the C-MAC video laryngoscope with the new Karl Storz video stylet in patients with simulated cervical fracture injuries. Material and methods The study, approved by the Board of Studies and the Ethical Committee of Jawaharlal Nehru Medical College and Hospital in Aligarh, involved 50 patients undergoing operative procedures under general anaesthesia. It was a prospective randomised controlled study on patients aged 20-60, weighing 30-80 kg, and classified as American Society of Anesthesiologists (ASA) Grades I and II, admitted for elective operative procedures. Patients were randomly assigned to two groups for intubation using different devices: the control group (N = 25) was intubated with the C-MAC (Mac blade) video laryngoscope (CM), and the study group (N = 25) was intubated with the Karl Storz video stylet (VS). The anaesthetic procedure involved a detailed pre-anesthetic check-up for all patients, including a medical history review, physical examination, and necessary tests based on age. Standard monitoring and pre-medication were administered uniformly. Anesthesia was induced and intubation was attempted using appropriate devices, following manual stabilisation of the neck. Parameters such as intubation attempts, time taken, failures, hemodynamic changes, and complications were recorded throughout the procedure. If intubation was unsuccessful, alternative measures were taken, and the operative procedure proceeded. Results The intubation success rates were compared between the two groups, CM and VS. In the CM group, all 25 patients (100%) were successfully intubated on the first attempt, while in the VS group, 23 patients (92%) were successfully intubated on the first attempt, and two patients (8%) required two attempts. The difference in the distribution of the number of attempts between the two groups was not statistically significant (p = 0.4915). The mean intubation time in the CM group was 27.24 ± 2.16 seconds, while in the VS group, the mean intubation time was significantly longer at 30.84 ± 6.81 seconds, with a statistically significant difference (p = 0.0105). Adjustment manoeuvres were required in only 4% of patients in the CM group compared to 0% in the VS group, although this difference was not statistically significant. The occurrence of blood on the device during intubation was recorded, and the distribution of patients with blood on the device among the two groups did not show a statistically significant difference (p = 0.617). Conclusion This study compared the effectiveness of two intubation devices. The C-MAC video laryngoscope showed a significantly higher rate of first-attempt successful intubations and required fewer attempts compared to the Karl Storz video stylet. The C-MAC also had shorter intubation times compared to the Karl Storz device. However, the Karl Storz video stylet demonstrated comparable performance to the C-MAC video laryngoscope in clinical settings, with both devices having similar safety profiles and minimal complications.

BACKGROUND: It is unknown whether ultra-early physiotherapy commenced during neonatal intensive care unit admission is of value for optimising developmental outcomes in preterm/term infants at high-risk of cerebral palsy or motor-delay.
OBJECTIVE: To determine whether ultra-early parent-administered physiotherapy to preterm/term high- risk infants commenced at earliest from 34-weeks post menstrual age, improves motor outcomes at 16-weeks corrected age (CA) compared to usual care.
METHODS: Single-blind randomised controlled pilot study with 30 infant participants. The primary outcome was the Alberta Infant Motor Scale (AIMS) total score at 16-weeks CA. Secondary outcomes included (i) parent Depression Anxiety and Stress Score and Parent Perceptions Survey at 16-weeks CA; and (ii) Bayley Scales of Infant Development at 12-months CA.
RESULTS: There were no clinically worthwhile effects at 16-weeks CA on the AIMS (mean between-group difference, 95% CI: -0.2, -2.4 to 2.0) or most secondary outcomes. However, the parents\' \"perception of treatment effectiveness\" and \"perception of change\" favoured the experimental group.
CONCLUSIONS: In this pilot trial, there was no clinically worthwhile effect of ultra-early parent-administered physiotherapy over usual care on the AIMS. However, the intervention was feasible for infants, acceptable to parents and parents perceived a benefit of treatment. Whilst this trial did not demonstrate treatment effectiveness using the AIMS, these findings should be interpreted cautiously because of the small sample size, the low responsivity of the AIMS to change in motor performance and the heterogeneity of the participants. Therefore, the intervention should not be abandoned on the basis of this trial, but rather further evaluated in a larger trial that addresses some of the learnings from this one.

