Patient-centered Outcomes Research Articles

A case study on the implementation of quality and comprehensive indicators set in routine diabetes care

IntroductionType 2 diabetes is a major public health issue in Mexico due to its high prevalence and its projection for the coming years for this disease. Findings on multidisciplinary care related to chronic diseases have proven effective, based on measurement of patient-centered outcomes, The Center of Comprehensive Care for Patients with Diabetes (CAIPaDi) is a multidisciplinary program focused on reducing diabetes complications. This case study aims to illustrate the results of implementing health outcomes measurements and demonstrate the beneficial effects of establishing a comprehensive model of care through a patient-centered approach.MethodsA descriptive analysis of the comprehensive care indicators of patients with type 2 diabetes treated in the CAIPaDi program between 2013 and 2023 was conducted. The results were structured according to the standard set of outcomes for diabetes proposed by the International Consortium for Health Outcomes Measurements (ICHOM).ResultsThe baseline and prospective registration of consultations was completed for five years, complying with 25 of the 26 indicators of the ICHOM set. In diabetes control, 56.5% of patients had A1c ≤ 7%, 87.9% had BP ≤ 130/80 mmHg, 60.9% had LDL-cholesterol < 100 mg/dl, and obesity rates decreased from 42.19% to 30.6% during annual consultations. Fewer years of diagnosis before the first visit is key to overall improvement in program adherence (P = 0.02).In acute events, a hyperglycemic crisis occurred in only two cases and severe hypoglycemia episodes in 8 patients. For chronic complications, no lower limb amputations occurred. Cardiovascular outcomes occurred in < 1%. Periodontal disease was analyzed, and periodontitis decreased from 82.9% to 78.7%. Mortality reports were low, with COVID-19 being the main cause of death. Patient-reported outcomes demonstrated reductions in anxiety, depression, and diabetes distress during follow-up.ConclusionRegistering quality-of-care indicators is feasible in a comprehensive care program. It allows improving the medical, mental health, and lifestyle outcomes of patients with type 2 diabetes and provides relevant data for planning health programs. A quick diagnosis before program adherence is crucial for overall improvement in patients.

Postoperative pain trajectory and opioid requirements after laparoscopic bariatric surgery: a single-centre historical cohort study.

Concerns around delayed emergence and opioid-induced ventilatory impairment in bariatric surgery can lead to intraoperative reliance on short-acting opioids and avoidance of long-acting analgesics with potential sedative effects. Nevertheless, an overly-conservative intraoperative analgesic strategy may result in significant pain at emergence and higher opioid requirements in later phases of care. We sought to establish the pattern of intraoperative analgesic use in bariatric surgical patients as well as their postoperative pain trajectory and opioid requirements. We undertook a single-centre historical cohort study. We explored associations between intraoperative analgesic interventions and pain scores and opioid requirements in postanesthesia care units (PACUs), and associations between the quality of analgesia at emergence and subsequent pain and patient-centred recovery outcomes. We extracted perioperative data for 939 patients who underwent bariatric metabolic surgery between January 2018 and October 2019. Only 39% of patients received long-acting opioids intraoperatively and there was minimal use of nonopioid analgesic adjuncts. Nearly 80% of patients reported moderate-to-severe pain on PACU arrival; 97% of patients received intravenous opioids for rescue analgesia (mean dose, 31mg oral morphine equivalents). Lower pain scores at PACU admission and discharge were associated with subsequent lower inpatient pain scores, lower opioid requirements, shorter time to ambulation, and shorter length of hospital stay. In bariatric surgical patients, effective intraoperative analgesic strategies that improve early pain control may have an impact on recovery and pain experience. Judicious use of intraoperative opioids coupled with opioid-sparing multimodal analgesic techniques should be considered and balanced against concerns regarding opioid-related adverse effects in this patient population.

Intravenous Idursulfase for the Treatment of Mucopolysaccharidosis Type II: A Systematic Literature Review.

