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1.
Ophthalmol Glaucoma ; 2024 Feb 16.
Artigo em Inglês | MEDLINE | ID: mdl-38369058

RESUMO

PURPOSE: To evaluate the efficacy and safety of combined cataract surgery with insertion of an ab interno trabecular microbypass device (iStent Inject, Glaukos Corporation) compared to cataract surgery alone in patients with mild-to-moderate glaucoma. DESIGN: Prospective, randomized, assessor-masked controlled trial at a single centre. PARTICIPANTS: Eyes with visually-significant cataract and mild-to-moderate glaucoma with preoperative intraocular pressure (IOP) of 12 to 30 mmHg on 0 to 3 ocular hypotensive medications. METHODS: Participants eyes were randomized (2017-2020) 1:1 to combined cataract surgery with iStent Inject (treatment group, n = 56) or cataract surgery alone (control group, n = 48), and followed up for 2 years. MAIN OUTCOME MEASURES: The co-primary effectiveness endpoints were the number of ocular hypotensive medications and IOP at 24-months post-surgery. The secondary effectiveness endpoints were ocular comfort as measured by the Ocular Surface Disease Index (OSDI) and vision-related quality of life as measured by the Glaucoma Activity Limitation Questionnaire (GAL-9) at 24-months. Safety measures included postoperative visual acuity, any unplanned return to the operating theatre, adverse events, and complications. RESULTS: Participants (67.3% male) were aged 53 to 85 years, and treatment groups were similar in terms of mean medicated IOP (treatment group 17.7 mmHg ± 4.0; control group 17.1 mmHg ± 3.1), and number of ocular hypotensive medications (treatment group 1.69 ± 1.05; control group 1.80 ± 1.22) at baseline. At 24 months, the number of ocular hypotensive medications were 0.7 ± 0.9 in the treatment groups compared to 1.5 ± 1.9 in the control group, with an adjusted difference of 0.6 fewer medications per eye in the treatment group (95% CI 0.2-1.1, P = 0.008). In the treatment group, 57% of eyes were on no glaucoma medications compared to 36% in the control group. There was no significant difference in IOP between the 2 groups beyond the 4-weeks. There were no differences in patient-reported outcomes between the 2 groups. The visual outcomes and safety profiles were similar between the 2 groups. CONCLUSIONS: Combined cataract surgery with iStent Inject achieved a clinically- and statistically-significantly greater reduction in ocular hypotensive medication usage at 24-months compared to cataract surgery alone, with no significant difference in IOP. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

2.
ACS Appl Bio Mater ; 6(10): 4392-4402, 2023 10 16.
Artigo em Inglês | MEDLINE | ID: mdl-37788457

RESUMO

The integration of degradable and biomimetic approaches in material and device development can facilitate the next generation of sustainable (bio) electronics. The use of functional degradable materials presents exciting opportunities for applications in healthcare, soft robotics, energy, and electronics. These include conformability to curved surfaces, matching of stiffness of tissue, and the ability to withstand mechanical deformations. Nature-derived materials such as silk fibroin (SF) provide excellent biocompatibility, resorbability, and tunable properties toward such goals. However, fibroin alone lacks the required mechanical properties and durability for processing in biointegrated electronics and dry conditions. To overcome these limitations, we report on an elastomeric photocurable composite of silk fibroin and poly(dimethylsiloxane) (PDMS). Photofibroin (containing methacryl functionalities) is doped with photoPDMS (methacryloxypropyl-terminated poly(dimethylsiloxane)) to form an elastomeric photofibroin (ePF) composite. The elastomeric silk is photocurable, allowing for microfabrication using UV photolithography. It is suitable for circuits, strain-sensing devices, and biointegrated systems. The ePF exhibits flexibility in both wet and dry conditions, enhanced mechanical strength and long-term durability, and optical transparency. It is stable at high temperatures, compatible with electronic materials, and cytocompatible while being enzymatically degradable. This work therefore highlights a path toward combining natural and synthetic materials to achieve versatile properties and demonstrates the potential of silk fibroin composites in (bio) electronics, encapsulation, and packaging.


