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Background: Traditional treatment approaches for prescription-type opioid use disorder (POUD), centered on abstinence, have limitations and hinder the development of interventions that meet the needs of people with POUD. Reduction in use without complete abstinence presents a promising avenue for intervention enhancement, but supporting data is scarce regarding its translation into positive patient outcomes. This study explores whether reducing opioid use frequency (OUF) during opioid agonist treatment correlates with reduced potential life problems in individuals with POUD, including those using fentanyl. Methods: This study is an exploratory analysis of the OPTIMA trial, a pragmatic, open-label, randomized controlled study comparing the effectiveness of flexible take-home dosing of buprenorphine/naloxone and supervised methadone in reducing opioid use amongst individuals with POUD. OUF was assessed every two weeks for 24 weeks after treatment initiation using the Timeline Followback. Potential life problems were evaluated at baseline and study completion using the Addiction Severity Index Self-Report. The 114 participants who completed both baseline and end-of-study questionnaires were included. A repeated-measures generalized linear mixed model (GLMM) was used to evaluate the influence of OUF on potential life problems. Results: Reducing OUF was significantly associated with fewer problems related to medical status (p = 0.049), psychiatric status (p = 0.019), and alcohol problem severity (p = 0.001). The interaction was non-significant for employment (p = 0.264), family status (p = 0.352) and legal status (p = 0.050). Life improvements emerged with ≤ 21 days of opioid use per 28-day period. Conclusion: Findings underscore the significance of harm reduction goals focusing on opioid use reduction, which translated in improvements across many life domains. Trial registration: Study was registered with ClinicalTrials.gov (NCT03033732) prior to participant enrollment. [ABSTRACT FROM AUTHOR]

Background: A key challenge for many critical care clinical trials is that some patients will die before their outcome is fully measured. This is referred to as "truncation due to death" and must be accounted for in both the treatment effect definition (i.e. the estimand), as well as the statistical analysis approach. It is unknown which analytic approaches to this challenge are most relevant to stakeholders. Methods: Using a modified Delphi process, we sought to identify critical attributes of analytic methods used to account for truncation due to death in critical care clinical trials. The Delphi panel included stakeholders with diverse professional or personal experience in critical care-focused clinical trials. The research team generated an initial list of attributes and associated definitions. The attribute list and definitions were refined through two Delphi rounds. Panelists ranked and scored attributes and provided open-ended rationales for responses. A consensus threshold was set as ≥ 70% of respondents rating an attribute as "Critical" (i.e., score ≥ 7 on a 9-point Likert scale) and ≤ 15% of respondents rating the measure as "Not Important" (i.e., a score of ≤ 3). Results: Thirty-one (91%) of 34 invited individuals participated in one or both rounds. The response rate was 82% in Round 1 and 85% in Round 2. Participants included eight (26%) personal experience experts and 26 (84%) professional experience experts. After two Delphi rounds, four attributes met the criteria for consensus: accuracy (the approach will identify effects if they exist, but will not if they do not), interpretability (the approach enables a straightforward interpretation of the intervention's effect), clinical relevance (the approach can directly inform patient care), and patient-centeredness (the approach is relevant to patients and/or their families). Attributes that did not meet the consensus threshold included sensitivity, comparability, familiarity, mechanistic plausibility, and statistical simplicity. Conclusions: We found that methods used to account for truncation due to death in the treatment effect definition and statistical approach in critical care trials should meet at least four defined criteria: accuracy, interpretability, clinical relevance, and patient-centeredness. Future work is needed to derive objective criteria to quantify how well existing estimands and analytic approaches encompass these attributes. [ABSTRACT FROM AUTHOR]

Objective: Patients with schizophrenia value improved life engagement, a term that describes positive health aspects across emotional, physical, social, and cognitive domains. This post hoc analysis of clinical trial data aimed to investigate the effect of brexpiprazole on patient life engagement in schizophrenia over the short and long term. Methods: Data were pooled from three 6-week, randomized, double-blind, placebo-controlled clinical trials (ClinicalTrials.gov identifiers: NCT01396421, NCT01393613, NCT01810380; N = 1385) and two 52-week, open-label extension studies (NCT01397786, NCT01810783; N = 408) of brexpiprazole in adults with schizophrenia. Patient life engagement was measured using a subset of 14 Positive and Negative Syndrome Scale items (score range: 14 [best] to 98 [worst]) that has previously demonstrated content validity. Mean score changes and response rates (based on minimal clinically important difference estimates of ≥5 and ≥10 points) were calculated. Results: Greater improvement in patient life engagement from baseline to Week 6 was observed for brexpiprazole 2–4 mg/day (least squares mean [standard error] change: −8.3 [0.3]; n = 868) versus placebo (−5.7 [0.4]; n = 517), with a least squares mean difference of −2.58 (95% confidence interval: −3.57 to −1.58; p < 0.001; Cohen's d effect size: 0.28). These improvements were maintained over 58 weeks on brexpiprazole 1–4 mg/day (n = 399). At Week 6, response rates among patients treated with brexpiprazole versus placebo were 71.6% versus 58.0% (≥5-point improvement; p < 0.001) and 43.5% versus 32.8% (≥10-point improvement; p < 0.001). At Week 58 (n = 179), response rates among patients treated with brexpiprazole were 90.5% (≥5-point improvement) and 78.2% (≥10-point improvement). Conclusion: Beyond its efficacy on psychotic symptoms, brexpiprazole has the potential to improve patient life engagement – an important patient-centered outcome in schizophrenia. PLAIN LANGUAGE SUMMARY: Schizophrenia is a serious mental disorder in which people may hear, see, or believe things that do not exist. Most people with schizophrenia hope to become more engaged with life, as well as to improve their schizophrenia symptoms. Being engaged with life means feeling happy and hopeful, having energy and motivation, being interested and involved in activities, and being alert and thinking clearly. This study investigated if brexpiprazole, a medicine for schizophrenia and some other medical conditions, can help to improve patients' engagement with life. The researchers looked at data from over a thousand people with schizophrenia across five previously completed clinical trials. To measure 'patient life engagement', the researchers used data from a questionnaire filled in by doctors during their meetings with the patients. The results showed that, on average, people taking brexpiprazole (rather than a 'placebo' tablet) became more engaged with life over the first 6 weeks of treatment. For some people who kept taking brexpiprazole, these improvements lasted for over a year. This means that brexpiprazole may help people with schizophrenia to become more engaged with life, as well as improving their schizophrenia symptoms. [ABSTRACT FROM AUTHOR]

