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PubMed2005

Fate of biomedical research protocols and publication bias in France: retrospective cohort study.

OBJECTIVES: To describe the fate of protocols approved by the French research ethics committees, a national system created by the French 1988 Huriet-Sérusclat Act; to assess publication bias at a national level. DESIGN: Retrospective cohort study. SETTING: Representative sample of 25/48 French research ethics committees in 1994. PROTOCOLS: 649 research protocols approved by committees, with follow-up information. MAIN OUTCOME MEASURES: Protocols' initial characteristics (design, study size, investigator) abstracted from committees' archives; follow-up information (rates of initiation, completion, and publication) obtained from mailed questionnaire to principal investigators. RESULTS: Completed questionnaires were available for 649/976 (69%) protocols. Of these, 581 (90%) studies were initiated, 501/581 (86%) were completed, and 190/501 (38%) were published. Studies with confirmatory results were more likely to be published as scientific papers than were studies with inconclusive results (adjusted odds ratio 4.59, 95% confidence interval 2.21 to 9.54). Moreover, studies with confirmatory results were published more quickly than studies with inconclusive results (hazard ratio 2.48, 1.36 to 4.55). CONCLUSION: At a national level, too many research studies are not completed, and among those completed too many are not published. We suggest capitalising on research ethics committees to register and follow all authorised research on human participants on a systematic and prospective basis.

Biomedical Research↗

PubMed2005

Gaps between policy, protocols and practice: a qualitative study of the views and practice of emergency ambulance staff concerning the care of patients with non-urgent needs.

AIM: To describe emergency ambulance crews' views about (1) how they make decisions on whether to convey patients to hospital; (2) an intervention enabling them to triage patients to non-conveyance; and (3) their experience of using new protocols for undertaking such triage. METHODS: Two focus groups were held at the outset of an evaluation of Treat and Refer (T&R) protocols: one with staff based at an ambulance station who were to implement the new service (intervention station), and the other with staff from a neighbouring station who would be continuing their normal practice during the study (control station). A third session was held with staff from the intervention station following training and 3 months' experience of protocol usage. RESULTS: Before the introduction of the T&R protocols, crews reported experience, intuition, training, time of call during shift, patient preference, and home situation as influencing their decisions concerning conveyance. Crews were positive about changing practice but foresaw difficulties with advising patients who wanted to go to hospital, and with referral to other agencies. Following experience of T&R protocol use, crews felt they had needed more training than had been provided. Some felt their practice and job satisfaction had improved. Problems with referral and with persuading some patients that they did not need to go to hospital were discussed. There was consensus that the initiative should be introduced across the service. CONCLUSIONS: With crews generally positive about this intervention, an opportunity to tackle this difficult area of emergency care now exists. This study has, however, highlighted the complexity of the change in practice and service delivery, and professional and organisational constraints that need to be considered.

Ambulances↗

PubMed1994

Effects of a computerised protocol management system on ordering of clinical tests.

OBJECTIVE: To assess the effects of a computerised protocol management system on the number, cost, and appropriateness of laboratory investigations requested. DESIGN: A before and after intervention. SETTING: A supraregional liver unit in a teaching hospital. PATIENTS: 1487 consecutive patients admitted during 1990 and 1991 (one year before and one year after introduction of the system). INTERVENTION: Introduction of a computerised protocol management system on 1 January 1991. MAIN MEASURES: The number and cost of clinical chemistry tests requested per patient day. RESULTS: The total number of clinical chemistry tests requested per patient day by the unit declined 17% (p < 0.001, Student's t test) and of out of hours tests requested per patient day from 0.31 to 0.16, 48% (p < 0.001; Mann-Whitney U test), resulting in a 28% reduction (p < 0.001) in direct laboratory expenditure per patient-day. Overall, the number of tests per admission decreased by 24% (p < 0.001; Mann-Whitney U test). CONCLUSION: Use of the computerised protocol management system resulted in closer compliance with the protocols and a significant reduction in the overall level of requesting. IMPLICATIONS: Although similar systems need to be tested in other clinical settings, computerised protocol management systems may be important in providing appropriate and cost effective health care.

