Treatment Decisions Research Articles

The economic impact of suboptimal treatment and treatment switch among patients with Crohn’s disease treated with a first-line biologic – A US retrospective claims database study

ABSTRACT AIMS: Suboptimal treatment indicators, including treatment switch, are common among patients with Crohn’s disease (CD), but little is known about their associated healthcare resource utilization (HRU) and costs. This study assessed the impact of suboptimal treatment indicators on HRU and costs among adults with CD newly treated with a first-line biologic. METHODS: Adult patients with CD were identified in the IBM® MarketScan® Commercial Subset (10/01/2015–03/31/2020). The index date was defined as initiation of the first-line biologic, and the study period was defined as the 12 months following the index date. Patients were classified into Suboptimal Treatment and Optimal Treatment cohorts based on observed indicators of suboptimal treatment during the study period. Patients in the Suboptimal Treatment Cohort with a treatment switch were classified into the Treatment Switch Cohort and compared to patients with no treatment switch. All-cause HRU and costs were measured during the study period and assessed for patients with suboptimal vs optimal treatment and patients with vs without a treatment switch. RESULTS: The study included 4,006 patients (Suboptimal Treatment: 2,091, Optimal Treatment: 1,915). Treatment switch was a common indicator of suboptimal treatment (Treatment Switch: 640, No Treatment Switch: 3,366). HRU and costs were significantly higher among patients with suboptimal treatment than those with optimal treatment (annual costs: $92,043 vs $73,764; p < 0.01), and among those with a treatment switch than those with no treatment switch (annual costs: $95,689 vs $81,027; p < 0.01). Increases in the number of suboptimal treatment indicators were associated with increased costs. LIMITATIONS: Claims data were used to identify suboptimal treatment indicators based on observed treatment patterns; reasons for treatment decisions could not be assessed. CONCLUSION: This study demonstrates that patients with suboptimal treatment indicators, including treatment switch, incur substantially higher HRU and costs compared to patients receiving optimal treatment and those that do not switch treatments.

A cluster-randomized trial of client and provider directed financial interventions to align incentives with appropriate case management in private medicine retailers: Results of the TESTsmART trial in Lagos, Nigeria.

Malaria remains a major health priority in Nigeria. Among children with fever who seek care, less than a quarter gets tested for malaria, leading to inappropriate use of the recommended treatment for malaria; Artemisinin-based Combination Therapy (ACT). Here we test an innovative strategy to target ACT subsidies to clients seeking care in Nigeria's private retail health sector who have a confirmed malaria diagnosis. We supported point-of-care malaria testing (mRDTs) in 48 Private Medicine Retailers (PMRs) in the city of Lagos, Nigeria and randomized them to two study arms; a control arm offering subsidized mRDT testing for USD $0.66, and an intervention arm where, in addition to access to subsidized testing as in the control arm, clients who received a positive mRDT at the PMR were eligible for a free (fully subsidized) first-line ACT and PMRs received USD $0.2 for every mRDT performed. Our primary outcome was the proportion of ACTs dispensed to individuals with a positive diagnostic test. Secondary outcomes included proportion of clients who were tested at the PMR and adherence to diagnostic test results. Overall, 23% of clients chose to test at the PMR. Test results seemed to inform treatment decisions and resulted in enhanced targeting of ACTs to confirmed malaria cases with only 26% of test-negative clients purchasing an ACT compared to 58% of untested clients. However, the intervention did not offer further improvements, compared to the control arm, in testing rates or dispensing of ACTs to test-positive clients. We found that ACT subsidies were not passed on to clients testing positive in the intervention arm. We conclude that mRDTs could reduce ACT overconsumption in Nigeria's private retail health sector, but PMR-oriented incentive structures are difficult to implement and may need to be complemented with interventions targeting clients of PMRs to increase test uptake and adherence. Trials registration: Clinical Trials Registration Number: NCT04428307. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7816435/ Correction: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9476591/.

Walking the line between fidelity and flexibility: A conceptual review of personalized approaches to manualized treatments for posttraumatic stress disorder.

