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PubMed2006

Clinical trial design issues raised during recombinant DNA advisory committee review of gene transfer protocols.

Gene transfer clinical trial protocols are reviewed by the Recombinant DNA Advisory Committee (RAC). Identifying the design concerns and suggestions commonly raised during RAC review may help investigators and sponsors shorten the process of protocol development and improve the quality of gene transfer trials. We therefore examined 53 full public reviews of gene transfer clinical trial protocols performed by the RAC between December 2000 and June 2004 to determine what trial design concerns or suggestions RAC members raised during written review or public discussion or in the formal letter to investigators after the review was completed. We also determined how frequently these concerns were raised. We found that RAC members raised issues regarding selection of subjects in 89% of reviews, dose escalation in 77%, selection of safety end points in 76%, biological activity measures in 66%, and overall design in 60% of reviews. The most common issue raised by RAC reviewers was the need to exclude subjects at increased risk for adverse events. Furthermore, in 89% of reviews, at least one design issue pertaining to safety of participants was raised. In 91% of reviews, at least one design concern was presented as a written RAC recommendation or concern to the investigator after the public review. When submitting protocols for RAC review, investigators and sponsors might devote more attention to issues that RAC reviewers commonly raise. Such attention might help strengthen clinical trial protocols, shorten the protocol development process, and enhance the protection of research participants.

Clinical Protocols↗

PubMed2005

Prediction of gentamicin peak and trough concentrations from six extended-interval dosing protocols for neonates.

PURPOSE: The ability of six extended-interval gentamicin dosing protocols to achieve desired peak and trough concentrations in neonates was evaluated using simulated calculations based on pooled patient data. METHODS: The demographic and pharmacokinetic data of 293 neonates age one week or less from three previously published studies were pooled and applied in each of six published protocols. The data collected, including weight, dosage, dosing interval, and measured serum or plasma gentamicin concentrations, were used to determine gentamicin clearance, elimination-rate constant, and distribution volume. Peak and trough gentamicin concentrations were calculated and compared with several therapeutic ranges that aim to achieve high peak concentrations for maximum efficacy and low trough concentrations for minimum toxicity. RESULTS: All protocols resulted in more than 95% of peak concentrations exceeding 5 mg/L. Peaks exceeded 10 mg/L in 26-42% of the simulations. Most of the protocols resulted in high trough concentrations (0.5-1.5 mg/L). Trough concentrations were below 1 mg/L in 51-83% of the simulations. CONCLUSION: Simulated calculations based on pooled patient data found that six gentamicin dosing protocols for neonates would likely yield acceptable peak concentrations and a trough concentration of < or = 1 mg/L for at least 50% of patients. It may be sufficient to monitor only the trough concentrations when applying these protocols.

Anti-Bacterial Agents↗

PubMed2006

Identifying determinants of protocol adoption by midwives: a comprehensive approach.

Adoption of potentially effective preventive interventions often fails. This study aimed to identify factors that determine why midwifery practices decide to use a smoking cessation protocol, using a comprehensive model of both organizational and psychosocial factors. A cross-sectional survey was conducted among representatives of all 446 Dutch midwifery practices, of whom 251 (56%) responded. The results show that adoption of the protocol was facilitated by the presence of practice assistants and impeded by a large proportion of clients of foreign ethnic origin. The most successful information channel was the midwives' professional association. A consistent positive attitude (perceiving a lot of advantages, few disadvantages and a low level of ambivalence) and positive social norms toward using the protocol, a perceived large proportion of midwives who use the protocol and knowledge about the protocol significantly increased the likelihood of adoption. The decision to use the protocol was better explained by personal awareness and motivation factors than by organizational factors.

Adult↗

PubMed2000

Use of a treatment protocol in the management of community-acquired lower respiratory tract infection.

