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JAMA Surgery Apr 2024Unlike medications, procedural interventions are rarely trialed against placebo prior to becoming accepted in clinical practice. When placebo-controlled trials are...
IMPORTANCE
Unlike medications, procedural interventions are rarely trialed against placebo prior to becoming accepted in clinical practice. When placebo-controlled trials are eventually conducted, procedural interventions may be less effective than previously believed.
OBJECTIVE
To investigate the importance of including a placebo arm in trials of surgical and interventional procedures by comparing effect sizes from trials of the same procedure that do and do not include a placebo arm.
DATA SOURCES
Searches of MEDLINE and Embase identified all placebo-controlled trials for procedural interventions in any specialty of medicine and surgery from inception to March 31, 2019. A secondary search identified randomized clinical trials assessing the same intervention, condition, and end point but without a placebo arm for paired comparison.
STUDY SELECTION
Placebo-controlled trials of anatomically site-specific procedures requiring skin incision or endoscopic techniques were eligible for inclusion; these were then matched to trials without placebo control that fell within prespecified limits of heterogeneity.
DATA EXTRACTION AND SYNTHESIS
Random-effects meta-regression, with placebo and blinding as a fixed effect and intervention and end point grouping as random effects, was used to calculate the impact of placebo control for each end point. Data were analyzed from March 2019 to March 2020.
MAIN OUTCOMES AND MEASURES
End points were examined in prespecified subgroups: patient-reported or health care professional-assessed outcomes, quality of life, pain, blood pressure, exercise-related outcomes, recurrent bleeding, and all-cause mortality.
RESULTS
Ninety-seven end points were matched from 72 blinded, placebo-controlled trials (hereafter, blinded) and 55 unblinded trials without placebo control (hereafter, unblinded), including 111 500 individual patient end points. Unblinded trials had larger standardized effect sizes than blinded trials for exercise-related outcomes (standardized mean difference [SMD], 0.59; 95% CI, 0.29 to 0.89; P < .001) and quality-of-life (SMD, 0.32; 95% CI, 0.11 to 0.53; P = .003) and health care professional-assessed end points (SMD, 0.40; 95% CI, 0.18 to 0.61; P < .001). The placebo effect accounted for 88.1%, 55.2%, and 61.3% of the observed unblinded effect size for these end points, respectively. There was no significant difference between unblinded and blinded trials for patient-reported end points (SMD, 0.31; 95% CI, -0.02 to 0.64; P = .07), blood pressure (SMD, 0.26; 95% CI, -0.10 to 0.62; P = .15), all-cause mortality (odds ratio [OR], 0.23; 95% CI, -0.26 to 0.72; P = .36), pain (SMD, 0.03; 95% CI, -0.52 to 0.57; P = .91), or recurrent bleeding events (OR, -0.12; 95% CI, -1.11 to 0.88; P = .88).
CONCLUSIONS AND RELEVANCE
The magnitude of the placebo effect found in this systematic review and meta-regression was dependent on the end point. Placebo control in trials of procedural interventions had the greatest impact on exercise-related, quality-of-life, and health care professional-assessed end points. Randomized clinical trials of procedural interventions may consider placebo control accordingly.
PubMed: 38630462
DOI: 10.1001/jamasurg.2024.0718 -
PLOS Global Public Health 2024Antimicrobial resistance (AMR) is a major global threat and AMR-attributable mortality is particularly high in Central, Eastern, Southern and Western Africa. The burden...
Antimicrobial resistance in bacterial wound, skin, soft tissue and surgical site infections in Central, Eastern, Southern and Western Africa: A systematic review and meta-analysis.