Mucopolysaccharidosis type II (MPS II; Hunter syndrome) is a rare, X-linked disorder caused by deficient activity of the enzyme iduronate-2-sulfatase. Signs and symptoms typically emerge at 1.5-4 years of age and may include cognitive impairment, depending on whether patients have the neuronopathic or non-neuronopathic form of the disease. Treatment is available in the form of enzyme replacement therapy (ERT) with recombinant iduronate-2-sulfatase (idursulfase). A systematic literature review was conducted to assess the evidence regarding efficacy, effectiveness, and safety of ERT with intravenous idursulfase for MPS II. Electronic databases were searched in January 2023, and 33 eligible articles were found. These were analyzed to evaluate the effects of intravenous idursulfase and the overall benefits and disadvantages in patient subgroups. Studies showed that intravenous idursulfase treatment resulted in improved short- and long-term clinical and patient-centered outcomes, accompanied by a favorable safety profile. Patients with non-neuronopathic MPS II had more pronounced improvements in clinical outcomes than those with neuronopathic MPS II. In addition, the review identified that improvements in clinical outcomes are particularly apparent if intravenous idursulfase is started early in life, strengthening previous recommendations for early ERT initiation to maximally benefit patients. This review provides a comprehensive summary of our current knowledge on the efficacy of ERT in different populations of patients with MPS II and will help to inform the overall management of the disease in an evolving treatment landscape.

Definition and management of right ventricular injury in adult patients receiving extracorporeal membrane oxygenation for respiratory support using the Delphi method: a PRORVnet study. Expert position statements.

Veno-venous extracorporeal membrane oxygenation (VV-ECMO) is an integral part of the management algorithm of patients with severe respiratory failure refractory to evidence-based conventional treatments. Right ventricular injury (RVI) pertaining to abnormalities in the dimensions and/or function of the right ventricle (RV) in the context of VV-ECMO significantly influences mortality. However, in the absence of a universally accepted RVI definition and evidence-based guidance for the management of RVI in this very high-risk patient cohort, variations in clinical practice continue to exist. Following a systematic search of the literature, an international Steering Committee consisting of eight healthcare professionals involved in the management of patients receiving ECMO identified domains and knowledge gaps pertaining to RVI definition and management where the evidence is limited or ambiguous. Using a Delphi process, an international panel of 52 Experts developed Expert position statements in those areas. The process also conferred RV-centric overarching open questions for future research. Consensus was defined as achieved when 70% or more of the Experts agreed or disagreed on a Likert-scale statement or when 80% or more of the Experts agreed on a particular option in multiple-choice questions. The Delphi process was conducted through four rounds and consensus was achieved on 31 (89%) of 35 statements from which 24 Expert position statements were derived. Expert position statements provided recommendations for RVI nomenclature in the setting of VV-ECMO, a multi-modal diagnostic approach to RVI, the timing and parameters of diagnostic echocardiography, and VV-ECMO settings during RVI assessment and management. Consensus was not reached on RV-protective driving pressure thresholds or the effect of prone positioning on patient-centric outcomes. The proposed definition of RVI in the context of VV-ECMO needs to be validated through a systematic aggregation of data across studies. Until further evidence emerges, the Expert position statements can guide informed decision-making in the management of these patients.

Preparation and Rationale for a Patient-Centered Clinical Outcome Assessment Set of Fluid Overload for Drug Development in Nephrotic Syndrome

