Abstract Background Transvenous implantable cardioverter-defibrillators (TV-ICDs) improve survival in patients at risk for sudden cardiac death, but complications remain an important drawback. The ...subcutaneous ICD (S-ICD) was developed to overcome lead-related complications. Comparison of clinical outcomes of both device types in previous studies was hampered by dissimilar patient characteristics. Objectives This retrospective study compares long-term clinical outcomes of S-ICD and TV-ICD therapy in a propensity-matched cohort. Methods The authors analyzed 1,160 patients who underwent S-ICD or TV-ICD implantation in 2 high-volume hospitals in the Netherlands. Propensity matching for 16 baseline characteristics, including diagnosis, yielded 140 matched pairs. Clinical outcomes were device-related complications requiring surgical intervention, appropriate and inappropriate ICD therapy, and were reported as 5-year Kaplan-Meier rate estimates. Results All 16 baseline characteristics were balanced in the matched cohort of 140 patients with S-ICDs and 140 patients with TV-ICDs (median age 41 years interquartile range: 30 to 52 years and 40% women). The complication rate was 13.7% in the S-ICD group versus 18.0% in the TV-ICD group (p = 0.80). The infection rate was 4.1% versus 3.6% in the TV-ICD groups (p = 0.36). Lead complications were lower in the S-ICD arm compared with the TV-ICD arm, 0.8% versus 11.5%, respectively (p = 0.03). S-ICD patients had more nonlead-related complications than TV-ICD patients, 9.9% versus 2.2%, respectively (p = 0.047). Appropriate ICD intervention (antitachycardia pacing and shocks) occurred more often in the TV-ICD group (hazard ratio HR: 2.42; p = 0.01). The incidence of appropriate (TV-ICD HR: 1.46; p = 0.36) and inappropriate shocks (TV-ICD HR: 0.85; p = 0.64) was similar. Conclusions The complication rate in patients implanted with an S-ICD or TV-ICD was similar, but their nature differed. The S-ICD reduced lead-related complications significantly, at the cost of nonlead-related complications. Rates of appropriate and inappropriate shocks were similar between the 2 groups.
Background. The optimal treatment of nontuberculosis mycobacterial cervical lymphadenitis in children has not been established. Until recently, surgical excision was the standard treatment, but the ...number of reports of successful antibiotic treatment is increasing, which questions whether surgery is the preferred treatment. In this randomized, multicenter trial, we compared surgical excision with antibiotic treatment. Methods. One hundred children with microbiologically proven nontuberculous mycobacterial cervicofacial lymphadenitis were randomly assigned to undergo surgical excision of the involved lymph nodes or to receive antibiotic therapy with clarithromycin and rifabutin for at least 12 weeks. The primary end point was cure, defined as regression of the lymph node enlargement by at least 75%, with cure of the fistula and total skin closure without local recurrence or de novo lesions after 6 months, as assessed by clinical and ultrasound evaluation. Secondary end points included complications of surgery and adverse effects of antibiotic therapy. Results. Intention-to-treat analysis revealed that surgical excision was more effective than antibiotic therapy (cure rates, 96% and 66%, respectively; 95% confidence interval for the difference, 16%–44%). Treatment failures were explained neither by noncompliance nor by baseline or acquired in vitro resistance to clarithromycin or rifabutin. Surgical complications were seen in 14 (28%) of 50 patients; staphylococcal wound infection occurred in 6 patients, and a permanent grade 2 facial marginal branch dysfunction occurred in 1 patient. The vast majority of patients who were allocated to antibiotic therapy reported adverse effects (39 78% of 50 patients), including 4 patients who had to discontinue treatment. Conclusions. Surgical excision is more effective than antibiotic treatment for children with nontuberculous mycobacterial cervicofacial lymphadenitis.
