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The Cochrane Database of Systematic... May 2018Patients in the intensive care unit (ICU) experience sleep deprivation caused by environmental disruption, such as high noise levels and 24-hour lighting, as well as... (Review)
Review
BACKGROUND
Patients in the intensive care unit (ICU) experience sleep deprivation caused by environmental disruption, such as high noise levels and 24-hour lighting, as well as increased patient care activities and invasive monitoring as part of their care. Sleep deprivation affects physical and psychological health, and patients perceive the quality of their sleep to be poor whilst in the ICU. Artificial lighting during night-time hours in the ICU may contribute to reduced production of melatonin in critically ill patients. Melatonin is known to have a direct effect on the circadian rhythm, and it appears to reset a natural rhythm, thus promoting sleep.
OBJECTIVES
To assess whether the quantity and quality of sleep may be improved by administration of melatonin to adults in the intensive care unit. To assess whether melatonin given for sleep promotion improves both physical and psychological patient outcomes.
SEARCH METHODS
We searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2017, Issue 8), MEDLINE (1946 to September 2017), Embase (1974 to September 2017), the Cumulative Index to Nursing and Allied Health Literature (CINAHL) (1937 to September 2017), and PsycINFO (1806 to September 2017). We searched clinical trials registers for ongoing studies, and conducted backward and forward citation searching of relevant articles.
SELECTION CRITERIA
We included randomized and quasi-randomized controlled trials with adult participants (over the age of 16) admitted to the ICU with any diagnoses given melatonin versus a comparator to promote overnight sleep. We included participants who were mechanically ventilated and those who were not mechanically ventilated. We planned to include studies that compared the use of melatonin, given at an appropriate clinical dose with the intention of promoting night-time sleep, against no agent; or against another agent administered specifically to promote sleep.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed studies for inclusion, extracted data, assessed risk of bias, and synthesized findings. We assessed the quality of evidence with GRADE.
MAIN RESULTS
We included four studies with 151 randomized participants. Two studies included participants who were mechanically ventilated, one study included a mix of ventilated and non-ventilated participants and in one study participants were being weaned from mechanical ventilation. Three studies reported admission diagnoses, which varied: these included sepsis, pneumonia and cardiac or cardiorespiratory arrest. All studies compared melatonin against no agent; three were placebo-controlled trials; and one compared melatonin with usual care. All studies administered melatonin in the evening.All studies reported adequate methods for randomization and placebo-controlled trials were blinded at the participant and personnel level. We noted high risk of attrition bias in one study and were unclear about potential bias introduced in two studies with differences between participants at baseline.It was not appropriate to combine data owing to differences in measurement tools, or methods used to report data.The effects of melatonin on subjectively rated quantity and quality of sleep are uncertain (very low certainty evidence). Three studies (139 participants) reported quantity and quality of sleep as measured through reports of participants or family members or by personnel assessments. Study authors in one study reported no difference in sleep efficiency index scores between groups for participant assessment (using Richards-Campbell Sleep Questionnaire) and nurse assessment. Two studies reported no difference in duration of sleep observed by nurses.The effects of melatonin on objectively measured quantity and quality of sleep are uncertain (very low certainty evidence). Two studies (37 participants) reported quantity and quality of sleep as measured by polysomnography (PSG), actigraphy, bispectral index (BIS) or electroencephalogram (EEG). Study authors in one study reported no difference in sleep efficiency index scores between groups using BIS and actigraphy. These authors also reported longer sleep in participants given melatonin which was not statistically significant, and improved sleep (described as "better sleep") in participants given melatonin from analysis of area under the curve (AUC) of BIS data. One study used PSG but authors were unable to report data because of a large loss of participant data.One study (82 participants) reported no evidence of a difference in anxiety scores (very low certainty evidence). Two studies (94 participants) reported data for mortality: one study reported that overall one-third of participants died; and one study reported no evidence of difference between groups in hospital mortality (very low certainty). One study (82 participants) reported no evidence of a difference in length of ICU stay (very low certainty evidence). Effects of melatonin on adverse events were reported in two studies (107 participants), and are uncertain (very low certainty evidence): one study reported headache in one participant given melatonin, and one study reported excessive sleepiness in one participant given melatonin and two events in the control group (skin reaction in one participant, and excessive sleepiness in another participant).The certainty of the evidence for each outcome was limited by sparse data with few participants. We noted study limitations in some studies due to high attrition and differences between groups in baseline data; and doses of melatonin varied between studies. Methods used to measure data were not consistent for outcomes, and use of some measurement tools may not be effective for use on the ICU patient. All studies included participants in the ICU but we noted differences in ICU protocols, and one included study used a non-standard sedation protocol with participants which introduced indirectness to the evidence.
