Standardized Outcome Measures Research Articles

“Cleft lip re-repair: How does it affect the nasolabial appearance? “

Cleft lip re-repair is a procedure frequently endorsed to enhance a compromised nasolabial appearance. However, the actual effect of such revision surgery on the nasolabial appearance has scarcely been studied. Therefore, the aim of this study was to critically review surgical outcomes of patients that underwent surgical re-do of their cleft lip, using well-validated objective and subjective methods and standardised outcome measures. 20 patients with at least 6 months follow-up after cleft lip re-repair were assessed. Standardised pre- and postoperative photographs were analysed. The objective assessment was carried out using the SymNose-software. Furthermore, a subjective evaluation of the nasolabial area was conducted by ten examiners who rated seven parameters using a Likert-scale ranging from 1to5. The objective evaluation showed substantial improvement regarding symmetry values. Significant postoperative decrease in labial asymmetry from 26.42% (±8.13) to 18.77% (±6.28) (p<0.001) and upper lip asymmetry in relation to the facial midline (26.91% (±8.03) vs. 18.27% (±5.17) (p<0.001)) was observed. Similar results were corroborated in the subjective analysis. Differences regarding the ratings were detected considering the examiners' professional background and level of expertise. Cleft re-repair was found to significantly improve upper lip symmetry and lead to a more harmonious nasolabial appearance.

Using Diet to Treat Inflammatory Bowel Disease: A Systematic Review.

To review the efficacy of various dietary interventions for induction of clinical remission in inflammatory bowel disease (IBD) and provide healthcare providers with a practical reference for recommending suitable diets for managing patients with IBD. PubMed, Medline(R), and Cochrane were searched from inception up to February 17, 2023 to identify all studies reporting information on using diet to treat IBD. Studies investigating the role of dietary interventions on adult patients with a confirmed diagnosis of active IBD for improvement or remission of IBD symptoms were rigorously considered. Sample meal plans, with a list of included and excluded foods, were also generated in order to provide clinicians with practical tools for advising patients on dietary intake. Eleven included studies provided data on 10 distinct diets: autoimmune protocol diet, high fiber diet, 4-SURE diet, highly restricted diet, McMaster elimination diet for Crohn's disease, specific carbohydrate diet, Mediterranean diet, Crohn's disease exclusion diet, individualized elimination diet, and the food-specific IgG4-guided exclusion diet. A total of 9 studies provided data on clinical remission. Many of these diets share common elements, such as an initial elimination phase with subsequent reintroduction of dietary components, inclusion of whole foods, and exclusion of highly or ultra-processed foods. Currently, there is limited evidence to support the use of specific diets to treat adult patients with mildly to moderately active IBD. Larger, randomized studies with standardized methodologies and outcome measures, rigorous adherence assessment, and an emphasis on endoscopic assessment outcome measures are required to validate most diets that have been studied for IBD. The included sample diet plans and dietary recommendations may prove helpful in the interim as part of a holistic strategy to manage patients with IBD.

New developments in the application of artificial intelligence to laryngology.

The purpose of this review is to summarize the existing literature on artificial intelligence technology utilization in laryngology, highlighting recent advances and current barriers to implementation. The volume of publications studying applications of artificial intelligence in laryngology has rapidly increased, demonstrating a strong interest in utilizing this technology. Vocal biomarkers for disease screening, deep learning analysis of videolaryngoscopy for lesion identification, and auto-segmentation of videofluoroscopy for detection of aspiration are a few of the new ways in which artificial intelligence is poised to transform clinical care in laryngology. Increasing collaboration is ongoing to establish guidelines and standards for the field to ensure generalizability. Artificial intelligence tools have the potential to greatly advance laryngology care by creating novel screening methods, improving how data-heavy diagnostics of laryngology are analyzed, and standardizing outcome measures. However, physician and patient trust in artificial intelligence must improve for the technology to be successfully implemented. Additionally, most existing studies lack large and diverse datasets, external validation, and consistent ground-truth references necessary to produce generalizable results. Collaborative, large-scale studies will fuel technological innovation and bring artificial intelligence to the forefront of patient care in laryngology.