IMPORTANCE: An objective assessment of children’s competence to consent to research participation is currently not possible. Age limits for asking children’s consent vary considerably between ...countries, and, to our knowledge, the correlation between competence and children’s age has never been systematically investigated. OBJECTIVES: To test a standardized competence assessment instrument for children by modifying the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR), to investigate its reliability and validity, and to examine the correlation of its assessment with age and estimate cutoff ages. DESIGN, SETTING, AND PARTICIPANTS: This prospective study included children and adolescents aged 6 to 18 years in the inpatient and outpatient departments of allergology, gastroenterology, oncology, ophthalmology, and pulmonology from January 1, 2012, through January 1, 2014. Participants were eligible for clinical research studies, including observational studies and randomized clinical trials. EXPOSURES: Competence judgments by experts aware of the 4 relevant criteria—understanding, appreciation, reasoning, and choice—were used to establish the reference standard. The index test was the MacCAT-CR, which used a semistructured interview format. MAIN OUTCOMES AND MEASURES: Interrater reliability, validity, and dimensionality of the MacCAT-CR and estimated cutoff ages for competence. RESULTS: Of 209 eligible patients, we included 161 (mean age, 10.6 years; 47.2% male). Good reproducibility of MacCAT-CR total and subscale scores was observed (intraclass correlation coefficient range, 0.68-0.92). We confirmed unidimensionality of the MacCAT-CR. By the reference standard, we judged 54 children (33.5%) to be incompetent; by the MacCAT-CR, 61 children (37.9%). Criterion-related validity of MacCAT-CR scores was supported by high overall accuracy in correctly classifying children as competent against the reference standard (area under the receiver operating characteristics curve, 0.78). Age was a good predictor of competence on the MacCAT-CR (area under the receiver operating characteristics curve, 0.90). In children younger than 9.6 years, competence was unlikely (sensitivity, 90%); in those older than 11.2 years, competence was probable (specificity, 90%). The optimal cutoff age was 10.4 years (sensitivity, 81%; specificity, 84%). CONCLUSIONS AND RELEVANCE: The MacCAT-CR demonstrated strong psychometric properties. In children aged 9.6 to 11.2 years, consent may be justified when competence can be demonstrated in individual cases by the MacCAT-CR. The results contribute to a scientific underpinning of regulations for clinical research directed toward children.
Abstract Holstege MS, Lindeboom R, Lucas C. Preoperative quadriceps strength as a predictor for short-term functional outcome after total hip replacement. Objective To determine the preoperative ...strength of the muscle group of the lower extremity that is most important in predicting functional recovery after primary unilateral total hip replacement (THR). Design Prospective observational study with inception cohort. Settings Joint care program (hospital care/clinical division of a nursing home/outpatient physical therapy). Participants Patients (N=55) undergoing primary unilateral THR. Interventions Not applicable. Main Outcome Measures Baseline measures within 2 weeks preoperative and follow-up at 6 and 12 weeks postoperative included isometric strength measurement of the hip (flexors, extensors, abductors, adductors) and knee (flexors, extensors) musculature using a handheld dynamometer. Functional outcome was tested using performance-based (Timed Up and Go Test, 6-Minute Walk Test) and self-report measures (Western Ontario and McMaster Universities Osteoarthritis Index, subscale Physical Function WOMAC PF, 36-Item Short Form Health Survey subscale Mental Health, visual analog scale for pain). Results Of the patients (N=55; mean age, 72.7±6.8y; 41 women) included; 18 dropped out, leaving 37 patients for analyses. After correction for WOMAC PF score at baseline, body mass index, sex, and age, the preoperative knee extensors strength measure of the operated site was the only muscle group showing a significant effect on functional outcome measured by using the WOMAC PF at 12 weeks postoperatively ( R2 =.355; β=−.105; P for β=.004). Conclusion Preoperative greater knee extensor strength of the operated site is associated with better physical function, measured by using the WOMAC PF at 12 weeks postoperative.
