Trials Of Non-pharmacological Interventions Research Articles

Post-stroke emotionalism: Diagnosis, pathophysiology, and treatment.

Post-stroke emotionalism affects one in five stroke sufferers 6 months after their stroke, but despite its frequency remains a poorly understood stroke symptom. The literature is limited, especially compared to other frequently observed neurological conditions such as aphasia and visual neglect. This narrative review presents a summary of the post-stroke emotionalism literature, to inform clinical practice and future research. We cover discussion of definitions, prevalence, neurobiology, predisposing and precipitating factors, and treatment. Increasing evidence suggests that damage to specific areas functionally linked to emotion expression or regulation processes, disruption to structural pathways and those related to serotonin production and modulation individually or in concert give rise to emotionalism-type presentations. A range of emotionalism measurement tools have been used in research contexts making between study comparisons difficult. Testing for Emotionalism after Recent Stroke-Questionnaire (TEARS-Q) has recently been developed to allow standardized assessment. Treatment options are limited, and there have been few adequately powered treatment trials. Antidepressants may reduce severity, but more trial data are required. There have been no randomized-controlled trials of non-pharmacological interventions. More research is needed to improve recognition and treatment of this common and disabling symptom. We conclude with research priorities and recommendations for the field.

Randomised controlled trials of non-pharmacological interventions to improve patient-reported outcomes of colonoscopy: a scoping review

Background and aimsNon-pharmacological interventions to improve patient-reported outcomes of colonoscopy may be effective at mitigating negative experiences and perceptions of the procedure, but research to characterise the extent and features...

Non-Pharmacological Interventions to Improve Physical Function in Patients with End-Stage Renal Disease: A Network Meta-Analysis

Introduction: Chronic kidney disease is estimated to become the fifth leading cause of death globally by 2040. Due to the high incidence of fatigue in patients with end-stage renal disease without reliable pharmacological treatments, more and more studies on non-pharmacological interventions to improve physical function appear; which might be the best approach remains unknown. This study aimed to compare and rank the efficacy of all known non-pharmacological interventions on improving physical function from multiple outcomes for adults with end-stage renal disease. Methods: This systematic review and network meta-analysis included searches of PubMed, Embase, CINAHL, and Cochrane Library from inception to September 1, 2022, for randomized controlled trials of non-pharmacological interventions to improve physical function in adults with end-stage renal disease. Literature screening, data extraction, and quality appraisal were performed systematically by two independent reviewers. The frequentist random-effect network meta-analysis was adopted to pool the evidence from five outcomes, namely, 6-min walk test, handgrip strength, knee extension strength, physical component summary, and mental component summary, respectively. Results: A total of 1,921 citations were identified by this search, of which 44 eligible trials enrolled 2,250 participants, and 16 interventions were identified. All subsequent figures refer to comparisons with usual care. For increasing walking distance, the combined resistance and aerobic exercise with virtual reality or music were the most effective interventions, with a mean difference plus 95% confidence interval of 90.69 (8.92–172.46) and 92.59 (23.13–162.06), respectively. Resistance exercise with blood flow restriction (8.13, 0.09–16.17) was the best treatment to improve handgrip strength. Combined resistance and aerobic exercise (11.93, 3.63–20.29) and whole-body vibration (6.46, 1.71–11.20) were associated with improving knee extension strength. For life quality, all treatment effects did not show statistically significant differences. Conclusions: It was found via network meta-analysis that combined resistance and aerobic exercise is the most effective intervention. Besides, if virtual reality or music is added to the training, there will be better results. Resistance exercise with blood flow restriction and whole-body vibration might be good alternative treatments for improving muscle strength. None of the interventions improved quality of life, suggesting a need for alternative interventions in this regard. The results of this study contribute evidence-based data to decision-making.

Leisure-Related Social Work Interventions for Patients with Cognitive Impairment: A Systematic Review and Meta-Analysis.

