Presenters. Show Me the Evidence: Finding, Understanding and Presenting the Data. What is Evidence???

Transcription

1 Presenters Show Me the Evidence: Finding, Understanding and Presenting the Data Barbara Lubejko, RN, MS Project Manager, Education Team Mark Vrabel, MLS, AHIP Information Resources Supervisor Linda Lillington, RN, DNSc Research Associate Goals for This Presentation By the end of this session, the learner will be able to: Outline resources and methods that can be utilized to search for evidence on a topic of interest. Discuss the process involved in critiquing and summarizing the evidence. Describe how the ONS Evidence-Based Education Guidelines can be used to more explicitly integrate evidence into presentations. Evidence Based Practice Evidence Based Practice (EBP) defines care that integrates best scientific evidence with clinical expertise, knowledge of pathophysiology, knowledge of psychosocial issues, and decision making preferences of patients. Rutledge, D.N. & Grant, M. (2002). Introduction. Seminars in Oncology Nursing, 18(1), 1-2. Clinical Experience Patient Values and Preferences The Next Step Review of the literature for evidence What is Evidence??? Wide variety of data or information that ranges from randomized clinical trials as the highest level of research evidence to expert opinion as the lowest level of non-research evidence. Oncology Nursing Society (2003). Evidence Based Education Guidelines. Retrieved December 6, 2006 from 1

2 What is Evidence??? ONS Levels of Evidence Research Meta-analysis of controlled trials Experimental studies Systematic reviews of all types of evidence Multiple nonexperimental studies Evidence based practice guidelines Non-Research Case studies Program evaluation or quality improvement data Case reports Expert opinions standards of practice Oncology Nursing Society (2003). Evidence Based Education Guidelines. Retrieved December 6, 2006 from Why is it important to put evidence into presentations??? ONS Evidence Based Practice Imperative Strategic Goal: Drive quality cancer care through education, research, leadership, and advocacy. Oncology nursing practice based on appropriate and current evidence. Imperative for oncology nurses to be able to locate, evaluate, articulate and apply evidence to their practice settings. ONS Evidence-Based Education Guidelines Support the integration of evidence into practice Establish minimum standards Apply to ONS sponsored educational events Identify resources/strategies Facilitate the explicit incorporation of evidence Evidence Based Education Guidelines Speaker Expectations Will: Direct you to resources to help you find, critique and rank evidence Give presentation tips Give formatting tips Outline the expectations ONS has for presenters Incorporate pertinent evidence into presentations Make clear reference to current evidence Identify the type and strength of evidence Focus on application of current evidence to practice and implications for practice changes Clearly cited on slides, handouts, and reference lists Based on assumption that speakers will search for, critique and rank the current evidence 2

3 Evidence Based Practice Process Identify a clinical question or problem Find the evidence Appraise the evidence Summarize the evidence Recommend appropriate practice changes ONS Evidence-Based Practice Resources Area Resources to assist you in: Finding the evidence Critiquing the evidence Appraising the evidence Screen captures of what s in EBP Resource Area Finding the Evidence Mark Vrabel, MLS, AHIP Information Resources Supervisor 3

4 Source Credit Formulating the Clinical Question Note: Material from several of the ensuing slides is adapted from the content of Evidence-Based Medicine and the Medical Librarian, an online course from the School of Information and Library Science at UNC-Chapel Hill ( The well-built clinical question begins with the following parameters and formulates an answerable question from them. Using this PICO approach, the structure of the question might look like this: In patients with [PROBLEM] does [INTERVENTION] or [COMPARISON, if any] affect [OUTCOME]? For example: In patients with cancer, what nursing interventions are effective in reducing fatigue? First Steps Formulating the Search Strategy Formulating a well-built clinical question before searching Using databases and resources that cover the medical and nursing literature (PubMed, MEDLINE, CINAHL, Cochrane, etc.) Engaging in effective searching skills retrieving the most topically relevant citations and limiting to systematic reviews, RCTs, etc. 1. Construct the question 2. Select the best resource (see handout) 3. Formulate the search strategy Search each concept separately Use subject headings whenever possible Use text words and truncation ( nurs$ for nurse, nurses, nursing, etc.) appropriately Use Boolean logic (AND, OR, NOT) to combine terms Use limiting features of the database 4. Review the retrieval If relevant, evaluate the studies If irrelevant, review the question, or try another database, or revise the search strategy Construct the Question Select the Best Resource In patients with cancer, what nursing interventions are effective in reducing fatigue? Note: This question will serve as the example for all ensuing database search strategies. Please consult the Evidence-Based Practice Resources handout for a more extensive listing of Websites and databases This session will focus on four databases: CINAHL - Cumulative Index to Nursing & Allied Health Literature MEDLINE - Medical Literature, Analysis, and Retrieval System Online Cochrane Database of Systematic Reviews PubMed 4

