United States Department of Veterans Affairs

ESP Reports in Progress

    ESP Reports in Progress

The following reports are under development at one of the four ESP sites. If you would like to provide comments about the topic under development, serve as a peer reviewer for the draft report, or know the timeline for completion, please contact the ESP Coordinating Center.

Prevention of Surgical "Never Events"

Background/Objectives of Review: The VA National Center for Patient Safety has requested an evidence review to examine the prevalence of and the root causes of "never events" (wrong site surgery, retained surgical items). The evidence review will also evaluate current guidelines and identify best practices for the prevention of "never events." Studies examining VA specific data are of special interest.

Key Questions, including PICOTS:

(1) What is the prevalence of: wrong-site surgery (defined as wrong-site, wrong-side, wrong procedure, wrong implant, or wrong patient) and retained surgical items?
(2) What are the identified root causes of: wrong-site surgery and retained surgical items?
(3) What is the quality of current guidelines in use to prevent: wrong-site surgery and retained surgical items?
(4) What is the effectiveness of the individually identified interventions for the prevention of wrong-site surgery and retained surgical items?

P: Patients undergoing surgery and staff involved in surgical procedures including preoperative care staff
I: Interventions aiming to prevent wrong-site surgery and retained surgical items including local guideline implementations
C (design): Studies focusing on prevalence data and estimates reported in included root cause analysis and intervention studies, empirical root cause analyses, controlled and uncontrolled intervention evaluations, published / pertinent guidelines
O: "Never events" and "near misses" together with a denominator and timeframe for the individual or composite outcomes of interest, mortality, serious adverse events, safety climate / pertinent intervention specific outcomes, identified causes, evidence base of guidelines
T: Interventions before, during, and after surgery; outcomes collected during or after surgery
S: Clinical settings, prevalence estimates will be restricted to VA-relevant settings

General search strategy: We will search the electronic databases PubMed, PubMed Health, CINAHL, Web of Science, SCOPUS, and IEEE XPlore to identify guidelines, reviews, and individual studies on wrong site surgery and retained surgical items. In addition, we will scan the references of included studies, search the Cochrane Effective Practice and Organisation of Care Group Specialised Register, perform a targeted web / grey literature search to identify guidelines, and consult experts for pertinent literature.

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Intimate Partner Violence: Prevalence among Veterans and Review of Intervention Approaches

Background: The main research questions for this review were developed after a meeting with key members of the VA Domestic Violence Task Force and preliminary review of published peer-reviewed literature. For the purposes of this review, the term intimate partner violence (IPV) describes physical, sexual, or psychological harm or stalking behavior by a current or former partner that occurs on a continuum of frequency and severity.

The key questions we will address are the following:

KQ1. What is the prevalence of intimate partner violence (IPV) among Veterans and active duty servicemembers and does the prevalence vary by cohort (e.g., Vietnam ere, OEF/OIF/OND era), gender or race?

KQ2. For persons who are at risk for, experience, or use intimate partner violence (IPV), what interventions are associated with decreased exposure to IPV and its associated physical or mental harms, or mortality?

Inclusion criteria will be the following: For both KQs, the studies must be English language, peer-reviewed full publications. Specifically, for KQ1 (prevalence), the population will be US Veterans and active duty servicemembers; the outcomes will be the proportion of US military service members or Veterans who have used IPV or who have experienced IPV; the timing will be lifetime exposure to IPV or IPV that occurred at the same time as service in the military or since military discharge; the settings will be VA healthcare facilities, community-based data (e.g., surveys), outpatient healthcare settings, military bases (domestic and abroad). For KQ2 (interventions) the population will be adults aged 18 and over who are at risk of experiencing IPV but have not been exposed, perpetrators of IPV or victims of IPV; interventions will be primary or secondary IPV prevention strategies used in the community or health care setting including those that focus on building healthy relationships (e.g., communication) and those that focus on reducing rates of IPV (e.g., screening, counseling, use of emergency shelters, education/training of healthcare personnel); comarators must be present and may be usual care or another intervention strategy; Outcomes will be rates of IPV perpetration and/or victimization and intermediate outcomes associated with prevention (e.g., identification, referral, treatment, change in attitude, relationship satisfaction, communication skills, physical harms, mental harms, mortality); timing will be end of treatment or beyond; settings will be community and outpatient healthcare); publications must by systematic reviews of fair or good quality published after 2006.

