Individualised computerised cognitive training (iCCT) for community-dwelling people with mild cognitive impairment (MCI): results on cognition in the 6-month intervention period of a randomised controlled trial (MCI-CCT study).

BACKGROUND: Computerised cognitive training (CCT) can improve the cognitive abilities of people with mild cognitive impairment (MCI), especially when the CCT contains a learning system, which is a type of machine learning (ML) that automatically selects exercises at a difficulty that corresponds to the person's peak performance and thus enables individualised training. METHODS: We developed one individualised CCT (iCCT) with ML and one basic CCT (bCCT) for an active control group (CG). The study aimed to determine whether iCCT in the intervention group (IG) resulted in significantly greater enhancements in overall cognitive functioning for individuals with MCI (age 60+) compared with bCCT in the CG across a 6-month period. This double-blind randomised controlled study was conducted entirely virtually. The 89 participants were community-dwelling people with a psychometric diagnosis of MCI living in Germany. The iCCT stimulates various cognitive functions, especially working memory, visuo-constructional reasoning, and decision-making. The bCCT includes fewer and simpler tasks. Both CCTs were used at home. At baseline and after 6 months, we assessed cognitive functioning with the Montreal Cognitive Assessment (MoCA). A mixed-model ANCOVA was conducted as the main analysis. RESULTS: Both CCTs led to significant increases in average global cognition. The estimated marginal means of the MoCA score increased significantly in the CG by an average of 0.9 points (95% CI [0.2, 1.7]) from 22.3 (SE = 0.25) to 23.2 (SE = 0.41) points (p = 0.018); in the IG, the MoCA score increased by an average of 2.2 points (95% CI [1.4, 2.9]) from 21.9 (SE = 0.26) to 24.1 (SE = 0.42) points (p < 0.001). In a confound-adjusted multiple regression model, the interaction between time and group was statistically significant (F = 4.92; p = 0.029). The effect size was small to medium (partial η2 = 0.057). On average, the participants used the CCTs three times per week with an average duration of 34.9 min per application. The iCCT was evaluated as more attractive and more stimulating than the bCCT. CONCLUSIONS: By using a multi-tasking CCT three times a week for 30 min, people with MCI living at home can significantly improve their cognitive abilities within 6 months. The use of ML significantly increases the effectiveness of cognitive training and improves user satisfaction. TRIAL REGISTRATION: ISRCTN14437015; registered February 27, 2020.

Efficacy of a Non-Pharmacological Intervention in Seasonal Allergic Rhinitis Symptoms.

BACKGROUND: Patients suffering from allergic rhinitis seek for several therapeutic symptomatic options, including nonconventional treatments, to control their symptoms. OBJECTIVES: Through the present proof-of-concept study, we prospectively investigated the potential role of Puressentiel® nasal protection spray (SNPA) in patients suffering from cypress pollen allergic rhinitis. METHODS: In 15 adults, we performed two nasal provocation tests, with a cypress pollen extract, with a 15-day interval, with and without previous randomized administration of SNPA, and evaluated a nasal symptom score, the nasal inspiratory peak flow, and the concentration of inflammatory cytokines in the nasal lavage after the procedures. RESULTS: Comparing results in patients challenged with and without the SNPA spray before the nasal challenge, we found a 57% mean decrease in symptoms, and a 62% average difference in inspiratory peak flow, after the use of the spray. CONCLUSIONS: Puressentiel® SNPA is effective in reducing nasal symptoms, as assessed by nasal symptoms score and nasal inspiratory peak flow, and could be a valid natural non-pharmacological option in patients suffering from allergic rhinitis.

Study protocol: randomized controlled trial of an individualized music intervention for people with dementia in the home care setting.

