OBJECTIVE:Imaging biomarkers for disease activity are urgently needed in giant cell arteritis (GCA). Whether 18F-fluorodeoxyglucose (FDG) positron emission tomography (PET) can be used to monitor disease activity in patients with large-vessel GCA (LV-GCA) is still unclear. This study aimed to determine how often large-vessel inflammation improves or becomes radiographically quiescent on follow-up PET in patients with LV-GCA who show clinical improvement with treatment. METHODS:Medical Literature Analysis and Retrieval System Online (MEDLINE), Embase, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Scopus, and the Cochrane Library were searched from inception through February 29, 2024. Studies describing patients with active LV-GCA on baseline PET who underwent follow-up PET and clinical assessment of disease activity after escalation of immunosuppressive therapy were included. Metaanalysis of the pooled sensitivities of improved PET for clinical improvement and normalized PET for clinical remission in treated patients with GCA was performed, with subgroup analysis of tocilizumab (TCZ)-treated patients. RESULTS:Of 3131 unique references, 25 studies were included. The pooled sensitivity of improved vascular FDG uptake on follow-up PET for clinical improvement in GCA was 0.95 (95% CI 0.82-1.00), and the pooled sensitivity of normalized vascular FDG uptake on follow-up PET for clinical remission was 0.53 (95% CI 0.34-0.72). In TCZ-treated patients, the pooled sensitivity of improvement and normalization of follow-up PET were 1.00 (95% CI 0.99-1.00) and 0.78 (95% CI 0.50-0.97), respectively. CONCLUSION:Follow-up PET findings improved in most patients (95%) with LV-GCA who showed clinical improvement with treatment, but large-vessel vasculitis became radiographically quiescent in only 53% of patients. Better responses were observed in those receiving TCZ. (PROSPERO ID: CRD42020219141).
Individuals living with chronic illness commonly experience co-occurring physical, psychological, and existential symptoms that cluster and reinforce one another, contributing to functional decline and distress. Yet, frailty and existential distress have rarely been examined alongside psychological and physical symptoms, and few studies have mapped how these symptoms interrelate across chronic conditions. This study used baseline patient-reported outcome measures (PROMs) from the eMPower randomized controlled trial to examine interconnections among symptoms across physical, psychological, and existential domains in adults living with chronic medical conditions. Adults aged ≥18 years (n = 825) were enrolled in the 12-week eMPower digital mind-body program (breathwork/meditation practices, movement, psychology-based coping skills curriculum based on acceptance and commitment therapy (ACT)). Baseline PROMs included the Hospital Anxiety and Depression Scale (HADS), Modified Fatigue Impact Scale (MFIS), EQ-5D-5L, SF-12, Edmonton Frail Scale Acute Care version (EFS-AC), online Fried Frailty Phenotype (online FFP), Demoralization Scale-II (DS-II), and PROMIS Sleep Disturbance SF-8a. Network analysis of pooled baseline data using LASSO-regularized partial correlations identified clusters and central symptoms. Participants had a mean age 55.6 ± 12.7 years and were predominantly female (84%). Across the cohort, symptom burden was high, frailty was prevalent, and quality of life was impaired. Network analysis identified three clusters: (i) mental health; (ii) fatigue and frailty; and (iii) quality of life, with physical fatigue emerging as the most central node linking psychological and functional domains. These findings suggest that fatigue, demoralization, and frailty are interconnected drivers of symptom burden in chronic illness. Targeting fatigue may represent an important strategy for improving mental health and functional outcomes in people living with chronic medical conditions.
The evidence base for telehealth treatments for mental health has grown substantially in the years following the COVID-19 pandemic. We conducted a narrative synthesis and meta-analysis of reviews investigating the efficacy of live, one-to-one telehealth interventions for common mental disorders. We conducted a search for systematic reviews of randomized controlled trials or controlled before-and-after studies. Two independent reviewers screened potentially eligible references and extracted data from all eligible reviews. A meta-regression was conducted with reviews containing data suitable for quantitative analysis. A narrative synthesis of results was undertaken for included reviews that did not contain suitable quantitative data. The search yielded 4180 references, from which 11 eligible reviews were identified. Seven systematic reviews with meta-analyses were included in the meta-regression. Only telehealth interventions for depression and anxiety disorders were identified in the eligible literature. A small significant effect was observed for interventions targeting depression and comparing to active control, where SMD = − 0.316, and p = 0.003. The results of the meta-regression and narrative synthesis indicate that live one-to-one telehealth produces similar reductions in symptom severity across diagnoses and comparator groups. We identified that most of the research on telehealth for common mental disorders includes low-intensity, self-help tools with reduced clinician involvement, highlighting that much of the research conducted in this area aims at providing care at reduced cost, despite the importance of therapeutic alliance in the provision of mental health care. Investigations of telehealth interventions targeting posttraumatic stress disorder in non-military populations are also needed.
