Unacceptable Outcome Research Articles

UNDERSTANDING THE MANAGEMENT OF MALIGNANT GLIOMAS DURING COVID-19 PANDEMIC IN A HIGH VOLUME TERTIARY GOVERNMENT HOSPITAL IN THE PHILIPPINES

Abstract AIMS Malignant glioma is a common primary brain tumor with a great burden of disease. When COVID-19 set in, it became a challenge to manage an already difficult treatment process in low-resource-setting centers. Despite this, conventional recommendations and standard treatment protocols are followed. However, outcomes were perceived to deviate from the convention, hence the reason for this study which is to understand the nature of outcomes in the management of malignant gliomas during the COVID-19 pandemic in Southern Philippines Medical Center (SPMC), the largest government tertiary hospital in the Philippines. METHOD A retrospective chart review of nine clinically and histologically diagnosed cases of malignant gliomas admitted in SPMC between April 2020 to September 2021 was performed. The clinical presentations, image correlation, and outcomes were listed. Then, classified as desirable, undesirable but acceptable, or unacceptable based on factors identified. Qualitative analysis by deduction including outcomes determining possible modifications in treatment of future cases was done. RESULTS Of the nine cases, one was listed as desirable, one with unacceptable outcome due to management complications, and the rest were labeled as undesirable but acceptable either because of advanced disease or poor KPS score. Three major factors were determined: the roles of pre-hospital and initial treatment delays, the decision for surgical treatment, and the COVID-19 pandemic. CONCLUSION The shift in the outcomes of malignant gliomas during COVID-19 shows the management challenge in low resource centers. There is an increase in highly malignant cases with guarded prognosis due to lack of education, support, and resources in terms of early diagnosis, treatment, and post-surgical care. This was aggravated by the restrictions imposed by the pandemic and financial crisis, especially for patients below the poverty line. Delays in management show a significant influence on prognosis regardless of treatment. As such, possible modifications in the current treatment algorithm are hereby recommended.

Hybrid, transarticular external fixation with platelet-rich plasma injection as a treatment for partial calcaneal tendon disruption in dogs without primary tenorrhaphy.

To report the use of a hybrid, transarticular external skeletal fixator and platelet-rich plasma injection without primary tenorrhaphy for management of partial calcanean tendon disruption in dogs. Multi-institutional retrospective study. A total of 11 client-owned dogs. Medical records from two referral centers from 2019 to 2022 were reviewed for inclusion in the study. Dogs diagnosed with partial, non-traumatic calcanean tendon disruption treated with hybrid, transarticular external skeletal fixation and platelet-rich plasma injection were included in the study. Cases that did not include complete postoperative follow-up over 8-12 weeks and owner-reported outcomes at >6 months were excluded from the study. Dogs with traumatic laceration or those in which a primary tenorrhaphy was performed were also excluded. A total of 11 (n = 11) dogs met the inclusion criteria. Median follow-up time was 18.5 months (6 months-34 months). Mean time of fixation was 9 weeks (6 weeks-12 weeks). Five dogs returned to full, pain-free function (5/11 = 45%). Five dogs had an acceptable return to function (5/11 = 45%). One dog had an unacceptable outcome (1/11 = 9%). Pin tract complications occurred in five dogs (5/11 = 45%) and resolved with medical intervention. The results of this study suggest that temporary tibiotarsal immobilization with a hybrid, transarticular external skeletal fixator and platelet-rich plasma injection without primary tenorrhaphy can lead to a successful outcome in dogs with partial calcanean tendon disruption. Temporary hybrid, transarticular external skeletal fixation and platelet-rich plasma injection without primary tenorrhaphy may play a role in the management of partial calcanean tendon disruption in dogs.