Assuntos
Fibroínas , Seda , Materiais Biocompatíveis , Dimetilpolisiloxanos
3.
J Patient Rep Outcomes ; 7(1): 110, 2023 Oct 31.
Artigo em Inglês | MEDLINE | ID: mdl-37906323

RESUMO

BACKGROUND: The Dysphagia Symptom Questionnaire (DSQ) is a patient-reported outcome measure that assesses the frequency and severity of dysphagia in patients with eosinophilic esophagitis (EoE); however, it has only been validated for use in patients with EoE aged 11-40 years. This study examined the content validity of the DSQ and its usability on an electronic handheld device in children aged 7-10 years with EoE. METHODS: In this qualitative, observational cohort study, participants were recruited to partake in two rounds of interviews. During visit 1, a cognitive interview examined EoE-associated concepts and the appropriateness of the DSQ for assessing dysphagia. Participants completed the DSQ daily for 2 weeks, and DSQ scores were calculated. After 2 weeks, a second interview assessed the usability of the DSQ on the electronic device and the burden associated with completing it daily. RESULTS: Overall, 16 participants were included (aged 7-8 years: n = 8; aged 9-10 years: n = 8); most were male (75%) and white (81%), and the mean (standard deviation [SD]) age was 8.4 (1.3) years. The most commonly reported EoE-associated concept was 'trouble with swallowing' (63% [10/16]). Most participants reported that the questions were 'easy to complete' and 'relevant to someone with EoE and dysphagia'. Overall, participants reported understanding the questions and associated responses; however, further probing demonstrated inconsistent comprehension. Key challenging concepts included 'solid food', 'trouble swallowing', 'vomit', and 'relief'; some participants also reported difficulty differentiating between pain levels (31% [4/13]). Most caregivers reported that their child had experienced dysphagia (94% [15/16]); however, mean (SD) DSQ scores over the study period were low (7.3 [7.4]), suggesting infrequent and mild dysphagia, or a lack of comprehension of the questions. Most participants reported that completing the DSQ on the electronic device was easy (93% [14/15]) and they would be willing to complete it for longer than 2 weeks (73% [11/15]). CONCLUSIONS: Difficulties with comprehension and comprehensiveness suggest that the DSQ may not be sufficiently comprehensive for use in all patients in this population, and wording/phrasing changes are required before use in a clinical trial setting.


Assuntos
Transtornos de Deglutição , Esofagite Eosinofílica , Criança , Feminino , Humanos , Masculino , Estudos de Coortes , Transtornos de Deglutição/diagnóstico , Esofagite Eosinofílica/complicações , Inquéritos e Questionários , Pesquisa Qualitativa
5.
ACS Biomater Sci Eng ; 9(10): 5793-5803, 2023 Oct 09.
Artigo em Inglês | MEDLINE | ID: mdl-37698556

RESUMO

Soft materials with tunable properties are valuable for applications such as tissue engineering, electronic skins, and human-machine interfaces. Materials that are nature-derived offer additional advantages such as biocompatibility, biodegradability, low-cost sourcing, and sustainability. However, these materials often have contrasting properties that limit their use. For example, silk fibroin (SF) has high mechanical strength but lacks processability and cell-adhesive domains. Gelatin, derived from collagen, has excellent biological properties, but is fragile and lacks stability. To overcome these limitations, composites of gelatin and SF have been explored. However, mechanically robust self-supported matrices and electrochemically active or micropatterned substrates were not demonstrated. In this study, we present a composite of photopolymerizable SF and photogelatin, termed photofibrogel (PFG). By incorporating photoreactive properties in both SF and gelatin, control over material properties can be achieved. The PFG composite can be easily and rapidly formed into free-standing, high-resolution architectures with tunable properties. By optimizing the ratio of SF to gelatin, properties such as swelling, mechanical behavior, enzymatic degradation, and patternability are tailored. The PFG composite allows for macroscale and microscale patterning without significant swelling, enabling the fabrication of structures using photolithography and laser cutting techniques. PFG can be patterned with electrically conductive materials, making it suitable for cell guidance and stimulation. The versatility, mechanical robustness, bioactivity, and electrochemical properties of PFG are shown for skeletal muscle tissue engineering using C2C12 cells as a model. Overall, such composite biomaterials with tunable properties have broad potential in flexible bioelectronics, wound healing, regenerative medicine, and food systems.