The social work profession has been exploring nonpharmacological interventions for patients with cognitive impairment, but there are few evidence-based research outputs. Systematically evaluating the effectiveness of social work interventions for people with cognitive impairment can shed light on the matter to further improve similar interventions. Randomized controlled trials of nonpharmacological interventions for patients with cognitive impairment were selected from key literature databases in both English and Chinese from 2010 to 2021. A systematic review and meta-analysis with Revman 5.4 were performed. Seven trials were included, involving 851 patients with cognitive impairment. The meta-analysis showed that, in terms of overall cognitive function, the Montreal Cognitive Assessment score (MD = 1.64, 95% CI [0.97, 2.30], p < 0.001) of the intervention group was superior to the control group, but there was no significant difference in the Mini-Mental State Examination score between the two groups (MD = 0.33, 95% CI [-0.16, 0.82], p = 0.18). Compared with the control group, nonpharmacological intervention can effectively improve the neuropsychiatric condition of patients (SMD = -0.42, 95% CI [-0.64, -0.20], p = 0.0002). In summary, the current evidence shows that nonpharmacological social work interventions had a positive effect on the cognitive function and neuropsychiatric status of patients with cognitive impairment. Suggestions for future nonpharmacological intervention practice are discussed.

Advancing cluster randomised trials in children’s therapy: a survey of the acceptability of trial behaviours to therapists and parents

BackgroundRandomised controlled trials of non-pharmacological interventions in children’s therapy are rare. This is, in part, due to the challenges of the acceptability of common trial designs to therapists and service users. This study investigated the acceptability of participation in cluster randomised controlled trials to therapists and service users.MethodsA national electronic survey of UK occupational therapists, physiotherapists, speech and language therapists, service managers, and parents of children who use their services. Participants were recruited by NHS Trusts sharing a link to an online questionnaire with children’s therapists in their Trust and with parents via Trust social media channels. National professional and parent networks also recruited to the survey. We aimed for a sample size of 325 therapists, 30 service managers, and 60 parents. Trial participation was operationalised as three behaviours undertaken by both therapists and parents: agreeing to take part in a trial, discussing a trial, and sharing information with a research team. Acceptability of the behaviours was measured using an online questionnaire based on the Theoretical Framework of Acceptability constructs: affective attitude, self-efficacy, and burden. The general acceptability of trials was measured using the acceptability constructs of intervention coherence and perceived effectiveness. Data were collected from June to September 2020. Numerical data were analysed using descriptive statistics and textual data by descriptive summary.ResultsA total of 345 survey responses were recorded. Following exclusions, 249 therapists and 40 parents provided data which was 69.6% (289/415) of the target sample size. It was not possible to track the number of people invited to take the survey nor those who viewed, but did not complete, the online questionnaire for calculation of response rates. A completion rate (participants who completed the last page of the survey divided by the participants who completed the first, mandatory, page of the survey) of 42.9% was achieved. Of the three specified trial behaviours, 140/249 (56.2%) therapists were least confident about agreeing to take part in a trial. Therapists (135/249, 52.6%) reported some confidence they could discuss a trial with a parent and child at an appointment. One hundred twenty of 249 (48.2%) therapists reported confidence in sharing information with a research team through questionnaires and interviews or sharing routine health data. Therapists (140/249, 56.2%) felt that taking part in the trial would take a lot of effort and resources. Support and resources, confidence with intervention allocation, and sense of control and professional autonomy over clinical practice were factors that positively affected the acceptability of trials. Of the 40 parents, twelve provided complete data. Most parents (18/40, 45%) agreed that it was clear how trials improve children’s therapies and outcomes and that a cluster randomised trial made sense to them in their therapy situation (12/29, 30%).ConclusionsUsing trials to evaluate therapy interventions is, in principle, acceptable to therapists, but their willingness to participate in trials is variable. The willingness to participate may be particularly influenced by their views related to the burden associated with trials, intervention allocation, and professional autonomy.

Comparative efficacy and acceptability of non-pharmacological interventions in fibromyalgia: Protocol for a network meta-analysis.