Identification of low muscle mass becomes increasingly relevant due to its prognostic value in cancer patients. In clinical practice, mid-upper arm muscle circumference (MAMC) and bioelectrical ...impedance analysis (BIA) are often used to assess muscle mass. For muscle-mass assessment, computed tomography (CT) is considered as reference standard. We investigated concordance between CT, BIA, and MAMC, diagnostic accuracy of MAMC, and BIA to detect low muscle mass and their relation with the clinical outcome malnutrition provided with the Patient-Generated Subjective Global Assessment Short Form (PG-SGA SF). This cross-sectional study included adult patients with advanced esophageal and gastrointestinal cancer. BIA, MAMC, and PG-SGA-SF were performed. Routine CT-scans were used to quantify psoas muscle index (PMI) and skeletal muscle area. Good concordance was found between CTPMI and both BIAFFMI (fat free mass index) (ICC 0.73), and BIAASMI (appendicular skeletal muscle index) (ICC 0.69) but not with MAMC (ICC 0.37). BIAFFMI (94%), BIAASMI (86%), and MAMC (86%) showed high specificity but low sensitivity. PG-SGA-SF modestly correlated with all muscle-mass measures (ranging from −0.17 to −0.43). Of all patients with low muscle mass, 62% were also classified with a PG-SGA-SF score of ≥4 points. Although CT remains the first choice, since both BIA and MAMC are easy to perform by dieticians, they have the potential to be used to detect low muscle mass in clinical practice.
To prevent negative effects of early-onset psychiatric disorders on children's development, structured diagnostics are needed. However, validated diagnostic instruments (based on DSM-5) for children ...aged 7 years and younger are scarce. The Diagnostic Infant and Preschool Assessment (DIPA) is a diagnostic interview developed in the USA for measuring 16 psychiatric disorders in young children. The psychometric properties of the American version of the DIPA have been validated. Here we determined the accuracy of the psychometric properties of the Dutch DSM-5 based version of the DIPA for the corresponding population.
Psychometric properties of the DSM-5 based version of the DIPA were determined based on a sample of 136 biological, foster, therapeutic foster and adoptive parents of clinically referred children and children involved in a serious accident (aged 1–7 years). In line with the American validation study, we included the following seven DIPA modules: posttraumatic stress disorder (PTSD), major depressive disorder (MDD), attention deficit hyperactivity disorder (ADHD), oppositional defiant disorder (ODD), separation anxiety disorder (SAD), generalized anxiety disorder (GAD), and obsessive-compulsive disorder (OCD). We administered the DIPA, Trauma Symptom Checklist for Young Children (TSCYC) and Child Behavior Checklist (CBCL). Analyses were conducted with continuous outcomes (number of symptoms) and categorical outcomes (diagnoses).
The Dutch DSM-5 based version of the DIPA showed good internal consistency and interrater reliability with both continuous and categorical variables. The concurrent validity was good; we found a good concordance between the DIPA and corresponding questionnaires on both the symptom and diagnoses level. In addition, the divergence on symptom level between the DIPA and non-corresponding questionnaires was adequate, which indicated adequate divergent validity. Due to a limited number of positive cases, we could not draw conclusions regarding its psychometric properties in the GAD and OCD modules.
Our study shows promising initial results regarding the reliability and validity of the Dutch version of the DIPA, that is based on the DSM-5. Therefore, we recommend the use of the DIPA in research and clinical practice.
•Valid instruments to diagnose psychiatric disorders in preschoolers are scarce.•The DIPA is one of the few interviews for diagnosing disorders in preschoolers.•Psychometric properties of the Dutch DIPA are adequate for the common disorders.•The DIPA can be used to determine the treatment focus and to monitor treatment progress and outcome.
Objectives
The aim of this study was to assess the predictive value of PMA measurement for mortality.
Background
Current surgical risk stratification have limited predictive value in the ...transcatheter aortic valve implantation (TAVI) population. In TAVI workup, a CT scan is routinely performed but body composition is not analyzed. Psoas muscle area (PMA) reflects a patient's global muscle mass and accordingly PMA might serve as a quantifiable frailty measure.
Methods
Multi‐slice computed tomography scans (between 2010 and 2016) of 583 consecutive TAVI patients were reviewed. Patients were divided into equal sex‐specific tertiles (low, mid, and high) according to an indexed PMA. Hazard ratios (HR) and their confidence intervals (CI) were determined for cardiac and all‐cause mortality after TAVI.