The aim of the present study was to examine the impact of an antimicrobial prescribing protocol on clinical and economic outcome measures in hospitalized patients with community-acquired lower respiratory tract infection (LRTI). The study was performed as a prospective controlled clinical trial within the medical wards at Antrim Area Hospital, Northern Ireland. Data were collected on all hospitalized adult patients with a primary diagnosis of LRTI during the period December 1994 to February 1995 (normal hospital practice; control group; n = 112). After an LRTI management protocol (medical, microbiological and pharmacy staff) had been developed, all hospitalized adult patients with a primary diagnosis of LRTI over the period December 1995 to February 1996 formed the intervention group (treated according to the protocol; n = 115). The results showed a statistically significant impact of the protocol in terms of clinical and economic outcome measures. Patients treated using the algorithmic prescribing protocol had significant reductions in length of hospital stay (geometric mean 4.5 versus 9.2 days), iv drug administration (34.8% versus 61.6%), duration of iv therapy (geometric mean 2.1 versus 5.7 days) and treatment failures (7.8% versus 31.3%). Healthcare costs were also significantly reduced. The use of the protocol was a major factor in streamlining the prescribing of antimicrobial therapy for community-acquired LRTI and led to more cost-effective patient management.

Aged↗

PubMed1988

The cost effects of protocol systems. The marginal cost-average cost dichotomy.

Protocol systems are a mechanism that some have contended will maintain high quality of patient care and will result in improved delivery of care, more efficient management of care, and in lower costs. Cost savings reported from protocol care generally are based on average costs. This article reports on an analysis of the cost effects of a pediatric protocol system. The impact of the system on both average and marginal costs was considered. The study results indicated that care adhering to the protocols, when compared to nonadherent care, resulted in a substantial savings measured against average costs. However, only a very small decrease in the marginal cost of care occurred. Ancillary department costs were found to be fixed in most cases and not subject to variation without substantial changes in the volume of services ordered. None of the volume changes attributable to the protocols were sufficiently large to result in the reallocation of labor resources or the reconfiguration of departmental equipment. Although protocol systems still may be of great value in generating more appropriate care, their ability to reduce costs is apparently less than was supposed.

Ancillary Services, Hospital↗

PubMed1992

The legal danger of written protocols and standards of practice.

Nurse practitioners have historically developed protocols and standards of practice to guide and improve the quality of their patient care. Written protocols and standards of practice can, however, create a potential malpractice problem. Lawyers who bring malpractice cases on behalf of patients will use the protocols and standards to measure the practitioner's care. The practice standards are often too high to be reasonably met by practitioners at all times and in all settings. As a result, the practitioner's care may breach those standards. Nurse practitioners should develop protocols that are based on a minimum safe level and not the maximum level aimed at ideal care. Standards and protocols should be updated and realistic. Once developed, protocols and standards must be followed precisely to limit potential liability.

Clinical Protocols↗

PubMedDate not supplied

Pharmacist designed and nursing-driven insulin infusion protocol to achieve and maintain glycemic control in critical care patients.

The objective of the quality assessment was to develop and evaluate a modified nurse-driven insulin infusion protocol for intensive care unit patients and compare the hours needed to achieve a targeted glycemic range and duration within a goal range (80-110 mg/dL) to that of our traditional protocol. With our modified nurse-driven protocol, the median time to reach the goal for patients with diabetes was 11.5 hours versus 21.5 hours with the traditional protocol. Patients without diabetes reached the goal in 8 hours with the modified-nurse driven protocol versus 12 hours with the traditional protocol. Percentage of time within the goal improved from 14.6% to 20.7% for patients with diabetes and from 7% to 24.3% for patients without diabetes.

Aged↗

PubMed1999

Developing practice protocols for advanced practice nursing.

In most states, the role of an advanced practice nurse is dependent on practice protocols that provide an organized method for analyzing and managing a disease or major symptom. They are also used to control the process of medical care and to specify steps in the delivery of that care. Creating appropriate practice protocols is one of the most important precursors to implementing the advanced practice role, because they virtually drive the clinician's ability to treat or manage clinical situations or disease states. This article outlines the steps involved in developing practice protocols and discusses the content that should be included in a protocol, providing an example of narrative and algorithm format protocols. Pros and cons, as well as legal issues related to practice protocols, are also presented.

Algorithms↗

PubMed2006

Implementation and outcomes of the Multiple Urgent Sepsis Therapies (MUST) protocol.

