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Management of Ontario children with acute lymphoblastic leukemia by the Dana-Farber Cancer Institute protocols.

There is ample evidence of the value of intensive therapeutic strategies in the management of acute lymphoblastic leukemia (ALL), the commonest form of malignant disease in children. Such a program, devised at the Dana-Farber Cancer Institute (DFCI), Boston, and incorporating high-dose L-asparaginase, was adopted in 1984 by the Children's Hospital at Chedoke-McMaster, Hamilton, Ont., and the Children's Hospital of Western Ontario, London. We describe the experience of these institutions in the treatment of 82 children with ALL, 19 of whom were switched to the DFCI protocols while in continuing first remission with other treatment programs to complete a minimum of 2 years of maintenance therapy; the remaining 63 children, who had recently diagnosed disease, were consecutively enrolled in the DFCI protocols. Each child was assigned at diagnosis to a category of risk for relapse and treated accordingly. There were no remission induction failures or deaths due to induction therapy among the patients with newly diagnosed disease. There were no differences in total or event-free survival rates between the patients in Hamilton and those in London or between those whose protocols were switched and those who were treated from the beginning with the DFCI protocols. With a median follow-up interval of 144 weeks the total survival rate was 95% and the event-free survival rate 88%. For patients at standard risk of relapse the event-free survival rate was 100%, for those at high risk the rate was 82%, and for those at very high risk the rate was 67%. If infants (all of whom suffered a relapse) are excluded from the last category the rate was 89%. These results were achieved with moderate toxic effects (except for two deaths, one of which was due to a therapeutic misadventure) and suggest that the prospect for cure in children with ALL. may now approximate 80%, a degree of success that demands that consideration be given to reducing total therapy, at least for children with standard-risk disease. Further follow-up will determine whether these high event-free survival rates will stabilize and meet the criteria for cure.

Antineoplastic Combined Chemotherapy Protocols↗

Protocol-driven ventilator management in a trauma intensive care unit population.

HYPOTHESIS: The use of weaning and sedation protocols affects the intensive care unit (ICU) course of a trauma population. DESIGN: Nonrandomized before-after trial. SETTING: A level I trauma center. PATIENTS: Three hundred twenty-eight consecutive trauma patients receiving mechanical ventilation treated in the ICU between October 1, 1997, and November 1, 1999. INTERVENTION: Sedation and weaning protocols were used to treat patients receiving mechanical ventilation during the second year of this study. MAIN OUTCOME MEASURES: Self-extubation rates, ventilator days, number of ICU days, and charges. RESULTS: There were 168 patients in the preprotocol group (year 1: October 1, 1997, to October 31, 1998) and 160 patients in the postprotocol group (year 2: November 1, 1998, to November 30, 1999). The groups were similar in age (P =.68), Injury Severity Score (P =.06), and Glasgow Coma Scale score (P =.29). There were no differences in self-extubation rates (P =.57), ventilator days (P =.83), ventilator charges (P =.83), number of ICU days (P =.67), or ICU charges (P =.67) between the 2 groups. No statistical difference was identified in any of these categories when long-term ventilator patients (defined as ventilator length of stay > or =3 SDs above the mean) were excluded. CONCLUSIONS: Use of weaning and sedation protocols did not affect the measured outcomes in this study. These findings may reflect difficulties inherent in the protocols or with their utilization. Further subgroup analysis focusing on ventilator-associated pneumonias and mortality may demonstrate benefits not identified herein.

Adult↗

Acute neurotoxicity in children with B-lineage acute lymphoblastic leukemia (B-ALL) treated with intermediate risk protocols.