Results
Low iPMA was associated with cardiac and all‐cause mortality in females. One‐year adjusted cardiac mortality HR in females for mid‐iPMA and high‐iPMA were 0.14 95%CI, 0.05–0.45 and 0.40 95%CI, 0.15–0.97, respectively. Similar effects were observed for 30‐day and 2‐years cardiac and all‐cause mortality. In females, adding iPMA to surgical risk scores improved the predictive value for 1‐year mortality. C‐statistics changed from 0.63 CI = 0.54–0.73 to 0.67 CI: 0.58–0.75 for EuroSCORE II and from 0.67 CI: 0.59–0.77 to 0.72 CI: 0.63–0.80 for STS‐PROM.
Conclusions
Particularly in females, low iPMA is independently associated with an higher all‐cause and cardiac mortality. Prospective studies should confirm whether PMA or other body composition parameters should be extracted automatically from CT‐scans to include in clinical decision making and outcome prediction for TAVI.
Clinical differences between atopic and atopiform dermatitis Brenninkmeijer, Elian E.A., MD; Spuls, Phyllis I., MD, PhD; Legierse, Catharina M., MD ...
Journal of the American Academy of Dermatology,
03/2008, Letnik:
58, Številka:
3
Journal Article
Recenzirano
Background Atopic dermatitis (AD) has been divided into the “extrinsic” and “intrinsic” type, in which “intrinsic AD” is characterized by the absence of allergen-specific IgE. Still, there is no ...consensus whether this “intrinsic type” of AD, which we denominate as atopiform dermatitis (AFD), is a distinct entity. Objective A case-control study was performed to compare the clinical and diagnostic features of AD and AFD. Methods Patients with a clinical diagnosis of AD were selected. Cases did not have demonstrable allergen-specific IgE. Matched control subjects were tested positive for allergen-specific IgE. Patients were evaluated for medical history, quality of life, disease severity, and Hanifin and Rajka, U.K. and Millennium diagnostic criteria. Results Eight percent (n = 34) of the selected patients had, in fact, AFD. Female predominance, absence of atopic diseases, later onset of disease, and milder disease severity were observed in AFD. A history of atopy, recurrent conjunctivitis, palmar hyperlinearity, keratosis pilaris, pityriasis alba, and hand and/or food eczema were significantly less present in AFD. Dennie-Morgan fold was positively associated with AFD. Limitations Not all patients with negative allergen-specific IgE participated and a relatively small number of AFD patients were studied. Conclusions In addition to the absence of allergen-specific IgE, our findings support that AFD is an entity distinct from AD. With a distinction shown between AFD and AD, patient groups will be better defined and more homogeneous. Implications of this distinction will be of importance for preventive and therapeutic advice; diagnostic processes; and for future research.
Background. We evaluated the diagnostic usefulness of tuberculin skin testing in the screening for nontuberculous mycobacterial (NTM) infection in children. Methods.We enrolled 180 children who had ...chronic cervicofacial lymphadenitis in our study. Skin testing was done using antigens of Mycobacterium tuberculosis, Mycobacterium avium, Mycobacterium kansasii, and Mycobacterium scrophulaceum. The reference standard for NTM infection was a positive culture result, identification by PCR, or both. Receiver operating characteristic analysis was used to identify the optimal cutoff point in skin induration for the detection of NTM infection. Accuracy of the mycobacterial skin tests was quantified using sensitivity and specificity rates and positive and negative predictive values at the optimal skin induration cutoff. Results. A total of 112 NTM infections were identified, of which 83 were caused by M. avium, 21 by Mycobacterium haemophilum, and 8 by other NTM species. At the optimal cutoff for a positive test (5 mm), tuberculin skin testing had a sensitivity and specificity of 70% and 98%, respectively, and a positive predictive value and a negative predictive value of 98% and 64%, respectively, compared with a sensitivity and a specificity of 93% and 97%, respectively; M. avium sensitin, the best-performing skin test, had positive and negative predictive values of 98% and 90%, respectively. Conclusion. Tuberculin skin testing could be valuable as a first step in the diagnostic analysis of cervicofacial lymphadenitis in children without a history of TB exposure or bacille Calmette-Guérin vaccination.
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