Application of Patient-Reported Outcome Measurements in Adult Tumor Clinical Trials in China: Cross-Sectional Study.

BACKGROUND: International health policies and researchers have emphasized the value of evaluating patient-reported outcomes (PROs) in clinical studies. However, the characteristics of PROs in adult tumor clinical trials in China remain insufficiently elucidated. OBJECTIVE: This study aims to assess the application and characteristics of PRO instruments as primary or secondary outcomes in adult randomized clinical trials related to tumors in China. METHODS: This cross-sectional study identified tumor-focused randomized clinical trials conducted in China between January 1, 2010, and June 30, 2022. The ClinicalTrials.gov database and the Chinese Clinical Trial Registry were selected as the databases. Trials were classified into four groups based on the use of PRO instruments: (1) trials listing PRO instruments as primary outcomes, (2) trials listing PRO instruments as secondary outcomes, (3) trials listing PRO instruments as coprimary outcomes, and (4) trials without any mention of PRO instruments. Pertinent data, including study phase, settings, geographic regions, centers, participant demographics (age and sex), funding sources, intervention types, target diseases, and the names of PRO instruments, were extracted from these trials. The target diseases involved in the trials were grouped according to the American Joint Committee on Cancer Staging Manual, 8th Edition. RESULTS: Among the 6445 trials examined, 2390 (37.08%) incorporated PRO instruments as part of their outcomes. Within this subset, 26.82% (641/2390) listed PRO instruments as primary outcomes, 52.72% (1260/2390) as secondary outcomes, and 20.46% (489/2390) as coprimary outcomes. Among the 2,155,306 participants included in these trials, PRO instruments were used to collect data from 613,648 (28.47%) patients as primary or secondary outcomes and from 74,287 (3.45%) patients as coprimary outcomes. The most common conditions explicitly using specified PRO instruments included thorax tumors (217/1280, 16.95%), breast tumors (176/1280, 13.75%), and lower gastrointestinal tract tumors (173/1280, 13.52%). Frequently used PRO instruments included the European Organisation for Research and Treatment of Cancer Quality of Life Core Questionnaire-30, the visual analog scale, the numeric rating scale, the Traditional Chinese Medicine Symptom Scale, and the Pittsburgh Sleep Quality Index. CONCLUSIONS: Over recent years, the incorporation of PROs has demonstrated an upward trajectory in adult randomized clinical trials on tumors in China. Nonetheless, the infrequent measurement of the patient's voice remains noteworthy. Disease-specific PRO instruments should be more effectively incorporated into various tumor disease categories in clinical trials, and there is room for improvement in the inclusion of PRO instruments as clinical trial end points.

Clinical Outcome Prediction of Early Brain Injury in Aneurysmal Subarachnoid Hemorrhage: the SHELTER-Score.

BACKGROUND: Despite intensive research on preventing and treating vasospasm and delayed cerebral ischemia in aneurysmal subarachnoid hemorrhage (aSAH), mortality and morbidity rates remain high. Early brain injury (EBI) has emerged as possibly the major significant factor in aSAH pathophysiology, emphasizing the need to investigate EBI-associated clinical events for improved patient management and decision-making. This study aimed to identify early clinical and radiological events within 72 h after aSAH to develop a conclusive predictive EBI score for clinical practice. METHODS: This retrospective analysis included 561 consecutive patients with aSAH admitted to our neurovascular center between 01/2014 and 09/2022. Fourteen potential predictors occurring within the initial 72 h after hemorrhage were analyzed. The modified Rankin Scale (mRS) score at 6 months, discretized to three levels (0-2, favorable; 3-5, poor; 6, dead), was used as the outcome variable. Univariate ordinal regression ranked predictors by significance, and forward selection with McFadden's pseudo-R2 determined the optimal set of predictors for multivariate proportional odds logistic regression. Collinear parameters were excluded, and fivefold cross-validation was used to avoid overfitting. RESULTS: The analysis resulted in the Subarachnoid Hemorrhage Associated Early Brain Injury Outcome Prediction score (SHELTER-score), comprising seven clinical and radiological events: age (0-4 points), World Federation of Neurosurgical Societies (0-2.5 points), cardiopulmonary resuscitation (CPR) (2 points), mydriasis (1-2 points), midline shift (0.5-1 points), early deterioration (1 point), and early ischemic lesion (2 points). McFadden's pseudo-R2 = 0.339, area under the curve for death or disability 0.899 and 0.877 for death. A SHELTER-score below 5 indicated a favorable outcome (mRS 0-2), 5-6.5 predicted a poor outcome (mRS 3-5), and ≥ 7 correlated with death (mRS 6) at 6 months. CONCLUSIONS: The novel SHELTER-score, incorporating seven clinical and radiological features of EBI, demonstrated strong predictive performance in determining clinical outcomes. This scoring system serves as a valuable tool for neurointensivists to identify patients with poor outcomes and guide treatment decisions, reflecting the great impact of EBI on the overall outcome of patients with aSAH.