BACKGROUND: Studies suggest that individualized music listening is an effective, non-pharmacological intervention for improving the quality of life of people with dementia in the institutional care setting. Noting that most people with dementia live at home, we conduct a randomized controlled trial to assess the feasibility and effectiveness of an app-based individualized music listening intervention for people with dementia in the home care setting. The intervention is delivered by family caregivers. METHODS: We will recruit N = 130 dyads consisting of one person with dementia living at home and their family caregiver. After a baseline assessment, dyads are randomly assigned by gender to either the intervention or control group. People with dementia in the intervention group listen to individualized music playlists for 20 min every other day for six weeks via the self-developed Individualized Music and Dementia app. The control group receives standard care. All dyads complete paper-and-pencil questionnaires six weeks before the start of the intervention (T0), directly before the intervention (T1), directly after the intervention (T2), and six weeks later (T3). During the intervention period, all caregivers also complete daily ecological momentary assessments via the app. During three home visits, a trained project member will observe the dyads and collect hair samples. After the intervention, semi-structured interviews will be conducted to collect information about participants' experiences with the app and intervention. The primary outcome is the attainment of individual goals established during the baseline assessment. Secondary outcomes are the well-being, physiological stress and quality of life of people with dementia and their caregivers; people with dementia's behavioural and psychological symptoms of dementia, resistance during care, and reactions to the music; caregivers' burden of care, positive aspects of care, and caregiving self-efficacy; and the quality of the caregiver-care recipient interaction. DISCUSSION: Our study will assess the extent to which an app-based individualized music listening intervention is feasible and effective for enhancing the well-being and quality of life of people with dementia living at home and their family caregivers. TRIAL REGISTRATION: German Clinical Trials Register DRKS00025502 and ISRCTN registry ISRCTN68084105, https://doi.org/10.1186/ISRCTN68084105.

The WE-RISE™ multi-domain intervention: a feasibility study for the potential reversal of cognitive frailty in Malaysian older persons of lower socioeconomic status.

BACKGROUND: Cognitive frailty (CF) is an emerging concern among older persons, particularly within lower socioeconomic statuses (SES) populations. Currently, there is limited evidence on the potential reversibility of CF through multi-domain interventions within this demographic. This study aimed to investigate the effectiveness of the WE-RISE™ multi-domain intervention in addressing the potential reversibility of CF among community-dwelling older persons of lower SES, the intervention effects on multiple health dimensions, and to determine if WE-RISE™ is of low cost. METHODS: This 24-week randomised controlled trial included 55 community-dwelling older persons of lower SES with CF, who were randomised into either the WE-RISE™ intervention group (n = 27), or the control group receiving usual care (n = 28). The WE-RISE™ intervention comprised of 12 weeks of instructor led, community-based intervention, followed by 12 weeks of WE-RISE™@Home. CF status, cognitive and physical function, nutrition, disability, health-related quality of life, exercise self-efficacy and depression were assessed at baseline, 12th and 24th weeks. Changes in CF status was analysed descriptively, while intervention effects were analyzed with split plot ANOVA. The cost of the WE-RISE™ intervention was calculated using activity-based costing. RESULTS: At baseline, all participants in both the intervention and control groups (100%) were classified as CF. Following 12 weeks of the WE-RISE™ intervention, 74.1% of participants in the experimental group no longer met the criteria for cognitive frailty, with 63% maintaining this improvement at 24 weeks. In contrast, the CF status of participants in the control group remained largely unchanged, with only 10.7% showing improvement at 12 weeks and falling to 3.6% at 24 weeks. Significant intervention effects were observed for cognition, physical function, body composition, disability, health-related quality of life and self-perceived exercise self-efficacy (p < 0.05) following participation in WE-RISE™. The cost per intervention session was RM4.06 (≈ RM3.88), and the cost per subject for 48 sessions was RM194.74 (≈ RM187.01). CONCLUSION: The WE-RISE™ multi-domain intervention has demonstrated potential in reversing CF among older persons of lower SES, leading to significant improvements across multiple health dimensions at a low cost. WE-RISE™ shows promise to enrich the well-being of ageing societies, contribute to societal health, and ensure equitable access to healthcare, supporting broader implementation by enhancing equitable access to health programs and addressing the needs of older persons, WE-RISE™. TRIAL REGISTRATION: This trial was registered in the Australian New Zealand Clinical Trials Registry (ACTRN12619001055190) on the 29th of July 2019 - retrospectively registered.

Nonpharmacological intervention therapies for dementia: potential break-even intervention price and savings for selected risk factors in the European healthcare system.