General search strategy: We plan to conduct a review of the literature by systematically searching, reviewing, and analyzing the empirical evidence as it pertains to the research questions. We plan comprehensive searches of PubMed, Psych Info, EMBASE, CINAHL, Cochrane, SSCI and clinicaltrials.gov. Information to answer the key questions will be abstracted from the selected articles and quality assessment of the articles will be performed using the key criteria described in the AHRQ methods manual adapted to this specific topic. We will synthesize the findings and if feasible compute a summary estimate of effect. The strength of the evidence for each key question will be assessed using the approach described in the EPC methods manual.

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Effects of Nurse-managed Protocols in the Outpatient Management of Adults with Chronic Conditions

Hypertension, type 2 diabetes, hyperlipidemia, and congestive heart failure (CHF) are common chronic diseases that cause substantial morbidity and mortality. There are well-established clinical guidelines for each of these conditions, and the majority of care is provided in outpatient settings. In an effort to serve more Veterans and improve the quality and efficiency of care, the VA is implementing Patient Aligned Care Teams (PACTs). Nurse practitioners already have been shown to provide effective and cost-effective primary care. Less well studied is the effectiveness of RNs or LPNs with expanded roles while functioning in PACT-type teams. If the RN or LPN-managed protocols are shown to be effective, nurse-managed care supported by carefully developed clinical protocols could improve access, improve care, and reduce the costs of caring for patients with selected chronic conditions. The VA is in the process of developing policies on nurse-managed protocols and has requested a systematic review to inform policy development. Therefore, we plan a synthesis of the current literature to describe the effects of nurse-managed protocols for the outpatient management of adults with common high-impact, chronic conditions.

The key questions we will address are the following:

KQ1. For adults with chronic medical conditions, do nurse-managed protocols versus usual care improve nursing staff experience, treatment adherence, quality measures such as process of care or biophysical markers, or resource utilization?

KQ2. In studies of nurse-managed protocols, how well do participating nurses adhere to the protocol?

KQ3. Are there adverse effects associated with the use of nurse-managed protocols?

We plan to conduct a review of the literature by systematically searching, reviewing, and analyzing the empirical evidence as it pertains to the research questions. We plan comprehensive searches of MEDLINE® (via PubMed®), Cochrane Central Register of Controlled Trials, Embase®, and CINAHL® and clinicaltrials.gov. Inclusion criteria will be the following: study designs recommended by the Cochrane Effective Practice and Organization of Care Group; population will be outpatient adults 18 years of age or older with CHF, diabetes, hyperlipidemia, hypertension, or combinations of these chronic medical conditions; intervention or "exposure" must meet this definition - an RN or LPN functioning beyond the usual scope of practice to include one or more of the following activities: adjusting medications, ordering diagnostic tests, or referring orders to specialists who are not part of the nurse's core clinical team. In addition, these activities must be based on a written protocol that specifies the scope of practice of these expanded clinical activities and that is designed to support longitudinal care for patients with chronic conditions; comparators will be usual care or another quality improvement strategy; relevant outcomes will be nurse experience, treatment adherence, laboratory or physiological markers, performance metrics,resource utilization, fidelity to the protocol and adverse effects; settings will be primary care setting or specialty clinic/practice; full publications will be English-language and peer-reviewed in specific countries where nursing standards are similar and published after 1975. Information to answer the key questions will be abstracted from the selected articles and quality assessment of the articles will be performed using the key criteria described in the AHRQ methods manual adapted to this specific topic. We will synthesize the findings and if feasible compute a summary estimate of effect. The strength of the evidence for each key question will be assessed using the approach described in the EPC methods manual.

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Systematic Review of The Treatment of Metastatic Non-small Cell Lung Cancer

Background/Objectives of Review:

This topic represents a high priority for the VA given lung cancers high incidence in the veteran population and the frequency of metastatic disease in non- small cell lung cancer. Lung cancer is the second leading cause of cancer among men and women and the leading cause of cancer related death in the United States (1). In 2010 it is estimate that there were approximately 222,520 new cases of lung cancer diagnosed and approximately 157,300 lung cancer associated deaths in the US (2). The cancer occurs at a higher frequency among Veterans due to higher rates of smoking and occupational exposures that increase veterans' risk of lung cancer. Since the majority of patients developing non-small cell lung cancer subsequently develop metastatic disease, the issue of how best to treat these patients is a critical one both in the VA and generally. Guidelines have been developed that recommend various combinations of chemotherapeutic agents given in differing schedules and this evidence synthesis is an attempt to critically review guideline recommended therapies to improve their use in these patients in hope of identifying regimens that are associated with better outcomes than others or similar outcomes with less harm and/or less cost.

