Category: Nevin Manimala

Dermatol Surg. 2024 Jul 17. doi: 10.1097/DSS.0000000000004322. Online ahead of print.

ABSTRACT

BACKGROUND: Burn scars are considered one of the challenging issues that can affect the quality of life by causing aesthetic and functional problems. Injecting nanofat particles, which are considered a source of stem cells, into the dermis and/or subcutis of the burned area is considered a promising procedure for the treatment of scars and the correction of volume shortage and skin renewal.

OBJECTIVE: To assess the safety and effectiveness of using autologous nanofat injections to treat burn scars.

METHODS: Thirty patients with postburn scars participated in the trial. Each patient received one session of liposuction, which was then converted into nanofat and injected back into the scar tissue. Four months after the session, the evaluation was conducted both objectively using the Antera camera 3D imaging and subjectively using the Vancouver scar scale (VSS).

RESULTS: Because there were statistically significant improvements in the treated scars’ height, color, vascularity, and pliability, the total VSS scores differed significantly before and after treatment. Furthermore, the Antera 3D imaging revealed a statistically significant variation in the treated scars’ indentations, erythema, and pigmentation scores.

CONCLUSION: The study findings demonstrated that nanofat is a successful postburn scar treatment option that improves patients’ quality of life.

PMID:39018082 | DOI:10.1097/DSS.0000000000004322

JAMA Netw Open. 2024 Jul 1;7(7):e2420837. doi: 10.1001/jamanetworkopen.2024.20837.

ABSTRACT

IMPORTANCE: The overdose epidemic continues in the US, with 107 941 overdose deaths in 2022 and countless lives affected by the addiction crisis. Although widespread efforts to train and support physicians to implement medications and other evidence-based substance use disorder interventions have been ongoing, adoption of these evidence-based practices (EBPs) by physicians remains low.

OBJECTIVE: To describe physician-reported reasons for reluctance to address substance use and addiction in their clinical practices using screening, treatment, harm reduction, or recovery support interventions.

DATA SOURCES: A literature search of PubMed, Embase, Scopus, medRxiv, and SSRN Medical Research Network was conducted and returned articles published from January 1, 1960, through October 5, 2021.

STUDY SELECTION: Publications that included physicians, discussed substance use interventions, and presented data on reasons for reluctance to intervene in addiction were included.

DATA EXTRACTION AND SYNTHESIS: Two reviewers (L.N., M.C., L.F., J.P., C.S., and S.W.) independently reviewed each publication; a third reviewer resolved discordant votes (M.C. and W.C.). This systematic review was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines and the theoretical domains framework was used to systematically extract reluctance reasons.

MAIN OUTCOMES AND MEASURES: The primary outcome was reasons for physician reluctance to address substance use disorder. The association of reasons for reluctance with practice setting and drug type was also measured. Reasons and other variables were determined according to predefined criteria.

RESULTS: A total of 183 of 9308 returned studies reporting data collected from 66 732 physicians were included. Most studies reported survey data. Alcohol, nicotine, and opioids were the most often studied substances; screening and treatment were the most often studied interventions. The most common reluctance reasons were lack of institutional support (173 of 213 articles [81.2%]), knowledge (174 of 242 articles [71.9%]), skill (170 of 230 articles [73.9%]), and cognitive capacity (136 of 185 articles [73.5%]). Reimbursement concerns were also noted. Bivariate analysis revealed associations between these reasons and physician specialty, intervention type, and drug.

CONCLUSIONS AND RELEVANCE: In this systematic review of reasons for physician reluctance to intervene in addiction, the most common reasons were lack of institutional support, knowledge, skill, and cognitive capacity. Targeting these reasons with education and training, policy development, and program implementation may improve adoption by physicians of EBPs for substance use and addiction care. Future studies of physician-reported reasons for reluctance to adopt EBPs may be improved through use of a theoretical framework and improved adherence to and reporting of survey development best practices; development of a validated survey instrument may further improve study results.