A quantitative risk assessment approach for developing contingency plans at a geologic carbon storage site

AbstractGeologic carbon storage (GCS) is an increasingly important technology for reducing carbon dioxide (CO2) emissions to the atmosphere. The leakage risks associated with GCS are an environmental and human health concern, however, and site operators must develop contingency plans that thoroughly consider leakage risks and identify potential mitigation strategies. Here, we use a GCS system model (the National Risk Assessment Partnership's Open‐Source Integrated Assessment Model, NRAP‐Open‐IAM) to evaluate different contingency plans for a hypothetical GCS site. In the scenario considered, an unplugged legacy well is discovered near the site after 5 years of CO2 injection. Our simulations show that the planned operation has a relatively high chance of causing brine leakage through the legacy well and into the two overlying aquifers, the shallower of which has potable water—an unacceptable outcome. To reduce this risk, we consider five remedial response scenarios that manipulate reservoir pressures through brine extraction, injection rate reduction, and early injection stopping. NRAP‐Open‐IAM is used to quantify the degree to which each scenario reduces the probability of brine leakage at the site amidst reservoir uncertainty. Evaluation of the different scenarios suggests that reduction of injection rates effectively reduces leakage risks while maintaining a substantial fraction of the initially intended cumulative CO2 storage. In the event of an emergency, the reservoir pressure management strategies considered here can provide operators more time while they pursue a more permanent solution. The analyses demonstrated here fit into a larger workflow we propose for evaluating the contingency plans of GCS sites. © 2023 Society of Chemical Industry and John Wiley & Sons, Ltd.

Prognostication and Goals of Care Decisions in Severe Traumatic Brain Injury: A Survey of The Seattle International Severe Traumatic Brain Injury Consensus Conference Working Group.

Best practice guidelines have advanced severe traumatic brain injury (TBI) care; however, there is little that currently informs goals of care decisions and processes despite their importance and frequency. Panelists from the Seattle International severe traumatic Brain Injury Consensus Conference (SIBICC) participated in a survey consisting of 24 questions. Questions queried use of prognostic calculators, variability in and responsibility for goals of care decisions, and acceptability of neurological outcomes, as well as putative means of improving decisions that might limit care. A total of 97.6% of the 42 SIBICC panelists completed the survey. Responses to most questions were highly variable. Overall, panelists reported infrequent use of prognostic calculators, and observed variability in patient prognostication and goals of care decisions. They felt that it would be beneficial for physicians to improve consensus on what constitutes an acceptable neurological outcome as well as what chance of achieving that outcome is acceptable. Panelists felt that the public should help to define what constitutes a good outcome and expressed some support for a "nihilism guard." More than 50% of panelists felt that if it was certain to be permanent, a vegetative state or lower severe disability would justify a withdrawal of care decision, whereas 15% felt that upper severe disability justified such a decision. Whether conceptualizing an ideal or existing prognostic calculator to predict death or an unacceptable outcome, on average a 64-69% chance of a poor outcome was felt to justify treatment withdrawal. These results demonstrate important variability in goals of care decision making and a desire to reduce this variability. Our panel of recognized TBI experts opined on the neurological outcomes and chances of those outcomes that might prompt consideration of care withdrawal; however, imprecision of prognostication and existing prognostication tools is a significant impediment to standardizing the approach to care-limiting decisions.

Effect of Titanium-Base Abutment Height on Optical Properties of Monolithic Anterior Zirconia Crowns.

The effects of different heights of ti-base abutments on the color of anterior screw-retained zirconia restorations fabricated using computer-aided design and computer-aided manufacturing (CAD-CAM) technologies may affect the optical clinical outcome. The purpose of this study was to measure and compare the color parameters of zirconia crowns in different shades on ti-base abutments. Identical specimens (N = 160) were milled to restore the screw-retained central maxillary incisor crown, using 5% mol yttria zirconia (5Y-TZP). The specimens were designed using computer design software to match 3.5 mm and 5.5-mm ti-base abutments and milled using one CAD-CAM technology. Specimens were divided into four main groups depending on zirconia shade (A1/0, A2/3, A3.5/4 and B2/3) and then assigned to two subgroups according to ti-base height. Color measurements in the CIELab coordinates were made using a spectrophotometer under room-light conditions. Color difference (ΔE*) values were calculated using the CIE76 and CIEDE2000 formula. Within the group of A0/1 and A2/3, for 5.5 mm abutment height, a significant difference was found between the means of colors ∆E00 and ∆Eab (<i>p</i> &amp;lt; 0.01). Using a 5.5 mm-height ti-base abutment may produce a clinically unacceptable outcome (ΔEab &amp;gt; 2) in A1/0 and A2/3 color groups.

'Out of hours' orthopaedics in an Irish regional trauma unit and the impact of COVID-19.