Three-Dimensional Morphological Study on the Effectiveness of Expanded Polytetrafluoroethylene Prosthesis in the Paranasal Augmentation.

BACKGROUND: The paranasal depression is a common facial feature of Oriental populations. One of the most wildly used method to improve it was paranasal augmentation using expanded polytetrafluoroethylene (ePTFE). The effectiveness of it should be tested by three-dimensional morphological measurements. METHODS: Patients who underwent paranasal augmentation using ePTFE between January 2017 and December 2022 were recruited in the study. The preoperative and postoperative clinical variables and three-dimensional measurement of patients were also collected. The satisfaction outcome were assessed. RESULTS: By establishing a coordinate system based on the Frankfurt plane, 16 landmarks including nasal alar crest, subnasal point, upper lip, pogonion, glabella, sub-cheek, orbitale, tragion in left and right side of faces were marked. Five segments, 4 ratios, and 3 angles were measured based on it. The significant increase of segments, ratios, and angles indicated that paranasal augmentation could increase the protrusion of paranasal area, both in absolute value and relative proportion. The significant decrease of other data indicated that the protrusion difference between paranasal base and upper lip, forehead, and chin, respectively, were shortened after surgery. The average size of implant was 6.54 ± 1.02 mm, and the average increase of paranasal height was 4.38 ± 1.04 mm postoperatively. This indicates that two-thirds of its height will ultimately be reflected effectively in the sagittal elevation of the paranasal base. CONCLUSIONS: Paranasal augmentation using ePTFE could effectively increase paranasal height and improve subunits relationships, and the ePTFE prosthesis should be designed and carve considering the 1/3 loss of height after implantation. LEVEL OF EVIDENCE III: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Varying-coefficients for regional quantile via KNN-based LASSO with applications to health outcome study.

Health outcomes, such as body mass index and cholesterol levels, are known to be dependent on age and exhibit varying effects with their associated risk factors. In this paper, we propose a novel framework for dynamic modeling of the associations between health outcomes and risk factors using varying-coefficients (VC) regional quantile regression via K-nearest neighbors (KNN) fused Lasso, which captures the time-varying effects of age. The proposed method has strong theoretical properties, including a tight estimation error bound and the ability to detect exact clustered patterns under certain regularity conditions. To efficiently solve the resulting optimization problem, we develop an alternating direction method of multipliers (ADMM) algorithm. Our empirical results demonstrate the efficacy of the proposed method in capturing the complex age-dependent associations between health outcomes and their risk factors.

Autologous Shuffling Lipo-Aspirated Fat Combined Mechanical Stretch in Revision Rhinoplasty for Severe Contractures in Asian Patients.

BACKGROUND: A severely contracted nose is a common occurrence. Intraoperative expansion is not sufficient to soften the severely constricted nasal envelope, which poses challenges in revision rhinoplasty. In recent years, adjuvant therapies, including nasal fat grafting and cell component injection, are applied before revision rhinoplasty to soften the nasal envelope. Herein, autologous shuffling lipo-aspirated fat and manual mechanical stretch were combined as adjuvant therapy before revision rhinoplasty. METHODS: A total of 24 patients with severe nasal contracture were included in this study. Of these, 8 received autologous shuffling lipo-aspirated fat and manual mechanical stretch before revision rhinoplasty (comprehensive therapy), 8 underwent mechanical stretch and revision rhinoplasty, and 8 patients underwent only revision rhinoplasty. The objective and subjective outcome assessment was processed in the follow-up period of 6 months. Nasal length, nasal tip projection, nasofrontal angle, and nasolabial angle were measured, and potential complications were assessed. RESULTS: All 24 patients underwent a successful revision rhinoplasty. In the comprehensive therapy group, no patient had postoperative wound infection and defect of the nasal column mucous. The comprehensive treatment group had the most significant improvement in nasal length and nasal tip projection, and the nasolabial angle was the closest to 90°, which indicated the most effective nasal revision and aesthetic contour. CONCLUSIONS: The adjuvant therapy combines autologous shuffling lipo-aspirated fat and manual mechanical stretch before revision rhinoplasty could effectively improve the surgical outcome and decrease the postoperative complications regarding severe nasal contractures. LEVEL OF EVIDENCE IV: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Change processes in psychotherapy for patients presenting with histrionic personality disorder.

