(1) State the type of research design used in the Schultz et al. report. (2) State the elements or characteristics of this type of design used in the Schultz report (

Case Study, Chapter 1, Health Care Delivery and Evidence-Based Nursing Practice 1. Suzanne Jones, 76-year-old patient with COPD is admitted to the ICU
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The following table gives the results of a study of smoking and a specific type of cancer.
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(1) State the type of research design used in the Schultz et al. report. (2) State the elements or characteristics of this type of design used in the Schultz report (

(1) State the type of research design used in the Schultz et al. report. (2) State the elements or characteristics of this type of design used in the Schultz report (see textbook for designs). (3) Does the research design fit with the research purpose? Provide rationale as to why or why not. (4) What is the dependent variable and independent variable? (5) Is there a conceptual model/framework described in the report? If yes, describe briefly in a few sentences the framework. If not, state such. (6) Describe what is meant by a type II error. (7) What is the meaning of the word “power” when talking about research (not power analysis)? Comparison of Normal Saline and Heparinized Saline for Patency of IV Locks in Neonates Alyce A. Schultz, Debra Drew, and Hilary Hewitt In this randomized double-blind experiment of 49 neonatal intensive care unit patients, probable time to catheter failure was significantly longer (p 0358) for catheters flushed with heparinized saline (median 127) compared with those flushed with normal saline (median 39). This is in contrast to the nonsignificant difference (p 841) in mean scores for six heparin-flushed catheters (M 41.5 hours, SD 44.0) compared with 18 saline-flushed catheters (M= 30.4 hours, SD 20.8) discontinued for reasons other than completion of treatment, We concluded that survival time analysis is necessary when evaluating results of time-dependent studies in which the end point may not be elective. Copyright c 2002 by W.B Saunders Company T HE USE OF NORMAL saline as the flush solution to maintain patency in large-gauge intravenous (IV) catheters (16 to 22 G) in the adult population has become an acceptable standard of practice in acute care and home care across the country. The use of heparinized saline flash solu tion is the more common protocol in the pediatric population and, more specifically, the neonatal population; however, there is no national standard (Bossert & Beecroft, 1994). Our search to identify a national standard yielded a variety of protocols in current use across the country Insertion of peripheral catheters in neonates can be difficult, painful, and time consuming. Reduc- ing the number of IV punctures by capping IV accesses is one way of decreasing these painful procedures. The current practice in our neonatal intensive care unit (NICU) to maintain the patency of capped IV accesses is to flush IV locks with normal saline before and after administration of a medication, then flush again with heparinized sa- coagulopathies (Malloy & Cutter, 1995; Spadone et al., 1992). It is posited that if flushing with normal saline is as effective as flushing with hep- arinized saline, there will be financial savings to patients and institutions, in addition to reducing the clinical risks of heparin (Goode et al, 1991). The current costs of using heparinized saline include a pharmacist’s time to prepare the solution and ad- ditional costs of materials used in the preparation. Nursing time is increased based on the multiple flushes within standard protocols. In summary, the benetits of not using heparin include: (1) decreased risk for incompatibility with other medications, (2) possible decreased risk for intraventricular hemor- thage and other coagulopathies, and (3) savings in both cost and time. These benefits must be weighed against the risks for increased failure of peripheral IVs and subsequent repeated painful procedures. REVIEW OF THE LITERATURE Since the mid-1980s interest in etuduin th Insertion of peripheral catheters in neonates can be difficult, painfiul, and time consuming. Reduc- ing the number of IV punctures by capping IV accesses is one way of decreasing these painful procedures. The current practice in our neonatal intensive care unit (NICU) to maintain the patency of capped IV accesses is to flush IV locks with normal saline before and after administration of a medication, then flush again with heparinized sa- line to avoid an interaction of these drugs with heparin. This additional heparin carries the poten- tial risk for intraventricular hemorrhage and other risk for incompatibility with other medications, (2) possible decreased risk for intraventricular hemor- rhage and other coagulopathies, and (3) savings in both cost and time. These benefits must be weighed against the risks for increased failure of peripheral IVs and subsequent repeated painful procedures. REVIEW OF THE LITERATURE Since the mid-1980s, interest in studying the