AUTHORS' CONCLUSIONS
We found insufficient evidence to determine whether administration of melatonin would improve the quality and quantity of sleep in ICU patients. We identified sparse data, and noted differences in study methodology, in ICU sedation protocols, and in methods used to measure and report sleep. We identified five ongoing studies from database and clinical trial register searches. Inclusion of data from these studies in future review updates would provide more certainty for the review outcomes.
Topics: Adult; Central Nervous System Depressants; Critical Care; Humans; Intensive Care Units; Lighting; Melatonin; Noise, Occupational; Randomized Controlled Trials as Topic; Respiration, Artificial; Sleep; Sleep Initiation and Maintenance Disorders
PubMed: 29746721
DOI: 10.1002/14651858.CD012455.pub2 -
Journal of Plastic, Reconstructive &... Jan 2024Artificial dermal substitutes (ADMs) have been trialled to improve outcomes at the donor site following the harvesting of a radial forearm free flap (RFFF). This...
BACKGROUND
Artificial dermal substitutes (ADMs) have been trialled to improve outcomes at the donor site following the harvesting of a radial forearm free flap (RFFF). This systematic review compares donor site aesthetic and functional outcomes, with the use of an ADM versus conventional practice.
METHODS
The databases Medline, Embase, Cochrane Library, Web of Science (Core Collection), and Scopus were searched for retrospective, prospective, and case-control studies and randomised control trials (RCTs) involving any ADM. Studies with adult patients having undergone RFFF harvesting and donor site repair with an ADM, commenting on appropriate clinical outcomes and without high risk of bias, were included. Direction-of-effect analysis was performed on relevant groupings of studies since heterogeneity in outcome measurement precluded meta-analyses.
RESULTS
Across eight non-comparative studies included, 132 patients had donor site coverage with AlloDerm™, Integra™, Matriderm™, or Rapiderm. Across 11 comparative studies included, 240 patients had donor site coverage with fish-skin matrix, AlloDerm™, amniotic membrane, MegaDerm™, Hyalomatrix, Integra™, or Matriderm™. Five out of 11 comparative studies demonstrated superior aesthetic outcomes with ADMs according to at least one aesthetic metric compared to controls, whilst 6/11 demonstrated superior functional outcomes with ADMs. No study demonstrated poorer aesthetic or functional outcomes with an ADM compared to conventional practice.
CONCLUSIONS
In summary, the lack of studies reporting poorer outcomes with them compared to conventional practices, and a cumulative effect direction in their favour, provide strong indications in support of the use of AlloDerm™, Integra™, or Matriderm™ grafts. Further comparative studies, including RCTs, are needed to reinforce these initial indications.
Topics: Adult; Humans; Esthetics; Free Tissue Flaps; Plastic Surgery Procedures; Retrospective Studies; Skin Transplantation
PubMed: 38101265
DOI: 10.1016/j.bjps.2023.11.046 -
Ontario Health Technology Assessment... 2021Wounds may be caused in a variety of ways. Some wounds are difficult to heal, such as diabetic foot ulcers and venous leg ulcers. We conducted a health technology...
BACKGROUND
Wounds may be caused in a variety of ways. Some wounds are difficult to heal, such as diabetic foot ulcers and venous leg ulcers. We conducted a health technology assessment of skin substitutes for adults with neuropathic diabetic foot ulcers and venous leg ulcers, which included an evaluation of effectiveness, safety, cost-effectiveness, the budget impact of publicly funding skin substitutes, and patient preferences and values.
METHODS
We performed a systematic literature search of the clinical evidence. We assessed the risk of bias of each included study using the Cochrane risk-of-bias tool for randomized studies (version 2), and the quality of the body of evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. We performed a systematic economic literature search and conducted a cost-utility analysis with a 26-week time horizon from a public payer perspective. We also analyzed the budget impact of publicly funding skin substitutes in adults with diabetic foot ulcers and venous leg ulcers in Ontario. We explored the underlying values, needs, and priorities of those who have lived experience with diabetic leg ulcers and venous leg ulcers, as well as their preferences for and perceptions of skin substitutes.
