- The medical literature is prone to overstating results, a condition not thoroughly recognized among policymakers. This article sets forth examples of potential problems with research integrity in the infectious disease literature. We describe articles that may be spun, categories lumped together in hopes of creating a significant effect (and sometimes an insignificant one), changes in metrics, and how trials may fail because of suboptimal interventions. When examined together, the examples show that the problems are widespread and illustrate the difficulty associated with interpreting medical research. The state of the current medical literature makes it of utmost importance that all sections of the manuscript are read, including associated letters to the editors and information on ClinicalTrials.gov before authors' recommendations are accepted. Kavanagh KT, Tower SS. Daniel DM. Journal of Patient Safety. Published online Mar. 24, 2016.
- Catheter-associated urinary tract infections (CAUTIs) occur in 290,000 U.S. hospital patients annually, with an estimated cost of $290 million. Two different measurement systems are being used to track the U.S. Healthcare system’s performance in lowering the rate of CAUTIs. Since 2010, the AHRQ metric has shown a 28.2% decrease, while the CDC metric has shown a 3% to 6% increase, since 2009. Differences in data acquisition and the definition of the denominator may explain this discrepancy. The AHRQ metric analyzed chart audited data and reflects both catheter utilization and care. The CDC metric analyzed self-reported data and primarily reflects catheter care. Because the ARHQ metric’s analysis showed a progressive change in performance over time, and the scientific literature supporting the importance of catheter-utilization in the prevention of CAUTIs, it is suggested that risk-adjusted catheter-utilization data be incorporated into metrics that are used for determining facility performance and for value-based purchasing Initiatives. Calderon LE, Kavanagh KT, Rice MK. American Journal of Infection Control. Published online Jul. 1, 2015.
- Active surveillance and isolation (ADI) for the prevention of methicillin-resistant Staphylococcus aureus (MRSA) has become a controversial topic. There have been calls from numerous authors for a movement away from rigid mandates and toward an evidence-based medicine approach. However, much of the evidence used is distorted. Negative findings in two major studies have been used to prevent recommendations on ADI for MRSA. However the findings in these studies can be explained by flaws in study implementation rather than the ineffectiveness of ADI. The use of daily chlorhexidine bathing has also been proposed as an alternative to surveillance and isolation. There is conflicting evidence in the literature regarding the effectiveness of chlorhexidine. In addition, the major concern with universal daily chlorhexidine bathing is the production of resistance. The use of ADI to address epidemics and common dangerous pathogens should solely depend upon ADI’s ability to prevent further spread to and infection of other patients through indirect contact. At present, there is a preponderance of evidence in the literature to support continuing use of ADI to prevent the spread of dangerous pathogens.
- The Journal's mission is to publish work that will make patients safer, and that should not be subverted by commercial interests. We regret the breach of trust to the readers of the Journal caused by Dr Denham. It is important for the Journal and for the field of quality and safety that readers have greater trust in the Journal going forward.We believe that the best way to deal with conflicts is for them to be declared and dealt with by greater transparency. Conflicts need to be managed appropriately, and organizations need to have a culture in which people are attentive to conflicts and willing to identify them. -- Wu AW, Kavanagh KT, Pronovost PJ, Bates DW. Conflict of Interest, Dr Charles Denham and the Journal of Patient Safety. J Patient Saf. 2014 Dec;10(4):181-185.
- The policy of not paying for certain hospital-acquired conditions (HACs) was mandated by the U.S.Congress for Medicare in the 2006 Deficit Reduction Act and for Medicaid by the Affordable Care Act and essentially enacted line item penalties in a largely bundled payment system; a plan some would argue was doomed to fail at its onset. -- Kavanagh KT. Letter to the Editor regarding: The effectiveness of Medicare's non-payment of hospital-acquired conditions policy. Health Policy. 2014 Aug 27. pii: S0168-8510(14)00221-8. doi: 10.1016/j.healthpol.2014.08.006. [Epub ahead of print]
- Two recommendations are emerging for the control of MRSA. The first is to screen for and treat carriers, them second is universally treat everyone and run the theoretical risk of worsening bacterial resistance and changing the microbiome of both the patient and the facility. The decade long policy followed in some, and hopefully few, facilities of not doing either of these interventions appears to no longer be an option. --- Kavanagh KT, Calderon LE, Saman DM, Abusalem SK. The use of surveillance and preventative measures for methicillin-resistant staphylococcus aureus infections in surgical patients. Antimicrob Resist Infect Control. 2014 May 14;3:18. eCollection 2014
- Given the evidence, it is unclear why the U.S. health care industry has not embraced ADI (active detection and isolation) as an integral part of infection control. Some patient advocates believe that one of the reasons is to prevent the passage of legislative mandates. If this is the case, the best way to prevent legislative mandates is by having a quality health care system that adopts and implements standards of care based upon the best evidence available. In view of the severity of the MDRO epidemic in the United States, a reevaluation of the setting of standards of care for the expanded and uniform use of active MRSA surveillance testing should be undertaken. --- Kavanagh KT, Saman DM, Yu Y. A perspective on how the united states fell behind Northern Europe in the battle against methicillin-resistant Staphylococcus aureus. Antimicrob Agents Chemother. 2013 Dec;57(12):5789-91. doi: 10.1128/AAC.01839-13. Epub 2013 Oct 7