OBJECTIVE: The prognostic value of declining prostate-specific antigen (PSA) levels is under investigation in patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) receiving PSMA-targeted radioligand therapy with [177Lu]Lu-PSMA-617 (177Lu-PSMA-617). This post hoc analysis of the phase 3 VISION trial aimed to evaluate associations between PSA decline and clinical and patient-reported outcomes in patients receiving 177Lu-PSMA-617.
METHODS: Of 831 enrolled patients with PSMA-positive progressive mCRPC treated previously with one or more androgen receptor pathway inhibitors and one to two taxanes, 551 were randomised to 177Lu-PSMA-617 plus protocol-permitted standard of care (SoC). Radiographic progression-free survival, overall survival, radiographic objective response rate, and patient-reported health-related quality of life (HRQoL) and pain were analysed in subgroups of patients categorised by the magnitude of unconfirmed PSA decline from baseline.
UNASSIGNED: Patients randomised to 177Lu-PSMA-617 with the best PSA declines of ≥0-<50% (96/551 [17%]), ≥50-<90% (152/551 [28%]), and ≥90% (83/551 [15%]) up to and including week 12 had 61%, 72%, and 88% reduced risks of radiographic disease progression or death, and 51%, 70%, and 87% reduced risks of death, respectively, versus those with increased PSA levels (160/551 [29%]), based on hazard ratios in a multivariate Cox proportional hazard model. In patients with greater PSA declines, radiographic responses were more frequent and median time to worsening in HRQoL and pain scores were longer.
CONCLUSIONS: The magnitude of PSA decline was associated with improvement in clinical and patient-reported outcomes in patients with mCRPC receiving 177Lu-PSMA-617 plus SoC in VISION. PSA decline therefore appears to have a prognostic value during 177Lu-PSMA-617 treatment in this population.

OBJECTIVE: Malnutrition is prevalent among hospitalised patients, and increases the morbidity, mortality, and medical costs; yet nutritional assessments on admission are not routine. This study assessed the clinical and economic benefits of using an artificial intelligence (AI)-based rapid nutritional diagnostic system for routine nutritional screening of hospitalised patients.
METHODS: A nationwide multicentre randomised controlled trial was conducted at 11 centres in 10 provinces. Hospitalised patients were randomised to either receive an assessment using an AI-based rapid nutritional diagnostic system as part of routine care (experimental group), or not (control group). The overall medical resource costs were calculated for each participant and a decision-tree was generated based on an intention-to-treat analysis to analyse the cost-effectiveness of various treatment modalities. Subgroup analyses were performed according to clinical characteristics and a probabilistic sensitivity analysis was performed to evaluate the influence of parameter variations on the incremental cost-effectiveness ratio (ICER).
RESULTS: In total, 5763 patients participated in the study, 2830 in the experimental arm and 2933 in the control arm. The experimental arm had a significantly higher cure rate than the control arm (23.24% versus 20.18%; p = 0.005). The experimental arm incurred an incremental cost of 276.52 CNY, leading to an additional 3.06 cures, yielding an ICER of 90.37 CNY. Sensitivity analysis revealed that the decision-tree model was relatively stable.
CONCLUSIONS: The integration of the AI-based rapid nutritional diagnostic system into routine inpatient care substantially enhanced the cure rate among hospitalised patients and was cost-effective.
BACKGROUND: NCT04776070 (https://clinicaltrials.gov/study/NCT04776070).

BACKGROUND: The World Health Organization\'s (WHO) Mental Health Gap Action Programme (mhGAP) is a validated intervention that can be provided by non-specialised healthcare workers to individuals with unhealthy alcohol use. However, it typically requires several in-person sessions at a health facility, which may limit its feasibility and effectiveness in remote settings. This trial compares mhGAP-Standard, a 4 to 6 in-person session intervention, to mhGAP-Remote, a 1 in-person session intervention followed by 8 week of short message service (SMS) in Lesotho. We hypothesise that mhGAP-Remote is superior to mhGAP-Standard in reducing alcohol use (as detailed by the primary and secondary outcomes below).
METHODS: This is a two-arm randomised open-label multicentre superiority trial. Participants allocated to mhGAP-Standard receive 4 in-person sessions using motivational interviewing, identifying triggers, and alternative behaviours, with the option of two additional booster sessions. Participants in the mhGAP-Remote arm receive 1 in-person session covering the same content, followed by standardised SMSs over 8 weeks that reinforce intervention content. Non-specialist providers deliver the intervention and receive weekly supervision. Adults (Nplanned = 248) attending participating health facilities for any reason and who meet criteria for unhealthy alcohol use based on the Alcohol Use Disorders Identification Test ([AUDIT] score ≥ 6 for women, ≥ 8 for men) are individually randomised to the two arms (1:1 allocation, stratified by participant sex and age (≥ 50 vs < 50 years old). Follow-up assessments occur at 8, 20, and 32 weeks post-randomisation. The primary outcome is change in self-reported alcohol use (continuous AUDIT score), from baseline to 8 weeks follow-up. Change in the AUDIT from baseline to 20 and 32 weeks follow-up is a secondary outcome. Change in the biomarker phosphatidylethanol (secondary), liver enzyme values in serum (exploratory), and HIV viral load (for people with HIV only; exploratory) are also evaluated from baseline throughout the entire follow-up period. A linear regression model will be conducted for the primary analysis, adjusted for the stratification factors. Three a priori sensitivity analyses for the primary outcome are planned based on per protocol treatment attendance, recovery from unhealthy alcohol use, and clinically significant and reliable change.
CONCLUSIONS: This trial will provide insight into feasibility and effectiveness of a shortened and primarily SMS supported version of mhGAP, which is especially relevant for settings where regular clinic attendance is a major barrier.
BACKGROUND: clinicaltrials.gov NCT05925270 . Approved on June 29th, 2023.

