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Journal of the Turkish German... Mar 2020In the new millennium, exclusive breastfeeding plays an important role in national and international policies. The effects of mother-infant skin-to-skin contact (SSC)...
In the new millennium, exclusive breastfeeding plays an important role in national and international policies. The effects of mother-infant skin-to-skin contact (SSC) after birth has been investigated in several studies. Given that there has been no overall estimate of this effects, the present study was conducted with the aim of investigating the effects of mother-infant SSC on the rate of exclusive breastfeeding through a systematic review and meta-analysis of randomized controlled trials. In the present study, the databases of Scopus, PubMed, Cochrane, SID, Magiran, IranDoc, and Google Scholar were searched to identify randomized controlled trials that evaluated the effects of mother-infant SSC immediately after birth on the rate of exclusive breastfeeding. The risk of bias and strength of evidence were examined according to the Cochrane Collaboration’s tool and the Grading of Recommendation, Assessment, Development, and Evaluation approach, respectively. The data analysis was performed using Stata software. To assess the publication bias and heterogeneity, Egger’s and Begg’s tests and I2 were used, respectively. In addition, the fixed effects model was employed to perform the meta-analysis. The heterogeneity of the factor of effects in the studies was determined as 16.2% (p<0.303). There was no publication bias among the studies included; the p values of Egger’s and Begg’s tests were 0.168 and 0.386, respectively. The effects of mother-infant SSC on exclusive breastfeeding was statistically significant [odds raito (OR)=2.19; 95% confidence interval (CI): (1.66-2); p<0.001]. The subgroup analysis results in the normal vaginal delivery group included OR=2.45 [95% CI: (1.76-3.35); p<0.001], for the cesarean delivery group the results were OR=1.44 [95% CI: (0.78-2.65); p=0.24], the results for the duration of exclusive breastfeeding as of the discharge time up to 3 months were OR=2.47 [95% CI: (1.76-3.48); p<0.001], and the results for the 3 to 6 months of exclusive breastfeeding were OR=1.71 [95% CI: (1.05-2.78); p=0.030]. The study results showed that mother-infant SSC increased the rate of exclusive breastfeeding. Therefore, this finding could be used by maternal and infant health care providers to develop evidence-based intervention programs.
PubMed: 30905140
DOI: 10.4274/jtgga.galenos.2019.2018.0138 -
Anesthesia and Analgesia Apr 2022Despite several clinical index tests that are currently applied for airway assessment, unpredicted difficult laryngoscopy may still represent a serious problem in... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Despite several clinical index tests that are currently applied for airway assessment, unpredicted difficult laryngoscopy may still represent a serious problem in anesthesia practice. The aim of this systematic review and meta-analysis was to evaluate whether preoperative airway ultrasound can predict difficult direct laryngoscopy in adult patients undergoing elective surgery under general anesthesia.
METHODS
We searched the Medline, Scopus, and Web of Science databases from their inception to December 2020. The population of interest included adults who required tracheal intubation for elective surgery under general anesthesia without clear anatomical abnormalities suggesting difficult laryngoscopy. A bivariate model has been used to assess the accuracy of each ultrasound index test to predict difficult direct laryngoscopy.
RESULTS
Fifteen studies have been considered for quantitative analysis of summary receiver operating characteristic (SROC). The sensitivity for distance from skin to epiglottis (DSE), distance from skin to hyoid bone (DSHB), and distance from skin to vocal cords (DSVC) was 0.82 (0.74-0.87), 0.71 (0.58-0.82), and 0.75 (0.62-0.84), respectively. The specificity for DSE, DSHB, and DSVC was 0.79 (0.70-0.87), 0.71 (0.57-0.82), and 0.72 (0.45-0.89), respectively. The area under the curve (AUC) for DSE, DSHB, DSVC, and ratio between the depth of the pre-epiglottic space and the distance from the epiglottis to the vocal cords (Pre-E/E-VC) was 0.87 (0.84-0.90), 0.77 (0.73-0.81), 0.78 (0.74-0.81), and 0.71 (0.67-0.75), respectively. Patients with difficult direct laryngoscopy have higher DSE, DSVC, and DSHB values than patients with easy laryngoscopy, with a mean difference of 0.38 cm (95% confidence interval [CI], 0.17-0.58 cm; P = .0004), 0.18 cm (95% CI, 0.01-0.35 cm; P = .04), and 0.23 cm (95% CI, 0.08-0.39 cm; P = .004), respectively.