BACKGROUND: This study describes the incidence of acute neurotoxicity (NT) in children with B-lineage acute lymphoblastic leukemia (ALL) treated with three intermediate risk protocols that differ in the intensity of central nervous system (CNS) "prophylaxis. " PROCEDURE: A total of 122 patients (64 boys; median age 5.3 years) with B-lineage ALL without CNS leukemia diagnosed between February 1987 and December 1997 were enrolled in the intermediate risk (IR) protocols: Associazione Italiana di Ematologia ed Oncologia Pediatrica (AIEOP)-ALL 87 (n = 33), 91 (n = 51), and 95 (n = 38). Presymptomatic CNS therapy consisted of intrathecal methotrexate (six doses) and cranial irradiation (18 Gy) in the IR AIEOP 87 study, and extended triple intrathecal therapy with methotrexate, cytarabine, and prednisone depending on age in the IR AIEOP-ALL 91 and 95 protocols (20 and 17 total doses, respectively). World Health Organization (WHO) grade 4 acute neurotoxicity criteria were employed. Patients with neurologic symptoms, in addition to physical examination, underwent EEG, computed tomography (CT) and/or magnetic resonance imaging (MRI), and lumbar puncture to exclude CNS leukemia and infection. RESULTS: Acute NT was not reported in AIEOP-ALL 87 treated patients, but we observed acute NT in 3 out of 51 (5.8%) AIEOP-ALL 91 patients, and in 7 out of 38 (18.4%) AIEOP-ALL 95 patients. CONCLUSIONS: There was an increased incidence of acute NT in our patients with ALL treated with current intermediate risk protocols. The intensification of treatment, however, bettered event free survival (EFS) to 58%, 72% and 85% in IR AIEOP 87, 91 and 95 studies, respectively.

Adolescent↗

Adjuvant chemotherapy for osteosarcoma of the extremity. Long-term results of two consecutive prospective protocol studies.

Seventy-six patients with classic high-grade osteosarcoma of an extremity received adjuvant chemotherapy by two protocols, initiated in 1972 and 1977, respectively, after appropriate amputations. Chemotherapy consisted of high-dose methotrexate, doxorubicin, and cyclophosphamide. Dose intensity of high-dose methotrexate and doxorubicin was greater for the patients treated with the protocol initiated in 1977. The proportion of long-term disease-free survivors on the two protocols are 46% and 56%. A better outcome (P = 0.042) was seen for the latter group, which received more intensive chemotherapy. Overall, metastases developed in 35 patients; in 19 who were receiving chemotherapy and in 16 after chemotherapy. The outcome for these two protocols, compared with two control groups that were given no chemotherapy or ineffective chemotherapy (biweekly vincristine and cyclophosphamide), confirms the results of controlled studies that showed an advantage of adjuvant chemotherapy after amputation for osteosarcoma.

Adolescent↗

A protocol is not enough to implement an enhanced recovery programme for colorectal resection.

BACKGROUND: Single-centre studies have suggested that enhanced recovery can be achieved with multimodal perioperative care protocols. This international observational study evaluated the implementation of an enhanced recovery programme in five European centres and examined the determinants affecting recovery and length of hospital stay. METHODS: Four hundred and twenty-five consecutive patients undergoing elective open colorectal resection above the peritoneal reflection between January 2001 and January 2004 were enrolled in a protocol that defined multiple perioperative care elements. One centre had been developing multimodal perioperative care for 10 years, whereas the other four had previously undertaken traditional care. RESULTS: The case mix was similar between centres. Protocol compliance before and during the surgical procedure was high, but it was low in the immediate postoperative phase. Patients fulfilled predetermined recovery criteria a median of 3 days after operation but were actually discharged a median of 5 days after surgery. Delay in discharge and the development of major complications prolonged length of stay. Previous experience with fast-track surgery was associated with a shorter hospital stay. CONCLUSION: Functional recovery in 3 days after colorectal resection could be achieved in daily practice. A protocol is not enough to enable discharge of patients on the day of functional recovery; more experience and better organization of care may be required.

Aged↗

Anaplastic large cell lymphoma treated with a leukemia-like therapy: report of the Italian Association of Pediatric Hematology and Oncology (AIEOP) LNH-92 protocol.

