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1.
Recenti Prog Med ; 115(6): 276-285, 2024 Jun.
Article in Italian | MEDLINE | ID: mdl-38853730

ABSTRACT

INTRODUCTION: New educational approaches are emerging to assist healthcare professionals in better personalizing patient's educational pathways. Specifically, "gamification" - the incorporation of game elements into non-game contexts - appears to be a novel and affordable approach. This scoping review aims to explore and map the literature that evaluates the efficacy of gamification in healthcare contexts. METHODS: A scoping review of reviews was conducted in MEDLINE, CINAHL, and PsycINFO using the JBI Manual for Evidence Synthesis guidelines and the PRISMA ScR checklist. RESULTS: A total of four systematic reviews and four meta-analyses were included. It appears that gamification, when used in conjunction with other conventional educational tools, improves physical activity, facilitates better self-management of type 2 diabetes, improves cognitive functions, and improves the quality of life, particularly among specific groups like the elderly. DISCUSSIONS: Gamification is an innovative educational approach that could be useful in patient's educational pathways. However, it seems that gamification is effective only in particular subgroups, and therefore the generalization of the results should also be assessed with caution due to the high risk of bias in the included studies and the small sample sizes considered. CONCLUSION: More randomized controlled trials and meta-analysis studies should be conducted to better understand the role and efficacy of gamification in patient education.


Subject(s)
Diabetes Mellitus, Type 2 , Patient Education as Topic , Quality of Life , Humans , Patient Education as Topic/methods , Diabetes Mellitus, Type 2/therapy , Systematic Reviews as Topic , Exercise , Self-Management/methods , Self-Management/education , Self Care/methods , Aged , Cognition , Randomized Controlled Trials as Topic
2.
J Foot Ankle Res ; 17(2): e12031, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38878299

ABSTRACT

INTRODUCTION: The objective of this systematic review is to determine the benefits and harms of heel lifts to any comparator for lower limb musculoskeletal conditions. METHODS: Ovid MEDLINE, Ovid AMED, Ovid EMCARE, CINAHL Plus and SPORTDiscus were searched from inception to the end of May 2024. Randomised, quasi-randomised or non-randomised trials comparing heel lifts to any other intervention or no-treatment were eligible for inclusion. Data was extracted for the outcomes of pain, disability/function, participation, participant rating of overall condition, quality of life, composite measures and adverse events. Two authors independently assessed risk of bias and certainty of evidence using the GRADE approach at the primary time point 12 weeks (or next closest). RESULTS: Eight trials (n = 903), investigating mid-portion Achilles tendinopathy, calcaneal apophysitis and plantar heel pain were included. Heel lifts were compared to exercise, ultrasound, cryotherapy orthotics, stretching, footwear, activity modification, felt pads and analgesic medication. No outcome was at low risk of bias and few effects (2 out of 47) were clinically important. Low-certainty evidence (1 trial, n = 199) indicates improved pain relief (55.7 points [95% CI: 50.3-61.1], on a 100 mm visual analogue scale) with custom orthotics compared to heel lifts at 12 weeks for calcaneal apophysitis. Very low-certainty evidence (1 trial, n = 62) indicates improved pain and function with heel lifts over indomethacin (35.5 points [95% CI: 21.1-49.9], Foot Function Index) at 12 months for plantar heel pain. CONCLUSIONS: Few trials have assessed the benefits and harms of heel lifts for lower limb musculoskeletal conditions. Only two outcomes out of 47 showed clinically meaningful between group differences. However, due to very low to low certainty evidence we are unable to be confident in the results and the true effect may be substantially different. REGISTRATION: PROSPERO registration number CRD42022309644.


Subject(s)
Heel , Humans , Treatment Outcome , Musculoskeletal Diseases/therapy , Male , Female , Lower Extremity , Randomized Controlled Trials as Topic , Pain Measurement/methods , Tendinopathy/therapy , Adult
3.
Physiother Res Int ; 29(3): e2106, 2024 Jul.
Article in English | MEDLINE | ID: mdl-38878302

ABSTRACT

PURPOSE: To investigate if Extracorporeal Shock Wave therapy (ESWT) is effective in reducing pain and disability, in improving function, quality of life and complete resorption rate of calcification in patients with Rotator Cuff Calcific Tendinopathy. To investigate which modality of ESWT brings the greatest clinical improvements between High (HE)-SWT and Low Energy (LE)-SWT and between Focal (F)-SWT and Radial (R)-SWT. METHODS: MEDLINE, EMBASE, CENTRAL Database, and PEDro databases until February 2024 were searched. Study registers were further investigated. The Risk of Bias (RoB) was assessed with the Revised Cochrane RoB Tool (RoB 2). The certainty of evidence was rated with GRADE. RESULTS: Twenty-one randomized controlled trials were included. None was judged as overall low RoB. Comparing ESWT and Ultrasound Guided Needling Procedures (USGNP), the pooled results reported a significant difference favoring USGNP in pain at <24 and <48 weeks (MD = 1.17, p = 0.004, I2 = 59%; MD = 1.31, p = 0.004, I2 = 42%, respectively). Comparing ESWT and sham-ESWT, the pooled results reported a clinically significant difference favoring ESWT in pain and function at 24 weeks (MD = -5.72, p < 0.00001, I2 = 0%; Standardized Mean Difference = 2.94, p = 0.02 I2 = 98%, respectively). Comparing HE-SWT and LE-SWT, HE-SWT was statistically and clinically superior in pain and function at <24 weeks (MD = -1.83, p = 0.03, I2 = 87%; MD = 14.60, p = 0.002, I2 = 77%, respectively) and showed a significantly higher complete resorption rate of calcification at 12 weeks (Risk Ratio = 2.53, p = 0.001, I2 = 0%). F-SWT and R-SWT appear equally effective in reducing pain, improving disability and resorption rate. The certainty of evidence was rated as very low through GRADE approach. CONCLUSION: USGNP was statistically superior to ESWT in pain reduction at <24 and <48 weeks. ESWT was clinically better to sham-ESWT in pain reduction and function improvement at 24 weeks. HE-SWT was clinically more effective than LE-SWT in reducing pain, improving function at <24 weeks, and resolving calcific deposits at 12 weeks, while no differences between F-SWT and R-SWT were reported.


