European Journal of Oncology Nursing 16 (2012) 17e25 Contents lists available at ScienceDirect European Journal of Oncology Nursing journal homepage: www.elsevier.com/locate/ejon Antineoplastic agents extravasation from peripheral intravenous line in children: A simple strategy for a safer nursing careq Daniella Cristina Chanes a, *, Mavilde da Luz Gonçalves Pedreira b,1, Maria Gaby Rivero de Gutiérrez b,1 a b Nurse at the Chemotherapy Outpatient Unit, IOP GRAACC UNIFESP, SAO Paulo, Brazil Federal University of Sao Paulo, 754 Napoleao de Barros Street, Vila Clementino, 04024-002 SAO Paulo, Brazil a b s t r a c t Keywords: Extravasation Antineoplastic agents Children Oncology nursing Safety Intravenous therapy Pediatric nursing Medication errors Quality of care Evidence-based nursing Purpose: The antineoplastic agents infusion through peripheral lines may lead to several adverse events such as extravasation that is one of the most severe acute reactions of this sort of treatment. The extravasation prevention and management must be part of a safe and evidence-based nursing care. Due to this fact, two algorithms were developed with the purpose of guiding nursing care to children who undergo chemotherapy through peripheral line. The objectives of this study were to determine the content validity of both algorithms with pediatric oncology nurses in Brazil and United States of America, and to verify the agreement between the evaluations of both groups. Methods and Sample: A descriptive validation study was carried out through the Delphi Technique that has the following steps: development of the data collection instrument, application to the specialists, data analysis, algorithms’ review, re-evaluation by the specialists, final data analysis and content validity determination. Results: The data analysis was descriptive and based on the specialists agreement consensus equal or higher than 80% in every step of the algorithms. The process showed that the agreement with both instruments ranged from 92.8% to 99.0%. Conclusion: The algorithms are valid for application in nursing care with the main purpose of preventing and managing the antineoplastic agents’ extravasation. Ó 2011 Elsevier Ltd. All rights reserved. Introduction According to the Oncology Nursing Society, extravasation is the passage or escape of antineoplastic drugs into the tissue that may lead to necrosis in severe conditions (Polovich et al., 2005). However, there are other definitions that consider extravasation as only the escape of vesicant drugs into the tissue (Infusion Nurses Society, 2006). Extravasation is described as the most severe acute complication in the peripheral intravenous therapy with antineoplastic drugs, resulting in extreme distress and suffering to the patient and its prevention must be part of nursing care. For that reason, it is necessary to have the best practice of highly trained professionals in administering antineoplastic drugs q This study is part of the Dissertation “Algorithms for Prevention, Treatment and Follow-up after Antineoplastic Agents Extravasation from Peripheral Intravenous Line in Children: Content Validation” presented to the Graduate Program in Nursing of the Federal University of Sao Paulo for obtaining Masters Degree in Nursing UNIFESP, 2009. * Corresponding author. Tel.: þ5511 55764430. E-mail addresses: [email protected] (D.C. Chanes), mpedreira@ unifesp.br (M.daL.G. Pedreira), [email protected] (M.G.R. de Gutiérrez). 1 Tel.: þ5511 55764430. 1462-3889/$ e see front matter Ó 2011 Elsevier Ltd. All rights reserved. doi:10.1016/j.ejon.2011.01.005 (Sauerland et al., 2006; Kassner, 2000). Once extravasation occurs, it is impossible to completely remove the drug from the tissue; however, a prompt and consistent intervention within the event time reduces significantly the risk of permanent injuries and distress to the patient. In addition, the prompt intervention minimizes possible costs related to treatment and avoids delay in the chemotherapy treatment which may negatively interfere with the patient prognosis (Wickham et al., 2006; Kassner, 2000). Furthermore, the tissue destruction caused by the extravasation of antineoplastic drugs is indolent and progressive. Most of the damage is not always immediately perceived after its occurrence, and it can remain imperceptible until the patient returns to the treatment center 24 or 48 h later, showing the first signs of progressive tissue injury. Due to this fact, either the suspicion or the occurrence of extravasation should be strictly monitored by the nursing team (Kumar et al., 2001). Because extravasation is a severe adverse event with serious consequences to the patient, its occurrence should be reported. This action allows monitoring of the cases, investigation of the possible causes involved, and adoption of procedures to treat the patient. Moreover, it provides important information to implement prevention strategies for new cases (Adami et al., 2005). 