Introduction: Fluid overload is a source of substantial morbidity for adults and children with nephrotic syndrome (NS). Preparation and Rationale for a Fluid Overload in Nephrotic Syndrome Clinical Outcomes Assessment Set for Drug Development (Prepare-NS, 5UG3FD007308) was funded by the US Food and Drug Administration to develop a core set of patient-reported and observer-reported (for young children) outcome measures of fluid overload for use in pharmaceutical trials across the lifespan. Methods: The Prepare-NS study team developed the proposed context of use with input from stakeholders. We conducted a scoping review to assess the available literature on relevant patient- and observer-reported measures and performed secondary analyses of existing qualitative and quantitative data. Results: The outcome set will aim to serve individuals 2 years of age and older with primary NS conditions (specifically focal segmental glomerulosclerosis, minimal change disease, IgM nephropathy, membranous nephropathy, and childhood-onset NS not biopsied). The existing literature describing patient-reported outcomes in NS largely relies on nonspecific measures of health-related quality of life; fluid overload has been associated with lower scores on these measures. Conclusion: To address the gap in measure availability and fluid overload content, the Prepare-NS team has launched a set of qualitative studies for concept elicitation from the population of interest to inform development of new measures. The resulting measures subsequently will undergo psychometric evaluation and validation in a survey study.

A pragmatic, stepped-wedge, hybrid type II trial of interoperable clinical decision support to improve venous thromboembolism prophylaxis for patients with traumatic brain injury

BackgroundVenous thromboembolism (VTE) is a preventable medical condition which has substantial impact on patient morbidity, mortality, and disability. Unfortunately, adherence to the published best practices for VTE prevention, based on patient centered outcomes research (PCOR), is highly variable across U.S. hospitals, which represents a gap between current evidence and clinical practice leading to adverse patient outcomes.This gap is especially large in the case of traumatic brain injury (TBI), where reluctance to initiate VTE prevention due to concerns for potentially increasing the rates of intracranial bleeding drives poor rates of VTE prophylaxis. This is despite research which has shown early initiation of VTE prophylaxis to be safe in TBI without increased risk of delayed neurosurgical intervention or death. Clinical decision support (CDS) is an indispensable solution to close this practice gap; however, design and implementation barriers hinder CDS adoption and successful scaling across health systems. Clinical practice guidelines (CPGs) informed by PCOR evidence can be deployed using CDS systems to improve the evidence to practice gap. In the Scaling AcceptabLE cDs (SCALED) study, we will implement a VTE prevention CPG within an interoperable CDS system and evaluate both CPG effectiveness (improved clinical outcomes) and CDS implementation.MethodsThe SCALED trial is a hybrid type 2 randomized stepped wedge effectiveness-implementation trial to scale the CDS across 4 heterogeneous healthcare systems. Trial outcomes will be assessed using the RE2-AIM planning and evaluation framework. Efforts will be made to ensure implementation consistency. Nonetheless, it is expected that CDS adoption will vary across each site. To assess these differences, we will evaluate implementation processes across trial sites using the Exploration, Preparation, Implementation, and Sustainment (EPIS) implementation framework (a determinant framework) using mixed-methods. Finally, it is critical that PCOR CPGs are maintained as evidence evolves. To date, an accepted process for evidence maintenance does not exist. We will pilot a “Living Guideline” process model for the VTE prevention CDS system.DiscussionThe stepped wedge hybrid type 2 trial will provide evidence regarding the effectiveness of CDS based on the Berne-Norwood criteria for VTE prevention in patients with TBI. Additionally, it will provide evidence regarding a successful strategy to scale interoperable CDS systems across U.S. healthcare systems, advancing both the fields of implementation science and health informatics.Trial registrationClinicaltrials.gov– NCT05628207. Prospectively registered 11/28/2022, https://classic.clinicaltrials.gov/ct2/show/NCT05628207.

Mosques and Public Health Promotion: A Scoping Review of Faith-Driven Health Interventions.

