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1.  Interactions between Non-Physician Clinicians and Industry: A Systematic Review 
PLoS Medicine  2013;10(11):e1001561.
In a systematic review of studies of interactions between non-physician clinicians and industry, Quinn Grundy and colleagues found that many of the issues identified for physicians' industry interactions exist for non-physician clinicians.
Please see later in the article for the Editors' Summary
Background
With increasing restrictions placed on physician–industry interactions, industry marketing may target other health professionals. Recent health policy developments confer even greater importance on the decision making of non-physician clinicians. The purpose of this systematic review is to examine the types and implications of non-physician clinician–industry interactions in clinical practice.
Methods and Findings
We searched MEDLINE and Web of Science from January 1, 1946, through June 24, 2013, according to PRISMA guidelines. Non-physician clinicians eligible for inclusion were: Registered Nurses, nurse prescribers, Physician Assistants, pharmacists, dieticians, and physical or occupational therapists; trainee samples were excluded. Fifteen studies met inclusion criteria. Data were synthesized qualitatively into eight outcome domains: nature and frequency of industry interactions; attitudes toward industry; perceived ethical acceptability of interactions; perceived marketing influence; perceived reliability of industry information; preparation for industry interactions; reactions to industry relations policy; and management of industry interactions. Non-physician clinicians reported interacting with the pharmaceutical and infant formula industries. Clinicians across disciplines met with pharmaceutical representatives regularly and relied on them for practice information. Clinicians frequently received industry “information,” attended sponsored “education,” and acted as distributors for similar materials targeted at patients. Clinicians generally regarded this as an ethical use of industry resources, and felt they could detect “promotion” while benefiting from industry “information.” Free samples were among the most approved and common ways that clinicians interacted with industry. Included studies were observational and of varying methodological rigor; thus, these findings may not be generalizable. This review is, however, the first to our knowledge to provide a descriptive analysis of this literature.
Conclusions
Non-physician clinicians' generally positive attitudes toward industry interactions, despite their recognition of issues related to bias, suggest that industry interactions are normalized in clinical practice across non-physician disciplines. Industry relations policy should address all disciplines and be implemented consistently in order to mitigate conflicts of interest and address such interactions' potential to affect patient care.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Making and selling health care goods (including drugs and devices) and services is big business. To maximize the profits they make for their shareholders, companies involved in health care build relationships with physicians by providing information on new drugs, organizing educational meetings, providing samples of their products, giving gifts, and holding sponsored events. These relationships help to keep physicians informed about new developments in health care but also create the potential for causing harm to patients and health care systems. These relationships may, for example, result in increased prescription rates of new, heavily marketed medications, which are often more expensive than their generic counterparts (similar unbranded drugs) and that are more likely to be recalled for safety reasons than long-established drugs. They may also affect the provision of health care services. Industry is providing an increasingly large proportion of routine health care services in many countries, so relationships built up with physicians have the potential to influence the commissioning of the services that are central to the treatment and well-being of patients.
Why Was This Study Done?
As a result of concerns about the tension between industry's need to make profits and the ethics underlying professional practice, restrictions are increasingly being placed on physician–industry interactions. In the US, for example, the Physician Payments Sunshine Act now requires US manufacturers of drugs, devices, and medical supplies that participate in federal health care programs to disclose all payments and gifts made to physicians and teaching hospitals. However, other health professionals, including those with authority to prescribe drugs such as pharmacists, Physician Assistants, and nurse practitioners are not covered by this legislation or by similar legislation in other settings, even though the restructuring of health care to prioritize primary care and multidisciplinary care models means that “non-physician clinicians” are becoming more numerous and more involved in decision-making and medication management. In this systematic review (a study that uses predefined criteria to identify all the research on a given topic), the researchers examine the nature and implications of the interactions between non-physician clinicians and industry.
What Did the Researchers Do and Find?
The researchers identified 15 published studies that examined interactions between non-physician clinicians (Registered Nurses, nurse prescribers, midwives, pharmacists, Physician Assistants, and dieticians) and industry (corporations that produce health care goods and services). They extracted the data from 16 publications (representing 15 different studies) and synthesized them qualitatively (combined the data and reached word-based, rather than numerical, conclusions) into eight outcome domains, including the nature and frequency of interactions, non-physician clinicians' attitudes toward industry, and the perceived ethical acceptability of interactions. In the research the authors identified, non-physician clinicians reported frequent interactions with the pharmaceutical and infant formula industries. Most non-physician clinicians met industry representatives regularly, received gifts and samples, and attended educational events or received educational materials (some of which they distributed to patients). In these studies, non-physician clinicians generally regarded these interactions positively and felt they were an ethical and appropriate use of industry resources. Only a minority of non-physician clinicians felt that marketing influenced their own practice, although a larger percentage felt that their colleagues would be influenced. A sizeable proportion of non-physician clinicians questioned the reliability of industry information, but most were confident that they could detect biased information and therefore rated this information as reliable, valuable, or useful.
What Do These Findings Mean?
These and other findings suggest that non-physician clinicians generally have positive attitudes toward industry interactions but recognize issues related to bias and conflict of interest. Because these findings are based on a small number of studies, most of which were undertaken in the US, they may not be generalizable to other countries. Moreover, they provide no quantitative assessment of the interaction between non-physician clinicians and industry and no information about whether industry interactions affect patient care outcomes. Nevertheless, these findings suggest that industry interactions are normalized (seen as standard) in clinical practice across non-physician disciplines. This normalization creates the potential for serious risks to patients and health care systems. The researchers suggest that it may be unrealistic to expect that non-physician clinicians can be taught individually how to interact with industry ethically or how to detect and avert bias, particularly given the ubiquitous nature of marketing and promotional materials. Instead, they suggest, the environment in which non-physician clinicians practice should be structured to mitigate the potentially harmful effects of interactions with industry.
Additional Information
Please access these websites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001561.
This study is further discussed in a PLOS Medicine Perspective by James S. Yeh and Aaron S. Kesselheim
The American Medical Association provides guidance for physicians on interactions with pharmaceutical industry representatives, information about the Physician Payments Sunshine Act, and a toolkit for preparing Physician Payments Sunshine Act reports
The International Council of Nurses provides some guidance on industry interactions in its position statement on nurse-industry relations
The UK General Medical Council provides guidance on financial and commercial arrangements and conflicts of interest as part of its good medical practice website, which describes what is required of all registered doctors in the UK
Understanding and Responding to Pharmaceutical Promotion: A Practical Guide is a manual prepared by Health Action International and the World Health Organization that schools of medicine and pharmacy can use to train students how to recognize and respond to pharmaceutical promotion.
The Institute of Medicine's Report on Conflict of Interest in Medical Research, Education, and Practice recommends steps to identify, limit, and manage conflicts of interest
The University of California, San Francisco, Office of Continuing Medical Education offers a course called Marketing of Medicines
doi:10.1371/journal.pmed.1001561
PMCID: PMC3841103  PMID: 24302892
2.  Optimum Methadone Compliance Testing 
Executive Summary
Objective
The objective of this analysis was to determine the diagnostic utility of oral fluid testing collected with the Intercept oral fluid collection device.
Clinical Need: Target Population and Condition
Opioids (opiates or narcotics) are a class of drugs derived from the opium poppy plant that typically relieve pain and produce a euphoric feeling. Methadone is a long-acting synthetic opioid used to treat opioid dependence and chronic pain. It prevents symptoms of opioid withdrawal, reduces opioid cravings and blocks the euphoric effects of short-acting opioids such as heroin and morphine. Opioid dependence is associated with harms including an increased risk of exposure to Human Immunodeficiency Virus and Hepatitis C as well as other health, social and psychological crises. The goal of methadone treatment is harm reduction. Treatment with methadone for opioid dependence is often a long-term therapy. The Ontario College of Physicians and Surgeons estimates that there are currently 250 physicians qualified to prescribe methadone, and 15,500 people in methadone maintenance programs across Ontario.
Drug testing is a clinical tool whose purpose is to provide objective meaningful information, which will reinforce positive behavioral changes in patients and guide further treatment needs. Such information includes knowledge of whether the patient is taking their methadone as prescribed and reducing or abstaining from using opioid and other drugs of abuse use. The results of drug testing can be used with behavior modification techniques (contingency management techniques) where positive reinforcements such as increased methadone take-home privileges, sustained employment or parole are granted for drug screens negative for opioid use, and negative reinforcement including loss of these privileges for drug screens positive for opioid used.
Body fluids including blood, oral fluid, often referred to as saliva, and urine may contain metabolites and the parent drug of both methadone and drugs of abuse and provide a means for drug testing. Compared with blood which has a widow of detection of several hours, urine has a wider window of detection, approximately 1 to 3 days, and is therefore considered more useful than blood for drug testing. Because of this, and the fact that obtaining a urine specimen is relatively easy, urine drug screening is considered the criterion measure (gold standard) for methadone maintenance monitoring. However, 2 main concerns exist with urine specimens: the possibility of sample tampering by the patient and the necessity for observed urine collection. Urine specimens may be tampered with in 3 ways: dilution, adulteration (contamination) with chemicals, and substitution (patient submits another persons urine specimen). To circumvent sample tampering the supervised collection of urine specimens is a common and recommended practice. However, it has been suggested that this practice may have negative effects including humiliation experienced by patient and staff, and may discourage patients from staying in treatment. Supervised urine specimen collection may also present an operational problem as staff must be available to provide same-sex supervision. Oral fluid testing has been proposed as a replacement for urine because it can be collected easily under direct supervision without infringement of privacy and reduces the likelihood of sample tampering. Generally, the results of oral fluid drug testing are similar to urine drug testing but there are some differences, such as lower concentrations of substances in oral fluid than urine, and some drugs remain detectable for longer periods of time in urine than oral fluid.