18 D.C. Chanes et al. / European Journal of Oncology Nursing 16 (2012) 17e25 Extravasation prevention and control should be part of institutional protocols, reflecting the concern of providing safe nursing care within the quality standards. Protocols that are easy to follow and are based on scientific evidence should be adopted in order to improve nursing care and to assure safety to the patient (Adami et al., 2005; Hadaway, 2007). Algorithms are one of the main quality management tools currently used in the development of Fig. 1. Algorithm for vesicant chemotherapy administration. Direction signs protocols and are an important way to organize processes involving quality (Ishikawa, 1993). Based on the importance to standardize nursing practices involved in the process of prevention, intervention, follow-up and documentation of this adverse event, two algorithms were built to achieve this goal by collecting inherent information and by proper reviewing of literature (Chanes et al., 2008). Beginning or end of a process, Action, Decision, Report, File, Wait, D.C. Chanes et al. / European Journal of Oncology Nursing 16 (2012) 17e25 19 Fig. 1. (continued). Thus, the main question of the present study is: what is the validity of the algorithms developed for vesicant drugs administration and for extravasation occurrence intervention and follow-up? Nursing from the United States of America (USA) and from Brazil (BR), as well as to identify the common points in the evaluation performed by both groups. Purpose Material and methods The purpose of the present study was to verify the content validity of the tools named Algorithm for vesicant chemotherapy administration (Fig. 1) and Algorithm for intervention in the occurrence of extravasation (Fig. 2) by specialists in Pediatric Oncology A descriptive study on content validation of measuring instruments was carried out by specialists of the St. Jude Children’s Research Hospital (SJCRH) in Memphis e Tennessee e USA, as well 20 D.C. Chanes et al. / European Journal of Oncology Nursing 16 (2012) 17e25 Fig. 2. Algorithm for intervention in the occurrence of extravasation. Direction signs Beginning or end of a process, as by specialists of several Brazilian institutions, all of them specialized in pediatric cancer treatment. The option chosen by SJCRH for data collection in the USA was based on the research partnership between the hospital and the institution where the researchers work. Action, Decision, Report, File, Wait, Content validation Validation is defined as the degree to which an instrument is able to measure what it was intended for. Content validation is a subjective judgment on whether a measure makes sense D.C. Chanes et al. / European Journal of Oncology Nursing 16 (2012) 17e25 intuitively and it refers to the degree to which an instrument represents a specific domain or the relevance of its elements/items (Polit et al., 2004; Hulley et al., 2007). Establishing content validation is a vital and rigorous process, in which the final outcome determines the extent to which the algorithms incorporate most of the elements and essential processes to the central theme. It can be determined by different methods, to include Delphi Technique, which stands out for enabling the consensus from a group of specialists or experts in a particular area of knowledge regarding a specific phenomenon (Polit et al., 2004). This technique requires the use of questionnaires containing scales such as Likert, to obtain expert opinion on the validity of each item individually and together (Polit et al., 2004). Thus, in the first step, more general and comprehensive, a domain is identified, and then items, which will be part of an instrument are built. By adopting the Delphi Technique, the idea is to obtain convergent opinions from several experts on the items, so that the validity, final product of this process, results of group consensus on a specific subject. The number of experts varies in the literature. According to Lynn (1986), a minimum of five judges would provide a sufficient level of control for agreement. On the other hand, the maximum number of judges has not been established, but it is unlikely to exceed 10. Consensus is determined in advance by the researcher and a value is provided. Consensus levels between 50% and 80% are found in the literature (Polit et al., 2004). For this study, the level of consensus was pre-established to be equal or higher than 80%. Sample In order to be included in this study, the research subjects were screened based on the following criteria: To be a nurse; To have at least five years of experience in the pediatric oncology area, preferably in the administration of antineoplastic drugs; To agree to participate in the study by signing the Informed Consent Form (ICF) in Portuguese or in English, according to the participant’s mother tongue. Data collection The study was approved in accordance with the ethical aspects by the two institutions involved: Federal University of Sao Paulo UNIFESP and SJCRH. In order to obtain specialists’ analyses, two instruments were developed, one in Portuguese and one in English, using a Likert-type scale containing three statements: 1. I totally agree. 