IntroductionAlthough several non-pharmacological interventions have been tested in the management of Fibromyalgia (FM), there is little consensus regarding the best options for the treatment of this health condition. The purpose of this network meta-analysis (NMA) is to investigate the comparative efficacy and acceptability of non-pharmacological interventions for FM, in order to assist clinical decision making through a ranking of interventions in relation to the most important clinical outcomes in these patients.Methods and analysisWe will perform a systematic search to identify randomised controlled trials of non-pharmacological interventions endorsed in guidelines and systematic reviews. Information sources searched will include major bibliographic databases without language or date restrictions (MEDLINE, Cochrane Library, EMBASE, AMED, PsycINFO and PEDro). Our primary outcomes will be pain intensity, patient-reported quality of life (QoL), and acceptability of treatment will be our secondary outcome. Risk of bias of the included trials will be assessed using the Cochrane risk of bias tool (RoB2). For each pairwise comparison between the different interventions, we will present mean differences (MDs) for pain intensity and QoL outcomes and Relative Risks (RRs) for acceptability, both with respective 95% confidence intervals (CIs). Initially, standard pairwise meta-analyses will be performed using a DerSimonian-Laird random effects model for all comparisons with at least two trials and then we will perform a frequentist NMA using the methodology of multivariate meta-analysis assuming a common heterogeneity parameter, using the mvmeta command and network suite in STATA. In the NMA, two different types of control group, such as placebo/sham and no intervention/waiting list will be combined as one node called “Control”. The competing interventions will be ranked using the P-score, which is the frequentist analogue of surface under the cumulative ranking curve (SUCRA) for the outcomes of interest at immediate- (intervention duration of up to 2 weeks), short- (over 2 weeks up to 12 weeks) and long-terms (over 12 weeks). The confidence in the results from NMA will be assessed using the Confidence in Network Meta‐analysis (CINeMA) framework.Ethics and disseminationThis work synthesises evidence from previously published studies and does not require ethics review or approval. A manuscript describing the findings will be submitted for publication in a peer-reviewed scientific journal.RegistrationOSF (DOI: 10.17605/OSF.IO/7MS25) and registered in the PROSPERO database (CRD42020216374).

Effects of the non-pharmacological interventions of traditional Chinese medicine on postpartum depression: A protocol for systematic review and network meta-analysis.

Background:Postpartum depression (PPD) has become one of the common disorders during the postpartum period. The non-pharmacological interventions of traditional Chinese medicine (TCM) have achieved good results in the treatment of PPD. However, the efficacy of different non-pharmacological interventions of TCM for PPD has not been fully elucidated. Due to the large number of non-pharmacological intervention of TCM modalities, the selection of appropriate non-pharmacological interventions of TCM has become an urgent clinical problem. The aim of this network meta-analysis was to explore the best choice for different non-pharmacological interventions of TCM for PPD.Methods:PubMed, Web of Science, Scopus, Cochrane Library, Embase, China Scientific Journal Database, China National Knowledge Infrastructure, Chinese Biomedical Literature Database, and Wanfang Data were searched to identify the randomized controlled trials of non-pharmacological interventions of TCM for PPD from the inception to February 2022. Two researchers will be independently responsible for literature screening, data extraction, and assessment of their quality. Standard pair-wise and Bayesian network meta-analysis will be performed to compare the efficacy of different non-pharmacological interventions of TCM for PPD via Stata 14.0 and WinBUGS1.4 software.Results:The results of this meta-analysis will be submitted to a peer-reviewed journal for publication.Conclusions:The conclusion of this systematic review will provide evidence for the selection of an optimal non-pharmacological interventions of TCM for PPD.Ethics and dissemination:Ethical approval is not required for this study. The systematic review will be published in a peer-reviewed journal, presented at conferences, and shared on social media platforms.OSF REGISTRATION NUMBER:DOI 10.17605/OSF.IO/TM96G.

Nonpharmaceutical therapy for autism spectrum disorder: A protocol for systematic review and network meta-analysis.