Subject(s)
Calcinosis , Extracorporeal Shockwave Therapy , Rotator Cuff , Tendinopathy , Humans , Tendinopathy/therapy , Calcinosis/therapy , Quality of Life , Randomized Controlled Trials as Topic , Treatment Outcome
4.
Med ; 5(6): 487-489, 2024 Jun 14.
Article in English | MEDLINE | ID: mdl-38878765

ABSTRACT

In locally advanced cervical cancer (LACC), the benefit of PD-1 blockade was unknown. In KEYNOTE-A18, Lorusso et al.1 compared the efficacy and safety of adding pembrolizumab to chemoradiation in LACC and demonstrated favorable outcomes. Given multiple approved indications of pembrolizumab in cervical cancer, strategies for optimal integration into management will be needed to maximize overall survival.


Subject(s)
Antibodies, Monoclonal, Humanized , Chemoradiotherapy , Uterine Cervical Neoplasms , Humans , Uterine Cervical Neoplasms/therapy , Uterine Cervical Neoplasms/drug therapy , Uterine Cervical Neoplasms/pathology , Female , Antibodies, Monoclonal, Humanized/therapeutic use , Chemoradiotherapy/methods , Immunotherapy/methods , Immune Checkpoint Inhibitors/therapeutic use , Immune Checkpoint Inhibitors/pharmacology , Randomized Controlled Trials as Topic
6.
Lancet Psychiatry ; 11(7): 545-553, 2024 Jul.
Article in English | MEDLINE | ID: mdl-38879276

ABSTRACT

BACKGROUND: Many patients with schizophrenia have symptoms that do not respond to antipsychotics. This condition is called treatment-resistant schizophrenia and has not received specific attention as opposed to general schizophrenia. Psychological and psychosocial interventions as an add-on treatment to pharmacotherapy could be useful, but their role and comparative efficacy to each other and to standard care in this population are not known. We investigated the efficacy, acceptability, and tolerability of psychological and psychosocial interventions for patients with treatment-resistant schizophrenia. METHODS: In this systematic review and network meta-analysis (NMA), we searched for published and unpublished randomised controlled trials (RCTs) through a systematic database search in BIOSIS, CINAHL, Embase, LILACS, MEDLINE, PsychInfo, ClinicalTrials.gov, and the WHO International Clinical Trials Registry Platform for articles published from inception up to Jan 31, 2020. We also searched the Cochrane Schizophrenia Group registry for studies published from inception up to March 31, 2022, and PubMed and Cochrane CENTRAL for studies published from inception up to July 31, 2023. We included RCTs that included patients with treatment-resistant schizophrenia. The primary outcome was overall symptoms. We did random-effects pairwise meta-analyses and NMAs to calculate standardised mean differences (SMDs) or risk ratios with 95% CIs. No people with lived experience were involved throughout the research process. The study protocol was registered in PROSPERO, CRD42022358696. FINDINGS: We identified 30 326 records, excluding 24 526 by title and abstract screening. 5762 full-text articles were assessed for eligibility, of which 5540 were excluded for not meeting the eligibility criteria, and 222 reports corresponding to 60 studies were included in the qualitative synthesis. Of these, 52 RCTs with 5034 participants (1654 [33·2%] females and 3325 [66·8%] males with sex indicated) comparing 20 psychological and psychosocial interventions provided data for the NMA. Mean age of participants was 38·05 years (range 23·10-48·50). We aimed to collect ethnicity data, but they were scarcely reported. According to the quality of evidence, cognitive behavioural therapy for psychosis (CBTp; SMD -0·22, 95% CI -0·35 to -0·09, 35 trials), virtual reality intervention (SMD -0·41, -0·79 to -0·02, four trials), integrated intervention (SMD -0·70, -1·18 to -0·22, three trials), and music therapy (SMD -1·27, -1·83 to -0·70, one study) were more efficacious than standard care in reducing overall symptoms. No indication of publication bias was identified. INTERPRETATION: We provide robust findings that CBTp can reduce the overall symptoms of patients with treatment-resistant schizophrenia, and therefore clinicians can prioritise this intervention in their clinical practice. Other psychological and psychosocial interventions showed promising results but need further investigation. FUNDING: DAAD-ASFE.


