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Original Research | 
Tobias Freund, MD; Frank Peters-Klimm, MD; Cynthia M. Boyd, MD; Cornelia Mahler, MA; Jochen Gensichen, MD; Antje Erler, MD; Martin Beyer, MA; Matthias Gondan, PhD; Justine Rochon, MSc; Ferdinand M. Gerlach, MD; and Joachim Szecsenyi, MD
Includes: Supplemental Content
Background:Patients with multiple chronic conditions are at high risk for potentially avoidable hospitalizations, which may be reduced by care coordination and self-management support. Medical assistants are an increasingly available resource for patient care in primary care practices. Objective:To determine whether protocol-based care management delivered by medical assistants improves care in patients at high risk for future hospitalization in primary care. Design:Two-year cluster randomized clinical trial. (Current Controlled Trials: ISRCTN56104508) Setting:115 primary care practices in Germany. Patients:2076 patients with type 2 diabetes, chronic obstructive pulmonary disease, or chronic heart failure and a likelihood of hospitalization in the upper quartile of the population, as predicted by an analysis of insurance data. Intervention:Protocol-based care management, including structured assessment, action planning, and monitoring delivered by medical assistants, compared with usual care. Measurements:All-cause hospitalizations at 12 months (primary outcome) and quality-of-life scores (12-Item Short Form Health Survey [SF-12] and EuroQol instrument [EQ-5D]). Results:Included patients had an average of 4 co-occurring chronic conditions. All-cause hospitalizations did not differ between groups at 12 months (risk ratio [RR], 1.01 [95% CI, 0.87 to 1.18]) and 24 months (RR, 0.98 [CI, 0.85 to 1.12]). Quality of life (differences, 1.16 [CI, 0.24 to 2.08] on SF-12 physical component and 1.68 [CI, 0.60 to 2.77] on SF-12 mental component) and general health (difference on EQ-5D, 0.03 [CI, 0.00 to 0.05]) improved significantly at 24 months. Intervention costs totaled $10 per patient per month. Limitation:Small number of primary care practices and low intensity of intervention. Conclusion:This low-intensity intervention did not reduce all-cause hospitalizations but showed positive effects on quality of life at reasonable costs in high-risk multimorbid patients. Primary Funding Source:AOK Baden-Württemberg and AOK Bundesverband.
Topics: hospitalization, patient care management, primary health care, chronic disease, quality of life, chronic obstructive airway disease, self-management, follow-up, primary care physicians, diabetes mellitus, type 2, heart failure, chronic
Original Research | 
Lindsey R. Baden, MD; Etienne Karita, MD; Gaudensia Mutua, MBChB; Linda-Gail Bekker, MD; Glenda Gray, MBBCh; Liesl Page-Shipp, MD; Stephen R. Walsh, MD; Julien Nyombayire, MD; Omu Anzala, MBChB, PhD; Surita Roux, MD; Fatima Laher, MBBCh; Craig Innes, MD; Michael S. Seaman, PhD; Yehuda Z. Cohen, MD; Lauren Peter; Nicole Frahm, PhD; M. Juliana McElrath, MD, PhD; Peter Hayes, PhD; Edith Swann, PhD; Nicole Grunenberg, MD; Maria Grazia-Pau, MSc; Mo Weijtens, PhD; Jerry Sadoff, MD; Len Dally, MSc; Angela Lombardo, PhD; Jill Gilmour, PhD; Josephine Cox, PhD; Raphael Dolin, MD; Patricia Fast, MD, PhD; Dan H. Barouch, MD, PhD; Dagna S. Laufer, MD, for the B003-IPCAVD004-HVTN091 Study Group
Includes: Supplemental Content
Background:A prophylactic HIV-1 vaccine is a global health priority. Objective:To assess a novel vaccine platform as a prophylactic HIV-1 regimen. Design:Randomized, double-blind, placebo-controlled trial. Both participants and study personnel were blinded to treatment allocation. (ClinicalTrials.gov: NCT01215149) Setting:United States, East Africa, and South Africa. Patients:Healthy adults without HIV infection. Intervention:2 HIV-1 vaccines (adenovirus serotype 26 with an HIV-1 envelope A insert [Ad26.EnvA] and adenovirus serotype 35 with an HIV-1 envelope A insert [Ad35.Env], both administered at a dose of 5 × 1010 viral particles) in homologous and heterologous combinations. Measurements:Safety and immunogenicity and the effect of baseline vector immunity. Results:217 participants received