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Validation of the Oregon scientific BPW810 blood pressure monitor according to the European Society of Hypertension Protocol.

OBJECTIVE: To determine the accuracy of the BPW810 blood pressure monitor developed by IDT Technology Limited, according to the international protocol of the European Society of Hypertension. DESIGN: The international protocol is divided into two phases: the first phase is performed on 15 selected participants and, if the device passes this phase, 18 more participants are included making a total of 33 participants on whom the final validation is performed. METHOD: According to the European Society of Hypertension requirements, for each of the 33 participants, four blood pressure measurements were taken simultaneously by two trained observers, using mercury sphygmomanometers alternately with three measurements by the test device. The difference between the blood pressure value given by the device and mean of the two observers' readings was calculated for each measurement. The 99 differences were classified into zones (< or =5, < or =10, and < or =15 mmHg). The number of differences in each zone was compared with the number required by the international protocol. Furthermore, an individual analysis was then done to determine for each participant the number of comparisons < or =5 mmHg, which requires that at least 22 of the 33 participants should have two of three comparisons < or =5 mmHg. RESULTS: The BPW810 passed the first phase of the validation process for systolic and diastolic blood pressure. For the second phase, the difference between the device and mean of two observers was -2.2+/-4.8 mmHg for systolic blood pressure and -0.5+/-3.7 mmHg for diastolic blood pressure. In the last phase, 26 participants fell in the zone of two of the three comparisons lying within 5 mmHg and none of the participants fell in the zone of all three of the comparisons over 5 mmHg apart. CONCLUSION: The BPW810 passed all the phases of the international protocol for both systolic and diastolic blood pressure.

Adult↗

Aggressive management of dengue shock syndrome may decrease mortality rate: a suggested protocol.

OBJECTIVES: Dengue shock syndrome is a leading cause of mortality among Indian children. In January 2000, we instituted a protocol for aggressive management of children with dengue shock syndrome. The objective of this study was to compare outcomes (duration of ventilation, pediatric intensive care unit stay, incidence of acute respiratory distress syndrome, and intensive care unit and hospital mortality) before and after the protocol. DESIGN: Retrospective chart review. SETTING: Pediatric intensive care unit at a tertiary teaching hospital. PATIENTS: One hundred and fourteen patients admitted between July 1997 and December 1999 received standard therapy recommended by the World Health Organization (WHO) and were designated as the WHO guidelines group (W), whereas 96 patients admitted between January 2000 and December 2001 were treated by our protocol and designated as the protocol group (P). INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: The patients in each group were equally matched in terms of age, Pediatric Risk of Mortality, and number with dengue hemorrhage fever grade IV, although the platelet counts were higher in the W group compared with the P group (geometric mean 42.2, confidence interval 36.9, 48.4 vs. geometric mean 36.7, confidence interval 33.3, 40.5, p < .05). Patients in the W group received less fluids in the first hour compared with the P group (median and interquartile range 20 mL/kg, 15 and 20 vs. 30 mL/kg, 20 and 60). Fluid was actively removed less often in the W group than the P group (6 of 111 vs. 45 of 96, p < .05). There was no difference in the need for ventilation or incidence of acute respiratory distress syndrome between groups, although among dengue hemorrhage fever grade IV patients, the number requiring ventilation (17 of 30 vs. 20 of 23, p < .05) and the incidence of acute respiratory distress syndrome (9 of 30 vs. 17 of 23, p < .05) were significantly greater in the W group compared with the P group. The duration of ventilation (1.5 +/- 1.7 vs. 4.2 +/- 2.9 days, p < .05) and length of intensive care unit stay (3.0 +/- 2.8 vs. 3.4 +/- 2.9 days, p < .05) were significantly less in the W group. The pediatric intensive care unit mortality (16.6% vs. 6.3%, p < .05) was significantly higher in the W group than in the P group. CONCLUSIONS: Patients with dengue shock syndrome are at high risk of mortality due to refractory shock and multiple organ failure. Survival was better for patients in the P group. Aggressive shock management and possibly the use of judicious fluid removal may decrease mortality rates in the severest forms of dengue shock syndrome.