Antimicrobial resistance (AMR) is a major global threat and AMR-attributable mortality is particularly high in Central, Eastern, Southern and Western Africa. The burden of clinically infected wounds, skin and soft tissue infections (SSTI) and surgical site infections (SSI) in these regions is substantial. This systematic review reports the extent of AMR from sampling of these infections in Africa, to guide treatment. It also highlights gaps in microbiological diagnostic capacity. PubMed, MEDLINE and Embase were searched for studies reporting the prevalence of Staphylococcus aureus, Eschericheria coli, Klebsiella pneumoniae, Pseudomonas aeruginosa and Acinetobacter baumannii in clinically infected wounds, SSTI and SSI in Central, Eastern, Southern or Western Africa, and studies reporting AMR from such clinical isolates. Estimates for proportions were pooled in meta-analyses, to estimate the isolation prevalence of each bacterial species and the proportion of resistance observed to each antibiotic class. The search (15th August 2022) identified 601 articles: 59 studies met our inclusion criteria. S. aureus was isolated in 29% (95% confidence interval [CI] 25% to 34%) of samples, E. coli in 14% (CI 11% to 18%), K. pneumoniae in 11% (CI 8% to 13%), P. aeruginosa in 14% (CI 11% to 18%) and A. baumannii in 8% (CI 5% to 12%). AMR was high across all five species. S. aureus was resistant to methicillin (MRSA) in >40% of isolates. E. coli and K. pneumoniae were both resistant to amoxicillin-clavulanic acid in ≥80% of isolates and resistant to aminoglycosides in 51% and 38% of isolates respectively. P. aeruginosa and A. baumannii were both resistant to anti-pseudomonal carbapenems (imipenem or meropenem) in ≥20% of isolates. This systematic review found that a large proportion of the organisms isolated from infected wounds, SSTI and SSI in Africa displayed resistance patterns of World Health Organisation (WHO) priority pathogens for critical or urgent antimicrobial development.
PubMed: 38626068
DOI: 10.1371/journal.pgph.0003077 -
Critical Reviews in Therapeutic Drug... 2024Cosmeceuticals have gained great importance and are among the top-selling products used for skin care. Because of changing lifestyles, climate, and increasing pollution,...
Cosmeceuticals have gained great importance and are among the top-selling products used for skin care. Because of changing lifestyles, climate, and increasing pollution, cosmeceuticals are utilized by every individual, thereby making cosmeceuticals a fruitful field for research and the economy. Cosmeceuticals provide incredibly pleasing aesthetic results by fusing the qualities of both cosmetics and medicinal substances. Cosmeceuticals are primarily utilized to improve the appearance of skin by making it smoother, moisturized, and wrinkle-free, in addition to treating dermatological conditions, including photoaging, burns, dandruff, acne, eczema, and erythema. Nanocosmeceuticals are cosmetic products that combine therapeutic effects utilizing nanotechnology, allowing for more precise and effective target-specific delivery of active ingredients, and improving bioavailability.
Topics: Humans; Cosmeceuticals; Skin Care; Skin; Acne Vulgaris; Nanotechnology
PubMed: 38608133
DOI: 10.1615/CritRevTherDrugCarrierSyst.v41.i5.20 -
Translational Stroke Research Apr 2024The objective of this study is to conduct a systematic review and meta-analysis aimed at evaluating the efficacy and safety of flow-diverting devices (FDs) treatment for...
The objective of this study is to conduct a systematic review and meta-analysis aimed at evaluating the efficacy and safety of flow-diverting devices (FDs) treatment for intracranial vertebral artery (VA) aneurysms. We searched PubMed, Web of Science, OVID, and Embase for English-language studies up to February 2024 and included clinical studies on FD treatment of intracranial VA aneurysms. Sensitivity analysis evaluated outcome stability. Of 2273 articles, 29 studies involving 541 aneurysms treated with FDs were included. Based on the Methodological Index for Non-Randomized Studies (MINORS), six were high-quality and 23 moderate quality. FD treatment showed a 95% rate of favorable clinical outcomes (95% CI, 89-99%), 81% (95% CI, 74-88%) complete aneurysmal occlusion, 4% (95% CI, 2-7%) ischemic complication incidence, 1% (95% CI, 0-3%) hemorrhagic complication incidence, 95% (95% CI, 87-100%) posterior inferior cerebellar artery (PICA) preservation, and 6% (95% CI, 3-10%) in-stent stenosis or occlusion across clinical and angiographic follow-up periods of 13.62 months (95% CI, 10.72-16.52) and 11.85 months (95% CI, 9.36-14.33), respectively. Subgroup analyses, based on a 12-month angiographic follow-up threshold, indicated no statistically significant differences in rates of complete aneurysm occlusion, PICA preservation, or in-stent stenosis or occlusion incidence (p > 0.05) between subgroups. Moreover, significant differences were observed in clinical and angiographic outcomes between ruptured and unruptured aneurysms, particularly in hemorrhagic complications (p < 0.05), without significant disparity in ischemic complications (p > 0.05). The results' stability was confirmed via sensitivity analysis. FDs treatment for VA aneurysms is efficacious and safe, offering high rates of positive clinical and angiographic outcomes with minimal complications, underscoring FDs' viability as a treatment option for VA aneurysms. The study was registered with PROSPERO (registration number: CRD42024499894).