2. I partially agree and 3. I disagree. The participants were asked to indicate the degree of agreement or disagreement in each item for both algorithms. The analysis of the instruments also comprised questions regarding to the specialists’ agreement on keeping the steps in the algorithm, as well as, keeping the sequence provided in the instrument. They were also invited to provide suggestions and/or comments about each step of the algorithms, if necessary. For the re-evaluation phase, another four instruments were developed, following the same standard, and the algorithms were re-submitted with the changes suggested highlighted in the instruments for the specialists to be able to evaluate the final version. Procedure of data collection 1st Phase e validation The specialists were screened according to the criteria previously mentioned. In Brazil, the screening process was held during 21 the 10th Brazilian Congress on Pediatric Oncology, and in the USA, during the traineeship held at SJCRH. The experts were personally invited by the researcher to take part in the study. They were also provided with information regarding the research objectives and instructions on how to complete the evaluation of the algorithms. Following that, all of them signed the ICF. The deadline for returning the instruments completed was set within five days after receipt. 2nd Phase e data analysis All instruments, either totally completed or at least 95% completed, returned within the five day-period were analyzed. Descriptive analysis was individually performed in all steps regarding agreement of Brazilian and US specialists; in addition, the responses provided by the two groups were also compared. The comments and suggestions provided to complete or to emphasize their evaluations were also analyzed. 3rd Phase e algorithm review All steps were reviewed based on the specialists’ answers, suggestions and comments, in addition to data from the literature, and were changed as required. 4th Phase e re-evaluation After proper changes, the new algorithms along with a new evaluation instrument were submitted to the specialists either by e-mail or conventional mail. Along with the algorithms, they were also given the results of the first phase, a letter describing the main findings and the objectives of the new phase. The deadline to return the instruments completed was set within 30 days. 5th Phase e final phase All steps were individually evaluated regarding the degree of agreement between the Brazilian and U.S. nurses, in addition to compare the responses provided by the two groups. The comments and suggestions provided to complete and highlight their evaluation were also evaluated. Following the descriptive analysis of the results and based on the consensus of the experts and their opinions the algorithms had their final form set and their validity was determined. Results Characterization of the subjects The work team comprised 14 pediatric oncology nursing specialists, with seven Brazilian and seven U.S. professionals, and all of them were female (Table 1). Brazilian nurse’s average age was around five years younger than U.S. nurses’, and the average of the two groups was 42 years old. The average time of experience in pediatric oncology of the U.S. nurses was about 8 years longer compared to the Brazilian nurses. It is important to mention that the specialist with the longest experience was a U.S. nurse who has been working for 31 years in pediatric oncology. Regarding the performance area, it is important to highlight that 11 out of the 14 Brazilian and U.S. nurses (78.8%) worked in assistance roles, at inpatient or outpatient units, bone marrow transplant unit or as line nurses (responsible for intravenous care). So that, all of them had experience with antineoplastic agents administration. The other three nurses worked in teaching and research, with two of them having previous experience as bedside pediatric oncology nurses. Overall, from the 14 nurses included in this study, 13 of them had a large experience related to nursing care in children undergoing chemotherapy 22 D.C. Chanes et al. / European Journal of Oncology Nursing 16 (2012) 17e25 Table 1 Characteristics of the Pediatric Oncology Nurses according to gender, age, time of experience, performance area and working place. Sao Paulo, 2009. Table 2 Agreement with the steps of the Algorithm for Vesicant Drugs Infusion, according to American and Brazilian nurses. Sao Paulo, 2009. n ¼ 14 Categories Nurses USA Gender (n ¼ 14) Female Male Age (n ¼ 14) 30e40years 41e50years 51 a 60 years Average (DP); min-max Time of