Comparative Efficacy of Budesonide/Formoterol Versus Fluticasone/Salmeterol in Patients With Moderate-to-Severe Chronic Obstructive Pulmonary Disease: A Systematic Review and Meta-Analysis.

BACKGROUND/OBJECTIVE: To compare the efficacy of budesonide/formoterol (BF) versus fluticasone/salmeterol (FS) in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD). METHODS: The PubMed, Embase, Cochrane Library, and Web of Science databases were searched for studies comparing BF versus FS in the treatment of COPD from inception to July 17, 2023. Outcomes, including exacerbations, hospitalizations, pneumonia, emergency department (ED) visits for COPD, length of hospitalization, and number of exacerbations, were compared using risk ratio (RR) with corresponding 95% confidence interval (CI) or weighted mean difference (WMD) with 95% CI. All statistical analyses were performed using Stata version 12.0. RESULTS: Ten studies comprising a total of 136,369 participants were included. Compared with those treated with FS, patients with COPD treated with BF experienced a reduced number of exacerbations (RR 0.91 [95% CI 0.83-1.00]; p = 0.040), hospitalizations (RR 0.77 [95% CI 0.67-0.88]; p < 0.001), and frequency of pneumonia (RR 0.77 [95% CI 0.64-0.92]; p = 0.05). However, no significant difference was observed between BF and FS in terms of ED visits for COPD (RR 0.87 [95% CI 0.69-1.10]; p = 0.243), length of hospitalization (WMD -0.18 [95% CI -0.62-0.27]; p = 0.437), and number of exacerbations (WMD -0.06 [95% CI -0.28-0.16]; p = 0.602). Notably, no significant heterogeneity was noted in length of hospitalization between the two groups, whereas clear heterogeneity was observed in other outcomes (I2 > 50%, p < 0.05). CONCLUSION: Compared with FS, BF therapy appears to be a more promising treatment strategy for patients with moderate-to-severe COPD; however, this should be verified in further high-quality studies.

Evaluation of SINERGIAPS, an intervention to improve patient safety in primary healthcare centers in Spain based on patients' perceptions and experiences: a protocol for a hybrid type I randomized clinical trial.

Background: Adverse events in the primary care setting result in a direct cost equivalent to at least 2.5% of total healthcare spending. Across OECD countries, they lead to more than seven million avoidable hospital admissions annually. In this manuscript, we describe the protocol of a trial aimed at evaluating the effectiveness of SinergiAPS (a patient-centered audit and feedback intervention) in reducing avoidable hospital admission and explore the factors that may affect its implementation. Methods: We will conduct a 24-month, parallel, open-label, multicenter, pragmatic, hybrid type 1 randomized clinical trial. 118 primary healthcare centers with wide geographical distribution in Spain will be randomly assigned (ratio 1:1) to two groups. The intervention group will receive two audits (baseline and intermediate at 12 months) based on information collected through the administration of the PREOS-PC questionnaire (a measure of patient-reported patient safety) to a convenience sample of 100 patients per center. The intervention group will receive reports on the results of both audits, along with educational resources aimed at facilitating the design and implementation of safety improvement plans. The control group will receive care as usual. The primary outcome will be the rate of avoidable hospitalizations (administrative data). Secondary outcomes: patient-reported patient safety experiences and outcomes (PREOS-PC questionnaire); patient safety culture as perceived by professionals (MOSPSC questionnaire); adverse events reported by healthcare professionals (ad hoc questionnaire); the number of safety improvement actions which the re has implemented (ad hoc questionnaire). Outcome data will be collected at baseline and 24 months follow-up. For the evaluation of the implementation of the SinergiAPS intervention, we will draw on the Consolidated Framework for Implementation Research (CFIR). We will collect and analyze qualitative and quantitative data (30 individual interviews, implementation logbooks; questionnaires for professionals from intervention centers, and level of use of the SinergiAPS web tool). Discussion: This study will expand the scarce body of evidence existing regarding the effects and implementation of interventions aimed at promoting patient and family engagement in primary healthcare, specifically for enhancing patient safety. The study has the potential to produce an impact on clinical practice, healthcare systems, and population health.Clinical Trial Registration: https://clinicaltrials.gov/study/NCT05958108?term=sinergiAPS&rank=1 (NCT05958108).