CONCLUSIONS
Our study demonstrates that airway ultrasound index tests are significantly different between patients with easy versus difficult direct laryngoscopy, and the DSE is the most studied index test in literature to predict difficult direct laryngoscopy. However, it is not currently possible to reach a definitive conclusion. Further studies are needed with better standardization of ultrasound assessment to limit all possible sources of heterogeneity.
Topics: Adult; Anesthesia, General; Humans; Intubation, Intratracheal; Laryngoscopy; Respiratory System; Ultrasonography
PubMed: 34914641
DOI: 10.1213/ANE.0000000000005839 -
BMJ Clinical Evidence Mar 2015More than 85% of women having a vaginal birth suffer some perineal trauma. Spontaneous tears requiring suturing are estimated to occur in at least one third of women in... (Review)
Review
INTRODUCTION
More than 85% of women having a vaginal birth suffer some perineal trauma. Spontaneous tears requiring suturing are estimated to occur in at least one third of women in the UK and US. Perineal trauma can lead to long-term physical and psychological problems.
METHODS AND OUTCOMES
We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of different methods and materials for primary repair of first- and second-degree tears and episiotomies? What are the effects of different methods and materials for primary repair of obstetric anal sphincter injuries (third- and fourth-degree tears)? We searched: Medline, Embase, The Cochrane Library, and other important databases up to November 2013 (Clinical Evidence reviews are updated periodically, please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
RESULTS
We found 33 studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
CONCLUSIONS
In this systematic review, we present information relating to the effectiveness and safety of the following interventions: conventional suturing; different methods and materials for primary repair of obstetric anal sphincter injuries; non-suturing of muscle and skin (or perineal skin alone); and sutures (absorbable synthetic sutures, catgut sutures, continuous sutures, interrupted sutures).
Topics: Anal Canal; Episiotomy; Female; Humans; Perineum; Pregnancy; Sutures; Treatment Outcome
PubMed: 25752310
DOI: No ID Found -
RMD Open Mar 2022Randomised controlled trials (RCTs) have compared biological and targeted systemic disease-modifying antirheumatic drugs (DMARDS) against placebo in psoriatic arthritis... (Meta-Analysis)
Meta-Analysis
Targeted systemic therapies for psoriatic arthritis: a systematic review and comparative synthesis of short-term articular, dermatological, enthesitis and dactylitis outcomes.
INTRODUCTION
Randomised controlled trials (RCTs) have compared biological and targeted systemic disease-modifying antirheumatic drugs (DMARDS) against placebo in psoriatic arthritis (PsA); few have compared them head to head.
OBJECTIVES
To compare the efficacy and safety of all evaluated DMARDs for active PsA, with a special focus on biological DMARDs (bDMARDs) licensed for PsA or psoriasis.
METHODS
A systematic review identified RCTs and Bayesian network meta-analysis (NMA) compared treatments on efficacy (American College of Rheumatology (ACR) response, Psoriasis Area and Severity Index (PASI) response, resolution of enthesitis and dactylitis) and safety (patients discontinuing due to adverse events (DAE)) outcomes. Subgroup analyses explored ACR response among patients with and without prior biological therapy exposure.
RESULTS
The NMA included 46 studies. Results indicate that some tumour necrosis factor inhibitors (anti-TNFs) may perform numerically, but not significantly, better than interleukin (IL) inhibitors on ACR response but perform worse on PASI response. Few significant differences between bDMARDs on ACR response were observed after subgrouping for prior bDMARD exposure. Guselkumab and IL-17A or IL-17RA inhibitors-brodalumab, ixekizumab, secukinumab-were best on PASI response. These IL-inhibitors and adalimumab were similarly efficacious on resolution of enthesitis and dactylitis. Infliximab with and without methotrexate, certolizumab 400 mg every 4 weeks and tildrakizumab showed the highest rates of DAE; abatacept, golimumab and the IL-inhibitors, the lowest.
CONCLUSIONS
Despite similar efficacy for ACR response, IL-17A and IL-17RA inhibitors and guselkumab offered preferential efficacy to anti-TNFs in skin manifestations, and for enthesitis and dactylitis, thereby supporting drug selection based on predominant clinical phenotype.
