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Risk factors of intracranial pressure monitoring in children with fiberoptic devices: a critical review.

BACKGROUND: Intracranial pressure (ICP) monitoring has become standard in the management of severe head injuries. A variety of monitoring techniques and devices are available, each with advantages and disadvantages; however there have been few studies in the pediatric population. METHODS: To study the risk factors, efficacy, and complication rate of fiberoptic ICP monitoring we studied 98 consecutive children with severe head injuries over a 2-year period. The average patient age was 9 years and most had an initial Childrens Coma Score (CCS) of 8 or less. The monitoring devices were placed in frontal parenchyma of all children and no prophylactic antibiotics were used. All fiberoptic catheter tips were cultured upon removal. RESULTS: The average duration of ICP monitoring was 7 days; the usual range was 3-15 days, with the exception of one patient who underwent monitoring for 40 days. No complications occurred during insertion of the ICP monitors. Catheter tip cultures were positive for Staphylococcus epidermidis in 7% of the children, but none developed clinical features of CNS infection. The hospital location of placement or duration of ICP monitoring did not affect the rate of catheter tips with positive cultures. There was a 13% mechanical failure rate of the fiberoptic device. CONCLUSIONS: We conclude that fiberoptic ICP monitoring is safe and effective; however, there is a relatively low mechanical failure rate. Infection in uncommon despite prolonged use and there is little risk of complications associated with placement of this monitor.

Adolescent↗

Current opinions on therapeutic drug monitoring of immunosuppressive drugs.

The pharmacokinetics of the immunosuppressive drugs cyclosporine, tacrolimus, mycophenolate mofetil (MMF), and sirolimus are complex and unpredictable. A narrow therapeutic index unique to each patient, as well as variable absorption, distribution, and elimination, are characteristics of these drugs. Therapeutic drug monitoring plays a key role in helping clinicians maintain blood and plasma levels of immunosuppressive drugs within their respective therapeutic ranges. Variation in concentrations outside the narrow therapeutic ranges can result in adverse clinical outcomes. Therapeutic drug monitoring ensures that concentrations are not too high or too low, thereby reducing the risks of toxicity or rejection, respectively. Therapeutic monitoring of immunosuppressive drugs has been based on several choices of assay and biologic fluid (i.e., whole blood, plasma) appropriate for a particular drug. High-performance liquid chromatography (HPLC) remains the gold standard among assay methods used to monitor immunosuppressive drugs. Although HPLC is the assay of choice for cyclosporine, newer monoclonal assays are suitable as well for routine monitoring. HPLC is also widely used for therapeutic drug monitoring of mycophenolic acid, the active metabolite of MMF, and an immunoassay (used in European centers) has been developed. Therapeutic drug monitoring of tacrolimus has been improved with the recent development of assays with greater sensitivity and specificity for tacrolimus than those previously available. No commercial assays are currently available for the therapeutic monitoring of sirolimus. It is also important to identify a specific pharmacokinetic parameter for each individual drug, whether it is trough or area under the concentration-time curve, that may be most useful as a tool for optimal therapeutic drug monitoring in clinical practice. With an increased understanding of the pharmacokinetics of immunosuppressive drugs, therapeutic drug monitoring guidelines will be more clearly defined to ensure the safe and effective management of transplant recipients.

Cyclosporine↗

Misinterpretation of drinking water quality monitoring data with implications for risk management.

A survey of two groups of environmental professionals was conducted to explore the degree of understanding in the interpretation of monitoring results for informing decision-making and responding to data appropriately to manage environmental health risks. Specifically, the understanding of the predictive value of a monitoring result and the appreciation that false positive results will inevitably predominate when monitoring for rare or infrequent hazards was explored. Results indicate evidence of misinterpretation and overconfidence in the meaning of monitoring results, and the ability of laboratory methods to detect reliably an infrequent hazard in environmental samples. A hypothetical monitoring scenario was presented with characteristics sufficient to estimate what level of confidence was warranted in a positive result. The majority of respondents in both groups (most of whom had more than 10 years experience in their field) reported between very likely to almost certain confidence (80-100% likelihood) in a hypothetical monitoring result which was, in fact, less than 5% likely to be correct. Additionally, there was little influence of the beliefs expressed about the validity of the monitoring result on the actions proposed to be taken in response to finding that monitoring result. The independence of respondents' follow-up action to what they believe of a monitoring result implies a level of detachment between the understanding of the monitoring data and the resulting risk management response.

