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Journal of Tissue Engineering 2023The high recurrence and complications associated with severe pressure injuries (PI) necessitate the exploration of advanced treatments, such as cell-based therapies, to... (Review)
Review
The high recurrence and complications associated with severe pressure injuries (PI) necessitate the exploration of advanced treatments, such as cell-based therapies, to facilitate wound healing. Such techniques harness the ability of different cell types to promote angiogenesis, re-epithelialization of the skin, and tissue regeneration. This systematic review explores the efficacy of cell-based therapies and tissue engineering in treating deep PI. We searched for interventional studies using cells in the treatment of PI in adults in four online libraries (PubMed, Embase, Ovid Medline, and Cochrane; latest search 10th June 2023). We found one randomized clinical trial (RCT), two non-RCT, and three pre-post studies, comprising 481 study participants with PI (253 intervention/228 controls). The risk of bias was categorized as moderate due to minimal bias in outcome measurements, or high owing to unclear patient randomization methods, as assessed by the ROBINS-I, NIH, and RoB-2 tools. Four cell types were identified in the context of cell-based therapies of PI: bone marrow mononuclear stem cells (BM-MNCs, = 2); hematopoietic derived stem cells (HSC, = 1); macrophages and activated macrophage suspensions (AMS, = 2); and cryopreserved placental membrane containing viable cells (vCPM, = 1). Wound healing outcomes were observed in patients undergoing cell-based therapies, including complete wound closure (AMS, vCPM; = 142), faster healing rate (BM-MNCs, AMS; = 146), improved granulation tissue formation (HSC, = 3) and shorter hospitalization time (BM-MNCs; = 108) compared to standard of care, with no adverse reactions. PI healing rate decreased only in one study with BM-MNC therapy, compared to control ( = 86). Based on the available data, though with limited evidence, it seems that macrophage deployment showed the most favorable outcomes. The results indicate that cell-based therapies offer a potential avenue for enhancing wound healing and tissue repair in PI; however, more extensive research is needed in this domain.
PubMed: 38029017
DOI: 10.1177/20417314231201071 -
Wounds : a Compendium of Clinical... Oct 2023Porcine-derived UBM, a type of acellular ECM, has demonstrated clinical utility for tissue repair and regeneration across various body systems. UBM acts as a...
Porcine-derived UBM, a type of acellular ECM, has demonstrated clinical utility for tissue repair and regeneration across various body systems. UBM acts as a full-thickness, exogenic skin substitute and scaffolding for soft tissue reconstruction while mimicking the function and properties of human ECM. This review presents an overview of the current literature evaluating UBM's clinical and preclinical utility across a broad range of applications. A compilation of studies of human and animal patients with a multitude of tissue defects resulting from various pathologic or injurious processes were systematically reviewed. The types of reconstructions included were categorized by the following surgical domains: abdominal wall; cardiothoracic and pulmonary; gastrointestinal; neurosurgery; oral and maxillofacial; otolaryngology or head and neck; ophthalmology; orthopedic or plastic or orthoplastic surgery; burn and wound care; and urology and gynecology. This systematic review illustrates that UBM may perform as well as or better than other ECM mimetics across various parameters, including reduced time to definitive wound closure, recurrence of wound, infection and/or complication rates, and immunogenic transplant rejection; reduction in overall cost burden to the patient, improved patient satisfaction, and ease of use and maintenance for providers; increased cellular recruitment, invasion, differentiation, and proliferation; and increased repair and regeneration of tissue. This tissue regeneration tends to be more functionally, mechanically, and histologically similar to native tissue through tissue-specific functional remodeling and maturation. This clinical outcome can be seen in various tissue types, levels of injury, and/or defect severity. UBM also proves valuable because of its ability to be used off-the-shelf in surgical, nonsurgical, or office and in-the-field treatment settings.
Topics: Swine; Humans; Animals; Urinary Bladder; Wound Healing; Extracellular Matrix; Tissue Scaffolds
PubMed: 37956347
DOI: 10.25270/wnds/23024 -
BMJ Open Nov 2023Head-to-head clinical trials are common in psoriasis, but scarce in psoriatic arthritis (PsA), making treatment comparisons between therapeutic classes difficult. This... (Meta-Analysis)
Meta-Analysis
OBJECTIVES
Head-to-head clinical trials are common in psoriasis, but scarce in psoriatic arthritis (PsA), making treatment comparisons between therapeutic classes difficult. This study describes the relative effectiveness of targeted synthetic (ts) and biologic (b) disease-modifying antirheumatic drugs (DMARDs) on patient-reported outcomes (PROs) through network meta-analysis (NMA).