Topics: Abatacept; Antirheumatic Agents; Arthritis, Psoriatic; Enthesopathy; Humans
PubMed: 35321874
DOI: 10.1136/rmdopen-2021-002074 -
Revista Brasileira de Terapia Intensiva 2021To present guidelines on sensory motor stimulation for newborns and infants in the intensive care unit.
OBJECTIVE
To present guidelines on sensory motor stimulation for newborns and infants in the intensive care unit.
METHODS
We employed a mixed methods design with a systematic review of the literature and recommendations based on scientific evidence and the opinions of physiotherapists with neonatal expertise. The research included studies published between 2010 and 2018 in the MEDLINE® and Cochrane databases that included newborns (preterm and term) and infants (between 28 days and 6 months of age) hospitalized in the intensive care unit and submitted to sensory motor stimulation methods. The studies found were classified according to the GRADE score by five physiotherapists in different regions of Brazil and presented at eight Scientific Congresses held to discuss the clinical practice guidelines.
RESULTS
We included 89 articles to construct the clinical practice guidelines. Auditory, gustatory and skin-to-skin stimulation stand out for enhancing vital signs, and tactile-kinesthetic massage and multisensory stimulation stand out for improving weight or sucking.
CONCLUSION
Although all modalities have good ratings for pain or stress control, it is recommended that sensory motor stimulation procedures be tailored to the infant's specific needs and that interventions and be carried out by expert professionals.
Topics: Brazil; Humans; Infant; Infant, Newborn; Infant, Premature; Intensive Care Units, Neonatal; Massage; Physical Therapy Modalities
PubMed: 33886850
DOI: 10.5935/0103-507X.20210002 -
The Cochrane Database of Systematic... Jun 2017Erysipelas and cellulitis (hereafter referred to as 'cellulitis') are common bacterial skin infections usually affecting the lower extremities. Despite their burden of... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Erysipelas and cellulitis (hereafter referred to as 'cellulitis') are common bacterial skin infections usually affecting the lower extremities. Despite their burden of morbidity, the evidence for different prevention strategies is unclear.
OBJECTIVES
To assess the beneficial and adverse effects of antibiotic prophylaxis or other prophylactic interventions for the prevention of recurrent episodes of cellulitis in adults aged over 16.
SEARCH METHODS
We searched the following databases up to June 2016: the Cochrane Skin Group Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, and LILACS. We also searched five trials registry databases, and checked reference lists of included studies and reviews for further references to relevant randomised controlled trials (RCTs). We searched two sets of dermatology conference proceedings, and BIOSIS Previews.
SELECTION CRITERIA
Randomised controlled trials evaluating any therapy for the prevention of recurrent cellulitis.
DATA COLLECTION AND ANALYSIS
Two authors independently carried out study selection, data extraction, assessment of risks of bias, and analyses. Our primary prespecified outcome was recurrence of cellulitis when on treatment and after treatment. Our secondary outcomes included incidence rate, time to next episode, hospitalisation, quality of life, development of resistance to antibiotics, adverse reactions and mortality.