OBJECTIVE: Histrionic personality disorder (HPD) with a lifetime prevalence rate of 1.8% is an under-researched psychiatric diagnosis. The present study therefore aimed to investigate both the processes and outcomes of psychotherapy for HPD in a non-controlled study. METHODS: A total of 159 patients diagnosed with HPD were recruited and received clarification-oriented psychotherapy. Sessions 15, 20, and 25 were video-recorded and analysed using the Process-Content-Relationship Scale. Therapy outcome was assessed with symptom measures at intake and discharge. Hierarchical linear modelling was applied to estimate the changes in the psychotherapeutic outcome and associations with patient and therapist process developments. RESULTS: Improvements in relationship processes of patients and therapists were systematically related to outcome while only partial relationships were found on the levels of process and content. CONCLUSION: The present study represents the first systematic insight into core changes in patients with HPD undergoing psychotherapy.

Empirical examination of long-term and intensive psychodynamic psychotherapy for severely disturbed patients.

OBJECTIVES: This study examines the effectiveness and efficiency of intensive psychodynamic psychotherapy for severely impaired patients. METHOD: 104 patients in four public mental health centers underwent intensive psychodynamic psychotherapy. The number and duration of psychiatric hospitalizations were monitored for these patients from one year before therapy to eight years after. Several outcome variables were measured every six months, six times in total over two and a half years, using a longitudinal design. A multi-level analytic approach was applied to account for repeated measurements and missing data. RESULTS: Significant improvement was found in all three symptomatic outcome measures (SCL-90, OQ-45, BDI) throughout treatment. The numbers of psychiatric hospitalizations and psychiatric hospitalization days decreased significantly from the level they were in the year before the start of psychodynamic treatment to three years after the start of treatment. These results were maintained for at least up to eight years. After capitalization, the overall cumulative 127.47-day decrease in hospitalization days equals savings of 115,850 NIS. The average cost of treatment after capitalization was 26,770 NIS. The insurer's estimated direct savings is 89,080 NIS (24,054 $). CONCLUSION: These findings support the hypothesis that psychodynamic psychotherapy is clinically effective and economically efficient for severely impaired patients.

Comparable outcomes with intramedullary nail and plate constructs for Schatzker VI tibial plateau fractures.

BACKGROUND: Outcomes data of intramedullary nail fixation (IMN) constructs for complex Schatzker VI tibial plateau fractures are scant in the literature. This study compares the clinical and radiographic outcomes of IMN, dual plate, and single plate constructs for Schatzker IV tibial plateau fractures. METHODS: Retrospective cohort study of sixty-two patients at a University-based Level 1 trauma center who underwent open reduction internal fixation for Schatzker VI tibial plateau fracture. Constructs evaluated were IMN (with or without raft screws), dual plating, and single plating. Demographic, clinical, and radiographic outcomes were recorded. All fractures were additionally classified based on the OTA classification for sub analyses. Mean follow-up was 13.2 (SD 13.3) months. Predictors of construct selection and outcomes were evaluated with bivariate logistic regression. Outcomes were compared between groups with independent samples t-tests and Chi Square tests. RESULTS: No significant demographic differences were found between IMN, dual plate or single plate construct cohorts. There was a higher proportion of open fractures within the IMN construct group versus the dual plate cohort (21.1% vs 3.6%). No statistically significant differences in radiographic outcomes were observed between cohort groups except for small but statistically significant differences in condylar width (CW) ratio change and tibial slope; when fracture cohorts were sub analyzed by specific OTA classification, there were no significant differences in any radiographic outcomes. There was a significant difference between the ratio of OTA 41C1, C2 and C3 fractures regarding treatment allocation (p = 0.004), favoring dual plate fixation for OTA 41C3 fractures. There were no significant differences found between treatment cohorts in terms of all cause complications (p > 0.05). IMN and single plate constructs were utilized when posteromedial condyle fractures were nondisplaced or minimally displaced. CONCLUSION: Intramedullary nail fixation with or without supplemental raft screws produced similar short-term clinical and radiographic results compared to dual and single plate constructs among patients with Schatzker VI fracture types, regardless of OTA classification. Level of Evidence Level III retrospective cohort.

Healing after surgical retreatment at four time points: A retrospective study.