5 CINAHL CINAHL (cont.) The Cumulative Index to Nursing & Allied Health Literature (CINAHL) database provides authoritative coverage of the literature related to nursing and allied health More than 1,200 journals are regularly indexed The database also provides access to healthcare books, nursing dissertations, selected conference proceedings, standards of professional practice, educational software, and audiovisual materials in nursing It is accessible via aggregators such as Ovid, EBSCO, and SilverPlatter, or by the CINAHLdirect online service (as of 2006, CINAHLdirect is an ANA member benefit) There are more than 10,000 CINAHL subject headings CINAHL (cont.) CINAHL (cont.) For the oncology nurse seeking reviews on nursing interventions for fatigue: Using Ovid: Type fatigue in the query box, making sure Map Term to Subject Heading is checked CINAHL (cont.) CINAHL (cont.) 5

6 CINAHL (cont.) CINAHL (cont.) For the Fatigue subject heading the narrower term Cancer Fatigue would be useful but Fatigue Syndrome, Chronic would not The nursing subheading may be applied ( Fatigue/nu[nursing] or Cancer Fatigue/nu[nursing] ) Using the Combine icon, combine those sets of citations with other subject headings such as Nursing Interventions or the exploded term Professional Practice, Evidence-Based CINAHL (cont.) CINAHL (cont.) This will retrieve citations to articles such as the following two from the Oncology Nursing Forum: Stricker CT. Drake D. Hoyer K. Mock V. Evidence-based practice for fatigue management in adults with cancer: exercise as an intervention. [Journal Article, CEU, Exam Questions, Research, Systematic Review, Tables/Charts] Oncology Nursing Forum Sep; 31(5): (57 ref) Given B. Given CW. McCorkle R. Kozachik S. Cimprich B. Rahbar MH. Wojcik C. Pain and fatigue management: results of a nursing randomized clinical trial. [Journal Article, Clinical Trial, Research, Tables/Charts] Oncology Nursing Forum Jul; 29(6): (42 ref) Evidence Pyramid Type of Evidence: ONS Levels of Evidence Check for most current version ONS Level Level of Evidence Subcategory Evidence Source Strength of Evidence Research Based Strongest I 1 Meta analysis or systematic reviews of multiple well designed, randomized, controlled clinical trials 2 Well-controlled, randomized clinical trials with adequate sample size 3 Well-designed trial without randomization II 4 Well-conducted, systematic review of non-experimental design studies 5 Well-conducted case control study 6 Poorly controlled studies (flawed randomized studies) Uncontrolled studies (correlational descriptive studies 7 Conflicting evidence or meta-analysis showing a trend that did not reach significance National Institutes of Health Consensus Report Published practice guidelines, for example by professional organizations, healthcare organizations, or federal agencies Source: III 8 Non-Research Based Qualitative designs, case studies, opinions of expert authorities, agencies or committees Weakest 6

7 Limiting the Search Results Limiting the Search Results (cont.) As interventions for cancer fatigue would be a treatment-related question, attempting to first locate a systematic review or meta-analysis the top level is a good starting point when engaging in EBP Limiting the Search Results (cont.) Filters Use the Publication Types limit option to choose Systematic Review this will retrieve citations such as the following (in addition to the ONF article from the earlier slide): Visovsky C. Schneider SM. Cancer-related fatigue. [Journal Article, Research, Systematic Review, Tables/Charts] Online Journal of Issues in Nursing Sep 30; 8(3): 17p. (98 ref) Note: This article is freely available at A wide variety of subject headings, publication types, and text words can potentially identify integrated reviews, guidelines, and other types of best evidence For example, the British Columbia Office of Health Technology Assessment Centre for Health Services and Policy Research created a MEDLINE search strategy that identifies 110 different alternative names for clinical guidelines Filters (cont.) Evidence-based Filter for Ovid CINAHL: Meta analysis Because of this, filters or search hedges have been created for each of the types of clinical questions (diagnosis, therapy, meta-analysis, etc.) Consult the Evidence-based Filters for Ovid CINAHL from the University of Rochester Medical Center Library at _library/tip_sheets/cinahl_eb_filters.pdf CINMETA Meta analysis 1. meta-analysis/ 2. literature review/ 3. exp literature searching/ 4. systematic review.pt. 5. practice guidelines.pt. 6. nursing interventions.pt. 7. (care plan or critical path or protocol).pt. 8. (metaanaly$ or meta analy$).tw. 9. metanaly$.tw. 10. ((systematic or quantitative or methodologic$) adj (overview$ or review$)).tw. 11. integrative research review$.tw. 12. research integration.tw. 13. (handsearch$ or ((hand or manual) adj search$).tw. 14. mantel haenszel.tw. 15. peto.tw. 16. fixed effect$.tw. 17. (medline or cinahl or psyc?info or psyc?lit or embase).tw. 18. (scisearch or science citation or isi citation or web of science).tw. 19. (dersimonian or der simonian).tw. 20. (pooled adj data).tw. 21. or/1-20 7