at least 1 vaccination, and 210 (>96%) completed follow-up. No vaccine-associated serious adverse events occurred. All regimens were generally well-tolerated. All regimens elicited humoral and cellular immune responses in nearly all participants. Preexisting Ad26- or Ad35-neutralizing antibody titers had no effect on vaccine safety and little effect on immunogenicity. In both homologous and heterologous regimens, the second vaccination significantly increased EnvA antibody titers (approximately 20-fold from the median enzyme-linked immunosorbent assay titers of 30–300 to 3000). The heterologous regimen of Ad26–Ad35 elicited significantly higher EnvA antibody titers than Ad35–Ad26. T-cell responses were modest and lower in East Africa than in South Africa and the United States. Limitations:Because the 2 envelope inserts were not identical, the boosting responses were complex to interpret. Durability of the immune responses elicited beyond 1 year is unknown. Conclusion:Both vaccines elicited significant immune responses in all populations. Baseline vector immunity did not significantly affect responses. Second vaccinations in all regimens significantly boosted EnvA antibody titers, although vaccine order in the heterologous regimen had a modest effect on the immune response. Primary Funding Source:International AIDS Vaccine Initiative, National Institutes of Health, Ragon Institute, Crucell Holland.
Topics: hiv-1, vaccines, safety, adenovirus infections, enzyme-linked immunosorbent assay, adenoviruses, vaccination
In this issue, Freund and colleagues report a trial of a modest intervention powered by medical assistants to keep patients out of the hospital. The editorialist notes that we do well with the care of acute conditions and rescue care, which the health care system devotes considerable resources to. To similarly master chronic illness care will require similar resources and careful coordination of appropriately trained personnel.
Topics: hospitalization, primary health care
Reviews | 
John Eng, MD; Renee F. Wilson, MS; Rathan M. Subramaniam, MD, PhD, MPH; Allen Zhang, BS; Catalina Suarez-Cuervo, MD; Sharon Turban, MD, MHS; Michael J. Choi, MD; Cheryl Sherrod, MD, MPH; Susan Hutfless, PhD; Emmanuel E. Iyoha, MBChB, MPH; and Eric B. Bass, MD, MPH
Background:Iodinated contrast media are essential components of many imaging procedures. An important potential side effect is contrast-induced nephropathy (CIN). Purpose:To compare CIN risk for contrast media within and between osmolality classes in patients receiving diagnostic or therapeutic imaging procedures. Data Sources:PubMed, EMBASE, Cochrane Library, Clinical Trials.gov, and Scopus through June 2015. Study Selection:Randomized, controlled trials that reported CIN-related outcomes in patients receiving low-osmolar contrast media (LOCM) or iso-osmolar contrast media for imaging. Data Extraction:Independent study selection and quality assessment by 2 reviewers and dual extraction of study characteristics and results. Data Synthesis:None of the 5 studies that compared types of LOCM reported a statistically significant or clinically important difference among study groups, but the strength of evidence was low. Twenty-five randomized, controlled trials found a slight reduction in CIN risk with the iso-osmolar contrast media agent iodixanol compared with a diverse group of LOCM that just reached statistical significance in a meta-analysis (pooled relative risk, 0.80 [95% CI, 0.65 to 0.99]; P = 0.045). This comparison's strength of evidence was moderate. In a meta regression of randomized, controlled trials of iodixanol, no relationship was found between route of administration and comparative CIN risk. Limitations:Few studies compared LOCM. Procedural details about contrast administration were not uniformly reported. Few studies specified clinical indications or severity of baseline renal impairment. Conclusion:No differences were found in CIN risk among types of LOCM. Iodixanol had a slightly lower risk for CIN than LOCM, but the lower risk did not exceed a criterion for clinical importance. Primary Funding Source:Agency for Healthcare Research and Quality.