Data Interpretation, Statistical↗

Monitoring vital signs in a bone marrow transplant unit: are they needed in the middle of the night?

Monitoring vital signs (VS) is a routine procedure in bone marrow transplant (BMT) units, but such monitoring can interfere with sleep. We hypothesized that middle of the night (MON) monitoring may not be needed in all patients. Charts of 20 consecutive patients who underwent BMT were reviewed for MON monitoring to determine the frequency with which monitoring resulted in a nursing intervention, call to the physician or change in treatment by the physician. Charts were also reviewed for day time events, which could predict the need for monitoring at night. MON monitoring was done on 457 of the 543 nights evaluated, 148 nursing interventions were performed during these 457 nights (32%) of which only 20 (4%) were the result of monitoring VS. In five instances, the nurse called the physician as a result of monitoring VS and in three of these five instances, the treatment was changed. The only day time event that was significantly associated was fever (P = 0.0002). There was also a trend for CNS events (P = 0.057) to be associated with MON intervention. Larger, prospective studies need to be done to accurately identify day time risk factors that can predict the need for night time monitoring.

Adult↗

Blunt trauma in the obstetric patient: monitoring practices in the ED.

This study was undertaken to determine the usually used approach to fetal monitoring in the emergency department (ED) of the less severely injured obstetric patient who has sustained blunt trauma. A written survey was sent to clinical directors of teaching programs in emergency medicine (EM) with inquiries on the usual way of monitoring, what studies were performed, and the usual disposition of the less-injured obstetric patient. From the 112 teaching programs surveyed in early 1996, there were 87 responses (78%). Seventy-eight percent of programs generally have fetal monitoring performed for 2 to 4 hours in obstetric trauma patients when the trauma is more than minor extremity injury. In 68%, fetal monitoring was not performed in the ED from the time of the initial assessment of fetal heart tones until the mother went to an obstetric area even though the average estimated time to radiographically clear a cervical spine was 36 minutes. In 92% of programs residents are taught cardiotocographic changes indicative of fetal distress but only 15% have such monitoring equipment in their department. However, 51% do have sonographic equipment in their department. Given a patient with a viable fetus who has no abdominal pain, 46% routinely use fetal monitoring if the mechanism is a simple fall whereas 92% use monitoring only if the mechanism is a rollover motor vehicle collision or a strike to the abdomen. It is generally recognized that fetal distress may occur subtly without overt clinical signs and that obstetric area monitoring for a period of several hours should take place. However, most teaching programs do not institute continuous fetal monitoring during the first 30 to 60 minutes that the mother is undergoing her work-up even though residents are taught such monitoring.

Abdominal Pain↗

Conscious sedation, clinically relevant complications and monitoring of endoscopy: results of a nationwide survey in Switzerland.

There is no conclusive evidence that electronic monitoring during gastrointestinal endoscopy reduces patient morbidity and mortality. The aim of this nationwide Swiss survey was to assess the impact of monitoring on the outcome for patients. We therefore evaluated the monitoring practice and the rate of sedation-related clinically relevant complications in a country with a low monitoring prevalence, and compared the results with those for a country in which monitoring is widely applied. A questionnaire pertaining to 1990 was mailed to all 173 Swiss gastroenterologists. The response rate was 71.1%. Data from 115,200 endoscopies performed by 123 gastroenterologists were analysed. Sixty percent of the procedures were performed under sedation. Patient's vital signs were rarely monitored clinically (< or = 25%). Electronic monitoring was virtually never performed: oximetry was used by 2.5% and an electrocardiogram by 0.8%. The overall sedation-related complication rate was 0.10%, and no deaths occurred. Thus, the morbidity and mortality related to conscious sedation in Switzerland is low, and not higher than it is in countries with a high monitoring level, such as the USA (0.06-0.54%). We conclude that clinically detectable and relevant complications attributable to conscious sedation are rare even when vital parameters are not monitored routinely. There is need for a prospective study to evaluate the effect of electronic monitoring on the complication rate for average-risk patients undergoing routine gastrointestinal endoscopy.

Colonoscopy↗

Are slow-acting anti-rheumatic drugs monitored too often? An audit of current clinical practice.