8 MEDLINE MEDLINE (cont.) MEDLINE is the U.S. National Library of Medicine's (NLM) premier bibliographic database covering the fields of medicine, nursing, dentistry, veterinary medicine, the healthcare system, and the preclinical sciences It contains bibliographic citations from more than 4,600 biomedical journals published in the United States and 70 other countries. The file contains more than 11 million citations dating back to the mid-1960s It is accessible via aggregators such as Ovid, EBSCO, and SilverPlatter, or via PubMed at MEDLINE uses Medical Subject Headings (MeSH ) (for complete information go to MEDLINE (cont.) MEDLINE (cont.) MeSH contains more than 19,000 main headings These subject headings are not identical to CINAHL subject headings; for example, CINAHL contains a subject heading for Cancer Fatigue but MEDLINE does not (in MEDLINE, the more general Fatigue MeSH term would be assigned to articles on cancer-related fatigue, although it may include a subheading like Fatigue/chemically induced ) For the oncology nurse seeking reviews on nursing interventions for fatigue: Using Ovid: Type fatigue in the query box, making sure Map Term to Subject Heading is checked Limiting the Search Results Limiting the Search Results (cont.) A variety of different limits may be applied; for example: Cancer as a subject subset Nursing Journals as a journal subset Meta analysis or Randomized Controlled Trial as a publication type 8

9 Limiting the Search Results (cont.) Limiting the Search Results (cont.) This will retrieve citations to articles such as the following two from the Oncology Nursing Forum: Sherwood P. Given BA. Given CW. Champion VL. Doorenbos AZ. Azzouz F. Kozachik S. Wagler-Ziner K. Monahan PO. A cognitive behavioral intervention for symptom management in patients with advanced cancer. [Journal Article. Randomized Controlled Trial] Oncology Nursing Forum. Online. 32(6):1190-8, 2005 Nov. It will also retrieve the following article previously retrieved in CINAHL: Given B. Given CW. McCorkle R. Kozachik S. Cimprich B. Rahbar MH. Wojcik C. Pain and fatigue management: results of a nursing randomized clinical trial. [Clinical Trial. Journal Article. Randomized Controlled Trial] Oncology Nursing Forum. Online. 29(6):949-56, 2002 Jul. Headley JA. Ownby KK. John LD. The effect of seated exercise on fatigue and quality of life in women with advanced breast cancer. [Clinical Trial. Journal Article. Randomized Controlled Trial] Oncology Nursing Forum. Online. 31(5):977-83, 2004 Sep. Filters Filters are available for MEDLINE Consult the Evidence-based Filters for Ovid MEDLINE from the University of Rochester Medical Center Library at gital_library/tip_sheets/ovid_eb_filters.pdf Evidence-based Filter for Ovid MEDLINE: Meta-analysis Medline - Meta-analysis 1 meta-analysis/ 2 meta-analysis.pt. 3 meta medline.ti,ab. 4 (metaanaly$ or (meta adj analy$5)).ti,ab. 5 overview$1.ti,ab. 6 clinical trial.pt. 7 systematic review$.ti.ab. 8 multicenter study.pt. 9 review.pt. 10 or/1-9 Cochrane Collaboration Cochrane (cont.) The Cochrane Collaboration is an international organization that aims to help people make well-informed decisions about healthcare by preparing, maintaining and promoting the accessibility of systematic reviews of the effects of interventions One study concluded that Cochrane reviews are more rigorous and better reported than those published in peer reviewed journals. Source: Jadad, A.R., Moher, M., Browman, G.P., Booker, L., Sigouin, C., Fuentes, M., et al. (2000). Systematic reviews and meta-analyses on treatment of asthma: Critical evaluation. BMJ, 320,

10 Cochrane (cont.) Cochrane (cont.) Another study found that Cochrane reviews were less likely to show evidence of publication bias compared to systematic reviews published in major print journals. Source: Egger, M., Davey Smith, G., Schneider, M., & Minder, C. (1997). Bias in meta-analysis detected by a simple, graphical test. BMJ, 315, Cochrane is useful for determining effectiveness of interventions, therapies, and treatments; for example, What strategies for smoking cessation are most effective? Cochrane is not useful for questions relating to the diagnosis, prognosis, epidemiology or risk factors for illness or disease Cochrane (cont.) Cochrane (cont.) Searching is by text word only, but the search can be restricted to certain fields such as title Since not all reviews are assigned MeSH headings, searching is not as easily refined as in MEDLINE Boolean searching is permitted (AND, OR, NOT) In the Cochrane Database of Systematic Reviews, a search of cancer AND fatigue in the title field will retrieve the following citation (still in the protocol stage: Note [Protocol] rather than [Systematic Review] ): Cramp, F. Prue, G. Gracey, J. Exercise for treatment of cancer related fatigue. [Protocol] Cochrane Pain, Palliative and Supportive Care Group Cochrane Database of Systematic Reviews. 3, Cochrane (cont.) Cochrane (cont.) Complete reviews regularly updated Cochrane Reviews prepared and maintained by Collaborative Review Groups will have [Systematic Review] next to the title Protocols the background, objectives, and methods of reviews currently being prepared will have [Protocol] next to the title In addition to searching via Ovid, the Cochrane Library can be searched directly at Abstracts of all reviews are freely available, but the reviews in their entirety require purchase See the next slide for the results of a cancer fatigue search when searching Title, Abstract or Keywords 10