Key Questions, including PICOTS:

(1) For patients with metastatic non-small cell lung cancer what is the comparative effectiveness of the different recommended (e.g. NCCN guidelines) first line chemotherapy regimens?

(2) For patients with metastatic non-small cell lung cancer what is the comparative effectiveness of the different recommended (e.g. NCCN guidelines) second line chemotherapy regimens?

(3) For patients with metastatic non-small cell lung cancer what is the benefit of maintenance therapy following first line chemotherapy regimens compared with no maintenance therapy?

(4) What is the relative cost and cost-effectiveness of the different approaches in (1), (2), and (3)? These key questions will be discussed and modified by the ESP center in conjunction with the Oncology Field Advisory Committee to assure that the questions can be answered based on available literature and that the stakeholder's questions are appropriately and effectively addressed.

General search strategy:

We searched PUBMED and COCHRANE databases for relevant literature from 1966 through 2012, using standard search terms such as lung neoplasms, lung cancer, non-small-cell, non-small cell, non small cell, metastatic, metastasi, advanced, cost-effective, cost-benefit, cost analysis, and economic. We limited the search to peer-reviewed articles involving human subjects and published in the English language.

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The Role of IL-2B Polymorphisms in Predicting Response to Treatment in Veteran's with Hepatitis C

Background/Objectives of Review:

Recent data have suggested that a common genetic variation within the IL-28B locus may be related to spontaneous clearance of HCV among untreated patients as well as being associated with HCV clearance among individuals treated with antiviral therapy. The implications of this research are of great importance to the VA for many reasons including:

  • The high prevalence of hepatitis C among Veteran's
  • Data suggesting that these polymorphisms are important prognostically and influence the natural history of HCV infection when present, as well as the outcomes of treatment with anti-viral therapy.
  • The cost and co-morbidity associated with treating hepatitis C. Could treatment be better directed to those who might benefit based on identifying these polymorphisms? Alternatively, are individuals with these polymorphisms more likely to clear their infection without treatment?
  • The laboratory costs for testing for these polymorphisms may be high given the prevalence of hepatitis C in the VA.

Key Questions, including PICOTS:

KQ1. What is the epidemiology of IL-28B polymorphisms in Hepatitis C? Do these polymorphisms vary by hepatitis C genotype? KQ2. What is the natural history and prognosis of untreated individuals with hepatitis C in the presence of IL-28B polymorphisms? KQ3. How does the epidemiology vary among sub-groups including: HIV infected individuals, by gender, age, co-infection status, etc? KQ4. How do IL-28B polymorphisms influence the prognosis of hepatitis C, as well as hepatitis C treatment options and the outcomes of treatment? KQ5. Do the outcomes of liver transplantation vary among hepatitis C infected individuals with and without IL-28B polymorphisms? KQ6. What are the costs associated with testing for IL-28B polymorphisms in patients with hepatitis C both in the community and in the VA?

General search strategy:

We will search PubMed, Web of Science, and Embase databases for articles from 1966-Feb. 2012 relating to our key questions. Search terms may include hepatitis, genetic testing, and other related terms.

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Effectiveness of Caregiver Interventions on Patient Outcomes among Adults with Cancer or Memory Impairment

Background and Objectives of Review:

Recent legislation (110-387 and 1963) expanded VA authority to provide enhanced services in connection with Service Connected and Non-Service Connected injuries and illnesses. This report will systematically review the evidence on the effect of family/caregiver interventions on outcomes for patients with cancer or memory impairment.

Key Questions, including PICOTS:

KQ1: What are the benefits of family and caregiver psychosocial interventions for adult patients with cancer or memory impairment? a. What are the harms of these interventions? b. Do these benefits/harms vary by condition, patient functional status, or outcome?

KQ2: What are the comparative benefits of family and caregiver oriented psychosocial interventions versus patient directed or alternative family oriented interventions in improving outcomes for adult patients with cancer or memory impairment [i.e., how do family oriented interventions compare to (a) any patient-oriented psychosocial intervention or (b) any alternative family oriented intervention]? a. What are the harms of these interventions? b. Do these benefits/harms vary by condition, patient functional status, or outcome?

