Standardized Diagnostic Tools Research Articles

The effectiveness of topical skin products in the treatment and prevention of incontinence-associated dermatitis: a systematic review protocol

The effectiveness of topical skin products in the treatment and prevention of incontinence-associated dermatitis: a systematic review protocol

The enigma of Bálint's syndrome: neural substrates and cognitive deficits

The enigma of Bálint's syndrome: neural substrates and cognitive deficits

Complex case conferences associated with reduced hospital admissions for high-risk patients with multiple comorbidities.

Reducing avoidable hospital readmissions presents an opportunity to improve health care quality and reduce avoidable costs. We studied the effect person-focused care may have on reducing avoidable admissions to the hospital. Among patients with heart failure discharged from the hospital, we evaluated the effect on 30-day readmissions of transitions-in-care interventions: home health visits, follow-up phone calls, and physician office visits. We also used a standardized diagnostic tool to interview readmitted patients to identify social reasons that may have contributed to the readmission. Finally, we used the learnings from both interventions to develop a new intervention: a single complex disease case conference that included the entire health care team. We measured hospital admissions for 21 patients during the 6 months before and after their complex case conferences. Observed-over-expected hospital readmission rates were lowest for patients receiving a postdischarge visit with a home health nurse and a follow-up visit with their physician (0.54), compared with solely a physician visit (0.81), home health visit (1.2), or phone call (1.55). Various social issues may contribute to hospital readmissions, including caregiver knowledge, ability to care for oneself at home, and issues related to medications (adherence, ability to pay, and knowledge about potential side effects). Substantially fewer hospital admissions occurred after complex case conferences. Complex case conferences with disease-focused and person-focused interventions may be associated with reduced hospital admissions for patients with heart failure and multiple comorbidities.

The risk of Bipolar Disorders in Multiple Sclerosis

BackgroundThe aim was to determine the risk of Mood Disorders (MD), particularly Bipolar Disorders (BD), in Multiple Sclerosis (MS) using standardized psychiatric diagnostic tools. MethodsCase–control study. Cases: 201 consecutive-patients with MS. Controls: 804 sex- and age-matched subjects without MS, randomly selected from a database concurrently used for an epidemiological study on the MD prevalence in the community. Psychiatric diagnoses according to DSM-IV were determined by physicians using structured interview tools (ANTAS-SCID). ResultsCompared to controls, MS patients had a higher lifetime prevalence of DSM-IV Major Depressive Disorders (MDD; P<0.0001), BD I (P=0.05), BD II (P<0.0001) and Cyclothymia (P=0.0001). As people with MS had a higher risk of depressive and bipolar spectrum disorders, ratio MDD/bipolar spectrum disorders was lower among cases (P<0.005) indicating a higher association with Bipolar Spectrum Disorders and MS. LimitationsMS diagnosis was differently collected in cases and controls. Even if this might have produced false negatives in controls, it would have reinforced the null hypothesis of no increased risk for MD in MS; therefore, it does not invalidate the results of the study. ConclusionsThis study was the first to show an association between BD and MS using standardized diagnostic tools and a case–control design. The results suggest a risk of under-diagnosis of BD (particularly type II) in MS and caution in prescribing ADs to people with depressive episodes in MS without prior excluding BD. The association between auto-immune degenerative diseases (like MS) and BD may be an interesting field for the study of the pathogenic hypothesis.

Which factors influence psychiatric diagnosing in substance abuse treatment?

