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The Cochrane Database of Systematic... Mar 2022Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and SJS/TEN overlap syndrome are rare, severe cutaneous adverse reactions usually triggered by... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and SJS/TEN overlap syndrome are rare, severe cutaneous adverse reactions usually triggered by medications. In addition to tertiary-level supportive care, various systemic therapies have been used including glucocorticoids, intravenous immunoglobulins (IVIGs), cyclosporin, N-acetylcysteine, thalidomide, infliximab, etanercept, and plasmapheresis. There is an unmet need to understand the efficacy of these interventions.
OBJECTIVES
To assess the effects of systemic therapies (medicines delivered orally, intramuscularly, or intravenously) for the treatment of SJS, TEN, and SJS/TEN overlap syndrome.
SEARCH METHODS
We searched the following databases up to March 2021: the Cochrane Skin Specialised Register, CENTRAL, MEDLINE, and Embase. We also searched five clinical trial registers, the reference lists of all included studies and of key review articles, and a number of drug manufacturer websites. We searched for errata or retractions of included studies.
SELECTION CRITERIA
We included only randomised controlled trials (RCTs) and prospective observational comparative studies of participants of any age with a clinical diagnosis of SJS, TEN, or SJS/TEN overlap syndrome. We included all systemic therapies studied to date and permitted comparisons between each therapy, as well as between therapy and placebo.
DATA COLLECTION AND ANALYSIS
We used standard methodological procedures as specified by Cochrane. Our primary outcomes were SJS/TEN-specific mortality and adverse effects leading to discontinuation of SJS/TEN therapy. Secondary outcomes included time to complete re-epithelialisation, intensive care unit length of stay, total hospital length of stay, illness sequelae, and other adverse effects attributed to systemic therapy. We rated the certainty of the evidence for each outcome using GRADE.
MAIN RESULTS
We included nine studies with a total of 308 participants (131 males and 155 females) from seven countries. We included two studies in the quantitative meta-analysis. We included three RCTs and six prospective, controlled observational studies. Sample sizes ranged from 10 to 91. Most studies did not report study duration or time to follow-up. Two studies reported a mean SCORe of Toxic Epidermal Necrosis (SCORTEN) of 3 and 1.9. Seven studies did not report SCORTEN, although four of these studies reported average or ranges of body surface area (BSA) (means ranging from 44% to 51%). Two studies were set in burns units, two in dermatology wards, one in an intensive care unit, one in a paediatric ward, and three in unspecified inpatient units. Seven studies reported a mean age, which ranged from 29 to 56 years. Two studies included paediatric participants (23 children). We assessed the results from one of three RCTs as low risk of bias in all domains, one as high, and one as some concerns. We judged the results from all six prospective observational comparative studies to be at a high risk of bias. We downgraded the certainty of the evidence because of serious risk of bias concerns and for imprecision due to small numbers of participants. The interventions assessed included systemic corticosteroids, tumour necrosis factor-alpha (TNF-alpha) inhibitors, cyclosporin, thalidomide, N-acetylcysteine, IVIG, and supportive care. No data were available for the main comparisons of interest as specified in the review protocol: etanercept versus cyclosporin, etanercept versus IVIG, IVIG versus supportive care, IVIG versus cyclosporin, and cyclosporin versus corticosteroids. Corticosteroids versus no corticosteroids It is uncertain if there is any difference between corticosteroids (methylprednisolone 4 mg/kg/day for two more days after fever had subsided and no new lesions had developed) and no corticosteroids on disease-specific mortality (risk ratio (RR) 2.55, 95% confidence interval (CI) 0.72 to 9.03; 2 studies; 56 participants; very low-certainty evidence). Time to complete re-epithelialisation, length of hospital stay, and adverse effects leading to discontinuation of therapy were not reported. IVIG versus no IVIG It is uncertain if there is any difference between IVIG (0.2 to 0.5 g/kg cumulative dose over three days) and no IVIG in risk of disease-specific mortality (RR 0.33, 95% CI 0.04 to 2.91); time to complete re-epithelialisation (mean difference (MD) -2.93 days, 95% CI -4.4 to -1.46); or length of hospital stay (MD -2.00 days, 95% CI -5.81 to 1.81). All results in this comparison were based on one study with 36 participants, and very low-certainty evidence. Adverse effects leading to discontinuation of therapy were not reported. Etanercept (TNF-alpha inhibitor) versus corticosteroids Etanercept (25 mg (50 mg if weight > 65 kg) twice weekly "until skin lesions healed") may reduce disease-specific mortality compared to corticosteroids (intravenous prednisolone 1 to 1.5 mg/kg/day "until skin lesions healed") (RR 0.51, 95% CI 0.16 to 1.63; 1 study; 91 participants; low-certainty evidence); however, the CIs were consistent with possible benefit and possible harm. Serious adverse events, such as sepsis and respiratory failure, were reported in 5 of 48 participants with etanercept and 9 of 43 participants with corticosteroids, but it was not clear if they led to discontinuation of therapy. Time to complete re-epithelialisation and length of hospital stay were not reported. Cyclosporin versus IVIG It is uncertain if there is any difference between cyclosporin (3 mg/kg/day or intravenous 1 mg/kg/day until complete re-epithelialisation, then tapered off (10 mg/day reduction every 48 hours)) and IVIG (continuous infusion 0.75 g/kg/day for 4 days (total dose 3 g/kg) in participants with normal renal function) in risk of disease-specific mortality (RR 0.13, 95% CI 0.02 to 0.98, 1 study; 22 participants; very low-certainty evidence). Time to complete re-epithelialisation, length of hospital stay, and adverse effects leading to discontinuation of therapy were not reported. No studies measured intensive care unit length of stay.
