U.S. Preventive Services Task Force Criteria Research Articles

PS2-4: Diabetes Screening and Detection in an Ambulatory Clinical Population

Background/AimsType 2 diabetes mellitus is associated with significant morbidity and mortality in the U.S. It is unknown whether racial/ethnic disparities in diabetes prevalence are being adequately addressed in clinical practice with respect to screening. Our aim was to determine diabetes screening and detection rates by race/ethnicity and whether they vary depending on screening criteria used. Racial/ethnic minority groups are generally found to have higher prevalence of diabetes, but little is known about whether screening and detection rates vary by race/ethnicity.MethodsData from electronic health records (EHR) in a large ambulatory group practice were used to construct a cohort of persons aged 35 and older without prevalent diabetes (N = 116,355). They were followed for diabetes screening (average follow up 17 months in 2007–2011). We computed standardized screening and detection rates in each racial/ethnic group and examined predictors of screening. We compared positive detection rates for those who met the U.S. Preventive Services Task Force (USPSTF) or American Diabetes Association (ADA) screening criteria and those who did not.ResultsMost patients (82%), including 75% of those meeting neither criteria, were screened during follow-up. Racial/ethnic minority groups had higher screening rates – Latino (82%), Asian subgroups (83% (Japanese) to 90% (Filipino)), non-Hispanic Black (92%) – than non-Hispanic White (80%) (P <0.001). Detection rates were also significantly higher for some minority groups (Latinos (2.1%), Asian Indians (2.4%), and Filipinos (3.8%)) than non-Hispanic White (1.3%) (P <0.05). Among screened, 1.6% had positive test results (number needed to screen (NNS) = 64). The NNS was 46 for those meeting ADA criteria, 36 for USPSTF criteria and 132 for those meeting neither.ConclusionsNearly all patients in our study population received screening, and racial/ethnic minority groups were not less likely to be screened. Current clinical practice screens a high proportion of individuals meeting neither ADA nor USPSTF guidelines. Given low screening costs that may be appropriate because many new cases were detected among those without risk factors. Given the substantial benefit of early detection of diabetes our study suggests that universal, preventive screening for diabetes for asymptomatic individuals may have utility.

Utility of the U.S. Preventive Services Task Force criteria for diabetes screening.

Federal law requires certain private insurers to cover and waive patient cost sharing for preventive medical services that receive a grade of B or better from the U.S. Preventive Services Task Force (USPSTF). The USPSTF recommends that asymptomatic adults who have a blood pressure (BP) higher than 135/80 mmHg be screened for type 2 diabetes. The goals of this study were to determine the sensitivity and specificity of the USPSTF screening criteria and to determine the prevalence of cardiovascular risk factors and comorbidity among undiagnosed individuals by USPSTF criteria. Data come from 7189 adults who participated in the 2003-2010 National Health and Nutrition Examination Survey; statistical analysis was conducted in 2011-2012. Participants with fasting plasma glucose ≥126 mg/dL or hemoglobin A1c (HbA1c) ≥6.5% who did not self-report a diagnosis of diabetes were categorized as having undiagnosed diabetes. Among people without diagnosed diabetes, 4.0% had undiagnosed diabetes. The proportion of adults with undiagnosed diabetes who were identified (sensitivity) using BP >135/80 mmHg as the screening standard was 44.4%; among individuals without undiagnosed diabetes, 74.8% had BP ≤135/80 mmHg (specificity). For those with undiagnosed diabetes, the prevalence of HbA1c 7.0%-<8.0% was 10.6% for those with BP ≤135/80 mmHg and 14.3% for those with BP >135/80 mmHg; and 12.8% and 9.4% for HbA1c ≥8.0%, respectively. Elevated low-density lipoprotein (100-160 mg/dL) was similar by BP cut-point (52%-53%). For those with BP ≤135/80 mmHg, 16.7% had a history of cardiovascular disease and 22.9% had chronic kidney disease. The USPSTF screening recommendations result in missing more than half of those who have undiagnosed diabetes, and a substantial proportion of these people have increased low-density lipoprotein and other cardiovascular risk factors.

Percutaneous Lumbar Mechanical Disc Decompression Utilizing Dekompressor®: An Update of Current Evidence