Religious institutions play a crucial role in health promotion and hold significant influence in the public health field. The aim of this review is to examine outcomes of health-promoting interventions involving the use of mosques as the intervention venue, its role in promoting health behavior change, and the role of theory in each intervention. A scoping review was conducted across 17 databases for relevant publications published up to and including August 2023 that involved the use of mosques as the intervention venue. Fourteen articles met inclusion criteria and were reviewed. The studies featured a wide range of interventions. However, only eight of these studies integrated theoretical frameworks into their approaches, indicating a need for more structured guidance in this field. These theoretical frameworks included Participatory Action Research (PAR), the theory of planned behavior, behavior-change constructs, the patient-centered outcomes research (PCOR) framework, and prolonged exposure techniques within Islamic principles. The review identified three main health-focused intervention categories: mental health, prevention, and communication, each providing valuable insights into initiatives within Muslim communities. This review underscores the significance of inclusive and culturally sensitive health interventions, emphasizing the effectiveness of faith-based approaches in improving health outcomes, promoting positive health behaviors, and addressing communication and cultural barriers. The reviews findings stress the need for further research that incorporates theoretical frameworks and tailored interventions to meet the specific cultural needs of these communities, ultimately contributing to enhanced well-being within them.

Automated Extraction of Patient-Centered Outcomes After Breast Cancer Treatment: An Open-Source Large Language Model-Based Toolkit.

Patient-centered outcomes (PCOs) are pivotal in cancer treatment, as they directly reflect patients' quality of life. Although multiple studies suggest that factors affecting breast cancer-related morbidity and survival are influenced by treatment side effects and adherence to long-term treatment, such data are generally only available on a smaller scale or from a single center. The primary challenge with collecting these data is that the outcomes are captured as free text in clinical narratives written by clinicians. Given the complexity of PCO documentation in these narratives, computerized methods are necessary to unlock the wealth of information buried in unstructured text notes that often document PCOs. Inspired by the success of large language models (LLMs), we examined the adaptability of three LLMs, GPT-2, BioGPT, and PMC-LLaMA, on PCO tasks across three institutions, Mayo Clinic, Emory University Hospital, and Stanford University. We developed an open-source framework for fine-tuning LLM that can directly extract the five different categories of PCO from the clinic notes. We found that these LLMs without fine-tuning (zero-shot) struggle with challenging PCO extraction tasks, displaying almost random performance, even with some task-specific examples (few-shot learning). The performance of our fine-tuned, task-specific models is notably superior compared with their non-fine-tuned LLM models. Moreover, the fine-tuned GPT-2 model has demonstrated a significantly better performance than the other two larger LLMs. Our discovery indicates that although LLMs serve as effective general-purpose models for tasks across various domains, they require fine-tuning when applied to the clinician domain. Our proposed approach has the potential to lead more efficient, adaptable models for PCO information extraction, reducing reliance on extensive computational resources while still delivering superior performance for specific tasks.

Review of the Longitudinal Management of Autoimmune Encephalitis, Potential Biomarkers, and Novel Therapeutics.

Increasing awareness and earlier diagnosis of autoimmune encephalitis (AE) have led to a greater number of patients being cared for longitudinally by neurologists. Although many neurologists are now familiar with the general approach to diagnosis and acute immunosuppression, this review aims to provide neurologists with guidance related to management beyond the acute phase of disease, including long-term immunosuppression, monitoring, potential biomarkers of disease activity, outcome measures, and symptom management. Observational studies in AE have demonstrated that early diagnosis and treatment is associated with improved neurologic outcomes, particularly in AE with antibodies targeting neuronal cell surface/synaptic proteins. The literature regarding long-term management is evolving. In addition to traditional immunosuppressive approaches, there is emerging use of novel immunosuppressive therapies (ISTs) in case series, and several randomized controlled trials are planned. Novel biomarkers of disease activity and methods to measure outcomes and response to treatment are being explored. Furthermore, it is increasingly recognized that many individuals have chronic symptoms affecting quality of life including seizures, cognitive impairment, fatigue, sleep disorders, and mood disorders, and there are emerging data supporting the use of patient centered outcome measures and multidisciplinary symptom-based care. This review aims to summarize recent literature and offer a practical approach to long-term management of adult patients with AE through a multidisciplinary approach. We summarize current knowledge on ISTs, potential biomarkers of disease activity, outcome measures, and long-term sequelae. Further research is needed to answer questions regarding optimal IST, biomarker validity, and sequelae of disease.