The heterogeneity of the core symptoms of posttraumatic stress disorder (PTSD), high rates of comorbid mental and physical health conditions, and substantial impact of the disorder on functioning and well-being contribute to complex clinical presentations that can be challenging to treat. Despite these challenges, there are excellent manualized treatments for PTSD with significant empirical support. Although the success of frontline treatments for PTSD is evident, there remains room for improvement as indicated by suboptimal response and attrition rates. To address challenges to optimal therapy outcomes (COTOs), researchers have conducted numerous clinical trials designed to (a) enhance the core structure of treatment protocols to increase flexibility or (b) expand the protocols to address comorbid conditions that inhibit recovery. However, it is implausible to ever conduct the number of enhancement and expansion clinical trials necessary to test manual modifications for the universe of possible COTOs. This conceptual review describes the concept of a personalized model of therapy that leverages a case formulation approach to implementing an evidence-based treatment for PTSD. This personalized approach provides guidance for the clinician in assessing the patient's COTOs, monitoring them throughout treatment, and relying on the patient's idiosyncratic data to inform treatment decisions, including how and when to diverge from treatment when clinically indicated and ensuring a clear path to return to trauma-focused work when the COTO is stabilized. This personalized, case formulation approach to treating PTSD provides guidance for adopting a more flexible approach to treating clinically complex patients while ensuring fidelity to the protocol.

Clinical diagnostic value of targeted next‑generation sequencing for infectious diseases (Review).

As sequencing technology transitions from research to clinical settings, due to technological maturity and cost reductions, metagenomic next‑generation sequencing (mNGS) is increasingly used. This shift underscores the growing need for more cost‑effective and universally accessible sequencing assays to improve patient care and public health. Therefore, targeted NGS (tNGS) is gaining prominence. tNGS involves enrichment of target pathogens in patient samples based on multiplex PCR amplification or probe capture with excellent sensitivity. It is increasingly used in clinical diagnostics due to its practicality and efficiency. The present review compares the principles of different enrichment methods. The high positivity rate of tNGS in the detection of pathogens was found in respiratory samples with specific instances. tNGS maintains high sensitivity (70.8‑95.0%) in samples with low pathogen loads, including blood and cerebrospinal fluid. Furthermore, tNGS is effective in detecting drug‑resistant strains of Mycobacterium tuberculosis, allowing identification of resistance genes and guiding clinical treatment decisions, which is difficult to achieve with mNGS. In the present review, the application of tNGS in clinical settings and its current limitations are assessed. The continued development of tNGS has the potential to refine diagnostic accuracy and treatment efficacy and improving infectious disease management. However, further research to overcome technical challenges such as workflow time and cost is required.

Survival outcomes after breast cancer surgery among older women with early invasive breast cancer in England: population-based cohort study.

This study assessed the influence of age, co-morbidity and frailty on 5-year survival outcomes after breast conservation surgery (BCS) with radiotherapy (RT) versus mastectomy (with or without RT) in women with early invasive breast cancer. Women aged over 50 years with early invasive breast cancer diagnosed in England (2014-2019) who had breast surgery were identified from Cancer Registry data. Survival estimates were calculated from a flexible parametric survival model. A competing risk approach was used for breast cancer-specific survival (BCSS). Standardized survival probabilities and cumulative incidence functions for breast cancer death were calculated for each treatment by age. Among 101 654 women, 72.2% received BCS + RT and 27.8% received mastectomy. Age, co-morbidity and frailty were associated with overall survival (OS), but only age and co-morbidity were associated with BCSS. Survival probabilities for OS were greater for BCS + RT (90.3%) versus mastectomy (87.0%), and the difference between treatments varied by age (50 years: 1.9% versus 80 years: 6.5%). Cumulative incidence functions for breast cancer death were higher after mastectomy (5.1%) versus BCS + RT (3.9%), but there was little change in the difference by age (50 years: 0.9% versus 80 years: 1.2%). The results highlight the change in baseline mortality risk by age for OS compared to the stable baseline for BCSS. For OS, the difference in survival probabilities for BCS + RT and mastectomy increased slightly with age. The difference in cumulative incidence functions for breast cancer death by surgery type was small regardless of age. Evidence on real-world survival outcomes among older populations with breast cancer is informative for treatment decision-making.

Use of Magnetic Resonance Direct Thrombus Imaging for the Diagnostic Management of Suspected Thrombosis in Routine Clinical Practice.