BACKGROUND: New effective treatments for dementia are lacking, and early prevention focusing on risk factors of dementia is important. Non-pharmacological intervention therapies aimed at these factors may provide a valuable tool for reducing the incidence of dementia. This study focused on the development of a mathematical model to predict the number of individuals with neurodegenerative diseases, specifically Alzheimer's disease, Parkinson's disease, vascular dementia, and amyotrophic lateral sclerosis. Scenarios for non-pharmacological intervention therapies based on risk factor reduction were also assessed. The estimated total costs and potential cost savings from societal were included. METHODS: Based on demographic and financial data from the EU, a mathematical model was developed to predict the prevalence and resulting care costs of neurodegenerative diseases in the population. Each disease (Alzheimer's disease, Parkinson's disease, vascular dementia, and amyotrophic lateral sclerosis) used parameters that included prevalence, incidence, and death risk ratio, and the simulation is related to the age of the cohort and the disease stage. RESULTS: A replicable simulation for predicting the prevalence and resulting cost of care for neurodegenerative diseases in the population exhibited an increase in treatment costs from 267 billion EUR in 2021 to 528 billion EUR by 2050 in the EU alone. Scenarios related to the reduction of the prevalence of dementia by up to 20% per decade led to total discounted treatment cost savings of up to 558 billion EUR. CONCLUSION: The model indicates the magnitude of the financial burden placed on EU healthcare systems due to the growth in the population prevalence of neurodegenerative diseases in the coming decades. Lifestyle interventions based on reducing the most common risk factors could serve as a prevention strategy to reduce the incidence of dementia with substantial cost-savings potential. These findings could support the implementation of public health approaches throughout life to ultimately prevent premature mortality and promote a healthier and more active lifestyle in older individuals.

Effect of non-pharmacological interventions on pain in preterm infants in the neonatal intensive care unit: a network meta-analysis of randomized controlled trials.

OBJECTIVE: To evaluate the effectiveness of different non-pharmacological interventions for pain management in preterm infants and provide high-quality clinical evidence. METHODS: Randomized controlled trials (RCTs) of various non-pharmacological interventions for pain management in preterm infants were searched from PubMed, Web of Science, Embase, and the Cochrane Library from 2000 to the present (updated March 2023). The primary outcome was pain score reported as standardized mean difference (SMD). The secondary outcomes were oxygen saturation and heart rate reported as the same form. RESULTS: Thirty five RCTs of 2134 preterm infants were included in the meta-analysis, involving 6 interventions: olfactory stimulation, combined oral sucrose and non-nutritive sucking (OS + NNS), facilitated tucking, auditory intervention, tactile relief, and mixed intervention. Based on moderate-quality evidence, OS + NNS (OR: 3.92, 95% CI: 1.72, 6.15, SUCRA score: 0.73), facilitated tucking (OR: 2.51, 95% CI: 1.15, 3.90, SUCRA score: 0.29), auditory intervention (OR: 2.48, 95% CI: 0.91, 4.10, SUCRA score: 0.27), olfactory stimulation (OR: 1.80, 95% CI: 0.51, 3.14, SUCRA score: 0.25), and mixed intervention (OR: 2.26, 95% CI: 0.10, 4.38, SUCRA score: 0.14) were all superior to the control group for pain relief. For oxygen saturation, facilitated tucking (OR: 1.94, 95% CI: 0.66, 3.35, SUCRA score: 0.64) and auditory intervention (OR: 1.04, 95% CI: 0.22, 2.04, SUCRA score: 0.36) were superior to the control. For heart rate, none of the comparisons between the various interventions were statistically significant. CONCLUSION: This study showed that there are notable variations in the effectiveness of different non-pharmacological interventions in terms of pain scores and oxygen saturation. However, there was no evidence of any improvement in heart rate.

Maternal singing reduced pain indexes in 2-month-old infants and increased proximity during vaccinations.

AIM: Immunisation is a global health priority, but methods of non-pharmacological pain relief are not widely used in routine clinical practice. In this study, we set out to investigate the effects of maternal singing during the routine vaccination of infants. METHODS: We recruited 67 mother-infant pairs at Health Centres in the Aosta Region of Italy. Infants aged 2-4 months were randomly allocated to a singing intervention group or to a control group whose injections were administered following standard practice. Pre- and post-immunisation pain was blindly assessed using the Modified Behavioural Pain Scale, and mother-infant proximity indexes were assigned based on muted video-tracks. RESULTS: When assessed for pain, the infants in the maternal singing group were assigned significantly lower movement indexes (p = 0.032) and marginally significantly lower cry indexes (p = 0.076). A higher frequency of mother-to-infant gaze (p < 0.005) was observed in the singing group dyads. Finally, the intervention group mothers' self-perceived ease in singing was correlated with their previous singing experience and with lower anxiety following the vaccination procedure (p < 0.05). CONCLUSION: Maternal singing during immunisation procedures benefits both mothers and babies. The practice of singing is a biologically rooted and adaptive form of intuitive parental communication that should be encouraged, especially in at-risk populations.

Effective reduction of anxiety in hospitalised children through bibliotherapy.