Ultrasound-guided thoracic nerve blocks for emergency department patients with rib fractures: a review

BackgroundRib fractures are frequently diagnosed and treated in the emergency department (ED). Thoracic trauma has serious morbidity and mortality, particularly in older adults, with complications including pulmonary contusions, hemorrhage, pneumonia, or death. Bedside ED-performed ultrasound-guided anesthesia is gaining in popularity, and early and adequate pain control has shown improved patient outcomes with rare complications. Objective of the ReviewWe describe thoracic nerve block options that can be used clinically for rib fractures or other thoracic pain or trauma. We identify the pros and cons of each type of block, describe their risk profile and advantages, and summarize the steps on how each is performed. DiscussionThoracic epidural and paravertebral blocks are more invasive, targeting the nerves closer to the spinal cord, thus they are primarily used in the operating room or by anesthesiology for surgical cases. However, newer blocks are gaining in popularity, particularly the erector spinae block (ESP), serratus anterior plane nerve block (SANB), and intercostal nerve block (ICNB). These blocks provide adequate anesthesia and can be performed in an ED setting. ConclusionsThoracic nerve blocks (e.g. ESP, SANB, ICNB) can be performed safely by appropriately trained emergency physicians, provide excellent anesthesia for rib fractures and thoracic trauma, and should be strongly considered for improved patient-centered outcomes. Furthermore, performing regional nerve blocks in the emergency department can reduce complications including adverse effects from opioids or other delirium-inducing medications.

Evolving oncology care management trends in the United States: A survey among health care decision makers.

There is limited knowledge of how US managed care professionals view and prioritize quality metrics/performance measures, care models, alternative payment models, and clinical pathways in oncology settings. To characterize payor perspectives on, and the use of, oncology clinical pathways and performance measures in their reimbursement/access decision-making process. A survey was implemented via SurveyMonkey software and distributed electronically to a national sample of the Academy of Managed Care Pharmacy (AMCP) Market Insights Panel members from July 11 through August 5, 2022. The survey was created by a steering committee based on literature reviews of the current and future oncology care landscapes. The survey consisted of 47 questions, including those to establish respondents' position, responsibilities, and demographics. The results are presented as descriptive statistics for 7 key questions that covered the perceptions and use of quality metrics/performance measures, alternative payment models, and oncology care pathways as prioritized by the steering committee. Among the 695 AMCP panel members who were sent the survey, 73 responded (response rate 10.5%), 54 were eligible to continue, and 31 completed the entire questionnaire; the low response rate may limit generalizability of the survey results. Specific oncology clinical and economic measures of performance were currently used (70%-88%) but generally received less endorsement for future use (39%-49%) except for chemotherapy during end of life, which was considered for future use by 80% of respondents but was only currently used by 31%. Benchmarking was the primary reason for the use of performance measures; only 27% used these to inform value-based agreements. Real-world data tracked by respondents' institutions primarily focused on managed care and pharmacy utilization (39%-85%), with patient-reported and clinical outcomes tracked by only 17%-34%. Almost one-third (31%) did not use clinical oncology pathways, and among those who did, fewer than half (48%) reported that their organization tracks whether treatment decisions agree with the oncology care pathways, and only 26% reported feedback to oncology providers on how often their treatment decisions agree with the pathways. When considering alternative payment models, patient-related components received lower rankings in importance than clinical relevance, actionability, and costs. Variation among payors regarding current trends in oncology care management, including on the importance of patient-centric outcomes and the use of oncology clinical pathways, suggests the need to focus on value-based health care and greater uptake of oncology clinical pathways.

Interventional Oncology: 2024 Update.

