Skin Failure Clinical Indicator Scale: Proposal of a Tool for Distinguishing Skin Failure From a Pressure Injury.

INTRODUCTION: Skin failure may be both visually similar in appearance and can occur concomitant to a pressure injury, but it has a fundamentally different etiology. To date, no validated assessment tools or clinical indicators are available that can help definitively distinguish skin failure from a pressure injury. OBJECTIVE: The Skin Failure Clinical Indicator Scale (SFCIS), a proposed tool that uses readily available variables to assist in more definitively identifying skin failure, was developed and assessed. METHODS: A retrospective case-control study was conducted among acute care hospital patients who experienced acute skin breakdown before death. Data were extracted from the electronic medical records of deceased acute care patients who experienced acute skin breakdown prior to death between January 1, 2017, and March 1, 2019, in 2 US hospitals. Using ICD-10 coding, patients were separated into 2 groups depending on if the skin breakdown occurred at locations typical for pressure injury formation or atypical (non-pressure) locations. Patient diagnostic and clinical data were compared between the 2 groups. Univariate and multivariate data analyses were performed via backward stepwise logistic regression in order to identify significant predictors of skin failure; regression coefficients were converted into integers in order to create a tool that could assist in probable identification of skin failure. RESULTS: Of the 52 patients included in this study, 16 experienced skin breakdown at locations typical for pressure injury and 36 had skin breakdown in atypical locations, which was assumed to be indicative of skin failure. Factors found to help distinguish between skin failure and pressure injury included a serum albumin level less than 3.5 mg/dL (P = .07), impaired blood flow (P = .05), presence of sepsis/multiorgan dysfunction syndrome (P = .001), vasopressor/inotrope use (P ⟨ .001), and mechanical ventilation (P = .06), which ultimately correctly identified 83.7% as cases of probable skin failure. CONCLUSIONS: This scale may provide a means to correctly recognize and diagnose skin failure, initiate appropriate interventions, and decrease potential reimbursement penalties to facilities. Further testing will be necessary in order to validate the specificity and selectivity of this instrument.

A carbohydrate-reduced high-protein diet improves HbA1c and liver fat content in weight stable participants with type 2 diabetes: a randomised controlled trial.

AIMS/HYPOTHESIS: Dietary recommendations for treating type 2 diabetes are unclear but a trend towards recommending a diet reduced in carbohydrate content is acknowledged. We compared a carbohydrate-reduced high-protein (CRHP) diet with an iso-energetic conventional diabetes (CD) diet to elucidate the effects on glycaemic control and selected cardiovascular risk markers during 6 weeks of full food provision of each diet. METHODS: The primary outcome of the study was change in HbA1c. Secondary outcomes reported in the present paper include glycaemic variables, ectopic fat content and 24 h blood pressure. Eligibility criteria were: men and women with type 2 diabetes, HbA1c 48-97 mmol/mol (6.5-11%), age >18 years, haemoglobin >6/>7 mmol/l (women/men) and eGFR >30 ml min-1 (1.73 m)-2. Participants were randomised by drawing blinded ballots to 6 + 6 weeks of an iso-energetic CRHP vs CD diet in an open label, crossover design aiming at body weight stability. The CRHP/CD diets contained carbohydrate 30/50 energy per cent (E%), protein 30/17E% and fat 40/33E%, respectively. Participants underwent a meal test at the end of each diet period and glycaemic variables, lipid profiles, 24 h blood pressure and ectopic fat including liver and pancreatic fat content were assessed at baseline and at the end of each diet period. Data were collected at Copenhagen University Hospital, Bispebjerg and Copenhagen University Hospital, Herlev. RESULTS: Twenty-eight participants completed the study. Fourteen participants carried out 6 weeks of the CRHP intervention followed by 6 weeks of the CD intervention, and 14 participants received the dietary interventions in the reverse order. Compared with a CD diet, a CRHP diet reduced the primary outcome of HbA1c (mean ± SEM: -6.2 ± 0.8 mmol/mol (-0.6 ± 0.1%) vs -0.75 ± 1.0 mmol/mol (-0.1 ± 0.1%); p < 0.001). Nine (out of 37) pre-specified secondary outcomes are reported in the present paper, of which five were significantly different between the diets, (p < 0.05); compared with a CD diet, a CRHP diet reduced the secondary outcomes (mean ± SEM or medians [interquartile range]) of fasting plasma glucose (-0.71 ± 0.20 mmol/l vs 0.03 ± 0.23 mmol/l; p < 0.05), postprandial plasma glucose AUC (9.58 ± 0.29 mmol/l × 240 min vs 11.89 ± 0.43 mmol/l × 240 min; p < 0.001) and net AUC (1.25 ± 0.20 mmol/l × 240 min vs 3.10 ± 0.25 mmol/l × 240 min; p < 0.001), hepatic fat content (-2.4% [-7.8% to -1.0%] vs 0.2% [-2.3% to 0.9%]; p < 0.01) and pancreatic fat content (-1.7% [-3.5% to 0.6%] vs 0.5% [-1.0% to 2.0%]; p < 0.05). Changes in other secondary outcomes, i.e. 24 h blood pressure and muscle-, visceral- or subcutaneous adipose tissue, did not differ between diets. CONCLUSIONS/INTERPRETATION: A moderate macronutrient shift by substituting carbohydrates with protein and fat for 6 weeks reduced HbA1c and hepatic fat content in weight stable individuals with type 2 diabetes. TRIAL REGISTRATION: ClinicalTrials.gov NCT02764021. FUNDING: The study was funded by grants from Arla Food for Health; the Novo Nordisk Foundation Center for Basic Metabolic Research, University of Copenhagen; the Department of Clinical Medicine, Aarhus University; the Department of Nutrition, Exercise and Sports, University of Copenhagen; and Copenhagen University Hospital, Bispebjerg.

