Exploration of the evidence to support clinical practice to decrease hospital readmission rates for patients with chronic pancreatitis
vii TABLE OF CONTENTS DEDICATION...............................................................................................................................iii ACKNOWLEDGEMENTS..............................................................................................................iv ABSTRACT....................................................................................................................................v LIST OF TABLES...........................................................................................................................vi CHAPTER I. INTRODUCTION........................................................................................................1 CHAPTER II. BACKGROUND.........................................................................................................4 2.1 Clinical Management......................................................................................................4 2.2 Quality and Safety Issues................................................................................................7 2.3 Heath Policy Issues.........................................................................................................8 2.4 Summary.......................................................................................................................10 CHAPTER III. EVIDENCE REVIEW APPROACH............................................................................11 3.1 Description of Evidence Sources..................................................................................11 3.2 Search Terms................................................................................................................14 3.3 Inclusion/Exclusion Criteria ..........................................................................................15 3.4 Search Process Description...........................................................................................16 3.5 Summary.......................................................................................................................20 CHAPTER IV. EVIDENCE FINDINGS AND INTERPRETATION.......................................................21 4.1 Evidence Table Development.......................................................................................21 4.2 Analysis of Findings.......................................................................................................23 4.3 Summary.......................................................................................................................44 CHAPTER V. EVIDENCE IMPLICATIONS AND CONCLUSIONS.....................................................46
viii 5.1 Evidence‐Based Recommendations.............................................................................46 5.2 Clinical Practice Implications........................................................................................48 5.3 Quality and Safety Implications....................................................................................52 5.4 Health Policy Implications............................................................................................53 5.5 Research Implications...................................................................................................56 5.6 Summary.......................................................................................................................57 REFERENCES..............................................................................................................................59 APPENDICES..............................................................................................................................71 A: Evidence Table................................................................................................................72 B: SIGN Critical Appraisal Notes and Checklists Tool.........................................................93 C: Key to Evidence Statements and Grades of Recommendations ....................................99 D: Evidence Level Analysis Summary................................................................................101
1 CHAPTER I I NTRODUCTION More than 14 million (9%) hospital admissions occur annually for digestive diseases. Kozak, Owings, & Hall (2005) reported that in 2002 10.4% (419,000) of digestive disease hospital admissions were for patients who had a primary diagnosis of chronic pancreatitis. In 2004, there were 881,000 (1%) ambulatory care visits in which the primary diagnosis was pancreatitis and 454,000 (4%) hos pital discharges with pancreatitis listed among all diagnoses (Everhart, 2008). Pancreatitis was among the 10 leading causes of “years of potential life lost” among patients with digestive diseases (Everhart, p3). Although individuals with chronic pancreatitis represent a small portion of the cases of gastrointestinal disorders, the impact is great. This chronic population has a high utilization of health care services. Mo reover, in 2008, direct and indirect costs for managing chronic pancreatitis were estimated at $307 billion (Ruhl, Sayer, Byrd‐Holt, & Brown, 2008). However, this number is most likely underestimated due to: (a) lack of inclusion of federal hospitals and physicians; (b ) use of Medicare reimbursement rates; (c) lack of inclusion of cost data for over‐the‐counter digestive disease drugs; and (d) lack of data related to lost wages. Given the magnitude of management and cost challenges associated with readmission of patients with chronic pancreatitis , it is important to assess the causes of current readmission patterns for this high‐risk population to determine more effective clinical interventions to decrease readmission rates. Readmission rates are considered
2 an important outcome measure because of the association between quality and cost of care (Lin, Chung, Casey, & Snow, 2007). These rates often indicate whether a hospital has been successful in transitioning patients from inpatient to outpatient settings (United States Department of Health and Human Services [USDHHS], 2009). Readmissions may result from incomplete tr eatment, poor care, or lack of coordination of services at the time of (or after) discharge (Halfon et al., 2006). The overall objective of this evidence‐based project was to identify best practices for management of individuals with chronic pancreatitis that can be translated into clinical practice to decrease hospital readmission rates. The specific purpose of th is project was to evaluate health care evidence being used to support clinical management of patients with chronic pancreatitis to decrease their hospital readmission rates. Melnyk and Fineout‐Overholt (2005) assert that clinical questions for evidence‐ based practice should be in a population, intervention, comparison, and outcome (PICO) format to obtain the most applicable and best evidenc e. The PICO question for this evidence‐based project was: What is the evidence supporting clinical practice to decrease hospital readmission rates for patients with chronic pancreatitis? The following definitions were used to guide evidence search and evaluation. Chro nic pancreatitis was defined as the progressive and permanent destruction of the pancreas resulting in exocrine and endocrine insufficiency and, often, chronic disabling pain (Nair, Lawler, & Miller, 2007). In chronic pancreatitis, inflammation becomes worse over time and is characterized by symptoms of pain, nausea, vomiting, steatorrhea, diarrhea, and weight loss that, when exac erbated, may lead to
3 hospitalization. (DiMagno & DiMagno, 2009; Hussain& Karnath, 2005; and Strayer & Schub, 2010). Readmissions are generally placed into one of 4 categories: (a) planned readmission related to the original admission; (b) planned readmission unrelated to the original admission; (c) unplanned readmission that is unrelated to the original admission; and (d) unplanned readmission related to the original admission (America n Hospital Association, 2009). For this evidence‐based practice project, readmission was defined as an unplanned rehospitalization related to the original admission for management of chronic pancreatitis. A 7 day readmission rate is the standard benchmark used by the Centers for Medicare and Medicaid Services and was therefore used in this project (Goldfield et al., 2008) . Clinical practice was defined as nursing, nutritional, pharmacotherapeutic, or psychosocial interventions used to manage chronic pancreatitis. In summary, clinical management of patients with chronic pancreatitis will impact the quality, costs, and care outcomes of this high risk population. The following chapters will provide background information for the identifi ed practice problem, a summary of the evidence review approach, and evidence review results. Evidence‐ based conclusions and recommendations for practice innovation and future research complete the paper.
4 CHAPTER II B ACKGROUND Practice consistency is needed to guide nurses in clinical management of patients with chronic pancreatitis. Standardized care is needed to guide post‐discharge care and encourage patient adherence to treatment plans. The following sections summarize background information related to implications for clinical management, quality and safety, and health policy change for the chronic pancreatitis patient population. 2.1 Clinical Management The primary and most dominant symptom leading to ho spital readmission for patients with chronic pancreatitis is pain (Conwell & Banks, 2008; DiMagno & Dimagno, 2009; Hussain & Karnath, 2005; Joshi & Toskes, 2005; and Nair et al., 2007). The complexity of the literat ure reporting its pathophysiology is described by Gupta & Toskes (2005) as “abundant and controversial” (p. 492). A better understanding of the disease is needed to better treat associated pain. Chronic pancreatitis is characterized by intermittent exacerbations and individuals can remain in remission without symptom manifestation for extended periods of time (Hussain & Karnath, 2005). When exa cerbations occur patients often require hospital admission. The most recent pain management guidelines from the American Gastroenterology Association (AGA) for patients with chronic pancreatitis were written in 1998 and have variable interpretations by nurses. These guidelines indicate that chronic pancreatic pain is “a highly variable phenomenon” and that “treatm ent has been haphazard, ill‐directed,
5 often unsuccessful, and controversial” (Warshaw, Banks, & Castillo, 1998, p.765). Evidence is needed that delineates an effective pain management approach to avoid readmission. Other problems leading to readmission also fall into categories defined in the clinical practice PICO definition. They include (a) nursing, (b) nutrition, (c) pharmacotherapeutics, and/or (d) psychosocial interventions (de Burgoa, Seidner, Hamilton, Stafford, & Steiger, 2006; de Lissovoy et al., 2009; Delegge, Bo rak & Moore, 2005; “Home care,” 2010; Pezzilli, 2009; Soler et al, 2010; Tucker, 2004; and Weaver et al., 2006). Some reasons for readmission of patients with chronic pancreatitis overlap categories of clinical practice. Nursing, has changed dramatical ly over the last decade. With the patient length of hospital stay decreasing, nurses are challenged to adequately prepare patients with chronic pancreatitis for discharge (Demarco & Nystrom, 2009). It is increasingly commonplace for these patients to be discharged to their homes to independently manage complex aspects of their care (Johnson, Sandford, & Tyndall, 2003). Lack of appropriate home health services, PICC infectio ns, feeding tube site infections, and/or inadequate patient education for self‐management may lead to hospital readmission. Structured treatment and teaching plans in other chronic populations (i.e. CHF, asthma, and diabetes), resulted in a substantial improvement in treatment adherence and often reduced readmission rates (Gruesser, Hoffstadt, & Joergens, 2003) . Nursing interventions are needed to help prepare patients with chronic pancreatitis for
6 discharge home and equip them with the knowledge required to effectively and safely manage their disease at home. Nutritional interventions also need evidence‐based support. At best, current nutritional management of patients with chronic pancreatitis is ambiguous, inconsistent, and based on traditional management approaches. Nutritional recommendations vary from low fat diet and oral replacem ent of missing digestive enzymes to multiple formulas of oral nutrition support (Aquino, 2008). There is also much controversy among nurses regarding enteral versus parenteral methods of nutrition support. Malnutrition that may result from inadequate absorption or lack of appropriate enteral or parenteral nutrition may lead to hospital readmissions. Evidence‐based approaches to nutritional management that can be consistently implem ented across health care settings to decrease readmissions are needed. Pharmacotherapeutics has been discussed briefly in terms of pain management, however, additional pharmacological agents have been identified in the treatment of chronic pancreatitis and consistency is needed among nurses. Medications such as pancreatic enzymes and antiemet ics may prove beneficial in the management of chronic pancreatitis. Inadequate nausea management or steatorrhea resulting from lack of or inadequate doses of pancreatic enzyme supplementation may lead to hospital readmissions. The appropriate medications and dosages need to be identified and implemented into practice. Management related self‐care strategies and psychosocial support are frequently not addressed (Lubkin & Larsen, 2009). Individuals with adequate social
7 support and confidence in their self‐care ability tend to experience fewer readmissions than do those living alone and those who perceive themselves as not ready to return home (Jacob & Politeik, 2008). Furthermore, those patients who demonstrate maladaptive psychosocial skills or inability and/or refusal to adhere to prescribed treatment plans may ex perience hospital readmission. Evidence‐based practice that addresses psychosocial strategies and interventions are needed to better manage care of patients with chronic pancreatitis. Clearly, generic evidence supports the effectiveness of various interventions in decreasing readmission rates. However, an appraisal of the existing literature is needed to identify appropriate clinical practices to reduce hospital readmissions in patients with chronic pancreatitis (Ag ency for Healthcare Research and Quality [AHRQ], 2008). Consistent clinical practice for patients with chronic pancreatitis could decrease readmission rates, improve quality of life, and increase patient satisfaction. 2.2 Quality and Safety Issues The Institute of Medicine (IOM) has defined quality as “the de gree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge” (Lohr, as cited in Mitchell, 2008, p.1). Quality clinical management is exactly what is needed for patients with chronic pancreatitis. Hospital readmission rates are often considered a surrogate outcome indicator of care quality. They f requently reflect the ability of hospital‐based nurses to provide care that prevents post discharge complications and assists patients to transition successfully into a home‐based self‐management mode (USDHHS, 2009).
8 Additional evidence is needed to support development and/or implementation of clinical care strategies that promote safe and high‐quality care for patients with chronic pancreatitis. Safety is the foundation of quality clinical management (Mitchell, 2008). Care management is needed that decreases errors and builds a culture of safety for individuals with chronic pancreatitis . Patients discharged from hospitals after severe bouts of chronic pancreatitis may have complex home care regimens that include enteral or parenteral nutrition or complex medication regimens. Diabetes management may also be an aspect of this care plan. Safety risks that exist in these post‐discharge complex situations must be addressed to prevent hazards such as medi cation errors, feeding tube errors or infections, and peripherally inserted central catheter (PICC) errors or infections. These hazards may result in patient harm and/or hospital readmission. A clear body of scientific knowledge must exist to support clinical practice to decrease readmissions of patients with chronic pancreatitis. Failure to distinguish effectiv e and harmful care compromises quality (Bodenheimer & Grumbach, 2002). 2.3 Health Policy Issues Much insight is needed about available evidence to support policy related to the management of patients with chronic pancreatitis. Health care’s changing paradigm of hospitals undergoing transitions in health care reform, hospital administrators facing decreased revenue, and cost containment efforts by Medicare and third party payo rs, have all led to health policy implications for effective clinical practice to decrease readmissions in patients with chronic pancreatitis.
9 Chronic pancreatitis was the seventh most common diagnosis in digestive disease hospital admissions in 2004 (Everhart, 2008). In the same year, hospital facility costs alone for patients with pancreatitis totaled almost $2 billion dollars ($1, 982,200,000) (Everhart, 2008). Hospitals experiencing high readmission rates of chronic pancreatitis patients need to implement appropriate interven tions to address this problem. The Center for Medicare and Medicaid Services (CMS) announced plans to reduce reimbursement for hospitals with high readmission rates (Commins, 2009). If trends continue, private insurance companies will follow suit. Hospitals can ill afford a blow of this magnitude on an already stressed health care system. Another area in which the impact of chronic pancreatitis is noted is retail pharmacy related health care costs. Everhart (2008) reported that retail costs of prescription s for pancreatitis in 2004 were $88.6 million. Changes in America’s economy have also led to decreased revenue for businesses. In an effort to cut costs to counteract lowe r revenue, some businesses have decreased employee insurance benefits that were once used to help cover the cost of medications. An additional financial impact on the system is lost wages and productivity. Pancreatitis was the number one reason among digestive diseases for lost wages during hospital stays in 2004 (Everhart, 2008). The impact is felt locally and nationally as such an employee is forced into public assistance programs when terminated for excessive absences or employers are forced int o high premium insurance plans. Readmissions caused by ineffective clinical management has a great financial impact on the entire system through lost wo rk hours, productivity, and wages for both employee and
10 employer. Appropriate clinical practice is needed to reduce this impact on health care, America’s workforce, and businesses’ viability. One final notable health policy implication for patients with chronic pancreatitis is found in the role of the nurse. Nurses must discern policy implications and seize the opportunity to inform public officials (Milstead, 2004). Resea rch dollars need to be allocated to explore trends in morbidity and mortality for patients with chronic pancreatitis and to develop interventions that may help reduce these numbers. Presenting information regarding the impact of chronic pancreatitis could lead to legislative programs that allocate funding for research and management programs in this populati on. Evidence‐based interventions inform policy. 2.4. Summary In summary, clinical practice needs to reflect solid evidence. There is a need for better understanding of chronic pancreatitis in its entirety. Clarity is needed for effective clinical management of patients with chronic pancreatitis including medication management; nutrition; patient and nursing education; and self car e skills to prevent complications of chronic pancreatitis that lead to readmissions. Finally, areas requiring research need to be identified to build a body of evidence to guide clinical management of patients with chronic pancreatitis.
