Ongoing Analytical Procedure Performance Verification Using a Risk-Based Approach to Determine Performance Monitoring Requirements.

The analytical procedure life cycle (APLC) provides a holistic framework to ensure analytical procedure fitness for purpose. USP's general chapter <1220> considers the validation activities that take place across the entire analytical procedure lifecycle and provides a three-stage framework for its implementation. Performing ongoing analytical procedure performance verification (OPPV) (stage 3) ensures that the procedure remains in a state of control across its lifecycle of use post validation (qualification) and involves an ongoing program to collect and analyze data that relate to the performance of the procedure. Knowledge generated during stages 1 (procedure design) and 2 (procedure performance qualification) is used as the basis for the design of the routine monitoring plan to support performance verification (stage 3). The extent of the routine monitoring required should be defined based on risk assessment, considering the complexity of the procedure, its intended purpose, and knowledge about process/procedure variability. The analytical target profile (ATP) can be used to provide or guide the establishment of acceptance criteria used to verify the procedure performance during routine use (e.g., through a system/sample suitability test (SST) or verification criteria applicable to procedure changes or transfers). An ATP however is not essentially required to perform OPPV, and a procedure performance monitoring program can be implemented even if the full APLC framework has not been applied. In these situations, verification criteria can be derived from existing validation or system suitability criteria. Elements of the life cycle approach can also be applied retrospectively if deemed useful.

Vascular adaptation to exercise: a systematic review and audit of female representation.

Biological sex is a salient factor in exercise-induced vascular adaptation. Although a male bias is apparent in the literature, the methodological quality of available studies in females is not yet known. This systematic review with narrative synthesis aimed to assess available evidence of exercise interventions on endothelial function, measured using flow-mediated dilation, in otherwise healthy individuals and athletes. A standardized audit framework was applied to quantify the representation of female participants. Using a tiered grading system, studies that met best-practice recommendations for conducting physiological research in females were identified. A total of 210 studies in 5,997 participants were included, with 18% classified as athletes. The primary exercise mode and duration were aerobic (49%) and acute (61%), respectively. Despite 53% of studies (n = 111) including at least one female, female participants accounted for only 39% of the total study population but 49% of the athlete population. Majority (49%) of studies in females were conducted in premenopausal participants. No studies in naturally menstruating, hormonal contraceptive-users or in participants experiencing menstrual irregularities met all best-practice recommendations. Very few studies (∼5%) achieved best-practice methodological guidelines for studying females and those that did were limited to menopause and pregnant cohorts. In addition to the underrepresentation of female participants in exercise-induced vascular adaptation research, there remains insufficient high-quality evidence with acceptable methodological control of ovarian hormones. To improve the overall methodological quality of evidence, adequate detail regarding menstrual status should be prioritized when including females in vascular and exercise research contexts.

Preparation of multilayer samples for scanning thermal microscopy examination.

Thin film multilayer materials are very important for a variety of key technologies such as hard drive storage. However, their multilayered nature means it can be difficult to examine them after production and determining properties of individual layers is harder still. Here, methods of preparing multilayer samples for examination using scanning thermal microscopy are compared, showing that both a combination of mechanical and ion beam polishing, and ion beam milling to form a crater produce suitable surfaces for scanning thermal microscopy examination. However, the larger exposed surfaces of the ion beam milled crater are the most promising for distinguishing between the layers and comparison of their thermal transport properties.

Low-calorie diets are effective for weight loss in patients undergoing benign upper gastrointestinal surgery: a systematic review and meta-analysis.

