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Journal of Plastic, Reconstructive &... Jun 2024Patient-reported outcome measures (PROM) are collected pre- and post-operatively following cosmetic surgery. Clinicians assess their own outcomes following surgery, but...
Patient-reported outcome measures (PROM) are collected pre- and post-operatively following cosmetic surgery. Clinicians assess their own outcomes following surgery, but without a validated clinician-reported outcome measure (CROM), there is no way to compare the clinical results among clinicians or compare these to PROM. Assessment of clinical outcomes is important to address the patients' expectations in the consenting process and to provide recommendations to patients preoperatively to improve post-operative appearance. To address the lack of validated CROM for cosmetic surgery, the Manchester Cosmetic Clinical Reported Outcome Questionnaire (MCCRO-Q) was developed. This study assessed the inter-rater reliability of assessors using the four-point scale pre- and post-operative MCCRO-Q questionnaires. Fifteen assessors reviewed photos from pre- and post-operative assessments in the UK between July 2016 and February 2020. Ninety-five patients were included in this validation study, with each patient assessed by a minimum of 3 assessors. MCCRO-Q showed consistency between reviewers, with all intra-class coefficient averages >0.5 for pre- and post-operative assessments. Moreover, 26% of preoperative assessments demonstrated perfect agreement, 56% had a maximum one-point difference and 18% had a two-point difference to the median score. Furthermore, 1% of postoperative assessments demonstrated perfect agreement, 36% had a one-point difference and 63% had a maximum point difference of 2 to the median score. The inter-rate agreement showed that MCCRO-Q is a reliable tool when used with 3 or more assessors to judge patient appearance clinically, preoperatively and post-operatively, concerning abdominoplasty.
PubMed: 38943700
DOI: 10.1016/j.bjps.2024.05.050 -
Gynecologic Oncology Jun 2024Racial and ethnic disparities in gynecologic cancer care have been documented. Treatment at academic facilities is associated with improved survival, yet no study has...
INTRODUCTION
Racial and ethnic disparities in gynecologic cancer care have been documented. Treatment at academic facilities is associated with improved survival, yet no study has examined independent associations between race and ethnicity with facility type among gynecologic cancer patients.
MATERIALS & METHODS
We used the National Cancer Database and identified 484,455 gynecologic cancer (cervix, ovarian, uterine) patients diagnosed between 2004 and 2020. Facility type was dichotomized as academic vs. non-academic, and we used logistic regression to estimate multivariable-adjusted odds ratios (ORs) and 95% confidence intervals (CIs) between race and ethnicity and facility type. Secondarily, we examined joint effects of race and ethnicity and facility type on overall survival using Cox proportional hazards regression.
RESULTS
We observed higher odds of treatment at academic (vs. non-academic) facilities among American Indian/Alaska Native (OR = 1.42, 95% CI = 1.28-1.57), Asian (OR = 1.64, 95% CI = 1.59-1.70), Black (OR = 1.69, 95% CI = 1.65-1.72), Hispanic (OR = 1.70, 95% CI = 1.66-1.75), Native Hawaiian/Pacific Islander (OR = 1.74, 95% CI = 1.57-1.93), and other race (OR = 1.29, 95% CI = 1.20-1.40) patients compared with White patients. In the joint effects survival analysis with White, academic facility-treated patients as the reference group, Asian, Hispanic, and other race patients treated at academic or non-academic facilities had improved overall survival. Conversely, Black patients treated at academic facilities [Hazard Ratio (HR) = 1.10, 95% CI = 1.07-1.12] or non-academic facilities (HR = 1.19, 95% CI = 1.16-1.21) had worse survival.
DISCUSSION
Minoritized gynecologic cancer patients were more likely than White patients to receive treatment at academic facilities. Importantly, survival outcomes among patients receiving care at academic institutions differed by race, requiring research to investigate intra-facility survival disparities.
PubMed: 38943692
DOI: 10.1016/j.ygyno.2024.06.018 -
Journal of Obstetrics and Gynaecology :... Dec 2024This study examined the improvement of dysmenorrhoea and menorrhagia after uterine artery embolisation (UAE) in women with symptomatic adenomyosis and identified factors...
BACKGROUND
This study examined the improvement of dysmenorrhoea and menorrhagia after uterine artery embolisation (UAE) in women with symptomatic adenomyosis and identified factors that could predict the improvement of dysmenorrhoea and menorrhagia.