BackgroundThe importance of diagnosing and treating co-occurring psychiatric disorders among substance abusers in treatment has received much attention. The aim of this study was to investigate to which extent co-occurring psychiatric disorders are diagnosed in a clinical population of substance abusers, and which factors (including the use of MINI-Plus) that influence the diagnosing of co-occurring psychiatric disorders.MethodsPatients (N = 275) who received inpatient substance use treatment in five different units in Northern Norway participated in the study. The patients’ clinicians gave information on diagnoses given during the stay in the units, and whether a systematic diagnostic tool was used for the diagnosing (MINI-Plus). Predictors of independent co-occurring psychiatric disorders were examined utilizing hierarchical regression analysis.ResultsOne third of the patients were given an independent psychiatric diagnosis. Less than half of the patients were assessed using a diagnostic tool. The main predictor of diagnosing of independent psychiatric disorders was the use of the diagnostic tool MINI-Plus. Younger patients and patients that used less alcohol, were given independent psychiatric diagnoses more frequently.ConclusionsThe number of co-occurring independent psychiatric diagnoses was lower compared to other studies using standardized diagnostic tools. The low number of patients assessed by such a tool, and the strong relationship between the use of such a tool and the diagnosing of co-occurring psychiatric disorders, suggest that the implementation of standardized diagnostic tools should be addressed in the units. Generally, patients suffering from substance use disorders should be systematically screened for other psychiatric disorders, in order to improve their treatment and health.

Cellular immune function monitoring after allogeneic haematopoietic cell transplantation: evaluation of a new assay

Managing the patient's immune system after haematopoietic cell transplantation (HCT) is a challenge, mainly in the unstable period immediately after the transplant. Currently there is no standardized non-invasive diagnostic tool for the evaluation of immunological complications such as graft-versus-host disease (GVHD) and for managing the cellular immune function of the transplant recipient. The ImmuKnow assay for cellular immune function monitoring has been incorporated successfully into the clinical follow-up routine of solid organ transplant recipients. This study aims to explore the relevance and potential contribution of immune monitoring using the assay in the setting of HCT. We found that ImmuKnow-level measurement can distinguish between states of immune function quiescence and between events of acute GVHD. ImmuKnow levels were significantly higher in patients going through GVHD than the levels measured for the same patients during immunological stability. Moreover, we demonstrate a patient case where longitudinal monitoring using the ImmuKnow assay provided a trustworthy depiction of the patient's cellular immune function post-HCT. In conclusion, we provide evidence for the potential contribution of the ImmuKnow assay for longitudinal individualized cellular immune function monitoring of patients following HCT. Further studies are necessary in order to establish the optimal practice for utilizing the assay for this purpose.

MOON-test - Determination of Motor Performance in the Pediatric Oncology

Pediatric cancer patients suffer from various negative consequences due to the disease, the medical therapy and the inactivity during the intensive treatment. Only few studies have systematically identified the adverse effects of cancer on motor performance in childhood. To determine the motor performance of pediatric cancer patients, a motor performance test was developed which is applicable for this specific patient group. Eight test items with reference values for healthy children were merged to the MOON-test (test for motor performance in the oncology). MOON was tested for feasibility and acceptance in 33 patients aged 4-18 years. Feasibility was confirmed for children with different types of cancer (hematological malignancies and solid tumors) and with amputation, endoprosthesis, during aplasia as well as reduced general condition. Furthermore the patients showed a broad acceptance. Based on the study findings, the use of MOON-test as a standardized motor performance diagnostic tool in clinical routine of oncological acute clinics as well as rehabilitation clinics can be recommended.·

A Monoclonal Antibody-Based Copro-ELISA Kit for Canine Echinococcosis to Support the PAHO Effort for Hydatid Disease Control in South America

Cystic echinococcosis is still a major concern in South America. While some regions show advances in the control of the disease, others have among the highest incidence in the world. To reverse this situation the Pan American Health Organization (PAHO) has launched a regional project on cystic echinococcosis control and surveillance. An early concern of the program was the lack of a standardized diagnostic tool to monitor infection in dogs, a key target of control programs. Under this premise, we have developed a new copro-ELISA test after extensive screening of a large panel of monoclonal antibodies (MAbs) and polyclonal sera, which performs with high standards of sensitivity (92.6%) and specificity (86.4%) as established by necropsy diagnosis of dogs. The key component of the test, MAbEg9 has a convenient IgG isotype and reacts with a periodate-resistant epitope found in high molecular weight components of the worm. Time-course analysis of experimentally infected dogs showed that even animals with a very low number of parasites could be detected as early as day 20 post infection. The test was formulated in a ready-to-use kit format with proven stability of each component for a minimum of 3 months at room temperature. This characteristic facilitates its standardized use and shipping to other laboratories, which was demonstrated by the identical results obtained by two different laboratories in Peru and our own laboratory when a large number of field samples were analyzed independently in a blind fashion.