RESULTS
We included 40 studies in the clinical evidence review. Adults with difficult-to-heal neuropathic diabetic foot ulcers who used dermal (GRADE: High) or multi-layered (GRADE: Moderate) skin substitutes as an adjunct to standard care were more likely to experience complete wound healing than those whose who used standard care alone. Adults with difficult-to-heal venous leg ulcers who used dermal (GRADE: Moderate) or multi-layered (GRADE: High) skin substitutes as an adjunct to standard care were more likely to experience complete wound healing than those who used standard care alone. The evidence for the effectiveness of epidermal skin substitutes was inconclusive for venous leg ulcers because of the small size of the individual studies (GRADE: Very low). We found no studies on epidermal skin substitutes for diabetic foot ulcers. We could not evaluate the safety of skin substitutes versus standard care, because the number of adverse events was either very low or zero (because sample sizes were too small).In our economic analysis, the use of skin substitutes as an adjunct to standard care was more costly and more effective than standard care alone for the treatment of difficult-to-heal diabetic foot ulcers and venous leg ulcers. For diabetic foot ulcers, the incremental cost-effectiveness ratio (ICER) of skin substitutes plus standard care compared with standard care alone was $48,242 per quality-adjusted life-year (QALY), and the cost per ulcer-free week was $158. For venous leg ulcers, the ICER was $1,868,850 per QALY, and the cost per ulcer-free week was $3,235. At the commonly used willingness-to-pay of $50,000 per QALY, the cost-effectiveness of skin substitutes plus standard care versus standard care alone was uncertain (47% probability of being cost-effective) for diabetic foot ulcers and highly unlikely (0% probability of being cost-effective) for venous leg ulcers. At the commonly used willingness-to-pay of $100,000 per QALY, the cost-effectiveness of skin substitutes plus standard care versus standard care alone was moderately likely (71% probability of cost-effectiveness) for people with diabetic foot ulcers and highly unlikely (0% probability of being cost-effective) for people with venous leg ulcers. The annual budget impact of publicly funding skin substitutes in Ontario over the next 5 years would range from an additional $0.17 million in year 1 to $1.2 million in year 5 for people with diabetic foot ulcers, and from $1 million in year 1 to $7.7 million in year 5 for people with venous leg ulcers.Direct patient engagement consisted of three participants for this assessment and 51 from previous health technology assessments that addressed interventions for diabetic foot ulcers and venous leg ulcers. Participants spoke of the negative impact on their quality of life with regard to mobility, employment, social activities, and emotional and mental health. No participants had direct experience using skin substitutes, but participants were open to this treatment option. Barriers to access included the limited use of skin substitutes across Ontario, lack of knowledge of skin substitutes among people with diabetic foot ulcers and venous leg ulcers, and cost.
CONCLUSIONS
Dermal and multi-layered skin substitutes, when used as an adjunct to standard care, were more effective than standard care alone in completely healing difficult-to-heal neuropathic diabetic foot ulcers and venous leg ulcers in adults. Using skin substitutes as an adjunct to standard care was more costly and more effective than standard care alone for the treatment of difficult-to-heal neuropathic diabetic foot ulcers and venous leg ulcers. For adults with diabetic foot ulcers, the likelihood of skin substitutes being cost-effective compared with standard care depends on the willingness to pay. The likelihood of skin substitutes being cost-effective compared with standard care is uncertain at $50,000 per QALY and moderately likely at $100,000 per QALY. For adults with venous leg ulcers, skin substitutes were highly unlikely to be cost-effective compared with standard care. We estimated that publicly funding skin substitutes in Ontario would result in additional costs of $3 million and $20 million over the next 5 years for people with diabetic foot ulcers and venous leg ulcers, respectively. The people with diabetic foot ulcers and venous leg ulcers we spoke with were open to using skin substitutes as a treatment option.
Topics: Adult; Cost-Benefit Analysis; Diabetes Mellitus; Diabetic Foot; Humans; Leg Ulcer; Quality of Life; Skin, Artificial; Technology Assessment, Biomedical
PubMed: 34211616
DOI: No ID Found -
Cancers Apr 2024Cutaneous melanoma remains an increasing global public health burden, particularly in fair-skinned populations. Advancing technologies, particularly artificial... (Review)
Review
BACKGROUND
Cutaneous melanoma remains an increasing global public health burden, particularly in fair-skinned populations. Advancing technologies, particularly artificial intelligence (AI), may provide an additional tool for clinicians to help detect malignancies with a more accurate success rate. This systematic review aimed to report the performance metrics of commercially available convolutional neural networks (CNNs) tasked with detecting MM.
METHODS
A systematic literature search was performed using CINAHL, Medline, Scopus, ScienceDirect and Web of Science databases.