experience (n ¼ 14) 5e15years 16e25years 26e35years Average (DP); min-max Performance area (n ¼ 14) Teaching and research Assistance Main activity (n ¼ 14) Ambulatorial care Inpatient unit Bone marrow transplant unit Line nurse Teaching and research n ¼ 14 Steps Agreement (%) USA BR General 1.0 2.0 2.1 2.2 2.1.1 2.1.2 3.0 3.1 3.2 3.2.1 3.2.2 4.0 5.0 6.0 6.1 6.2 7.0 7.1 7.2 7.2.1 7.2.2 8.0 8.1 8.2 8.1.1 8.2.1 9.0 9.1 9.1.1 9.1.2 9.2 10.0 General 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 85.7 100.0 100.0 100.0 100.0 100.0 85.7 85.7 85.7 85.7 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 97.6 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 85.7 100.0 100.0 100.0 85.7 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 99.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 92.8 92.8 100.0 100.0 92.8 100.0 100.0 92.8 92.8 92.8 92.8 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 98.3 BR N % N % 7 e 50.0 e 7 e 50.0 e 3 21.4 2 14.3 2 14.3 44.7 (9.2); 32.9e55.6 6 42.8 e e 1 7.2 39.3 (7.2); 35.0 e54.4 3 21.4 2 14.3 2 14.3 18.6 (8.6); 7.0-31.0 7 50.0 e e e e 10.7 (3.7); 5.015.0 1 6 7.2 42.8 2 5 14.4 35.6 4 e e 2 1 28.4 e e 14.3 7.2 2 2 1 e 2 14.3 14.3 7.2 e 14.3 Algorithm validation for vesicant drugs administration The results regarding the agreement with the procedures recognized by the Algorithm for Vesicant Drugs Administration were descriptively and comparatively analyzed between the two groups of specialists. The agreement with the steps ranged from 85.7% to 100%, and, regarding the evaluation of the instrument as a whole, the agreement achieved was between 97.6% and 99.0% (Table 2). All suggestions and comments from the experts were taken into account, even those related to the steps with high level of agreement. For that reason, the entire instrument was reviewed. Among these procedures, the items 3.2.1 and 3.2.2 stand out. Both refer to the intravenous device to be used for peripheral venous puncture, which are respectively, the needle-catheter and the catheter over needle. The use of the needle-catheter showed 85.7% of agreement among the Brazilian expert. However, the two nurses who disagreed stated that this device is not used to administer vesicant drugs in their institutions. One of the specialists also stated that the needle-catheter increases the risk of antineoplastic drugs extravasation. On the other hand, the use of the catheter over needle showed 85.7% of agreement among the U.S. nurses. Two of them stated that this kind of device should not be used for administration of vesicant drugs. One of the specialists of the U.S. group recommended the use of the needle-catheter. A further interesting result concerns the item 6.0, which evaluates the permeability of the catheter while injecting 10 ml of saline solution with subsequent aspiration to assess the blood return and the catheter patency. This procedure showed 85.7% of agreement among the Brazilian experts. The main comments about this action were regarding the prescribed volume, as some specialists stated that 5 ml of saline solution would be sufficient to determine the permeability of the catheter. Also, regarding the evaluation of the catheter adequacy for administration of vesicant antineoplastic drugs, the application of the Infiltration Score of Infusion Nurses Society (INS), in order to evaluate infiltration signs in the catheterized site, as stated in items 7.0, 7.1 and 7.2, showed agreement of 85.7% among the U.S. nurses. The main comments were about the unfamiliarity and non-use of the score in their practice. They were also concerned about the score content and stated that would be important to simplify it and train the team for its application. Yet, the removal of the venous device procedure, in case of infiltration signs, stated in item 7.2.1, achieved 85.7% of agreement among the U.S. nurses. They pointed out that it would be necessary to evaluate the need to administer phentolamine at the extravasation site, and in this case, the venous device would be required. It is possible to state, based on the final results, that both analysis, from each group and from the 14 experts, demonstrated an agreement greater than 85.7%, above the 80% preestablished in this study. Validation of the algorithm of intervention in the extravasation occurrence The results concerning the agreement with the procedures recognized by the Algorithm of Intervention in the Extravasation Occurrence were descriptively and comparatively analyzed between the two groups of specialists. The agreement with the steps ranged from 74.4% to 100%, and with regard to the evaluation of the instrument as a whole, the agreement was between 92.8% and 97.9% (Table 3). As in the previous instrument, we highlighted the steps contained in the instrument that had, in the comparative analysis, agreement below 100.0%. The first step analyzed is item 1.1 referring to immediately stop the administration of