6.
Parkinsonism Relat Disord ; 113: 105491, 2023 08.
Artigo em Inglês | MEDLINE | ID: mdl-37495500

RESUMO

BACKGROUND: The complexity of antiparkinsonian medications makes patients vulnerable to medication deviations. This study examines the frequency and outcomes of deviations between outpatient and inpatient medication administrations in patients with Parkinson's disease (PD). METHODS: We included hospital admissions of patients with PD during a 12-month period at the Cleveland Clinic Main and Fairview campuses. Outpatient regimens were compared with hospital medication administration records to establish rates of deviations in terms of levodopa equivalent daily dose (LEDD) difference, timing deviations/omissions of time-critical medications, substitution of levodopa compounds, and administration of antidopaminergic medications. Logistic regression analyses were used to investigate associations with length of stay (LOS), readmission rates, and mortality. RESULTS: The study included 492 patients with 725 admissions. Of those on time-critical medications, 43% had a LEDD deviation and 19% had levodopa formulation substitutions. Of the admission days with known outpatient timing regimens, 47% had an average deviation of more than 30 min and 22% had at least one missed levodopa dose. LOS was longer with each additional day of over-dose (4%), under-dose (14%), missed dose (21%), timing deviation (15%) and substitution (19%), (all p < 0.0001). Administration of antidopaminergic medications (9.9% of admissions) was associated with increased 30-day readmission/death (OR 1.85, p = 0.041), 90-day mortality (OR 2.2, p = 0.018), and LOS (7.6 vs. 3.8 days, p < 0.0001). LEDD underdose was associated with 30-day readmission/death (OR 1.78, p = 0.025) and 90-day mortality (OR 1.14, CI 1.05-1.24, p = 0.002). CONCLUSIONS: Deviations between outpatient and hospital regimens, and administration of antidopaminergic medications, were associated with poor outcomes.


Assuntos
Doença de Parkinson , Humanos , Doença de Parkinson/tratamento farmacológico , Doença de Parkinson/complicações , Levodopa/uso terapêutico , Pacientes Internados , Antiparkinsonianos/uso terapêutico , Hospitalização
7.
Mult Scler J Exp Transl Clin ; 9(1): 20552173221150370, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-36714174

RESUMO

Background: Treatment decisions for multiple sclerosis (MS) are influenced by many factors such as disease symptoms, comorbidities, and tolerability. Objective: To determine how much relapsing MS patients were willing to accept the worsening of certain aspects of their MS in return for improvements in symptoms or treatment convenience. Methods: A web-based discrete choice experiment (DCE) was conducted in patients with relapsing MS. Multinomial logit models were used to estimate relative attribute importance (RAI) and to quantify attribute trade-offs. Results: The DCE was completed by 817 participants from the US, the UK, Poland, and Russia. The most valued attributes of MS therapy to participants were effects on physical fatigue (RAI = 22.3%), cognitive fatigue (RAI = 22.0%), relapses over 2 years (RAI = 20.7%), and MS progression (RAI = 18.4%). Participants would accept six additional relapses in 2 years and a decrease of 7 years in time to disease progression to improve either cognitive or physical fatigue from "quite a bit of difficulty" to "no difficulty." Conclusion: Patients strongly valued improving cognitive and physical fatigue and were willing to accept additional relapses or a shorter time to disease progression to have less fatigue. The impact of fatigue on MS patients' quality of life should be considered in treatment decisions.

8.
Neurourol Urodyn ; 42(3): 573-585, 2023 03.
Artigo em Inglês | MEDLINE | ID: mdl-36655731

RESUMO

OBJECTIVES: To explore the impact of nocturnal polyuria (NP) on health-related quality of life (HRQoL), work productivity, mental health, fatigue, bother, and daytime sleepiness. MATERIALS AND METHODS: This large-scale, US population-representative epidemiologic study was conducted in two parts: a web-based survey and 3-day bladder diary. Consenting participants completed the baseline Epidemiology of NP (EpiNP) survey online (Lower Urinary Tract Symptoms [LUTS] Tool, comorbidities, burden, and multiple HRQoL measures). Participants who reported ≥2 voids/night, and a random sample of 100 respondents each reporting 0 or 1 void/night, were sent urine measurement containers and asked to complete the 3-day bladder diary. NP was defined as Nocturnal Polyuria Index >0.33 (NPI33) or nocturnal urine production >90 ml/h (NUP90). Five subgroups were created: Idiopathic NP (NP with no underlying cause), NP associated with symptoms of overactive bladder (NPOAB) or bladder outlet obstruction (NPBOO; men only), NP associated with other comorbidities (NPCOM; e.g., diabetes, hypertension, heart disease, sleep apnea), and no NP (did not meet NP criteria). RESULTS: A total of 4893 men and 5297 women completed the EpiNP survey; mean age was 54.4 (SD = 14.7). Significantly greater patient burden (p < 0.0001) was evidenced in the nocturia group (≥2 voids/night) versus no nocturia group (0-1 void/night) on daily impact of nocturia, LUTS Bother, prostate symptoms (men only), work productivity, physical and mental health component scores, depression, fatigue, and daytime sleepiness. NP subgroup analyses showed men in the NPBOO group and women in the NPOAB group reported the greatest impact on LUTS bother, fatigue, physical health, work productivity impairment, daytime sleepiness, and depression (women only). CONCLUSION: This was the first large-scale, epidemiologic study to explore the impact of different forms of NP on patients' HRQoL. Findings demonstrate that NP associated with other urologic or comorbid conditions appears to have greater patient burden than idiopathic NP, in particular for women.