AIM: The process of being admitted to a hospital is widely recognised as a distressing encounter for children, frequently resulting in notable levels of anxiety. The main aim was to assess the effectiveness of bibliotherapy in reducing anxiety and to associate anxiety levels with demographic and clinical variables. METHODS: This study was conducted at a paediatric ward in a tertiary care hospital located in Tamil Nadu, India, for 3 months from 1 August 2023-30 October 2023. In this study, a one-group pre-test and post-test design was employed. A sample of 60 children, aged between 5 and 12 years, was recruited using a convenience sampling method. Spence Children Anxiety Scale was used for assessing anxiety levels. RESULTS: The mean age of the participants was 8.46 ± 1.91 years, and the majority, comprising 57%, were male. Following bibliotherapy, 72% of children showed mild anxiety, 28% showed moderate anxiety and no individual had considerable anxiety. Anxiety scores dropped 27%. Significant associations were found between anxiety reduction and variables such as age, educational status, and type of family. CONCLUSION: Bibliotherapy was notably effective in substantially reducing anxiety levels among children aged 5-12 years who were admitted to hospitals.

The effectiveness of non-pharmacological interventions on reducing pain in patients undergoing bone marrow aspiration and biopsy: A systematic review and meta-analysis of randomized controlled trials.

BACKGROUND: Patients often consider bone marrow aspiration and biopsy to be one of the most painful medical procedures. The effectiveness of non-pharmacological interventions to reduce pain during bone marrow aspiration and biopsy remains unclear. AIM: To synthesize existing evidence regarding the effectiveness of non-pharmacological interventions in mitigating procedural pain among patients undergoing bone marrow aspiration and biopsy. DESIGN: A systematic review and meta-analysis of randomized controlled trials. METHODS: Six electronic databases, including PubMed, EMBASE, CINAHL, PsycINFO, Cochrane Library and Web of Science were searched from inception to July 15, 2023. The risk of bias was assessed using the Cochrane Risk of Bias Tool Version 2.0. Meta-analysis was conducted using STATA 16. The certainty of the evidence was assessed by the GRADE approach. RESULTS: This meta-analysis included 18 studies derived from 17 articles involving a total of 1017 participants. The pooled results revealed statistically significant pain reduction effects using distraction (SMD: -.845, 95% CI: -1.344 to -.346, p < .001), powered bone marrow biopsy system (SMD: -.266, 95% CI: -.529 to -.003, p = .048), and acupoint stimulation (SMD: -1.016, 95% CI: -1.995 to -.037, p = .042) among patients undergoing bone marrow aspiration and biopsy. However, the pooled results on hypnosis (SMD: -1.228, 95% CI: -4.091 to 1.515, p = .368) showed no significant impact on pain reduction. Additionally, the pooled results for distraction did not demonstrate a significant effect on operative anxiety (MD: -2.942, 95% CI: -7.650 to 1.767, p = .221). CONCLUSIONS: Distraction, powered bone marrow biopsy system and acupoint stimulation are effective in reducing pain among patients undergoing bone marrow aspiration and biopsy. PATIENT OR PUBLIC CONTRIBUTION: Not applicable. RELEVANCE TO CLINICAL PRACTICE: This meta-analysis highlights the effectiveness of distraction, powered bone marrow biopsy system and acupoint stimulation for reducing pain in patients undergoing bone marrow biopsy. Healthcare professionals should consider integrating these interventions into pain management practices for these patients. REGISTRATION: (PROSPERO): CRD42023422854.

Effectiveness of non-pharmacological interventions in improving sleep quality after cardiac surgery: A systematic review and meta-analysis.

BACKGROUND: Sleep disturbance is highly prevalent among post-operative cardiac patients, with negative impacts on surgical recovery and rehabilitation. Post-operative pain and anxiety commonly seen in cardiac surgery patients are associated with poor sleep. Sleep medications commonly used are not ideal with prolonged usage, and non-pharmacological interventions can be good alternatives or complements. AIM: To examine effectiveness of non-pharmacological interventions in post-operative cardiac settings on sleep quality, pain intensity and anxiety. DESIGN: Systematic review and meta-analysis. METHODS: PubMed, CENTRAL, Embase, CINAHL, Scopus, CNKI and ProQuest Dissertations and Theses were searched on 12 October 2022. Randomised controlled trials of non-pharmacological interventions examining sleep quality for adult post-operative cardiac patients were included. Included studies were appraised using Cochrane Risk of Bias tool version 1. Meta-analysis was conducted using RevMan version 5.4.1, and heterogeneity was assessed using I2 statistics and Cochran Q's test. RESULTS: Eighteen studies involving 1701 participants were identified. Coronary artery bypass graft was most common. Non-pharmacological interventions varied in types and duration. All intervention groups were compared to usual care, placebo, no interventions or active comparators. Statistically significant improvement in sleep quality (SMD = -.91, 95% CI = -1.17 to -.65) was found among intervention groups that explored cognitive behavioural therapy, relaxation techniques, exercise, massage, acupressure, aromatherapy, music, eye mask and earplugs. Pain intensity was reduced (SMD = -.63, 95% CI = -1.05 to -.20) with cognitive behavioural therapy, relaxation techniques, massage, music and eye mask. Anxiety was improved (SMD = -.21, 95% CI = -.38 to -.04) with exercise and music. CONCLUSION: The overall use of non-pharmacological interventions can optimise sleep after cardiac surgery. Further research with greater methodological rigour is needed to investigate different intervention-related characteristics while considering potential confounders. RELEVANCE TO CLINICAL PRACTICE: Post-operative cardiac settings can consider incorporating non-pharmacological interventions. Patients and healthcare providers can be better informed about the use of such interventions to improve sleep. REGISTRATION: PROSPERO CRD42022384991.