Subject(s)
Network Meta-Analysis , Psychosocial Intervention , Schizophrenia, Treatment-Resistant , Humans , Psychosocial Intervention/methods , Schizophrenia, Treatment-Resistant/therapy , Randomized Controlled Trials as Topic , Psychotherapy/methods , Antipsychotic Agents/therapeutic use , Treatment Outcome , Schizophrenia/therapy
7.
Minerva Anestesiol ; 90(6): 561-572, 2024 06.
Article in English | MEDLINE | ID: mdl-38869266

ABSTRACT

INTRODUCTION: The full extent of intravenous lidocaine's effectiveness in alleviating postoperative pain and enhancing gastrointestinal function recovery remains uncertain. EVIDENCE ACQUISITION: We conducted an exhaustive search of databases to identify randomized controlled trials that compared intravenous lidocaine infusion's efficacy to that of a placebo or routine care in patients undergoing gastrointestinal surgery. The primary outcome measure was resting pain scores 24 h postoperatively. We utilized a random-effects model based on the intention-to-treat principle for the overall results. EVIDENCE SYNTHESIS: This study included twenty-four trials with 1533 patients. Intravenous lidocaine significantly reduced resting pain scores 24 h after gastrointestinal surgery (twenty trials, SMD -0.67, 95% CI -1.09 to -0.24, P=0.002, I2 = 90%). This finding was consistent in subgroup analyses and sensitivity analyses. The benefit was also observed at other resting and moving time points (1, 2, 4, and 12 h) postoperatively. Intravenous lidocaine significantly decreased opioid consumption within 24 h after surgery (eleven trials, SMD: -1.19; 95% CI: -1.99 to -0.39; P=0.003). Intravenous lidocaine also shortened the time to bowel sound (MD: -8.51; 95% CI: -14.59 to -2.44; P=0.006), time to first flatus (MD: -6.00; 95% CI: -9.87 to -2.13; P=0.002), and time to first defecation (MD: -9.77; 95% CI: -17.19 to -2.36; P=0.01). CONCLUSIONS: Perioperative intravenous lidocaine can alleviate acute pain and expedite gastrointestinal function recovery in patients undergoing gastrointestinal surgery. However, the results should be interpreted with caution due to substantial heterogeneity. Further large-scale studies are necessary to validate these findings.


Subject(s)
Anesthetics, Local , Digestive System Surgical Procedures , Lidocaine , Pain, Postoperative , Lidocaine/administration & dosage , Lidocaine/therapeutic use , Humans , Pain, Postoperative/drug therapy , Pain, Postoperative/prevention & control , Anesthetics, Local/administration & dosage , Anesthetics, Local/therapeutic use , Recovery of Function/drug effects , Infusions, Intravenous , Randomized Controlled Trials as Topic
8.
Neurology ; 103(2): e209495, 2024 Jul 23.
Article in English | MEDLINE | ID: mdl-38870442

ABSTRACT

BACKGROUND AND OBJECTIVES: Robot technology to support upper limb (UL) rehabilitation poststroke has rapidly developed over the past 3 decades. We aimed to assess the effects of UL-robots (UL-RTs) on recovery of UL motor functioning and capacity poststroke when compared with any non-UL-RT and to identify variables that are associated with the found effect sizes (ESs). METHODS: Randomized controlled trials (RCTs) comparing UL-RTs with any other intervention on patients with UL limitations poststroke were identified in electronic searches from PubMed, Wiley/Cochrane Libraries, Embase, Cumulative Index of Nursing and Allied Health Literature, Web of Science, SportDISCUS, Physiotherapy Evidence Database (PEDro), and Google Scholar from inception until August 1, 2022. Two reviewers independently extracted relevant data using a Microsoft Excel spreadsheet. Meta-analyses were performed for measures of UL-muscle synergism, muscle power, muscle tone, capacity, self-reported motor performance, and basic activities of daily living (ADLs). Subgroup, sensitivity, and meta-regression analyses were applied to identify factors potentially associated with found ESs. Analyses were performed using Review Manager version 5.4 or IBM SPSS statistics version 27. RESULTS: Ninety RCTs (N = 4,311) were included (median PEDro score 6 [6-7]). Meta-analyses of 86 trials (N = 4,240) showed small significant improvements in UL-muscle synergism (Fugl-Meyer Assessment of the UL [FM-UL]) (mean difference 2.23 [1.11-3.35]), muscle power (standardized mean difference [SMD] 0.39 [0.16-0.61]), motor performance (SMD 0.11 [0.00-0.21]), and basic ADLs (SMD 0.28 [0.10-0.45]). No overall effects were found for muscle tone (SMD -0.1 [-0.26 to 0.07]) or UL-capacity (SMD 0.04 [-0.10 to 0.18]), except with exoskeletons (SMD 0.27 [0.10-0.43]). Meta-regressions showed a significant positive association between baseline mean FM-UL and ESs for UL-capacity (r = 0.339; p = 0.03), in particular in the acute and early-subacute phases poststroke (r = 0.65; p = 0.01). No further significant subgroup differences or associations were found in our analyses. DISCUSSION: The small significant effects found at the level of motor impairment do not show generalization to clinically meaningful effects at the level of UL-capacity. Meta-regressions suggest that selected participants with some potential of UL-recovery may benefit most from UL-RT, especially earlier poststroke. The robustness and consistency of our findings suggest that the development of the next generation of UL-RT needs to be guided by a better mechanistic understanding about assumed underlying interaction effects between motor learning and motor recovery poststroke. TRIAL REGISTRATION INFORMATION: A prospectively registered study protocol is available in the PROSPERO database under ID CRD42020197450.