Background The noninvasive magnetic resonance direct thrombus imaging (MRDTI) technique can be used to diagnose acute deep vein thrombosis (DVT), without the use of intravenous contrast. MRDTI holds the potential to differentiate between acute and chronic DVT and could be helpful when diagnosing thrombosis is challenging. Objectives Our objective was to evaluate the application of MRDTI in clinical practice, including the frequency and indications of MRDTI scans performed in practice-based conditions, results, impact on treatment decisions, and associated patient outcomes. Methods A retrospective study was performed at the Leiden University Medical Center, the Netherlands. MRDTI scans performed since its implementation in patients aged ≥18 years as part of clinical practice for the diagnostic management of suspected thrombosis were evaluated. Results Between October 2015 and September 2023, 36 patients had undergone MRDTI for the diagnostic evaluation of thrombosis. MRDTI application increased since 2019 (five-eight scans per year). The most common indication was to differentiate between acute and chronic thrombosis, mainly for suspected recurrent ipsilateral DVT after inconclusive compression ultrasonography. In over a third of patients, acute thrombosis was confirmed by MRDTI. MRDTI results determined treatment decisions in all except two patients. One patient had symptomatic thrombosis of the lower extremity within 3 months after an MRDTI of the upper extremity without signs of acute thrombosis (1/23; 4.3%, 95% confidence interval: 0.77-21). Conclusion Over the past 4 years, MRDTI has been used increasingly in our hospital. MRDTI results guided treatment decisions, which confirms the clinical impact and feasibility of its application in daily practice.

How Do Exercise, Sleep and Depression Affect Disease Scores and Quality of Life in Primary Sjögren's Syndrome Patients?

Primary Sjögren's syndrome (PSS) has many effects such as fatigue, pain, physical activity limitation and sleep disturbance, which limit patient's daily and social lives. The aim of our study was to assess fatigue, depression, physical activity status and quality of life in patients with PSS, and to determine the relationship between these data and disease-related parameters. This study was conducted with 117 primary Sjögren's syndrome patients. Demographic and anthropometric characteristics, disease activity (ESSDAI), quality of life scale (SF36), depression (Beck Depression Scale), physical activity status (International Physical Activity Questionnaire Short Form (IPAQ) score) and sleep status (Pittsburgh Sleep Quality Scale) of PSS patients were evaluated and relationships have been examined. According to the results of our study, we found that sleep disorders are common in PSS patients (74.4%). Overweight patients, particularly higher lean mass sleep better (r:-0.201, p:0.043). Poor sleep causes fatigue (p=0.062) and depression (p=0.030). Sleep disturbance could not be explained by depressive state alone. However, after controlling for depression, the effect of sleep on fatigue seriously decreases (p=0.311). Exercise did not improve sleep quality (p=0.35) and the rate of poor sleep was higher among who exercised (p=0.192). Based on the results of our study, we believe that, treating depression in PSS patients is crucial for reducing fatigue. Patients need education on performing the correct exercises and weight gain should done in a professional manner. Gaining a deeper understanding of the multisystem involvement of the disease and the impact of exercise on the disease, will have positive effects on patient care and treatment decisions.

How debunking biases in research and development decisions could lead to more equitable healthcare?

Decades of research have demonstrated that a variety of cognitive biases can affect our judgment and ability to make rational decisions in personal and professional environments. The lengthy, risky, and costly nature of pharmaceutical research and development (R&D) makes it vulnerable to biased decision-making. Moreover, cognitive biases can play a role in regulatory and clinical decision-making, the latter impacting diagnostic and treatment decisions in the therapeutic use of medicines. These inherent and/or institutionalized biases (e.g., in assumptions, data, or decision-making practices) could conceivably contribute to health inequities. In this mini-review, we provide a broad perspective on how cognitive biases can affect pharmaceutical R&D, regulatory evaluation, and therapeutic decision-making. Example approaches to mitigate the effect of common biases in the development, approval, and use of new therapeutics, such as quantitative decision criteria, multidisciplinary reviews, regulatory and treatment guidelines, and evidence-based clinical decision support systems are illustrated. Mitigating the impact of cognitive biases could increase pharma R&D efficiency, change the perspective and prioritization of unmet medical needs, increase representativeness and quality of evidence generated through clinical trials and real-world research, leading to higher quality insights and more effective medication use, and as such could eventually contribute to more equitable healthcare.