AIM: To evaluate the outcome of surgical retreatment at four time points, that is 6, 12, 24 and 48 months post-operatively, and to search for prognostic factors that may affect the outcome. METHODOLOGY: Clinical records and intraoral periapical radiographs were collected from patients who had undergone surgical retreatment between 2009 and 2015 and attended 6-, 12-, 24- and 48-month follow-up visits. Surgical retreatment was performed by one endodontist and involved minimal root-end resection and maximal length root-end preparation using prebent ultrasonic files. Outcomes were categorized as complete, incomplete, uncertain or unsatisfactory healing, based on clinical and radiographic findings. The complete and incomplete categories were pooled and considered successes, while uncertain and unsatisfactory outcomes were considered failures. Changes in healing outcome were analysed using the McNemar-Bowker test, and prognostic factors were analysed using univariate analysis. RESULTS: The study cohort included 297 patients with 384 teeth. The overall success rate after 48 months was 90.6% compared with 88.5%, 93% and 92.4% after 6, 12 and 24 months respectively. Age, gender, presence of isthmus and length of canal preparation had no significant influence on the outcome. Lesion size and tooth type had a significant influence only after 6 and 12 months, respectively, with no significant differences at other time points. Fifty per cent of the teeth classified as unsatisfactory or uncertain healing at the 6 months follow-up improved to incomplete or complete healing after 12 months. None of the cases classified as unsatisfactory healing after 12 months subsequently improved, and only 2 cases that were classified as uncertain healing after 12 months improved after 24 months. CONCLUSIONS: Surgical retreatment was found to be a predictable procedure with a high success rate of 90.6% after 4 years. Over the follow-up periods, only a minor regression in the success rate was found. The 12 months follow-up results closely indicated the long-term outcome of surgical retreatment.

Radial Extracorporeal Shockwave Therapy (rESWT) is not superior to "minimal-dose" rESWT for patients with chronic plantar fasciopathy; a double-blinded randomised controlled trial.

BACKGROUND: Investigating outcomes following radial-extra-corporeal-shockwave-therapy (rESWT) in patients with chronic plantar fasciopathy METHODS: This double-blinded RCT in a single NHS Sports medicine clinic recruited 117 patients with chronic plantar fasciopathy randomised equally to either 3 sessions of rESWT or "minimal-dose" respectively. Mean age 51.7 ± 9.6 years, 66 % female, symptom duration: 32.6 ± 30.8 months. RESULTS: "Average pain" improved by 50 % at 6-months, (>1/3 at interim time-points). Statistically significant within-group improvements were identified in pain, local function, and "ability" PROMs in both groups. Fewer benefits in activity levels or mood. No between-group differences were seen at the interim or final time-points. CONCLUSION: 3 sessions of "recommended-dose" rESWT is non-superior to "minimal-dose" rESWT in patients with chronic plantar fasciopathy. rESWT may be ineffective in the treatment of patients with chronic plantar fasciopathy, "minimal-dose" rESWT may be sufficient for a therapeutic effect, or a greater number of treatment sessions may be required for benefit. LEVEL OF EVIDENCE: Level I - Randomised controlled trial.

ASA classification and surgical severity grading used to identify a high-risk population, a multicenter prospective cohort study in Swedish tertiary hospitals.

BACKGROUND: Identification of surgical populations at high risk for negative outcomes is needed for clinical and research purposes. We hypothesized that combining two classification systems, ASA (American Society of Anesthesiology physical status) and surgical severity, we could identify a high-risk population before surgery. We aimed to describe postoperative outcomes in a population selected by these two classifications system. METHODS: Data were collected in a Swedish multicentre, time-interrupted prospective, consecutive cohort study. Eligibility criteria were age ≥18 years, ASA ≥3, elective or emergent, major to Xmajor/complex (Specialist Procedure Codes used in United Kingdom), gastrointestinal, urogenital or orthopaedic procedures. Postoperative morbidity was identified by the Postoperative Morbidity Survey on postoperative days 3 ± 1, 7 ± 1, 10 + 5 and graded for severity by the Clavien-Dindo system. Mortality was assessed at 30, 180 and 360 days. RESULTS: Postoperative morbidity was 78/48/47 per cent on postoperative days 3/7/10. Majority of morbidities (67.5 per cent) were graded as >1 by Clavien-Dindo. Any type of postoperative morbidity graded >1 was associated with increased risk for death up to one year. The mortality was 5.7 per cent (61/1063) at 30 days, 13.3 per cent (142/1063) at 6 months and 19.1 per cent (160/1063) at 12 months. CONCLUSION: Severity classification as major to Xmajor/complex and ASA ≥3 could be used to identify a high-risk surgical population concerning postoperative morbidity and mortality before surgery. Combining the two systems future electronic data extraction is possible of a high-risk population in tertiary hospitals.

