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Towards complete and accurate reporting of studies of diagnostic accuracy: The STARD Initiative.

OBJECTIVE: To improve the accuracy and completeness of reporting of studies of diagnostic accuracy, to allow readers to assess the potential for bias in the study and to evaluate its generalisability. METHODS: The Standards for Reporting of Diagnostic Accuracy (STARD) steering group searched the literature to identify publications on the appropriate conduct and reporting of diagnostic studies and extracted potential items into an extensive list. Researchers, editors, and members of professional organisations shortened this list during a two-day consensus meeting with the goal of developing a checklist and a generic flow diagram for studies of diagnostic accuracy. RESULTS: The search for published guidelines regarding diagnostic research yielded 33 previously published checklists, from which we extracted a list of 75 potential items. At the consensus meeting, participants shortened the list to a 25-item checklist, using evidence, whenever available. A prototypical flow diagram provides information about the method of patient recruitment, the order of test execution and the numbers of patients undergoing the test under evaluation, the reference standard or both. CONCLUSIONS: Evaluation of research depends on complete and accurate reporting. If medical journals adopt the checklist and the flow diagram, the quality of reporting of studies of diagnostic accuracy should improve to the advantage of the clinicians, researchers, reviewers, journals, and the public.

Algorithms↗

[The Framingham function overestimates stroke risk for diabetes and metabolic syndrome among Spanish population].

OBJECTIVE: To estimate stroke risk for diabetes, isolated or associated to metabolic syndrome (MS) according WHO and National Cholesterol Education Program (NCEP) criteria. DESIGN: Multicentre and prospective cohort study. SETTING: Primary health care. PARTICIPANTS: Subjects between 55-85 years-old without any evidence of stroke, included from 1998 in a random population sample for MS follow-up during routine practice in Reus (Tarragona, Spain). MAIN MEASUREMENTS: Stroke risk was achieved using Framingham function by means of a computerized algorithm using a diagnostic factorial design (diabetes and/or MS). Theoretical stroke risk and cumulated incidence of stroke events (1998-2003) were compared. RESULTS: Among 728 subjects (412 women, mean age =66 years old, body mass index =29 kg/m2), 457 (62.8%) did not have diabetes, nor MS, 93 (12.8%) had MS without diabetes, 72 (9.9%) diabetes without MS, and 106 (14.5%) presented both conditions (WHO rules). According NCEP criteria were 60.7%, 14.8%, 7.8%, and 16.7%, respectively. Ten-year estimated stroke risk accounted for (WHO/NCEP) 8.4/9.1%, 10.8/10.5%, 18/17.3%, and 18.8/19.1%. Cumulated incidence for stroke events were: 2.8%, 1.4%, 5.4%, and 3.8% (WHO), and 2.5%, 2.8%, 3.5%, and 5.8%, respectively (NCEP). CONCLUSIONS: Stroke risk scores were extremely increased among diabetic subjects irrespective to MS diagnose. The Framingham function probably overestimates stroke risk among Spanish individuals.

Diabetes Mellitus, Type 2↗

Clostridium difficile infection: risk factors, medical and surgical management.

BACKGROUND: Clostridium difficile has become recognized as a cause of nosocomial infection which may progress to a fulminant disease. METHODS: Literature review using electronic literature research back to 1966 utilizing Medline and Current Contents. All publications on antibiotic-associated diarrhea, antibiotic-associated colitis, and pseudomembranous colitis as well as C. difficile infection were included. We addressed established and potential risk factors for C. difficile disease such as an impaired immune system and cost benefits of different diagnostic tests. An algorithm is outlined for diagnosis and both medical and surgical management of mild, moderate and severe C. difficile disease. RESULTS: Diagnosis of C. difficile infection should be suspected in patients with diarrhea, who have received antibiotics within 2 months or whose symptoms started after hospitalization. A stool specimen should be tested for the presence of leukocytes and C. difficile toxins. If this is negative and symptoms persist, stool should be tested with 'rapid' enzyme immunoabsorbent and stool cytotoxin assays, which are the most cost-effective tests. Endoscopy and other imaging studies are reserved for severe and rapidly progressive courses. Oral metronidazole or vancomycin are the antibiotics of choice. Surgery is rarely required for selected patients refractory to medical treatment. The threshold for surgery in severe cases with risk factors including an impaired immune system should be low. CONCLUSION: C. difficile infection has been recognized with increased frequency as a nosocomial infection. Early diagnosis with immunoassays of the stool and prompt medical therapy have a high cure rate. Metronidazole has supplanted oral vancomycin as the drug of first choice for treating C. difficile infections.