A prediction nomogram for fractured vertebra re-collapse after posterior reduction and pedicle screw fixation in thoracolumbar fractures

This study aimed to establish a predictive nomogram model for re-collapse of fractured vertebra after posterior pedicle screw fixation in thoracolumbar fractures (TLFs). Patients undergoing posterior pedicle screw fixation for TLFs at our hospital between January 2016 and December 2021 were retrospectively reviewed. Patients were divided into two groups according to the presence or absence of re-collapse of the fractured vertebra at the final follow-up. The predictors for fractured vertebra re-collapse were identified by univariate and multivariable logistic regression analysis, and a nomogram model was developed. The prediction performance and internal validation were established. A total of 224 patients were included in this study. Of these, 46 (20.5%) patients developed re-collapse of fractured vertebra. Age, thoracic and lumbar injury severity score (TLICS), screw distribution in the fractured vertebra, and anterior vertebral height compression (AVHC) ratio were associated with vertebral re-collapse. These predictors were used to construct a predictive nomogram. The area under the receiver operating characteristic curve (AUC) of the nomogram model was 0.891. The concordance index (C-index) was 0.891, and it was 0.877 with bootstrapping validation. The calibration curves and decision curve analysis (DCA)also suggested that the nomogram model had excellent predictive performances for fractured vertebra re-collapse. A clinical nomogram incorporating four variables was constructed to predict fractured vertebra re-collapse after posterior pedicle screw fixation for TLFs. The nomogram demonstrated good calibration and discriminative abilities, which may help clinicians to make better treatment decisions.

A prediction nomogram for fractured vertebra re-collapse after posterior reduction and pedicle screw fixation in thoracolumbar fractures

This study aimed to establish a predictive nomogram model for re-collapse of fractured vertebra after posterior pedicle screw fixation in thoracolumbar fractures (TLFs). Patients undergoing posterior pedicle screw fixation for TLFs at our hospital between January 2016 and December 2021 were retrospectively reviewed. Patients were divided into two groups according to the presence or absence of re-collapse of the fractured vertebra at the final follow-up. The predictors for fractured vertebra re-collapse were identified by univariate and multivariable logistic regression analysis, and a nomogram model was developed. The prediction performance and internal validation were established. A total of 224 patients were included in this study. Of these, 46 (20.5%) patients developed re-collapse of fractured vertebra. Age, thoracic and lumbar injury severity score (TLICS), screw distribution in the fractured vertebra, and anterior vertebral height compression (AVHC) ratio were associated with vertebral re-collapse. These predictors were used to construct a predictive nomogram. The area under the receiver operating characteristic curve (AUC) of the nomogram model was 0.891. The concordance index (C-index) was 0.891, and it was 0.877 with bootstrapping validation. The calibration curves and decision curve analysis (DCA)also suggested that the nomogram model had excellent predictive performances for fractured vertebra re-collapse. A clinical nomogram incorporating four variables was constructed to predict fractured vertebra re-collapse after posterior pedicle screw fixation for TLFs. The nomogram demonstrated good calibration and discriminative abilities, which may help clinicians to make better treatment decisions.

Development of a Web-Based Interactive Tool for Visualizing Breast Cancer Clinical Trial Tolerability Data.

Longitudinal patient tolerability data collected as part of randomized controlled trials are often summarized in a way that loses information and does not capture the treatment experience. To address this, we developed an interactive web application to empower clinicians and researchers to explore and visualize patient tolerability data. We used adverse event (AE) data (Common Terminology Criteria for Adverse Events) and patient-reported outcomes (PROs) from the NSABP-B35 phase III clinical trial, which compared anastrozole with tamoxifen for breast cancer-free survival, to demonstrate the tools. An interactive web application was developed using R and the Shiny web application framework that generates Sankey diagrams to visualize AEs and PROs using four tools: AE Explorer, PRO Explorer, Cohort Explorer, and Custom Explorer. To illustrate how users can use the interactive tool, examples for each of the four applications are presented using data from the NSABP-B35 phase III trial and the NSABP-B30 trial for the Custom Explorer. In the AE and PRO explorers, users can select AEs or PROs to visualize within specified time periods and compare across treatments. In the cohort explorer, users can select a subset of patients with a specific symptom, severity, and treatment received to visualize the trajectory over time within a specified time interval. With the custom explorer, users can upload and visualize structured longitudinal toxicity and tolerability data. We have created an interactive web application and tool for clinicians and researchers to explore and visualize clinical trial tolerability data. This adaptable tool can be extended for other clinical trial data visualization and incorporated into future patient-clinician interactions regarding treatment decisions.