11 CHAPTER III E VIDENCE R EVIEW A PPROACH An evidence review was completed to address the PICO question, “What is the evidence to support clinical practice to decrease hospital readmission rates for patients with chronic pancreatitis?” The following sections describe the components of the evidence review approach including: (a) description of evidence sources; (b) search terms; (c) inclusion/ exclusion criteri a and (d) search process description. 3.1 Description of Evidence Sources A total of nine sources were searched: Cochrane Database of Systematic Reviews (CDSR), Cumulative Index of Nursing and Allied Health Literature (CINAHL), the National Library of Medicine’s Medical Literature Analysis and Retrieval System Online (MEDLINE), the Society of Gastroenterology Nurses and Associates (SG NA), the American Gastroenterology Association (AGA), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Joanna Briggs Institute, Dissertations & Theses: Full Text database, and National Guidelines Clearinghouse (NGC). The search began with larger more general sources and was narrowed to gastroenterology‐specific journals and sites. Burns and Grove (2005) recommend initially searching evidence for the “widest possible interpret ation” to gain an idea of available relevant literature (p. 97). Each evidence source is described in the following sections. Although CINAHL and MEDLINE represent broad databases; CDSR was searched first because of its valuable preappraised evidence (Melnyk & Fineout‐Overholt, 2005). Melnyk & Fineout‐OverhoIt (2005) r ecommend that CDSR be the first database in a
12 search when seeking an answer to a broad clinical question. CDSR has a reputation of high quality, reliable, independent evidence (Burns & Grove, 2005). It is internationally recognized for evidence‐based health care systematic reviews. CDSRs investigate interventions and outcomes for treatment in a health care setting (The Cochrane Collaboration, 2010). Each review de als with a clearly formulated research question. According to Burns & Grove (2005), systematic reviews of high quality randomized controlled trials (RCTs) for the PICO population would yield the highest level of evidence. Melnyk & Fineout‐Overholt (2005) also propose that systematic reviews yield the strongest level of evidence for practice decisions because they combi ne samples of each study in the review to create one larger study with more precise summary statistics than individual findings. Therefore systematic reviews of high quality RCTs in chronic pancreatitis populations were searched to provide the highest quality population specific evidence to answer the PICO question. The second database searched, CINAHL, is the most releva nt print database in nursing (Burns & Grove, 2005). It contains citations of nursing literature published after 1955. CINAHL contains comprehensive citations of available literature related to nursing care of patients with chronic pancreatitis. The next database in the search process was MEDLINE because of its large electronic bibliographical records (Bu rns & Grove, 2005). The National Library of Medicine is the world’s largest medical library. MEDLINE is a database of over 16 million references to journal articles in life sciences with a concentration on biomedicine (U.S. National Library of Medicine, n.d.). It also contai ns in‐process citations and those that
13 preceded the date of a journal selected for MEDLINE indexing. The latest information regarding chronic pancreatitis was available among a large array of available journals through the National Library of Medicine. Ovid Technologies were used to search the MEDLINE database. Ovid is a search instrument that offers customizable tools that enhance search precision through med ical subject headings (MeSH) (Ovid, 2010). SGNA journal specifically focuses on nursing care of patients with gastrointestinal (GI) disorders. Although a search of this journal would likely yield a few duplicate results to the CINAHL database search, the potential to obtain landmark GI specific literature existed. GI specific literatu re that may have been published outside of the year range criteria could also be searched without the barrier of sorting through multiple non‐GI specific documents that might appear in a search unrestricted by date in a database such as CINAHL. AGA and NIDDK websites were explored for citations of pancreat itis related studies or reviews that may have been published in journals that were not revealed in previous searches. AGA (2010) publishes information on their site about clinical practice and practice management for the GI patient. NIDDK publishes information regarding current clinical research in gastroenterology. The final sources searched were the Joanna Briggs Institute, Dissertations & Theses: Full Text database, and NGC. Joanna Br iggs Institute is an International nonprofit research and development organization that compiles evidence‐based resources for health care professionals. Dissertations & Theses: Full Text database was searched to locate chronic pancreatitis related reviews that have not yet been published
14 in journals. NGC is supported by the Agency for Healthcare Research and Quality (AHRQ) through health services research initiatives that seek to improve the quality of health care in America. AHRQ's mission is to improve the quality, safety, efficiency, effectiveness, and cost‐effectiveness of health care for all Americans (AHRQ, 2007). NGC houses guideline summari es and links to full text guidelines, where available. After these final sites were reviewed the search was deemed exhaustive because multiple duplicates were found. 3.2 Search Terms Overall key terms used in the search were readmission, chronic pancreatitis, pancreatitis, clinical practice, and recidivism. These were important because of their direct link to the PICO question. Chronic pancreat itis was the specific population of interest. However pancreatitis was often used in the searches to obtain a larger group of records for review. Clinical Practice was the intervention in the PICO question and was used in searches in larger databases to narrow results. Clinical practice interventions that specifically address ed nursing, nutritional, pharmacological, and/or psychosocial interventions were sought because these were identified components in the definition of clinical practice. Readmission was the outcome in the PICO question and was therefore also a critical term in the search for evidence. Recidivism was also searched because of its close definition and fr equent use in clinical practice terminology related to readmissions. Lastly, the comparisons in the PICO question were interventions compared in studies and their efficacy in preventing readmissions in patients with chronic pancreatitis.
15 3.3 Inclusion/Exclusion Criteria In establishing the search inclusion/exclusion criteria (Table 1), the PICO question and pertinent definitions for the project were considered. Evidence addressed clinical practice interventions that related to nursing, nutritional, pharmacotherapeutic, or psychosocial interventions identified in the PICO question definition that would prevent readmissions for patients with chronic pancreatitis. Therefore, re cords that directly addressed clinical practice in these categories for patients with chronic pancreatitis qualified for inclusion. Studies on surgical technique/ procedures were excluded because they included invasive management that would require specialist or physician management. Those records that addressed diagnoses of chronic pancreatitis as the core subject matter were excluded because AGA guidelines adeq uately address diagnosis and they were not the subject of this evidence‐based project. Dates were not initially limited because previous searches yielded lack of evidence related to the subject. However search results earlier than 2000 were not included in these results because of relevance. Table 1. Inclusion/Exclusion Criteria Inclusion Exclusion adult populations acute pancreatitis chronic pancreatitis animals (non‐human) subjects hospital readmission diagnostic interventions hospital recidivism endoscopic procedures nursing intervention mental disease nutritional management non‐English language peer review journals pediatric/children/adolescent subjects pharmacotherapeutic intervention psychosocial intervention year = 2000 to 2010 (except landmark) surgical procedures
16 3.4 Search Process Description A Boolean search strategy was used to eliminate unrelated documents. Boolean was found to be the most effective way to logically combine search terms in many sources. The search strategies that worked best overall were those in which the search began with broad terms (e.g., pancreatitis), followed by combining other terms in the PICO questi on (e.g., chronic or readmission) and then ending with limitation of results to “year”, “adults”, or “readmissions”. Reference lists of resources were reviewed for additional resources, but studies included in systematic reviews were not re‐analyzed for inclusion. After the initial search was completed and evidence revi ewed, it was noted that disease management interventions were reported as having successful results and a positive impact on other chronic illnesses yet there were none found specifically for patients with chronic pancreatitis. A new search was therefore completed for systematic reviews in the Cochrane database using search terms chronic, disease, management, and pain. Pain was included in the search because pain is often the number one symptom of chronic pancreatitis. The results of specific search te rms from evidence sources are recorded in Table 2. Also included are numbers of records retained from each search. Table 2. Search Process Summary Evidence Source Search terms Results Number retained Cochrane pancreatitis 46 records 1 readmission 6076 records readmission & hospital 30 records 5
17 Of note, Cochrane Library displays an “other reviews” tab with search results. For this search the tab revealed 4 reviews and 1 was suitable for this review and was retained. 1 pancreatitis and readmission being combined in an advanced search There were 3 items found. All 3 were related to surgical i nterventions and were excluded. 0 chronic, disease, management, and pain 23 records; only studies that addressed chronic pain therapy were kept. Eliminated children/ adoles‐cents, acute pain, musculo‐skeletal pain, pelvic pain, enteral nutrition, and breathlessness in malignant states. 8 chronic disease management 103 records; repeated 8 eliminated 4 CINAHL pancreatitis and Readmission 0 records chronic pancreatitis and Recidivism 0 records chronic pancreatitis 318 records limited to adults 126 records 3 advanced search combining the terms readmission and pancreatitis 3 records and none were kept readmission and hospital 1157 records narrowed w/chronic 150 records 7 recidivism & pancreatitis 0 records recidivism & chronic 21 records 0 recidivism and hospita l 31 records 0 clinical, practice, & readmission combined 137 records; 2 were repeats 1
18 One record in this group (Potera, 2009) was a summary of two studies completed to lower hospital readmissions and costs. The two referenced studies were retrieved and the original record was not included. 2 Ovid MEDLINE #1 chronic pancreatitis “map term to subject head” subheadings complications, diet thera py, drug therapy, metabolism, therapy, prevention & control, rehabilitation, & psychology 549 records #2 readmission searched with subheadings patient readmission, risk factors, and length of stay selected which resulted in 270476 records Combined #1 and #2 Results of these two groups were combined and yielded 35 records 2 recidivism with subheadings Adults or Recurrence 1,203,481 records recidivism combined with chronic pancreatitis 225 records; dupli cate records eliminated 13 SGNA pancreatitis 47 records chronic pancreatitis 39 records; One of these 3 was outside of the date range (Shepp et al., 1999) but was kept because of the PICO specific psychosocial intervention not found in other searches. 3 AGA chronic pancreatitis 105 records; Duplicates found for CINAHL & Ovid MEDLINE 2 NIDDK chronic pancreatitis 46 records 2
19 Joanna Briggs Institute advanced search combining chronic and pancreatitis 0 records pancreatitis 12 records; 10 of 12 were titled Acute Pancreatitis. Of the remaining 2, one was excluded because it dealt specifically with management of chemotherapy induced acute pancreatitis. Final item met inclusion criteria but was summary of dissertation from Adelaide. The full dissertation was unavailable through library services. This item was not deeme d appropriate based on limited data in the summary. 0 readmission 1 record which dealt with post‐operative nausea and was not kept recidivism 0 records Clinical combined with practice in an advanced search 104 records 0 Dissertations & Theses database chronic and pancreatitis combined in an advanced search 26 records; Fou r were kept but, upon review, one item had only an abstract and was “not available for purchase”. Contacted publisher (Clinical Nurse Specialist Journal) & learned that item was abstract presentation. Emailed author and received "unknown recipient error". Another item was written in Hungarian. The remaining 2 ite ms were animal research. 0 NGC chronic pancreatitis 48 records; There were multiple repeats of articles found in other resource searches 4 Total Records kept 58
20 3.5 Summary A systematic approach was implemented to identify and retrieve evidence relevant to clinical practice to decrease readmissions for patients with chronic pancreatitis. Applying inclusion/exclusion criteria required considerable time as all of the records identified required manual review. However, retrieval of records was less complex than expected because of the availability of services such as librarian consultation, elect ronic databases, interlibrary loan services, and full‐text article downloads. The final evidence search resulted in 58 records being retained.