BACKGROUND: Childhood anaplastic large cell lymphoma (ALCL) is a well defined entity with a rather poor prognosis. Different approaches have been adopted in the treatment of ALCL in various cooperative trials, including short high-dose intensive therapy and leukemia-like protocols. In the early 1990s, the Italian Association of Pediatric Hematology and Oncology (AIEOP) initiated a multicenter trial for the treatment of ALCL based on a modified LSA2-L2 protocol. METHODS: Thirty-four consecutive eligible children with newly diagnosed ALCL were enrolled in the AIEOP LNH-92 protocol. Treatment was comprised of an induction of remission phase, followed by consolidation and maintenance for a total duration of 24 months, independently of disease stage. RESULTS: Thirty of 34 patients (88%) achieved complete disease remission and 8 patients experienced disease recurrence. With a median follow-up of 8.4 years, the probabilities of survival and event-free survival were 85% (range, 79-91%) and 65% (range, 57-73%), respectively. Therapy was well tolerated and hematologic toxicity was the most frequent toxicity. CONCLUSIONS: The leukemia-like protocol AIEOP LNH-92 was found to be an effective treatment for childhood ALCL. Its long duration may be beneficial to specific patient subgroups, but optimal treatment duration in ALCL remains to be elucidated.

Adolescent↗

Development and Validation of Amplicon-Based Protocol for Sequencing of Respiratory Syncytial Virus Genome.

The most prevalent cause of severe respiratory infections in children is the human respiratory syncytial virus (RSV). The advent of next-generation sequencing (NGS) has made it possible to incorporate this technology into pathogen monitoring and surveillance. Whole-genome sequencing (WGS) of RSV has now become a relatively widely used method for tracking viral evolution. Here we report an improved high-throughput RSV-WGS assay performed directly on clinical samples that is suitable for short-read sequencing platforms. A total of 100 RSV-positive samples collected between November 2022 and March 2024 fulfilled the inclusion cycle quantification criteria and were randomly included in the validation process. The WGS protocol was designed to amplify three distinct amplicons to cover the entire RSV genome. The protocol described here can be successfully replicated in several instances (approximately 95%) in samples with a relatively low viral load, typically corresponding to cycle of quantification values of 27-32. The amplicon-based protocol produced meaningful sequencing results in terms of median depth of coverage (more than 12000×) and median of mapped reads (> 1 × 106 reads). The sequences that had passed the filters showed a coverage of at least 98% across the entire genome, with cycle quantification values of 32. Based on the obtained data resulting in an easy-to-perform protocol helpful for the molecular epidemiology surveillance of RSV.

Humans↗

Protocol-based titration of intravenous terbutaline decreases length of stay in pediatric status asthmaticus.

Although frequently used to treat status asthmaticus in children, intravenous (IV) terbutaline has not been shown to decrease hospital length of stay (LOS). We theorized that this lack of demonstrable benefit resulted from variations in dosing and titration, rather than the drug per se, and that intensive care unit (ICU) LOS would be shortened by the administration of terbutaline according to a protocol incorporating a quantitative assessment of severity of illness. We prospectively treated 20 consecutive children with status asthmaticus with IV terbutaline according to a protocol that titrated the dose based on a clinical asthma score, the Modified Pulmonary Index Score (MPIS). Data were compared to a historic cohort of the previous 20 consecutive ICU patients with status asthmaticus who were treated with IV terbutaline prior to initiation of the protocol. Patients who received terbutaline by standardized protocol had significantly shorter ICU LOS (3.5 +/- 1.1 vs. 5.0 +/- 2.0 days, P = 0.01), shorter hospital LOS (5.5 +/- 1.3 vs. 8.3 +/- 2.7 days, P < 0.01), and reduced hospital charges ($19,298 +/- $10,516 vs. $26,528 +/- $12,328, P = 0.04). The method of administration of IV terbutaline significantly influenced ICU length of stay and hospital charges.

Adrenergic beta-Agonists↗

Performance of computerized protocols for the management of arterial oxygenation in an intensive care unit.