Objective:The Adult Attention-Deficit-Hyperactivity-Disorder (ADHD) Self-Report Scale (ASRS) is widely used for ADHD screening in primary care clinics worldwide. While it offers a quick and efficient method to screen for ADHD, it also has a high false positive rate. The standard ASRS format-shaded responses for screen-positive items and grouping the key questions in Part A-may contribute to this issue. The objective of this study is to examine whether these design features impact the screen positive rate. Methods:This is a 2x2 factorial randomized controlled trial that ran from July to October 2024. Individuals 19 to 65 years old attending a family medicine clinic received at random one of four ASRS forms on registration (standard, grouping only, shading only, and no shading and no grouping). Logistic regression was used to analyze the results. Results:A total of 595 participants completed the study: mean age 39 (standard deviation 12), 79% women, 85% with at least some post-secondary education, 54% White, 33% Asian, 13% other ethnicities. Additionally, 14% had a prior ADHD diagnosis, and 23% suspected they had undiagnosed ADHD. Overall, 32% of participants screened positive for ADHD, and grouping and shading were not statistically significant predictors of a positive ADHD screen (Odds ratio [OR] 1.25, 95% CI 0.98-1.58 and OR 0.88 95% CI 0.69-1.12 respectively). In contrast, prior ADHD diagnosis and suspected undiagnosed ADHD were statistically significant predictors (OR 47.4, 95% CI 23,1-97.0 and OR 16.2, 95% CI 9.7-27.2, respectively). Conclusion:The standard ASRS does not appear to increase the screen positive rate. Nevertheless, the high positive screening rate highlights the need for more effective ADHD screening tools in primary care. Clinical trial registration:Clinicaltrials.gov, identifier NCT06530758.
Background Behaviour change techniques (BCTs) are key components of eHealth physical activity interventions. They may be especially important for older adults and individuals with frailty or sarcopenia, who often face additional barriers to sustaining physical activity. This review aimed to identify BCTs used in eHealth physical activity trials and examine which techniques are associated with greater effectiveness. Methods Six databases (MEDLINE, Embase, CINAHL, CENTRAL, PsycINFO, and Scopus) were searched for randomized controlled trials (RCTs) published up to 2024. Eligible studies evaluated eHealth physical activity interventions delivered to older adults (mean age ≥60 years) or adults with frailty or sarcopenia. Trials delivered exclusively through virtual reality, wearable devices, or telephone-based modalities were excluded. Random-effects meta-analysis estimated pooled effects on physical activity, with subgroup analyses examining differences according to BCTs reported and behavioural theory. Completion, adherence, and adverse events were summarized descriptively. Results Eighty-seven studies met inclusion criteria, and 53 contributed to the meta-analysis. eHealth interventions produced a small positive effect on physical activity (standardized mean difference = 0.22, 95% confidence interval: 0.13 to 0.31). Completion was generally high and adherence moderate, with few reported adverse events. The most frequently used BCTs were feedback on behaviour, goal setting, social support, self-monitoring, and prompts/cues. Among these BCTs, all were non-significant, with social support (unspecified) having a p=0.05. Conclusions eHealth interventions yield modest improvements in physical activity among older adults, although evidence specific to frailty and sarcopenia remains limited. Further research is needed to better understand the role of social support and other BCTs in eHealth physical activity interventions among older adults. Systematic review registration PROSPERO CRD42025641608.