Rheumatologists usually recommend monthly blood monitoring when patients with rheumatoid arthritis (RA) are treated with slow-acting anti-rheumatic drugs (SAARDs). Is monthly monitoring needed or could its frequency be reduced? We audited the opinions of UK rheumatologists and reviewed clinical experience at three centres. To ascertain the interval at which patients are monitored and the determinants of monitoring policy we sent a questionnaire to 193 consultant rheumatologists; 143 (74%) replied. The majority use monthly monitoring for most SAARDs except sulphasalazine, chloroquine and hydroxychloroquine. There is extensive variation, which is not related to the type of rheumatology unit or whether a shared scheme with general practitioners is used. Reviewing experience in 390 patients treated with SAARDs at three adjacent rheumatology units in London showed that haematological adverse reactions were infrequent. During 1560 patient-years of treatment involving 18,720 monthly monitoring visits there were 13 haematological adverse reactions (11 thrombocytopenias and two leucopenias). Five thrombocytopenias developed after 6 months of treatment; five occurred gradually over 5 months or more and one borderline low platelet count was seen once. The two leucopenias were borderline low white cell counts occurring gradually over 3-6 months. Such frequent monitoring is expensive. The total cost of monitoring 390 patients for 1560 patient-years was 420,000 pounds. The cost of detecting each adverse reaction was 32,000 pounds. Three-monthly monitoring when therapy is established after an initial stabilizing period would have identified seven out of eight late adverse reactions. Monitoring policies are mainly based on clinical consensus with few prospective studies of their value; they need re-evaluation.

Antirheumatic Agents↗

Temperature monitoring and management during neuraxial anesthesia: an observational study.

UNLABELLED: Temperature monitoring and thermal management are rare during spinal or epidural anesthesia because clinicians apparently restrict monitoring to patients with an expected risk of hypothermia. This implies that anesthesiologists can predict patient thermal status without monitoring core temperature. We therefore, tested the hypotheses that during neuraxial anesthesia: 1) amount of core hypothermia depends on the magnitude and duration of surgery; 2) temperature monitoring and thermal management are used selectively in patients at high risk of hypothermia; and 3) anesthesiologists can estimate patient thermal status. We evaluated thermal status on arrival in the recovery room along with intraoperative thermal management and monitoring in 120 patients. Anesthesiologists were asked if their patients were hypothermic (<36 degrees C). There was no correlation between the magnitude or duration of surgery and initial postoperative core temperature in unwarmed patients. Temperature monitoring and thermal management were not used selectively in high-risk patients. Initial postoperative tympanic membrane temperatures were <36 degrees C in 77% of patients and <35 degrees C in 22%. Body temperature was monitored intraoperatively in 27% of the patients and forced-air warming was used in 31%. Anesthesiologists failed to accurately estimate whether their patients were hypothermic. Our results suggest that temperature monitoring and management during neuraxial anesthesia is currently inadequate. IMPLICATIONS: In this observational study, we evaluated core temperatures and intraoperative thermal management in patients undergoing spinal or epidural anesthesia. Hypothermia was common, however, rarely detected either by temperature monitoring or estimates by anesthesiologists. In addition, it was not treated with active warming. Consequently, temperature monitoring and management have to be done during neuraxial anesthesia.

Aged↗

Clinical utilization of pulmonary artery catheter monitoring.

Since the introduction of PA catheter monitoring in 1970, the applications for it have dramatically broadened. PA catheters are used to obtain hemodynamic data for the assessment, monitoring, and therapeutic management of critically ill, high-risk surgical patients. Because of potential complications associated with PA catheter monitoring, numerous editorials and articles have questioned the procedure's risk-to-benefit ratio. These articles address the inadequacy of outcome data and suggest no demonstrated benefit from PA monitoring. Subgroups of patients have been identified, however, in whom PA monitoring data altered clinicians' assessment and management. In spite of a study by Rao and colleagues implying that PA catheter monitoring can decrease the mortality rate in critically ill patients, no scientific study has confirmed this impression. A more recent article evaluated the impact of PA catheter monitoring on mortality with emphasis on how the information is used. This prospective study noted a potential benefit from PA catheter monitoring in a protocol group, but the limited sample size and selection criteria prevent definitive conclusions. Unfortunately, many of the reported studies are retrospective, nonrandomized, unblinded, limited in scope or size, and founded on subjective end points. Careful evaluation of individual studies is mandatory to avoid overinterpretation of the conclusions. Understanding the limits of PA monitoring is needed for therapy to be successful. Problems may stem not from technology but from the knowledge and expectations of clinicians. "Human" complications from inadequate understanding of the physiological data is not uncommon. Measured pressures by themselves can be misleading; indeed use of absolute numbers rather than trends or relative changes in the values monitored can compromise clinical assessment. Overzealous acceptance and utilization of any quantitative measurement without sound clinical judgment is fraught with failure.