DESIGN
A systematic literature review (SLR) was conducted in January 2020. Bayesian NMAs were conducted to compare treatments on Health Assessment Questionnaire Disability Index (HAQ-DI) and 36-item Short Form (SF-36) Health Survey including Mental Component Summary (MCS) and Physical Component Summary (PCS) scores.
DATA SOURCES
Ovid MEDLINE (including Epub Ahead of Print, In-Process & Other Non-Indexed Citations and Daily),Embase and Cochrane Central Register of Controlled Trials.
ELIGIBILITY CRITERIA
Phase III randomised controlled trials (RCTs) evaluating patients with PsA receiving tsDMARDS, bDMARDs or placebo were included in the SLR; there was no restriction on outcomes.
DATA EXTRACTION AND SYNTHESIS
Two independent researchers reviewed all citations. Data for studies meeting all inclusion criteria were extracted into a standardised Excel-based form by one reviewer and validated by a second reviewer. A third reviewer was consulted to resolve any discrepancies, as necessary. Risk of bias was assessed using the The National Institute for Health and Care Excellence clinical effectiveness quality assessment checklist.
RESULTS
In total, 26 RCTs were included. For HAQ-DI, SF-36 PCS and SF-36 MCS scores, intravenous tumour necrosis factor (TNF) alpha inhibitors generally ranked higher than most other classes of therapies available to treat patients with PsA. For almost all outcomes, several interleukin (IL)-23, IL-17A, subcutaneous TNF and IL-12/23 agents offered comparable improvement, while cytotoxic T-lymphocyte-associated antigen 4, phosphodiesterase-4 and Janus kinase inhibitors often had the lowest efficacy.
CONCLUSIONS
While intravenous TNFs may provide some improvements in PROs relative to several other tsDMARDs and bDMARDs for the treatment of patients with PsA, differences between classes of therapies across outcomes were small.
Topics: Humans; Arthritis, Psoriatic; Antibodies, Monoclonal; Network Meta-Analysis; Antirheumatic Agents; Patient Reported Outcome Measures
PubMed: 37940157
DOI: 10.1136/bmjopen-2022-062306 -
European Journal of Cancer (Oxford,... Dec 2023The number of systemic anticancer therapy (SACT) regimens has expanded rapidly over the last decade. There is a need to ensure quality of SACT delivery across cancer... (Review)
Review
PURPOSE
The number of systemic anticancer therapy (SACT) regimens has expanded rapidly over the last decade. There is a need to ensure quality of SACT delivery across cancer services and systems in different resource settings to reduce morbidity, mortality, and detrimental economic impact at individual and systems level. Existing literature on SACT focuses on treatment efficacy with few studies on quality or how SACT is delivered within routine care in comparison to radiation and surgical oncology.
METHODS
Systematic review was conducted following PRISMA guidelines. EMBASE and MEDLINE were searched and handsearching was undertaken to identify literature on existing quality indicators (QIs) that detect meaningful variations in the quality of SACT delivery across different healthcare facilities, regions, or countries. Data extraction was undertaken by two independent reviewers.
RESULTS
This review identified 63 distinct QIs from 15 papers. The majority were process QIs (n = 55, 87.3%) relating to appropriateness of treatment and guideline adherence (n = 28, 44.4%). There were few outcome QIs (n = 7, 11.1%) and only one structural QI (n = 1, 1.6%). Included studies solely focused on breast, colorectal, lung, and skin cancer. All but one studies were conducted in high-income countries.
CONCLUSIONS
The results of this review highlight a significant lack of research on SACT QIs particularly those appropriate for resource-constrained settings in low- and middle-income countries. This review should form the basis for future work in transforming performance measurement of SACT provision, through context-specific QI SACT development, validation, and implementation.
Topics: Humans; Quality Indicators, Health Care; Benchmarking; Treatment Outcome; Skin Neoplasms; Delivery of Health Care
PubMed: 37924649
DOI: 10.1016/j.ejca.2023.113389 -
Human Vaccines & Immunotherapeutics Dec 2023Varicella is a highly contagious disease caused by the varicella zoster virus (VZV). While the disease is usually mild, severe complications can occur requiring costly...
