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Annals of Internal Medicine SUPPLEMENT The Michigan Appropriateness Guide for Intravenous Catheters (MAGIC): Results From a Multispecialty Panel Using the RAND/UCLA Appropriateness Method Vineet Chopra,
Annals of Internal Medicine SUPPLEMENT The Michigan Appropriateness Guide for Intravenous Catheters (MAGIC): Results From a Multispecialty Panel Using the RAND/UCLA Appropriateness Method Vineet Chopra, MD, MSc; Scott A. Flanders, MD; Sanjay Saint, MD, MPH; Scott C. Woller, MD; Naomi P. O Grady, MD; Nasia Safdar, MD, PhD; Scott O. Trerotola, MD; Rajiv Saran, MD, PhD; Nancy Moureau, BSN, RN; Stephen Wiseman, PharmD; Mauro Pittiruti, MD; Elie A. Akl, MD, MPH, PhD; Agnes Y. Lee, MD, MSc; Anthony Courey, MD; Lakshmi Swaminathan, MD; Jack LeDonne, MD; Carol Becker, MHSA; Sarah L. Krein, PhD, RN; and Steven J. Bernstein, MD, MPH Use of peripherally inserted central catheters (PICCs) has grown substantially in recent years. Increasing use has led to the realization that PICCs are associated with important complications, including thrombosis and infection. Moreover, some PICCs may not be placed for clinically valid reasons. Defining appropriate indications for insertion, maintenance, and care of PICCs is thus important for patient safety. An international panel was convened that applied the RAND/ UCLA Appropriateness Method to develop criteria for use of PICCs. After systematic reviews of the literature, scenarios related to PICC use, care, and maintenance were developed according to patient population (for example, general hospitalized, critically ill, cancer, kidney disease), indication for insertion (infusion of peripherally compatible infusates vs. vesicants), and duration of use ( 5 days, 6 to 14 days, 15 to 30 days, or 31 days). Within each scenario, appropriateness of PICC use was compared with that of other venous access devices. After review of 665 scenarios, 253 (38%) were rated as appropriate, 124 (19%) as neutral/uncertain, and 288 (43%) as inappropriate. For peripherally compatible infusions, PICC use was rated as inappropriate when the proposed duration of use was 5 or fewer days. Midline catheters and ultrasonography-guided peripheral intravenous catheters were preferred to PICCs for use between 6 and 14 days. In critically ill patients, nontunneled central venous catheters were preferred over PICCs when 14 or fewer days of use were likely. In patients with cancer, PICCs were rated as appropriate for irritant or vesicant infusion, regardless of duration. The panel of experts used a validated method to develop appropriate indications for PICC use across patient populations. These criteria can be used to improve care, inform quality improvement efforts, and advance the safety of medical patients. Ann Intern Med. 2015;163:S1-S39. doi: /m For author affiliations, see end of text. Reliable venous access is a cornerstone of safe and effective care of hospitalized patients. Spurred by technological advances, several venous access devices (VADs) for use during and beyond hospitalization are available to meet this need. In recent years, peripherally inserted central catheters (PICCs) have become popular for venous access in hospital settings (1, 2). Compared with traditional central venous catheters (CVCs), PICCs offer several advantages, including safer insertion in the arm, cost-effective and convenient placement via vascular access nursing teams, and selfcare compatibility that facilitates use beyond hospitalization (3 5). It is therefore not surprising that use of PICCs has grown considerably worldwide (6 8). Despite these advantages, PICCs are central venous catheters that may lead to important complications (9). For instance, problems such as luminal occlusion, malpositioning, and dislodgement occur frequently with these devices (10 12). Similarly, superficial thrombophlebitis or infection at the site of PICC insertion may occur despite uneventful and optimal placement (13, 14). In addition, PICCs are associated with morbid complications, including venous thromboembolism and central line associated bloodstream infection (15 17). Ensuring appropriate use of PICCs is thus vital to preventing these costly and potentially fatal adverse events. A growing number of studies suggest substantial variation and potentially inappropriate use of PICCs in hospitalized patients. For example, in a from a large academic medical center, many PICCs were not actively used or were inserted in patients who also had peripheral intravenous catheters (18). In a decade-long conducted in a tertiary hospital, changes in patterns of PICC use, including shorter dwell times and ambiguous indications for insertion, were reported (19). Additional cause for concern comes from a recent, which found that 1 in 5 inpatient providers did not know that their patients had CVCs, with lack of awareness being greatest for PICCs (20). Surveys of inpatient providers have also demonstrated knowledge gaps related to appropriate indications and care practices for PICCs (21, 