METHODS
This retrospective study included women with adenomyosis who underwent bilateral UAE between December 2014 and December 2016. The percentage of the volume of the absence of contrast enhancement on T1-weighted images was evaluated 5-7 days after UAE. A receiver operating characteristic (ROC) analysis was used to determine a cut-off point and predict the improvement of dysmenorrhoea and menorrhagia.
RESULTS
Forty-eight patients were included. At 24 and 36 months after UAE, the improvement rates for dysmenorrhoea and menorrhagia were 60.4% (29/48) and 85.7% (30/35), and the recurrence rates were 19.4% (7/36) and 9.1% (3/33), respectively. Only the percentage of the volume of the absence of contrast enhancement on T1-weighted images was associated with the improvement of dysmenorrhoea (=0.001, OR = 1.051; 95% CI: 1.02-1.08) and menorrhagia (=0.006, OR = 1.077; 95% CI: 1.021-1.136). When the cut-off value of the ROC analysis was 73.1%, sensitivity, specificity, positive predictive value, and negative predictive value for the improvement of dysmenorrhoea were 58.6%, 94.7%, 94.4%, and 60%, while they were 58.9%, 80%, 100%, 100%, and 45.5% for the improvement of dysmenorrhoea.
CONCLUSION
Bilateral UAE for symptomatic adenomyosis led to good improvement of dysmenorrhoea and menorrhagia. The percentage of the volume of the absence of contrast enhancement on T1-weighted images of the uterus in postoperative magnetic resonance imaging might be associated with the improvement of dysmenorrhoea and menorrhagia.
Topics: Humans; Female; Menorrhagia; Adenomyosis; Dysmenorrhea; Retrospective Studies; Uterine Artery Embolization; Adult; Treatment Outcome; Middle Aged; Magnetic Resonance Imaging; ROC Curve
PubMed: 38943550
DOI: 10.1080/01443615.2024.2372645 -
The Oncologist Jun 2024PREDICT is a web-based tool for forecasting breast cancer outcomes. PREDICT version 3.0 was recently released. This study aimed to validate this tool for a large...
BACKGROUND
PREDICT is a web-based tool for forecasting breast cancer outcomes. PREDICT version 3.0 was recently released. This study aimed to validate this tool for a large population in mainland China and compare v3.0 with v2.2.
METHODS
Women who underwent surgery for nonmetastatic primary invasive breast cancer between 2010 and 2020 from the First Affiliated Hospital of Wenzhou Medical University were selected. Predicted and observed 5-year overall survival (OS) for both v3.0 and v2.2 were compared. Discrimination was compared using receiver-operator curves and DeLong test. Calibration was evaluated using calibration plots and chi-squared test. A difference greater than 5% was deemed clinically relevant.
RESULTS
A total of 5424 patients were included, with median follow-up time of 58 months (IQR 38-89 months). Compared to v2.2, v3.0 did not show improved discriminatory accuracy for 5-year OS (AUC: 0.756 vs 0.771), same as ER-positive and ER-negative patients. However, calibration was significantly improved in v3.0, with predicted 5-year OS deviated from observed by -2.0% for the entire cohort, -2.9% for ER-positive and -0.0% for ER-negative patients, compared to -7.3%, -4.7% and -13.7% in v2.2. In v3.0, 5-year OS was underestimated by 9.0% for patients older than 75 years, and 5.8% for patients with micrometastases. Patients with distant metastases postdiagnosis was overestimated by 10.6%.
CONCLUSIONS
PREDICT v3.0 reliably predicts 5-year OS for the majority of Chinese patients with breast cancer. PREDICT v3.0 significantly improved the predictive accuracy for ER-negative groups. Furthermore, caution is advised when interpreting 5-year OS for patients aged over 70, those with micrometastases or metastases postdiagnosis.
PubMed: 38943540
DOI: 10.1093/oncolo/oyae164 -
Iranian Journal of Immunology : IJI Jun 2024Hematopoietic stem cell transplantation (HSCT) is the only curative therapy for β-thalassemia major in children. However, it often induces graft-versus-host-disease...