IntroductionMRHT is the regional trauma service for the Midlands, providing 24/7 orthopaedic cover. ‘Out of hours’ surgery is reserved for those occasions where waiting for the next operating list during normal working hours would result in an unacceptable outcome for the patient.AimsTo identify how many ‘out-of-hours’ surgeries were performed and what proportion of the total workload was made up by these cases.Secondly, to identify the impact of COVID-19 on our workload as an acute trauma service.MethodsWe performed a retrospective analysis of all operations performed in the emergency orthopaedic theatre between January 2017 and October 2020. Included were all emergency orthopaedic procedures performed after 6 p.m. and before 8 a.m.We compared this to the total number of trauma surgeries performed in the same time period to calculate the percentage of our total operations.ResultsThere were a total of 7615 orthopaedic trauma operations performed in the 193 weeks. 164 of these were ‘out-of-hours’. This represents 2.2% of the total operations performed and is equal to 0.84 cases per week.55 of the 164 (33.5%) were performed in children under the age of 18.62 were performed between 6 and 8 p.m., 61 between 8 and 10 p. m., 31 between 10 p.m. and midnight, and the remaining 10 were performed between midnight and 3 a.m.ConclusionSurgery out of hours has been associated with increased complications, and so decisions to perform emergency surgery should not be made lightly. However, sometimes they are unfortunately necessary and are some of the most important operations we can perform as orthopaedic surgeons.

Evaluation of Fife Forensic CMHT Liaison Services Over 10 Years

AimsFife FCMHT offer two forms of liaison; a court liaison service and a consultation service open to any professional requiring guidance on managing a person with mental disorder and offending behaviour. Our aims are to evaluate these services by analysing the number of referrals, reason for referral and outcomes in order to assess how our services are being used and help identify any areas for improvement.MethodsDetails about each referral made to the court liaison and consultation services and outcomes were recorded from January 2011 to December 2021. Data were analysed in excel.ResultsCourt Liaison Service1044 referrals were made; 778 of these were assessed. 98.7% were seen on day of referral. 76 required inpatient admission, 9 of whom had to be remanded in custody to await appropriate bed. Age ranged 15–78 years. Of those deemed fit to continue through court, 33% were felt to require further mental health input.Consultation Service280 referrals were made. Age ranged 15–83 years. The majority of referrals to this service came from criminal justice social work and NHS fife services. The majority of referrals were for specific advice or help with risk assessment and management. The average time between referral and consultation was 9.4 days.ConclusionReassuringly, our team responds promptly to referrals.25.5% of referrals made to the court service did not require assessment after triage. Only 7.3% of referrals required diversion away from the court system. Whilst 33% of those deemed fit to continue were identified as requiring further mental health input, this was often in the form of signposting to local services. As referrals are usually seen by health care in custody, this suggests mental health training for these teams would be of benefit to prevent delays in court proceedings and prevent unnecessary referrals.Of concern are those patients remanded in custody to await a psychiatric bed. Whilst numbers are small, it is an unacceptable outcome for these patients. This occurs due to no bed being available or a requirement for assessment by the admitting unit. This mirrors findings from the Barron Report.Our consultation service sees requests from a vast array of professionals. We believe this to be an efficient way for services to access the expertise within our team, avoiding unnecessary referrals causing delays to patient care. The majority of these referrals were for advice over a specific matter which can be dealt with succinctly by the team.

Moral Exclusion, Dehumanisation, and Continued Resistance to Return: Experiences of Refused Afghan Asylum Seekers in the Netherlands

ABSTRACT This article examines how policies that deny the basic provision of shelter, food, and clothing to refused asylum seekers impact these individuals’ lived experiences and their decision-making regarding return migration. A key policy argument for the removal of government assistance in the Netherlands is that refused asylum seekers will be more likely to accept and enter return procedures when they are not given these provisions. This article contests this claim. Through 40 interviews with refused Afghan asylum seekers in the Netherlands, this article first explores the embodied effects of state practices of dehumanisation for refused asylum seekers. Second, the article demonstrates that, despite experiencing dehumanised conditions in the Netherlands, return to Afghanistan is strongly resisted by refused asylum seekers who consider return an impossible and unacceptable outcome. The analysis centres refused asylum seekers as a key actor within the geopolitics of return governance and highlights their resistance to state coercion. The results conclude that the human rights of refused asylum seekers should be protected and that the provision of basic welfare should be considered a separate issue from that of enforcing returns.

