Category: Nevin Manimala

N Engl J Med. 2024 Apr 4;390(13):1163-1175. doi: 10.1056/NEJMoa2313487.

ABSTRACT

BACKGROUND: Trials evaluating the omission of completion axillary-lymph-node dissection in patients with clinically node-negative breast cancer and sentinel-lymph-node metastases have been compromised by limited statistical power, uncertain nodal radiotherapy target volumes, and a scarcity of data on relevant clinical subgroups.

METHODS: We conducted a noninferiority trial in which patients with clinically node-negative primary T1 to T3 breast cancer (tumor size, T1, ≤20 mm; T2, 21 to 50 mm; and T3, >50 mm in the largest dimension) with one or two sentinel-node macrometastases (metastasis size, >2 mm in the largest dimension) were randomly assigned in a 1:1 ratio to completion axillary-lymph-node dissection or its omission (sentinel-node biopsy only). Adjuvant treatment and radiation therapy were used in accordance with national guidelines. The primary end point was overall survival. We report here the per-protocol and modified intention-to-treat analyses of the prespecified secondary end point of recurrence-free survival. To show noninferiority of sentinel-node biopsy only, the upper boundary of the confidence interval for the hazard ratio for recurrence or death had to be below 1.44.

RESULTS: Between January 2015 and December 2021, a total of 2766 patients were enrolled across five countries. The per-protocol population included 2540 patients, of whom 1335 were assigned to undergo sentinel-node biopsy only and 1205 to undergo completion axillary-lymph-node dissection (dissection group). Radiation therapy including nodal target volumes was administered to 1192 of 1326 patients (89.9%) in the sentinel-node biopsy-only group and to 1058 of 1197 (88.4%) in the dissection group. The median follow-up was 46.8 months (range, 1.5 to 94.5). Overall, 191 patients had recurrence or died. The estimated 5-year recurrence-free survival was 89.7% (95% confidence interval [CI], 87.5 to 91.9) in the sentinel-node biopsy-only group and 88.7% (95% CI, 86.3 to 91.1) in the dissection group, with a country-adjusted hazard ratio for recurrence or death of 0.89 (95% CI, 0.66 to 1.19), which was significantly (P<0.001) below the prespecified noninferiority margin.

CONCLUSIONS: The omission of completion axillary-lymph-node dissection was noninferior to the more extensive surgery in patients with clinically node-negative breast cancer who had sentinel-node macrometastases, most of whom received nodal radiation therapy. (Funded by the Swedish Research Council and others; SENOMAC ClinicalTrials.gov number, NCT02240472.).

PMID:38598571 | DOI:10.1056/NEJMoa2313487

PLoS One. 2024 Apr 10;19(4):e0295293. doi: 10.1371/journal.pone.0295293. eCollection 2024.

ABSTRACT

RiSE study aims to evaluate a race-based stress-reduction intervention as an effective strategy to improve coping and decrease stress-related symptoms, inflammatory burden, and modify DNA methylation of stress response-related genes in older AA women. This article will describe genomic analytic methods to be utilized in this longitudinal, randomized clinical trial of older adult AA women in Chicago and NYC that examines the effect of the RiSE intervention on DNAm pre- and post-intervention, and its overall influence on inflammatory burden. Salivary DNAm will be measured at baseline and 6 months following the intervention, using the Oragene-DNA kit. Measures of perceived stress, depressive symptoms, fatigue, sleep, inflammatory burden, and coping strategies will be assessed at 4 time points including at baseline, 4 weeks, 8 weeks, and 6 months. Genomic data analysis will include the use of pre-processed and quality-controlled methylation data expressed as beta (β) values. Association analyses will be performed to detect differentially methylated sites on the targeted candidate genes between the intervention and non-intervention groups using the Δβ (changes in methylation) with adjustment for age, health behaviors, early life adversity, hybridization batch, and top principal components of the probes as covariates. To account for multiple testing, we will use FDR adjustment with a corrected p-value of <0.05 regarded as statistically significant. To assess the relationship between inflammatory burden and Δβ among the study samples, we will repeat association analyses with the inclusion of individual inflammation protein measures. ANCOVA will be used because it is more statistically powerful to detect differences.