Alzheimer Disease and Related Dementia Following Hormone-Modulating Therapy in Patients With Breast Cancer.

Hormone-modulating therapy (HMT) is a widely accepted treatment for hormone receptor-positive breast cancer, although its cognitive effects, including a potential link to Alzheimer disease and related dementias (ADRD), remain understudied. To investigate the association between HMT for breast cancer treatment and risk of developing ADRD in women aged 65 years or older. This cohort study used a comprehensive dataset from the Surveillance, Epidemiology, and End Results (SEER)-Medicare linked database to identify patients who did and did not receive HMT treatment within 3 years after the initial diagnosis of breast cancer and assessed their risk of developing ADRD in later life. Individuals with a preexisting diagnosis of ADRD or receiving HMT before the diagnosis of breast cancer were excluded. This study was performed from June 2022 through January 2024. Receipt of HMT. Risk of ADRD associated with HMT; associations of risk with age, self-identified race, and HMT type. Risk was measured using hazard ratios (HRs) with 95% CIs and adjusted for potential confounders such as demographic, sociocultural, and clinical variables. Among 18 808 women aged 65 years and older diagnosed with breast cancer between 2007 and 2009 (1266 Black [6.7%], 16 526 White [87.9%], 1016 other [5.4%]), 12 356 (65.7%) received HMT within 3 years after diagnosis, while 6452 (34.3%) did not. The most common age group in both samples was the 75 to 79 years age group (HMT, 2721 women [22.0%]; no HMT, 1469 women [22.8%]), and the majority of women in both groups self-identified as White (HMT, 10 904 women [88.3%]; no HMT, 5622 women [87.1%]). During an average of 12 years of follow-up, 2926 (23.7%) of HMT users and 1802 (27.9%) of non-HMT users developed ADRD. HMT was associated with a 7% lower relative risk of ADRD overall (HR, 0.93; 95% CI, 0.88-0.98; P = .005). The association decreased with age and varied by race. The reduction in ADRD risk associated with HMT was greatest for women aged 65 to 74 years who self-identified as Black (HR, 0.76; 95% CI, 0.62-0.92). This association decreased among women aged 75 years or older (HR, 0.81; 95% CI, 0.67-0.98). Women aged 65 to 74 years who self-identified as White had an 11% relative risk reduction (HR, 0.89; 95% CI, 0.81-0.97), but the association disappeared for women aged 75 years or older (HR, 0.96; 95% CI, 0.90-1.02). Other races showed no significant association between HMT and ADRD. Age- and race-based associations also varied by HMT type. In this retrospective cohort study, hormone therapy was associated with protection against ADRD in women aged 65 years or older with newly diagnosed breast cancer; the decrease in risk was relatively greater for Black women and women under age 75 years, while the protective effect of HMT diminished with age and varied by race in women. When deciding to use HMT for breast cancer in women aged 65 years or more, clinicians should consider age, self-identified race, and HMT type in treatment decisions.

Optimal extreme learning machine for diagnosing brain tumor based on modified sailfish optimizer