11 Cochrane (cont.) PubMed PubMed ( is freely available and provides access to bibliographic information, including but not limited to MEDLINE The following article provides helpful strategies for identifying systematic reviews when using PubMed: Shojania, K.G., & Bero, L.A. (2001). Taking advantage of the explosion of systematic reviews: An efficient MEDLINE search strategy. Effective Clinical Practice, 4, Retrieved November 6, 2006, from PubMed Clinical Queries PubMed Clinical Queries Filters: Systematic Reviews Select the Clinical Queries option on the left-hand side of the PubMed home page in order to use various filters, such as Systematic Reviews Or go to it directly at PubMed (cont.) Limiting the Search Results A search of cancer AND fatigue AND nursing in the Find Systematic Reviews query box will retrieve citations such as the following: Stricker CT, Drake D, Hoyer KA, Mock V. Related Articles, Links Evidence-based practice for fatigue management in adults with cancer: exercise as an intervention. Oncol Nurs Forum Sep 17;31(5): Print 2004 Sep. Review. PMID: [PubMed - indexed for MEDLINE] Cope DG. Related Articles, Links Oncology Patient Evidence-Based Notes (OPEN): cancer-related fatigue. Clin J Oncol Nurs Sep-Oct;7(5): No abstract available. PMID: [PubMed - indexed for MEDLINE] Mock V. Related Articles, Links Clinical excellence through evidence-based practice: fatigue management as a model. Oncol Nurs Forum Sep-Oct;30(5): Review. No abstract available. PMID: [PubMed - indexed for MEDLINE] Like CINAHL and other databases, PubMed offers a variety of limiting options to further refine the search Some of these include: The Journal Groups subset of Nursing Journals Type of Article publication types such as Meta- Analysis or Practice Guideline or Randomized Controlled Trial See the next slide for an example of how a very general PubMed search of cancer AND fatigue can be refined using these limiting options 11

12 Limiting the Search Results (cont.) Guidelines Agency for Healthcare Research and Quality (AHRQ) Evidence Report Topics, Evidence Technical Reviews and Clinical Guidelines National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology Updated continually and based upon evaluation of scientific data integrated with expert judgment by multidisciplinary panels of experts National Guideline Clearinghouse A public resource for evidence-based clinical practice guidelines, sponsored by the Agency for Healthcare Research and Quality (AHRQ) Points to Consider Points to Consider (cont.) Remember the variations in the controlled vocabularies of CINAHL and MEDLINE; for example, the former uses Nursing Practice, Evidence-Based while the latter uses Evidence- Based Medicine (even for nursing-related articles) Practice makes perfect the best way to become familiar with the different databases is simply by using them regularly! (and always use more than one in order to ensure optimal retrieval) If possible, enlist the assistance of a librarian when conducting a search. For the ONS PEP project, librarian assistance was acknowledged in the October 2006 CJON via In addition to working with an APN, we had the good fortune of working with a medical librarian Become familiar with narrowing techniques such as Boolean terms (AND, OR, NOT), filters, etc. If you are in possession of one article, set of guidelines, etc. that is precisely what you seek, use that as a springboard to others by seeing how it is indexed in the various databases Step III: Critiquing the Evidence Critiquing and Summarizing the Evidence Linda Lillington, RN, DNSc Research Associate Our goal is to evaluate the scientific merit and potential clinical applicability of the evidence to determine what findings have a strong enough basis to be used in practice: - Merit (scientific soundness) - Feasibility (ease of application to practice) - Utility (potential impact on patient care) 12

