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Frontiers in Neurology 2022To investigate the available evidence on early supported discharge (ESD) and transitional care (TC) delivery service in patients with cerebrovascular disease.
OBJECTIVE
To investigate the available evidence on early supported discharge (ESD) and transitional care (TC) delivery service in patients with cerebrovascular disease.
METHODS
A systematic literature search was conducted to collect all available evidence on the use of ESD and TC services. We included cluster-randomized pragmatic trials or randomized controlled trials (RCTs) that recruited patients with stroke or transient ischemic attack to receive either conventional care or any care service intervention that included rehabilitation or support provided by professional medical personnel with the aim of accelerating and supporting home discharge. Relevant data were electronically searched through international databases (Cochrane Library, EMBASE, and PubMed) and incorporated into a summary grid to investigate research outcomes and provide a narrative synthesis. Furthermore, we compared the outcomes in terms of length of hospital stay, patient and caregiver outcomes, and mortality through meta-analysis.
RESULTS
We identified and included a total of 20 publications of various original randomized studies. There were 18 studies conducted in western countries and 2 in eastern countries. The meta-analysis revealed a tendency that ESD or TC could decrease the length of hospital stay more than the usual care [standardized mean difference (SMD) -0.13; 95% confidence interval (CI) -0.31 to 0.04 days; = 0.14]. Moreover, there was a tendency that ESD resulted in better activities of daily living (ADL) than usual care (SMD 0.29; 95% CI -0.04 to 0.61; = 0.08). Patient outcome based on modified Rankin scale (mRS) score (SMD -0.11; 95% CI -0.38 to 0.17; = 0.45] and mortality (odds ratio 0.80; 95% CI 0.56-1.17; = 0.25) did not reveal any significant difference. The Caregiver Strain Index revealed no difference.
CONCLUSION
We did not find a large effect size for the use of TC and ESD. When implementing the TC and ESD model from western to Asian countries, services should be prepared and implemented in accordance with national medical rehabilitation pathways for cerebrovascular disease.
PubMed: 35370909
DOI: 10.3389/fneur.2022.755316 -
The Journal of Allergy and Clinical... Jul 2022Inhaled medications are central to treating asthma and chronic obstructive pulmonary disease (COPD), yet critical inhaler technique errors are made by up to 90% of...
Is Inhaler Technique Adequately Assessed and Reported in Clinical Trials of Asthma and Chronic Obstructive Pulmonary Disease Therapy? A Systematic Review and Suggested Best Practice Checklist.
BACKGROUND
Inhaled medications are central to treating asthma and chronic obstructive pulmonary disease (COPD), yet critical inhaler technique errors are made by up to 90% of patients. In the clinical research setting, recruitment of subjects with poor inhaler technique may give a false impression of both the benefits and the necessity of add-on treatments such as biologic therapies.
OBJECTIVE
To assess the frequency with which inhaler technique is assessed and reliably optimized before and during patient enrollment into randomized controlled trials (RCTs) addressing the efficacy of topical therapy, and the escalation of therapy for asthma and COPD.
METHODS
Systematic searches were conducted of PubMed and Embase for RCTs published in the past 10 years involving patients with a diagnosis of asthma or COPD undergoing escalation of baseline inhaled therapy (stepping up, changing, adding, switching, increasing, etc) or the introduction of biologic agents.
RESULTS
Searches highlighted 1,014 studies, 118 of which were eligible after the removal of duplicates as well as screening and full text review. Of these, only 14 (11.9%) included accessible information in the methods section or referred to such information in online supplements or protocols concerning assessment of participants' inhaler technique. We therefore developed the proposed Best Practice Inhaler Technique Assessment and Reporting Checklist.
CONCLUSIONS
Our study identifies a concerning lack of checking and correcting inhaler technique, or at least reporting that this was undertaken, before enrollment in asthma and COPD RCTs, which may affect the conclusions drawn. Mandating the use of a standardized checklist in RCT protocols and ensuring all published RCTs report checking and correcting inhaler technique before enrollment are important next steps.