AUTHORS' CONCLUSIONS
When compared to corticosteroids, etanercept may result in mortality reduction. For the following comparisons, the certainty of the evidence for disease-specific mortality is very low: corticosteroids versus no corticosteroids, IVIG versus no IVIG and cyclosporin versus IVIG. There is a need for more multicentric studies, focused on the most important clinical comparisons, to provide reliable answers about the best treatments for SJS/TEN.
Topics: Acetylcysteine; Adrenal Cortex Hormones; Adult; Autoimmune Diseases; Child; Cyclosporine; Etanercept; Female; Humans; Immunoglobulins, Intravenous; Male; Middle Aged; Observational Studies as Topic; Stevens-Johnson Syndrome; Thalidomide; Tumor Necrosis Factor-alpha
PubMed: 35274741
DOI: 10.1002/14651858.CD013130.pub2 -
Annals of Internal Medicine Jul 2013Pressure ulcers are associated with substantial health burdens but may be preventable. (Review)
Review
BACKGROUND
Pressure ulcers are associated with substantial health burdens but may be preventable.
PURPOSE
To review the clinical utility of pressure ulcer risk assessment instruments and the comparative effectiveness of preventive interventions in persons at higher risk.
DATA SOURCES
MEDLINE (1946 through November 2012), CINAHL, the Cochrane Library, grant databases, clinical trial registries, and reference lists.
STUDY SELECTION
Randomized trials and observational studies on effects of using risk assessment on clinical outcomes and randomized trials of preventive interventions on clinical outcomes.
DATA EXTRACTION
Multiple investigators abstracted and checked study details and quality using predefined criteria.
DATA SYNTHESIS
One good-quality trial found no evidence that use of a pressure ulcer risk assessment instrument, with or without a protocolized intervention strategy based on assessed risk, reduces risk for incident pressure ulcers compared with less standardized risk assessment based on nurses' clinical judgment. In higher-risk populations, 1 good-quality and 4 fair-quality randomized trials found that more advanced static support surfaces were associated with lower risk for pressure ulcers compared with standard mattresses (relative risk range, 0.20 to 0.60). Evidence on the effectiveness of low-air-loss and alternating-air mattresses was limited, with some trials showing no clear differences from advanced static support surfaces. Evidence on the effectiveness of nutritional supplementation, repositioning, and skin care interventions versus usual care was limited and had methodological shortcomings, precluding strong conclusions.
LIMITATION
Only English-language articles were included, publication bias could not be formally assessed, and most studies had methodological shortcomings.
CONCLUSION
More advanced static support surfaces are more effective than standard mattresses for preventing ulcers in higher-risk populations. The effectiveness of formal risk assessment instruments and associated intervention protocols compared with less standardized assessment methods and the effectiveness of other preventive interventions compared with usual care have not been clearly established.
Topics: Bandages; Bedding and Linens; Beds; Comparative Effectiveness Research; Dietary Supplements; Humans; Nursing Diagnosis; Patient Positioning; Pressure Ulcer; Risk Assessment; Skin Cream
PubMed: 23817702
DOI: 10.7326/0003-4819-159-1-201307020-00006 -
The Cochrane Database of Systematic... Jun 2013Patients awaiting surgical procedures often experience significant anxiety. Such anxiety may result in negative physiological manifestations, slower wound healing,... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Patients awaiting surgical procedures often experience significant anxiety. Such anxiety may result in negative physiological manifestations, slower wound healing, increased risk of infection, and may complicate the induction of anaesthesia and impede postoperative recovery. To reduce patient anxiety, sedatives and anti-anxiety drugs are regularly administered before surgery. However, these often have negative side effects and may prolong patient recovery. Therefore, increasing attention is being paid to a variety of non-pharmacological interventions for reduction of preoperative anxiety such as music therapy and music medicine interventions. Interventions are categorized as 'music medicine' when passive listening to pre-recorded music is offered by medical personnel. In contrast, music therapy requires the implementation of a music intervention by a trained music therapist, the presence of a therapeutic process, and the use of personally tailored music experiences. A systematic review was needed to gauge the efficacy of both music therapy and music medicine interventions for reduction of preoperative anxiety.
OBJECTIVES
To examine the effects of music interventions with standard care versus standard care alone on preoperative anxiety in surgical patients.