The effect of the DNA preparation method on the sensitivity of PCR for the detection of Trypanosoma evansi in rodents and implications for epidemiological surveillance efforts

Trypanosoma evansi is responsible for the most largely distributed animal trypanosomosis, affecting a wide range of wild and domestic animals. Its surveillance requires the implementation of standardized and reliable diagnostic tools. Although the development of polymerase chain reaction (PCR) tools has greatly improved our diagnostic capacity, factors affecting their sensitivity need to be acknowledged and accounted for in the interpretation of results. The targeted gene and the primer design have already been shown to greatly affect the sensitivity of a PCR, and the best-performing sets of primers have been previously identified. However, the sensitivity of the PCR is also largely influenced by the DNA extraction or sample preparation method. In this paper, we selected 6 DNA extraction or blood sample preparation methods representative of what would be used in a budget-constrained setting: phenol–chloroform, Chelex®, Flexigen (Qiagen®) kit, Genekam® kit and two original protocols using sodium hydroxide. We studied the effects of the preparation method on the detection limit of the subsequent PCR. Our results show that the extraction method strongly affects the PCR sensitivity. The classical phenol–chloroform extraction method allowed for the PCR with the lowest detection limit. Some combinations of extraction method and primer set had detection limits that were not compatible with their use as a reliable diagnostic test, and would severely reduce the performance of a surveillance program. Therefore, we encourage laboratories to carefully select their sample preparation and PCR protocols, depending on the aimed sensitivity, cost, safety, time requirement and objectives.

Influence de l'âge sur la santé sexuelle masculine

With the increase in life expectancy, men's sexual health has become a major concern for elderly couples. Erectile dysfunction (ED) is responsible for a 50 % decrease of sexually active men between 60 and 85. The aim of this study was to identify objective elements to evaluate the influence of age on male sexual health. Data on the effects of aging on men's sexual health have been explored in Medline and Embase using the MeSH keywords: prostate; sexuality and erectile dysfunction; aging. The articles were selected based on their methodology, relevance, date and language of publication. ED concerns 64 % of 70 years old patients and up to 77.5 % after 75 years. The screening of this pathology is based on standardized diagnostic tools. The most used of them remains the "International Index of Erectile function" which, in its simplified version with 5 items (IIEF-5 or SHIM), presents at the cutoff score of 21, a sensitivity of 98 %, a specificity of 88 % and a kappa index of 0.82. The ED is often responsible for a decrease in the quality of life for 60 % of elderly couples wishing to pursue sexual activity. Some diagnostic tools, such as the "Self-Esteem And Relationship" (SEAR) questionnaire or the "Sexual Experience Questionnaire" (SEX-Q) assess individual and couple satisfaction. Physiological aging seems to favor erection disorders by the development of an Androgen Deficiency of the Aging Male (ADAM) but pathological aging appears to be primarily responsible. Cardiovascular or neurological diseases and lower urinary tract symptoms (LUTS) are, with the polymedication, modifiable risk factors of ED to systematically screen in elderly subjects. Many diagnostic tools allow to detect ED and assess the impact on the quality of life of elderly men. The fundamental element of the management of ED is the research of modifiable risk factors including cardiovascular.

Bipolar disorders and Wilson's disease.