Subject(s)
Recovery of Function , Robotics , Stroke Rehabilitation , Upper Extremity , Humans , Stroke Rehabilitation/methods , Stroke Rehabilitation/instrumentation , Recovery of Function/physiology , Upper Extremity/physiopathology , Stroke/physiopathology , Stroke/complications , Randomized Controlled Trials as Topic
10.
BMJ Open ; 14(6): e077975, 2024 Jun 04.
Article in English | MEDLINE | ID: mdl-38834315

ABSTRACT

INTRODUCTION: Diabetes and depression are among the 10 biggest health burdens globally. They often coexist and exhibit a strong bidirectional relationship. Depression leads to decreased adherence to self-care activities. This impacts glycaemic control and worsens type 2 diabetes mellitus (T2D). Both conditions have a synergistic effect and lead to greater complications, hospitalisations, healthcare expenditure and a worse quality of life. There is no consensus on managing people with comorbid T2D and depression. Bupropion is an efficacious antidepressant with many properties suitable for T2D with depression, including a favourable metabolic profile, persistent weight loss and improvement in sexual dysfunction. We will assess the efficacy and safety of add-on bupropion compared with standard care in people with T2D and mild depression. This study can give valuable insights into managing the multimorbidity of T2D and depression. This can help mitigate the health, social and economic burden of both these diseases. RESEARCH DESIGN AND METHODS: This cross-over randomised controlled trial will recruit people with T2D (for 5 years or more) with mild depression. They will be randomised to add-on bupropion and standard care. After 3 months of treatment, there will be a washout period of 1 month (without add-on bupropion while standard treatment will continue). Following this, the two arms will be swapped. Participants will be assessed for glycosylated haemoglobin, adherence to diabetes self-care activities, lipid profile, urine albumin-to-creatinine ratio, autonomic function, sexual function, quality of life and adverse events. ETHICS AND DISSEMINATION: The Institutional Ethics Committee at All India Institute of Medical Sciences, Jodhpur has approved this study (AIIMS/IEC/2022/4172, 19 September 2022). We plan to disseminate the research findings via closed group discussions at the site of study, scientific conferences, peer-reviewed published manuscripts and social media. TRIAL REGISTRATION NUMBER: CTRI/2022/10/046411.


Subject(s)
Bupropion , Cross-Over Studies , Depression , Diabetes Mellitus, Type 2 , Self Care , Humans , Diabetes Mellitus, Type 2/drug therapy , Diabetes Mellitus, Type 2/complications , Bupropion/therapeutic use , Depression/drug therapy , Randomized Controlled Trials as Topic , Antidepressive Agents, Second-Generation/therapeutic use , Glycemic Control/methods , Quality of Life , Multimorbidity , Medication Adherence , Male
11.
BMJ Open ; 14(6): e081281, 2024 Jun 04.
Article in English | MEDLINE | ID: mdl-38834328

ABSTRACT

INTRODUCTION: Patients with breast cancer often suffer from depressive symptoms throughout various stages of cancer, significantly impacting their quality of life and treatment outcomes. Non-pharmaceutical interventions such as psychotherapy, mind-body therapies and physical exercise have shown effectiveness in addressing cancer-related depression. However, the efficacy and safety of different non-pharmacological interventions remain a topic of debate. Therefore, to provide an objective assessment and comparison of the impact of different non-pharmaceutical interventions on depression, we will conduct a network meta-analysis (NMA) to explore the effects of different non-pharmaceutical interventions on reducing depressive symptoms among patients with breast cancer. METHODS AND ANALYSIS: We will search nine Chinese and English-language databases, from database inception to 31 July 2023, for randomised controlled trials published in Chinese or English. The English-language databases are PubMed, Medline, Embase, Web of Science and Cochrane Central Register of Controlled Trials, and the Chinese databases are CBM, CNKI, VIP and Wanfang. Two independent researchers will perform information extraction from eligible articles. The primary outcome will be the changes in depressive symptoms, while the secondary outcome will include adverse events. STATA V.15.0 will be used to conduct paired meta-analysis and NMA. Grading of Recommendations Assessment, Development and Evaluation will be used to assess the quality of evidence, and the Cochrane tool for assessing the risks of bias in randomised trials V.2 will be used for risk of bias assessment. ETHICS AND DISSEMINATION: The study does not require ethical approval as it will analyse data from existing studies. It is expected that the results of the study will be published in peer-reviewed journals and presented at relevant conferences. PROSPERO REGISTRATION NUMBER: CRD42023450494.