Supporting staff wellbeing in healthcare settings through multi-levelled creative psychological intervention – a feasibility study

ABSTRACT Background There is growing evidence that the arts and arts-based therapies can support the wellbeing of healthcare workers. However, there are few large trials, limiting the use of such therapies in routine practice. Aim To establish the feasibility of introducing a multi-levelled, evidence-based creative psychological intervention delivered by qualified arts psychotherapists and targeting the wellbeing of NHS clinical staff. Methods This is a feasibility study with pre/post mixed methods design, the first to explore the value of an evidence-based, multi-levelled creative psychological package targeting the diverse needs of clinical staff within different healthcare settings. The intervention wasadapted from a 12-session group therapy titled Arts for the Blues into a three-level package that included: (i) one-off drop-in sessions to release tension, (ii) workshops for staff development, (iii) group sessions for psychological support. It was delivered by qualified arts psychotherapists (i.e., art, drama and dance movement psychotherapists) and used brief evaluation forms, arts-based data and standardised outcome measures to establish acceptability. Results Findings indicate difficulties with recruitment, but the 49 participants placed high value on the different levels offered. All the outcome measures used identified positive change and indicated medium to large effects of the multi-levelled intervention on improvement of wellbeing and resilience, as well as reduction of distress, anxiety, depression and trauma. Conclusions Although the small sample does not allow the generalisation of results, the study suggests that this multi-levelled creative psychological intervention offers acceptable support. Implications for practice/policy/research Further research is needed to establish the effectiveness of this intervention with specific teams of professionals. However, the diverse options proposed in this intervention need to be considered further for routine practice, expanding on current job descriptions for art psychotherapists. Plain-language summary Pressures on healthcare services mean that healthcare workers need support for their wellbeing. It is possible that the arts and arts therapies can offer this support, but we need to conduct more research to be certain. In this study we wanted to see if clinical staff working in health services liked a new creative intervention we developed based on our review of the research literature. We modified this intervention from the Arts for the Blues model, a 12-session group therapy that uses a mixture of different artistic forms. We used this new model to support the wellbeing of clinical staff in a large hospital in the North West of England. We did this in three different ways: Creative activities for the whole organisation to release tension (up to 30 min) Creative psychoeducational workshops with teams for staff development (up to 4 h) Creative psychotherapy sessions with individuals in a group for psychological support (up to 18 h). Arts psychotherapists, including art psychotherapists, designed the content of this work and facilitated their delivery. We collected information from 49 clinical staff before and after each of these activities through questionnaires and a brief evaluation form. Although clinical staff were very busy, they liked the different options of the intervention and their wellbeing scores improved. We need to do further research with a larger number of participants. However, the findings so far show that art psychotherapists can work not only with patients, but also with other healthcare workers to improve their wellbeing.

Comparative evaluation of cognitive behavioural therapy versus standard treatment in temporomandibular disorders: Asystematic review.

Temporomandibular disorders (TMDs) are musculoskeletal and neuromuscular conditions affecting the temporomandibular joint and associated structures. Cognitive-behavioural therapy (CBT) has emerged as a potential intervention for TMDs, but its comparative effectiveness against standard treatments remains unclear. This systematic review aimed to evaluate and compare the efficacy of CBT versus standard treatment interventions in managing TMDs. A comprehensive search was conducted across multiple databases using MeSH keywords and Boolean operators. Inclusion criteria encompassed clinical trials comparing CBT/CBT in combination with standard treatment interventions or a control group in individuals with TMDs. The primary outcome measured was pain. Secondary outcomes such as disability, depression and jaw function were also looked into. Two reviewers independently assessed for the eligibility of the articles and conducted data extraction. Quality assessments were performed using RoB 2.0 for randomised clinical trials. The initial search identified 623 articles, of which a total of eight clinical studies met the inclusion criteria and were included in the systematic review. Seven out of eight studies demonstrated improvements in outcomes related to TMD. Pain was significantly decreased in studies that showed a positive outcome. Jaw function, quality of life and psychological well-being were superior among individuals receiving CBT alone or in combination with conventional modalities, as well as hypnotic therapy coupled with CBT-based interventions. The quality of studies assessed showed all articles to be of good quality as per RoB-2 evaluation. This systematic review highlights the potential benefits of CBT in managing TMDs, suggesting its effectiveness in improving pain outcomes and enhancing overall well-being. The findings indicate that CBT may be a valuable adjunct or alternative to standard treatment interventions for individuals with TMDs. However, further research with larger sample sizes and standardised outcome measures is warranted to establish definitive conclusions regarding the comparative efficacy of CBT versus standard treatments in TMD management.

