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Machine learning (ML) methods are proliferating in scientific research. However, the adoption of these methods has been accompanied by failures of validity, reproducibility, and generalizability. These failures can hinder scientific progress, lead to false consensus around invalid claims, and undermine the credibility of ML-based science. ML methods are often applied and fail in similar ways across disciplines. Motivated by this observation, our goal is to provide clear recommendations for conducting and reporting ML-based science. Drawing from an extensive review of past literature, we present the REFORMS checklist (recommendations for machine-learning-based science). It consists of 32 questions and a paired set of guidelines. REFORMS was developed on the basis of a consensus of 19 researchers across computer science, data science, mathematics, social sciences, and biomedical sciences. REFORMS can serve as a resource for researchers when designing and implementing a study, for referees when reviewing papers, and for journals when enforcing standards for transparency and reproducibility.
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Consenso , Aprendizaje Automático , Humanos , Reproducibilidad de los Resultados , CienciaRESUMEN
Background: To effectively counsel patients prior to shoulder arthroplasty, surgeons should understand the overall life trajectory and life expectancy of patients in the context of the patient's shoulder pathology and medical comorbidities. Such an understanding can influence both operative and nonoperative decision-making and implant choices. This study evaluated 5-year mortality following shoulder arthroplasty in patients ≥65 years old and identified associated risk factors. Methods: We utilized Centers for Medicare & Medicaid Services Fee-for-Service inpatient and outpatient claims data to investigate the 5-year mortality rate following shoulder arthroplasty procedures performed from 2014 to 2016. The impact of patient demographics, including fracture diagnosis, year fixed effects, and state fixed effects; patient comorbidities; and hospital-level characteristics on 5-year mortality rates were assessed with use of a Cox proportional hazards regression model. A p value of <0.05 was considered significant. Results: A total of 108,667 shoulder arthroplasty cases (96,104 nonfracture and 12,563 fracture) were examined. The cohort was 62.7% female and 5.8% non-White and had a mean age at surgery of 74.3 years. The mean 5-year mortality rate was 16.6% across all shoulder arthroplasty cases, 14.9% for nonfracture cases, and 29.9% for fracture cases. The trend toward higher mortality in the fracture group compared with the nonfracture group was sustained throughout the 5-year postoperative period, with a fracture diagnosis being associated with a hazard ratio of 1.63 for mortality (p < 0.001). Medical comorbidities were associated with an increased risk of mortality, with liver disease bearing the highest hazard ratio (3.07; p < 0.001), followed by chronic kidney disease (2.59; p < 0.001), chronic obstructive pulmonary disease (1.92; p < 0.001), and congestive heart failure (1.90; p < 0.001). Conclusions: The mean 5-year mortality following shoulder arthroplasty was 16.6%. Patients with a fracture diagnosis had a significantly higher 5-year mortality risk (29.9%) than those with a nonfracture diagnosis (14.9%). Medical comorbidities had the greatest impact on mortality risk, with chronic liver and kidney disease being the most noteworthy. This novel longer-term data can help with patient education and risk stratification prior to undergoing shoulder replacement. Level of Evidence: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.
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BACKGROUND: Attempts to understand biosocial phenomena using scientific methods are often presented as value-neutral and objective; however, when used to reduce the complexity of open systems such as epidemics, these forms of inquiry necessarily entail normative considerations and are therefore fashioned by political worldviews (ideologies). From the standpoint of poststructural theory, the character of these representations is at most limited and partial. In addition, these modes of representation (as stories) do work (as technologies) in the service of, or in resistance to, power. METHODS: We focus on a single Ebola case cluster from the 2013-2016 outbreak in West Africa and examine how different disciplinary forms of knowledge production (including outbreak forecasting, active epidemiological surveillance, post-outbreak serosurveys, political economic analyses, and ethnography) function as Story Technologies. We then explore how these technologies are used to curate 'data,' analysing the erasures, values, and imperatives evoked by each. RESULTS: We call attention to the instrumental-in addition to the descriptive-role Story Technologies play in ordering contingencies and establishing relationships in the wake of health crises. DISCUSSION: By connecting each type of knowledge production with the systems of power it reinforces or disrupts, we illustrate how Story Technologies do ideological work. These findings encourage research from pluriversal perspectives and advocacy for measures that promote more inclusive modes of knowledge production.