Computerized protocols were created to direct the management of arterial oxygenation in critically ill ICU patients and have now been applied routinely, 24 hours a day, in the care of 80 such patients. The protocols used routine clinical information to generate specific instructions for therapy. We evaluated 21,347 instructions by measuring how many were correct and how often they were followed by the clinical staff. Instructions were followed 63.9% of the time in the first 8 patients and 92.3% in the subsequent 72 patients. Instruction accuracy improved after the initial 8 patients, increasing from 71.5% of total instructions to 92.8%. Instruction inaccuracy was primarily caused by software errors and inaccurate and untimely entry of clinical data into the computer. Software errors decreased from 7.2% in the first 8 patients to 0.8% in subsequent patients, while data entry problems decreased from 7.5% to 4.2%. We also assessed compliance with the protocols in a subset of 12 patients (2637 instructions) as a function of 1) the mode of ventilatory support, 2) whether the instruction was to increase or decrease the intensity of therapy or to wait for an interval of time and 3) whether the instruction was 'correct' or 'incorrect'. The mode of ventilatory support did not affect compliance with protocol instructions. Instructions to wait were more likely to be followed than instructions to change therapy. Ninety-seven percent of the correct instructions were followed and 27% of the incorrect instructions were followed.(ABSTRACT TRUNCATED AT 250 WORDS)

Blood Gas Analysis↗

Morphological diagnoses of the Japan adult leukemia study group acute myeloid leukemia protocols: central review.

A morphological review system of the Japan Adult Leukemia Study Group has developed from the AML-87 through the AML-92 experience. We reviewed 1427 (90%) of 1592 cases enrolled in the AML-87, -89, or -92 protocols for morphology; 1408 (88%) were eligible. The rate of diagnostic concordance between each institute and the Committee on Morphological Diagnosis ranged from 76% to 80%. Acute myeloid leukemia (AML) subtypes were as follows: AML M0, 27 (2%); M1, 179 (13%); M2, 472 (34%); M3, 358 (25%); M4, 265 (19%); M5, 57 (4%); M6, 39 (3%); and M7, 11 (1%). The reason for the high number of patients with AML M3 is that many M3 patients were enrolled in the AML-92 protocol, which contained all-trans-retinoic acid. AML M0, M6 and M7 belonged to the poor prognostic groups. Auer bodies were found in 284 (53%) of 538 patients who survived significantly longer than those without Auer bodies in AML-87/-89. In AML-92 except for AML M3, 259 (43%) of 602 cases were Auer+ and also showed better survival rates. The survival of patients with >50% myeloperoxidase (MPO)-positive blast cells was better than those with < or =50% MPO+ blast cells in AML-87/-89. This trend was also seen in AML-92 excluding M3. AML with trilineage dysplasia (AML/TLD) is characterized as a subtype of de novo AML that shows morphological dysplasia of mature hematopoietic cells on a background of leukemic blast cells The number of patients with AML/TLD was 89 (16.5%) of 545 patients reviewed in AML-87/-89. AML-92, except for M3, showed a higher rate of patients with TLD (161 cases; 27.6%) because there were no patients with TLD in the AML M3 group. Survival rates for AML/TLD were worse than those for AML/non-TLD in both the AML-87/-89 and -92 protocols. Eighty percent of all cases (793/986) entered in AML-92 were analyzed cytogenetically. Fifty-one cases were not available for karyotyping because of a lack of mitoses or inappropriate preparations. The most frequent karyotype was normal, which accounted for 34.2%. The t(15;17), t(8;21), and inv(16) karyotypes, which are regarded as good risk factors, were 23.8%, 9.2%, and 1.6%, respectively. Abnormal chromosomes 5, 7, t(9;22), and t(6;9) were considered to be poor or intermediate risk factors As a new system of karyotyping begins in the ongoing AML protocol, useful chromosomal data will be obtained in the near future.

Acute Disease↗

Validity of an abbreviated indirect calorimetry protocol for measurement of resting energy expenditure in mechanically ventilated and spontaneously breathing critically ill patients.