Varicella is a highly contagious disease caused by the varicella zoster virus (VZV). While the disease is usually mild, severe complications can occur requiring costly hospitalization. A thorough understanding of the healthcare resource use (HCRU) and costs of varicella is needed to inform health-economic models of preventive strategies. A systematic literature review was carried out to retrieve relevant publications between 1999 and 2021, reporting HCRU and cost outcomes for varicella and its complications. Data were extracted and stratified according to pre-specified age groups and complication categories. Costs were re-based to a $US2020 footing using both purchasing power parity and the medical component of consumer price indexes. Data were summarized descriptively due to high heterogeneity in study design and outcome reporting. Forty-four publications fulfilled the inclusion and exclusion criteria of which 28 were conducted in Europe, 6 in Middle East and Asia, 5 in South America, 3 in North America, and 2 in multiple regions. Primary healthcare visits accounted for 30% to 85% of total direct costs. Hospitalization costs varied between $1,308 and $38,268 per episode depending on country, complication type, and length of stay, contributing between 2% and 60% to total direct costs. Indirect costs, mostly driven by workdays lost, accounted for approximately two-thirds of total costs due to varicella. The management of varicella and related complications can lead to substantial HCRU and costs for patients and the healthcare system. Additional research is needed to further characterize the varicella-associated economic burden and its broader impact from a societal standpoint.
Topics: Humans; Chickenpox; Herpesvirus 3, Human; Hospitalization; Communicable Diseases; Delivery of Health Care
PubMed: 37885425
DOI: 10.1080/21645515.2023.2266225 -
International Journal of Nursing Studies Jan 2024Central venous catheters are commonly used in healthcare, but they come with a range of potential complications. Over the last 15 years, an influx of securement and... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Central venous catheters are commonly used in healthcare, but they come with a range of potential complications. Over the last 15 years, an influx of securement and dressing products has been released, with unknown overall effectiveness to prevent these complications.
OBJECTIVE
To compare the effects of dressings and securement devices for central venous catheters on a range of common complications including catheter-related bloodstream infection, catheter tip colonisation, entry/exit-site infection, skin colonisation, skin irritation, failed catheter securement, dressing durability and mortality.
DESIGN
Systematic review with meta-analysis.
METHODS
Following standard Cochrane methods, a systematic search of Cochrane Wounds Trials Register, Cochrane Central Register of Controlled Trials, MEDLINE Ovid, Embase Ovid, EBSCO CINAHL, and multiple clinical trial registries was completed in November 2022. Randomised controlled trials evaluating the effectiveness of dressing and securement devices for all CVC types were included. A random-effects model was used during the meta-analysis. Results were expressed using risk ratio (RR), rate ratio, or mean difference (MD), with 95 % confidence intervals (CIs). Methodological quality and bias were assessed.
RESULTS
We included 46 studies involving 10,054 participants. All studies had either an unclear or high-performance bias. The blinding of outcome assessment was unclear in most studies. Chlorhexidine gluconate-impregnated dressings, compared with standard polyurethane dressings, may reduce the incidence (7 studies; N = 5816; RR 0.60, 95 % CI 0.44-0.83; low certainty evidence) and rate (4 studies; N = 4447; RR 0.51, 95 % CI 0.32-0.79; moderate certainty evidence) of catheter-related bloodstream infection and catheter tip colonisation (8 studies; N = 4788; RR 0.70, 95 % CI 0.52-0.95; very low certainty evidence). Medication-impregnated dressings may reduce the incidence of catheter-related bloodstream infection (6 studies; N = 5687; RR 0.60, 95 % CI 0.39-0.93; low certainty evidence) and catheter-tip colonisation (7 studies; N = 4769; RR 0.60, 95 % CI 0.47-0.76; low certainty evidence) relative to non-impregnated dressing types. Tissue adhesive may increase the risk of skin irritation or damage compared with integrated securement dressings (3 studies; N = 166; RR 1.88, 95 % CI 1.09-3.24; low certainty evidence) or sutureless securement devices (4 studies; N = 241; RR 1.64, 95 % CI 1.10-2.44; moderate certainty evidence). Tissue adhesive increased dressing durability compared with integrated securement dressings (MD 43.03 h, 95 % CI 4.88-81.18; moderate certainty evidence) and sutureless securement devices (MD 42.90 h, 4.64-81.16; moderate certainty evidence). Tissue adhesive increased failed catheter securement rate compared with suture (2 studies; N = 103; RR 9.33, 95 % CI 1.10-79.21; moderate certainty evidence).
CONCLUSIONS
The findings of the review provide insights and guidance for clinicians in selecting the appropriate dressings and securements for catheters. Findings should be interpreted with caution due to heterogeneity in catheters and patient types.
REGISTRATION
#CD010367.
TWEETABLE ABSTRACT
Time to implement chlorhexidine gluconate-impregnated dressings to prevent catheter-related bloodstream infections; a meta-analysis by @GraceNP and team.