We evaluated the feasibility and acceptability of the Multidisciplinary Support To Access living donor Kidney Transplant (MuST AKT) intervention, developed to increase living donor kidney transplantation (LDKT). In this pilot randomized controlled trial, we randomly assigned transplant candidates to receive standard care or the MuST AKT intervention, where transplant candidates and their social network addressed barriers to LDKT across four 60-90-minute sessions. Feasibility was assessed by consent/recruitment, retention, study protocol adherence, intervention adherence, and intervention engagement. Acceptability was assessed by questionnaire and post-intervention interviews. The recruitment rate was 61% (43/71), with 38 participants randomized 1:1. Among intervention participants, 1 was excluded for not meeting study criteria prior to start. Among those that started (18), 100% completed 1 session, 94% completed 2 sessions, 83% completed 3 sessions, and 56% completed all 4 sessions. The intervention was delivered in 71 days (mean), shorter than anticipated. The intervention participants reported increased confidence for communicating about LDKT from pre-to post-intervention, and all recommended MuST AKT to their peers. Intervention participants and invitees from their social network described a positive experience and provided recommendations for improvement. The MuST AKT intervention is feasible with minor modifications and acceptable to transplant candidates and their social network.
The large number of people infected by SARS-CoV-2 necessitates estimation of the future health care burdens. We updated a systematic review examining associations between SARS-CoV-2 infection and incidence of new diagnoses and exacerbations of chronic conditions. Updated searches were run September 4, 2024, in the MEDLINE and Embase databases for observational studies with a control group, adjustment by sex and comorbid conditions, and reporting age-stratified data for 1 or more chronic condition category (n = 12) or condition type (n = 46) of interest. Two human reviewers screened 50% of titles and abstracts, then DistillerAI acted as second reviewer. Two human reviewers assessed full texts of relevant studies for eligibility based on a priori criteria. One reviewer extracted data and assessed risk of bias using the JBI cohort studies checklist; a second reviewer verified results data and risk-of-bias assessments. Pooled hazard ratios (HRs) were estimated with inverse-variance weighting. Using the Grading of Recommendations, Assessment, Development, and Evaluation approach, 2 reviewers assessed certainty in conclusions of little to no association (ie, HR = 0.75-1.25), small to moderate association (ie, HR = 0.51-0.74 or 1.26-1.99), or large association (ie, HR ≤ 0.50 or ≥ 2.00). We identified 46 new studies and brought forward 23 studies from the original review. After SARS-CoV-2 infection, there is probably increased risk of new diagnoses for several chronic conditions, especially in adults. Most findings are based on data from earlier pandemic periods; their relevance to contemporary populations is uncertain due to differences in vaccination rates and circulating variants of concern. PROSPERO registration identifier CRD42024585278.
Despite emerging evidence for new pharmacotherapies to improve outcomes in patients with heart failure (HF) and kidney dysfunction, data on contemporary HF therapy use in this population are lacking. This study evaluated contemporary longitudinal treatment patterns in patients with HF across the spectrum of kidney function and left ventricular ejection fraction (LVEF). In a prospective, observational cohort of 1401 HF patients, we examined HF therapy use over 2 years and dose intensity stratified by ambulatory estimated glomerular filtration rate (eGFR ≥60, 30 to <60 and <30 mL/min/1.73 m 2 ) and HF with reduced (HFrEF), mildly reduced (HFmrEF) and preserved (HFpEF) ejection fraction. Clinical outcomes, incidence of hyperkalaemia (serum potassium > 5.5 mmol/L) and clinician-reported reasons for underutilizing HF therapies were examined. Median age was 68 (58 to 76) years; 29% were female; 54%, 37% and 9% had an eGFR of ≥60, 30 to <60 and <30, respectively. Among patients with eGFR ≥60, 95%, 94%, 75% and 15% were on a beta-blocker (BB), renin–angiotensin system inhibitor (RASi), mineralocorticoid receptor antagonist (MRA) and sodium glucose cotransporter-2 inhibitor, respectively. In patients with eGFR <30, corresponding baseline rates were 88%, 68%, 35% and 7%. Utilization rates were similar in patients with eGFR 30 to <60 compared with eGFR ≥60; however, fewer patients were on guideline-directed dose intensities with 44% versus 57% for RASi and 19% versus 26% for MRA. However, >90% of patients were on a BB, with similar utilization rates across HF and eGFR categories. Baseline ARNI use was 29%, 24% and 11% in eGFR ≥60, 30 to <60 and <30, respectively. Trends in HF therapy use persisted over 2 years. Among patients with eGFR <30, kidney dysfunction was the most frequently cited reason for underutilizing RASi. Patients with eGFR <60 experienced higher all-cause mortality, hospitalization and higher rates of hyperkalaemia. Gaps in HF therapy use persist in patients with comorbid kidney dysfunction. Targeted strategies to implement new therapies and improve adherence to HF treatments are necessary to improve outcomes in a highly comorbid and at-risk population.