197. A Predictive Model for the Prompt Identification of Suspected Sepsis Patients with High Death Risk

Abstract Background How to improve the high mortality rate of sepsis? The prompt identification of at-risk patients, and the interdisciplinary sepsis treatment protocol implementation are interventions that can reverse such unacceptable outcome. The objective of our study is to summarize main results of the protocol for the management of sepsis and septic shock, implemented at Biocor Instituto, a general hospital in Belo Horizonte, a 3,000,000 inhabitants city from Brazil. Methods Prospective cohort study of patients with sepsis, evaluated between May/2018-Apr/2020. Univariate and multivariate analysis by logistic regression to identify risk factors for hospital death. Results Over 28 months, 220 patients were included in sepsis protocol: 121 hospital deaths, a crude mortality = 121/220 = 55% (95%C.I. = [48%;62%]). 136 patients (62%) came from the emergency room. In 97 cases (44%) it was possible to isolate 111 microorganisms, with a predominance of Klebsiella, E.coli, and S.aureus. 75% of the cases (165) had definition of APACHE, with the absolute majority of these (88%) having APACHE between 25 and 40. Most patients (52%) received antibiotic (ATB) in 15 minutes and only 4% received ATB after 60 minutes of waiting time. In 198 patients (90%) it was possible to identify the focus of sepsis, with a predominance of pulmonary (47%), urinary (21%) and abdominal (15%). Hospital mortality varied from 30 to 62%, when the focus was pulmonary (p-value = 0.045). In univariate analysis (Figure 1), pulmonary sepsis, creatinine, lactate, and APACHE were significantly associated with hospital death. The time for ATB administration was typically close to 20 minutes, and time to receive the therapeutic antibiotic were not associated with the patient’s death. By using the logistic model (Figure 2) to assign cases of predicted hospital death for probabilities &amp;gt;= 0.5 and controls for probabilities &amp;lt; 0.5, the prediction model had a sensitivity of 0.68 (0.59–0.76), a specificity of 0.58 (0.48–0.67), an area under the curve of the receiver operating characteristic curve of 0.75 (0.68–0.82). There was no significant difference between observed versus expected mortality by APACHE (Figure 3). Figure 1. Univariate analysis to identify risk factors for hospital death. Figure 2. Logistic model for predicting hospital death. Figure 3. Observed X Expected/severity-adjusted mortality (APACHE). Conclusion The logistic model developed uses only creatinine and lactate data to predict suspected sepsis patients with high death risk. Disclosures All Authors: No reported disclosures

A Practical Derivation of the Uncertainty Factor Applied to Adjust the Extractables/Leachables Analytical Evaluation Threshold (AET) for Response Factor Variation.

The analytical evaluation threshold (AET) establishes which chromatographic peaks, produced during organic extractables/leachables (E&L) screening, require toxicological safety risk assessment because the peaks are associated with compounds of potentially unacceptable toxicity. Thus, the AET protects patient safety as its proper application ensures that all potentially unsafe E&L are necessarily assessed. Generally, application of the AET involves the presumption that all organic E&L have the same detector response factor, an assumption that is not valid for any of the detection methods commonly used in E&L screening. Thus, the AET's ability to be protective is compromised for poorly responding compounds, as they will appear to be below the AET when in fact they are not. This unacceptable outcome is addressed by adjusting the AET with an uncertainty factor (UF) whose value is dictated by the magnitude of response factor variation, with a larger variation resulting in a larger UF and a lower adjusted AET. Although the concept of the UF is straightforward, setting a generally accepted, scientifically valid, and practical value for the UF has been challenging. In this article, a database of relative response factors obtained for nearly 1200 E&L via the most commonly applied chromatographic screening methods (gas chromatography/mass spectrometry [GC/MS], liquid chromatography/mass spectrometry with atmospheric pressure chemical ionization [LC/MS-APCI], and LC/MS with electrospray ionization [LC/MS-ESI]) is used to justify UFs for these methods, individually and as a combined practice, based on the practical principle of "the point of diminishing returns". Using this concept results in nearly 92% of the compounds in the database being properly flagged as above an AET adjusted with a UF = 3. Ninety-five percent (95%) coverage of the compounds can be achieved when a UF of 4 is applied to the combination of GC/MS and LC/MS methods or with other combinations of UF values applied to the various methods individually. Coverage is increased to 97% when a UF of 4 is individually applied to the GC/MS method and a UF of 10 is individually applied to the LC/MS methods. Furthermore, the available data suggest that application of both APCI and ESI ionization in LC/MS screening (as opposed to either method separately) provides the greatest coverage of E&L.