PubMed: 38602659
DOI: 10.1007/s12975-024-01251-y -
BMJ Supportive & Palliative Care Apr 2024Precise prognostic information, if available, is very helpful for guiding treatment decisions and resource allocation in patients with non-cancer non-communicable...
BACKGROUND
Precise prognostic information, if available, is very helpful for guiding treatment decisions and resource allocation in patients with non-cancer non-communicable chronic diseases (NCDs). This study aimed to systematically review the existing evidence, examining prognostic models and factors for identifying end-of-life non-cancer NCD patients.
METHODS
Electronic databases, including Medline, Embase, CINAHL, Cochrane Library, PsychINFO and other sources, were searched from the inception of these databases up until June 2023. Studies published in English with findings mentioning prognostic models or factors related to identifying end-of-life in non-cancer NCD patients were included. The quality of studies was assessed using the Quality in Prognosis Studies tool.
RESULTS
The analysis included data from 41 studies, with 16 focusing on chronic obstructive pulmonary diseases (COPD), 10 on dementia, 6 on heart failure and 9 on mixed NCDs. Traditional statistical modelling was predominantly used for the identified prognostic models. Common predictors in COPD models included dyspnoea, forced expiratory volume in 1 s, functional status, exacerbation history and body mass index. Models for dementia and heart failure frequently included comorbidity, age, gender, blood tests and nutritional status. Similarly, mixed NCD models commonly included functional status, age, dyspnoea, the presence of skin pressure ulcers, oral intake and level of consciousness. The identified prognostic models exhibited varying predictive accuracy, with the majority demonstrating weak to moderate discriminatory performance (area under the curve: 0.5-0.8). Additionally, most of these models lacked independent external validation, and only a few underwent internal validation.
CONCLUSION
Our review summarised the most relevant predictors for identifying end-of-life in non-cancer NCDs. However, the predictive accuracy of identified models was generally inconsistent and low, and lacked external validation. Although efforts to improve these prognostic models should continue, clinicians should recognise the possibility that disease heterogeneity may limit the utility of these models for individual prognostication; they may be more useful for population level health planning.
PubMed: 38580395
DOI: 10.1136/spcare-2023-004656 -
BMC Infectious Diseases Mar 2024Annually, 175.4 million people are infected with scabies worldwide. Although parasitic infections are important nosocomial infections, they are unrecognized compared to...
BACKGROUND
Annually, 175.4 million people are infected with scabies worldwide. Although parasitic infections are important nosocomial infections, they are unrecognized compared to bacterial, fungal, and viral infections. In particular, nonspecific cutaneous manifestations of scabies lead to delayed diagnosis and frequent nosocomial transmission. Hospital-based studies on the risk factors for scabies have yet to be systematically reviewed.
METHODS
The study followed the PRISMA guidelines and was prospectively registered in PROSPERO (CRD42023363278). Literature searches were conducted in three international (PubMed, Embase, and CINAHL) and four Korean (DBpia, KISS, RISS, and Science ON) databases. We included hospital-based studies with risk estimates calculated with 95% confidence intervals for risk factors for scabies infection. The quality of the studies was assessed using the Joanna Briggs Institute critical appraisal tools. Two authors independently performed the screening and assessed the quality of the studies.
RESULTS
A total of 12 studies were included. Personal characteristics were categorized into demographic, economic, residential, and behavioral factors. The identified risk factors were low economic status and unhygienic behavioral practices. Being a patient in a long-term care facility or institution was an important factor. Frequent patient contact and lack of personal protective equipment were identified as risk factors. For clinical characteristics, factors were categorized as personal health and hospital environment. People who had contact with itchy others were at higher risk of developing scabies. Patients with higher severity and those with a large number of catheters are also at increased risk for scabies infection.
CONCLUSIONS
Factors contributing to scabies in hospitals range from personal to clinical. We emphasize the importance of performing a full skin examination when patients present with scabies symptoms and are transferred from settings such as nursing homes and assisted-living facilities, to reduce the transmission of scabies. In addition, patient education to prevent scabies and infection control systems for healthcare workers, such as wearing personal protective equipment, are needed.
