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PubMedDate not supplied

[Performance evaluation of a tool for institutional protocol quality assurance].

BACKGROUND: Few data are available on the quality of the protocols promoted by the University Hospital Centers (CHU) in France, and there is no standardised method for evaluating protocol quality. The Clinical Research Centre (CIC) of Nancy developed a checklist-based tool aimed at evaluating the quality of institutional protocols. OBJECTIVE: The objective of this study was to evaluate the performance of this tool for assessing the quality of the protocols promoted by the CHU. METHODS: A prospective parallel-group study design, controlled with cluster randomisation, was used. The checklist was applied within the Directions of Clinical Research (DRC) for 4 months. Sixty four protocols were analysed. RESULTS: Before intervention there was no significant difference in quality scores between the two groups. Compared with baseline, there was a significant improvement of the methodological and regulation median score (81.7 +/- 13.7 vs 90.4 +/- 9.2) only in the intervention group (p = 0.040). Changes in the two groups over time were not significantly different from each other using analysis of variance (p = 0.501). CONCLUSION: In an observation limited to 12 CHU in France, the quality of the promoted protocols was judged as suboptimal and able to be improved. Initiation of quality assurance tools, such as the one used in this study, was associated with some spontaneous improvement, but did not improve the result significantly.

France↗

PubMed1998

Pregnancy rates of postpartum beef cows that were synchronized using Syncro-Mate-B or the Ovsynch protocol.

We compared pregnancy rates of beef cows subjected to the traditional Syncro-Mate-B protocol or the new Ovsynch protocol and timed insemination. Multiparous Angus cows (n = 436) were stratified by age, postpartum interval, and AI sire and were randomly divided into two treatment groups for synchronization of estrus/ovulation. Approximately half of the cows (n = 216) received the traditional Syncro-Mate-B protocol with 48-h calf removal from the time of implant removal until breeding. The remaining cows (n = 220) received the Ovsynch protocol, which consists of an injection of GnRH (100 microg) on d -10, an injection of PGF2alpha (25 mg) and 48-h calf removal on d -3, another injection of GnRH and calf return on d -1, and timed insemination 24 h later (d 0). Blood samples were collected from all cows before treatment to identify anestrous and cyclic females. Pregnancy rates were higher (P < .025) for Ovsynch-treated cows (54%) than for Syncro-Mate-B-treated cows (42%). Pregnancy rates of cyclic Ovsynch-treated cows (59%) were higher (P < .005) than pregnancy rates of cyclic Syncro-Mate-B-treated cows (38%). Pregnancy rates of anestrous cows also tended to favor synchronization with the Ovsynch protocol. From these data, we conclude that the Ovsynch protocol is capable of inducing a fertile ovulation in cyclic and anestrous beef cows and that pregnancy rates to a timed insemination are higher than those obtained with synchronization of estrus using Syncro-Mate-B.

Animals↗

PubMed2000

Effect of day of the estrous cycle at the initiation of a timed artificial insemination protocol on reproductive responses in dairy heifers.

Our objectives were to identify stages of the estrous cycle at which initiation of a timed artificial insemination (Ovsynch/TAI) protocol may reduce pregnancy rates and to monitor ovarian follicle dynamics and corpus luteum development after initiation of the Ovsynch/TAI protocol at different stages of the cycle. Cycling Holstein heifers (n = 24) were injected twice with prostaglandin F2alpha to induce estrus and were scanned by ovarian ultrasonography to determine the day of ovulation (d 0). Heifers were assigned to initiate the Ovsynch/TAI protocol at d 2 (n = 5), 5 (n = 5), 10 (n = 4), 15 (n = 5), or 18 (n = 5) of the cycle. The Ovsynch/TAI was initiated with an injection of gonadotropin-releasing hormone agonist followed 7 d later with an injection of prostaglandin F2alpha. At 36 h after injection of prostaglandin F2alpha, heifers were injected with gonadotropin-releasing hormone agonist and inseminated 16 h later. Heifers were scanned daily during the Ovsynch/TAI protocol and every other day after insemination until 16 d later. Blood samples were collected daily starting at the 1st day heifers were scanned and continued until 16 d after insemination. Initiation of the Ovsynch/TAI protocol at d 15 of the estrous cycle caused heifers to ovulate prior to insemination. A shortened return to estrus (< 16 d) was caused by ovulation failure to the second gonadotropin-releasing hormone injection, by incomplete regression of the corpus luteum, and by short life-span of the induced corpus luteum. Day of the cycle in which the Ovsynch/TAI protocol is initiated affects dynamics of follicular development, plasma progesterone profiles, and occurrence of premature ovulation. Size of the pre-ovulatory follicle was associated positively with subsequent progesterone concentrations following insemination.