Bacterial Toxins↗

Management of abnormal uterine bleeding by northern, rural and isolated primary care physicians: PART II: What do we need?

BACKGROUND: Abnormal uterine bleeding (AUB) is a common problem that affects one in five women during the pre-menopausal years. It is frequently managed by family physicians, especially in northern, rural and isolated areas where severe shortages of gynecologists exist. METHODS: We surveyed 194 family physicians in northern, rural and isolated areas of Ontario, Canada to determine their educational and resource needs for the management of AUB, with a specific focus on the relevance and feasibility of using clinical practice guidelines (CPGs). RESULTS: Most physicians surveyed did not use CPGs for the management of AUB because they did not know that such guidelines existed. The majority were interested in further education on the management of AUB through mailed CPGs and locally held training courses. A major theme among respondents was the need for more timely and effective gynecological referrals. CONCLUSION: A one-page diagnostic and treatment algorithm for AUB would be easy to use and would place minimal restrictions on physician autonomy. As the majority of physicians had Internet access, we recommend emailing and web posting in addition to mailing this algorithm. Local, hands-on courses including options for endometrial biopsy training would also be helpful for northern, rural and isolated physicians, many of whom cannot readily take time away from their practices.

Journal Article↗

Application of the development stages of a cluster randomized trial to a framework for valuating complex health interventions.

INTRODUCTION: Trials of complex health interventions often pose difficult methodologic challenges. The objective of this paper is to assess the extent to which the various development steps of a cluster randomized trial to optimize antibiotic use in nursing homes are represented in a recently published framework for the design and evaluation of complex health interventions. In so doing, the utility of the framework for health services researchers is evaluated. METHODS: Using the five phases of the framework (theoretical, identification of components of the intervention, definition of trial and intervention design, methodological issues for main trial, promoting effective implementation), corresponding stages in the development of the cluster randomized trial using diagnostic and treatment algorithms to optimize the use of antibiotics in nursing homes are identified and described. RESULTS: Synthesis of evidence needed to construct the algorithms, survey and qualitative research used to define components of the algorithms, a pilot study to assess the feasibility of delivering the algorithms, methodological issues in the main trial including choice of design, allocation concealment, outcomes, sample size calculation, and analysis are adequately represented using the stages of the framework. CONCLUSIONS: The framework is a useful resource for researchers planning a randomized clinical trial of a complex intervention.

Aged↗

Optimizing antibiotics in residents of nursing homes: protocol of a randomized trial.

BACKGROUND: Antibiotics are frequently prescribed for older adults who reside in long-term care facilities. A substantial proportion of antibiotic use in this setting is inappropriate. Antibiotics are often prescribed for asymptomatic bacteriuria, a condition for which randomized trials of antibiotic therapy indicate no benefit and in fact harm. This proposal describes a randomized trial of diagnostic and therapeutic algorithms to reduce the use of antibiotics in residents of long-term care facilities. METHODS: In this on-going study, 22 nursing homes have been randomized to either use of algorithms (11 nursing homes) or to usual practise (11 nursing homes). The algorithms describe signs and symptoms for which it would be appropriate to send urine cultures or to prescribe antibiotics. The algorithms are introduced by inservicing nursing staff and by conducting one-on-one sessions for physicians using case-scenarios. The primary outcome of the study is courses of antibiotics per 1000 resident days. Secondary outcomes include urine cultures sent and antibiotic courses for urinary indications. Focus groups and semi-structured interviews with key informants will be used to assess the process of implementation and to identify key factors for sustainability.

Aged↗

Evolutional analysis in determining pathogenic versus nonpathogenic mutations of ATPase 6 in human mitochondriopathy.

Because mitochondrial ATPase 6 plays an important role in ATP synthesis, mutations affecting ATPase 6 can undoubtedly cause human diseases. In contrast, the ATPase 6 gene is known to be a fast-evolving gene and has generated enough polymorphisms to allow identity investigation for forensic casework. To investigate these seemingly opposite views, we analyzed amino acid sequences of ATPase 6 in at least 1,266 humans, 102 mammals, and 213 vertebrates. The result showed that the amino acids of human ATPase 6 could be divided into the following four groups. Amino acid residue 192 (affected by alteration at nt 9101) and 79 other residues were variable, and therefore substitutions of these residues would not be pathogenic. Amino acid residue 156 (affected by alteration at nt 8993) and 93 other residues were conserved in Homo sapiens, but not in Mammalia. Therefore, they were potentially pathogenic if altered. Function studies would be necessary to confirm their role in pathogenesis. Amino acid residue 217 (affected by alteration at nt 9176) and 9 other residues were conserved across all species, including S. cerevisiae and E. coli. Mutations involving these residues would be pathogenic, some of which might even be life threatening. The remainder (42 residues) were conserved in Mammalia, but not in yeast and E. coli. They were probably pathogenic if mutated. The classification proposed in this study may, therefore, provide an algorithm for a diagnostic approach when a newly identified change of ATPase 6 is suspected for human mitochondriopathy.