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Epidemias , Fiebre Hemorrágica Ebola , Humanos , Fiebre Hemorrágica Ebola/epidemiología , Brotes de Enfermedades/prevención & control , África Occidental/epidemiología , Antropología CulturalRESUMEN
BACKGROUND: Despite the touted potential of artificial intelligence (AI) and machine learning (ML) to revolutionize health care, clinical decision support tools, herein referred to as medical modeling software (MMS), have yet to realize the anticipated benefits. One proposed obstacle is the acknowledged gaps in AI translation. These gaps stem partly from the fragmentation of processes and resources to support MMS transparent documentation. Consequently, the absence of transparent reporting hinders the provision of evidence to support the implementation of MMS in clinical practice, thereby serving as a substantial barrier to the successful translation of software from research settings to clinical practice. OBJECTIVE: This study aimed to scope the current landscape of AI- and ML-based MMS documentation practices and elucidate the function of documentation in facilitating the translation of ethical and explainable MMS into clinical workflows. METHODS: A scoping review was conducted in accordance with PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) guidelines. PubMed was searched using Medical Subject Headings key concepts of AI, ML, ethical considerations, and explainability to identify publications detailing AI- and ML-based MMS documentation, in addition to snowball sampling of selected reference lists. To include the possibility of implicit documentation practices not explicitly labeled as such, we did not use documentation as a key concept but as an inclusion criterion. A 2-stage screening process (title and abstract screening and full-text review) was conducted by 1 author. A data extraction template was used to record publication-related information; barriers to developing ethical and explainable MMS; available standards, regulations, frameworks, or governance strategies related to documentation; and recommendations for documentation for papers that met the inclusion criteria. RESULTS: Of the 115 papers retrieved, 21 (18.3%) papers met the requirements for inclusion. Ethics and explainability were investigated in the context of AI- and ML-based MMS documentation and translation. Data detailing the current state and challenges and recommendations for future studies were synthesized. Notable themes defining the current state and challenges that required thorough review included bias, accountability, governance, and explainability. Recommendations identified in the literature to address present barriers call for a proactive evaluation of MMS, multidisciplinary collaboration, adherence to investigation and validation protocols, transparency and traceability requirements, and guiding standards and frameworks that enhance documentation efforts and support the translation of AI- and ML-based MMS. CONCLUSIONS: Resolving barriers to translation is critical for MMS to deliver on expectations, including those barriers identified in this scoping review related to bias, accountability, governance, and explainability. Our findings suggest that transparent strategic documentation, aligning translational science and regulatory science, will support the translation of MMS by coordinating communication and reporting and reducing translational barriers, thereby furthering the adoption of MMS.