Hematopoietic stem cell transplantation (HSCT) is the only curative therapy for β-thalassemia major in children. However, it often induces graft-versus-host-disease (GVHD), which is associated with complications. In the present study, we used cyclophosphamide (Cy) to treat a thalassemia patient post-HSCT to reduce the adverse effects of GVHD. We monitored the numbers and phenotype of granulocytes. In this case study, an 11-year-old female patient, diagnosed with β-thalassemia major (Pesaro class II), was treated with Cy before and after HSCT with mobilized CD34+ cells. Both the relative and absolute granulocyte counts, as well as CD33+CD11b+ cell counts, increased significantly after HSCT until day 56. However, they suddenly began to decrease after day 56, accompanied by severe diarrhea, skin rash, and a decrease in bilirubin levels compared to day -12. Furthermore, compared to day -12, IL-22 levels increased until day 56, and then decreased, while IDO levels continued to rise after day 56. Our data suggest the potential use of IL-22 and IDO as biomarkers for GVHD assessment. It also indicates that Cy promotes HSCT reconstitution by increasing CD33+CD11b+ cells, which may play a crucial role in reducing GVHD risks. However, further studies are needed to elucidate the mechanism behind GVHD recurrence.
Topics: Humans; Female; Hematopoietic Stem Cell Transplantation; Cyclophosphamide; Child; Graft vs Host Disease; beta-Thalassemia; Treatment Outcome; Biomarkers; Immunosuppressive Agents
PubMed: 38943529
DOI: 10.22034/iji.2024.101584.2752 -
Health Technology Assessment... Jun 2024Gallstone disease is a common gastrointestinal disorder in industrialised societies. The prevalence of gallstones in the adult population is estimated to be... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Gallstone disease is a common gastrointestinal disorder in industrialised societies. The prevalence of gallstones in the adult population is estimated to be approximately 10-15%, and around 80% remain asymptomatic. At present, cholecystectomy is the default option for people with symptomatic gallstone disease.
OBJECTIVES
To assess the clinical and cost-effectiveness of observation/conservative management compared with laparoscopic cholecystectomy for preventing recurrent symptoms and complications in adults presenting with uncomplicated symptomatic gallstones in secondary care.
DESIGN
Parallel group, multicentre patient randomised superiority pragmatic trial with up to 24 months follow-up and embedded qualitative research. Within-trial cost-utility and 10-year Markov model analyses. Development of a core outcome set for uncomplicated symptomatic gallstone disease.
SETTING
Secondary care elective settings.
PARTICIPANTS
Adults with symptomatic uncomplicated gallstone disease referred to a secondary care setting were considered for inclusion.
INTERVENTIONS
Participants were randomised 1: 1 at clinic to receive either laparoscopic cholecystectomy or observation/conservative management.
MAIN OUTCOME MEASURES
The primary outcome was quality of life measured by area under the curve over 18 months using the Short Form-36 bodily pain domain. Secondary outcomes included the Otago gallstones' condition-specific questionnaire, Short Form-36 domains (excluding bodily pain), area under the curve over 24 months for Short Form-36 bodily pain domain, persistent symptoms, complications and need for further treatment. No outcomes were blinded to allocation.
RESULTS
Between August 2016 and November 2019, 434 participants were randomised (217 in each group) from 20 United Kingdom centres. By 24 months, 64 (29.5%) in the observation/conservative management group and 153 (70.5%) in the laparoscopic cholecystectomy group had received surgery, median time to surgery of 9.0 months (interquartile range, 5.6-15.0) and 4.7 months (interquartile range 2.6-7.9), respectively. At 18 months, the mean Short Form-36 norm-based bodily pain score was 49.4 (standard deviation 11.7) in the observation/conservative management group and 50.4 (standard deviation 11.6) in the laparoscopic cholecystectomy group. The mean area under the curve over 18 months was 46.8 for both groups with no difference: mean difference -0.0, 95% confidence interval (-1.7 to 1.7); -value 0.996; = 203 observation/conservative, = 205 cholecystectomy. There was no evidence of differences in quality of life, complications or need for further treatment at up to 24 months follow-up. Condition-specific quality of life at 24 months favoured cholecystectomy: mean difference 9.0, 95% confidence interval (4.1 to 14.0), < 0.001 with a similar pattern for the persistent symptoms score. Within-trial cost-utility analysis found observation/conservative management over 24 months was less costly than cholecystectomy (mean difference -£1033). A non-significant quality-adjusted life-year difference of -0.019 favouring cholecystectomy resulted in an incremental cost-effectiveness ratio of £55,235. The Markov model continued to favour observation/conservative management, but some scenarios reversed the findings due to uncertainties in longer-term quality of life. The core outcome set included 11 critically important outcomes from both patients and healthcare professionals.