Psychodynamic psychotherapy is associated with sustained reduction in health care utilization and cost.

Our objective was to examine the effectiveness and efficiency of psychodynamic psychotherapy on the reduction in health care utilization and cost while controlling for age, gender, and year. Health care utilization and cost were examined yearly in 1,675 patients from 2 years before outpatient psychotherapy (i.e., baseline) to three consecutive years after psychotherapy in a naturalistic longitudinal design. A multilevel analytic approach (LMLM) was applied to account for repeated measures effect and missing data. In the year prior to psychotherapy, there was a significant increase in total cost compared with baseline (14.8%) and in use of health care services (primary and specialist doctors' visits and outsourced referrals). In the first year following therapy, there was a significant decrease in total cost (10%) and in use of health care services (all doctors' visits, imaging, and outsourced referrals). The decrease was to baseline levels or lower and was maintained for two additional years. Psychiatric medication usage increased significantly after psychotherapy and remained so. The overall cumulative decrease in total cost per patient over 3 years after therapy was 3,665.92 NIS, equalling a 69% average cost of psychotherapy. Further cost saving can be expected due to the reduction in sick leave, disability, and psychiatric hospitalization. These findings support the notion that providing outpatient psychodynamic psychotherapy can be financially beneficial to health care systems, although further research is required for causal inferences. Also, an increase in health care utilization along with scarce physical findings may indicate unaddressed psychological distress and warrant referral for mental assessment and possible psychotherapy.

Short-term psychodynamic infant-parent interventions at Child health centers: Outcomes on parental depression and infant social-emotional functioning.

Randomized controlled trials (RCTs) demonstrate efficacy of parent-infant psychotherapy, but its applicability and effectiveness in public health care are less known. The method followed is Naturalistic study evaluating Short-term Psychodynamic Infant-Parent Interventions at Child Health Centers (SPIPIC) in Stockholm, Sweden. One hundred distressed mothers with infants were recruited by supervised nurses. Six therapists provided 4.3 therapy sessions on average (SD = 3.3). Sessions typically included the mothers, often with the baby present, while fathers rarely attended sessions. The Edinburgh Postnatal Depression Scale (EPDS) and the Ages and Stages Questionnaire: Social-Emotional (ASQ: SE) were distributed at baseline and at 3 and 9 months later. Data from a nonclinical group were collected simultaneously to provide norm data. Multilevel growth models on the mothers' questionnaire scores showed significant decreases over time on both measures. Nine months after baseline, 50% achieved a reliable change on the EPDS and 14% on the ASQ: SE. Prepost effect-sizes (d) were 0.70 and 0.40 for EPDS and ASQ: SE, figures that are comparable to results of other controlled studies. Psychotherapists integrated with public health care seem to achieve good results when supporting distressed mothers with brief interventions in the postnatal period. SPIPIC needs to be compared with other modalities and organizational frameworks.

Los ensayos controlados al azar demuestran lo eficaz de de la sicoterapia progenitor-infante, pero su aplicabilidad y efectividad en el cuidado de la salud pública menos conocidas. Método: Estudio naturalista de evaluación de la Intervención Sicodinámica a Corto Plazo entre Infante y Progenitor en Centros de Salud Infantil (SPIPIC) en Estocolmo, Suecia. Se reclutaron 100 madres afligidas con infantes a través de enfermeras supervisadas. Seis terapeutas proveyeron 4.3 sesiones de terapia en promedio (SD = 3.3). Las sesiones típicamente incluyeron a las madres, a menudo con su bebé presente, mientras que los papás raramente asistieron a las sesiones. Se distribuyeron la Escala de Depresión Postnatal de Edimburgo (EPDS) y el Cuestionario de Edades y Estados: Socio-emocional (ASQ: SE) al punto de partida inicial básico, y a los tres y nueve meses después. Simultáneamente se recogió información de un grupo no clínico con el fin de proveer información de la norma. Resultados: Modelos de crecimiento de niveles múltiples basados en los puntajes de cuestionarios de las madres mostraron significativas bajas a lo largo del tiempo en ambas medidas. Nueve meses después del punto de partida inicial básico, el 50% logró un cambio confiable en la EPDS y 14% en el ASQ; SE. Los tamaños del efecto anterior y posterior (d) fueron 0,70 y 0.40 para la EPDS y el ASQ: SE, lo cual es comparable con resultados estudios controlados. Conclusiones: Los sicoterapeutas integrados con el cuidado de salud pública parecen lograr buenos resultados cuando apoyan a madres afligidas con intervenciones breves perinatalmente. La SPIPIC necesita ser comparada con otras modalidades y marcos de trabajo organizacionales.