Clinical Laboratory Techniques↗

PubMed2006

The long-term survival of a patient with pancreatic cancer with metastases to the liver after treatment with the intravenous alpha-lipoic acid/low-dose naltrexone protocol.

The authors describe the long-term survival of a patient with pancreatic cancer without any toxic adverse effects. The treatment regimen includes the intravenous alpha-lipoic acid and low-dose naltrexone (ALA-N) protocol and a healthy lifestyle program. The patient was told by a reputable university oncology center in October 2002 that there was little hope for his survival. Today, January 2006, however, he is back at work, free from symptoms, and without appreciable progression of his malignancy. The integrative protocol described in this article may have the possibility of extending the life of a patient who would be customarily considered to be terminal. The authors believe that life scientists will one day develop a cure for metastatic pancreatic cancer, perhaps via gene therapy or another biological platform. But until such protocols come to market, the ALA-N protocol should be studied and considered, given its lack of toxicity at levels reported. Several other patients are on this treatment protocol and appear to be doing well at this time.

Adenocarcinoma↗

PubMed2006

Split course hyperfractionated accelerated radio-chemotherapy (SCHARC) for patients with advanced head and neck cancer: influence of protocol deviations and hemoglobin on overall survival, a retrospective analysis.

BACKGROUND: The advantage of hyperfractionated accelerated radiation therapy for advanced head and neck cancer has been reported. Furthermore, randomized trials and meta-analyses have confirmed the survival benefit of additional chemotherapy to radiotherapy. We retrospectively analyzed the efficiency and toxicity of the Regensburg standard therapy protocol "SCHARC" and the overall survival of our patients. METHODS: From 1997 to 2004, 64 patients suffering from advanced head and neck cancer (88 % stage IV, 12 % stage III) were assigned to receive the SCHARC protocol. Around half of the patients were diagnosed with oro-hypopharynx carcinoma (52 %), one third with tongue and floor of mouth tumors (29 %) and one fifth (19 %) suffered from H & N cancer at other sites. The schedule consisted of one therapy block with 30 Gy in 20 fractions over a two week period with concomitant chemotherapy (d 1-5: 20 mg/m2/d DDP + 750-1000 mg/m2/d 5FU (cont. infusion). This therapy block was repeated after a fortnight break up to a cumulative dose of 60 Gy and followed by a boost up to 70 Gy (69-70.5 Gy). All patients assigned to this scheme were included in the survival evaluation. RESULTS: Forty patients (63 %) received both radiation and chemotherapy according to the protocol. The mean follow up was 2.3 years (829 d) and the median follow up was 1.9 years (678 d), respectively. The analysis of survival revealed an estimated 3 year overall survival rate of 57 %. No patient died of complications, 52 patients (80 %) had acute grade 2-3 mucositis, and 33 patients (58 %) suffered from acute grade 3 skin toxicity. Leucopenia was no major problem (mean nadir 3.4 g/nl, no patient < 1.0 g/nl) and the mean hemoglobin value decreased from 13.2 to 10.5 g/dl. Univariate analysis of survival showed a better outcome for patients with a hemoglobin nadir >10.5 g/dl and for patients who completed the protocol. CONCLUSION: The SCHARC protocol was effective in patients diagnosed with advanced head and neck cancer. It led to long-term disease control and survival in about 50 % of the patients with significant but acceptable toxicity. Most patients were not anemic at beginning of therapy. Therefore, we could assess the influence of pre-treatment hemoglobin on survival. However, a low hemoglobin nadir was associated with poor outcome. This result suggests an influence of anemia during therapy on prognosis.

Adult↗

PubMed1986

Treatment of small-cell lung cancer on protocol: potential bias of results.

During a 27-month period, 215 new cases of lung cancer were diagnosed at five McGill University hospitals. Only 44 patients (20%) so diagnosed were treated on available chemotherapy protocols. Six categories were used to define reasons for nonparticipation. The most important were medical reasons (MRs), 46%; non-medical reasons (NMRs), 20%; and physician preference (PP), 16%. The three remaining categories, representing 18% of exclusions, were death before diagnosis (DBD), surgical treatment (S), and a miscellaneous group (M). Median survival of patients on and off protocol was 10 and 7 months, respectively. Patients with limited disease treated off protocol for NMR and those treated with surgery did better than patients on protocol. Patients with extensive disease not enrolled because of MR did worse, and those excluded because of PP did better than patients treated on protocol. The implication of these findings for other cancer studies is that analysis of chemotherapy trials often represents treatment results in a small proportion of all patients with a given neoplasm. As such, caution must be exercised when extrapolating results to the group as a whole. We suggest that complete demographic data, including proportion of patients participating and reasons for exclusion, be included in all chemotherapeutic trial reports.