Primary care scribes: writing a new story for safety net clinics.

The spread of electronic health records systems (EHRs) poses challenges for both patient and provider care experience. Limited research suggests that scribes offer potential benefits to productivity and clinician satisfaction in emergency health and specialty settings. We conducted this evaluation of trained volunteer scribes for primary care clinics serving a diverse, low-income population in a US safety net system, which implemented a new EHR 2011-2014. The scribe programme trained and managed scribes for 51 providers (25% participation) from 5 of 12 San Francisco Health Network primary care clinics. We evaluated the programme using four measures. Providers reported spending less time out of clinic completing notes after sessions with scribes versus sessions without scribes (14.0 min vs 30.2 min, p<0.01). The rate of incomplete EHR notes at 72 hours was not significantly different for clinics using and not using scribes (16.9% vs 16.7%, p=0.4). Mean visit length using EHR-recorded provider cycle time was shorter for sessions with scribes (24.0 min), compared with sessions without scribes (26.4 min, p<0.01). Patients at clinics using scribes were as likely to recommend their provider (74.5%), compared with patients at clinics not using scribes (74.3%). Limitations of our evaluation include selection bias and possible confounding by clinic- and provider-level factors. In a safety net primary care system, trained volunteer scribes were associated with improved clinician efficiency and experience and no difference in patient satisfaction.

Discordance between urine pH measured by dipstick and pH meter: implications for methotrexate administration protocols.

OBJECTIVES: To minimize toxicity of high-dose methotrexate (MTX) therapy, urinary alkalinization with frequent monitoring of urine pH is required. Urine pH is usually assessed by fast and convenient dipstick methods. When urine color interferes with dipstick measurement, as occurs in patients receiving MTX, alternative methods such as pH meters are used. Nursing staff caring for patients on high-dose MTX reported that urine pH results from dipstick and pH analyzers were often clinically discordant. As a result urine pH by dipstick and pH meter were compared in patients on high-dose MTX therapy and patients with normal-colored urine samples. DESIGN AND METHODS: We measured urine pH by dipstick and pH meter in 116 urine samples from 4 patients receiving high-dose MTX therapy, and in 50 normal-colored urine samples from 50 patients not on MTX therapy. RESULTS: In patients on MTX therapy the mean (±standard deviation) bias between dipstick and pH meter urine pH was 0.7±0.4, compared to 0.4±0.3 in patients not on MTX. For patients on MTX clinical concordance between dipstick and pH meter urine results was poor around a clinical cut-off of pH 8.0. Of the 92 samples with a meter urine pH≤8.0, 72 had a discordant value by dipstick (pH>8). CONCLUSIONS: Urine pH readings by dipstick and pH meter are not equivalent, and the bias between them is exacerbated in patients on MTX. Institutions with high-dose MTX therapy protocols should not alternate between dipstick and pH meter urine pH monitoring.

"On the other hand ...": the evidence does not support the use of hand-carried ultrasound by hospitalists.

In the right hands, ultrasound is a safe and helpful diagnostic imaging tool. However, evidence supporting the use of hand-carried ultrasound (HCU) by hospitalist physicians has not kept pace with expanding application of these devices. In spite of its strategic point-of-care benefit, use of this technology by hospitalists may not ultimately translate into improved efficiency and better clinical outcomes. Optimal levels of training in image acquisition and interpretation remain to be established. Novelty, availability, and the results of a few small studies lacking patient-centered outcomes remain insufficient grounds to justify the expanded clinical utilization of these medical imaging devices by nonspecialists.

Gastric banding or bypass? A systematic review comparing the two most popular bariatric procedures.

