What is the evidence?

Transcription

1 Katie Snell, MSN, AGNP-C NP CARE Clinic, University of Colorado Hospital, Dept of Oncology EBP is the integration of clinical expertise, patient values, and the best research evidence into the decision making process for patient care. Clinical expertise refers to the clinician s cumulated experience, education and clinical skills. The patient brings to the encounter his or her own personal preferences and unique concerns, expectations, and values. The best research evidence is usually found in clinically relevant research that has been conducted using sound methodology. (Sackett D, 2002) Experiential knowledge Reflective practice Experience and opinions of Others Carper- 4 ways of knowing in nursing- Empirics, ethics, esthetics, personal Intuition Unknowing EBP

2 A blend of evidence, tradition and experiential practice How do you know if what you practice is based on the evidence? Is there any evidence? Fear of harming patient Understanding of pathophysiology behind treatment Totally implantable device Used for long term access and therefore a frequent choice in the infusion center Lowest rate of infection when compared to other central access devices Port infections can occur due to contamination during insertion and migration of resident epidermal flora such as staphylococcus and candida (Eisenberg, 2011) Infection can occur in the portal body or within the catheter lumen (Camp-Sorrell,2009) It is often very difficult to determine the source of infection and the cause Sterile versus clean technique Sterile or aseptic technique- use of sterile gloves, mask, sterile field, disinfect skin, use sterile saline to prime sterile non coring port needle, no touch technique (Baumgartner et al, 2007) Clean procedure- non sterile gloves, clean field, disinfect skin, use prefilled saline syringe to prime sterile non coring port needle, no touch technique (Camp-Sorrell, 2009) What is the evidence? CDC Scrub port site with chlorhexidine and use sterile device 1A. Clean or sterile gloves INS standards aseptic technique when accessing port, use of mask is recommended but unresolved due to lack of research D National EB guidelines UK- Aseptic technique should be used for any procedure that breeches the body s natural defense (Loveday et al, 2014). D ONS Recommendation- Although evidence does not exist to support sterile maintenance procedures for specialty access devices (e.g. access to CSF), expert opinion and sound nursing judgment supports use of sterile technique when accessing these devices, as life-threatening infection could occur (Cope, 2011). No PEP guidelines Rinke et al, (2012)- Studies advocating sterile techniques when accessing ports are inconclusive- peds Bard access systems aseptic technique ASCO- In 2003 and 2006, the American Society of Clinical Oncology (ASCO) convened an expert panel to develop guidelines for VAD maintenance and care (including port access and deaccess) and management of complications. To date, the panel has not been able to develop guidelines based on current data. Thus, ASCO has not recommended sterile technique Schulmeister (1987) evaluated non sterile v sterile gloves for port access. 40 venous ports randomly assigned to gloved or non gloved procedure. No infection rate in either group Camp- Sorrell (2009)- Clean technique used to access ports in rural hem- onc clinic over 1 year period. Chart review showed of 62 patients, six developed port infection. However, patients had co morbidities that may have caused infection including cellulitis, infected sutures and neutropenic fevers Hemsworth et al (2007)- Non sterile gloves worn during 36 month prospective study on oncology peds unit in UK. Not exclusively port access. NO difference in infection rates

3 Cost saving- sterile technique is more expensive Time saving- sterile technique takes longer to set up Patient satisfaction? How do you really achieve a sterile field in an open infusion area? Very few randomized clinical trials- based on experience and expert consensus. Every facility is different and not based on facts (Conley, 2015) 30 second scrub is EBP, nothing else is! To date, no satisfactory studies have examined a relationship between wearing sterile gloves and prevention of infection in central lines- ritualistic not EBP (Hemsworth et al, 2007) Sterile technique during insertion has proven benefits, is this why recommendations still advocate sterile technique when accessing? (Eisenberg, 2011). Randomized clinical trials are needed Is there enough evidence to support change in practice? Change in culture We all give drugs in a particular order Why? Evidence or experience? A common misconception is that agents have been tested as part of a regimen Most commonly used sequences for multi drugs based on how it was done in clinical trials Some sequences based on pharmacology Sequencing rarely affects efficacy but can cause toxicity Affects repair of cancer cells Synergy Multi drug regimens Additive effects of individual drugs when combined Single agents have not increased cure rate Based on common sense and clinical practice- Vesicant-irritant-non vesicant Monoclonal antibody first- deal with reaction early. (Conflicting evidence in R-CHOPP) Evidence based interventions- Avastin first- more effective chemo delivery Pay your taxes first!! If platinum's given first there is 33% reduction in Taxol clearance causing increased myelosuppression