Topics: radiographic contrast agent nephropathy, contrast media
Reviews | 
Rathan M. Subramaniam, MD, PhD, MPH; Catalina Suarez-Cuervo, MD; Renee F. Wilson, MS; Sharon Turban, MD, MHS; Allen Zhang, BS; Cheryl Sherrod, MD, MPH; Jonathan Aboagye, MD, MPH; John Eng, MD; Michael J. Choi, MD; Susan Hutfless, PhD; and Eric B. Bass, MD, MPH
Background:N-acetylcysteine, sodium bicarbonate, statins, and ascorbic acid have been studied for reducing contrast-induced nephropathy (CIN). Purpose:To evaluate the comparative effectiveness of interventions to reduce CIN in adults receiving contrast media. Data Sources:MEDLINE, EMBASE, Cochrane Library, ClinicalTrials.gov, and Scopus databases through June 2015. Risk of bias of studies and overall strength of evidence (SOE) were assessed. Study Selection:Randomized, controlled trials of N-acetylcysteine, sodium bicarbonate, statins, or ascorbic acid that used intravenous (IV) or intra-arterial contrast media and defined CIN with enough data for meta-analysis. Data Extraction:Two reviewers independently extracted data and assessed study quality. Data Synthesis:Low-dose N-acetylcysteine compared with IV saline (risk ratio [RR], 0.75 [95% CI, 0.63 to 0.89]; low SOE), N-acetylcysteine compared with IV saline in patients receiving low-osmolar contrast media (RR, 0.69 [CI, 0.58 to 0.84]; moderate SOE), and statins plus N-acetylcysteine versus N-acetylcysteine (RR, 0.52 [CI, 0.29 to 0.93]; low SOE) had clinically important and statistically significant benefits. The following 3 comparisons suggested a clinically important difference that was not statistically significant: sodium bicarbonate versus IV saline in patients receiving low-osmolar contrast media (RR, 0.65 [CI, 0.33 to 1.25]; low SOE), statins plus IV saline versus IV saline (RR, 0.68 [CI, 0.39 to 1.20]; low SOE), and ascorbic acid versus IV saline (RR, 0.72 [CI, 0.48 to 1.01]; low SOE). Strength of evidence was generally insufficient for comparisons of the need for renal replacement, cardiac events, and mortality. Limitation:Too few studies were done in patients receiving IV contrast media. Conclusion:The greatest reduction in CIN was seen with N-acetylcysteine in patients receiving LOCM and with statins plus N-acetylcysteine. Primary Funding Source:Agency for Healthcare Research and Quality.
Topics: statins, radiographic contrast agent nephropathy, contrast media, acetylcysteine, sodium bicarbonate, ascorbic acid, normal saline, saline solution
Ideas and Opinions | 
Hannah L. Semigran, BA; Ateev Mehrotra, MD, MPH, MS; and Ann Hwang, MD, MPhil
The current medical billing system is a common source of patients' frustration with health care. Most patients are inundated with bills and insurance statements that are sometimes confusing or inaccurate and often arrive long after their health care encounters. This article proposes strategies for providing real-time point-of-care information on health care costs to patients.
Topics: drowning, patient-centered care, Billing and payment, social cognition and emotional assessment
Ideas and Opinions | 
David Moher, PhD; and Ester Moher, PhD
Predatory publishers and journals are morally corrupt businesses that circumvent the fabric of scientific publishing. This commentary discusses how to identify and avoid them and help bring them down.