This study proposes a hierarchical automated methodology for detecting brain tumors in Magnetic Resonance Imaging (MRI), focusing on preprocessing images to improve quality and eliminate artifacts or noise. A modified Extreme Learning Machine is then used to diagnose brain tumors that are integrated with the Modified Sailfish optimizer to enhance its performance. The Modified Sailfish optimizer is a metaheuristic algorithm known for efficiently navigating optimization landscapes and enhancing convergence speed. Experiments were conducted using the “Whole Brain Atlas (WBA)” database, which contains annotated MRI images. The results showed superior efficiency in accurately detecting brain tumors from MRI images, demonstrating the potential of the method in enhancing accuracy and efficiency. The proposed method utilizes hierarchical methodology, preprocessing techniques, and optimization of the Extreme Learning Machine with the Modified Sailfish optimizer to improve accuracy rates and decrease the time needed for brain tumor diagnosis. The proposed method outperformed other methods in terms of accuracy, recall, specificity, precision, and F1 score in medical imaging diagnosis. It achieved the highest accuracy at 93.95 %, with End/End and CNN attaining high values of 89.24 % and 93.17 %, respectively. The method also achieved a perfect score of 100 % in recall, 91.38 % in specificity, and 75.64 % in F1 score. However, it is crucial to consider factors like computational complexity, dataset characteristics, and generalizability before evaluating the effectiveness of the method in medical imaging diagnosis. This approach has the potential to make substantial contributions to medical imaging and aid healthcare professionals in making prompt and precise treatment decisions for brain tumors.

Rethinking Blood Eosinophils for Assessing ICS Response in COPD: A Post-Hoc Analysis from FLAME.

BackgroundThe varied treatment response to inhaled corticosteroids (ICS) in COPD, and the increased risk of pneumonia necessitate a personalised ICS therapeutic approach. This is informed by blood eosinophil count (BEC), which predicts ICS treatment response. However, BEC appears to change in response to ICS treatment. Research questionDoes BEC measured on or off ICS treatment or the change in BEC during ICS treatment, best predict treatment response to ICS in COPD? Study design and methodsFLAME, a 52-week, double-blind RCT compared LABA/LAMA versus LABA/ICS. Corticosteroids were prohibited during a 4-week run-in period. We chose patients previously on ICS, thereby allowing pre- and post-run-in period BEC to represent BEC on and off ICS, respectively. In this post-hoc analysis, we revisited outcome data, exploring how the three BEC biomarkers interacted with treatment response to the ICS containing regimen. ResultsOur study confirms that LABA/LAMA combination is superior, or at least non-inferior, to LABA/ICS in curbing exacerbations for most FLAME participants. However, higher BEC off and BEC on ICS and significant BEC suppression during ICS treatment corresponded to superior response to LABA/ICS in terms of exacerbation rate, time-to-first exacerbation, and time-to-first pneumonia. In a subgroup, including 9% of participants, BEC changed significantly during ICS treatment (≥200 cells/μL), and higher BEC on ICS did not predict ICS treatment response. For these patients, BEC off ICS and BEC change proved more predictive. Excess pneumonia risk associated with ICS appeared to be confined to patients who do not benefit from this treatment. BEC were not predictive of treatment effects on lung function and health status. InterpretationThis exploratory analysis advocates preferentially using BEC off ICS or BEC change during ICS treatment for guiding ICS treatment decisions. BEC measured on ICS is less predictive of treatment response. Clinical trial registrationNCT01782326

Nomogram to Predict Tube Occlusion During Hyperthermic Intraperitoneal Chemotherapy for Pseudomyxoma Peritonei.

To investigate the factors contributing to the blockage of perfusion tubes during hyperthermic intraperitoneal chemotherapy (HIPEC) in patients with appendiceal pseudomyxoma peritonei (PMP) undergoing combined cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy treatment, and to construct a nomogram for predicting the risk of tube occlusion. Observational study. Place and Duration of the Study: Department of Gastrointestinal Surgery, Central Hospital Affiliated to Shandong First Medical University, Jinan, China, from June 2017 to December 2023. Tube occlusion was defined as the inability to achieve 30 minutes of continuous unobstructed perfusion. Statistical methods such as univariate analysis, multivariate analysis, and Lasso regression were employed for data analysis. The results revealed that 27% of the 383 hyperthermic intraperitoneal chemotherapy perfusion treatments resulted in the tube occlusion events. Multivariate logistic regression analysis identified age, CA-125, CA19-9, and pathological type as the independent risk factors. A nomogram predicting the tube occlusion was constructed and validated for its predictive accuracy and clinical utility. This study successfully developed a nomogram to predict the tube occlusion risk during cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy treatment for patients with pseudomyxoma peritonei, providing valuable guidance for clinical practice and aiding in personalised treatment decisions to improve patient prognosis. However, further research is needed to validate the reliability and clinical applicability of the model, as well as to investigate the impact of tube occlusion on treatment outcomes and corresponding management strategies. Pseudomyxoma peritonei, Cytoreductive surgery, Hyperthermic intraperitoneal chemotherapy treatment, Tube occlusion, Nomogram.