PMID:38598554 | DOI:10.1371/journal.pone.0295293

PLoS One. 2024 Apr 10;19(4):e0297941. doi: 10.1371/journal.pone.0297941. eCollection 2024.

ABSTRACT

BACKGROUND AND AIM: Stroke is a serious threat to human life and health, and post-stroke insomnia is one of the common complications severely impairing patients’ quality of life and delaying recovery. Early understanding of the relationship between stroke and post-stroke insomnia can provide clinical evidence for preventing and treating post-stroke insomnia. This study was to investigate the prevalence of insomnia in patients with stroke.

METHODS: The Web of Science, PubMed, Embase, and Cochrane Library databases were used to obtain the eligible studies until June 2023. The quality assessment was performed to extract valid data for meta-analysis. The prevalence rates were used a random-efect. I2 statistics were used to assess the heterogeneity of the studies.

RESULTS: Twenty-six studies met the inclusion criteria for meta-analysis, with 1,193,659 participants, of which 497,124 were patients with stroke.The meta-analysis indicated that 150,181 patients with stroke developed insomnia during follow-up [46.98%, 95% confidence interval (CI): 36.91-57.18] and 1806 patients with ischemic stroke (IS) or transient ischemic attack (TIA) developed insomnia (47.21%, 95% CI: 34.26-60.36). Notably, 41.51% of patients with the prevalence of nonclassified stroke developed insomnia (95% CI: 28.86-54.75). The incidence of insomnia was significantly higher in patients with acute strokes than in patients with nonacute strokes (59.16% vs 44.07%, P < 0.0001).Similarly, the incidence of insomnia was significantly higher in the patients with stroke at a mean age of ≥65 than patients with stroke at a mean age of <65 years (47.18% vs 40.50%, P < 0.05). Fifteen studies reported the follow-up time. The incidence of insomnia was significantly higher in the follow-up for ≥3 years than follow-up for <3 years (58.06% vs 43.83%, P < 0.05). Twenty-one studies used the Insomnia Assessment Diagnostic Tool, and the rate of insomnia in patients with stroke was 49.31% (95% CI: 38.59-60.06). Five studies used self-reporting, that the rate of insomnia in patients with stroke was 37.58% (95% CI: 13.44-65.63).

CONCLUSIONS: Stroke may be a predisposing factor for insomnia. Insomnia is more likely to occur in acute-phase stroke, and the prevalence of insomnia increases with patient age and follow-up time. Further, the rate of insomnia is higher in patients with stroke who use the Insomnia Assessment Diagnostic Tool.

PMID:38598535 | DOI:10.1371/journal.pone.0297941

PLoS One. 2024 Apr 10;19(4):e0298209. doi: 10.1371/journal.pone.0298209. eCollection 2024.

ABSTRACT

BACKGROUND: Radiation dermatitis (RD) is a prevalent and difficult-to-manage consequence of radiation therapy (RT). A variety of interventions have been proven effective in preventing and treating RD. However, the optimal approach remains unclear. This network meta-analysis (NMA) conducted a comparison and ranking of the effectiveness and patient-reported outcomes (PROs) of the interventions currently utilized in RD.

METHODS: PubMed, Web of Science, Embase, and Cochrane Library were searched to identify pertinent randomized controlled trials (RCTs) focused on the prevention and treatment of RD. The primary outcome measures included the incidence of grade≥2 RD (i.e., percentage of moist desquamation) and RD score. The secondary outcome measures encompassed patients’ subjective assessment scores of pains, itching and burning sensations.