Facial nerve reconstruction for flaccid facial paralysis: a systematic review and meta-analysis.

To determine the functional outcome after facial nerve reconstruction surgery in patients with flaccid facial paralysis. A systematic review and meta-analysis was performed on studies reporting outcomes after direct facial nerve suture (DFS), facial nerve interpositional graft suture (FIGS), hypoglossal-facial nerve suture (HFS), masseteric-facial nerve suture (MFS), and cross-face nerve suture (CFS). These studies were identified from PubMed/MEDLINE, Embase, and Web of Science databases. Two independent reviewers performed two-stage screening and data extraction. A favorable result was defined as a final House-Brackmann grade I-III and is presented as a ratio of all patients in percentage. Pooled proportions were calculated using random-effects models. From 4,932 screened records, 54 studies with 1,358 patients were included. A favorable result was achieved after DFS in 42.67% of the patients [confidence interval (CI): 26.05%-61.12%], after FIGS in 66.43% (CI: 55.99%-75.47%), after HFS in 63.89% (95% CI: 54.83%-72.05%), after MFS in 63.11% (CI: 38.53%-82.37%), and after CFS in 46.67% (CI: 24.09%-70.70%). There was no statistically significant difference between the techniques (Q = 6.56, degrees of freedom = 4, p = 0.1611). The established facial nerve reconstruction techniques including the single nerve cross-transfer techniques produce satisfactory results in most of the patients with permanent flaccid facial paralysis. An international consensus on standardized outcome measures would improve the comparability of facial reanimation techniques.

Exploring Outcomes and Mediating Factors Following Supercharged End-to-Side Anterior Interosseous Nerve to Ulnar Nerve Transfer: A Scoping Review With Expert Insight

This scoping review with expert insight aims to map outcome measures following supercharged end-to-side anterior interosseous nerve to ulnar nerve transfer procedures, integrating clinical, patient-reported, and electrodiagnostic measures. It also explores surgical rationale and recovery trajectories, aiming to standardize methodologies and enhance patient care in nerve transfer surgeries. Our search encompassed multiple online databases, including MEDLINE, Embase, PubMed, and Google Scholar, ensuring rigor and comprehensiveness in identifying relevant literature. Through scrutiny of 17 studies involving 300 patients from 300 articles, along with expert consultations on supercharged end-to-side nerve transfer for ulnar nerve entrapment, promising outcomes emerge, particularly in cubital tunnel syndrome. Primary measures such as Medical Research Council scale assessments and Disabilities of the Arm, Shoulder, and Hand scores demonstrate notable postsurgery improvements, with minor complications noted. Factors influencing recovery include preoperative dysfunction duration and surgical technique. Surgery indications prioritize high ulnar nerve injuries and severe cubital tunnel syndrome. The review highlights the importance of standardized outcome measures, early intervention, and comprehensive rehabilitation for optimizing supercharged end-to-side anterior interosseous nerve to ulnar nerve transfer outcomes. Therapeutic IIIa.

