STROCSS 2021: Strengthening the reporting of cohort, cross-sectional and case-control studies in surgery.

INTRODUCTION: Strengthening The Reporting Of Cohort Studies in Surgery (STROCSS) guidelines were developed in 2017 in order to improve the reporting quality of observational studies in surgery and updated in 2019. In order to maintain relevance and continue upholding good reporting quality among observational studies in surgery, we aimed to update STROCSS 2019 guidelines. METHODS: A STROCSS 2021 steering group was formed to come up with proposals to update STROCSS 2019 guidelines. An expert panel of researchers assessed these proposals and judged whether they should become part of STROCSS 2021 guidelines or not, through a Delphi consensus exercise. RESULTS: 42 people (89%) completed the DELPHI survey and hence participated in the development of STROCSS 2021 guidelines. All items received a score between 7 and 9 by greater than 70% of the participants, indicating a high level of agreement among the DELPHI group members with the proposed changes to all the items. CONCLUSION: We present updated STROCSS 2021 guidelines to ensure ongoing good reporting quality among observational studies in surgery.

Intravenous Recombinant Tissue Plasminogen Activator and Ischemic Stroke: Focused Update of 2010 Clinical Practice Advisory From the American Academy of Emergency Medicine.

BACKGROUND: Stroke treatment is a continuum that begins with the rapid identification of symptoms and treatment with transition to successful rehabilitation. Therapies for acute ischemic stroke (AIS) may vary based on anatomic location, interval from symptom onset, and coexisting health conditions. Successful therapy requires a seamless systematic approach with coordination from prehospital environment through acute management at medical facilities to disposition and long-term care of the patient. The emergency physician must balance the benefits and risks of alteplase recombinant tissue plasminogen activator (rtPA) for AIS management. OBJECTIVE: We review the recent medical literature on the topic of AIS and assess intravenous rtPA for the following questions: 1) is there any applicable, new, high-quality evidence that the benefits of intravenous rtPA are justified in light of the harms associated with it, and 2) if so, does the evidence clarify which patients, if any, are most likely to benefit from the treatment. METHODS: A MEDLINE literature search from January 2010 to October 2016 and limited to human studies written in English for articles with keywords of cerebrovascular accident and (thromboly* OR alteplase). Guideline statements and nonsystematic reviews were excluded. Studies targeting differences between specific populations (males vs. females) were excluded. Studies identified then underwent a structured review from which results could be evaluated. RESULTS: Three hundred twenty-two papers on thrombolytic use were screened and nine appropriate articles were rigorously reviewed and recommendations given. CONCLUSIONS: No new studies published between 2010 and 2016 meaningfully reduced uncertainty regarding our understanding of the benefits and harms of intravenous rtPA for AIS. Discussions regarding benefit and harm should occur for patients, and risk prediction scores may facilitate the conversation.

Computed Tomography Use for Adults With Head Injury: Describing Likely Avoidable Emergency Department Imaging Based on the Canadian CT Head Rule.

BACKGROUND: Millions of head computed tomography (CT) scans are ordered annually, but the extent of avoidable imaging is poorly defined. OBJECTIVES: The objective was to determine the prevalence of likely avoidable CT imaging among adults evaluated for head injury in 14 community emergency departments (EDs) in Southern California. METHODS: We conducted an electronic health record (EHR) database and chart review of adult ED trauma encounters receiving a head CT from 2008 to 2013. The primary outcome was discordance with the Canadian CT Head Rule (CCHR) high-risk criteria; the secondary outcome was use of a neurosurgical intervention in the discordant cohort. We queried systemwide EHRs to identify CCHR discordance using criteria identifiable in discrete data fields. Explicit chart review of a subset of discordant CTs provided estimates of misclassification bias and assessed the low-risk cases who actually received an intervention. RESULTS: Among 27,240 adult trauma head CTs, EHR data classified 11,432 (42.0%) discordant with CCHR recommendation. Subsequent chart review showed that the designation of discordance based on the EHR was inaccurate in 12.2% (95% confidence interval [CI] = 5.6% to 18.8%). Inter-rater reliability for attributing CCHR concordance was 95% (κ = 0.86). Thus, we estimate that 36.8% of trauma head CTs were truly likely avoidable (95% CI = 34.1% to 39.6%). Among the likely avoidable CT group identified by EHR, only 0.1% (n = 13) received a neurosurgical intervention. Chart review showed none of these were actually "missed" by the CCHR, as all 13 were misclassified. CONCLUSION: About one-third of head CTs currently performed on adults with head injury may be avoidable by applying the CCHR. Avoidance of CT in such patients is unlikely to miss any important injuries.

Sensitivity of plain radiography for pediatric cervical spine injury.