The Technology Being Reviewed
The Intercept Oral Specimen Collection Device (Ora-Sure Technologies, Bethlehem, PA) consists of an absorbent pad mounted on a plastic stick. The pad is coated with common salts. The absorbent pad is inserted into the mouth and placed between the cheek and gums for 3 minutes on average. The pad absorbs the oral fluid. After 3 minutes (range 2min-5 min) the collection device is removed from the mouth and the absorbent pad is placed in a small vial which contains 0.8mL of pH-balanced preservative, for transportation to a laboratory for analysis. It is recommended that the person undergoing oral fluid drug testing have nothing to eat or drink for a 10- minute period before the oral fluid specimen is collected. This will remove opportunity for adulteration. Likewise, it is recommended that the person be observed for the duration of the collection period to prevent adulteration of the specimen. An average of 0.4 mL of saliva can be collected. The specimen may be stored at 4C to 37C and tested within 21 days of collection (or within 6 weeks if frozen).
The oral fluid specimen must be analyzed in a laboratory setting. There is no point-of-care (POC) oral fluid test kit for drugs of abuse (other than for alcohol). In the laboratory the oral fluid is extracted from the vial after centrifugation and a screening test is completed to eliminate negative specimens. Similar to urinalysis, oral fluid specimens are analyzed first by enzyme immunoassay with positive specimens sent for confirmatory testing. Comparable cut-off values to urinalysis by enzyme immunoassay have been developed for oral fluids
Review Strategy
 
Research Question
What is the diagnostic utility of the Intercept oral specimen device?
Inclusion criteria:
Studies evaluating paired urine and oral fluid specimens from the same individual with the Intercept oral fluid collection device.
The population studied includes drug users.
Exclusion criteria:
Studies testing for marijuana (THC) only.
Outcomes:
Sensitivity and Specificity of oral fluid testing compared to urinalysis for methadone (methadone metabolite), opiates, cocaine, benzodiazepines, and alcohol.
Quality of the Body of Evidence
The Grading of Recommendations Assessment, Development and Evaluation (GRADE) system was used to evaluate the overall quality of the body of evidence (defined as 1 or more studies) supporting the research questions explored in this systematic review. A description of the GRADE system is reported in Appendix 1.
Summary of Findings
A total of 854 potential citations were retrieved. After reviewing titles and abstracts, 2 met the inclusion and exclusion criteria. Two other relevant studies were found after corresponding with the author of the 2 studies retrieved from the literature search. Therefore a total of 4 published studies are included in this analysis. All 4 studies carried out by the same investigator meet the definition of Medical Advisory Secretariat level III (not a-randomized controlled trial with contemporaneous controls) study design. In each of the studies, paired urine and oral fluid specimens where obtained from drug users. Urine collection was not observed in the studies however, laboratory tests for pH and creatinine were used to determine the reliability of the specimen. Urine specimens thought to be diluted and unreliable were removed from the evaluation. Urinalysis was used as the criterion measurement for which to determine the sensitivity and specificity of oral fluid testing by the Intercept oral fluid device for opiates, benzodiazepines, cocaine and marijuana. Alcohol was not tested in any of the 4 studies. From these 4 studies, the following conclusions were drawn:
The evidence indicates that oral fluid testing with the Intercept oral fluid device has better specificity than sensitivity for opiates, benzodiazepines, cocaine and marijuana.
The sensitivity of oral fluids testing with the Intercept oral fluid device seems to be from best to worst: cocaine > benzodiazepines >opiates> marijuana.
The sensitivity and specificity for opiates of the Intercept oral fluid device ranges from 75 to 90% and 97- 100% respectively.
The consequences of opiate false-negatives by oral fluid testing with the Intercept oral fluid device need to be weighed against the disadvantages of urine testing, including invasion of privacy issues and adulteration and substitution of the urine specimen.
The window of detection is narrower for oral fluid drug testing than urinalysis and because of this oral fluid testing may best be applied in situations where there is suspected frequent drug use. When drug use is thought to be less frequent or remote, urinalysis may offer a wider (24-48 hours more than oral fluids) window of detection.
The narrow window of detection for oral fluid testing may mean more frequent testing is needed compared to urinalysis. This may increase the expense for drug testing in general.
POC oral fluid testing is not yet available and may limit the practical utility of this drug testing methodology. POC urinalysis by immunoassay is available.
The possible applications of oral fluid testing may include:
Because of its narrow window of detection compared to urinalysis oral fluid testing may best be used during periods of suspected frequent or recent drug use (within 24 hours of drug testing). This is not to say that oral fluid testing is superior to urinalysis during these time periods.
In situations where an observed urine specimen is difficult to obtain. This may include persons with “shy bladder syndrome” or with other urinary conditions limiting their ability to provide an observed urine specimen.
When the health of the patient would make urine testing unreliable (e,g., renal disease)
As an alternative drug testing method when urine specimen tampering practices are suspected to be affecting the reliability of the urinalysis test.
Possible limiting Factors to Diffusion of Oral Fluid Technology
No oral fluid POC test equivalent to onsite urine dips or POC analyzer reducing immediacy of results for patient care.
Currently, physicians get reimbursed directly for POC urinalysis. Oral fluid must be analyzed in a lab setting removing physician reimbursement, which is a source of program funding for many methadone clinics.
Small amount of oral fluid specimen obtained; repeat testing on same sample will be difficult.
Reliability of positive oral fluid methadone (parent drug) results may decrease because of possible contamination of oral cavity after ingestion of dose. Therefore high methadone levels may not be indicative of compliance with treatment. Oral fluid does not as yet test for methadone metabolite.
There currently is no licensed provincial laboratory that analyses oral fluid specimens.
Abbreviations
2-ethylidene- 1,5-dimethyl-3,3-diphenylpyrrolidine
enzyme immunoassay
Enzyme Linked Immunosorbent Assay (ELISA),
Enzyme Multiplied Immunoassay Test (EMIT)
Gas chromatography
gas chromatography/mass spectrometry
High-performance liquid chromatography
Limit of Detection
Mass spectrometry
Methadone Maintenance Treatment
Oral fluid testing
Phencyclidine
Point of Care Testing
tetrahydrocannabinol
11-nor-delta-9-tetrhydrocannabinol-9-carboxylic acid
urine drug testing
PMCID: PMC3379523  PMID: 23074492
3.  The attitude of Belgian social insurance physicians towards evidence-based practice and clinical practice guidelines 
BMC Family Practice  2009;10:64.
Background
Evidence-based medicine has broadened its scope and is starting to reach insurance medicine. Although still in its initial stages, physicians in the area of insurance medicine should keep up-to-date with the evidence on various diseases in order to correctly assess disability and to give appropriate advice about health care reimbursement. In order to explore future opportunities of evidence-based medicine to improve daily insurance medicine, there is a need for qualitative studies to better understand insurance physicians' perceptions of EBM. The present study was designed to identify the attitude of insurance physicians towards evidence-based medicine and clinical practice guidelines, and to determine their ability to access, retrieve and appraise the health evidence and the barriers for applying evidence to practice.
Methods
A cross-sectional survey study was carried out among all Dutch-speaking insurance physicians employed at one of the six Belgian social insurance sickness funds and at the National Institute of Disability and Health care Insurance (n = 224). Chi-square tests were used to compare nominal and ordinal variables. Student's t-tests, ANOVA, Mann-Whitney and Kruskal-Wallis were used to compare means of continuous variables for different groups.
Results
The response rate was 48.7%. The majority of respondents were positive towards evidence-based medicine and clinical practice guidelines. Their knowledge of EBM was rather poor. Perceived barriers for applying evidence to practice were mainly time and lack of EBM skills.
Conclusion
Although the majority of physicians were positive towards EBM and welcomed more guidelines, the use of evidence and clinical practice guidelines in insurance medicine is low at present. It is in the first place important to eradicate the perceived inertia which limits the use of EBM and to further investigate the EBM principles in the context of insurance medicine. Available high-quality evidence-based resources (at the moment mainly originating from other medical fields) need to be structured in a way that is useful for insurance physicians and global access to this information needs to be ensured.
doi:10.1186/1471-2296-10-64
PMCID: PMC2745368  PMID: 19740436
4.  Epidemiological urinalysis of children from kindergartens of Can Gio, Ho Chi Minh City - Vietnam 
BMC Pediatrics  2013;13:183.
Background
Recent studies on Vietnamese children have shown that kidney diseases are not detected early enough to prevent chronic renal failure. The dipstick test is a simple and useful tool for detecting urinary abnormalities, especially in isolated or remote areas of Vietnam, where children have limited access to health care.