Factors Affecting Life-Sustaining Treatment Decisions and Changes in Clinical Practice after Enforcement of the Life-Sustaining Treatment Decision (LST) Act: A Tertiary Hospital Experience in Korea.

In Korea, the act on hospice and palliative care and decisions on life-sustaining treatment (LST) was implemented on February 4, 2018. We aimed to investigate relevant factors and clinical changes associated with LST decisions after law enforcement. This single-center retrospective study included patients who completed LST documents using legal forms at Asan Medical Center from February 5, 2018, to June 30, 2020. 5896 patients completed LST documents, of which 2704 (45.8%) signed the documents in person, while family members of 3,192 (54%) wrote the documents on behalf of the patients. Comparing first year and following year of implementation of the act, the self-documentation rate increased (43.9% to 47.2%, p=0.014). Moreover, the number of LST decisions made during or after ICU admission decreased (37.8% vs. 35.2%, p=0.045), and the completion rate of LST documents during chemotherapy increased (6.6% vs. 8.9%, p=0.001). In multivariate analysis, age < 65 (OR, 1.724; 95% CI, 1.538-1.933; p<0.001), unmarried status (OR, 1.309; 95% CI, 1.097-1.561; p=0.003), palliative care consultation (OR, 1.538; 95% CI, 1.340-1.765; p<0.001), malignancy (OR, 1.864; 95% CI, 1.628-2.133; p<0.001), and changes in timing on the first year versus following year (OR, 1.124, 95% CI, 1.003-1.260, p=0.045) were related to a higher self-documentation rate. Age < 65, unmarried status, malignancy, and referral to a palliative care team were associated with patients making LST decisions themselves. Furthermore, the subject and timing of LST decisions have changed with the LST act.

Utilizing Diagnostic Musculoskeletal Ultrasound for Assessment of the Infraspinatus Muscle and Tendon: Implications for Rehabilitation Professionals

The rotator cuff, comprising the subscapularis, supraspinatus, infraspinatus, and teres minor muscles, plays a crucial role in stabilizing the glenohumeral joint by securing the head of the humerus within the glenoid cavity of the scapula. The tendinous insertions of these muscles generate tension within the capsule, enhancing joint stability during muscular activity. The rotator cuff is susceptible to damage from disease, injury, or trauma, which can result in tears or ruptures of one or more tendons. The evaluation of the infraspinatus muscle and tendon is vital for diagnosing and managing various shoulder pathologies. Accurate imaging to determine the specific muscle involvement and injury severity significantly impacts treatment decisions. Diagnostic musculoskeletal ultrasound (MSK-US) has emerged as a valuable tool for assessing the infraspinatus muscle and tendon, offering real-time, dynamic assessment capabilities essential for precise diagnosis and effective rehabilitation planning. This article reviews the utility and advantages of MSK-US in evaluating the infraspinatus muscle and tendon, emphasizing technique specifics, diagnostic accuracy, and comparative efficacy against other imaging modalities. It details a systematic approach to the ultrasound examination technique for the infraspinatus, including patient positioning and identification of common pathologies such as tears, tendinopathy, and calcifications. With recent advancements in transducer strength, image resolution, and operator training, ultrasound serves as an excellent alternative imaging modality for diagnosing rotator cuff tears. This article aims to equip rehabilitation professionals with a comprehensive understanding of MSK-US as a diagnostic tool for the infraspinatus, promoting more precise diagnosis, treatment planning and improved patient outcomes.