SEARCH METHODS
We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2012, Issue 7), MEDLINE (1950 to August 2012), CINAHL (1980 to August 2012), AMED (1985 to April 2011; we no longer had access to AMED after this date), EMBASE (1980 to August 2012), PsycINFO (1967 to August 2012), LILACS (1982 to August 2012), Science Citation Index (1980 to August 2012), the specialist music therapy research database (March 1 2008; database is no longer functional), CAIRSS for Music (to August 2012), Proquest Digital Dissertations (1980 to August 2012), ClinicalTrials.gov (2000 to August 2012), Current Controlled Trials (1998 to August 2012), and the National Research Register (2000 to September 2007). We handsearched music therapy journals and reference lists, and contacted relevant experts to identify unpublished manuscripts. There was no language restriction.
SELECTION CRITERIA
We included all randomized and quasi-randomized trials that compared music interventions and standard care with standard care alone for reducing preoperative anxiety in surgical patients.
DATA COLLECTION AND ANALYSIS
Two review authors independently extracted the data and assessed the risk of bias. We contacted authors to obtain missing data where needed. Where possible, results were presented in meta analyses using mean differences and standardized mean differences. Post-test scores were used. In cases of significant baseline differences, we used change scores.
MAIN RESULTS
We included 26 trials (2051 participants). All studies used listening to pre-recorded music. The results suggested that music listening may have a beneficial effect on preoperative anxiety. Specifically, music listening resulted, on average, in an anxiety reduction that was 5.72 units greater (95% CI -7.27 to -4.17, P < 0.00001) than that in the standard care group as measured by the Stait-Trait Anxiety Inventory (STAI-S), and -0.60 standardized units (95% CI -0.90 to -0.31, P < 0.0001) on other anxiety scales. The results also suggested a small effect on heart rate and diastolic blood pressure, but no support was found for reductions in systolic blood pressure, respiratory rate, and skin temperature. Most trials were assessed to be at high risk of bias because of lack of blinding. Blinding of outcome assessors is often impossible in music therapy and music medicine studies that use subjective outcomes, unless in studies in which the music intervention is compared to another treatment intervention. Because of the high risk of bias, these results need to be interpreted with caution.None of the studies included wound healing, infection rate, time to discharge, or patient satisfaction as outcome variables. One large study found that music listening was more effective than the sedative midazolam in reducing preoperative anxiety and equally effective in reducing physiological responses. No adverse effects were identified.
AUTHORS' CONCLUSIONS
This systematic review indicates that music listening may have a beneficial effect on preoperative anxiety. These findings are consistent with the findings of three other Cochrane systematic reviews on the use of music interventions for anxiety reduction in medical patients. Therefore, we conclude that music interventions may provide a viable alternative to sedatives and anti-anxiety drugs for reducing preoperative anxiety.
Topics: Anxiety; Blood Pressure; Heart Rate; Humans; Music Therapy; Preoperative Care; Randomized Controlled Trials as Topic; Surgical Procedures, Operative
PubMed: 23740695
DOI: 10.1002/14651858.CD006908.pub2 -
The Cochrane Database of Systematic... Aug 2016Kangaroo mother care (KMC), originally defined as skin-to-skin contact between a mother and her newborn, frequent and exclusive or nearly exclusive breastfeeding, and... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Kangaroo mother care (KMC), originally defined as skin-to-skin contact between a mother and her newborn, frequent and exclusive or nearly exclusive breastfeeding, and early discharge from hospital, has been proposed as an alternative to conventional neonatal care for low birthweight (LBW) infants.
OBJECTIVES
To determine whether evidence is available to support the use of KMC in LBW infants as an alternative to conventional neonatal care before or after the initial period of stabilization with conventional care, and to assess beneficial and adverse effects.
SEARCH METHODS
We used the standard search strategy of the Cochrane Neonatal Review Group. This included searches in CENTRAL (Cochrane Central Register of Controlled Trials; 2016, Issue 6), MEDLINE, Embase, CINAHL (Cumulative Index to Nursing and Allied Health Literature), LILACS (Latin American and Caribbean Health Science Information database), and POPLINE (Population Information Online) databases (all from inception to June 30, 2016), as well as the WHO (World Health Organization) Trial Registration Data Set (up to June 30, 2016). In addition, we searched the web page of the Kangaroo Foundation, conference and symposia proceedings on KMC, and Google Scholar.
SELECTION CRITERIA
Randomized controlled trials comparing KMC versus conventional neonatal care, or early-onset KMC versus late-onset KMC, in LBW infants.
DATA COLLECTION AND ANALYSIS
Data collection and analysis were performed according to the methods of the Cochrane Neonatal Review Group.