Methods
This cross-sectional study was conducted in 2011 at seven kindergartens in Can Gio district, Ho Chi Minh City, Vietnam. Two thousand and twelve children, aged 3 to 5, were enrolled. Morning mid-stream urine samples were examined by dipstick. Children with abnormal findings were re-examined with a second dipstick and underwent further investigations.
Results
Urinalysis was available for 1,032 boys and 980 girls. Mean age was 4.4 ± 0.8 years. Urinary abnormalities were detected in 108 (5.5%) of the subjects. Among them, nitrituria and leucocyturia accounted for more than 50%. Positive fractions of proteinuria, hematuria, nitrituria, leucocyturia, and combined nitrituria and leucocyturia after two dipsticks were 0.1%, 0.1%, 2%, 1% and 0.3%, respectively. Abnormal findings were more common in girls than boys (p < 0.001), and higher in communes with very low (< 50 persons/km2) population density (14.3% vs 4.1%, p < 0.001). A renal ultrasound detected four cases of hydronephrosis and one case of duplication of ureter.
Conclusions
The prevalence of urinary abnormalities in asymptomatic children in South Vietnam demonstrates the need for hygiene education among parents. Training for dipstick usage for all medical staff at health stations, especially in remote areas and in places with very low population density, is also clearly necessary. Routine urinalysis can be set up if a close control is conducted at locations.
doi:10.1186/1471-2431-13-183
PMCID: PMC3829665  PMID: 24206763
Chronic kidney disease; Dipstick; Urinary screening; Can Gio; Vietnam
5.  New Rapid Diagnostic Tests for Neisseria meningitidis Serogroups A, W135, C, and Y 
PLoS Medicine  2006;3(9):e337.
Background
Outbreaks of meningococcal meningitis (meningitis caused by Neisseria meningitidis) are a major public health concern in the African “meningitis belt,” which includes 21 countries from Senegal to Ethiopia. Of the several species that can cause meningitis, N. meningitidis is the most important cause of epidemics in this region. In choosing the appropriate vaccine, accurate N. meningitidis serogroup determination is key. To this end, we developed and evaluated two duplex rapid diagnostic tests (RDTs) for detecting N. meningitidis polysaccharide (PS) antigens of several important serogroups.
Methods and Findings
Mouse monoclonal IgG antibodies against N. meningitidis PS A, W135/Y, Y, and C were used to develop two immunochromatography duplex RDTs, RDT1 (to detect serogroups A and W135/Y) and RDT2 (to detect serogroups C and Y). Standards for Reporting of Diagnostic Accuracy criteria were used to determine diagnostic accuracy of RDTs on reference strains and cerebrospinal fluid (CSF) samples using culture and PCR, respectively, as reference tests. The cutoffs were 105 cfu/ml for reference strains and 1 ng/ml for PS. Sensitivities and specificities were 100% for reference strains, and 93.8%–100% for CSF serogroups A, W135, and Y in CSF. For CSF serogroup A, the positive and negative likelihood ratios (± 95% confidence intervals [CIs]) were 31.867 (16.1–63.1) and 0.065 (0.04–0.104), respectively, and the diagnostic odds ratio (± 95% CI) was 492.9 (207.2–1,172.5). For CSF serogroups W135 and Y, the positive likelihood ratio was 159.6 (51.7–493.3) Both RDTs were equally reliable at 25 °C and 45 °C.
Conclusions
These RDTs are important new bedside diagnostic tools for surveillance of meningococcus serogroups A and W135, the two serogroups that are responsible for major epidemics in Africa.
There are several strains ofNeisseria meningitidis that can cause seasonal outbreaks of meningitis in Africa. Treatment of patients and containment of the epidemic through vaccination depends on which strain is responsible. The new dipstick tests described here are accurate and suitable for storage and use in resource-poor settings.
Editors' Summary
Background
Bacterial meningitis, a potentially deadly infection of tissues that line the brain and spinal cord, affects over 1 million people each year. Patients with bacterial meningitis usually have fever, headache, and stiff neck, and may become unconscious and die if the disease is not treated within hours. Most cases of bacterial meningitis occur in Africa, particularly in the arid savannah region south of the Sahara known as the Sahel, where epidemic outbreaks of meningitis occur periodically. This region, also called the “meningitis belt,” extends from Senegal and adjacent coastal countries in West Africa across the continent to Ethiopia. Although most outbreaks tend to occur in the dry season, they differ in frequency in different areas of the meningitis belt, and may involve any of several kinds of bacteria. One of the major causes of epidemic meningitis is Neisseria meningitidis, a meningococcus bacterium that exists in several different groups. Group A has been a common cause of epidemic meningitis in Africa, and some outbreaks were due to group C. More recently, group W135 has emerged as an epidemic strain. In addition to prompt diagnosis and treatment of individual cases, effective public health strategies for controlling meningococcal meningitis include rapid identification of outbreaks and determination of the type of bacteria involved, followed by mass vaccination of people in the surrounding area without delay. Vaccines are chosen on the basis of the responsible meningococcal serogroup: either the inexpensive bivalent vaccine A/C or the expensive, less readily available trivalent vaccine A/C/W135. Before the advent of W135 as an epidemic clone, bivalent vaccine was applied in the meningitis belt without identification of the serogroup. With the appearance of the W135 strain in 2003, however, the determination of serogroup before vaccination is important to select an effective vaccine and avoid misspending of limited funds.
Why Was This Study Done?
Because there are few laboratories in the affected countries and epidemiological surveillance systems are inadequate, it is difficult for health authorities to mount a rapid and effective vaccination campaign in response to an outbreak. In addition, because the two main bacteria (meningococcus and pneumococcus) that cause meningitis require different antibiotic treatments, it is important for doctors to find out quickly which bacteria is causing an individual case. The authors of this study wanted to develop a rapid and easy test that can tell whether meningococcus is the cause of a particular case of meningitis, and if so, which group of meningococcus is involved. As most outbreaks in the meningitis belt occur in rural areas that are distant from well-equipped medical laboratories, it was necessary to develop a test that can be carried out at the patient's bedside by nurses, does not require refrigeration or laboratory equipment, and is highly accurate in distinguishing among the different groups of meningococcus.
What Did the Researchers Do and Find?
The researchers have developed a rapid test to determine whether a patient's meningitis is caused by one of the four most common groups of meningococcus circulating in Africa. The test is done on the patient's spinal fluid, which is obtained by a lumbar puncture (spinal tap) as part of the usual evaluation of a patient thought to have meningitis. The test uses two paper strips, also called dipsticks (one for groups A and W135/Y, and the other for groups C and Y), that can be placed in two separate tubes of the patient's spinal fluid. After several minutes, the appearance of red lines on the dipsticks shows whether one of the four groups of meningococcus is present. The dipsticks can be produced in large quantities and relatively cheaply. The researchers showed that the test dipsticks are stable for weeks in hot weather, and are therefore practical for bedside use in resource-poor settings. They examined the test on stored spinal fluid from patients in Niger and found that the dipstick test was able to identify the correct group of meningococcus more than 95% of the time for the three groups represented in these specimens (the results were compared to a standard DNA test or culture that are highly accurate for identifying the type of bacteria present but much more complicated and expensive).
What Do These Findings Mean?
The new dipstick test for meningococcal meningitis represents a major advance for health-care workers in remote locations affected by meningitis epidemics. This test can be stored without refrigeration and used at bedside in the hot temperatures typical of the African savannah during the meningitis season. The dipsticks are easier to use than currently available test kits, give more rapid results, and are more accurate in telling the difference between group Y and the increasingly important group W135. Further research is needed to determine whether the test can be used with other clinical specimens (such as blood or urine), and whether the test is dependable for detecting group C meningococcus, which is common in Europe but rare in Africa. Nonetheless, the dipstick test promises to be an important tool for guiding individual treatment decisions as well as public health actions, including vaccine selection, against the perennial threat of epidemic meningitis.
Additional Information.
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.0030337.
World Health Organization fact sheet on meningococcal meningitis
PATH Meningitis Vaccine Project
US Centers for Disease Control and Prevention page on meningococcal disease
doi:10.1371/journal.pmed.0030337
PMCID: PMC1563501  PMID: 16953658
6.  Physicians' Initial Management of Acute Low Back Pain Versus Evidence-Based Guidelines 
Journal of General Internal Medicine  2005;20(12):1132-1135.
Background
Little information is available on physician characteristics and patient presentations that may influence compliance with evidence-based guidelines for acute low back pain.
Objective
To assess whether physicians' management decisions are consistent with the Agency for Health Research Quality's guideline and whether responses varied with the presentation of sciatica or by physician characteristics.
Design
Cross-sectional study using a mailed survey.
Participants
Participants were randomly selected from internal medicine, family practice, general practice, emergency medicine, and occupational medicine specialties.
Measurements
A questionnaire asked for recommendations for 2 case scenarios, representing patients without and with sciatica, respectively.
Results
Seven hundred and twenty surveys were completed (response rate=25%). In cases 1 (without sciatica) and 2 (with sciatica), 26.9% and 4.3% of physicians fully complied with the guideline, respectively. For each year in practice, the odds of guideline noncompliance increased 1.03 times (95% confidence interval [CI]=1.01 to 1.05) for case 1. With occupational medicine as the referent specialty, general practice had the greatest odds of noncompliance (3.60, 95% CI=1.75 to 7.40) in case 1, followed by internal medicine and emergency medicine. Results for case 2 reflected the influence of sciatica with internal medicine having substantially higher odds (vs case 1) and the greatest odds of noncompliance of any specialty (6.93, 95% CI=1.47 to 32.78), followed by family practice and emergency medicine.