Repair of Fractures of the Lateral Aspect of the Humeral Condyle in Skeletally Mature Dogs with Locking and Non-Locking Plates

The aim of this study was to report the functional outcome and complications following transcondylar screw and epicondylar plate fixation of skeletally mature dogs with fractures of the lateral aspect of the humeral condyle using a string of pearls, limited contact dynamic compression plate (LC-DCP) or locking compression plate (LCP). This study was a retrospective review of clinical records, radiographic images and canine brief pain inventory evaluation with a supplementary non-validated questionnaire. Thirty-one fractures in 29 dogs were included. The majority of dogs were Spaniels (23/29). Thirty fractures had evidence of humeral intracondylar fissure. Sixteen fractures had string of pearls, eight LCP and seven LC-DCP. There were two minor complications and three major complications. Perioperative (median: 6 weeks, range: 6-12) outcome was considered fully functional for 24 fractures and acceptable for 6 fractures. One dog had an unacceptable outcome due to the failure of an LCP that healed following revision surgery. Fractures with radiographic follow-up had a persistent visible intracondylar fracture line in 20/26. Twenty-six of twenty-seven owners perceived an excellent outcome (median: 135 weeks, range: 25-246). Repair of fractures of the lateral aspect of the humeral condyle with a transcondylar screw and epicondylar plate has a good perioperative, mid- and long-term outcome with 10% major complication rate, despite incomplete or non-union of the intracondylar fracture in 20/26 elbows.

Inflation Risk?

Inflation is on the rise again in the industrialised world. This has led to fears of a sustained surge in inflation. This article argues that while such fears may make sense in the US, they do not in the eurozone, where the monetary-fiscal policy mix has been much less expansionary than in the US. The fear expressed by some that the monetary overhang from the large injections of liquidity through quantitative easing might lead to inflation in the eurozone does not stand up to scrutiny either. The conclusion offers some observations on the monetary operating procedures in the ECB. It argues that in the future, when interest rates rise again, the ECB risks transferring all (and even more) of its profits to the banking system. This article proposes a way to avoid this unacceptable outcome.

School Based Tooth Brushing and Annual Silver Diammine Fluoride Application as a Highest Priority Package for Achieving Universal Oral Health Care for Cambodian Children

Background: Achieving Universal Oral Health Care among Low-to Middle-Income settings is challenging and little literature exists around exploring what a “Highest Priority Package” of care might look like in the context of oral health. The Healthy Kids Cambodia (HKC) program differs from most conventional school dental services in that the initial package of care that is offered is daily toothbrushing with 1,500 ppm fluoride toothpaste (DTB) together with the topical application of Silver Diamine fluoride (SDF) for management of lesions in primary teeth.Aim: To examine tooth level outcomes for 8- to 10-year old children from two schools that performed DTB with application of SDF at differing time-points.Design: This was an observational cohort study that examined lesion progression among children in late mixed dentition at two schools. Data were collected using the dmft and pufa indices. Both schools received materials and training for DTB at baseline. School One received SDF at baseline while School Two received SDF after 9-months. Intraoral examinations were performed and the presentation of primary teeth with cavitated carious lesions were compared at baseline and 12 m. If a tooth was still caries-active or had become pulpally involved, this was considered to be an unacceptable outcome. Descriptive analysis was performed the chi-squared test was used to examine differences in the proportion of teeth with unacceptable outcomes by school membership.Results: Of the 521 children recruited, 470 (90.2%) were followed. Where there was a delay in SDF application (School 2) there was a three times greater chance of an unacceptable outcome. Ten percentage of primary teeth in School One and 33% of primary teeth in the School Two had unacceptable outcomes.Conclusion: The present study offers data on expected effect sizes that might inform future step-wedged clinical trials to validate an oral health Highest Priority Package of care for Cambodian children. The delivery of a package of care that includes both DTB and SDF can prevent adverse outcomes, such as dental infections, in primary teeth with carious lesions.