OBJECTIVES: To describe the effectiveness of a comprehensive, interdisciplinary sepsis treatment protocol with regard to both implementation and outcomes and to compare the mortality rates and therapies of patients with septic shock with similar historical controls. DESIGN: Prospective, interventional cohort study with a historical control comparison group. SETTING: Urban, tertiary care, university hospital with 46,000 emergency department visits and 4,100 intensive care unit admissions annually. PATIENTS: Inclusion criteria were a) emergency department patients aged > or =18 yrs, b) suspected infection, and c) lactate of >4 mmol/L or septic shock. Exclusion criteria were a) emergent operation, b) prehospital cardiac arrest, and c) comfort measures only. Time period: protocol, November 10, 2003, through November 9, 2004; historical controls, February 1, 2000, through January 31, 2001. INTERVENTION: A sepsis treatment pathway incorporating empirical antibiotics, early goal-directed therapy, drotrecogin alfa, steroids, intensive insulin therapy, and lung-protective ventilation. MEASUREMENTS AND MAIN RESULTS: There were 116 protocol patients, with a mortality rate of 18% (11-25%), of which 79 patients had septic shock. Comparing these patients with 51 historical controls, protocol patients received more fluid (4.0 vs. 2.5 L crystalloid, p < .001), earlier antibiotics (90 vs. 120 mins, p < .013), more appropriate empirical coverage (97% vs. 88%, p < .05), more vasopressors in the first 6 hrs (80% vs. 45%, p < .001), tighter glucose control (mean morning glucose, 123 vs. 140, p < .001), and more frequent assessment of adrenal function (82% vs. 10%, p < .001), with a nonstatistically significant increase in dobutamine use (14% vs. 4%, p = .06) and red blood cell transfusions (30% vs. 18%, p = .07) in the first 24 hrs. For protocol patients with septic shock, 28-day in-hospital mortality was 20.3% compared with 29.4% for historical controls (p = .3). CONCLUSIONS: Clinical implementation of a comprehensive sepsis treatment protocol is feasible and is associated with changes in therapies such as time to antibiotics, intravenous fluid delivery, and vasopressor use in the first 6 hrs. No statistically significant decrease in mortality was demonstrated, as this trial was not sufficiently powered to assess mortality benefits.

Aged↗

PubMed2005

Second induction in pediatric patients with recurrent acute lymphoid leukemia using DFCI-ALL protocols.

Between 15% and 30% of children with acute lymphoblastic leukemia (ALL) experience disease recurrence. With the possible exception of patients presenting with late isolated extramedullary relapse, induction of second complete remission (CR) is employed as a stepping stone to allogeneic hematopoietic stem cell transplantation (HSCT). The authors report their institutional experience in the management of children with recurrent ALL using the Dana Farber Cancer Institute (DFCI) ALL protocol in patients treated initially with that same protocol. Successful reinduction was followed by allogeneic HSCT when possible. Between April 1986 and May 2003, 34 patients with recurrent ALL, treated at initial diagnosis with DFCI-ALL protocol therapy, were given the same protocol as repeat induction chemotherapy. The median age was 4.6 years at diagnosis and 7.1 years at recurrence. Median duration of CR1 was 30.3 months. Second CR was obtained in 29 (85%) patients. Twenty went on to allogeneic HSCT; 10 of them currently remain in CR. Two additional patients treated with chemotherapy without HSCT are also in continuous CR2. Overall, 13 (38%) of the 34 patients are alive with a median follow-up of 105 months. There were no toxic deaths due to the reinduction therapy. One child died of cardiac failure after autologous HSCT. The treatment of children with recurrent ALL using the DFCI-ALL protocol induction regimen after initial use of the same protocol is associated with a high rate of second CR with no excess toxicity. However, the overall prognosis in these patients remains unsatisfactory and needs to be improved.

Adolescent↗

PubMed2006

Use of a feeding protocol to improve nutritional support through early, aggressive, enteral nutrition in the pediatric intensive care unit.

