Development of Evidence-based Nursing Practice Guidelines for Peripheral Intravenous Catheter Management in Hospitalized Children and Adult

Aims: The purpose of this study was to report on the development of evidence-based practice guidelines. Design: Developmental research for practice guidelines. Methods: The guidelines developmental process was designed according to a procedure provided by Scottish Intercollegiate Guidelines Network (SIGN). A first step, key clinical questions were selected. Next, 74 studies were selected from studies of 719 according to a search strategy, and then methodological quality of those studies was evaluated using assessment tool of SIGN. After the evaluation of draft guidelines including recommendations and their grades, the contents were modified. Last, definitive guidelines were evaluated using Appraisal of Guidelines for Research and Evaluation (AGREE) tool. Result: The guidelines consist of three categories and 64 recommendations, i.e. nine recommendations for user before peripheral intravenous catheterization (PIVC), 26 recommendations during PIVC, and 29 recommendations after PIVC. Content validity was revealed to 70-78% by experts’ agreement. Conclusion: These guidelines were completed throughout systematic reviews and evaluations by clinical experts. Their contents are also included about overall managements for PIV therapy. Therefore these guidelines could help PIV practitioners to make evidence based decision. Relevance to clinical practice: The method and result of this study are described specifically in figures, tables and appendix, which could give guidance to nurses who develop guidelines regarding other subjects.

Since it is important to maintain PIV therapies without complications, nurses should manage it in a standardized method (Kim JS, Lee YR, & NS., 2012;Noonan et al., 2006).When evidence-based guidelines for the prevention of intravascular catheter-related infections introduced by the U.S. Center for Disease Control and Prevention were checked up, those were focused on a wide range of catheter-related injections rather than on PIV or child-specific information (O'Grady et al., 2011;O'Grady et al., 2002).Previous systematic reviews had reported the optimized peripheral device intravenous replacement period of PIV devices (Idvall & Gunningberg, 2006;Webster, Osborne, Rickard, & Hall, 2010).When viewed as a whole, the researches focused on the specific situation of PIVC, and the provided information was fragmentary (Dalal et al., 2009;Doniger, Ishimine, Fox, & Kanegaye, 2009;Panebianco et al., 2009;Perry, Caviness, & Hsu, 2011;Rickard, McCann, Munnings, & McGrail, 2010;Small et al., 2008).Therefore the PIVC management should be explained in the context of a series as guidelines.

Guidelines Users and Study Subjects
The intended users of these guidelines are clinical practitioners.The intended study subjects are adult and children scheduled to receive PIV therapy.Contents limited to children were based on below 7 years of age.Classifications of pediatric patients are somewhat different among nations.Puberty stage is included or not.Since puberty-related hormonal change causes a variety of physical and mental changes (McMahon, C., Stryjewski, & R., 2011) and it can vary considerably with age, only children ≤7 years of age were considered.

Ethical Approval
Ethical approval was not required.

Guidelines Development Process
Development process was accomplished according to the guidelines provided by SIGN (Scottish Intercollegiate Guidelines Network).The development process was consists of eight-step (Figures 1~ 2).
Step 1 Identification of guidelines development scope

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Step 2 Assignment of level evidence from studies

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Step 3 Decision regarding recommendation grades

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Step 5 Experts' evaluation about the draft

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Step 6 Modification of the draft guidelines

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Step 8 Verification of its validity Figure 1.Process of developing guidelines Phase1: Search of related studies

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The following databases were used to confirm the evidence concerning the clinical questions: PubMed, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Cochrane, Database of Abstracts of Reviews of Effects (DARE), Guidelines Clearing House (GCH), The Joanna Briggs Institute, Bandolier and domestic engines.

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The search terms were divided into two categories: treatment and complication.
MeSH terms and text words were used for searches (Table 1).

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Search for filters were used; studies involved human subjects, in English, and registered in recent five years.→ Classification of study designs was made up of four systematic literature reviews, 16 randomized controlled trials, 10 cohort studies, one case-control study, eight cross-sectional studies, and two economic evaluation studies.Thirty-three were non-analytical studies or experts opinions.→ Assessment tool of SIGN was used for methodological quality evaluation of those studies.