Leslie Citrome,1 Mark Suett,2 Kelli R Franzenburg,3 Roy Eshet,4 Anna Elgart,4 Glen L Davis 3rd,5 Eran Harary,4 Orna Tohami,4 Marko A Mychaskiw,6 John M Kane7– 9 1Department of Psychiatry and Behavioral Sciences, New York Medical College, Valhalla, NY, USA; 2Global Medical Affairs, Teva UK Limited, Harlow, UK; 3Global Medical Affairs, Teva Branded Pharmaceutical Products R&D, Inc., West Chester, PA, USA; 4Innovative Medicines, Global Clinical Development, Teva Pharmaceutical Industries Ltd, Netanya, Israel; 5Global Clinical Operations, Teva Branded Pharmaceutical Products R&D, Inc., West Chester, PA, USA; 6Global Health Economics and Outcomes Research, Teva Branded Pharmaceutical Products R&D, Inc, West Chester, PA, USA; 7Department of Psychiatry, The Zucker Hillside Hospital, Northwell Health, Glen Oaks, NY, USA; 8Department of Psychiatry and Molecular Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY, USA; 9Institute of Behavioral Science, Feinstein Institutes for Medical Research, Manhasset, NY, USACorrespondence: Leslie Citrome, Department of Psychiatry and Behavioral Sciences, New York Medical College, 40 Sunshine Cottage Road, Valhalla, NY, 10595, USA, Email nntman@gmail.comBackground: TV46000 is a long-acting subcutaneous antipsychotic (LASCA) formulation of risperidone approved for the treatment of schizophrenia in adults.Methods: The RISE study (NCT03503318) compared TV-46000 once monthly (q1m) and once every 2 months (q2m) with placebo (1:1:1) in patients with schizophrenia who underwent stabilization on oral risperidone. The SHINE study (NCT03893825) evaluated the long-term safety, tolerability, and effectiveness of TV-46000 in patients who completed RISE without relapse (rollover; placebo rollover randomized [1:1] to q1m or q2m; TV-46000 rollover continued assigned treatment) or who were newly recruited (de novo; randomized [1:1] to q1m or q2m after oral stabilization). Patient-centered outcomes included the Schizophrenia Quality of Life Scale (SQLS), the 5-Level EuroQoL 5-Dimensions Questionnaire (EQ-5D-5L), the Personal and Social Performance Scale (PSP), and the Drug Attitudes Inventory 10-item version (DAI-10).Results: In RISE, SQLS least-squares mean changes (SE) improved to last assessment (LA) for TV-46000 q1m (– 4.15 [1.03]) and q2m (– 3.28 [1.06]) but worsened for placebo (1.75 [1.07]; P< 0.001 for both). PSP, EQ5D-5L, and DAI-10 showed similar trends. In SHINE, SQLS decreased (improved) at LA for both TV-46000 q1m (− 0.43 [0.98]) and q2m (− 2.16 [0.98]); reductions were observed in the de novo (q2m only) and placebo rollover (q1m and q2m) cohorts, but not for the TV46000 rollover cohort. Results for PSP, EQ5D-5L, and DAI-10 were consistent with those reported in the RISE study.Conclusion: Improvements in patient-centered outcomes were observed across cohorts, with the largest improvements observed for patients who began TV-46000 during SHINE (ie, de novo and placebo rollover cohorts), while gains made during RISE were minimally improved or maintained in the TV-46000 rollover cohort, indicating the benefit of uninterrupted TV-46000 treatment. These data support the effectiveness of TV-46000 to improve patient-centered outcomes in patients with schizophrenia.Plain Language Summary: RISE and SHINE were clinical studies where patients with schizophrenia received TV-46000. TV-46000 is injected under the skin once monthly or once every 2 months to treat schizophrenia in adults. In RISE, patients took pills for the first 3 months, and then received injections under the skin. Some patients received inactive (placebo) injections. Comparing results among groups showed the effectiveness and side effects of TV-46000. Patients who completed RISE could continue into SHINE. SHINE included patients who had not been part of RISE as well. All patients received TV-46000 in SHINE to see if results were the same long term. This report summarizes the results of patient-centered outcomes. These included measures of quality of life and attitudes toward the medicine. In RISE, quality of life and attitudes toward the medicine improved with TV-46000, but worsened with placebo. In SHINE, the patient-centered outcomes also improved. The largest improvements were for patients who began taking TV-46000 during SHINE. This analysis showed that there is a benefit in taking TV-46000 for longer times without breaks. It also showed that TV-46000 improves quality of life and attitudes toward the medicine.Keywords: schizophrenia, long-acting injectable, risperidone, patient-centered outcomes

Abstract Background Hip fracture surgery under general or spinal anesthesia is a common procedure for older adults in the United States (US). Although spinal or general anesthesia can be appropriate for many patients, and the choice between anesthesia types is preference-sensitive, shared decision-making is not consistently used by anesthesiologists counseling patients on anesthesia for this procedure. We designed an Option Grid™-style conversation aid, My Anesthesia Choice─Hip Fracture, to promote shared decision making in this interaction. This study will refine the aid and evaluate its implementation and effectiveness in clinical practice. Methods The study will be conducted over 2 phases: qualitative interviews with relevant clinicians and patients to refine the aid, followed by a stepped wedge cluster randomized trial of the intervention at 6 settings in the US. Primary outcomes will include the percentage of eligible patients who receive the intervention (intervention reach) and the change in quality of patient/clinician communication (intervention effectiveness). Secondary outcomes addressing other RE-AIM (reach, effectiveness, adoption, implementation, and maintenance) domains will also be collected. Outcomes will be compared between baseline data and an active implementation period and then compared between the active implementation period and a sustainment period. Implementation strategies are guided by three constructs from the Practical, Robust Implementation and Sustainability Model (PRISM): intervention, recipients, and implementation and sustainability infrastructure. Discussion This is a novel, large-scale trial evaluating and implementing a shared decision-making conversation aid for anesthesia choices. Strong buy-in from site leads and expert advisors will support both the success of implementation and the future dissemination of results and the intervention. Results from this study will inform the broader implementation of this aid for patients with hip fractures and can lead to the development and implementation of similar conversation aids for other anesthesia choices. Trial registration ClinicalTrials.gov, NCT06438640

Rationale: Individuals with chronic obstructive pulmonary disease (COPD) have airflow obstruction and maldistribution of ventilation. For those living at high altitude, any gas exchange abnormality is compounded by reduced partial pressures of inspired oxygen. Objectives: Does residence at higher altitude exposure affect COPD outcomes, including lung function, imaging characteristics, symptoms, health status, functional exercise capacity, exacerbations, and mortality? Methods: From the SPIROMICS (Subpopulation and Intermediate Outcome Measures in COPD Study) cohort, we identified individuals with COPD living below 1,000 ft (305 m) elevation (n = 1,367) versus above 4,000 ft (1,219 m) elevation (n = 288). Multivariable regression models were used to evaluate associations of exposure to high altitude with COPD-related outcomes. Measurements and Main Results: Living at higher altitude was associated with reduced functional exercise capacity as defined by 6-minute-walk distance (−32.3 m [95% confidence interval, −49.8 to −14.8 m]). There were no differences in patient-reported outcomes as defined by symptoms (COPD Assessment Test and modified Medical Research Council dyspnea scale), or health status (St. George's Respiratory Questionnaire). Higher altitude was not associated with a different rate of FEV1 decline. Higher altitude was associated with lower odds of severe exacerbations (incidence rate ratio, 0.65 [95% confidence interval, 0.46 to 0.90]). There were no differences in small airway disease, air trapping, or emphysema. In longitudinal analyses, higher altitude was associated with increased mortality (hazard ratio, 1.25 [95% confidence interval, 1.0 to 1.55]); however, this association was no longer significant when accounting for air pollution. Conclusions: Long-term altitude exposure is associated with reduced functional exercise capacity in individuals with COPD, but this did not translate into differences in symptoms or health status. In addition, long-term high-altitude exposure did not affect progression of disease as defined by longitudinal changes in spirometry. Clinical trial registered with (NCT 01969344). [ABSTRACT FROM AUTHOR]

Background/Objectives: Inpatient exercise-based rehabilitation has been shown to improve health-related quality of life (HRQOL) in cancer survivors. However, there is a lack of studies on the impact of community-based cancer rehabilitation programs on health-related quality of life, especially in Asian countries. Methods: This was a retrospective cohort study involving patients with cancer at an outpatient community-based rehabilitation center. There were 197 patients who were recruited and enrolled in a physician-led rehabilitation program which included physiotherapists, occupational therapists, nutritionists and exercise physiologists. Results: Most of the patients had a diagnosis of breast cancer (61.4%), while 76 (38.6%) had a diagnosis of other cancers. On initial assessment, we found a mean Distress Thermometer (DT) level of 3.37 (SD = 2.41) and a mean Functional Assessment of Cancer Therapy-General-7 Item Version (FACT-G7) score of 11.83 (SD = 4.01). On follow-up assessment after 3–6 months of rehabilitation, there was a significant reduction in mean DT level to 2.42 (SD = 2.25) and an improvement in mean FACT-G7 score to 13.09 (SD = 4.77). Multivariate regression analysis revealed that significant factors for improvement in FACT-G7 scores were age (p = 0.046) and number of exercise therapy sessions (p < 0.001). Conclusions: This study demonstrates the positive impact of a community-based cancer rehabilitation program on HRQOL among cancer patients. [ABSTRACT FROM AUTHOR]