OBJECTIVE: To evaluate the effects of instituting a feeding protocol with inclusive bowel regimen on tolerance and time to accomplish goal feeding in the pediatric intensive care unit. DESIGN: Retrospective comparison chart review before and after the initiation of a feeding protocol. PATIENTS: A total of 91 patients in the year 2000, before the initiation of the protocol, who received nasogastric feedings and 93 patients in year 2002 after the protocol was initiated. MEASURES AND MAIN RESULTS: Patients were selected for review if they received nasogastric tube feedings while in the pediatric intensive care unit. The data were reviewed from time of admission in the pediatric intensive care unit through 7 days of goal feedings or discharge from the pediatric intensive care unit. Data examined included: days in the pediatric intensive care unit and hospital, time to goal feedings, concomitant use of cardiovascular medications, sedation, analgesia, episodes of feedings held, vomiting, diarrhea, and constipation. The protocol group achieved goal nutrition in an average of 18.5 hrs and a median of 14 hrs. The retrospective group achieved goal feedings at an average of 57.8 hrs and a median of 32 hrs (p < .0001). Also noted were a reduction in the percentage of patients vomiting from 20% to 11% and a reduction in constipation from 51% to 33%. CONCLUSION: This comparison study suggests that the institution of a feeding protocol will not only achieve goal feedings at a substantially reduced time but also improve tolerance of enteral feedings in patients admitted to the pediatric intensive care unit.

Child, Preschool↗

PubMed2004

From birth to maturity: a group of patients who have completed their protocol management. Part I. Unilateral cleft lip and palate.

The optimal management of the cleft lip and palate patient from birth to completion of treatment presents a formidable challenge to the plastic surgeon and the associated health care system. The multidisciplinary team approach for the management of these patients is widely accepted. However, a paucity of literature exists discussing specific protocol management, interventions, and the long-term outcomes of patients who have completed a strict treatment protocol with a consistent multidisciplinary team. The aim of this study was to present the details of the specific management protocol at the Australian Craniofacial Unit for cleft lip and palate patients and to present a group of patients who have completed this specific protocol and discuss the details of their long-term care. During a 28-year period from 1974 to 2002, the records of 337 patients treated for unilateral cleft lip and palate were evaluated. Of these 337 patients, 22 have completed the same specific protocol management. The same surgeon (David, the senior author) has been responsible for performing all operative interventions and for overseeing the care of each of the 22 patients, ensuring that the treatment protocol has been executed appropriately and without deviation. The interventions and outcomes were analyzed on the basis of speech, hearing, nasal airway, occlusion, psychosocial adjustment, and appearance. Because of the large volume of data and potential differences in outcomes, the authors' intention is to present this as part I of a four-part series beginning with unilateral cleft lip and palate. The results of isolated cleft palate, isolated cleft lip, and bilateral cleft lip and palate will be presented as parts II, III, and IV, respectively. Speech results were assessed as normal speech, mild abnormality, or severe abnormality by objective measures, and intervention for velopharyngeal insufficiency was noted. Seventeen patients were rated as having normal speech. Four patients were rated as having mild speech abnormality, one patient was rated as having severe speech abnormality, and seven patients required surgery for velopharyngeal insufficiency. Hearing results were measured objectively, and good hearing results were obtained in 18 cases. Five patients required tympanoplasty. All patients required alveolar bone grafting. The high Le Fort I osteotomy was performed in six cases. Bimaxillary surgery was performed in one case. Of all the patients assessed from birth to maturity, 13 required between three and five surgical interventions, and nine required six operations or more. Further details and photographs of preoperative and postoperative examples are provided.

Adolescent↗

PubMed2006

A statewide, prehospital emergency medical service selective patient spine immobilization protocol.

BACKGROUND: To evaluate the practices and outcomes associated with a statewide, emergency medical services (EMS) protocol for trauma patient spine assessment and selective patient immobilization. METHODS: An EMS spine assessment protocol was instituted on July 1, 2002 for all EMS providers in the state of Maine. Spine immobilization decisions were prospectively collected with EMS encounter data. Prehospital patient data were linked to a statewide hospital database that included all patients treated for spine fracture during the 12-month period following the spine assessment protocol implementation. Incidence of spine fractures among EMS-assessed trauma patients and the correlation between EMS spine immobilization decisions and the presence of spine fractures-stable and unstable-were the primary investigational outcomes. RESULTS: There were 207,545 EMS encounters during the study period, including 31,885 transports to an emergency department for acute trauma-related illness. For this cohort, there were 12,988 (41%) patients transported with EMS spine immobilization. Linkage of EMS and hospital data revealed 154 acute spine fracture patients; 20 (13.0%) transported without EMS-reported spine immobilization interventions. This nonimmobilized group included 19 stable spine fractures and one unstable thoracic spine injury. The protocol sensitivity for immobilization of any acute spine fracture was 87.0% (95% confidence interval [CI], 81.7-92.3) with a negative predictive value of 99.9% (95% CI, 99.8-100). CONCLUSIONS: The use of this statewide EMS spine assessment protocol resulted in one nonimmobilized, unstable spine fracture patient in approximately 32,000 trauma encounters. Presence of the protocol affected a decision not to immobilize greater than half of all EMS-assessed trauma patients.

