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Evaluating Colonoscopy Quality by Performing Provider Type

J Natl Cancer Inst. 2024 Apr 8:djae080. doi: 10.1093/jnci/djae080. Online ahead of print.

ABSTRACT

BACKGROUND: Colorectal Cancer (CRC) is the third most diagnosed cancer and the second leading cause of cancer death in the United States. Colonoscopy is an essential tool for screening, used both as a primary approach and follow-up to an abnormal stool-based CRC screening result. Colonoscopy quality is often measured with four key indicators: bowel preparation, cecal intubation, mean withdrawal time, and adenoma detection. Colonoscopies are most often performed by gastroenterologists (GI), however, in rural and medically underserved areas non-GI providers often perform colonoscopies. This study aims to evaluate the quality and safety of screening colonoscopies performed by non-GI providers, comparing their outcomes to those of GI providers.

METHODS: Descriptive statistics were used to characterize the study population. Results for quality indicators were stratified by provider type and compared. Statistical significance was determined using p < 0.05 as the threshold for all comparisons; all p-values were two-sided.

RESULTS: No statistical difference was found when comparing performance by provider type. Median performance for gastroenterologists, general surgeons, and family medicine providers ranged form 98-100% for cecal intubation; 97.4-100% for bowel preparation; 57.4-88.9% for male adenoma detection rate; 47.7-62.13% for female adenoma detection rate; and 0:12:10-0:20:16 for mean withdrawal time. All provider types met and exceeded the goal metric for each of the quality indicators (p < 0.001). In this analysis, non-GI providers can be expected to perform colonoscopies with similar quality to GI providers based on performance outcomes for the key quality metrics.

PMID:38588561 | DOI:10.1093/jnci/djae080

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Comparative Effectiveness of Placental Allografts in the Treatment of Diabetic Lower Extremity Ulcers and Venous Leg Ulcers in U.S. Medicare Beneficiaries: A Retrospective Observational Cohort Study Using Real-World Evidence

Adv Wound Care (New Rochelle). 2024 Apr 8. doi: 10.1089/wound.2023.0143. Online ahead of print.

ABSTRACT

Objective: To compare the effectiveness of cellular tissue products (CTP) versus standard care in U.S. Medicare beneficiaries with diabetic lower extremity ulcers (DLEUs) or venous leg ulcers (VLUs). Approach: We performed a retrospective cohort study using real-world evidence from U.S. Medicare claims for DLEUs or VLUs between 2016 and 2020. There were three cohorts evaluated: viable cryopreserved placental membrane (vCPM) or viable lyopreserved placental membrane (vLPM); other CTP; and standard care. Claims were collapsed into episodes of care. Univariate and bivariate statistics were used to examine the frequency distribution of demographics and clinical variables. Multivariable zero-inflated binomial regressions were used to evaluate mortality and recurrence trends. Logistic regression compared three adverse outcomes (AOs): amputation; 1-year mortality; and wound recurrence. Results: There were 333,362 DLEU episodes among 261,101 beneficiaries, and 122,012 VLU episodes among 80,415 beneficiaries. DLEU treatment with vLPM was associated with reduced 1-year mortality (-26%), reduced recurrence (-91%), and reduced AOs (-71%). VLU treatment with vCPM or vLPM was associated with reduced 1-year mortality (-23%), reduced recurrence (-80%), and 66.77% reduction in AOs. These allografts were also associated with a 49% and 73% reduced risk of recurrence in DLEU and VLU, respectively, compared with other CTPs. Finally, vCPM or vLPM were associated with noninferior prevention of AOs related to amputation, mortality, and recurrence (95% CI: 0.69-1.14). Conclusions: DLEUs and VLUs treated with vCPM and vLPM allografts are associated with lowered 1-year mortality, wound recurrence, and AOs in DLEUs and VLUs compared with standard care. Decision makers weighing coverage of placental allografts should consider these added short- and long-term clinical benefits relative to costly management and high mortality of Medicare’s most frequent wounds.

PMID:38588554 | DOI:10.1089/wound.2023.0143

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Mobile Technology Use in Clinical Research Examining Challenges and Implications for Health Promotion in South Africa: Mixed Methods Study

JMIR Form Res. 2024 Apr 8;8:e48144. doi: 10.2196/48144.

ABSTRACT

BACKGROUND: The use of mobile technologies in fostering health promotion and healthy behaviors is becoming an increasingly common phenomenon in global health programs. Although mobile technologies have been effective in health promotion initiatives and follow-up research in higher-income countries and concerns have been raised within clinical practice and research in low- and middle-income settings, there is a lack of literature that has qualitatively explored the challenges that participants experience in terms of being contactable through mobile technologies.