CONCLUSIONS
The results suggested that in the short term (up to 24 months) observation/conservative management may be a cost-effective use of National Health Service resources in selected patients, but subsequent surgeries in the randomised groups and differences in quality of life beyond 24 months could reverse this finding. Future research should focus on longer-term follow-up data and identification of the cohort of patients that should be routinely offered surgery.
TRIAL REGISTRATION
This trial is registered as ISRCTN55215960.
FUNDING
This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 14/192/71) and is published in full in ; Vol. 28, No. 26. See the NIHR Funding and Awards website for further award information.
Topics: Humans; Gallstones; Cholecystectomy, Laparoscopic; Cost-Benefit Analysis; Male; Female; Middle Aged; Quality of Life; Quality-Adjusted Life Years; Conservative Treatment; Adult; Technology Assessment, Biomedical; Aged; United Kingdom; Markov Chains
PubMed: 38943314
DOI: 10.3310/MNBY3104 -
Nigerian Journal of Clinical Practice Jun 2024The creation of pneumoperitoneum using higher pressure is believed to be associated with increased postoperative abdominal pain. (Randomized Controlled Trial)
Randomized Controlled Trial Comparative Study
BACKGROUND
The creation of pneumoperitoneum using higher pressure is believed to be associated with increased postoperative abdominal pain.
AIM
This study aimed to compare postoperative abdominal pain following low pressure laparoscopic appendectomy and standard pressure laparoscopic appendectomy.
METHODS
This was a prospective, double-blind, randomized controlled trial of 54 patients aged between 18 and 56 years with clinical and/or radiologic diagnosis of acute appendicitis. The patients were randomly allocated to two groups: low pressure laparoscopic appendectomy (n = 26) and standard pressure laparoscopic appendectomy (n = 28). The intra-abdominal pressure was kept in either low pressure (9 mm Hg) or standard pressure (13 mm Hg). Abdominal and shoulder pain scores were assessed using the visual analog scale at 6 hours and 3 days post procedure. Postoperative analgesia requirement, duration of surgery, complications, and hospital stay were recorded.
RESULTS
Both groups match for the demographic parameters. Three patients required conversion from low to standard pressure. There was no difference between the two groups in terms of abdominal pain (P = 0.86) and shoulder pain (P = 0.33), duration of surgery (P = 0.51), complications (P = 0.17), and length of hospital stay (P = 0.83).
CONCLUSION
The use of low pressure pneumoperitoneum did not reduce the incidence of abdominal pain in patients who had laparoscopic appendectomy. Patients with acute appendicitis can be treated with either low or normal pressure pneumoperitoneum depending on the experience of the surgeon.
Topics: Humans; Appendectomy; Adult; Laparoscopy; Female; Male; Pneumoperitoneum, Artificial; Double-Blind Method; Appendicitis; Middle Aged; Prospective Studies; Pain, Postoperative; Young Adult; Adolescent; Pressure; Length of Stay; Pain Measurement; Treatment Outcome; Abdominal Pain
PubMed: 38943300
DOI: 10.4103/njcp.njcp_802_23 -
Nigerian Journal of Clinical Practice Jun 2024Demyelinating disorders of the central nervous system (CNS) are rare disorders characterized by inflammation and the selective destruction of CNS myelin. The incidence...
BACKGROUND
Demyelinating disorders of the central nervous system (CNS) are rare disorders characterized by inflammation and the selective destruction of CNS myelin. The incidence of this disorder is increasing in developed countries. Nigerian studies on the pediatric population on the subject are very scarce.
AIMS
The aim of the study was to document the epidemiology, clinical profile, and impact of late presentation on the treatment outcome of demyelinating diseases of the CNS in pediatric patients.
METHODS
The retrospective review of patients aged 1-15 years admitted in a tertiary hospital from January 2018 to December 2022 with various symptoms suggestive of demyelinating CNS disorders. The diagnosis was clinically and radiologically confirmed. Information retrieved from the case notes included patients' demographics, clinical symptoms and signs, number of days with symptoms to presentation in the hospital, results of the magnetic resonance imaging (MRI), treatment, and treatment outcomes. Data were entered in Excel sheet and results were presented in tables and percentages.