21 CHAPTER IV E VIDENCE F INDINGS AND I NTERPRETATION The goal in analyzing evidence was to retrieve the “highest quality of knowledge in providing care to produce the greatest impact” in reducing readmissions in patients with chronic pancreatitis (Melnyk & Fineout‐Overholt, 2005, p.75). The following sections discuss findings and interpretations of the evidence review in terms of evidence table develo pment and evidence analysis. 4.1 Evidence Table Development Evidence obtained from the search was placed into an evidence table (Appendix A) for further evaluation and grading. The selection of the evidence table headings was guided by Scottish Intercollegiate Guidelines Network (SIGN) templates (2008) and Burns and Grove’s (2005, pp. 106‐109) exampl e of literature review summary table. Each record in the table was evaluated and graded for its accuracy regarding cause‐ effect or causal relationship, quality of measurement, and dependability of results. For further evaluation, the evidence in the table was categorized by clinical practice categories of nursing, nutritional, pharmacological, and psychosocial interventions. Nursing evidence was vast and required further se paration into subcategories to synthesize findings. There were three subcategories identified: (a) general management, (b) discharge planning/case management, and (c) education/self‐ management. Within each category, evidence was listed by evidence level (highest to lowest). Records that were assigned the same evidence lev el (e.g. 1++A) were sorted
22 alphabetically. While there were overlapping areas in some categories, records were assigned by the primary area addressed in the studies. Evidence Evaluation Tool The SIGN Critical Appraisal Notes and Checklists tool (Appendix B) was used to assess the reliability and validity of the records in the evidence table (SIGN, 2009b). The tool was de veloped using an explicit methodology to aid appraisers in the evaluation of systematic reviews, meta‐analyses, randomized controlled trials (RCTs), cohort studies, case‐control studies, and diagnostics studies (SIGN, 2009b). The checklists are intended to assist in developing guidelines that accelerate conversion of new knowledge into practice, to lessen differences in practice and improve patient outcomes (SIGN, 2009a). Evidence Ra ting & Grading The SIGN Key to Evidence Statements and Grades of Recommendations tool (Appendix C) allowed categorization of evidence in a two‐fold approach, resulting in a rating of the quality of each piece of evidence, as well as a grade based on both quali ty and the relevance of that evidence to the target population. Each piece of evidence evaluated with the SIGN Critical Appraisal Notes and Checklists tool (Appendix B), was assigned a rating from highest (1++), to lowest (4) based on the Evidence Statements of the SIGN Key to Eviden ce Statements section of Appendix C. High quality meta‐analyses, systematic reviews of RCTs, or RCTs with a very low risk of bias were given ratings of 1++. Ratings were graduated to the lowest level of 4 (expert opinion papers). Although the SIGN tool did not specifically include a rating for evidence‐bas ed clinical practice guidelines, for purposes of this project,
23 guidelines were considered among the highest levels of evidence, as they are based on “a methodologically rigorous review of the best evidence on a specific topic” (Melnyk & Fineout‐Overholt, 2005, p.11). After evidence is rated, the tool’s Grades of Recommendations section allowed further categorization into grades of evidence. Evidence was graded A to D corresponding to the st udy population’s relationship to the target population and overall study quality. The highest grade of A was assigned to studies directly applicable to the target population with at least one meta‐analysis, systematic review, or RCT rated 1++. Grades were graduated to the lowest grade of D, representing extra polated evidence from studies rated as 2+ (see Appendix C). Since much of the evidence reviewed involved populations other than patients with chronic pancreatitis, this was beneficial in appropriately categorizing extrapolated evidence. 4.2 Analysis of Findings In analyzing the evidence, judgments were made using the evidence grading tools . Although prior expert knowledge about patients with chronic pancreatitis existed, the tools were followed exclusively so as not to bias interpretation of the evidence. The evidence was analyzed to answer the PICO question. 4.2.1. Clinical Practice Category Analysis Nursing Interventions More than half of the records (n=33) related directly to primary nursing interventions. Among the sources of nursing interventions evaluated were high quality meta‐anal yses and systematic reviews of randomized controlled trials (RCTs). The
24 following subcategories were evaluated separately to address nursing interventions related to (a) general management, (b) discharge planning/case management, and (c) education/self‐management (see Appendix A). General Interventions The major general nursing interventions addressed in the studies reviewed were patient lifestyle change recommendations (e.g., alcohol and smoking cessation, dietary changes), education about the disease process and self‐management, hyperlipidemia management, nausea management, nutrition support, and pain management. Education, nutrition support (including dietary changes), and pain management are discussed in separate sections to foll ow because there were other records that specifically addressed these interventions and evidence was evaluated in its totality. The evidence to support the clinical practice of promoting alcohol and smoking cessation included high quality systematic reviews of RCTs or well conducted studies and evidence‐based clinical practice guidelines directly related to patients with chronic pancreatitis. Alcohol and smoking c essation recommendations were supported by 8 of 9 records that addressed general nursing interventions (see Appendix A). The Editorial Board Palliative Care guidelines  did not address alcohol or smoking cessation. Additionally, 7 of the 8 records that addressed al cohol and smoking cessation were rated at least 2+ and all 8 dealt specifically with the chronic pancreatitis patient population. Alcohol use and smoking cigarettes were found to accelerate the onset of pancreatic calcification and increased the risk of diabetes in patients with chronic
25 pancreatitis (Maisonneuve et al., 2006 and Gupta & Toskes, 2005). There was also significant correlation between the presence of calcification & smoking habits (Maisonneuve et al., 2006 and Talamini et al., 2007). Talamini et al. (2007) found, however, that smoking cessation in the first years from the clinical onset of chronic pancreatitis reduced the risk of developing pancreatic calcifications. Addi tionally, smoking cessation after the onset of chronic pancreatitis significantly reduced the risk of pancreatic calcifications in comparison to nonsmokers (Talamini et al., 2007). These risks associated with drinking alcohol and smoking coupled with the benefits of quitting can be used as persuasive educational strategies in supporti ng cessation in patients with chronic pancreatitis. Promotion of alcohol and smoking cessation are evidence‐based clinical practices that can delay the progression of chronic pancreatitis and may prevent hospital admissions that result from symptoms associated with progressive disease. Hyperlipidemia management was the next general recommendation reviewed. Hyperlipidemia is a complication ex perienced by some individuals with chronic pancreatitis after receiving parenteral nutrition therapy with lipids administration (Gianotti et al., 2009). Elevated triglyceride levels may trigger attacks of pancreatitis, which often result in hospital admissions. Three guidelines made recommendations in the management of triglyceride levels and were among the highest rated evidence (1++A). Common recommendatio ns were increased activity/exercise, dietary changes, medication management such as bile acid‐binding sequestrants, cholesterol absorption inhibitors, fibrates, and statins, and normalizing weight. Specific dose recommendations and cost concerns were also addressed in the guidelines, providing nurses with
26 complete information on which to base clinical implementation of hyperlipidemia management in patients with chronic pancreatitis. Evidence exists that would guide nurses in directing patients on lifestyle changes (e.g., activity and dietary changes) to lower triglyceride levels. If, however, lifestyle changes alone do not decrease triglyceride levels, a medication management approach is also well supported. Managing triglyceride leve ls can help prevent pancreatitis flares that may lead to hospital admissions. The final general nursing intervention discussed in this section is nausea management. There were no studies conducted on patients with chronic pancreatitis experiencing nausea. However, the Editorial Board Palliative Care’s (2006) guideline intended for patients with palliative diseases was rated 1++B . The following recommendations could be extrapolated to patients with chronic pancreatitis: (a) treatment of the underlying cause(s) of nausea; (b) providing nutritional advice; (c) monitoring of fluid and electrolytes, and (d) administration of antiemetics. Using these recommendations, nurses could teach patients with chronic pancreatitis to monitor their diets for causes of nausea and make adjust ments as needed. Additionally fluid and electrolyte balance for patients with chronic pancreatitis experiencing emesis could be monitored by nurses. Finally, antiemetics could be prescribed if relief is not experienced via other modifications. All recommendations have low safety risks exc ept administration of antiemetics. Before complete support can be given to the use of specific antiemetics recommended by EBPC (2006), studies implementing antiemetic therapy in patients with chronic pancreatitis should be conducted.
27 Discharge Planning/Case Management Discharge Planning/Case Management was the largest subcategory of nursing interventions and contained many interventions to prevent hospital readmissions (see Appendix A). Evidence levels varied considerably but no study was rated below 2+C. There were also no studies in this group in which patients with chronic pancreatitis were the focus population except one study that evaluated outcomes of patients discharged home after an endoscopic procedure (Shields et al., 2000). Seven high quality systematic re views of RCTs that evaluated discharge planning and case management interventions received the highest rating (1++) (see Appendix A). However, these seven received grades of B because populations were not patients with chronic pancreatitis and analysis required extrapolation of evidence. Many of the studies, however, used populations with chronic diseases similar to chr onic pancreatitis. Populations included diseases that have a potential of complications that may lead to hospital readmissions (e.g. asthma, CHF, COPD, diabetes, fibromyalgia, and sickle cell disease). This couple d with the fact that none of the discharge planning or case management interventions had high safety risks, made extrapolation of findings and recommendations feasible. Discharge planning studies found that the key to successful discharge planning was two‐fold: successful identification of patients who needed discharge planning and implementation of appr opriate interventions to prevent hospital readmissions. Outcome variables that were shown to predict readmission patterns in subtypes within cohorts of individuals with chronic diseases included (a) predisposing characteristics (i.e., age, gender, education or literacy level, marital status, occupation, & disease
28 category), (b) enabling resources (i.e., financial status, social support, and comprehensive social security assistance), (c) health behavior (i.e., personal health practices, previous readmissions, and length of stay in days), and (d) health outcomes (i.e., quality of life, activities of daily living, and satisfaction score) (Anthony et al., 2005; Chan et al., 2008; “Disc harge Planning Advisor,” 2001; and Huws et al., 2008). Once individuals who needed discharge planning were identified, the literature reflected the following discharge planning interventions were effective: (a) case finding on admission, (b) identification, assessment, and preparation of a discharge plan, (c) implementation of the discharge plan, (d) monitoring of the discharge plan, and (e) follow‐up after discharge (Anthony et al., 2005; Kim & Soeken, 2005; Jack et al., 2009; Makowsky et al., 2009; and S hepperd et al., 2010). Another recurring theme in discharge planning was interventions by clinical pharmacists (Anthony, 2009; Huws et al, 2008; and Makowsky et al., 2009). Makowsky et al. (2009) repres ented level 1++B evidence. Team care patients in multidisciplinary care groups that had a team‐based clinical pharmacist experienced fewer readmissions at 3 months after discharge. Having a pharmacist review medications at admission and discharge insured accurate transition to home with the appropriate discharge medications. Additional ly, a review of medications at discharge was a prompt for teaching related to new medications at discharge. Key case management recommendations included (a) comprehensive assessment of patient and family; (b) identification of education needs; (c) multidisciplinary collaboration to plan and coordinate health services; (d) discharge
29 planning, (e) linkage of patients with needed resources; and (f) monitoring the suitability of services arranged (Chan et al., 2008; Huws et al., 2008; and Jack et al., 2009). Additionally, core principles emerged: role delineation, patient education, team collaboration, patient literacy, written discharge plan, post discharge plan, and quality control (Anthony et al., 2005; Chan et al., 2008; Coleman, et al., 2004; and Jack et al ., 2009). The overall evidence to support key case management interventions is from well conducted systematic reviews of RCTs and high quality cohort studies. The literature provided vital information that can be used to help identify chronic pancreatitis patients at risk for hospital readmission. Additionally, implement ing an appropriate discharge plan with case management across the inpatient/outpatient continuum has proven benefits in reducing hospital readmissions. Five discharge planning/case management interventions did not show positive impact on lowering hospital admissions. They were (a) Admission avoidance hospital at home; (b) Chronic disease nurse consultant (CDNC); (c ) clinical pathways (CPW) for conditions managed on a CPW, regardless of diagnosis; (d) early discharge hospital at home shared care interventions; and (e) shared care interventions. Admission avoidance and early discharge interventions included hospital level of care delivered in the home. The chronic disease nurse consultant study attempted impl ementation of a multifaceted integrated health service program (Brand et al., 2004). When the results were not favorable for lowering hospital readmissions, it was difficult for the researchers to determine which aspect(s) of the intervention had been unsuccessful. While clinical pathways were not effective at lowering readmission rates, they did show
30 a positive effective on reducing inpatient complications and improved documentation (Rotter et al., 2010). Lastly, thirteen of fifteen studies in a review evaluating care coordination programs showed no difference in hospitalizations (Peikes et al., 2009). Of note, missing from care coordination programs was a transitional care component. Although these five studies did not sho w benefits in reducing hospital readmissions, they did reveal potential areas for future studies including care coordination with a transitional component, clinical pathway with a discharge planning component, and implementation/evaluation of selected components of a chronic disease model separately. Overall there were evidence‐based clinical practice interventions that support practice cha nge for discharge planning and case management. Kim & Soeken (2005) found in a high quality meta‐analysis of RCTs that discharge planning decreased hospital readmissions by 6%. Discharge planning strategies that identify patients at risk for readmissions so that implementation of effective interventions can occur. Additionally, adding pharmacist medi cation reconciliation and teaching component to discharge planning proved useful in decreasing medication errors. Successful case management interventions mimicked the nursing process of assessment, diagnosis, planning, implementation, and evaluation. Finally, collaboration with multidisciplinary team members proved to be a valuable aspect of case management. Discharge planning and case management interventions are supported in the literat ure.
31 Education/Self Management Interventions Six records specifically addressed education/self‐management and evidence levels were 1++B (3), 1+B (1), 2++C (1), and 3D (1). The evidence for education/self‐ management contained recommendations for professional development as well as patient education/self‐management. Joshi & Toskes (2005) was the only record in education/self‐management that addressed professional education. The case bas ed review and commentary received a rating of 3D because evidence was mostly expert opinion. However, recommendations for practice were congruent with those made in higher quality guidelines in general interventions (see Appendix A). The authors presented a continuing education module of assessment and management of patients with chronic pancreatitis . The key point that nurses should draw from Joshi & Toskes (2005) is the importance of maintaining current and accurate knowledge in nursing that is used to teach patients with chronic pancreatitis. In addressing patient education/self‐management, three of four systematic reviews were 1++ studies, with each having over 1900 participants (see Appendix A). These systematic re views showed that interventions with the following components significantly lowered readmission rates and improved self‐management skills: (a) patients were taught to carry out medical regimens specific to their disease, (b) patients were taught self‐management skills, (c) patients received a written education plan, (d) patients received written disease information, (e) patients received information about when to call the doctor, and (f) patients received emotional support that guided behavior change and supported patients/families in adapting to diagnosis. The
32 educational interventions in Effing et al. (2007), Tapp et al. (2007), and Coleman et al. (2004), resulted in fewer hospital admissions. These studies were rated 1++B, 1++B, and 2++C, respectively. Chronic populations included in these studies that compare to chronic pancreatitis were arthritis, congestive heart failure, COPD, diabetes, and hypertension. (Additional study populations are listed in Appendix D). Like chronic pancreatitis, these conditions all have home self‐care manag ement aspects and require patient compliance to prevent complications and/or disease exacerbation. While all of the interventions mentioned are safe enough to implement, efficacy should be evaluated in the primary population through monitoring of outcomes. The only intervention in education/self‐management that was not successful in reducing hospital readmissions was lay‐led self‐managemen t education programs (Foster et al., 2007). Foster et al. (2007) was a 1++B rated study and although the intervention did not impact readmissions, it did lead to modest, short‐term improvements in patients’ ability to manage their condition and in their perceptions of their own health. This sho uld be further evaluated specifically in patients with chronic pancreatitis because self‐management and health perceptions have been noted among causes that lead to hospital readmissions in patients with chronic pancreatitis. And if an intervention improves patients with chronic pancreatitis’ ability to better manage their condition, th e end result may be a decrease in hospital readmissions. Education is a key component in empowering patients with chronic pancreatitis to successfully self‐manage at home. To accomplish this feat , nurses must acquire and maintain current knowledge of chronic pancreatitis. After self preparation, nurses can
33 assess chronic pancreatitis patients for risks associated with hospital readmission and develop education plans that help them learn about their disease and how to manage their disease in a way that prevents hospital readmissions. Summary of Nursing Intervention Evidence Overall, nursing interventions are well documented in the evidence table. The literature supports nursing interventions that promote lifestyle changes for patients with chronic pancreatitis and management of hyperlipidemia. Additionally nausea management is supported with caution to prescribing nurses for antiemetic therapy. Discharge planning\case management and education/self‐management interventions are also well supported by the literature found in this review. The evidence to support nursing interventions included high quality RCTs , systematic reviews, and guidelines and should be implemented in caring for patients with chronic pancreatitis. Nutritional Interventions Nutritional interventions contained the highest level evidence upon which recommendations can be based (4 of 7 records were 1++A). The 4 highest level records in this category included en teral nutrition guidelines, a systematic review of comparison of enteral to parenteral feeding methods, parenteral nutrition guidelines, and comparison of homemade food with commercial supplements. The nutritional intervention records addressed malnutrition and steatorrhea prevention and proper use of enteral and nutrition therapy in p atients with chronic pancreatitis. Malnutrition and steatorrhea caused by pancreatic exocrine insufficiency are two major concerns for patients with chronic pancreatitis. Steatorrhea consists of fecal
34 excretion of more than 6g of fat per day, weight loss, and abdominal discomfort (Pezzilli, 2009). Fat malabsorption also causes a deficit of fat‐soluble vitamins (A, D, E and K). Treatment recommendations in this group take into account the need to correct pancreatic insufficiency with pancreatic extracts and promote duodenal pH to permit optimal absorption of pancre atic extracts (Pezilli, 2009). Normally, individuals eat food and the body’s natural digestion allows for adequate absorption of nutrients and elimination of waste. The best interventions for nutrition in individuals with chronic pancreatitis will mimic the natural process as much as possible. Studies supported benefits of implementing dietary chang es for individuals with chronic pancreatitis. Recommendations to change dietary intake to low fat diets (20 grams of fat per day) and small meals spread throughout the day were supported by all records in Nutritional Interventions and level 1++A records in the General Interventions sections of Appendix A. These recommendatio ns for diet modification were from consistent, quality evidence and are substantial enough to support practice. The evidence also supported dietary consultation for chronic pancreatitis patients experiencing malnutrition and/or steatorrhea (Singh et al, 2008; Trolli et al., 2001; Meier et al., 2006; and Gianotti et al., 2009). Dieticians are able to evaluate a patient’s nutritional status. A thorough nutritional assessment combined with personal prefer ences and limitations caused by chronic pancreatitis can be used to develop practical home meal plans. Dietary counseling for regular homemade food proved to be as effective as the use of commercial food supplements in im proving malnutrition in chronic pancreatitis patients (Singh et al., 2008). Enabling patients to prepare and eat
35 regular homemade foods could improve compliance with dietary recommendations because of flexibility and palatability of home food versus commercial food supplements. Additionally, the evidence supports pancreatic enzyme therapy to improve nutritional status (Callery & Freedman, 2008; Gupta & Toskes, 2005; Meier et al., 2006; Nair et al., 2007; Pezzilli, 2009; and Trolli et al., 2001). Patients who recei ved enzyme therapy had better serum albumin levels and were closer to their ideal body weights than those who did not receive pancreatic enzymes (Trolli et al., 2001). Meier et al. (2006) purport that more than 80 % of chronic pancreatitis patients can be treated with normal food and pancreatic enzyme combination therapy. Patients with a home regimen of a low fat diet with pancreatic enzym e supplementation could avoid malnutrition and steatorrhea that might lead to hospital admissions. The evidence supported the use of enteral nutrition only when patients are unable to eat food (Lordon et al., 2009; Krenitsky et al., 2007; and Meier et al., 2006). Krenitsky et al. (2007) and Meier et al. (2006) were both rated 1++A; however, Lordon et al. (2009) was underpowered. The literature reflected that after postprandial pain is managed, th e majority of individuals with chronic pancreatitis will be able to increase caloric intake. Adequate intake cou pled with pancreatic enzymes is sufficient to maintain ample nutrition and prevent malnutrition (Lordon et al., 2009; Krenitsky et al., 2007; and Meier et al., 2006). Tube feeding is only recommended in about 5% of chronic pancreatitis patients (Meier et al., 2006).
