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At least 415 records · Page 23Linked to original sources

PubMed1993

Effects of different heavy-resistance exercise protocols on plasma beta-endorphin concentrations.

To examine the changes of plasma beta-endorphin (beta-EP) concentrations in response to various heavy-resistance exercise protocols, eight healthy male subjects randomly performed each of six heavy-resistance exercise protocols, which consisted of identically ordered exercises carefully designed to control for the repetition maximum (RM) resistance (5 vs. 10 RM), rest period length (1 vs. 3 min), and total work (joules). Plasma beta-EP, ammonia, whole blood lactate and serum cortisol, creatine kinase, urea, and creatinine were determined preexercise, midexercise, immediately postexercise, and at various time points after the exercise session (5 min-48 h), depending on the specific blood variable examined. Only the high total work-exercise protocol [1 min rest, 10 RM load (H10/1)] demonstrated significant increases in plasma beta-EP and serum cortisol at midexercise and 0, 5, and 15 min postexercise. Increases in lactate were observed after all protocols, but the largest increases were observed after the H10/1 protocol. Within the H10/1 protocol, lactate concentrations were correlated (r = 0.82, P < 0.05) with plasma beta-EP concentrations. Cortisol increases were significantly correlated (r = 0.84) with 24-h peak creatine kinase values. The primary finding of this investigation was that beta-EP responds differently to various heavy-resistance exercise protocols. In heavy-resistance exercise, it appears that the duration of the force production and the length of the rest periods between sets are key exercise variables that influence increases in plasma beta-EP and serum cortisol concentrations. Furthermore the H10/1 protocol's significant challenge to the acid-base status of the blood, due to marked increases in whole blood lactate, may be associated with mechanisms modulating peripheral blood concentrations of beta-EP and cortisol.

Adult↗

PubMed2006

Discovery of cancer vaccination protocols with a genetic algorithm driving an agent based simulator.

BACKGROUND: Immunological prevention of cancer has been obtained in HER-2/neu transgenic mice using a vaccine that combines 3 different immune stimuli (Triplex vaccine) that is repeatedly administered for the entire lifespan of the host (Chronic protocol). Biological experiments leave open the question of whether the Chronic protocol is indeed the minimal vaccination schedule affording 100% protection, or whether shorter protocols could be applied that would result in the same efficacy. A biological solution would require an enormous number of experiments, each lasting at least one year. Therefore we approached this problem by developing a simulator (SimTriplex) which describes the immune response activated by Triplex vaccine. This simulator, tested against in vivo experiments on HER-2/neu mice, reproduces all the vaccination protocols used in the in vivo experiments. The simulator should describe any vaccination protocol within the tested range. A possible solution to the former open question using a minimal search strategy based on a genetic algorithm is presented. This is the first step toward a more general approach of biological or clinical constraints for the search of an effective vaccination schedule. RESULTS: The results suggest that the Chronic protocol included a good number of redundant vaccine administrations, and that maximal protection could still be obtained with a number of vaccinations approximately 40% less than with the Chronic protocol. CONCLUSION: This approach may have important connotations with regard to translation of cancer immunopreventive approaches to human situations, in which it is desirable to minimize the number of vaccinations. We are currently setting up experiments in mice to test whether the actual effectiveness of the vaccination protocol agrees with the genetic algorithm.

Algorithms↗

PubMed2002

Comparison of the peak exercise response measured by the ramp and 1-min step cycle exercise protocols in patients with exertional dyspnea.