RESULTS
The incidence of demyelinating disorders over the period was 0.013% (10 out of 769 patients admitted over the period). Acute demyelinating encephalomyelitis (ADEM) was the most common disorder seen in the study population (60%, n = 6), followed by transverse myelitis and two (20%) had optic neuritis (ON). Most of the patients with ADEM were in the 1-5-year age group. The female-to-male ratio was 2.3:1. Paraplegia, visual impairment, and ataxia were the most common clinical presentations in the study population. One of the patients met the criteria for the diagnosis of multiple sclerosis during follow-up. Human immunodeficiency virus (HIV) was identified as the cause of demyelination in one case. Most of the patients improved with steroids.
CONCLUSION
ADEM was the most common clinical phenotype seen in this study. Patients with ADEM and ON had a better prognosis than transverse myelitis. Late presentation was also identified as a poor prognostic factor. Follow-up of cases is very important to monitor disease progression to multiple sclerosis.
Topics: Humans; Nigeria; Child; Female; Male; Adolescent; Child, Preschool; Retrospective Studies; Infant; Demyelinating Diseases; Magnetic Resonance Imaging; Incidence; Treatment Outcome; Myelitis, Transverse; Optic Neuritis
PubMed: 38943292
DOI: 10.4103/njcp.njcp_155_23 -
ESC Heart Failure Jun 2024Inflammation has emerged as a potential key pathophysiological mechanism in heart failure (HF) in general and acute HF (AHF) specifically, with inflammatory biomarkers...
AIMS
Inflammation has emerged as a potential key pathophysiological mechanism in heart failure (HF) in general and acute HF (AHF) specifically, with inflammatory biomarkers shown to be highly predictive of adverse outcomes in these patients. The CORTAHF study builds on both these data and the fact that steroid burst therapy has been shown to be effective in the treatment of respiratory diseases and COVID-19. Our hypothesis is that in patients with AHF and elevated C-reactive protein (CRP) levels without symptoms or signs of infection, a 7-day course of steroid therapy will lead to reduced inflammation and short-term improvement in quality of life and a reduced risk of worsening HF (WHF) events.
METHODS AND RESULTS
The study, which is currently ongoing, will include 100 patients with AHF ages 18-85, regardless of ejection fraction, screened within 12 h of presentation. Patients will be included who have NT-proBNP > 1500 pg/mL and CRP > 20 mg/L at screening. Exclusion criteria include haemodynamic instability and symptoms and signs of infection. After signed consent, eligible patients will be randomized according to a central randomization scheme stratified by centre 1:1 to either treatment once daily for 7 days with 40 mg prednisone orally or to standard care. Patients will be assessed at study day 2, day 4 or at discharge if earlier, and at days 7 and 31 at the hospital; and at day 91 through a telephone follow-up. The primary endpoint is the change in CRP level from baseline to day 7, estimated from a mixed model for repeated measures (MMRM) including all measured timepoints, in patients without a major protocol violation. Secondary endpoints include the time to the first event of WHF adverse event, readmission for HF, or death through day 91; and changes to day 7 in EQ-5D visual analogue scale score and utility index. Additional clinical and laboratory measures will be assessed.
CONCLUSIONS
The results of the study will add to the knowledge of the role of inflammation in AHF and potentially inform the design of larger studies with possibly longer duration of anti-inflammatory therapies in AHF.
PubMed: 38943232
DOI: 10.1002/ehf2.14930 -
Successful treatment of fulminant and recurrent lymphocytic myocarditis with calcineurin inhibitors.ESC Heart Failure Jun 2024Lymphocytic myocarditis (LM) is primarily triggered by various factors including viral infections and subsequent immune responses. While rare, some patients with LM...
Lymphocytic myocarditis (LM) is primarily triggered by various factors including viral infections and subsequent immune responses. While rare, some patients with LM experience recurrence with a life-threatening fulminant form. Although combining steroids and immunosuppressants, such as azathioprine and mycophenolate mofetil, has demonstrated favourable outcomes in patients with LM, their efficacy is limited to the chronic phase. Indeed, various immunosuppressants have been used for LM with fulminant manifestation; however, their evidence remains lacking. In our case series, two patients with LM experienced fulminant relapses during steroid tapering, and another presented persistent cardiac enzymes elevation despite steroid therapies. Consequently, we initiated calcineurin inhibitors alongside steroids, resulting in well-controlled clinical courses without further recurrence of LM and significant adverse effects. Our cases suggest calcineurin inhibitors as therapeutic options for managing steroid-resistant LM with fulminant relapse.
PubMed: 38943229
DOI: 10.1002/ehf2.14896