A gummy smile is the visualization of more than 3 mm of gingiva above the maxillary incisors. This study aimed to evaluate the long-term effects on aesthetics and patient satisfaction of a new hyaluronic acid infiltration technique in reducing the gummy smile. Fifty patients with gummy smiles were treated using hyaluronic acid infiltration points by applying 0.1 mL per injection at specific points. Post-treatment evaluations were performed one week, one month, three months, six months, and 12 months later. A questionnaire assessed patient satisfaction, willingness to recommend the treatment, and side effects (pain and bruising during and after treatment). An average reduction of 2.5 mm in gingival exposure during smiling was observed. After one week, the reduction was constant. At six months, 40% of the original gingival exposure was recovered, and recovery was complete at 12 months. Patient satisfaction was 82.1%, and 100% of patients would recommend the treatment. Bruising, swelling, and pain decreased to 0% from the first month. In conclusion, this technique is a safe and effective option to improve the smile's appearance with minimal complications. [ABSTRACT FROM AUTHOR]

Background: Hip fracture surgery under general or spinal anesthesia is a common procedure for older adults in the United States (US). Although spinal or general anesthesia can be appropriate for many patients, and the choice between anesthesia types is preference-sensitive, shared decision-making is not consistently used by anesthesiologists counseling patients on anesthesia for this procedure. We designed an Option Grid™-style conversation aid, My Anesthesia Choice─Hip Fracture, to promote shared decision making in this interaction. This study will refine the aid and evaluate its implementation and effectiveness in clinical practice. Methods: The study will be conducted over 2 phases: qualitative interviews with relevant clinicians and patients to refine the aid, followed by a stepped wedge cluster randomized trial of the intervention at 6 settings in the US. Primary outcomes will include the percentage of eligible patients who receive the intervention (intervention reach) and the change in quality of patient/clinician communication (intervention effectiveness). Secondary outcomes addressing other RE-AIM (reach, effectiveness, adoption, implementation, and maintenance) domains will also be collected. Outcomes will be compared between baseline data and an active implementation period and then compared between the active implementation period and a sustainment period. Implementation strategies are guided by three constructs from the Practical, Robust Implementation and Sustainability Model (PRISM): intervention, recipients, and implementation and sustainability infrastructure. Discussion: This is a novel, large-scale trial evaluating and implementing a shared decision-making conversation aid for anesthesia choices. Strong buy-in from site leads and expert advisors will support both the success of implementation and the future dissemination of results and the intervention. Results from this study will inform the broader implementation of this aid for patients with hip fractures and can lead to the development and implementation of similar conversation aids for other anesthesia choices. Trial registration: ClinicalTrials.gov, NCT06438640 [ABSTRACT FROM AUTHOR]

AbstractThis article aims to summarize the existing evidence on shared decision-making and collaborative care models for acute and chronic pain management. We searched the PubMed database for articles published between 1980 and 2023 and scanned included articles’ references to identify additional sources. Two reviewers independently screened titles and abstracts. Studies met inclusion criteria if they implemented or evaluated shared decision-making or collaborative care interventions in patients with acute or chronic pain. A total of 690 articles were reviewed, with 32 full text articles meeting inclusion criteria. Most studies assessed changes in prescription opioid quantities and patient-reported pain levels. Secondary measures generally included patient satisfaction, 30-day refill rate, and use of non-opioid analgesics. Shared decision-making and collaborative care models are promising interventions to improve pain management. These interventions are effective at reducing opioid consumption among acute and chronic pain patients without compromising patient-reported pain levels. There is further research needed to evaluate how shared decision-making and collaborative care interventions impact patient-centered outcomes such as patient satisfaction, quality of life, and patient-provider communication. [ABSTRACT FROM AUTHOR]

PurposeFollowing curative-intent therapy of lung cancer, many survivors experience dyspnea and physical inactivity. We investigated the feasibility, acceptability, safety, and potential efficacy of inspiratory muscle training (IMT) and walking promotion to disrupt a postulated "dyspnea-inactivity" spiral.MethodsBetween January and December 2022, we recruited lung cancer survivors from Kaiser Permanente Colorado who completed curative-intent therapy within 1-6 months into a phase-IIb, parallel-group, pilot randomized trial (1:1 allocation). The 12-week intervention, delivered via telemedicine, consisted of exercise training (IMT + walking), education, and behavior change support. Control participants received educational materials on general exercise. We determined feasibility a priori: enrollment of ≥ 20% eligible patients, ≥ 75% retention, study measure completion, and adherence. We assessed acceptability using the Telemedicine-Satisfaction-and-Usefulness-Questionnaire and safety events that included emergency department visits or hospitalizations. Patient-centered outcome measures (PCOMs) included dyspnea (University-of-California-San-Diego-Shortness-of-Breath-Questionnaire), physical activity (activPAL™ steps/day), functional exercise capacity (mobile-based-six-minute-walk-test), and health-related quality of life (HRQL, St.-George's-Respiratory-Questionnaire). We used linear mixed-effects models to assess potential efficacy.ResultsWe screened 751 patients, identified 124 eligible, and consented 31 (25%) participants. Among 28 participants randomized (14/group), 22 (11/group) completed the study (79% retention). Intervention participants returned > 90% of self-reported activity logs, completed > 90% of PCOMs, and attended > 90% of tele-visits; 75% of participants performed IMT at the recommended dose. Participants had high satisfaction with tele-visits and found the intervention useful. There was no statistically significant difference in safety events between groups. Compared to control participants from baseline to follow-up, intervention participants had statistically significant and clinically meaningful improved HRQL (SGRQ total, symptom, and impact scores) (standardized effect size: -1.03 to -1.30).ConclusionsAmong lung cancer survivors following curative-intent therapy, telemedicine-based IMT + walking was feasible, acceptable, safe, and had potential to disrupt the "dyspnea-inactivity" spiral. Future efficacy/effectiveness trials are warranted and should incorporate IMT and walking promotion to improve HRQL.Trial registrationClinicalTrials.gov NCT05059132.

Background and aimSubcutaneous immunoglobulin (SCIg) has emerged as an alternative to intravenous administration for patients with primary (PID) and secondary immunodeficiencies (SID), offering benefits such as fewer systemic adverse reactions and greater patient autonomy. However, comprehensive real-world data on SCIg use, including clinical and patient-centered outcomes, remain scarce. This study, conducted by expert immunodeficiency nursing teams, assesses the clinical characteristics, reported adverse effects, and quality-of-life outcomes associated with SCIg therapy with different formulations in patients with PID and SID across Spain.MethodsA multicenter, cross-sectional study was conducted across 8 immunodeficiency nursing units in Spain, involving 223 adult patients treated with SCIg from 2004 to 2024. Data on demographics, comorbidities, SCIg treatment characteristics, reported adverse events, and quality-of-life metrics (EuroQol-5D-3L, Gijón Scale) were collected and analyzed.ResultsThe cohort (61.4% female, mean age: 47.1 years) included 65% PID patients, with common variable immunodeficiency being the most frequent diagnosis (39.8%). SCIg demonstrated good tolerability overall, with no significant differences in global adverse event rates between facilitated 10% (fSCIg) and 20% formulations. However, 10% fSCIg was associated with higher reported frequencies of mild local rash (58.7% vs. 36.9%, p=0.002) and fever (10.6% vs. 1.7%, p=0.01). Quality-of-life scores indicated minimal limitations in mobility and self-care, with a mean subjective health rating of 72.7/100. Patients using 20% SCIg required fewer educational sessions for self-administration compared to the 10% group.ConclusionThe different SCIg formulations in this large, multicenter cohort was effective and generally well-tolerated, supporting its use for maintaining adequate IgG levels and promoting patient independence in PID and SID. The study’s findings advocate for tailored approaches that optimize patient satisfaction and address individual needs, emphasizing the critical role of dedicated immunodeficiency nursing teams in ensuring safe, effective, and patient-centered SCIg administration.