Assuntos
Distúrbios do Sono por Sonolência Excessiva , Sintomas do Trato Urinário Inferior , Noctúria , Masculino , Humanos , Feminino , Estados Unidos/epidemiologia , Pessoa de Meia-Idade , Poliúria/etiologia , Qualidade de Vida , Sintomas do Trato Urinário Inferior/epidemiologia , Sintomas do Trato Urinário Inferior/complicações , Estudos Epidemiológicos , Distúrbios do Sono por Sonolência Excessiva/complicações
9.
Mult Scler ; 29(3): 427-435, 2023 03.
Artigo em Inglês | MEDLINE | ID: mdl-36550636

RESUMO

BACKGROUND: In the OPTIMUM trial in patients with relapsing MS, treatment differences in annualized relapse rate (ARR, 0.088) and change in fatigue at week 108 (3.57 points, measured using the Fatigue Symptoms and Impacts Questionnaire-Relapsing Multiple Sclerosis, symptom domain (FSIQ-RMS-S)) favored ponesimod over teriflunomide. However, the importance of the fatigue outcome to patients was unclear. OBJECTIVE: To assess the importance of the OPTIMUM FSIQ-RMS-S results using data from an MS discrete choice experiment (DCE). METHODS: The DCE included components to correlate levels of physical and cognitive fatigue with FSIQ-RMS-S scores. Changes in relapses/year and time to MS progression equivalent to the treatment difference in fatigue in OPTIMUM were determined for similar fatigue levels as mean baseline fatigue in OPTIMUM. RESULTS: DCE participants would accept 0.06 more relapses/year or a 0.15-0.17 year decrease in time to MS progression for a 3.57-point difference in physical fatigue on the FSIQ-RMS-S. To improve cognitive fatigue by 3.57-points on the FSIQ-RMS-S, DCE participants would accept 0.09-0.10 more relapses/year or a 0.24-0.28 year decrease in time to MS progression. CONCLUSION: MS patients would accept 0.06 more relapses/year to change their fatigue by a similar magnitude as the between-treatment difference observed in the OPTIMUM trial.


Assuntos
Esclerose Múltipla Recidivante-Remitente , Esclerose Múltipla , Humanos , Esclerose Múltipla Recidivante-Remitente/diagnóstico , Preferência do Paciente , Doença Crônica , Recidiva
10.
Front Aging Neurosci ; 15: 1278322, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-38304735

RESUMO

Electronic Health Record (EHR) systems are often configured to address challenges and improve patient safety for persons with Parkinson's disease (PWP). For example, EHR systems can help identify Parkinson's disease (PD) patients across the hospital by flagging a patient's diagnosis in their chart, preventing errors in medication and dosing through the use of clinical decision support, and supplementing staff education through care plans that provide step-by-step road maps for disease-based care of a specific patient population. However, most EHR-based solutions are locally developed and, thus, difficult to scale widely or apply uniformly across hospital systems. In 2020, the Parkinson's Foundation, a national and international leader in PD research, education, and advocacy, and Epic, a leading EHR vendor with more than 35% market share in the United States, launched a partnership to reduce risks to hospitalized PWP using standardized EHR-based solutions. This article discusses that project which included leadership from physician informaticists, movement disorders specialists, hospital quality officers, the Parkinson's Foundation and members of the Parkinson's community. We describe the best practice solutions developed through this project. We highlight those that are currently available as standard defaults or options within the Epic EHR, discuss the successes and limitations of these solutions, and consider opportunities for scalability in environments beyond a single EHR vendor. The Parkinson's Foundation and Epic launched a partnership to develop best practice solutions in the Epic EHR system to improve safety for PWP in the hospital. The goal of the partnership was to create the EHR tools that will have the greatest impact on outcomes for hospitalized PWP.