Algorithms↗

The short-term outcome of seizure management by prehospital personnel: a comparison of two protocols.

OBJECTIVE: To evaluate the impact of an emergency medical service protocol with reduced diazepam dose on the intubation rate of children with seizure activity treated by emergency medical service personnel and to evaluate the short-term outcome comparing 2 emergency medical service treatment protocols. METHODS: Retrospective review of the emergency medical service and hospital databases of children 0-18 years with seizure activity. Prior to January 1996, the county emergency medical service protocol recommended a diazepam dose of 0.2-0.5 mg/kg i.v. or pr for termination of seizure activity (group 1). As of January 1996, the diazepam dose was reduced to 0.05-0.1 mg/kg i.v. or pr (group 2). Demographics, emergency medical service and emergency department interventions, and disposition data were abstracted. RESULTS: 1516 subjects met the enrollment criteria: 1003 (66%) in group 1 and 513 (34%) in group 2. Emergency medical service administered diazepam to 288 subjects: 189 (19%) in group 1 and 99 (19%) in group 2. Twenty (7%) of all treated subjects required intubation: 19 in group 1 and 1 in group 2 (relative risk 9.7, 95% CI 1.30-72.5). Mean diazepam dose was 0.17 mg/kg in group 1 and 0.13 mg/kg in group 2 (mean difference 0.04, 95% CI 0.02-0.06). No significant difference in the requirement for repeated anticonvulsant dose, complications, or emergency department interventions was noted. However, hospital admission rate was lower in group 2 (rate difference 0.06, 95% CI 0.01-0.11). CONCLUSIONS: Our study demonstrated a reduction in intubation rate and a need for hospitalization in the reduced diazepam dose emergency medical service protocol. The reduction in the diazepam dose was effective in terminating the seizure activity and did not increase the risk of adverse events.

Anticonvulsants↗

Protocols for pediatric poisonings from nontoxic substances: are they valid?

OBJECTIVES: Most pediatric poisonings have favorable outcomes and are managed in the home by poison control centers utilizing protocols that deem products or substances as nontoxic. We sought to evaluate the validity of protocols for nontoxics. METHODS: This is retrospective study in which poison control center case records within a statewide poison control center system during calendar year 2001 were searched for products or substances involved in a pediatric poisoning ingestion and identified in the poison control center nontoxic substance or product list. This was coupled with systematic literature search to ascertain if any significant medical outcomes were associated with ingestion of a nontoxic substance or product. RESULTS: During the 1-year study period, 20,900 pediatric ingestions involving 46 different nontoxic substances or products were analyzed for significant outcomes. Only 6 cases (0.03%) had a potentially serious clinical effect requiring emergency hospital management. The literature search revealed 2326 ingestion cases of nontoxic products from 635,000 citations in 50 different databases. Of these, 28 cases (1.2%) described an effect, although none was described as significant. CONCLUSIONS: Poisoning protocols for pediatric ingestions of substances or products we deemed as nontoxic were rarely associated with significant outcomes. However, non-dose-related potentially life-threatening effects are possible. Therefore, use of nontoxic protocols by other health care practitioners for telephone triage or by the public directly requires further study to be valid. Our study suggests that the term nontoxic is misleading and recommends that it be replaced with "minimally toxic" as a more appropriate term for identifying the lowest level of risk of toxicity from a substance or product.

California↗

Evidence-based protocol for diabetic foot ulcers.