Les essais contrôlés randomisés démontrent l'efficacité de la psychothérapie parent-nourrisson mais son application et son efficacité pour le soin de santé publique sont moins connues. Méthode: étude naturelle évaluant l'Intervention Psychodynamique Nourrisson-Parent à Court Terme dans des Centres de Santé de l'Enfant (SPIPIC) à Stockholm en Suède. Cent mères en détresse avec des nourrissons ont été recrutées par des infirmières supervisées. Six thérapeutes ont offerts 4,3 séances thérapeutiques en moyenne (SD = 3,3). Les séances ont typiquement inclus les mères, souvent avec le bébé présent, alors que les pères sont rarement venus aux séances. L'échelle de dépression postnatale d'Edinbourg (EPDS) et le ASQ: SE, questionnaire Etapes et Ages sur le développement socio-développemental et comportemental a été distribué au départ, à trois mois et à neuf mois plus tard. Des données d'un groupe non-clinique ont été collectées simultanément afin d'offrir des données de normes. Résultats: des modèles de croissance multiniveau sur les scores aux questionnaires des mères ont fait preuve de baisses importantes au fil du temps sur les deux mesures. Neuf mois après le départ, 50% ont fait preuve d'un changement important pour ce qui concerne l'EPDS et 14% pour ce qui concerne l'ASQ: SE. Les effets pré-post observés (d) étaient de 0,70 et 0,40 pour l'EPDS et l'ASQ: SE, comparable aux résultats d'études de contrôle. Conclusions: les psychothérapeutes intégrés avec un soin de santé publique semblent être parvenus à de bons résultats alors qu'ils soutenaient les mères en détresse avec de brèves interventions périnatales. Le SPIPIC doit être comparé à d'autres modalités et d'autres structures organisationnelles.

What is the effect of emotional processing on depression? A longitudinal study.

Emotional processing is an empirically established predictor of pre-post therapy improvement in depression. However, its relationship to symptom alleviation over time requires clarification. To clarify the contribution of emotional processing to gradual symptom improvement, we explored both (1) the effect of emotional processing on pre-post therapy changes in depressive symptoms (final outcome) and (2) its association with the intensity of clinical symptoms across sessions (session-by-session outcome). These relationships were estimated in a sample of 50 depressed clients treated with cognitive-behavioral therapy (CBT) or emotion-focused therapy (EFT). Emotional processing was measured by the Experiencing Scale during Emotion Episodes in five sessions taken across therapy. As expected, we found that a greater increase in emotional processing during treatment predicted a greater pre-post therapy improvement in depressive symptoms. Higher levels of emotional processing predicted next-session lower intensity on clinical symptoms, but the intensity of symptoms contributed to explaining the subsequent level of emotional processing achieved. Our observations suggest that clients' capabilities to process their emotions may both facilitate and be promoted by gradual improvement in symptoms. These results suggest the reciprocal predictive influence of emotional processing and symptoms on the therapeutic change in depression.

Development of a core outcome set for myelodysplastic syndromes - a Delphi study from the EUMDS Registry Group.

Treatment options for myelodysplastic syndromes (MDS) vary widely, depending on the natural disease course and patient-related factors. Comparison of treatment effectiveness is challenging as different endpoints have been included in clinical trials and outcome reporting. Our goal was to develop the first MDS core outcome set (MDS-COS) defining a minimum set of outcomes that should be reported in future clinical studies. We performed a comprehensive systematic literature review among MDS studies to extract patient- and/or clinically relevant outcomes. Clinical experts from the European LeukemiaNet MDS (EUMDS) identified 26 potential MDS core outcomes and participated in a three-round Delphi survey. After the first survey (56 experts), 15 outcomes met the inclusion criteria and one additional outcome was included. The second round (38 experts) resulted in six included outcomes. In the third round, a final check on plausibility and practicality of the six included outcomes and their definitions was performed. The final MDS-COS includes: health-related quality of life, treatment-related mortality, overall survival, performance status, safety, and haematological improvement. This newly developed MDS-COS represents the first minimum set of outcomes aiming to enhance comparability across future MDS studies and facilitate a better understanding of treatment effectiveness.

A systematic approach to evaluate practice-based process- and outcome data applied to the treatment of neovascular age-related macular degeneration.