PICOTS

Population: Adult patients with cancer or memory impairment and their family members. These conditions were chosen based on their high prevalence and health impact in the VA population.

Intervention: Family-oriented care, including counseling, education, or social support (emotional, instrumental, informational support; companionship). The patient is not required to be present for the intervention.

Comparators: KQ1: 1) No treatment; or, 2) usual care that involves no additional patient or family directed treatment beyond that usually provided to patients. KQ2: An alternative active treatment directed at: 1) patients (e.g., an additional active patient intervention; 2) families (e.g., another family/couple-oriented intervention)

Outcomes: Patient (not care giver) centered outcomes (e.g., quality of life, hospitalizations institutionalization, instrumental and other activities of daily living, problem behavior, and symptom control/management). Results will be stratified by outcome, primary condition/problem of interest and functional status/severity of condition (e.g., cancer stage, need for ADL assistance). Adverse effects will also be reported.

Timing: Immediate post-intervention, long-term (>6 months).

Setting: Information on where participants were recruited and where participants received treatment will be extracted.

General search strategy: We will search MEDLINE and PsycINFO for randomized controlled trials and systematic reviews published in English Language from 1980 to the present.

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The Comparative Effectiveness of Older and Newer Anticoagulants for Short-term Prophylaxis of VTE in Total Hip and/or Knee Replacement Surgery

Background and Objectives of Review:

Venous thromboembolic (VTE) events are common causes of morbidity in elective orthopedic surgery. Current guidelines recommend thromboprophylaxis using one of a number of potential agents: low molecular weight heparin (LMWH), unfractionated heparin (UFH), aspirin, warfarin or one of the newer oral anticoagulants (NOAC). Given the wide range of therapeutic options for thromboprophylaxis, differences in costs, and potential for important differences in adverse effects, a comparative effectiveness review could inform clinical management and pharmacy benefits policy in the VHA.

Key Questions, including PICOTS:

1.) For patients undergoing major elective orthopedic surgery (hip and knee replacement (THR, TKR), hip fracture surgery (HFS)), what is the comparative effectiveness of aspirin, warfarin, LMWH, injectable FXa inhibitor, UFH, and NOAC, on the incidence of symptomatic, objectively confirmed, venous thromboembolism and total mortality? 2.) For patients undergoing major elective orthopedic surgery, what are the relative effects of LMWH, injectable FXa inhibitors, UFH, and NOAC on fatal bleeding, major bleeding, and minor bleeding? Population will be adults undergoing THR, TKR or HFS. We will examine all possible comparisons, but the main intervention will be NOAC and the main comparator will be LMWH. The primary outcomes for KQ1 will be symptomatic VTE, major bleeding and mortality. For KQ2, outcomes will be specific to the intervention, but will include all types of bleeding complications. Studies must report outcomes at > 1 week post-operatively. Interventions will be administered through inpatient, surgical settings

General Search Strategy:

As this report will be a "review of reviews," our first step will be to conduct a comprehensive search for existing relevant systematic reviews. To identify relevant systematic reviews, we will search MEDLINE® via PubMed®, Embase®, and the Cochrane Database of Systematic Reviews, limiting the search to 2009 and forward. We will supplement the electronic searches with a manual search of citations from a set of key systematic review and clinical guideline articles. To ensure that we have identified the most relevant literature, we will conduct a supplementary search for primary studies of the newer oral anticoagulants published since the most recent included systematic review.

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Screening for Post Traumatic Stress Disorder (PTSD) in Primary Care

Background and Objectives of Review:

Post traumatic stress disorder (PTSD) is the mental health condition most frequently associated with combat, sexual assault and other traumatic experiences that may occur during the course of military service. Many veterans are first screened for PTSD in a primary care setting. The purpose of this review is to identify the screening tools used to detect PTSD in primary care clinics and to examine the evidence of their ability to identify PTSD in that setting. The report will focus on psychometric properties of the different screening tools used and their administration with an emphasis on how those characteristics may vary based on age, gender, race/ethnicity, substance abuse status, or presence of other comorbidities.