Animals↗

PubMed1992

Steroidogenesis in vitro of human granulosa-luteal cells pretreated in vivo with two gonadotropin releasing hormone analogs employing different protocols.

We have previously observed impaired progesterone accumulation in vitro in response to human chorionic gonadotropin (hCG) by cells pretreated in vivo with a gonadotropin releasing hormone analog (GnRH-a). The present study was conducted in order to evaluate different protocols for GnRH-a in in vitro fertilization (IVF), employing two different available analogs. Granulosa-luteal cells were collected at ovum pick-up and stimulated with hCG. Buserelin (Bus) was employed as long (Bus-L) and short (Bus-S) protocol, and Leuprolide (Leu) was also used as long (Leu-L) and short (Leu-S) protocol. Progesterone accumulation in vitro was compared with cells treated with clomiphene citrate (CC) and gonadotropins. Maximal progesterone production was observed on culture day 6 using Bus-L in comparison to day 4 when clomiphene citrate was employed. While Leu-S showed a similar pattern of progesterone accumulation to clomiphene citrate, Leu-L and Bus-S had an intermediate pattern. The response to hCG was maximal on day 4 for the clomiphene citrate- and Leu-S-treated cells, while the rest of the protocols had a peak on day 6. In addition, hCG consistently stimulated progesterone production in all protocols except in Bus-L. These results confirm an altered progesterone accumulation in vitro when GnRH-a are used. The effect seems to be more evident in long protocols, especially when buserelin is used, suggesting a higher accumulation of the analog in follicular fluid.

Buserelin↗

PubMedDate not supplied

Childhood cancer: patterns of protocol participation in a national survey.

Cancer is still the chief cause of death by disease in children, ages one to 14. As improved survival rates have been reported for pediatric cancer patients who are treated on controlled clinical trials, it is important to understand the national utilization of such protocols. In 1993, a survey of childhood cancer was conducted by the Commission on Cancer of the American College of Surgeons. Data regarding type of disease, protocol participation, age, sex, race, insurance, and geographical region were voluntarily submitted by more than 200 hospital cancer registries. Included in this study were 2,208 children and adolescents 21 years of age or younger who were diagnosed in 1987, and 2,293 who were diagnosed in 1992. Pediatric centers (i.e., members of the Pediatric Oncology Group or Children's Cancer Group) submitted 55.1% of the cases and other institutions, 44.9%. It was found that more patients treated at pediatric centers were on protocols (53.8%) than were those treated at other institutions (25.1%). In general, the younger the patient (five years of age or younger), the greater the chance of being on protocol (pediatric centers, 63.7%; others, 42.0%), with very poor adolescent protocol participation (pediatric centers, 34.8%; others, 12.1%). Nevertheless, overall protocol participation was still lower than expected, even in children younger than five years of age, and adolescent participation in controlled clinical trials was low and similar to adult figures. The percentage of childhood cancer cases seen at pediatric centers was smaller than in other series. It was concluded that pediatric cancer centers need to continue to encourage patient participation in controlled clinical trials, with special emphasis on adolescents.

Adolescent↗

PubMed1989

The validity of verbal protocols.