Integrating palliative care in patients with advanced multiple sclerosis: a scoping review.

BACKGROUND: Multiple sclerosis (MS) often presents a long and uncertain evolution. Treatment decisions in advanced MS are supported by robust evidence, but recent guidelines have suggested a shift to a palliative approach as the disease progresses. This study aims to describe what is known about the integration of palliative care (PC) in patients with severe MS (cost-effectiveness, moment of reference, and perspective of stakeholders). METHODS: A scoping review was developed, and the Scopus, Medline (PubMed), ISI Web of Knowledge, and SAGE databases were consulted, using the key terms: "multiple sclerosis" AND "palliative care". Studies on the perspectives of patients, caregivers, and health professionals regarding the integration of PC in MS were included. No restrictions were applied regarding the subtype of MS, gender, ethnicity, frequency of use of health services, and language. RESULTS: Of 158 articles identified, 19 were included in the review. Key factors were identified, such as the effectiveness of PC intervention in severe MS, the financial impact of providing PC compared to conventional care, the reduction of symptoms and caregiver burden, and the perception of unmet needs by users, health professionals, and caregivers during the PC approach. CONCLUSIONS: Patients with MS should have access to specialized PC when they reach the severe phase of the disease. Providing a multidisciplinary team to provide targeted consultations based on the patient's needs may be most appropriate. These issues have important implications for the future planning and provision of PC services.

How do opt-in versus opt-out settings nudge patients toward electronic health record adoption? An exploratory study of facilitators and barriers in Austria and France.

BACKGROUND: Electronic health records (EHR) are becoming an integral part of the health system in many developed countries, though implementations and settings vary across countries. Some countries have adopted an opt-out policy, in which patients are enrolled in the EHR system following a default nudge, while others have applied an opt-in policy, where patients have to take action to opt into the system. While opt-in systems may exhibit lower levels of active user requests for access, this contrasts with opt-out systems where a notable percentage of users may passively retain access. Thus, our research endeavor aims to explore facilitators and barriers that contribute to explaining EHR usage (i.e., actively accessing the EHR system) in two countries with either an opt-in or opt-out setting, exemplified by France and Austria. METHODS: A qualitative exploratory approach using a semi-structured interview guideline was undertaken in both countries: 1) In Austria, with four homogenously composed group discussions, and 2) in France, with 19 single patient interviews. The data were collected from October 2020 to January 2021. RESULTS: Influencing factors were categorized into twelve subcategories. Patients have similar experiences in both countries with regard to all facilitating categories, for instance, the role of health providers, awareness of EHR and social norms. However, we highlighted important differences between the two systems regarding hurdles impeding EHR usage, namely, a lack of communication as well as transparency or information security about EHR. CONCLUSION: Implementing additional safeguards to enhance privacy protection and supporting patients to improve their digital ability may help to diminish the perception of EHR-induced barriers and improve patients' health and commitment in the long term. PRACTICAL IMPLICATIONS: Understanding the differences and similarities will help to develop practical implications to tackle the problem of low EHR usage rates in the long run. This problem is prevalent in countries with both types of EHR default settings.

Usability of the 4Ms Worksheet in the Emergency Department for Older Patients: A Qualitative Study.