Adenosine Triphosphatases↗

The use of information technologies for diagnosis in ophthalmology.

In 2003, a health IT programme for clinical decision support started in Lithuania. An initial goal was to create databases for ophthalmology images and to develop processing algorithms to extract diagnostically valuable information from images. We have investigated how vectors, consisting of the parameters derived from fundus images, are distributed and whether they form specific groups. When analysing the multidimensional patient data vectors, comprising all the 27 image parameters, it was impossible to separate the healthy eyes from the diseased ones. However, it was possible to simplify the system by eliminating redundant parameters and introducing new ones that represent a subset of parameters from the initial group. Thus it may prove possible to identify glaucoma using this system of parameters.

Diagnostic Techniques, Ophthalmological↗

Toward complete and accurate reporting of studies of diagnostic accuracy. The STARD initiative.

Our objective was to improve the accuracy and completeness of reporting of studies of diagnostic accuracy, to allow readers to assess the potential for bias in the study, and to evaluate its generalizability. The Standards for Reporting of Diagnostic Accuracy Steering Committee searched the literature to identify publications on the appropriate conduct and reporting of diagnostic studies and extracted potential items into an extensive list. Researchers, editors, and members of professional organizations shortened this list during a 2-day consensus meeting with the goal of developing a checklist and a generic flow diagram for studies of diagnostic accuracy. The search for published guidelines regarding diagnostic research yielded 33 previously published checklists, from which we extracted a list of 75 potential items. At the consensus meeting, participants shortened the list to a 25-item checklist, using evidence whenever available. A prototypical flow diagram provides information about the method of patient recruitment, the order of test execution, and the numbers of patients undergoing the test under evaluation, the reference standard, or both. Evaluation of research depends on complete and accurate reporting. If medical journals adopt the checklist and the flow diagram, the quality of reporting of studies of diagnostic accuracy should improve, to the advantage of clinicians, researchers, reviewers, journals, and the public.

Algorithms↗

Towards complete and accurate reporting of studies of diagnostic accuracy: the STARD initiative. Standards for Reporting of Diagnostic Accuracy.

BACKGROUND: To comprehend the results of diagnostic accuracy studies, readers must understand the design, conduct, analysis, and results of such studies. That goal can be achieved only through complete transparency from authors. OBJECTIVE: To improve the accuracy and completeness of reporting of studies of diagnostic accuracy to allow readers to assess the potential for bias in the study and to evaluate its generalisability. METHODS: The Standards for Reporting of Diagnostic Accuracy (STARD) steering committee searched the literature to identify publications on the appropriate conduct and reporting of diagnostic studies and extracted potential items into an extensive list. Researchers, editors, and members of professional organisations shortened this list during a two-day consensus meeting with the goal of developing a checklist and a generic flow diagram for studies of diagnostic accuracy. RESULTS: The search for published guidelines on diagnostic research yielded 33 previously published checklists, from which we extracted a list of 75 potential items. The consensus meeting shortened the list to 25 items, using evidence on bias whenever available. A prototypical flow diagram provides information about the method of patient recruitment, the order of test execution and the numbers of patients undergoing the test under evaluation, the reference standard or both. CONCLUSIONS: Evaluation of research depends on complete and accurate reporting. If medical journals adopt the checklist and the flow diagram, the quality of reporting of studies of diagnostic accuracy should improve to the advantage of clinicians, researchers, reviewers, journals, and the public.

Algorithms↗

The STARD statement for reporting studies of diagnostic accuracy: explanation and elaboration.