Cross-condition risk and protective factors for psychosocial distress in parents and carers of children and young people with appearance-affecting conditions and injuries

Alongside typical parenting challenges, initial condition-specific research suggests thadifferent experiences and support needs.t parents of children with different visible differences may experience similar psychosocial difficulties. Despite this, large-scale cross-condition research to identify risk and protective factors for parental distress and psychosocial adjustment has been lacking. Two hundred and nine parents and carers of children with a range of visible differences completed an online survey comprised of standardised outcome measures, study-specific measures, and open-ended questions. Multiple regression modelling identified possible risk and protective factors, and data collected via open-ended questions were analysed using content analysis. Findings support themes previously identified in small-scale cross-condition qualitative research with parents of children with visible differences. Risk factors for parental negative affect and stress included parental reports of the noticeability of their child’s visible difference and teasing. Protective factors included good parent-child communication, self-compassion, knowledge of their child’s condition and satisfaction with treatment. The risk and protective factors identified provide important insight into the experiences of this parent population and indicate possible avenues for psychosocial intervention.

Connecting Practice to Data: Implementation Strategies to Increase Collection of Core Outcome Measures in an Inpatient Rehabilitation Facility.

To describe a quality improvement project aimed at increasing collection of a "Core Set" of functional outcome measures in an inpatient rehabilitation facility (IRF), characterize implementation strategies used across 4 study phases, and evaluate program adoption and maintenance. A 30-bed brain injury unit of a 132-bed IRF. Participants included physical therapists (5 full-time, 2 part-time, and 30 hourly as needed) and 764 individuals with traumatic brain injury (TBI) who received care during the project period. In this descriptive observational study, we operationalize implementation strategies selected for 4 project phases: Exploration, Preparation, Implementation, and Sustainment. We define each implementation strategy using the Expert Recommendations for Implementing Change and report on program adoption and maintenance. Adoption (proportion of TBI-related admissions with completed outcome measures) and maintenance (adoption over 4years). Preparation phase strategies focused on local adaptations, education, environmental preparation, and collaboration with informatics. Implementation phase strategies included reminders, feedback, champions, and iterative adjustments. Sustainment strategies focused on integration into standard practice. Adoption increased postinitiation for all measures except one. Despite improvements, a notable portion of measures remained incomplete. Increases in outcome measure collection were maintained for 2 to 4years, but a significant decline in paired admission and discharge scores suggests a reduced ability to monitor change over time. This study provides an example of a clinically driven quality improvement project and selected implementation strategies used to increase the collection of standard outcome measures in IRF. By leveraging the Expert Recommendations for Implementing Change framework, we aim to enhance comparability with similar efforts elsewhere. The results demonstrate the program's successes and challenges, highlighting the need for interdisciplinary clinical and research collaboration to support the translation of knowledge between research and clinical practice and inform meaningful improvements in care across TBI rehabilitation.

416 The Impact of Pancreas Transplantation on Secondary Diabetic Complications: A Systematic Review

Abstract Aim Pancreas transplantation (PT) provides diabetic cure for patients with complicated Type 1 Diabetes Mellitus (T1DM). We aimed to examine the impact of PT on secondary diabetic complications, including retinopathy, neuropathy, and cardiovascular disease. Method A database search using MedLINE for publications up to April 2023 was conducted employing MeSH terms ‘Pancreas Transplantation’ AND ‘Diabetes Mellitus, Type 1’ AND ‘Diabetic Retinopathy’ OR ‘Heart Disease’ OR ‘Cardiovascular Diseases’ OR ‘Peripheral Vascular Disease’ OR “Amputation’ OR ‘Neuropathy.” Results 223 articles were screened, with 172 excluded as per study design (total included 51). 64.7% (n=33) of studies were retrospective case control studies, 35.3% (n=18) of studies were retrospective cohort studies. A total of 5616 patients with a mean of 99.1 (SD± 262.4) simultaneous kidney transplant (SPK) patients and 48.2 (SD± 262.4) pancreas transplant alone (PTA) patients per article were studied. All articles examining diabetic retinopathy concluded that retinopathy improved or stabilized. 69% (n=11) of papers demonstrated no significant change to visual acuity. An equal number of articles (n=4) demonstrated increased peripheral nerve conduction velocity after SPK and PTA. 40% (n=2) of articles examining vibration perception studies demonstrated an increase post-transplantation. Improvements in cardiac events incidence, metabolic factors, and heart structure were seen in 79% (n=15) of cardiovascular articles. Conclusions Despite significant heterogeneity in outcome measures observed, PT provides benefits in mitigating the complication profile of T1DM. Standardised outcome measurement should be adopted to allow assessment of the impact of beta-cell replacement with the potential for objective evidence reversibility of secondary complications.