11.
ACS Appl Bio Mater ; 2022 Sep 30.
Artigo em Inglês | MEDLINE | ID: mdl-36179055

RESUMO

Biomimetic substrates that incorporate functionality such as electroactivity and mechanical flexibility, find utility in a variety of biomedical applications. Toward these uses, nature-derived materials such as gelatin offer inherent biocompatibility and sustainable sourcing. However, issues such as high swelling, poor mechanical properties, and lack of stability at biological temperatures limit their use. The enzymatic crosslinking of gelatin via microbial transglutaminase (mTG) yields flexible and robust large area substrates that are stable under physiological conditions. Here, we demonstrate the fabrication and characterization of strong, stretchable, conductive mTG crosslinked gelatin thin films. Incorporation of the conductive polymer poly(3,4-ethylenedioxythiophene) polystyrene sulfonate in the gel matrix with a bioinspired polydopamine surface coating is used to enable conductivity with enhanced mechanical properties such as extensibility and flexibility, in comparison to plain gelatin or crosslinked gelatin films. The electroconductive substrates are conducive to cell growth, supporting myoblast cell adhesion, viability, and proliferation and could find use in creating active cell culture systems incorporating electrical stimulation. The substrates are responsive to motion such as stretching and bending while being extremely handleable and elastic, making them useful for applications such as electronic skin and flexible bioelectronics. Overall, this work presents facile, yet effective development of bioinspired conductive composites as substrates for bio-integrated devices and functional tissue engineering.

12.
Adv Exp Med Biol ; 1379: 275-306, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-35760996

RESUMO

Practical screening tools and ultrasensitive technologies can play pivotal roles in precision cancer profiling for early diagnosis at asymptomatic stages, as well as for monitoring prognosis, risk stratification, and disease recurrence. While a number of sensors and diagnostic tools continue to be developed for ultrasensitive detection and off-site analysis, there has been an increasing interest in point-of-care devices, particularly those that are mechanically flexible and potentially wearable by the patient. In this chapter, we present a critical insight into the integrated engineering approaches involved in such flexible systems. We consider various aspects in the design of flexible devices, the biomarkers of interest, and the different transduction mechanisms by which mechanically flexible devices can be used in the area of cancer monitoring. We then discuss the different types of flexible biosensing platforms that have been developed to date, including wearables on skin and on clothing, and exhaled breath and implantable sensors. Finally, we discuss the design challenges and future outlook in the development of flexible platforms that can provide comprehensive cancer biomarker panels for patients and clinicians.


Assuntos
Técnicas Biossensoriais , Líquidos Corporais , Neoplasias , Dispositivos Eletrônicos Vestíveis , Biomarcadores/análise , Líquidos Corporais/química , Humanos , Neoplasias/diagnóstico , Sistemas Automatizados de Assistência Junto ao Leito
13.
Adv Mater ; 34(18): e2109550, 2022 May.
Artigo em Inglês | MEDLINE | ID: mdl-35073433

RESUMO

Mechanically flexible and conformable materials and integrated devices have found diverse applications in personalized healthcare as diagnostics and therapeutics, tissue engineering and regenerative medicine constructs, surgical tools, secure systems, and assistive technologies. In order to impart optimal mechanical properties to the (bio)materials used in these applications, various strategies have been explored-from composites to structural engineering. In recent years, geometric cuts inspired by the art of paper-cutting, referred to as kirigami, have provided innovative opportunities for conferring precise mechanical properties via material removal. Kirigami-based approaches have been used for device design in areas ranging from soft bioelectronics to energy storage. In this review, the principles of kirigami-inspired engineering specifically for biomedical applications are discussed. Factors pertinent to their design, including cut geometry, materials, and fabrication, and the effect these parameters have on their properties and configurations are covered. Examples of kirigami designs in healthcare are presented, such as, various form factors of sensors (on skin, wearable), implantable devices, therapeutics, surgical procedures, and cellular scaffolds for regenerative medicine. Finally, the challenges and future scope for the successful translation of these biodesign concepts to broader deployment are discussed.