MAIN RESULTS
We included six trials, with a total of 573 evaluable participants, who were aged on average between 50 and 70. There were few previous episodes of cellulitis in those recruited to the trials, ranging between one and four episodes per study.Five of the six included trials assessed prevention with antibiotics in participants with cellulitis of the legs, and one assessed selenium in participants with cellulitis of the arms. Among the studies assessing antibiotics, one study evaluated oral erythromycin (n = 32) and four studies assessed penicillin (n = 481). Treatment duration varied from six to 18 months, and two studies continued to follow up participants after discontinuation of prophylaxis, with a follow-up period of up to one and a half to two years. Four studies were single-centre, and two were multicentre; they were conducted in five countries: the UK, Sweden, Tunisia, Israel, and Austria.Based on five trials, antibiotic prophylaxis (at the end of the treatment phase ('on prophylaxis')) decreased the risk of cellulitis recurrence by 69%, compared to no treatment or placebo (risk ratio (RR) 0.31, 95% confidence interval (CI) 0.13 to 0.72; n = 513; P = 0.007), number needed to treat for an additional beneficial outcome (NNTB) six, (95% CI 5 to 15), and we rated the certainty of evidence for this outcome as moderate.Under prophylactic treatment and compared to no treatment or placebo, antibiotic prophylaxis reduced the incidence rate of cellulitis by 56% (RR 0.44, 95% CI 0.22 to 0.89; four studies; n = 473; P value = 0.02; moderate-certainty evidence) and significantly decreased the rate until the next episode of cellulitis (hazard ratio (HR) 0.51, 95% CI 0.34 to 0.78; three studies; n = 437; P = 0.002; moderate-certainty evidence).The protective effects of antibiotic did not last after prophylaxis had been stopped ('post-prophylaxis') for risk of cellulitis recurrence (RR 0.88, 95% CI 0.59 to 1.31; two studies; n = 287; P = 0.52), incidence rate of cellulitis (RR 0.94, 95% CI 0.65 to 1.36; two studies; n = 287; P = 0.74), and rate until next episode of cellulitis (HR 0.78, 95% CI 0.39 to 1.56; two studies; n = 287). Evidence was of low certainty.Effects are relevant mainly for people after at least two episodes of leg cellulitis occurring within a period up to three years.We found no significant differences in adverse effects or hospitalisation between antibiotic and no treatment or placebo; for adverse effects: RR 0.87, 95% CI 0.58 to 1.30; four studies; n = 469; P = 0.48; for hospitalisation: RR 0.77, 95% CI 0.37 to 1.57; three studies; n = 429; P = 0.47, with certainty of evidence rated low for these outcomes. The existing data did not allow us to fully explore its impact on length of hospital stay.The common adverse reactions were gastrointestinal symptoms, mainly nausea and diarrhoea; rash (severe cutaneous adverse reactions were not reported); and thrush. Three studies reported adverse effects that led to discontinuation of the assigned therapy. In one study (erythromycin), three participants reported abdominal pain and nausea, so their treatment was changed to penicillin. In another study, two participants treated with penicillin withdrew from treatment due to diarrhoea or nausea. In one study, around 10% of participants stopped treatment due to pain at the injection site (the active treatment group was given intramuscular injections of benzathine penicillin).None of the included studies assessed the development of antimicrobial resistance or quality-of-life measures.With regard to the risks of bias, two included studies were at low risk of bias and we judged three others as being at high risk of bias, mainly due to lack of blinding.
AUTHORS' CONCLUSIONS
In terms of recurrence, incidence, and time to next episode, antibiotic is probably an effective preventive treatment for recurrent cellulitis of the lower limbs in those under prophylactic treatment, compared with placebo or no treatment (moderate-certainty evidence). However, these preventive effects of antibiotics appear to diminish after they are discontinued (low-certainty evidence). Treatment with antibiotic does not trigger any serious adverse events, and those associated are minor, such as nausea and rash (low-certainty evidence). The evidence is limited to people with at least two past episodes of leg cellulitis within a time frame of up to three years, and none of the studies investigated other common interventions such as lymphoedema reduction methods or proper skin care. Larger, high-quality studies are warranted, including long-term follow-up and other prophylactic measures.
Topics: Aged; Anti-Bacterial Agents; Antibiotic Prophylaxis; Arm; Cellulitis; Erysipelas; Erythromycin; Hospitalization; Humans; Leg Dermatoses; Middle Aged; Penicillin G Benzathine; Penicillin V; Randomized Controlled Trials as Topic; Recurrence; Secondary Prevention; Selenium
PubMed: 28631307
DOI: 10.1002/14651858.CD009758.pub2 -
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 -
The Cochrane Database of Systematic... Sep 2015Central venous catheters (CVCs) play a vital role in the management of acute and chronic illness. Dressings and securement devices must ensure CVCs do not dislodge or... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Central venous catheters (CVCs) play a vital role in the management of acute and chronic illness. Dressings and securement devices must ensure CVCs do not dislodge or fall out, provide a barrier protection from microbial colonisation and infection, and be comfortable for the patient. There is a large range of dressing and securement products available for clinicians to use.
OBJECTIVES
To compare the available dressing and securement devices for CVCs, in terms of catheter-related bloodstream infection (BSI), catheter colonisation, entry- and exit-site infection, skin colonisation, skin irritation, failed catheter securement, dressing condition and mortality.