BackgroundThe aim of this study was to determine the risk for Bipolar Disorder (BD) in Wilson’s disease (WD) and to measure the impaired Quality of Life (QL) in BD with WD using standardized psychiatric diagnostic tools and a case control design.MethodsThis was a case control study. The cases were 23 consecutive patients with WD treated at the University Hospital in Cagliari, Italy, and the controls were 92 sex- and age-matched subjects with no diagnosis of WD who were randomly selected from a database used previously for an epidemiological study. Psychiatric diagnoses according to DSM-IV criteria were determined by physicians using structured interview tools (ANTAS-SCID). QL was measured by means of SF-12.ResultsCompared to controls, WD patients had lower scores on the SF-12 and higher lifetime prevalence of DSM-IV major depressive disorders (OR = 5.7, 95% CI 2.4–17.3) and bipolar disorders (OR = 12.9, 95% CI 3.6–46.3). BD was associated with lower SF-12 in WD patients.ConclusionsThis study was the first to show an association between BD and WD using standardized diagnostic tools and a case control design. Reports in the literature about increased schizophrenia-like psychosis in WD and a lack of association with bipolar disorders may thus have been based on a more inclusive diagnosis of schizophrenia in the past. Our findings may explain the frequent reports of loss of emotional control, hyperactivity, loss of sexual inhibition, and irritability in WD patients. This study was limited by a small sample size.

Diagnosing Pulmonary Tuberculosis with the Xpert MTB/RIF Test

Tuberculosis (TB) due to Mycobacterium tuberculosis (MTB) remains a major public health issue: the infection affects up to one third of the world population1, and almost two million people are killed by TB each year.2 Universal access to high-quality, patient-centered treatment for all TB patients is emphasized by WHO's Stop TB Strategy.3 The rapid detection of MTB in respiratory specimens and drug therapy based on reliable drug resistance testing results are a prerequisite for the successful implementation of this strategy. However, in many areas of the world, TB diagnosis still relies on insensitive, poorly standardized sputum microscopy methods. Ineffective TB detection and the emergence and transmission of drug-resistant MTB strains increasingly jeopardize global TB control activities.2 Effective diagnosis of pulmonary TB requires the availability - on a global scale - of standardized, easy-to-use, and robust diagnostic tools that would allow the direct detection of both the MTB complex and resistance to key antibiotics, such as rifampicin (RIF). The latter result can serve as marker for multidrug-resistant MTB (MDR TB) and has been reported in > 95% of the MDR-TB isolates.4, 5 The rapid availability of reliable test results is likely to directly translate into sound patient management decisions that, ultimately, will cure the individual patient and break the chain of TB transmission in the community.2 Cepheid's (Sunnyvale, CA, U.S.A.) Xpert MTB/RIF assay6, 7 meets the demands outlined above in a remarkable manner. It is a nucleic-acids amplification test for 1) the detection of MTB complex DNA in sputum or concentrated sputum sediments; and 2) the detection of RIF resistance-associated mutations of the rpoB gene.8 It is designed for use with Cepheid's GeneXpert Dx System that integrates and automates sample processing, nucleic acid amplification, and detection of the target sequences using real-time PCR and reverse transcriptase PCR. The system consists of an instrument, personal computer, barcode scanner, and preloaded software for running tests and viewing the results.9 It employs single-use disposable Xpert MTB/RIF cartridges that hold PCR reagents and host the PCR process. Because the cartridges are self-contained, cross-contamination between samples is eliminated.6 Current nucleic acid amplification methods used to detect MTB are complex, labor-intensive, and technically demanding. The Xpert MTB/RIF assay has the potential to bring standardized, sensitive and very specific diagnostic testing for both TB and drug resistance to universal-access point-of-care settings3, provided that they will be able to afford it. In order to facilitate access, the Foundation for Innovative New Diagnostics (FIND) has negotiated significant price reductions. Current FIND-negotiated prices, along with the list of countries eligible for the discounts, are available on the web.10

Diagnosing pulmonary tuberculosis with the Xpert MTB/RIF test.