The effectiveness, acceptability, and sustainability of non-pharmacological interventions for chronic pain management in older adults in mainland China: A systematic review.

OBJECTIVES: This systematic review aims to assess the effectiveness, acceptability, and sustainability of non-pharmacological pain management interventions for older adults in mainland China. MATERIALS AND METHODS: Articles searching was conducted across six databases, including MEDLINE, PubMed, PsycINFO, Web of Science, China National Knowledge Infrastructure (CNKI), and WanFangdata. Quality appraisal was performed using the revised Cochrane risk of bias tool. RESULTS: A total of 26 articles met the inclusion criteria, involving 2,197 participants with a mean age of 69.19 years. The participants' ages ranged from 63.85 to 81.75 years. The evaluated non-pharmacological interventions included psychotherapy, acupuncture, exercise, massage, neurotherapy, and multidisciplinary interventions. The overall changes in pain intensity varied from -5.19 to -0.65 on a numeric rating scale ranging from zero to ten. CONCLUSIONS: Non-pharmacological interventions proved effective in alleviating pain intensity among older adults in mainland China. The findings suggest that mindfulness, exercise and pain education can be promoted as viable strategies for enhancing the well-being of the elderly population.

Effectiveness of Psychotherapy for Community-Dwelling Vulnerable Older Adults with Depression and Care Needs: Findings from the PSY-CARE Trial.

BACKGROUND: For older adults with care needs, evidence for the effectiveness of psychotherapy on depression is scarce. METHODS: In PSY-CARE, a pragmatic randomized controlled trial, N = 197 home-living older adults with depression and care needs were randomized into outpatient psychotherapy or an active control condition. Residential psychotherapists offered age-sensitive cognitive-behavioral psychotherapy (at-home if needed). Control group participants received telephone counseling and a self-help guide. Outcomes were assessed at baseline (T1), after (T2), 3 months after (T3), and 12 months after the intervention (T4). RESULTS: There was a significant decrease in depressive symptoms across both arms with Cohen's d T4-T1 = .52 in the psychotherapy and .55 in the control group. Mixed models revealed no statistically significant difference in primary and secondary outcomes between interventions. Posthoc, we found control group participants with greater ADL limitations experienced significantly increased depressive symptoms compared to those reporting lower limitations. CONCLUSIONS: Interventions were successful in reducing depressive symptoms, even though treatment fidelity was decreased due to the COVID-19 pandemic. We could not demonstrate superior effectiveness of psychotherapy for older adults with care needs. CLINICAL IMPLICATIONS: Findings suggest that psychotherapy may be an important and superior treatment to circumvent aggravation of depression in older patients with high functional limitations. TRIAL REGISTRATION: The trial was prospectively registered with the ISRCTN registry (Trial registration number: ISRCTN55646265, February 15, 2019).

Comparison of efficacy of non-pharmacological intervention for post-stroke dysphagia: a systematic review and Bayesian network meta-analysis.

Increasingly, non-pharmacological interventions are being identified and applied to post-stroke dysphagia. Nevertheless, there is insufficient evidence to assess which type of interventions are more effective. In this study, the randomized controlled trials of non-pharmacological interventions on post-stroke dysphagia were retrieved from the relevant databases. Including 96 studies and 12 non-drug treatments. Then, and the network meta-analysis is carried out by statistical software. The results show: In the aspects of videofluoroscopic swallowing study (VFSS), Standardized Swallowing Assessment (SSA), swallowing-quality of life (SWAL-QOL), Water swallow test (WST); Acupuncture + electrotherapy + rehabilitation training, acupuncture + rehabilitation training + massage, electrotherapy + rehabilitation training, acupuncture + electrotherapy + rehabilitation training, electrotherapy, acupuncture + rehabilitation training + acupoints sticking application have significant effects in post-stroke dysphagia. Compared with other interventions, they have more advantages in improving the above indicators. A substantial number of high-quality randomized clinical trials are still necessary in the prospective to validate the therapeutic effectiveness of non-pharmacological interventions in post-stroke dysphagia and the results of this Bayesian network meta-analysis.