RESULTS
A total of 16 articles reporting MM were included in this review. The combined number of melanomas detected was 1160, and non-melanoma lesions were 33,010. The performance of market-approved technology and clinician performance for classifying melanoma was highly heterogeneous, with sensitivity ranging from 16.4 to 100.0%, specificity between 40.0 and 98.3% and accuracy between 44.0 and 92.0%. Less heterogeneity was observed when clinicians worked in unison with AI, with sensitivity ranging between 83.3 and 100.0%, specificity between 83.7 and 87.3%, and accuracy between 86.4 and 86.9%.
CONCLUSION
Instead of focusing on the performance of AI versus clinicians for classifying melanoma, more consistent performance has been obtained when clinicians' work is supported by AI, facilitating management decisions and improving health outcomes.
PubMed: 38611119
DOI: 10.3390/cancers16071443 -
The Cochrane Database of Systematic... Dec 2018Melanoma accounts for a small proportion of all skin cancer cases but is responsible for most skin cancer-related deaths. Early detection and treatment can improve...
BACKGROUND
Melanoma accounts for a small proportion of all skin cancer cases but is responsible for most skin cancer-related deaths. Early detection and treatment can improve survival. Smartphone applications are readily accessible and potentially offer an instant risk assessment of the likelihood of malignancy so that the right people seek further medical attention from a clinician for more detailed assessment of the lesion. There is, however, a risk that melanomas will be missed and treatment delayed if the application reassures the user that their lesion is low risk.
OBJECTIVES
To assess the diagnostic accuracy of smartphone applications to rule out cutaneous invasive melanoma and atypical intraepidermal melanocytic variants in adults with concerns about suspicious skin lesions.
SEARCH METHODS
We undertook a comprehensive search of the following databases from inception to August 2016: Cochrane Central Register of Controlled Trials; MEDLINE; Embase; CINAHL; CPCI; Zetoc; Science Citation Index; US National Institutes of Health Ongoing Trials Register; NIHR Clinical Research Network Portfolio Database; and the World Health Organization International Clinical Trials Registry Platform. We studied reference lists and published systematic review articles.
SELECTION CRITERIA
Studies of any design evaluating smartphone applications intended for use by individuals in a community setting who have lesions that might be suspicious for melanoma or atypical intraepidermal melanocytic variants versus a reference standard of histological confirmation or clinical follow-up and expert opinion.
DATA COLLECTION AND ANALYSIS
Two review authors independently extracted all data using a standardised data extraction and quality assessment form (based on QUADAS-2). Due to scarcity of data and poor quality of studies, we did not perform a meta-analysis for this review. For illustrative purposes, we plotted estimates of sensitivity and specificity on coupled forest plots for each application under consideration.
MAIN RESULTS
This review reports on two cohorts of lesions published in two studies. Both studies were at high risk of bias from selective participant recruitment and high rates of non-evaluable images. Concerns about applicability of findings were high due to inclusion only of lesions already selected for excision in a dermatology clinic setting, and image acquisition by clinicians rather than by smartphone app users.We report data for five mobile phone applications and 332 suspicious skin lesions with 86 melanomas across the two studies. Across the four artificial intelligence-based applications that classified lesion images (photographs) as melanomas (one application) or as high risk or 'problematic' lesions (three applications) using a pre-programmed algorithm, sensitivities ranged from 7% (95% CI 2% to 16%) to 73% (95% CI 52% to 88%) and specificities from 37% (95% CI 29% to 46%) to 94% (95% CI 87% to 97%). The single application using store-and-forward review of lesion images by a dermatologist had a sensitivity of 98% (95% CI 90% to 100%) and specificity of 30% (95% CI 22% to 40%).The number of test failures (lesion images analysed by the applications but classed as 'unevaluable' and excluded by the study authors) ranged from 3 to 31 (or 2% to 18% of lesions analysed). The store-and-forward application had one of the highest rates of test failure (15%). At least one melanoma was classed as unevaluable in three of the four application evaluations.
AUTHORS' CONCLUSIONS
Smartphone applications using artificial intelligence-based analysis have not yet demonstrated sufficient promise in terms of accuracy, and they are associated with a high likelihood of missing melanomas. Applications based on store-and-forward images could have a potential role in the timely presentation of people with potentially malignant lesions by facilitating active self-management health practices and early engagement of those with suspicious skin lesions; however, they may incur a significant increase in resource and workload. Given the paucity of evidence and low methodological quality of existing studies, it is not possible to draw any implications for practice. Nevertheless, this is a rapidly advancing field, and new and better applications with robust reporting of studies could change these conclusions substantially.