RESULTS: Our meta-analysis encompassed 42 studies and 4884 participants. Regarding the primary outcomes, photobiomodulation treatment (PBMT) ranked first in surface under curve cumulative ranking area (SUCRA:0.92) for reducing the incidence of grade≥2 RD. It demonstrated a significant difference when compared to Trolamine (OR 0.18,95%CrI 0.09-0.33) and Xonrid® (OR 0.28,95%CrI 0.12-0.66). Mepitelfilm (SUCRA: 0.98) achieved the highest rank in reducing the RD score, demonstrating superiority over StrataXRT® (MD -0.89, 95% CrI -1.49, -0.29). Henna (SUCRA: 0.89) demonstrated the highest effectiveness in providing pain relief, with a significant difference compared to Hydrofilm (MD -0.44, 95% CrI -0.84, -0.04) and Mepitelfilm (MD -0.55, 95% CrI -0.91, -0.19). Hydrofilm (SUCRA: 0.84) exhibited the fewest itching sensations, demonstrating superiority over Mepitelfilm (MD -0.50, 95% CrI -0.84, -0.17). No statistically significant difference was observed among various interventions in the assessment of burning sensations.

CONCLUSION: PBMT and Mepitelfilm demonstrated better efficacy in reducing the incidence of grade≥2 RD and RD score, respectively. In terms of PROs, Henna and Hydrofilm had fewer complaints in pain and itching sensations, respectively. However, studies with larger sample size on different interventions are warranted in the future.

TRIAL REGISTRATION: PROSPERO registration number CRD42023428598.

PMID:38598529 | DOI:10.1371/journal.pone.0298209

PLoS One. 2024 Apr 10;19(4):e0300207. doi: 10.1371/journal.pone.0300207. eCollection 2024.

ABSTRACT

BACKGROUND: In Canada, there is a recognized underrepresentation of women in the field of surgery. However, the extent to which this trend applies across various surgical specialties is not well delineated. The aim of this study is to identify existing disparities and trends over time to inform the need for future interventions to make the match process more equitable for applicants.

METHODS: Data regarding surgical specialty applicants was extracted from the Canadian Resident Matching Service (CaRMS)’s 2003 to 2022 reports.

RESULTS: A total of 9,488 applicants ranked surgical specialties as their first choice from 2003-2022. Increases in the proportion of women applicants comparing periods 2003-2007 to 2018-2022 were significant for cardiac surgery (22% to 43%, p = 0.03), general surgery (46% to 60%, p<0.001), orthopedic surgery (23% to 35%, p<0.001), urology (23% to 38%, p<0.001), and all aggregated surgical specialties (‘all surgery’) (45% to 55%, p<0.001). An increase in the proportion of women applicants who matched over the same periods was observed for general surgery (+47% to 60%, p<0.001), orthopedic surgery (24% to 35%, p<0.01), urology (21% to 34%, p<0.001), and all surgery (46% to 54%, p<0.001). From 2003-2022, a lower match rate for women compared to men was observed for otolaryngology (0.60 v 0.69, p = 0.008), urology (0.61 v 0.72, p = 0.003), and all surgery (0.71 v 0.73, p = 0.038), while higher match rates were observed for ophthalmology (0.65 v 0.58, p = 0.04). No statistically significant differences in match rate were observed from 2018-2022.

CONCLUSIONS: While the proportion of women applicants to surgical specialties in Canada has been increasing, women remain underrepresented in several surgical specialties. This underrepresentation cannot be solely attributed to fewer women applying to these specialties, as women experience lower success rates when matching to specific surgical specialties. Further research is essential to identify and address the underlying causes of these disparities.

PMID:38598528 | DOI:10.1371/journal.pone.0300207

JMIR Form Res. 2024 Apr 10;8:e56143. doi: 10.2196/56143.

ABSTRACT

BACKGROUND: Digitalizing oral health data through an app can help manage the extensive data obtained through oral health surveys. The Tooth Memo app collects data from oral health surveys and personal health information.

OBJECTIVE: This study aims to evaluate the evaluate the time efficiency, reliability, and user satisfaction of the Tooth Memo app.