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BACKGROUND: Studies assessing the relationship between surgeon volume and outcomes have shown mixed results, depending on the specific procedure analyzed. This volume relationship has not been well studied in patients undergoing total shoulder arthroplasty (TSA), but it should be, because this procedure is common, expensive, and potentially morbid. QUESTIONS/PURPOSES: We performed this study to assess the association between increasing surgeon volume and decreasing rate of revision at 2 years for (1) anatomic TSA (aTSA) and (2) reverse TSA (rTSA) in the United States. METHODS: In this retrospective study, we used Centers for Medicare and Medicaid Services (CMS) fee-for-service inpatient and outpatient data from 2015 to 2021 to study the association between annual surgeon aTSA and rTSA volume and 2-year revision shoulder procedures after the initial surgery. The CMS database was chosen for this study because it is a national sample and can be used to follow patients over time. We included patients with Diagnosis-related Group code 483 and Current Procedural Terminology code 23472 for TSA (these codes include both aTSA and rTSA). We used International Classification of Diseases, Tenth Revision, procedural codes. Patients who underwent shoulder arthroplasty for fracture (10% [17,524 of 173,242]) were excluded. We studied the variables associated with the subsequent procedure rate through a generalized linear model, controlling for confounders such as patient age, comorbidity risk score, surgeon and hospital volume, surgeon graduation year, hospital size and teaching status, assuming a binomial distribution with the dependent variable being whether an episode had at least one subsequent procedure within 2 years. The regression was fitted with standard errors clustered at the hospital level, combining all TSAs and within the aTSA and rTSA groups, respectively. Hospital and surgeon yearly volumes were calculated by including all TSAs, primary procedure and subsequent, during the study period. Other hospital-level and surgeon-level characteristics were obtained through public files from the CMS. The CMS Hierarchical Condition Category risk score was controlled because it is a measure reflecting the expected future health costs for each patient based on the patient's demographics and chronic illnesses. We then converted regression coefficients to the percentage change in the odds of having a subsequent procedure. RESULTS: After controlling for confounding variables including patient age, comorbidity risk score, surgeon and hospital volume, surgeon graduation year, and hospital size and teaching status, we found that an annual surgeon volume of ≥ 10 aTSAs was associated with a 27% decreased odds of revision within 2 years (95% confidence interval 13% to 39%; p < 0.001), while surgeon volume of ≥ 29 aTSAs was associated with a 33% decreased odds of revision within 2 years (95% CI 18% to 45%; p < 0.001) compared with a volume of fewer than four aTSAs per year. Annual surgeon volume of ≥ 29 rTSAs was associated with a 26% decreased odds of revision within 2 years (95% CI 9% to 39%; p < 0.001). CONCLUSION: Surgeons should consider modalities such as virtual planning software, templating, or enhanced surgeon training to aid lower-volume surgeons who perform aTSA and rTSA. More research is needed to assess the value of these modalities and their relationship with the rates of subsequent revision. LEVEL OF EVIDENCE: Level III, therapeutic study.
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Artroplastía de Reemplazo de Hombro , Articulación del Hombro , Cirujanos , Humanos , Anciano , Estados Unidos , Artroplastía de Reemplazo de Hombro/efectos adversos , Artroplastía de Reemplazo de Hombro/métodos , Estudios Retrospectivos , Medicare , Factores de Riesgo , Articulación del Hombro/cirugía , Resultado del TratamientoRESUMEN
Introduction: The purpose of this study was to assess racial disparities in total shoulder arthroplasty (TSA) in the United States and to determine whether these disparities were affected by the COVID-19 pandemic. Methods: Centers for Medicare and Medicaid Services (CMS) 100% sample was used to examine primary TSA volume from April to December from 2019 to 2020. Utilization was assessed for White, Black, Hispanic, and Asian populations to determine if COVID-19 affected these groups differently. A regression model adjusted for age, sex, CMS-hierarchical condition categories (HCC) score, dual enrollment (proxy for socioeconomic status), time-fixed effects, and core-based statistical area fixed effects was used to study difference across groups. Results: In 2019, the TSA volume per 1000 beneficiaries was 1.51 for White and 0.57 for non-White, with a 2.6-fold difference. In 2020, the rate of TSA in White patients (1.30/1000) was 2.9 times higher than non-White (0.45/1000) during the COVID-19 pandemic (P < .01). There was an overall 14% decrease in TSA volume per 1000 Medicare beneficiaries in 2020; non-White patients had a larger percentage decrease in TSA volume than White (21% vs. 14%, estimated difference; 8.7%, P = .02). Black patients experienced the most pronounced disparity with estimated difference of 10.1%, P = .05, compared with White patients. Similar disparities were observed when categorizing procedures into anatomic and reverse TSA, but not proximal humerus fracture. Conclusions: During the COVID-19 pandemic, overall TSA utilization decreased by 14% with White patients experiencing a decrease of 14%, and non-White patients experiencing a decrease of 21%. This trend was observed for elective TSA, while disparities were less apparent for proximal humerus fracture.