Background: The primary goal of the surgical treatment of nerve root compression from a disc protrusion continues to be the relief of compression by removing the herniated nuclear material with open discectomy. However, poor results have been reported for contained disc herniations with open surgical interventions. In recent years, a number of minimally invasive nuclear decompression techniques for lumbar disc prolapse, protrusion, and/or herniation have been introduced, including the Dekompressor®. The efficacy of several alternative techniques, including the Dekompressor, automated percutaneous discectomy, and laser discectomy, has been described, but is not convincing. There is a continued paucity of evidence for all decompression techniques. Objective: The objective of this systematic review is to evaluate and update the literature describing the clinical effectiveness of Dekompressor, a high rotation per minute (RPM) device used in mechanical lumbar disc decompression. Study Design: A systematic review of the literature focusing on mechanical disc decompression with Dekompressor. Methods: The available literature on the use of percutaneous disc decompression (PDD) with Dekompressor to manage chronic low back and lower extremity pain was reviewed using the Cochrane Musculoskeletal Review Group criteria for randomized trials and the Newcastle-Ottawa Scale criteria for observational studies. The level of evidence was classified as good, fair, and limited or poor based on the US Preventive Services Task Force (USPSTF) system for grading the quality of evidence. Data sources included relevant literature identified through PubMed and EMBASE from 1966 through September 2012, and manual searches of the bibliographies of known primary and review articles. Outcome Measures: Pain relief was the primary outcome measure. Secondary outcome measures were functional improvement, improvement of psychological status, opioid intake, and return to work. Short-term effectiveness was defined as one year or less. Long-term effectiveness was defined as greater than one year. Results: Only 5 studies were considered for inclusion. Of those, only 3 of them met inclusion criteria. Based on USPSTF criteria, the level of evidence for PDD with Dekompressor is limited. Limitations: Paucity of high quality literature. Conclusion: This systematic review found limited evidence for PDD with Dekompressor. Key words: Intervertebral disc disease, chronic low back pain, mechanical disc decompression, disc protrusion, disc extrusion, radiculitis, Dekompressor.

An Updated Review of Automated Percutaneous Mechanical Lumbar Discectomy for the Contained Herniated Lumbar Disc

Background: Lumbar disc prolapse, protrusion, and extrusion are the most common causes of nerve root pain and surgical interventions, and yet they account for less than 5% of all low back problems. The typical rationale for traditional surgery is that it is an effort to provide more rapid relief of pain and disability. It should be noted that the majority of patients do recover with conservative management. The primary rationale for any form of surgery for disc prolapse associated with radicular pain is to relieve nerve root irritation or compression due to herniated disc material. The primary modality of treatment continues to be either open or microdiscectomy, although several alternative techniques, including automated percutaneous mechanical lumbar discectomy, have been described. There is, however, a paucity of evidence for all decompression techniques, specifically alternative techniques including automated and laser discectomy. Study Design: A systematic review of the literature of automated percutaneous mechanical lumbar discectomy for the contained herniated lumbar disc. Objective: To evaluate and update the effectiveness of automated percutaneous mechanical lumbar discectomy. Methods: The available literature on automated percutaneous mechanical lumbar discectomy in managing chronic low back and lower extremity pain was reviewed. The quality assessment and clinical relevance criteria utilized were the Cochrane Musculoskeletal Review Group criteria, as utilized for interventional techniques for randomized trials, and the criteria developed by the Newcastle-Ottawa Scale criteria for observational studies. The level of evidence was classified as good, fair, and limited or poor, based on the quality of evidence scale developed by the U.S. Preventive Services Task Force (USPSTF). Data sources included relevant literature identified through searches of PubMed and EMBASE from 1966 to September 2012, and manual searches of the bibliographies of known primary and review articles. Outcome Measures: Pain relief was the primary outcome measure. Other outcome measures were functional improvement, improvement of psychological status, opioid intake, and return to work. Short-term effectiveness was defined as one year or less, whereas long-term effectiveness was defined as greater than one year. Results: Nineteen studies were included; none of the randomized trials and 19 observational studies met inclusion criteria for methodological quality assessment. Overall, 5,515 patients were studied with 4,412 patients (80%) showing positive results lasting one year or longer. Based on USPSTF criteria, the indicated evidence for automated percutaneous mechanical lumbar discectomy is limited for short- and long-term relief. Limitations: A paucity of randomized controlled trials in the literature describing automated percutaneous mechanical disc decompression. Conclusion: This systematic review shows limited evidence for automated percutaneous mechanical lumbar discectomy. Automated percutaneous mechanical lumbar discectomy may provide appropriate relief in properly selected patients with contained lumbar disc herniation. Key words: Intervertebral disc disease, chronic low back pain, mechanical disc decompression, automated percutaneous mechanical lumbar discectomy, internal disc disruption, radiculitis.

An Update of the Systematic Assessment of Mechanical Lumbar Disc Decompression with Nucleoplasty