Outcome of Open Long Bone Fractures in Dogs Stabilized with Linear External Skeletal Fixator

Background: External skeletal fixator (ESF) has been recommended as biological method to stabilize open fracture as it does not involves the wound site, besides protecting adjacent soft tissue structures. Considering the advantages of ESF, this study was envisaged with an objective to study the outcome of open fractures of radius-ulna and tibia-fibula stabilized with linear ESF in dogs.Methods: This study included 17 dogs suffering from open long bone fractures of radius-ulna and tibia-fibula, divided into three groups; linear ESF type I or II (group I, n=8) and type III (group II, n=3). In group III (n=6), open fractures were initially treated using conservative methods i.e management of open wound till complete healing followed by delayed internal fixation using intramedullary pin or bone plating.Result: Majority of the open fractures of radius-ulna and tibia-fibula were transverse (64.71%), involving distal third diaphysis (47.06%) in heavy weight (54.55%), 1-3 year old (64.71%), non-descript (35.29%), male (88.23%) dogs due to automobile accidents (58.82%). Neutrophilic (81.47±4.45%) leukocytosis (24610±2461.88 per cumm) and elevated levels of alkaline phosphatase and creatine kinase were observed. Staphylococcus spp. was the common isolated bacteria sensitive to Gentamicin, Cefotaxime, Tobramycin, Amikacin and Neomycin. High per cent fractures (83.33%) in group III had acceptable functional outcome as compared to fractures treated with linear ESF (55.55%) in groups I and II. Osteomyelitis due to pin tract infections was the major complication (8/11; 72.7%) recorded in ESF groups (Group I and II) that lead to delayed and/or nonunion. Weight bearing score improved markedly after removal of the ESF frame. In conclusions, immediate fixation of the long bone fracture using linear ESF in the presence of open contaminated / infected wounds leads to unacceptable outcome. Poor animal compliance, pin tract discharge, osteomyelitis, delayed union and nonunion are major complications associated with linear ESF. Conservative management of the open fracture wound using standard treatment for 2-3 weeks till complete wound healing followed by internal fixation with intramedullary pin or bone plate is recommended for open long bone fractures in dogs.

AB093. SOH21AS240. ‘Out of hours’ orthopaedics—the experience in a regional Irish trauma unit

Background: Tullamore Hospital is the regional trauma service for the Midlands, providing 24/7 orthopaedic cover. ‘Out of Hours’ surgery is reserved for those occasions where waiting for the next operating list during normal working hours would result in an unacceptable outcome for the patient.

Determining sample size for progression criteria for pragmatic pilot RCTs: the hypothesis test strikes back!

BackgroundThe current CONSORT guidelines for reporting pilot trials do not recommend hypothesis testing of clinical outcomes on the basis that a pilot trial is under-powered to detect such differences and this is the aim of the main trial. It states that primary evaluation should focus on descriptive analysis of feasibility/process outcomes (e.g. recruitment, adherence, treatment fidelity). Whilst the argument for not testing clinical outcomes is justifiable, the same does not necessarily apply to feasibility/process outcomes, where differences may be large and detectable with small samples. Moreover, there remains much ambiguity around sample size for pilot trials.MethodsMany pilot trials adopt a ‘traffic light’ system for evaluating progression to the main trial determined by a set of criteria set up a priori. We construct a hypothesis testing approach for binary feasibility outcomes focused around this system that tests against being in the RED zone (unacceptable outcome) based on an expectation of being in the GREEN zone (acceptable outcome) and choose the sample size to give high power to reject being in the RED zone if the GREEN zone holds true. Pilot point estimates falling in the RED zone will be statistically non-significant and in the GREEN zone will be significant; the AMBER zone designates potentially acceptable outcome and statistical tests may be significant or non-significant.ResultsFor example, in relation to treatment fidelity, if we assume the upper boundary of the RED zone is 50% and the lower boundary of the GREEN zone is 75% (designating unacceptable and acceptable treatment fidelity, respectively), the sample size required for analysis given 90% power and one-sided 5% alpha would be around n = 34 (intervention group alone). Observed treatment fidelity in the range of 0–17 participants (0–50%) will fall into the RED zone and be statistically non-significant, 18–25 (51–74%) fall into AMBER and may or may not be significant and 26–34 (75–100%) fall into GREEN and will be significant indicating acceptable fidelity.DiscussionIn general, several key process outcomes are assessed for progression to a main trial; a composite approach would require appraising the rules of progression across all these outcomes. This methodology provides a formal framework for hypothesis testing and sample size indication around process outcome evaluation for pilot RCTs.