MAIN RESULTS
Twenty-one studies, including 3042 infants, fulfilled inclusion criteria. Nineteen studies evaluated KMC in LBW infants after stabilization, one evaluated KMC in LBW infants before stabilization, and one compared early-onset KMC with late-onset KMC in relatively stable LBW infants. Sixteen studies evaluated intermittent KMC, and five evaluated continuous KMC. KMC versus conventional neonatal care: At discharge or 40 to 41 weeks' postmenstrual age, KMC was associated with a statistically significant reduction in the risk of mortality (risk ratio [RR] 0.60, 95% confidence interval [CI] 0.39 to 0.92; eight trials, 1736 infants), nosocomial infection/sepsis (RR 0.35, 95% CI 0.22 to 0.54; five trials, 1239 infants), and hypothermia (RR 0.28, 95% CI 0.16 to 0.49; nine trials, 989 infants; moderate-quality evidence). At latest follow-up, KMC was associated with a significantly decreased risk of mortality (RR 0.67, 95% CI 0.48 to 0.95; 12 trials, 2293 infants; moderate-quality evidence) and severe infection/sepsis (RR 0.50, 95% CI 0.36 to 0.69; eight trials, 1463 infants; moderate-quality evidence). Moreover, KMC was found to increase weight gain (mean difference [MD] 4.1 g/d, 95% CI 2.3 to 5.9; 11 trials, 1198 infants; moderate-quality evidence), length gain (MD 0.21 cm/week, 95% CI 0.03 to 0.38; three trials, 377 infants) and head circumference gain (MD 0.14 cm/week, 95% CI 0.06 to 0.22; four trials, 495 infants) at latest follow-up, exclusive breastfeeding at discharge or 40 to 41 weeks' postmenstrual age (RR 1.16, 95% CI 1.07 to 1.25; six studies, 1453 mothers) and at one to three months' follow-up (RR 1.20, 95% CI 1.01 to 1.43; five studies, 600 mothers), any (exclusive or partial) breastfeeding at discharge or at 40 to 41 weeks' postmenstrual age (RR 1.20, 95% CI 1.07 to 1.34; 10 studies, 1696 mothers; moderate-quality evidence) and at one to three months' follow-up (RR 1.17, 95% CI 1.05 to 1.31; nine studies, 1394 mothers; low-quality evidence), and some measures of mother-infant attachment and home environment. No statistically significant differences were found between KMC infants and controls in Griffith quotients for psychomotor development at 12 months' corrected age (low-quality evidence). Sensitivity analysis suggested that inclusion of studies with high risk of bias did not affect the general direction of findings nor the size of the treatment effect for main outcomes. Early-onset KMC versus late-onset KMC in relatively stable infants: One trial compared early-onset continuous KMC (within 24 hours post birth) versus late-onset continuous KMC (after 24 hours post birth) in 73 relatively stable LBW infants. Investigators reported no significant differences between the two study groups in mortality, morbidity, severe infection, hypothermia, breastfeeding, and nutritional indicators. Early-onset KMC was associated with a statistically significant reduction in length of hospital stay (MD 0.9 days, 95% CI 0.6 to 1.2).
AUTHORS' CONCLUSIONS
Evidence from this updated review supports the use of KMC in LBW infants as an alternative to conventional neonatal care, mainly in resource-limited settings. Further information is required concerning the effectiveness and safety of early-onset continuous KMC in unstabilized or relatively stabilized LBW infants, as well as long-term neurodevelopmental outcomes and costs of care.
Topics: Bacterial Infections; Breast Feeding; Humans; Infant; Infant Care; Infant Mortality; Infant, Low Birth Weight; Infant, Newborn; Infant, Premature, Diseases; Kangaroo-Mother Care Method; Length of Stay; Object Attachment; Physical Stimulation; Randomized Controlled Trials as Topic; Weight Gain
PubMed: 27552521
DOI: 10.1002/14651858.CD002771.pub4 -
The Cochrane Database of Systematic... Mar 2013An acute burn wound is a complex and evolving injury. Extensive burns produce systemic consequences, in addition to local tissue damage. Treatment of partial thickness... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
An acute burn wound is a complex and evolving injury. Extensive burns produce systemic consequences, in addition to local tissue damage. Treatment of partial thickness burn wounds is directed towards promoting healing and a wide variety of dressings are currently available. Improvements in technology and advances in understanding of wound healing have driven the development of new dressings. Dressing selection should be based on their effects on healing, but ease of application and removal, dressing change requirements, cost and patient comfort should also be considered.
OBJECTIVES
To assess the effects of burn wound dressings on superficial and partial thickness burns.
SEARCH METHODS
For this first update we searched The Cochrane Wounds Group Specialised Register (searched 8 November 2012); The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2012, Issue 10); Ovid MEDLINE (2008 to October Week 4 2012); Ovid MEDLINE (In-Process & Other Non-Indexed Citations, November 07, 2012); Ovid EMBASE (2008 to 2012 Week 44); AND EBSCO CINAHL (1982 to 2 November 2012).
SELECTION CRITERIA
All randomised controlled trials (RCTs) that evaluated the effects of burn wound dressings on the healing of superficial and partial thickness burns.
DATA COLLECTION AND ANALYSIS
Two authors extracted the data independently using standardised forms. We assessed each trial for internal validity and resolved differences by discussion.