OBJECTIVE: This study aims to explore the challenges that participants experience in terms of being contactable through mobile technologies in a trial conducted in Soweto, South Africa.

METHODS: A convergent parallel mixed methods research design was used. In the quantitative phase, 363 young women in the age cohorts 18 to 28 years were contacted telephonically between August 2019 and January 2022 to have a session delivered to them or to be booked for a session. Call attempts initiated by the study team were restricted to only 1 call attempt, and participants who were reached at the first call attempt were classified as contactable (189/363, 52.1%), whereas those whom the study team failed to contact were classified as hard to reach (174/363, 47.9%). Two outcomes of interest in the quantitative phase were “contactability of the participants” and “participants’ mobile number changes,” and these outcomes were analyzed at a univariate and bivariate level using descriptive statistics and a 2-way contingency table. In the qualitative phase, a subsample of young women (20 who were part of the trial for ≥12 months) participated in in-depth interviews and were recruited using a convenience sampling method. A reflexive thematic analysis approach was used to analyze the data using MAXQDA software (version 20; VERBI GmbH).

RESULTS: Of the 363 trial participants, 174 (47.9%) were hard to reach telephonically, whereas approximately 189 (52.1%) were easy to reach telephonically. Most participants (133/243, 54.7%) who were contactable did not change their mobile number. The highest percentage of mobile number changes was observed among participants who were hard to reach, with three-quarters of the participants (12/16, 75%) being reported to have changed their mobile number ≥2 times. Eight themes were generated following the analysis of the transcripts, which provided an in-depth account of the reasons why some participants were hard to reach. These included mobile technical issues, coverage issues, lack of ownership of personal cell phones, and unregistered number.

CONCLUSIONS: Remote data collection remains an important tool in public health research. It could, thus, serve as a hugely beneficial mechanism in connecting with participants while actively leveraging the established relationships with participants or community-based organizations to deliver health promotion and practice.

PMID:38588527 | DOI:10.2196/48144

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Proteomic profiling for biomarker discovery in heparin-induced thrombocytopenia

Blood Adv. 2024 Apr 8:bloodadvances.2024012782. doi: 10.1182/bloodadvances.2024012782. Online ahead of print.

ABSTRACT

New analytical techniques can assess hundreds of proteins simultaneously with high sensitivity, facilitating the observation of their complex interplay and role in disease mechanisms. We hypothesized that proteomic profiling targeting proteins involved in thrombus formation, inflammation, and the immune response would identify potentially new biomarkers for heparin-induced thrombocytopenia (HIT). Four existing panels of the Olink proximity extension assay covering 356 proteins involved in thrombus formation, inflammation, and immune response were applied to randomly selected patients with suspected HIT (confirmed HIT, n=32; HIT ruled-out, n=38; positive heparin/PF4 [H/PF4] antibodies, n=28). The relative difference in protein concentration was analyzed using a linear regression model adjusted for sex and age. To confirm the test results, soluble P-selectin was determined using ELISA in above mentioned patients and an additional second dataset (n=49). HIT was defined as a positive heparin-induced platelet aggregation test (HIPA; washed platelet assay). Among 98 patients of the primary dataset, the median 4Ts score was 5 in patients with HIT, 4 in patients with positive heparin/PF4 antibodies, and 3 in patients without HIT. The median OD of a polyspecific heparin/PF4 ELISA was 3.0, 0.9, and 0.3, respectively. Soluble P-selectin remained statistically significant after multiple test adjustments. The area under the receiver-operating-characteristics-curve was 0.81 for Olink and 0.8 for ELISA. Future studies shall assess the diagnostic and prognostic value of soluble P-selectin in the management of HIT.

PMID:38588487 | DOI:10.1182/bloodadvances.2024012782

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Knowledge and perceived confidence of Brazilian psychiatrists about eating disorders´ diagnosis and treatment recommendations

Braz J Psychiatry. 2024 Apr 8. doi: 10.47626/1516-4446-2023-3516. Online ahead of print.

ABSTRACT

OBJECTIVE: To investigate Brazilian psychiatrists ́ knowledge and perceived confidence, both in diagnosis and in evidence-based treatments for eating disorders (ED).

METHODS: In this cross-sectional study, 259 psychiatrists filled out an online form including: sociodemographic data, questions about ED diagnosis and management based on standard guidelines. Descriptive statistics described sample characteristics and levels of ED knowledge and perceived confidence.