Topics: atrial premature complexes, ethics, textiles, knowledge acquisition, outreach, cancer, complement system proteins, journal impact factor
Ideas and Opinions | 
Lin H. Chen, MD; and Davidson H. Hamer, MD
Zika virus is a mosquito-borne flavivirus that was rarely identified until outbreaks occurred on in Micronesia in 2007 and has been rapidly emerging in the Western Hemisphere over the past few months. Clinicians should advise patients to use antivector measures when traveling to regions with Zika transmission. Given the possible association between Zika virus and microcephaly, pregnant women should avoid travel to areas that are reporting outbreaks or practice meticulous mosquito avoidance.
Topics: zika virus
On Being a Patient | 
Lois Snyder Sulmasy, JD; and Daniel P. Sulmasy, MD, PhD
Clinical Guidelines | 
Matthew Nielsen, MD, MS; Amir Qaseem, MD, PhD, for the High Value Care Task Force of the American College of Physicians
Background:The presence of blood in the urine, or hematuria, is a common finding in clinical practice and can sometimes be a sign of occult cancer. This article describes the clinical epidemiology of hematuria and the current state of practice and science in this context and provides suggestions for clinicians evaluating patients with hematuria. Methods:A narrative review of available clinical guidelines and other relevant studies on the evaluation of hematuria was conducted, with particular emphasis on considerations for urologic referral. High-Value Care Advice 1:Clinicians should include gross hematuria in their routine review of systems and specifically ask all patients with microscopic hematuria about any history of gross hematuria. High-Value Care Advice 2:Clinicians should not use screening urinalysis for cancer detection in asymptomatic adults. High-Value Care Advice 3:Clinicians should confirm heme-positive results of dipstick testing with microscopic urinalysis that demonstrates 3 or more erythrocytes per high-powered field before initiating further evaluation in all asymptomatic adults. High-Value Care Advice 4:Clinicians should refer for further urologic evaluation in all adults with gross hematuria, even if self-limited. High-Value Care Advice 5:Clinicians should consider urology referral for cystoscopy and imaging in adults with microscopically confirmed hematuria in the absence of some demonstrable benign cause. High-Value Care Advice 6:Clinicians should pursue evaluation of hematuria even if the patient is receiving antiplatelet or anticoagulant therapy. High-Value Care Advice 7:Clinicians should not obtain urinary cytology or other urine-based molecular markers for bladder cancer detection in the initial evaluation of hematuria.
Topics: hematuria, urologic cancer
Ideas and Opinions | 
Jacob West, MPP; and Ateev Mehrotra, MD, MPH
In 1961, an article with a similar title changed our understanding about who receives medical care. This article updates our understanding since then, describes the trends changing the ecology of care, and reviews the implications for the health care system.
Topics: ecology
Original Research | 
Christopher D. Jensen, PhD, MPH; Douglas A. Corley, MD, PhD; Virginia P. Quinn, PhD, MPH; Chyke A. Doubeni, MD, MPH; Ann G. Zauber, PhD; Jeffrey K. Lee, MD, MAS; Wei K. Zhao, MPH; Amy R. Marks, MPH; Joanne E. Schottinger, MD; Nirupa R. Ghai, PhD; Alexander T. Lee, MD; Richard Contreras, MS; Carrie N. Klabunde, PhD; Charles P. Quesenberry, PhD; Theodore R. Levin, MD; and Pauline A. Mysliwiec, MD
Background:The fecal immunochemical test (FIT) is a common method for colorectal cancer (CRC) screening, yet its acceptability and performance over several rounds of annual testing are largely unknown. Objective:To assess FIT performance characteristics over 4 rounds of annual screening. Design:Retrospective cohort study. Setting:Kaiser Permanente Northern and Southern California. Patients:323 349 health plan members aged 50 to 70 years on their FIT mailing date in 2007 or 2008 who completed the first round of FIT and were followed for up to 4 screening rounds. Measurements:Screening participation, FIT positivity (≥20 µg of hemoglobin/g), positive predictive values for adenoma and CRC, and FIT sensitivity for detecting CRC obtained from Kaiser Permanente electronic databases and cancer registries. Results:Of the patients invited for screening, 48.2% participated in round 1. Of those who remained eligible, 75.3% to 86.1% participated in subsequent rounds. Median follow-up was 4.0 years, and 32% of round 1 participants crossed over to endoscopy over 4 screening rounds—7.0% due to a positive FIT result. The FIT positivity rate (5.0%) and positive predictive values (adenoma, 51.5%; CRC, 3.4%) were highest in round 1. Overall, programmatic FIT screening detected 80.4% of patients with CRC diagnosed within 1 year of testing, including 84.5% in round 1 and 73.4% to 78.0% in subsequent rounds. Limitation:Screening detection, rather than long-term cancer prevention, was evaluated. Conclusion:Annual FIT screening was associated with high sensitivity for CRC, with high adherence to annual follow-up screening among initial participants. The findings indicate that annual programmatic FIT screening is feasible and effective for population-level CRC screening. Primary Funding Source:National Institutes of Health.