MAIN RESULTS
A total of 30 RCTs are included in this review. Overall both the quality of trial reporting and trial conduct were generally poor and meta analysis was largely precluded due to study heterogeneity or poor data reporting. In the context of this poor quality evidence, silver sulphadiazine (SSD) was consistently associated with poorer healing outcomes than biosynthetic (skin substitute) dressings, silver-containing dressings and silicon-coated dressings. Burns treated with hydrogel dressings appear to heal more quickly than those treated with usual care.
AUTHORS' CONCLUSIONS
There is a paucity of high-quality evidence regarding the effect of different dressings on the healing of superficial and partial thickness burn injuries. The studies summarised in this review evaluated a variety of interventions, comparators and clinical endpoints and all were at risk of bias. It is impossible to draw firm and confident conclusions about the effectiveness of specific dressings, however silver sulphadiazine was consistently associated with poorer healing outcomes than biosynthetic, silicon-coated and silver dressings whilst hydrogel-treated burns had better healing outcomes than those treated with usual care.
Topics: Bandages; Bandages, Hydrocolloid; Burns; Humans; Randomized Controlled Trials as Topic; Silicon Compounds; Silver Sulfadiazine; Skin, Artificial; Wound Healing
PubMed: 23543513
DOI: 10.1002/14651858.CD002106.pub4 -
The Cochrane Database of Systematic... Nov 2016Incontinence-associated dermatitis (IAD) is one of the most common skin problems in adults who are incontinent for urine, stool, or both. In practice, products and... (Review)
Review
BACKGROUND
Incontinence-associated dermatitis (IAD) is one of the most common skin problems in adults who are incontinent for urine, stool, or both. In practice, products and procedures are the same for both prevention and treatment of IAD.
OBJECTIVES
The objective of this review was to assess the effectiveness of various products and procedures to preventand treat incontinence-associated dermatitis in adults.
SEARCH METHODS
We searched the Cochrane Incontinence Group Specialised Trials Register, which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE In-Process, MEDLINE Epub Ahead of Print, CINAHL, ClinicalTrials.gov, WHO ICTRP and handsearching of journals and conference proceedings (searched 28 September 2016). Additionally we searched other electronic databases: CENTRAL(2015, Issue 4), MEDLINE (January 1946 to May Week 3 2015), MEDLINE In-Process (inception to 26 May 2015), CINAHL(December 1981 to 28 May 2015), Web of Science (WoS; inception to 28 May 2015) and handsearched conference proceedings (to June 2015) and the reference lists of relevant articles, and contacted authors and experts in the field.
SELECTION CRITERIA
We selected randomised controlled trials (RCTs) and quasi-RCTs, performed in any healthcare setting, with included participants over 18 years of age, with or without IAD. We included trials comparing the (cost) effectiveness of topical skin care products such as skin cleansers, moisturisers, and skin protectants of different compositions and skin care procedures aiming to prevent and treat IAD.
DATA COLLECTION AND ANALYSIS
Two review authors independently screened titles, abstracts and full-texts, extracted data, and assessed the risk of bias of the included trials.
MAIN RESULTS
We included 13 trials with 1295 participants in a qualitative synthesis. Participants were incontinent for urine, stool, or both, and were residents in a nursing home or were hospitalised.Eleven trials had a small sample size and short follow-up periods. .The overall risk of bias in the included studies was high. The data were not suitable for meta-analysis due to heterogeneity in participant population, skin care products, skin care procedures, outcomes, and measurement tools.Nine trials compared different topical skin care products, including a combination of products. Two trials tested a structured skin care procedure. One trial compared topical skin care products alongside frequencies of application. One trial compared frequencies of application of topical skin care products.We found evidence in two trials, being of low and moderate quality, that soap and water performed poorly in the prevention and treatment of IAD (primary outcomes of this review). The first trial indicated that the use of a skin cleanser might be more effective than the use of soap and water (risk ratio (RR) 0.39, 95% confidence interval (CI) 0.17 to 0.87; low quality evidence). The second trial indicated that a structured skin care procedure, being a washcloth with cleansing, moisturising, and protecting properties, might be more effective than soap and water (RR 0.31, 95% CI 0.12 to 0.79; moderate quality evidence). Findings from the other trials, all being of low to very low quality, suggest that applying a leave-on product (moisturiser, skin protectant, or a combination) might be more effective than not applying a leave-on product. No trial reported on the third primary outcome 'number of participants not satisfied with treatment' or on adverse effects.
AUTHORS' CONCLUSIONS
Little evidence, of very low to moderate quality, exists on the effects of interventions for preventing and treating IAD in adults. Soap and water performed poorly in the prevention and treatment of IAD. Application of leave-on products (moisturisers, skin protectants, or a combination) and avoiding soap seems to be more effective than withholding these products. The performance of leave-on products depends on the combination of ingredients, the overall formulation and the usage (e.g. amount applied). High quality confirmatory trials using standardised, and comparable prevention and treatment regimens in different settings/regions are required. Furthermore, to increase the comparability of trial results, we recommend the development of a core outcome set, including validated measurement tools. The evidence in this review is current up to 28 September 2016.