RESULTS: Sample was composed mainly by women (65,64%), with mean age of 42.86, from the Southeast of Brazil (56,37%), working predominantly in private practice (59,85%), with less than ten years of experience in Psychiatry (51,74%). We found that 33.21% of participants correctly chose diagnostic criteria for anorexia nervosa (AN); 29.73% for bulimia nervosa (BN), and 38.22% for binge eating disorder (BED). Correct answers for therapeutic options were similar in BN and BED (20.8%), being considerably lower for AN (2.7%). Additionally, reported ED training were: 15.1% during medical school; 59.8% during medical residency/postgraduate studies; 58.7% as complementary training. Only 8.89% felt satisfied with their ED training; 50.97% felt confident diagnosing ED and 37.07% in managing ED patients.

CONCLUSION: These results demonstrated an important gap in ED knowledge of Brazilian psychiatrists, and its consequences on their confidence and competence in managing ED patients.

PMID:38588459 | DOI:10.47626/1516-4446-2023-3516

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Investigation and Validation of the TEG6s During Rotary Wing Aeromedical Flight

J Trauma Acute Care Surg. 2024 Apr 8. doi: 10.1097/TA.0000000000004335. Online ahead of print.

ABSTRACT

INTRODUCTION: In order to improve rural and austere trauma care, hospital-based testing performed at the point of injury may shorten the time lapsed from injury to intervention. This study aimed to evaluate the use of the TEG6s® device in a rotary wing aircraft. Prior attempts suffered from limitation related to lack of vibration mitigation.

METHODS: This was an investigator initiated, industry supported study. Haemonetics® provided a TEG6s® analyzer. The device underwent a standard validation. It was secured in place on the aircraft utilizing shipping foam for vibration mitigation. Donors provided 2 tubes of sample blood in one sitting. Paired studies were performed on the aircraft during level flight and in the hospital, using the Global Hemostasis with Lysis Cartridge. Both normal and presumed pathologic samples were tested in separate phases. Paired T-tests were performed.

RESULTS: For normal donors, mean R (minutes) for laboratory compared to the aircraft was 6.2 vs. 7.2 (p = 0.025). Mean CRT MA (mm) was 59.3 and 55.9 ± 7.3 (p < 0.001) for lab and aircraft (p < 0.001). Among normal donors, R was within normal range for 17/18 laboratory and 18/18 aircraft tests (p > 0.99).During the testing of pathologic samples mean R time was 14.8 for lab samples and 12.6 minutes for aircraft (p = 0.02). Aircraft samples were classified as abnormal in 78% of samples, this was not significantly different than lab samples (p = 0.5).

CONCLUSIONS: The use of the TEG6s® for inflight viscoelastic testing appears promising. While statistically significant differences are seen in some results, these values are not considered clinically significant. Classifying samples as normal or abnormal demonstrated a higher correlation. Future studies should focus on longer flight times to evaluate for LY30, takeoff and landing effects. Overall, this study suggests that TEG6s® can be utilized in a prehospital environment, and further study is warranted.

LEVEL OF EVIDENCE: Level II, Diagnostic Tests or Criteria.

PMID:38587897 | DOI:10.1097/TA.0000000000004335

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Understanding Adolescents’ Experiences With Menstrual Pain to Inform the User-Centered Design of a Mindfulness-Based App: Mixed Methods Investigation Study

JMIR Pediatr Parent. 2024 Apr 8;7:e54658. doi: 10.2196/54658.

ABSTRACT

BACKGROUND: Digital interventions are increasingly popular for the provision of nonpharmacological pain interventions, but few exist for adolescents with menstrual pain. User-centered design involves incorporating users across phases of digital health intervention design, development, and implementation and leads to improved user engagement and outcomes. A needs assessment is the first step of this approach.

OBJECTIVE: The goal of this study was to conduct a needs assessment to understand menstrual pain management needs and preferences and mindfulness experiences, preferences, and knowledge of adolescents with menstrual pain to inform the future development of an app for managing menstrual pain.

METHODS: We used an explanatory sequential mixed method design that included a survey followed by focus groups. Adolescents aged 13-17 years completed a survey (n=111) and participated in focus groups (n=16). Data were analyzed using descriptive statistics and thematic content analysis and synthesized to provide specific recommendations based on adolescent responses.

