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"
- Intimate Partner Violence: Prevalence among Veterans and Review of Intervention Approaches
- Effects of Nurse-managed Protocols in the Outpatient Management of Adults with Chronic Conditions
- Role of the Routine Pelvic Examination in Asymptomatic Women
- Antimicrobial Stewardship Programs in Outpatient Settings
- Antimicrobial Stewardship Programs in Inpatient Settings
- Screening for Hepatocellular Cancer in Chronic Liver Disease
- Early Warning Scoring Systems
- Computer-based Cognitive Behavioral Interventions for Adults with Depressive or Anxiety Disorder
- Evidence Mapping Project: Acupuncture
- Benefits and Harms of Femtosecond Laser Assisted Cataract Surgery
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 and the root causes of wrong site surgery, retained surgical items, and surgical fires. The evidence review will also evaluate current guidelines and identify best practices for the prevention of these events. Studies examining VA specific data are of special interest.
Key Questions:
KQ1: What is the prevalence of: wrong-site surgery (defined as wrong-site, wrong-side, wrong procedure, wrong implant, or wrong patient), retained surgical items, and surgical fires?
KQ2: What are the identified root causes of: wrong-site surgery, retained surgical items, and surgical fires?
KQ 3: What is the quality of current guidelines in use to prevent wrong-site surgery, retained surgical items, and surgical fires?
KQ4: What is the effectiveness of the individually identified interventions for the prevention of wrong-site surgery, retained surgical items, and surgical fires?
PICOTS:
Population: Patients undergoing surgery and staff involved in surgical procedures including preoperative care staff
Intervention: Interventions aiming to prevent wrong-site surgery, retained surgical items, and surgical fires including local guideline implementations
Comparator (design): Prevalence data studies, empirical root cause analyses, published/pertinent guidelines, controlled and uncontrolled intervention evaluations
Outcomes: "Never events" and "near misses" together with a denominator and timeframe for the individual or composite outcomes of interest, identifie d causes and risk factors; evidence base of guidelines
Timing: Interventions and guidelines applicable before, during, and after surgery; outcomes collected before, during or after surgery
Setting: Clinical settings, prevalence estimates will be restricted to VA-relevant settings
General Search Strategy:
We will search PubMed, PubMed Health, CINAHL, Web of Science, SCOPUS, and IEEE XPlore to identify guidelines, reviews, and individual studies. 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.
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:
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.
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:
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.
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.
Antimicrobial Stewardship Programs in Outpatient Settings
Background and Objectives:
An antimicrobial stewardship program is an intervention designed to control and/or change how antimicrobial agents are selected and administered. The aim is to optimize antimicrobial therapy, improve patient care, reduce antimicrobial resistance, and manage costs. (Ohl, 2011) 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 healthcare utilization. The purpose of this review is to examine the effectiveness of stewardship programs in outpatient settings, to identify components that best predict success, and to identify important implementation elements.
Key Questions:
KQ1. What is the effectiveness of antimicrobial stewardship programs in outpatient settings on the following:
a. Primary Outcome: Patient centered outcomes (mortality, hospital admission, clostridium difficile diarrhea, adverse effects)
b. Secondary Outcomes: 1) Antimicrobial prescribing (timing, use, selection, dose, duration); 2) Microbial outcomes (resistance in study population); 3) Costs (healthcare costs, program costs, opportunity costs, drug costs)
KQ2. What are the key intervention components associated with effective outpatient antimicrobial stewardship (e.g., persuasive, restrictive, structural, or combination intervention; personnel mix; level of support)?
KQ3. Does effectiveness vary by: a) clinic type or setting (rural, urban, internal medicine, family practice, VA, nonVA) or b) suspected patient condition?
KQ4. What are the harms of antimicrobial stewardship programs in outpatient settings?
KQ5. Within the included studies, what have we learned about barriers to implementation, sustainability, and scalability of antimicrobial stewardship programs in outpatient settings?
PICOTS:
Population: Outpatients with proven or suspected infectious disease.
Interventions: Persuasive, restrictive, structural, or other interventions delivered by or targeted to physicians, pharmacists, mid-level providers, or combined teams.
Comparator: Usual care without the use of antimicrobial stewardship programs or another antimicrobial stewardship program.
Outcomes: Patient (e.g., morbidity, mortality), prescribing (e.g., decision to prescribe, appropriateness of prescription), microbial (e.g., infection caused by antibiotic resistant bacteria), harms, or costs; process outcomes (e.g., barriers to implementation, sustainability, scalability, etc.) will be addressed in narrative.