Interventional Oncology (IO) stands at the forefront of transformative cancer care, leveraging advanced imaging technologies and innovative interventions. This narrative review explores recent developments within IO, highlighting its potential impact facilitated by artificial intelligence (AI), personalized medicine and imaging innovations. The integration of AI in IO holds promise for accelerating tumour detection and characterization, guiding treatment strategies and refining predictive models. Imaging modalities, including functional MRI, PET and cone beam CT are reshaping imaging and precision. Navigation, fusion imaging, augmented reality and robotics have the potential to revolutionize procedural guidance and offer unparalleled accuracy. New developments are observed in embolization and ablative therapies. The pivotal role of genomics in treatment planning, targeted therapies and biomarkers for treatment response prediction underscore the personalization of IO. Quality of life assessment, minimizing side effects and long-term survivorship care emphasize patient-centred outcomes after IO treatment. The evolving landscape of IO training programs, simulation technologies and workforce competence ensures the field's adaptability. Despite barriers to adoption, synergy between interventional radiologists' proficiency and technological advancements hold promise in cancer care.

Emphasizing Patient-centered Outcomes and Improved Exclusion Criteria in Randomized Controlled Trials for Clinical Nutrition in Critically Ill Patients.

How to cite this article: Sundarsingh V, Kumar M. Emphasizing Patient-centered Outcomes and Improved Exclusion Criteria in Randomized Controlled Trials for Clinical Nutrition in Critically Ill Patients. Indian J Crit Care Med 2024;28(8):804-805.

Author Response: Emphasizing Patient-centered Outcomes and Improved Exclusion Criteria in Randomized Control Trials for Clinical Nutrition in ICU.

How to cite this article: Govil D, Chandrasekaran A, Pachisia AV, Harne R, Patel SJ, Pal D. Author Response: Emphasizing Patient-centered Outcomes and Improved Exclusion Criteria in Randomized Control Trials for Clinical Nutrition in ICU. Indian J Crit Care Med 2024;28(8):806-807.

An evaluation of patient experience before and after elective colectomy for diverticulitis between patients older and younger than 65 years: A pilot feasibility study in mobile health use

BackgroundMobile health (mHealth) platforms are being used to understand patient-reported experiences before and after surgery. Currently, there is limited literature describing the feasibility of using mHealth to evaluate patient experience among older adults. The objective of this study was to determine the feasibility of using mHealth to evaluate patient-reported outcomes among patients older and younger than 65 years undergoing elective colectomy for diverticulitis. MethodsA prospective pilot study was performed between June 1, 2020 and August 31, 2021, enrolling patients aged > 18 years undergoing elective colectomy for diverticulitis at a single academic center (n = 62). A Health Insurance Portability and Accountability Act-compliant mHealth platform was used to deliver patient-reported quality-of-life surveys at 3 time points: preoperatively, 3 months postoperatively, and 6 months postoperatively. The primary outcome was the feasibility of using mHealth in patients older and younger than 65 years to collect outcomes using recruitment, engagement, and survey completion rates. Preliminary findings of patient experiences were evaluated for patients older and younger than 65 years as secondary outcomes. ResultsOverall, 33.9% of participants were older than 65 years with a median age of 59.8 years (IQR, 53.3–67.9). mHealth enrollment was high (100%) with survey response rates of 79% preoperatively, 64.5% at 3 months postoperatively, and 17.7% at 6 months postoperatively. Response rates were similar among patients older and younger than 65 years (P = .79 preoperatively and P = .39 at 3 months postoperatively). ConclusionUtilization of mHealth to evaluate patient-reported outcomes is feasible in the preoperative and early postoperative settings, including older adults undergoing elective surgery for diverticulitis. Future work will focus on improving long-term outcomes to better examine potential differences when considering patient-centered outcomes among older adult patients.