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BACKGROUND: COVID-19 triggered disruption in the conventional care pathways for many orthopedic procedures. The current study aims to quantify the impact of the COVID-19 pandemic on shoulder arthroplasty hospital surgical volume, trends in surgical case distribution, length of hospitalization, posthospital disposition, and 30-day readmission rates. METHODS: This study queried all Medicare (100% sample) fee-for-service beneficiaries who underwent a shoulder arthroplasty procedure (Diagnosis-Related Group code 483, Current Procedural Terminology code 23472) from January 1, 2019, to December 18, 2020. Fracture cases were separated from nonfracture cases, which were further subdivided into anatomic or reverse arthroplasty. Volume per 1000 Medicare beneficiaries was calculated from April to December 2020 and compared to the same months in 2019. Length of stay (LOS), discharged-home rate, and 30-day readmission for the same period were obtained. The yearly difference adjusted for age, sex, race (white vs. nonwhite), Centers for Medicare & Medicaid Services Hierarchical Condition Category risk score, month fixed effects, and Core-Based Statistical Area fixed effects, with standard errors clustered at the provider level, was calculated using a multivariate analysis (P < .05). RESULTS: A total of 49,412 and 41,554 total shoulder arthroplasty (TSA) cases were observed April through December for 2019 and 2020, respectively. There was an overall decrease in shoulder arthroplasty volume per 1000 Medicare beneficiaries by 14% (19% reduction in anatomic TSA, 13% reduction in reverse shoulder arthroplasty, and 3% reduction in fracture cases). LOS for all shoulder arthroplasty cases decreased by 16% (-0.27 days, P < .001) when adjusted for confounders. There was a 5% increase in the discharged-home rate (88.0% to 92.7%, P < .001), which was most prominent in fracture cases, with a 20% increase in discharged-home cases (65.0% to 73.4%, P < .001). There was no significant change in 30-day hospital readmission rates overall (P = .20) or when broken down by individual procedures. CONCLUSIONS: There was an overall decrease in shoulder arthroplasty volume per 1000 Medicare beneficiaries by 14% during the COVID-19 pandemic. A decrease in LOS and increase in the discharged-home rates was also observed with no significant change in 30-day hospital readmission, indicating that a shift toward an outpatient surgical model can be performed safely and efficiently and has the potential to provide value.
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Artroplastía de Reemplazo de Hombro , COVID-19 , Anciano , Humanos , COVID-19/epidemiología , Tiempo de Internación , Medicare , Pandemias , Readmisión del Paciente , Cuidados Posoperatorios , Estudios Retrospectivos , Estados Unidos/epidemiologíaRESUMEN
A 54-year-old lady was brought to our emergency department after falling from a stepladder onto the base of her artificial Christmas tree. The metallic rod impaled her through the right buttock. X-rays and a computerized tomography were performed prior to transport to a trauma center causing delays to her surgery.