Background Transcatheter edge‐to‐edge repair of the mitral valve (mTEER) reduced a hierarchical end point that included death and heart failure hospitalization in COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation Trial). However, the magnitude to which mTEER increases the number of days a patient spends at home (DAH) in the first few years after treatment, a patient‐centered end point not captured routinely in clinical trials, has not been evaluated. We compared 1‐ and 2‐year DAH among patients with functional mitral regurgitation and heart failure randomized to mTEER plus medical therapy versus medical therapy alone (control) by linking the COAPT trial to comprehensive health care claims data. Methods and Results We linked data from COAPT trial participants to Medicare fee‐for‐service claims. DAH was calculated as the number of days alive and spent outside a hospital, skilled nursing facility, inpatient rehabilitation, long‐term acute care hospital, emergency department, or observation stay after randomization. Treatment groups were compared using quantile regression to calculate the area under the curve of cumulative distribution functions. We linked 271 patients (mTEER 136/302, control 135/312) for a 2‐year follow‐up. Mean±SD DAH at 1 year was 312.0±95.6 in mTEER and 298.1±107.5 in controls with similar area under the curve (difference 13.9 days [−10.5 to 38.3], P=0.26). DAH at 2 years was 577.2±235.6 in mTEER and 518.2±253.0 in control with a higher area under the curve in mTEER (difference 59.0 days [0.07 to 117.9], P=0.0497). Conclusions In the COAPT trial linked to Medicare claims, patients randomized to mTEER spent a similar number of DAH at 1 year but more time at home at 2 years compared with medical therapy alone.

Purpose: To evaluate the safety and performance of a potential novel strategy to resolve the above scenario by simultaneously performing implant-related surgery and endodontic microsurgery (EMS). Materials and Methods: A total of 25 subjects requiring GBR during implant placement in anterior areas were allocated into two groups. In the experimental group (adjacent teeth with periapical lesions) with 10 subjects, implantation and GBR were performed for edentulous areas with simultaneous EMS for adjacent teeth. In the control group (adjacent teeth without periapical lesions) with 15 subjects, implantation and GBR were performed for edentulous areas. The clinical outcomes, radiographic bone remodeling, and patient-reported outcomes were assessed. Results: Within a 1-year follow-up, the implant survival rate was 100% in both groups, with no significant difference regarding complications. All teeth achieved complete healing following EMS. Repeated analysis of variance (ANOVA) measurements revealed a significant change over time in horizontal bone widths and postoperative patient-reported outcomes, but no intergroup statistically significant differences (P > .05) in horizontal bone widths and visual analog scale scores of pain, swelling, and bleeding were observed. Likewise, the bone volumetric decrease (7.4% ± 4.5% in the experimental group and 7.1% ± 5.2% in the control group) from T1 (suture removal) to T2 (6 months after implantation) revealed no intergroup differences. The horizontal bone width gain at the implant platform was slightly lower in the experimental group (P < .05). Interestingly, the color-coded figures of both groups showed a facial reduction of grafted material in edentulous areas. However, the apical regions following EMS exhibited stable bone remodeling in the experimental group. Conclusion: This novel approach to address the problem involving implant-related surgery close to the periapical lesion of adjacent teeth appeared safe and reliable (no.: ChiCTR2000041153). [ABSTRACT FROM AUTHOR]

INTRODUCTION AND HYPOTHESIS: In randomized trials both percutaneous tibial nerve stimulation (PTNS) and sham result in clinically significant improvements in accidental bowel leakage (ABL). We aimed to identify subgroups who may preferentially benefit from PTNS in women enrolled in a multicenter randomized trial. METHODS: This planned secondary analysis explored factors associated with success for PTNS vs sham using various definitions: treatment responder using three cutoff points for St. Marks score (≥3-, ≥4-, and ≥5-point reduction); Patient Global Impression of Improvement (PGI-I) of ≥ much better; and ≥50% reduction in fecal incontinence episodes (FIEs). Backward logistic regression models were generated using elements with significance of p

Abstract Introduction The aging population is a challenge for the healthcare system that must identify strategies that meet their needs. Practicing patient-centered care has been shown beneficial for this patient-group. The effect of patient-centered care is called patient-centered outcomes and can be appraised using outcomes measurements. Objectives The main aim was to review and map existing knowledge related to patient-centered outcomes and patient-centered outcomes measurements for older people, as well as identify key-concepts and knowledge-gaps. The research questions were: How can patient-centered outcomes for older people be measured, and which patient-centered outcomes matters the most for the older people? Study design Scoping review. Methods Search for relevant publications in electronical databases, grey literature databases and websites from year 2000 to 2021. Two reviewers independently screened titles and abstracts, followed by full text review and extraction of data using a data extraction framework. Results Eighteen studies were included, of which six with involvement of patients and/or experts in the process on determine the outcomes. Outcomes that matter the most to older people was interpreted as: access to- and experience of care, autonomy and control, cognition, daily living, emotional health, falls, general health, medications, overall survival, pain, participation in decision making, physical function, physical health, place of death, social role function, symptom burden, and time spent in hospital. The most frequently mentioned/used outcomes measurements tools were the Adult Social Care Outcomes Toolkit (ASCOT), EQ-5D, Gait Speed, Katz- ADL index, Patient Health Questionnaire (PHQ9), SF/RAND-36 and 4-Item Screening Zarit Burden Interview. Conclusions Few studies have investigated the older people’s opinion of what matters the most to them, which forms a knowledge-gap in the field. Future research should focus on providing older people a stronger voice in what they think matters the most to them.

Background Various studies across different settings have validated Days Alive and Out of Hospital (DAOH) as a valuable outcome for clinical research in surgery and other fields. However, there is no clear consensus on the definitions and methods used to handle and report DAOH in perioperative care studies. Objective We aim to identify, describe, and summarize the available research on DAOH to understand how it is being conceptualized and utilized in clinical studies on perioperative care. Methods We will conduct a scoping review to analyze and synthesize the existing studies using DAOH to measure clinical results on perioperative care. We will search MEDLINE, Embase, Web of Science, ClinicalTrials.gov and CENTRAL. Screening, eligibility, inclusion and data extraction processes will be performed by two reviewers, with a third reviewer solving disagreements. We will present our results descriptively. Conclusions We expect to provide a comprehensive overview of how DAOH is conceptualized and utilized in clinical studies on perioperative care, with particular attention to methodological approaches and the role of electronic health-care records (EHRs) among the different regions.

Introduction: Assessing the quality of life (QOL) has gained significant importance in modern times. Dental researchers are now focusing not only on treating patients' dental issues but also on examining how treatments affect their QOL. Following scaling and root planning (SRP), patient-centered outcomes such as bleeding gums, functionality, appearance of teeth and gums, tooth sensitivity, and bad breath are rarely evaluated from the patient's viewpoint. Therefore, it is crucial to assess patient-based outcomes after SRP, as these directly impact the patients' QOL. Materials and Methods: A questionnaire study was carried out in the department of periodontology. After fulfilling the inclusion and exclusion criteria, the participants were divided into two groups who were evaluated by self-designed questionnaire. Participants were given the questionnaire consisting of 14 questions to be filled by the patients, 1 week after SRP and data from the filled questionnaire were subjected for statistical analysis. Results: The findings revealed a statistically significant difference among the groups in hypersensitivity after 7 days. However, there was no significant relevance detected in pain, anxiety, or food lodgment during the same time frame. In addition, 100% of patients from both the groups strongly affirmed experiencing confident smile posttreatment. Conclusion: SRP done by the dentists in patients with gingivitis and periodontitis showed a positive impact on QOL. The questionnaire serves as an objective tool for assessing QOL and concluded that sensitivity of teeth after SRP is an important aspect to be considered by the dentists. [ABSTRACT FROM AUTHOR]