Key Questions, including PICOTS:

1) What tools are used to screen for PTSD in primary care settings, and what are their characteristics (i.e., length, format, etc.)? 2) What are the psychometric properties and utility of the screening tools (sensitivity, specificity, reliability, etc.) and their implementability (e.g., ease of administration) in primary care clinics? 3) Do the psychometric properties and utility of each of the screening tools differ according to: age, gender, race/ethnicity, substance abuse, or other comorbidities? Population: Adults (18 and over) in the United States
Intervention: Screening methods for PTSD including self-report, interview and multi-stage screening strategies
Comparator: Structured clinical interviews for PTSD (e.g., CAPS), or other “gold standard” in-depth clinical interviews for PTSD
Outcomes: Diagnostic accuracy (e.g., sensitivity, specificity), implementability (e.g., resources needed for administration/ease of administration)
Timing: Any
Setting: Primary care clinics

General Search Strategy:
MEDLINE and the PILOTS database (from the National Center for PTSD) will be searched for studies published in English from 1981 to the present.

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Role of the Routine Pelvic Examination in Asymptomatic Women

Background and Objectives of Review:

In the United States, the routine pelvic examination (including inspection of the external genitalia, speculum evaluation of the vagina and cervix, bimanual examination of the adnexa, uterus, ovaries, and bladder, and rectal/rectovaginal examination) is part of many women's annual health visits. However, it is unclear whether there is evidence to support this practice, particularly in women for whom an annual Pap test is no longer recommended. The purpose of this review is to summarize the available evidence and/or highlight the lack of evidence on potential benefits and harms of screening pelvic examinations in asymptomatic, non-pregnant women.

Key Questions:

KQ1: Does detection of malignancy (cervical, ovarian, uterine, bladder, vaginal or vulvar cancer) in asymptomatic women by pelvic examination reduce morbidity and/or mortality?

KQ2: Does diagnosis of pelvic inflammatory disease in asymptomatic women by pelvic examination reduce morbidity and/or mortality?

KQ3: What are the benefits of detection of other conditions by a screening pelvic examination? (fibroids, vaginal/vulvar abnormalities, warts, atrophic vaginitis, bacterial vaginosis, others)

KQ4: What are the immediate benefits/harms of performing a screening pelvic examination in asymptomatic women?

KQ5: What are the harms of the diagnostic evaluations that result from the detection of pathology during a routine pelvic examination in asymptomatic women?

PICOTS:

Population: Asymptomatic non-pregnant women

Intervention: Screening pelvic examination

Comparator: No pelvic examination

Outcomes: Changes in morbidity and/or mortality associated with earlier detection and treatment of cancer, pelvic inflammatory disease, or other pathology; harms related to the pelvic examination (i.e., harms from performing the examination and harms from patient avoidance of care due to fear of the examination); and harms related to the diagnostic evaluation following pelvic examination (i.e., over diagnosis, false positive diagnosis, diagnostic procedure induced harms)

Timing: Annual or periodic exams

Setting: Outpatient

General Search Strategy:

MEDLINE will be searched for studies published in English from 1946 to the present. The search strategy includes terms associated with pelvic or gynecological examination, women’s health, and screening in asymptomatic individuals. We will include clinical trials and cohort studies reporting benefits and harms of screening pelvic examination and any type of study reporting patient expectations or provider perceptions of patient expectations related to pelvic examination.

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Antimicrobial Stewardship Programs in Inpatient Settings

Background and Objectives:

Inappropriate and unnecessary antimicrobial use leads to avoidable drug toxicity, increased selection of pathogenic organisms, and increased prevalence of resistant organisms. Infections with drug-resistant pathogens negatively impact patient morbidity and mortality and increase hospital length of stay and health care costs. The purpose of this review is to examine the effectiveness of stewardship programs, to identify components that best predict success, and to identify important implementation elements.

Key Questions:

KQ1. What is the effectiveness of inpatient antimicrobial stewardship programs on the following:

a. Primary Outcome: Patient centered outcomes (LOS, 30 day readmission, morbidity, mortality, clostridium difficile diarrhea, changes in signs and symptoms relevant to disease, adverse effects)

b. Secondary Outcomes: 1) Antimicrobial prescribing (timing, use, selection, dose, route, duration); 2) Microbial outcomes (institutional resistance, resistance in study population); 3) Costs (healthcare, program, opportunity, drug)

KQ2. What are the key intervention components associated with effective inpatient antimicrobial stewardship (e.g., persuasive, restrictive, structural, or combination intervention; personnel mix; level of support)?