Topics: Adult; Algorithms; Diagnostic Errors; Early Detection of Cancer; Humans; Melanoma; Mobile Applications; Sensitivity and Specificity; Skin Neoplasms; Smartphone; Triage; Melanoma, Cutaneous Malignant
PubMed: 30521685
DOI: 10.1002/14651858.CD013192 -
The Cochrane Database of Systematic... Dec 2018Early accurate detection of all skin cancer types is essential to guide appropriate management and to improve morbidity and survival. Melanoma and cutaneous squamous... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Early accurate detection of all skin cancer types is essential to guide appropriate management and to improve morbidity and survival. Melanoma and cutaneous squamous cell carcinoma (cSCC) are high-risk skin cancers which have the potential to metastasise and ultimately lead to death, whereas basal cell carcinoma (BCC) is usually localised with potential to infiltrate and damage surrounding tissue. Anxiety around missing early curable cases needs to be balanced against inappropriate referral and unnecessary excision of benign lesions. Computer-assisted diagnosis (CAD) systems use artificial intelligence to analyse lesion data and arrive at a diagnosis of skin cancer. When used in unreferred settings ('primary care'), CAD may assist general practitioners (GPs) or other clinicians to more appropriately triage high-risk lesions to secondary care. Used alongside clinical and dermoscopic suspicion of malignancy, CAD may reduce unnecessary excisions without missing melanoma cases.
OBJECTIVES
To determine the accuracy of CAD systems for diagnosing cutaneous invasive melanoma and atypical intraepidermal melanocytic variants, BCC or cSCC in adults, and to compare its accuracy with that of dermoscopy.
SEARCH METHODS
We undertook a comprehensive search of the following databases from inception up to August 2016: Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE; Embase; CINAHL; CPCI; Zetoc; Science Citation Index; US National Institutes of Health Ongoing Trials Register; NIHR Clinical Research Network Portfolio Database; and the World Health Organization International Clinical Trials Registry Platform. We studied reference lists and published systematic review articles.
SELECTION CRITERIA
Studies of any design that evaluated CAD alone, or in comparison with dermoscopy, in adults with lesions suspicious for melanoma or BCC or cSCC, and compared with a reference standard of either histological confirmation or clinical follow-up.
DATA COLLECTION AND ANALYSIS
Two review authors independently extracted all data using a standardised data extraction and quality assessment form (based on QUADAS-2). We contacted authors of included studies where information related to the target condition or diagnostic threshold were missing. We estimated summary sensitivities and specificities separately by type of CAD system, using the bivariate hierarchical model. We compared CAD with dermoscopy using (a) all available CAD data (indirect comparisons), and (b) studies providing paired data for both tests (direct comparisons). We tested the contribution of human decision-making to the accuracy of CAD diagnoses in a sensitivity analysis by removing studies that gave CAD results to clinicians to guide diagnostic decision-making.
MAIN RESULTS
We included 42 studies, 24 evaluating digital dermoscopy-based CAD systems (Derm-CAD) in 23 study cohorts with 9602 lesions (1220 melanomas, at least 83 BCCs, 9 cSCCs), providing 32 datasets for Derm-CAD and seven for dermoscopy. Eighteen studies evaluated spectroscopy-based CAD (Spectro-CAD) in 16 study cohorts with 6336 lesions (934 melanomas, 163 BCC, 49 cSCCs), providing 32 datasets for Spectro-CAD and six for dermoscopy. These consisted of 15 studies using multispectral imaging (MSI), two studies using electrical impedance spectroscopy (EIS) and one study using diffuse-reflectance spectroscopy. Studies were incompletely reported and at unclear to high risk of bias across all domains. Included studies inadequately address the review question, due to an abundance of low-quality studies, poor reporting, and recruitment of highly selected groups of participants.Across all CAD systems, we found considerable variation in the hardware and software technologies used, the types of classification algorithm employed, methods used to train the algorithms, and which lesion morphological features were extracted and analysed across all CAD systems, and even between studies evaluating CAD systems. Meta-analysis found CAD systems had high sensitivity for correct identification of cutaneous invasive melanoma and atypical intraepidermal melanocytic variants in highly selected populations, but with low and very variable specificity, particularly for Spectro-CAD systems. Pooled data from 22 studies estimated the sensitivity of Derm-CAD for the detection of melanoma as 90.1% (95% confidence interval (CI) 84.0% to 94.0%) and specificity as 74.3% (95% CI 63.6% to 82.7%). Pooled data from eight studies estimated the sensitivity of multispectral imaging CAD (MSI-CAD) as 92.9% (95% CI 83.7% to 97.1%) and specificity as 43.6% (95% CI 24.8% to 64.5%). When applied to a hypothetical population of 1000 lesions at the mean observed melanoma prevalence of 20%, Derm-CAD would miss 20 melanomas and would lead to 206 false-positive results for melanoma. MSI-CAD would miss 14 melanomas and would lead to 451 false diagnoses for melanoma. Preliminary findings suggest CAD systems are at least as sensitive as assessment of dermoscopic images for the diagnosis of invasive melanoma and atypical intraepidermal melanocytic variants. We are unable to make summary statements about the use of CAD in unreferred populations, or its accuracy in detecting keratinocyte cancers, or its use in any setting as a diagnostic aid, because of the paucity of studies.