STUDY OBJECTIVES: To compare the peak exercise response and determine the limits of agreement between the ramp and the 1-min step cycle protocols in a representative population of patients with exertional breathlessness attending a respiratory outpatient clinic. DESIGN: Crossover with the test order double blinded and randomized. SETTING: Outpatient exercise physiology laboratory. PATIENTS: Twenty-two patients (12 men; mean [SD] age, 59 [8] years; FEV(1), 71% [21%]) with lung disease and/or exertional breathlessness. INTERVENTION: Symptom-limited, maximum cycle exercise tests using a ramp and a 1-min step work rate (WR) protocols. The two protocols were assigned to subjects in a randomized manner. MEASUREMENTS AND RESULTS: Oxygen uptake (O(2)), minute ventilation (E), heart rate (HR), WR, exercise time, and Borg scores were compared at symptom-limited peak exercise. The mean (SD) peak values for the ramp and the step protocols, respectively, were as follows: peak O(2), 1.51 (0.44) L/min and 1.49 (0.43) L/min; peak E, 50.8 (12.9) L/min and 49.9 (14.5) L/min; and peak HR, 133 (24) beats/min and 131 (22) beats/min (p > 0.05). There were no significant differences between breathlessness and perceived exertion at peak exercise. Peak WR (WRpeak) and exercise time were significantly higher using the ramp protocol: 110.5 (37.1) W vs 105.6 (35.6) W, and 8.2 (2.0) min vs. 7.6 (1.9) min, respectively. CONCLUSIONS: The ramp protocol leads to a higher WRpeak, and this may have implications for exercise prescription. However, there were no significant differences between the two protocols for the peak physiologic responses. The choice of protocol for the measurement of maximal exercise capacity remains one of laboratory preference.

Aged↗

PubMed2007

Intensive insulin therapy in critical care: a review of 12 protocols.

OBJECTIVE: To review performance characteristics of 12 insulin infusion protocols. RESEARCH DESIGN AND METHODS: We systematically identify and compare 12 protocols and then apply the protocols to generate insulin recommendations in the management of a patient with hyperglycemia. The main focus involves a comparison of insulin doses and patterns of insulin administration. RESULTS: There is great variability in protocols. Areas of variation include differences in initiation and titration of insulin, use of bolus dosing, requirements for calculation in adjustment of the insulin infusion, and method of insulin protocol adjustments. Insulin recommendations for a sample patient are calculated to highlight differences between protocols, including the patterns and ranges of insulin dose recommended (range 27-115 units [mean +/- SD 66.7 +/- 27.9]), amount recommended for glucose readings >200 mg/dl, and adjustments nearing target glucose. CONCLUSIONS: The lack of consensus in the delivery of intravenous insulin infusions is reflected in the wide variability of practice noted in this survey. This mandates close attention to the choice of a protocol. One protocol may not suffice for all patients.

Blood Glucose↗

PubMed2000

Development of an estrus synchronization protocol for beef cattle with short-term feeding of melengestrol acetate: 7-11 synch.

An estrus synchronization protocol (7-11 Synch) was developed to synchronize the first follicular wave and timing of ovulation in postpartum beef cows. In Exp. 1, follicular development and timing of ovulation in response to the following protocol were evaluated. Beef heifers (n = 12) and cows (n = 6), at random stages of the estrous cycle, were fed melengestrol acetate (MGA; .5 mg x animal(-1) x d(-1)) for 7 d and injected with PGF2alpha (PG; 25 mg) on the last day of MGA. A second injection of PG was administered 11 d after cessation of MGA. After the second injection of PG, estrus was synchronized in 6/12 heifers and 3/6 cows. The interval to estrus in heifers and cows was 54 and 64 h, respectively (P > .10). All animals exhibiting estrus ovulated first-wave follicles. Animals that failed to respond to the second injection of PG were in estrus later than 6 d after cessation of MGA and had corpora lutea that were unresponsive to the injection of PG. Based on the variation in interval to estrus following the first PG injection on the last day of MGA feeding in Exp. 1, an injection of GnRH (100 microg) was added to the protocol 4 d after the cessation of MGA to ensure ovulation or luteinization of dominant follicles and synchronization of first-wave follicular development. This revised protocol was termed "7-11 Synch." In Exp. 2, two estrus synchronization protocols were compared. Multiparous beef cows were stratified by breed and postpartum interval and randomly assigned to the 7-11 Synch (n = 44) or Select Synch protocols (GnRH injection followed by PG injection 7 d later; n = 45). Timing of estrus after the last PG injection (0 h) ranged from 42 to 102 h in the 7-11 Synch group and -30 to 114 h in the Select Synch group. Eight cows (18%) in the Select Synch group exhibited estrus 30 h before to 18 h after PG. Synchronized estrus peaked between 42 and 66 h after the last PG injection, and a maximum number of cows were in estrus at 54 h for both treatment groups. Synchrony of estrus from 42 to 66 h was greater (P < .05) in 7-11 Synch (91%: 41/44) than in Select Synch cows (69%: 31/45). Artificial insemination pregnancy rate from 42 to 66 h was greater (P < .05) in the 7-11 Synch group (66%: 29/44) than in the Select Synch group (40%: 18/45). In summary, the 7-11 Synch protocol improved synchrony of estrus without reducing fertility. This protocol has potential future application for fixed-time AI in beef cattle production systems.