Adult↗

PubMed1994

Are informed consent forms that describe clinical oncology research protocols readable by most patients and their families?

PURPOSE: This study was conducted to assess the readability of informed consent forms that describe clinical oncology protocols. METHODS: One hundred thirty-seven consent forms from 88 protocols that accrued patients at The Johns Hopkins Oncology Center were quantitatively analyzed. These included 58 of 99 (59%) institutional protocols approved by The Johns Hopkins Oncology Center's Clinical Research Committee and the Institutional Review Board (IRB) over a 2-year period, and 30 active Eastern Cooperative Oncology Group (ECOG), Radiation Therapy Oncology Group (RTOG), and Pediatric Oncology Group (POG) trials. The consent forms described phase I (17%), phase I/II (36%), phase III (29%), and nontherapeutic (18%) studies. Each was optically scanned, checked for accuracy, and analyzed using readability software. The following three readability indices were obtained for each consent form: the Flesch Reading Ease Score, and grade level readability as determined by the Flesch-Kincaid Formula and the Gunning Fog Index. RESULTS: The mean +/- SD Flesch Reading Ease Score for the consent forms was 52.6 +/- 8.7 (range, 33 to 78). The mean grade level was 11.1 +/- 1.67 (range, 6 to 14) using the Flesch-Kincaid Formula and 14.1 +/- 1.8 (range, 8 to 17) using the Gunning Fog Index. Readability at or below an eighth-grade level was found in 6% of the consent forms using the Flesch-Kincaid Formula and in 1% using the Gunning Fog Index. Readability was similar for consent forms that described institutional, cooperative group, and phase I, II, and III protocols. CONCLUSION: Consent forms from clinical oncology protocols are written at a level that is difficult for most patients to read, despite national, cooperative group, institutional, and departmental review. The consent process, which is crucial to clinical research, should be strengthened by improving the readability of the consent forms.

Clinical Protocols↗

PubMed1990

Medical research in infants and children in the eighties: analysis of rejected protocols.

We reviewed the 351 protocols dealing with research in infants and children in our institute between July 1982 and August 1988 to identify ethical issues that complicate the execution of pediatric research. Of the 16 rejected protocols (4.5%) 12 were drug studies, three dealt with the nature or course of disease states and one was in the area of behavioral sciences. Drug studies were significantly more likely to be rejected than all other studies. The most common reason for rejection (n = 10) were major scientific flaws that, according to the Committee, would result in inability of the study to answer the questions posed by the researchers. In nine cases the Committee judged a study to be physically invasive without a direct benefit to the involved infant/child. In three cases, the Committee rejected a study because patients with serious medical conditions might be randomized to receive placebo and not a drug that, based on current knowledge from adults, would possibly improve their condition. In three protocols, current antimicrobial therapy covered all pathogens causing the infection and the proposed new therapy could not improve the prognosis further but only be equal or inferior. Researchers who had more than one protocol rejected had significantly more protocols submitted (7.17 +/- 1.35) than those who had only one rejection (1.86 +/- 0.36, p less than 0.0005) or than the 10 researchers with the highest number of studies without a single rejection (4.2 +/- 0.4, p less than 0.05). These numbers suggest that scientists who perform more research are more likely to stand at the front line of unresolved ethical issues.

Adolescent↗

PubMed1997

A survey of routine head CT protocols in Australia.

The choice of scanning protocol in CT will affect the dose delivered to the patient. A nationwide survey of CT operators was carried out in Australia in 1994 to determine the variation in routine head CT protocols. Only 29% of respondents used the supraorbitomeatal (SOM) baseline and thus avoided scanning the eyes. At 74% of sites, the routine protocol included scans both before and after injection of contrast. However, the post-contrast protocol differed from that used in the pre-contrast series in a number of cases. Where 5 mm thick slices were used, the mAs was 16% higher than for 10 mm thick slices. Increased awareness of the influence of baseline, slice thickness/spacing and accompanying exposure factors on patient dose may lead to greater standardization of head CT scanning protocols.