PMID:39018077 | DOI:10.1001/jamanetworkopen.2024.20837

JAMA Netw Open. 2024 Jul 1;7(7):e2421676. doi: 10.1001/jamanetworkopen.2024.21676.

ABSTRACT

IMPORTANCE: Labor unions are a mechanism for employee advocacy, but their role in surgery resident wellness is poorly characterized.

OBJECTIVE: To understand experiences with unionization among general surgery residents and residency program faculty and staff.

DESIGN, SETTING, AND PARTICIPANTS: This exploratory qualitative study included data from the Surgical Education Culture Optimization Through Targeted Interventions Based on National Comparative Data (SECOND) trial. In the exploratory phase of the SECOND trial (from March 6, 2019, to March 12, 2020), semistructured interviews about wellness were conducted with residents, faculty (attending physicians), and staff (program administrators) at 15 general surgery residency programs. Unionization was identified as an emergent theme in the interviews. Data analysis was performed from March 2019 to May 2023.

MAIN OUTCOMES AND MEASURES: The main outcome was resident and faculty experience with resident labor unions. In the qualitative analysis, lexical searches of interview transcripts identified content regarding resident labor unions. A codebook was developed inductively. Transcripts were coded by dyads, using a constant comparative approach, with differences reconciled by consensus.

RESULTS: A total of 22 interview transcripts were identified with relevant content. Of these, 19 were individual interviews conducted with residents (n = 10), faculty (n = 4), administrative staff (n = 1), a program director (n = 1), a department chair (n = 1), and designated institutional officials (n = 2), and 3 were from resident focus groups. Residents from all postgraduate year levels, including professional development (ie, research) years, were represented. Interviewees discussed resident unions at 2 programs (1 recently unionized and 1 with a decades-long history). Interviewees described the lack of voice and the lack of agency as drivers of unionization (“Residents…are trying to take control of their well-being”). Increased salary stipends and/or housing stipends were the most concretely identified union benefits. Unanticipated consequences of unionization were described by both residents and faculty, including (1) irrelevance of union-negotiated benefits to surgical residents, (2) paradoxical losses of surgery department-provided benefits, and (3) framing of resident-faculty relationships as adversarial. Union executives were noted to be nonphysician administrators whose participation in discussions about clinical education progression may increase the time and effort to remediate a resident and/or reduce educators’ will to meaningfully intervene. Active surgical resident participation within the union allows for an understanding of surgical trainees’ unique needs and reduced conflict.

CONCLUSIONS AND RELEVANCE: In this qualitative study, unionization was a mechanism for resident voice and agency; the desire to unionize likely highlighted the lack of other such mechanisms in the training environment. However, these findings suggest that unionization may have had unintended consequences on benefits, flexibility, and teaching. Effective advocacy, whether within or outside the context of a union, was facilitated by participation from surgical residents. Future research should expand on this exploratory study by including a greater number of institutions and investigating the evolution of themes over time.

PMID:39018072 | DOI:10.1001/jamanetworkopen.2024.21676

JAMA Psychiatry. 2024 Jul 17. doi: 10.1001/jamapsychiatry.2024.1382. Online ahead of print.

ABSTRACT

IMPORTANCE: Complex biological, socioeconomic, and psychological variables combine to cause mental illnesses, with mounting evidence that early-life experiences are associated with adulthood mental health.

OBJECTIVE: To evaluate whether changing neighborhood income deprivation and residential moves during childhood are associated with the risk of receiving a diagnosis of depression in adulthood.

DESIGN, SETTING, AND PARTICIPANTS: This cohort study included the whole population of 1 096 916 people born in Denmark from January 1, 1982, to December 31, 2003, who resided in the country during their first 15 years of life. Individuals were followed up from 15 years of age until either death, emigration, depression diagnosis, or December 31, 2018. Longitudinal data on residential location was obtained by linking all individuals to the Danish longitudinal population register. Statistical analysis was performed from June 2022 to January 2024.

EXPOSURES: Exposures included a neighborhood income deprivation index at place of residence for each year from birth to 15 years of age and a mean income deprivation index for the entire childhood (aged ≤15 years). Residential moves were considered by defining “stayers” as individuals who lived in the same data zone during their entire childhood and “movers” as those who did not.