Timing: Patient outcomes within 30 days from initial contact with provider; no time limit on microbial outcomes
Setting: US and non-US studies published in English language; type of clinic to be documented
Antimicrobial Stewardship Programs in Inpatient Settings
Background and Objectives:
An antimicrobial stewardship program is an intervention designed to control and/or change how antimicrobial agents are selected and administered. The aim is to optimize antimicrobial therapy, improve patient care, reduce antimicrobial resistance, and manage costs. (Ohl, 2011) 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 outcomes and increase hospital length of stay and health care costs. This review will examine the effectiveness of stewardship programs, identify components that best predict success, and 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 (30 day readmission, mortality, clostridium difficile diarrhea, length of stay, 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 are the 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, drug, microbiological, costs and harms; 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: U.S. and non-U.S. studies published in English language; type of hospital to be documented.
General Search Strategy:
MEDLINE will be searched for randomized or controlled clinical trials, interrupted time series with at least 3 data points before and after the intervention, and controlled before and after 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.
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.
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.
Computer-based Cognitive Behavioral Interventions for Adults with Depressive or Anxiety Disorder
Background and Objectives of Review:
Computer-based self-help programs grounded in cognitive behavioral therapy (CBT) have been shown to produce significant reductions in depressive symptoms in participants who complete such programs. For people with anxiety disorders, computer-based CBT interventions have been shown to be effective compared to controls. Yet, little is known about the parameters of such a support function: Who can provide this type of support? How often should they be in contact with the participant? What are the advantages and disadvantages of using different communication media? Developed in a partnership of the VA and DoD, the Integrated Mental Health Strategy consists of a series of 28 Strategic Actions designed to help both agencies to better meet the unique mental health needs of OIF/OEF Veterans. One of these strategic actions has led to the creation of a series of web-based self-help programs. This SR is commissioned to inform the ways in which VA staff, family members, and other lay people can support Veterans’ engagement with, and completion of, these programs. This knowledge will in turn be used to inform the development of training materials and marketing messages for these audiences. The SR also will be used to inform the development of VA policy regarding the deployment of web-based self-help programs currently under development.
Key Questions:
KQ 1: For adults with depressive disorder, posttraumatic stress disorder, panic disorder, or generalized anxiety disorder, what are the effects of computer-based self-help interventions compared with inactive controls?
KQ 2: For computer-based self-help interventions, what level, type, and modality of user support is provided (e.g., daily telephone calls, weekly email correspondence); who provides this support (e.g., therapist, graduate student, peer); what is the clinical context (primary intervention, adjunct); and how is this support related to patient outcomes?
KQ 3: For adults with depressive disorder, posttraumatic stress disorder, panic disorder, or generalized anxiety disorder, what are the effects of computer-based self-help interventions compared with face-to-face therapy?
PICOTS:
Population: Outpatient adults 18 years of age or older with a depressive or anxiety disorder or symptoms above threshold for same
Intervention: Intervention or “exposure” must be a computer-based therapy adhering to CBT principles and used for acute-phase treatment; setting will be primary care, mental health, specialty or community clinics
Comparators: Usual care, waitlist, attention control, and for KQ3, face to face, non-computer-based other therapy
Outcomes (by validated method): Patient experience, adherence to the intervention, symptom measurement, functional status and safety
Setting: RCTs with an n>20 conducted since 1990. Full publications will be English-language and peer-reviewed in westernized countries.
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 MEDLINE® (via PubMed®), Cochrane Central Register of Controlled Trials, Embase®, and PsychInfo® 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.
Evidence Mapping Project: Acupuncture
Background/Objectives of Review:
Currently, the VA offers a wide variety of complementary and alternative medicine or integrative medicine modalities such as acupuncture, both for treatment and for the promotion of wellness. The effectiveness and harms associated with acupuncture, however, are to a large extent unknown. Given the VA's desire to promote evidence-based practice, this evidence mapping project will help provide guidance to VA leadership.
Scope of Project:
- An Evidence Map that provides a visual overview of the distribution of evidence (both what is known and where there is little or no evidence base) for acupuncture; and
- A set of executive summaries that will help stakeholders interpret the state of the evidence to inform policy and clinical decision making.
We will map the literature for the indications pain, mental health, and wellness; as well as any clinical area for which at least three reviews and/or recent large RCTs exist. We will develop a suitable deliverable format by operationalizing the visual overview as a bubble plot and modifying the executive summary of the ESP report template.