Background:Autism spectrum disorder (ASD) is a widespread developmental disorder of the nervous system with an unclear etiology and pathogenesis. Its global incidence is currently increasing, and no effective drugs are available to improve its core symptoms. Nonpharmaceutical therapy can effectively relieve the core symptoms of autism, has fewer side effects than drugs, and is easily accepted by patients. This systematic and network meta-analysis aimed to evaluate the impact of non-pharmaceutical therapy on autism to explore preferable therapeutic options for autism.Methods:Online databases, including the China National Knowledge Infrastructure [CNKI], SinoMed, Wanfang Database [WF], China Science and Technology Journal Database [VIP], MEDLINE, Web of Science, EMBASE, and the Cochrane Library will be searched for randomized controlled trials of nonpharmacological interventions for autism published before October 2021. Two researchers will be independently responsible for the literature screening, data extraction, and quality assessment. Standard paired and Bayesian network meta-analyses will be performed using RevMan 5.3 Software and GEMTC 0.14.3, to compare the efficacy and safety of different nonpharmacological regimens.Results:The results of this systematic and network meta-analysis will be submitted to a peer-reviewed journal for publication.Conclusion:This study provides a comprehensive and reliable evidence-based reference for the efficacy and safety of different non-pharmacological interventions for autism.PROSPERO registration number:CRD 42021275571

Effect of non-pharmacological interventions on anxiety, depression, sleep quality, and pain after orthopedic surgery: A protocol for systematic review and network meta-analysis.

Background:Patients after orthopedic surgery often experience the pain, anxiety, depression, and sleep disturbances, which can be greatly reduced by non-pharmacologic interventions as alternative therapies. Randomized controlled trials of nonpharmacologic interventions for anxiety, depression, sleep quality, and pain in patients after orthopedic surgery have been reported, but the results may be conflicting. Evidence to determine the optimal non-pharmacological intervention with a high efficacy is limited. This study aims to assess the effects of non-pharmacologic interventions on the bone anxiety, depression, sleep quality, and pain in patients after orthopedic surgery through a network meta-analysis, thus providing guidance in clinical application.Methods:A systematic search of randomized controlled trials reporting the effects of non-pharmacological interventions on anxiety, depression, sleep quality and pain after orthopedic surgery published before October 2021 will be searched in Wanfang, VIP Information Chinese Journal Service Platform, China National Knowledge Infrastructure, Chinese BioMedicine Literature Database, Pubmed, Embase, Cochrane, and Web of science. Two reviewers will be independently responsible for study selection, quality appraisal, and data extraction. Stata 14.0 software will be used to perform the network meta-analysis.Results:The findings of this research will be reported in a recognized journal.Conclusion:This meta-analysis will provide the stronger evidence for non-pharmacological interventions on alleviating bone anxiety, depression, sleep quality, and pain in patients after orthopedic surgery, which will help clinicians and decision makers in their choices.Open Science Framework registration number: DOI 10.17605/OSF.IO/2SCBD.

Effects of Antihypertensive Deprescribing Strategies on Blood Pressure, Adverse Events, and Orthostatic Symptoms in Older Adults: Results From TONE.

The Trial of Nonpharmacologic Interventions in the Elderly (TONE) demonstrated the efficacy of weight loss and sodium reduction to reduce hypertension medication use in older adults. However, the longer-term effects of drug withdrawal (DW) on blood pressure (BP), adverse events, and orthostatic symptoms were not reported. TONE enrolled adults, ages 60-80 years, receiving treatment with a single antihypertensive and systolic BP (SBP)/diastolic BP <145/<85 mm Hg. Participants were randomized to weight loss, sodium reduction, both, or neither (usual care) and followed up to 36 months; ~3 months postrandomization, the antihypertensive was withdrawn and only restored if needed for uncontrolled hypertension. BP and orthostatic symptoms (lightheadedness, feeling faint, imbalance) were assessed at randomization and throughout the study. Two physicians independently adjudicated adverse events, masked to intervention, classifying symptomatic (lightheadedness, dizziness, vertigo), or clinical events (fall, fracture, syncope). Among the 975 participants (mean age 66 years, 48% women, 24% black), mean (±SD) BP was 128 ± 9/71 ± 7 mm Hg. Independent of assignment, DW increased SBP by 4.59 mm Hg (95% confidence interval [CI]: 3.89, 5.28) compared with baseline. There were 113 adverse events (84 symptomatic, 29 clinical), primarily during DW. Compared with usual care, combined weight loss and sodium reduction mitigated the effects of DW on BP (β = -4.33 mm Hg; 95% CI: -6.48, -2.17) and reduced orthostatic symptoms long term (odds ratio = 0.62; 95% CI: 0.41, 0.92), without affecting adverse events (hazard ratio = 1.81; 95% CI: 0.90, 3.65). In contrast, sodium reduction alone increased risk of adverse events (hazard ratio = 1.75; 95% CI: 1.04, 2.95), mainly during DW. In older adults, antihypertensive DW may increase risk of symptomatic adverse events, highlighting the need for caution in withdrawing their antihypertensive medications. Trial Number NCT00000535.