KQ3. Does effectiveness vary by a) hospital setting (rural, urban, academic, VA, non-VA) or b) suspected patient condition?

KQ4. What are the harms of inpatient antimicrobial stewardship programs?

KQ5. Within the included studies, what have we learned about barriers to implementation, sustainability, and scalability of inpatient antimicrobial stewardship programs?

PICOTS:

Population: Hospital inpatients with proven or suspected infectious disease.

Interventions: Persuasive, restrictive, structural, or other interventions delivered by or targeted to physicians, pharmacists, or combined teams.

Comparator: Usual care without the use of antimicrobial stewardship programs or another antimicrobial program.

Outcomes: Clinical (e.g., morbidity, mortality), drug (e.g., decision to prescribe, appropriateness of prescription), microbiological (e.g., infection caused by antibiotic resistant bacteria), or other (e.g., costs); process outcomes (e.g., barriers to implementation), sustainability, scalability, etc. will be addressed in narrative.

Timing: Patient outcomes within 30 days from hospital discharge; no time limit on microbial outcomes

Setting: US and non-US studies published in English language; type of hospital to be documented.

General Search Strategy:

MEDLINE will be searched for clinical trials, time series, before and after studies, and cohort studies published in English from 2000 to the present. The start date for the search was chosen based on the search dates of an existing Cochrane review (Davey et al., 2009). The search strategy includes terms associated with antibiotic and antimicrobial, drug prescription/utilization, guideline adherence/quality assurance, and study design types.

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Screening for Hepatocellular Cancer in Chronic Liver Disease


Background and Objectives of Review:

Chronic liver disease is a common problem in the VA and is a major risk factor for hepatocellular cancer (HCC). In the VA, chronic liver disease is most frequently caused by hepatitis C, with a prevalence of approximately 1.8 percent in the general U.S. population when evaluated in the Third National Health and Nutrition Examination Survey and a higher prevalence among Veterans (Chak 2011). The prevalence is especially high among Vietnam era Veterans, and hepatitis C is considered one of the most important emerging pathogens in the VA (Bini 2003). Other less common but important causes of chronic liver disease includes hepatitis B, hemochromatosis, primary biliary cirrhosis, environmental toxins and alcohol. Chronic liver disease from some of these disorders may also be associated with HCC and because HCC survival is highest among individuals detected and treated in early stages, there are reasons to think that screening for HCC while at an early stage might be beneficial. This topic is a high priority for the VA given the high prevalence of hepatitis C and cirrhosis from multiple causes among Veterans, and the controversy of guidelines on this topic. To be certain of whether screening improves mortality, data is required, ideally from randomized controlled trials (RCTs) that overcome the biases of lead-time, length and volunteer bias, that can make observational studies of screening appear beneficial. However, only two randomized trials on screening have been conducted (Chen 2003; Zhang 2004) and these trials were limited in several ways including: 1) patients had hepatitis B, not necessarily cirrhosis; 2) all cause mortality was not evaluated; 3) patients were excluded after randomization; 4) the analysis was not intention to screen; and 5) the studies were conducted in China (Lederle 2012). In spite of the limitations of this database, the findings from these two trials have been used to support screening for HCC in other populations, including Veterans and those with cirrhosis from other causes. In 2005, the American Society for Liver Disease began recommending screening for HCC and currently recommends screening every six months (Bruix 2011).

Key Questions and PICOTS:

1a. In which subgroups of patients with chronic liver disease have the health outcome effects of HCC screening been evaluated?

1b. What are the effects of HCC screening on disease-specific and all-cause mortality in these patient subgroups?

1c. Are there particular HCC screening modalities that are more effective than others?

Population: Chronic active viral hepatitis, alcohol-related liver disease, non-alcoholic steatohepatitis, non-alcoholic fatty liver disease, hemochromatosis, primary biliary cirrhosis, primary sclerosing cholangitis, autoimmune hepatitis – all with or without cirrhosis.

Intervention: Ultrasound, CT, and/or alpha-fetal protein screening for HCC.

Comparator: No screening, more or less frequent screening, comparative effectiveness of different screening modalities.

Outcomes: HCC mortality, all-cause mortality, liver-disease mortality.

Setting: Controlled clinical trials, prospective and retrospective cohort studies, modeling studies. Cohort studies with selection bias and/or high loss to follow-up rates will be excluded.

2. What are the harms of HCC screening among patients with chronic liver disease?

Population: Same as above.