Pediatric patients with suspected cervical spine injuries (CSI) often receive a computed tomography (CT) scan as an initial diagnostic imaging test. While sensitive, CT of the cervical spine carries significant radiation and risk of lethal malignant transformation later in life. Plain radiographs carry significantly less radiation and could serve as the preferred screening tool, provided they have a high functional sensitivity in detecting pediatric patients with CSI. We hypothesize that plain cervical spine radiographs can reliably detect pediatric patients with CSI and seek to quantify the functional sensitivity of plain radiography as compared to CT. We analyzed data from the NEXUS cervical spine study to assess the sensitivity of plain radiographs in the evaluation of CSI. We identified all pediatric patients who underwent plain radiographic imaging, and all pediatric patients found to have CSI. We then determined the sensitivity of plain radiographs in detecting pediatric patients with CSI. We identified 44 pediatric patients with CSI in the dataset with age ranging from 2 to 18 years old. Thirty-two of the 44 pediatric patients received cervical spine plain films as a part of their workup. Plain films were able to identify all 32 pediatric patients with CSI to yield a sensitivity of 100 % in detecting injury victims (95 % confidence interval 89.1-100.0 %). Plain radiography was highly sensitive for the identification of CSI in our cohort of pediatric patients and is useful as a screening tool in the evaluation of pediatric CSI.

Inadequate Sensitivity of Laboratory Risk Indicator to Rule Out Necrotizing Fasciitis in the Emergency Department.

INTRODUCTION: Necrotizing fasciitis (NF) is a life-threatening illness, particularly when surgical debridement is delayed. The Laboratory Risk Indicator for Necrotizing Fasciitis (LRINEC) score was developed to identify patients at higher risk for NF. Despite limited information in this regard, the LRINEC score is often used to "rule out" NF if negative. We describe the sensitivity of the LRINEC score in emergency department (ED) patients for the diagnosis of NF. METHODS: We conducted a chart review of ED patients in whom coding of hospital discharge diagnoses included NF. We employed standard methods to minimize bias. We used laboratory data to calculate the LRINEC score, and confirmed the diagnosis of NF via explicit chart review. We then calculated the sensitivity of a positive LRINEC score (standardly defined as six or greater) in our cohort. We examined the role of patient characteristics in the performance of the LRINEC score. Finally, we performed sensitivity analyses to estimate whether missing data for c-reactive protein (CRP) results were likely to impact our results. RESULTS: Of 266 ED patients coded as having a discharge diagnosis of NF, we were able to confirm the diagnosis, by chart review, in 167. We were able to calculate a LRINEC score in only 80 patients (due to absence of an initial CRP value); an LRINEC score of 6 or greater had a sensitivity of 77%. Sensitivity analyses of missing data supported our finding of inadequate sensitivity to rule out NF. In sub-analysis, NF patients with concurrent diabetes were more likely to be accurately categorized by the LRINEC score. CONCLUSION: Used in isolation, the LRINEC score is not sufficiently sensitive to rule out NF in a general ED population.

Poor Outcomes After Emergency Department Discharge of the Elderly: A Case-Control Study.

STUDY OBJECTIVE: The emergency department (ED) is an inherently high-risk setting. Our objective is to identify the factors associated with the combined poor outcome of either death or an ICU admission shortly after ED discharge in older adults. METHODS: We conducted chart review of 600 ED visit records among adults older than 65 years that resulted in discharge from any of 13 hospitals within an integrated health system in 2009 to 2010. We randomly chose 300 patients who experienced the combined outcome within 7 days of discharge and matched case patients to controls who did not experience the outcome. Two emergency physicians blinded to the outcome reviewed the records and identified whether a number of characteristics were present. Predictors of the outcome were identified with conditional logistic regression. RESULTS: Of 1,442,594 ED visits to Kaiser Permanente Southern California in 2009 to 2010, 300 unique cases and 300 unique control records were randomly abstracted. Characteristics associated with the combined poor outcome included cognitive impairment (adjusted odds ratio [AOR] 2.10; 95% confidence interval [CI] 1.19 to 3.56), disposition plan change (AOR 2.71; 95% CI 1.50 to 4.89), systolic blood pressure less than 120 mm Hg (AOR 1.48; 95% CI 1.00 to 2.20), and pulse rate greater than 90 beats/min (AOR 1.66; 95% CI 1.02 to 2.71). CONCLUSION: We found that older patients discharged from the ED with a change in disposition from "admit" to "discharge," cognitive impairment, systolic blood pressure less than 120 mm Hg, and pulse rate greater than 90 beats/min were at increased risk of death or ICU admission shortly after discharge. Increased awareness of these high-risk characteristics may improve ED disposition decisionmaking.