Conclusions
A majority of primary care physicians continue to be noncompliant with evidence-based back pain guidelines. Sciatica dramatically influenced clinical decision-making, increasing the extent of noncompliance, particularly for internal medicine and family practice. Physicians' misunderstanding of sciatica's natural history and belief that more intensive initial management is indicated may be factors underlying the observed influence of sciatica.
doi:10.1111/j.1525-1497.2005.0230.x
PMCID: PMC1490268  PMID: 16423103
back pain; guidelines; practice variation; clinical vignette; decision making
7.  Correlation between dipstick urinalysis and urine sediment microscopy in detecting haematuria among children with sickle cell anaemia in steady state in Ilorin, Nigeria 
Introduction
Haematuria is one of the clinical manifestations of sickle cell nephropathy. Although dipstick urinalysis detects haemoglobin and by extension haematuria; it does not confirm haematuria. Urine sediment microscopy confirms haematuria and constitutes a non-invasive “renal biopsy”. The need to correlate dipstick urinalysis and urine sediment microscopy findings becomes important because of the cheapness, quickness and simplicity of the former procedure.
Methods
Dipstick urinalysis and urine sediment microscopy were carried (both on first contact and a month after) among consecutive steady state sickle cell anaemia children attending sickle cell clinic at the University of Ilorin Teaching Hospital between October 2004 and July 2005.
Results
A total of 75 sickle cell anemia children aged between 1-17 years met the inclusion criteria. Haematuria was found in 12 children (16.0%) and persistent haematuria in 10 children 13.3%. Age and gender did not have significant relationship with haematuria both at first contact (p values 0.087 and 0.654 respectively) and at follow-up (p values 0.075 and 0.630 respectively). Eumorphic haematuria was confirmed in all the children with persistent haematuria with Pearson correlation +0.623 and significant p value of 0.000.
Conclusion
The study has revealed a direct significant correlation for haematuria detected on dipstick urinalysis and at urine sediment microscopy. It may therefore be inferred that dipstick urinalysis is an easy and readily available tool for the screening of haematuria among children with sickle cell anaemia and should therefore be done routinely at the sickle cell clinics.
doi:10.11604/pamj.2013.15.135.1854
PMCID: PMC3852513  PMID: 24319525
Sickle cell nephropathy; children; haematuria; dipstick urinalysis; urine sediment microscopy
8.  Design of the Balance@Work project: systematic development, evaluation and implementation of an occupational health guideline aimed at the prevention of weight gain among employees 
BMC Public Health  2009;9:461.
Background
Occupational health professionals may play an important role in preventive health promotion activities for employees. However, due to a lack of knowledge and evidence- and practice based methods and strategies, interventions are hardly being implemented by occupational physicians to date. The aim of the Balance@Work project is to develop, evaluate, and implement an occupational health guideline aimed at the prevention of weight gain among employees.
Methods
Following the guideline development protocol of the Netherlands Society of Occupational Medicine and the Intervention Mapping protocol, the guideline was developed based on literature, interviews with relevant stakeholders, and consensus among an expert group. The guideline consists of an individual and an environmental component. The individual component includes recommendations for occupational physicians on how to promote physical activity and healthy dietary behavior based on principles of motivational interviewing. The environmental component contains an obesogenic environment assessment tool. The guideline is evaluated in a randomised controlled trial among 20 occupational physicians. Occupational physicians in the intervention group apply the guideline to eligible workers during 6 months. Occupational physicians in the control group provide care as usual. Measurements take place at baseline and 6, 12, and 18 months thereafter. Primary outcome measures include waist circumference, daily physical activity and dietary behavior. Secondary outcome measures include sedentary behavior, determinants of behavior change, body weight and body mass index, cardiovascular disease risk profile, and quality of life. Additionally, productivity, absenteeism, and cost-effectiveness are assessed.
Discussion
Improving workers' daily physical activity and dietary behavior may prevent weight gain and subsequently improve workers' health, increase productivity, and reduce absenteeism. After an effect- and process evaluation the guideline will be adjusted and, after authorisation, published. Together with several implementation aids, the published guideline will be disseminated broadly by the Netherlands Society of Occupational Medicine.
Trial Registration
ISRCTN73545254/NTR1190
doi:10.1186/1471-2458-9-461
PMCID: PMC2799413  PMID: 20003405
9.  Feasibility and impact of an evidence-based electronic decision support system for diabetes care in family medicine: protocol for a cluster randomized controlled trial 
Background
In Belgium, the construction of the national electronic point-of-care information service, EBMPracticeNet, was initiated in 2011 to optimize quality of care by promoting evidence-based decision-making. The collaboration of the government, healthcare providers, Evidence-Based Medicine (EBM) partners, and vendors of Electronic Health Records (EHR) is unique to this project. All Belgian healthcare professionals get free access to an up-to-date database of validated Belgian and nearly 1,000 international guidelines, incorporated in a portal that also provides EBM information from sources other than guidelines, including computerized clinical decision support that is integrated in the EHRs.
The EBMeDS system is the electronic evidence-based decision support system of EBMPracticeNet. The EBMeDS system covers all clinical areas of diseases and could play a crucial role in response to the emerging challenge posed by chronic conditions. Diabetes was chosen as the analysis topic of interest. The objective of this study is to assess the effectiveness of EBMeDS use in improving diabetes care. This objective will be enhanced by a formal process evaluation to provide crucial information on the feasibility of using the system in daily Belgian family medicine.
Methods
The study is a cluster-randomized trial with before/after measurements conducted in Belgian family medicine. Physicians’ practices will be randomly assigned to the intervention or control group in a 1:1 ratio, to receive either the EBMeDS reminders or to follow the usual care process. Randomization will be performed by a statistical consultant with an electronic random list generator, anonymously for the researchers. The follow-up period of the study will be 12 months with interim analysis points at 3, 6 and 9 months. Primary outcome is the one-year pre- to post-implementation change in HbA1c. Patients will not be informed about the intervention. Data analysts will be kept blinded to the allocation.
Discussion
The knowledge obtained in this study will be useful for further integration in other Belgian software packages. Users’ perceptions and process evaluation will provide information for improving the feasibility of the system.
Trial registration
The trial is registered with the ClinicalTrials.gov registry: NCT01830569.
doi:10.1186/1748-5908-8-83
PMCID: PMC3751256  PMID: 23915250
Diabetes mellitus; Decision support systems; Clinical; Point-of-care systems; Electronic health records; Guideline implementation
10.  EBMPracticeNet: A Bilingual National Electronic Point-Of-Care Project for Retrieval of Evidence-Based Clinical Guideline Information and Decision Support 
JMIR Research Protocols  2013;2(2):e23.
Background
In Belgium, the construction of a national electronic point-of-care information service, EBMPracticeNet, was initiated in 2011 to optimize quality of care by promoting evidence-based decision-making. The collaboration of the government, health care providers, evidence-based medicine (EBM) partners, and vendors of electronic health records (EHR) is unique to this project. All Belgian health care professionals get free access to an up-to-date database of validated Belgian and nearly 1000 international guidelines, incorporated in a portal that also provides EBM information from other sources than guidelines, including computerized clinical decision support that is integrated in the EHRs.
Objective
The objective of this paper was to describe the development strategy, the overall content, and the management of EBMPracticeNet which may be of relevance to other health organizations creating national or regional electronic point-of-care information services.
Methods
Several candidate providers of comprehensive guideline solutions were evaluated and one database was selected. Translation of the guidelines to Dutch and French was done with translation software, post-editing by translators and medical proofreading. A strategy is determined to adapt the guideline content to the Belgian context. Acceptance of the computerized clinical decision support tool has been tested and a randomized controlled trial is planned to evaluate the effect on process and patient outcomes.
Results
Currently, EBMPracticeNet is in "work in progress" state. Reference is made to the results of a pilot study and to further planned research including a randomized controlled trial.
Conclusions
The collaboration of government, health care providers, EBM partners, and vendors of EHRs is unique. The potential value of the project is great. The link between all the EHRs from different vendors and a national database held on a single platform that is controlled by all EBM organizations in Belgium are the strengths of EBMPracticeNet.
doi:10.2196/resprot.2644
PMCID: PMC3713937  PMID: 23842038
evidence-based medicine; practice guidelines as topic; decision support systems; clinical; point-of-care systems; biomedical technology; medical informatics; information storage and retrieval; information management; ambulatory care information systems
11.  Can urine dipstick testing for urinary tract infection at point of care reduce laboratory workload? 
Journal of Clinical Pathology  2005;58(9):951-954.
Aim: The University Hospitals of Leicester NHS Trust microbiology laboratory receives 150 000 urine samples each year, approximately 80% of which prove to be culture negative. The aim of this study was to reduce the proportion of culture negative urines arriving in the laboratory, by producing local evidence based guidelines for the use of urine dipstick testing at point of care within the trust’s three acute hospitals.
Methods: One thousand and seventy six unborated urine samples were dipstick tested at the point of care using an automatic strip reader. Quantitative results for the four infection associated markers—leucocyte esterase, nitrite, blood, and protein—were compared with the results of conventional laboratory microscopy and culture.