Effectiveness of Non-Pharmacological Interventions for Agitation during Post-Traumatic Amnesia following Traumatic Brain Injury: A Systematic Review.

Agitation is common in the early recovery period following traumatic brain injury (TBI), known as post-traumatic amnesia (PTA). Non-pharmacological interventions are frequently used to manage agitation, yet their efficacy is largely unknown. This systematic review aims to synthesize current evidence on the effectiveness of non-pharmacological interventions for agitation during PTA in adults with TBI. Key databases searched included MEDLINE Ovid SP interface, PubMed, CINAHL, Excerpta Medica Database, PsycINFO and CENTRAL, with additional online reviewing of key journals and clinical trial registries to identify published or unpublished studies up to May 2020. Eligible studies included participants aged 16 years and older, showing agitated behaviours during PTA. Any non-pharmacological interventions for reducing agitation were considered, with any comparator accepted. Eligible studies were critically appraised for methodological quality using Joanna Briggs Institute Critical Appraisal Instruments and findings were reported in narrative form. Twelve studies were included in the review: two randomized cross-over trials, three quasi-experimental studies, four cases series and three case reports. Non-pharmacological interventions were music therapy, behavioural strategies and environmental modifications, physical restraints and electroconvulsive therapy. Key methodological concerns included absence of a control group, a lack of formalised agitation measurement and inconsistent concomitant use of pharmacology. Interventions involving music therapy had the highest level of evidence, although study quality was generally low to moderate. Further research is needed to evaluate non-pharmacological interventions for reducing agitation during PTA after TBI.Systematic review registration number: PROSPERO (CRD42020186802), registered May 2020.

Self-administered non-invasive vagus nerve stimulation therapy for severe pharmacoresistant restless legs syndrome: outcomes at 6 months.

Severe pharmacoresistant restless legs syndrome (RLS) is difficult to manage and a source of suffering to patients. We studied the effectiveness at 6 months of an innovative treatment: transauricular vagus nerve stimulation (taVNS) in the left cymba concha in a case series of 15 patients, 53% male, mean (SD) age 62.7 (12.3) years with severe pharmacoresistant RLS (mean [SD] International Restless Legs Rating Scale [IRLS] score of 31.9 [2.9]) at baseline. Following an 8-week non-randomised hospital-based study with eight 1-h sessions of taVNS, patients were trained to administer taVNS at home and were followed up for 6 months. The primary outcome measure was the IRLS score, secondary outcome measures were quality of life, mood disorders using the Hospital Anxiety and Depression scale (HAD) subscales for depression (HADD) and anxiety (HADA). At the 6-month follow-up 13/15 patients continued to use weekly taVNS. Symptom severity decreased (mean [SD] IRLS score 22.2 [9.32] at 6 months, p = 0.0005). Four of the 15 patients had an IRLS score of <20 at 6 months and two an IRLS score of 5. Quality of life significantly improved compared to baseline (mean [SD] score at baseline 49.3 [18.1] versus 65.66 [22.58] at 6 months, p = 0.0005) as did anxiety and depression symptoms (mean [SD] HADA score at baseline 8.9 [5.4] versus 7.53 [4.42] at 6 months, p = 0.029; and HADD score at baseline 5.2 [4.5] versus 4.73 [4.44] at 6 months, p = 0.03). Treatment was well tolerated, and no adverse events were reported. Our case series shows a potential role for self-administered taVNS in patients with severe pharmacoresistant RLS. Randomised controlled trials are needed to confirm the utility of taVNS.

Effect of self-determination theory-based integrated creative art (SDTICA) program on older adults with mild cognitive impairment in nursing homes: Study protocol for a cluster randomised controlled trial.