Assuntos
Dispositivos Eletrônicos Vestíveis , Atenção à Saúde , Próteses e Implantes
14.
BMJ Open Ophthalmol ; 6(1): e000903, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34796271

RESUMO

OBJECTIVE: To describe the development and implementation of a web-based high-quality data collection tool to track the outcomes of glaucoma treatments in routine practice. METHODS AND ANALYSIS: This is a prospective observational registry study. An international steering committee undertook an iterative structured process to define a minimum, patient-centred data set designed to track outcomes of glaucoma treatment. The outcomes were coded into a web-based programme allowing easy access for rapid data entry. Clinicians receive personal reports enabling instant audit of their outcomes. Analyses of aggregated anonymised data on real-world outcomes are analysed and periodically reported with the goal of improving patient care. RESULTS: The minimum data set developed by the international steering committee includes the following: a baseline visit captures 13 mandatory fields in order to accurately phenotype each patient's subtype of glaucoma and to allow comparison between services, and a follow-up visit includes only four mandatory fields to allow completion within 30 s.Currently, there are 157 surgeons in 158 ophthalmology practices across Australia and New Zealand who are registered. These surgeons are tracking 5570 eyes of 3001 patients and have recorded 67 074 visits. The median number of eyes per surgeon is 22 eyes with a range of 1-575. The most common glaucoma procedure, excluding cataract surgery, is iStent inject, with 2316 cases. CONCLUSION: This software tool effectively facilitates data collection on safety and efficacy outcomes of treatments for different subgroups of glaucoma within a real-world setting. It provides a template to evaluate new treatments as they are introduced into practice.

15.
Patient ; 14(6): 775-790, 2021 11.
Artigo em Inglês | MEDLINE | ID: mdl-33950476

RESUMO

BACKGROUND: As the number and type of cancer treatments available rises and patients live with the consequences of their disease and treatments for longer, understanding preferences for cancer care can help inform decisions about optimal treatment development, access, and care provision. Discrete choice experiments (DCEs) are commonly used as a tool to elicit stakeholder preferences; however, their implementation in oncology may be challenging if burdensome trade-offs (e.g. length of life versus quality of life) are involved and/or target populations are small. OBJECTIVES: The aim of this review was to characterise DCEs relating to cancer treatments that were conducted between 1990 and March 2020. DATA SOURCES: EMBASE, MEDLINE, and the Cochrane Database of Systematic Reviews were searched for relevant studies. STUDY ELIGIBILITY CRITERIA: Studies were included if they implemented a DCE and reported outcomes of interest (i.e. quantitative outputs on participants' preferences for cancer treatments), but were excluded if they were not focused on pharmacological, radiological or surgical treatments (e.g. cancer screening or counselling services), were non-English, or were a secondary analysis of an included study. ANALYSIS METHODS: Analysis followed a narrative synthesis, and quantitative data were summarised using descriptive statistics, including rankings of attribute importance. RESULT: Seventy-nine studies were included in the review. The number of published DCEs relating to oncology grew over the review period. Studies were conducted in a range of indications (n = 19), most commonly breast (n =10, 13%) and prostate (n = 9, 11%) cancer, and most studies elicited preferences of patients (n = 59, 75%). Across reviewed studies, survival attributes were commonly ranked as most important, with overall survival (OS) and progression-free survival (PFS) ranked most important in 58% and 28% of models, respectively. Preferences varied between stakeholder groups, with patients and clinicians placing greater importance on survival outcomes, and general population samples valuing health-related quality of life (HRQoL). Despite the emphasis of guidelines on the importance of using qualitative research to inform attribute selection and DCE designs, reporting on instrument development was mixed. LIMITATIONS: No formal assessment of bias was conducted, with the scope of the paper instead providing a descriptive characterisation. The review only included DCEs relating to cancer treatments, and no insight is provided into other health technologies such as cancer screening. Only DCEs were included. CONCLUSIONS AND IMPLICATIONS: Although there was variation in attribute importance between responder types, survival attributes were consistently ranked as important by both patients and clinicians. Observed challenges included the risk of attribute dominance for survival outcomes, limited sample sizes in some indications, and a lack of reporting about instrument development processes. PROTOCOL REGISTRATION: PROSPERO 2020 CRD42020184232.