Cardiac Output↗

Cost-effectiveness of intraoperative facial nerve monitoring in middle ear or mastoid surgery.

OBJECTIVES: Despite the utility of intraoperative facial nerve monitoring in reducing the risk of iatrogenic facial nerve injury during neurotologic surgery, its routine use during primary or revision surgery remains controversial. One of the major barriers to its acceptance is cost. This study evaluates the cost-effectiveness of intraoperative facial nerve monitoring during middle ear or mastoid surgery. RESEARCH DESIGN/METHODS: A simple decision analytic cost-effectiveness model and a societal approach were used to evaluate three cohorts of individuals who received (1) intraoperative facial nerve monitoring for both primary and revision middle ear or mastoid surgeries, or (2) facial nerve monitoring for revision surgeries only, or (3) no monitoring for any middle ear or mastoid surgeries. RESULTS: Our results strongly favored the use of intraoperative facial nerve monitoring in all patients undergoing middle ear or mastoid surgery, adding about $222.73 to $528.00 US dollars to the total cost. The strategy to monitor primary and revision surgeries had the greatest effectiveness and lowest cost, with an average quality-adjusted life-year (QALY) of 45.68 at an average cost of $238 US dollars. Facial nerve monitoring in revision patients only had similar QALYs (45.67) and higher costs ($292.1). Finally, the strategy not to monitor had the lowest QALY (45.65) and highest cost ($449.8). The analysis was robust across a wide range of changes in both costs and probabilities. CONCLUSIONS: Facial nerve monitoring is cost-effective, and its routine use should be adopted to reduce the risk of iatrogenic facial nerve injury during otologic surgery.

Cost-Benefit Analysis↗

Transcranial electrical motor-evoked potential monitoring during surgery for spinal deformity: a study of 145 patients.

STUDY DESIGN: A descriptive historic cohort study was conducted. OBJECTIVES: To determine intraoperative response amplitude criteria for transcranial electrical motor-evoked potential monitoring that warn of neurologic damage, and to determine the additional value of monitoring six instead of two muscle sites. SUMMARY OF BACKGROUND DATA: Transcranial electrical motor-evoked potential monitoring provides immediate and reliable information about the integrity of the motor pathways during spine surgery. Although this monitoring technique is more frequently used, criteria for interpretation of the amplitude responses have not been defined. METHODS: The intraoperative monitoring outcomes were compared with the patient's clinical outcomes. The sensitivity, specificity, positive predictive value, and negative predictive value were determined for four different monitoring criteria. RESULTS: Transcranial electrical motor-evoked potential monitoring was possible 142 of 145 patients undergoing corrective surgery. In this study, 16 patients had a neurologic event, and 11 patients showed recovery of response amplitude after a second surgical maneuver, whereas the remaining 5 patients had permanent partial neurologic damage. The criterion that at least one of six recordings must show an amplitude decrease of more than 80% was sufficiently strict to achieve a sensitivity of 1.0 and a specificity of 0.91. Less strict criteria, including recording at two instead of six sites, resulted in lower sensitivity, with the lower bound of the 95% confidence interval at 0.62. CONCLUSIONS: Transcranial electrical motor-evoked potential monitoring allowed successful intraoperative monitoring. The criterion of one recording showing a response amplitude decrease of more than 80% during a surgical action can be considered a valuable warning criterion for neurologic damage. The authors also consider that monitoring at six instead of two muscles improves the value of neuromonitoring.

Adolescent↗

The 'ABPM effect' gradually decreases but does not disappear in successive sessions of ambulatory monitoring.