Topics: Administration, Topical; Adult; Amitriptyline; Dermatitis; Dermatologic Agents; Fecal Incontinence; Humans; Petrolatum; Randomized Controlled Trials as Topic; Skin Care; Skin Cream; Soaps; Urinary Incontinence; Zinc Oxide
PubMed: 27841440
DOI: 10.1002/14651858.CD011627.pub2 -
The British Journal of Dermatology May 2012Nonmelanoma skin cancer (NMSC) is the most common cancer affecting white-skinned individuals and the incidence is increasing worldwide. (Review)
Review
BACKGROUND
Nonmelanoma skin cancer (NMSC) is the most common cancer affecting white-skinned individuals and the incidence is increasing worldwide.
OBJECTIVES
This systematic review brings together 75 studies conducted over the past half century to look at geographical variations and trends worldwide in NMSC, and specifically incidence data are compared with recent U.K. cancer registry data.
METHODS
Following the development of a comprehensive search strategy, an assessment tool was adapted to look at the methodological quality of the eligible studies.
RESULTS
Most of the studies focused on white populations in Europe, the U.S.A. and Australia; however, limited data were available for other skin types in regions such as Africa. Worldwide the incidence for NMSC varies widely with the highest rates in Australia [>1000/100, 000 person-years for basal cell carcinoma (BCC)] and the lowest rates in parts of Africa (< 1/100, 000 person-years for BCC). The average incidence rates in England were 76·21/100, 000 person-years and 22·65/100, 000 person-years for BCC and squamous cell carcinoma (SCC), respectively, with highest rates in the South-West of England (121·29/100, 000 person-years for BCC and 33·02/100, 000 person-years for SCC) and lowest rates by far in London (0·24/100, 000 person-years for BCC and 14·98/100, 000 person-years for SCC). The incidence rates in the U.K. appear to be increasing at a greater rate when compared with the rest of Europe.
CONCLUSIONS
NMSC is an increasing problem for health care services worldwide. This review highlights a requirement for prevention studies in this area and the issues surrounding incomplete NMSC registration. Registration standards of NMSC should be improved to the level of other invasive disease.
Topics: Carcinoma, Basal Cell; Carcinoma, Squamous Cell; Global Health; Humans; Incidence; Registries; Skin Neoplasms
PubMed: 22251204
DOI: 10.1111/j.1365-2133.2012.10830.x -
International Journal of Environmental... Dec 2022Peristomal skin complications (PSCs) are the most common skin problems seen after ostomy surgery. They have a considerable impact on a patient's quality of life and... (Review)
Review
BACKGROUND
Peristomal skin complications (PSCs) are the most common skin problems seen after ostomy surgery. They have a considerable impact on a patient's quality of life and contribute to a higher cost of care.
METHODS
A systematic review was conducted, querying three databases. The analysis was performed on international studies focused on the clinical-epidemiological burden of PSCs in adult patients with ileostomy/colostomy.
RESULTS
Overall, 23 studies were considered. The main diseases associated with ostomy surgery were rectal, colon and gynecological cancers, inflammatory bowel diseases, diverticulitis, bowel obstruction and intestinal perforation. Erythema, papules, skin erosions, ulcers and vesicles were the most common PSCs for patients with an ostomy (or stoma). A PSCs incidence ranging from 36.3% to 73.4% was described. Skin complications increased length of stay (LOS) and rates of readmission within 120 days of surgery.
CONCLUSIONS
PSCs data are still limited. A knowledge of their burden is essential to support health personnel and decision-makers in identifying the most appropriate responses to patients' needs. Proper management of these complications plays a fundamental role in improving the patient's quality of life. A multidisciplinary approach, as well as increased patient education and their empowerment, are priority measures to be implemented to foster a value-based healthcare.
Topics: Adult; Humans; Colostomy; Ileostomy; Quality of Life; Public Health; Erythema
PubMed: 36612395
DOI: 10.3390/ijerph20010079 -
The Cochrane Database of Systematic... Jan 2020Ageing has a degenerative effect on the skin, leaving it more vulnerable to damage. Hygiene and emollient interventions may help maintain skin integrity in older people... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Ageing has a degenerative effect on the skin, leaving it more vulnerable to damage. Hygiene and emollient interventions may help maintain skin integrity in older people in hospital and residential care settings; however, at present, most care is based on "tried and tested" practice, rather than on evidence.
OBJECTIVES
To assess the effects of hygiene and emollient interventions for maintaining skin integrity in older people in hospital and residential care settings.
SEARCH METHODS
We searched the Cochrane Skin Specialised Register, CENTRAL, MEDLINE, Embase, and CINAHL, up to January 2019. We also searched five trials registers.
SELECTION CRITERIA
Randomised controlled trials comparing hygiene and emollient interventions versus placebo, no intervention, or standard practices for older people aged ≥ 60 years in hospital or residential care settings.