Animals↗

PubMed2003

Health professionals' knowledge of prevention strategies and protocol following percutaneous injury.

Prevention strategies and protocols for the management of percutaneous injuries are developed for the purpose of preventing transmission of HIV and other infections. However, implementation thereof requires health professionals to be conversant with the content of protocols and ways to prevent percutaneous injuries. The purpose of the study was to determine health professionals' knowledge of prevention strategies and protocols following percutaneous injury. The purpose was addressed within a quantitative survey design. Data were collected by means of a self-administered questionnaire. The study was conducted at a public-sector tertiary academic hospital in Gauteng. Seven units within the hospital were randomly selected for investigation. These included, trauma, intensive care, medical, surgical, maternity, theatre and paediatrics. A population of 800 health professionals worked within the sampled units. Health professionals were stratified according to the following three categories, doctors, registered and enrolled nurses and medical and nursing students. A sample size of 200 health professionals was purposively selected of which a response rate of 79.5% (n = 159) was achieved. The sample consisted of 76.7% (n = 122) registered and enrolled nurses, 13.2% (n = 21) doctors and 8.8% (n = 14) medical and nursing students; 1.3% (n = 2) did not specify their health professional category. Awareness of the existence of a protocol for percutaneous injury amounted to 96.2% (n = 153). General knowledge of the contents of the protocol reflected a different picture; only 26.4% (n = 42) of health professionals could accurately quote the procedure following a percutaneous injury as recommended by the South African Institute of Medical Research (SAIMR) protocol. The lack of knowledge of the existence of a protocol was most evident in the medical and surgical units. A total of 16.4% (n = 26) of health professionals reported having sustained a percutaneous injury. A doctor (33.3%) was more likely to sustain a percutaneous injury than a nurse (15.6%). Intensive care units reported the highest incidence of percutaneous injuries (31%; n = 9). Health professionals were unlikely to report a percutaneous injury; as only 53.8% (n = 14) reported the injury. The results of this research indicate that although knowledge of protocol and prevention strategies was inadequate these alone are insufficient to reduce the incidence of percutaneous injury.

Blood-Borne Pathogens↗

PubMedDate not supplied

Assessment of motoneuron excitability using recurrent inhibition and paired reflex depression protocols: a test of reliability.

Motor output may be regulated by both pre- and post-synaptic mechanisms. The purpose of this study was to investigate the reliability of two measurement protocols, which purport to examine spinal mechanisms responsible for gating motoneuron excitability. Nine subjects (aged 29 +/- 5 years) were tested using two soleus H-reflex protocols; 1) recurrent inhibition (RI) and 2) paired reflex depression (PRD). The dependent variable for each protocol was the peak-to-peak amplitude of the conditioned Hoffmann reflex (H-reflex). Seven trials were obtained for each subject under each condition as well as control values to assess test-retest reliability. After all trials were collected the subjects rested for at least five minutes after which the process was repeated. Each subject returned to the lab after a period of no less than 24 hours at which time the process was repeated. Protocol #1: Control reflexes (20% of maximal motor response) were obtained during quiet stance. After obtaining control trials two reflex responses were elicited which were separated by 10 ms on each trial to assess recurrent inhibition (Pierrot-Deseilligny et al., 1976; Bussel and Pierrot-Deseilligny, 1977). Protocol #2: Again a double-pulse technique was used to assess reflex activation history on motoneuron pool output (Trimble et al., 2000). This protocol utilized two reflex stimuli of the same intensity separated by 80 ms. The peak-to-peak amplitude of the control, RI conditioned and PRD conditioned H-reflexes exhibited intraclass reliability estimates of .97, .97 and .93 respectively. To achieve a reliability of rI > or = .80, it is recommended that a minimum of 2 trials be used for the RI protocol and that 4 trials be used for the PRD protocol. The results indicate that both techniques provide a means to objectively and reliably measure spinal mechanisms for gating motoneuron pool output.

Adult↗

PubMed2002

Which is the best distension protocol to study rectal sensitivity in the irritable bowel syndrome?