Laparoscopic repair vs open repair for perforated peptic ulcers: Quality of life assessment

PurposeStudies reporting patient-centered outcomes, including quality of life and satisfaction, in perforated peptic ulcer (PPU) treatment are insufficient. This study was designed to assess the relative efficacy of laparoscopic repair (LR) as opposed to open surgical repair (OR) in the treatment of and its impact on quality of life. MethodsThis investigation performed a retrospective review of patients who underwent treatment for PPU at a secondary care hospital between January 2017 and April 2020. Patients were categorized into 2 separate groups according to the type of surgical procedure received: LR and OR. Comparisons were made based on a variety of factors, such as demographic data, intra- and postoperative metrics, pain control, patient contentment, and quality of life indicators. ResultsIn the analysis, there were no statistically significant differences in demographic or clinical characteristics between the LR (n = 35) and OR (n = 62) groups (P > .05). Conversely, the rates of incisional hernia and surgical site infection were significantly greater in the OR group (P < .05). Moreover, the LR exhibited benefits such as a shorter length of hospital stay (P < .05), more rapid resumption of a normal diet, and fewer surgical site infections—factors that contributed to a lower rate of overall postoperative complications. According to the quality-of-life questionnaire, the LR group exhibited significantly greater scores for physical function, role, pain, and general health by the 30th postoperative day (P = .003, P < .001, P = .006, and P = .001, respectively), and by the 1-year follow-up, the LR group showed substantial improvements in physical function, physical role, emotional role, pain and general health (P = .047, P = .004, P = .039, P = .001, and P = .021, respectively), indicating its effectiveness in patient recovery and quality of life enhancement after surgery. ConclusionThis study showed that LR could provide certain benefits in managing PPUs, such as reduced lengths of hospital stay and lower incidences of surgical site infections. Although LR reported promising directions in patient satisfaction and quality of life indicators, the limited duration of postoperative monitoring necessitates caution in broadly applying these results.

Breast implant illness: A United Kingdom patient-centred approach

Silicone breast implants are widely prevalent. An increasing group of patients detail self-reported somatic and psychological symptoms that have been ascribed as breast implant illness (BII) and seek capsulectomy and implant removal. To guide consultations and shared decision making, more outcome data relating to this intervention are required. To present a multicentre study of patient-centred (n = 100) outcome data, following total capsulectomy with implant removal for BII. A questionnaire survey was cross-referenced with medical records. Collected data included demographics, operation details, pre- and postoperative symptom scores, overall self-perceived percentage improvement in BII symptoms and breast shape satisfaction ratings after explantation. The 10 most frequently self-reported symptoms were fatigue (81%), pains/aches (72%), brain/memory fog (56%), mood disturbances (36%), neuropathic pain (28%), hair loss (28%), headaches (25%), gastric symptoms/intolerances (24%), eczema/rash (18%) and vision disturbance (17%). A high proportion of patients (98%) experienced a 62 ± 4% average symptom improvement; most self-reported symptoms (21/28) improved significantly after explantation with total capsulectomy (p < 0.05). Furthermore, patients had high overall self-perceived BII percentage improvement (76 ± 3%) and satisfaction with breast shape numerical rating score (8 ± 0.30) postoperatively. Despite BII not being a defined disease entity, symptom association with silicone breast implants continues for a growing number of patients. It is important to recognise that in this patient group, capsulectomy and implant removal may not be curative, however we have demonstrated that symptom improvement can occur. It is very difficult to prove a causal link between breast implants and BII; to do so will require extensive prospective data collection.

Digital health technologies to strengthen patient-centred outcome assessment in clinical trials in inflammatory arthritis.

Common to all inflammatory arthritides, namely rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, and juvenile idiopathic arthritis, is a potential for reduced mobility that manifests through joint pain, swelling, stiffness, and ultimately joint damage. Across these conditions, consensus has been reached on the need to capture outcomes related to mobility, such as functional capacity and physical activity, as core domains in randomised controlled trials. Existing endpoints within these core domains rely wholly on self-reported questionnaires that capture patients' perceptions of their symptoms and activities. These questionnaires are subjective, inherently vulnerable to recall bias, and do not capture the granularity of fluctuations over time. Several early adopters have integrated sensor-based digital health technology (DHT)-derived endpoints to measure physical function and activity in randomised controlled trials for conditions including Parkinson's disease, Duchenne's muscular dystrophy, chronic obstructive pulmonary disease, and heart failure. Despite these applications, there have been no sensor-based DHT-derived endpoints in clinical trials recruiting patients with inflammatory arthritis. Borrowing from case studies across medicine, we outline the opportunities and challenges in developing novel sensor-based DHT-derived endpoints that capture the symptoms and disease manifestations most relevant to patients with inflammatory arthritis.