Intervention: Same as above.

Comparator: Same as above.

Outcomes: Anxiety, stress, depression, liver biopsy-related complications (bleeding, infection), renal insufficiency, overdiagnosis, cost.

Setting: Any.

3. What are the benefits and harms of treating screen-detected HCC?

Population: Chronic liver disease + asymptomatic HCC discovered through screening or imaging done for other reasons.

Intervention: Resection, transplant, radiofrequency ablation, transarterial chemoembolization, sorafenib.

Comparator: No treatment, comparing different treatments.

Outcomes: Mortality, hospitalizations, bleeding, pain, acute liver injury, infections, quality of life.

Setting: Controlled clinical trials.

Contextual key question: What are the recommendations and methodology of existing HCC screening guidelines?

General Search Strategy:

We will begin by searching MEDLINE®, Embase®, and the Cochrane database of systematic reviews. To identify in-progress or unpublished studies, we will also search ClinicalTrials.gov. Search strategies will be developed in consultation with a research librarian.

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Early Warning Scoring Systems


Background and Objectives of Review:

Early warning scoring systems (EWSS) are tools used by nurses to recognize the early signs of clinical deterioration in order to initiate early intervention and management, such as increasing nursing attention, informing the provider, or activating a rapid response or medical emergency team (Whittington, 2007). These tools involve assigning a numeric value to several physiologic parameters (e.g., systolic blood pressure, heart rate, oxygen saturation, respiratory rate, level of consciousness, and urine output) to derive a composite score that is used to predict a patient’s risk of deterioration. Observational studies suggest that patients often show signs of clinical deterioration up to 24 hours prior to a serious clinical event requiring an intensive intervention (McGaughey, 2009). Delays in treatment or inadequate care of patients on general hospital wards may result in increased admissions to the intensive care unit (ICU), increased length of hospital stay, cardiac arrest, or death (McGaughey, 2009). The purpose of the Early Warning System (EWS) is to ensure timely and appropriate management of deteriorating patients on general hospital wards. This is potentially a significant topic for the VA, as the Portland, Oregon VA Medical Center has implemented Modified Early Warnings Systems (MEWS) and there are plans to implement MEWS nationally. This evidence review will be used by the Office of Nursing Services Clinical Practice Programs ICU Workgroup to develop guidelines for the development and implementation of EWS at facilities within the VA system and will be used to identify gaps in evidence that warrant further research.

Key Questions and PICOTS:

1. What is the predictive value in using Early Warning System (EWS) scores for predicting patient health outcomes?

1a. Which factors contribute to the predictive ability of EWS scores?

1b: Does predictive ability of EWS scores vary with specific subgroups of patient?

Population: Admitted patients on general medicine or surgical wards.

Intervention: EWS or other established scoring system designed to identify deteriorating patients on general hospital wards. Potential interventions includes but is not limited to the following: Modified Early Warnings Systems (MEWS), Patient at Risk (PAR) score, Physiological Scoring Systems (PSS), Vital Sign Score (VSS), Manchester Triage System, BioSign, VialPAC Earl Warning Score (VIEWS), and Physiological Observation Track and Trigger System (POTTS).

Comparator: No EWS.

Outcomes: Patient health outcomes including all cause or disease specific mortality, cardiac arrest, and pulmonary arrest.

Setting: English language validity studies including observation studies.

2. What are the effects of Early Warning Systems on patient health outcomes including mortality, morbidity, cardiac arrest, and pulmonary arrest?

2a: What is the impact of EWS on resource utilization (e.g., ICU admissions, length of hospital stay, use of Rapid Response Teams)?

Population: Same as above.

Intervention: Same as above.

Comparator: Same as above.

Outcomes: Patient health outcomes including mortality, morbidity (cardiovascular events, number of ventilator days), cardiac arrest, and pulmonary arrest. Resource utilization outcomes including ICU admission and length of hospital stay.

Setting: English language systematic reviews, randomized controlled trials, controlled clinical trials, controlled before and after studies, and interrupted-time-series designs.

General Search Strategy:

We will begin by searching MEDLINE®, Embase®, CINAHL, and the Cochrane database of systematic reviews. We will further evaluate the bibliographies of included primary studies and any systematic or nonsystematic reviews that are identified. To identify in-progress or unpublished studies, we will also search ClinicalTrials.gov. Search strategies will be developed in consultation with a research librarian.

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