36 The evidence supports reserving the use of parenteral nutrition for patients with gastric outlet obstruction secondary to duodenal obstruction and in those with complex fistula disease that prevents the natural introduction of nutrition into the intestinal lumen (Gianotti et al., 2009; Krenitsky et al., 2007; Lordan et al., 2009; and Meier et al., 2006) . ESPEN guidelines for parenteral nutrition management do not oppose the use of parenteral nutrition, but assert that less than 1% of patients with chronic pancreatitis will need it. In fact, existing evidence from a review of 22 RCTs supports jejunal enteral nutrition as the preferred route of nutrition sup port when patients with chronic pancreatitis are unable to tolerate oral intake (Krenitsky et al., 2007). The evidence behind these statements is substantial enough to support clinical practice. By and large, the evidence for nutritional interventions supports oral intake with pancreatic enzyme therapy to prevent malnutrition and steatorrhea in patients with chronic pancreatitis. Th e small percentage of the population who are unable to tolerate food during bouts of painful flares should be fed enterally through the jejunum. Finally, parenteral nutrition should only be used in cases in which it is not possible to deliver nutrition enterally. Standardizing nutrition management using this stepwise approach should yield more independence an d improved quality of life for patients with chronic pancreatitis. Furthermore, a decrease in the use of feeding tubes and PICC lines for enteral and parenteral nutrition should yield fewer therapy complications that may lead to hospital readmissions for patients with chronic pancreatitis.
37 Pharmacological Interventions Pain is the chief reason that patients with chronic pancreatitis are readmitted to hospitals (Navaneethan & Vankataraman, 2010). Pancreatic pain has always been a subject of great interest and controversy. The precise pathogenesis of pain and its persistence in chronic pancreatitis patients remain unknown. There are, however, 3 pain theories: pancreatic, neurogenic and central (N avaneethan & Vankataraman, 2010). In the pancreatic theory, patients with a dilated main pancreatic duct experience increased intraductal pressure due to strictures/calculi, presence of interstitial hypertension, pancreatic ischemia and fibrosis, and pseudocyst (Navaneethan & Vankataraman, 2010). Neurogenic or neuropathic theory maintains that patients with chronic pancreatitis have enlarg ed intrapancreatic nerves with microscopic damage to nerve sheaths that makes them more susceptible to mediators (Navaneethan & Vankataraman, 2010). The central theory proposes that reorganization of neurons in the insula within the cerebral cortex may explain the chronic pain in these patients (Navaneethan & Vankataraman, 2010). Pharmacological pain management evidence addressed the se areas through (a) recommended approaches to chronic pain management in patients with chronic pancreatitis, (b) the use pancreatic enzymes and antioxidants, (c) the use of anticonvulsant/antipsychotic agents, and (d) the use of narcotics. While much of the evidence that addressed pharmacological interventions was high quality evidence, it did not support practice interventions for pain m anagement in patients with chronic pancreatitis. Three of 12 studies were 1++ rated studies and 8 of
38 12 were rated at least 1‐. However, many of these studies addressed pain in other populations and extrapolation would not be safe with the current evidence. Additionally, the studies that did address chronic pancreatitis pain, either did not show positive results from the intervention (Shafiq et al., 2009) or were grossly underpowered (Kongkam et al., 2009 an d Lieb II et al., 2009). Two reviews gave recommendations for chronic narcotic use for patients with chronic pancreatitis. Rated 1‐A and 2+D, respectively, Nair et al. (2007) and Gupta & Toskes (2005) both recommend a stepwise approach to pain management; avoiding narcotic prescribing because of the risk of dependence and addiction. Th ey advocate for the use of NSAIDs, acetaminophen, tramadol, and propoxphene before starting strong narcotic therapy. When narcotic usage is required, both authors propose introduction of long acting narcotics followed by short acting narcotics. However, recommendations for pain management from both these authors were made from expert opinion and need research in patients with chronic pancreatitis before practice changes can be support ed. Steer (as cited in Shafiq et al., 2009) claimed that pancreatic enzymes are the “mainstay of treatment for exocrine pancreatic insufficiency in chronic pancreatitis” (p. 3). It suppresses the release of cholecystokinin (CCK ) releasing peptide through negative feedback and may also produce pain relief through this same mechanism (Shafiq et al., 2009 and Pezzilli, 2009). However, the evidence in this review is contradictory. Shafiq et al. (2009) (a 1++A rated systematic review of RCTs) evaluated pancreatic enzyme therapy for pain management in patients with chronic pancreatitis
39 and determined that pancreatic enzymes may be an efficacious means to manage pain and fecal fat in patients with chronic pancreatitis. Winstead and Wilcox (2009) (rated 2++B) found that most studies in their review (5 of 9) reported that patients with chronic pancreatitis had no improvement in pain with pancreatic enzymes. Pancreatic enzym es’ use is an effective option in improving steatorrhea and weight loss, but their effect on pain management remains unclear. Although there is more evidence for than against, current published studies have not made the case for the usefulness of pancreatic enzymes in managing chronic pancreatitis pain. In keeping with the pancreatic theory, propon ents of antioxidant therapy propose that it has a positive effect on oxidative stress. Bhardwaj et al. (2009) found that antioxidant supplementation in patients with chronic pancreatitis showed a reduction in the number of painful days per month was significantly lower in patients receiving antioxidants. The study did demonstrate efficacy in pain relief over a 6 month period. Bhardwaj et al. (2009) was a 1+A rated we ll conducted double‐blinded placebo controlled study and results can be used for practice change; however, outcome measurements should be monitored to insure similar results in higher numbers of patients with chronic pancreatitis. Five pharmacological stu dies in the evidence table that evaluated analgesia in chronic neuropathic pain states were high quality systematic reviews from Cochrane Review (See Pharmacological Interventions, Appendix A). Five tricycle antipsychotic agents (flupentixol, fluphenazine, thioridazine, levomepromazine, prochlorperazine); a butyrophenone (haloperidol); and three benzamides (sulpiride, tiapride, pimozide) were evaluated. Four anticonvulsants were evaluated
40 (carbamazepine, gabapentin, lamotrigine, and pregabalin). All of these studies were rated at least 1+. However, the studies reported mixed results in addressing pain using antipsychotic and anticonvulsant agents. Although, antipsychotic therapy showed beneficial results, extrapyramidal side effects were experienced by some participants. Of the anticonvulsants, only carbamazepine and gabapentin had positive results. Carbamaz apine was effective in two thirds of study participants, but study samples were small. Forty two percent of patients receiving gabapentin reported decreased pain, versus 19% of patients receiving a placebo. The risks of implementing antipsychotics and anticonvulsants in patients with chronic pancreatitis may outweigh the benefits. Only three studies evaluated narcotic therap y (Dunlop & Bennett, 2006; Kongkam et al., 2009; and Staahl et al., 2007). A 1‐B rated systematic review; Dunlop & Bennett (2006) evaluated NSAIDS, strong opiods, and corticosteroids in sickle cell management and found that parenteral coritcosteroids appeared to shorten the length of hospital stay. This, ho wever, required inpatient hospitalization for administration and the purpose of this review was to identify interventions to prevent hospital readmissions for patients with chronic pancreatitis. Kongkam et al. (2009) and Staahl et al. (2007) (rated 2‐C & 2+C, respectively) were both grossly underpowered (having samples of less than 15 each) and n eed further research. Interventions evaluated in these 2 studies included the efficacy of intrathecal narcotic pump use and the use of oxycodone versus morphine. One final study that evaluated pharmacological management was also underpowered and need further research (Lieb II et al., 2009).
41 The studies and systematic reviews of interventions to manage pain in individuals with chronic pancreatitis varied greatly. Shafiq et al. (2009) and Bhardwaj et al. (2009) were the only studies that evaluated pain management interventions in the chronic pancreatitis patient population. Other study populations included patients with neuropathic pain, those with neurologic pain, sickle ce ll patients, and other chronic pain states. Had the evidence reflected successful interventions in these populations, extrapolation may have been used to recommend clinical trials in patients with chronic pancreatitis using the neurogenic theory for etiology of pancreatic pain. Conversely, the literature in this review demonstrated that pharmacological interventions for pain managemen t in chronic pancreatitis remain an issue of ambivalence. Thus, there is a need for more clearly focused research for pain management in patients with chronic pancreatitis. Psychosocial Interventions The pain of chronic pancreatitis, urgency of unexpected steatorrhea, and the disease’s unpredictability may all affect quality of life. Healt h related quality of life as perceived by the patient is a major concern in evaluating interventions to manage chronic pancreatitis (Pezzilli et al., 2006). This issue becomes more complex when the aim of interventions is keeping patients symptom free and out of the hospital for longer periods of time (Pezzilli et al., 2006) . There were five studies reviewed that focused on improving quality of life. Psychosocial interventions ranged from assessment of quality of life intended to improve medical management to alternative therapies for improving quality of life. Alternative therapies have offered benefits to many patients over the
42 course of history. From biofeedback to intensive psychotherapy, many individuals have experienced success when alternative therapies have been introduced as an adjunct to other well established clinical practices. Two studies that received the highest rating (1++A) evaluated the Short Form (SF‐12TM) Health Survey tool. The tool allows assessors to query patients about physical fun ctioning, role limitations, bodily pain, general health, vitality, social functioning, and general mental health. The SF‐12TM was determined to be a valid measure of self‐reported health status indicators developed to assess and monitor functional health for quality of life during the clinical course of chronic pancreatitis (Pezzilli, Morselli‐Labate, Fantini, Campana, & Corinaldesi, 2007 and Pezzilli, Morselli‐ Labate, Fant ini, Gullo, & Corinaldesi, 2007). It was also shown to be effective in identifying health needs to improve decision making, resource utilization, and health outcomes for patients with chronic pancreatitis (Pezzilli, Morselli‐Labate, Fantini, Campana, & Corinaldesi, 2007 and Pezzilli, Morselli‐Labate, Fantini, Gullo, & Corinaldesi, 2007) . Most patients with chronic pancreatitis who were followed over a 2 year period had stable scores in mental and physical component summaries of the SF12TM (Pezzilli, Morselli‐Labate, Fantini, Gullo, & Corinaldesi, 2007). The only clinical variable positively related to improvement in the mental component summary was age. Younger patients with chronic pancreatitis appear to need more ps ychological support for their disease. Recognizing the need for additional psychological support, nurses have an opportunity to design and develop interventions that offer this additional needed support.
43 The main additional value of quality of life measurements for patients with chronic pancreatitis is the reflection of patients’ direct points of view regarding the disease’s impact and their function and/or well‐being (Pezzilli, Morselli‐Labate, Fantini, Gullo, & Corinaldesi, 2007). The use of the SF‐12TM as a valid and reliable measure of quality of life in patients with chronic pancreatitis has strong clinical evidence and can be used to evaluate nursing and alternative therapies’ effecti veness for patients with chronic pancreatitis. Three records documented the use of alternative therapies to improve quality of life for patients. One study, rated 2++B, evaluated yoga for patients with chronic pancreatitis (Sareen et al ., 2007). Another study, rated 2+C, evaluated psychosocial support for patients with chronic pancreatitis (Shepp et al., 1999). The systematic review, rated 1‐B, investigated the use of hypnotherapy in a non‐pancreatitis gastrointestinal population (Webb et al., 2007). All three resulted in rep orted improved quality of life by participants, but sample sizes in the 2 studies were small and the review reported “poor methodological quality” and small sample sizes in individual studies (Webb et al., 2007, p. 8). Although Astin, Shapiro, Eisenberg, & Forys (2003) confirmed the efficacy of mind‐body therapies in other illnesses, these 3 alternative therapies require further resea rch. All three of these records present valuable evidence to consider. Implementing any of these interventions in a study using the SF12‐TM to monitor quality of life may support the interventions’ benefit to patients with chronic pancreatitis.
44 4.2.2 Evidence Level Analysis An evidence level analysis summary was compiled to note the total level of evidence found in this review (see Appendix D). Although, the evidence was synthesized by clinical practice category, it was important to note the overall evidence ratings. Thirty five (60%) of the 58 records were rated as level 1 or above. Addi tionally, 56 (96%) of the 58 were rated in level 2 or higher. Finally, 26 (44%) of the 58 records reviewed had patients with chronic pancreatitis as the target population and 10 (38%) of those records met criteria for the highest evidence level. The level of high quali ty evidence found in this review supports recommendations for practice change and solidifies the need for additional research in areas as noted in the clinical practice analysis. 4.3 Summary The evidence analysis revealed a variety of effective interventions that may be implemented to decrease hospital readmissions in patients with chronic pancreatitis. Evidence supported alcohol & smok ing cessation and hyperlipidemia management. Additionally, high quality population specific evidence was found that supported dietary and nutrition therapy recommendations. Likewise, the evidence related to discharge planning, case management, education, SF12‐TM health survey, and self‐management all had strong implications for nursing practice. In contrast, the analysis of evidence relat ed to pain management for patients with chronic pancreatitis confirmed prior reports of ambiguity. When the results of two high quality studies contradict one another, practitioners are left confounded by such
45 results. The evidence does not solidly identify which pain management strategies are effective for patients with chronic pancreatitis. While there were some high quality evidence sources available to promote nursing practice that prevented hospital readmission in this population, much research and knowledge building is still needed to improve clinical management of this grou p. Proven interventions need to be implemented in clinical settings and outcomes monitored to confirm decreases in hospital readmissions for patients with chronic pancreatitis. Areas in which the evidence is weak or absent could be improved by collaborative partnerships of clinical nurses and nurse researchers.