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OBJECTIVE: Artificial intelligence (AI) models may propagate harmful biases in performance and hence negatively affect the underserved. We aimed to assess the degree to which data quality of electronic health records (EHRs) affected by inequities related to low socioeconomic status (SES), results in differential performance of AI models across SES. MATERIALS AND METHODS: This study utilized existing machine learning models for predicting asthma exacerbation in children with asthma. We compared balanced error rate (BER) against different SES levels measured by HOUsing-based SocioEconomic Status measure (HOUSES) index. As a possible mechanism for differential performance, we also compared incompleteness of EHR information relevant to asthma care by SES. RESULTS: Asthmatic children with lower SES had larger BER than those with higher SES (eg, ratio = 1.35 for HOUSES Q1 vs Q2-Q4) and had a higher proportion of missing information relevant to asthma care (eg, 41% vs 24% for missing asthma severity and 12% vs 9.8% for undiagnosed asthma despite meeting asthma criteria). DISCUSSION: Our study suggests that lower SES is associated with worse predictive model performance. It also highlights the potential role of incomplete EHR data in this differential performance and suggests a way to mitigate this bias. CONCLUSION: The HOUSES index allows AI researchers to assess bias in predictive model performance by SES. Although our case study was based on a small sample size and a single-site study, the study results highlight a potential strategy for identifying bias by using an innovative SES measure.
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Inteligencia Artificial , Asma , Asma/diagnóstico , Sesgo , Niño , Atención a la Salud , Humanos , Aprendizaje Automático , Clase SocialRESUMEN
To those involved in discussions about rigor, reproducibility, and replication in science, conversation about the "reproducibility crisis" appear ill-structured. Seemingly very different issues concerning the purity of reagents, accessibility of computational code, or misaligned incentives in academic research writ large are all collected up under this label. Prior work has attempted to address this problem by creating analytical definitions of reproducibility. We take a novel empirical, mixed methods approach to understanding variation in reproducibility discussions, using a combination of grounded theory and correspondence analysis to examine how a variety of authors narrate the story of the reproducibility crisis. Contrary to expectations, this analysis demonstrates that there is a clear thematic core to reproducibility discussions, centered on the incentive structure of science, the transparency of methods and data, and the need to reform academic publishing. However, we also identify three clusters of discussion that are distinct from the main body of articles: one focused on reagents, another on statistical methods, and a final cluster focused on the heterogeneity of the natural world. Although there are discursive differences between scientific and popular articles, we find no strong differences in how scientists and journalists write about the reproducibility crisis. Our findings demonstrate the value of using qualitative methods to identify the bounds and features of reproducibility discourse, and identify distinct vocabularies and constituencies that reformers should engage with to promote change.
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Investigación/normas , Autoria , Análisis Factorial , Humanos , Publicaciones , Reproducibilidad de los ResultadosRESUMEN
BACKGROUND: In the United States, Black Americans are suffering from a significantly disproportionate incidence of COVID-19. Going beyond mere epidemiological tallying, the potential for racial-justice interventions, including reparations payments, to ameliorate these disparities has not been adequately explored. METHODS: We compared the COVID-19 time-varying Rt curves of relatively disparate polities in terms of social equity (South Korea vs. Louisiana). Next, we considered a range of reproductive ratios to back-calculate the transmission rates ßiâj for 4â¯cells of the simplified next-generation matrix (from which R0 is calculated for structured models) for the outbreak in Louisiana. Lastly, we considered the potential structural effects monetary payments as reparations for Black American descendants of persons enslaved in the U.S. would have had on pre-intervention ßiâj and consequently R0. RESULTS: Once their respective epidemics begin to propagate, Louisiana displays Rt values with an absolute difference of 1.3-2.5 compared to South Korea. It also takes Louisiana more than twice as long to bring Rt below 1. Reasoning through the consequences of increased equity via matrix transmission models, we demonstrate how the benefits of a successful reparations program (reflected in the ratio ßbâb/ßwâw) could reduce R0 by 31-68%. DISCUSSION: While there are compelling moral and historical arguments for racial-injustice interventions such as reparations, our study considers potential health benefits in the form of reduced SARS-CoV-2 transmission risk. A restitutive program targeted towards Black individuals would not only decrease COVID-19 risk for recipients of the wealth redistribution; the mitigating effects would also be distributed across racial groups, benefiting the population at large.