- Value-based purchasing is in its infancy. Devising an effective system that recognizes and incorporates nursing measures will facilitate the success of this initiative. NSVBP needs to be designed and incentivized to decrease adverse events, hospital stays, and readmission rates, thereby decreasing societal healthcare costs. At the heart of NSVBP is the concept that one cannot have a quality institution without providing highly trained and skilled nursing care. Yet nursing is at risk for inadequate support, both in staffing numbers and skill mix, particularly in today’s cost-driven and financially stressed healthcare delivery systems. --- Kavanagh KT, Cimiotti JP, Abusalem S, Coty MB. Moving healthcare quality forward with nursing-sensitive value-based purchasing. J Nurs Scholarsh. 2012 Dec;44(4):385-95. doi: 10.1111/j.1547-5069.2012.01469.x. Epub 2012 Oct 15
- The comparison of the Dartmouth Atlas Medicare Reimbursement Data with Malpractice Reform State Rankings, which are used by the PRI, did not support the hypothesis that defensive medicine is a driver of rising health-care costs. Additionally, comparing Medicare reimbursements, premedical and postmedical tort reform, we found no consistent effect on health-care expenditures. Together, these data indicate that medical tort reform seems to have little to no effect on overall Medicare cost savings. --- Kavanagh KT, Calderon LE, Saman DM. The Relationship Between Tort Reform and Medical Utilization. J Patient Saf. 2013 Oct 7. [Epub ahead of print]
- If there is a USA Beef Cow Density Map by county, why can't we have a MRSA map or a map for all Health Care Acquired Infections ?? Posted by the Center for Disease Dynamics, Economics and Policy. Authors: Dr Daniel Saman, DrPH, MPH, CPH and Dr Kevin Kavanagh, MD, MS
- Using national datasets, we found that inpatients' hospital experiences were significantly associated with an increased risk of ICU reported CLABSIs. This study suggests that hospitals with lower staff responsiveness, perhaps because of an understaffing of nurse and supportive personnel, are at an increased risk for CLABSIs. This study bolsters the evidence that patient surveys may be a useful surrogate to predicting the incidence of hospital acquired conditions, including CLABSIs. Moreover, our study found that poor staff responsiveness may be indicative of greater hospital problems and generally poorly performing hospitals; and that this finding may be a symptom of hospitals with a multitude of problems, including patient safety problems, and not a direct cause. --- Saman DM, Kavanagh KT, Johnson B, Lutfiyya MN. Can inpatient hospital experiences predict central line-associated bloodstream infections? PLoS One. 2013;8(4):e61097. doi: 10.1371/journal.pone.0061097. Epub 2013 Apr 5.
- To be most understandable to the consumer, the Standarized Infection Ratio National Benchmark of 1.0 should reflect what is obtainable. The SIR is a tool intended to be used by consumers in value purchasing to compare differences between facilities and thus should not adjust for these differences. Ideally, factors used in risk adjustment should solely be based upon patient characteristics. Thus, facility-specific adjustments (i.e., medical school affiliation, major teaching institution and unit bed size) should be used with caution in calculating the SIR and their use made clearly transparent to health-care consumers. -- Saman DM, Kavanagh KT, Abusalem SK. Redefining the standardized infection ratio to aid in consumer value purchasing. J Patient Saf. 2013 Jun;9(2):55-8. doi: 10.1097/PTS.0b013e3182809f31
- Evidence is mounting that all hospitals should be able to achieve a near zero incidence of CLABSIs and that these infections may in fact be near 'never events', which begs whether risk adjustment with the SIR is needed and whether it adds more information than does rate adjustment using CLABSI rates. … nearly 70% of 1721 reporting hospitals with at least 1000 central line days had five or fewer infections during 2011. These hospitals had 39.3% of the total central line days and a significantly lower SIR than poorer performing hospitals with six or more CLABSIs (p<0.0001). In addition, 19 hospitals are presented which had central line days between 9000 to over 22,000 that also had zero to three CLABSIs. --- Saman DM, Kavanagh KT. Assessing the necessity of the standardized infection ratio for reporting central line-associated bloodstream infections. PLoS One. 2013 Nov 4;8(11):e79554. doi: 10.1371/journal.pone.0079554. eCollection 2013
- Two prominent studies have been used by policy makers to prevent the enactment of standards of care regarding active surveillance of patients with methicillin-resistant Staphylococcus aureus in hospital settings. In this brief review and perspective of those studies, we contend that both studies have serious limitations (i.e., the intervention group was not given optimal intervention) that may not have been scrutinized by many policy makers, health officials, and other researchers. These studies seem to have had a disproportionate impact on health-care policy despite their limitations. Furthermore, health-care policy and treatment standards need to reflect the preponderance of evidence with appropriate weight given to research studies based on their strengths and limitations. --- Kavanagh K, Abusalem S, Saman DM. A perspective on the evidence regarding methicillin-resistant Staphylococcus aureus surveillance. J Patient Saf. 2012 Sep;8(3):140-3. doi: 10.1097/PTS.0b013e3182627b89
- As a further initiative to promote quality, financial incentives have been implemented by the Centers for Medicare and Medicaid Services. Surgeons have lived under stringent financial incentives since the mid-1980s when they were placed under global surgical fees. Medicare currently must make expenditure reductions because it is at risk of becoming insolvent within the decade. Implementation of financial incentives should depend upon a balance between the nonpayment of providers for nonpreventable HAC verses the promotion of health care quality and patient safety, the reduction in patient morbidity and mortality, the spurring of mechanisms to further reduce HAC, and the recouping of taxpayer dollars for HAC that could have been prevented. --- Kavanagh KT. Financial incentives to promote health care quality: the hospital acquired conditions nonpayment policy. Soc Work Public Health. 2011;26(5):524-41. doi: 10.1080/19371918.2011.533554