Adolescent↗

PubMed1994

Clinical protocols are key to quality health care delivery.

The use of clinical protocols allows health care providers to offer appropriate diagnostic treatment and care services to patients, variance reports to purchasers and quality training to clinical staff. Such protocols provide a locally agreed standard to which clinicians and the organization can work and against which they can be audited. By embedding protocols into patients' records and reporting by exception, the use of protocols may help to tackle a raft of other issues successfully such as the reduction in junior doctors' hours, and the facilitation of shared care. It may also bolster the medico-legal robustness of the health care delivered. If the protocols are sufficiently detailed, costing, coding and other resource usage information can flow directly from the clinical records. Such benefits may be maximized by using protocols within the framework of an electronic patient record system.

Clinical Protocols↗

PubMed2004

A consensus protocol for the determination of the threshold doses for allergenic foods: how much is too much?

BACKGROUND: While the ingestion of small amounts of an offending food can elicit adverse reactions in individuals with IgE-mediated food allergies, little information is known regarding these threshold doses for specific allergenic foods. While low-dose challenge trials have been conducted on an appreciable number of allergic individuals, a variety of different clinical protocols were used making the estimation of the threshold dose very difficult. OBJECTIVE: A roundtable conference was convened to develop a consensus clinical protocol for low-dose challenge trials for the estimation of threshold doses for specific allergenic foods. METHODS: In May 2002, 20 clinical allergists and other interested parties were invited to participate in a roundtable conference to develop consensus of the key elements of a clinical protocol for low-dose challenge trials. RESULTS: A consensus protocol was developed. Patients with convincing histories of food allergies and supporting diagnostic evidence including past challenge trials or high CAP-RAST scores can be enrolled in low-dose challenge trials. Care must be taken with younger patients to assure that they have not outgrown their food allergy. An approach was developed for the medication status of patients entering such trials. Challenge materials must be standardized, for example, partially defatted peanut flour composed of equal amounts of the three major varieties of peanuts (Florunner, Virginia, Spanish). Challenge materials must be appropriately blinded with sensory evaluation used to confirm the adequacy of blinding. A double-blind, placebo-controlled design should be used for low-dose challenge trials. Low-dose challenge trials would begin at doses of 10 microg of the allergenic food and would continue with doses of 100 microg and 1 mg followed by specific higher doses up to 100 mg depending upon the expert judgement of the physician; even higher doses might be applied to assure that the patient is indeed reactive to the particular food. A 30-min time interval would be used between doses, and reactive doses would be expressed as both discrete and cumulative doses. The goal of each challenge would be to develop objective symptoms; trials should not be discontinued on the basis of subjective symptoms only. Statistically, a minimum of 29 patients would be enrolled in low-dose challenge trials for each allergenic food because 0 reactors out of 29 patients at a particular dose allow the conclusion that there is 95% certainty that 90% of allergic individuals will not react to that dose. CONCLUSION: A consensus protocol was developed. Using this protocol, it will be possible to estimate threshold doses for allergenic foods, the lowest amount that elicits mild, objective symptoms in highly sensitive individuals.

Allergens↗

PubMed1999

One year follow-up of an emergency department protocol for abused women.