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Negro o Afroamericano , COVID-19 , Humanos , Louisiana , República de Corea , SARS-CoV-2 , Estados Unidos/epidemiologíaRESUMEN
Background In the United States, Black Americans are suffering from significantly disproportionate incidence and mortality rates of COVID-19. The potential for racial-justice interventions, including reparations payments, to ameliorate these disparities has not been adequately explored. Methods We compared the COVID-19 time-varying R t curves of relatively disparate polities in terms of social equity (South Korea vs. Louisiana). Next, we considered a range of reproductive ratios to back-calculate the transmission rates ß iâj for 4 cells of the simplified next-generation matrix (from which R 0 is calculated for structured models) for the outbreak in Louisiana. Lastly, we modeled the effect that monetary payments as reparations for Black American descendants of persons enslaved in the U.S. would have had on pre-intervention ß iâj . Results Once their respective epidemics begin to propagate, Louisiana displays R t values with an absolute difference of 1.3 to 2.5 compared to South Korea. It also takes Louisiana more than twice as long to bring R t below 1. We estimate that increased equity in transmission consistent with the benefits of a successful reparations program (reflected in the ratio ß bâb / ß wâw ) could reduce R 0 by 31 to 68%. Discussion While there are compelling moral and historical arguments for racial injustice interventions such as reparations, our study describes potential health benefits in the form of reduced SARS-CoV-2 transmission risk. As we demonstrate, a restitutive program targeted towards Black individuals would not only decrease COVID-19 risk for recipients of the wealth redistribution; the mitigating effects would be distributed across racial groups, benefitting the population at large.
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BACKGROUND: Hookah tobacco smoking (HTS) is a particularly important issue for public health professionals to address owing to its prevalence and deleterious health effects. Social media sites can be a valuable tool for public health officials to conduct informational health campaigns. Current social media platforms provide researchers with opportunities to better identify and target specific audiences and even individuals. However, we are not aware of systematic research attempting to identify audiences with mixed or ambivalent views toward HTS. OBJECTIVE: The objective of this study was to (1) confirm previous research showing positively skewed HTS sentiment on Twitter using a larger dataset by leveraging machine learning techniques and (2) systematically identify individuals who exhibit mixed opinions about HTS via the Twitter platform and therefore represent key audiences for intervention. METHODS: We prospectively collected tweets related to HTS from January to June 2016. We double-coded sentiment for a subset of approximately 5000 randomly sampled tweets for sentiment toward HTS and used these data to train a machine learning classifier to assess the remaining approximately 556,000 HTS-related Twitter posts. Natural language processing software was used to extract linguistic features (ie, language-based covariates). The data were processed by machine learning tools and algorithms using R. Finally, we used the results to identify individuals who, because they had consistently posted both positive and negative content, might be ambivalent toward HTS and represent an ideal audience for intervention. RESULTS: There were 561,960 HTS-related tweets: 373,911 were classified as positive and 183,139 were classified as negative. A set of 12,861 users met a priori criteria indicating that they posted both positive and negative tweets about HTS. CONCLUSIONS: Sentiment analysis can allow researchers to identify audience segments on social media that demonstrate ambiguity toward key public health issues, such as HTS, and therefore represent ideal populations for intervention. Using large social media datasets can help public health officials to preemptively identify specific audience segments that would be most receptive to targeted campaigns.
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Promoción de la Salud/métodos , Aprendizaje Automático/normas , Salud Pública/métodos , Medios de Comunicación Sociales/normas , Humanos , Estudios Prospectivos , Pipas de AguaRESUMEN
Perineal hernias following pelvic surgery are rare. Traumatic small bowel perforation in a patient with a perineal hernia is yet to be described. This case report describes a 69-year-old female who following an abdominoperineal resection for cancer developed a perineal hernia and unfortunately sustained perineal trauma. She presented with peritonitis and findings on laparotomy were that of two points of perforation to terminal ileal loop adherent to perineal defect. Resection and a side-to-side anastomosis performed. Repair of the hernia using mesh was considered but not performed due to risk of mesh infection. Perineal hernias have become more common since the advent of laparoscopic pelvic surgery. Although various methods have been described to repair these hernias, there is lack of robust evidence supporting one repair technique over others.