46 CHAPTER V E VIDENCE I MPLICATIONS AND C ONCLUSIONS Etiologies surrounding unplanned hospital admissions can be classified into one of three categories: (a) health care system related issues, (b) clinician related issues, and (c) patient related issues (Anthony et al., 2005). Proactively identifying these barriers to successful discharge transition for patients with chronic pancreatitis is critical in preventing readmissions. A successful process should have a multidisciplinary approach to care, a cl ear delineation of roles and responsibilities in the process, and implementation of a clearly defined process. The following sections address, (a) evidence‐based recommendations (b) clinical practice implications, (c) quality and safety implications, (d) health policy implications, and (e) research implications in the managemen t of patients with chronic pancreatitis.. The chapter concludes with a summary of evidence‐based implications and conclusions about…. 5.1 Evidence‐Based Recommendations Evidence‐based practice recommendations are listed below by categories used in the evidence table (see Appendix A). The level of evidence to support practice recommend ations is inserted in parentheses following each recommendation. Nursing Interventions (1) Alcohol and smoking cessation recommendations are supported by multiple studies (Evidence Level 1++A). (2) Hypertriglyceridemia management should involve increased activity/exercise, dietary changes, medication management such as bile acid‐binding sequestrants,
47 cholesterol absorption inhibitors, fibrates, and statins, and normalizing weight (Evidence Level 1++A). (3) Patients with chronic pancreatitis at high risk for readmission should be assigned to inpatient and outpatient case management (Evidence Level 1++B). (4) Patient education should include (a) teaching about the pathophysiology and management of chronic pancreatitis, (b) home self‐management skills, (c) written education plans, (d) written disease infor mation, (e) list of symptoms or complications for which to call the doctor, (f) family or caregiver involvement and (g) emotional support (Evidence Level 1++B). Nutritional Interventions (1) Nurses should recommend dietary changes for individuals with chronic pancreatitis. Dietary intake should include low fat diets (20 grams of fat per day) an d small meals spread throughout the day (Evidence Level 1++A). (2) Patients with chronic pancreatitis should receive dietary consultation to manage and prevent malnutrition and/or steatorrhea (Evidence Level 1++A). (3) Pancreatic enzyme therapy should be used to improve nutritional status (Evidence Level 1++A). (4) Enteral n utrition should only be used when patients are unable to physically eat (Evidence Level 1++A). (5) Parenteral nutrition should only be used for patients with gastric outlet obstruction secondary to duodenal obstruction and in those with complex fistula
48 disease that prevent the natural introduction of nutrition into the intestinal lumen (Evidence Level 1++A). Psychosocial Interventions (1) SF‐12TM Health Survey should be used to assess and monitor functional health status for patients with chronic pancreatitis (Evidence Level 1++A). 5.2 Clinical Practice Implications Nurses practicing in a variety of settings and roles can utilize evidence‐based nursing interventions in clinical practice. Regardless of the area of nursing practice, effective management of chronic pancreatitis requires a collaborative multidisciplinary team approach that includes nursing, nutritional, pharmacological, and psychosocial interventions. Advanced practice nurses have clearly delin eated roles and implications in the management of patients with chronic pancreatitis. Implications for the following advanced practice nursing roles are discussed in this section: (a) Nurse Case Managers, (b) Clinical Nurse Specialists, and (c) Nurse Practitioners. 5.2.1 Advanced Practice Implications Nurse Case Managers The Case Management Society of America (2010) describes case manag ement as the “collaborative process of assessment, planning, facilitation and advocacy for options and services to meet an individual's health needs through communication and available resources to promote quality cost‐effective outcomes.” Nurse case managers should view the findings of this evidence‐based practice project and implement supported case managemen t and discharge planning into clinical practice. Nurse case managers caring
49 for patients with chronic pancreatitis should function in inpatient and outpatient roles. Advanced practice nurse case managers must insure that patients with chronic pancreatitis receive cost‐effective inpatient interventions in a timely manner. They should also insure that patients with chronic pancreatitis are discharged with appropriate community resources, such as primary ca re physician follow‐up, pain management, gastroenterology follow‐up, and home health when needed for nutritional support in enteral or parenteral therapy. Furthermore, the nurse case manager should insure telephone follow‐up with patients occurs to verify that the discharge plan has transpired as planned and that patients have received discharge resources. Additionally, the nurse case manager should communicate the plan of care with team members across the continuum so th at all health care providers and patients are aware of the treatment plan. Communication should also be forwarded to the outpatient case management teams for continuity of care for patients with chronic pancreatitis. Finally, nurse case man agers should regularly monitor outcome data related to hospital readmissions for patients with chronic pancreatitis to confirm impact of case management services. Clinical Nurse Specialists Like the nurse case manager, the clinical nurse specialist (CNS) can function in inpatient and outpatient settings. The National Association of Clinical Nurse Specialists developed a framework for CNS practice that organizes competenci es around three spheres of influence. They are represented by the stakeholders of CNS practice: patients, nursing personnel, and organizations network (Zuzelo, 2003). The CNS
50 managing chronic pancreatitis patients in an inpatient setting should facilitate translation of research into practice by helping nursing staff understand evidence‐based implications for nursing care of patients with chronic pancreatitis. The CNS should insure that patient education occurs early in the hospital stay so that patients with chronic pancreatitis understand anatomy/physiology of the disease and treatment options . The CNS should also integrate nursing knowledge to develop, implement, and evaluate nursing care for the patient with chronic pancreatitis through quality improvement initiatives. In the outpatient arena, this process should be continued by the CNS to insure that care provided continues to be evidence‐based an d that the patient understands the plan of care and appropriate resources to use in managing this chronic illness. The outpatient CNS should continue education started inpatient in structured outpatient education that includes written and verbal information about and how to manage the disease will improve patients’ self‐management skills. Practice innovations such as hom e visits in which the CNS is able to observe patients preparing healthy meals and demonstrating the ability to utilize pancreatic enzyme therapy may also prevent hospital readmissions. Finally, both inpatient and outpatient CNSs should participate in research to build evidence‐based knowledge for patients with chronic pancreatitis. Nurse Practitioners Nurse practitioners (APRNs) in primary car e who are prepared to manage patients with chronic pancreatitis can also help prevent costly readmissions. APRNs are likely to see patients in primary care who have been diagnosed with chronic pancreatitis or who,
51 because of lifestyle risk factors (alcohol use, smoking, high fat diets, etc), may develop chronic pancreatitis. Carefully assessing patients with chronic pancreatitis for malnutrition and steatorrhea to prescribe appropriate diet changes and pancreatic enzyme therapy is an important implication for APRNs in primary care. APRNs should only refer chronic pancreatitis patients for enteral or parenteral nutritio n when patients are unable to eat or have gastric outlet obstruction because of duodenal obstruction, respectively. When patients have been managed on parenteral nutrition, APRNs must monitor trigyceride levels and treat for hyperlipidemia, accordingly. Knowledge of the latest evidence related to chronic pancreatitis will help insure that the APRN provides appropriate care and recommends proper therapy through education, interventions, and referral s when needed. Additionally, the ability of APRNs to manage patients with chronic pancreatitis in rural areas who, might not otherwise, have timely access to care can help prevent the progression of disease and avoid readmissions by managing complicatio ns as they arise. 5.2.2 Summary The evidence‐based practice recommendations from this review can aid advanced practice nurses in management of chronic pancreatitis in several ways. First, is primary prevention in which the advanced practice nurse provides education regarding risk factors of chronic pancreatitis, such as alcohol ingestion and smoking, is key in averti ng the incidence of the disease. Secondary prevention, such as early diagnosis of chronic pancreatitis, encouraging alcohol and smoking cessation, encouraging adherence to diet and medication regimens, and implementing
52 psychosocial interventions to reduce chronic pancreatitis‐related stress are all crucial roles of the advanced practice nurse. Lastly, because the evidence does not support practice changes in pain management, Nurse Practitioners must carefully assess the use of narcotic therapy for patients with chronic pancreatitis in individual practice settings. The nurse case manager, clinical nurse specialis t, and nurse practitioner should form collaborative partnerships to combine knowledge and practice skills to better manage nursing care of patients with chronic pancreatitis. 5.3 Quality and Safety Implications Nurses should implement evidence‐based interventions that will improve delivery of quality care for patients with chronic pancreatitis to decrease readmissions (see Evidence‐based Recommendations 5.1) . Interventions listed are based on evidence from high quality meta‐analyses, systematic reviews of randomized controlled trials, and well conducted randomized trials. Pain management and infection control are the two major areas of safety concerns in the clinical management of patients with chronic pancreatitis. Chronic opioid analgesic therapy (COAT) for benign nonmalignant pain is controversial (Fish bain, Lewis, Gao, Cole, & Rosomoff, 2009). Use of unsubstantiated COAT practice for chronic pancreatitis patients may result in inappropriate pain management and under or over prescribing of COAT. Given the lack of evidence to support practice, nurses must exercise due diligence in this area. In cases that necessitate the use of COAT, referra ls to pain specialists may be warranted. When APRNs find it necessary to manage patients
53 on COAT, compliance monitoring should be undertaken to protect patients from harm and nurses against cases of alleged medical mismanagement (Fishbain et al., 2009). As for infection control, implementing evidence‐based interventions, such as only using parenteral nutrition when other alternatives have failed will decrease complications related to enteral and jejunal tube feeding an d peripherally inserted central catheter (PICC) therapy. Additionally, teaching chronic pancreatitis patients who must receive PICC and or jejunal feeding to safely manage therapy in the home will also improve patient safety and decrease complications that lead to hospital readmissions. Interdisciplinary collaboration with team pharmacist is also an evidence‐based recommend ation. The evidence showed that patients who received medication education from a clinical pharmacist as part of interdisciplinary team rounds and planning had a less medication errors that led to hospital readmissions. Another role of the pharmacist that improved patient safety and decreased medication errors is medication reconciliation. Nurses mu st insure team collaboration for the most effective implementation of evidence‐based recommendations. Nurses delivery of evidence‐based practice that prevent problems with pain management and decrease infections can help prevent complications that lead to hospital readmissions. Additionally collaboration with other disciplines to achieve positive quality and safe outcomes is an expect ed role of the nurse. 5.4 Health Policy Implications Implications for health care policy from this evidence‐based practice project focus on hospital policy development, hospital/sponsor collaboration, and
54 implementation of national health care reform benefits. These 3 areas have an impact on how organizations should deliver, provide and finance services for patients with chronic pancreatitis. Project findings support efforts by hospital administrators to develop policies for enteral and parenteral nutrition in patients with chronic pancreatitis. Support for these interventions should incl ude employee training to minimize the use of enteral and parenteral nutrition therapy in patients with chronic pancreatitis. This may result in lower jejunostomy tube and peripherally inserted central catheter complications that can lead to readmissions. Consistent use of this practice could also result in lower use of enteral and parenteral nutrition and improve car e outcomes and minimize Medicare related non‐payment penalties for hospital readmissions. Additionally, decreasing readmissions related to chronic pancreatitis could yield more available hospital beds, thus potentially increasing hospital revenue. Early identification of patients at risk for readmission secondary to complications from chronic pancreatitis also has he alth policy implications. Many insurance companies have case managers who can collaborate with hospital case managers to implement evidence‐based interventions to reduce subsequent costs and adverse health outcomes. A collaborative partnership of hospital and insurance case managers can help prevent hospital readmissions. Nurses need to combine knowledge of evidence‐based interv entions for patients with chronic pancreatitis with health care reform initiatives to improve patient care. Provisions in health care reform intended to help patients like those with chronic
55 pancreatitis that have already taken effect include (a) small business tax credits, (b) ending of rescission, (c) interim high risk pool, and (d) increased funding to community health centers (Health care reform, 2010). Individuals with chronic pancreatitis who may have lost a job because their chronic illness led to higher insurance pr emiums for small business employers may no longer be so unfortunate. Small businesses that offer affordable coverage to employees can take a tax credit to offset the cost. Health care reform also ended rescission, prohibiting health plans from cancelling enrollees’ coverage when they get sick. Furthermore, interim high risk pool benefits for uninsured patients with chronic pancreatitis could mean the difference in affording high cost pancreatic enzyme prescriptions. Th ese benefits may decrease stress related to potential job loss, insurance coverage, and ability to afford medications; and subsequently prevent a pancreatitis flare. Finally, health care reform’s increased funding to community health centers will allow nurses to see more patients and increas e access to care. Collectively, these benefits of health care reform and nurses’ knowledge of evidence‐based interventions for patients with chronic pancreatitis can help prevent hospital readmissions. In summary, nurses need to identify policy changes to improve care for patients with chronic pancreatitis . Nurses need to help patients with chronic pancreatitis identify and access health care resources. Nurses should also be active in health policy initiatives at organizational and/or national levels. Moreover, nurses must wholeheartedly embrace opportunities to collaborate with sponsors and utilize available resources to help improve overall management of patients with chronic pancreatitis.
56 5.5 Research Implications Nursing, nutritional, pharmacological, and psychosocial interventions for patients with chronic pancreatitis require further research in the areas of: (a) discharge planning and case management, (b) clarification of overall pain management, (c) the role of pancreatic enzymes in pain management, and (d) identification of appropriate psychosocial interventions to yield improved quality of life. Much high quality evidence was found that reported effectiv e interventions for discharge planning and case management in hospitalized and outpatient populations. These interventions were shown to be effective in lowering hospital readmission rates in other chronic populations. However, successful interventions should be evaluated in patients with chronic pancreatitis for population specific re sults in preventing hospital readmissions. The area requiring the most research is pain management. Pharmacological research is needed to clarify pain management interventions that can be consistently implemented across practice settings for patients with chronic pancreatitis. The literature reflects three different theories of the etiology of pain in chronic pancreatitis. Resea rchers must first determine which is most accurate so that pharmacological interventions may be directed to the correct source of the pain. Then, large scale double‐blinded randomized controlled trials should be conducted to determine effective medications and adequate dosage needed to treat pain in chronic pancreatitis patien ts. Another pain management area that needs additional research is the use of pancreatic enzymes. Although pancreatic enzymes to improve pancreatic exocrine
57 function have been studied with positive results, the effect of pancreatic enzyme therapy in pain management has received varying results. A complete review of all individual studies that evaluated pancreatic enzymes’ use in pain management, followed by clearly focused research, is needed to evaluate efficacy of pancreatic enzymes for managing pain. Finally, re search is needed to identify appropriate techniques for helping patients with chronic pancreatitis cope with their illness. Families and caregivers should be included. Randomized controlled trials that evaluate alternative therapies using the SF‐12 health survey to measure quality of life would help identify effective psychosocial strategies for patients with chronic pancreatitis. Improved quality of life could help these patien ts manage this debilitating disease and decrease hospital readmissions. Research conducted to identify successful interventions to develop safe discharge plans, manage pain, and improve quality of life for patients with chronic pancreatitis could decrease hospital readmission. Given the burden to patients & families and the financial implication s of readmissions on the health care system, nurse researchers and clinicians need to collaborate to gather a body of evidence that can be successfully translated into practice. 5.6 Summary Individuals with chronic pancreatitis often report a life filled with pain, dysfunctional relationships related to maladaptive responses to illness, and multiple hospital readmissions (Pezilli, Morselli‐Labate, Fantini, Gullo, & Corinaldesi, 2007).