Changes in the Functional Classification of Spirometry Using the New Interpretation Standard 2022: A Multicenter Study

IntroductionPulmonary function tests are vital for diagnosing lung diseases, assessing treatment responses, and monitoring respiratory health. Recent updates to interpretive standards by the European Respiratory and American Thoracic Societies (ERS/ATS) in 2022 introduced significant changes compared to the 2005 standards. They include incorporating lung volume measurements, non-specific and mixed disorders, introducing z-scores for functional abnormality assessment, reducing severity categories from five to three, and revising criteria for positive bronchodilator responses. MethodsWe conducted a retrospective, multi-center study across four centers using spirometric data spanning from 2002 to 2022. We categorized spirometry results using both the 2005 and 2022 ATS/ERS standards and calculated predicted values following the GLI 2012 equation (Caucasian subset). ResultsAmong 79,039 subjects, we observed that 23% shifted from an obstructive diagnosis under the 2005 standard to a mixed pattern diagnosis under the 2022 standard, necessitating lung volume assessments. In the evaluation of bronchodilator responses among 59,203 tests, 12.3% of those initially classified as responders were reclassified as non-responders with the new standards. We found variations in severity categorization across age groups, with older patients tending to receive milder severity classifications and younger individuals receiving greater severity classifications under the 2022 standards. ConclusionsThe 2022 document emphasizes early lung volume assessment, potentially leading to increased utilization of more complex tests. Furthermore, the bronchodilator response was predominant in extreme age groups and among individuals with milder spirometric impairments. This shift may impact treatment decisions, potentially initiating medication in milder cases and de-escalating treatment in more severe cases.

Colposcopically Directed Biopsy Before Ablative Treatment Versus Direct Ablative Treatment in Patients With Cervical Oncogenic HPV.

In the past, the standard of care for women with abnormal cervical cytology has been the performance of colposcopically guided biopsy, followed by conization or large loop excision of the transition zone (LLETZ) where biopsy revealed pre-cancerous or cancerous areas. More straightforward protocols are emerging which advocate performing LLETZ in all women with highly suspicious cytology, suspicious colposcopic impression, or the presence of high-risk oncogenic human papilloma virus (HPV) strains in their cervical swabs. This, theoretically, would reduce the rate of false-negative diagnoses, but at the price of overtreating a significant number of healthy women. We retrospectively analyzed cervical cancer screening protocols in two large cohorts of women with high-risk HPV. The study compared outcomes between patients undergoing a colposcopically directed biopsy before LLETZ (n=683) and those proceeding directly to LLETZ without a biopsy (n=136). The primary focus was to assess whether intervening biopsies would reduce unnecessary ablative procedures without compromising the detection of high-grade lesions. The biopsy group had a high false-negative rate, with several high-grade lesions (CIN3) and a case of invasive cancer initially underdiagnosed. Conversely, the direct-to-LLETZ approach, while ensuring no high-grade lesions were missed, led to overtreatment of lower grade lesions. These findings raise concern about the reliance on biopsy results for treatment decisions. Neither protocol was entirely satisfactory, although the more aggressive one avoided the potentially life-threatening consequence of false-negative results. Further research is mandatory to accurately diagnose all cases requiring aggressive treatment, without subjecting healthy women to ablative treatments they do not need.

Ethical challenges in health care during collective hunger strikes in public or occupied spaces.

Public collective hunger strikes take place in complex social and political contexts, require medical attention and present ethical challenges to physicians. Empirical research, the ethical debate to date and existing guidelines by the World Medical Association focus almost exclusively on hunger strikes in detention. However, the public space differs substantially with regard to the conditions for the provision of health care and the diverse groups of healthcare providers or stakeholders involved. By reviewing empirical research on the experience of health professionals with public collective hunger strikes, we identified the following ethical challenges: (1) establishment of a trustful physician-striker relationship, (2) balancing of medico-ethical principles in medical decision-making, (3) handling of loyalty conflicts and (4) preservation of professional independence and the risk of political instrumentalization. Some of these challenges have already been described and discussed, yet not contextualized for public collective strikes, while others are novel. The presence of voluntary physicians may offer opportunities for a trustful relationship and, hence, for ethical treatment decisions. According to our findings, it requires more attention to how to realise autonomous medical decisions in the complex context of a dynamic, often unstructured and politically charged setting, which ethical norms should shape the professional role of voluntary physicians, and what is the influence of the hunger strikers'collective on individual healthcare decisions. Our article can serve as a starting point for further ethical discussion. It can also provide the basis for the development of potential guidelines to support health professionals involved in public collective hunger strikes.