Topics: Administration, Inhalation; Asthma; Checklist; Humans; Nebulizers and Vaporizers; Pulmonary Disease, Chronic Obstructive
PubMed: 35364340
DOI: 10.1016/j.jaip.2022.03.013 -
The Cochrane Database of Systematic... Mar 2023Regularly transfused people with sickle cell disease (SCD) and people with thalassaemia are at risk of iron overload. Iron overload can lead to iron toxicity in... (Review)
Review
BACKGROUND
Regularly transfused people with sickle cell disease (SCD) and people with thalassaemia are at risk of iron overload. Iron overload can lead to iron toxicity in vulnerable organs such as the heart, liver and endocrine glands, which can be prevented and treated with iron-chelating agents. The intensive demands and uncomfortable side effects of therapy can have a negative impact on daily activities and wellbeing, which may affect adherence.
OBJECTIVES
To identify and assess the effectiveness of different types of interventions (psychological and psychosocial, educational, medication interventions, or multi-component interventions) and interventions specific to different age groups, to improve adherence to iron chelation therapy compared to another listed intervention, or standard care in people with SCD or thalassaemia.
SEARCH METHODS
We searched CENTRAL (Cochrane Library), MEDLINE, PubMed, Embase, CINAHL, PsycINFO, ProQuest Dissertations & Global Theses, Web of Science & Social Sciences Conference Proceedings Indexes and ongoing trial databases (13 December 2021). We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group's Haemoglobinopathies Trials Register (1 August 2022).
SELECTION CRITERIA
For trials comparing medications or medication changes, only randomised controlled trials (RCTs) were eligible for inclusion. For studies including psychological and psychosocial interventions, educational interventions, or multi-component interventions, non-randomised studies of interventions (NRSIs), controlled before-after studies, and interrupted time series studies with adherence as a primary outcome were also eligible for inclusion.
DATA COLLECTION AND ANALYSIS
For this update, two authors independently assessed trial eligibility and risk of bias, and extracted data. We assessed the certainty of the evidence using GRADE.
MAIN RESULTS
We included 19 RCTs and one NRSI published between 1997 and 2021. One trial assessed medication management, one assessed an education intervention (NRSI) and 18 RCTs were of medication interventions. Medications assessed were subcutaneous deferoxamine, and two oral chelating agents, deferiprone and deferasirox. We rated the certainty of evidence as very low to low across all outcomes identified in this review. Four trials measured quality of life (QoL) with validated instruments, but provided no analysable data and reported no difference in QoL. We identified nine comparisons of interest. 1. Deferiprone versus deferoxamine We are uncertain whether or not deferiprone affects adherence to iron chelation therapy (four RCTs, unpooled, very low-certainty evidence), all-cause mortality (risk ratio (RR) 0.47, 95% confidence interval (CI) 0.18 to 1.21; 3 RCTs, 376 participants; very low-certainty evidence), or serious adverse events (SAEs) (RR 1.43, 95% CI 0.83 to 2.46; 1 RCT, 228 participants; very low-certainty evidence). Adherence was reported as "good", "high" or "excellent" by all seven trials, though the data could not be analysed formally: adherence ranged from 69% to 95% (deferiprone, mean 86.6%), and 71% to 93% (deferoxamine, mean 78.8%), based on five trials (474 participants) only. 2. Deferasirox versus deferoxamine We are uncertain whether or not deferasirox affects adherence to iron chelation therapy (three RCTs, unpooled, very low-certainty evidence), although medication adherence was high in all trials. We are uncertain whether or not there is any difference between the drug therapies in serious adverse events (SAEs) (SCD or thalassaemia) or all-cause mortality (thalassaemia). 3. Deferiprone versus deferasirox We are uncertain if there is a difference between oral deferiprone and deferasirox based on a single trial in children (average age 9 to 10 years) with any hereditary haemoglobinopathy in adherence, SAEs and all-cause mortality. 4. Deferasirox film-coated tablet (FCT) versus deferasirox dispersible tablet (DT) One RCT compared deferasirox in different tablet forms. There may be a preference for FCTs, shown through a trend for greater adherence (RR 1.10, 95% CI 0.99 to 1.22; 1 RCT, 88 participants), although medication adherence was high in both groups (FCT 92.9%; DT 85.3%). We are uncertain if there is a benefit in chelation-related AEs with FCTs. We are uncertain if there is a difference in the incidence of SAEs, all-cause mortality or sustained adherence. 5. Deferiprone and deferoxamine combined versus deferiprone alone We are uncertain if there is a difference in adherence, though reporting was usually narrative as triallists report it was "excellent" in both groups (three RCTs, unpooled). We are uncertain if there is a difference in the incidence of SAEs and all-cause mortality. 6. Deferiprone and deferoxamine combined versus deferoxamine alone We are uncertain if there is a difference in adherence (four RCTs), SAEs (none reported in the trial period) and all-cause mortality (no deaths reported in the trial period). There was high adherence in all trials. 7. Deferiprone and deferoxamine combined versus deferiprone and deferasirox combined There may be a difference in favour of deferiprone and deferasirox (combined) in rates of adherence (RR 0.84, 95% CI 0.72 to 0.99) (one RCT), although it was high (> 80%) in both groups. We are uncertain if there is a difference in SAEs, and no deaths were reported in the trial, so we cannot draw conclusions based on these data (one RCT). 8. Medication management versus standard care We are uncertain if there is a difference in QoL (one RCT), and we could not assess adherence due to a lack of reporting in the control group. 9. Education versus standard care One quasi-experimental (NRSI) study could not be analysed due to the severe baseline confounding.