the antineoplastic drug in case of extravasation and to not remove the venous device. Among Brazilian nurses, D.C. Chanes et al. / European Journal of Oncology Nursing 16 (2012) 17e25 Table 3 Agreement with the steps of the Algorithm for Intervention after Antineoplastic Drugs Extravasation, according to American and Brazilian nurses. Sao Paulo, 2009. n ¼ 14 Steps 1.0 1.1 1.2 1.3 2.0 3.0 3.1 3.2 3.1.1 3.1.2 3.2.1 4.0 4.1 4.2 5.0 General Agreement (%) USA BR General 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 85.7 100.0 100.0 100.0 85.7 100.0 100.0 97.9 100.0 71.4 71.4 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 85.7 100.0 100.0 71.4 92.8 100.0 85.7 85.7 100.0 100.0 100.0 100.0 100.0 92.8 100.0 100.0 92.8 92.8 100.0 85.7 95.4 the agreement was 71.4% and the main reason was that they would immediately remove the device in case of extravasation Table 3. One of them stated that, even in case of blood return, it would not be prudent to use the venous access and that the amount of drug to be aspirated would not justify such action, either. As for disconnecting the infusion device delivering the antineoplastic drug and connecting a new syringe to the catheter to aspire the residual drug, which corresponds to procedure 1.2, there was an agreement of 71.4% among Brazilian nurses. These specialists were the same respondents who disagreed on the step 1.1 and came up with the same rationale to disagree with item 1.2. Among the U.S. experts, one of them stated that the residual drug could be aspirated either by a new syringe or by the device containing the antineoplastic drug, and the latter would be a more efficient option to save time for the intervention. The thermal and positioning interventions, represented by steps 3.1 and 3.2, showed 100% of agreement. However, the elevation of the affected limb (3.2.1) aroused comments from two Brazilian nurses who pointed out the need to check the conditions of the patient before applying this intervention. Also, those experts stated they did not believe this intervention would be appropriate to be performed in children. Regarding the use of hot packs four times a day, during 20 min, for 48e72 h, in cases of the extravasation of vincristine, vinblastine, vinorelbine, etoposide and teniposide (3.1.1), there was an agreement of 85.7% among the U.S. nurses. Their main concern was related to the consequences of applying hot packs to the site, which could increase the risk of burns and infection. The monitoring results were pointed out in steps 4.0, 4.1, 4.2 and 5.0. The item 4.0, showed 85.7% of agreement among the Brazilian nurses. They suggested that the follow-up procedure (type of intervention and period) should be described in the instrument. Additionally, patient discharge in case of reduction or disappearance of edema, pain or extension of the extravasation area, item 4.1, achieved an agreement of 85.7% among the U.S. experts. Those specialists stated that the tissue necrosis may progress for over six months and, for this reason, the follow-up with doctor and nurse appointments is essential. Furthermore, they stated that the patient should receive written instructions, regarding care and symptoms to be reported, and they also emphasized the importance to provide instructions to the patient’s family in order to assist the patient during the home care period, even after the patient’s discharge. 23 Finally, the documentation of the occurrence, procedure 5.0, achieved 100% of agreement among the U.S. specialists, whereas only 71.4% of agreement was obtained among Brazilian nurses, who stated that the documentation should be done from the very beginning of the extravasation occurrence, not just after its resolution. When analyzing the results of the Algorithm of Intervention in the Extravasation Occurrence, it is possible to verify that the level of agreement on each item as well as on the instrument as a whole was higher than 85.7%, which is above the pre-established goal in this study (80%). Results of the re-evaluation phase The analysis of both algorithms has demonstrated that the agreement was higher than the pre-established one (80%) for all items, even those achieving 100% of agreement were re-evaluated. Such a fact is thought to be due to a number of factors, and one of them is the increase of knowledge acquired on the subject by the researchers throughout this study process, which was provided by proper literature review, opinion from peer-reviewed scientific journal regarding the stage of building the algorithm, as well as, the experts’ comments and suggestions. One of the first points re-evaluated was the title of both instruments. It is important to mention, at this point, that the titles had not been part of the analysis in the validation process. However, one observation that brought this to our attention was the fact that some nurses were concerned to the issue and suggested some changes. For this