MAIN OUTCOMES AND MEASURES: Multilevel survival analysis determined associations between neighborhood-level income deprivation and depression incidence rates after adjustment for individual factors. Results were reported as incidence rate ratios (IRRs) with 95% credible intervals (95% CrIs). The hypotheses were formulated before data collection.

RESULTS: A total of 1 096 916 individuals (563 864 male participants [51.4%]) were followed up from 15 years of age. During follow-up, 35 098 individuals (23 728 female participants [67.6%]) received a diagnosis of depression. People living in deprived areas during childhood had an increased risk of depression (IRR, 1.10 [95% CrI, 1.08-1.12]). After full individual-level adjustment, the risk was attenuated (IRR, 1.02 [95% CrI, 1.01-1.04]), indicating an increase of 2% in depression incidence for each 1-SD increase in income deprivation. Moving during childhood, independent of neighborhood deprivation status, was associated with significantly higher rates of depression in adulthood compared with not moving (IRR, 1.61 [95% CrI, 1.52-1.70] for 2 or more moves after full adjustment).

CONCLUSIONS AND RELEVANCE: This study suggests that, rather than just high or changing neighborhood income deprivation trajectories in childhood being associated with adulthood depression, a settled home environment in childhood may have a protective association against depression. Policies that enable and support settled childhoods should be promoted.

PMID:39018054 | DOI:10.1001/jamapsychiatry.2024.1382

J Glaucoma. 2024 Jul 17. doi: 10.1097/IJG.0000000000002466. Online ahead of print.

ABSTRACT

PRCIS: Selective laser trabeculoplasty (SLT) and medical therapy groups displayed comparable intraocular pressure (IOP) at most follow-ups. SLT was associated with significantly decreased rates of glaucoma surgeries, antiglaucomatous medications, and ocular adverse effects.

PURPOSE: To evaluate the efficacy and safety of selective laser trabeculoplasty (SLT) compared to medical therapy in the treatment of open-angle glaucoma (OAG) or ocular hypertension (OHT).

METHODS: A systematic search was performed in PubMed, Embase, Cochrane Library and Web of Science databases. Randomized controlled trials (RCTs) comparing SLT with medical therapy were included. We computed mean differences (MDs) or standardized mean differences (STDs) for continuous endpoints and risk ratios (RRs) for binary endpoints, with 95% confidence intervals (CIs). Heterogeneity was assessed with I2 statistics. Software R, version 4.2.1, was used for statistical analyses. Subgroup analyses were performed on treatment-naive patients and on the class of drugs in the medical therapy group.

RESULTS: Fourteen RCTs comprising 1,706 patients were included, of whom 936 were submitted to SLT. Medical therapy was associated with a significantly improved IOP at 1 month and a higher proportion of patients achieving ≥20% IOP reduction. There were no significant differences between groups in IOP at 2, 3, 6, and 12 months, IOP fluctuation, rate of eyes at target IOP, visual field, and quality of life. The SLT group exhibited significantly decreased rates of glaucoma surgeries, antiglaucoma medications, and ocular adverse effects.

CONCLUSION: SLT demonstrated comparable efficacy to medical therapy in IOP control at most follow-ups, along with favorable impacts on critical treatment-related factors. Our findings support SLT as a safe and effective treatment for OAG or OHT.

PMID:39018052 | DOI:10.1097/IJG.0000000000002466

JAMA Dermatol. 2024 Jul 17. doi: 10.1001/jamadermatol.2024.2131. Online ahead of print.

ABSTRACT

IMPORTANCE: Cendakimab selectively targets interleukin (IL)-13, a type 2 cytokine implicated in atopic dermatitis (AD) pathogenesis, by inhibiting binding to its receptors (IL13R-α1 and IL13R-α2). Proof-of-concept work in AD supports using cendakimab for type 2 inflammatory diseases.

OBJECTIVE: To evaluate the efficacy and safety of cendakimab compared with placebo in patients with moderate to severe AD.