BACKGROUND: The cognitive benefits of early non-pharmacological approaches have been demonstrated in older adults with mild cognitive impairment (MCI). However, older adults living in nursing homes have more severe cognitive impairment problems and lower initiative and compliance to participate in complex interventions. Hence, it important to investigate more attractive and sustainable methods to prevent or delay cognitive decline. The present study adopts the self-determination theory (SDT) as a theoretical framework to innovatively develop an integrated art-based intervention for older adults with MCI in nursing homes in China and aims to evaluate its effects on cognitive function, mental health, and other health-related outcomes. METHODS: The study is a nursing home-based, cluster randomised controlled trial (RCT) that targets older adults (aged ≥ 60 years) with MCI in Fuzhou City, China. All nursing homes in the area covered by Fuzhou City are invited to participate. Eligible nursing homes are randomised to one of two groups: intervention group (receive a 14-week, 27-session intervention) and waitlist control group (receive the usual care). The SDT-based integrated creative art (SDTICA) program reasonably adopts the SDT as a theoretical framework to innovatively develop an integrated art-based intervention for older adults with MCI in nursing homes. The primary (global cognitive function and psychological indicator) and secondary (daily activity function, social function, and specific domains of cognitive function) outcomes will be measured at baseline, after the intervention, and during follow-up. DISCUSSION: This study aims to evaluate the effects of SDTICA program on neuropsychological outcomes in older adults with MCI and provide scientific evidence for art-based non-pharmacologic interventions in nursing homes, which may reduce dementia risk in older adults with MCI. TRIAL REGISTRATION: The trial was prospectively registered at the Chinese Clinical Trials Registry with the registration number ChiCTR2200061681 on 30 June 2022.

Cost-effectiveness and potential budget impact of non-pharmacological interventions for early management in prehypertensive people: an economic evaluation for China.

BACKGROUND: Non-pharmacological interventions (NPIs) could be considered in the early management of prehypertensive population. This study aimed to evaluate the potential cost-effectiveness of NPIs and the budget impact of implementing NPIs on prehypertensive population in China and provide evidence of chronic disease management innovation for decision-makers. METHODS: Five NPIs including usual care, lifestyle, strengthen exercise, relaxation, and diet therapy were selected based on the practice of hypertension management in China. A nine-state Markov model was constructed to evaluate the lifetime costs and health outcomes of five NPIs and a non-intervention group from the perspective of Chinese healthcare system. The effectiveness of NPIs was obtained from a published study. Parameters including transition probabilities, costs and utilities were extracted or calculated from published literature and open-access databases. Sensitivity analyses were conducted to test the uncertainty of all parameters. The impact of duration of intervention was considered in scenario analyses. A budget impact analysis (BIA) was conducted to evaluate the total cost and the medical cost saving of a hypothetical nationwide implementation of potential cost-effective NPI in prehypertensive people. Management strategies including focusing on patients with specific ages or different CVE risk levels, and different duration of implementation were taken into consideration. RESULTS: Strengthen exercise was the most cost-effective intervention with a probability of 78.1% under the given WTP threshold. Our results were sensitive to the cost of interventions, and the utility of prehypertension and hypertension. The duration of implementation had limited impact on the results. BIA results showed that the program cost was hefty and far more than the medical cost saving with the course of simulation time. Applying management strategies which focused on individual characteristics could largely reduce the program cost despite it remained higher than medical cost saving. CONCLUSIONS: Strengthen exercise was a potential NPI that can be considered in priority for early management in prehypertensive population. Although early management can acquire medical cost saving, the related program cost can be quite hefty. Precise strategies which may help reduce the cost of early management should be taken into consideration in program design.

SARS-CoV-2 spread and area economic disadvantage in the italian three-tier restrictions: a multilevel approach.

BACKGROUND: To face the second wave of COVID-19, Italy implemented a tiered restriction system with different limitation levels (yellow = medium; orange = medium-high, red = high) at the beginning of November 2020. The restrictions systematically reduced the transmission of SARS-CoV-2 with increasing strength for increasing tier. However, it is unknown whether the effect of limitations was equal between provinces with different socioeconomic levels. Therefore, we investigated the association between the province's socioeconomic level and SARS-CoV-2 infection daily reproduction number in each restriction level. METHODS: We measured the province's socioeconomic level as the percentage of individuals whose 2019 total yearly income was lower than 10,000€, using the measure as a proxy of economic disadvantage. We estimated the daily reproduction number (Rt) at the province level using the SARS-CoV-2 daily incidence data from November 2020 to May 2021. We then used multilevel linear regression models with random intercepts stratified by restriction level to estimate the association between economic disadvantage and Rt. We also adjusted the analyses for potential confounders of the association between the province's economic disadvantage and the Rt: the percentage of people with 0-5 years, the quartiles of population density, and the geographical repartition. RESULTS: Overall, we found increasing Rt in yellow (+ 0.004 p < 0.01, from Rt = 0.99 to 1.08 in three weeks) and containing effects for the orange (-0.005 p < 0.01, from Rt = 1.03 to 0.93) and the red tier (-0.014 p < 0.01, from Rt = 1.05 to 0.76). More economically disadvantaged provinces had higher Rt levels in every tier, although non-significantly in the yellow level (yellow = 0.001 p = 0.19; orange = 0.002 p = 0.02; red = 0.004 p < 0.01). The results showed that the association between economic disadvantage and Rt differed by level of restriction. The number of days into the restriction and the economic disadvantage had statistically significant interactions in every adjusted model. Compared to better off, more economically disadvantaged provinces had slower increasing trends in yellow and steeper Rt reductions in orange, but they showed slower Rt reductions in the highest tier. CONCLUSION: Lower tiers were more effective in more economically disadvantaged provinces, while the highest restriction level had milder effects. These results underline the importance of accounting for socioeconomic level when implementing public health measures.