Subject(s)
Breast Neoplasms , Depression , Network Meta-Analysis , Systematic Reviews as Topic , Humans , Breast Neoplasms/complications , Breast Neoplasms/psychology , Female , Depression/therapy , Depression/etiology , Meta-Analysis as Topic , Quality of Life , Research Design , Psychotherapy/methods , Randomized Controlled Trials as Topic
12.
BMJ Open ; 14(6): e082076, 2024 Jun 04.
Article in English | MEDLINE | ID: mdl-38834330

ABSTRACT

INTRODUCTION: Schizophrenia, a chronic mental problem, significantly impacts cognition, emotion and social functioning. Conventional pharmacotherapy faces challenges including numerous side effects, low adherence to medication and substantial costs. In this context, group arts therapies (GATs) emerge as a promising complementary approach for symptom alleviation in schizophrenia patients. Nonetheless, the effectiveness and safety of GATs are yet to be firmly established. This study aims to systematically assess the therapeutic impact of all group-based artistic interventions as complementary treatments for schizophrenia, focusing on their potential benefits. METHODS AND ANALYSIS: This study will search four English-language databases (PubMed, Web of Science, Cochrane Library and Embase), two Chinese databases (Wanfang Data and China National Knowledge Infrastructure) and three Korean databases (RISS, Korean Citation Index and DBpia) from their inception until October 2023. It will include all randomised controlled trials that compare GATs for schizophrenia with standard rehabilitation methods. The primary outcome is the improvement in patients' positive and negative symptoms. Methodologies such as bias risk assessment, data synthesis, sensitivity analysis and subgroup analysis will be implemented using Review Manager V.5.4. Study results with high heterogeneity will be merged using a random-effects model (I 2>50% or p<0.1). In cases where meta-analysis is not viable due to significant clinical and methodological heterogeneity, a qualitative summary of the findings will be provided. ETHICS AND DISSEMINATION: The data used in this systematic review are anonymised, devoid of any private information, eliminating the requirement for ethical approval. Dissemination of the research findings will be conducted via peer-reviewed publications. PROSPERO REGISTRATION NUMBER: CRD42023471583.


Subject(s)
Art Therapy , Meta-Analysis as Topic , Schizophrenia , Systematic Reviews as Topic , Humans , Schizophrenia/therapy , Schizophrenia/rehabilitation , Art Therapy/methods , Research Design , Psychotherapy, Group/methods , Randomized Controlled Trials as Topic
13.
BMJ Open ; 14(6): e084068, 2024 Jun 05.
Article in English | MEDLINE | ID: mdl-38839388

ABSTRACT

BACKGROUND: In adult patients with high myopia (HM), progressive axial elongation poses a significant risk for the development of subsequent ocular complications that may lead to visual impairment. Effective strategies to reduce or prevent further axial elongation in highly myopic adult patients have not been available so far. Recent studies suggested that medically lowering intraocular pressure (IOP) may reduce axial elongation. OBJECTIVE: This clinical randomised controlled trial (RCT) aims to evaluate the efficacy of medical IOP reduction in adult patients with progressive HM (PHM). TRIAL DESIGN: Single-centre, open-label, prospective RCT. METHODS: This RCT will recruit 152 participants with PHM at the Zhongshan Ophthalmic Center (ZOC). Randomised in a ratio of 1:1, participants will receive IOP-lowering eyedrops (intervention group) or will be followed without treatment (control group) for 12 months. Follow-up visits will be conducted at 1, 6 and 12 months after baseline. Only one eye per eligible participant will be included for analysis. The primary outcome is the change in axial length (AL) within the study period of 12 months. Secondary outcomes include the incidence and progression of visual field (VF) defects, changes in optic disc morphology and incidence and progression of myopic maculopathy. Difference in AL changes between the two groups will be analysed using linear regression analysis. For the secondary outcomes, a multifactor Poisson regression within a generalised linear model will be used to estimate the relative risk of progression in VF defects and myopic maculopathy, and the rate of thinning in retinal nerve fibre layer and ganglion cell-inner plexiform will be assessed through Kaplan-Meier curves and log-rank tests. ETHICS AND DISSEMINATION: Full ethics approval for this trial has been obtained from the Ethics Committee of ZOC, Sun Yat-sen University, China (ID: 2023KYPJ110). Results of this trial will be disseminated through peer-reviewed journals and conference presentations. TRIAL REGISTRATION NUMBER: NCT05850936.


Subject(s)
Intraocular Pressure , Myopia, Degenerative , Humans , Prospective Studies , Adult , Disease Progression , Randomized Controlled Trials as Topic , Ophthalmic Solutions , Male , Female , Axial Length, Eye , Middle Aged , Visual Fields
14.
BMJ Open ; 14(6): e088312, 2024 Jun 05.
Article in English | MEDLINE | ID: mdl-38839394