13 Objectives: Critiquing the Evidence: Key Points Melnyk & Fineour 2005 Discuss the process involved in critiquing evidence Review tools and resources available to identify the type and strength of evidence Discuss strategies to assist in summarizing and synthesizing evidence in order to make practice recommendations Evidence-based clinical decisions are based on: Valid research evidence as the primary basis Clinical expertise which guides the use of evidence tailored to the individual patient needs Patient preferences Certainty: Clinical action will produce desired outcome Critiquing the Evidence: Where do We Begin? Type of Evidence: ONS Levels of Evidence Check for most current version ONS Level Level of Evidence Subcategory Evidence Source Strength of Evidence Identify the type of evidence Identify the level of evidence Evaluate the strength of evidence Decide whether recommendations for practice can be made based on the evidence Resources: ONS Web Site EBP Resource Area Oxford-Centre for Evidence-Based Medicine I II Research Based Meta analysis or systematic reviews of multiple well designed, randomized, controlled clinical trials Well-controlled, randomized clinical trials with adequate sample size Well-designed trial without randomization Well-conducted, systematic review of non-experimental design studies Well-conducted case control study Poorly controlled studies (flawed randomized studies) Uncontrolled studies (correlational descriptive studies Conflicting evidence or meta-analysis showing a trend that did not reach significance National Institutes of Health Consensus Report Published practice guidelines, for example by professional organizations, healthcare organizations, or federal agencies Strongest Non-Research Based III 8 Qualitative designs, case studies, opinions of expert authorities, agencies or committees Weakest Strength of Evidence Hadorn et al Three domains are used (AHRQ, 2002): Quality (study validity concern about bias) Selection of patients Allocation of patients to research groups Therapeutic regimen Study administration Withdrawals from study Patient blinding (randomized clinical trials) Outcome measurement Statistical analysis Quantity (number of studies evaluating the question, sample size across all studies) Consistency (numerous studies report similar findings) Strength of Evidence: ONS Levels of Evidence Check for most current version ONS Level I II Level of Evidence Subcategory Evidence Source Research Based Meta analysis or systematic reviews of multiple well designed, randomized, controlled clinical trials Well-controlled, randomized clinical trials with adequate sample size Well-designed trial without randomization Well-conducted, systematic review of non-experimental design studies Well-conducted case control study Poorly controlled studies (flawed randomized studies) Uncontrolled studies (correlational descriptive studies) Conflicting evidence or meta-analysis showing a trend that did not reach significance National Institutes of Health Consensus Report Published practice guidelines, for example by professional organizations, healthcare organizations, or federal agencies Strength of Evidence Strongest Non-Research Based III 8 Qualitative designs, case studies, opinions of expert authorities, agencies or committees Weakest 13

14 Critiquing the Evidence:Key Issues to Consider Melnyk & Fineout 2005 Does the article/study content fit with the topic of interest? What were the results of the study? (clearly stated, statistically significant) Are the results valid? (scientifically sound) Will the results of the study facilitate the care of the patients? (generalizability and feasibility and applicability to practice) Questions to Ask in Critiquing the Evidence Melnyk & Fineout 2005 Why was the study done? (purpose) What was the study design? (type of evidence) Who participated in the study? (sample) What was the sample size and how was it decided? (eligibility, inclusion/exclusion) What measures were used? (valid and reliable) Were the intervention and procedures described? (sufficient detail to repeat) Questions to Ask in Critiquing the Evidence (Melnyk & Fineout 2005) How was data collected and what side effects were assessed? What were the limitations of the study? (e.g. small sample size, high drop-out rates, dissimilar comparison groups, selection bias) How do the results compare to previous research in the area? (consistent, inconsistent) What does the research mean for clinical practice? (merit, feasibility, utility, sufficient evidence for practice recommendations) Questions to Ask in Critiquing Clinical Practice Guidelines and Melnyk & Fineout 2005 Are the recommendations valid? Expert clinician and patient involvement in development Use of a rigorous systematic approach (evidence-based) Sources of evidence are referenced Comprehensive includes all reasonable treatment options What are the recommendations? Meaningful and practical Clear and specific, not ambiguous Will the recommendations help patient care? Fit with the setting, age & gender and comorbidities of the patient and type of clinician providing care Allow individualized treatment based on patient circumstances and needs Questions to Ask in Critiquing Clinical Practice Guidelines AGREE Appraisal Instrument (23 items): Scope and purpose Stakeholder involvement Rigor of development Clarity and presentation Applicability Editorial independence Questions to Ask in Critiquing Quality Improvement Reports QI reports assess processes of care: Was the QI effort explicit: How were outcomes selected? How were data collected? How was the number of records/patients selected? Was bias inherent in the methods used? Optimal outcomes determined: Were thresholds identified for outcomes, if so how? If thresholds not met, what was the QI process for identifying problems? 14