Introduction: Older adults often have multiple comorbidities; therefore, they are at high risk for adverse events after discharge. The 4Ms framework-what matters, medications, mentation, mobility-has been used in acute and ambulatory care settings to identify risk factors for adverse events in older adults, although it has not been used in the emergency department (ED). We aimed to determine whether 1) use of the 4Ms worksheet would help emergency clinicians understand older adult patients' goals of care and 2) use of the worksheet was feasible in the ED. Methods: We conducted a qualitative, descriptive study among patients aged ≥60 years and emergency clinicians from January-June 2022. Patients were asked to fill out a 4Ms worksheet; following this, semi-structured interviews were conducted with patients and clinicians separately. We analysed data to create codes, which were divided into categories and sub-categories. Results: A total of 20 older patients and 19 emergency clinicians were interviewed. We identified two categories based on our aims: understanding patient goals of care (sub-categories: clinician/ patient concordance; understanding underlying goals of care; underlying goals of care discrepancy) and use of 4Ms Worksheet (sub-categories: worksheet to discussion discrepancy; challenges using worksheet; challenge completing worksheet before discharge). Rates of concordance between patient and clinician on main concern/goal of care and underlying goals of care were 82.4% and 15.4%, respectively. Conclusion: We found that most patients and emergency clinicians agreed on the main goal of care, although clinicians often failed to elicit patients' underlying goal(s) of care. Additionally, many patients preferred to have the interviewer fill out the worksheet for them. There was often discrepancy between what was written and what was discussed with the interviewer. More research is needed to determine the best way to integrate the 4Ms framework within emergency care.

Informed Consent for Psychotherapy: The Moderating Role of Therapeutic Alliance, Prior Knowledge and Autonomous Motivation on Decision-Making and Treatment Expectation.

BACKGROUND: Informed consent is an ethical prerequisite for psychotherapy. There are no routinely used standardized strategies for obtaining informed consent. A new optimized informed consent consultation (OIC) strengthened treatment-relevant aspects. It remains unclear which factors influence the OIC efficacy regarding clinical and decision-related outcomes. METHODS: N = 122 adults were included in a randomized controlled online trial. Participants received an information brochure on psychotherapy (TAU; n = 61) or OIC + TAU (n = 61). The main and interaction effects of group allocation, therapeutic alliance, prior knowledge about psychotherapy and treatment motivation on treatment expectations, decisional conflict and capacity to consent were tested. Floodlight analyses were conducted for significant interactions. RESULTS: Large interaction effects were shown between treatment motivation and group allocation on treatment expectations (ß = -0.53) and between prior knowledge and group assignment on capacity to consent (ß = 0.68). The interaction between treatment motivation and group allocation was significant up to a motivation score of 5.54 (range: 1-7). The interaction between prior knowledge and group assignment was significant up to a knowledge score of 14.38 (range: 5-20). CONCLUSION: Moderator analyses indicated varying efficacy degrees for the OIC regarding decisional outcomes and expectation. Especially patients with little treatment motivation or low prior knowledge benefited from optimized information about the efficacy and possible side effects of psychotherapy. TRIAL REGISTRATION: PsychArchives (https://doi.org/10.23668/psycharchives.4929): 17.06.2021.

Racial/ethnic differences in 21-gene recurrence score and survival among patients with estrogen receptor-positive breast cancer.