A Comparative Study on Aesthetic and Pain Outcomes in Flap Versus Implant Breast Reconstruction After Mastectomy.

Breast cancer is the most commonly diagnosed cancer and the leading cause of cancer death among women worldwide. Surgical treatments, including mastectomy and subsequent breast reconstruction, are critical components of breast cancer management. This systematic review compares the outcomes of flap versus implant reconstruction post-mastectomy, focusing on aesthetic differences, pain, recovery, and psychological adaptation. Adhering to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses(PRISMA) 2020 guidelines, we conducted a comprehensive literature search across PubMed, Cochrane, and ScienceDirect databases. Inclusion criteria targeted studies comparing aesthetic outcomes, pain, recovery costs, duration, and psychological adaptation between flap and implant breast reconstructions. We excluded non-English and non-Spanish studies, case reports, and those without full-text availability. The risk of bias was assessed using the Newcastle-Ottawa Scale (NOS). From an initial pool of 25,881 articles, 16 high-quality studies involving 14,196 participants were selected for synthesis. Flap reconstruction was associated with higher patient satisfaction regarding aesthetic outcomes and psychological well-being but also had higher complication rates, including infections and wound dehiscence. Implant reconstruction showed fewer complications but did not achieve the same level of patient satisfaction. Flap reconstruction, despite its higher complication rates, tends to provide superior aesthetic and psychological outcomes compared to implant reconstruction. These findings highlight the importance of personalized treatment plans considering individual patient needs and preferences. Future research should focus on long-term randomized controlled trials (RCTs) and standardized outcome measures to further delineate the comparative effectiveness of these reconstruction techniques. Personalized care and ongoing research are essential to improving the quality of life for breast cancer survivors undergoing reconstruction.

Validation and correlations of the Angioedema Activity Score (AAS), Angioedema Quality of Life (AE-QoL) questionnaire, and Angioedema Control Test (AECT) in Chinese patients with angioedema

BackgroundThe impact of recurrent angioedema can be severely debilitating and remains difficult to quantify. Several standardized patient-reported outcome measures (PROMs), including the Angioedema Activity Score (AAS), Angioedema Quality of Life Questionnaire (AE-QoL) and Angioedema Control Test (AECT), have been developed and translated into different languages. However, these PROMs have yet to be validated in Chinese and their correlations in the Chinese population remain unknown. ObjectiveTo validate the Chinese AAS, AE-QoL, and AECT and to assess their inter-correlations. MethodsA prospective cohort of 118 Chinese patients with recurrent angioedema at the Angioedema and Urticaria Centre of Reference and Excellence in Hong Kong completed the traditional Chinese versions of the AAS, AE-QoL, and AECT. We analysed the reliability and validity of these PROMs and their correlations with each other and with generic PROMs. ResultsThe Chinese AAS, AE-QoL and AECT demonstrated excellent internal consistency (Cronbach’s α: 0.920, 0.976, and 0.832; McDonald’s ω: 0.972, 0.977, and 0.901; respectively). Confirmatory factor analysis for the AE-QoL showed an acceptable fit to the 4-dimensional model (comparative fit index=0.869, Tucker–Lewis’s index=0.842). The AECT showed significant correlations with both the AAS and AE-QoL (ρ=-0.750 and -0.456 respectively, both p<0.05). The AE-QoL moderately correlated with certain domains of generic PROMs such as WPAI-GH V2.0 and SF-12v2 (all ρ<0.60). ConclusionThe Chinese AE-QoL, AAS, and AECT are valid and reliable tools for Chinese patients. More validated tools should be made available to improve patient care and research for all angioedema patients globally.