BACKGROUND: Diabetic foot ulcers are the single biggest risk factor for nontraumatic foot amputations in persons with diabetes. Foot ulcers occur in 12 to 25 percent of persons with diabetes and precede 84 percent of all nontraumatic amputations in this growing population. Because of the high incidence of foot ulcers, amputations remain a source of morbidity and mortality in persons with diabetes. Strict adherence to evidence-based protocols as described herein will prevent the majority of these amputations. METHODS: The collective experience of treating patients with neuropathic diabetic foot ulcers in four major diabetic foot programs in the United States and Europe was analyzed. RESULTS: The following protocol was developed for patients with diabetic foot ulcers: (1) establishment of good communication among the patient, the wound healing team, and the primary medical doctor; (2) comprehensive, protocol-driven care of the entire patient, including hemoglobin A1c, microalbuminuria, and cholesterol as well as early treatment of retinopathy, nephropathy, and cardiac disease; (3) weekly objective measurement of the wound with digital photography, planimetry, and documentation of the wound-healing process using the Wound Electronic Medical Record, if available; (4) objective evaluation of blood flow in the lower extremities (e.g., noninvasive flow studies); (5) débridement of hyperkeratotic, infected, and nonviable tissue; (6) use of systemic antibiotics for deep infection, drainage, and cellulitis; (7) off-loading; (8) maintenance of a moist wound bed; (9) use of growth factor and/or cellular therapy if the wound is not healing after 3 weeks with this protocol; and (10) consideration of the use of vacuum-assisted therapy in complex wounds. CONCLUSIONS: In diabetic foot ulcers, availability of the above modalities, in combination with early recognition and comprehensive treatment, ensures rapid healing, minimizes morbidity and mortality rates, and eliminates toe and limb amputations in the absence of ischemia and osteomyelitis.

Anti-Bacterial Agents↗

Protocol-driven nonoperative management in patients with blunt splenic trauma and minimal associated injury decreases length of stay.

BACKGROUND: The purpose of this study was to analyze the impact of more selective use of admission angiography combined with protocolized nonoperative management for blunt splenic injury. METHODS: This was a retrospective chart review of all patients with splenic injuries and Injury Severity Score < 20 managed by protocol and comparison with a prior matched group managed with admission angiography. RESULTS: Forty-three patients were managed under the protocol, with 22 patients treated with admission angiography and the remainder undergoing observation only. Nonoperative salvage was 100% in this group, with a length of stay of 3.3 days. The matched, nonprotocol group had a nonoperative salvage rate of 95%, with a length of stay of 6.8 days. CONCLUSION: Protocol-driven management of splenic injury using admission angiography selectively for higher grade splenic injuries led to a decreased length of stay, higher therapeutic yield, and decreased use of hospital resources without any increase in the failure rate of nonoperative management in a selected group of patients with isolated splenic injuries.

Adult↗

Implementation of a norepinephrine-based protocol for management of septic shock: a pilot feasibility study.

BACKGROUND: The subject of the best vasopressor for hemodynamic management of septic shock (SS) is controversial. One of the difficulties in planning such studies is that physicians are reluctant to use one vasopressor exclusively, and there is considerable variation in practice. The aim of this study was to test the feasibility of implementing a single pressor-based algorithm (in this case, norepinephrine [NE]). METHODS: A NE-based algorithm was applied prospectively to 100 consecutive SS patients. A formal training program was implemented before starting the protocol and applied to 72 physicians and nurses involved in intensive care unit (ICU) patient care. Compliance, protocol violations, probable adverse effects, and outcome were evaluated on a daily basis by an independent group of fellows and a research nurse. RESULTS: In 100 patients, there were 7,139 hours of algorithm use. Only 13 protocol violations were observed, mostly in the timing of inotropic drugs. Senior staff physicians or busy night shifts accounted for most of these violations. ICU mortality was 33%, which is comparable to that predicted by Acute Physiology and Chronic Health Evaluation II and Sequential Organ Failure Assessment scores. Adverse events probably related to NE were not observed. CONCLUSIONS: The present algorithm, applied after a strict training program, obtained an overall good acceptance and compliance with very few protocol violations in more than 7,000 hours of use. Safety was demonstrated by a global mortality comparable to that predicted by severity scores and absence of specific drug-related morbidity. The implementation of a single pressor-based algorithm for SS is feasible and safe.

Adult↗

Implementation of a tight glycaemic control protocol using a web-based insulin dose calculator.