Chronic physical conditions (CPCs) are conditions that persist for long periods and may not have a cure. Fatigue is a common symptom experienced by people living with CPCs. Mind-body internet and mobile-based interventions (IMIs) offer an accessible management strategy. The objective of this review was to assess the impact of mind-body IMIs on fatigue symptoms in adults with CPCs. Six databases were searched from inception to July 2024. Inclusion required randomized controlled trials (RCTs) of mind-body IMIs in adults (≥ 18) with CPCs that assessed fatigue pre-and post-intervention using self-report questionnaires. The primary outcome was the standardized mean fatigue change scores (Hedges' g). Sub-group analyses were conducted on CPC type, mind-body technique, fatigue questionnaire, and personnel support level. Meta-regression was performed on IMI length and age. Study quality was assessed using the Cochrane Risk of Bias 2.0 tool. The search retrieved 5239 studies. Seventeen studies met inclusion criteria: 47% neurological (n = 8), 29% cancer (n = 5), and 24% autoimmune (n = 4). Seven studies (41%) included cognitive behavioural therapy (CBT), seven used CBT combined with non-CBT techniques, and three employed non-CBT techniques. Mind-body IMIs led to significant reductions in fatigue (SMD = -0.74 [-1.09, -0.39]; p < 0.0001), with a greater effect in younger participants (p = 0.005). Heterogeneity was moderate to high. In conclusion, mind-body IMIs show promise in reducing fatigue symptoms in adults with CPCs. Further high-quality RCTs, expanding beyond CBT techniques, and using at least one common fatigue scale across conditions, would be helpful in evaluating the impact of IMIs across a broader range of CPCs.
OBJECTIVE:To assess whether commercially available virtual reality (VR)-based distraction reduces distress when added to standard of care (SOC) for children undergoing intravenous insertion (IVI) in the pediatric emergency department. STUDY DESIGN:Children aged 6-17 years requiring IVI were recruited for a two-arm randomized controlled trial. The primary outcome was child distress, measured using the Observational Scale of Behavioral Distress-Revised (score range 0-23.5). Secondary outcomes included children's procedural pain (verbal Numerical Rating Scale, score range 0-10) and fear (Children's Fear Scale, score range 0-4). RESULTS:Mean (SD) children age was 11.1 years (2.9) and 54% (45/82) were female. Mean (SD) preprocedural Observational Scale of Behavioral Distress-Revised scores were similarly low in both the VR [0.39 (0.70)] and SOC arms [0.18 (0.49)] (P = .16). Use of VR during IVI was not associated with lower mean (SD) total procedural distress [1.1 (1.5)] vs SOC [0.7 (1.4)] (P = .08), mean (SD) procedural pain intensity [3.0 (2.9)] vs SOC [2.1 (2.3)] (P = .14), or mean (SD) Children's Fear Scale score [0.97 (1.33)] vs SOC [0.97 (1.15)]. Technical issues with the VR equipment were reported in 26% (10/39) of cases. CONCLUSIONS:VR distraction therapy employing commercially available software was not associated with reduction in procedural distress, pain or fear, above that provided with SOC, for children undergoing IVI in the pediatric emergency department. Given no differences and frequency of technical issues, other forms of distraction may be more appropriate in this setting. TRIAL REGISTRATION:Clinicaltrials.gov Identifier: NCT04291404.