Background: Dental implants are a widely accepted method for replacing missing teeth, but the timing of implant placement--whether immediate (at the time of tooth extraction) or delayed (after a healing period)--remains a debated topic. Immediate implant placement is believed to preserve alveolar bone and soft tissue contours, potentially improving aesthetic outcomes. However, concerns persist about increased postoperative pain and complications. Delayed implants, on the other hand, are considered more predictable in terms of osseointegration, but they require longer treatment times and multiple surgical interventions. This study aimed to compare patient-centered outcomes, including pain, aesthetic satisfaction, quality of life, implant stability, and bone loss, between immediate and delayed implant placement. Objectives: This randomized controlled trial sought to evaluate and compare the patient-centered outcomes of immediate versus delayed implant placement in terms of pain, aesthetics, quality of life, implant stability, and peri-implant bone loss. Materials and Methods: A total of 60 patients requiring single-tooth implants in the anterior or premolar region were randomly allocated to either the immediate implant placement group (n=30) or the delayed implant placement group (n=30). Two patients were lost to follow-up, resulting in 58 participants. Pain levels were assessed using a Visual Analog Scale (VAS), aesthetic satisfaction using the Pink Esthetic Score (PES), and quality of life using the Oral Health Impact Profile (OHIP-14). Implant stability was evaluated using resonance frequency analysis (RFA), and peri-implant bone loss was measured radiographically at six months. Data were analyzed using SPSS 25.0 version Results: Patients in the immediate implant group experienced significantly higher pain on the first postoperative day (VAS score = 5.8 ± 1.4) compared to the delayed group (VAS score = 4.1 ± 1.2, p = 0.002), but pain levels equalized by day seven. The immediate implant group had significantly higher aesthetic satisfaction at six months (PES = 10.6 ± 1.1) compared to the delayed group (PES = 9.3 ± 1.5, p = 0.01). Quality of life scores were also better in the immediate group (OHIP-14 score = 5.1 ± 2.8) compared to the delayed group (OHIP-14 score = 7.2 ± 3.0, p = 0.03). Both groups demonstrated comparable implant stability and minimal peri-implant bone loss at six months (p > 0.05), with no implant failures, resulting in a 100% survival rate. Conclusions: Immediate implant placement provided superior aesthetic outcomes and enhanced quality of life compared to delayed placement, although it was associated with higher early postoperative pain. Both approaches achieved high implant stability, minimal bone loss, and excellent implant survival. Immediate implant placement may be preferred when aesthetics and rapid restoration are priorities. [ABSTRACT FROM AUTHOR]

Sensor-based digital health technology (DHT) has emerged as a promising means to assess patient functioning within and outside clinical trials. Sensor-based functional outcomes (SBFOs) provide valuable insights that complement other measures of how a patient feels or functions to enhance understanding of the patient experience to inform medical product development. This perspective paper provides recommendations for defining SBFOs, discusses the core evidence required to support SBFOs to inform decision-making, and considers future directions for the field. The clinical outcome assessment (COA) development process provides an important starting point for developing patient-centered SBFOs; however, given the infancy of the field, SBFO development may benefit from a hybrid approach to evidence generation by merging exploratory data analysis with patient engagement in measure development. Effective SBFO development requires combining unique expertise in patient engagement, measurement and regulatory science, and digital health and analytics. Challenges specific to SBFO development include identifying concepts of interest, ensuring measurement of meaningful aspects of health, and identifying thresholds for meaningful change. SBFOs are complementary to other COAs and, as part of an integrated evidence strategy, offer great promise in fostering a holistic understanding of patient experience and treatment benefits, particularly in real-world settings. [ABSTRACT FROM AUTHOR]

Introduction: The aging population is a challenge for the healthcare system that must identify strategies that meet their needs. Practicing patient-centered care has been shown beneficial for this patient-group. The effect of patient-centered care is called patient-centered outcomes and can be appraised using outcomes measurements. Objectives: The main aim was to review and map existing knowledge related to patient-centered outcomes and patient-centered outcomes measurements for older people, as well as identify key-concepts and knowledge-gaps. The research questions were: How can patient-centered outcomes for older people be measured, and which patient-centered outcomes matters the most for the older people? Study design: Scoping review. Methods: Search for relevant publications in electronical databases, grey literature databases and websites from year 2000 to 2021. Two reviewers independently screened titles and abstracts, followed by full text review and extraction of data using a data extraction framework. Results: Eighteen studies were included, of which six with involvement of patients and/or experts in the process on determine the outcomes. Outcomes that matter the most to older people was interpreted as: access to- and experience of care, autonomy and control, cognition, daily living, emotional health, falls, general health, medications, overall survival, pain, participation in decision making, physical function, physical health, place of death, social role function, symptom burden, and time spent in hospital. The most frequently mentioned/used outcomes measurements tools were the Adult Social Care Outcomes Toolkit (ASCOT), EQ-5D, Gait Speed, Katz- ADL index, Patient Health Questionnaire (PHQ9), SF/RAND-36 and 4-Item Screening Zarit Burden Interview. Conclusions: Few studies have investigated the older people's opinion of what matters the most to them, which forms a knowledge-gap in the field. Future research should focus on providing older people a stronger voice in what they think matters the most to them. [ABSTRACT FROM AUTHOR]

Rationale: Hospital-free days (HFDs), a measure of the number of days alive spent outside the hospital, is increasingly used as an endpoint in studies of patients with acute respiratory failure (ARF) or other critical and serious illnesses. Current approaches to measuring HFDs do not account for decrements in functional status or quality of life that ARF survivors and family members value. Objectives: To develop an acceptable approach to measure quality-weighted HFDs using patient-reported outcomes. Methods: We conducted a four-round modified Delphi process among ARF experts: those with lived or professional experience. Experts rated survivorship domains, instrument and data collection characteristics, and methods to translate responses into quality-weighted HFDs. The consensus threshold was that ⩾70% of respondents rated an item "totally acceptable" or "acceptable" and ⩽15% of respondents rated the item "totally unacceptable," "unacceptable," or "slightly unacceptable." Results: Fifty-seven experts participated in round 1. Response rates were 82–93% for subsequent rounds. Priority survivorship domains were physical function and health-related quality of life. Participants reached a consensus that data collection during ARF recovery should take less than 15 minutes per assessment, allow surrogate completion when patients are unable, and continue for at least 24 months of follow-up. Using the EuroQol-5 Dimensions (EQ-5D) questionnaire to quality weight HFDs met consensus criteria for acceptability. A majority of panelists preferred quality-weighted HFDs to unweighted HFDs or survival for use in future ARF studies. Conclusions: Quality-weighting HFDs using patient and/or surrogate responses to the EQ-5D captured stakeholder priorities and was acceptable to this Delphi panel. [ABSTRACT FROM AUTHOR]

Since their release, the medical community has been actively exploring large language models' (LLMs) capabilities, which show promise in providing accurate medical knowledge. One potential application is as a patient resource. This study analyzes and compares the ability of the currently available LLMs, ChatGPT-3.5, GPT-4, and Gemini, to provide postoperative care recommendations to plastic surgery patients. We presented each model with 32 questions addressing common patient concerns after surgical cosmetic procedures and evaluated the medical accuracy, readability, understandability, and actionability of the models' responses. The three LLMs provided equally accurate information, with GPT-3.5 averaging the highest on the Likert scale (LS) (4.18 ± 0.93) (p = 0.849), while Gemini provided significantly more readable (p = 0.001) and understandable responses (p = 0.014; p = 0.001). There was no difference in the actionability of the models' responses (p = 0.830). Although LLMs have shown their potential as adjunctive tools in postoperative patient care, further refinement and research are imperative to enable their evolution into comprehensive standalone resources. [ABSTRACT FROM AUTHOR]

BackgroundApplied behavior analysis (ABA) is an evidence-based approach to autism spectrum disorder that has been shown in clinical trials to improve child functional status. There is substantial focus in ABA on setting and tracking individualized goals that are patient-centered, but limited research on how to measure progress on such patient-centered outcomes.PurposeThe purpose of this investigation was to assess concordance between patient-centered and standard outcome measures of treatment progress in a real-world clinical sample of children receiving ABA for autism spectrum disorder.MethodsThis observational study used a clinical sample of children ages 3 to 16 years (N = 154) who received 24 months of ABA from an integrated health system. Concordance between three outcome measures after ABA was assessed using a correlation matrix: (1) patient-centered measures of progress on individualized treatment goals, (2) caregiver-centered measure of progress on treatment participation goals, and (3) the Vineland Adaptive Behavior Scales adaptive behavior composite.ResultsThere was limited concordance among measures at both 12 and 24 months of ABA. None of the patient-centered measures showed significant positive correlation with adaptive behavior composite difference scores at either 12 or 24 months, nor did the caregiver measure. The percentage of children achieving clinically meaningful gain on patient-centered goal measures increased between 12 and 24 months of ABA, while the percentage of children achieving clinically meaningful gains in adaptive behavior declined during the same time period.ConclusionsIn a health system implementation of ABA, there was limited concordance between patient-centered and standard measures of clinically meaningful treatment progress for children with ASD. Clinicians should have ongoing dialogue with patients and parents/caregivers to ensure that interventions for ASD are resulting in progress towards outcomes that are meaningful to patients and families.