Adult↗

PubMed1998

Three-dimensional spiral CT angiography in pancreatic surgical planning using non-tailored protocols: comparison with conventional angiography.

The aim of this study was to investigate three-dimensional spiral computed tomography (3DCT) as an adjunct to routine pancreatic CT scanning, with particular regard to the identification of surgically important hepatic arterial anomalies, correlated with conventional visceral angiography. 32 patients underwent spiral CT scans prior to pancreatic surgery using established protocols. Oral contrast medium was used throughout. 150 ml of intravenous contrast medium was given at 3 ml s-1 with a 24 s spiral CT sequence starting 35 s after the start of infusion. Two protocols were employed, both with a pitch of 1:3 mm table feed/collimation (n = 17) and 5 mm table feed/collimation (n = 15). Overlapping (1 mm minimum) axial reformats were reconstructed. 3DCT shaded-surface displays of the visceral arteries were assessed for visceral arterial anomalies. Visceral angiography (n = 23) was independently correlated. Satisfactory 3D angiograms were performed in all but one patient, in whom the coeliac axis was missed. (i) 3 mm protocol: 3DCT (n = 17) showed three anomalous right hepatic arteries (ARHA), one trifurcation anomaly and one splenic artery with an aortic origin. Angiography (n = 11) confirmed these findings, although one patient with an ARHA did not have angiography. A left gastric arterial supply to the left liver was not detected. (ii) 5 mm protocol: 3DCT (n = 15) showed two cases of ARHA. While confirming these findings, angiography (n = 12) showed a third case of ARHA, in which the coeliac and superior mesenteric artery had very close origins. A left gastric supply to the left liver was also missed. It is concluded that satisfactory 3DCT is possible without changing existing scanning protocols, although narrow sections are required for the confident assessment of right hepatic arterial anomalies, and any left hepatic supply via the left gastric artery was poorly assessed in this series.

Adolescent↗

PubMed2006

16-slice CT: achievable effective doses of common protocols in comparison with recent CT dose surveys.

The aim of the study was to investigate achievable dose levels in 16-slice CT by evaluating CT dose indices (CTDI) and effective doses of dose-optimized protocols compared with 4-slice dose surveys. Normalized CTDI free in air and in 16 cm and 32 cm diameter phantoms were measured on four different 16-slice CT scanners in the Netherlands. All collimation and tube potential settings were analysed. Volume CTDI was calculated for adult protocols for brain, chest, pulmonary angiography (CTPA), abdomen and biphasic liver CT. Effective doses were calculated first using volume CTDI with conversion factors and second from CTDIair values using the ImPACT dose calculator. Average results of the 16-slice scanners were correlated to results of dose surveys with predominantly 4-slice scanners. Statistical analysis was done with Student t-tests with a Bonferroni correction; therefore p < 0.017 was significant. The results of CTDIair and weighted CTDI were documented for all scanners. Effective doses averaged over four scanners for brain, chest, CTPA, abdomen and biphasic liver protocols were 1.9+/-0.4, 3.8+/-0.4, 3.0+/-0.2, 7.2+/-0.9 and 10.2+/-1.3 mSv, respectively. Compared with dose surveys achievable effective doses were equal (p = 0.069) to significantly lower (p < 0.017) for chest and abdomen protocols. For 16-slice spiral brain CT there was a trend of equal doses compared with sequential brain CT in the dose surveys. Thus, with dose-optimized protocols 16-slice CT can achieve equal to lower effective doses in examinations of the chest and abdomen compared with 4-slice CT, while doses can remain stable in the brain.

Brain Neoplasms↗

PubMed2000

Performance-based home care for the elderly: the quality of circumstance protocol.

The paper introduces a performance-based protocol for use by case managers in home care programs for the elderly. Drawing upon the goal attainment approach to service planning and evaluation, the protocol specifies a set of five observable conditions ranging from the highly desirable to the highly undesirable that correspond to each ADL and IADL dimension plus five other dimensions of importance to community residing frail elders. The conditions documented through the protocol provide a basis for setting explicit expectations of what can be achieved through home care interventions. The paper describes a pilot effort to test the protocol in the Massachusetts state funded home care program. Both the protocol's client assessment form and data collection guide are included as appendices.