BACKGROUND: Following the principles of value-based health care, outcomes and processes of daily-practice eye care need to be systematically evaluated. We illustrate an approach that can be used to support data-driven quality improvements. We used patient data regarding the treatment of neovascular age-related macular degeneration (nAMD). METHODS: In a cohort study, we reviewed medical records of patients with nAMD confirmed on fluorescein angiography (FA). Patients were treated with intravitreal injections with bevacizumab; ranibizumab; or photodynamic therapy (PDT). Visual acuity (VA), ophthalmic exam results and treatments were recorded. VA was compared between treatments by linear mixed model. Diagnosis was re-evaluated on the original FAs. Outcome analysis was performed by 1) selecting VA as the relevant outcome parameter; 2) Preventing selection by comparing treatments with historical untreated cohort and cohorts from the literature, 3) correcting for confounding due to lesion type, and 4) identifying relevant process variables that affect the outcome. These were severity of disease at presentation, and doctor- and patient dependent process variables. RESULTS: In total, 473 eyes were included. At 12 months, change in VA was 0.54, 0.48, 0.09, and 0.07 LogMAR in the no-treatment, photodynamic therapy (PDT), bevacizumab, and ranibizumab groups, respectively. Lesion type on FA differed between groups. Diagnosis of nAMD could not be confirmed in 104 patients. Patient delay, inaccurate diagnosis and treatment intervals may have impacted outcomes. CONCLUSIONS: The effect of PDT was small to absent. Anti-VEGFs were effective and appeared as effective as in RCTs. Correct selection of a comparator cohort and addressing confounding, including confounding by indication and effect modification, are needed to achieve valid results and interpretation. Patient delay, diagnosis accuracy, indication for and application of treatment can potentially be improved to improve treatment outcomes. In a value-based care perspective, systematic evaluation of diagnostic accuracy, treatment indication, protocols, and outcomes of new interventions is needed at an early stage to improve outcomes.

Characteristics of male triple negative breast cancer: A population-based study.

Male triple negative breast cancer (TNBC), which lacks expression of the estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor 2 (HER2), is a very rare entity, comprising only a very small percentage of all male breast cancer cases. Management strategies are typically based off research conducted in female TNBC patients; however, there is still much that remains unknown in the male cohort, such as risk factors for developing these malignancies, the optimal treatment approach, and both short-term and long-term outcome data. In this retrospective cohort study, we aimed to address these concerns by assessing both the characteristics of male patients who develop TNBC as well as their outcomes. We harnessed data from the National Cancer Institute Surveillance, Epidemiology, and End Results (SEER) Program and identified 66 male patients diagnosed with TNBC between 2010 and 2016. Patients were stratified by several variables including age, insurance status, time period of diagnosis, histology, nodal status, tumor grade, tumor stage at diagnosis, and treatment strategy employed for the assessment of overall survival (OS) differences. Our analysis demonstrated that stage remains the most important prognostic factor for OS, with higher stage corresponding to worse OS. A significant OS benefit was also identified in men undergoing a total mastectomy, compared to partial mastectomy or no surgery at all. We also identified that male patients are more likely to present with more advanced disease stages compared to their female counterparts and, therefore, have worse outcomes on average. This may be due to various factors, including the rarity of male TNBC cases and less clear screening guidelines for male breast cancer in general. Trends toward poorer OS with higher tumor grade, higher tumor T stage, advanced age, earlier time period of diagnosis, and ductal histology were also identified, but did not achieve statistical significance. The remaining variables did not appear to influence outcomes in a meaningful manner. In summary, our study suggests, similar to population studies of women with TNBC, that tumor stage is a major prognostic factor of OS in men with TNBC. The data also suggest that the surgical treatment strategy employed is also likely of significance, with improved OS being seen with total mastectomies over partial mastectomies. Other variables such as tumor grade and T stage also likely play a role, but did not achieve statistical significance owing to the small population size. Owing to the rarity of cases, further studies of male TNBC are needed to better understand this rare entity and guide future management strategies.

A Randomized Controlled Trial of Healthy Families: 6-Month and 1-Year Follow-Up.

Home visitation research remains on the forefront as policy makers look to evidence for programs they believe are worthy of investment, particularly in terms of child abuse prevention. A randomized controlled trial (N = 245) of the Healthy Families Arizona home visitation program was conducted. Outcomes were assessed across several key domains related to child abuse and neglect: safety and resources, parenting attitudes and behaviors, health and maternal outcomes, and mental health and coping. Findings revealed significant differences between the groups at both 6-month and 1-year follow-up assessments on use of resources, mobilizing resources, home environment, subsequent pregnancy, positive affect, and problem solving favoring the Healthy Families group. A significant difference was also found between the groups on total violence measured at the 1-year follow-up favoring the Healthy Families group. A qualitative linguistic inquiry and word count analysis was conducted of parent's descriptions of their children and their parenting experiences. Results again revealed significant differences between the groups in narrative descriptions that favored the Healthy Families group. Implications of these findings are discussed in light of the existing evidence for home visitation programs.