OBJECTIVES: Previous results have indicated that ambulatory monitoring provides a pressor effect on patients using the device for the first time, but not on successive sessions of monitoring. Our objective was to validate and quantify the extent and duration of this pressor effect in hypertensive patients repeatedly evaluated every few months. METHODS: We studied 823 mild-to-moderate hypertensive subjects (347 men), 53.4 +/- 14.1 years of age. Blood pressure was measured at 20-min intervals during the day and at 30-min intervals at night for 48 consecutive hours, and physical activity was simultaneously evaluated every minute with a wrist actigraph. Forty per cent of the patients were evaluated twice or more. RESULTS: In patients evaluated for the first time, results indicated a highly statistically significant (P < 0.001) reduction during the second day of monitoring as compared to the first in the diurnal mean of systolic and diastolic blood pressure, but not in heart rate or physical activity. This pressor effect remained statistically significant for the first 10 h of monitoring, independent of gender, day of the week of monitoring, or number of antihypertensive drugs used by the patients. The nocturnal mean of blood pressure was, however, similar between both days of sampling. This 'ambulatory monitoring effect' was diminished, although not eliminated, in extent and duration for successive sessions of ambulatory monitoring. CONCLUSIONS: Ambulatory monitoring for 48 h revealed a statistically significant pressor response that could mostly reflect a novelty effect in the use of the monitoring device. This effect has marked implications in both research and clinical daily practice for a proper diagnosis of hypertension and evaluation of treatment efficacy by the use of ambulatory monitoring.

Adolescent↗

Home monitoring for infants at risk of the sudden infant death syndrome.

This study evaluates the effectiveness and social implications of home monitoring of 31 infants at risk of sudden infant death syndrome (SIDS). Thirteen siblings of children dying of SIDS, nine near miss SIDS infants and nine preterm infants with apnoea persisting beyond 40 weeks post conceptual age were monitored from a mean age of 15 days to a mean of 10 months. Chest movement detection monitors were used in 27 and thoracic impedance monitors in four. Genuine apnoeic episodes were reported by 21 families, and 13 infants required resuscitation. Apnoeic episodes occurred in all nine preterm infants but in only five (38%) of the siblings of SIDS (P less than 0.05). Troublesome false alarms were a major problem occurring with 61% of the infants and were more common with the preterm infants than the siblings of SIDS. All but two couples stated that the monitor decreased anxiety and improved their quality of life. Most parents accepted that the social restrictions imposed by the monitor were part of the caring process but four couples were highly resentful of the changes imposed on their lifestyle. The monitors used were far from ideal with malfunction occurring in 17, necessitating replacement in six, repair in six and cessation of monitoring in three. The parents became ingenious in modifying the monitors to their own individual requirements. Although none of these 31 'at risk' infants died the study sample was far too small to conclude whether home monitoring prevented any cases of SIDS.

Apnea↗

Intermittent versus continuous electronic monitoring in labour: a randomised study.

OBJECTIVE: To compare the efficacy in detecting signs of fetal hypoxia in labour of intermittent (I-group) versus continuous (C-group) electronic fetal monitoring in women with low or moderate risk factors for fetal distress. DESIGN: A prospective, randomised study. SETTING: A tertiary referral centre. SUBJECTS: Four thousand and forty-four parturients at low risk for obstetric complications with a reactive fetal heart rate admission test at arrival in labour. During the study period (October 5 1989 to May 31 1991), 5647 women were delivered in the labour ward. Of these, 1178 women (20.9%) were excluded because of high risk factors in pregnancy or at admission for labour, including women undergoing elective caesarean section. Of the remaining 4469 women 4044 (90.5%) were randomised to either intermittent (n = 2015) or continuous monitoring (n = 2029) during the first stage of labour. METHODS: In the C-group the fetal heart rate was recorded continuously with electronic fetal monitoring during the first stage of labour. In the I-group the fetal heart rate was recorded with electronic fetal monitoring for 10 to 30 min every 2 to 2.5 h during the first stage of labour, and the fetal heart rate was auscultated every 15 to 30 min in between recording periods. If complications occurred, recording was changed to continuous. In the second stage of labour all the women were monitored continuously. Umbilical cord artery acid-base status was assessed at birth. MAIN OUTCOME MEASURES: Duration of electronic fetal monitoring, rates of abnormal fetal heart rate patterns, caesarean section for fetal distress, acidosis in umbilical cord arterial blood at birth, Apgar scores of less than 7 at 1 or 5 min, and referrals to the neonatal intensive care unit. RESULTS: There were no significant differences between the study groups in the incidence of ominous fetal heart rate recordings: 6.3% (I-group) versus 6.6% (C-group), or the interval from arrival to first detected abnormal fetal heart rate, although the number of suspicious fetal heart rate patterns was higher in the C-group (28.6%) than in the I-group (24.6%). In the I-group electronic fetal monitoring was performed for (median monitoring time) 38.8% of the first stage of labour as compared with 78.6% in the C-group. The incidence of caesarean section for fetal distress was similarly low in both groups: 1.2% versus 1.0%. There were no significant differences in the immediate neonatal outcome in terms of umbilical artery pH, Apgar scores, or admissions to the neonatal care unit. CONCLUSIONS: Intermittent use of electronic fetal monitoring at regular intervals (with stethoscopic auscultation in between) appears to be as safe as continuous electronic fetal monitoring in low risk labours.