BACKGROUND: Despite numerous studies on racial/ethnic disparities among patients with breast cancer, there is a paucity of literature evaluating racial/ethnic differences in 21-gene recurrence score (RS) and survival differences stratified by RS risk categories. We thus performed an observational cohort study to examine racial/ethnic disparities in the context of RS. METHODS: The National Cancer Database (NCDB) was queried for female patients diagnosed between 2006 and 2018 with estrogen receptor (ER)-positive, pT1-3N0-1aM0 breast cancer who received surgery followed by adjuvant endocrine therapy and had RS data available. Logistic multivariable analysis (MVA) was built to evaluate variables associated with RS ≥ 26. Cox MVA was used to evaluate OS. Subgroup analyses were performed to compare the magnitude of racial/ethnic differences stratified by RS. P values less than 0.017 were considered statistically significant based on Bonferroni correction. RESULTS: A total of 140,133 women were included for analysis. Of these, 115,651 (82.5%), 8,213 (5.9%), 10,814 (7.7%), and 5,455 (3.9%) were NHW, Hispanic, Black, and API women, respectively. Median (IQR) follow up was 66.2 months (48.0-89.8). Logistic MVA showed that, compared with NHW women, Black women were associated with higher RS (≥ 26 vs < 26: adjusted odds ratio [aOR] 1.19, 95% confidence interval [CI] 1.12-1.26, p < 0.001), while HW (aOR 0.93, 95% CI 0.86-1.00, p = 0.04) and API women (aOR 1.03, 95% CI 0.95-1.13, p = 0.45) were not. Cox MVA showed that, compared with NHW women, Black women had worse OS (adjusted hazards ratio [aHR] 1.10, 95% CI 1.02-1.19, p = 0.012), while HW (aHR 0.85, 95% CI 0.77-0.94, p = 0.001) and API (aHR 0.66, 95% CI 0.56-0.77, p < 0.001) women had better OS. In subgroup analysis, similar findings were noted among those with RS < 26, while only API women were associated with improved OS among others with RS ≥ 26. CONCLUSION: To our knowledge, this is the largest study using nationwide oncology database to suggest that Black women were associated with higher RS, while HW and API women were not. It also suggested that Black women were associated with worse OS among those with RS < 26, while API women were associated with improved OS regardless of RS when compared to NHW women.

Cranial Base Measurements in Skeletal Malocclusion among Orthodontic Patients.

BACKGROUND: Facial growth and development is necessary for proper orthodontic diagnosis and treatment planning. Growth of cranial base is linked to the overall growth of facial bones, especially the maxilla and mandible. Any change in the amount and direction of growth of the cranial base can have direct or indirect effects on the developing maxilla and mandible. Thus the aim of this study was to determine the linear and angular cranial base measurements in different skeletal malocclusion in Nepalese population. METHODS: Pretreatment lateral cephalograms of 225 patients aged between 17-30 years were collected. Linear measurements Sella-Nasion (S-N), Sella-Articulare (S-Ar), Articulare-Gonion (Ar-Go), Gonion-Gnathion (Go-Gn) and angular measurements Saddle angle (N-S-Ar), Articular angle (S-Ar-Go) and Gonial angle (Ar-Go-Gn) were measured. RESULTS: In angular measurements statistically significant differences were found in the saddle and gonial angles between class I, II, and III skeletal pattern. In linear measurements, anterior and posterior cranial base lengths were not significantly different among groups however, ramal height and mandibular body length were significantly different among groups with a P value < 0.05. CONCLUSIONS: Skeletal class III has a larger gonial angle, ramal height and mandibular length. Males have larger linear measurements and females have larger angular measurements.

ASSESSMENT OF OSTEOPONTIN, SCLEROSTIN, AND OSTEOCALCIN LEVELS IN PATIENTS WITH HYPOTHYROIDISM ON MEDICAL THERAPY.

Thyroid hormones are critical regulators of bone maintenance in adulthood and play an important part in the development of bones. They also play a function in the formation of bones. Childhood hypothyroidism leads to delayed skeletal development, limited linear growth, and impaired bone mineral accumulation. This research aims to assess the serum concentration of sclerostin, osteocalcin, and osteopontin in women diagnosed with hypothyroidism. Additionally, it seeks to examine the impact of medical treatment on the levels of sclerostin, osteocalcin, and osteopontin in individuals with hypothyroidism. This research examined a total of 180 women, divided into three groups: 70 women before treatment, 70 women after treatment, and 40 control subjects. The age range of the participants was between 15 and 54 years. The participants in this research are categorized into three distinct groups: The first cohort consisted of 70 women diagnosed with hypothyroidism, as confirmed by medical professionals. The second group consisted of 70 women who had undergone treatment for hypothyroidism. The research included a control group consisting of healthy women with no family history of thyroid illness. These women were in good health and their ages were similar to those of the women with hypothyroidism. According to the presented data show a decrease in the mean of the serum level of sclerostin, and osteocalcin in hypothyroidism women before and after treatment compared with the control group (13.4±4.9 versus 19.8±5.1 and 21.5±5.0), (9.8±4.7 versus 14.35±12.63 and 15.20±14.73), respectively. The result was significant (p<0.01), with no differences in osteopontin levels between study groups. It was concluded that the sclerostin, and osteocalcin decreased in women with hypothyroidism before treatment in comparison with women after treatment and healthy women, while Furthermore no differences in Osteopontin levels between the three groups.