22). Collectively, these data have not only led to reviews of PICC use in hospitals (23) but also to calls by the Choosing Wisely initiative to improve PICC practices across the United States (24, 25). The concepts of inappropriate overuse and underuse of medical devices are by no means unique to PICCs. Rather, such issues accompany the diffusion of many novel health technologies. In many such instances, a key barrier to achieving appropriate use is See also: Web-Only Supplement CME quiz MOC activity Annals of Internal Medicine Vol. 163 No. 6 (Supplement) 15 September 2015 S1 SUPPLEMENT Michigan Appropriateness Guide for Intravenous Catheters (MAGIC) the fact that evidence at a level of detail needed to apply to the range of patients seen in everyday practice is not available. Nevertheless, clinicians must make choices regarding such innovations on a daily basis, potentially fueling inconsistent practice. In the absence of high-quality evidence, an approach that combines available data with the experience and insight of clinical experts is valuable as it would provide guidance where none is otherwise available. Given this background, we organized and conducted a multidisciplinary meeting of national and international experts to develop appropriateness criteria for use, care, and management of PICCs and related VADs in hospitalized patients. Our objectives were to 1) develop a list of appropriate indications for use of PICCs in relation to other VADs, 2) define the appropriateness of practices associated with the insertion and care of PICCs, 3) determine appropriate practices for treatment and prevention of PICC complications, and 4) rate the appropriateness of peripheral intravenous catheter use in situations that prompt PICC placement. METHODS Overview of the RAND/UCLA Appropriateness Method We used the RAND Corporation/University of California Los Angeles (RAND/UCLA) Appropriateness Method to create criteria for appropriate use of PICCs and related VADs (10). Introduced in the 1980s, the RAND/UCLA method was developed to enable measurement of overuse of medical and surgical procedures. According to this methodology, a procedure is considered appropriate when the expected health benefits (e.g., increased life expectancy, relief of pain, reduction of anxiety or pain) exceed the expected negative consequences (e.g., mortality, morbidity, anxiety, pain) by a sufficiently wide margin such that the procedure is worth doing, exclusive of cost. The approach has thus been applied to an array of procedures, including coronary angiography (26), surgical procedures (27, 28), cataract removal (29), and transplant organ allocation (30). Recently, the method was also used to develop criteria for appropriate use of urinary catheters in hospitalized patients (31). The RAND/UCLA method was particularly valuable for developing PICC appropriateness criteria for several reasons. First, the approach allowed the synthesis of the best available evidence with practice-based, domain-specific insights from experts. This unique combination ensured both clinical relevance and evidentiary support for the developed recommendations. Second, unlike other group-rating methods, the focus of the RAND/UCLA approach is not to ensure consensus, but minimize artifactual disagreement that may arise from misunderstanding of scenarios being rated. This nuance is highly relevant in the case of PICCs, because available evidence is derived from heterogeneous designs (for example, retrospective, case control studies and randomized trials), populations (for example, critically ill, cancer), and clinical specialties (nursing, radiology, medical or surgical disciplines) and is thus prone to misinterpretation. Because the RAND/ UCLA method pairs clear instructions and precise clinical definitions with a systematic, reliable, and reproducible rating system (27), the recommendations generated will have high internal validity. Finally, should clinical scenarios lack sufficient detail to make an informed judgment regarding appropriateness, the RAND/UCLA method encourages clarification by panelists so as to make ratings more relevant and precise. In this fashion, generalizability and external validity of the developed appropriateness indications are also ensured. Proper conduct of the RAND/UCLA Appropriateness Method requires the sequential performance of several steps, including information synthesis, panelist selection, creation of scenarios, rating process, and analysis of results. Information Synthesis The first step of the RAND/UCLA Appropriateness Method is to systematically review and synthesize the available literature. With the assistance of 2 research librarians, we searched for English-language articles (between 12 November 2012 and 1 July 2013) by using the following databases: MEDLINE via Ovid (1950 to present), EMBASE (1946 to present), BIOSIS (1926 to present), and the Cochrane Central Register of Controlled Trials via Ovid (1960 to present). The search strategy incorporated Boolean logic, controlled vocabularies (for