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Phase 3: Evidence level assignment (Appendix 8-10) → Evidence levels of those studies were assigned using an 8 phase system of SIGN: the system is based on the methodological quality evaluation by the assessment tool of SIGN.(http://www.sign.ac.uk).Step 1. Identification of the guidelines development scope To identify of contents and scope that would be included in guidelines, the key clinical questions were taken from comments of 15 nurses, including 10 pediatric ward nurses and five neonatal ward nurses, all of whom had more than two years of clinical experience in their respective clinical ward.
Twenty-two clinical questions were formulated, based on practitioner experience, literature search in order to identify the scope of guidelines.The PICO (P; Patient or Problem, I; Intervention, C; Comparison, O; Outcome) form was used ("Establish of Guidelines development plan," 2010) to present clinical questions (Appendix 1).
Step 2. Assignment of evidence levels from studies This step was consisted of three phases.Medical Subject Headings (MeSH) terms and text words were used according to the designed search strategy at phase 1. (Table 1).The following search sources were used to confirm the evidence about the clinical questions; PubMed, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Cochrane, Database of Abstracts of Reviews of Effects (DARE), Guidelines Clearing House (GCH), and The Joanna Briggs Institute, Bandolier and domestic engines.Total number of searched studies was 719.Next 124 studies were selected by confirming duplication.98 studies were selected through title and abstract review.74 studies were selected through second full text review (Figure 2).Their study designs were classified and then methodological quality was evaluated at phase 2. Two nurses pursuing a nursing master's degree evaluated methodological quality of the selected studies that excluded non-analytical studies and expert opinions using an assessment tool of SIGN.To ensure objectivity, they conducted in separate rooms.As a result, evaluation about three studies did not coincide, so that issues were discussed by another evaluator pursuing a nursing master's degree.There were different opinions about confused variables; using of antibiotics, sample size (RCT-11, RCT-9; Appendix 2-2), and blinded control (CS-29; Appendix 2-3).At phase 3, evidence levels from those studies were assigned using an 8 phase system of SIGN.

23) Contamination, Equipment
Contaminations, Equipment Equipment Contaminations Step 3. Decision regarding recommendation grades Recommendations from the evidence were graded according to SIGN grading system ("SIGN 50: A guidelines developer's handbook," 2008).The grade of recommendation is moved to 'A' from 'D' according to the evidence levels and a number of the supported studies.
Step 4. Draft guidelines The recommendations and their grades were described in the draft guidelines.
Step 5. Experts' evaluation about the draft A group for draft guidelines evaluation was composed of experts regarding pediatric PIV therapy.In other words, seven practical experts and seven theoretical experts were selected; nurses who worked in pediatric wards, neonatal wards, pediatric emergency center and practitioners who administer and educate about intravenous therapy.The experts evaluated on adequacy, effectiveness, and application possibility of the recommendations using RAND corporation scale (Sachs GS, Printz DJ, Kahn DA, Carpenter D, & JP., 2005).The evaluation results using Fehring method were converted into a one-point scale; measurement of 1, 2, 3, 4, and/or 5 indicated respective points of 0. 0.25, 0.5, 0.75, and 1 (Fehring, 1987) 1998).
Step 6. Modification of the draft Depending upon the aforementioned point of step 5, experts opinion analysis and literature review were conducted in order to modify uncertain recommendations.
Step 7. Definitive guidelines The guidelines were consisted of three categories and 64 recommendations.They are nine recommendations before PIVC, 26 recommendations during PIVC, and 29 recommendations after PIVC.
Step 8. Verification of its validity To evaluate validity of the definitive guidelines content, Tool of Appraisal of Guidelines for Research and Evaluation (AGREE) was used ("AGREE Korean version," 2001).And, experts consisted of six individuals with extensive theoretical knowledge regarding clinical guidelines: 1) one professor of nursing fundamentals 2) one infection control expert 3) one pediatrician 4) one pediatric orthopedic surgeon 5) two experts, both with Ph.Ds. in Nursing, with more than 15 years of clinical experience.

Methodological Quality Assessment for Assignment of the Evidence Level
Step 2, The result of the methodological quality assessment using the assessment tool of SIGN became evidences level for clinical questions which were derived from the guidelines development scope of step 1.
Four systematic literature reviews, sixteen randomized controlled trials, ten prospective cohort studies, one case-control study, nine cross-sectional studies and two economic evaluation studies were evaluated (Appendix 2-1~2-5).