Abstract Background Patients often desire involvement in anesthesia decisions, yet clinicians rarely explain anesthesia options or elicit preferences. We developed My Anesthesia Choice-Hip Fracture, a conversation aid about anesthesia options for hip fracture surgery and tested its preliminary efficacy and acceptability. Methods We developed a 1-page, tabular format, plain-language conversation aid with feedback from anesthesiologists, decision scientists, and community advisors. We conducted an online survey of English-speaking adults aged 50 and older. Participants imagined choosing between spinal and general anesthesia for hip fracture surgery. Before and after viewing the aid, participants answered a series of questions regarding key outcomes, including decisional conflict, knowledge about anesthesia options, and acceptability of the aid. Results Of 364/409 valid respondents, mean age was 64 (SD 8.9) and 59% were female. The proportion indicating decisional conflict decreased after reviewing the aid (63–34%, P

Background: Immediate post-extraction dental implants are increasingly popular, but ensuring primary stability and managing peri-implant tissues remain challenging. Implant macro-design significantly impacts stability and osseointegration. This study used Cone-beam Computed Tomography (CBCT) to evaluate changes in alveolar bone following immediate placement of two implant designs, System 2P and Dura-Vit 3P, which feature semi-conical microgeometry and apical self-tapping portions for improved stability and bone regeneration. Methods: With a 1:1 allocation ratio, the current investigation was a two-arm parallel group randomized clinical trial. Patients qualified if they required immediate dental replacements with adequate buccal bone support. Two types of implants were placed: System 2P (cylindrical shape) and Dura-Vit 3P (more conical shape, with a particular architecture of threads). Following the intervention, CBCT was performed both immediately (T1) and six months later (T2). Measurements of CBCT horizontal bone level at apical, medial, and bevel height on the palatal/lingual and vestibular sides as well as the buccal vertical gap were the primary results. Complications, implant stability quotient (ISQ), and torque insertion were evaluated. The Mann–Whitney test was used to determine time-based differences within each group, while the Wilcoxon test was used to estimate differences between groups. The impact of baseline marginal gap dimension and gingival biotype was estimated using multiple regressions. Results: Thirty patients were recruited and randomized to treatments, with two lost to follow-up. One System 2P implant failed and two patients of the Dura-Vit 3P group dropped out. At T1, the Dura-Vit 3P group exhibited a lower mean insertion torque and a higher ISQ than the System 2P group. Furthermore, the Dura-Vit 3P group showed lower bone reduction compared to System 2P at horizontal and vertical measurements with significant differences for the vestibular and palatal base and medial level (p-values < 0.05). Regression models indicated a positive effect of thick biotypes on gap filling and dimensional bone reduction. No complications were observed in both groups. Conclusions: The Dura-Vit 3P implant exhibits high primary stability when inserted in post-extraction sites. Furthermore, this kind of implant stimulates higher bone stability on both the palatal and buccal side when compared to the System 2P implant. The present findings support the evidence that the macro-design of the Dura-Vit 3P implant promotes increased primary stability and reduces bone loss.

Background: Patients often desire involvement in anesthesia decisions, yet clinicians rarely explain anesthesia options or elicit preferences. We developed My Anesthesia Choice-Hip Fracture, a conversation aid about anesthesia options for hip fracture surgery and tested its preliminary efficacy and acceptability. Methods: We developed a 1-page, tabular format, plain-language conversation aid with feedback from anesthesiologists, decision scientists, and community advisors. We conducted an online survey of English-speaking adults aged 50 and older. Participants imagined choosing between spinal and general anesthesia for hip fracture surgery. Before and after viewing the aid, participants answered a series of questions regarding key outcomes, including decisional conflict, knowledge about anesthesia options, and acceptability of the aid. Results: Of 364/409 valid respondents, mean age was 64 (SD 8.9) and 59% were female. The proportion indicating decisional conflict decreased after reviewing the aid (63–34%, P < 0.001). Median knowledge scores increased from 50% correct to 67% correct (P < 0.001). 83% agreed that the aid would help them discuss options and preferences. 76.4% would approve of doctors using it. Conclusion: My Anesthesia Choice-Hip Fracture decreased decisional conflict and increased knowledge about anesthesia choices for hip fracture surgery. Respondents assessed it as acceptable for use in clinical settings. Practice implications: Use of clinical decision aids may increase shared decision-making; further testing is warranted. [ABSTRACT FROM AUTHOR]

Background: While surgery is generally necessary for most solid-organ cancers, curative-intent resection is occasionally aborted due to unanticipated unresectability or occult metastases. Following aborted cancer surgery (ACS), patients have unique and complex care needs and yet little is known about the optimal approach to their management. Objective: The aim of this study was to define the practice patterns and perspectives of an international cohort of cancer surgeons on the management of ACS. Methods: A validated survey assessing surgeon perspectives on patient care needs and management following ACS was developed. The survey was distributed electronically to members of the Society of Surgical Oncology (SSO). Results: Among 190 participating surgeons, mean age was 49 ± 11 years, 69% were male, 61% worked at an academic institution, and most had a clinical practice focused on liver/pancreas (30%), breast (23%), or melanoma/sarcoma cancers (20%). Participants estimated that ACS occurred in 7 ± 6% of their cancer operations, most often due to occult metastases (67%) or local unresectability (30%). Most surgeons felt (very) comfortable addressing their patients' surgical needs (92%) and cancer treatment-related questions (90%), but fewer expressed comfort addressing psychosocial needs (83%) or symptom-control needs (69%). While they perceived discussing next available therapies as the patients' most important priority after ACS, surgeons reported avoiding postoperative complications as their most important priority (p < 0.001). While 61% and 27% reported utilizing palliative care and psychosocial oncology, respectively, in these situations, 46% noted care coordination as a barrier to addressing patient care needs. Conclusions: Results from this SSO member survey suggest that ACS is relatively common and associated with unique patient care needs. Surgeons may feel less comfortable assessing psychosocial and symptom-control needs, highlighting the need for novel patient-centered approaches. [ABSTRACT FROM AUTHOR]

Purpose of review This review examines the role of pragmatic clinical trials (PCTs) in addressing the underrepresentation of older adults with cancer (OAC) in clinical trials. Focusing on real-world evidence (RWE), it aims to provide a comprehensive overview of PCT utilization, emphasizing their potential to enhance treatment decisions and patient outcomes. Existing knowledge gaps in PCT implementation are also discussed. Recent findings PCTs are identified as effective tools to include OACs with comorbidities and complex conditions in research, bridging the representation gap. Despite their proven value in healthcare provision, their application in OAC contexts remains limited, hindering comprehensive understanding and inclusivity in clinical trials. Summary While randomized controlled trials (RCTs) are considered the gold standard in oncology research, OACs have historically been excluded, perpetuating underrepresentation. Furthermore, even in current oncology clinical development trials, this demographic continues to be underrepresented. PCTs offer a valuable avenue for the identification and evaluation of therapies within authentic RW contexts, encompassing various healthcare settings, such as hospitals, clinics, and physician practices. RCTs and PCTs complement one another, and the utilization of PCTs has the potential to inform clinical decision-making across the OACs entire treatment trajectory. [ABSTRACT FROM AUTHOR]

ObjectivesWe aimed to describe emergency department (ED) care transition interventions delivered to older adults with cognitive impairment, identify relevant patient-centered outcomes, and determine priority research areas for future investigation.DesignSystematic scoping review.Setting and participantsED patients with cognitive impairment and/or their care partners.MethodsInformed by the clinical questions, we conducted systematic electronic searches of medical research databases for relevant publications following published guidelines. The results were presented to a stakeholder group representing ED-based and non-ED-based clinicians, individuals living with cognitive impairment, care partners, and advocacy organizations. After discussion, they voted on potential research areas to prioritize for future investigations.ResultsFrom 3848 publications identified, 78 eligible studies underwent full text review, and 10 articles were abstracted. Common ED-to-community care transition interventions for older adults with cognitive impairment included interdisciplinary geriatric assessments, home visits from medical personnel, and telephone follow-ups. Intervention effects were mixed, with improvements observed in 30-day ED revisit rates but most largely ineffective at promoting connections to outpatient care or improving secondary outcomes such as physical function. Outcomes identified as important to adults with cognitive impairment and their care partners included care coordination between providers and inclusion of care partners in care management within the ED setting. The highest priority research area for future investigation identified by stakeholders was identifying strategies to tailor ED-to-community care transitions for adults living with cognitive impairment complicated by other vulnerabilities such as social isolation or economic disadvantage.Conclusions and implicationsThis scoping review identified key gaps in ED-to-community care transition interventions delivered to older adults with cognitive impairment. Combined with a stakeholder assessment and prioritization, it identified relevant patient-centered outcomes and clarifies priority areas for future investigation to improve ED care for individuals with impaired cognition, an area of critical need given the current population trends.