The quality of reporting of studies of diagnostic accuracy is less than optimal. Complete and accurate reporting is necessary to enable readers to assess the potential for bias in the study and to evaluate the generalisability of the results. A group of scientists and editors has developed the STARD (Standards for Reporting of Diagnostic Accuracy) statement to improve the reporting the quality of reporting of studies of diagnostic accuracy. The statement consists of a checklist of 25 items and flow diagram that authors can use to ensure that all relevant information is present. This explanatory document aims to facilitate the use, understanding and dissemination of the checklist. The document contains a clarification of the meaning, rationale and optimal use of each item on the checklist, as well as a short summary of the available evidence on bias and applicability. The STARD statement, checklist, flowchart and this explanation and elaboration document should be useful resources to improve reporting of diagnostic accuracy studies. Complete and informative reporting can only lead to better decisions in healthcare.

Algorithms↗

Priapism--a review of the medical management.

Priapism is characterised by the presence of prolonged, often painful penile erection in the absence of a sexual stimulus. This rare condition has a range of aetiologies, but is most common following self-administration of injection therapy for impotence. Priapism may be classified into high- and low-flow states. Low-flow priapism is an emergency ischaemic condition requiring prompt recognition and treatment to avoid devastating long-term complications of erectile dysfunction. Wide-ranging medical therapies are covered in this review. Diagnostic and treatment algorithms are suggested in light of the current available literature.

Humans↗

Breast cancer expression profiling: the impact of microarray testing on clinical decision making.

The available clinical prognostic tools show an obvious limitation in predicting the outcome of breast cancer patients, and pathological features cannot classify tumours accurately. Microarray-based molecular classification of breast tumours or selection of gene expression panels to improve risk prediction or treatment outcomes are thought to be theoretically superior to established clinical and pathological criteria, based on guidelines such as the St Gallen and National Institute of Health consensus, or which use specific prognostic tools, such as the Nottingham Prognostic Index or Adjuvant-Online algorithm. Although two diagnostic tests based on gene expression profiling of breast cancer are commercially available, a new molecular classification and molecular forecasting of breast cancer based on expression profiling cannot outperform the standard tumour diagnostic at present. This review focuses on some important problems in the practical application of molecular profiling of breast cancer for clinical purposes.

Breast Neoplasms↗

Diagnosis and treatment of feeding disorders in children with developmental disabilities.

OBJECTIVES: To determine the results of diagnostic evaluation and the effects of nutritional intervention on energy consumption, weight gain, growth, and clinical status of children with neurodevelopmental disabilities and suspected feeding disorders. METHODS: We studied 79 children with moderate to severe motor or cognitive dysfunction (male:female, 38:41; age, 5.8 +/- 3.7 years) who were referred for diagnosis and treatment of feeding or nutritional problems. Initial assessments included a 3-day calorie intake record, videofluoroscopic swallowing study (VFSS), 24-hour intraesophageal pH monitoring, milk scintigraphy, and esophagogastroduodenoscopy. RESULTS: These studies demonstrated gastroesophageal reflux (GER) with or without aspiration in 44 of 79 patients (56%), oropharyngeal dysphagia in 21 (27%), and aversive feeding behaviors in 14 (18%). Diagnosis-specific approaches included medical GER therapy in 20 patients (25%), fundoplication plus gastrostomy tube (GT) in 18 (23%), oral supplements in 17 (22%), feeding therapy only in 14 (18%), and GT only in 10 (13%). After 24.6 +/- 3.0 months, relative calorie intake, expressed as intake (kcal/d)/recommended daily allowance (RDA, kcal/d), improved significantly (initial:final = 0.78 +/- 0.36:1.23 +/- 0.27). The z scores increased significantly for both weight (initial:final = -2.80 +/- 1.33:-0.81 +/- 0.69) and height (-3.14 +/- 0.98:-2.00 +/- 0.67). Improved subcutaneous tissue stores were demonstrated by increased thickness of both subscapular skinfolds (change = 71% +/- 26%) and triceps skinfolds (38% +/- 17%). After nutritional intervention, the acute care hospitalization rate, compared with the 2-year period before intervention, decreased from 0.4 +/- 0.18 to 0.15 +/- 0.06 admissions per patient-year and included only 3 admissions (0.02 per patient-year) related to feeding problems. CONCLUSIONS: In children with developmental disabilities, diagnosis-specific treatment of feeding disorders results in significantly improved energy consumption and nutritional status. These data also indicate that decreased morbidity (reflected by a lower acute care hospitalization rate) may be related, at least in part, to successful management of feeding problems. Our results emphasize the importance of a structured approach to these problems, and we propose a diagnostic and treatment algorithm for children with developmental disabilities and suspected feeding disorders.children, developmental disabilities, fundoplication, gastroesophageal reflux, gastrostomy, hospitalization, nutrition.