58 Some live with the stigma of being pain seekers or not having real pain and do not seek treatment until pain has escalated to a level that requires inpatient management. Evidence‐based recommendations identified in this review may greatly impact the quality and safety of clinical practice for patients with chronic pancreatitis. Additionally, the recommendations may improve patients’ q uality of life while significantly lowering hospital admissions and the associated financial ramification. Moreover, further research in areas of need will help identify additional nursing, nutritional, pharmacological, and psychosocial interventions that, when implemented, will reduce hospital readmissions for patients with chronic pancreatitis.
59 REFERENCES (2001). DISCHARGE PLANNING ADVISOR. Initiative cuts ED visits, hospital admissions: 'phone monitor' role gives continuity to program. Hospital Case Management, 9(4), 59. Retrieved from CINAHL Plus with Full Text database. (2010). Home care nurses help patients avoid readmission: hospital, agency collaborate to ensure safe transition. Hospital Case Management, 18(2), 22. Retriev ed from CINAHL Plus with Full Text database. Agency for Healthcare Research and Quality (AHRQ). (2007). Agency for Healthcare Research and Quality Strategic Plan. Retrieved online March 24, 2010 at http://www.ahrq.gov/about/stratpln.htm Agency for Healthcare Research and Quality. (2008). Quality/effectiveness research, Retrieved online February 1, 2010 at http://www.ahrq.gov/research/nov08/1108RA17.htm American Gastroenterology Association (2010). Website review. http://www.gastro.org/ American Hospital Association. (2009). Framework for classifying readmissions that may be appropriate for inclusion in proposed readmissions policies in: Readmissions and Efficiency Initiatives – American Hospital Association Conference 2009. Anthony, D., Chetty, V. K., Kartha, A., McKenna, K., DePaoli, M. R., & Jack, B. (2005). Re‐ engineering the hospital discharge: An exampl e of a multifaceted process evaluation. Advances in Patient Safety, 2, 379‐394. Aquino, A.C. (Ed.). (2008). Gastroenterology Nursing: A Core Curriculum (Third ed.). Saint Louis: Society of Gastroenterology Nurses and Associates. Appraisal of Guidelines for Research & Evaluation Collaboration. (2001). Appraisal of Guidelines for Research & Evaluation (AGREE) Instrument. Retriev ed online March 06, 2009 at http://www.agreecollaboration.org/pdf/agreeinstrumentfinal.pdf Astin, J.A., Shapiro, S.L., Eisenberg, D.M., & Forys, K.L. (2003). Mind‐body medicine: state of the science, implications for practice. Journal of American Board of Family Practice, 16 (2), 131‐147. doi: 10.3122/jabfm.16.2.131 Bhardwaj, P., Garg, P. K., Maulik, S. K., Saraya, A., Tandon, R. K., & Acharya, S. K. (2009). A randomized controlled trial of antioxidant supplementation for pain relief in patients with chronic pancreatitis. [d oi: DOI: 10.1053/j.gastro.2008.09.028]. Gastroenterology, 136(1), 149‐159.
60 Bodenheimer, T. S., & Grumbach, K. (Eds.). (2002). Understanding Health Policy: A Clinical Approach (Third ed.). New York: Lange Medical, McGraw‐Hill. Brand, C., Jones, C., Lowe, A., Nielsen, D., Roberts, C., King, B., et al. (2004). A transitional care service for elderly chronic disease patients at risk of readmission. Australian Health Review, 28(3), 275‐284. Retrieved from CINAH L Plus with Full Text database. Burns, N. & Grove, S.K. (2005). Review of Relevant Literature in: The practice of nursing research: conduct, critique, and utilization, 5 th edition. St. Louis: Elsevier Saunders. Callery, M. P., & Freedman, S. D. (2008). A 21‐year‐old man with chronic pancreatitis. JAMA: Journal of the American Medical Association, 299(13), 1588‐1594. Case Management Society of America. (2010). What is a case manager? Retrieved online February 13, 2010 at http://www.cmsa.org/PolicyMaker/ResourceKit/AboutCaseManagers/tabid/141 /Default.aspx Castro, M., Zimmermann, N.A., Crocker, S., Bradley, J., Leven, C., & Schechtman, K.B. (2003). Asthma intervention program prevents readmission in high healthcare users. American Journal of Respiratory and Critical Care Medicine 168. 1095‐ 1099. Originally Published in Press as DOI: 10.1164/rccm.200208‐877OC on June 13, 2003.
61 de Burgoa, L., Seidner, D., Hamilton, C., Stafford, J., & Steiger, E. (2006). Examination of factors that lead to complications for new home parenteral nutrition patients. Journal of Infusion Nursing, 29(2), 74‐80. Retrieved from CINAHL Plus with Full Text database. de Lissovoy, G., Fraeman, K., Hutchins, V., Murphy, D., Song, D., & Vaugh n, B. (2009). Surgical site infection: incidence and impact on hospital utilization and treatment costs. American Journal of Infection Control, 37(5), 387‐397. Retrieved from CINAHL Plus with Full Text database. DeLegge, M., Borak, G., & Moore, N. (2005). Central venous access in the home parenteral n utrition population‐you PICC. JPEN Journal of Parenteral & Enteral Nutrition, 29(6), 425‐428. Retrieved from CINAHL Plus with Full Text database. Demarco, J., & Nystrom, M. (2009). Expanding education technology to meet the needs of Patients, families, and clinicians. Health Promotion Practice, 10(1), 15‐23. Retrieved January 28, 2009, from CINAHL Plus with Full Text database. DiMagno, M. J. & DiMagno, E.P. (2009). Chronic pancreatitis. Current Opinion in Gastroenterology, 25: 454‐459. Douglas, S., Daly, B., Kelley, C., O'Toole, E., & Montenegro, H. (2007). Chronically critically ill patients: health‐related quality of life and resource use after a disease man agement intervention. American Journal of Critical Care, 16(5), 447‐ 457. Retrieved from CINAHL Plus with Full Text database. Dunlop, R. & Bennett, K.C.L.B. (2009). Update. Pain management for sickle cell disease in children and adults. Cochrane Database of Systematic Reviews 2006, Issue 2. Art. No.: CD003350. DOI: 10.1002/14651858.CD003350.pub2 Editorial Board Palliative Car e: Practice Guidelines. (2006). Nausea and vomiting. Utrecht, The Netherlands: Association of Comprehensive Cancer Centres (ACCC); NGC:006067. Retrieved online February 2, 2010 at http://ngc.gov/summary/pdf.aspx?doc_id=11793&stat=1&string=nausea+and+v omiting Effing, T., Monninkhof, E.E.M., van der Valk, P.P., Zielhuis, G.G.A., Walters, E.H., van der Palen, J.J., & Zwerink, M. (2007). Self‐management education for patients with chronic obstructive pulmonary disease. Cochrane Database of Systematic Reviews 2007, Issue 4. Art. No.: CD002990. DOI: 10.1002/14651858.CD002990.pub2.
62 European Society for Clinical Nutrition and Metabolism (ESPEN). (n.d.). Guidelines and position papers from the European Society for Clinical Nutrition and Metabolism. Viewed online April 23, 2010 at http://www.espen.org/espenguidelines.html Everhart, J.E. (2008). Pancreatitis In: Everhart JE, editor. The burden of digestive diseases in the United States. US Department of Health and Human Services, Public Health Service, National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases. Washington, DC: US Government Printing Office; NIH Publication No. 09‐6443 [119‐123] . Retrieved online January 31, 2010 at http://www2.niddk.nih.gov/NR/rdonlyres/0B814CEA‐222A‐4677‐9B38‐ 89D3BC34E1F4/0/BurdenDD_US_Bookmarks_Jan2009.pdf Fishbain, D.A., Lewis, J.E., Gao, J., Cole, B., & Rosomoff, R.S. (2009). Alleged medical abandonment in chronic opioid analgesic therapy: Case report. American Academy of Pain Medicine, 10(4), 722‐729. Fletcher, B., Berra, K., Ades, P., Braun, L. T., Burke, L. E., Durstine, J. L., et al. (2005). Managing abnormal blood lipids: a collaborative approach. . Circulati on, 112(20), 3184‐3209.Retrieved online February 2, 2010 at http://ngc.gov/summary/summary.aspx?doc_id=8463&nbr=004724&string=Ma naging+AND+abnormal+AND+blood+AND+lipids%3a+AND+collaborative+AND+a pproach Foster, G., Taylor, S.J.C., Eldridge, S., Ramsay, J., & Griffiths, C.J. (2007). Self‐ management education programmes by lay leaders for people with chronic conditions. Cochrane Database of Systematic Reviews 2007, Issue 4. Art. No.: CD005108. DOI: 10.1002/14651858.CD005108.pub2. Gianotti, L., Meier R., Lobo, D.N., Bassi, C., Dejong, C.H., Ockenga, J., Irtun, O., Mac Fie, J. (2009). ESPEN Guidelines on parenteral nutrition: Pancreas. European Society for Clinical Nutrition and Metabolism, Clinical Nutrition, 28(4), 428‐35. [Practice Guideline] UI: 19464771 Goldfield, N.I., McCullough, E.C., Hughes, J.S., Tang, A.M., Eastman, B., Rawlins, L.K., and Averill, R. F. (2008). Identifying potentially preventable readmissions. Health Care Financi ng Review 30(1), 75‐91. Retrieved January 23, 2009 from http://www.cms.hhs.gov/HealthCareFinancingReview/downloads/08Fallpg75.pd f Greenwald, J., & Jack, B. (2009). Preventing the preventable: reducing rehospitalizations through coordinated, patient‐centered discharge processes. Professional Case Management, 14(3), 135‐142. Retrieved from CINAHL Plus with Full Text database.
63 Gruesser, M., Hoffstadt, K., & Joergens, V. (2003). Structured outpatient education and Treatment programs for the patients with diabetes mellitus and/or hypertension: the German experience. Disease Management & Health Outcomes, 11(4), 217‐223. Retrieved January 28, 2009, from CINAHL Plus with Full Text database Guarner, L., Navalpotro B., Molero X., Giralt J., & Malagelada J.R. (2009). Management of painful chronic pancreatitis with single‐dose radiotherapy. American Journal of Gastroent erology. 104(2):349‐55. UI: 19190609 Gupta, V. and Toskes, P. (2005). Diagnosis and management of chronic pancreatitis. Postgraduate Medical Journal, 81(958): 491–497. doi: 10.1136/pgmj.2003.009761. Halfon, P., Eggli, Y., Pretre‐Rohrbach, I., Meylan, D., Marazzi, A., & Burnand, B. (2006). Validation of the potentially avoidable hospital readmission rate as a routine indicator of the quality of hospital care. Medical Car e 44(11), 972‐981, November 2006. Health care reform. (2010). Fact Sheet: The Affordable Care Act’s New Patient’s Bill of Rights. Accessed online June 22, 2010 at http://healthreform.gov/newsroom/new_patients_bill_of_rights.html Hussain, N. & Karnath, B. (2005). Chronic pancreatitis. Emergency Medicine, 37(5), 11‐ 17. Huws, D. W., Cashmore, D., Newcombe, R. G., Roberts, C., Vincent, J., & Elwyn, G. (2008). Impact of case management by advanced practice nurses in primary care on unplanned hospital admissions: a controlled intervention study. BMC Health Services Re search, 8, 115‐115. Institute for Clinical Systems Improvement (ICSI) (2007). Lipid management in adults. Bloomington (MN): Institute for Clinical Systems Improvement (ICSI) NGC:005886; Retrieved online February 2, 2010 at http://ngc.gov/summary/pdf.aspx?doc_id=11285&stat=1&string=lipid+AND+ma nagement+AND+adults Jack, B. W., Chetty, V. K. et al. (2009). A reengineered hospital discharge program to decrease rehospitalization. Annals of Internal Medicine 150(3): 178‐187. Jacob, L., & Poletick, E. (2008). Systematic review: predictors of successful transition to community‐based care for adults with chronic care needs. Care Management Journals, 9(4), 154‐165. Retrieved from CINAHL Plus with Full Text database.