DESIGN, SETTING, AND PARTICIPANTS: This phase 2, randomized, double-blind, placebo-controlled, parallel-group, dose-ranging clinical trial was conducted from May 2021 to November 2022. Adult patients with moderate to severe AD and inadequate response to topical medications were enrolled at 69 sites in 5 countries (US [n = 26], Japan [n = 17], Canada [n = 9], Poland [n = 9], and Czech Republic [n = 8]). Data were analyzed between April 25, 2023, and October 16, 2023.

INTERVENTIONS: Patients were randomized (1:1:1:1) to receive subcutaneous cendakimab, 360 mg, every 2 weeks; 720 mg, every 2 weeks; 720 mg, once weekly; or placebo.

MAIN OUTCOME AND MEASURE: Mean percentage change in Eczema Area and Severity Index scores from baseline to week 16. Hierarchical testing with multiplicity adjustment was performed for 720 mg, once weekly vs placebo, then 720 mg, every 2 weeks vs placebo, and then 360 mg, every 2 weeks vs placebo.

RESULTS: Overall, 221 patients were randomized, and 220 received study drug (95 women [43%]; mean [SD] age, 37.7 [13.9] years; 720 mg, once weekly [54 (24%)]; 720 mg, every 2 weeks [55 (25%)]; 360 mg, every 2 weeks [55 (25%)]; placebo [56 (26%)]). The primary efficacy end point was met for cendakimab, 720 mg, once weekly vs placebo (-84.4 vs -62.7; P = .003) but missed statistical significance for 720 mg, every 2 weeks (-76.0 vs -62.7; P = .06). The treatment effect for 360 mg, every 2 weeks (-16.3; nominal P = .03 vs placebo) was comparable with 720 mg, once weekly (-21.8); however, significance was not claimed because the hierarchical testing sequence was interrupted. Of patients with treatment-emergent adverse events leading to discontinuation, 4 (7.4%) received 720 mg, once weekly; 2 (3.6%) 720 mg, every 2 weeks; 1 (1.8%) 360 mg, every 2 weeks; and 2 (3.6%) placebo.

CONCLUSIONS AND RELEVANCE: The results of this randomized clinical trial indicated that cendakimab was effective, generally safe, and well-tolerated in patients with moderate to severe AD. The primary end point was met with a significant reduction in Eczema Area and Severity Index scores with 720 mg, once weekly at week 16. Cendakimab demonstrated progressive AD improvement at all doses during 16 weeks of treatment.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04800315.

PMID:39018038 | DOI:10.1001/jamadermatol.2024.2131

J Glaucoma. 2024 Jul 17. doi: 10.1097/IJG.0000000000002459. Online ahead of print.

ABSTRACT

PRCIS: Preserflo® surgery is a safe procedure, effective in reducing intraocular pressure into the “low teens”, surgical survival is greatest in cases of high baseline intraocular pressure (above 21 mmHg) and when performed as a standalone procedure.

PURPOSE: To evaluate midterm surgical survival and safety profile of Preserflo® filtering surgery.

METHODS: Retrospective, cohort study. Consecutive patients who underwent standardized Preserflo® implantation with mitomycin C from December 2019 to April 2021 were included. Clinical data was retrieved from patient charts. Primary outcome was surgical survival at twenty-four months in accordance with World Glaucoma Association guidelines. Survival was evaluated using Kaplan-Meier statistics. Analysis was performed at eye-level and as intention-to-treat.

RESULTS: Ninety-five eyes were included in this study (18 cases combined with cataract surgery). Over half of cases (n=51) were primary open angle glaucoma, with over a fifth having a prior filtering glaucoma procedure. Intraocular pressure at twenty-four months was significantly decreased from baseline (22.4±6.28 mmHg vs 12.0±3.43 mmHg), as well as the need for IOP-lowering medication (2.88 (±0.92) vs 0.79 (±1.3), P<0.001 all comparisons. Standalone Preserflo® achieved a qualified survival (irrespective of medication) of 71% (CI 95% 62%-83%) and 44% (CI 95% 27%-75%) in the combined procedure subgroup (P<0.05 when considering absolute survival). Eyes with baseline intraocular pressure ≥21 mmHg showed a greater qualified survival when compared to eyes with baseline ≤18 mmHg (80% (CI 95% 65%-100%) vs (50% (CI 95% 32%-76%; P<0.05). Intra and early operative complications were few, self-limited, and did not require surgical management. The reoperation rate was low (18%).