SEARCH METHODS
In June 2015 we searched: The Cochrane Wounds Group Specialised Register; The Cochrane Central Register of Controlled Trials (CENTRAL); The Database of Abstracts of Reviews of Effects (DARE); NHS Economic Evaluation Database (NHSEED); Ovid MEDLINE; Ovid MEDLINE (In-Process & Other Non-Indexed Citations); Ovid EMBASE; EBSCO CINAHL; six clinical trial registries and reference lists of identified trials. There were no restrictions based on language or date of publication or study setting.
SELECTION CRITERIA
We included randomised controlled trials that evaluated the effects of dressing and securement devices for CVCs. All types of CVCs were included, i.e. short- and long-term CVCs, tunnelled and non-tunnelled, port-a-caths, haemodialysis catheters, and peripherally-inserted central catheters (PICCs).
DATA COLLECTION AND ANALYSIS
We used standard Cochrane Collaboration methods including independent review of titles and abstracts for relevance, data extraction, and risk of bias assessment of the included studies by two review authors. Results are expressed using risk ratio (RR) for categorical data with 95% confidence intervals (CIs). For outcomes best presented as a rate-per-time-period, rate ratios and standard errors have been used. We performed multiple treatment meta-analyses to rank the effectiveness of each intervention for each outcome.
MAIN RESULTS
We included 22 studies involving 7436 participants comparing nine different types of securement device or dressing. All included studies were at unclear or high risk of performance bias due to the different appearances of the dressings and securement devices. The extent of blinding of outcome assessment was unclear in most studies. The quality of evidence varied between different comparisons and outcomes. We mainly downgraded the quality of evidence for imprecision, indirectness, risk of bias and inconsistency.It is unclear whether there is a difference in the rate of catheter-related BSI between securement with gauze and tape and standard polyurethane (SPU) (RR 0.64, 95% CI 0.26 to 1.63, low quality evidence), or between chlorhexidine gluconate-impregnated (CGI) dressings and SPU (RR 0.65, 95% CI 0.40 to 1.05, moderate quality evidence). There is high quality evidence that medication-impregnated dressings reduce the incidence of catheter-related BSI relative to all other dressing types (RR 0.60, 95% CI 0.39 to 0.93).There is moderate quality evidence that CGI dressings reduce the frequency of catheter-related BSI per 1000 patient days compared with SPU dressings (RR 0.51, 95% CI 0.33 to 0.78).There is moderate quality evidence that catheter tip colonisation is reduced with CGI dressings compared with SPU dressings (RR 0.58, 95% CI 0.47 to 0.73), but the relative effects of gauze and tape and SPU are unclear (RR 0.95, 95% CI 0.51 to 1.77, very low quality evidence). It is unclear if there is a difference in rates of skin irritation or damage when CGI dressings are compared with SPU dressings (moderate quality evidence) (RR 11.17, 95% CI 0.84 to 149.48).A multiple treatment meta-analysis found sutureless securement devices as likely to be the most effective at reducing the incidence of catheter-related BSI (low quality evidence), with CGI dressings ranked second (low quality evidence).
AUTHORS' CONCLUSIONS
Medication-impregnated dressing products reduce the incidence of catheter-related BSI relative to all other dressing types. There is some evidence that CGI dressings, relative to SPU dressings, reduce catheter-related BSI for the outcomes of frequency of infection per 1000 patient days, risk of catheter tip colonisation and possibly risk of catheter-related BSI. A multiple treatment meta-analysis found that sutureless securement devices are likely to be the most effective at reducing catheter-related BSI though this is low quality evidence. Most studies were conducted in intensive care unit (ICU) settings. More, high quality research is needed regarding the relative effects of dressing and securement products for CVCs. Future research may adjust the estimates of effect for the products included in this review and is needed to assess the effectiveness of new products.