BACKGROUND: Obesity may increase surgical complexity in patients undergoing abdominal surgery by limiting visualization and increasing the risk of peri-operative complications. A preoperative reduction in weight and liver volume may improve surgical outcomes. The aim of our study was to evaluate the efficacy of a low-calorie diet (LCD) versus a very low-calorie diet (VLCD) in reducing weight and liver volume prior to laparoscopic surgery. METHODS: A systematic search was conducted using the following inclusion criteria: obese patients undergoing preoperative weight loss using a VLCD or LCD, evaluation of liver volume reduction, and the use of an imaging modality before and after the diet. RESULTS: A total of 814 patients from 21 different studies were included in this systematic review and meta-analysis, with 544 female patients (66.8%) and a mean age range between 24 and 54 years old. There was a total mean weight loss of 6.42% and mean liver volume reduction of 16.7%. Meta-analysis demonstrated that a preoperative diet (LCD or VLCD) significantly reduced weight [SMD = - 0.68; 95% CI (- 0.93, - 0.42), I2 = 82%, p ≤ 0.01] and liver volume [SMD = - 2.03; 95% CI (- 4.00, - 0.06), I2 = 94%, p ≤ 0.01]. When assessed individually, a VLCD led to significant weight reduction [SMD = - 0.79; CI (- 1.24; - 0.34), p ≤ 0.01, I2 = 90%], as did an LCD [SMD = - 0.60; CI (- 0.90; - 0.29), p ≤ 0.01, I2 = 68%). Similarly, there was a significant reduction in liver volume following a VLCD [SMD = - 1.40; CI (- 2.77, - 0.03), p ≤ 0.01, I2 = 96%], and an LCD [SMD = - 2.66; CI (- 6.13, 0.81), p ≤ 0.01, I2 = 93%]. However, there was no significant difference between the two regimens. CONCLUSIONS: Preoperative restrictive calorie diets are effective in reducing weight and liver volume prior to laparoscopic surgery. Whilst a VLCD was better than an LCD at reducing both weight and liver volume, the difference was not significant.

Quality of life following repair of large hiatal hernia is not influenced by the use of mesh-Longer-term follow-up from a randomized trial.

INTRODUCTION: The use of prosthetic mesh in laparoscopic repair of large hiatus hernias remains controversial. Clinical and quality of life outcomes from a randomized controlled trial of mesh versus suture repair previously showed few differences at early follow-up. This study evaluated longer-term quality of life outcomes from that trial. METHODS: A prospective, multicentre, double blind randomized controlled trial assessed three methods of repair for large hiatus hernias: sutures-only versus absorbable mesh versus non-absorbable mesh. Quality of life was assessed using the Short-Form 36 (SF-36) questionnaire which was completed preoperatively and then at 3, 6, 12 months following surgery and annually thereafter. SF-36 outcomes were compared across the three repair techniques at longer-term follow-up (3-6 years), and to earlier baseline and 12-month outcomes. RESULTS: 126 patients were randomized; 43-suture-only, 41-absorbable mesh and 42-non-absorbable mesh. Questionnaires were completed by 118 patients preoperatively, 115 at 12 months and 98 at longer-term follow-up (median 5 years). There were no significant differences between the repair techniques for the subscale and composite scores at longer-term follow-up. The mental component score improved significantly after surgery and was sustained across follow-up for all techniques. The physical component score also improved significantly but was lower at longer-term follow-up compared to the 12-month follow up in both mesh groups. CONCLUSION: Surgical repair of large hiatus hernias provides sustained long-term improvement in quality of life. The addition of mesh does not improve quality of life. TRIAL REGISTRATION: This trial is registered with the Australia and New Zealand Clinical Trials Registry ACTRN12605000725662.

Mucosal impedance as a diagnostic tool for gastroesophageal reflux disease: an update for clinicians.

Mucosal impedance is a marker of esophageal mucosal integrity and a novel technique for assessing esophageal function and pathology. This article highlights its development and clinical application for gastroesophageal reflux disease (GERD), Barrett's esophagus, and eosinophilic esophagitis. A narrative review of key publications describing the development and use of mucosal impedance in clinical practice was conducted. A low mean nocturnal baseline impedance (MNBI) has been shown to be an independent predictor of response to anti-reflux therapy. MNBI predicts medication-responsive heartburn better than distal esophageal acid exposure time. Patients with equivocal evidence of GERD using conventional methods, with a low MNBI, had an improvement in symptoms following the initiation of PPI therapy compared to those with a normal MNBI. A similar trend was seen in a post fundoplication cohort. Strong clinical utility for the use of mucosal impedance in assessing eosinophilic esophagitis has been repeatedly demonstrated; however, there is minimal direction for application in Barrett's esophagus. The authors conclude that mucosal impedance has potential clinical utility for the assessment and diagnosis of GERD, particularly when conventional investigations have yielded equivocal results.

Gastro-esophageal diagnostic workup before bariatric surgery or endoscopic treatment for obesity: position statement of the International Society of Diseases of the Esophagus.