AUTHORS' CONCLUSIONS
The medication comparisons included in this review had higher than average adherence rates not accounted for by differences in medication administration or side effects, though often follow-up was not good (high dropout over longer trials), with adherence based on a per protocol analysis. Participants may have been selected based on higher adherence to trial medications at baseline. Also, within the clinical trial context, there is increased attention and involvement of clinicians, thus high adherence rates may be an artefact of trial participation. Real-world, pragmatic trials in community and clinic settings are needed that examine both confirmed or unconfirmed adherence strategies that may increase adherence to iron chelation therapy. Due to lack of evidence this review cannot comment on intervention strategies for different age groups.
Topics: Child; Humans; Anemia, Sickle Cell; Chelating Agents; Chelation Therapy; Deferoxamine; Drug-Related Side Effects and Adverse Reactions; Iron; Thalassemia
PubMed: 36877640
DOI: 10.1002/14651858.CD012349.pub3 -
The Cochrane Database of Systematic... Jul 2019When human milk is not available for feeding preterm infants, protein hydrolysate, rather than standard cow's milk formulas (with intact proteins), is often used because...
BACKGROUND
When human milk is not available for feeding preterm infants, protein hydrolysate, rather than standard cow's milk formulas (with intact proteins), is often used because it is perceived as being tolerated better and less likely to lead to complications. However, protein hydrolysate formulas are more expensive than standard formulas, and concern exists that their use in practice is not supported by high-quality evidence.
OBJECTIVES
To assess the effects of feeding preterm infants hydrolysed formula (vs standard cow's milk formula) on risk of feed intolerance, necrotising enterocolitis, and other morbidity and mortality.
SEARCH METHODS
We used the standard Cochrane Neonatal search strategy including electronic searches of the Cochrane Central Register of Controlled Trials (CENTRAL; 2019, Issue 1), in the Cochrane Library; Ovid MEDLINE (1966 to 28 January 2019); Ovid Embase (1980 to 28 January 2019); and the Cumulative Index to Nursing and Allied Health Literature (CINAHL) (28 January 2019), as well as conference proceedings and previous reviews.
SELECTION CRITERIA
Randomised and quasi-randomised controlled trials that compared feeding preterm infants protein hydrolysate versus standard (non-hydrolysed) cow's milk formula.
DATA COLLECTION AND ANALYSIS
Two review authors assessed trial eligibility and risk of bias and extracted data independently. We analysed treatment effects as described in the individual trials and reported risk ratios and risk differences for dichotomous data, and mean differences for continuous data, with respective 95% confidence intervals (CIs). We used a fixed-effect model in meta-analyses and explored potential causes of heterogeneity in sensitivity analyses. We assessed quality of evidence at the outcome level using the GRADE approach.