RESULTS: Adolescents (n=111) who completed the survey reported a moderate understanding of mindfulness and menstrual pain. Over three-quarters (n=87, 78%) of participants practiced some form of mindfulness and 87% (n=97) of survey participants used nonpharmacological pain management strategies. Teens had a moderate perception that mindfulness could help their menstrual pain (mean 4.51/10, SD 2.45, with higher scores suggesting more interest). Themes were generated related to mindfulness experiences, menstrual pain knowledge and experiences, and app functionality. These themes underscored adolescents’ need for continued support and flexible access to mindfulness activities; their awareness of multiple influences to pain, with potential for further education in this area; and the need for menstrual pain-specific content, along with content relevant to typical day-to-day experiences of adolescents.

CONCLUSIONS: Adolescents with menstrual pain have an interest in using a mindfulness app for pain but have unique needs that need to be addressed to ensure app engagement and relevance for this population. Concrete recommendations for future app development are provided.

PMID:38587886 | DOI:10.2196/54658

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Early Seizure Prophylaxis in Mild and Moderate Traumatic Brain Injury: A Systematic Review and Meta-Analysis

JAMA Neurol. 2024 Apr 8. doi: 10.1001/jamaneurol.2024.0689. Online ahead of print.

ABSTRACT

IMPORTANCE: Guidelines recommend seizure prophylaxis for early posttraumatic seizures (PTS) after severe traumatic brain injury (TBI). Use of antiseizure medications for early seizure prophylaxis after mild or moderate TBI remains controversial.

OBJECTIVE: To determine the association between seizure prophylaxis and risk reduction for early PTS in mild and moderate TBI.

DATA SOURCES: PubMed, Google Scholar, and Web of Science (January 1, 1991, to April 18, 2023) were systematically searched.

STUDY SELECTION: Observational studies of adult patients presenting to trauma centers in high-income countries with mild (Glasgow Coma Scale [GCS], 13-15) and moderate (GCS, 9-12) TBI comparing rates of early PTS among patients with seizure prophylaxis with those without seizure prophylaxis.

DATA EXTRACTION AND SYNTHESIS: The Preferred Reporting Items for Systematic Reviews and Meta-analysis (PRISMA) reporting guidelines were used. Two authors independently reviewed all titles and abstracts, and 3 authors reviewed final studies for inclusion. A meta-analysis was performed using a random-effects model with absolute risk reduction.

MAIN OUTCOME MEASURES: The main outcome was absolute risk reduction of early PTS, defined as seizures within 7 days of initial injury, in patients with mild or moderate TBI receiving seizure prophylaxis in the first week after injury. A secondary analysis was performed in patients with only mild TBI.

RESULTS: A total of 64 full articles were reviewed after screening; 8 studies (including 5637 patients) were included for the mild and moderate TBI analysis, and 5 studies (including 3803 patients) were included for the mild TBI analysis. The absolute risk reduction of seizure prophylaxis for early PTS in mild to moderate TBI (GCS, 9-15) was 0.6% (95% CI, 0.1%-1.2%; P = .02). The absolute risk reduction for mild TBI alone was similar 0.6% (95% CI, 0.01%-1.2%; P = .04). The number needed to treat to prevent 1 seizure was 167 patients.

CONCLUSION AND RELEVANCE: Seizure prophylaxis after mild and moderate TBI was associated with a small but statistically significant reduced risk of early posttraumatic seizures after mild and moderate TBI. The small absolute risk reduction and low prevalence of early seizures should be weighed against potential acute risks of antiseizure medications as well as the risk of inappropriate continuation beyond 7 days.

PMID:38587858 | DOI:10.1001/jamaneurol.2024.0689

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Clinical Effectiveness of Newborn Screening for Spinal Muscular Atrophy: A Nonrandomized Controlled Trial

JAMA Pediatr. 2024 Apr 8. doi: 10.1001/jamapediatrics.2024.0492. Online ahead of print.

ABSTRACT

IMPORTANCE: There is increasing evidence that early diagnosis and treatment are key for outcomes in infants with spinal muscular atrophy (SMA), and newborn screening programs have been implemented to detect the disease before onset of symptoms. However, data from controlled studies that reliably confirm the benefits of newborn screening are lacking.

OBJECTIVE: To compare data obtained on patients with SMA diagnosed through newborn screening and those diagnosed after clinical symptom onset.

DESIGN, SETTING, AND PARTICIPANTS: This nonrandomized controlled trial used data from the SMARTCARE registry to evaluate all children born between January 2018 and September 2021 with genetically confirmed SMA and up to 3 SMN2 copies. The registry includes data from 70 participating centers in Germany, Austria, and Switzerland. Data analysis was performed in February 2023 so that all patients had a minimal follow-up of 18 months.