4 First agent Second agent Sequence benefit 5FU MTX Better response and survival rates Cisplatin Irinotecan Better response rate, less toxicity Cytoxan Paclitaxel Less cytopenias Taxotere Vinorelbine Decreased neutropenia Taxotere Topotecan Decreased neutropenia, reverse sequence causes a 50% reduction in taxotere clearance Doxorubicin Paclitaxel Reversed sequence leads to decreased clearance of doxorubicin leading to myelosuppression and mucositis Doxorubicin Docetaxel Less grade 4 neutropenia Epirubicin Paclitaxel Reversed sequence leads to decreased clearance of epirubicin leading to myelosuppression and mucositis Fludarabine Cytarabine Enhances efficacy Gemcitabine Cisplatin Increases effect of Cisplatin and lessens neutropenia, less toxic Ifosfamide Docetaxel Less myelosuppression Irinotecan 5FU Additive efficacy, less diarrhea and neutropenia Leucovorin 5FU Stabilizes thymidylate synthase increase 5FU cytotoxicity and efficacy MTX Leucovorin Leucovorin rescues cells after MTX administered to reduce toxicity. If leucovorin given first, it decreases efficacy of MTX What infusions do you titrate? Is this evidence based practice? Why do you titrate? Should you titrate every infusion? Paclitaxel Cisplatin Less neutropenia Paclitaxel Gemcitabine Synergy, less risk of hepatotoxicity Pemetrexed Gemcitabine Most efficacious, less toxic Topotecan Carboplatin Less risk of neutropenia and thrombocytopenia Topotecan Cisplatin Less risk of neutropenia and thrombocytopenia Definition: a disorder characterized by adverse reaction to the infusion of pharmacological or biological substances Taxanes- 44% minor reactions, 1.5-3% major anaphylaxis. 95% of all taxane reactions are with dose 1 and are rapid onset Monoclonal antibodies-77% of patients react to dose 1, but rarely grade 3-4 reaction Platinums- 27% incidence in patients receiving 7 or more infusions, 1.5-3% in less than 7 3 Types: Hypersensitivity- IgE antibodies produced in response to foreign body. Bind to receptors on mast cells and basophils With subsequent infusions the IgE antibodies react to known antigens causing histamine release Platinums Anaphylactoid Immediate effect Directly affects immune cells causing histamine release Occurs with first or second infusion, progresses rapidly Taxanes Cytokine release Produced by T cells during inflammatory response to non human part of monoclonal antibody Cytokines act as messengers and coordinate immune and inflammatory response Monoclonal antibodies

5 Know what you are giving and the risk of reaction Know what kind of reaction you may see Thorough patient history- prior reactions to current meds and any others. Allergy history, asthma, atopic history, iodine, shellfish allergy, female. High lymphocyte count (>25,000) Test dosing is unreliable and not based on evidence Standard pre medication regimen Patient education Anaphylactoid type reaction Immediate onset Reaction to cremaphor (castor oil and ethanol) There is no evidence to support or refute titration Common sense- if someone may react, go slow so they get less drug. Titrating past dose 2 is not necessary Dexamethasone PO 12 and 6 hours prior to treatment is superior to IV dexamethasone 30 min prior Gently invert Taxol bag prior to hanging Pre medications Decadron- stabilizes mast cell membranes and prevents degranulation H1 blockers- Blocks binding of histamine to H1 receptors on target cells H2 blockers- stops cells from responding to histaminereduces mucous secretion and vascular smooth muscle relaxation Tylenol- Antipyretic Reaction medications Epinephrine- drug of choice for anaphylaxis, rarely used. ROA, no contraindications H1, H2 blockers- slow onset Bronchodilators Corticosteroids- decrease duration and prevents biphasic reactions IV fluids, Dopamine Rituxan can safely be given Over 90 mins if no or Minimal reaction to dose 1 EBP- RATE trial 2012 Approved by FDA At present only approved in NHL/Follicular lymphoma. Plan for CLL and non heme conditions No CV disease, lymphocyte count less than 5000 Dose 2 onwards- 20% over 30 min, 80% over 1 hour Usually given in less volume Patient satisfaction

6 Used frequently in infusion centers for Crohns, Colitis, rheumatiod arthritis Increasingly used to treat side effects of immunotherapy Anti TNF monoclonal antibody Manufacturers recommend 2 hour titrated infusion with each dose- 20cc/hr x 5cc, 40cc/hr x 10cc, 80cc/hr x 20cc, 160cc/hr x 40cc and 250cc x remainder Studies performed in IBD and RA. No change in infusion reactions if given rapidly Protocols recommend doses 1-4 over 2 hours, 5-10 over 1 hour, then 30 mins thereafter Pre medication not universal What is your burning question?? Consider undertaking evidence based practice projects in your infusion center You have a captive audience, use them! Ask why? Review literature and stay up to date Question own practice Question MD orders and standardized protocols Use drug companies, they can provide literature Librarian, Nursing research councils