MAIN RESULTS
We identified 11 trials for inclusion in the review. All trials were small (total participants 665) and had various methodological limitations including uncertainty about methods to ensure allocation concealment and blinding. Most participants were clinically stable preterm infants of less than about 34 weeks' gestational age or with birth weight less than about 1750 g. Fewer participants were extremely preterm, extremely low birth weight, or growth restricted. Most trials found no effects on feed intolerance, assessed variously as mean pre-feed gastric residual volume, incidence of abdominal distension or other gastrointestinal signs of concern, or time taken to achieve full enteral feeds (meta-analysis was limited because studies used different measures). Meta-analysis showed no effect on the risk of necrotising enterocolitis (typical risk ratio 1.10, 95% CI 0.36 to 3.34; risk difference 0.00, 95% CI -0.03 to 0.04; 5 trials, 385 infants) (low-certainty evidence; downgraded for imprecision and design weaknesses).
AUTHORS' CONCLUSIONS
The identified trials provide only low-certainty evidence about the effects of feeding preterm infants protein hydrolysate versus standard formula. Existing data do not support conclusions that feeding protein hydrolysate affects the risk of feed intolerance or necrotising enterocolitis. Additional large, pragmatic trials are needed to provide more reliable and precise estimates of effectiveness and cost-effectiveness.
Topics: Humans; Infant; Infant Formula; Infant Nutritional Physiological Phenomena; Infant, Newborn; Infant, Premature; Protein Hydrolysates; Randomized Controlled Trials as Topic
PubMed: 31339557
DOI: 10.1002/14651858.CD012412.pub3 -
Frontiers in Neurology 2024Painful diabetic neuropathy (PDN) is a common chronic neurological complication of diabetes mellitus. Medications are often used to relieve pain, but with significant...
BACKGROUND
Painful diabetic neuropathy (PDN) is a common chronic neurological complication of diabetes mellitus. Medications are often used to relieve pain, but with significant side effects. Acupuncture is now a component of pragmatic and integrative treatment for PDN. An increasing number of relevant randomized controlled trials have been published in recent years, but a comprehensive meta-analysis has not yet been performed. The aim of this paper is to verify the effectiveness and safety of acupuncture for PDN by meta-analysis and trial sequential analysis (TSA).
METHODS
All participants in this study should have had a PDN diagnosis and the trial group was treated with acupuncture. Eight databases, including EMbase, PubMed, Web of science, Cochrane Library, China Biology Medicine disc (CBM), China National Knowledge Infrastructure (CNKI), Wanfang and Chongqing VIP (CQVIP) were retrieved from inception to 5 April 2023. Meta-analysis was conducted utilizing RevMan 5.3 and Stata 15.0. TSA was performed to assess the adequacy of sample size for the outcomes.
RESULTS
A total of 36 studies, comprising 2,739 PDN patients, were included. Among them, 1,393 patients were assigned to the trial group and 1,346 patients were treated in the control group. Outcomes covers the primary indicator Total effective rate (RR = 1.42, 95%CI [1.34, 1.52], < 0.00001), with 21 studies reported, Pain intensity (SMD = -1.27, 95%CI [-1.58, -0.95], p < 0.00001), with 23 studies reported, and other outcomes, including motor nerve conduction velocity (MCV; MD = 3.58, 95%CI [2.77, 4.38], < 0.00001), sensory nerve conduction velocity (SCV; MD = 3.62, 95%CI [2.75, 4.49], < 0.00001), Depression score (SMD = -1.02, 95%CI [1.58, 0.46]), Toronto clinical scoring system (TCSS; MD = -2.41, 95%CI [-3.37, -1.45], < 0.00001), Quality of life (SMD = 1.06, 95%CI [0.66, 1.46]), traditional Chinese medicine (TCM) syndrome score (MD = -4.99, 95%CI [-6.79, -3.18], < 0.00001), suggesting that acupuncture have an ameliorating effect on PDN in various respect. Egger's test revealed publication bias for four outcomes. TSA showed that as for Total effective rate, Pain Intensity, MCV and SCV, the number of included studies was sufficient to support the conclusions.
CONCLUSION
Acupuncture demonstrates significant effectiveness in improving PDN outcomes, including Total effective rate, Pain intensity, MCV, SCV, Depression score, TCSS, Quality of life, TCM syndrome score. But the Adverse events rate is no different in trail group and control group. The publication bias presented in Total effective rate, Pain intensity, MCV and SCV can be remedied by Trim and filling method.