Activities of Daily Living↗

PubMed2004

An insulin infusion protocol in critically ill cardiothoracic surgery patients.

BACKGROUND: Critically ill cardiothoracic patients are prone to hyperglycemia and an increased risk of surgical site infections postoperatively. Aggressive insulin treatment is required to achieve tight glycemic control (TGC) and improve outcomes. OBJECTIVE: To examine and report on the performance of an insulin infusion protocol to maintain TGC, defined as a blood glucose level of 80-150 mg/dL, in critically ill cardiothoracic surgical patients. METHODS: A nurse-driven insulin infusion protocol was developed and initiated in postoperative cardiothoracic surgical intensive care patients with or without diabetes. In this before-after cohort study, 2 periods of measurement were performed: a 6-month baseline period prior to the initiation of the insulin infusion protocol (control group, n = 174) followed by a 6-month intervention period in which the protocol was used (TGC group, n = 168). RESULTS: Findings showed percent and time of blood glucose measurements within the TGC range (control 47% vs TGC 61%; p = 0.001), AUC of glucose exposure >150 mg/dL versus time for the first 24 hours of the insulin infusion (control 28.4 vs TGC 14.8; p < 0.001), median time to blood glucose <150 mg/dL (control 9.4 h vs TGC 2.1 h; p < 0.001), and percent blood glucose <65 mg/dL as a marker for hypoglycemia (control 9.8% vs TGC 16.7%; NS). CONCLUSIONS: An insulin infusion protocol designed to achieve a goal blood glucose range of 80-150 mg/dL efficiently and significantly improved TGC in critically ill postoperative cardiothoracic surgery patients without significantly increasing the incidence of hypoglycemia.

Blood Glucose↗

PubMed2005

Statin initiation following coronary artery bypass grafting: outcome of a hospital discharge protocol.

STUDY OBJECTIVES: To evaluate the outcome of a hospital discharge statin drug therapy initiation protocol following coronary artery bypass graft (CABG) surgery. Our goal was to measure the percentage of patients receiving statin drugs at hospital discharge and at a post-hospital discharge assessment following the implementation of the statin drug therapy initiation protocol. We also evaluated low-density lipoprotein cholesterol (LDL-C) goal attainment (ie, < 100 mg/dL), safety monitoring, and tolerability of the statin drug. DESIGN: Single-center, observational study with a historical control group. SETTING: University-affiliated health system with a comprehensive heart care program that included a 14-bed cardiac surgery ICU. Approximately 400 CABG procedures are performed annually. PATIENTS: Patients who underwent CABG surgery were eligible for inclusion in the study. The exclusion criteria were as follows: contraindications to statin therapy; refusal to take a statin drug; refusal to give informed consent; and age < 18 years. INTERVENTION: A protocol was implemented to recommend treatment with a statin drug at hospital discharge in all post-CABG surgery patients if the presurgical LDL-C level was > 100 mg/dL or the patient was receiving a statin prior to hospital admission. The protocol also included a presurgical assessment of lipoprotein levels and hepatic function. All cardiac surgery staff were educated regarding the specifics of the protocol. RESULTS: A total of 403 patients were included in the study. The historical control group (202 subjects) and the intervention group (201 subjects) were similar with respect to gender, age, and baseline lipoprotein levels. The follow-up assessment interval was approximately 6 months in both groups. Overall, patients were more likely to receive a statin at hospital discharge in the intervention group compared to the control group (relative risk [RR], 1.6; 95% confidence interval [CI], 1.3 to 2.0). Attainment of the goal for LDL-C level was similar between the intervention and control groups in the overall sample. Patients who were not at their LDL-C goal at baseline were more likely to have a follow-up LDL-C level of < 100 mg/dL in the intervention group (RR, 1.9; 95% CI, 1.0 to 3.5). The rate of liver function assessment was similar in the control and intervention groups. No patients in either group experienced elevations of alanine aminotransferase levels that were more than three times the upper limit of normal, and no cases of muscle toxicity were noted. CONCLUSION: The initiation of therapy with a statin drug at hospital discharge following CABG surgery was associated with increased utilization rates. The LDL-C goal attainment improved in patients who were not at their goal prior to surgery. However, the persistence of medication use declined within 6 months. Statin therapy initiation was well-tolerated in this cohort of patients.