Tuberculosis (TB) due to Mycobacterium tuberculosis (MTB) remains a major public health issue: the infection affects up to one third of the world population(1), and almost two million people are killed by TB each year. Universal access to high-quality, patient-centered treatment for all TB patients is emphasized by WHO's Stop TB Strategy. The rapid detection of MTB in respiratory specimens and drug therapy based on reliable drug resistance testing results are a prerequisite for the successful implementation of this strategy. However, in many areas of the world, TB diagnosis still relies on insensitive, poorly standardized sputum microscopy methods. Ineffective TB detection and the emergence and transmission of drug-resistant MTB strains increasingly jeopardize global TB control activities. Effective diagnosis of pulmonary TB requires the availability - on a global scale - of standardized, easy-to-use, and robust diagnostic tools that would allow the direct detection of both the MTB complex and resistance to key antibiotics, such as rifampicin (RIF). The latter result can serve as marker for multidrug-resistant MTB (MDR TB) and has been reported in > 95% of the MDR-TB isolates. The rapid availability of reliable test results is likely to directly translate into sound patient management decisions that, ultimately, will cure the individual patient and break the chain of TB transmission in the community. Cepheid's (Sunnyvale, CA, U.S.A.) Xpert MTB/RIF assay meets the demands outlined above in a remarkable manner. It is a nucleic-acids amplification test for 1) the detection of MTB complex DNA in sputum or concentrated sputum sediments; and 2) the detection of RIF resistance-associated mutations of the rpoB gene. It is designed for use with Cepheid's GeneXpert Dx System that integrates and automates sample processing, nucleic acid amplification, and detection of the target sequences using real-time PCR and reverse transcriptase PCR. The system consists of an instrument, personal computer, barcode scanner, and preloaded software for running tests and viewing the results. It employs single-use disposable Xpert MTB/RIF cartridges that hold PCR reagents and host the PCR process. Because the cartridges are self-contained, cross-contamination between samples is eliminated. Current nucleic acid amplification methods used to detect MTB are complex, labor-intensive, and technically demanding. The Xpert MTB/RIF assay has the potential to bring standardized, sensitive and very specific diagnostic testing for both TB and drug resistance to universal-access point-of-care settings, provided that they will be able to afford it. In order to facilitate access, the Foundation for Innovative New Diagnostics (FIND) has negotiated significant price reductions. Current FIND-negotiated prices, along with the list of countries eligible for the discounts, are available on the web.

RT-qPCR detection ofAspergillus fumigatusRNAin vitroand in a murine model of invasive aspergillosis utilizing the PAXgene®and Tempus™ RNA stabilization systems

Molecular diagnosis of invasive aspergillosis (IA) is a potentially life-saving tool in the care of at-risk individuals. To date, the development of PCR-based diagnostic tests has been hampered by the lack of standardization in the methods for such critical activities. In this study, we used both spiked volunteer blood samples and a murine model of IA to test the utility of the PAXgene and Tempus systems for stabilization and isolation of fungal RNA from blood as part of an evaluation of a new diagnostic strategy. In spiking experiments, RNA isolation followed by RT-qPCR that targeted the 18S gene was compared to a standard DNA isolation and qPCR assay that targeted the ITS ribosomal region. We demonstrated that both PAXgene and Tempus RNA stabilization and extraction systems followed by RT-qPCR had similar performance in detecting fungal RNA in blood samples from Aspergillus fumigates-infected mice. In spiked samples, the Tempus system performed better than the PAXgene system as it detected 100% of all samples spiked with 10 or 20 germinated Aspergillus conidia/ml blood sample as compared to the PAXgene system which detected 33% and 56% of the samples spiked with 10 or 20 conidia/ml, respectively. The stabilization of fungal nucleic acids in blood samples and its efficient isolation by a commercial method is an important step in the development of standardized molecular diagnostic tools that are needed to improve the outcomes for individuals with IA.

Conversation with Raul Caetano

In this occasional series we record the views and personal experience of people who have especially contributed to the evolution of ideas in the Journal's field of interest. Raul Caetano qualified in medicine in Brazil. While retaining close academic and cultural links with his native country, he has developed a career as an alcohol epidemiologist with research positions first in Berkeley,California and then at the University of Texas. He has contributed very widely to epidemiological research on drinking but with a sustained ability to develop the important ethnic dimensions of such studies.