METHODS: There are 2 sections in the Tooth Memo app: oral health survey and personal oral health record. For the oral health survey section of the Tooth Memo app, different data entry methods were compared and user satisfaction was evaluated. Fifth-year dental students had access to the oral health survey section in the Tooth Memo app during their clinical work. The time required for data entry, analysis, and summary of oral health survey data by 3 methods, that is, pen-and-paper (manual), Tooth Memo app on iOS device, and Tooth Memo app on Android device were compared among 3 data recorders who entered patients’ information on decayed, missing, and filled permanent teeth (DMFT) index and community periodontal index (CPI), which were read aloud from the database of 103 patients by another dental personnel. The interobserver reliability of the 3 different data-entering procedures was evaluated by percent disagreement and kappa statistic values. Laypeople had access to the personal oral health record section of this app, and their satisfaction was evaluated through a Likert scale questionnaire. The satisfaction assessments for both sections of the Tooth Memo app involved the same set of questions on the app design, usage, and overall satisfaction.

RESULTS: Of the 103 dental records on DMFT and CPI, 5.2% (177/3399) data points were missing in the manual data entries, but no data on tooth status were missing in the Android and iOS methods. Complete CPI information was provided by all 3 methods. Transferring data from paper to computer took an average of 55 seconds per case. The manual method required 182 minutes more than the iOS or Android methods to clean the missing data and transfer and analyze the tooth status data of 103 patients. The users, that is, 109 fifth-year dental students and 134 laypeople, expressed high satisfaction with using the Tooth Memo app. The overall satisfaction with the oral health survey ranged between 3 and 10, with an average (SD) of 7.86 (1.46). The overall satisfaction with the personal oral health record ranged between 4 and 10, with an average (SD) of 8.09 (1.28).

CONCLUSIONS: The Tooth Memo app was more efficacious than manual data entry for collecting data of oral health surveys. Dental personnel as well as general users reported high satisfaction when using this app.

PMID:38598287 | DOI:10.2196/56143

JMIR Res Protoc. 2024 Apr 10;13:e54002. doi: 10.2196/54002.

ABSTRACT

BACKGROUND: The increasing number of requests for help for acutely ill patients and their management is a major problem in the health systems of many countries, but especially in Germany. Rescue coordination centers and ambulances in Germany are increasingly overloaded. As a result, rides as a part of rescue operations have been increasing in length for years, yet a relevant proportion of these operations represent low-acuity calls (LACs). The basic objective of this pilot study is the quantitative analysis of the potential misuse of requests to the rescue control center. Indications for alternative treatment options and how to handle these treatment options in nonacute, non-life-threatening health conditions, such as minor injuries or minor infectious diseases, will be assessed. The identification of these LACs is vital in order to prevent health care resources in emergency medical care becoming inadequate.

OBJECTIVE: The overarching goal of this study is to determine the percentage of unnecessary rescue missions on site and subsequently to obtain an impression of the paramedics’ assessment of alternative treatment options or alternative methods of rescue transportation.

METHODS: This will be an exploratory, noninterventional, cross-sectional study with a quantitative approach. The study is multicentric, with 21 ambulances in 12 different locations. The data for this study were collected via a questionnaire, newly developed for this study, for rescue personnel. Additionally, secondary data from the responsible control center will be linked and processed in an initial descriptive analysis. This descriptive analysis will form the basis for a subsequent variance analysis.

RESULTS: Data collection started as projected on September 18, 2023, and was ongoing until end of November 2023. We expect the documentation of several thousand rescue operations. We expect the following study results: (1) many unnecessary rescue operations, (2) immediate on-site assessment of correct care and treatment, and (3) patients’ reasons for calling a rescue coordination center.

CONCLUSIONS: To our knowledge, this is the first observational study in which acute rescue operations are recorded on site. The focus of this study is on the trained paramedics’ assessment of whether rescue operations are necessary or not. Additionally, alternative treatments, such as out-of-hours care service or primary care service, are shown for each individual case. The study also intends to cover the question of which factors are relevant and statistically significantly connected to the misuse of ambulances.