Adult↗

PubMed2006

Development of a triage protocol for critical care during an influenza pandemic.

BACKGROUND: The recent outbreaks of avian influenza (H5N1) have placed a renewed emphasis on preparing for an influenza pandemic in humans. Of particular concern in this planning is the allocation of resources, such as ventilators and antiviral medications, which will likely become scarce during a pandemic. METHODS: We applied a collaborative process using best evidence, expert panels, stakeholder consultations and ethical principles to develop a triage protocol for prioritizing access to critical care resources, including mechanical ventilation, during a pandemic. RESULTS: The triage protocol uses the Sequential Organ Failure Assessment score and has 4 main components: inclusion criteria, exclusion criteria, minimum qualifications for survival and a prioritization tool. INTERPRETATION: This protocol is intended to provide guidance for making triage decisions during the initial days to weeks of an influenza pandemic if the critical care system becomes overwhelmed. Although we designed this protocol for use during an influenza pandemic, the triage protocol would apply to patients both with and without influenza, since all patients must share a single pool of critical care resources.

Clinical Protocols↗

PubMed2006

Radiation dose to the female breast from 16-MDCT body protocols.

OBJECTIVE: The objective of our study was to determine the radiation dose to the female breast from current 16-MDCT body examinations. MATERIALS AND METHODS: Metal oxide semiconductor field effect transistor (MOSFET) detectors were placed in four quadrants of the breast of a female-configured anthropomorphic phantom to determine radiation dose to the breast. Imaging was performed on a 16-MDCT scanner (LightSpeed, GE Healthcare) using current clinical protocols designed to assess pulmonary embolus (PE) (140 kVp, 380 mA, 0.8-sec rotation, 16 x 1.25 mm collimation), appendicitis (140 kVp, 340 mA, 0.5-sec rotation, 16 x 0.625 mm collimation), and renal calculus (140 kVp, 160 mA, 0.5-sec rotation, 16 x 0.625 mm collimation). RESULTS: Radiation dose to the breast ranged from 4 to 6 cGy for the PE protocol and up to 1-2 cGy in the inferior aspect of the right breast and lateral aspect of the left breast for the appendicitis protocol. The renal calculus protocol yielded less than 150 microGy absorbed breast dose. CONCLUSION: Current clinical chest and abdomen protocols result in vairable radiation doses to the breast. The magnitude of exposure may have implications for imaging strategies.

Breast↗

PubMed1993

Collaborative patient care protocols: a development process.

Computerization of these protocols is in progress. This project is funded for one year with projected completion in January 1994. This study will form a framework in which further research can be completed. Utilizing protocols will allow the measurement of nursing decision making by testing relationships between parameters and interventions and by identifying rules for decision making. For example, questions that may be answered include which physiologic parameters do clinicians treat and in what order or priority, as well as what is the impact on patient outcomes in regard to cost of care and complications. Computerized patient care protocols can be further developed to meet patient-specific needs. A computerized data base will facilitate managing large amounts of patient data and tailoring instructions to these patients. One of the goals of this project was to measure the feasibility of developing computerized patient care protocols and implementing them in a critical care setting. Eventually, this experience will facilitate implementing computerized protocols at other sites. An additional benefit is the ability to implement continuous quality improvement strategies in a prospective manner rather than by retrospective review.

Algorithms↗

PubMed1997

Clinical protocol development using Inter/IntraNet technology: the FENARETE system.

In this work we present FENARETE, a software tool to design and distribute clinical protocols in an Inter/IntraNet framework. We consider a medical protocol as a clinical behaviour scheme, formally and clearly defined with sufficient details. Our work allows the knowledge content of any clinical protocol to be fully represented in a symbolic style. A computer based support tool that works as an interface between clinicians and the protocol knowledge base is regarded by the authors as a basic building block developing an integrated environment for medical protocols design and management. The FENARETE application has been developed in Java and it is available for any Internet-linked machine with a Java-compatible browser.

Clinical Protocols↗