AUTHORS' CONCLUSIONS
In highly selected patient populations all CAD types demonstrate high sensitivity, and could prove useful as a back-up for specialist diagnosis to assist in minimising the risk of missing melanomas. However, the evidence base is currently too poor to understand whether CAD system outputs translate to different clinical decision-making in practice. Insufficient data are available on the use of CAD in community settings, or for the detection of keratinocyte cancers. The evidence base for individual systems is too limited to draw conclusions on which might be preferred for practice. Prospective comparative studies are required that evaluate the use of already evaluated CAD systems as diagnostic aids, by comparison to face-to-face dermoscopy, and in participant populations that are representative of those in which the test would be used in practice.
Topics: Adult; Algorithms; Carcinoma, Basal Cell; Carcinoma, Squamous Cell; Clinical Decision-Making; Dermoscopy; Diagnosis, Computer-Assisted; Electric Impedance; False Positive Reactions; Humans; Melanoma; Sensitivity and Specificity; Skin Neoplasms; Melanoma, Cutaneous Malignant
PubMed: 30521691
DOI: 10.1002/14651858.CD013186 -
Journal of Comparative Effectiveness... Sep 2020Venous leg ulcers (VLUs) present a significant economic burden on the US healthcare system and payers (US$14.9 billion). To evaluate the quality of life (QoL) of...
Venous leg ulcers (VLUs) present a significant economic burden on the US healthcare system and payers (US$14.9 billion). To evaluate the quality of life (QoL) of patients with VLUs; to analyze the limitations of standard of care (SOC) for VLUs; and to explain how using bilayered living cellular construct (BLCC) with SOC for treatment of VLUs can help heal more VLUs faster (than using SOC alone) as well as help improve QoL and help reduce the burden on the US healthcare system and payers. This is a review study. The search was conducted in February 2020 by way of electronic databases to find relevant articles that provided information related to QoL of patients with VLUs, limitations of SOC for VLUs and economic analyses of using BLCC for treatment of VLUs. VLUs impact patients' physical, functional and psychological status and reduce QoL. A total 75% of VLU patients who used SOC alone failed to achieve healing in a timely fashion, which led to increased healthcare costs and healthcare resource utilization. Although the upfront cost is high, the greater effectiveness of BLCC offsets the added cost of the product during the time period of the studies. Therefore, BLCC helps to improve the QoL of VLU patients. As an example, for every 100 VLU patients in a healthcare plan, the use of BLCC can create cost savings of US$1,349,829.51. Payers' coverage of BLCC results in reduction of the overall medical cost for treating VLU patients.
Topics: Cost-Benefit Analysis; Health Care Costs; Humans; Leg Ulcer; Quality of Life; Skin, Artificial; Varicose Ulcer; Wound Healing
PubMed: 32969709
DOI: 10.2217/cer-2020-0076 -
BMC Medical Imaging Feb 2019Computer-aided diagnosis of skin lesions is a growing area of research, but its application to nonmelanoma skin cancer (NMSC) is relatively under-studied. The purpose of...
BACKGROUND
Computer-aided diagnosis of skin lesions is a growing area of research, but its application to nonmelanoma skin cancer (NMSC) is relatively under-studied. The purpose of this review is to synthesize the research that has been conducted on automated detection of NMSC using digital images and to assess the quality of evidence for the diagnostic accuracy of these technologies.
METHODS
Eight databases (PubMed, Google Scholar, Embase, IEEE Xplore, Web of Science, SpringerLink, ScienceDirect, and the ACM Digital Library) were searched to identify diagnostic studies of NMSC using image-based machine learning models. Two reviewers independently screened eligible articles. The level of evidence of each study was evaluated using a five tier rating system, and the applicability and risk of bias of each study was assessed using the Quality Assessment of Diagnostic Accuracy Studies tool.