Background: Lumbar disc prolapse, protrusion, and extrusion account for less than 5% of all low back problems, but are the most common causes of nerve root pain and surgical interventions. The primary rationale for any form of surgery for disc prolapse is to relieve nerve root irritation or compression due to herniated disc material. The primary modality of treatment continues to be either open or microdiscectomy, although several alternative techniques are also utilized, including nucleoplasty, automated percutaneous discectomy and laser discectomy. There is a paucity of evidence for all decompression techniques, specifically alternative techniques including nucleoplasty. Study Design: A systematic review of the literature of mechanical lumbar disc decompression with nucleoplasty. Objective: To determine the effectiveness and update the effectiveness of mechanical lumbar disc decompression with nucleoplasty. Methods: The available literature on mechanical lumbar disc decompression with nucleoplasty was reviewed. The quality assessment and clinical relevance criteria utilized were the Cochrane Musculoskeletal Review Group criteria as utilized for interventional techniques for randomized trials and the criteria developed by the Newcastle-Ottawa Scale criteria for observational studies. The level of evidence was classified as good, fair, and limited or poor based on the quality of evidence developed by the U.S. Preventive Services Task Force (USPSTF). Data sources included relevant literature identified through searches of PubMed and EMBASE from 1966 to September 2012, and manual searches of the bibliographies of known primary and review articles. Outcome Measures: Pain relief and functional improvement were the primary outcome measures. Other outcome measures were improvement of psychological status, reduction in opioid intake, and return to work. Short-term effectiveness was defined as one year or less, whereas long-term effectiveness was defined as greater than one year. Results: For this systematic review, 37 studies were considered for inclusion. Of these, there was one randomized trial and 14 observational studies meeting inclusion criteria for methodological quality assessment. Based on USPSTF criteria, the level of evidence for nucleoplasty is limited to fair in managing radicular pain due to contained disc herniation. Limitations: A paucity of literature with randomized trials. Conclusion: This systematic review illustrates limited to fair evidence for nucleoplasty in managing radicular pain due to contained disc herniation. Key words: Intervertebral disc disease, chronic low back pain, disc herniation, disc protrusion, radiculitis, contained disc herniation, mechanical disc decompression, nucleoplasty, Coblation technology, nucleotomy

Percutaneous Lumbar Laser Disc Decompression: An Update of Current Evidence

Background: Since the descriptions by Mixter and Barr of surgical treatment for rupture of the intervertebral disc in 1934, open surgical procedures have become a common practice. Disc herniations are often classified as being contained or non-contained. The results of open surgical discectomy for contained disc herniation have been poor. Consequently, several less invasive techniques have been developed including percutaneous lumbar laser disc decompression. Study Design: A systematic review of the literature of percutaneous lumbar laser disc decompression. Objective: The objective of this systematic review is to evaluate and update the clinical effectiveness of percutaneous lumbar laser discectomy in managing radicular pain secondary to contained disc herniation. Methods: The available literature on lumbar laser disc decompression in managing chronic low back and lower extremity pain was reviewed. Quality assessment and clinical relevance of randomized trials were graded according to the Cochrane Musculoskeletal Review Group criteria for interventional techniques, and observational studies according to the Newcastle-Ottawa Scale criteria. The level of evidence was classified as good, fair, and limited or poor based on the quality of evidence developed by the U.S. Preventive Services Task Force (USPSTF). Data sources included relevant literature identified through searches of PubMed and EMBASE from 1966 to September 2012, and manual searches of the bibliographies of known primary and review articles. Outcome Measures: Pain relief was the primary outcome measure. Other outcome measures were functional improvement, improvement of psychological status, opioid intake, and return-to-work. Short-term effectiveness was defined as effectiveness lasting one year or less, whereas, long-term effectiveness was defined as benefit persisting for greater than one year. Results: Based on USPSTF criteria, the indicated level of evidence for percutaneous lumbar laser disc decompression is limited for short- and long-term relief. Limitations: Although laser discectomy has been utilized for many years, there is a paucity of randomized clinical trials. Conclusion: This systematic review shows limited evidence for percutaneous lumbar laser disc decompression. Key words: Intervertebral disc disease, chronic low back pain, disc herniation, disc protrusion, radiculitis, contained disc herniation, mechanical disc decompression, percutaneous lumbar laser discectomy, laser assisted spinal endoscopy

Percutaneous Adhesiolysis in the Management of Chronic Low Back Pain in Post Lumbar Surgery Syndrome and Spinal Stenosis: A Systematic Review