reason, the reformulation of the titles were considered necessary; thus, based on the available suggestions, the instruments were changed as follows: Algorithm for Administration of Vesicant Antineoplastic Drugs in Children Through Peripheral Venous Access and Algorithm of Intervention in the Occurrence of Extravasation of Antineoplastic Drugs administered through Peripheral Venous Access in Children. Furthermore, both analysis of the degree of agreement on the comments and the suggestions provided by the nurses on the steps of the instruments were taken into account to maintain and/or change them in the instruments. Therefore, based on a new literature review and on the comments and suggestions provided by the professionals involved, it was decided to maintain the original sequence of the steps, once there was high proportion of agreement and suitability with the literature. Thus, only the content of four steps in the Algorithm for Administration of Vesicant Drugs and one procedure in the Algorithm of Intervention in the Occurrence of Extravasation were changed. Next, the items of the Algorithm for Administration of Vesicant Antineoplastic Drugs in Children through Peripheral Venous Access were submitted to a new analysis, called re-evaluation. The modified items are presented in their original and reformulated form, according to Chart 1. With regard to the Algorithm of Intervention in the Occurrence of Extravasation of Antineoplastic Drugs Administered Through Peripheral Venous Access, only the action 5.0, regarding the documentation of the event, was modified. The original presented the action in a simple way. After reviewe, it emphasizes that documentation should contain information of all stages of the process. All items modified showed 100% of agreement between Brazilian and U.S. specialists. Discussion Health care takes place in a very complex system and has characteristics, which may predispose to errors and aggravate their consequences in a level rarely identified in other human activities (Harada et al., 2006). Safe nursing care is synonym of error-free care. Such errors could cause negative impact on the patient’s 24 D.C. Chanes et al. / European Journal of Oncology Nursing 16 (2012) 17e25 Original Content Final Content (2.0) Identify if the antineoplastic drug is (2.0) Check the patient´s name, drug, vesicant route, dosage and infusion time. Identify if the drug is vesicant. (2.1) Identify the infusion technique (2.1) Verify the infusion technique (2.1.2) Continuos/ Intermitent INFUSION (2.1.2) Intermitent INFUSION - Less than 60 minutes (6.0) Verify catheter patency in the (6.0) Verify catheter patency in the infusion of 10cc saline solution and infusion of 5 to 10cc saline solution and aspirate to verify blood´s backflow aspirate to verify blood´s backflow Chart 1. Original and final content of the steps sent to re-evaluation from the Algorithm for antineoplastic agent infusion in children through peripheral vein. quality of life. However, there are a number of factors that may affect patient’s safety, which is not always under control (Kline, 2004; Stratton et al., 2004). The expansion of treatment regimens in oncology and the development of new drugs and combinations require an increasing number of specialists with knowledge and skills for their administration and control of the risks associated (Jones and Coe, 2004). The health care professionals should be able to prevent the occurrence of an adverse advent, or even, use their knowledge to abolish or mitigate its deleterious consequences in case they occur, as it is the case of antineoplastic drug extravasation (Kloth, 2002). Aiming to provide the best possible performance, the development and implementation of protocols have been incremented since the 90’s in order to support administrative and clinic decisions to provide the most appropriate nursing care to the users in specific situations (Lacey et al., 2006). The use of clinical protocols based on the existing relationship between care, scientific evidence and quality of care is essential. Quality can be characterized by the presence of professionals with high level of competence to perform their functions, to effectively use the resources, to reduce to the lowest level the risk of lesions produced or resulted from assistance, to satisfy clients/patients’ demands regarding their expectations and access to health care, and to provide a favorable effect in the population’s health (Harada et al., 2006). Some authors point out that the incidence of extravasation in an institution may and should be used as a quality indicator of the nursing care provided, and this score should be close to zero (Lacey et al., 2006). Different factors should be taken into account to evaluate the quality of health care services and, in order to comprise these multiple dimensions, aiming to guide and reformulate the strategies for continuous improvement of health