64 Jansen, M. & Zwygart‐Stauffacher, M. (2010). Healthcare policy: Implications for advanced practice nurses in Advanced Practice Nursing: Core Concepts for Professional Role Development. Springer Publishing Company: New York. pp 123‐152. Johnson, A., Sandford, J., & Tyndall, J. (2003). Written and verbal information versus verbal information only for patients being discharged from acute hospital settings to ho me. Cochrane Database of Systematic Reviews 2003, Issue 4, 2003, Art. No.: CD003716. DOI: 10.1002/14651858.CD003716. Jencks, S.F., Williams, M.V., & Coleman, E.A. (2009). Rehospitalizations among patients in the medicare fee‐for‐service program, New England Journal of Medicine, (360), 1418‐1423. Joshi, P, & Toskes, P.P. ( 2005) Clinical approach to chronic pancreatitis. Journal of Clinical Outcomes Management. 12(8),419–428. Kim, Y.J. & Soeken, K.L. (2005). A meta‐analysis of the effect of hospital‐based case management on hospital length‐of‐stay and readmission. Nursing Research 54(4), 255–264. Kongkam, P., Wagner, D. L., Sherman, S., Fogel, E. L., Whittaker, S. C., Watkins, J. L., et al. (2009) . Intrathecal narcotic infusion pumps for intractable pain of chronic pancreatitis: A pilot series. The American Journal of Gastroenterology, 104(54), 1249‐1255. Kozak, L.J., Owings, M.F., Hall, M.J. (2005). National Hospital Discharge Survey: 2002 annual summary with detailed diag nosis and procedure data. National Center for Health Statistics. Vital Health Statistics 13(158). Retrieved online February 16, 2010 at http://digestive.niddk.nih.gov/statistics/statistics.htm Krenitsky, J., Makola, D., Parrish, C.R. (2007). Parenteral nutrition in pancreatitis is passé?: But are we ready for gastric feeding? A critical evaluation of the literature – part I. Practical Gastroenterology 31(9), 92‐104. Lichtenstein, G., & Ginsberg, G. (2006). The Clinician's guide to Pancreaticobiliary Disorders. In N. Ahmad (Ed.), Ch ronic pancreatitis (pp. 179‐216). Thorofare, NJ: Slack Incorporated. Lieb, J.G.II, Shuster, J.J., Theriaque D., Curington C., Cintron M., & Toskes P.P. (2009). A pilot study of Octreotide LAR vs. octreotide tid for pain and quality of life in chronic pancreatitis. Jop: Journal of the Pancreas [Electronic Resource]. 10(5), 518‐22. UI: 19734628
65 Lin, G., Chung, E.S., Casey, D.E., & Snow, R. (2007). Redefining hospital readmissions to better reflect clinical course of care for heart failure patients. American Journal of Medical Quality, 22(2), 98‐102. DOI: 10.1177/1062860606298245 Retrieved online April 3, 2009 at http://ajm.sagepub.com/cgi/content/abstract/22/2/98?ck=nck Lordan, J., Phillips, M., Chun, J., Worthington, T., Menezes, N., Lightwood, R., et al. (2009). A safe, effective, and cheap method of achieving pancreatic rest in patients with chronic pancreatitis with refractory symptoms and malnutrition. Pancreas, 38(6), 689‐692. Lubkin, I. & Larsen, P. (2009). Chronic illness: Impact and intervention. Boston: Jones and Bartlett Pub lishers. ISBN 13: 978‐07637‐51265 Maisonneuve, P., Frulloni, L., Mullhaupt, B., Faitini, K., Cavallini, G., Lowenfels, A, & Ammann, R. W.(2006). Impact of smoking on patients with idiopathic chronic pancreatitis. Pancreas, 33(2), 163‐8. Makowsky, M., Koshman, S., Midodzi, W., & Tsuyuki, R. (2009). Capturing outcomes of clinical activ ities performed by a rounding pharmacist practicing in a team environment: the COLLABORATE study [NCT00351676]. Medical Care, 47(6), 642‐ 650. Retrieved from CINAHL Plus with Full Text database. Meier, R., J. Ockenga, et al. (2006). ESPEN Guidelines on Enteral Nutrition: Pancreas. Clinical Nutrition, 25(2), 275‐284. DO I: 10.1016/j.clnu.2006.01.019 Melnyk, B.M. & Fineout‐Overrholt, E. (2005). Evidence‐based practice in nursing and health care. A guide to best practice. Philadelphia, PA: Lippincott Williams & Wilkins Milstead, J. A. (Ed.). (2004). Health Policy and Politics: A Nurse's Guide (Second Edition ed.). Sudbury: Jones and Bartlett Publishers. Mitchell, P. H. (2008) . Defining Patient Safety and Quality Care. In R. G. Hughes (Ed.), Patient Safety and Quality: An Evidence‐Based Handbook for Nurses Available from http://www.ahrq.gov/qual/nurseshdbk/docs/MitchellP_DPSQ.pdf Moore, R.A., Straube, S., Wiffen, P.J., Derry, S., & McQuay, H.J. (2009). Pregabalin for acute and chronic pain in adults. Cochrane Database of Systematic Reviews 2009, Issue 3. Art. No.: CD007076. DOI: 10.1002/14651858.CD007076.pub2.
66 Nair, R.J., Lawler, L., and Miller, M.R. (2007). Chronic pancreatitis. American Family Physician. 76(11), 1679‐1688. Retrieved February 12, 2009 at http://www.aafp.org/afp/20071201/1679.pdf Navaneethan, U., & Vankataraman, J. (2010). Recent advancements in the pathogenesis of pain in chronic pancreatitis: the argument continues. Minerva Gastroenterological E Dietologica, 56(1), 55‐63. National Center for Health Statistics. (Technical Appendix from Vital Statistics of the United States: Mortality). 2002. Hyattsville, Maryland: 2004. Ovid Technologies. (2010). Website review. http://www.ovid.com/si te/about/index.jsp?top=42 Pearson, P., Procter, S., Wilcockson, J., & Allgar, V. (2004). The process of hospital discharge for medical patients: a model. Journal of Advanced Nursing, 46(5), 496‐ 505. Retrieved from CINAHL Plus with Full Text database. Peikes, D., A. Chen, et al. (2009). "Effects of Care Coordination on Hospitalization, Quality of Care , and Health Care Expenditures Among Medicare Beneficiaries: 15 Randomized Trials." JAMA,301(6), 603‐618. Pezzilli, R. (2009). Chronic pancreatitis: Maldigestion, intestinal ecology and intestinal inflammation. World Journal of Gastroenterology, 15(14), 1673‐1676. Pezzilli, R., Bini, L., Fantini, L., Baroni, E., Campana, D., Tomassetti, P. & Corinaldesi, R. (2006). Quality of life in chronic pancreatitis. DOI: 10.3748/ wjg.15.1673. PMCID: PMC2668772. DOI: 10.3748/wjg.15.1673. PMCID: PMC2668772. World Journal of Gastroenterology 12(39), 6249‐6251. Pezzilli, R., Morselli‐Labate, A. M., Fantini, L., Campana, D., & Corinaldesi, R. (2007). Assessment of the quality of life in chronic pancreatitis using Sf‐12 and EORTC Qlq‐C30 questionnaires. [doi: DOI: 10.1016/j.dld .2007.06.014]. Digestive and Liver Disease, 39(12), 1077‐1086. Pezzilli, R., Morselli Labate, A. M., Fantini, L., Gullo, L., & Corinaldesi, R. (2007). Quality of Life and Clinical Indicators for Chronic Pancreatitis Patients in a 2‐Year Follow‐ Up Study. Pancreas, 34(2), 191‐6. Potera, C. (2009). Lowering hospital r eadmissions and costs. American Journal of Nursing, 109(5), 19. Retrieved February 15, 2010 from CINAHL Plus with Full Text database.
67 Rotter T, Kinsman L, James E, Machotta A, Gothe H, Willis J, Snow P, Kugler J. Clinical pathways: effects on professional practice, patient outcomes, length of stay and hospital costs. CochraneDatabase of Systematic Reviews 2010, Issue 3. Art.No.:CD006632. DOI: 10.1002/14651858.CD006632.pub2. Ruhl, C. E., Sayer, B., Byrd‐Holt, D. D., & Brown, D. M. (2008). Costs of Di gestive Diseases. In J. E. Everhart (Ed.), The burden of digestive diseases in the United States. US Department of Health and Human Services, Public Health Service, National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases. Washington, DC: US Government Printing Office; NIH Publication No. 09‐6443 [119‐123] . Retrieved online January 31, 2010 at http://www2.niddk.nih.gov/NR/rdonlyres/0B814CEA‐222A‐4677‐9B38‐ 89D3BC34E1F4/0/BurdenDD_US_Bookmarks_Jan2009.pdf Sareen, S., Kumari, V., Gajebasia, K. S., & Gajebasia, N. K. (2007). Yoga: A tool for improving the quality of life in chronic pancreatitis. World Journal of Gastroenterology, 21(13), 391‐397. Schu¨tza, T., Herbst, B., & Koller, M. (2006). Methodology for the development of the ESPEN guidelines on enteral nutrition In: Introduction part to the ESPEN guidelines on enteral nu trition. Clinical Nutrition, 25, 203–209. Scottish Intercollegiate Guidelines Network (2009a). About SIGN. Retrieved online April 15, 2010 at http://www.sign.ac.uk/about/index.html Scottish Intercollegiate Guidelines Network, (2008). A guideline developer’s handbook. Edinburgh: Elliot House. Retrieved February 25, 2009, from http://www.sign.ac.uk/guidelines/fulltext/50/compevidence.html Scottish Intercollegiate Guidelines Network, (2009b). SIGN 50: A guideline developer’s handbook – Annex B: Key to evidence statements and grades of recommendations. Retrieved February 23, 2009, from http://www.sign.ac.uk/guidelines/fulltext/50/annexb.html Scottish Intercollegiate Guidelines Network (2004). SIGN 50: A guideline developer’s handbook –Annex C: Critical appraisal notes and checklists. Retrieved online February 10, 2009 at http://cys.bvsalud.org/lildbi/docsonline/1/7/171‐ sign50annexc.pdf Seidel, S., Aigner, M., Ossege, M., Pernicka, E., Wildner, B., & Sycha, T. (2008). Antipsychotics for acute and chronic pain in adults. Cochrane Database of Systematic Reviews 2008, Issue 4. Art. No.: CD004844. DOI: 10.1002/14651858.CD004844.pub2.
68 Shafiq, N., Rana, S., Bhasin, D., Pandhi, P., Srivastava, P., Sehmby, S. S., et al. (2009). Pancreatic enzymes for chronic pancreatitis. Cochrane Database of Systematic Reviews(4). Shepp, P., Chase, P., Rawls, E. (1999). Pancreatitis partners: A sharing and educational support group. Gastroenterology Nursing, 22 (4), 155‐157. Retrieved online at March 3, 2009 http://www.gastroenterologynursin g.com/pt/re/gastronurse/fulltext.00001610‐ 199907000‐ 00002.htm;jsessionid=J2Tcm2QjggNF0ZVQx3QL1LNdKpyF0sqjRWr2BTvn2y6pZrd h89hs!‐1046349743!181195628!8091!‐1 Shepperd, S., Doll, H., Angus, R. M., Clarke, M. J., Iliffe, S., Kalra, L., et al. (2008). Admission avoidance hospital at home. . Cochrane Database of Systematic Reviews 2008, (4). doi:10.1002/14651858.CD007491 Shepperd, S., McClaran, J., Phillips, C. O., Lannin, N. A., Clemson, L. M., McCluskey, A., et al. (2010). Discharge planning from hospital to ho me. Cochrane Database of Systematic Reviews(1). Shepperd, S., Parkes, J., McClaran, J. J., & Phillips, C. (2009). Discharge planning from hospital to home. Cochrane Database of Systematic Reviews (4), 47. Shields, N., Freeman, M. L., Nelson, D. B., Sherman, S., Haber, G., Fennerty, M. B., et al. (2000). Sam e‐day discharge after endoscopic biliary sphincterotomy: Observations from a prospective multicenter complication study. gastroenterology Nursing, 23(2), 86‐87. Singapore Ministry of Health (2006). Lipids. National Guideline Clearinghouse. Retrieved from http://www.guideline.gov/summary/summary.aspx?doc_id=9476. Singh, S., Midha, S., Singh, N., Joshi, Y. K., & Garg, P. K. (2008). Dietary Counseling Versus Dietary Supplements for Malnutrition in Chronic Pancreatitis: A Randomized Controlled Trial. Clinical gastroent erology and hepatology: the official clinical practice journal of the American Gastroenterological Association, 6(3), 353‐359. Soler, R., Juvinyà Canal, D., Noguer, C., Poch, C., Brugada Motge, N., & Gil, M. (2010). Continuity of care and monitoring pain after discharge: patient perspective. Journ al of Advanced Nursing, 66(1), 40‐48. Retrieved from CINAHL Plus with Full Text database Smith, S.M., Allwright, S., & O’Dowd, T. (2007). Effectiveness of shared care across the interface between primary and specialty care in chronic disease management.
69 Cochrane Database of Systematic Reviews 2007, Issue 3. Art. No.: CD004910. DOI: 10.1002/14651858.CD004910.pub2. Staahl, C., Drewes, A.M., & Arendt‐Nielsen, L. (2007). Managing pain in chronic pancreatitis: Therapeutic value of opioid treatment. Journal of Pain & Palliative Care Pharmacotherapy 21(3), 63‐5. Strayer, D., & Schub, T. (2010). Pancreatitis, Chronic. Retrieved from CINAHL Plus with Full Text database. Tapp, S., Lasserson, T.J ., & Rowe, B.H. (2007). Education interventions for adults who attend the emergency room for acute asthma. Cochrane Database of Systematic Reviews, Issue 3. Art. No.: CD003000. DOI: 10.1002/14651858.CD003000.pub2. Talamini, G., Bassi, C., Falconi, M., Sartori, N., Vaona, B., Bovo, P., et al. (2007) . Smoking cessation at the clinical onset of chronic pancreatitis and risk of pancreatic calcifications. Pancreas, 35(4), 320‐326. Taylor, S.J.C., Bestall, J.C., Cotter, S., Falshaw, M., Hood, S.G., Parsons, S., et al. (2005). Clinical service organisation for heart failure. Cochrane Database of Systematic Reviews, Issue 2. Art. No .: CD002752. DOI: 10.1002/14651858.CD002752.pub2. Trolli, P., Conwell, Darwin, L. & Zuccaro, G. Jr., (2001). Pancreatic enzyme therapy and nutritional status of outpatients wth chronic pancreatitis. Gastroenterology Nursing 24 (2), 84‐87. Tsai, A.C., Morton, S.C., Mangione, C.M., Keeler, E.B. (2005). A meta‐analysis of interventions to improve care for chr onic illnesses. The American Journal of Managed Care. 11(8), 478‐488. The AGREE Collaboration. (2001). Appraisal of guidelines for research and evaluation instrument. St. George’s Hospital Medical School: London. Retrieved online February 15, 2009 at http://www.agreecollaboration.org/pdf/agreeinstrumentfinal.pdf The Cochrane Collaboration. (2010). Website review. http://www.cochrane.org/ Tucker, A. (2004). [Commentary on] Postoperative jejunal feeding and outcome of pancreaticoduodenectomy. Nutrition in Clinical Practice, 19(5), 533‐534. Retrieved from CINAHL Plus with Full Text database. U.S. Department of Health and Human Services (2009). Hospital Compare – A quality tool provided by Medicare. Retrieved online October 16, 2009 at http://www.hospitalcompare.hhs.gov
70 United States National Library of Medicine (n.d.). Fact Sheet MEDLINE. Accessed March 23, 2010. http://www.nlm.nih.gov/pubs/factsheets/medline.html Warshaw, A.L., Banks, P.A., & Castillo, C.F. (1998). AGA technical review: treatment of pain in chronic pancreatitis. Gastroenterology, 115(3), 765‐776. Weaver, C., Schiech, L., Held‐Warmkessel, J., Kedziera, P., Haney, E., DiLullo, G., Babb, J.S., Ruth, K., Dell, D., & Barsevick, A. (2006). Risk for unplanned hospital readmission of patients with cancer: results of a retrospectiv e medical record review. Oncology Nursing Forum, 33(3), E44‐52. Retrieved from CINAHL Plus with Full Text database. Webb, A.N., Kukuruzovic, R., Catto‐Smith, A.G., & Sawyer, S.M. (2008). Hypnotherapy for treatment of irritable bowel syndrome. Cochrane Database of Systematic Reviews 2007, Issue 4. Art . No.: CD005110. DOI: 10.1002/14651858.CD005110.pub2. Wiffen,P.J., McQuay, H.J., & Moore, R.A. (2009). Update. Carbamazepine for acute and chronic pain in adults. Cochrane Database of Systematic Reviews 2005, Issue 3. Art. No.: CD005451. DOI: 10.1002/14651858.CD005451. Wiffen, P.J., McQuay, H.J., Rees, J., & Moore, R.A. (2005). Gabapentin for acute and chronic pain. Cochrane Database of Systematic Review s 2005, Issue 3. Art. No.: CD005452. DOI: 10.1002/14651858.CD005452. Wiffen, P.J. & Rees, J. (2007). Lamotrigine for acute and chronic pain. Cochrane Database of Systematic Reviews 2007, Issue 2. Art. No.: CD006044. DOI: 10.1002/14651858.CD006044.pub2. Winstead, N. S., & Wilcox, C. M. (2009). Clinical trials of pancreatic enzym e replacement for painful chronic pancreatitis ‐ A review. Pancreatology, 9, 344‐350. Zerull, L. (2005). Community interventions aid self‐care, prevention. Hospital Case Management, 13(12), 181‐2, 187 Full Text: COPYRIGHT 2005 A Thomson Healthcare Company Record Number: A138575812. Retrieved online January 28, 2009 at http://galenet.galegroup.com/servlet/HWRC/hits?index1=RN&tcit=0_1_0_0_0& rlt=2&origSearch=true&t=RK&s=11&r=d&items=0&secondary=false&n=10&l=d& sgPhrase=true&c=1&bucket=per&text1=A138575812&docNum=A138575812&lo cID=musc_main Zuzelo, P.R. (2003). Clinical nurse specialist practices – Spheres of influence. AORN, 77 (2), 361‐372.