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BACKGROUND AND OBJECTIVE: The aim of this study was to compare the effectiveness of single port/incision laparoscopic surgery (SPILS) with standard three-port laparoscopic surgery for appendicectomy in adults. Feasibility data was collected to evaluate generalizability to other single-port techniques such as cholecystectomy. METHODS: This was a single-center, randomized controlled trial. Participants were randomized to receive either SPILS or standard three-port laparoscopic appendicectomy. The primary patient-reported outcomes were body image and cosmesis at 6 weeks. The primary clinical outcome was pain at 1-7 days. Secondary outcomes included duration of operation, conversion rates, complication rates, use of analgesia, hospital re-admission rates, re-operation rates, and time to return to normal activities. RESULTS: Seventy-nine patients were randomized. Sixty-seven completed the day 1-7 diary and 53 completed the 6-week follow-up. SPILS patients answered significantly more favorably to the items in the body image scale [mean (SD) 5.6 (1.0) vs. 7.0 (3.3); -1.4 (95 % CI -2.8 to 1.5; p = 0.03)] and the cosmetic scale [18.9 (4.1) vs. 15.3 (5.8); 3.6 (95 % CI 0.7-6.5; p = 0.016)] compared with patients in the Standard group. The duration of operation was shorter for SPILS, and patients required less morphine in recovery; however, there were no statistically significant differences in other outcomes. CONCLUSIONS: Patient-reported body image and cosmesis outcomes were better, and surgical outcomes were similar following SPILS. However, the SPILS procedure is more technically demanding and may not be achievable or necessary in routine clinical care. Further assessment of the findings is needed through larger multicenter studies.
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Apendicectomía/métodos , Apendicitis/cirugía , Laparoscopía/métodos , Adolescente , Adulto , Anciano , Imagen Corporal , Colecistectomía Laparoscópica/métodos , Estética , Estudios de Factibilidad , Femenino , Estudios de Seguimiento , Humanos , Análisis de Intención de Tratar , Masculino , Persona de Mediana Edad , Dolor Postoperatorio , Resultado del Tratamiento , Adulto JovenRESUMEN
BACKGROUND: Laparoscopic surgery has become the preferred approach for many procedures because of reduced post-operative pain, better recovery, shorter hospital stay and improved cosmesis. Single incision laparoscopic surgery is one of the many recent variants where either standard ports or a specially designed single multi-channel port is introduced through a single skin incision. While the cosmetic advantage of this is obvious, the evidence base for claims of reduced morbidity and better post-operative recovery is weak. This study aims to compare the effectiveness of single port/incision laparoscopic appendicectomy with standard three-port laparoscopic appendicectomy in adult patients at six weeks post-surgery. We also wish to assess the feasibility of a multicentre randomised controlled trial comparing single port/incision laparoscopic surgery with standard three-port laparoscopic surgery for other surgical techniques. METHODS AND DESIGN: Patients diagnosed with suspected appendicitis and requiring surgical treatment will be randomised to receive either standard three-port or single incision laparoscopic surgery. Data will be collected from clinical notes, operation notes and patient reported questionnaires. The following outcomes will be considered:1. Effectiveness of the surgical procedure in terms of:â¢patient reported outcomesâ¢clinical outcomesâ¢resource use2. Feasibility of conducting a randomised controlled trial (RCT) in the emergency surgical setting by quantifying:â¢patient eligibilityâ¢randomisation acceptabilityâ¢feasibility of blinding participants to the intervention receivedâ¢completion rates of case report forms and patient reported questionnaires TRIAL REGISTRATION: ISRCTN66443895 (assigned 10 March 2011, first patient randomised 09 January 2011).