15 Organizing and Displaying the Evidence for a Summary of the Review: Reviewing Abstracts and Research Articles Where do we look for information to critique the quality of the evidence? Tables of Evidence: Title, Year, Author, Source Purpose, Hypothesis, Study Question Intervention Sample (eligibility, inclusion/exclusion criteria), Setting Study Design Measures Operational Definitions of Independent/Dependent Variables Results and Conclusions Limitations, contraindications, Feasibility, Applicability Type and Level of Evidence Oncology Nursing Forum July 2002, Volume 29, Number 6 Pain and Fatigue Management: Results of a Nursing Randomized Clinical Trial Barbara Given, RN, PhD, FAAN, Charles W. Given, PhD, Ruth McCorkle, RN, PhD, FAAN, Sharon Kozachik, RN, MSN, Bernadine Cimprich, RN, PhD, FAAN, Mohammad Hossein Rahbar, PhD, and Chris Wojcik, MPH Abstract Purpose/Objectives: Through a randomized clinical trial, to compare patients undergoing an initial course of chemotherapy who report pain and fatigue at baseline and who are receiving conventional care alone with those receiving conventional care plus a nursing intervention on outcomes reported at 20 weeks. Setting: Chemotherapy clinics of two comprehensive and two community cancer centers. Methods: Interviews were conducted at baseline and 10 and 20 weeks. An 18-week, 10-contact nursing intervention utilizing problem-solving approaches to symptom management and improving physical functioning and emotional health was implemented. Sample: The sample consisted of 53 patients in the experimental arm and 60 in the control arm who reported pain and fatigue at baseline. Variables: Pain and fatigue, numbers of other symptoms, and physical role impact and social-functioning subscales from the Medical Outcomes Study 36 Short Form. Findings: Patients who received the intervention reported a significant reduction in the number of symptoms experienced and improved physical and social functioning. Fewer patients in the experimental arm reported both pain and fatigue at 20 weeks. Conclusions: Behavioral interventions targeted to patients with pain and fatigue can reduce symptom burden, improve the quality of the daily life of patients, and demonstrate the "value-added" role of nursing care for patients undergoing chemotherapy. Implications for Nursing: These data support the "value-added" role of nursing interventions for symptom management and improved quality of life during the course of cancer treatment. Pain and Fatigue Management: Results of a Nursing Randomized Clinical Trial Introduction (Excerpt from full text article) Purpose The purpose of this study was to compare data from a 20-week, randomized, clinical trial of a supportive nursing intervention plus conventional care versus conventional care alone among patients undergoing an initial course of chemotherapy who reported pain and fatigue at baseline... Rationale information is not available to establish how patients who present with both pain and fatigue describe their symptom experience and the impact on patient care outcomes. Clearly, further exploration is needed to understand the complexity of multiple symptoms and determine effective management approaches that address multiple symptoms Pain and Fatigue Management: Results of a Nursing Randomized Clinical Trial Methods (Excerpt from full text article) Design A randomized clinical trial was designed to test the effectiveness of a supportive nursing intervention on patients' symptom management, the physical role impact, and social functioning... Setting Four outpatient cancer treatment sites were used for this study... Sample Eligible patients were within 56 days of initiating their first cycle of chemotherapy following a new cancer diagnosis. Patients were at least 40 years old and receiving chemotherapy for a new diagnosis of colon, breast, or lung cancer, non-hodgkin's lymphoma, or other solid tumors. All patients had to have reported both pain and fatigue at their baseline interview. Patients had to be cognitively intact, able to read English to comprehend the consent forms, and willing to participate in the 10-session nursing intervention that covered 20 weeks. Patients had to have caregivers who were willing to participate in this study. Patients were excluded if they were not expected to survive the 20-week intervention and the 12-week follow-up data collection period. Pain and Fatigue Management: Results of a Nursing Randomized Clinical Trial Instruments (Excerpt from full text article) All data were collected through telephone interviews. Patients' age, education, employment, gender, income, and living arrangements were collected at baseline. Symptoms: The Symptom Experience Scale developed by the current study's researchers asked patients if they had experienced any of the following symptoms associated with cancer or cancer treatment in the previous two weeks: nausea, vomiting, pain, fatigue, insomnia, difficulty breathing, coordination problems, fever, cough, dry mouth, constipation, anorexia, diarrhea, or mouth sores. A sum of the number of symptoms reported by each patient formed the count of symptoms for this study Functioning: Two subscales from the Medical Outcomes Study 36 Short Form (SF- 36) (Ware, 1993) were used to measure the impact of the intervention on patients' social and physical role performance... 15