RESULTS
Thirty-nine studies were reviewed. Twenty-four models were designed to detect basal cell carcinoma, two were designed to detect squamous cell carcinoma, and thirteen were designed to detect both. All studies were conducted in silico. The overall diagnostic accuracy of the classifiers, defined as concordance with histopathologic diagnosis, was high, with reported accuracies ranging from 72 to 100% and areas under the receiver operating characteristic curve ranging from 0.832 to 1. Most studies had substantial methodological limitations, but several were robustly designed and presented a high level of evidence.
CONCLUSION
Most studies of image-based NMSC classifiers report performance greater than or equal to the reported diagnostic accuracy of the average dermatologist, but relatively few studies have presented a high level of evidence. Clinical studies are needed to assess whether these technologies can feasibly be implemented as a real-time aid for clinical diagnosis of NMSC.
Topics: Area Under Curve; Carcinoma, Basal Cell; Carcinoma, Squamous Cell; Diagnosis, Computer-Assisted; Humans; Image Interpretation, Computer-Assisted; Machine Learning; Sensitivity and Specificity; Skin Neoplasms
PubMed: 30819133
DOI: 10.1186/s12880-019-0307-7 -
The Cochrane Database of Systematic... May 2020Chronic plaque psoriasis is an immune-mediated, chronic, inflammatory skin disease, which can impair quality of life and social interaction. Disease severity can be... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Chronic plaque psoriasis is an immune-mediated, chronic, inflammatory skin disease, which can impair quality of life and social interaction. Disease severity can be classified by the psoriasis area and severity index (PASI) score ranging from 0 to 72 points. Indoor artificial salt bath with or without artificial ultraviolet B (UVB) light is used to treat psoriasis, simulating sea bathing and sunlight exposure; however, the evidence base needs clear evaluation.
OBJECTIVES
To assess the effects of indoor (artificial) salt water baths followed by exposure to artificial UVB for treating chronic plaque psoriasis in adults.
SEARCH METHODS
We searched the following databases up to June 2019: the Cochrane Skin Group Specialised Register, CENTRAL, MEDLINE, Embase, and LILACS. We also searched five trial registers, and checked the reference lists of included studies, recent reviews, and relevant papers for further references to relevant trials.
SELECTION CRITERIA
Randomised controlled trials (RCTs) of salt bath indoors followed by exposure to artificial UVB in adults who have been diagnosed with chronic plaque type psoriasis. We included studies reporting between-participant data and within-participant data. We evaluated two different comparisons: 1) salt bath + UVB versus other treatment without UVB; eligible comparators were exposure to psoralen bath, psoralen bath + artificial ultraviolet A UVA) light, topical treatment, systemic treatment, or placebo, and 2) salt bath + UVB versus other treatment + UVB or UVB only; eligible comparators were exposure to bath containing other compositions or concentrations + UVB or UVB only.
DATA COLLECTION AND ANALYSIS
We used standard methodological procedures expected by Cochrane. We used GRADE to assess the certainty of the evidence. The primary efficacy outcome was PASI-75, to detect people with a 75% or more reduction in PASI score from baseline. The primary adverse outcome was treatment-related adverse events requiring withdrawal. For the dichotomous variables PASI-75 and treatment-related adverse events requiring withdrawal, we estimated the proportion of events among the assessed participants. The secondary outcomes were health-related quality of life using the Dermatology Life Quality Index, (DLQI) pruritus severity measured using a visual analogue scale, time to relapse, and secondary malignancies.
MAIN RESULTS
We included eight RCTs: six reported between-participant data (2035 participants; 1908 analysed), and two reported within-participant data (70 participants, 68 analysed; 140 limbs; 136 analysed). One study reported data for the comparison salt bath with UVB versus other treatment without UVB; and eight studies reported data for salt bath with UVB versus other treatment with UVB or UVB only. Of these eight studies, only five reported any of our pre-specified outcomes and assessed the comparison of salt bath with UVB versus UVB only. The one included trial that assessed salt bath plus UVB versus other treatment without UVB (psoralen bath + UVA) did not report any of our primary outcomes. The mean age of the participants ranged from 41 to 50 years of age in 75% of the studies. None of the included studies reported on the predefined secondary outcomes of this review. We judged seven of the eight studies as at high risk of bias in at least one domain, most commonly performance bias. Total trial duration ranged between at least two months and up to 13 months. In five studies, the median participant PASI score at baseline ranged from 15 to 18 and was balanced between treatment arms. Three studies did not report PASI score. Most studies were conducted in Germany; all were set in Europe. Half of the studies were multi-centred (set in spa centres or outpatient clinics); half were set in a single centre in either an unspecified settings, a psoriasis daycare centre, or a spa centre. Commercial spa or salt companies sponsored three of eight studies, health insurance companies funded another, the association of dermatologists funded another, and three did not report on funding. When comparing salt bath plus UVB versus UVB only, two between-participant studies found that salt bath plus UVB may improve psoriasis when measured using PASI 75 (achieving a 75% or more reduction in PASI score from baseline) (risk ratio (RR) 1.71, 95% confidence interval (CI) 1.24 to 2.35; 278 participants; low-certainty evidence). Assessment was conducted at the end of treatment, which was equivalent to six to eight weeks after start of treatment. The two trials which contributed data for the primary efficacy outcome were conducted by the same group, and did not blind outcome assessors. The German Spas Association funded one of the trials and the funding source was not stated for the other trial. Two other between-participant studies found salt bath plus UVB may make little to no difference to outcome treatment-related adverse events requiring withdrawal compared with UVB only (RR 0.96, 95% CI 0.35 to 2.64; 404 participants; low-certainty evidence). One of the studies reported adverse events, but did not specify the type of events; the other study reported skin irritation. One within-participant study found similar results, with one participant reporting severe itch immediately after Dead Sea salt soak in the salt bath and UVB group and two instances of inadequate response to phototherapy and conversion to psoralen bath + UVA reported in the UVB only group (low-certainty evidence).