Physical exercise to promote regeneration after peripheral nerve injury in animal models: A systematic review.

Peripheral nerve injuries are common injuries that often have a drastic effect on patient's activities of daily living and physical function. While techniques for the surgical repair of these injuries have improved over time, rehabilitation methods following these repairs have been non-standardized and under researched. Electronic searches were conducted in Ovid/Medline and SCOPUS to identify articles that discuss rehabilitation and exercise following peripheral nerve injury in animal models and its effects on peripheral nerve regeneration and recovery of function. Thirty-eight articles met inclusion criteria; all were prospective studies in animal models. This systematic review suggests that exercise is a useful tool in returning autonomy to the individual and has beneficial effects in the recovery from peripheral nerve injury. It is beneficial to use rehabilitation exercises following the repair of peripheral nerve injuries to promote regeneration, and timing of that exercise may be just as important as the exercise prescribed. However, further studies with standardized models and outcome measures need to be conducted before translation to clinical trials.

Limbal stem cell therapy.

To highlight the progress and future direction of limbal stem cell (LSC) therapies for the treatment of limbal stem cell deficiency (LSCD). Direct LSC transplantation have demonstrated good long-term outcomes. Cultivated limbal epithelial transplantation (CLET) has been an alternative to treat severe to total LSCD aiming to improve the safety and efficacy of the LSC transplant. A prospective early-stage uncontrolled clinical trial shows the feasibility and safety of CLET manufactured under xenobiotic free conditions. Other cell sources for repopulating of the corneal epithelium such as mesenchymal stem cells (MSCs) and induced pluripotent stem cells are being investigated. The first clinical trials of using MSCs showed short-term results, but long-term efficacy seems to be disappointing. A better understanding of the niche function and regulation of LSC survival and proliferation will lead to the development of medical therapies to rejuvenate the residual LSCs found in a majority of eyes with LSCD in vivo. Prior efforts have been largely focused on improving LSC transplantation. Additional effort should be placed on improving the accuracy of diagnosis and staging of LSCD, and implementing standardized outcome measures which enable comparison of efficacy of different LSCD treatments for different severity of LSCD. The choice of LSCD treatment will be customized based on the severity of LSCD in the future. New approaches for managing different stages of LSCD are being developed. This concise review summarizes the progresses in LSC therapies for LSCD, underlying mechanisms, limitations, and future areas of development.

Implementing a Uniform Outcome Measurement Approach for Early Interventions of Autism Spectrum Disorders

Naturalistic developmental behavioral interventions for children with autism spectrum disorder show evidence for effectiveness for specific social communication targets such as joint attention or engagement. However, combining evidence from different studies and comparing intervention effects across those studies have not been feasible due to lack of a standardized outcome measure of broader social communication skills that can be applied uniformly across trials. This investigation examined the usefulness of the Brief Observation of Social Communication Change (BOSCC) as a common outcome measure of general social communication skills based on secondary analyses of data obtained from previously conducted randomized controlled trials of 3 intervention models, Early Social Intervention (ESI), Early Start Denver Model (ESDM) and Joint Attention Symbolic Play Engagement and Regulation (JASPER). The subset of datasets from the 3 randomized controlled trials was created to examine differences in the BOSCC scores between intervention and control groups over the course of the interventions. Based on 582 videos from 207 caregiver-child dyads, the BOSCC noted significant differences between intervention vs control groups in broad social communication skills within 2 of the 3 intervention models, which were longer in duration and focused on a broad range of developmental skills. The BOSCC offers the potential to take a uniform measurement approach across different intervention models to capture the effect of intervention on general social communication skills but may not pick up the effects of some brief interventions targeting proximal outcomes. Comparing Parent-Implemented Interventions for Toddlers With Autism Spectrum Disorders; https://www. gov/; NCT00760812. Intensive Intervention for Toddlers With Autism (EARLY STEPS); https://www. gov/; NCT00698997. Social and Communication Outcomes for Young Children With Autism; https://www. gov/; NCT00953095.