Results: The performance of different marker combinations was calculated against the routine laboratory methods. One hundred and seventy five (16.3%) samples were negative for all four markers. Of these dipstick negative samples, only three (1.7% of all true positives) were positive by culture. The absence of all four infection associated markers was found to have a greater than 98% negative predictive value and a sensitivity and specificity of 98.3% and 19.2%, respectively.
Conclusions: A urinary dipstick testing algorithm for infection associated markers was derived for use in hospital patients to screen out negative urines. Two years after distributing the algorithm and promoting access to reagent strips and strip readers, a reduction in the urine workload has been seen against an otherwise increasing laboratory specimen load.
doi:10.1136/jcp.2004.025429
PMCID: PMC1770822  PMID: 16126876
algorithm; infection associated markers; urinary tract infection; urine dipstick testing; workload
12.  A Risk Prediction Model for the Assessment and Triage of Women with Hypertensive Disorders of Pregnancy in Low-Resourced Settings: The miniPIERS (Pre-eclampsia Integrated Estimate of RiSk) Multi-country Prospective Cohort Study 
PLoS Medicine  2014;11(1):e1001589.
Beth Payne and colleagues use a risk prediction model, the Pre-eclampsia Integrated Estimate of RiSk (miniPIERS) to help inform the clinical assessment and triage of women with hypertensive disorders of pregnancy in low-resourced settings.
Please see later in the article for the Editors' Summary
Background
Pre-eclampsia/eclampsia are leading causes of maternal mortality and morbidity, particularly in low- and middle- income countries (LMICs). We developed the miniPIERS risk prediction model to provide a simple, evidence-based tool to identify pregnant women in LMICs at increased risk of death or major hypertensive-related complications.
Methods and Findings
From 1 July 2008 to 31 March 2012, in five LMICs, data were collected prospectively on 2,081 women with any hypertensive disorder of pregnancy admitted to a participating centre. Candidate predictors collected within 24 hours of admission were entered into a step-wise backward elimination logistic regression model to predict a composite adverse maternal outcome within 48 hours of admission. Model internal validation was accomplished by bootstrapping and external validation was completed using data from 1,300 women in the Pre-eclampsia Integrated Estimate of RiSk (fullPIERS) dataset. Predictive performance was assessed for calibration, discrimination, and stratification capacity. The final miniPIERS model included: parity (nulliparous versus multiparous); gestational age on admission; headache/visual disturbances; chest pain/dyspnoea; vaginal bleeding with abdominal pain; systolic blood pressure; and dipstick proteinuria. The miniPIERS model was well-calibrated and had an area under the receiver operating characteristic curve (AUC ROC) of 0.768 (95% CI 0.735–0.801) with an average optimism of 0.037. External validation AUC ROC was 0.713 (95% CI 0.658–0.768). A predicted probability ≥25% to define a positive test classified women with 85.5% accuracy. Limitations of this study include the composite outcome and the broad inclusion criteria of any hypertensive disorder of pregnancy. This broad approach was used to optimize model generalizability.
Conclusions
The miniPIERS model shows reasonable ability to identify women at increased risk of adverse maternal outcomes associated with the hypertensive disorders of pregnancy. It could be used in LMICs to identify women who would benefit most from interventions such as magnesium sulphate, antihypertensives, or transportation to a higher level of care.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Each year, ten million women develop pre-eclampsia or a related hypertensive (high blood pressure) disorder of pregnancy and 76,000 women die as a result. Globally, hypertensive disorders of pregnancy cause around 12% of maternal deaths—deaths of women during or shortly after pregnancy. The mildest of these disorders is gestational hypertension, high blood pressure that develops after 20 weeks of pregnancy. Gestational hypertension does not usually harm the mother or her unborn child and resolves after delivery but up to a quarter of women with this condition develop pre-eclampsia, a combination of hypertension and protein in the urine (proteinuria). Women with mild pre-eclampsia may not have any symptoms—the condition is detected during antenatal checks—but more severe pre-eclampsia can cause headaches, blurred vision, and other symptoms, and can lead to eclampsia (fits), multiple organ failure, and death of the mother and/or her baby. The only “cure” for pre-eclampsia is to deliver the baby as soon as possible but women are sometimes given antihypertensive drugs to lower their blood pressure or magnesium sulfate to prevent seizures.
Why Was This Study Done?
Women in low- and middle-income countries (LMICs) are more likely to develop complications of pre-eclampsia than women in high-income countries and most of the deaths associated with hypertensive disorders of pregnancy occur in LMICs. The high burden of illness and death in LMICs is thought to be primarily due to delays in triage (the identification of women who are or may become severely ill and who need specialist care) and delays in transporting these women to facilities where they can receive appropriate care. Because there is a shortage of health care workers who are adequately trained in the triage of suspected cases of hypertensive disorders of pregnancy in many LMICs, one way to improve the situation might be to design a simple tool to identify women at increased risk of complications or death from hypertensive disorders of pregnancy. Here, the researchers develop miniPIERS (Pre-eclampsia Integrated Estimate of RiSk), a clinical risk prediction model for adverse outcomes among women with hypertensive disorders of pregnancy suitable for use in community and primary health care facilities in LMICs.
What Did the Researchers Do and Find?
The researchers used data on candidate predictors of outcome that are easy to collect and/or measure in all health care settings and that are associated with pre-eclampsia from women admitted with any hypertensive disorder of pregnancy to participating centers in five LMICs to build a model to predict death or a serious complication such as organ damage within 48 hours of admission. The miniPIERS model included parity (whether the woman had been pregnant before), gestational age (length of pregnancy), headache/visual disturbances, chest pain/shortness of breath, vaginal bleeding with abdominal pain, systolic blood pressure, and proteinuria detected using a dipstick. The model was well-calibrated (the predicted risk of adverse outcomes agreed with the observed risk of adverse outcomes among the study participants), it had a good discriminatory ability (it could separate women who had a an adverse outcome from those who did not), and it designated women as being at high risk (25% or greater probability of an adverse outcome) with an accuracy of 85.5%. Importantly, external validation using data collected in fullPIERS, a study that developed a more complex clinical prediction model based on data from women attending tertiary hospitals in high-income countries, confirmed the predictive performance of miniPIERS.
What Do These Findings Mean?
These findings indicate that the miniPIERS model performs reasonably well as a tool to identify women at increased risk of adverse maternal outcomes associated with hypertensive disorders of pregnancy. Because miniPIERS only includes simple-to-measure personal characteristics, symptoms, and signs, it could potentially be used in resource-constrained settings to identify the women who would benefit most from interventions such as transportation to a higher level of care. However, further external validation of miniPIERS is needed using data collected from women living in LMICs before the model can be used during routine antenatal care. Moreover, the value of miniPIERS needs to be confirmed in implementation projects that examine whether its potential translates into clinical improvements. For now, though, the model could provide the basis for an education program to increase the knowledge of women, families, and community health care workers in LMICs about the signs and symptoms of hypertensive disorders of pregnancy.
Additional Information
Please access these websites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001589.
The World Health Organization provides guidelines for the management of hypertensive disorders of pregnancy in low-resourced settings
The Maternal and Child Health Integrated Program provides information on pre-eclampsia and eclampsia targeted to low-resourced settings along with a tool-kit for LMIC providers
The US National Heart, Lung, and Blood Institute provides information about high blood pressure in pregnancy and a guide to lowering blood pressure in pregnancy
The UK National Health Service Choices website provides information about pre-eclampsia
The US not-for profit organization Preeclampsia Foundation provides information about all aspects of pre-eclampsia; its website includes some personal stories
The UK charity Healthtalkonline also provides personal stories about hypertensive disorders of pregnancy
MedlinePlus provides links to further information about high blood pressure and pregnancy (in English and Spanish); the MedlinePlus Encyclopedia has a video about pre-eclampsia (also in English and Spanish)
More information about miniPIERS and about fullPIERS is available
doi:10.1371/journal.pmed.1001589
PMCID: PMC3897359  PMID: 24465185
13.  Pediatric screening urinalysis: a difference-in-differences analysis of how a 2007 change in guidelines impacted use 
BMC Pediatrics  2014;14(1):260.
Background
Practice guidelines can promote higher-quality care, yet they are inconsistently adopted. The purpose of this study is to evaluate the impact of a 2007 American Academy of Pediatrics recommendation to discontinue routine screening urinalysis in children.
Methods
Using data from the National Ambulatory Medical Care Survey, we used a difference-in-differences approach to estimate visit-level screening urinalysis proportions before (2005-2006, n = 1,247) and after (2008-2009, n = 1,772) the 2007 AAP recommendation. We compared visits by children 4-18 years old to visits by young adults aged 19-32. Analyses were adjusted for continuous patient age, patient race/ethnicity, physician specialty, and stratified by patient gender and visit setting.
Results
The 2007 recommendation was associated with no significant change in adjusted visit-level screening urinalysis proportions in child visits (20.4% to 22.5%) compared to an increase in young adult visits (20.1% to 27.0%) – a differential impact of -4.8 percentage points (95% Confidence Interval [CI] -9.0, -0.5). In private practices, visit proportions differentially decreased by 7.6 percentage points (95% CI -13.7, -1.5) in female children and by 0.5 percentage points (95% CI -10.6, 9.6) in male children. In community health centers, visit proportions differentially decreased by 17.4 percentage points (95% CI -27.9, -6.8) in female children and by 33.5 percentage points (95% CI -47.4, -19.7) in male children.