AUTHORS' CONCLUSIONS
Salt bath with artificial ultraviolet B (UVB) light may improve psoriasis in people with chronic plaque psoriasis compared with UVB light treatment alone, and there may be no difference in the occurrence of treatment-related adverse events requiring withdrawal. Both results are based on data from a limited number of studies, which provided low-certainty evidence, so we cannot draw any clear conclusions. The reporting of our pre-specified outcomes was either non-existent or limited, with a maximum of two studies reporting a given outcome. The same group conducted the two trials which contributed data for the primary efficacy outcome, and the German Spas Association funded one of these trials. We recommend further RCTs that assess PASI-75, with detailed reporting of the outcome and time point, as well as treatment-related adverse events. Risk of bias was an issue; future studies should ensure blinding of outcome assessors and full reporting.
Topics: Adult; Baths; Chronic Disease; Combined Modality Therapy; Female; Ficusin; Humans; Male; Middle Aged; Mineral Waters; PUVA Therapy; Photosensitizing Agents; Psoriasis; Randomized Controlled Trials as Topic; Sodium Chloride; Ultraviolet Therapy
PubMed: 32368795
DOI: 10.1002/14651858.CD011941.pub2 -
PloS One 2021To compare the safety and effectiveness between helmet and face mask noninvasive mechanical ventilation (NIMV) in patients with acute respiratory failure (ARF). (Meta-Analysis)
Meta-Analysis
OBJECTIVE
To compare the safety and effectiveness between helmet and face mask noninvasive mechanical ventilation (NIMV) in patients with acute respiratory failure (ARF).
METHODS
English databases included PubMed, EMBASE, Cochrane Central Register of Controlled Trials and Web of Science. Chinese databases involved Wanfang Data, China Knowledge Resource Integrated Database and Chinese Biological Medicine Database. Randomized controlled trials (RCTs) comparing helmet and face mask NIMV for patients with ARF were searched. Meta-analysis was performed using Review manager 5.1.0.
RESULTS
Twelve trials with a total of 569 patients were eligible. Our meta-analysis showed that, comparing with face mask, helmet could significantly decrease the incidences of intolerance [risk ratio (RR) 0.19; 95% confidence interval (CI) 0.09-0.39], facial skin ulcer (RR 0.19; 95% CI 0.08-0.43) and aerophagia (RR 0.15; 95% CI 0.06-0.37), reduce respiratory rate [mean difference (MD) -3.10; 95% CI -4.85 to -1.34], intubation rate (RR 0.39; 95% CI 0.26-0.59) and hospital mortality (RR 0.62; 95% CI 0.39-0.99) in patients with ARF, and improve oxygenation index in patients with hypoxemic ARF (MD 55.23; 95% CI 31.37-79.09). However, subgroupanalysis for hypercapnic ARF revealed that PaCO2 was significantly reduced in face mask group compared with helmet group (MD 5.34; 95% CI 3.41-7.27).
CONCLUSION
NIMV with helmet can improve the patient's tolerance, reduce adverse events, increase oxygenation effect, and decrease intubation rate and hospital mortality comparing to face mask. However, the low number of patients from included studies may preclude strong conclusions. Large RCTs are still needed to provide more robust evidence.
Topics: Acute Disease; Head Protective Devices; Humans; Noninvasive Ventilation; Respiration, Artificial; Respiratory Insufficiency
PubMed: 33857228
DOI: 10.1371/journal.pone.0250063