Decision of Recommendation Grade
The recommendations were graded by the tool of SIGN.The grade was assigned from 'A' to 'D' according to number of supported studies, evidence level and practical possibility.
Step 3, the numbers of A, B, C, and D were six, 22, 13, and 23, respectively.

Draft Guidelines Evaluation
Draft guidelines derived in step 4 were evaluated in step 5.The adequacy and effectiveness scores of below 0.60 were two; 1) Application of lidocaine cream or 1% lidocaine using needle-free jet injection prior to insertion.2) When a peripheral catheter is inserted to lower extremities, patients over eight years old are examined about a risk of thrombophlebitis by a physician.
And a low application was four: 3) if PIV therapy was required for more than six days, peripherally inserted central vein or midline should be regarded as alternative methods 4) PIV detection using ultrasound or near-infrared imaging 5) to compensate for the vasoconstrictor effect of lidocaine, glyceryl trinitrate cream that expands blood vessels should be applied for 10 minutes before PIVC 6) clean gloves should be worn in order to protect practitioners (Tables 2~3).

Modification of the Draft Guidelines
Step 6, the experts opinions about recommendations need to be deleted were as follows: 1) lidocaine cream or 1% lidocaine using needle-free jet injection causes blood vessels constriction, waiting period is needed after lidocaine application; such a process becomes more complicated if an insertion site should be changed, and then additional medical expenses are incurred 2) PIV detection using the ultrasound or near-infrared imaging was evaluated as an insufficient recommendation from a lack of awareness and evidence.
The experts opinions about recommendations need to be modified were as follows: 1) The prescription that allows low extremities to be inserted with PIV catheters for children ≥ eight years of age, the recommendation was so modified that risk factors would be described and any agreement/dissent was recorded.
2) The recommendation for a peripherally inserted central catheter or a midline catheter is limited by situations where there is a lack of professionals to perform the procedure.Therefore, the information was modified as professional staff training and validation of the staffing.
3) The recommendation was modified as the use of clean gloves would not always be required due to the difficulty of detecting a vein, except for cases where an infective disease of patient or hand injury of practitioner is suspected.

Definitive Guidelines Assessment
Step 7, the definitive guidelines were evaluated by the six experts using AGREE tool.The overall content validity of these guidelines scored 83% and the domain-specific scores were between 70-78% (Table 4).Overall assessment 1 3.0 4.0 83

Definitive Guidelines
Step 8, these guidelines consist of three categories and 64 recommendations were defined.The three categories consist of recommendation in, before, and after PIVC (Appendix 8-10).

Discussion
The success rate of PIVC using the new methods (Doniger et al., 2009) did not higher than the conventional methods (Panebianco et al., 2009;Perry et al., 2011).Therefore, the recommendation was not included in these guidelines.However, PIVC using an improved method should be sought so as to reduce pain, anxiety, and tissue damage.Therefore, further evaluations are needed based on pain relief, cost of lidocaine, and patient satisfaction.
Iodine requires about two minutes for drying after being applied (O'Grady et al., 2002) and the skin is stained with darkened red, so the detection of veins becomes difficult.But 2% chlorhexidine disinfectant mixed with 70% alcohol requires only thirty seconds (Aziz, 2009;O'Grady et al., 2011) and the skin is not stained.Also, that disinfectant is more effective in coagulase-negative staphylococcus and streptococcus infection than other disinfectants (Small et al., 2008).
The recommendation regarding the transparent sterile dressing was included these guidelines, but expert evaluated it as relatively lower probability because additional medical payment was incurred if health care's policy did not permit using of that dressing.However, injection site observation through the transparent sterile dressing should be guaranteed in order to perform PIV catheter replacement depending on the patient's clinical symptoms.
The catheter replacement depending on patient's clinical symptoms shall reduce pain, stress, and tissue damage.So, practitioners could manage other interventions due to reduction in the PIVC time.In addition, medical cost savings can be expected through a reduction of PIV consumables.(Webster et al., 2010).