Apgar Score↗

Central fetal monitoring: effect on perinatal outcomes and cesarean section rate.

BACKGROUND: In a trend similar to continuous electronic fetal monitoring, many hospitals are incorporating central fetal monitoring into labor and delivery suites. The objective of this study was to investigate whether the use of central fetal monitoring had an effect on neonatal outcomes or cesarean section rate. METHODS: This retrospective study involved patient data from deliveries occurring at Women and Children's Hospital of Buffalo, Buffalo, New York, between the years 2000 and 2003. In the period from January 1, 2000, to December 31, 2001, central fetal monitoring was available, whereas in the period from February 1, 2002, to December 31, 2003, it was unavailable. Data on deliveries at Women and Children's Hospital of Buffalo were obtained using the Western New York Perinatal Data System, which is an electronic data set based on birth certificate information. The method of delivery, admission to the neonatal intensive care unit, and 5-minute Apgar scores less than 7 were compared for deliveries occurring with and without the use of central fetal monitoring. These outcomes were further subdivided into full-term and preterm deliveries. RESULTS: Three thousand five hundred and twelve deliveries used central monitoring and 3,007 deliveries did not. For full-term deliveries, in the years with central fetal monitoring compared with the years without it, no differences in the cesarean section rate (13.4 vs 14.5%, not significant [NS]), the admission rate in neonatal intensive care unit (3.3 vs 3.3%, NS), or the incidence of Apgar score less than 7 (0.6 vs 0.5%, NS) were observed. For preterm deliveries, comparing the years with central fetal monitoring with the years without, no differences in the cesarean section rate (21.3 vs 21.3%, NS), the admission rate in neonatal intensive care unit (17.7 vs 20.1%, NS), or the incidence of Apgar score less than 7 (7.0 vs 6.5%, NS) were observed. Analyses pooling all deliveries also failed to show any differences in any of the parameters. CONCLUSIONS: No statistically significant difference was demonstrated in the rates of cesarean section, admission to the neonatal intensive care unit, or incidence of Apgar scores of less than 7 associated with the use of central fetal monitoring. Therefore, we could not identify any benefit to the use of central fetal heart rate monitoring.

Adolescent↗

Use of home apnea monitors.

OBJECTIVE: To examine the frequency of use of home apnea monitors, reasons for not using them, and factors associated with their use among families of infants for whom home monitoring had been prescribed. DESIGN: Cross-sectional study, including a telephone interview to collect demographic data and a mailed questionnaire to obtain data on monitor use. SETTING: The apnea clinics in two tertiary-care centers. PARTICIPANTS: Ninety-three families (representing an 80.9% response rate) with infants considered at increased risk of sudden infant death syndrome and requiring home monitors. Infants with tracheostomies or bronchopulmonary dysplasia and families with monitored twins, a mother known to be drug addicted, or no home telephone were excluded. RESULTS: Of concern were that 23.1% of mothers reported using the monitor 12 or fewer hours per day and that 10.8% believed their infants did not need a monitor. Of 11 variables examined, only color change in the infant was associated with frequency of monitor use. CONCLUSIONS: Clear, consistent communication with families regarding the use of apnea monitors is essential to improve compliance with proper monitoring techniques.

Cross-Sectional Studies↗

Comparison of NucliSens and Amplicor monitor assays for quantification of human immunodeficiency virus type 1 (HIV-1) RNA in plasma of persons with HIV-1 subtype A infection in Abidjan, Côte d'Ivoire.