The reactivity of a "think aloud" verbal protocol and the veridicality of different retrospective protocols were tested over four dissimilar tasks. Generating a concurrent protocol altered accuracy in two tasks, simple addition and a choice between two gambles, and generally prolonged response times. Such reactivity partially qualifies the dominant theory of protocol generation (Ericsson & Simon, 1984). Retrospective protocols yielded substantial forgetting or fabrication in all tasks, supporting the consensus on the nonveridicality of these methods. It is concluded that protocol validity should be based on an empirical check rather than on theory-based assurances.

Adult↗

PubMed2003

Transient evoked otoacoustic emissions in adults: a comparison between two test protocols.

This study compares the performance of the Quickscreen and Default protocols of the ILO-96 Otodynamics Analyzer in recording transient evoked otoacoustic emissions (TEOAEs) from adults using clinical decision analysis. Data were collected from 25 males (mean age = 29.0 years, SD = 6.8) and 35 females (mean age = 28.1 years, SD = 9.6). The results showed that the mean signal-to-noise ratios obtained from the Quickscreen were significantly greater than those from the Default protocol at 1, 2, and 4 kHz. The comparison of the performance of the two protocols, based on the results using receiver operating characteristics curves, revealed a higher performance of the Quickscreen than the Default protocol at 1 and 4 kHz but not at 2 kHz. In view of the enhanced performance of the Quickscreen over the Default protocol in general, the routine use of the Default protocol for testing adults in audiology clinics should be reconsidered.

Acoustic Impedance Tests↗

PubMed2026

A Standardized Nursing-Led Protocol Integrated Pain, Sleep, Medication Adherence, and Symptom Management in Postherpetic Neuralgia.

Postherpetic neuralgia (PHN) is a persistent neuropathic pain condition after herpes zoster that frequently coexists with sleep disturbance, medication-related problems, and fluctuating symptoms. This study evaluated whether a standardized nursing-led protocol could improve multidimensional short-term outcomes beyond usual care. In this prospective, parallel-group randomized controlled trial, 128 adults with PHN were allocated 1:1 to usual care or usual care plus an eight-week protocol integrating structured pain assessment, sleep monitoring, medication-adherence support, and rule-based digital symptom monitoring. The primary outcome was the between-group difference in change in Numeric Rating Scale (NRS) pain score from baseline to Week 8. Secondary outcomes included Pittsburgh Sleep Quality Index (PSQI), MMAS-8 medication adherence, symptom burden, pain-related nocturnal awakenings, breakthrough pain, rescue analgesic use, adverse events, rule-based alerts, and nursing satisfaction. Week-8 data were available for 116 participants (57 usual care; 59 protocol). Mean NRS scores decreased from 7.19 ± 1.08 to 4.82 ± 1.53 in the usual-care group and from 7.28 ± 1.05 to 3.24 ± 1.28 in the protocol group. An NRS reduction of at least 2 points occurred in 49.1% and 76.3% of participants, respectively. The protocol group also showed larger improvements in PSQI, MMAS-8, symptom burden, and nocturnal awakenings, with fewer breakthrough-pain episodes and less rescue-analgesic use. These findings support further evaluation of the standardized nursing-led protocol in preregistered multicenter trials with intention-to-treat analyses and longer follow-up.

Humans↗

PubMed2004

Zero-check: a zero-knowledge protocol for reconciling patient identities across institutions.

CONTEXT: Large, multi-institutional studies often involve merging data records that have been de-identified to protect patient privacy. Unless patient identities can be reconciled across institutions, individuals with records held in different institutions will be falsely "counted" as multiple persons when databases are merged. OBJECTIVE: The purpose of this article is to describe a protocol that can reconcile individuals with records in multiple institutions. DESIGN: Institution A and Institution B each create a random character string and send it to the other institution. Each institution receives the random string from the other institution and sums it with their own random string, producing a random string common to both institutions (RandA+B). Each institution takes a unique patient identifier and sums it with RandA+B. The product is a random character string that is identical across institutions when the patient is identical in both institutions. A comparison protocol can be implemented as a zero-knowledge transaction, ensuring that neither institution obtains any knowledge of its own patient or of the patient compared at another institution. RESULTS: The protocol can be executed at high computational speed. No encryption algorithm or 1-way hash algorithm is employed, and there is no need to protect the protocol from discovery. CONCLUSION: A zero-knowledge protocol for reconciling patients across institutions is described. This protocol is one of many computational tools that permit pathologists to safely share clinical and research data.