SYSTEMATIC REVIEW REGISTRATION
Prospero, https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=477295.
PubMed: 38903165
DOI: 10.3389/fneur.2024.1402458 -
Biomedicines Feb 202110 kHz spinal cord stimulation (SCS) is increasingly utilized globally to treat chronic pain syndromes. Real-world evidence complementing randomized controlled trials... (Review)
Review
10 kHz spinal cord stimulation (SCS) is increasingly utilized globally to treat chronic pain syndromes. Real-world evidence complementing randomized controlled trials supporting its use, has accumulated over the last decade. This systematic review aims to summarize the retrospective literature with reference to the efficacy and safety of 10 kHz SCS. We performed a systematic literature search of PubMed between 1 January 2009 and 21 August 2020 for English-language retrospective studies of ≥3 human subjects implanted with a Senza 10 kHz SCS system and followed-up for ≥3 months. Two independent reviewers screened titles/abstracts of 327 studies and 46 full-text manuscripts. In total, 16 articles were eligible for inclusion; 15 reported effectiveness outcomes and 11 presented safety outcomes. Follow-up duration ranged from 6-34 months. Mean pain relief was >50% in most studies, regardless of follow-up duration. Responder rates ranged from 67-100% at ≤12 months follow-up, and from 46-76% thereafter. 32-71% of patients decreased opioid or nonopioid analgesia intake. Complication incidence rates were consistent with other published SCS literature. Findings suggest 10 kHz SCS provides safe and durable pain relief in pragmatic populations of chronic pain patients. Furthermore, it may decrease opioid requirements, highlighting the key role 10 kHz SCS can play in the medium-term management of chronic pain.
PubMed: 33670252
DOI: 10.3390/biomedicines9020180 -
Implementation Science Communications Dec 2021Self-collection of samples for HPV testing may increase women's access to cervical cancer screening in low- and middle-income settings. However, implementation remains... (Review)
Review
INTRODUCTION
Self-collection of samples for HPV testing may increase women's access to cervical cancer screening in low- and middle-income settings. However, implementation remains poor in many regions. The purpose of this systematic review was to examine implementation data from randomized controlled trials evaluating human papillomavirus (HPV) self-collection testing among women in sub-Saharan Africa using the RE-AIM (Reach, Efficacy/Effectiveness, Adoption, Implementation, and Maintenance) framework.
METHODS
We searched four electronic databases (PubMed, CINAHL, Web of Science, and Global Health) for pragmatic randomized controlled trials that promote HPV self-collection among women in sub-Saharan Africa. Study selection and data extraction were conducted according to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-analyses) checklist. Two researchers independently extracted information from each article using a RE-AIM data extraction tool. The reporting of RE-AIM dimensions was summarized and synthesized across included interventions.
RESULTS
We identified 2008 citations, and eight studies were included. These reported on five unique interventions. The five interventions were conducted in five countries: Cameroon, Ethiopia, Kenya, Nigeria, and Uganda. Intervention reach (80%) was the most commonly reported RE-AIM dimension, followed by adoption (56%), efficacy/effectiveness (52%), implementation (47%), and maintenance (0%). All the interventions described increased uptake of HPV testing among study participants (effectiveness). However, the majority of the studies focused on reporting internal validity indicators such as inclusion criteria (100%) and exclusion criteria (100%), and few reported on external validity indicators such as participation rate (40%), intervention cost (40%), staff selection (20%), and cost of maintenance (0%).
CONCLUSIONS
Our review highlights the under-reporting of external validity indicators such as participation rate, intervention, and maintenance costs in studies of self-collection for HPV testing among women in SSA. Future research should focus on including factors that highlight internal validity factors and external validity factors to develop a greater understanding of ways to increase not only reach but also implementation and long-term maintenance of these interventions. Such data may advance the translation of HPV interventions into practice and reduce health disparities in SSA. Findings highlight the need for innovative tools such as participatory learning approaches or open challenges to expand knowledge and assessment of external validity indicators to ultimately increase the uptake of HPV testing among women in SSA.