OBJECTIVE: To test a short indirect calorimetry protocol with five stable 1-min readings (5-min steady state) against the commonly used protocol of 30 1-min readings (30-min steady state) in critically ill patients with various modes of ventilation. DESIGN: A prospective clinical study. SETTING: A medical ICU of a university hospital. SUBJECTS: Forty-six mechanically ventilated patients (group A and B), and 16 spontaneously breathing patients (group C). INTERVENTION: Indirect calorimetry with the Deltatrac II MBM-200 Metabolic Monitor. RESULTS: Mechanically ventilated patients were classified into group A (controlled) and B (assisted) depending on the ventilation mode. All patients in group A, but only 48.8% of those in group B, received some form of analgosedation, and the doses were significantly higher in group A. The 30-min steady state test was 100.0%, 83.7%, and 75.0% successful in group A, B, and C, respectively. The corresponding rate for the 5-min steady state test was 100.0%, 81.4%, and 100.0%, respectively. The coefficient of determination (r2) for resting energy expenditure between the two protocols ranged between 0.972 and 0.994. The time required to collect the 5-min steady state data was 5.5+/-1.1, 9.9+/-5.7, and 6.5+/-3.3 min for group A, B, and C, respectively. CONCLUSION: Indirect calorimetry with 5-min steady state test correlated very well with the 30-min steady state test in both mechanically ventilated and spontaneously breathing patients. The time required varies depending on the mode of ventilation, and it is influenced by the level of sedation in mechanically ventilated patients. The abbreviated protocol may be more acceptable to spontaneously breathing patients.

Calorimetry, Indirect↗

The effect of a fracture protocol on hospital prescriptions after minimal trauma fractured neck of the femur: a retrospective audit.

Effective therapies for the treatment of osteoporosis and fracture have been available for a number of years. Despite this, there are numerous reports indicating very low uptake rates in those admitted to hospital with fracture. The aim of this retrospective audit was to assess the impact of a fracture protocol on inpatient prescriptions of osteoporosis therapy. A fracture protocol was arrived at by consensus and was based on recommendations from the Australian Fracture Prevention Summit, which included specific advice on the commencement in hospital of calcium, vitamin D, synthetic estrogen receptor modulators (SERMs) and bisphosphonates. We studied subjects who were treated for fractured neck of the femur at Royal Hobart Hospital from March 2002 to March 2004 and included 161 prior to the start of the protocol and 93 after. As compared to the baseline period, subjects after the introduction of the protocol had higher rates of in-hospital prescription for any treatment (58 vs. 36%, P <0.01), calcium (51 vs. 26%, P <0.01), vitamin D (48 vs. 29%, P <0.01) and oral bisphosphonates (24 vs. 5%, P <0.01), but not SERMs as expected (1 vs. 1%, P =0.70). Additional factors affecting the decision to start any treatment included in-hospital death (OR 0.16, 95% CI 0.05-0.49), dementia (OR 0.39, 95% CI 0.21-0.74), a trend for female sex (OR 1.79, 95%CI 0.96-3.36), but not age. In conclusion, a structural approach to changing hospital policy from the top down is effective at substantially increasing the usage of effective therapy after fractured neck of the femur.

Aged↗

Salvage chemotherapy according to the ASHAP protocol: a single-center study of 24 patients with relapsed or refractory aggressive non-Hodgkin's lymphomas.

Numerous salvage protocols for relapsed or refractory aggressive non-Hodgkin's lymphomas have been described. The purpose of this retrospective study was to evaluate the efficacy and the toxicity of the ASHAP protocol, which combines a continuous infusion of doxorubicin and cisplatin with high-dose cytarabine and methylprednisolone. Twenty-four patients with relapsed or refractory aggressive non-Hodgkin's lymphomas were treated with a median of 3 cycles (range: 1-5) of ASHAP. Twelve patients achieved a complete and four a partial remission for an overall response rate of 67%. The 3-year overall and progression-free survival rates were 60% and 40%, respectively. Ten of the responding patients were consolidated by high-dose chemotherapy. After a median follow-up of 15.5 months, four patients are in continuous complete remission, while six patients suffered relapses (two fatal). For reasons of low risk profile [international prognostic index (IPI) score of 0, n=2] or age >60 years ( n=4), consolidation was limited to involved-field radiotherapy in six patients. All of these patients are alive after a median follow-up of 37 months, with two relapses. Factors predicting a poor response to salvage therapy were primary refractory disease, elevated lactate dehydrogenase activity, and an IPI score of >/=2. The principal toxicity was myelosuppression with grade III or IV neutropenia or thrombocytopenia occurring in 88% or 75%, respectively, of the patients. Nonhematological toxicity was generally mild. There were no treatment-related deaths. The ASHAP regimen is a highly active and well-tolerated salvage protocol for patients with relapsed aggressive non-Hodgkin's lymphomas which compares favorably with other established protocols.