OBJECTIVE: To evaluate any differences in rectal distension perception between healthy subjects and patients with irritable bowel syndrome (IBS) according to an isobaric distension protocol (progressive or phasic). MATERIAL AND METHODS: 10 healthy subjects and 41 patients with IBS (Rome II criteria). Rectal distension was performed using a barostat connected to a 500 mL bag, and a progressive distension protocol (continuous distension at a rate of 0.36 mmHg/sec) was compared to phasic distension protocol (distensions for 60 sec with 4 mmHg increases separated by 0 mmHg pressures during 60 sec). Perception was evaluated using three descriptive scales of 7 categories each for perception type, intensity, and affectivity. Perception thresholds were assessed. RESULTS: No significant differences in any perception thresholds were found between control subjects and IBS patients using a progressive distension protocol. Differences in the perception of inconvenient distension and maximum tolerable distension were encountered with the phasic distension protocol. Uncomfortable distension thresholds below those of controls were found in 48.8% of patients with IBS when a phasic distension protocol was used, versus only 9.7% with a progressive protocol. CONCLUSION: Hypersensitivity in patients with IBS is mainly seen with the use of phasic distension isobaric protocols for affective negative perceptions.

Adult↗

PubMed2004

Outcome of a surgical treatment protocol for late consecutive exotropia following bilateral medial rectus recession for esotropia.

PURPOSE: To describe a specific protocol for the surgical treatment of Late Consecutive Exotropia (LCXT) following bilateral medial rectus (MR) recessions, and to report the results of surgery, performed according to this protocol, in a series of 119 children followed 6 months to 15 years after surgery for consecutive exotropia. METHOD: The senior author (JLM) performed a retrospective chart review of 15 years of his experience following a specific protocol for the surgical treatment of LCXT. In individual cases, following this protocol led to recessions of the overacting inferior oblique (IO) with anterior transposition if dissociated vertical deviation (DVD) was also present, weakening of the overacting superior oblique (SO) with simultaneous 10 mm recessions of the superior rectus (SR) with 3 mm of nasal transposition (to ameliorate DVD which might be aggravated by SO tenotomies), graded recessions of one lateral rectus (LR) 7.0 to 8.5 mm if the distance deviation was equal to or less than 23 prism diopters (PD) of XT, and advancement of one previously recessed MR to the insertion if the distance deviation was equal to or greater than 24 PD XT. RESULTS: "Success" was defined as 8 PD ET to 6 PD XT, with both distance and near fixation. Among 14 patients receiving SR recessions, SO tenotomies, and recession of one LR, 12 of the 14 were "successes" at 6 months postop' and 10 of 14 at an average of 3 years postop'. Among 26 receiving advancement of one MR, "successes" were 23 of 26 at 6 months postop' and 20/26 at two years after surgery. Among 22 receiving IO recession with anterior transposition if DVD was present, "successes" were 18 of 22 at 6 months and 12 of 22 at 3.6 years. Among 57 receiving only recession of one LR, 53 of 57 were "successes" at 6 months postop' and 45 of 57 at 4 years postop'. The overall "success" rate for this protocol for these 119 patients was 89% at 6 months and 74% at 2 to 4 years postop'. Treatment of simultaneous IO overaction and LCXT was associated with the highest long term "failure" rate in this protocol. CONCLUSION: This specific surgical protocol for treatment of late consecutive exotropia is reasonably safe and effective and comparable to the few other reported protocols of various surgical treatments for consecutive exotropia.

Adolescent↗

PubMed2006

Time at or near VO2max during continuous and intermittent running. A review with special reference to considerations for the optimisation of training protocols to elicit the longest time at or near VO2max.

Several authors have suggested that training at or near VO2max (i.e. > or = 95% VO2max) is the most effective training intensity to enhance VO2max and that for highly trained endurance athletes, training at or near VO2max may be necessary to increase it further. Consequently, there is an interest in characterising training protocols that allow the longest time at or near VO2max (T@VO2max). Intermittent running protocols have been found to be more effective than continuous protocols for increasing T@VO2max. Intermittent protocols can be manipulated by altering the warm-up intensity and timing, work and relief interval velocity and duration, amplitude, interval number per set, and the number of sets performed. To increase T@VO2max it is recommended that work interval intensity should generally range between 90% and 105% vVO2max and relief interval intensity between 50% vVO2max and the lactate threshold velocity. Work and relief interval durations should be between 15 and 30 seconds. The warm-up period prior to the intermittent protocol should be about 10 to 15 minutes in duration at 1 or 2 km x h(-1) below the lactate threshold velocity, with no gap between the warm-up and the intermittent protocol. When designing intermittent training protocols for the enhancement of VO2max, the simultaneous enhancement of other physiological performance determinants should also be considered. Further experimental research is required to identify the specific physiological responses and adaptations to various intermittent running protocols that are designed to elicit the longest time at or near VO2max, before recommendations can be given to competitive endurance runners.