Conclusions
A 2007 recommendation to discontinue routine screening urinalysis in children was associated with no change in use in child visits relative to an increase in use in adult visits. Overall, nearly one-quarter of child visits still included screening urinalysis.
doi:10.1186/1471-2431-14-260
PMCID: PMC4287447  PMID: 25303836
Preventive services; Practice guidelines; Screening urinalysis
14.  Dipstick haematuria and bladder cancer in men over 60: results of a community study. 
BMJ : British Medical Journal  1989;299(6706):1010-1012.
OBJECTIVE--To investigate the prevalence and relevance of dipstick haematuria in a group of men in the community. DESIGN--Prospective study of elderly men invited to attend a health centre for urine screening as part of a health check. SETTING--An inner city health centre in Leeds. SUBJECTS--578 Of 855 men aged 60-85 responding to an invitation to participate. INTERVENTIONS--The subjects had their urine tested with a dipstick (Multistix) for the presence of blood and then tested their urine once a week for the next 10 weeks. Those with one or more positive test results were offered full urological investigation. MAIN OUTCOME MEASURE--The prevalence of urological disease in those subjects with dipstick haematuria. RESULTS--78 Men (13%) had dipstick haematuria on a single test and a further 54 (9%) had evidence of dipstick haematuria when testing their urine once a week during a subsequent 10 week period. Investigation of 87 men disclosed urological disease in 45, including four with a bladder tumour and seven with epithelial dysplasia. CONCLUSION--Dipstick haematuria is a common incidental finding in men over 60 and is associated with appreciable urological disease. The introduction of less invasive methods of investigation, particularly flexible cystoscopy and ultrasonography, has made investigation of these patients simple and safe and makes screening for bladder cancer in the community more feasible.
PMCID: PMC1837876  PMID: 2511941
15.  Urinary ATP and visualization of intracellular bacteria: a superior diagnostic marker for recurrent UTI in renal transplant recipients? 
SpringerPlus  2014;3:200.
Renal transplant recipients (RTR) are highly susceptible to urinary tract infections (UTIs) with over 50% of patients having at least one UTI within the first year. Yet it is generally acknowledged that there is considerable insensitivity and inaccuracy in routine urinalysis when screening for UTIs. Thus a large number of transplant patients with genuine urine infections may go undiagnosed and develop chronic recalcitrant infections, which can be associated with graft loss and morbidity. Given a recent study demonstrating ATP is released by urothelial cells in response to bacteria exposure, possibly acting at metabotropic P2Y receptors mediating a proinflammatory response, we have investigated alternative, and possibly more appropriate, urinalysis techniques in a cohort of RTRs.
Mid-stream urine (MSU) samples were collected from 53 outpatient RTRs. Conventional leukocyte esterase and nitrite dipstick tests, and microscopic pyuria counts (in 1 μl), ATP concentration measurements, and identification of intracellular bacteria in shed urothelial cells, were performed on fresh unspun samples and compared to ‘gold-standard’ bacterial culture results.
Of the 53 RTRs, 22% were deemed to have a UTI by ‘gold-standard’ conventional bacteria culture, whereas 87%, 8% and 4% showed evidence of UTIs according to leukocyte esterase dipstick, nitrite dipstick, and a combination of both dipsticks, respectively. Intracellular bacteria were visualized in shed urothelial cells of 44% of RTRs, however only 1 of the 23 RTRs (44%) was deemed to have a UTI by conventional bacteria culture. A significant association of the ‘gold-standard’ test with urinary ATP concentration combined with visualization of intracellular bacteria in shed urothelial cells was determined using the Fisher’s exact test.
It is apparent that standard bedside tests for UTIs give variable results and that seemingly quiescent bacteria in urothelial cells are very common in RTRs and may represent a focus of subclinical infection. Furthermore, our results suggest urinary ATP concentration combined with detection of intracellular bacteria in shed urinary epithelial cells may be a sensitive means by which to detect ‘occult’ infection in RTRs.
doi:10.1186/2193-1801-3-200
PMCID: PMC4022969  PMID: 24839587
Intracellular bacteria; IBC; Pyuria; Urinary ATP; Bladder; Acridine orange stain
16.  Caution required when relying on a colleague's advice; a comparison between professional advice and evidence from the literature 
Background
Occupational Physicians rely especially on advice from colleagues when answering their information demands. On the other hand, Evidence-based Medicine (EBM) promotes the use of up-to-date research literature instead of experts. To find out if there was a difference between expert-based practice and EBM we compared professional advice on occupational health topics with best evidence from the literature.
Methods
We asked 14 occupational physicians to consult their usual information sources on 12 pre-conceived occupational health problems. The problems were presented in the form of case vignettes which contained sufficient clinical information to be used by the occupational physicians for the consultation of their experts. We had searched the literature for the best available evidence on the 12 problems, which made it possible to answer the clinical questions with a clear yes or no.
Results
The cases could be used by the occupational physicians as arising from their own practice. All together the occupational physicians consulted 75 different experts. Almost half of the consulted experts were near colleagues, 10% were industrial hygienists, 8% medical specialists and the rest had a varied background. Fifty three percent (95% confidence interval 42% to 65%) of all professional advice was not in line with the research literature. In 18 cases (24%) professional advice explicitly referred to up-to-date research literature as their used source. These cases were substantially less incorrect (17%) than advice that had not mentioned the literature as a source (65%) (difference 48%, 95% Confidence Interval from 27% to 69%).
Conclusion
Advice that occupational physicians routinely get in their daily practice differs substantially from best evidence from the literature. Occupational physicians who ask professional advice should always ask about the evidence of this advice.
doi:10.1186/1472-6963-5-59
PMCID: PMC1208884  PMID: 16131405
17.  Developing clinical rules to predict urinary tract infection in primary care settings: sensitivity and specificity of near patient tests (dipsticks) and clinical scores 
Background
Suspected urinary tract infection (UTI) is one of the most common presentations in primary care. Systematic reviews have not documented any adequately powered studies in primary care that assess independent predictors of laboratory diagnosis.
Aim
To estimate independent clinical and dipstick predictors of infection and to develop clinical decision rules.
Design of study
Validation study of clinical and dipstick findings compared with laboratory testing.
Setting
General practices in the south of England.
Method
Laboratory diagnosis of 427 women with suspected UTI was assessed using European urinalysis guidelines. Independent clinical and dipstick predictors of diagnosis were estimated.
Results
UTI was confirmed in 62.5% of women with suspected UTI. Only nitrite, leucocyte esterase (+ or greater), and blood (haemolysed trace or greater) independently predicted diagnosis (adjusted odds ratios 6.36, 4.52, 2.23 respectively). A dipstick decision rule, based on having nitrite, or both leucocytes and blood, was moderately sensitive (77%) and specific (70%); positive predictive value (PPV) was 81% and negative predictive value (NPV) was 65%. Predictive values were improved by varying the cut-off point: NPV was 73% for all three dipstick results being negative, and PPV was 92% for having nitrite and either blood or leucocyte esterase. A clinical decision rule, based on having two of the following: urine cloudiness, offensive smell, and dysuria and/or nocturia of moderate severity, was less sensitive (65%) (specificity 69%; PPV 77%, NPV 54%). NPV was 71% for none of the four clinical features, and the PPV was 84% for three or more features.
Conclusions
Simple decision rules could improve targeting of investigation and treatment. Strategies to use such rules need to take into account limited negative predictive value, which is lower than expected from previous research.
PMCID: PMC1874525  PMID: 16882379
clinical scoring algorithms; diagnosis, urinary tract infection; dipsticks
18.  Renal Status of Children With Sickle Cell Disease in Accra, Ghana 
Ghana Medical Journal  2011;45(4):155-160.
Summary
Introduction
In West Africa, the prevalence of sickle cell disease (SCD) is 2%. The disease adversely affects growth, development and organ function including the kidneys. There is however a dearth of information about the renal status of SCD children in Ghana.
Objectives
To assess the renal status of children with SCD in steady state.
Design
A cross-sectional case-control study.
Setting
Paediatric Sickle Cell Clinic, Korle Bu Teaching Hospital, Accra.
Participants
Cases-357 SCD cases and 70 of their HbAA siblings as controls.
Methods
Documentation of their socio-demographic data, clinical data and dipstick urinalysis findings, and renal ultrasonography on selected participants.
Results
The mean [SD] age was 7.18 [3.15]yrs for cases and 5.16[3.28]yrs for controls. The genotypes were Hb SS (76.7%), Hb SC (21.8 %), and Hb Sβthal (1.4%). Urinalysis showed leucocyturia in 12.6% versus 5.7% (χ2=62.5 and the p=0.000)), isolated proteinuria in 2.8% versus 1.43% (χ2=10.01 and p=0.001) haematuria in 2.6% versus 0% (χ2=9.233, p=0.002) and nitrites in 2.2% versus 1.4% (χ2 =16.3,p=0.02) of cases and controls respectively. The youngest SCD case with proteinuria was 2yrs. old. Proteinuria prevalence increased with age, , occurring in 5.7% of cases aged 9–11yrs. and 20.6% of cases aged 12yrs. Two-thirds of the proteinuria cases were aged 9–12yrs., of whom 50% were aged 12yrs. Renal ultrasound findings were normal in all those examined.