Levels of methamphetamine use and addiction among gay, bisexual, and other men who have sex with men

Methamphetamine (MA) and poly-drug use among gay, bisexual, and other men who have sex with men (MSM) may be linked to risky sexual behaviors and the subsequent transmission of the human immunodeficiency virus. The goal of this analysis was to examine, quantify, and describe lifetime use of MA as well as MA use in the past year in relation to other substances by means of a standardized diagnostic tool, and along key socio-demographic variables. Data for this analysis were gathered from the screening assessment of a larger cross-sectional study examining MA use and psychosocial states in a sample of 215 MSM in New York City. Based on criteria set forth by the Mini International Neuropsychiatric Inventory, clinical dependence to MA was shown in 78% of participants. Of this group, over 70% were codependent on other substances, including cocaine and Ecstasy. Further, 95% of Black MSM reported MA use in the past year, of which 97% were classified as dependent. These findings suggest that MA continues to be used at significant rates among MSM and often in conjunction with other substances, and is increasingly used and abused by ethnic and racial minority MSM. Findings suggest the need for programs to address multiple drug dependence and in relation to co-occurring health problems.

Understanding Clinicians’ Diagnostic Practices: Attitudes Toward the Utility of Diagnosis and Standardized Diagnostic Tools

Data on clinician diagnostic practices suggest they may not align with evidence-based guidelines. To better understand these practices, a multidisciplinary survey of 1,678 child clinicians examined attitudes toward the utility of diagnosis and standardized diagnostic tools. Psychiatrists were more likely than other disciplines to value diagnosis, whereas psychologists were more likely than others to value standardized diagnostic tools. Private practitioners held less positive views in both domains than other practitioners. Both attitude scales predicted self-reported diagnostic practices, although views of diagnosis utility were more associated with diagnosing in general, whereas views of diagnostic tools were more predictive of standardized tool use.

Bipolar Phenomenology: Have We Learned All We Can Learn?

Bipolar Phenomenology: Have We Learned All We Can Learn?

Pearl Kendrick, Grace Eldering, and the Pertussis Vaccine

In light of the reemergence of pertussis (whooping cough), the pioneering research of Pearl Kendrick and Grace Eldering is worth revisiting. In the 1930s, working in the Michigan Department of Health laboratory in Grand Rapids, Michigan, USA, they began researching a pertussis vaccine. Their research offers an instructive case study of the creative public health research performed in state health department laboratories during the interwar years. State department of health laboratory directors actively promoted research by supporting advanced education; making facilities and funding available for individual projects; and, when possible, procuring new facilities. Using Michigan Department of Health resources and local and federal funding, Kendrick and Eldering developed standardized diagnostic tools; modified and improved extant vaccines; conducted the first successful, large-scale, controlled clinical trial of pertussis vaccine; and participated in international efforts to standardize and disseminate the vaccine. Their model may again offer a promising avenue for groundbreaking research.

Who benefits from early intervention in autism spectrum disorders?

Research in autism spectrum disorders (ASD) described individual differences in response to intervention. This study explored child and parental characteristics at baseline that predict outcomes in adaptive skills and acquisition of cognitive gains. Seventy-eight children aged 15–35 months diagnosed with ASD by standardized diagnostic tools were included. Evaluations of verbal and non-verbal abilities, adaptive skills and autism severity were obtained at pre-intervention (T1) and after one year of intervention (T2). At T2, children improved significantly in their verbal ability and the severity of autism symptoms was reduced. Outcome in adaptive skills was best predicted by baseline verbal ability and maternal age. Better verbal ability especially in those with severe autism symptoms, and older maternal age predicted better adaptive skills outcome. T1 autism severity, child's age and maternal age and educational attainment best predicted cognitive gains. Less severe autism symptoms, younger child's age at start of intervention, older maternal age and higher maternal education predicted greater cognitive gains with intervention. The study suggests biological factors including age, language abilities and autism severity and environmental factors including maternal age and education, impact the ability to benefit from early intervention in ASD.