The feasibility of a multidomain dementia risk reduction randomised controlled trial for people experiencing cognitive decline: the Body, Brain, Life for Cognitive Decline (BBL-CD).

OBJECTIVES: To evaluate the feasibility of a proof-of-concept multidomain dementia risk reduction intervention. METHOD: An 8-week, parallel-group RCT, focused on increasing adherence to lifestyle domains of Mediterranean diet (MeDi), Physical Activity (PA), and Cognitive Engagement (CE). Feasibility was evaluated against the Bowen Feasibility Framework objectives of: Acceptability of the intervention, compliance with the protocol, and efficacy of the intervention to change behaviour in the three domains of interest. RESULTS: High acceptability of the intervention was demonstrated through a participant retention rate of 80.7% (Intervention: 84.2%; Control: 77.4%). Compliance to the protocol was strong with 100% of participants completing all educational modules and all MeDi and PA components, with 20% compliance for CE. Linear mixed models demonstrated efficacy to change behaviour through significant effects of adherence to MeDi (χ2 = 16.75, df = 3, p < .001) and CE (χ2 = 9.83, df = 3, p =.020), but not PA (χ2 = 4.48, df = 3, p =.211). CONCLUSION: Overall the intervention was shown to be feasible. Recommendations for future trials in this area are: The implementation of practical, one-on-one sessions as they are more effective than passive education at eliciting behaviour change; use of booster sessions to increase likelihood of lifestyle changes being sustained; and collection of qualitative data to identify barriers to change.

Efficacy of non-pharmacological interventions to reduce pain in people with dementia: A systematic review and meta-analysis.

AIMS AND OBJECTIVES: To identify the efficacy of non-pharmacological interventions designed to reduce pain in people with dementia. BACKGROUND: Pain is prevalent among patients with dementia but frequently remains untreated. Although non-pharmacological interventions have been used to reduce pain in people with dementia, the efficacy of these interventions for pain management in people with dementia has not been thoroughly synthesised. DESIGN: Systematic review and meta-analysis. METHODS: The study was conducted in accordance with PRISMA guidelines and Cochrane criteria for systematic reviews. A comprehensive search was performed using the Academic Search Complete, CINAHL, Cochrane Library, EMBASE, MEDLINE, PubMed, OVID and Web of Science databases, from databases inception to 13 March 2022. The modified Cochrane risk-of-bias tool (ROB-2) was used to evaluate the methodological quality of each included study. Standardised mean differences (SMDs) with 95% confidence intervals (CIs) were synthesised using a random-effects model to assess the efficacy of non-pharmacological interventions for reducing pain in people with dementia (using Stata 16.0). RESULTS: The final analysis assessed 12 studies, including 989 persons with dementia. Non-pharmacological interventions were found to reduce pain in 4-8 weeks after the interventions (SMD: -0.32; 95% CI: -0.62 to -0.02). However, the effects of intervention frequency and patient age remain unknown. CONCLUSIONS: Non-pharmacological interventions are effective for reducing pain in people with dementia. Further investigations remain necessary to explore the effectiveness of specific non-pharmacological therapies for pain reduction in people with dementia (e.g. aromatherapy, play activity, singing or robotic care). RELEVANCE TO CLINICAL PRACTICE: The findings of this study can guide healthcare practitioners when considering the use of non-pharmacological pain management methods for people with dementia and may improve the implementation of these methods in clinical practice. PATIENT OR PUBLIC CONTRIBUTIONS: The study suggests non-pharmacological interventions to reduce pain and underlines the relevance of health provider's viewpoints. The types, duration and length of follow-up of non-pharmacological interventions can be offered based on patient's conditions and the standard of clinical practice.