Background. Gangliosides - glycosphingolipids that modulate cell signaling and neuronal functions - are decreased in Huntington disease (HD) models and the brain of patients. Restoring ganglioside GM1 has therapeutic benefits in HD mice, slowing neurodegeneration and improving symptoms. This suggests gangliosides might contribute to HD pathogenesis. However, their link to disease severity and progression in patients remains unclear. Objectives. This study examined plasma ganglioside differences between HD gene carriers and controls, and their prognostic potential. Methods. Plasma gangliosides were quantified in 67 HD carriers and 46 healthy participants, using liquid chromatography-tandem mass spectrometry. Statistical modelling assessed associations with clinical measures and prognostic potential. Results. Levels of most gangliosides were similar between groups, but GM3 was higher and GT1b lower in HD carriers. Within the HD group, higher GM2 levels correlated with better cognition, and higher GM1 and GD1a with greater functional capacity and independence. Higher GM1 predicted HD status, but its decline and an increase in GD3 were strongly associated with disease progression. Individual gangliosides had limited disease classification ability. Conclusions. The correlation between higher GM2, GD1a and GM1 and milder symptoms suggests a protective role of these gangliosides in HD. The association between higher GM1 levels and HD status, along with its decline predicting disease progression, suggests GM1 increase may be a compensatory neuroprotective mechanism that deteriorates over time. While plasma gangliosides are not strong disease classifiers, our findings provide novel insights into their role in HD progression and prognostic potential. ### Competing Interest Statement Simonetta Sipione holds a patent for the use of GM1 in Huntington disease (Patent Number US 09023812) and is an Advisory Board Member and consultant for Zulia Inc., USA. There are no other financial disclosure/conflicts to report. ### Funding Statement This work was supported by a Brain Canada Multi-Investigator Research Initiative grant to SS, OS, SC, JC and JS, and by Canadian Institutes of Health Research (CIHR) and GlycoNET grants to SS. We thank the Alberta SPOR SUPPORT Unit and EPICORE at the University of Alberta for statistical support services. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The University of Alberta Health Research Ethics Board gave ethical approval for this work (Pro00067917). I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes All data produced in the present study are available upon reasonable request to the authors
BACKGROUND:Advances in alternative oral anticoagulants has reduced use and clinician comfort with warfarin. Our specialty anticoagulation clinic (AC) operates at maximum capacity and must transfer patients to accept new referrals. OBJECTIVES:To compare time within therapeutic range (TTR) during 6 months of AC care versus following transfer to primary care for a minimum of 6 months and to a maximum of 24 months. Secondarily, to compare frequency of INR assessments, proportion of INRs ≤1.5 and > 5, and rates of bleeding and thromboembolic events post-transfer to primary care. METHODS:Mixed retrospective chart review and administrative audit with a before-after study design for patients managed by the University of Alberta's AC for at least 6 months that were transferred to primary care. RESULTS:177 (27.7 %) patients were included, managed by the AC for 3.4 years (1.3, 7.9). TTR declined during the first 6 months post-transfer with AC care achieving 69.2 % and primary care 64.5 % (p = 0.02) and when compared to the 24-month interval (69.2 % vs 63.4 %; respectively; p = 0.003). A shorter interval between INRs in AC care was observed (28.9 (24.4) vs 34.5 (31.7) days, respectively; p = 0.0004). Similar numbers of critical INRs occurred between groups, whereas more INRs ≤1.5 occurred in primary care (7.3 % vs 4.7 %, respectively; p = 0.0003). Bleeding and thromboembolic event rates were balanced following transfer to primary care with both occurring at 9.4 % per patient year. CONCLUSION:A decline in anticoagulation control after transfer to primary care was observed, which appeared to be driven by a greater proportion of subtherapeutic INRs.
OBJECTIVE:To examine how clinical usefulness in pediatric research with randomized controlled trials (RCTs) has changed over a 10-year period via a research usefulness tool composed of unique clinical usefulness criteria. STUDY DESIGN:We leveraged a pre-existing sample of child health RCTs published in 2007, used by our team in a previous study. Using the same methods, a research librarian executed a literature search in the Cochrane Central Register of Controlled Trials for the 2017 cohort. We included the first 300 eligible citations from the randomly ordered list for each year, creating two cohorts of 300 publications each, 1 in 2007 and 1 in 2017. Each publication was analyzed and data regarding primary and secondary outcomes, as well as 11 unique criteria of clinical usefulness, were extracted. Each publication was then graded using a tool created by our research team. After quality review, statistical analysis was then performed. RESULTS:Six hundred pediatric RCT publications were included in this review. The mean score increased from 6.07 in 2007 to 9.20 in 2017 (P < .001). Usefulness factors that saw the largest increase in reporting were context placement, funding statements, and conflict of interest statements, while patient centeredness, value for money, and raw data availability remained infrequently reported. CONCLUSION:Our results demonstrate that clinical usefulness of pediatric research improved over this 10-year period, but there are still areas that need a great deal of improvement in order to maximize clinical usefulness and reduce research waste.