We describe the implementation of a glucose control protocol supported by a web-based insulin dose calculator in a 16-bedded intensive care unit. The protocol was introduced and then modified after 15 months' use. Glucose concentrations were retrospectively reviewed and compared for the 9-month period before introduction of the protocol (288 patients), for 15 months after its introduction (502 patients) and for a further 5 months after its modification to increase insulin dose (101 patients). The mean (SD) blood glucose concentrations decreased from 7.3 (1.8) mmol.l(-1) to 6.6 (1.6) mmol.l(-1) and then to 6.2 (1.3) mmol.l(-1). The proportion of values < 8.0 mmol.l(-1) increased from 69% to 81% and then to 89%. Blood glucose concentrations were increased by the use of intravenous nutrition and by vasoactive drugs but not by the administration of propofol. The odds ratio [95% CI] for death for glucose values > 8.0 mmol.l(-1) was 2.10 [1.19-3.73] compared to values < 6.1 mmol.l(-1). However, patient mortality remained constant during the study. Glycaemic control was improved outside a research setting using a protocol supported by a web-based insulin dose calculator.

Adult↗

Internet based clinical trial protocols -- as applied to a study of warfarin pharmacogenetics.

AIMS: To describe and evaluate the use of an Internet-based study protocol in a multicentre study of genetic risk factors in anticoagulant treatment. METHODS: A web-based study protocol, similar to existing anticoagulation medical record systems, was developed for entry of clinical data. It was also supplied with a separate interface for study monitoring. Measures were taken to assure the confidentiality of transferred data. In addition, software modifications were made to enable automated transfer of clinical data from an existing medical record system to the study database. RESULTS: The system has been in use since March 2002, and at present 39 centres have included 909 patients with a dropout rate of 2.8%. The need for education of participating clinicians has been satisfactorily provided for by means of written instructions and telephone support. CONCLUSIONS: Our study demonstrates the usability of Internet-based data acquisition techniques in a full-scale multicentre clinical trial. The main advantages of such a protocol are automated data validation and standardization, fast data transfer independent of geographical distance, user feedback, synchronization of protocol updates and automatic data formatting facilitating statistical analyses. Safety and accessibility are possibly cumbersome areas and should be addressed duly.

Adult↗

A protocol for recording the sign of flexural dermatitis in children.

The presence of visible flexural dermatitis is a key feature in diagnosing atopic dermatitis. We describe a protocol for recording this sign in population-based studies, which could be used by suitably trained non-dermatologists. The protocol was developed using a standard set of photographs and accompanying instructions, which define the terms 'dermatitis' and 'flexural'. When assessed during a survey of skin disease in primary schoolchildren, there was excellent agreement between a trained nurse and a dermatologist with regard to the presence or absence of this sign in 73 consecutive children, with perfect agreement in 71 children (97%), and a chance corrected agreement index (kappa statistic) of 0.90 (95% confidence interval [CI] 0.77-0.99). Agreement between two nurses on 114 consecutive schoolchildren was not quite as good, with perfect agreement in 102 children (90%), and a kappa value of 0.51 (95% CI 0.26-0.77). The protocol is easy to perform, does not require children to undress, takes < 1 min to carry out, and is highly acceptable to children and staff. This protocol may be useful in standardizing the assessment of atopic dermatitis in population studies of children.

Child↗

Steroid avoidance in renal transplantation using basiliximab induction, cyclosporine-based immunosuppression and protocol biopsies.

BACKGROUND: Reducing chronic steroid exposure is important to minimize steroid-related morbidity, particularly for susceptible renal transplant recipients. Steroid-free and steroid-sparing protocols have shown benefits, but safety has not been established for all populations. We investigated the safety of steroid avoidance (SA) in a population including African-Americans, using modern immunosuppression with protocol biopsy monitoring. METHODS: A randomized-controlled SA trial (early discontinuation, days 2-7) was conducted in a population (n = 77) including African-Americans and cadaveric kidney recipients. Patients received basiliximab, cyclosporine (CsA), and mycophenolate mofetil (MMF). In controls, steroids were tapered to 5 mg prednisone/d by day 30. Protocol biopsies were performed (1, 6, 12 and 24 months) to evaluate subclinical acute rejection (SCAR) and chronic allograft nephropathy (CAN). RESULTS: The SA did not result in significantly higher incidences of graft loss, AR, SCAR, CAN, or renal fibrosis. SA patients experienced similar renal function, comparable serum lipid levels, and a trend toward fewer cases of new-onset diabetes. Clinical outcomes of African-American and non-African-American patients did not significantly differ. CONCLUSIONS: The SA is safe in the context of basiliximab induction and CsA-based immunosuppression. This protocol could minimize steroid-related side effects in susceptible groups, including African-Americans, without increasing the risk of AR or graft failure.