Navigating Pain: Exploring the Therapeutic Potential of Virtual Reality for Fibromyalgia Management

Background: Fibromyalgia syndrome (FMS) affects a significant portion of the global population, predominantly women, with profound impacts on quality of life due to widespread pain and associated symptoms. Traditional treatments, while beneficial, may not fully address all aspects of the condition. Virtual Reality (VR) therapy offers a novel approach, leveraging immersive environments to distract from pain and improve patient engagement. Methodology: This randomized controlled trial evaluated the efficacy of non-immersive VR therapy in managing FMS symptoms. Participants (n=52) were recruited from a tertiary care hospital and assigned to either VR therapy or standard care groups. Outcome measures included pain intensity, physical function (FIQ), and quality of life (SF-36), assessed at baseline, post-intervention (4 weeks), and follow-up (12 weeks). Results: VR therapy significantly reduced pain intensity compared to standard care (mean difference -2.5, p&lt;0.001). While improvements in physical function and quality of life were observed in the VR group, they were not statistically significant. Importantly, VR therapy effectively reduced kinesiophobia, demonstrating its potential to enhance patient participation in physical activities crucial for managing FMS. Conclusion: VR therapy shows promise as a standalone treatment for reducing pain intensity and addressing kinesiophobia in FMS patients. Future research should focus on larger samples, longer follow-up periods, and standardized outcome measures to elucidate VR therapy's broader impacts on physical function and quality of life in fibromyalgia management. Keywords: Fibromyalgia, Virtual Reality Therapy, Pain Management, Kinesiophobia.

Effectiveness of custom seating and mobility services for individuals with disabilities in Guatemala

The purpose of this study was to evaluate the effectiveness of custom seating and mobility services provided via an international service learning (ISL) model on the occupational performance of individuals with disabilities in Guatemala. A one-group prospective pretest-posttest design was implemented using the standardized Wheelchair Outcome Measure (WhOM – Spanish) administered on the day of wheelchair fitting, and at 3- and 6-month intervals after receiving seating and mobility services. A two-tailed t-test demonstrated a statistically significant (p < 0.001) improvement in satisfaction for in-home and out-of-home occupations for all participants (n = 71) at 3-months with a huge effect size (d > 2) and this improvement was maintained at the 6-month interval. The results were consistent for various areas of occupational performance (e.g. activities of daily living). The provision of customized seating and mobility services by occupational therapists through an ISL model demonstrated effectiveness at improving satisfaction with occupational performance for individuals with disabilities in Guatemala. Cultural humility, customization of equipment based on personal and environmental factors, inclusion of education and training, and collaboration with in-country partners were identified as contributors to positive outcomes.

Development of a differential treatment selection model for depression on consolidated and transformed clinical trial datasets

Major depressive disorder (MDD) is the leading cause of disability worldwide, yet treatment selection still proceeds via “trial and error”. Given the varied presentation of MDD and heterogeneity of treatment response, the use of machine learning to understand complex, non-linear relationships in data may be key for treatment personalization. Well-organized, structured data from clinical trials with standardized outcome measures is useful for training machine learning models; however, combining data across trials poses numerous challenges. There is also persistent concern that machine learning models can propagate harmful biases. We have created a methodology for organizing and preprocessing depression clinical trial data such that transformed variables harmonized across disparate datasets can be used as input for feature selection. Using Bayesian optimization, we identified an optimal multi-layer dense neural network that used data from 21 clinical and sociodemographic features as input in order to perform differential treatment benefit prediction. With this combined dataset of 5032 individuals and 6 drugs, we created a differential treatment benefit prediction model. Our model generalized well to the held-out test set and produced similar accuracy metrics in the test and validation set with an AUC of 0.7 when predicting binary remission. To address the potential for bias propagation, we used a bias testing performance metric to evaluate the model for harmful biases related to ethnicity, age, or sex. We present a full pipeline from data preprocessing to model validation that was employed to create the first differential treatment benefit prediction model for MDD containing 6 treatment options.