example, Medical Subject Heading terms) and free-text words. Because the panel was focused on determining the appropriateness of PICC use in hospitalized adults, articles that included only pediatric patients or devices not comparable with PICCs (for example, arterial or hemodialysis catheters) were excluded. We also included relevant guidelines, such as the Infusion Nursing Society Standards of Practice (32), Centers for Disease Control and Prevention/Healthcare Infection Control Practices Advisory Committee central line associated bloodstream infection prevention guidelines (33), American Society of Anesthesiology Task Force on Central Venous Access (34), American College of Chest Physicians Antithrombotic Therapy and Prevention of Thrombosis Guidelines (35), and International Clinical Practice Guidelines for the Treatment and Prophylaxis of Thrombosis Associated With Central Venous Catheters in Patients With Cancer (36). All retrieved articles were independently scanned for eligibility by 2 of the authors. Disagreements on eligibility were resolved by consensus, and a final list of eligible studies and tables summarizing the evidence were created. The search strategy is provided in Appendix Table 1 (available at ), and Table 1 (on page S25) summarizes the included articles. Participant and Panelist Selection Viewpoints related to PICC use are known to vary across specialties; thus, what may be appropriate in one field may not be appropriate in another. To foster discussions about these issues, specialists representing vascular access nursing, hospital-based medicine, inter- S2 Annals of Internal Medicine Vol. 163 No. 6 (Supplement) 15 September 2015 Michigan Appropriateness Guide for Intravenous Catheters (MAGIC) SUPPLEMENT nal medicine, infectious disease, critical care, nephrology, hematology/oncology, pharmacy, surgery, and interventional radiology were considered necessary to ensure representativeness of the panel. Leading national and international experts from each of these professions who are eminent scholars or researchers, represent relevant medical societies, or have substantial clinical experience in the field were invited to participate. To ensure that deliberations took into account patient-centered viewpoints, we also invited a patient to participate on our panel. We recognized that the ideal patient had to be able to speak about experiences with PICCs and related VADs. We recruited such a patient from our university practice in Ann Arbor, Michigan. Owing to the scientific nature of the material, however, the patient panelist did not rate scenarios and instead contributed to panelist discussions. Through this process, 15 multispecialty panelists were recruited to develop the Michigan Appropriateness Guide for Intravenous Catheters (MAGIC) (Appendix Table 2, available at ). Creation of Scenarios On the basis of articles found through the systematic literature searches, we created clinical scenarios to rate the appropriateness of insertion, maintenance, and care of PICCs. To accurately reflect clinical decision making, devices, including peripheral intravenous catheters, ultrasonography-guided peripheral intravenous catheters, midline catheters, nontunneled CVCs, tunneled CVCs, and ports, were compared with PICCs (Figure 1). Scenarios were crafted so as to allow judgment of real-world use of PICCs; thus, areas of consensus, controversy, and ambiguity were purposefully included. To further ensure validity, we asked each expert to provide a list of concerns related to PICC use that were most relevant to their practice (Appendix Table 3, available at ). If not already represented, these issues were also incorporated into scenarios of appropriateness. We developed a conceptual framework to ensure that scientific content, clinical indications, relevant VADs, and contextual factors were adequately represented when drafting scenarios (Figure 2). Thus, indications for PICC insertion were systematically categorized into 1) duration of venous access ( 5 days, 6 to 14 days, 15 to 30 days, 31 days); 2) type of infusate (for example, irritants or vesicants, including parenteral nutrition and chemotherapy); and 3) use for specific reasons, such as frequent obtaining of blood samples, poor or difficult venous access, and continuation of intravenous therapies in the outpatient setting. For each of these instances, clinical scenarios incorporating 1) patientspecific factors (for example, critical illness, cancer diagnosis, stage of chronic kidney disease [CKD]), 2) device-specific factors (number of lumens, gauge, type of PICC, alternative VADs), and 3) provider-specific factors (the operator inserting the PICC, technique for PICC insertion) were created. In addition, scenarios regarding appropriate practices for care, management, and treatment of PICC complications were written. Finally, because lack of peripheral access often prompts PICC use for specific clinical needs (for example, need for contrast-based studies or blood transfusion), scenarios related to use of peripheral intravenous