PICOTS:
Population: Patients undergoing acupuncture for any health-related indication
Intervention: Acupuncture using needles, including traditional Chinese acupuncture and other related acupuncture concepts, with or without electro stimulation, with or without moxibustion, whole body as well as microsystem acupuncture. Reviews or trials exclusively targeting acupressure, laser acupuncture, transcutaneous electrical nerve simulation, or dry needling are excluded.
Comparators (design): Systematic reviews (defined as reporting search sources and the number of identified studies) and recent randomized controlled trials (RCTs) not yet included in reviews focusing on acupuncture
Outcomes: Patient outcomes summarized in reviews or addressed in the recent trials
Timing: Any intervention duration and any follow-up point
Setting: Healthcare-related settings
General Search Strategy:
We will search the electronic databases PubMed using the systematic review clinical query, the Database of Abstracts of Reviews of Effects (DARE), the Cochrane Library of Systematic Reviews, and AMED (Allied and Complementary Medicine database) to identify English-language systematic reviews published since 2005 focusing on acupuncture. Recently published, English-language acupuncture RCTs, indexed in PubMed will also be identified. In addition, we will identify relevant studies through the review registry PROSPERO, published reviews of reviews, reference mining of pertinent reviews, and topic experts.
Benefits and Harms of Femtosecond Laser Assisted Cataract Surgery
Background/Objectives of Review:
The preferred method of removing cataracts in the developed world is phacoemulsification (Uy 2012). Using this technique, ultrasonic energy softens the dense lens material of the cataract, which is then extracted from the eye with suction and irrigation. Current practice includes creating manual corneal incisions and anterior capsulotomies, followed by phacoemulsification (Palanker 2010). Recently these three manual procedures have been performed in an automated fashion with the use of the femtosecond laser (FSL). Several FSL systems have been approved by the FDA for use in the U.S. for some or all of these procedural steps in cataract surgery. FSL technology has been widely used in various refractive surgery applications in recent years (He 2011). Studies have suggested decreased phacoemulsification energy use with FSL cataract surgery (Abell 2012) and have examined the potential advantages of more precise corneal incisions (Masket 2010) and capsulotomy formation (Kranitz 2010).
Cataract surgery is a frequently performed operation in the VHA (VA Office of Inspector General, 2013), with more than 49,000 performed in 2012. As a result, the VHA National Surgery Office has been tasked with making a recommendation regarding whether femtosecond lasers provide appropriate cost-benefit and risk-benefit ratios to support implementation for cataract surgery in the VA. Thus, an unbiased evidence review examining the harms and benefits of femtosecond laser assisted cataract surgery (FLACS) will aid VA leadership in determining policy for the use of FLACS. Key questions were developed in conjunction with the stakeholders to address the effectiveness, safety, adverse consequences, and economic implications of adopting this new technology into the VA system.
Key Questions:
KQ 1. What are the benefits of FLACS compared with conventional cataract surgery?
KQ 2a: What are the risks associated with FLACS?
KQ 2b: How do the risks of FLACS compare with conventional cataract surgery?
KQ 3. How are the risks of FLACS affected by the experience of the surgeon?
PICOTS:
Population: Adults undergoing cataract surgery.
Interventions: Femtosecond laser technology is used in cataract surgery to assist or replace aspects of conventional cataract surgery, including corneal incisions, capsulotomy, and lens fragmentation.
Comparators: Conventional cataract surgery, defined as small-incision, phacoemulsification with posterior-chamber intraocular lenses (IOL) implantation.
Outcomes: Visual acuity (post-operative day 1, after post-operative day 1—typically recorded post-operative 1 week, 1 month, or 90 days); Quality of Life (QOL) measures. Intra-operative: capsular blockage syndrome, dislocated nucleus, capsular tear, docking failure. Post-operative: infection, retinal swelling/Cystoid Macular Edema, intraocular decentration, corneal edema).
Timing: Our operational definition to be used for timing of patient outcomes is as follows: Short-term—patient outcomes on post-operative day 1; long term—patient outcomes > after post-operative day 1 (no upper limit).
Setting: Any
Study designs: Controlled studies including randomized controlled trials, non-randomized controlled clinical trials, and observational studies comparing FLACS to conventional cataract surgery. Case reports, case series to inform on risks.
General Search Strategy:
We will begin by searching MEDLINE®, 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.