Topics: Humans; Central Venous Catheters; Tissue Adhesives; Bandages; Sepsis
PubMed: 37879273
DOI: 10.1016/j.ijnurstu.2023.104620 -
BMC Pregnancy and Childbirth Oct 2023Skin-to-skin contact between mother and infant after birth is recommended to promote breastfeeding and maternal-infant bonding. However, its impact on the incidence of... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Skin-to-skin contact between mother and infant after birth is recommended to promote breastfeeding and maternal-infant bonding. However, its impact on the incidence of neonatal hypoglycaemia is unknown. We conducted a systematic review and meta-analysis to assess this.
METHODS
Published randomised control trials (RCTs), quasi-RCTs, non-randomised studies of interventions, cohort, or case-control studies with an intervention of skin-to-skin care compared to other treatment were included without language or date restrictions. The primary outcome was neonatal hypoglycaemia (study-defined). We searched 4 databases and 4 trial registries from inception to May 12, 2023. Quality of studies was assessed using Cochrane Risk of Bias 1 or Effective Public Health Practice Project Quality Assessment tools. Certainty of evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. Results were synthesised using RevMan 5.4.1 or STATA and analysed using random-effects meta-analyses where possible, otherwise with direction of findings tables. This review was registered prospectively on PROSPERO (CRD42022328322).
RESULTS
This review included 84,900 participants in 108 studies, comprising 65 RCTs, 16 quasi-RCTs, seven non-randomised studies of intervention, eight prospective cohort studies, nine retrospective cohort studies and three case-control studies. Evidence suggests skin-to-skin contact may result in a large reduction in the incidence of neonatal hypoglycaemia (7 RCTs/quasi-RCTs, 922 infants, RR 0.29 (0.13, 0.66), p < 0.0001, I = 47%). Skin-to-skin contact may reduce the incidence of admission to special care or neonatal intensive care nurseries for hypoglycaemia (1 observational study, 816 infants, OR 0.50 (0.25-1.00), p = 0.050), but the evidence is very uncertain. Skin-to-skin contact may reduce duration of initial hospital stay after birth (31 RCTs, 3437 infants, MD -2.37 (-3.66, -1.08) days, p = 0.0003, I = 90%, p for Egger's test = 0.02), and increase exclusive breastmilk feeding from birth to discharge (1 observational study, 1250 infants, RR 4.30 (3.19, 5.81), p < 0.0001), but the evidence is very uncertain.
CONCLUSION
Skin-to-skin contact may lead to a large reduction in the incidence of neonatal hypoglycaemia. This, along with other established benefits, supports the practice of skin-to-skin contact for all infants and especially those at risk of hypoglycaemia.
Topics: Infant, Newborn; Infant; Female; Humans; Breast Feeding; Mothers; Fetal Diseases; Hypoglycemia; Case-Control Studies; Observational Studies as Topic
PubMed: 37865757
DOI: 10.1186/s12884-023-06057-8 -
Skin Health and Disease Oct 2023Topical corticosteroids (TCS) are a first-line treatment for eczema, but there are concerns about their safety when used long-term.
BACKGROUND
Topical corticosteroids (TCS) are a first-line treatment for eczema, but there are concerns about their safety when used long-term.
OBJECTIVES
To systematically review adverse effects associated with longer-term use of TCS for eczema.
METHODS
Randomised controlled trials (RCTs), cohort and case-control studies reporting adverse effects of TCS (comparators: no TCS treatment, other topicals) in patients with eczema were identified. Included studies had greater than one year of follow-up, minimum cohort size of 50 participants, or minimum 50 per arm for RCTs. Evidence was GRADE-assessed. Prospero registration CRD42021286413.
RESULTS
We found seven studies (two randomised, five observational); two RCTs ( = 2570, including 1288 receiving TCS), two cohort (all received TCS = 148) and three case-control studies (cases = 10 322, controls = 12 201). Evidence from two RCTS ( = 2570, children, three and five years' duration) comparing TCS to topical calcineurin inhibitors found intermittent TCS use probably results in little to no difference in risk of growth abnormalities, non-skin infections, impaired vaccine response and lymphoma/non lymphoma malignancies. The five-year RCT reported only one episode of skin atrophy ( = 1213 TCS arm; mild/moderate potency), suggesting TCS use probably results in little to no difference in skin thinning when used intermittently to treat flares. No cases of clinical adrenal insufficiency were reported in 75 patients using mild/moderate TCS in the three-year RCT. Small associations between TCS and type-2 diabetes and lymphoma were identified in two case-control studies compared to no TCS, but the evidence is very uncertain. No long-term studies concerning topical steroid withdrawal or eye problems were identified.