Background: Low back pain after either post lumbar surgery syndrome or spinal stenosis in the absence of surgery is a vexing problem. Post lumbar surgery syndrome can occur in any age group, while low back and radicular pain from spinal stenosis is a disease of aging. As the population ages, the incidence of symptomatic spinal stenosis will increase. There are currently limited treatment options for either group. Further surgery is not uniformly effective in relieving pain after previous surgery. While therapies are being developed to treat pain due to spinal stenosis, no therapy other than adhesiolysis will treat pain due to scarring. Adhesiolysis was developed as a means of removing epidural scarring leading directly or indirectly to compression, inflammation, swelling, or a decreased nutritional supply of nerve roots. Adhesiolysis utilizes a number of modalities in the effort to break up epidural scarring, including the use of a wirebound catheter for mechanical adhesiolysis, placement of the catheter in the ventro-lateral aspect of the epidural space at the site of the exiting nerve root, and the use of high volumes of injectate, including local anesthetics and saline, either hypertonic or isotonic, along with steroids. Study Design: A systematic review of percutaneous adhesiolysis in the treatment of refractory low back and leg pain due to post lumbar surgery syndrome or spinal stenosis. Objective: To evaluate the effectiveness of percutaneous adhesiolysis in the treatment of refractory low back and leg pain due to post lumbar surgery syndrome or spinal stenosis. The severity of risks and adverse events associated with percutaneous adhesiolysis were also evaluated. Methods: The available literature on percutaneous adhesiolysis for the treatment of refractory low back and leg pain due to post lumbar surgery syndrome or spinal stenosis was reviewed. The quality assessment and clinical relevance criteria utilized were the Cochrane Musculoskeletal Review Group criteria as utilized for interventional techniques for randomized trials and the criteria developed by the Newcastle-Ottawa Scale criteria for observational studies. The level of evidence was classified as good, fair, and limited (or poor) based on the quality of evidence developed by the U.S. Preventive Services Task Force (USPSTF). Data sources included relevant literature identified through searches of PubMed and EMBASE from 1966 to June 2012, and manual searches of the bibliographies of known primary and review articles. Outcome Measures: The primary outcome measure was pain relief of at least 6 months. Secondary outcome measures were improvement in functional status, change in psychological status, return to work, and reduction in opioid use or interventions. Results: For this systematic review, 15 studies were identified and selected for review. Of these, 5 randomized controlled trials and 2 observational studies met the inclusion criteria. Applying the USPSTF criteria, these studies indicate that there is fair evidence that percutaneous adhesiolysis is effective in relieving low back and/or leg pain caused by post lumbar surgery syndrome and that there is fair evidence that percutaneous adhesiolysis is effective in relieving low back and/ or leg pain caused by spinal stenosis The incidence of complications from percutaneous adhesiolysis is low and the complications are generally minimal and self-limited. The procedure should be considered to be low risk for serious adverse events when performed by well-trained physicians. Limitations: The limitations of this systematic review include the paucity of literature. Conclusion: In summary, there is fair evidence that percutaneous adhesiolysis is effective in relieving low back and/or leg pain due to post lumbar surgery syndrome or spinal stenosis. Key words: Spinal pain, chronic low back pain, leg pain, adhesiolysis, Racz procedure, post lumbar surgery syndrome, spinal stenosis

Back to Wilson and Jungner: 10 Good Reasons to Screen for Type 2 Diabetes Mellitus

The US Preventive Services Task Force (USPSTF) operates under the Agency for Healthcare Research and Quality, one of 11 divisions of the US Department of Health and Human Services. A panel of preventive medicine and health care experts, the USPSTF reviews existing literature and evidence to make recommendations regarding preventive care measures.1 Primary care practitioners rely on such guidelines to make medical decisions, and insurance companies and government agencies use this information to determine payment for services rendered and for credentialing of institutions. Recently, the USPSTF updated its guidelines on screening adults for type 2 diabetes mellitus2,3 (Table 1).4 This report was based on a literature review of the existing data in both MEDLINE and the Cochrane Library databases. Members of the USPSTF concluded that screening for diabetes in asymptomatic individuals with hypertension (blood pressure >135/80 mm Hg) was merited. Unfortunately, they did not recommend or highlight the importance of screening other at-risk populations who would be screened under the American Diabetes Association (ADA) guidelines, citing lack of direct or indirect evidence supporting population screening.2 However, the authors acknowledge that direct evidence, such as a randomized trial that compared treated vs untreated persons in whom screening detected diabetes, will not be available because “withholding treatment from persons with known diabetes is unethical….” The ADA also concluded that a study of this type is unlikely to occur and developed guidelines based on existing data and expert opinion that recommend screening for diabetes mellitus in a much wider population because of the epidemic in the United States.4 TABLE 1. ADA and USPSTF Criteria to Screen for Diabetes Mellitusa In addition, the criteria used to develop these new USPSTF recommendations have been a subject of interest. Although USPSTF states its guidelines are based on explicit criteria,1 experts have questioned its more restrictive screening criteria used to develop its diabetes screening guidelines compared with that used for another chronic disease, obesity.5 This query has merit considering the impact USPSTF guidelines have on population health. Clearly, screening for disease must meet certain criteria to be medically and financially acceptable. Perhaps the most recognized criteria were determined by Wilson and Jungner6 in 1968. These principles (Table 2), which the World Health Organization follows, define the basis of preventive medicine 40 years later and are largely considered the standards by which screening tests are judged and determined. TABLE 2. Wilson and Jungner Criteria for Disease Screening (Adopted by the World Health Organization) Because of the potential far-reaching implications of the new USPSTF guidelines, it is important to examine the merits of diabetes screening using the 10 criteria of Wilson and Jungner since national screening recommendations profoundly affect health care delivery and outcomes.