ABSTRACT

BACKGROUND: Little is known about the impact of an ecological dynamics (ED) intervention (EDI) on primary school children's physical literacy and well-being in the Hong Kong context. The aim of this project is to introduce a physical literacy and well-being framework through an EDI that allows primary school children to develop good physical activity (PA) and daily behavioural habits. METHODS AND ANALYSIS: A four-arm (cluster) randomised controlled trial will be conducted to examine the effect of EDI on physical literacy and well-being in primary schools located in each of the 18 administrative districts of Hong Kong. Four classes in senior primary students (grade 4) at each school will be randomly assigned to the four different conditions. These participating schools will be equipped with sit-stand desks, PA recess facility and equipment, and sleep pillows. The research team will adopt both objective measures (aerobic fitness, fundamental movement skills, daily behaviour-physical activity and cognitive function) and self-reported measures (perceived physical literacy, quality of life, sleep quality) covering the elements and domains of physical literacy and well-being to examine the effects of EDIs at four time points, including baseline assessment, 3 months after intervention, postintervention and 3-month follow-up assessment. One-way analyses of variance (ANOVAs) will be used to test for differences in the baseline characteristics of participants between groups. Repeated measure ANOVAs and MANCOVA, with time (baseline, after intervention and follow-up) as within-subjects factor, and intervention group as between-subjects factors, will be used to evaluate the effects of different interventions on the students' physical literacy and well-being. A Bonferonni correction to the p value will be calculated to adjust for multiple tests. ETHICS AND DISSEMINATION: Ethical approval was sought from the Joint CUHK-NTEC Clinical Research Ethics Committee in Hong Kong (CREC Ref.No.:2024.027). The finding of this study will be disseminated via peer-reviewed journals, international conference presentations and academic lectures. For secondary analysis of the data, please contact the corresponding author for permission. TRIAL REGISTRATION NUMBER: ISRCTN84025914.


Subject(s)
Exercise , Quality of Life , Schools , Humans , Hong Kong , Child , Health Promotion/methods , Female , Randomized Controlled Trials as Topic , Male , Health Literacy , Physical Fitness , Students/psychology , School Health Services
15.
BMJ Open ; 14(6): e075727, 2024 Jun 06.
Article in English | MEDLINE | ID: mdl-38844396

ABSTRACT

INTRODUCTION: A cluster randomised controlled trial, the Meaning, Agency and Nurturing Autonomy (MANA) study, is underway comparing the effects of occupational performance coaching (OPC) and usual care on the social participation, health and well-being of children with neurodisability and their caregivers. This protocol presents the realist process evaluation which is occurring in parallel with the trial to allow testing and further refinement of OPC programme theory, as represented in its logic model. The aim of this realist evaluation is to examine what works, for whom, in the implementation of OPC with caregivers of children with neurodisability (in particular, Maori and Pasifika) in current service delivery contexts. METHODS AND ANALYSIS: Guided by OPC programme theory and realist evaluation processes, mixed-methods data collected from the MANA study OPC group will be analysed to elucidate when OPC works (outcomes), for whom, how (mechanisms) and under what circumstances (contexts). This will culminate in the synthesis of Intervention-Actor Context-Mechanism-Outcome configurations. Descriptive analyses will be reported for quantitative measures of treatment fidelity (OPC-Fidelity Measure), caregiver emotional response to OPC (Session Rating Scale) preintervention emotional state (Depression Stress and Anxiety Scale) and client outcomes (Canadian Occupational Performance Measure). Reflexive thematic analysis will be undertaken to analyse realist interviews with therapists who implemented OPC above and below fidelity thresholds and culturally focused interviews with clients of Maori or Pasifika ethnicity, informing understanding of the contexts influencing therapists' implementation of OPC with fidelity, and the mechanisms triggered within therapists or caregivers to elicit a response to the intervention. The MANA study trial outcomes will be reported separately. ETHICS AND DISSEMINATION: Ethical approval for this study was granted by the New Zealand Health and Disability Ethics Committee (20/STH/93). In all participating jurisdictions local area approval was obtained, involving a process of local Maori consultation. Results will be disseminated to all participants, and more broadly to clinicians and policy-makers through conference presentations and peer-reviewed journal publications, which will inform decision-making about resourcing and supporting effective delivery of OPC to optimise outcomes for children and caregivers. TRIAL REGISTRATION NUMBER: ACTRN12621000519853.


Subject(s)
Caregivers , Humans , Caregivers/psychology , New Zealand , Occupational Therapy/methods , Child , Mentoring/methods , Randomized Controlled Trials as Topic
16.
Medicine (Baltimore) ; 103(23): e38403, 2024 Jun 07.
Article in English | MEDLINE | ID: mdl-38847671

ABSTRACT

BACKGROUND: Electroacupuncture (EA) is considered as an effective treatment for urinary retention (UR). METHODS: Up to April 7, 2023, randomized controlled trials (RCTs) of EA for UR were extensively searched in 8 databases, including Pubmed, Cochrane, Embase, Web of Science, Chinese Biomedical Literature Database, Chinese Journal Full-text Database, Wanfang Data, and VIP Full-text e-Journals Database. The Cochrane Risk of Bias tool and the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) were utilized to evaluate the quality of all included RCTs. Meta-analysis was conducted using Stata 15.0 software. RESULTS: A total of 23 trials were included, and the meta-analysis results suggested that compared with the control group, EA can effectively treat various types of UR (risk ratio [RR] = 1.22, 95CI%: 1.14, 1.31) and promote bladder function recovery, with a significant reduce in residual urine volume (weighted mean differences [WMD] = -49.60, 95CI%: -64.10, -35.11), an increase in maximum bladder capacity (WMD = 47.00, 95CI%: 12.76, 81.24), a shorten in the first urination time (standardized mean difference [SMD] = -1.42, 95CI%: -2.08, -0.76), and less adverse reactions (RR = 0.21, 95CI%: 0.07, 0.65). CONCLUSION: EA has significant advantages in treating UR, but the efficacy and safety are still needed to be further verified through large-sample and high-quality RCTs.