A gummy smile is the visualization of more than 3 mm of gingiva above the maxillary incisors. This study aimed to evaluate the long-term effects on aesthetics and patient satisfaction of a new hyaluronic acid infiltration technique in reducing the gummy smile. Fifty patients with gummy smiles were treated using hyaluronic acid infiltration points by applying 0.1 mL per injection at specific points. Post-treatment evaluations were performed one week, one month, three months, six months, and 12 months later. A questionnaire assessed patient satisfaction, willingness to recommend the treatment, and side effects (pain and bruising during and after treatment). An average reduction of 2.5 mm in gingival exposure during smiling was observed. After one week, the reduction was constant. At six months, 40% of the original gingival exposure was recovered, and recovery was complete at 12 months. Patient satisfaction was 82.1%, and 100% of patients would recommend the treatment. Bruising, swelling, and pain decreased to 0% from the first month. In conclusion, this technique is a safe and effective option to improve the smile’s appearance with minimal complications.

IntroductionAgitation is a common symptom in patients with Alzheimer's dementia. But agitation can be a heterogeneous symptom, encompassing a diverse array of behaviors exhibited by patients. The Cohen-Mansfield Agitation Inventory (CMAI) is a 29-item scale that is used to systematically assess the frequency and severity of agitation in older adults as rated by a primary caregiver. The CMAI was originally designed for use by professional care givers in institutional care settings. Alzheimer's dementia, however, is associated with a significant burden on family members, who provide the majority of care, and other informal care partners.MethodsOur qualitative study aimed to assess the accuracy and applicability of the CMAI according to the needs and perceptions of non-professional care partners. Specifically, we wanted to determine if the behaviors included in the instrument reflect: (a) the care partner's experience with agitation in Alzheimer's dementia patients, (b) how the behaviors and their frequency are related to the perception of agitation severity, and (c) what changes in agitation behaviors are meaningful to care partners. We interviewed 30 care partners for patients with Alzheimer's dementia in the United States.ResultsThe care partners confirmed all behaviors listed in the CMAI as relevant. The behaviors reflect a spectrum of severity, with aggressive behaviors considered more severe than non-aggressive behaviors and physical behaviors generally considered more severe than verbal behaviors. Any reduction or increase in the frequency of a behavior was meaningful to care partners. Generally, a change from physical to verbal behaviors and aggressive to non-aggressive was considered a meaningful improvement while a change from verbal to physical and non-aggressive to aggressive was considered a meaningful worsening.DiscussionThe CMAI appropriately captures relevant behaviors of agitation in Alzheimer's dementia and provides insight into the relative improvement or worsening of agitation symptoms.

Background: Periodontal disease, characterized by inflammation and infection of the supporting structures of teeth, poses a significant oral health challenge. Traditional periodontal surgery and non-surgical therapy, such as scaling and root planing, are established treatment approaches for addressing periodontal disease. Materials and Methods: The study enrolled 120 adult patients diagnosed with moderate to severe periodontal disease. Participants were randomly allocated to one of two groups: the traditional surgery group (TSG) or the non-surgical therapy group (NSTG). In the TSG, patients underwent traditional periodontal surgery, which included flap surgery and grafts when deemed necessary. The surgical procedures were performed by experienced periodontal surgeons. In contrast, the NSTG received non-surgical therapy in the form of scaling and root planing administered by trained dental hygienists. Outcome measures encompassed clinical parameters and patient-centered outcomes. Periodontal pocket depth and clinical attachment level, both measured in millimeters, were assessed at baseline, 3 months, and 6 months. Patient-reported outcomes, including pain, discomfort, and satisfaction, were collected through standardized questionnaires at each follow-up visit. Results: Patients in the TSG experienced a notable reduction in pocket depth from a baseline of 6.8 mm to 3.7 mm at the 6-month mark, resulting in a change of -3.1 mm. Conversely, the NSTG exhibited a reduction from 6.7 mm to 4.0 mm, with a change of -2.7 mm. In the TSG, the baseline attachment level of 7.2 mm decreased to 5.1 mm at 6 months, indicating a change of -2.1 mm. In the NSTG, the attachment level decreased from 7.1 mm to 5.5 mm, resulting in a change of -1.6 mm. Patients in the TSG reported an average pain score of 3.6 on a 1–10 scale, discomfort of 4.2, and satisfaction of 7.8. In contrast, patients in the NSTG reported lower pain (2.1) and discomfort (2.9) scores but similar satisfaction levels (8.4). Conclusion: In this randomized controlled trial (RCT), both traditional periodontal surgery and non-surgical therapy demonstrated improvements in clinical parameters and patient-reported outcomes. Traditional surgery resulted in greater reductions in periodontal pocket depth and clinical attachment loss at the 6-month follow-up.

Objective: To evaluate short‐ and long‐term measures of health care utilization—days in the emergency department (ED), inpatient (IP) care, and rehabilitation in a post‐acute care (PAC) facility—to understand how home time (i.e., days alive and not in an acute or PAC setting) corresponds to quality of life (QoL). Data Sources: Survey data on community‐residing veterans combined with multipayer administrative data on health care utilization. Study Design: VA or Medicare health care utilization, quantified as days of care received in the ED, IP, and PAC in the 6 and 18 months preceding survey completion, were used to predict seven QoL‐related measures collected during the survey. Elastic net machine learning was used to construct models, with resulting regression coefficients used to develop a weighted utilization variable. This was then compared with an unweighted count of days with any utilization. Principal Findings: In the short term (6 months), PAC utilization emerged as the most salient predictor of decreased QoL, whereas no setting predominated in the long term (18 months). Results varied by outcome and time frame, with some protective effects observed. In the 6‐month time frame, each weighted day of utilization was associated with a greater likelihood of activity of daily living deficits (0.5%, 95% CI: 0.1%–0.9%), as was the case with each unweighted day of utilization (0.6%, 95% CI: 0.3%–1.0%). The same was true in the 18‐month time frame (for both weighted and unweighted, 0.1%, 95% CI: 0.0%–0.3%). Days of utilization were also significantly associated with greater rates of instrumental ADL deficits and fair/poor health, albeit not consistently across all models. Neither measure outperformed the other in direct comparisons. Conclusions: These results can provide guidance on how to measure home time using multipayer administrative data. While no setting predominated in the long term, all settings were significant predictors of QoL measures. [ABSTRACT FROM AUTHOR]