Effect of non-pharmacological interventions on sleep in preterm infants in the neonatal intensive care unit: A protocol for systematic review and network meta-analysis.

Background:Premature infants are prone to suffer multisystem complications after birth due to the incomplete development of organ tissues and low immunity, and they require a longer period of supervised treatment in the neonatal intensive care unit (NICU). However, due to the specificity of medical care in the NICU, the sleep of preterm infants is highly susceptible that has an impact on the prognosis of preterm infants. Recently, various non-pharmacological interventions have been applied to the sleep of preterm infants in the NICU, which have shown positive outcomes. However, the efficacy and safety of them are unclear. This study aims to evaluate the effects of non-pharmacological interventions on sleep in preterm infants in the NICU through a network meta-analysis.Methods:Randomized controlled trials of non-pharmacological interventions on sleep in preterm infants in the NICU published before September 2021 will be searched in online databases, including the Chinese Scientific Journal Database, China National Knowledge Infrastructure Database, Wanfang, China Biomedical Literature Database, PubMed, Cochrane Library, Embase, and Web of Science. Two researchers will be independently responsible for screening and selecting eligible literatures, extracting data and evaluating the risk of bias in the included studies. Stata 14.0 software will be used for data analysis.Results:The results of this meta-analysis will be submitted to a peer-reviewed journal for publication.Conclusion:This study will provide comprehensive and reliable evidence-based references for the efficacy and safety in different non-pharmacological interventions on sleep in preterm infants in the NICU.

Effects of non-pharmacological interventions on anxiety, depression, and sleep quality in patients with postoperative glaucoma: A protocol for systematic review and network meta-analysis.

Background:Glaucoma is the second most-common blinding ophthalmic disease in the world, and its incidence has been rising year by year in recent years. Currently, the main treatment of glaucoma still relies on surgery. Glaucoma patients often suffer from various psychological problems like anxiety and depression not only because of the lack of understanding of the surgical treatment of glaucoma, but also the long-term stress and the poor prognosis. As alternative therapies, non-pharmacological interventions can greatly alleviate psychological burdens and improve sleep quality in surgically treated glaucoma patients. Randomized controlled trials of non-pharmacologic interventions for glaucoma have been reported, although the results remain conflicting. Evidences for determining the efficacy of non-pharmacologic interventions for glaucoma are scant. This study aims to assess the effects of non-pharmacological interventions on anxiety, depression, and sleep quality in patients with postoperative glaucoma through a network meta-analysis.Methods:A systematic search of relevant literatures published before August 2021 about the effects of non-pharmacological interventions on anxiety, depression, and sleep quality in patients with postoperative glaucoma will be performed in Wanfang, VP Information Chinese Journal Service Platform, China National Knowledge Infrastructure, Chinese BioMedicine Literature Database, Pubmed, Embase, Cochrane, and Web of science. Two reviewers will be independently responsible for literature screening and selection, quality assessment, and data extraction. WinBUGS 1.4 will be used for the network meta-analysis.Results:This meta-analysis will provide additional and stronger evidences for non-pharmacological interventions on anxiety, depression, and sleep quality in patients with postoperative glaucoma, which will help clinicians and decision makers to make an optimal therapeutic strategy.Conclusion:This study will provide a reliable evidence-based basis for the clinical application of non-pharmacological interventions on anxiety, depression, and sleep quality in patients with postoperative glaucoma.Ethics and dissemination:Ethical approval was not required for this study. The systematic review will be published in a peer-reviewed journal, presented at conferences, and shared on social media platforms. This review would be disseminated in a peer-reviewed journal or conference presentations.OSF registration number:DOI 10.17605/OSF.IO/TYJPK.