OBJECTIVE: Bariatric surgical procedures have increased exponentially in the United States. Laparoscopic adjustable gastric banding is now promoted as a safer, potentially reversible and effective alternative to Roux-en-Y gastric bypass, the current standard of care. This study evaluated the balance of patient-oriented clinical outcomes for laparoscopic adjustable gastric banding and Roux-en-Y gastric bypass. METHODS: The MEDLINE database (1966 to January 2007), Cochrane clinical trials database, Cochrane reviews database, and Database of Abstracts of Reviews of Effects were searched using the key terms gastroplasty, gastric bypass, laparoscopy, Swedish band, and gastric banding. Studies with at least 1 year of follow-up that directly compared laparoscopic adjustable gastric banding with Roux-en-Y gastric bypass were included. Resolution of obesity-related comorbidities, percentage of excess body weight loss, quality of life, perioperative complications, and long-term adverse events were the abstracted outcomes. RESULTS: The search identified 14 comparative studies (1 randomized trial). Few studies reported outcomes beyond 1 year. Excess body weight loss at 1 year was consistently greater for Roux-en-Y gastric bypass than laparoscopic adjustable gastric banding (median difference, 26%; range, 19%-34%; P < .001). Resolution of comorbidities was greater after Roux-en-Y gastric bypass. In the highest-quality study, excess body weight loss was 76% with Roux-en-Y gastric bypass versus 48% with laparoscopic adjustable gastric banding, and diabetes resolved in 78% versus 50% of cases, respectively. Both operating room time and length of hospitalization were shorter for those undergoing laparoscopic adjustable gastric banding. Adverse events were inconsistently reported. Operative mortality was less than 0.5% for both procedures. Perioperative complications were more common with Roux-en-Y gastric bypass (9% vs 5%), whereas long-term reoperation rates were lower after Roux-en-Y gastric bypass (16% vs 24%). Patient satisfaction favored Roux-en-Y gastric bypass (P=.006). CONCLUSION: Weight loss outcomes strongly favored Roux-en-Y gastric bypass over laparoscopic adjustable gastric banding. Patients treated with laparoscopic adjustable gastric banding had lower short-term morbidity than those treated with Roux-en-Y gastric bypass, but reoperation rates were higher among patients who received laparoscopic adjustable gastric banding. Gastric bypass should remain the primary bariatric procedure used to treat obesity in the United States.

Who is responsible for evaluating the safety and effectiveness of medical devices? The role of independent technology assessment.

INTRODUCTION: The global medical technology industry brings thousands of devices to market every year. However, significant gaps persist in the scientific literature, in the medical device approval process, and in the realm of postmarketing surveillance. Although thousands of drugs obtain approval only after review in randomized controlled trials, relatively few new medical devices are subject to comparable scrutiny. OBJECTIVE: To improve health outcomes, we must enhance our scrutiny of medical devices, and, without simply deferring to the Food and Drug Administration, we must ask ourselves: Who is responsible for evaluating the safety and effectiveness of medical devices? CONCLUSIONS: Technology assessments by independent organizations are a part of the solution to this challenge and may motivate further research focused on patient outcomes.

Alcohol use among older persons in a rural state.

OBJECTIVE: Older individuals are vulnerable to adverse consequences from alcoholism; unfortunately, alcohol-related problems are often under-identified in this group. METHODS: We characterized the demographic features of alcohol use among older adults (over age 65) in a statewide community survey. RESULTS: Approximately 15% were at risk for alcoholism. As a group, the at-risk individuals were younger than the remaining sample. Twenty percent indicated that they had previously tried unsuccessfully to stop drinking, but only 10% had received any type of treatment. CONCLUSION: This low rate of treatment intervention implies a need for enhanced recognition of alcoholism among older adults in rural settings.

Screening for alcoholism in the primary care setting: are we talking to the right people?

BACKGROUND: This study assessed which demographic groups were most likely to consume alcohol excessively, and which groups had received inquiries and discussion about alcohol use from their physicians compared with discussions about other health risks. STUDY DESIGN: This was a cross-sectional study using data from the Centers for Disease Control Behavioral Risk Factors Surveillance System 1997 data set that represents a stratified random sample in the United States. POPULATION: We selected 23,349 adults who reported a routine physical examination within the last 3 years. OUTCOMES MEASURED: The main variables involved responses to questions about alcohol intake and whether the respondent's physician had initiated discussions about drinking. RESULTS: Physicians spoke to patients about alcohol use much less frequently than about other health-related behaviors. Discussions were roughly targeted to groups with the largest intake. However, physicians were least likely to speak with white patients, women, and widows who drank significantly. CONCLUSIONS: Regularly asking patients about alcohol use could substantially reduce the under-recognition of alcoholism. Since brief counseling is effective, negative consequences of excessive alcohol intake may be avoided.