Adolescent↗

Exploring the relationship between nursing protocols and nursing practice in an Irish intensive care unit.

Nursing practice no longer relies on tradition or ritual; instead, it is based on research and empirical evidence. The emphasis on evidence-based nursing, as well as standardization of nursing practice, has resulted in the production of policies, protocols and guidelines aimed at directing numerous aspects of nursing care. The aim of this study was to explore the relationship between these documents and actual nursing practice. To this end, this descriptive study employed a case study approach to examine the experiences of nurses in an Irish intensive care unit with a protocol on endotracheal tube suctioning. Focus group interviews of 17 nurses in six focus groups provided a significant insight into the experiences of these nurses in relation to policies, protocols and guidelines. Analysis of the data afforded some highly relevant findings, including the fact that nurses adapt clinical protocols as they see fit, thus demonstrating the importance that they place on their own professional judgement and autonomy.

Attitude of Health Personnel↗

Assessment of a protocol for prophylactic antibiotics to prevent perioperative infection in urological surgery: a preliminary study.

BACKGROUND: The aim of the present study was to assess the usability and efficacy of our new protocol of prophylactic antibiotic use to prevent perioperative infection in urological surgery. METHODS: We prospectively investigated 339 cases of typical urological surgery in our department between April 2001 and March 2002 (group I). We classified surgical procedures into four categories by invasiveness and contamination levels: category A, clean less invasive or endoscopic surgery; category B, clean invasive or clean contaminated surgery; category C, urinary tract diversion using the intestine; and category D, infected surgery. Antibiotics were administrated intravenously according to our protocol: category A, first or second generation cephems or penicillins during the operative day only; category B, first and second generation cephems or penicillins for 3 days; and category C, second or third generation cephems for 4 days. Category D was excluded from the analysis. To judge perioperative infections, the wound condition and general conditions were evaluated in terms of the surgical site infection (SSI) as well as remote infection (RI) up to postoperative day (POD) 14. We retrospectively reviewed 308 patients who underwent urological surgery between April 2000 and March 2001 (group II) as reference cases that were administered antibiotics without any restriction. RESULTS: Perioperative infection rates (SSI + RI) in group I and group II were 25 of 339 (7.4%) and 35 of 308 (11.4%), respectively. Surgical site infection rates of categories A, B, and C in group I were 1.8%, 7.6%, and 30.0%, respectively, while those in group II were 2.0%, 7.4%, and 46.2%, respectively. There was no significant difference in infection rates in terms of RI and SSI between group I and group II. The amounts, as well as the prices, for intravenously administrated antibiotics and oral antibiotics decreased to approximately half and one-fifth, respectively. CONCLUSION: Our protocol effectively decreased the amount of antibiotics used without increasing perioperative infection rates. Thus, our protocol of prophylactic antibiotic therapy would be recommended as an appropriate method for preventing perioperative infection in urological surgery.

Adolescent↗

Outcome evaluation of an emergency department protocol of care on partner abuse.

STUDY OBJECTIVE: To evaluate the impact of a protocol on partner abuse (PA) at increasing identification and improving acute management of abused women by emergency department (ED) staff. METHODS: A community intervention trial compared two public hospital EDs at baseline and following implementation of a PA intervention. The intervention involved training staff at one ED in a protocol for the identification and acute management of abused women. Outcomes were assessed by reviewing a random sample of women's medical records. Identification of PA was assessed for each record on a yes/no basis. Identified cases were classified as 'confirmed' or 'suspected' PA. Acute management was assessed by ascertaining staff documentation of abuse and use of interventions. RESULTS: Approximately equal numbers of records were reviewed at each ED, pre and post implementation (total n = 8,051). Eighty-nine per cent of ED staff were trained. No difference in the overall identification of PA was found (chi 2 = 0.13, p = 0.72), but logistic regression analyses showed other significant changes. At the intervention site, there was an increase in confirmed cases of PA (chi 2 = 7.6, p = 0.006), a trend towards increased documentation (chi 2 = 3.5, p = 0.06) and a significant increase in interventions offered (chi 2 = 13.8, p = 0.002). Changes at the comparison site failed to reach significance. CONCLUSION: Implementation of this protocol resulted in a moderate increase in confirmed cases of abuse and improved the acute management offered to identified victims. The findings reinforce recommendations for widespread implementation of training and protocols to address partner abuse.