Anxiety and emotional distress have not been studied in large, diverse samples of patients with pulmonary nodules. How common are anxiety and distress in patients with newly identified pulmonary nodules, and what factors are associated with these outcomes? This study surveyed participants in the Watch the Spot Trial, a large, pragmatic clinical trial of more vs less intensive strategies for radiographic surveillance of patients with small pulmonary nodules. The survey included validated instruments to measure patient-centered outcomes such as nodule-related emotional distress (Impact of Event Scale-Revised) and anxiety (Six-Item State Anxiety Inventory) 6 to 8 weeks following nodule identification. Mixed-effects models were used to compare outcomes between study arms following adjustment for potential confounders and clustering within enrollment site, while also examining a limited number of prespecified explanatory factors, including nodule size, mode of detection, type of ordering clinician, and lack of timely notification prior to contact by the study team. The trial enrolled 34,699 patients; 2,049 individuals completed the baseline survey (5.9%). Respondents and nonrespondents had similar demographic and nodule characteristics, although more respondents were non-Hispanic and White. Impact of Event Scale-Revised scores indicated mild, moderate, or severe distress in 32.2%, 9.4%, and 7.2% of respondents, respectively, with no difference in scores between study arms. Following adjustment, greater emotional distress was associated with larger nodule size and lack of timely notification by a clinician; distress was also associated with younger age, female sex, ever smoking, Black race, and Hispanic ethnicity. Anxiety was associated with lack of timely notification, ever smoking, and female sex. Almost one-half of respondents experienced emotional distress 6 to 8 weeks following pulmonary nodule identification. Strategies are needed to mitigate the burden of distress, especially in younger, female, ever smoking, and minoritized patients, and those with larger nodules. ClinicalTrials.gov ; No.: NCT02623712; URL: www.clinicaltrials.gov [Display omitted] [ABSTRACT FROM AUTHOR]

BackgroundQuantitative evaluations of the effectiveness of intensive primary care (IPC) programs for high-needs patients have yielded mixed results for improving healthcare utilization, cost, and mortality. However, IPC programs may provide other value.ObjectiveTo understand the perspectives of high-needs patients and primary care facility leaders on the effects of a Veterans Affairs (VA) IPC program on patients.DesignA total of 66 semi-structured telephone interviews with high-needs VA patients and primary care facility leaders were conducted as part of the IPC program evaluation.ParticipantsHigh-needs patients (n = 51) and primary care facility leaders (n = 15) at 5 VA pilot sites.ApproachWe used content analysis to examine interview transcripts for both a priori and emergent themes about perceived IPC program effects.Key resultsPatients enrolled in VA IPCs reported improvements in their experience of VA care (e.g., patient-provider relationship, access to their team). Both patients and leaders reported improvements in patient motivation to engage with self-care and with their IPC team, and behaviors, especially diet, exercise, and medication management. Patients also perceived improvements in health and described receiving assistance with social needs. Despite this, patients and leaders also outlined patient health characteristics and contextual factors (e.g., chronic health conditions, housing insecurity) that may have limited the effectiveness of the program on healthcare cost and utilization.ConclusionsPatients and primary care facility leaders report benefits for high-needs patients from IPC interventions that translated into perceived improvements in healthcare, health behaviors, and physical and mental health status. Most program evaluations focus on cost and utilization, which may be less amenable to change given this cohort's numerous comorbid health conditions and complex social circumstances. Future IPC program evaluations should additionally examine IPC's effects on quality of care, patient satisfaction, quality of life, and patient health behaviors other than utilization (e.g., engagement, self-efficacy).

Abstract Introduction We examined acceptability of and preferences for potential medications for treating methamphetamine use disorder (MUD) among people who use methamphetamine and examined how benefits and drawbacks of methamphetamine use affect perceived acceptability and preferences. Methods We conducted qualitative interviews as part of a larger study in 2019–2020. The interview assessed patterns of substance use (including methamphetamine), benefits and drawbacks of methamphetamine use, and interest in a medication to treat MUD. Analysis used an inductive thematic approach, guided by three primary questions: (1) would participants be interested in taking a potential medication for MUD?; (2) what effects would they would like from such a medication?; and (3) what would their ideal treatment route and schedule be (e.g. daily pill, monthly injection)?. Results We interviewed 20 people reporting methamphetamine use in the past 3 months (10 from Reno, Nevada, USA and 10 from Rio Arriba County, New Mexico, USA). Seven used exclusively methamphetamine, while thirteen used other substances in addition to methamphetamine. Most were enthusiastic about a potential medication to treat MUD. Of those who were not interested (n = 5), all indicated no current concerns about their methamphetamine use. Perceived functional benefits of methamphetamine use (i.e., energy, counteracting opioid sedation, and improved social and emotional wellbeing) informed preferences for a replacement-type medication that would confer the same benefits while mitigating drawbacks (e.g., psychosis, hallucinations, withdrawal). Opinions on preferred dosing varied, with some preferring longer acting medications for convenience, while others preferred daily dosing that would align with existing routines. Conclusion Participants were excited about a potential for a medication to treat MUD. Their preferences were informed by the functional role of methamphetamine in their lives and a desire to maintain the stimulant effects while mitigating harms of illicit methamphetamine. Treatment outcomes that emphasize functioning and wellbeing, rather than abstinence, should be explored.

Abstract This article provides a summary of a previously published paper: Terminal Complement Inhibitor Ravulizumab in Generalized Myasthenia Gravis. The paper reported the results of the CHAMPION-MG trial which investigated the drug ravulizumab in the rare disease, myasthenia gravis. Terminal Complement Inhibitor Ravulizumab in Generalized Myasthenia Gravis (MP4 594600 KB)

Abstract Introduction: Patient and stakeholder involvement enhances the conduct and applicability of comparative effectiveness research (CER). However, examples of engagement practices for CER leveraging real-world data (i.e., data from routine clinical practice) are scarce. Notably, these studies differ from traditional clinical trials in their technical complexity and minimal prospective data collection, posing unique challenges for stakeholder involvement. This paper describes patient and stakeholder engagement in a CER study of type 2 diabetes (T2D) medications using real-world data from a large administrative claims database. Methods: A Patient and Stakeholder Advisory Group (PSAG) was formed to guide study design, conduct, and dissemination. The PSAG (n = 12) included individuals with T2D, clinicians, health systems leaders, professional society representatives, and a payer representative. Members were surveyed post-study initiation to assess their participation goals and experiences to date. Results: PSAG members influenced key design and methodological decisions, including cohort selection and adding an aim focused on patient preference elicitation. Survey results indicated high satisfaction with engagement processes and a desire for ongoing involvement. Most PSAG members cited their main goals as impacting the lives of people with T2D and ensuring the research’s relevance to clinicians. Conclusions: Best practices for engaging stakeholders in CER using real-world data are underdeveloped. Our experience suggests that an inclusive, stakeholder-engaged approach enriches the research process and ensures diverse perspectives are integrated into study design and conduct. Ongoing efforts will focus on assessing long-term engagement outcomes and PSAG member satisfaction.

Background: Males constitute 25% of older adults who experience hip fractures in the United States; a concerning upward trend given poorer health and outcomes among male survivors. Male sex is associated with worse cognitive performance after hip fracture, impacting participation in rehabilitation and long‐term outcomes especially for those with Alzheimer's disease or related dementias (ADRD). However, little research has evaluated whether sex differences in post‐fracture recovery are greater among those living with ADRD. Methods: Data were drawn from 2010 to 2017 Medicare fee‐for‐service beneficiaries aged 65 years and older who survived hospitalization for hip fracture (n = 69,581). The primary outcome was days alive and at home (DAAH), a validated patient‐centered claims‐based outcome calculated as 365 days from fracture minus days in hospital, nursing home, rehabilitation facility, emergency department, or time after death. Multivariable Poisson regressions with an interaction term between sex and ADRD status were to model the association between DAAH and ADRD in the 12 months post hip fracture, adjusting for demographics, injury severity, chronic disease burden, and hospital‐level fixed effects. Results: Compared to females, males were younger and had more comorbidities at the time of fracture. Among survivors, males with ADRD spent a mean of 160.7 DAAH compared to 228.4 for males without ADRD, 177.8 for females with ADRD, and 248.0 for females without ADRD. In adjusted analyses, males without ADRD spent 8.2% fewer DAAH compared to females (rate ratio [RR] = 0.92, 95% CI 0.92–0.92). This relative sex difference increased significantly when comparing those living with ADRD, with males spending an additional 3.3% fewer DAAH (interaction RR = 0.96, 95% CI 0.96–0.97). Conclusions: Males spend fewer DAAH after hip fracture than females, and this difference increases modestly for males living with ADRD compared to females. This suggests that cognitive impairment may be a small but significant contributor to sex‐based differences observed during hip fracture recovery. [ABSTRACT FROM AUTHOR]