16 Pain and Fatigue Management: Results of a Nursing Randomized Clinical Trial Intervention (Excerpt from full text article) Pain and Fatigue Management: Results of a Nursing Randomized Clinical Trial Results (Excerpt from full text article) The intervention was comprised of evidence-based intervention strategies All study participants, regardless of random assignment, completed the observation interviews. Trained personnel who were not nurses conducted all of the telephone interviews. All patients received conventional care as prescribed by their oncology care team... The supportive care intervention consisted of 10 contacts, 6 in person and 4 via telephone, occurring at two-week intervals over a 20-week period. This cognitivebehavioral intervention focused on both patients and caregivers; however, this report is limited to patient data. The intervention was targeted to assess and intervene with previously identified symptoms. At each visit, the nurse assessed all symptoms... Sample Used in Analysis For the purposes of this analysis, 113 patients who reported pain and fatigue at the baseline interview were examined; 53 patients were assigned to the experimental group and 60 to the control group. Test for Baseline Equivalence between Treatment and Control Groups The tests for equivalency at baseline between the experimental and control groups regarding sociodemographic, independent, and dependent variables are presented in Table 1. No significant differences between the groups at baseline Pain and Fatigue Management: Results of a Nursing Randomized Clinical Trial Results (Excerpt from full text article) Effects of the Intervention A logistic regression model comparing the effect of group on the proportion of patients reporting pain and fatigue examined with those reporting either or neither symptoms at 20 weeks was run, and no significant difference was found by group. This lack of significance may be the result of relatively small numbers of patients distributed among the pain and fatigue, either pain or fatigue, or neither categories. This forced the researchers to compare only two groups at the 20-week observation. However, the trends were very encouraging Limitations Although no differences were found between the experimental and control groups by age or gender, the sample was inadequately powered and not all covariates that could affect the outcomes were entered into the analysis. The disproportionately large number of patients with breast cancer in the sample may limit generaliziability. In addition, further exploration is needed to determine why such a large number of participants were unemployed. The researchers recognize these limitations in the interpretations made in this research. Pain and Fatigue Management: Results of a Nursing Randomized Clinical Trial Discussion and Implications for Practice (Excerpt from full text article) The findings from this study indicate that although the results were not significant, substantially more patients in the experimental group (n = 10) reported neither pain nor fatigue compared with only three patients who reported neither pain nor fatigue in the control group. this research underscored the sentinel role of pain and fatigue as risk factors for the inclusion of patients in behavioral interventions... Conclusion: Behavioral interventions targeted to patients with pain and fatigue can reduce the symptom burden, improve the quality of the daily lives of patients, and demonstrate the "value-added" role of nursing care for patients undergoing chemotherapy In terms of implications for practice that can be derived from the review of this report The sample was inadequately powered. Not all covariates that could affect the outcomes were entered in the analysis. Generalizability is limited by the large number of participants with breast cancer. Of note is that the intervention was delivered by professionals; and its costs may be offset by the fact that some of the intervention can be delivered by telephone. Using the ONS Levels of Evidence - this would be categorized as a Level II subcategory 7 Research based study showing a trend that did not reach significance. Step IV: Summarizing the Evidence Goal is to combine the findings from the evidence reviewed to arrive at a solution for the clinical problem of interest Definition: Summarizing the evidence is an intellectual job involving a move from the literature search and critique phase into the synthesis phase Research evidence may be combined with other evidence to make concrete practice recommendations 16

17 Step IV: Summarizing the Evidence When possible work in a multidisciplinary group (identify group leaders, co-leaders) Use the Summary Table of Evidence Organize results by concepts, setting, variables Evaluate applicability to practice by reviewing and substantiating evidence, fit and feasibility Step IV: Summarizing the Evidence Questions to ask: What is the strength of the research base? (number of studies, size of the total sample) Have the research studies been examined for scientific merit? What are the potential risks to patients? Were findings consistent or inconsistent across all the studies? Does the evidence support the intervention in a particular setting/sample? (practical relevance) How should the findings be used?: update for practice, policy/procedure, algorithm, program, position paper? Sample Table of Evidence: ONS PEP Resources ONS PEP Resources Cards ONS Web Site Outcomes Resource Area (ORA) 17

18 Weighing the Evidence: ONS PEP Resources Definitions Weighing the Evidence: Recommended for Practice effectiveness established Likely to be Effective evidence less well established Benefits Balanced with Harms clinicians and patients should weigh individual benefits/risks Effectiveness Not Established insufficient/inadequate data Effectiveness Unlikely lack of effectiveness is less well established Not Recommended for Practice - clear evidence demonstrating ineffectiveness or harmfulness; cost exceeds potential benefit Expert Opinion limited evidence exists however, experts may make recommendations based on experience, clinical judgment ONS Resources for Nursing-Sensitive Patient Outcomes Currently available: Fatigue Nausea and Vomiting Prevention of Infection Sleep/Wake Disturbances In progress: Care Giver Strain and Burden Constipation Depression Dyspnea Mucositis Pain Peripheral Neuropathy Prevention of Bleeding Unplanned Hospitalizations Presentation Tips: Research Findings Adding Evidence to Presentations The Nuts and Bolts Barbara Lubejko, RN, MS Project Manager, Education Team Translate into clinically relevant terms Try to verbally cite the specific source of the evidence Summarize the findings most pertinent to your point 18