Introduction: Kidney dysfunction is highly comorbid in heart failure (HF) patients and contributes to suboptimal utilization of goal-directed medical therapy (GDMT). Worsening hyperkalemia is a common concern in GDMT implementation. We aimed to evaluate the prevalence of kidney dysfunction and rates of hyperkalemia in a specialized heart function clinic (HFC) cohort in Edmonton, Alberta, and characterize the impact of renal dysfunction on clinical outcomes. Methods: HF patients were enrolled in the HFC from Feb 2018 to Nov 2022. Outpatient serum creatinine measurements were used to estimate glomerular filtration rate (eGFR) using the 2021 CKD-EPI equation. Medication records (renin-angiotensin system inhibitors [RAASi], angiotensin receptor neprilysin inhibitors [ARNI], β-blockers, mineralocorticoid inhibitors [MRA], sodium-glucose cotransporter 2 inhibitors [SGLT2i]), laboratory results, and comorbidities using ICD-10 codes were obtained. Hyperkalemia events were defined as any serum potassium ≥5.5 mmol/L measured in a year. Adjusting for clinical covariates, we analyzed the association between GDMT use and hyperkalemia rates as well as between eGFR and all-cause mortality and hospitalization. Results: Our HFC cohort of 1401 patients (median age 68, 29% female) includes 54% with an eGFR ≥60, 37% with an eGFR from 30 to <60, and 9% with an eGFR <30. Prevalence of hyperkalemia increased with worsening renal function, from 9.1% in eGFR >60, 18.1% in eGFR 30-60, to 34.2% in eGFR <30 (p<0.001). After adjusting for baseline clinical characteristics, ARNI, RAASi, MRA, and SGLT2i uses were not associated with increased rates of hyperkalemia. Using eGFR ≥60 as a reference, all-cause mortality increased in eGFR 30-60 (aHR 1.58, 95% CI 1.23-2.02) and eGFR <30 (aHR 3.40, 95% CI 2.45-4.72). In addition, RAASi (aHR 0.57, 95% CI 0.43-0.74) and ARNI use (aHR 0.66, 95% CI 0.48-0.91) were associated with improved all-cause mortality. These results were similar across all-cause hospitalization. Conclusion: Although hyperkalemia is often viewed as a barrier to initiating and up-titrating GDMT, our results show no association between GDMT use and increased hyperkalemia rates. Given the high mortality and morbidity in patients with heart failure and renal dysfunction, further research on improving GDMT utilization and mitigating hyperkalemia in the context of worsening renal function is warranted.
Background: The Cirrhosis Care Alberta (CCAB) Project has created an expert-guided educational video for patients with decompensated cirrhosis. The effect of this video on improving disease-related knowledge in patients with decompensated cirrhosis has yet to be determined. Methods: In-patients with decompensated cirrhosis were prospectively recruited between November 2022 and August 2023. A pre-post-intervention design employing a questionnaire on managing complications of decompensated cirrhosis was used to evaluate whether the CCAB educational video was effective in improving disease-related knowledge, the primary outcome. Baseline knowledge was defined as preintervention questionnaire scores. Learning was defined as the difference between postintervention and preintervention questionnaire scores. Follow-up occurred 30 days when the same questionnaire was readministered. Univariate and multivariate regression analyses evaluated if any participant demographics and disease-related characteristics predicted baseline knowledge or learning. Results: Fifty participants were included. Study participants were predominantly biologically male (62%), aged 40-75 (78%), and had an average of 2.4 (SD: 2.8) prior cirrhosis-related hospitalizations. The mean baseline knowledge score among participants was 62% (SD: 17.3). The mean questionnaire scores following the educational video rose to 72.5% (SD: 20.2%, p < 0.001). Sixteen (32%) participants completed the 30-day follow-up questionnaire with a mean score of 78.8% (SD: 14.7, p = 0.02). Univariate analysis demonstrated that age, number of prior cirrhosis-related hospitalizations, and number of decompensating events predicted baseline knowledge scores (p values < 0.05). Conclusion: The CCAB educational video is effective in improving disease-related knowledge scores. Further investigation evaluating this effect on clinical outcomes is needed.