BACKGROUND: Midfoot osteoarthritis (OA) is a painful and disabling condition. Arch contouring foot orthoses have been recommended for midfoot OA, yet there is no high-quality evidence from randomised controlled trials to support their use. This clinical trial aims to evaluate the efficacy of arch contouring foot orthoses for midfoot OA.
METHODS: This will be a parallel-group randomised controlled superiority trial. One-hundred and forty community-dwelling people with painful midfoot OA will be randomised to receive either arch contouring foot orthoses or flat sham inserts. Outcome measures will be obtained at baseline, 4, 8 and 12 weeks; the primary endpoint for assessing efficacy being 12 weeks. The primary outcome measure will be average midfoot pain whilst walking over the last 7 days on an 11-point numerical rating scale. Secondary outcome measures include function (walking/standing subscale of the Manchester-Oxford Foot Questionnaire), participants\' perception of overall treatment effect (self-reported global rating of change on a 15-point Likert scale), physical activity (Incidental and Planned Exercise Questionnaire), general health-related quality of life (Short Form-12 Version® 2.0), use of co-interventions and adverse events.
CONCLUSIONS: This trial will evaluate the efficacy of arch contouring foot orthoses for relieving pain and improving function, physical activity and health-related quality of life in people with midfoot OA. The findings will provide high-quality evidence as to whether arch contouring foot orthoses are efficacious and will help to inform clinical guidelines about the use of foot orthoses for midfoot OA.
BACKGROUND: Australian and New Zealand Clinical Trial Registry (ACTRN12623000953639).

OBJECTIVE: The use and duration of androgen deprivation therapy (ADT) with postoperative radiotherapy (RT) have been uncertain. RADICALS-HD compared adding no (\"None\"), 6-months (\"Short\"), or 24-mo (\"Long\") ADT to study efficacy in the long term.
METHODS: Participants with prostate cancer were indicated for postoperative RT and agreed randomisation between all durations. ADT was allocated for 0, 6, or 24 mo. The primary outcome measure (OM) was metastasis-free survival (MFS). The secondary OMs included freedom from distant metastasis, overall survival, and initiation of nonprotocol ADT. Sample size was determined by two-way comparisons. Analyses followed standard time-to-event approaches and intention-to-treat principles.
UNASSIGNED: Between 2007 and 2015, 492 participants were randomised one of three groups: 166 None, 164 Short, and 162 Long. The median age at randomisation was 66 yr; Gleason scores at surgery were as follows: <7 = 64 (13%), 3+4 = 229 (47%), 4+3 = 127 (26%), and 8+ = 72 (15%); T3b was 112 (23%); and T4 was 5 (1%). The median follow-up was 9.0 yr and, with MFS events reported for 89 participants (32 None, 31 Short, and 26 Long), there was no evidence of difference in MFS overall (logrank p = 0.98), and, for Long versus None, hazard ratio = 0.948 (95% confidence interval 0.54-1.68). After 10 yr, 80% None, 77% Short, and 81% Long patients were alive without metastatic disease. The three-way randomisation was not powered to conventional levels for assessment, yet provides a fair comparison.
CONCLUSIONS: Long-term outcomes after radical prostatectomy are usually favourable. In those indicated for postoperative RT and considered suitable for no, short-term, or long-term ADT, there was no evidence of improvement with addition of ADT. Future research should focus on patients at a higher risk of metastases in whom improvements are required more urgently.