Adolescent↗

[Gastrointestinal stromal tumor of small intestine--case report].

Gastrointestinal stromal tumor is a form of mesenchimal neoplasm that may be present in all parts of gastrointestinal system. We are reviewing diagnostic and therapeutic algorithms for patient with diagnosed gastrointestinal neoplasm of small intestine, experiencing repeated episodes of painful bleeding from gastrointestinal trackt.

Gastrointestinal Hemorrhage↗

Unlinked anonymous HIV screening of pregnant women in a low-prevalence population.

Unlinked anonymous screening was optimized and used for a survey of HIV prevalence in Finland. In 1993, 66,170 serum samples, covering more than 99% of pregnant women in the country were tested in pools of 5 sera. The pools tested were coded but it was possible to trace the region from where the samples had been collected. A total of 5 positive samples were found corresponding to a prevalence of 1/13,000 (0.01%) which is in accordance with prevalence estimates from earlier serosurveys and the national HIV registry. Information from voluntary regional HIV-testing programmes for pregnant women indicated that probably at least 3 of these positive cases had been identified by voluntary testing. Nine commercial EIAs were evaluated to investigate the effect of pooling on sensitivity and specificity of anti-HIV detection. Only 3 EIAs detected all pools with known positive samples. Individual sera from repeatedly positive pools were tested using the same EIA and positive results were confirmed by Western blot. This algorithm saved more than 80% of the cost compared to the conventional test algorithm used in diagnostic laboratories. The savings were mainly due to the reduced number of primary and supplemental tests.

AIDS Serodiagnosis↗

A clinical dilemma: abdominal tuberculosis.

AIM: To evaluate the clinical, radiological and microbiological properties of abdominal tuberculosis (TB) and to discuss methods needed to get the diagnosis. METHODS: Thirty-one patients diagnosed as abdominal TB between March 1998 and December 2001 at the Gastroenterology Department of Kartal State Hospital, Istanbul, Turkey were evaluated prospectively. Complete physical examination, medical and family history, blood count erythrocyte sedimentation rate, routine biochemical tests, Mantoux skin test, chest X-ray and abdominal ultrasonography (USG) were performed in all cases, whereas microbiological examination of ascites, upper gastrointestinal endoscopy, colonoscopy or barium enema, abdominal tomography, mediastinoscopy, laparoscopy or laparotomy were done when needed. RESULTS: The median age of patients (14 females,17 males) was 34.2 years (range 15-65 years). The most frequent symptoms were abdominal pain and weight loss. Eleven patients had active pulmonary TB. The most common abdominal USG findings were ascites and hepatomegaly. Ascitic fluid analysis performed in 13 patients was found to be exudative and acid resistant bacilli were present in smear and cultured only in one patient with BacTec (3.2 %). Upper gastrointestinal endoscopy yielded nonspecific findings in 16 patients. Colonoscopy performed in 20 patients showed ulcers in 9 (45 %), nodules in 2 (10 %) and, stricture, polypoid lesions, granulomatous findings in terminal ileum and rectal fistula each in one patient (5 %). Laparoscopy on 4 patients showed dilated bowel loops, thickening in the mesentery, multiple ulcers and tubercles on the peritoneum. Patients with abdominal TB were divided into three groups according to the type of involvement. Fifteen patients (48 %) had intestinal TB, 11 patients (35.2 %) had tuberculous peritonitis and 5 (16.8 %) tuberculous lymphadenitis. The diagnosis of abdominal TB was confirmed microbiologically in 5 (16 %) and histo-pathologically in 19 patients (60.8 %). The remaining nine patients (28.8 %) had been diagnosed by a positive response to antituberculous treatment. CONCLUSION: Neither clinical signs, laboratory, radiological and endoscopic methods nor bacteriological and histopathological findings provide a gold standard by themselves in the diagnosis of abdominal TB. However, an algorithm of these diagnostic methods leads to considerably higher precision in the diagnosis of this insidious disease which primarily necessitate a clinical awareness of this serious health problem.

Adolescent↗

Diagnosing and treating plantar fasciitis: a conservative approach to plantar heel pain.

Plantar fasciitis is the most common cause of pain at the weight-bearing surface of the heel, and may coexist with other sources of heel pain. This has led to a confusing array of treatment strategies, including surgery. We offer a simple, effective diagnostic and treatment algorithm that emphasizes nonsurgical treatment options for this often frustrating condition.

Algorithms↗