Adult↗

Assessment of image quality of a standard and three dose-reducing protocols in adult cranial CT.

The purpose of this study was to analyze the effect of various tube current settings (mAs) and optimize the image quality and dose for adult cranial CT protocol. Sixty adult patients who underwent a cranial CT scanning for different indications were subdivided into three subgroups. Subjective image and noise quality scores and quantitative noise measurements were selectively studied on three reference levels (cerebellar, basal ganglia and centrum semiovale levels). For each subgroup, only one level was studied. Head circumference (HC) and the maximum anteroposterior diameter (MAPD) of each patient were measured. At 50% decreased dose protocol, there was no poor quality score at any level. At nearly 60% decreased dose protocol, the incidence of poor quality scores was much higher at the cerebellar level than at the other two levels. For the same protocol number, quantitative noise measurements were higher at the cerebellar level than the other two supratentorial levels. The correlation was found to be significant between HC, MAPD and quantitative noise measurements, and there was a non-significant correlation between HC and subjective noise scores. In adult cranial CT, depending on the level, a dose reduction of up to 60% may be possible while maintaining image quality.

Adolescent↗

Development of an accelerated MSCT protocol (Triage MSCT) for mass casualty incidents: comparison to MSCT for single-trauma patients.

During multiple casualty incidents (MCI) emergency radiology departments have to deal with a large number of patients with suspected severe trauma within a short period of time. The aim of this study was to develop a suitable accelerated multislice computed tomography (MSCT) protocol to increase patient throughput for this kind of emergency situation. We presumed a scenario of 15 patients being admitted to the trauma service with suspicion of severe injuries after a MCI over a period of 2 h. An accelerated Triage MSCT protocol was developed and evaluated for MSCT scanner productivity (patients per hour) and time (minutes) needed for a total MSCT body workup using an anthropomorphic phantom. In addition, time (minutes) for transfer and preparation was measured. These timeframes were compared to a control group consisting of 144 single patients with multiple trauma undergoing standard MSCT according to our trauma room protocol. All MSCT studies were conducted using a 4-detector row scanner. (1) For the study group (Triage MSCT), average time for patient transfer and preparation was 2.9 min (2.5-4.3 min), mean CT examination time was 2.1 min (1.7-2.4 min); image reconstruction took 4.0 min (3.3-4.3 min). Total time in scanner room was 8.9 min (7.7-11.3 min), resulting in a maximal productivity of 6.7 patients per hour. Image transfer to the digital picture archive and communication system archive was completed after an average 9.5 min (8.9-10.8 min). (2) For the control group (single casualty MSCT), the mean time for patient transfer and preparation was 20.4 min (9.0-39.2 min), mean examination time was 6.0 min (3.1-11.3 min). Times for image reconstructions were not recorded in the patient series. Mean total time in scanner room was 25.3 min (11.0-72.4 min), resulting in a patient throughput of 2.4 patients per hour. MSCT has potential to serve as a powerful tool in triage of multiple casualty patients. The introduction of a Triage MSCT scanning protocol resulted in an increase of patient throughput per hour by a factor of almost 3.

Clinical Protocols↗

Evaluation of a protocol-based management of rectal cancer.