Topics: adenoma, follow-up, colorectal cancer screening, participation in ward rounds, fecal immunochemical test, cancer, colonoscopy, colorectal cancer
Summaries for Patients | 
Topics: hematuria, urine, urologic cancer, american college of physicians
Evidence-based medicine and big data are very different approaches to producing evidence. In this commentary, the author posits that “combining these 2 ways of knowing offers the best path for enlarging and strengthening the knowledge base of clinical medicine.”
Topics: evidence-based medicine
Editorials | 
Darren B. Taichman, MD, PhD; Joyce Backus, MSLS; Christopher Baethge, MD; Howard Bauchner, MD; Peter W. de Leeuw, MD; Jeffrey M. Drazen, MD; John Fletcher, MB, BChir, MPH; Frank A. Frizelle, MBChB, FRACS; Trish Groves, MBBS, MRCPsych; Abraham Haileamlak, MD; Astrid James, MBBS; Christine Laine, MD, MPH; Larry Peiperl, MD; Anja Pinborg, MD; Peush Sahni, MBBS, MS, PhD; and Sinan Wu, MD
The International Committee of Medical Journal Editors (ICMJE) believes that there is an ethical obligation to responsibly share data generated by interventional clinical trials because participants have put themselves at risk. In this commentary, ICMJE editors outline proposed requirements to help meet this obligation.
Topics: ethics, peritoneal dialysis, intermittent, diplacusis, data sharing, invasive pneumococcal disease
Ideas and Opinions | 
Aaron S. Kesselheim, MD, JD, MPH; and Thomas J. Hwang, AB
In 2012, Congress gave the U.S. Food and Drug Administration (FDA) authority to designate new drugs with promise of substantial benefit as “breakthrough” drugs and then take steps to expedite their pathway to possible approval. Congress is now deciding whether to give the FDA the authority to give medical devices the same designation. This article examines the risks, benefits, and ethical considerations of that decision.
Topics: ethics, united states food and drug administration, treatment outcome, technology
Clinical Guidelines | 
Aaron M. Harris, MD, MPH; Lauri A. Hicks, DO; Amir Qaseem, MD, PhD, MHA, for the High Value Care Task Force of the American College of Physicians and for the Centers for Disease Control and Prevention
Includes: Supplemental Content
Background:Acute respiratory tract infection (ARTI) is the most common reason for antibiotic prescription in adults. Antibiotics are often inappropriately prescribed for patients with ARTI. This article presents best practices for antibiotic use in healthy adults (those without chronic lung disease or immunocompromising conditions) presenting with ARTI. Methods:A narrative literature review of evidence about appropriate antibiotic use for ARTI in adults was conducted. The most recent clinical guidelines from professional societies were complemented by meta-analyses, systematic reviews, and randomized clinical trials. To identify evidence-based articles, the Cochrane Library, PubMed, MEDLINE, and EMBASE were searched through September 2015 using the following Medical Subject Headings terms: “acute bronchitis,” “respiratory tract infection,” “pharyngitis,” “rhinosinusitis,” and “the common cold.” High-Value Care Advice 1Clinicians should not perform testing or initiate antibiotic therapy in patients with bronchitis unless pneumonia is suspected. High-Value Care Advice 2Clinicians should test patients with symptoms suggestive of group A streptococcal pharyngitis (for example, persistent fevers, anterior cervical adenitis, and tonsillopharyngeal exudates or other appropriate combination of symptoms) by rapid antigen detection test and/or culture for group A Streptococcus. Clinicians should treat patients with antibiotics only if they have confirmed streptococcal pharyngitis. High-Value Care Advice 3Clinicians should reserve antibiotic treatment for acute rhinosinusitis for patients with persistent symptoms for more than 10 days, onset of severe symptoms or signs of high fever (>39 °C) and purulent nasal discharge or facial pain lasting for at least 3 consecutive days, or onset of worsening symptoms following a typical viral illness that lasted 5 days that was initially improving (double sickening). High-Value Care Advice 4Clinicians should not prescribe antibiotics for patients with the common cold.