Abstract MP59: Effects Of Sodium Reduction And Weight Loss On Lightheadedness And Falls In Older Adults: Results From TONE

Background: The Trial of Nonpharmacologic Interventions in the Elderly (TONE) demonstrated the efficacy of sodium reduction and weight loss to reduce hypertension medication use in older adults. However, adverse events related to lightheadedness and falls have not been reported. Objective: To determine whether sodium reduction and weight loss are associated with greater risk of lightheadedness and falls among older adults. Methods: TONE was a randomized trial of 60-80 year-old adults with systolic BP (SBP) and diastolic BP (DBP) below 145 and 85 mm Hg, respectively, while receiving treatment with a single antihypertensive medication. Participants were randomized to behavioral interventions focused on sodium reduction, weight loss, both, or neither (usual care); 3 months after randomization, the antihypertensive medication was withdrawn and only restored later during the study if needed for uncontrolled hypertension. Total follow-up was 36 months post-randomization. Two physicians independently adjudicated adverse event logs, masked to intervention assignment. The primary outcome was a composite of the first occurrence of adverse event related to falls (total N=95): 72 involved orthostatic symptoms (lightheadedness, dizziness, vertigo), while 23 involved hard events (fall or syncope). Hazard ratios were determined via Cox proportional hazards models. Results: Among the 975 participants (mean age 66 yrs, 48% women, 24% black), mean SBP and DBP were 128 and 71 mm Hg. The cumulative incidence of adverse events at 30 months was 0.08, 0.13, 0.11, and 0.14 for usual care, reduced sodium, weight loss, or both, respectively ( Figure ). In adjusted multi-variable analyses, sodium reduction was associated with higher risk of an adverse event (HR 1.52; 95% CI: 1.02, 2.27), while weight loss was not associated with adverse events (HR 1.18; 0.77, 1.79). Conclusions: In the context of antihypertensive medication withdrawal, sodium reduction was associated with a higher risk of fall-related adverse events, predominantly symptoms.

Fibromyalgia Transcutaneous Electrical Nerve Stimulation in Physical Therapy Study (FM TIPS): an embedded pragmatic clinical trial in physical therapy clinics

Fibromyalgia (FM) is a chronic pain condition characterized by widespread musculoskeletal pain with significant movement-evoked pain. Transcutaneous electrical nerve stimulation (TENS), a non-pharmacological treatment, is efficacious for reduction of pain and fatigue in FM. While physical therapists are trained in the use of TENS, it is an underutilized tool in physical therapy (PT) clinics. To this end, we designed a pragmatic clinical trial to test if using TENS in a PT setting is feasible and if FM patients using TENS show reduced movement-evoked pain, improved adherence to PT, are more likely to reach their therapeutic goals. During a 1-year planning period the study team designed and set up procedures to implement the trial into 24 physical therapy clinics within 5 healthcare systems. Surveys and interviews with PT sites and interactions with the NIH Collaboratory group guided design of this pragmatic trial. The 24 PT clinics will be cluster-randomized and stratified by healthcare system into two groups: (1) No TENS (PT usual care) or (2) TENS+ (TENS plus PT usual care) with a goal of enrolling 600 participants the trial. Assessments will be collected at baseline then at 30-, 60-, 90- and 180-days from randomization through electronic data capture from participants directly and from the electronic health record. The primary outcome is a reduction in movement-evoked pain during a sit and stand test (baseline to 60 days) with secondary outcomes across multiple domains including pain, fatigue, sleep, disease impact, medication usage, psychosocial variables, patient-specific functional goals, and adherence to PT. Successful completion of this trial will provide generalizable effectiveness data on TENS for referring providers, physical therapists, patients, and insurers and will inform future pragmatic trials of non-pharmacological treatments conducted in PT practices. NIH; 4UH3AR076387-02 REVISED.