Continuous positive airway pressure is unsafe for radiofrequency ablation of lung cancer under sedation: a randomised controlled trial

ObjectiveTo evaluate the safety of a minimum continuous positive airway pressure of 4 cmH2O (CPAP + 4) during computed tomography (CT)-guided radiofrequency ablation (RFA) for lung malignancies under procedural sedation and analgesia (PSA).MethodsThis was a prospective, randomised, single-blind, parallel-group, placebo-controlled trial with an open-label medical device conducted at a single tertiary university hospital in Barcelona, Spain. Forty-six patients over 18 years of age scheduled for CT-guided RFA of a malignant pulmonary tumour under PSA were randomised to receive either CPAP + 4 or a modified mask for placebo CPAP (Sham-CPAP). Exclusion criteria included contraindications for RFA, refusal to participate, inability to understand the procedure or tolerate the CPAP test, lung biopsy just prior to RFA, intercurrent diseases, or previous randomisation for additional pulmonary RFA. Primary outcomes were the percentage of patients reporting at least one serious adverse event (SAE), classification for complications from the Cardiovascular and Interventional Radiological Society of Europe (CIRSE), and Clavien-Dindo classifications for complications, hospital stay, and readmissions. Secondary outcomes included adverse events (AEs), respiratory parameters, airway management, and the local radiological efficacy of pulmonary ablation.ResultsCPAP + 4 prolonged hospital stay (1.5 ± 1.1 vs. 1.0 ± 0 inpatient nights, p = 0.022) and increased the risk of AE post-RFA (odds ratio (95% CI): 4.250 (1.234 to 14.637), p = 0.021 with more pneumothorax cases (n = 5/22, 22.7% vs. n = 0/24, 0%, p = 0.019). Per-protocol analysis revealed more SAEs and CIRSE grade 3 complications in the CPAP + 4 group (23.5% vs. 0%, p = 0.036). No significant differences were found in the effectiveness of oxygenation, ventilation, or pulmonary ablation.ConclusionCPAP is unsafe during CT-guided RFA for lung cancer under PSA even at the lowest pressure setting.Trial registrationClinicalTrials.Gov, ClinicalTrials.gov ID NCT02117908, Registered 11 April 2014, https://www.clinicaltrials.gov/study/NCT02117908Critical relevance statementThis study highlights the hazards of continuous positive airway pressure during radiofrequency ablation of lung cancer, even at minimal pressures, deeming it unsafe under procedural sedation and analgesia in pulmonary interventional procedures. Findings provide crucial insights to prioritise patient safety.Key PointsNo prior randomised controlled trials on CPAP safety in percutaneous lung thermo-ablation.Standardised outcome measures are crucial for radiology research.CPAP during lung RFA raises hospital stay and the risk of complications.CPAP is unsafe during CT-guided RFA of lung cancer under procedural sedoanalgesia.Graphical

Mass General Brigham’s Patient-Reported Outcomes Measurement System: A Decade of Learnings

This article describes the strategies that leaders at the Mass General Brigham (MGB) health system have used in launching a standardized patient-reported outcome measure (PROM) collection program in 2012, a major step in the value-based transformation of health care. This article documents many benefits to patients, clinicians, and payers from the effective design, collection, and use of PROMs. These benefits include shared decision-making aligned to patients’ goals; improving patient expectations about their likely experiences and outcomes from treatment; empowering patients to self-monitor during recovery; facilitating communication between physicians and patients about what matters most to patients; enhancing treatment by having PROMs embedded in the patients’ electronic health record; and reducing disparities in access, treatment, and outcomes for previously underserved racial and ethnic groups. For payers, PROMs allow payments to be based on patient outcomes. By continuously answering each stakeholder’s “what’s in it for me” question, MGB has taken an important step toward building a learning health system to equitably achieve health outcomes that align with patients’ goals for their health. Working together, the MGB PROMs Program and the Brigham and Women’s Hospital’s Patient-Reported Outcomes, Value, and Experience Center, a transdisciplinary PROMs research hub, plan to continue their efforts to improve and expand the use of PROMs to accelerate the shift toward accountable, patient-centered care.