Mind-body internet- and mobile-based intervention (IMIs) are gaining traction as scalable and effective strategies to manage mental health symptoms experienced by people living with chronic physical conditions. Sex and gender have implications for mind-body IMI participation, adherence, and efficacy. The objective of this secondary analysis was to assess the extent and nature of reporting of sex and/or gender in randomized controlled trials retrieved by a primary systematic review of mind-body IMIs assessing depression and anxiety symptoms among adults living with chronic physical conditions. The collected information included whether sex and gender-based analyses were carried out and explored the role of sex and gender on mental health outcomes, attrition, and recruitment rates. The protocol was registered with PROSPERO. A comprehensive search of six electronic databases was completed from database inception to March 2023. Sex and gender terms were summarized according to a standardized, three-point criteria: (1) non-binary use (i.e., > 2 categories used for both sex and gender definitions) (2) use of appropriate categories (i.e., sex = male/female/intersex, gender = man/woman/gender-diverse) and (3) non-interchangeable use of sex or gender terms throughout the citation. The use of sex and gender terms was deemed correct if all three criteria were met. The role of sex and gender on mental health outcomes, attrition and recruitment data were extracted where available. In the 56 included studies, 7691 participants were evaluated with a mean age of 43 years and 4780 (62%) were described as females/women. Two (4%) studies defined sex or gender using non-binary categorization. Twenty-eight (50%) studies used appropriate categories to define sex or gender. Twenty-five (45%) studies used sex and gender terms non-interchangeably. No studies met all three sex/gender criteria. Only one study provided stratified mental health scores by sex and/or gender within the publication. Eleven (20%) studies reported sex or gender imbalance as being a potential reason for outcome differences, with 3 studies conducting an adjusted statistical analysis investigating sex/gender as a moderator. Findings highlight low uptake of sex and gender considerations in the context of mind-body IMIs. Results underscore the need to incorporate guideline-based sex and gender terms and concepts, from data collection and analysis to reporting of evidence to inform mind-body IMI development and guide future research. Stratified sex and/or gender analyses are encouraged in future studies to assess intervention outcome differences.
BACKGROUND:About 20-30% of older adults (≥ 65 years old) experience one or more falls each year, and falls are associated with substantial burden to the health care system, individuals, and families from resulting injuries, fractures, and reduced functioning and quality of life. Many interventions for preventing falls have been studied, and their effectiveness, factors relevant to their implementation, and patient preferences may determine which interventions to use in primary care. The aim of this set of reviews was to inform recommendations by the Canadian Task Force on Preventive Health Care (task force) on fall prevention interventions. We undertook three systematic reviews to address questions about the following: (i) the benefits and harms of interventions, (ii) how patients weigh the potential outcomes (outcome valuation), and (iii) patient preferences for different types of interventions, and their attributes, shown to offer benefit (intervention preferences). METHODS:We searched four databases for benefits and harms (MEDLINE, Embase, AgeLine, CENTRAL, to August 25, 2023) and three for outcome valuation and intervention preferences (MEDLINE, PsycINFO, CINAHL, to June 9, 2023). For benefits and harms, we relied heavily on a previous review for studies published until 2016. We also searched trial registries, references of included studies, and recent reviews. Two reviewers independently screened studies. The population of interest was community-dwelling adults ≥ 65 years old. We did not limit eligibility by participant fall history. The task force rated several outcomes, decided on their eligibility, and provided input on the effect thresholds to apply for each outcome (fallers, falls, injurious fallers, fractures, hip fractures, functional status, health-related quality of life, long-term care admissions, adverse effects, serious adverse effects). For benefits and harms, we included a broad range of non-pharmacological interventions relevant to primary care. Although usual care was the main comparator of interest, we included studies comparing interventions head-to-head and conducted a network meta-analysis (NMAs) for each outcome, enabling analysis of interventions lacking direct comparisons to usual care. For benefits and harms, we included randomized controlled trials with a minimum 3-month follow-up and reporting on one of our fall outcomes (fallers, falls, injurious fallers); for the other questions, we preferred quantitative data but considered qualitative findings to fill gaps in evidence. No date limits were applied for benefits and harms, whereas for outcome valuation and intervention preferences we included studies published in 2000 or later. All data were extracted by one trained reviewer and verified for accuracy and completeness. For benefits and harms, we relied on the previous review team's risk-of-bias assessments for benefit outcomes, but otherwise, two reviewers independently assessed the risk of bias (within and across study). For the other questions, one reviewer verified another's assessments. Consensus was used, with adjudication by a lead author when necessary. A coding framework, modified from the ProFANE taxonomy, classified interventions and their attributes (e.g., supervision, delivery format, duration/intensity). For benefit outcomes, we employed