We compared the sensitivity and accuracy of the NucliSens assay and those of both the standard and modified (addition of a new primer set, primer mix 1, supplied by Roche) Amplicor HIV Monitor assays to quantify human immunodeficiency virus type 1 (HIV-1) RNA in persons infected with HIV-1 subtype A in Abidjan, Côte d'Ivoire. Seventy-one plasma samples from HIV-1-seropositive persons at different stages of HIV infection and 15 samples from HIV antibody-negative persons were analyzed. The HIV-1 genetic subtype was determined either by DNA sequencing or by a restriction fragment length polymorphism assay. Of the 71 samples, 70 (98%) were subtype A and 1 was subtype G. Of the 70 subtype A samples, the proportion of RNA-positive plasma samples and mean HIV-1 RNA levels were significantly higher by the modified HIV Monitor assay (n = 67 [96%]; mean RNA levels, 5.2 log10 HIV-1 RNA copies/ml) than the NucliSens assay (n = 56 [80%]; 4.3 log10 HIV-1 RNA copies/ml) or the standard HIV Monitor assay (n = 44 [63%]; mean RNA levels, 3.8 log10 HIV-1 RNA copies/ml) (all P values were <0.05). The HIV-1 RNA levels by the modified HIV Monitor assay correlated significantly with those by the NucliSens assay (r = 0.76; P < 0.001) and the standard HIV Monitor assay (r = 0.57; P < 0.001), as did the RNA levels by the NucliSens and the standard HIV Monitor assays (r = 0.60; P < 0. 001). Lower CD4 cell counts were significantly correlated with higher HIV-1 RNA levels by all three assays (r = -0.47 for the NucliSens assay, -0.45 for the standard HIV Monitor assay, and -0.62 for the modified HIV Monitor assay). These results indicate that the modified HIV Monitor assay has the highest sensitivity and efficiency at quantifying the levels of RNA in persons infected with HIV-1 subtype A and thus constitutes a valuable tool for the monitoring of RNA levels in areas of Africa were HIV-1 subtype A is predominant.

Acquired Immunodeficiency Syndrome↗

Targets and self monitoring in hypertension: randomised controlled trial and cost effectiveness analysis.

OBJECTIVES: To assess whether blood pressure control in primary care could be improved with the use of patient held targets and self monitoring in a practice setting, and to assess the impact of these on health behaviours, anxiety, prescribed antihypertensive drugs, patients' preferences, and costs. DESIGN: Randomised controlled trial. SETTING: Eight general practices in south Birmingham. PARTICIPANTS: 441 people receiving treatment in primary care for hypertension but not controlled below the target of < 140/85 mm Hg. INTERVENTIONS: Patients in the intervention group received treatment targets along with facilities to measure their own blood pressure at their general practice; they were also asked to visit their general practitioner or practice nurse if their blood pressure was repeatedly above the target level. Patients in the control group received usual care (blood pressure monitoring by their practice). MAIN OUTCOME MEASURES PRIMARY OUTCOME: change in systolic blood pressure at six months and one year in both intervention and control groups. SECONDARY OUTCOMES: change in health behaviours, anxiety, prescribed antihypertensive drugs, patients' preferences of method of blood pressure monitoring, and costs. RESULTS: 400 (91%) patients attended follow up at one year. Systolic blood pressure in the intervention group had significantly reduced after six months (mean difference 4.3 mm Hg (95% confidence interval 0.8 mm Hg to 7.9 mm Hg)) but not after one year (mean difference 2.7 mm Hg (- 1.2 mm Hg to 6.6 mm Hg)). No overall difference was found in diastolic blood pressure, anxiety, health behaviours, or number of prescribed drugs. Patients who self monitored lost more weight than controls (as evidenced by a drop in body mass index), rated self monitoring above monitoring by a doctor or nurse, and consulted less often. Overall, self monitoring did not cost significantly more than usual care (251 pounds sterling (437 dollars; 364 euros) (95% confidence interval 233 pounds sterling to 275 pounds sterling) versus 240 pounds sterling (217 pounds sterling to 263 pounds sterling). CONCLUSIONS: Practice based self monitoring resulted in small but significant improvements of blood pressure at six months, which were not sustained after a year. Self monitoring was well received by patients, anxiety did not increase, and there was no appreciable additional cost. Practice based self monitoring is feasible and results in blood pressure control that is similar to that in usual care.

Adult↗