Topics: Bandages; Catheter-Related Infections; Catheterization, Central Venous; Central Venous Catheters; Chlorhexidine; Humans; Randomized Controlled Trials as Topic
PubMed: 26358142
DOI: 10.1002/14651858.CD010367.pub2 -
The Cochrane Database of Systematic... Jan 2023Cutaneous melanoma is amongst the most aggressive of all skin cancers. Neoadjuvant treatment is a form of induction therapy, given to shrink a cancerous tumour prior to... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Cutaneous melanoma is amongst the most aggressive of all skin cancers. Neoadjuvant treatment is a form of induction therapy, given to shrink a cancerous tumour prior to the main treatment (usually surgery). The purpose is to improve survival and surgical outcomes. This review systematically appraises the literature investigating the use of neoadjuvant treatment for stage III and IV cutaneous melanoma.
OBJECTIVES
To assess the effects of neoadjuvant treatment in adults with stage III or stage IV melanoma according to the seventh edition American Joint Committee on Cancer (AJCC) staging system.
SEARCH METHODS
We searched the following databases up to 10 August 2021 inclusive: Cochrane Skin Specialised Register, CENTRAL, MEDLINE, Embase, LILACS and four trials registers, together with reference checking and contact with study authors to identify additional studies. We also handsearched proceedings from specific conferences from 2016 to 2020 inclusive.
SELECTION CRITERIA
Randomised controlled trials (RCTs) of people with stage III and IV melanoma, comparing neoadjuvant treatment strategies (using targeted treatments, immunotherapies, radiotherapy, topical treatments or chemotherapy) with any of these agents or current standard of care (SOC), were eligible for inclusion.
DATA COLLECTION AND ANALYSIS
We used standard Cochrane methods. Primary outcomes were overall survival (OS) and adverse effects (AEs). Secondary outcomes included time to recurrence (TTR), quality of life (QOL), and overall response rate (ORR). We used GRADE to evaluate the certainty of the evidence.
MAIN RESULTS
We included eight RCTs involving 402 participants. Studies enrolled adults, mostly with stage III melanoma, investigated immunotherapies, chemotherapy, or targeted treatments, and compared these with surgical excision with or without adjuvant treatment. Duration of follow-up and therapeutic regimens varied, which, combined with heterogeneity in the population and definitions of the endpoints, precluded meta-analysis of all identified studies. We performed a meta-analysis including three studies. We are very uncertain if neoadjuvant treatment increases OS when compared to no neoadjuvant treatment (hazard ratio (HR) 0.43, 95% confidence interval (CI) 0.15 to 1.21; 2 studies, 171 participants; very low-certainty evidence). Neoadjuvant treatment may increase the rate of AEs, but the evidence is very uncertain (26% versus 16%, risk ratio (RR) 1.58, 95% CI 0.97 to 2.55; 2 studies, 162 participants; very low-certainty evidence). We are very uncertain if neoadjuvant treatment increases TTR (HR 0.51, 95% CI 0.22 to 1.17; 2 studies, 171 participants; very low-certainty evidence). Studies did not report ORR as a comparative outcome or measure QOL data. We are very uncertain whether neoadjuvant targeted treatment with dabrafenib and trametinib increases OS (HR 0.28, 95% CI 0.03 to 2.25; 1 study, 21 participants; very low-certainty evidence) or TTR (HR 0.02, 95% CI 0.00 to 0.22; 1 study, 21 participants; very low-certainty evidence) when compared to surgery. The study did not report comparative rates of AEs and overall response, and did not measure QOL. We are very uncertain if neoadjuvant immunotherapy with talimogene laherparepvec increases OS when compared to no neoadjuvant treatment (HR 0.49, 95% CI 0.15 to 1.64; 1 study, 150 participants, very low-certainty evidence). It may have a higher rate of AEs, but the evidence is very uncertain (16.5% versus 5.8%, RR 2.84, 95% CI 0.96 to 8.37; 1 study, 142 participants; very low-certainty evidence). We are very uncertain if it increases TTR (HR 0.75, 95% CI 0.31 to 1.79; 1 study, 150 participants; very low-certainty evidence). The study did not report comparative ORRs or measure QOL. OS was not reported for neoadjuvant immunotherapy (combined ipilimumab and nivolumab) when compared to the combination of ipilimumab and nivolumab as adjuvant treatment. There may be little or no difference in the rate of AEs between these treatments (9%, RR 1.0, 95% CI 0.75 to 1.34; 1 study, 20 participants; low-certainty evidence). The study did not report comparative ORRs or measure TTR and