19 Presentation Tips: Synthesizing Evidence Summarize your evaluation of the type and strength of the evidence When discussing strength of evidence, use descriptive terms such as case study or controlled clinical trial instead of a number or letter from a hierarchy Include both supporting and contradictory evidence Use clinical examples, especially from your own experience Chemo-hormonal Therapy: Impact on Cognitive Function Bender, 2003 Prospective Longitudinal study (baseline, immediately post, 1 yr post chemo) Sample (n = 48) Stage I-II Breast CA Chemo alone, or Chemo + Tamoxifen CONTROLS: DCIS, no chemo/tam Results: Chemo + Tam more severe, greater # deficits, < attention, memory, flexibility, & psychomotor speed? Role of hormone levels 1 Bender (2003). Cognitive Dysfunction in Cancer and Cancer Treatment. ent. Plenary Session, Oncology Nursing Society 7 th Annual Conference on Cancer Nursing Research; ; San Diego, CA. Cognitive Dysfunction: Prevention and Management Anemia prevention and management 1 (Randomized clinical trial) Mehthyphenidate 2 (Systematic review) Restorative activities 3,4 (Meta-analysis of cohort studies, Descriptive study) Behavioral compensatory interventions 5 (Research currently in progress) Presentation Tips: Summarizing Implications Summarize practice implications Provide suggestions for using the evidence to change practice Discuss significant barriers Areas of future research 1 O Shaughnessy J, et al. (2002). San Antonio Breast Cancer Symposium m Abstract Myers CA et al. (1998) Journal of Clinical Oncology. 3 Cimprich B. (1993). Cancer Nursing. 4 Cimprich B (2003). Cancer Nursing. 26(4):284-92; quiz 293-4, 2003 Aug. 5 Bender (2003). Cognitive Dysfunction in Cancer and Cancer Treatment. ent. Plenary Session, Oncology Nursing Society 7 th Annual Conference on Cancer Nursing Research; ; San Diego, CA. Adjuvant Breast Cancer Therapy and Cognition: Clinical Implications Standard-dose adjuvant breast cancer CT impairs cognitive function Independent of mood changes and self-reported dysfunction 1, 2 May be related to fatigue 3 Anemia appears to exacerbate cognitive impairment 1,2,4 Cognitive deficits can be long lasting 3 Long-term cognitive deficits can impair QOL of breast cancer survivors 3 Impact of Cognitive Dysfunction in Adjuvant Breast Cancer Patients Acute effects Interference with learning and decision making surrounding cancer treatment Long term effects Decreased QOL Intellectual achievement Occupational performance and enhancement extreme concerns about ability to maintain employment due to inability to maintain attention following chemotherapy (Hilfinger-Messias, 1997). Family and community roles and relationships 1 Schagen SB, et al. (1999). Cancer. 2 Brezden CB, et al. (2000). J Clin Oncol. 3 Bender, C (2001). J Pain Symptom Mgmt 4 O Shaughnessy J, et al. (2002). San Antonio Breast Cancer Symposium m Abstract Bender, C. (2001). Cognitive function and reproductive hormones in adjuvant therapy for breast cancer: a critical review. Journal of Pain & Symptom Management 21(5),

20 Format Tips: Slides Translate into visually appealing graphics Consider careful use of animation Provide citation for evidence: Use author name and year at bottom of slide OR Full reference on the bottom of slide Cite copyrighted material Summary slide with key implications Citing Resources Rutledge, D.N. & Grant, M. (2002). Introduction. Seminars in Oncology Nursing, 18(1), 1-2. Rutledge & Grant (2002) Cognitive Function Multidimensional Concept 7 Major Components Attention and Concentration Learning and Memory Psychomotor Efficiency Visuospatial Ability Verbal Processing Executive Functions General Intelligence (IQ) Formatting Tips: Reference List or Bibliography Highlight citations containing strongest evidence Key websites Include references that support and differ from your conclusions APA format Conference Syllabus: Key slides including implications for practice - Bender, C. (2001). Cognitive function and reproductive hormones in adjuvant therapy for breast cancer: a critical review. Journal of Pain & Symptom Management 21(5), Bibliography/Reference List Show Me the Evidence Example #1 Bender, C. (2001). Cognitive function and reproductive hormones in adjuvant therapy for breast cancer: a critical review. Journal of Pain & Symptom Management 21(5), (Integrative review) Example #2 Siswek, J., Gourlay, M.L., Slawson, D.C., & Shaughnessy, A.F. (2002). How to write an evidence-based clinical review article. American Family Physician, 65(2), Straus, S.E. (1998). Using research findings in clinical practice. British Medical Journal, 317, Retrieved December 12, 2003, from Focus - Highest quality cancer care. Imperative for oncology nurses to be able to locate, evaluate, articulate and apply evidence to their practice settings. Facilitated by evidence-based presentations. Locating, critiquing, summarizing and integrating evidence into presentations. 20