INTRODUCTION: The management of rectal cancer is multidisciplinary. We have devised and implemented a standardized protocol. This study was designed to evaluate the protocol and identify areas for improvement. METHODS: All patients with a diagnosis of rectal cancer were staged preoperatively. Magnetic resonance imaging and computed tomography were used to predict whether surgical resection would be complete (RO) or involved (R1/2). Data were collected on preoperative adjuvant therapy, surgical procedure, and subsequent pathologic stage, including circumferential resection margin status. RESULTS: Between January 2000 and October 2002, 163 patients were studied (107 male; median age, 70 (range, 60-77) years). One hundred and fifty seven patients underwent surgical excision for rectal cancer of whom 155 were discussed in the multidisciplinary meeting. One hundred seventeen patients (75 percent) had pelvic magnetic resonance scan and staging computed tomography of chest and abdomen, whereas 38 had computed tomography only. Seventy-seven tumors were predicted as R0 and 78 as likely R1/2. In the predicted RO group, 50 had surgery alone, 25 had short-course radiotherapy, and 2 had chemoradiotherapy. Twelve patients (15.5 percent) had involved circumferential resection margin on the histologic specimen. In the predicted R1/2 group (n = 78), 40 patients received chemoradiotherapy, 11 had short-course radiotherapy, and 27 had surgery alone. Thirty patients (38.4 percent) had involved circumferential resection margin. Circumferential margin involvement was seen in 11 of 40 patients (27.5 percent) who received chemoradiotherapy, 6 of 11 patients (54.5 percent) who received short-course preoperative radiotherapy, and 13 of 27 patients (48.1 percent) who had surgery alone. CONCLUSIONS: Protocol-driven management of rectal cancer within the context of a multidisciplinary team has been demonstrated to work. Regular audit allows for modification and improvement of the protocol as newer management strategies evolve.

Aged↗

Surgical resection is necessary to maximize tumor control in function-preserving, aggressive chemoradiation protocols for advanced squamous cancer of the head and neck (stage III and IV).

BACKGROUND: The role of surgery in aggressive chemoradiation protocols for advanced head and neck cancer has been questioned because of the quoted high clinical response rates in many series. METHODS: The role of surgical resection was examined in an aggressive neoadjuvant protocol of weekly paclitaxel, carboplatin, and radiation for stage III and IV with completion of radiation to 72 Gy if biopsy at the primary site was negative after administration of 45 Gy. Of 43 patients enrolled, 38 completed the protocol. The clinical response was 100% (including 18 complete and 20 partial responses). RESULTS: The complete pathologic response (negative primary site biopsy at 45 Gy) was 25 of 38 (66%). Of patients who presented with N1 to N3 nodes, neck dissection revealed residual nodal metastases in 22%. Surgical resection of the primary site was required in 13 patients, including 5 with larynx cancer and 2 with base of tongue cancers. Four patients had resection with reconstruction for advanced mandible floor of mouth cancer, and one had resection of nasal-maxillary cancer. Functional resection was performed in 9 of 12 patients. The median progression free and overall survival was 64% and 68%, respectively, at median follow-up of 50 months. Nine patients developed recurrence (three local and six distant). There were no failures in the neck. Salvage surgery was performed in one patient with local and one with distant disease. CONCLUSIONS: Surgical resection is an essential component of aggressive chemoradiation protocols to ensure tumor control at the primary site and in the neck.

Adult↗

Development, implementation and a first evaluation of a protocol processing system (ProtoVIEW).

In this contribution the protocol information system ProtoVIEW is presented. The system provides the necessary information to physicians about diagnostic procedures and therapies. It is implemented as a stand alone system. The design criteria are discussed and the results of a first evaluation presented. It appears that interns can easily find the required information with the help of the system. The time that they need for accessing the relevant information is relatively short (about 1 min). The users expressed the opinion that the system is easy to use and does support them in the management of their patients. On the basis of this evaluation and evaluations reported elsewhere it is concluded (a) that stand-alone protocol systems can support daily patient management in a positive way and (b) that the design criteria for a protocol information system as presented in this paper are useful for prospective protocol information system developers.

Attitude of Health Personnel↗