DATA COLLECTION AND ANALYSIS
We used standard methodological procedures as expected by Cochrane. Primary outcomes were frequency of skin damage, for example, complete loss of integrity (tears or ulceration) or partial loss of integrity (fissuring), and side effects. Secondary outcomes included transepidermal water loss (TEWL), stratum corneum hydration (SCH), erythema, and clinical scores of dryness or itch. We used GRADE to assess the quality of evidence.
MAIN RESULTS
We included six trials involving 1598 residential care home residents; no included trial had a hospital setting. Most participants had a mean age of 80+ years; when specified, more women were recruited than men. Two studies included only people with diagnosed dry skin. Studies were conducted in Asia, Australasia, Europe, and North America. A range of hygiene and emollient interventions were assessed: a moisturising soap bar; combinations of water soak, oil soak, and lotion; regular application of a commercially available moisturiser; use of two different standardised skin care regimens comprising a body wash and leave-on body lotion; bed bath with "wash gloves" containing numerous ingredients; and application of a hot towel after usual care bed bath. In five studies, treatment duration ranged from five days to six months; only one study had post-treatment follow-up (one to eight days from end of treatment). Outcomes in the hot towel study were measured 15 minutes after the skin was wiped with a dry towel. Three studies each had high risk of attrition, detection, and performance bias. Only one trial (n = 984) assessed frequency of skin damage via average monthly incidence of skin tears during six months of treatment. The emollient group (usual care plus twice-daily application of moisturiser) had 5.76 tears per month per 1000 occupied bed-days compared with 10.57 tears in the usual care only group (ad hoc or no standardised skin-moisturising regimen) (P = 0.004), but this is based on very low-quality evidence, so we are uncertain of this result. Only one trial (n = 133) reported measuring side effects. At 56 ± 4 days from baseline, there were three undesirable effects (itch (mild), redness (mild/moderate), and irritation (severe)) in intervention group 1 (regimen consisting of a moisturising body wash and a moisturising leave-on lotion) and one event (mild skin dryness) in intervention group 2 (regimen consisting of body wash and a water-in-oil emulsion containing emollients and 4% urea). In both groups, the body wash was used daily and the emollient twice daily for eight weeks. There were zero adverse events in the usual care group. This result is based on very low-quality evidence. This same study also measured TEWL at 56 ± 4 days in the mid-volar forearm (n = 106) and the lower leg (n = 105). Compared to usual care, there may be no difference in TEWL between intervention groups, but evidence quality is low. One study, which compared application of a hot towel for 10 seconds after a usual care bed bath versus usual care bed bath only, also measured TEWL at 15 minutes after the skin was wiped with a dry towel for one second. The mean TEWL was 8.6 g/m²/h (standard deviation (SD) 3.2) in the hot towel group compared with 8.9 g/m²/h (SD 4.1) in the usual care group (low-quality evidence; n = 42), showing there may be little or no difference between groups. A lower score is more favourable. Three studies (266 participants) measured SCH, but all evidence is of very low quality; we did not combine these studies due to differences in treatments (different skin care regimens for eight weeks; wash gloves for 12 weeks; and single application of hot towel to the skin) and differences in outcome reporting. All three studies showed no clear difference in SCH at follow-up (ranging from 15 minutes after the intervention to 12 weeks from baseline), when compared with usual care. A clinical score of dryness was measured by three studies (including 245 participants); pooling was not appropriate. The treatment groups (different skin care regimens for eight weeks; a moisturising soap bar used for five days; and combinations of water soak, oil soak, and lotion for 12 days) may reduce dryness compared to standard care or no intervention (results measured at 5, 8, and 56 ± 4 days after treatment was initiated). However, the quality of evidence for this outcome is low. Outcomes of erythema and clinical score of itch were not assessed in any included studies.
AUTHORS' CONCLUSIONS
Current evidence about the effects of hygiene and emollients in maintaining skin integrity in older people in residential and hospital settings is inadequate. We cannot draw conclusions regarding frequency of skin damage or side effects due to very low-quality evidence. Low-quality evidence suggests that in residential care settings for older people, certain types of hygiene and emollient interventions (two different standardised skin care regimens; moisturising soap bar; combinations of water soak, oil soak, and lotion) may be more effective in terms of clinical score of dryness when compared with no intervention or standard care. Studies were small and generally lacked methodological rigour, and information on effect sizes and precision was absent. More clinical trials are needed to guide practice; future studies should use a standard approach to measuring treatment effects and should include patient-reported outcomes, such as comfort and acceptability.