TRIAL REGISTRATION: German Register for Clinical Studies (Deutsches Register für Klinische Studien) DRKS00032510; https://drks.de/search/en/trial/DRKS00032510.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/54002.

PMID:38598281 | DOI:10.2196/54002

JMIR Hum Factors. 2024 Apr 10;11:e46698. doi: 10.2196/46698.

ABSTRACT

BACKGROUND: Improving shared decision-making (SDM) for patients has become a health policy priority in many countries. Achieving high-quality SDM is particularly important for approximately 313 million surgical treatment decisions patients make globally every year. Large-scale monitoring of surgical patients’ experience of SDM in real time is needed to identify the failings of SDM before surgery is performed. We developed a novel approach to automating real-time data collection using an electronic measurement system to address this. Examining usability will facilitate its optimization and wider implementation to inform interventions aimed at improving SDM.

OBJECTIVE: This study examined the usability of an electronic real-time measurement system to monitor surgical patients’ experience of SDM. We aimed to evaluate the metrics and indicators relevant to system effectiveness, system efficiency, and user satisfaction.

METHODS: We performed a mixed methods usability evaluation using multiple participant cohorts. The measurement system was implemented in a large UK hospital to measure patients’ experience of SDM electronically before surgery using 2 validated measures (CollaboRATE and SDM-Q-9). Quantitative data (collected between April 1 and December 31, 2021) provided measurement system metrics to assess system effectiveness and efficiency. We included adult patients booked for urgent and elective surgery across 7 specialties and excluded patients without the capacity to consent for medical procedures, those without access to an internet-enabled device, and those undergoing emergency or endoscopic procedures. Additional groups of service users (group 1: public members who had not engaged with the system; group 2: a subset of patients who completed the measurement system) completed user-testing sessions and semistructured interviews to assess system effectiveness and user satisfaction. We conducted quantitative data analysis using descriptive statistics and calculated the task completion rate and survey response rate (system effectiveness) as well as the task completion time, task efficiency, and relative efficiency (system efficiency). Qualitative thematic analysis identified indicators of and barriers to good usability (user satisfaction).

RESULTS: A total of 2254 completed surveys were returned to the measurement system. A total of 25 service users (group 1: n=9; group 2: n=16) participated in user-testing sessions and interviews. The task completion rate was high (169/171, 98.8%) and the survey response rate was good (2254/5794, 38.9%). The median task completion time was 3 (IQR 2-13) minutes, suggesting good system efficiency and effectiveness. The qualitative findings emphasized good user satisfaction. The identified themes suggested that the measurement system is acceptable, easy to use, and easy to access. Service users identified potential barriers and solutions to acceptability and ease of access.

CONCLUSIONS: A mixed methods evaluation of an electronic measurement system for automated, real-time monitoring of patients’ experience of SDM showed that usability among patients was high. Future pilot work will optimize the system for wider implementation to ultimately inform intervention development to improve SDM.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1136/bmjopen-2023-079155.

PMID:38598276 | DOI:10.2196/46698

J Ocul Pharmacol Ther. 2024 Apr 10. doi: 10.1089/jop.2023.0186. Online ahead of print.