random-effects NMA using a frequentist approach and a consistency model. Transitivity and coherence were assessed using meta-regressions and global and local coherence tests, as well as through graphical display and descriptive data on the composition of the nodes with respect to major pre-planned effect modifiers. We assessed heterogeneity using prediction intervals. For intervention-related adverse effects, we pooled proportions except for vitamin D for which we considered data in the control groups and undertook random-effects pairwise meta-analysis using a relative risk (any adverse effects) or risk difference (serious adverse effects). For outcome valuation, we pooled disutilities (representing the impact of a negative event, e.g. fall, on one's usual quality of life, with 0 = no impact and 1 = death and ~ 0.05 indicating important disutility) from the EQ-5D utility measurement using the inverse variance method and a random-effects model and explored heterogeneity. When studies only reported other data, we compared the findings with our main analysis. For intervention preferences, we used a coding schema identifying whether there were strong, clear, no, or variable preferences within, and then across, studies. We assessed the certainty of evidence for each outcome using CINeMA for benefit outcomes and GRADE for all other outcomes. RESULTS:A total of 290 studies were included across the reviews, with two studies included in multiple questions. For benefits and harms, we included 219 trials reporting on 167,864 participants and created 59 interventions (nodes). Transitivity and coherence were assessed as adequate. Across eight NMAs, the number of contributing trials ranged between 19 and 173, and the number of interventions ranged from 19 to 57. Approximately, half of the interventions in each network had at least low certainty for benefit. The fallers outcome had the highest number of interventions with moderate certainty for benefit (18/57). For the non-fall outcomes (fractures, hip fracture, long-term care [LTC] admission, functional status, health-related quality of life), many interventions had very low certainty evidence, often from lack of data. We prioritized findings from 21 interventions where there was moderate certainty for at least some benefit. Fourteen of these had a focus on exercise, the majority being supervised (for > 2 sessions) and of long duration (> 3 months), and with balance/resistance and group Tai Chi interventions generally having the most outcomes with at least low certainty for benefit. None of the interventions having moderate certainty evidence focused on walking. Whole-body vibration or home-hazard assessment (HHA) plus exercise provided to everyone showed moderate certainty for some benefit. No multifactorial intervention alone showed moderate certainty for any benefit. Six interventions only had very-low certainty evidence for the benefit outcomes. Two interventions had moderate certainty of harmful effects for at least one benefit outcome, though the populations across studies were at high risk for falls. Vitamin D and most single-component exercise interventions are probably associated with minimal adverse effects. Some uncertainty exists about possible adverse effects from other interventions. For outcome valuation, we included 44 studies of which 34 reported EQ-5D disutilities. Admission to long-term care had the highest disutility (1.0), but the evidence was rated as low certainty. Both fall-related hip (moderate certainty) and non-hip (low certainty) fracture may result in substantial disutility (0.53 and 0.57) in the first 3 months after injury. Disutility for both hip and non-hip fractures is probably lower 12 months after injury (0.16 and 0.19, with high and moderate certainty, respectively) compared to within the first 3 months. No study measured the disutility of an injurious fall. Fractures are probably more important than either falls (0.09 over 12 months) or functional status (0.12). Functional status may be somewhat more important than falls. For intervention preferences, 29 studies (9 qualitative) reported on 17 comparisons among single-component interventions showing benefit. Exercise interventions focusing on balance and/or resistance training appear to be clearly preferred over Tai Chi and other forms of exercise (e.g., yoga, aerobic). For exercise programs in general, there is probably variability among people in whether they prefer group or individual delivery, though there was high certainty that individual was preferred over group delivery of balance/resistance programs. Balance/resistance exercise may be preferred over education, though the evidence was low certainty. There was low certainty for a slight preference for education over cognitive-behavioral therapy, and group education may be preferred over individual education. CONCLUSIONS:To prevent falls among community-dwelling older adults, evidence is most certain for benefit, at least over 1-2 years, from supervised, long-duration balance/resistance and group Tai Chi interventions, whole-body vibration, high-intensity/dose education or cognitive-behavioral therapy, and interventions of comprehensive multifactorial assessment with targeted treatment plus HHA, HHA plus exercise, or education provided to everyone. Adding other interventions to exercise does not appear to substantially increase benefits. Overall, effects appear most applicable to those with elevated fall risk. Choice among effective interventions that are available may best depend on individual patient preferences, though when implementing new balance/resistance programs delivering individual over group sessions when feasible may be most acceptable. Data on more patient-important outcomes including fall-related fractures and adverse effects would be beneficial, as would studies focusing on equity-deserving populations and on programs delivered virtually. SYSTEMATIC REVIEW REGISTRATION:Not registered.