Exercise↗

PubMed2006

Initial experience with an intensive care hyperglycemia protocol in a Saudi Arabian intensive care unit.

OBJECTIVE: To study the efficacy of nurse-driven intensive glucose management protocol in an intensive care setting. METHODS: This cohort study took place at King Abdul-Aziz National Guard Hospital, Al-Hasa, Saudi Arabia from April 2005 through June 2005. We modified a validated nurse-driven glycemic protocol when glucose level was >11.1 mmol/L. Protocol was applied to 103 consecutive patients. Three months after implementing the protocol, we analyzed the glucose control and relevant patient variables. To check the efficacy, glucose values were compared with patients admitted consecutively 2 months prior to the implementation of the protocol. Duration and mean insulin infusion rates were also recorded. A brief nursing survey was also conducted. RESULTS: The median blood glucose upon ICU admission was 8.7 mmol/L (interquartile range 6.9-12.05). Our cohort included 45 patients with history of diabetes while the remaining 58 were non-diabetics. Mean blood glucose decreased from 10 +/- 4.4 mmol/L on admission to 8.2 +/- 1.8 mmol/L for the duration of ICU stay. Protocol was effective in both diabetics and non-diabetics. Insulin infusion was employed in 33 patients. Median insulin infusion rate required throughout the ICU length of stay was 4.3 units/hour. Duration and rate of insulin infusion were not statistically significant between diabetics and non-diabetics. The glucose control was significantly better when compared with the prior practices of glucose control. CONCLUSION: Our study demonstrates that nurse-driven hyperglycemia protocol were manageable to used in critically ill patients. Moreover, the protocol is equally effective in both diabetic and non-diabetic patients.

Adult↗

PubMed1991

[A comparison of sudden near maximal exercise test (dash method) and Bruce protocol for pediatric patients].

We examined 24 pediatric patients to evaluate the usefulness of sudden near maximal exercise test (dash method), where the subjects began to run at Bruce protocol of the last stage. 1) No considerable differences between two protocols were found in maximal oxygen consumption (V O2max), maximal heart rate (HRmax), maximal systolic blood pressure, and findings of electrocardiography. 2) The sudden maximal exercise test could be completed during a shorter period compared to Bruce protocol. 3) The sudden maximal exercise protocol reached 84% of HRmax and 47% of V O2max at one minute after the onset of the protocol, and produced 96% of HRmax and 89% of V O2max at two minutes after the onset. We considered that sudden maximal exercise protocol was useful to obtain a response similar to Bruce protocol at maximal exercise within a short period. We have to pay attention to the safety of the patients because their cardiopulmonary response to sudden maximal exercise protocol is dramatic.

Adolescent↗

PubMed1991

Repeatability and protocol comparability of presyncopal symptom limited lower body negative pressure exposures.

Data on repeatability and comparability of different presyncopal symptom-limited lower body negative pressure (PSL-LBNP) exposure protocols, while scarce, are critical to the interpretation of studies using PSL-LBNP methods. To investigate if PSL-LBNP tolerance, heart rate, and blood pressure were repeatable, 11 subjects were exposed to 4 PSL-LBNP tests; each test occurring at the same time of day, separated by at least 72 h, and using the same protocol. No significant differences were found in either the heart rate or blood pressure responses to the PSL-LBNP or the tolerance indices (cumulative stress index; maximum negative pressure tolerated; and duration of negative pressure exposure). To study the comparability of different PSL-LBNP protocols, nine subjects were exposed randomly to five PSL-LBNP tests using protocols that varied in stage duration but not pressure profile. The protocols had 1-, 3-, 5-, 7-, or 9-min stage durations. These PSL-LBNP exposures were conducted at the same time of day and separated by at least 72 h. While no differences were noted in either the response pattern or magnitude of heart rate or blood pressure to the differing protocols, the cumulative stress index and the duration of negative pressure exposure varied proportionally with the length of the stage durations. With the exception of the 1-min protocol, the maximum negative pressure tolerated did not vary regardless of the protocol used.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗

PubMed1986

An interactive computerized protocol for the management of hypertension: effects on the general practitioner's clinical behaviour.