Confidentiality↗

PubMed2000

Developing and implementing computerized protocols for standardization of clinical decisions.

Humans have only a limited ability to incorporate information in decision making. In certain situations, the mismatch between this limitation and the availability of extensive information contributes to the varying performance and high error rate of clinical decision makers. Variation in clinical practice is due in part to clinicians' poor compliance with guidelines and recommended therapies. The use of decision-support tools is a response to both the information revolution and poor compliance. Computerized protocols used to deliver decision support can be configured to contain much more detail than textual guidelines or paper-based flow diagrams. Such protocols can generate patient-specific instructions for therapy that can be carried out with little interclinician variability; however, clinicians must be willing to modify personal styles of clinical management. Protocols need not be perfect. Several defensible and reasonable approaches are available for clinical problems. However, one of these reasonable approaches must be chosen and incorporated into the protocol to promote consistent clinical decisions. This reasoning is the basis of an explicit method of decision support that allows the rigorous evaluation of interventions, including use of the protocols themselves. Computerized protocols for mechanical ventilation and management of intravenous fluid and hemodynamic factors in patients with the acute respiratory distress syndrome provide case studies for this discussion.

Algorithms↗

PubMed1995

Informatics for care protocols and guidelines: towards a European knowledge model.

The DILEMMA Generic Protocol Model (DGPM) is a trans-national ontology of clinical protocols designed using a blend of logic engineering and business modelling techniques, and developed as part of the AIM programme's DILEMMA project. It allows the declarative representation of clinical activities and the knowledge associated with them. It is being used to represent protocols of all sorts-including standards and guidelines-for use in acute, primary, home and shared care. Central to the model are the states that protocol-derived actions can assume, and the statements that must be true before transitions between those states can be proposed. Proposed transitions may then be scrutinised by clinicians, patients and carers, and approved or rejected. This approach enables the model to handle anticipated exception situations, as well as more normal protocol selection and application. Links to multi-media material are being investigated, to enable users to examine the evidence upon which protocols are based, and to provide decision support where deterministic reasoning is not readily available. The model is being discussed with other AIM projects, with a view to developing a European consensus, and generating a version of the model for submission to CEN TC251 as a European pre-normative standard.

Artificial Intelligence↗

PubMed1998

Automated blood pressure measurement: state of the market in 1998 and the need for an international validation protocol for blood pressure measuring devices.

The market for blood pressure measuring devices is increasing rapidly. A vast market for self-measuring devices has existed for many years and this continues to grow. There is also a large market for autoated devices in specialized hospital areas, such as operating theatres and intensive care units. Since the introduction of ambulatory blood pressure monitoring into clinical practice, a growing market for devices to measure blood pressure over time has been created. The states of these three markets are reviewed in this paper. With the likely banning of mercury from clinical use, the traditional sphygmomanometer will disappear and it is inevitable that a new and large market will be created by the demand for an automated alternative to the mercury sphygmomanometer in hospitals and in general practice. It is mandatory that such automated devices are validated independently for accuracy and performance. At present two validation protocols are widely used to test the accuracy of blood pressure measuring devices - the British Hypertension Society and the Association for the Advancement of Medical Instrumentation protocols. These protocols have a common purpose and many similarities. It is proposed that a common protocol should be devised for international use. Experience with these protocols allows one to make suggestions concerning how such an international protocol might be simplified and improved.

Journal Article↗

PubMedDate not supplied

Protocols in ambulatory care.