Obesity is a chronic and multifactorial condition characterized by abnormal weight gain due to excessive adipose tissue accumulation that represents a growing worldwide challenge for public health. In addition, obese patients have an increased risk of hiatal hernia, esophageal, and gastric dysfunction, as well as gastroesophageal reflux disease, which has a prevalence over 40% in those seeking endoscopic or surgical intervention. Surgery has been demonstrated to be the most effective treatment for severe obesity in terms of long-term weight loss, comorbidities, and quality of life improvements and overall mortality decrease. The recent emergence of bariatric endoscopic techniques promises less invasive, more cost-effective, and reproducible approaches to the treatment of obesity. With the endorsement of the International Society for Diseases of the Esophagus, we started a Delphi process to develop consensus statements on the most appropriate diagnostic workup to preoperatively assess gastroesophageal function before bariatric surgical or endoscopic interventions. The Consensus Working Group comprised 11 international experts from five countries. The group consisted of gastroenterologists and surgeons with a large expertise with regard to gastroesophageal reflux disease, bariatric surgery and endoscopy, and physiology. Ten statements were selected, on the basis of the agreement level and clinical relevance, which represent an evidence and experience-based consensus of the International Society for Diseases of the Esophagus.

Accurate Dosing Weight: When the 10% Really Matters.

INTRODUCTION: Children are at increased risk of medication-associated adverse events, often due to weight-based dosing errors. We aimed to reduce the proportion of medications that were administered where the dosing weight was ≥ 10% different from the recorded weight. METHODS: We adopted in-situ usability testing to iteratively improve design of clinical decision support that would enable accurate dosing weight documentation by prompting clinicians to update weight if recorded weight was > 10% different and it had been at least 7 days since the last dosing weight update. RESULTS: The proportion of medication administrations with difference >10% between their recorded weight and dosing weight decreased from 13.1% (56,256/ 429,006) in the baseline period to 9.5% (35,560 / 372,443) in the intervention period (P < 0.001). DISCUSSION AND CONCLUSION: User-centered design of an interruptive alert improved the accuracy of dosing weights during medication administrations without substantial alert burden. In-situ usability testing is an effective approach to rapidly obtain feedback from frontline users and iterate on the design to effect desired behavior changes.

CIC 2023: A Discount Approach to Reducing Nursing Alert Burden.

Background and Significance Numerous programs have arisen to address interruptive clinical decision support (CDS) with the goals of reducing alert burden and alert fatigue. These programs often have standing committees with broad stakeholder representation, significant governance efforts, and substantial analyst hours to achieve reductions in alert burden which can be difficult for hospital systems to replicate. Objective To reduce nursing alert burden with a primary nurse informaticist and small support team through a quality improvement approach focusing on high volume alerts. Methods Target alerts were identified from the period of January 2022 to April 2022 and four of the highest firing alerts were chosen initially, which accounted for 43% of all interruptive nursing alerts and an estimated 86 hours per month of time across all nurses occupied resolving these alerts per month. Work was done concurrently for each alert with design changes based on the Five Rights of CDS and following a quality improvement framework. Priority for work was based on operational engagement for design review and approval. Once initial design changes were approved, alerts were taken for in-situ usability testing and additional changes were made as needed. Final designs were presented to stakeholders for approval prior to implementation. Results The total number of interruptive nursing alert firings decreased by 58% from pre-intervention period (01/01/2022 - 06/30/2022) to post-intervention period (07/01/2022 - 12/31/2022). Action taken on alerts increased from 8.1 % to 17.3%. The estimated time spent resolving interruptive alerts summed across all nurses in the system decreased from 197 hours/month to 114 hours/month. Conclusion While CDS may improve use of evidence-based practices, implementation without a clear framework for evaluation and monitoring often results in alert burden and fatigue without clear benefits. An alert burden reduction effort spearheaded by a single empowered nurse informaticist efficiently reduced nursing alert burden substantially.

Efficient Workflow Analysis to Address Paper Persistence in Tuberculin Testing.