Intrathecal Therapy for Cancer and Non-Cancer Pain

Background: Intrathecal drug infusion therapy is usually considered when spinal-acting analgesics or antispasmodics administered via the oral or transdermal routes fail to control patients’ pain or are associated with unacceptable side effects. The intrathecal administration of centrally acting agents bypasses the blood-brain-barrier resulting in much higher cerebrospinal fluid (CSF) concentrations while using reduced amounts of medication to achieve equipotent doses. The intrathecal approach is associated with higher rates of satisfactory pain relief and lower rates of treatment failures and technical complications compared to the epidural route. A paucity of randomized controlled trials (RCTs) has led to concern regarding proper use, selection criteria, and safety of these devices. Cost effectiveness and comparative therapies have now also become a focus of discussion. Objective: The purpose of this systematic review is to evaluate and update the available evidence for the efficacy and safety of intrathecal infusions used in long-term management (&gt; 6 months) of chronic pain. This paper will not focus on intrathecal administration for spasticity or movement disorders. Study Design: A systematic review of intrathecal infusion through implanted drug delivery devices for chronic pain. Methods: Literature search through EMBASE, Medline, Cochrane databases, and systematic reviews as well as peer-reviewed non-indexed journals from 1980 to December 2010. Studies are assessed using the Agency for Healthcare Research and Quality (AHRQ) criteria for observational studies and the Cochrane Musculoskeletal Review Group criteria for randomized trials. The level of evidence was determined using 5 levels of evidence, ranging from Level I to III with 3 subcategories in Level II, based on the quality of evidence developed by the U.S. Preventive Services Task Force (USPSTF). Outcome Measures: The primary outcome measure for chronic non-cancer is pain relief (short-term relief ≤ one-year and long-term &gt; one-year), whereas it is 3 months for cancer. Secondary outcome measures of improvement in functional status, psychological status, return to work, and reduction in opioid intake. Results: The level of evidence for this systematic review of non-cancer pain studies meeting the inclusion criteria of continuous use of an intrathecal drug delivery system (IDDS) for at least 12 months duration with at least 25 patients in the cohort, is Level II-3 based on USPSTF criteria. The level of evidence for this systemic review for cancer-related pain studies meeting the inclusion criteria of continuous use of IDDS for at least 3 months duration with at least 25 patients in the cohort is Level II-2 based on USPSTF criteria. Conclusion: Based on the available evidence, the recommendation for intrathecal infusion systems for cancer-related pain is moderate recommendation based on the high quality of evidence and the recommendation is limited to moderate based on the moderate quality of evidence from nonrandomized studies for non-cancer related pain. Key words: Intrathecal infusion, intrathecal drug delivery device, intrathecal drug delivery system, intraspinal infusion, programmable infusion systems, spinal infusion, intra-spinal infusion devices, baclofen infusion, intrathecal opioids

Analysis of Guidelines for Screening Diabetes Mellitus in an Ambulatory Population

To compare the case-finding ability of current national guidelines for screening diabetes mellitus and characterize factors that affect testing practices in an ambulatory population. In this retrospective analysis, we reviewed a database of 46,991 nondiabetic patients aged 20 years and older who were seen at a large Midwestern academic physician practice from January 1, 2005, through December 31, 2007. Patients were included in the sample if they were currently being treated by the physician group according to Wisconsin Collaborative for Healthcare Quality criteria. Pregnant patients, diabetic patients, and patients who died during the study years were excluded. The prevalence of patients who met the American Diabetes Association (ADA) and/or US Preventive Services Task Force (USPSTF) criteria for diabetes screening, percentage of these patients screened, and number of new diabetes diagnoses per guideline were evaluated. Screening rates were assessed by number of high-risk factors, primary care specialty, and insurance status. A total of 33,823 (72.0%) of 46,991 patients met either the ADA or the USPSTF screening criteria, and 28,842 (85.3%) of the eligible patients were tested. More patients met the ADA criteria than the 2008 USPSTF criteria (30,790 [65.5%] vs 12,054 [25.6%]), and the 2008 USPSTF guidelines resulted in 460 fewer diagnoses of diabetes (33.1%). By single high-risk factor, prediabetes (15.8%) and polycystic ovarian syndrome (12.6%) produced the highest rates of diagnosis. The number of ADA high-risk factors predicted diabetes, with 6 (23%) of 26 patients with 6 risk factors diagnosed as having diabetes. Uninsured patients were tested significantly less often than insured patients (54.9% vs 85.4%). Compared with the ADA recommendations, the new USPSTF guidelines result in a lower number of patients eligible for screening and decrease case finding significantly. The number and type of risk factors predict diabetes, and lack of health insurance decreases testing.

Folic Acid Supplementation for the Prevention of Neural Tube Defects: An Update of the Evidence for the U.S. Preventive Services Task Force

Neural tube defects (NTDs) are among the most common birth defects in the United States. In 1996, the U.S. Preventive Services Task Force (USPSTF) recommended that all women planning a pregnancy or capable of conception take a supplement containing folic acid to reduce the risk for NTDs. To search for new evidence published since 1996 on the benefits and harms of folic acid supplementation for women of childbearing age to prevent neural tube defects in offspring, to inform an updated USPSTF recommendation. MEDLINE and Cochrane Central Register of Controlled Trials searches from January 1995 through December 2008, recent systematic reviews, reference lists of retrieved articles, and expert suggestions. English-language randomized, controlled trials; cohort studies; case-control studies; systematic reviews; and meta-analyses were selected if they provided information on the benefits and harms of folic acid supplementation in women of childbearing age to reduce NTDs in offspring. All studies were reviewed, abstracted, and rated for quality by using predefined USPSTF criteria. Four observational studies reported benefit of reduction of risk for NTDs associated with folic acid-containing supplements. Differences in study type and methods prevent the calculation of a summary of the reduction in risk. The one included study on harms reported that the association of twinning with folic acid intake disappeared after adjustment for in vitro fertilization and underreporting of folic acid intake. The evidence on dose was limited. No evidence was found on the potential harm of masking vitamin B(12) deficiency in women of childbearing age. The search focused on the association of NTDs with supplementation only and therefore does not provide a comprehensive review of the effects of folic acid on all possible outcomes or of the effects of dietary intake of folic acid. New observational evidence supports previous evidence from a randomized, controlled trial that folic acid-containing supplements reduce the risk for NTD-affected pregnancies. The association of folic acid use with twin gestation may be confounded by fertility interventions.