PubMed: 34911573
DOI: 10.1186/s43058-021-00243-5 -
International Journal of Language &... Jul 2022It is widely acknowledged that children with developmental language disorder (DLD) predominantly have difficulties in the areas of grammar and vocabulary, with preserved...
BACKGROUND
It is widely acknowledged that children with developmental language disorder (DLD) predominantly have difficulties in the areas of grammar and vocabulary, with preserved pragmatic skills. Consequently, few studies focus on the pragmatic skills of children with DLD, and there is a distinct lack of studies examining the effectiveness of pragmatic interventions.
AIMS
To carry out a systematic review of the literature on pragmatic interventions for children with DLD.
METHODS & PROCEDURES
This systematic review was registered with PROSPERO (ID = CRD42017067239). A systematic search in seven databases yielded 1031 papers, of which 11 met our inclusion criteria. The included papers focused on interventions for children with DLD (mean = 3-18 years), enhancing oral language pragmatic skills, published between January 2006 and May 2020, and were based on a group-study design such as randomized control trial or pre-post-testing. Study participants were monolingual speakers. The quality of papers was appraised using the Cochrane Risk of bias tool for randomized controlled trials.
OUTCOMES & RESULTS
There was a high degree of variability between the included intervention studies, especially regarding intensity, intervention targets and outcomes. The evidence suggested that pragmatic intervention is feasible for all models of delivery (individual, small and large group) and that interventions for pragmatic language are mostly focused on encouragement of conversation and narrative skills observed through parent-child interaction or shared book-reading activities.
CONCLUSIONS & IMPLICATIONS
This study highlights the importance of promoting and explicitly teaching pragmatic skills to children with DLD in structured interventions. A narrative synthesis of the included studies revealed that in addition to direct intervention, indirect intervention can also contribute to improving oral pragmatic skills of children with DLD.
WHAT THIS PAPER ADDS
What is already known on the subject? An increasing number of studies have shown that difficulties in acquiring pragmatic language is not only present in children with autism. What this study adds to existing knowledge? Interventions for pragmatic language in children with DLD are mostly focused on encouragement of conversation and narrative skills, very often through parent-child interaction or shared book-reading activities. Interventions that target language pragmatic are feasible for all models of delivery (individual, small and large group). What are the potential or actual clinical implications of this work? The efficacy of the existing studies varies, and it is difficult to give recommendations regarding the intensity and duration of the specific intervention. In addition to offering pragmatic intervention directly from a specialist, pragmatic interventions can also be carried out indirectly if the intervention is under the continuous supervision of a specialist.
Topics: Communication; Humans; Language Development Disorders; Linguistics; Parent-Child Relations; Randomized Controlled Trials as Topic; Vocabulary
PubMed: 35445482
DOI: 10.1111/1460-6984.12716 -
International Journal of Environmental... Dec 2022The main contributor to excess mortality in severe mental illness (SMI) is poor physical health. Causes include unfavorable health behaviors among people with SMI,... (Review)
Review
BACKGROUND
The main contributor to excess mortality in severe mental illness (SMI) is poor physical health. Causes include unfavorable health behaviors among people with SMI, stigmatization phenomena, as well as limited access to and utilization of physical health care. Patient centered interventions to promote the utilization of and access to existing physical health care facilities may be a pragmatic and cost-effective approach to improve health equity in this vulnerable and often neglected patient population.
OBJECTIVE/METHODS
In this study, we systematically reviewed the international literature on such studies (sources: literature databases, trial-registries, grey literature). Empirical studies (quantitative, qualitative, and mixed methods) of interventions to improve the utilization of and access to medical health care for people with a SMI, were included.
RESULTS
We identified 38 studies, described in 51 study publications, and summarized them in terms of type, theoretical rationale, outcome measures, and study author's interpretation of the intervention success.
CONCLUSIONS
Useful interventions to promote the utilization of physical health care for people with a SMI exist, but still appear to be rare, or at least not supplemented by evaluation studies. The present review provides a map of the evidence and may serve as a starting point for further quantitative effectiveness evaluations of this promising type of behavioral intervention.
Topics: Humans; Mental Disorders; Outcome Assessment, Health Care; Behavior Therapy; Empirical Research; Health Equity
PubMed: 36612457
DOI: 10.3390/ijerph20010126