Protocols offer a mechanism for bringing together two major trends in outpatient care. The first trend is the delegation of certain clinical tasks and responsibilities to health workers other than physicians, and to patients themselves. The second trend is the movement toward standard-setting, peer review, audit and quality assurance, and cost-effectiveness of medical practices. Most of the studies of the use of protocols have been with nurse practitioners, physician assistants, office nurses, and health workers. These studies indicate that non-physicians using protocols - in comparison with physicians using traditional methods - give care that is equally thorough, and that leads to comparably accurate diagnosis treatment, and appropriate referral to physicians. Additionally, health workers guided by protocols achieve relief of patients; symptoms and patient satisfaction, and provide care that is efficient in terms of practitioner time, medication, and test ordering. Consequently, health workers using protocols can reduce the cost of care. Protocols have been developed for use in out-patient areas in both developed and developing nations. Protocosl can also be easily audited as part of a quality assurance program, effecting even further saving in costly provider time.

Allied Health Personnel↗

PubMed1998

Toward clinical end-user computing: programmable order protocols for efficient human computer interaction.

We have developed and implemented an efficient method of managing routine patient care information as a programmable group order protocol. The purpose of protocol is to minimize a labor-intensive manual computer interaction by grouping clinically related routine orders as a single entity, thus to greatly speed up the time taken for manual entry such as keyboard stroke and/or mouse clicking. User programmability is added to facilitate insertion, deletion and update of order items to be a locally independent operation. A sequence of menu screen is also programmable when a change of standard operation is needed. Department specific order protocols are classified into four categories to improve user convenience. The degree of efficiency is measured by a number of key strokes and entry time. In most cases the time to enter order protocol with correction is found to take less than one minute with less than five key strokes. The method of order protocol entry clearly demonstrates end-user computing capability so that department specific requirements are resolved without resorting to computer department personnel. Flexibility of managing individual physician specific protocols is also beneficial enough to enhance the morale toward a hospital information system currently in use.

Computer Graphics↗

PubMedDate not supplied

[A proposed protocol for obstetrical ultrasound examination].

INTRODUCTION: Ultrasound has a number of valuable functions in obstetrics including dating, confirming viability, counting the number of fetuses and the exclusion of gross fetal anomalies. During two routine obstetric ultrasound scans, between 11 and 14 gestational weeks and around 20 weeks, the fetus should be carefully examined after which the existence of anomalies can be confirmed or, with a limited certainty that ultrasound enables, excluded. In order to obtain high standards of ultrasound screening, a uniformed protocol is needed, which would enable standardized examination. In this paper the Novi Sad University Department of Obstetrics and Gynaecology presents a new protocol for ultrasound examination which would ensure standardized ultrasound scanning and adequate record keeping. MATERIAL AND METHODS: The protocol is based on contemporary recommendations of the Royal College of Obstetricians and Gynaecologists of Great Britain, the Royal College of Radiologists of Great Britain, the American College of Obstetricians and Gynaecologists, as well as protocols used in routine ultrasound examinations of low-risk population (1,2,3,4,5,6). RESULTS: There are two protocols: one for scanning in the first and the other in the second/third trimester. All the findings are recorded in adequate forms. In the first trimester number, viability, gestational age and expected date of delivery are established (4,6). At the end of the first trimester an anomaly scan can be performed as well (8,9,10,11,12). It includes measuring of crown-rump length, nuchal translucency and fetal heart rate, and examination of placenta, skull, brain, spine, abdomen, stomach, bladder and upper and lower extremities. An adjusted risk of chromosomal abnormality is given, based on maternal age and nuchal translucency measurement. In the second and third trimester the usual fetal biometry is performed as well as a detailed scan of anatomy, which includes searching for ultrasound markers of chromosomal abnormality. At 23 weeks the transvaginal evaluation of cervical length is performed, in an attempt to screen for women at risk of preterm delivery. A new, adjusted risk of chromosomal risk can be given, based on maternal age, nuchal translucency measurement in the first trimester and presence/absence of ultrasound markers of chromosomal abnormality. DISCUSSION: Ultrasound in obstetrics has a major role. All scans in pregnancy must have clear aims, which in early pregnancy are (2): establishing fetal viability; establishing gestational age; identification of multiple pregnancies and their horionicity; exclusion of major fetal anomalies; psychological support and in second trimester are (4,13): (1) establishing normal ultrasound appearances of the fetus, which does not mean that the fetus is normal. The expression 'normal' should be avoided because of possible medico-legal implications. (2) identification of: anomalies incompatible with life; anomalies linked with high morbidity and long-term handicap; fetal conditions than that can be treated during intrauterine life; fetal conditions that will need postnatal tests and therapy. CONCLUSION: New protocol and forms will enable an easier systematic obstetric ultrasound examination.