Topics: Humans; Scabies; Cross Infection; Nursing Homes; Hospitals; Risk Factors
PubMed: 38575893
DOI: 10.1186/s12879-024-09167-6 -
European Journal of Dermatology : EJD Feb 2024Gel manicures have become part of a popular personal care service in the last two decades due to increased longevity of the polish and the added strength to the nail...
Gel manicures have become part of a popular personal care service in the last two decades due to increased longevity of the polish and the added strength to the nail plate. Prolonged exposure to nail ultraviolet (UV) lamps is required to cure the gel polish. Despite the increased use of UV nail lamps, there is limited consensus in the literature on the risk of skin malignancy associated with UV nail lamps. The objective of this article was to provide a systematic review of the risk of skin malignancy associated with the use of UV nail lamps and to synthesize evidence-based recommendations on their safe usage. A systematic review of the literature was conducted on the databases, Medline and Embase, in accordance with PRISMA guidelines. The search yielded 2,331 non-duplicate articles. Nine were ultimately included, of which three were case reports, one was a cross-sectional study, and five were experimental studies. The risk of bias per the Joanna Briggs Institute guidelines was high or unclear, likely due to the number of case reports included. Prolonged and repeated exposure to UV nail lamps may pose a low risk of skin cancer. It is important to note that the available evidence is weak, and patients should be informed about the limited data to make their own decisions. Dermatologists and other healthcare providers should be updated with the latest evidence to address patients' concerns about gel manicures and suggest practices which can effectively reduce the risk of cutaneous malignancy associated with gel manicures, such as the use of UV-blocking gloves or properly applied sunscreens.
Topics: Humans; Beauty; Cross-Sectional Studies; Skin Neoplasms; Nails; Sunscreening Agents; Ultraviolet Rays
PubMed: 38557455
DOI: 10.1684/ejd.2024.4616 -
European Journal of Physical and... Mar 2024The intersection of ageing and spinal cord injury (SCI) is of global concern. Two scenarios have been described: 1) "SCI with ageing," an increase in the average age of...
Evidence-based recommendations for the rehabilitation and management of the ageing population with spinal cord injury: a systematic review of clinical practice guidelines.
INTRODUCTION
The intersection of ageing and spinal cord injury (SCI) is of global concern. Two scenarios have been described: 1) "SCI with ageing," an increase in the average age of SCI onset, and 2) "ageing with SCI," an increase in post-injury life expectancy. These scenarios entail complex health care and rehabilitation needs due to the accumulation of comorbidities, ageing-related and SCI-induced physiological changes, and post-SCI secondary health conditions. We systematically reviewed Clinical Practice Guidelines (CPGs) with the objective of identifying the extent to which SCI CPGs include recommendations for the rehabilitation and management of people who are "ageing with SCI" or who have acquired an "SCI with ageing". We termed these as "ageing-related recommendations". We also aimed to describe them and identify gaps.
EVIDENCE ACQUISITION
We searched PubMed (NCBI), CINAHL Complete (EBSCOhost) and Embase (Elsevier) for relevant CPGs between 28 December 2022 and 5 January 2023. Included CPGs were evidence-based and had at least one ageing-related recommendation for SCI rehabilitation and management. We used the two core sets of the International Classification of Functioning, Disability and Health (ICF) to identify gaps.
EVIDENCE SYNTHESIS
Only 16 (30%) of the 52 identified CPGs included ageing-related recommendations. Most were recent US or European publications and lacked specific chapters on ageing. These CPGs included 40 ageing-related recommendations, mostly "strong" but based on "low" to "very low" quality of evidence. The overall quality of the development process was low and did not consider the values and preferences of stakeholders and patients. Common topics included cardiovascular, bone, metabolic, bowel, bladder, and skin health. The recommendations could be linked to 30 ICF categories which represented only 18% of the ICF categories included in the comprehensive versions of two ICF Core Sets. Key gaps were found in mobility, interpersonal interactions, and relationships, neuromusculoskeletal and movement-related, mental, sensory and pain functions.
CONCLUSIONS
There is a notable lack of high-quality ageing-related recommendations for SCI management and rehabilitation. Future research should prioritize the generation of high-quality evidence to develop age-sensitive CPGs. Future SCI CPGs need to address the complex challenges at the interface of ageing and SCI, considering patient and stakeholder preferences.