This paper reports an experimental study of general practitioners' use of an interactive computerized protocol for the management of hypertension, focussing particularly on the protocol's effects on doctors' clinical behaviour. Prior to its computerization a paper-based version of the protocol was used enabling a comparison of the alternative forms. Doctors' delivery of care was assessed from video recordings of 89 consultations and from the records made during these consultations. Comparisons were made of consultations conducted under control and experimental conditions. Use of paper and computer protocols resulted in significant improvements in the doctors' delivery of care, in terms of the range of verbal and physical examinations conducted and recorded. The protocol's effects were most marked when the computerized version was used. However, use of the computer protocol resulted in the recording of information on the non-occurrence of certain events which had not been explicitly elicited during the verbal examination; features of the design which were intended to encourage adherence to the protocol may have been inappropriate to the realities of a general practice consultation. The findings provide some useful insights for the design of future computerized protocols for the management of chronic conditions.

Behavior↗

PubMedDate not supplied

Rectosigmoid polyps as markers of proximal colonic neoplasms: a cost benefit analysis of different diagnostic protocols.

The predictive value of hyperplastic polyps of the rectosigmoid for neoplastic lesions in the proximal colon is controversial. Some authors who deny predictive value have proposed a protocol which entails initially biopsying rectosigmoid polyps, and only in the case of adenomas then proceeding to total colonoscopy (protocol 1). The diagnostic and economic efficiency of this protocol, and of an alternative which entailed the full exploration of the colon during the initial examination in the case of rectosigmoid polyps (protocol 2), were evaluated by retrospectively simulating their application to 216 patients who had undergone total colonoscopy. A proximal neoplastic pathology was present in 49.5% of patients with rectosigmoid adenoma, 27.3% of patients with distal non neoplastic polyps alone (33.3% if only distal hyperplastic polyps were considered) and 11% of patients with no distal polyps. Protocol 1 gave rise to a higher cost ($ 58,413), not only compared to protocol 2 ($ 50,276), but also compared to total colonoscopy in all patients ($ 57,008); there was also a larger number of patients who eluded diagnosis (29%, against 16% in protocol 2). In terms of cost per lesion detected and of colorectal cancers prevented (on the basis of an evolution to cancer of 5% of adenomas), total colonoscopy for all patients on principle is advantageous compared to either protocol ($ 864 per proximal lesion and $ 7,082 per cancer prevented). Since distal hyperplastic polyps are also predictive of proximal neoplastic pathology, when rectosigmoid polyps are detected it is both indicated and economic to proceed with the exploration of the entire colon during the initial examination. This appears to be a reasonable compromise compared to total colonoscopy on principle, which has higher overall costs. The latter management, however, should not be ruled out, since it has a better diagnostic yield and lower cost per lesion detected and per cancer prevented.

Adenoma↗

PubMed1995

Prospective randomized study on the cryopreservation of human embryos with dimethylsulfoxide or 1,2-propanediol protocols.