safety, tolerability, and effectiveness of normal sa- line flushing of peripheral IV catheters in children has increased. Findings have been inconsistent for the primary variable of interest, duration of pa- tency. Several studies included children ranging in age from 1 to 18 years (Beecroft et al., 1997; Danek & Noris, 1992; Kleiber, Hanrahan, Fagan, & Zittergruen, 1993; Lombardi, Gundersen, Zam- mett, Walters, & Morris, 1988; McMullen, Fiora- vanti, Pollack, Ridecout, & Sciera, 1993; Mudge, Forcier, & Slattery, 1998); one study did not report the age range of the sample (Hanrahan, Kleiber, & Fagan, 1994). As might be anticipated, this wide Alyce A. Schultz, RN, PhD, Nurse Researcher, Maine Med ieal Center, Portland, ME; Debra Drew, RN, MS, NNP, Apria Healthcare, Yarmouth, ME: Hilary Hewitt, RN, HA, BSN, Apria Healthcare, Yarmouth, ME. Address reprint requests to Alyce A. Schultz, RN, PhD, Nurse Researcher, Maine Medical Center, 22 Bramhall St, Portland ME 04102. E-mail: schula@mmc.org Copyright o 2002 by W.B. Saunders Company 0897-1897/02/1501-0005535.000 dot:10.1053apur 2002.29320 20 Applied Nursing Research, Vol. 15, No. 1 (February), 2002: pp 28-34 HISON IN NEONATES 29 age variation in the studies precluded control over the size of the IV catheter. Catheter size was cited as predictive of longevity, with larger catheters remaining patent longer than smaller catheters (Beecroft et al., 1997; Danek & Noris, 1992; Mudge et al., 1998; Paisley, Stamper, Brown, Brown, & Ganong, 1997). The use of survival statistics to analyze the duration of patency was considered an important parameter for critique and synthesis. Comparison of findings across studies was confounded by the lack of clear criteria and definitions for discontinu ing catheters. Generally, catheters in the studies were discontinued for “elective” reasons when the or they did not use survival analysis to determine duration of patency differences (Golberg, Sanka- ran, Givelichian, & Sankaran, 1999). The sample size for catheters discontinued for nonelective rea- sons in these latter studies did not meet the prede- termined optimal sample size based on power anal- ysis for comparative statistics. The potential for type II errors must be considered, i.e, the possi- bility that sample sizes were not adequate to detect significant difference in mean duration of time, if S a it existed. Type II errors are an important clinical consid- eration when synthesizing results regarding the use of heparinized or normal saline flushes in pediatric patients and, more specifically, critically ill nee nates. One way of avoiding type II errors is to have adequate sample size to detect differences when they are present. For example, McMullen et al. opti- treatment was no longer needed and for “nonelec- tive” reasons when there was infiltration, leakage, occlusion, phlebitis, or accidental dislocation. It was not always clear which catheters were in- cluded in the analyses. If the duration of patency analyzed for all catheters regardless of the reason for discontinuation, the reported findings could erroneously lead the reader to false conclu sions. For example, results of one study were re- ported as no statistically significant difference in hours of duration for 124 catheters based on saline or heparin flush solutions (Kleiber et al., 1993) The rescarchers further reported that there was not a statistically significant difference among elective and nonelective reasons for discontinuing cathe- ters. However, only 20 catheters in the saline group and 14 catheters in the heparin group were re- moved for nonelective reasons. There was no re- ported analysis on length of patency for these 34 catheters. There may be a difference in survival probability based on those catheters that continued to be patent until discontinued for elective reasons. In two of seven studies that included neonates, an (1993) used power analysis to determine an mal sample size of 146 based on a clinically rele- vant 8-hour difference in longevity. Their well- designed study reported on comparison of mean duration of patency, age, medication type infiused, was and catheter size and placement for 142 subjects The rescarchers also reported the number of ceth- eters that were discontinued nonelectively, i.e. catheters for which the heparin/saline comparison of duration is clinically and statistically meaning- ful. They reported a nonsignificant difference between the two groups in mean duration for catheters remain- ing patent longer than 48 hours; however, the sam- ple size had been reduced to 81 subjects. Accepting these findings as valid may support a type II error This is particularly important when changing prac- tice could increase the risk for catheter occlusion and the potential for repeated venipunctures and related sequelac. One study had an adequate sam- ple size for catheters (N- 254) discontinued for clinical reasons and used life-table analvsis to there was no statistically significant difference in in of natency between the two flushing compare longevity between the flushing methods .. hon

 

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