CONCLUSION: Preserflo ® filtering surgery is effective in reducing intraocular pressure into the “low teens” and presents an adequate surgical survival and safety profile. Surgical survival appears greatest when performed as standalone and when pre-operative intraocular pressure is high (≥21 mmHg).

PMID:39018034 | DOI:10.1097/IJG.0000000000002459

Int J Qual Health Care. 2024 Jul 17:mzae060. doi: 10.1093/intqhc/mzae060. Online ahead of print.

ABSTRACT

Background Control charts, used in healthcare operations to monitor process stability and quality, are essential for ensuring patient safety and improving clinical outcomes. This comprehensive research study aims to provide a thorough understanding of the role of control charts in healthcare quality monitoring and future perspectives by utilizing a dual methodology approach involving a systematic review and a pioneering bibliometric analysis. Materials and Methods A systematic review of 73 out of 223 articles was conducted, synthesizing existing literature (1995-2023) and revealing insights into key trends, methodological approaches, and emerging themes of control charts in healthcare. In parallel, a bibliometric analysis (1990-2023) on 184 articles gathered from Web of Science and Scopus was performed, quantitatively assessing the scholarly landscape encompassing control charts in healthcare. Results Among 25 countries the United States is the foremost user of control charts, accounting for 33% of all applications, whereas among 14 health departments, epidemiology leads with 28% of applications. The practice of control charts in health monitoring increased by more than one-third during the last three years. Globally, Exponentially Weighted Moving Average (EWMA) charts are the most popular, but interestingly the USA remained the top user of Shewhart charts. The study also uncovers a dynamic landscape in healthcare quality monitoring, with key contributors, research networks, research hotspot tendencies, and leading countries. Influential authors, such as J.C. Benneyan, W.H. Woodall, and M.A. Mohammed played a leading role in this field. In-countries networking, USA-UK leads the largest cluster, while other clusters include Denmark-Norway-Sweden, China-Singapore, and Canada-South Africa. From 1990 to 2023, healthcare monitoring evolved from studying efficiency to focusing on conditional monitoring and flowcharting, with human health, patient safety, and health surveys dominating 2011-2020, and recent years emphasizing epidemic control, COVID-19 SPC, hospitals, and human health monitoring using control charts. It identifies a transition from conventional to artificial intelligence (AI) approaches, with increasing contributions from machine learning (ML) and deep learning (DL) in the context of Industry 4.0. New researchers and journals are emerging, reshaping the academic context of control charts in healthcare. Discussion and Conclusion Our research reveals the evolving landscape of healthcare quality monitoring, surpassing traditional reviews. We uncover emerging trends, research gaps, and a transition in leadership from established contributors to newcomers amidst technological advancements. This study deepens the importance of control charts, offering insights for healthcare professionals, researchers, and policymakers to enhance healthcare quality. Future challenges and research directions are also provided.

PMID:39018022 | DOI:10.1093/intqhc/mzae060

Infection. 2024 Jul 17. doi: 10.1007/s15010-024-02347-1. Online ahead of print.

ABSTRACT

BACKGROUND: WHO postulates the application of adaptive design features in the global clinical trial ecosystem. However, the adaptive platform trial (APT) methodology has not been widely adopted in clinical research on vaccines.

METHODS: The VACCELERATE Consortium organized a two-day workshop to discuss the applicability of APT methodology in vaccine trials under non-pandemic as well as pandemic conditions. Core aspects of the discussions are summarized in this article.