OBJECTIVE: To investigate the optimal protocol for cryopreservation of human embryos obtained from IVF. DESIGN: Prospective randomized study. SETTING: Consenting patients in an academic research environment. PATIENTS: Couples undergoing IVF. INTERVENTIONS: A cohort of 2,220 supernumerary multicellular embryos were obtained from 488 patients who were randomized over slow freezing protocols with dimethylsulfoxide (DMSO, 819 embryos), 1,2-propanediol (699 embryos) or a mixture of DMSO and 1,2-propanediol (702 embryos). A total of 725 embryos have been thawed (DMSO, 232 embryos; 1,2-propanediol, 250 embryos and DMSO and 1,2-propanediol, 243 embryos) for transfer in natural ovarian cycles. MAIN OUTCOME MEASURES: Embryo survival rate, embryo implantation rate, clinical pregnancy rate (PR), delivery rate, live-birth rate. RESULTS: The embryo survival rate was significantly higher with the DMSO protocol (52.6%) than with the 1,2-propanediol (32.0%) or the DMSO and 1,2-propanediol protocols (34.9%). The clinical PR per thawing cycle was significantly higher in the DMSO protocol (17.2%) than in the 1,2-propanediol protocol (3.9%). The clinical implantation rate per embryo thawed was significantly different between a DMSO-frozen embryo (4.7%) and a 1,2-propanediol-frozen embryo (1.2%). A DMSO and 1,2-propanediol-frozen embryo had a 3.7% chance of of implantation. The delivery rate per thawing cycle was significantly higher in the DMSO protocol (12.5%) than in the 1,2-propanediol protocol (2.6%). The live-birth rates per embryo thawed were 3.5%, 0.8%, and 2.9% in the DMSO, 1,2-propanediol, and DMSO and 1,2-propanediol groups, respectively. CONCLUSION: Supernumerary multicellular embryos as presented in daily clinical IVF practice have the highest chance of survival and of implantation after cryopreservation when DMSO has been used.

Birth Rate↗

PubMed1995

Limited-stage small-cell lung cancer: patient survival after combined chemotherapy and radiation therapy with and without treatment protocols.

PURPOSE: To compare survival of patients who undergo treatment in protocols versus survival of patients not in protocols. MATERIALS AND METHODS: Records of 81 adult patients with small-cell lung cancer who underwent chemotherapy and radiation therapy in 1987-1992 were reviewed retrospectively. Forty-one patients were in a protocol; 40 patients were not. Patient demographics and prognostic factors were not statistically significantly different. RESULTS: Median overall survival was 16.7 months in the nonprotocol group versus 29.0 months in the protocol group (P = .0023). Median disease-specific survival was 18.3 months in the nonprotocol group versus 27.1 months in the protocol group (P = .0176). Survival was not statistically significantly influenced by Karnofsky performance status, weight loss, or thoracic radiation dose. CONCLUSION: There was a highly statistically significant difference in survival outcome in the nonprotocol group versus the protocol group (P = .0023). Differences in chemotherapy-radiation therapy timing and other treatment-related factors may have contributed substantially to the improved survival in the protocol group.

Adult↗

PubMed2004

Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles.

CONTEXT: Selective reporting of outcomes within published studies based on the nature or direction of their results has been widely suspected, but direct evidence of such bias is currently limited to case reports. OBJECTIVE: To study empirically the extent and nature of outcome reporting bias in a cohort of randomized trials. DESIGN: Cohort study using protocols and published reports of randomized trials approved by the Scientific-Ethical Committees for Copenhagen and Frederiksberg, Denmark, in 1994-1995. The number and characteristics of reported and unreported trial outcomes were recorded from protocols, journal articles, and a survey of trialists. An outcome was considered incompletely reported if insufficient data were presented in the published articles for meta-analysis. Odds ratios relating the completeness of outcome reporting to statistical significance were calculated for each trial and then pooled to provide an overall estimate of bias. Protocols and published articles were also compared to identify discrepancies in primary outcomes. MAIN OUTCOME MEASURES: Completeness of reporting of efficacy and harm outcomes and of statistically significant vs nonsignificant outcomes; consistency between primary outcomes defined in the most recent protocols and those defined in published articles. RESULTS: One hundred two trials with 122 published journal articles and 3736 outcomes were identified. Overall, 50% of efficacy and 65% of harm outcomes per trial were incompletely reported. Statistically significant outcomes had a higher odds of being fully reported compared with nonsignificant outcomes for both efficacy (pooled odds ratio, 2.4; 95% confidence interval [CI], 1.4-4.0) and harm (pooled odds ratio, 4.7; 95% CI, 1.8-12.0) data. In comparing published articles with protocols, 62% of trials had at least 1 primary outcome that was changed, introduced, or omitted. Eighty-six percent of survey responders (42/49) denied the existence of unreported outcomes despite clear evidence to the contrary. CONCLUSIONS: The reporting of trial outcomes is not only frequently incomplete but also biased and inconsistent with protocols. Published articles, as well as reviews that incorporate them, may therefore be unreliable and overestimate the benefits of an intervention. To ensure transparency, planned trials should be registered and protocols should be made publicly available prior to trial completion.

Clinical Protocols↗