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Apendicectomía/métodos , Apendicitis/cirugía , Laparoscopía/métodos , Proyectos de Investigación , Apendicectomía/efectos adversos , Apendicitis/diagnóstico , Protocolos Clínicos , Determinación de la Elegibilidad , Servicio de Urgencia en Hospital , Estudios de Factibilidad , Humanos , Laparoscopía/efectos adversos , Escocia , Encuestas y Cuestionarios , Factores de Tiempo , Resultado del TratamientoRESUMEN
BACKGROUND: Surgical smoke containing potentially carcinogenic and irritant chemicals is an inevitable consequence of intraoperative energized dissection. Different energized dissection methods have not been compared directly in human laparoscopic surgery or against commonly encountered pollutants. This study undertook an analysis of carcinogenic and irritant volatile hydrocarbon concentrations in electrocautery and ultrasonic scalpel plumes compared with cigarette smoke and urban city air control samples. METHODS: Once ethical approval was obtained, gas samples were aspirated from the peritoneal cavity after human laparoscopic intraabdominal surgery solely using either electrocautery or ultrasonic scalpels. All were adsorbed in Tenax tubes and concentrations of carcinogenic or irritant volatile hydrocarbons measured by gas chromatography. The results were compared with cigarette smoke and urban city air control samples. The analyzing laboratory was blinded to sample origin. RESULTS: A total of 10 patients consented to intraoperative gas sampling in which only one method of energized dissection was used. Six carcinogenic or irritant hydrocarbons (benzene, ethylbenzene, styrene, toluene, heptene, and methylpropene) were identified in one or more samples. With the exception of styrene (P = 0.016), a nonsignificant trend toward lower hydrocarbon concentrations was observed with ultrasonic scalpel use. Ultrasonic scalpel plumes had significantly lower hydrocarbon concentrations than cigarette smoke, with the exception of methylpropene (P = 0.332). No significant difference was observed with city air. Electrocautery samples contained significantly lower hydrocarbon concentrations than cigarette smoke, with the exception of toluene (P = 0.117) and methyl propene (P = 0.914). Except for toluene (P = 0.028), city air showed no significant difference. CONCLUSIONS: Both electrocautery and ultrasonic dissection are associated with significantly lower concentrations of the most commonly detected carcinogenic and irritant hydrocarbons than cigarette smoke. A nonsignificant trend toward lower hydrocarbon concentrations was seen with ultrasonic scalpel dissection compared with diathermy. The contamination levels in city air were largely comparable with those seen after ultrasonic scalpel use. Although hydrocarbon concentrations are low, cumulative exposures may increase health risks. Where concerns arise, ultrasonic scalpel dissection may be preferable.
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Electrocoagulación/efectos adversos , Sustancias Peligrosas/análisis , Hidrocarburos/análisis , Laparoscopía/efectos adversos , Humo/análisis , Procedimientos Quirúrgicos Ultrasónicos/efectos adversos , Contaminantes Atmosféricos/análisis , Electrocoagulación/instrumentación , Gases/análisis , Humanos , Método Simple Ciego , Instrumentos Quirúrgicos , Contaminación por Humo de Tabaco/análisis , Procedimientos Quirúrgicos Ultrasónicos/instrumentaciónRESUMEN
A 46-year-old gentleman, being investigated for symptoms of generalised weakness, low-grade fever and weight loss, was found to have a large, infiltrative mass of the liver on CT scan. The radiological impression was that of advanced hepatic malignancy with involvement of lesser curve of the stomach and regional lymph nodes. Multiple biopsy attempts failed to yield an adequate tissue sample for histopathological diagnosis. Surgery was planned for left hemihepatectomy with resection of the hepatogastric ligament and partial gastrectomy. Frozen section of a peroperative tissue sample confirmed the diagnosis of hepatic tuberculosis (TB). The granulomatous area was debrided and anti-TB treatment was started postoperatively. Recovery was unremarkable and the patient is currently asymptomatic.