catheter in such settings were created. We pilot-tested all scenarios with 2 hospitalmedicine physicians and further edited them for content and clarity on the basis of their feedback. In this manner, 665 scenarios and 391 unique indications for PICCs and related VADs were developed. Rating Process Rating of scenarios and indications were conducted over 2 rounds. In round 1, each panelist received the literature review, definitions of all terms used, a rating document, and instructions for rating. Panelists were asked to dedicate at least 4 hours to complete the rating document. In accordance with the RAND/UCLA method, panelists were instructed not to consider cost when making judgments; rather, they were asked to use the available scientific evidence and best clinical judgment in rating appropriateness (Supplement, available at ). To ensure that appropriateness was rated exclusive of confounding circumstances (such as specialist availability), panelists were also instructed to assume availability of all resources related to the scenarios. For each indication, panel members rated appropriateness by considering the benefit harm ratio on a scale of 1 to 9, where 1 indicated that harms outweigh benefit and 9 signified that benefits outweigh harm; Appendix Table 4 (available at ) provides examples of this process. A middle rating of 5 signified that harms or benefits were equal, or that the rater could not make an informed judgment on the indication. For a series of indications where 2 devices were appropriate, we asked panelists to rate preference for use of one device compared with the other, regardless of cost. Median ratings on opposite ends of the scale (for example, 1 to 3 or 7 to 9) were used to indicate preference of one device over another; a rating in the range of 4 to 6 suggested no preference. Each panelist rated every scenario twice in a 2-round, modified Delphi process. In the first round, ratings were made individually and no interaction between panelists occurred. In the second round, panel members traveled to Ann Arbor, Michigan, for an inperson meeting where individualized documents showing their ratings along with the distribution of all firstround ratings of the panel were provided. Over 2 days, a RAND/UCLA methodology expert and a scientific content expert moderated a panel discussion of all indications and scenarios. The sessions were structured to encourage debate and discussion specifically about ratings where disagreement (opposite ratings) or neutrality/uncertainty (ratings of 4 to 6) occurred in round 1. For instance, it often became apparent in the second round that panelists had disagreed not on the indication, but on the patient or circumstances being considered because of inherent assumptions, specialty-specific views, or ambiguity in Annals of Internal Medicine Vol. 163 No. 6 (Supplement) 15 September 2015 S3 SUPPLEMENT Michigan Appropriateness Guide for Intravenous Catheters (MAGIC) Figure 1. Vascular access devices reviewed to formulate appropriateness ratings. A. Peripheral IV Catheter D. Nontunneled Central Venous Catheter B. US-Guided Peripheral IV Catheter G. Peripherally Inserted Central Catheter E. Tunneled Central Venous Catheter C. Midline Catheter F. Implanted Port IV = intravenous; US = ultrasonography. A. Peripheral IV catheter. These devices are typically 3 to 6 cm, enter and terminate in the peripheral veins (cross-section), and are often placed in the upper extremity in veins of the hand. B. US-guided peripheral IV catheter. Ultrasonography may be used to facilitate placement of peripheral intravenous catheters in arm veins that are difficult to palpate or visualize. Long peripheral IV catheters (typically 8 cm) that are specifically designed to reach deeper veins are also available for insertion under US guidance. C. Midline catheter. These devices are 7.5 to 25 cm in length and are typically inserted in veins above the antecubital fossa. The catheter tip resides in the basilic or cephalic vein, terminating just short of the subclavian vein. These devices cannot accommodate irritant or vesicant infusions. D. Nontunneled central venous catheter. Also referred to as acute or short-term central venous catheters, these are often inserted for durations of 7 to 14 d. They are typically 15 to 25 cm and are placed via direct puncture and cannulation of the internal jugular, subclavian, or femoral veins. E. Tunneled central venous catheter. These differ from nontunneled catheters in that the insertion site on the skin and site of ultimate venipuncture are physically separated, often by several centimeters, reducing the risk for bacterial entry into the bloodstream and facilitating optimal location of the catheter for care of the exit site. Tunneled devices may be cuffed or noncuffed; the former devices have a polyethylene or silicone flange that anchors the catheter within the subcutaneous tissue and limits entry of bacteria along the extraluminal surface of the device. F. Implanted port. Port
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