ABSTRACT

Purpose: To compare the efficacy of Brinzolamide-Brimonidine (BB) (1%+0.2%) with the gold standard Latanoprost-Timolol (LT) (0.005%+0.5%) in treating primary open-angle glaucoma (POAG) and ocular hypertension (OHT). Methods: A 1-year prospective study, spanning from May 2022 to May 2023, conducted at a tertiary eye-care hospital. Participants, aged 40-60, with a baseline intraocular pressure (IOP) >21 mm Hg, requiring a >30% reduction, were enrolled. Group A (n = 100) received BB, and Group B (n = 100) received LT. Outcomes were assessed at 1 month (IOP difference from baseline), 3 and 6 months (mean diurnal variations). Results: The mean age at presentation was 55.5 ± 4.5 years in Group A and 54.7 ± 4.2 years in Group B. At 1 month, Group A exhibited a mean IOP of 18.7 mm Hg, while Group B had 17.6 mm Hg, with no statistically significant difference (P = 0.53). No significant diurnal variation was observed in either group (P = 0.07). Target pressure was achieved in 88% of patients in Group A and slightly higher at 92% in Group B. Moreover, no serious side effects were reported, and compliance was higher in Group B (98%) compared to Group A (96%). Conclusion: Although LT showed slightly better and sustained IOP reduction, the difference was not statistically significant. Both BB and LT demonstrated comparable outcomes for managing POAG and OHT.

PMID:38598266 | DOI:10.1089/jop.2023.0186

JAMA Netw Open. 2024 Apr 1;7(4):e245692. doi: 10.1001/jamanetworkopen.2024.5692.

ABSTRACT

IMPORTANCE: Given the growth of home health agency (HHA) care, it is important to understand whether quality reporting programs, such as star ratings, are associated with improved patient outcomes.

OBJECTIVE: To assess the immediate and long-term association of the introduction of HHA star ratings with patient-level quality outcomes, comparing claims-based and agency-reported measures.

DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional study used Medicare HHA claims and agency-reported assessments to identify sequential patient episodes (ie, spells) among US adults with traditional Medicare who received HHA care (2013-2019). An interrupted time series (ITS) model was used to measure changes in trends and levels before and after the introduction of star ratings. Statistical analysis was performed from November 2022 to September 2023.

EXPOSURE: The exposure was the introduction of HHA star ratings. The postexposure period was set as starting January 1, 2016, to account for the period when both star ratings (quality of patient care and patient satisfaction rating) were publicly reported.

MAIN OUTCOMES AND MEASURES: The main outcomes included claims-based hospitalization measures (both during the patient spell and 30 days after HHA discharge) and agency-reported functional measures, such as improvement in ambulation, bathing, and bed transferring. There was also a measure to capture timely initiation of care among post-acute care HHA users, defined as HHA care initiated within 2 days of inpatient discharge.

RESULTS: This study identified 22 958 847 patient spells to compare annual changes over time; 9 750 689 patient spells were included during the pre-star ratings period from January 1, 2013, to December 31, 2015 (6 067 113 [62.2%] female; 1 100 145 [11.3%] Black, 512 487 [5.3%] Hispanic, 7 845 197 [80.5%] White; 2 656 124 [27.2%] dual eligible; mean [SD] patient spell duration, 70.9 [124.9] days; mean [SD] age, 77.4 [12.0] years); 13 208 158 patient spells were included during the post-star ratings period from January 1, 2016, to December 31, 2019 (8 104 69 [61.4%] female; 1 385 180 [10.5%] Black, 675 536 [5.1%] Hispanic, 10 664 239 [80.7%] White; 3 318 113 [25.1%] dual eligible; mean [SD] patient spell duration, 65.3 [96.2] days; mean [SD] age, 77.7 [11.6] years). Results from the ITS models found that the introduction of star ratings was associated with an acceleration in the mean [SE] hospitalization rate during the spell (0.39% [0.05%] per year) alongside functional improvements in ambulation (2.40% [0.29%] per year), bed transferring (3.95% [0.48%] per year) and bathing (2.34% [0.19%] per year) (P < .001). This occurred alongside a 1.21% (0.12%) per year reduction in timely initiation of care (P < .001).

CONCLUSIONS AND RELEVANCE: This cross-sectional study found an observed improvement in agency-reported functional measures, which contrasted with slower increases in more objective measures such as hospitalization rates and declines in timely initiation of care. These findings suggest a complex picture of HHA quality of care after the introduction of star ratings.

PMID:38598240 | DOI:10.1001/jamanetworkopen.2024.5692