Sequential Radiographic Evaluation During Closed Treatment of Distal Radius Fracture.

To test the null hypothesis that there is no significant change in radiographic parameters, which determines an acceptable reduction, beyond 3 weeks in distal radius fractures with closed treatment. Retrospective review of a prospectively gathered registry of distal radius fractures. Academic medical center. Patients who underwent closed treatment of distal radius fracture. Sequential radiographic evaluation. Change of radiographic measurement including radial inclination, radial height, ulnar variance, articular tilt, teardrop angle, anteroposterior distance, intra-articular gap, and step-off. We compared postreduction radiographic parameters once within 2 weeks, at the third week, at cessation of immobilization, and analyzed the interobserver reliability test. There was a statistically significant difference between radiographic measurements, which determined an acceptable reduction between radiographs performed within 2 weeks versus the third week. Radial inclination and ulnar variance were statistically different at the third week compared with the time of cessation of immobilization. Seventy-seven percent of patients who had an acceptable reduction after 2 weeks maintained acceptable alignment at cessation of immobilization. Eighty-five percent of patients with acceptable reduction after 3 weeks maintained acceptable alignment at cessation of immobilization. Radial shortening >1.8 mm at the third week predicts an unacceptable radiographic outcome at cessation of immobilization (sensitivity 94.5% and specificity 90%). Radiographic parameters that determine acceptable reduction for closed treatment of distal radius fractures change minimally after 3-week postacceptable closed reduction. Radial shortening at the third week can be used to predict an unacceptable radiographic outcome. Prognostic Level IV. See Instructions for Authors for a complete description of levels of evidence.

Procedural Justice and the Risks of Consumer Voting

Firms are increasingly giving consumers the vote. Eight studies show that, when firms empower consumers to vote, consumers infer a series of implicit promises—even in the absence of explicit promises. We identify three implicit promises to which consumers react negatively when violated: representation (Experiments 1A–1C), consistency (Experiment 2), and nonsuppression (Experiment 3). However, when firms honor these implicit promises, voting can mitigate the disappointment that arises from receiving an undesired outcome (Experiment 4). Finally, Experiment 5 identifies one instance when suppressing the vote outcome is condoned: when voters believe that the process of voting has resulted in an unacceptable outcome. More generally, we show that procedural justice plays a key mediating role in determining the relative success or failure of various empowerment initiatives—from soliciting feedback to voting. Taken together, we offer insight into how firms can realize the benefits of empowerment strategies while mitigating their risks. This paper was accepted by Elke Weber, judgment and decision making.

New Role for the Anesthesia Preoperative Clinic: Helping to Ensure That Surgery Is the Right Choice for Patients With Serious Illness.

New Role for the Anesthesia Preoperative Clinic: Helping to Ensure That Surgery Is the Right Choice for Patients With Serious Illness.

Facebook’s Anticompetitive Lean in Strategies

Facebook is under fire on several fronts and with good reason. Regulators strive to make sense of and address a plethora of seemingly unrelated issues that arise from the operation of its platform. These range from antitrust, privacy violations, dissemination of harmful content and speech, deception and polarisation to political manipulation. This paper identifies Facebook’s unrestricted and excessive data collection as a unifying theme that requires immediate antitrust action. Once a privacy-oriented social network, Facebook soon mutated into a surveillance machine designed to hoover people’s personal data to identify and understand people’s interests, preferences and emotions and turn that knowledge into profit through the sale of targeted ads. Since people’s innate preference for privacy stood in the way of Facebook’s growth, Facebook resorted to privacy intrusions and deception to access as much user data as possible, thereby gaining market power. Currently, its overwhelming dominant position in the social media market means that no matter how much data Facebook extracts from users, how transparent its information about its data processing practices is and how many privacy scandals ensue from its reckless handling of data, users have nowhere else to go. This paper provides a course of action to correct this unacceptable anticompetitive outcome. The imposition of unfair commercial terms on consumers, the distortion of the competitive process through privacy violations and misleading practices, the squeezing of news publishers’ traffic and foreclosure of actual and potential competitors by Facebook, can be stopped. A combination of data and consumer protection measures alone cannot stop Facebook’s actions, but antitrust enforcement can be used to curb Facebook’s ability to reinforce its data-driven abuse of its market power.