Conclusion
Urinary abnormalities suggesting nephropathy occur early in SCD patients in Ghana. Routine dipstick screening at clinic visits countrywide would help early detection and prompt intervention to limit renal impairment.
PMCID: PMC3283093  PMID: 22359421
Kidney; Sickle Cell Disease; Children; Ghana
19.  Information from Pharmaceutical Companies and the Quality, Quantity, and Cost of Physicians' Prescribing: A Systematic Review 
PLoS Medicine  2010;7(10):e1000352.
Geoff Spurling and colleagues report findings of a systematic review looking at the relationship between exposure to promotional material from pharmaceutical companies and the quality, quantity, and cost of prescribing. They fail to find evidence of improvements in prescribing after exposure, and find some evidence of an association with higher prescribing frequency, higher costs, or lower prescribing quality.
Background
Pharmaceutical companies spent $57.5 billion on pharmaceutical promotion in the United States in 2004. The industry claims that promotion provides scientific and educational information to physicians. While some evidence indicates that promotion may adversely influence prescribing, physicians hold a wide range of views about pharmaceutical promotion. The objective of this review is to examine the relationship between exposure to information from pharmaceutical companies and the quality, quantity, and cost of physicians' prescribing.
Methods and Findings
We searched for studies of physicians with prescribing rights who were exposed to information from pharmaceutical companies (promotional or otherwise). Exposures included pharmaceutical sales representative visits, journal advertisements, attendance at pharmaceutical sponsored meetings, mailed information, prescribing software, and participation in sponsored clinical trials. The outcomes measured were quality, quantity, and cost of physicians' prescribing. We searched Medline (1966 to February 2008), International Pharmaceutical Abstracts (1970 to February 2008), Embase (1997 to February 2008), Current Contents (2001 to 2008), and Central (The Cochrane Library Issue 3, 2007) using the search terms developed with an expert librarian. Additionally, we reviewed reference lists and contacted experts and pharmaceutical companies for information. Randomized and observational studies evaluating information from pharmaceutical companies and measures of physicians' prescribing were independently appraised for methodological quality by two authors. Studies were excluded where insufficient study information precluded appraisal. The full text of 255 articles was retrieved from electronic databases (7,185 studies) and other sources (138 studies). Articles were then excluded because they did not fulfil inclusion criteria (179) or quality appraisal criteria (18), leaving 58 included studies with 87 distinct analyses. Data were extracted independently by two authors and a narrative synthesis performed following the MOOSE guidelines. Of the set of studies examining prescribing quality outcomes, five found associations between exposure to pharmaceutical company information and lower quality prescribing, four did not detect an association, and one found associations with lower and higher quality prescribing. 38 included studies found associations between exposure and higher frequency of prescribing and 13 did not detect an association. Five included studies found evidence for association with higher costs, four found no association, and one found an association with lower costs. The narrative synthesis finding of variable results was supported by a meta-analysis of studies of prescribing frequency that found significant heterogeneity. The observational nature of most included studies is the main limitation of this review.
Conclusions
With rare exceptions, studies of exposure to information provided directly by pharmaceutical companies have found associations with higher prescribing frequency, higher costs, or lower prescribing quality or have not found significant associations. We did not find evidence of net improvements in prescribing, but the available literature does not exclude the possibility that prescribing may sometimes be improved. Still, we recommend that practitioners follow the precautionary principle and thus avoid exposure to information from pharmaceutical companies.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
A prescription drug is a medication that can be supplied only with a written instruction (“prescription”) from a physician or other licensed healthcare professional. In 2009, 3.9 billion drug prescriptions were dispensed in the US alone and US pharmaceutical companies made US$300 billion in sales revenue. Every year, a large proportion of this revenue is spent on drug promotion. In 2004, for example, a quarter of US drug revenue was spent on pharmaceutical promotion. The pharmaceutical industry claims that drug promotion—visits from pharmaceutical sales representatives, advertisements in journals and prescribing software, sponsorship of meetings, mailed information—helps to inform and educate healthcare professionals about the risks and benefits of their products and thereby ensures that patients receive the best possible care. Physicians, however, hold a wide range of views about pharmaceutical promotion. Some see it as a useful and convenient source of information. Others deny that they are influenced by pharmaceutical company promotion but claim that it influences other physicians. Meanwhile, several professional organizations have called for tighter control of promotional activities because of fears that pharmaceutical promotion might encourage physicians to prescribe inappropriate or needlessly expensive drugs.
Why Was This Study Done?
But is there any evidence that pharmaceutical promotion adversely influences prescribing? Reviews of the research literature undertaken in 2000 and 2005 provide some evidence that drug promotion influences prescribing behavior. However, these reviews only partly assessed the relationship between information from pharmaceutical companies and prescribing costs and quality and are now out of date. In this study, therefore, the researchers undertake a systematic review (a study that uses predefined criteria to identify all the research on a given topic) to reexamine the relationship between exposure to information from pharmaceutical companies and the quality, quantity, and cost of physicians' prescribing.
What Did the Researchers Do and Find?
The researchers searched the literature for studies of licensed physicians who were exposed to promotional and other information from pharmaceutical companies. They identified 58 studies that included a measure of exposure to any type of information directly provided by pharmaceutical companies and a measure of physicians' prescribing behavior. They then undertook a “narrative synthesis,” a descriptive analysis of the data in these studies. Ten of the studies, they report, examined the relationship between exposure to pharmaceutical company information and prescribing quality (as judged, for example, by physician drug choices in response to clinical vignettes). All but one of these studies suggested that exposure to drug company information was associated with lower prescribing quality or no association was detected. In the 51 studies that examined the relationship between exposure to drug company information and prescribing frequency, exposure to information was associated with more frequent prescribing or no association was detected. Thus, for example, 17 out of 29 studies of the effect of pharmaceutical sales representatives' visits found an association between visits and increased prescribing; none found an association with less frequent prescribing. Finally, eight studies examined the relationship between exposure to pharmaceutical company information and prescribing costs. With one exception, these studies indicated that exposure to information was associated with a higher cost of prescribing or no association was detected. So, for example, one study found that physicians with low prescribing costs were more likely to have rarely or never read promotional mail or journal advertisements from pharmaceutical companies than physicians with high prescribing costs.
What Do These Findings Mean?
With rare exceptions, these findings suggest that exposure to pharmaceutical company information is associated with either no effect on physicians' prescribing behavior or with adverse affects (reduced quality, increased frequency, or increased costs). Because most of the studies included in the review were observational studies—the physicians in the studies were not randomly selected to receive or not receive drug company information—it is not possible to conclude that exposure to information actually causes any changes in physician behavior. Furthermore, although these findings provide no evidence for any net improvement in prescribing after exposure to pharmaceutical company information, the researchers note that it would be wrong to conclude that improvements do not sometimes happen. The findings support the case for reforms to reduce negative influence to prescribing from pharmaceutical promotion.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1000352.
Wikipedia has pages on prescription drugs and on pharmaceutical marketing (note that Wikipedia is a free online encyclopedia that anyone can edit; available in several languages)
The UK General Medical Council provides guidelines on good practice in prescribing medicines
The US Food and Drug Administration provides information on prescription drugs and on its Bad Ad Program
Healthy Skepticism is an international nonprofit membership association that aims to improve health by reducing harm from misleading health information
The Drug Promotion Database was developed by the World Health Organization Department of Essential Drugs & Medicines Policy and Health Action International Europe to address unethical and inappropriate drug promotion
doi:10.1371/journal.pmed.1000352
PMCID: PMC2957394  PMID: 20976098
20.  Evaluation of dipstick analysis among elderly residents to detect bacteriuria: a cross-sectional study in 32 nursing homes 
BMC Geriatrics  2009;9:32.
Background
Few studies have evaluated dipstick urinalysis for elderly and practically none present confidence intervals. Furthermore, most previous studies combine all bacteria species in a "positive culture". Thus, their evaluation may be inappropriate due to Yule-Simpson's paradox. The aim of this study was to evaluate diagnostic accuracy of dipstick urinalysis for the elderly in nursing homes.
Methods
In this cross-sectional study voided urine specimens were collected from 651 elderly individuals in nursing homes. Dipstick urinalysis for nitrite, leukocyte esterase and urine culture were performed. Sensitivity, specificity, positive and negative predictive values with 95% confidence intervals were calculated. Visual readings were compared to readings with a urine chemistry analyzer.
Results
207/651 (32%) of urine cultures showed growth of a potentially pathogenic bacterium. Combining the two dipsticks improved test characteristics slightly compared to using only one of the dipsticks. When both dipsticks are negative, presence of potentially pathogenic bacteria can be ruled out with a negative predictive value of 88 (84–92)%. Visual and analyzer readings had acceptable agreement.