An ethics analysis of antipsychotic dose reduction and discontinuation: Principles for supporting recovery from psychosis.

To examine the evidence and practice of antipsychotic dose reduction from the lens of biomedical ethics (specifically principlism) to support evidence-based practice and patient choice and self-determination. An overview of the evidence from randomized controlled trials of antipsychotic dose reduction versus maintenance is presented. This is followed by a theoretical examination of the four key biomedical ethical principles of autonomy, nonmaleficence, beneficence, and justice and how they apply in the case of antipsychotic dose reduction. Existing clinical trial research is dominated by relapse as the primary outcome, with dose reduction associated with a higher risk of relapse than maintenance. Few studies have measured other patient-centered outcomes but have shown preliminary evidence for superior cognitive functioning, lower negative symptoms, and better functioning following dose reduction. Respect for autonomy is a cornerstone of psychiatric rehabilitation, and this includes the right of people to choose to reduce or discontinue antipsychotic medication. Reduced capacity for treatment decision making can be supported. Autonomy and appraisal of nonmaleficence and beneficence associated with dose reduction can be facilitated through shared or supported decision making. Clinicians should continue to strive for justice through the fair allocation of resources to support all people who request antipsychotic dose reduction. Clinicians have a responsibility to balance the four core ethical principles to the best of their ability when supporting a person in their recovery journey. Exploring, trialing, and supporting antipsychotic dose reduction may be part of this process if that is the patient's choice. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Crosswalk Algorithms for Cognitive and Functional Outcomes Among 2013–2018 Medicare Beneficiaries With Dementia

ObjectiveBefore 2019, the Minimum Data Set (MDS) and Outcome and Assessment Information Set (OASIS) had incongruent response categories for rating cognitive impairment and activities of daily living (ADLs), hindering direct comparisons between nursing facilities and home health. We devised rule-based algorithms to compare cognitive impairment and ADL limitations between these 2 care settings among people with Alzheimer's disease and Alzheimer's disease–related dementias (ADRD). DesignA retrospective cohort study. Setting and ParticipantsIncluded fee-for-service Medicare beneficiaries (2013–2018) transitioning from nursing facilities to home health, with 1-year of continuous enrollment, aged ≥65 years, diagnosed ADRD, and with complete MDS discharge and OASIS admission assessments (N = 398,496). MethodsWe identified target phenotypes using the Cognitive Function Scale (CFS) and ADL items from the MDS discharge assessment as reference standards. We compared 6 OASIS-based algorithms for cognitive impairment and 1 for each ADL limitation by estimating sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV). ResultsThe average age was 83.5 (SD = 7.5) years and 82.3% transitioned from nursing to home health within 3 days. In the MDS discharge assessment, 42.2% had moderate-to-severe cognitive impairment. ADL limitations ranged from 71.4% for feeding to 97.8% for bathing. Compared with the moderate-to-severe cognitive impairment (CFS ≥3) on the MDS, the OASIS cognitive assessment indicating “considerable assistance to total dependence in routine situations” had 24% sensitivity, 94% specificity, 75% PPV, and 63% NPV. The ADL limitation algorithms exhibited high sensitivities (>96%) and PPVs (>94%) except for feeding (Sensitivity: 82%; PPV: 74%). Despite the short time frame between the 2 assessments, the OASIS admission assessment showed a higher prevalence of ADL limitations than the MDS discharge assessment. Conclusions and ImplicationsWe highlighted differences in patient function between post-acute care settings. Our algorithms can help researchers, clinicians, and policymakers standardize patient-centered outcomes for comparative effectiveness research or quality initiatives.