RESULTS: An “ever-warm” APT appears ideally suited to improve efficiency and speed of vaccine research. Continuous learning based on accumulating APT trial data allows for pre-planned adaptations during its course. Given the relative design complexity, alignment of all stakeholders at all stages of an APT is central. Vaccine trial modelling is crucial, both before and in a pandemic emergency. Various inferential paradigms are possible (frequentist, likelihood, or Bayesian). The focus in the interpandemic interval may be on research gaps left by industry trials. For activation in emergency, template Disease X protocols of syndromal design for pathogens yet unknown need to be stockpiled and updated regularly. Governance of a vaccine APT should be fully integrated into supranational pandemic response mechanisms.

DISCUSSION: A broad range of adaptive features can be applied in platform trials on vaccines. Faster knowledge generation comes with increased complexity of trial design. Design complexity should not preclude simple execution at trial sites. Continuously generated evidence represents a return on investment that will garner societal support for sustainable funding. Adaptive design features will naturally find their way into platform trials on vaccines.

PMID:39017997 | DOI:10.1007/s15010-024-02347-1

Appl Health Econ Health Policy. 2024 Jul 17. doi: 10.1007/s40258-024-00902-3. Online ahead of print.

ABSTRACT

BACKGROUND AND OBJECTIVE: Globally, emergency medical services (EMSs) report that their demand is dominated by non-emergency (such as urgent and primary care) requests. Appropriately managing these is a major challenge for EMSs, with one mechanism employed being specialist community paramedics. This review guides policy by evaluating the economic impact of specialist community paramedic models from a healthcare system perspective.

METHODS: A multidisciplinary team (health economics, emergency care, paramedicine, nursing) was formed, and a protocol registered on PROSPERO (CRD42023397840) and published open access. Eligible studies included experimental and analytical observational study designs of economic evaluation outcomes of patients requesting EMSs via an emergency telephone line (‘000’, ‘111’, ‘999’, ‘911’ or equivalent) responded to by specialist community paramedics, compared to patients attended by usual care (i.e. standard paramedics). A three-stage systematic search was performed, including Peer Review of Electronic Search Strategies (PRESS) and Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA). Two independent reviewers extracted and verified 51 unique characteristics from 11 studies, costs were inflated and converted, and outcomes were synthesised with comparisons by model, population, education and reliability of findings.

RESULTS: Eleven studies (n = 7136 intervention group) met the criteria. These included one cost-utility analysis (measuring both costs and consequences), four costing studies (measuring cost only) and six cohort studies (measuring consequences only). Quality was measured using Joanna Briggs Institute tools, and was moderate for ten studies, and low for one. Models included autonomous paramedics (six studies, n = 4132 intervention), physician oversight (three studies, n = 932 intervention) and/or special populations (five studies, n = 3004 intervention). Twenty-one outcomes were reported. Models unanimously reduced emergency department (ED) transportation by 14-78% (higher quality studies reduced emergency department transportation by 50-54%, n = 2639 intervention, p < 0.001), and costs were reduced by AU$338-1227 per attendance in four studies (n = 2962). One study performed an economic evaluation (n = 1549), finding both that the costs were reduced by AU$454 per attendance (although not statistically significant), and consequently that the intervention dominated with a > 95% chance of the model being cost effective at the UK incremental cost-effectiveness ratio threshold.

CONCLUSIONS: Community paramedic roles within EMSs reduced ED transportation by approximately half. However, the rate was highly variable owing to structural (such as local policies) and stochastic (such as the patient’s medical condition) factors. As models unanimously reduced ED transportation-a major contributor to costs-they in turn lead to net healthcare system savings, provided there is sufficient demand to outweigh model costs and generate net savings. However, all models shift costs from EDs to EMSs, and therefore appropriate redistribution of benefits may be necessary to incentivise EMS investment. Policymakers for EMSs could consider negotiating with their health department, local ED or insurers to introduce a rebate for successful community paramedic non-ED-transportations. Following this, geographical areas with suitable non-emergency demand could be identified, and community paramedic models introduced and tested with a prospective economic evaluation or, where this is not feasible, with sufficient data collection to enable a post hoc analysis.

PMID:39017994 | DOI:10.1007/s40258-024-00902-3