QOL. Neoadjuvant immunotherapy (combined ipilimumab and nivolumab) likely results in little to no difference in OS when compared to neoadjuvant nivolumab monotherapy (P = 0.18; 1 study, 23 participants; moderate-certainty evidence). It may increase the rate of AEs, but the certainty of this evidence is very low (72.8% versus 8.3%, RR 8.73, 95% CI 1.29 to 59; 1 study, 23 participants); this trial was halted early due to observation of disease progression preventing surgical resection in the monotherapy arm and the high rate of treatment-related AEs in the combination arm. Neoadjuvant combination treatment may lead to higher ORR, but the evidence is very uncertain (72.8% versus 25%, RR 2.91, 95% CI 1.02 to 8.27; 1 study, 23 participants; very low-certainty evidence). It likely results in little to no difference in TTR (P = 0.19; 1 study, 23 participants; low-certainty evidence). The study did not measure QOL. OS was not reported for neoadjuvant immunotherapy (combined ipilimumab and nivolumab) when compared to neoadjuvant sequential immunotherapy (ipilimumab then nivolumab). Only Grade 3 to 4 immune-related AEs were reported; fewer were reported with combination treatment, and the sequential treatment arm closed early due to a high incidence of severe AEs. The neoadjuvant combination likely results in a higher ORR compared to sequential neoadjuvant treatment (60.1% versus 42.3%, RR 1.42, 95% CI 0.87 to 2.32; 1 study, 86 participants; low-certainty evidence). The study did not measure TTR and QOL. No data were reported on OS, AEs, TTR, or QOL for the comparison of neoadjuvant interferon (HDI) plus chemotherapy versus neoadjuvant chemotherapy. Neoadjuvant HDI plus chemotherapy may have little to no effect on ORR, but the evidence is very uncertain (33% versus 22%, RR 1.75, 95% CI 0.62 to 4.95; 1 study, 36 participants; very low-certainty evidence).
AUTHORS' CONCLUSIONS
We are uncertain if neoadjuvant treatment increases OS or TTR compared with no neoadjuvant treatment, and it may be associated with a slightly higher rate of AEs. There is insufficient evidence to support the use of neoadjuvant treatment in clinical practice. Priorities for research include the development of a core outcome set for neoadjuvant trials that are adequately powered, with validation of pathological and radiological responses as intermediate endpoints, to investigate the relative benefits of neoadjuvant treatment compared with adjuvant treatment with immunotherapies or targeted therapies.
Topics: Adult; Humans; Antineoplastic Agents; Ipilimumab; Melanoma; Nivolumab; Skin Neoplasms; Randomized Controlled Trials as Topic; Neoplasm Staging; Melanoma, Cutaneous Malignant
PubMed: 36648215
DOI: 10.1002/14651858.CD012974.pub2 -
Journal of Ambient Intelligence and... 2023Artificial intelligence can assist providers in a variety of patient care and intelligent health systems. Artificial intelligence techniques ranging from machine...
Artificial intelligence can assist providers in a variety of patient care and intelligent health systems. Artificial intelligence techniques ranging from machine learning to deep learning are prevalent in healthcare for disease diagnosis, drug discovery, and patient risk identification. Numerous medical data sources are required to perfectly diagnose diseases using artificial intelligence techniques, such as ultrasound, magnetic resonance imaging, mammography, genomics, computed tomography scan, etc. Furthermore, artificial intelligence primarily enhanced the infirmary experience and sped up preparing patients to continue their rehabilitation at home. This article covers the comprehensive survey based on artificial intelligence techniques to diagnose numerous diseases such as Alzheimer, cancer, diabetes, chronic heart disease, tuberculosis, stroke and cerebrovascular, hypertension, skin, and liver disease. We conducted an extensive survey including the used medical imaging dataset and their feature extraction and classification process for predictions. Preferred reporting items for systematic reviews and Meta-Analysis guidelines are used to select the articles published up to October 2020 on the Web of Science, Scopus, Google Scholar, PubMed, Excerpta Medical Database, and Psychology Information for early prediction of distinct kinds of diseases using artificial intelligence-based techniques. Based on the study of different articles on disease diagnosis, the results are also compared using various quality parameters such as prediction rate, accuracy, sensitivity, specificity, the area under curve precision, recall, and F1-score.
PubMed: 35039756
DOI: 10.1007/s12652-021-03612-z