EXPOSURE: Patients born in 2 federal states in Germany underwent screening in a newborn screening pilot project. All other patients were diagnosed after clinical symptom onset. All patients received standard care within the same health care system.

MAIN OUTCOMES: The primary end point was the achievement of motor milestones.

RESULTS: A total of 234 children (123 [52.6%] female) were identified who met inclusion criteria and were included in the analysis: 44 (18.8%) in the newborn screening cohort and 190 children (81.2%) in the clinical symptom onset cohort. The mean (SD) age at start of treatment with 1 of the approved disease-modifying drugs was 1.3 (2.2) months in the newborn screening cohort and 10.7 (9.1) months in the clinical symptom onset cohort. In the newborn screening cohort, 40 of 44 children (90.9%) gained the ability to sit independently vs 141 of 190 (74.2%) in the clinical symptom onset cohort. For independent ambulation, the ratio was 28 of 40 (63.6%) vs 28 of 190 (14.7%).

CONCLUSIONS AND RELEVANCE: This nonrandomized controlled trial demonstrated effectiveness of newborn screening for infants with SMA in the real-world setting. Functional outcomes and thus the response to treatment were significantly better in the newborn screening cohort compared to the unscreened clinical symptom onset group.

TRIAL REGISTRATION: German Clinical Trials Register: DRKS00012699.

PMID:38587854 | DOI:10.1001/jamapediatrics.2024.0492

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Driver’s Licensure and Driving Outcomes Among Youths With Mood Disorders

JAMA Netw Open. 2024 Apr 1;7(4):e245543. doi: 10.1001/jamanetworkopen.2024.5543.

ABSTRACT

IMPORTANCE: Mood disorders are prevalent among adolescents and young adults, and their onset often coincides with driving eligibility. The understanding of how mood disorders are associated with youth driving outcomes is limited.

OBJECTIVE: To examine the association between the presence of a mood disorder and rates of licensing, crashes, violations, and suspensions among adolescents and young adults.

DESIGN, SETTING, AND PARTICIPANTS: This cohort study was conducted among New Jersey residents who were born 1987 to 2000, age eligible to acquire a driver’s license from 2004 to 2017, and patients of the Children’s Hospital of Philadelphia network within 2 years of licensure eligibility at age 17 years. The presence of a current (ie, ≤2 years of driving eligibility) mood disorder was identified using International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) or International Statistical Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) codes. Rates of licensure and driving outcomes among youths who were licensed were compared among 1879 youths with and 84 294 youths without a current mood disorder from 2004 to 2017. Data were analyzed from June 2022 to July 2023.

MAIN OUTCOMES AND MEASURES: Acquisition of a driver’s license and first involvement as a driver in a police-reported crash and rates of other adverse driving outcomes were assessed. Survival analysis was used to estimate adjusted hazard ratios (aHRs) for licensing and driving outcomes. Adjusted rate ratios (aRRs) were estimated for driving outcomes 12 and 48 months after licensure.

RESULTS: Among 86 173 youths (median [IQR] age at the end of the study, 22.8 [19.7-26.5] years; 42 894 female [49.8%]), there were 1879 youths with and 84 294 youths without a mood disorder. A greater proportion of youths with mood disorders were female (1226 female [65.2%]) compared with those without mood disorders (41 668 female [49.4%]). At 48 months after licensure eligibility, 75.5% (95% CI, 73.3%-77.7%) and 83.8% (95% CI, 83.5%-84.1%) of youths with and without mood disorders, respectively, had acquired a license. Youths with mood disorders were 30% less likely to acquire a license than those without a mood disorder (aHR, 0.70 [95% CI, 0.66-0.74]). Licensed youths with mood disorders had higher overall crash rates than those without mood disorders over the first 48 months of driving (137.8 vs 104.8 crashes per 10 000 driver-months; aRR, 1.19 [95% CI, 1.08-1.31]); licensed youths with mood disorders also had higher rates of moving violations (aRR, 1.25 [95% CI, 1.13-1.38]) and license suspensions (aRR, 1.95 [95% CI, 1.53-2.49]).

CONCLUSIONS AND RELEVANCE: This study found that youths with mood disorders were less likely to be licensed and had higher rates of adverse driving outcomes than youths without mood disorders. These findings suggest that opportunities may exist to enhance driving mobility in this population and elucidate the mechanisms by which mood disorders are associated with crash risk.

PMID:38587843 | DOI:10.1001/jamanetworkopen.2024.5543