Não se limite a fazer algo, esteja lá / Don't just do something, stand there / No se limite a hacer algo, esté allí

Imagine a (hypothetical) screening test which, done in a population of average risk, saves one person from dying from cancer out of every 10,000 people screened. Imagine as well that every one of those 10,000 pays a price in terms of time and money spent, as well as discomfort, and that some or even many of them will also have to deal with increased anxiety, repeat testing, biopsies, and in a few cases, surgery. Finally, a few will have serious adverse effects like infection or organ failure. Presented with this information, some people would undoubtedly decline to have the test ("You mean only one out of 10,000 who get the test will benefit?!"), while others would choose to have it ("I'll put up with all that if it could save my life"). That is to say, informed patients would understand that they are making a choice between a very rare but very important benefit, that would however accrue to almost none of the people getting the test, and very frequent, but far more manageable, harms, that would have to be dealt with by almost everyone getting the test. Now imagine a patient with osteoarthritis offered treatment with a (hypothetical) non-steroidal anti-inflammatory drug (NSAID), where the doctor notes that most patients would get a fairly small degree of benefit (more pain relief than with an analgesic with fewer side effects), but that perhaps one in 10,000 would suffer terrible harm (from GI bleeding, or renal failure). In this case, an informed patient would understand that this is a choice between a very small benefit that would apply to many people, and a terrible harm that would nevertheless be very rare. The two situations are comparable, such that it would make sense that after a shared decision-making discussion with an informed physician, almost all informed patients would choose both to forgo the screening test and to take the NSAID, or to do just the opposite in both instances. The first combination should be the choice of individuals who are not terribly concerned about extremely rare events, no matter how important they might be, and are more interested in very common effects (harms in the case of screening, and benefits in the case of the NSAID), even if they are relatively less important. The opposite choice would be made by those who are greatly concerned about a critical problem (a hidden disease that a screening test might detect, or a terrible drug side effect), no matter how rare. There could be occasional exceptions to this pattern, but one would expect the large majority of people to make similar choices consistent with the same set of underlying values and preferences. So how is it that in today's world most patients ­ and most of their doctors ­ automatically choose both a series of screening tests that have an extremely high number-needed-to-screen for one person to benefit, and drugs that offer only a very small additive benefit while occasionally producing life-threatening harm? (One could argue, in fact, that the two scenarios presented are both overly optimistic, since few if any screening tests actually affect overall, rather than disease-specific, mortality, and because there are very few conditions where an NSAID actually provides any advantage over acetaminophen.) Physicians are taught, right from the start of medical school, that medical care is a powerful weapon to be used in fighting disease. This is of course in some ways true. They are also taught that harm can occur with all sorts of individual treatments. But this is typically little more than an afterthought; medical thinking generally precedes along the lines of "what shall we do (as safely as possible, of course"), rather than "should we do something?" That is to say, while we acknowledge the possibility of harm, we viscerally believe ­ and have taught patients also to believe ­ that doing something should be the default choice whenever a patient is sick … and often even before they are actually sick. We rely on concepts of "disease" that are in fact only risk factors, and find reassurance in "successful" treatment of surrogate markers, even when (as is the rule, rather than the exception) such success is unassociated with any change in patient-oriented outcomes. We have internalized ­ and again, led patients to believe almost as a matter of faith ­ a number of truly dangerous myths about healthcare, such as "earlier is better" (and more is always better), "technology will solve all our problems," "miracles are right around the corner," "once we identify genetic risk factors there will be a perfect tailored treatment for each of us," and ultimately ­ if we're only clever enough … and spend enough ­ death will soon be optional. Quaternary prevention, or P4, offers a new paradigm, by insisting that medical harm is far from a trivial, or secondary, concern. It tells us that preventing harm from medical interventions ­ which has been proven to be a major cause of death and disability in "advanced" societies ­ deserves equal consideration as does preventing harm from disease. This is different than the commonly cited "first do no harm," which is commonly misunderstood to mean "don't do anything that could cause harm." P4, on the other hand, acknowledges the critical fact that everything we do in health care can cause harm ­ so refusing to do anything that isn't perfectly safe would mean never doing anything! That would be a terrible mistake, as medicine does indeed have a great deal to offer. But in helping patients make decisions we, and they, must consider the potential for harm every bit as prominently as we consider the potential for benefit. Furthermore, by asking, "should we do something," we don't actually mean "do nothing." We can always offer support, and comfort, and symptomatic care ­ for all of which the number needed to treat to benefit one patient … approaches one. (Compare that to most chronic disease treatments, where the NNT is at least 100 … which means that with such "treatment" the likelihood that any given individual will benefit is in fact remote.) Acknowledging this in our heads is only a tiny first step; if we want to reverse a milieu where "medicine's much hailed ability to help the sick is fast being challenged by its propensity to harm the healthy,"1 we must incorporate, into the very DNA of medical education, and practice, P4's simple and obvious, but also revolutionary, admonishment ­ that doing what we can to prevent medical harm must become one of the pillars of modern healthcare. Only when we viscerally incorporate this into our practice will we become worthy contributors to truly rational shared decision-making with our patients.