Conclusion
These practical guidelines were based on the clinical questions asked by practitioners who actually performed PIVC management, and the search strategy consisted with the phases of 3 was used to find evidence regarding the clinical questions.For the content validity of guidelines, twice evaluation processes were undergone by many relevant experts.
The number of recommendations grade "A" is six: 1) The formation of PIV injection team 2) Although skin is sterilized, if the skin is touched again by hands, the area is assumed to be contaminated 3) PIV Catheters should be re-placed only in cases of complications 4) The fluid set injected glucose and amino acid independently should not be replaced within 72 or 96 hours unless there is a special condition requiring it.5) According to an increased number of peripherally injected medications, the complication rate shall be increased.6) Risk of phlebitis shall be increased when irritating medication is injected.The recommendation graded "B" is twenty-two, "C" thirteen, and "D" twenty-three.

What This Paper Adds
Various nursing interventions are performed for peripheral catheterization.Also during the practice, practitioners may have many decisions-making in accordance with various conditions.At that time, these recommendations and its grades could be considered.

No
Focused question

Appendix 2-3. Quality appraisal of cohort studies
Study topics included the comparative study of phlebitis and its factors in peripheral intravenous catheters (CS-21, CS-22, CS-23, CS-25, CS-26, CS-28, CS-30), the success rate of peripheral vein detection using ultrasound (CS-24), the contamination rate associated with the use of a peripheral intravenous catheter (CS-27), and comparison of peripheral intravenous and catheter-related complications occurring in the Emergency Room and in the general hospital environment (CS-29).

No
Focused

Appendix 2-4. Quality appraisal of case-control studies and cross-sectional studies
The topics were education and the performance of peripheral intravenous catheterization.Nine, cross-sectional studies (CSSs) were evaluated.CSS topics were regional differences in the management of peripheral intravenous catheters (CSS-33), inconsistent guidelines and the nursing practice regarding peripheral intravenous catheters (CSS-32), recognition of and performance for preventing peripheral intravenous complications (CSS-34), factors influencing peripheral intravenous catheter failure (CSS-35), peripheral intravenous catheter reinsertion factors (CSS-36, CSS-39, CSS-40), pain caused by peripheral intravenous insertion (CSS-37), and selective replacement of peripheral intravenous catheters (CSS-38).

No
Focused

Explain to the child and the caregivers who participate in the course of intravenous therapy how to take precautions.
3-1.For children younger than three years, it is effective to explain the course of intravenous therapy by using a real model as an example as they are unable to understand an example if an explanation is made through a dummy or other representative object.The explanation should be provided in simple and clear words.Gloves are not essential in order to ensure hand hygiene and when using the 'no-touch' technique (No touch after sterilization).However, it is necessary to wear clean gloves so as to protect the medical service provider if the child has an infectious disease or is there is a wound on the clinician's hand.

Figure 2 .
Figure 2. Three phases of the step 2

Table 2 .
Scores of low-graded recommendations in the experts evaluation of the draft

Table 4 .
Content validity results of the guidelines
httpsGuidelines for the prevention of intravascular catheter-related infections.Am J Infect Control, 39(4 Suppl 1), S1-34.https://doi.org/10.1016/j.ajic.2011.01.003O'Grady,N.P., Alexander, M., Dellinger, E.P., Gerberding, J.L., Heard, S.O.,Maki, D.G., ... Weinstein, R.A.  (2002).Guidelines for the prevention of intravascular catheter-related infections.Centers for Disease Control and Prevention.MMWR Recomm Rep, 51(RR-10), 1-29.Panebianco, N.L., Fredette, J.M., Szyld, D., Sagalyn, E.B., Pines, J.M., & Dean, A.J. (2009).What you see (sonographically) is what you get: vein and patient characteristics associated with successful ultrasound-guided peripheral intravenous placement in patients with difficult access.Acad Emerg Med, 16(12), 1298-1303.https://doi.org/10.1111/j.1553-2712.2009.00520.xPerry, A.M., Caviness, A.C., & Hsu, D.C. (2011).Efficacy of a near-infrared light device in pediatric  1~6: before peripheral intravenous catheterization  7~15: during peripheral intravenous catheterization 9. Does it reduce complications to select a smaller gauge catheter?10.Could it reduce of complications that only hand hygiene is maintained without wearing disinfected gloves?11.Is the 2% chlorhexidine more effective as a skin disinfectant?12. Does the most visible vein to be recommended for catheterization?13.Is it more efficient for the prevention of complications to insert a catheter into lower extremities than upper?14.Could it prevent complications to support the peripheral catheterization site using a splint?15.Is it more effective to use a topical anesthetic for children's pain relief during peripheral catheterization?16.Does it prevent complications to replace peripheral intravenous catheter routinely?17.Does it prevent complications to replace extension devices routinely, i.e. extension tube and 3-way stopcock, and infusion set? 18.Does it prevent complications to use assessment tools about phlebitis or infiltration?19.Does the use of dressing devices affect to complications? 20.Is it more secure to inject via an infusion pump than natural dropping?21.Is it beneficial to recognize what kind of drug to be administered via peripheral veins?22.Does it prevent complications to explain how can monitor its symptoms to children and their caregivers?Appendix 2-1.
Not reported; 6, Not applicable; ++, All or most of the criteria have been fulfilled; +, Some of the criteria have been fulfilled; -, Few or no criteria fulfilled.
Not applicable; ++, All or most of the criteria have been fulfilled; +, Some of the criteria have been fulfilled; -, Few or no criteria fulfilled.