Systematic Assessment of Diagnostic Accuracy and Therapeutic Utility of Lumbar Facet Joint Interventions

Lumbar facet joints are a well recognized source of low back pain and referred pain in the lower extremity in patients with chronic low back pain. Conventional clinical features and other non-invasive diagnostic modalities are unreliable in diagnosing lumbar zygapophysial joint pain. Controlled diagnostic studies have shown the prevalence of lumbar facet joint pain in 27% to 40% of the patients with chronic low back pain without disc displacement or radiculitis, with a false-positive rate of 27% to 47% with a single diagnostic block. A systematic review of diagnostic and therapeutic lumbar facet joint interventions. To determine the clinical utility of diagnostic and therapeutic lumbar facet joint interventions in managing chronic low back pain of facet joint origin. Review of the literature for clinical studies on efficacy and utility of facet joint interventions in diagnosing and managing facet joint pain was performed according to the Agency for Healthcare Research and Quality (AHRQ) criteria for diagnostic studies and observational studies and the Cochrane Musculoskeletal Review Group criteria as utilized for interventional techniques for randomized trials. Data sources included relevant literature of the English language identified through searches of Medline and EMBASE from 1966 to December 2008 and manual searches of bibliographies of known primary and review articles. Analysis results were performed for diagnostic and therapeutic interventions separately. The level of evidence was defined as Level I, II, or III with 3 subcategories in Level II based on the quality of evidence developed by the U.S. Preventive Services Task Force (USPSTF) for therapeutic interventions. For diagnostic interventions, studies must have been performed utilizing controlled local anesthetic blocks. Pain relief was categorized as at least 80% pain relief from baseline pain and ability to perform previously painful movements. For therapeutic interventions, the primary outcome measure was pain relief with secondary outcome measures of improvement in functional status, psychological status, return to work, and reduction in opioid intake. For therapeutic interventions, short-term pain relief was defined as relief lasting 6 months or less and long-term relief as longer than 6 months. Based on USPSTF criteria, evidence showed Level I or II-1 for diagnostic facet joint nerve blocks. Based on the review of included therapeutic studies, Level II-1 to II-2 evidence was indicated for lumbar facet joint nerve blocks with indicated level of evidence of Level II-2 to II-3 for lumbar radiofrequency neurotomy. The shortcoming of this systematic review of lumbar facet joint interventions is the paucity of published literature. The evidence for diagnosis of lumbar facet joint pain with controlled local anesthetic blocks is Level I or II-1. The indicated level of evidence for therapeutic lumbar facet joint interventions is Level II-1 or II-2 for lumbar facet joint nerve blocks, Level II-2 or II-3 evidence for radiofrequency neurotomy, and Level III (limited) evidence for intraarticular injections.

Screening for Skin Cancer: An Update of the Evidence for the U.S. Preventive Services Task Force

Skin cancer is the most commonly diagnosed cancer in the United States. The majority of skin cancer is nonmelanoma cancer, either basal cell cancer or squamous cell cancer. The incidence of both melanoma and nonmelanoma skin cancer has been increasing over the past 3 decades. In 2001, the U.S. Preventive Services Task Force (USPSTF) found insufficient evidence to recommend for or against routine screening for skin cancer by using whole-body skin examination for early detection of skin cancer. To update the evidence of benefits and harms of screening for skin cancer in the general population. MEDLINE and Cochrane Library searches from 1 June 1999 to 9 August 2005 for English-language articles; recent systematic reviews; reference lists of retrieved articles; and expert suggestions. English-language studies were selected to answer the following key question: Does screening in asymptomatic persons with whole-body examination by a primary care clinician or by self-examination reduce morbidity and mortality from skin cancer? Randomized, controlled trials and case-control studies of screening for skin cancer were selected. One author selected English-language studies to answer the following contextual questions: Can screening with whole-body examination by primary care clinicians or by self-examination accurately detect skin cancer? Does screening with whole-body examination or by self-examination detect melanomas at an earlier stage (thinner lesions)? All studies for the key question were reviewed, abstracted, and rated for quality by using predefined USPSTF criteria. No new evidence from controlled studies was found that addressed the benefit of screening for skin cancer with a whole-body examination by a physician. One article of fair quality, which reanalyzed data from a 1996 study identified for the 2001 report for the USPSTF, provides limited but insufficient evidence on the benefit of skin self-examination in the reduction of morbidity and mortality from melanoma. Direct evidence linking skin cancer screening to improved health outcomes is lacking. Information is limited on the accuracy of screening by physicians or patients using real patients and lesions. The limited evidence prevents accurate estimation of the benefits of screening for skin cancer in the general primary care population.