Despite widespread adoption and maturity, paper persistence endures in many Electronic Health Record (EHR) systems, particularly for complex workflows involving multiple steps from different stakeholders separated in time. In our health system, Latent Tuberculosis Infection (LTBI) testing was one such workflow where a Tuberculin Skin Test (TST) must be administered and then correctly read 48-72 hours later and documented. This paper discusses a low-resource workflow analysis and clinical decision support approach to replace a paper workflow and garner the benefits of the EHR for clearer documentation and retrieval of LTBI results. Our approach resulted in a significant increase in completed TST documentation, 57% (24/42) to 95% (18/19), P < 0.003. Human-centered design practices such as work system analysis and formative usability testing are feasible with limited resources and improve the likelihood of success of electronic workflows by designing solutions that fit existing clinical workflows and automating processes wherever possible.

Antireflux surgery in patients with gastroesophageal reflux but a negative 24-hour pH study: late outcomes.

PURPOSE: Patients with gastroesophageal reflux disease often undergo a 24-hour pH test to confirm pathologic reflux before surgery. However, a negative pH test can occur in some individuals with reflux, and a case might still be made for antireflux surgery based on symptoms of reflux even in the absence of endoscopic esophagitis. The long-term outcomes in patients who underwent antireflux surgery despite negative preoperative test results were determined. METHODS: Patients were selected from a prospective database. A total of 745 patients met the inclusion criteria, which included typical esophageal reflux symptoms, absence of a large hiatus hernia, preoperative 24-hour pH study performed, endoscopy, and postoperative symptom and satisfaction follow-up available at 5 years. Patients were divided into 3 groups based on 24-hour pH study and endoscopy results: negative pH and negative endoscopy (n = 65), negative pH and positive endoscopy (n = 72), and positive pH (n = 608). The negative pH and negative endoscopy group underwent surgery based on clinical assessment and typical esophageal reflux symptoms. Baseline and follow-up outcomes at 5 years were evaluated using 0 to 10 analog scores, which assessed heartburn, dysphagia, and satisfaction with the overall outcome. Data were analyzed to compare the groups. RESULTS: The groups were well matched for demographics and preoperative symptom scores. At the median 5-year follow-up, clinical outcome scores were similar among the groups for heartburn, dysphagia, and overall satisfaction. The mean heartburn scores were 1.80 in the negative pH and negative endoscopy group, 1.88 in the negative pH and positive endoscopy group, and 1.91 in the positive pH group (P = .663). The mean satisfaction scores were high in all groups: 8.13, 7.31, and 7.72, respectively (P = .293). CONCLUSION: No difference in clinical outcome scores was observed. The negative pH and negative endoscopy group had high satisfaction scores and low heartburn and dysphagia scores. Our findings support antireflux surgery in well-selected symptomatic patients with a negative preoperative pH test.

Implementation of Clinical Decision Support to Identify and Improve Treatment for Severe PIVIE.

Pediatric patients are at high risk of peripheral intravenous infiltration or extravasation (PIVIE) leading to injury and increased costs. Most of the work in addressing PIVIE has focused on the implementation of workflow bundles and evidenced based guidelines. This project showed that Clinical Decision Support can be used to help support identification and treatment of Severe PIVIE through use of an interruptive alert that increases placement of vascular access team consults.

Avoiding Unintended Consequences of Pediatric Blood Order Set Updates through In Situ Usability Testing.

Background Blood product ordering is a complex process, and mistakes can lead to patient harm and poor outcomes. Orders and order sets can be designed to help mitigate errors, but major changes in design can unintentionally cause new errors. Objectives (1) Utilize formative in situ usability testing to iteratively improve the design of a redesigned blood product order set prior to go-live, (2) implement changes based on feedback derived from this testing, and (3) Compare the error rate, System Usability Scale (SUS) score, time to task completion, and click counts between the prior order set in use at the time and the revised redesigned order set. Methods A multidisciplinary project team convened to redesign blood product orders and order sets from scratch based on a review of literature and benchmarking against four pediatric academic institutions with the goal of addressing prior ordering errors. The new redesigned blood product order set was iteratively updated via in situ formative usability testing performed with available clinical users using a concurrent think-aloud protocol in real clinical environments. Errors, SUS scores, time to task completion, and click counts were assessed for the revised redesigned order set using summative testing. Results Formative usability testing with 20 participants led to seven design changes in the redesigned order set which reduced the error rate at go-live. Summative usability testing showed that even though the usability scores were only slightly improved for the revised redesigned order set, the error rates in blood orders were significantly decreased. Conclusion Usability testing can identify design errors early in the process which can be rectified prior to implementation, thus avoiding unintended consequences of changes.