OBJECTIVE: To evaluate if the positive effects of an initially successful emergency department protocol of care for victims of partner abuse (PA) were maintained at one year follow-up. METHOD: A community intervention trial compared two public hospital EDs in Auckland, NZ, at baseline (BL), following implementation of a PA intervention (PI), and at one year follow-up (FU). The initial intervention involved training staff at one ED in a protocol for the identification and acute management of abused women. Later, an on-site protocol co-ordinator worked to ensure that new staff received training in protocol use. 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 use of interventions and documentation of abuse. RESULTS: Approximately equal numbers of records were reviewed at each ED at BL, PI and FU (total n = 10,961). Significant interactions were found for classification of PA and acute management offered to victims between EDs over the different study phases. However, the increase in identification of confirmed cases and the improved acute management offered to identified victims found at the intervention ED in the PI phase were not maintained at follow-up. CONCLUSION: Although staff training in the use of protocols for victims of partner abuse can result in improved care, these effects were not maintained. IMPLICATIONS: More intensive institutional efforts are needed if protocol benefits are to be maintained.

Adolescent↗

PubMed1994

Programmed ventricular stimulation using tandem versus simple sequential protocols.

UNLABELLED: The objective was to determine whether two commonly used ventricular stimulation protocols, one more complex than the other, produced concordant results. If such were the case, the simpler protocol would streamline activities in clinical electrophysiology laboratories. BACKGROUND: Two programmed ventricular stimulation protocols were compared. (1) With the tandem method, the first extrastimulus (S2) is moved stepwise to the effective refractory period and then moved out 50 msec; the second extrastimulus (S3) is then decremented until it fails to capture; S2 and S3 are then decremented in a semialternating (tandem) fashion so that both continue to capture. When S2 reaches the refractory period + 10 msec and S3 fails to capture, S3 is then moved out 50 msec, and S4 is decremented as described for S3. (2) With the simple sequential method, the first extrastimulus (S2) is decremented stepwise to the refractory period, and then moved out 10 msec to assure capture; S3 is then similarly decremented to the refractory period and then moved out 10 msec; and S4 is then similarly decremented. METHODS: This was a prospective, randomized, crossover, consecutive series study. Both protocols were tested in each patient on the same day in randomized order. RESULTS: There were 84 matched studies. Fifty-six patients provided data from baseline electrophysiological studies, and 28 of these provided additional data during drug trials. There was a 93% concordance between the two methods, including the primary outcomes of inducibility of clinical arrhythmias, inducibility of nonclinical arrhythmias, and noninducibility (P < 0.001). Discordances were few and evenly distributed between the two protocols (P = NS). Results were similar for baseline studies and drug trials. The simple sequential method required less time to perform (P < or = 0.01). CONCLUSIONS: Tandem and simple sequential protocols provide concordant results. No advantage could be demonstrated for the more complex tandem method.

Adolescent↗

PubMed2001

The Hong Kong Bridge Protocol. Immediate loading of mandibular Brånemark fixtures using a fixed provisional prosthesis: preliminary results.

BACKGROUND: The Brånemark System Classic is well documented for its successful and predictable results in dental implant rehabilitation. However, the classic two-stage protocol is associated with problems, such as long treatment time and high treatment cost. To overcome these problems, new developments, including early functional loading protocol and Brånemark System Novum, have been introduced by various groups of researchers. In Hong Kong, a protocol has been developed to immediately load the Brånemark System fixtures with a fixed provisional prosthesis. PURPOSE: The goal of this prospective study was to present the Hong Kong Bridge protocol and report the short-term evaluation of this protocol in a group of patients who had undergone dental implant treatment for their edentulous mandibles. MATERIALS AND METHODS: Twenty-seven consecutive patients being treated at the Hong Kong Osseointegration Implant Centre between June 1998 and December 2000 were included in this study. A total of 123 Brånemark System fixtures were installed and regularly followed up for 3 to 30 months. The prosthesis stability and the marginal bone level were regularly evaluated clinically and radiographically, respectively, after the implant surgery. RESULTS: Fifteen of the 27 patients had been followed up for 1 year or longer. Two patients with eight fixtures were withdrawn from the study. Two of the 115 remaining fixtures failed, resulting in an overall implant survival rate of 98.3%. The mean marginal bone change was reported on 49 fixtures that had passed the 1-year review. The mean marginal bone loss was 0.60 mm (p < .05) after 1 year of functional loading. CONCLUSIONS: To load the mandibular Brånemark System fixtures immediately according to the Hong Kong Bridge protocol was a predictable and simple method with good results during this preliminary study period.

Adult↗