P121 The efficacy of treatment interventions on fatigue in adolescents with juvenile idiopathic arthritis: a literature review

Abstract Background/Aims Fatigue has been reported by young people and professionals alike as a major challenge for people living with juvenile idiopathic arthritis (JIA) . It remains unclear as to how therapeutic interventions impacts on this major symptom. The aim of this review was to determine the current evidence for the effectiveness of therapeutic interventions, non- pharmacological and pharmacological, on improving fatigue in adolescents with JIA. Methods Three electronic databases (MEDLINE, EMBASE, PsycINFO) were searched from 2000 to Feb 2020; in addition to manual searches. Articles were eligible for inclusion if they (i) were original research papers, (ii) had fatigue as a primary outcome measure (iii) included adolescents (10-25 years) and (iv) were available in the English language. Results Of the 3,142 records identified, 31 underwent full text assessment and 4 studies were included in the qualitative synthesis including 2 from the Netherlands, 1 Germany, and 1 from Canada. The total number of participants across the 4 studies was 824. Three were randomised controlled trials of nonpharmacological interventions and one was a cohort study from a national drug registry including older adolescents JIA (mean: 19-years). Measurement tools included the Paediatric Quality of life multidimensional fatigue scale, (2 studies), the Checklist for Individual Strength CIS-20 (1 study), a numeric rating scale (1 study). In one study a visual analogue scale for energy level was also utilised. In 2 studies baseline prevalence of fatigue was reported as 60% and 76% respectively. Significant reduction in fatigue was observed in all three nonpharmacological studies. In the registry study, fatigue was noted to be prevalent in spite of the disease being in inactive or minimally active on biologic therapy. In 3 studies the relationship between health-related quality of life and fatigue was highlighted and showed a decreased quality of life in fatigued young people. Conclusion Fatigue is a significant problem in JIA during adolescence and influences quality of life. Improvements in fatigue with non-pharmacological interventions have been reported. However, at present, data is insufficient to conclusively decide which treatment intervention is most efficacious in treating fatigue in young people with JIA. Fatigue should be considered as an important outcome measure for the management of JIA in future evaluations of interventions. Disclosure S. Moshtael: None. S. Khanom: None. J.E. McDonagh: None.

Non-Pharmacologic Interventions for Caregivers of People With Dementia in Latin America: A Review

In a scenario of increasing longevity and social inequalities, Latin-America is an important contributor to the worldwide dementia burden. Caregivers’ health is fundamental to maintain the person with dementia quality of life. However, caregiving is a culturally sensible role that requires tailored solutions. The aim is to synthesize the evidence about non-pharmacologic interventions targeted to caregivers of people with dementia in Latin-American contexts. A comprehensive review of interventions in caregivers and persons with dementia in Latin-American countries was conducted using MEDLINE, Embase, PsycINFO, and Scopus with studies published until January 27th, 2020. Randomized clinical trials of non-pharmacologic interventions targeted to caregivers of people with dementia or dyads where included. Qualitative synthesis of the evidence was presented and analyzed. Overall, 9 pilot RCT were included for the final analysis (6 Brazil, 1 Colombia, 1 Mexico, 1 Perú). The biggest study recruited 69 caregivers and the smallest 13 dyads, with follow-up range of 3-6 months. 5 control groups received at least some other non-standard care type of intervention. 8 were targeted exclusively to caregivers (4 group intervention, 3 individual, and 1 combined) and 1 multicomponent intervention. Most frequent measured outcomes were caregiver’s burden, anxiety, depressive symptoms, and quality of life, and person with dementia neuropsychiatric symptoms. Individual interventions report better results in caregiver parameters such as burden and depressive symptoms and person with dementia neuropsychiatric symptoms. Group interventions presented mixed results. Nevertheless, the quality of evidence was low. There is a critical need to study interventions for caregivers in Latin-American contexts.

Nonpharmacological interventions for respiratory health in Parkinson's disease: A systematic review and meta-analysis.