Topics: Administration, Topical; Aged; Aged, 80 and over; Emollients; Female; Humans; Hygiene; Male; Patient Satisfaction; Pruritus; Randomized Controlled Trials as Topic; Skin Care; Soaps; Wounds and Injuries
PubMed: 32006460
DOI: 10.1002/14651858.CD011377.pub2 -
The Cochrane Database of Systematic... Jul 2016The central venous catheter (CVC) is a device used for many functions, including monitoring haemodynamic indicators and administering intravenous medications, fluids,... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
The central venous catheter (CVC) is a device used for many functions, including monitoring haemodynamic indicators and administering intravenous medications, fluids, blood products and parenteral nutrition. However, as a foreign object, it is susceptible to colonisation by micro-organisms, which may lead to catheter-related blood stream infection (BSI) and in turn, increased mortality, morbidities and health care costs.
OBJECTIVES
To assess the effects of skin antisepsis as part of CVC care for reducing catheter-related BSIs, catheter colonisation, and patient mortality and morbidities.
SEARCH METHODS
In May 2016 we searched: The Cochrane Wounds Specialised Register; The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library); Ovid MEDLINE (including In-Process & Other Non-Indexed Citations and Epub Ahead of Print); Ovid EMBASE and EBSCO CINAHL Plus. We also searched clinical trial registries for ongoing and unpublished studies. There were no restrictions with respect to language, date of publication or study setting.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) that assessed any type of skin antiseptic agent used either alone or in combination, compared with one or more other skin antiseptic agent(s), placebo or no skin antisepsis in patients with a CVC in place.
DATA COLLECTION AND ANALYSIS
Two authors independently assessed the studies for their eligibility, extracted data and assessed risk of bias. We expressed our results in terms of risk ratio (RR), absolute risk reduction (ARR) and number need to treat for an additional beneficial outcome (NNTB) for dichotomous data, and mean difference (MD) for continuous data, with 95% confidence intervals (CIs).
MAIN RESULTS
Thirteen studies were eligible for inclusion, but only 12 studies contributed data, with a total of 3446 CVCs assessed. The total number of participants enrolled was unclear as some studies did not provide such information. The participants were mainly adults admitted to intensive care units, haematology oncology units or general wards. Most studies assessed skin antisepsis prior to insertion and regularly thereafter during the in-dwelling period of the CVC, ranging from every 24 h to every 72 h. The methodological quality of the included studies was mixed due to wide variation in their risk of bias. Most trials did not adequately blind the participants or personnel, and four of the 12 studies had a high risk of bias for incomplete outcome data.Three studies compared different antisepsis regimens with no antisepsis. There was no clear evidence of a difference in all outcomes examined, including catheter-related BSI, septicaemia, catheter colonisation and number of patients who required systemic antibiotics for any of the three comparisons involving three different antisepsis regimens (aqueous povidone-iodine, aqueous chlorhexidine and alcohol compared with no skin antisepsis). However, there were great uncertainties in all estimates due to underpowered analyses and the overall very low quality of evidence presented.There were multiple head-to-head comparisons between different skin antiseptic agents, with different combinations of active substance and base solutions. The most frequent comparison was chlorhexidine solution versus povidone-iodine solution (any base). There was very low quality evidence (downgraded for risk of bias and imprecision) that chlorhexidine may reduce catheter-related BSI compared with povidone-iodine (RR of 0.64, 95% CI 0.41 to 0.99; ARR 2.30%, 95% CI 0.06 to 3.70%). This evidence came from four studies involving 1436 catheters. None of the individual subgroup comparisons of aqueous chlorhexidine versus aqueous povidone-iodine, alcoholic chlorhexidine versus aqueous povidone-iodine and alcoholic chlorhexidine versus alcoholic povidone-iodine showed clear differences for catheter-related BSI or mortality (and were generally underpowered). Mortality was only reported in a single study.There was very low quality evidence that skin antisepsis with chlorhexidine may also reduce catheter colonisation relative to povidone-iodine (RR of 0.68, 95% CI 0.56 to 0.84; ARR 8%, 95% CI 3% to 12%; ; five studies, 1533 catheters, downgraded for risk of bias, indirectness and inconsistency).Evaluations of other skin antiseptic agents were generally in single, small studies, many of which did not report the primary outcome of catheter-related BSI. Trials also poorly reported other outcomes, such as skin infections and adverse events.
AUTHORS' CONCLUSIONS
It is not clear whether cleaning the skin around CVC insertion sites with antiseptic reduces catheter related blood stream infection compared with no skin cleansing. Skin cleansing with chlorhexidine solution may reduce rates of CRBSI and catheter colonisation compared with cleaning with povidone iodine. These results are based on very low quality evidence, which means the true effects may be very different. Moreover these results may be influenced by the nature of the antiseptic solution (i.e. aqueous or alcohol-based). Further RCTs are needed to assess the effectiveness and safety of different skin antisepsis regimens in CVC care; these should measure and report critical clinical outcomes such as sepsis, catheter-related BSI and mortality.
Topics: Adult; Anti-Infective Agents, Local; Antisepsis; Catheter-Related Infections; Central Venous Catheters; Chlorhexidine; Ethanol; Humans; Povidone-Iodine; Randomized Controlled Trials as Topic; Skin
PubMed: 27410189
DOI: 10.1002/14651858.CD010140.pub2