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93 Appendix B SIGN 50: A guideline developer’s handbook –Annex C: Critical appraisal notes and checklists METHODOLOGY CHECKLIST 1: SYSTEMATIC REVIEWS AND META‐ANALYSES Study identification (Include author, title, year of publication, journal title, pages) Guideline topic: Key Question No: Checklist completed by: Section 1: Internal validity In a well conducted systematic review In this study this criterion is: 1.1 The study addresses an appropriate and clearly focused question. Well covered Adequately addressed Poorly addressed Not addressed Not reported Not applicable 1.2 A description of the methodology used is included. Well covered Adequately addressed Poorly addressed Not addressed Not reported Not applicable 1.3 The literature search is sufficiently rigorous to identify all the relevant studies. Well covered Adequately addressed Poorly addressed Not addressed Not reported Not applicable 1.4 Study quality is assessed and taken into account. Well covered Adequately addressed Poorly addressed Not addressed Not reported Not applicable 1.5 There are enough similarities between the studies selected to make combining them reasonable. Well covered Adequately addressed Poorly addressed Not addressed Not reported Not applicable Section 2: Overall assessment of the study 2.1 How well was the study done to minimise bias? Code ++, +, or ‐ 2.2 If coded as +, or ‐ what is the likely direction in which bias might affect the study results? METHODOLOGY CHECKLIST 2: RANDOMISED CONTROLLED TRIALS Study identification (Include author, title, year of publication, journal title, pages) Guideline topic: Key Question No: Checklist completed by: Section 1: Internal validity In a well conducted RCT study... In this study this criterion is: 1.1 The study addresses an appropriate and clearly focused question. Well covered Adequately addressed Poorly addressed Not addressed Not reported Not applicable
94 1.2 The assignment of subjects to treatment groups is randomised Well covered Adequately addressed Poorly addressed Not addressed Not reported Not applicable 1.3 An adequate concealment method is used Well covered Adequately addressed Poorly addressed Not addressed Not reported Not applicable 1.4 Subjects and investigators are kept ‘blind’ about treatment allocation Well covered Adequately addressed Poorly addressed Not addressed Not reported Not applicable 1.5 The treatment and control groups are similar at the start of the trial Well covered Adequately addressed Poorly addressed Not addressed Not reported Not applicable 1.6 The only difference between groups is the treatment under investigation Well covered Adequately addressed Poorly addressed Not addressed Not reported Not applicable 1.7 All relevant outcomes are measured in a standard, valid and reliable way Well covered Adequately addressed Poorly addressed Not addressed Not reported Not applicable 1.8 What percentage of the individuals or clusters recruited into each treatment arm of the study dropped out before the study was completed? 1.9 All the subjects are analysed in the groups to which they were randomly allocated (often referred to as intention to treat analysis) Well covered Adequately addressed Poorly addressed Not addressed Not reported Not applicable 1.10 Where the study is carried out at more than one site, results are comparable for all sites Well covered Adequately addressed Poorly addressed Not addressed Not reported Not applicable Section 2: Overall assessment of the study 2.1 How well was the study done to minimise bias? Code ++, +, or ‐ 2.2 If coded as +, or ‐ what is the likely direction in which bias might affect the study results? 2.3 Taking into account clinical considerations, your evaluation of the methodology used, and the statistical power of the study, are you certain that the overall effect is due to the study intervention? 2.4 Are the results of this study directly applicable to the patient group targeted by this guideline? METHODOLOGY CHECKLIST 3: COHORT STUDIES Study identification (Include author, title, year of publication, journal title, pages) Guideline topic: Key Question No: Checklist completed by: Section 1: Internal validity
95 In a well conducted cohort study: In this study the criterion is: 1.1 The study addresses an appropriate and clearly focused question. Well covered Adequately addressed Poorly addressed Not addressed Not reported Not applicable Selection of subjects 1.2 The two groups being studied are selected from source populations that are comparable in all respects other than the factor under investigation. Well covered Adequately addressed Poorly addressed Not addressed Not reported Not applicable 1.3 The study indicates how many of the people asked to take part did so, in each of the groups being studied. Well covered Adequately addressed Poorly addressed Not addressed Not reported Not applicable 1.4 The likelihood that some eligible subjects might have the outcome at the time of enrolment is assessed and taken into account in the analysis. Well covered Adequately addressed Poorly addressed Not addressed Not reported Not applicable 1.5 What percentage of individuals or clusters recruited into each arm of the study dropped out before the study was completed. 1.6 Comparison is made between full participants and those lost to follow up, by exposure status. Well covered Adequately addressed Poorly addressed Not addressed Not reported Not applicable Assessment 1.7 The outcomes are clearly defined. Well covered Adequately addressed Poorly addressed Not addressed Not reported Not applicable 1.8 The assessment of outcome is made blind to exposure status. Well covered Adequately addressed Poorly addressed Not addressed Not reported Not applicable 1.9 Where blinding was not possible, there is some recognition that knowledge of exposure status could have influenced the assessment of outcome. Well covered Adequately addressed Poorly addressed Not addressed Not reported Not applicable 1.10 The measure of assessment of exposure is reliable. Well covered Adequately addressed Poorly addressed Not addressed Not reported Not applicable 1.11 Evidence from other sources is used to demonstrate that the method of outcome assessment is valid and reliable. Well covered Adequately addressed Not addressed Not reported Not applicable
96 Poorly addressed 1.12 Exposure level or prognostic factor is assessed more than once. Well covered Adequately addressed Poorly addressed Not addressed Not reported Not applicable Confounding 1.13 The main potential confounders are identified and taken into account in the design and analysis. Well covered Adequately addressed Poorly addressed Not addressed Not reported Not applicable Statistical analysis 1.14 Have confidence intervals been provided? Section 2: Overall assessment of the study 2.1 How well was the study done to minimise the risk of bias or confounding, and to establish a causal relationship between exposure and effect? Code ++, +, or ‐ 2.2 Taking into account clinical considerations, your evaluation of the methodology used, and the statistical power of the study, are you certain that the overall effect is due to the exposure being investigated? 2.3 Are the results of this study directly applicable to the patient group targeted in this guideline? METHODOLOGY CHECKLIST 4: CASE‐CONTROL STUDIES Study identification (Include author, title, year of publication, journal title, pages) Guideline topic: Key Question No: Checklist completed by: Section 1: Internal validity In an well conducted case control study: In this study the criterion is: 1.1 The study addresses an appropriate and clearly focused question Well covered Adequately addressed Poorly addressed Not addressed Not reported Not applicable Selection of subjects 1.2 The cases and controls are taken from comparable populations Well covered Adequately addressed Poorly addressed Not addressed Not reported Not applicable
97 1.3 The same exclusion criteria are used for both cases and controls Well covered Adequately addressed Poorly addressed Not addressed Not reported Not applicable 1.4 What percentage of each group (cases and controls) participated in the study? Cases: Controls: 1.5 Comparison is made between participants and non‐participants to establish their similarities or differences Well covered Adequately addressed Poorly addressed Not addressed Not reported Not applicable 1.6 Cases are clearly defined and differentiated from controls Well covered Adequately addressed Poorly addressed Not addressed Not reported Not applicable 1.7 It is clearly established that controls are non‐cases Well covered Adequately addressed Poorly addressed Not addressed Not reported Not applicable Assessment 1.8 Measures will have been taken to prevent knowledge of primary exposure influencing case ascertainment Well covered Adequately addressed Poorly addressed Not addressed Not reported Not applicable 1.9 Exposure status is measured in a standard, valid and reliable way Well covered Adequately addressed Poorly addressed Not addressed Not reported Not applicable Confounding 1.10 The main potential confounders are identified and taken into account in the design and analysis Well covered Adequately addressed Poorly addressed Not addressed Not reported Not applicable Statistical analysis 1.11 Confidence intervals are provided Section 2: Overall assessment of the study 2.1 How well was the study done to minimise the risk of bias or confounding? Code ++, +, or ‐ 2.2 Taking into account clinical considerations, your evaluation of the methodology used, and the statistical power of the study, are you certain that the overall effect is due to the exposure being investigated? 2.3 Are the results of this study directly applicable to the patient group targeted by this guideline? Adapted from Scottish Intercollegiate Guidelines Network (2004). SIGN 50: A guideline developer’s handbook –Annex C: Critical appraisal notes and checklists.
98 Retrieved online February 10, 2009 at http://cys.bvsalud.org/lildbi/docsonline/1/7/171‐sign50annexc.pdf
99 Appendix C Key to Evidence Statements and Grades of Recommendations Key to Evidence Statements 1++ High quality meta‐analyses, systematic reviews of RCTs, or RCTs with a very low risk of bias 1+ Well conducted meta‐analyses, systematic reviews, or RCTs with a low risk of bias 1‐ Meta‐analyses, systematic reviews, or RCTs with a high risk of bias 2++ High quality systematic re views of case control or cohort or studies High quality case control or cohort studies with a very low risk of confounding or bias and a high probability that the relationship is causal 2+ Well conducted case con trol or cohort studies with a low risk of confounding or bias and a moderate probability that the relationship is causal 2‐ Case control or cohort studies with a high risk of confounding or bias and a significant risk that the relationship is not causal 3 Non‐analytic studies, e.g. case reports, case series 4 Expert opinion Grades At least one meta‐analysis, systematic review, or RCT rated as 1++, and directly applicable to the target population; or A body of evidence consisting principally of studies rated as 1+, directly applicable to the target population, and demonstrating overall consistency of results A body of evidence including studies rated as 2++, directly applicable to the target population, and demonstrating overall consistency of results; or Extrapolated evidence from studies rated as 1++ or 1+ A body of evidence including studies rated as 2+, directly applicable to the target population and demonstrating overall consistency of results; or Extrapolated evidence from studies rated as 2++ Evidence level 3 or 4; or Extrapolated evidence from studies rated as 2+
100 Scottish Intercollegiate Guidelines Network, (2009). SIGN 50: A guidelinedeveloper’s handbook – Annex B: Key to evidence statements and grades of recommendations. Retrieved February 23, 2009, from http://www.sign.ac.uk/guidelines/fulltext/50/annexb.html
101 Appendix D Evidence Level Analysis Summary Rating Study Type Total Intervention or Topic Populations 1++A guideline (5), systematic reviews (SR) of RCTs (3), RCTs (2) 10 (17%) general management, hyper‐lipidemia, (3), parenteral nutrition recommendations, quality of life assessment (2) enteral vs parenteral nutrition, pancreatic enzyme pain management, nutrition (home made food) chronic pancreatitis 1++B guideline, SR of RCTs (7), meta‐ analysis (2), RCTs (3) 13 (22%) nausea & vomiting, lay‐led management programs, case management (3), discharge planning, patient education, team based clinical pharmacist, clinical pathways, admission avoidance hospital at home, anticonvulsants (pregabalin, gabapentin) palliative diseases, arthritis, asthma, cancer, diabetes, hypertension, heart disease, lung disease, stro ke, HIV, CHF, pain, COPD, frail elder, epilepsy, CAD, CAP, Guillian Barre' syndrome, neuralgia, diabetic neuropathy, fibromyalgia, cellulitis, mix of medical & surgical conditions, spinal cord injury, 1+A placebo‐con‐ trolled double blind trial 1 (2%) antioxidant chronic pancreatitis 1+B SR of RCTs & clinical controlled trials, RCTs (5), SR of RCTs (2) 8 (14%) discharge planning (2), case management (2), written vs verbal education, antipsychotics, anticonvulsant (carbamazepine, lamotrigine) CAD, CHF, COPD, diabetes, ICU patients, medical‐surgical, post‐ herpetic neuralgia, terminal cancer, postop‐erative pain, headache, myocardial infarction, HIV neuropathy, i rritable bowel syndrome, temporomandibular joint dysfunction, spinal cord injury 1‐B SR of RCTs (2), systema‐tic review 3 (5%) pain management, hypnotherapy, general management sickle cell, irritable bowel syndrome, chronic pancreatitis (1) 2++B cohort, retrospective prospective study, SR of RCTs (2), RCT, retrospective chart review 6 (10%) impact of smoking, yoga therapy, discharge planning (2), nutritional assessment, pancreatic enzyme therapy chronic pancreatitis (4), CVA, COPD, mixed conditions 2++C descriptive correlational survey, Quas‐ iexperimental design study, 2 (3%) readmission patterns, discharge planning, chronic illnesses, CHF, COPD, CAD, diabetes, stroke, back conditions, PVD, hip fracture, cardiac arrythmias 2+C SR, qualita‐tive cohort study, con‐ trolled clinical trial, single site study 4 (7%) pancreatic enzymes, psychosocial support, morphine versus oxycodone, smoking cessation, chronic pancreatitis (4), 2+D Quasi‐ experimental controlled trial, longi‐tudinal study, literature re‐view, non‐RCT interven‐ tional study, qualitative study 5 (9%) discharge planning (2), case management, general management, chronic pancreatitis (1) general medical patients, mixed chronic diseases, medical & geriatric patients
102 2‐C controlled clinical trial, pilot studies (2), prospec‐tive study, 4 (7%) octreotide, enteral versus parenteral nutrition, radiotherapy for pain, intrathecal narcotics pump, chronic pancreatitis(4) 3D Case review 2 (3%) general management (2) chronic pancreatitis Total 58