Respiratory dysfunction in Parkinson's disease (PD) is often an underdiagnosed and untreated impairment associated with the disease. Clinically, a reactive approach to respiratory morbidity is taken, rather than preventative approaches that address underlying impairment/s. This systematic review identifies the current evidence to support nonpharmacological interventions to improve respiratory impairments in individuals with PD. The relevant literature was searched using a customised and systematic strategy. Randomised and nonrandomised control trials of nonpharmacological interventions targeting respiratory outcome measures in PD were included. Outcomes of interest were respiratory morbidity and mortality, respiratory muscle strength, spirometry measures, lung volumes, peak cough flow, and perception of dyspnoea. Nonpharmacological interventions included: functional training, generalised strength training, respiratory muscle strength training, aerobic exercise, qigong, yoga, breath stacking, incentive spirometry and singing. Methodological quality of included studies varied. Meta-analyses of nonpharmacological interventions demonstrated significant effects for inspiratory muscle strength (mean difference [MD] 19.68; confidence interval [CI] 8.49, 30.87; z=3.45; p=0.0006; I2 =2%), expiratory muscle strength (MD 18.97; CI 7.79, 30.14; z=3.33; p=0.0009; I2 =23%) and peak expiratory flow (MD 72.21; CI 31.19, 113.24; z=3.45; p=0.0006; I2 =0%). Best-evidence synthesis identified level 1 evidence supporting nonpharmacological interventions for improving peak cough flow and perceived dyspnoea. No studies were identified reporting outcomes of respiratory rate, inspiration:expiration ratio or respiratory morbidity or mortality in PD. Nonpharmacological interventions improved respiratory muscle strength and peak expiratory flow in PD. Additional trials targeting respiratory dysfunction and longitudinal studies examining the relationship between respiratory dysfunction and morbidity and mortality rates in PD are required.

More pilot trials could plan to use qualitative data: a meta-epidemiological study

BackgroundPilot trials often use quantitative data such as recruitment rate and retention rate to inform the design and feasibility of a larger trial. However, qualitative data such as patient, healthcare provider, and research staff perceptions of an intervention may also provide insights for a larger trial.MethodsAs part of a larger study investigating the reporting of progression criteria in pilot studies, we sought to determine how often pilot studies planned to use qualitative data to inform the design and feasibility of a larger trial and the factors associated with plans to use qualitative data. We searched for protocols of pilot studies of randomized trials in PubMed between 2013 and 2017.ResultsWe included 227 articles. Only 92 (40.5%; 95% confidence interval [CI] 34.1–47.2) reported plans to collect qualitative data. The factors associated with collecting qualitative data were large studies (defined as sample size ≥ 60; adjusted odds ratio [aOR] 2.77; 95% CI 1.47–5.23; p = 0.002) and studies from Europe (aOR 3.86; 95% CI 1.68–8.88; p = 0.001) compared to North America and the rest of the world. Pilot trials with pharmacological interventions were less likely to plan to collect qualitative data (aOR 0.20; 95% CI 0.07–0.58; p = 0.003).ConclusionsQualitative data is not used enough in pilot trials. Large pilot trials, pilot trials from Europe, and pilot trials of non-pharmacological interventions are more likely to plan for qualitative data.

Quality of reporting in abstracts of RCTs published in emergency medicine journals: a systematic survey of the literature suggests we can do better

ObjectiveWe investigated the association between the publication of the Consolidated Standards of Reporting Trials extension for abstracts (CONSORT-EA) and other variables of interest on the quality of reporting of abstracts...

Analysis of articles directly related to randomized trials finds poor protocol availability and inconsistent linking of articles

Interpreting a randomized trial requires access to more than the main results paper. We aimed to determine the (1) proportion of trials referring to the protocol in the trial report and their accessibility, (2) proportion of protocols accessible from trial registry entry and by trial registration number search, and (3) types of additional publications associated with trial reports. A previously gathered sample of randomized trials of nonpharmacological interventions published in 2009 was used. Trial reports and registry entries were searched for protocol mentions and obtained when possible. Related publications were identified using citation searching. Of 133 trials, 96 (72%) mentioned the protocol within the report, 61 (64%) contained details about protocol acquisition, with 48 (36%) protocols obtainable. Of the 129 registered trials, 32 (25%) had protocols obtainable from registry entry. Citation tracking identified 1,030 related publications, most common were secondary analyses and qualitative studies. Trial protocols facilitate good trial conduct and interpretation. However, they are often not linked to the main report or registry and can be difficult to obtain. Many trials have related publications that are inconsistently linked. Trial registries and registration numbers could facilitate the threading of articles related to a trial, but currently do not.