Self-administered, web-based screening of family history of cancer as a method to select appropriate patients for genetic assessment.

Abstract Abstract #1096 Background: The US Preventive Services Task Force (USPSTF) recommends that women with family histories suggesting increased risk of hereditary breast-ovarian cancer (HBOC) be referred to genetic counseling. Feasible methods for family history risk assessment are needed in order to implement this guideline. This study is conducted to assess the feasibility of using a computer-assisted family history tool to identify appropriate candidates for genetics referral among women seen in a multispecialty breast diagnostic center. Material and Methods: The Web-based Genetic Risk Easy Assessment Tool (GREAT) uses a validated, self-administered questionnaire to collect personal and family history of cancer. It connects with CancerGene to calculate breast cancer risks by Gail, Claus, and BRCA-PRO models and BRCA mutation probabilities. Validated algorithms in GREAT identify increased risk of HBOC according to USPSTF criteria, modified to include women with breast cancer. It provides a personalized report including cancer risk and prevention messages and a family tree. We invited consecutive women obtaining mammograms or consultations at the UH Breast Center to use the GREAT and obtained users' immediate feedback about the Website and personal report. Each user's responses were evaluated by genetics professionals to determine whether genetics referral would be indicated, and whether the woman herself or a living relative would be appropriate for genetic cancer susceptibility testing. Preliminary Results (participant enrollment is ongoing): 2065 women, mean age 57, were invited in the first 5 months of 2008. 22% had breast or ovarian cancer, 30% had a relative with breast or ovarian cancer, and 48% had no family or personal history. 194 women returned questionnaires to decline participation (mean age 56, 43% African-American); 37% did not have a computer or internet access, and 26% were concerned about privacy and internet security. 105 women consented and 67 so far had completed the GREAT (mean age 60, 16% African-American, 22% with a history of breast cancer). 28% of GREAT users received reports indicating increased risk for HBOC; all were considered appropriate for genetic counseling. &amp;gt;90% of users found the website easy to navigate, the questionnaire and personal report easy to understand, and the time taken not too long; none found the process upsetting. Most participants planned to talk with family members and show the report to relatives. Discussion: A self-selected, higher-risk group of women found the web-based GREAT an acceptable means of personal and familial cancer risk assessment in the context of a visit to the Breast Center. Lack of internet access and concerns about internet security posed barriers for some would-be participants. If analyses confirm the sensitivity and specificity of risk algorithms, providing access to this tool at the time of mammography may increase the feasibility of identifying and referring women for genetic consultation regarding hereditary breast-ovarian cancer susceptibility. Citation Information: Cancer Res 2009;69(2 Suppl):Abstract nr 1096.

Back to Wilson and Jungner: 10 good reasons to screen for type 2 diabetes mellitus.

The US Preventive Services Task Force (USPSTF) operates under the Agency for Healthcare Research and Quality, one of 11 divisions of the US Department of Health and Human Services. A panel of preventive medicine and health care experts, the USPSTF reviews existing literature and evidence to make recommendations regarding preventive care measures.1 Primary care practitioners rely on such guidelines to make medical decisions, and insurance companies and government agencies use this information to determine payment for services rendered and for credentialing of institutions. Recently, the USPSTF updated its guidelines on screening adults for type 2 diabetes mellitus2,3 (Table 1).4 This report was based on a literature review of the existing data in both MEDLINE and the Cochrane Library databases. Members of the USPSTF concluded that screening for diabetes in asymptomatic individuals with hypertension (blood pressure >135/80 mm Hg) was merited. Unfortunately, they did not recommend or highlight the importance of screening other at-risk populations who would be screened under the American Diabetes Association (ADA) guidelines, citing lack of direct or indirect evidence supporting population screening.2 However, the authors acknowledge that direct evidence, such as a randomized trial that compared treated vs untreated persons in whom screening detected diabetes, will not be available because “withholding treatment from persons with known diabetes is unethical….” The ADA also concluded that a study of this type is unlikely to occur and developed guidelines based on existing data and expert opinion that recommend screening for diabetes mellitus in a much wider population because of the epidemic in the United States.4 TABLE 1. ADA and USPSTF Criteria to Screen for Diabetes Mellitusa In addition, the criteria used to develop these new USPSTF recommendations have been a subject of interest. Although USPSTF states its guidelines are based on explicit criteria,1 experts have questioned its more restrictive screening criteria used to develop its diabetes screening guidelines compared with that used for another chronic disease, obesity.5 This query has merit considering the impact USPSTF guidelines have on population health. Clearly, screening for disease must meet certain criteria to be medically and financially acceptable. Perhaps the most recognized criteria were determined by Wilson and Jungner6 in 1968. These principles (Table 2), which the World Health Organization follows, define the basis of preventive medicine 40 years later and are largely considered the standards by which screening tests are judged and determined. TABLE 2. Wilson and Jungner Criteria for Disease Screening (Adopted by the World Health Organization) Because of the potential far-reaching implications of the new USPSTF guidelines, it is important to examine the merits of diabetes screening using the 10 criteria of Wilson and Jungner since national screening recommendations profoundly affect health care delivery and outcomes.