Assuntos
Neoplasias , Qualidade de Vida , Humanos , Masculino , Tecnologia Biomédica , Neoplasias/tratamento farmacológico
16.
Curr Med Res Opin ; 37(3): 505-514, 2021 03.
Artigo em Inglês | MEDLINE | ID: mdl-33331184

RESUMO

OBJECTIVES: Content validation is essential in the development of patient-reported instruments to ensure relevancy and understandability. The aim was to evaluate patient understanding of the Prescription Opioid Misuse and Abuse Questionnaire (POMAQ) using cognitive interviewing among adults with chronic moderate to severe pain. METHODS: This qualitative study involved a one-time in-clinic visit to conduct one-on-one cognitive interviews among participants with chronic moderate to severe pain from four groups: (1) Known Opioid Abuse; (2) Known Abuse of Other Substances (e.g. alcohol, benzodiazepines); (3) Opioid Non-abuse; and (4) No Chronic Opioid Use. Patients were recruited from 6 US clinical centers. Concept elicitation questions regarding misuse and abuse were asked at interview start; the POMAQ was completed via a web interface followed by a cognitive interview regarding POMAQ items and response options. RESULTS: 56 patients were enrolled. Mean age was 48.7 ± 12.3 years; 57% female; 80% Caucasian; mean duration of chronic pain was 11.2 ± 8.2 years with lower back pain predominating at 75%. Overall, the POMAQ was well-understood and received positive feedback. A few (n = 6, 11%) expressed concerns about completing the POMAQ using a secure internet site as they either indicated they were not computer savvy (n = 3, 5%) or were concerned about internet security (n = 3, 5%). Minor wording modifications were made to the POMAQ to enhance clarity and understanding of the POMAQ. CONCLUSIONS: The POMAQ demonstrated content validity among patients with moderate to severe chronic pain and is undergoing psychometric evaluation among a larger cohort of patients.


Assuntos
Dor Crônica , Transtornos Relacionados ao Uso de Opioides , Uso Indevido de Medicamentos sob Prescrição , Adulto , Analgésicos Opioides/uso terapêutico , Benzodiazepinas/uso terapêutico , Dor Crônica/tratamento farmacológico , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Transtornos Relacionados ao Uso de Opioides/tratamento farmacológico , Transtornos Relacionados ao Uso de Opioides/epidemiologia , Inquéritos e Questionários
17.
Adv Ther ; 37(10): 4458-4478, 2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-32880822

RESUMO

INTRODUCTION: Eosinophilic esophagitis (EoE) is a chronic, immune-mediated esophageal disease for which there is currently no approved treatment in the USA and only one approved therapy in Europe. EoE can significantly affect the lives of patients and caregivers; however, little has been published about patients' experiences from symptom onset to diagnosis and treatment. METHODS: This was a cross-sectional, qualitative research study. During one-on-one semi-structured interviews, patients with EoE in the USA and their caregivers provided information about their experiences of EoE before and during diagnosis, and their current experiences. Qualitative data were analyzed using a content analysis approach. RESULTS: The study included children aged 6-11 years with EoE (n = 4) and their caregivers (n = 4); adolescents aged 12-17 years with EoE (n = 7) and their caregivers (n = 7); and adults aged ≥ 18 years with EoE (n = 20). The diagnosis of EoE was often arduous and took many years. Patients and caregivers were frequently frustrated with the complexities of diagnosing EoE, which often involved multiple healthcare providers and procedures. Patients reported physical and psychosocial burdens associated with EoE before diagnosis, including interference with social activities, school, and work. Patients also reported feeling frustrated or anxious. These burdens frequently remained after diagnosis. Caregivers also reported anxiety and, in some cases, interference with their ability to work. CONCLUSION: This study of EoE describes the difficult journey faced by patients and their caregivers from symptom onset to diagnosis and beyond.


Assuntos
Esofagite Eosinofílica , Adolescente , Adulto , Cuidadores , Criança , Estudos Transversais , Esofagite Eosinofílica/diagnóstico , Europa (Continente) , Humanos , Pesquisa Qualitativa
20.
J Vis Commun Med ; 42(4): 153-157, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31402723

RESUMO

We present a novel method to image the vasculature of the anterior segment of the eye using a non-invasive optical coherence tomography angiography (OCTA) system with a modified lens system. This system utilises the Heidelberg Spectralis OCTA and a 3D printed lens mount holding a simple biconvex lens in place to allow capture of images in the anterior segment.


Assuntos
Olho/diagnóstico por imagem , Angiofluoresceinografia , Tomografia de Coerência Óptica , Humanos
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