CONCLUSION
This review provides some reassuring data on growth and skin thinning when TCS are used intermittently for up to 5 years, but many knowledge gaps remain.
PubMed: 37799373
DOI: 10.1002/ski2.268 -
BMC Palliative Care Oct 2023Although oncological palliative care is increasingly being offered by multidisciplinary teams, there is still a lack of data about some symptoms handled by these teams,...
BACKGROUND
Although oncological palliative care is increasingly being offered by multidisciplinary teams, there is still a lack of data about some symptoms handled by these teams, such as dysphagia, in patients with advanced cancer outside swallow regions. This study aimed to estimate the occurrence of dysphagia in prognosis studies of adults with advanced cancer outside the head, neck, and upper gastrointestinal tract, and to determine if there is an association with mortality.
METHODS
A systematic review of studies that evaluated dysphagia and mortality was conducted (PROSPERO: CRD42021257172).
DATA SOURCES
BVS, PubMed, CINAHL, Web of Science, and Scopus. Data between 2011 and 2023 were selected.
RESULTS
Among the 608 articles screened, only 14 were included, which covered different types of cancer, primarily Lung, and Genitourinary, Skin, Hematological, and Central Nervous System as well. Dysphagia demonstrated a variable frequency, and almost half of the studies found a percentage of dysphagia above 60%, appearing most as a symptom that affects health-related quality of life and prove to be a toxicity of treatment. The association between dysphagia and mortality was only evaluated in three articles that studied advanced lung cancer, in which, after controlling for covariates, swallowing disorders were associated with worse survival, with prevalences of dysphagia and hazard ratios of 78.5% (1.12 [1.04-1.20]), 4% (1.34 [1.28-1.35]), and 3% (1.40 [1.07-1.81]), respectively.
CONCLUSIONS
The occurrence of dysphagia in advanced cancer outside the head, neck, and upper GI tract is common, and there seems to be an association with significantly decreased survival in patients with advanced lung cancer.
Topics: Humans; Adult; Deglutition Disorders; Deglutition; Head and Neck Neoplasms; Quality of Life; Lung Neoplasms; Upper Gastrointestinal Tract
PubMed: 37798715
DOI: 10.1186/s12904-023-01268-4 -
Lupus Science & Medicine Oct 2023SLE is a common multisystem autoimmune disease with chronic inflammation. Many efficacy evaluation indicators of randomised clinical trials (RCTs) for SLE have been...
OBJECTIVE
SLE is a common multisystem autoimmune disease with chronic inflammation. Many efficacy evaluation indicators of randomised clinical trials (RCTs) for SLE have been proposed but the comparability remains unknown. We aim to explore the preference and comparability of indicators reporting response rate and provide basis for primary outcome selection when evaluating the efficacy of SLE pharmaceutical treatment.
METHODS
We systematically searched three databases and three registries to identify pharmacological intervention-controlled SLE RCTs. Relative discriminations between indicators were assessed by the Bayesian hierarchical linear mixed model.
RESULTS
33 RCTs met our inclusion criteria and we compared eight of the most commonly used indicators reporting response rate. SLE Disease Activity Index 4 (SLEDAI-4) and SLE Responder Index 4 were considered the best recommended indicators reporting response rate to discriminate the pharmacological efficacy. Indicator preference was altered by disease severity, classification of drugs and outcome of trials, but SLEDAI-4 had robust efficacy in discriminating ability for most interventions. Of note, BILAG Index-based Combined Lupus Assessment showed efficacy in trials covering all-severity patients, as well as non-biologics RCTs. The British Isles Lupus Assessment Group response and Physician's Global Assessment response were more cautious in evaluating disease changes. Serious adverse event was often applied to evaluate the safety and tolerability of treatments rather than efficacy.
CONCLUSIONS
The impressionable efficacy discrimination ability of indicators highlights the importance of flexibility and comprehensiveness when choosing primary outcome(s). As for trials that are only evaluated by SLEDAI-4, attention should be paid to outcome interpretation to avoid the exaggeration of treatment efficacy. Further subgroup analyses are limited by the number of included RCTs.
PROSPERO REGISTRATION NUMBER
CRD42022334517.
Topics: Humans; Antibodies, Monoclonal, Humanized; Lupus Erythematosus, Systemic; Treatment Outcome; Severity of Illness Index; Pharmaceutical Preparations
PubMed: 37798046
DOI: 10.1136/lupus-2023-000942