Subject(s)
Electroacupuncture , Urinary Retention , Urinary Retention/therapy , Electroacupuncture/methods , Electroacupuncture/adverse effects , Humans , Randomized Controlled Trials as Topic , Treatment Outcome , Urination/physiology
17.
Medicine (Baltimore) ; 103(23): e38334, 2024 Jun 07.
Article in English | MEDLINE | ID: mdl-38847692

ABSTRACT

BACKGROUND: Traditionally, herbal medicines have been used to alleviate nausea and vomiting; however, a comprehensive clinical evaluation for postoperative nausea and vomiting (PONV), especially after laparoscopic surgery, remains limited. This review aimed to evaluate the efficacy and safety of herbal medicine as an alternative therapy to prevent and manage nausea and vomiting after laparoscopic surgery compared with untreated, placebo, and Western medicine groups. METHODS: We searched 11 databases, including EMBASE, PubMed, and the Cochrane Library, to collect randomized controlled trials (RCTs) of herbal medicines on PONV after laparoscopic surgery on July 7, 2022. Two independent reviewers screened and selected eligible studies, extracted clinical data, and evaluated the quality of evidence using the Cochrane risk-of-bias tool. The primary outcome was the incidence of PONV, whereas the secondary outcomes included the frequency and intensity of PONV, symptom improvement time, antiemetic requirement frequency, and incidence of adverse events. Review Manager Version 5.3. was used for the meta-analysis. RESULTS: We identified 19 RCTs with 2726 participants comparing herbal medicine with no treatment, placebo, and Western medicine. The findings showed that compared with no treatment, herbal medicine demonstrated significant effects on vomiting incidence (risk ratio [RR] = 0.43, 95% confidence interval [CI] 0.32-0.57, P < .00001). Compared with placebo, herbal medicine revealed a significant effect on the severity of nausea 12 hours after laparoscopic surgery (standardized mean difference = -2.04, 95% CI -3.67 to -0.41, P = .01). Herbal medicines showed similar effects with Western medicine on the incidence of postoperative nausea (RR = 0.94, 95% CI 0.63-1.42, P = .77) and vomiting (RR = 0.68, 95% CI 0.25-1.84, P = .45). Furthermore, comparing the experimental group containing herbal medicine and control group excluding herbal medicine, adverse events were considerably lower in the group with herbal medicine (RR = 0.45, 95% CI 0.27-0.72, P = .001). CONCLUSION: Herbal medicine is an effective and safe treatment for nausea and vomiting secondary to laparoscopic surgery. However, the number of studies was small and their quality was not high; thus, more well-designed RCTs are warranted in the future.


Subject(s)
Laparoscopy , Postoperative Nausea and Vomiting , Humans , Postoperative Nausea and Vomiting/prevention & control , Postoperative Nausea and Vomiting/drug therapy , Laparoscopy/adverse effects , Randomized Controlled Trials as Topic , Antiemetics/therapeutic use , Phytotherapy/methods , Drugs, Chinese Herbal/therapeutic use , Drugs, Chinese Herbal/adverse effects , Herbal Medicine/methods
18.
Medicine (Baltimore) ; 103(23): e38277, 2024 Jun 07.
Article in English | MEDLINE | ID: mdl-38847673

ABSTRACT

BACKGROUND: We conducted this meta-analysis based on updated literature and research to compare the efficacy and safety of epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) as treatments for patients with non-small cell lung cancer (NSCLC). METHODS: A literature search was conducted using PubMed, Embase, Medline and Web of Science databases to perform a systematic literature search based on random control trials. In these articles, EGFR-TKIs were compared with placebos, chemotherapy, or whole-brain irradiation as treatments for NSCLC. In this research, a meta-analysis of the literature was performed to produce a combined risk ratio (RR) with a 95% confidence interval (CI) for progression-free survival (PFS), overall survival (OS), and adverse events. The data were synthesized with Review Manager 5.3 software, which was used to manage the process. RESULTS: There were 15 random control trials included in the study, involving 4249 patients in total. There was evidence that EGFR-TKIs can significantly prolong OS (RR: 0.87, 95% CI: 0.75-1) and PFS (RR: 0.75, 95% CI: 0.66-0.86) in NSCLC patients. There was an increase in the incidence of adverse events after treatment with EGFR-TKI, including diarrhea (RR: 0.18, 95% CI: 0.10-0.26), infection (RR: 0.09, 95% CI: 0.02-0.16), and rash (RR: 0.37, 95% CI: 0.22-0.51). CONCLUSIONS: It has been shown that EGFR-TKIs prolong OS and PFS in patients with NSCLC. NSCLC patients may benefit from EGFR-TKIs as an important treatment option in order to prolong their survival.