Adolescent↗

An efficacious oral health care protocol for immunocompromised patients.

A twice-weekly oral and perioral examination was provided to 120 patients receiving antineoplastic therapy. Sixty patients were monitored while following the traditional hospital oral care protocol (chlorhexidine, hydrogen peroxide, sodium bicarbonate, thymol glycol, benzocaine mouthrinse, and nystatin). The mouth care protocol was then changed (experimental protocol = chlorhexidine, benzocaine lozenges, amphotericin B lozenges), and patients were monitored until the sample size matched that of the hospital mouth care regime. There was a statistically significant reduction in oral complications upon introduction and maintenance of the experimental protocol.

Adolescent↗

Practical protocols for the prevention of dental disease in community settings for people with special needs: preface.

This issue of Special Care in Dentistry presents protocols that were designed during a conference, Practical Protocols for the Prevention of Dental Disease in Community Settings for People with Special Needs, which was held at the University of the Pacific School of Dentistry on February 1, 2002. After each expert reviewed and reported on one area of the literature, which included risk assessment; chlorhexidine mouth rinses; xylitol chewing gum; topical fluoride and fluoride varnish applications; and methods to control or treat periodontal disease, practical protocols were developed. Next, a strategy of implementation and dissemination will be designed using nurses, case managers, social workers, caregivers, and others to encourage people with special needs to use these protocols. A plan will also be implemented to increase social and health care provider awareness about these interventions through professional publications and educational opportunities. The goal is to reduce dental disease in special needs populations and thereby decrease the need for difficult and costly treatment.

Clinical Protocols↗

Unexpected neurotoxicity in dogs receiving a cyclophosphamide, dactinomycin, and 5-fluorouracil chemotherapy protocol.

An inexpensive combination chemotherapy protocol containing cyclophosphamide, dactinomycin, and 5-fluorouracil was evaluated in dogs with carcinomas. Fifteen dogs were entered in this study, and there were 1 complete response and 2 partial responses among 12 evaluable dogs. However, 6 of 15 dogs (40%) developed neurotoxicity. The neurotoxicity of this protocol was compared with a previous 5-fluorouracil-containing protocol and found to be significantly higher. Due to the unacceptably high rate of neurotoxicity, this protocol cannot be recommended for use in dogs with cancer.

Animals↗

Differences in electron beam dosimetry using two commercial ionization chambers and the TG-21 protocol: another reason to switch to TG-51.

Two of the most popular dosimetry systems used for calibration of megavoltage photon and electron beams in radiation therapy are (i) cylindrical Farmer-type chambers in liquid water and (ii) Holt Memorial parallel-plate chambers in clear polystyrene. Since implementation of the AAPM TG-21 calibration protocol, the Radiological Physics Center (which uses the Farmer in-water system) has compared machine calibrations on two occasions with those of Memorial Sloan-Kettering Cancer Center (which uses the Holt in-polystyrene system). Two years post publication of the TG-51 protocol, 70% of the clinics monitored by the RPC still use TG-21. Seventeen photon beams from cobalt-60 to 18 MV and 31 electron beams from 6 to 20 MeV were compared using the TG-21 protocol. These data represent the most comprehensive comparison of the two most popular systems in use. Based on the average percent difference, the two systems yielded the same absorbed dose to water at the reference point in phantom to within 1.5% for both modalities. No energy dependence was evident in the results; however, a systematic average percent difference between photons and electrons was seen, with the Farmer in-water system consistently predicting a dose 1.3% lower for electrons than the Holt in-polystyrene system. For photons both systems predicted the same dose to within 0.3% on average. When a physicist converts from TG-21 to TG-51, these data may be of assistance in explaining unexpected changes in output that are different from previously published values. Implementation of the TG-51 protocol should eliminate any of the observed differences in electron beam dosimetry between the two dosimetry systems because the Holt system cannot be used with TG-51.

Calibration↗