Topics: antibiotics, respiratory tract infections, american college of physicians, centers for disease control and prevention (u.s.)
Topics: antibiotics, respiratory tract infections, american college of physicians, centers for disease control and prevention (u.s.)
Ideas and Opinions | 
Steven E. Nissen, MD
On 7 January 2016, the U.S. Department of Health and Human Services and Department of Agriculture released the Dietary Guidelines for Americans 2015–2020. This commentary discusses the new guidelines and how strong the scientific evidence supporting the current guidelines is.
Topics: nutrition guidelines, diet, coronary heart disease
Reviews | 
Heidi D. Nelson, MD, MPH; Rochelle Fu, PhD; Amy Cantor, MD, MPH; Miranda Pappas, MA; Monica Daeges, BA; and Linda Humphrey, MD, MPH
Background:In 2009, the U.S. Preventive Services Task Force recommended biennial mammography screening for women aged 50 to 74 years and selective screening for those aged 40 to 49 years. Purpose:To review studies of the effectiveness of breast cancer screening in average-risk women. Data Sources:MEDLINE and Cochrane databases to 4 June 2015. Study Selection:English-language randomized, controlled trials and observational studies of screening with mammography, magnetic resonance imaging, and ultrasonography that reported breast cancer mortality, all-cause mortality, or advanced breast cancer outcomes. Data Extraction:Investigators extracted and confirmed data and dual rated study quality; discrepancies were resolved through consensus. Data Synthesis:Fair-quality evidence from a meta-analysis of mammography trials indicated relative risks (RRs) for breast cancer mortality of 0.92 for women aged 39 to 49 years (95% CI, 0.75 to 1.02) (9 trials; 3 deaths prevented per 10 000 women over 10 years); 0.86 for those aged 50 to 59 years (CI, 0.68 to 0.97) (7 trials; 8 deaths prevented per 10 000 women over 10 years); 0.67 for those aged 60 to 69 years (CI, 0.54 to 0.83) (5 trials; 21 deaths prevented per 10 000 women over 10 years); and 0.80 for those aged 70 to 74 years (CI, 0.51 to 1.28) (3 trials; 13 deaths prevented per 10 000 women over 10 years). Risk reduction was 25% to 31% for women aged 50 to 69 years in observational studies of mammography screening. All-cause mortality was not reduced with screening. Advanced breast cancer was reduced for women aged 50 years or older (RR, 0.62 [CI, 0.46 to 0.83]) (3 trials) but not those aged 39 to 49 years (RR, 0.98 [CI, 0.74 to 1.37]) (4 trials); less evidence supported this outcome. Limitations:Most trials used imaging technologies and treatments that are now outdated, and definitions of advanced breast cancer were heterogeneous. Studies of effectiveness based on risk factors, intervals, or other modalities were unavailable or methodologically limited. Conclusion:Breast cancer mortality is generally reduced with mammography screening, although estimates are not statistically significant at all ages and the magnitudes of effect are small. Advanced cancer is reduced with screening for women aged 50 years or older. Primary Funding Source:Agency for Healthcare Research and Quality.
Topics: breast cancer, breast neoplasm screening, mortality, mammography
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