The Medical Outcome Study-HIV Health Survey: A systematic review and reliability generalization meta-analysis.

The Medical Outcome Study-HIV Health Survey (MOS-HIV) is one of the most used questionnaires for the evaluation of the health-related quality of life (HRQoL) in people living with HIV (PLWHIV) in both medical settings and research studies. This study aimed to estimate the average reliability of the MOS-HIV scores and to evaluate the characteristics of the studies that could explain the variability between reliability estimates. Furthermore, the study aimed to estimate the induction rate of the reliability of the MOS-HIV. A systematic review of the previous literature, including studies that reported α and/or test-retest coefficients with the data at hand for the total score of the MOS-HIV and the subscales, was conducted. Fifty studies (52 samples; N = 14,132) were included in the reliability generalization meta-analysis. The average α coefficient for the total score of MOS-HIV was .91 and above .80 for all of the subscales, except for role functioning, which had an average coefficient of .76. Different study dimensions were related to the heterogeneity of reliability between studies. Reliability induction was found to be 76.1%. The results obtained in the present study indicate that the MOS-HIV is a reliable instrument for HRQoL evaluation in PLWHIV, for clinical and research purposes. In the clinical practice of health services, nurses could employ this gold standard for reliable evaluations of HRQoL in PLWHIV.

Durability of open surgical repair of type I-III thoracoabdominal aortic aneurysm.

OBJECTIVE: Early outcomes and late mortality after open repair of extent I to III thoracoabdominal aortic aneurysms (TAAAs) are described, but late graft and aortic events are seldom detailed. This study investigated long-term aortic and graft outcomes as these data are increasingly important as endovascular repair matures. METHODS: During 28 years, 516 patients underwent repair (type I, n = 177 [34%]; type II, n = 100 [20%]; type III, n = 239 [46%]). Patients were monitored for late events. Late aortic events were defined as native aortic disease leading to death or further intervention. Planned secondary procedures were excluded. Graft complications included anastomotic aneurysm, graft infection, and branch occlusions. Variables were assessed for association with end points using log-rank methods and Cox proportional hazards regression. Time-to-event analysis was performed using Kaplan-Meier methods. RESULTS: In-hospital death occurred in 40 patients (8%), leaving 476 for surveillance. Mean age was 69.8 ± 10.5 years. Mean follow-up was 4.9 ± 4.6 years. Repair conduct included distal aortic perfusion and motor evoked potential monitoring (n = 169 [35.5%]), clamp and sew (n = 307 [64.5%]), and selectively applied in-line mesenteric shunting (n = 172 [36.1%]). At the time of repair, 117 patients (24.6%) had 122 synchronous, noncontiguous aortic aneurysms. There were 98 late aortic and graft events in 89 patients (18.7%); 62 aortic-related events occurred in 56 patients (12%; elective repair, n = 47; emergent repair, n = 14; type A dissection, n = 1) at a mean of 4.4 ± 4.2 years after repair. Variables independently predictive of an aortic event were aortic clamp time (hazard ratio [HR], 1.02/min; P = .001), type III extent (HR, 2.5; P = .008), and expansion of retained aorta (HR, 10.4; P < .0005). There were 33 patients (7%) who experienced 36 graft-related events (anastomotic aneurysm, n = 14 [3% of cohort; aortic, n = 7; visceral patch, n = 6; side graft, n = 1]; graft infection, n = 12; renovisceral occlusion/repair, n = 9 [1.9%; side-arm graft, n = 8; native, n = 1]; and anastomotic stricture, n = 1) occurring at 4.7 ± 4.5 years. Variables predictive of graft-related complication were type II extent (HR, 3.4; P = .002) and distal aortic perfusion and motor evoked potential monitoring (HR, 3.6; P = .02). Freedom from aortic- or graft-related event was 80% at 5 years. Freedom from any aortic or graft reintervention was 84% at 5 years. Aortic-related mortality after discharge was 2.7% and estimated to be 3.1% at 5 years. Overall survival was 67% and 44% at 5 and 10 years, respectively. CONCLUSIONS: After type I-III TAAA repair, late aortic and graft-related events occur in 19% of patients. Native aortic disease sequelae are more common than graft complication. Aortic events are predicted by complex operation and degree of remaining aorta. Extensive reconstruction drives graft-related events. Ultimately, reintervention is rare and aorta-related mortality low. These findings verify durability of extensive TAAA repair, serving as benchmarks for endovascular repair.