Female↗

PubMed2000

Screening for hyperglycaemia in pregnancy: analysis of two screening protocols and review of current methods.

We assessed the ability of two screening protocols to detect varying degrees of hyperglycaemia in pregnancy and to compare fetal outcome in those found to have normal and abnormal glucose metabolism by either protocol. 493 pregnant women were identified by one of two screening protocols to be at risk of hyperglycaemia in pregnancy. Pregnancy complications, induction of labour, method of delivery, birth weight, incidence of congenital anomalies and neonatal complications were assessed; there were no significant differences between those with normal and abnormal glucose metabolism detected by either protocol apart from a significant linear trend for the incidence of large for gestational infants with increasing hyperglycaemia in both groups. Protocol B was as effective in detecting new hyperglycaemia in pregnancy as Protocol A. It involved the use of a breakfast meal profile in the initial assessment of those screened positive, reducing the need for glucose tolerance tests in the vast majority of cases. In the population studied, hyperglycaemia in pregnancy was not associated with adverse fetal outcome.

Diet↗

PubMed2001

Weaning children from mechanical ventilation: a prospective randomized trial of protocol-directed versus physician-directed weaning.

OBJECTIVE: Compare outcomes between physician-directed and protocol-directed weaning from mechanical ventilation in pediatric patients. DESIGN: Prospective-randomized. SETTING: Pediatric and cardiac intensive care units in a 307-bed tertiary referral hospital for children. INTERVENTIONS: The control group (physician-directed) was weaned according to individual physician order for reduction in minute ventilation, positive end-expiratory pressure, and ordered oxygen saturation parameters for reduction in fraction of inspired oxygen (F(IO)(2)). The study group (protocol-directed) was weaned according to a predetermined algorithm developed for the purpose of this investigation. METHODS: The study enrolled 223 patients (116 physician-directed, 107 protocol-directed). All patients were monitored for hemodynamics, ventilator parameters, arterial blood gas values when available, oxygen saturation, weaning time, pre-weaning time, extubation time, and time on F(IO)(2) > or = 0.40. We also monitored the incidence of reintubation, subglottic stenosis, tracheitis, and pneumonia. The protocol-directed group had additional measurements of actual versus predicted minute volume, comparisons of respiratory rate (actual versus predicted for age), and presence of spontaneous breathing effort for 10 consecutive minutes. Data analysis was done according to intent to treat. RESULTS: There was no significant difference in 12-hour and 24-hour pediatric risk of mortality (PRISM III) scores between groups. The protocol-directed group overall had shorter total ventilation time, weaning time, pre-weaning time, time to extubation, and time on F(IO)(2) >0.40, although after stratification for respiratory diagnosis, only the difference in weaning time remained significant. There was no difference in the incidence of reintubation, new-onset tracheitis, subglottic stenosis, or pneumonia. CONCLUSIONS: Protocol-directed weaning resulted in a shorter weaning time than physician-directed weaning in these pediatric patients.

Algorithms↗

PubMed2001

A novel interactive electronic protocol review system.

This report describes a new protocol review system which was designed as a Lotus Notes database. This system encompasses all elements of investigator protocol generation, review and approval by the laboratory animal veterinarian and institutional animal care and use committee (IACUC), and notification of approval to personnel responsible for animal ordering. Unique features of the system are interactive dialog between IACUC members and the investigator and confidential protocol discussion among IACUC members. The advantages of the system are multiple: 1. it allows for interactive protocol discussion online; 2. it is an essentially paperless process; 3. inclusion of the outside IACUC member is easily accomplished by using an offsite personal computer and secure remote local-area network access; 4. the time required for protocol generation, review, and approval is streamlined due to the automatic features of the database and the speed of e-mail; and 5. all documentation relating to the protocol and the approval process is archived online.

Animals↗