Subject(s)
Carcinoma, Non-Small-Cell Lung , ErbB Receptors , Lung Neoplasms , Protein Kinase Inhibitors , Randomized Controlled Trials as Topic , Carcinoma, Non-Small-Cell Lung/drug therapy , Humans , ErbB Receptors/antagonists & inhibitors , Lung Neoplasms/drug therapy , Protein Kinase Inhibitors/therapeutic use , Protein Kinase Inhibitors/adverse effects , Antineoplastic Agents/therapeutic use , Antineoplastic Agents/adverse effects , Progression-Free Survival
19.
Medicine (Baltimore) ; 103(23): e38441, 2024 Jun 07.
Article in English | MEDLINE | ID: mdl-38847675

ABSTRACT

INTRODUCTION: The prevalence of cardiac arrhythmia, which can lead to cardiac death, heart failure, and cardioembolic stroke, is increasing. Although various Western medicines for cardiac arrhythmias have been developed, there are still various difficulties in the management of arrhythmias. Traditional herbal medicines (THM) are widely used to manage arrhythmia in East Asia. Therefore, this study aimed to assess the effectiveness and safety of THM in the treatment of arrhythmia. METHOD: Using a systematic review methodology, we searched for randomized clinical trials on herbal medicines for arrhythmia without complications in 4 databases up to September 2022. The literature search was carried out again, targeting papers published until April 2024.We conducted a risk-of-bias assessment and meta-analysis. This study was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. RESULTS: Eighty-two randomized clinical trials were included in this meta-analysis. Total effective rate was significantly better in unspecified arrhythmia (risk ratio [RR]: 1.20, 95% confidence interval [CI]: 1.13-1.26), premature ventricular contraction (RR: 1.29, 95% CI: 1.29-1.33), sinus bradycardia (RR: 1.26, 95% CI: 1.17-1.36), tachycardia (RR: 1.23 95% CI: 1.15-1.32), and atrial fibrillation (RR: 1.17, 95% CI: 1.07-1.27). No severe adverse events were associated with THM. The overall risk of bias was relatively high. The total effective rate was the most frequently assessed clinical outcome variable. Most outcomes were surrogates and not clinical endpoints. CONCLUSION: THM, alone or in combination with Western medicine, has therapeutic effects on cardiac arrhythmic diseases. However, additional disease-specific clinical outcome variables are required for further studies on THM. Owing to the low quality of the included studies and their small sample sizes, additional large-scale, long-term follow-up, and well-designed randomized controlled clinical trials are required. SYSTEMATIC REVIEW REGISTRATION NUMBER: Details of the protocol for this systematic review and meta-analysis were registered on the Open Science Framework (OSF. io). (https://osf.io/7r8kn/).


Subject(s)
Arrhythmias, Cardiac , Randomized Controlled Trials as Topic , Humans , Arrhythmias, Cardiac/drug therapy , Phytotherapy/methods , Herbal Medicine/methods , Treatment Outcome
20.
Medicine (Baltimore) ; 103(23): e38418, 2024 Jun 07.
Article in English | MEDLINE | ID: mdl-38847680

ABSTRACT

BACKGROUND: Previous findings on the effect of general versus spinal anesthesia on postoperative delirium in elderly people with hip fractures are somewhat controversial. This article included the latest randomized controlled study for meta-analysis to evaluate the effect of general anesthesia (GA) and spinal anesthesia (SA) on delirium after hip fracture surgery in the elderly, so as to guide the clinical. METHODS: Cochrane Library, PubMed, Web Of Science, and Embase were searched from inception up to January 16, 2024. Randomized controlled trial (RCT) was included to evaluate the postoperative results of GA and SA in elderly patients (≥50 years old) undergoing hip fracture surgery. Two researchers independently screened for inclusion in the study and extracted data. Heterogeneity was assessed by the I²and Chi-square tests, and P < .1 or I² ≥ 50% indicated marked heterogeneity among studies. The Mantel-Haenszel method was used to estimate the combined relative risk ratio (RR) and the corresponding 95% confidence interval (CI) for the binary variables. RESULTS: Nine randomized controlled trials were included. There was no significant difference (RR = 0.93, 95% CI = 0.774-1.111, P > .05) in the incidence of postoperative delirium between the GA group and the SA group. In intraoperative blood transfusion (RR = 1.0, 95% CI = 0.77-1.28, Z = 0.04, P = .971), pulmonary embolism (RR = 0.795, 95% CI = 0.332-1.904, Z = 0.59, P = .606), pneumonia (RR = 1.47, 95% CI = 0.75-2.87, P = .675), myocardial infarction (RR = 0.97, 95% CI = 0.24-3.86, Z = 0.05, P = .961), heart failure (RR = 0.80, 95% CI = 0.26-2.42, Z = 0.40, P = .961), urinary retention (RR = 1.42, 95% CI = 0.77-2.61, Z = 1.11, P = .267) were similar between the 2 anesthetic techniques. CONCLUSION: There is no significant difference in the effect of GA and SA on postoperative delirium in elderly patients with hip fracture, and their effects on postoperative complications are similar.


Subject(s)
Anesthesia, General , Anesthesia, Spinal , Delirium , Hip Fractures , Postoperative Complications , Randomized Controlled Trials as Topic , Aged , Aged, 80 and over , Female , Humans , Male , Anesthesia, General/adverse effects , Anesthesia, General/methods , Anesthesia, Spinal/adverse effects , Anesthesia, Spinal/methods , Delirium/etiology , Delirium/epidemiology , Delirium/prevention & control , Emergence Delirium/epidemiology , Emergence Delirium/prevention & control , Emergence Delirium/etiology , Hip Fractures/surgery , Postoperative Complications/epidemiology , Postoperative Complications/etiology , Postoperative Complications/prevention & control , Middle Aged
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