5. Quality appraisal of the economic evaluation studies
Not addressed; 5, Not reported; 6, Not applicable; ++, All or most of the criteria have been fulfilled; +, Some of the criteria have been fulfilled; -, Few or no criteria fulfilled.Effectiveness analysis topics considering the cost were chlorhexidine and iodine, and a comparison was made of pain relief medications.Not applicable; ++, All or most of the criteria have been fulfilled; +, Some of the criteria have been fulfilled; -, Few or no criteria fulfilled.

Check the application period of the peripheral intravenous injection therapy in order to reduce repeated venipuncture. 4-1. When
Photos or illustration can help the subject remember the contents of the information provided.-Itispossible to effectively prepare them by allowing them to observe the catheterization of other children.-In the case of a child between three and seven years of age, the preparatory course which is organized according to stories read by their parents is effective.For children older than seven years of age, it is more effective to help them prepare by providing general information.However, it can be more effective to provide the least amount of information in case a patient receives repeated intravenous injections.In children between six and 11 years of age, an emotional explanation should be avoided and the detailed procedure should be explained, e.g. the arm will be sterilized; it will be cold..The course and sensations should be explained in a stable tone of voice according to the order of the procedure.

Prepare the skin with disinfectant that is effective for preventing complications and is easy to use.
There is an increased chance of the occurrence of phlebitis if an intravenous catheter is used in the same area more than once.

It is possible to consider the maintenance of the intravenous injection on the lower limb for the children younger than seven years of age. 7-1.
For the vein, the front and back of the upper limb, including basilic vein, cephalic vein, and metacarpal vein should first be checked.The site where complications occurred, such as phlebitis, should be evaluated for 48 hours following the removal of a catheter.As chemical phlebitis is caused by medicine, the speed of the medicine's injection should be reduced and properly diluted medicine should be injected.-To access edema, the patient's arms should be lifted and if the roundness around the catheter placement area is large and spreads to the sides when lit by a flashlight, it indicates stagnated solution under the skin.3-3.Even in cases of medication injected using an infusion pump, there should be frequent monitoring.As a certain amount of medicine is introduced through an infusion pump on a regular basis, a medication should be given periodically regardless of internal damage, even in cases of complication generation.As more medicine can be accumulated through the pressure introduced by an infusion pump, thus organ damage can thus be accelerated.There are more cases of phlebitis even using isotonic solution if irritating medicine, such as KCL, is mixed with the isotonic solution.As the osmotic pressure and pH of the highly concentrated solution (more than 500 mOsm/L of osmotic pressure) and a solution with a high pH (more than pH 9, less than 5) cause mechanical and chemical damage to the intima-media of blood vessels, the risk of phlebitis increases.Parenteral nutrition of the particles with high osmotic pressure cannot be introduced peripherally even for a short period of time due to the risk of serious phlebitis and thrombosis.Bolus injection causes anaphylactic reactions as well as the risk of speed shock, infiltration, and phlebitis.Injection should be done with the solution diluted as much as possible within the limit of drug instructions.When using multi-dose drugs, the vial's cap should be disinfected with 70% alcohol before use while taking care not to contaminate it by touching it.

5. Explain how to monitor complications to the child or caregivers who maintain the peripheral intravenous injection. 5-1.
The information needed to monitor the catheterized area should be provided to the caregivers and children who are able to communicate, so that they can immediately inform the medical experts if there is any problem related to the peripheral intravenous injection.