Conclusion
When investigating for bacteriuria in elderly people at nursing homes we suggest nitrite and leukocyte esterase dipstick be combined. There are no clinically relevant differences between visual and analyzer dipstick readings. When dipstick urinalysis for nitrite and leukocyte esterase are both negative it is unlikely that the urine culture will show growth of potentially pathogenic bacteria and in a patient with an uncomplicated illness further testing is unnecessary.
doi:10.1186/1471-2318-9-32
PMCID: PMC2724370  PMID: 19635163
21.  Danish general practitioners' estimation of urinary albumin concentration in the detection of proteinuria and microalbuminuria. 
BACKGROUND. Microalbuminuria may predict proteinuria and increased mortality in non-insulin dependent diabetic patients. Early detection of microalbuminuria may therefore be essential. AIM. The primary objective of this study was to describe the association between the presence of albuminuria in diabetic patients as detected by general practitioners using conventional reagent strip dipstick tests for albumin, and the urinary albumin concentration as measured in a hospital laboratory. METHOD. A total of 675 newly diagnosed diabetic patients aged 40 years or over were included in the Danish study, diabetes care in general practice. Data for urinary albumin concentration from a morning urine sample and the results of three consecutive dipstick tests for albumin were collected for 417 patients. RESULTS. When defining elevated urinary albumin concentration as 200 mg l-1 or more (proteinuria) the finding of at least one positive test out of the three dipstick tests for albumin had a diagnostic sensitivity of 73% and a specificity of 89%. When the microalbuminuric range (15.0 to 199.9 mg l-1) was added to the definition of renal involvement, the sensitivity of the dipstick test became as low as 28% with a specificity of 96%. CONCLUSION. It is essential for general practitioners to be able to identify proteinuric patients. To achieve this by means of the conventional dipstick test, general practice procedures need to be improved. As it is becoming increasingly well-documented that microalbuminuric non-insulin dependent diabetic patients may benefit from pharmacological treatment of even slight arterial hypertension and heart failure, it seems reasonable to suggest that the use of dipsticks for albumin in general practice be replaced by laboratory quantitative determination of urinary albumin concentration in a morning urine sample.
PMCID: PMC1239138  PMID: 7702885
22.  Cost-effectiveness of chronic kidney disease mass screening test in Japan 
Background
Chronic kidney disease (CKD) is a significant public health problem. Strategy for its early detection is still controversial. This study aims to assess the cost-effectiveness of population strategy, i.e. mass screening, and Japan’s health checkup reform.
Methods
Cost-effectiveness analysis was carried out to compare test modalities in the context of reforming Japan’s mandatory annual health checkup for adults. A decision tree and Markov model with societal perspective were constructed to compare dipstick test to check proteinuria only, serum creatinine (Cr) assay only, or both.
Results
Incremental cost-effectiveness ratios (ICERs) of mass screening compared with do-nothing were calculated as ¥1,139,399/QALY (US $12,660/QALY) for dipstick test only, ¥8,122,492/QALY (US $90,250/QALY) for serum Cr assay only and ¥8,235,431/QALY (US $91,505/QALY) for both. ICERs associated with the reform were calculated as ¥9,325,663/QALY (US $103,618/QALY) for mandating serum Cr assay in addition to the currently used mandatory dipstick test, and ¥9,001,414/QALY (US $100,016/QALY) for mandating serum Cr assay and applying dipstick test at discretion.
Conclusions
Taking a threshold to judge cost-effectiveness according to World Health Organization’s recommendation, i.e. three times gross domestic product per capita of ¥11.5 million/QALY (US $128 thousand/QALY), a policy that mandates serum Cr assay is cost-effective. The choice of continuing the current policy which mandates dipstick test only is also cost-effective. Our results suggest that a population strategy for CKD detection such as mass screening using dipstick test and/or serum Cr assay can be justified as an efficient use of health care resources in a population with high prevalence of the disease such as in Japan and Asian countries.
doi:10.1007/s10157-011-0567-1
PMCID: PMC3328680  PMID: 22167460
Chronic kidney disease; Cost-effectiveness; Dipstick test; Mass screening; Proteinuria; Serum creatinine
23.  Effectiveness of guideline-based care by occupational physicians on the return-to-work of workers with common mental disorders: design of a cluster-randomised controlled trial 
BMC Public Health  2013;13:193.
Background
Sickness absence due to common mental disorders (such as depression, anxiety disorder, adjustment disorder) is a problem in many Western countries. Long-term sickness absence leads to substantial societal and financial costs. In workers with common mental disorders, sickness absence costs are much higher than medical costs. In the Netherlands, a practice guideline was developed that promotes an activating approach of the occupational physician to establish faster return-to-work by enhancing the problem-solving capacity of workers, especially in relation to their work environment. Studies on this guideline indicate a promising association between guideline adherence and a shortened sick leave duration, but also minimal adherence to the guideline by occupational physicians. Therefore, this study evaluates the effect of guideline-based care on the full return-to-work of workers who are sick listed due to common mental disorders.
Methods/design
This is a two-armed cluster-randomised controlled trial with randomisation at the occupational physician level. During one year, occupational physicians in the intervention group receive innovative training to improve their guideline-based care whereas occupational physicians in the control group provide care as usual. A total of 232 workers, sick listed due to common mental disorders and counselled by participating occupational physicians, will be included. Data are collected via the registration system of the occupational health service, and by questionnaires at baseline and at 3, 6 and 12 months. The primary outcome is time to full return-to-work. Secondary outcomes are partial return-to-work, total number of sick leave days, symptoms, and workability. Personal and work characteristics are the prognostic measures. Additional measures are coping, self-efficacy, remoralization, personal experiences, satisfaction with consultations with the occupational physician and with contact with the supervisor, experiences and behaviour of the supervisor, and the extent of guideline adherence.
Discussion
If the results show that guideline-based care in fact leads to faster and sustainable return-to-work, this study will contribute to lowering personal, societal and financial costs.
Trial registration
ISRCTN86605310
doi:10.1186/1471-2458-13-193
PMCID: PMC3599838  PMID: 23496948
Common mental disorders; Sick leave; Return-to-work; Occupational health service; Occupational physicians; Guideline adherence; Guideline-based care
24.  Validating the prediction of lower urinary tract infection in primary care: sensitivity and specificity of urinary dipsticks and clinical scores in women 
Background
Dipsticks are one of the most commonly used near-patient tests in primary care, but few clinical or dipstick algorithms have been rigorously developed.
Aim
To confirm whether previously documented clinical and dipstick variables and algorithms predict laboratory diagnosis of urinary tract infection (UTI).
Design of study
Validation study.
Setting
Primary care.
Method
A total of 434 adult females with suspected lower UTI had bacteriuria assessed using the European Urinalysis Guidelines.
Results
Sixty-six per cent of patients had confirmed UTI. The predictive values of nitrite, leucocyte esterase (+ or greater), and blood (haemolysed trace or greater) were confirmed (independent multivariate odds ratios = 5.6, 3.5, and 2.1 respectively). The previously developed dipstick rule — based on presence of nitrite, or both leucocytes and blood — was moderately sensitive (75%) but less specific (66%; positive predictive value [PPV] 81%, negative predictive value [NPV] 57%). Predictive values were improved by varying the cut-off point: NPV was 76% for all three dipstick results being negative; the PPV was 92% for having nitrite and either blood or leucocyte esterase. Urine offensive smell was not found to be predictive in this sample; for a clinical score using the remaining three predictive clinical features (urine cloudiness, dysuria, and nocturia), NPV was 67% for none of the features, and PPV was 82% for three features.
Conclusion
A clinical score is of limited value in increasing diagnostic precision. Dipstick results can modestly improve diagnostic precision but poorly rule out infection. Clinicians need strategies to take account of poor NPVs.
doi:10.3399/bjgp10X514747
PMCID: PMC2894378  PMID: 20594439
algorithms, clinical scoring; diagnosis, urinary tract infection; primary care; urinalysis
25.  Intimate Partner Violence. The gynaecologist’s perspective 
Intimate partner violence (IPV) is an important public health problem, which has been extensively studied all over the world, yet Belgian data are limited. IPV remains a taboo resulting in denial and underreporting. For an obstetrician-gynaecologist (OB/GYN), IPV, committed by a male partner to a woman, is of particular interest, because of its negative impact on women’s and children’s health. In Belgium there are few data on IPV and guidelines for OB/GYN are missing.
In a multi-centered survey surveillance study which was carried out among pregnant women attending 5 large hospitals in the province of East Flanders, the lifetime prevalence of IPV was estimated to be 10.1% and the period prevalence during pregnancy and/or in the year preceding pregnancy 3.4%. In our highly medicalised society, only 19.2% and 6.6% of the victims of physical and sexual abuse respectively sought medical care. Routine screening for IPV by a general practitioner or OB/GYN was found to be largely acceptable.
In a questionnaire-based Knowledge, Attitude, and Practice survey among OB/GYN in Flanders, OB/GYN prove unfamiliar with IPV and largely underestimate the extent of the problem. Merely 6.8% of the respondents ever received any education on IPV. They refute the incentive of universal screening, even during pregnancy and one of the major barriers is fear of offending patients. Physician education was found to be the strongest predictor of a positive attitude towards screening and of current screening practices.
Hence, there is a definite need to improve women’s awareness regarding abuse and to endorse physician training on IPV.
PMCID: PMC4251275  PMID: 25478074
Barriers; health seeking behaviour; intimate partner violence; sexual violence; physical violence; patient care

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