services, several indicators of structure, process and results are required to evaluate the quality of health assistance provided to the patients (Harada et al., 2006). The use of protocols enables the standardization of practice, which also provides monitoring of the care implemented and prevention of waste. A study demonstrated that the standardization of nursing care to patients undergoing antineoplastic chemotherapy by implementing protocols based on evidence was able to reduce in 50% the incidence of adverse events in a 15-month period (Leape et al., 2000). Evidence-based care implies the use and application of research results for decision making. However, health professionals have broader evidence interests that relate to the experience of health, illness, and health care. Indeed, it is not unusual within the broad field of health care to find that best available evidence on a given topic cannot be reduced to a quantifiable value (Pearson et al., 2008). In this context, the non-identified extravasation or extravasation wrongly treated may lead to severe and progressive tissue damage, and many authors consider its occurrence a medical emergency (Jones and Coe, 2004; Wickham et al., 2006). Nevertheless, there is a lack of evidence-based nursing care in the literature regarding antineoplastic agents’ extravasation management. For instance, the Oncology Nursing Society (Polovich et al., 2005) and the European Oncology Nursing Society (Wengstrom and Margulies, 2008), describe in their guidelines the lack of evidence regarding the use of antidotes on extravasation treatment. The lack of large-scale comparative trials due to the non-frequent nature of extravasation episodes leads to the controversial use of those agents. Notwithstanding, some authors describe and advocate the use of antidotes in contrast to the recommendations recognized by societies, such as ONS. The algorithms, main purpose of this study, stand out as an important tool for extravasation management. The Joanna Briggs Institute describes evidence-based practice as clinical decision making, taking into account the best available evidence, the context in which the care is provided, client preference, and the professional nurse judgment (Pearson et al., 2008). In concern to the context of care, it is important to emphasize that in developing countries, such as Brazil, the best practice regarding antineoplastic drug administration are not yet available to all the patients in all care settings. So, even taking notice and agreeing with guidelines from the Centers for Disease Control and Prevention (CDC, 2002), Oncology Nursing Society (Polovich et al., 2005), European Oncology Nurses Society (Wengstrom and Margulies, 2008), and many others, the use of intravenous devices, such as the steel needle-catheter, is a reality in many pediatric oncology care institutions. For that reason, we believe that the algorithms developed and validated by this study provide a comprehensive and detailed overview of the processes, both involved in the administration of antineoplastic drugs and in the interventions in case of extravasation occurrence, and are good measures to assure quality of care and provide the highest safety as possible to children undergoing chemotherapy through peripheral intravenous line in developing countries. Content validation by Brazilian and U.S. specialists Brazilian and U.S. nurses have differences that transcend geographic distance. The professional background in nursing, concepts and values inherent to the culture of each country, in addition to the different work environments, make these two groups quite different from each other. One study demonstrated that cultural and ethnical differences influence the answers from specialists involved in the content validation processes (Evans, 2004). In this study, the diversity of cultures and conditions of nursing practice between U.S. and Brazilian nurses have not affected the final result, as the answers not only were very similar but also brought validity to the proposed instruments. D.C. Chanes et al. / European Journal of Oncology Nursing 16 (2012) 17e25 Conclusion Based on the results of the present study, it is possible to conclude that there was no difference in the answers obtained from Brazilian and U.S. nurses, and that the Algorithm for Administration of Vesicant Antineoplastic Drugs in Children through Peripheral Venous Access and Algorithm of Intervention in the Occurrence of Extravasation of Antineoplastic Drugs administered through Peripheral Venous Access in Children were considered validated, according to results of a Delphi Technique. Implications for nursing practice The standardization of nursing care for children undergoing chemotherapy through peripheral lines by the use of protocols based on scientific evidence is essential when quality of care and patient safety are considered. 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