Indirect Versus Direct Evidence in U.S. Preventive Services Task Force Recommendations

Letters6 May 2008Indirect Versus Direct Evidence in U.S. Preventive Services Task Force RecommendationsDavid L. Hahn, MD, MSDavid L. Hahn, MD, MSFrom Dean Medical Center, Madison, WI 53715.Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/0003-4819-148-9-200805060-00013 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail TO THE EDITOR:Clinicians and policymakers rely on the U.S. Preventive Services Task Force (USPSTF) for reliable and accurate information. In their recent update on USPSTF methods, Sawaya and colleagues (1) described USPSTF criteria for constructing and evaluating an indirect “chain of evidence” for the effectiveness of a preventive service when direct evidence from 1 or more randomized effectiveness studies is unavailable. They also stated that their methods for making evidence-based recommendations would continue to evolve. I have a comment about the chain-of-evidence approach and suggest the next step in the evolution of the recommendation process.Positive recommendations based on ...

Screening for Chronic Obstructive Pulmonary Disease Using Spirometry: Summary of the Evidence for the U.S. Preventive Services Task Force

Background: Chronic obstructive pulmonary disease (COPD) is the fourth leading cause of death in the United States. Fewer than half of the estimated 24 million Americans with airflow obstruction have received a COPD diagnosis, and diagnosis often occurs in advanced stages of the disease. Purpose: To summarize the evidence on screening for COPD using spirometry for the U.S. Preventive Services Task Force (USPSTF). Data Sources: English-language articles identified in PubMed and the Cochrane Library through January 2007, recent systematic reviews, expert suggestions, and reference lists of retrieved articles. Study Selection: Explicit inclusion and exclusion criteria were used for each of the 8 key questions on benefits and harms of screening. Eligible study types varied by question. Data Extraction: Studies were reviewed, abstracted, and rated for quality by using predefined USPSTF criteria. Data Synthesis: Pharmacologic treatments for COPD reduce acute exacerbations in patients with severe disease. However, severe COPD is uncommon in the general U.S. population. Spirometry has not been shown to independently increase smoking cessation rates. Potential harms from screening include false-positive results and adverse effects from subsequent unnecessary therapy. Data on the prevalence of airflow obstruction in the U.S. population were used to calculate projected outcomes from screening groups defined by age and smoking status. Limitation: No studies provide direct evidence on health outcomes associated with screening for COPD. Conclusion: Screening for COPD using spirometry is likely to identify a predominance of patients with mild to moderate airflow obstruction who would not experience additional health benefits if labeled as having COPD. Hundreds of patients would need to undergo spirometry to defer a single exacerbation.

Screening for Hereditary Hemochromatosis: A Systematic Review for the U.S. Preventive Services Task Force

The U.S. Preventive Services Task Force (USPSTF) has not previously considered screening for hereditary hemochromatosis for a recommendation as a clinical preventive service for primary care clinicians. To conduct a focused systematic review of hereditary hemochromatosis screening relating to 2 USPSTF criteria, the burden of suffering and the potential effectiveness of a preventive intervention, to determine whether evidence is sufficient for a USPSTF recommendation. MEDLINE, CINAHL, and Cochrane Library databases from 1966 through February 2005. The authors supplemented literature searches with source materials from experts in the field and the bibliographies of key reviews and included studies. Studies were retrieved to answer 3 key questions: 1) What is the risk for developing clinical hemochromatosis among those with a homozygous C282Y genotype? 2) Does earlier therapeutic phlebotomy of individuals with primary iron overload due to hereditary hemochromatosis reduce morbidity and mortality compared with treatment after diagnosis in routine clinical care? 3) Are there groups at increased risk for developing hereditary hemochromatosis that can be readily identified before genetic screening? The authors critically appraised studies using quality criteria specific to their design. The authors abstracted all studies into evidence tables using condition definitions and diagnostic criteria. Data were insufficient to define a very precise estimate of penetrance. Available data suggest that up to 38% to 50% of C282Y homozygotes may develop iron overload, with up to 10% to 33% eventually developing hemochromatosis-associated morbidity. Prevalence of C282Y homozygosity is higher in family members of probands and other high-risk patient groups defined by signs, symptoms, and phenotypic screening. This review considered genetic screening for HFE-related hereditary hemochromatosis in C282Y homozygotes only. Available research is limited, is based solely on observational designs, and is plagued by poor or inconsistent reporting. Research addressing genetic screening for hereditary hemochromatosis remains insufficient to confidently project the impact of, or estimate the benefit from, widespread or high-risk genetic screening for hereditary hemochromatosis.