Co-designing a Health Journey Mapping resource for culturally safe health care with and for First Nations people.

Background Many healthcare professionals and services strive to improve cultural safety of care for Australia's First Nations people. However, they work within established systems and structures that do not reliably meet diverse health care needs nor reflect culturally safe paradigms. Journey mapping approaches can improve understanding of patient/client healthcare priorities and care delivery challenges from healthcare professionals' perspectives leading to improved responses that address discriminatory practices and institutional racism. This project aimed to review accessibility and usability of the existing Managing Two Worlds Together (MTWT) patient journey mapping tools and resources, and develop new Health Journey Mapping (HJM) tools and resources. Method Four repeated cycles of collaborative participatory action research were undertaken using repeated cycles of look and listen, think and discuss, take action together. A literature search and survey were conducted to review accessibility and usability of MTWT tools and resources. First Nations patients and families, and First Nations and non-First Nations researchers, hospital and university educators and healthcare professionals (end users), reviewed and tested HJM prototypes, shaping design, format and focus. Results The MTWT tool and resources have been used across multiple health care, research and education settings. However, many users experienced initial difficulty engaging with the tool and offered suggested improvements in design and usability. End user feedback on HJM prototypes identified the need for three distinct mapping tools for three different purposes: clinical care, detailed care planning and strategic mapping, to be accompanied by comprehensive resource materials, instructional guides, videos and case study examples. These were linked to continuous quality improvement and accreditation standards to enhance uptake in healthcare settings. Conclusion The new HJM tools and resources effectively map diverse journeys and assist recognition and application of strengths-based, holistic and culturally safe approaches to health care.

From code to care: Clinician and researcher perspectives on an optimal therapeutic web portal for acute myeloid leukemia.

BACKGROUND: Acute myeloid leukemia (AML), a rapidly progressing cancer of the blood and bone marrow, is the most common and fatal type of adult leukemia. Therapeutic web portals have great potential to facilitate AML research advances and improve health outcomes by increasing the availability of data, the speed and reach of new knowledge, and the communication between researchers and clinicians in the field. However, there is a need for stakeholder research regarding their optimal features, utility, and implementation. METHODS: To better understand stakeholder perspectives regarding an ideal pan-Canadian web portal for AML research, semi-structured qualitative interviews were conducted with 17 clinicians, researchers, and clinician-researchers. Interview guides were inspired by De Laat's "fictive scripting", a method where experts are presented with scenarios about a future technology and asked questions about its implementation. Content analysis relied on an iterative process using themes extracted from both existing scientific literature and the data. RESULTS: Participants described potential benefits of an AML therapeutic portal including facilitating data-sharing, communication, and collaboration, and enhancing clinical trial matchmaking for patients, potentially based on their specific genomic profiles. There was enthusiasm about researcher, clinician, and clinician-researcher access, but some disagreement about the nature of potential patient access to the portal. Interviewees also discussed two key elements they believed to be vital to the uptake and thus success of a therapeutic AML web portal: credibility and user friendliness. Finally, sustainability, security and privacy concerns were also documented. CONCLUSIONS: This research adds to existing calls for digital platforms for researchers and clinicians to supplement extant modes of communication to streamline research and its dissemination, advance precision medicine, and ultimately improve patient prognosis and care. Findings are applicable to therapeutic web portals more generally, particularly in genomic and translational medicine, and will be of interest to portal end-users, developers, researchers, and policymakers.