PubMed: 38551520
DOI: 10.23736/S1973-9087.24.08244-3 -
Nursing Reports (Pavia, Italy) Feb 2024(1) Background: The ongoing COVID-19 pandemic has led to an increasing number of women giving birth while also grappling with SARS-CoV-2. The objective of this review is... (Review)
Review
(1) Background: The ongoing COVID-19 pandemic has led to an increasing number of women giving birth while also grappling with SARS-CoV-2. The objective of this review is to examine the possibility of transmission of the virus from mother to infant through breastfeeding, skin-to-skin contact, and rooming-in and to explore methods for managing COVID-19-positive mother-infant dyads. (2) Methods: A comprehensive search strategy was employed that covered pertinent studies from the Cochrane Library, PubMed Central, and Scopus databases. The Matrix Method and PRISMA guidelines were utilized by the researchers, with the search being updated until 20 December 2021, one year after the initial vaccine delivery. The inclusion criteria for the study involved articles published in English, those employing broad search terms, and those comprising full-text reviews. Additionally, the researchers required that the articles be published from December 2019 onwards. To further analyze the data, a meta-analysis was performed to estimate the rate of infant infection from mothers who engaged in breastfeeding, skin-to-skin contact, and rooming-in practices. (3) Results: Eighteen studies were analyzed in this review, with an infected infant rate of 2.8%. The maternal practices used in these studies ranged from direct separation of the infant to direct skin-to-skin contact, rooming-in, and exclusive breastfeeding. One study investigated the factors associated with positive test results in newborns and found that only the maternal social vulnerability index >90 was a significant predictor. The type of delivery, rooming-in, and the mother's symptom status were not associated with positive neonatal outcomes. (4) Conclusions: According to current data, the incidence of perinatal infection with SARS-CoV-2 is relatively low. It is advised that mothers adhere to several supportive care measures, including engaging in breastfeeding, skin-to-skin contact, and rooming-in. These measures ought to be complemented by diligent hand hygiene, the wearing of masks, and the cleansing of breasts solely when necessary.
PubMed: 38535712
DOI: 10.3390/nursrep14010040 -
Dermatologic Surgery : Official... Jul 2024Mohs micrographic surgery (MMS) is increasingly used to treat cutaneous melanoma. However, it is unclear whether intraoperative immunohistochemistry (IHC) improves... (Meta-Analysis)
Meta-Analysis
Intraoperative Immunohistochemistry During Mohs Micrographic Surgery and Staged Excision Decreases Local Recurrence Rates for Invasive Cutaneous Melanoma: A Systematic Review and Meta-Analysis.
BACKGROUND
Mohs micrographic surgery (MMS) is increasingly used to treat cutaneous melanoma. However, it is unclear whether intraoperative immunohistochemistry (IHC) improves surgical outcomes.
OBJECTIVE
To determine whether intraoperative IHC during MMS and staged excision is associated with a decreased risk of poor surgical outcomes.
MATERIALS AND METHODS
Search of 6 databases identified comparative and noncomparative studies that reported local recurrence after MMS or staged excision with or without IHC for melanoma. Random-effects meta-analysis was used to estimate pooled local recurrence rates, nodal recurrence, distant recurrence, and disease-specific mortality.
RESULTS
Overall, 57 studies representing 12,043 patients with cutaneous melanoma and 12,590 tumors met inclusion criteria. Combined MMS and staged excision with IHC was associated with decreased local recurrence in patients with invasive melanoma (0.3%, 95% CI: 0-0.6) versus hematoxylin and eosin alone (1.8%, 95% CI: 0.8%-2.8%) [ p < .001]. Secondary outcomes including nodal recurrence, distant recurrence, and disease-specific mortality were not significantly different between these 2 groups. Study heterogeneity was moderately-high.
CONCLUSION
Local recurrence of invasive melanoma is significantly lower after MMS and staged excision with IHC as opposed to without IHC. These findings suggest that the use of intraoperative IHC during MMS or staged excision should strongly be considered, particularly for invasive melanoma.Trial Registration PROSPERO Identifier: CRD42023435630.
Topics: Humans; Skin Neoplasms; Melanoma; Mohs Surgery; Neoplasm Recurrence, Local; Immunohistochemistry; Neoplasm Invasiveness; Intraoperative Care
PubMed: 38530980
DOI: 10.1097/DSS.0000000000004164