RESUMEN
OBJECTIVES: Recovery from sexual trauma can be complex and multi-faceted. Most current psychological treatment protocols for trauma use a cognitive model of post-traumatic stress disorder (PTSD). However, sexual trauma may include specific complexities beyond that of a cognitive model of PTSD, such as relational factors. The distress experienced after sexual abuse may involve variables not exclusive to a PTSD model. Compassion focused therapy (CFT) is an approach that incorporates evolutionary, relational and social perspectives. This study explored the relationships between variables associated with CFT, PTSD and distress in survivors of sexual abuse to determine the role of CFT-related variables. METHODS: 155 adults who had experienced sexual abuse or any unwanted sexual experience at any point in their lives completed online questionnaires pertaining to various CFT variables (self-compassion, receiving compassion from others, having a fear of compassion from others, having a fear of compassion from the self, shame and self-criticism) and questionnaires measuring global distress as the outcome of sexual abuse and PTSD symptoms. RESULTS: An exploratory model involving CFT-related variables explained significantly more of the variance (4.4%) in global distress than PTSD symptomology alone. Self-criticism was found to be the variable with significant contribution. CONCLUSIONS: That CFT treatments, targeting self-criticism, should be developed alongside the standard cognitive model of PTSD based treatments for survivors of sexual abuse was supported. Future research may explore experimental designs utilizing CFT in this population, as well as further investigations on the roles of these specific CFT variables.
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Empatía , Trastornos por Estrés Postraumático , Humanos , Trastornos por Estrés Postraumático/psicología , Trastornos por Estrés Postraumático/terapia , Adulto , Femenino , Masculino , Persona de Mediana Edad , Trauma Sexual/psicología , Adulto Joven , Distrés Psicológico , Encuestas y Cuestionarios , Delitos Sexuales/psicología , Adolescente , VergüenzaRESUMEN
BACKGROUND: Little is known about the skills involved in clinical formulation. The individual case formulation (ICF) approach, based on functional analysis, employs clinical descriptions that are theory-free and depicts formulations constructed according to a set of basic conventions. AIMS: We report a test of whether this method could be taught and if the quality of the resulting diagrams could be reliably rated. METHOD: Participants (n=40) participated in a training course in formulation. A draft rating scale was refined in the course of rating formulation diagrams and basic inter-rater reliability established. RESULTS: Results of the study support further development of the ICF approach.
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Competencia Clínica , Humanos , Reproducibilidad de los ResultadosRESUMEN
Imagery rescripting (ImRs) is a therapy technique that, unlike traditional re-living techniques, focuses less on exposure and verbal challenging of cognitions and instead encourages patients to directly transform the intrusive imagery to change the depicted course of events in a more desired direction. However, a comprehensive account of how and in what circumstances ImRs brings about therapeutic change is required if treatment is to be optimised, and this is yet to be developed. The present study reports on the development of a coding scheme of ImRs psychotherapy elements identified in the literature as potential ImRs mechanisms. The codes were assessed in relation to short-term outcomes of 27 individuals undergoing ImRs for post-traumatic stress disorder. The timing of the change in the image, degree of activation of the new image and associated cognitive, emotional and physiological processes, self-guided rescripting, rescript believability, narrative coherence and cognitive and emotional shift were identified as being related to symptom change and so are potentially important factors for the re-scripting process.
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Trastornos por Estrés Postraumático , Humanos , Trastornos por Estrés Postraumático/terapiaRESUMEN
A 2017 service evaluation identified a lack of information and knowledge among patients who were referred on to early phase oncology clinical trials (Hood, 2020). An educational booklet was developed to improve patients' knowledge and experience. To build upon this work, a patient co-designed website was developed. This study examined the impact, if any, of a patient co-designed educational intervention within the clinical pathway for patients who are referred for an early phase oncology clinical trial at an experimental cancer medicine centre (ECMC). AIMS: 1. To understand the experiences of patients who have been referred to an ECMC for an early phase clinical trial pre- and post-intervention. 2. To investigate if the intervention reduced anxiety levels in newly referred patients. METHOD: A convergent mixed-methods design was used in this study, to collect quantitative and qualitative data in parallel. OUTCOMES: This study examined the experiences of advanced cancer patients who attended their initial research outpatient appointment to discuss the possibility of taking part in an early phase clinical trial and the impact of an educational resource.
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Investigación Biomédica , Neoplasias , Humanos , Neoplasias/terapia , Pacientes Ambulatorios , Oncología Médica , Vías ClínicasRESUMEN
Survivor guilt can arise after surviving a trauma in which others die. No studies have systematically investigated psychological treatment for survivor guilt. The present study was a proof-of-concept investigation of treatment of survivor guilt using imagery rescripting. Thirteen participants with post-traumatic stress disorder and self-reported survivor guilt attended two consecutive imagery therapy sessions, to first elaborate and then rescript related imagery. Significant improvements were observed on idiographic process measures of cognitons, emotions and distress related to survivor guilt following the rescripting session. The study provides preliminary evidence that imagery rescripting can be used as an experiential technique to treat survivor guilt.
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Imágenes en Psicoterapia , Trastornos por Estrés Postraumático , Emociones , Culpa , Humanos , Trastornos por Estrés Postraumático/terapia , SobrevivientesRESUMEN
BACKGROUND: Imagery rescripting (ImRs) is an experiential therapy technique used to change the content and meaning of intrusive imagery in post-traumatic stress disorder (PTSD) by imagining alternative endings to traumatic events. There is growing evidence that ImRs is an effective treatment for PTSD; however, little is known about how it brings about change. AIMS: This study aimed to explore the role of mental simulation as a candidate mechanism of action in ImRs, and, specifically, whether well-simulated imagery rescripts are associated with greater change in symptom severity during ImRs. METHOD: Using a single-case experimental design, seven participants receiving cognitive therapy for PTSD were assessed before, during and after sessions of imagery rescripting for one intrusive image. Participants completed continuous symptom severity measures. Sessions were recorded, then coded for goodness of simulation (GOS) as well as additional factors (e.g. rescript believability, vividness). RESULTS: Participants were divided into high- and low-responders and coding was compared across groups. Correlational analyses were supported by descriptive analysis of individual sessions. High-responders' rescripts tended to be rated as well-simulated compared with those of low-responders. Specific factors (e.g. intensity of thoughts/emotions related to original and new imagery elements, level of cognitive and emotional shift and belief in the resultant rescript) were also associated with reductions in symptom severity. CONCLUSIONS: There was tentative evidence that well-simulated rescripted images tended to be associated with greater reductions in symptom severity of the target image. Clinical implications and avenues for further research are discussed.
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Terapia Cognitivo-Conductual , Trastornos por Estrés Postraumático , Emociones , Humanos , Imágenes en Psicoterapia , Trastornos por Estrés Postraumático/terapia , Resultado del TratamientoRESUMEN
Childhood ITP is often considered to be a relatively mild haematological disorder, with only a minority of patients requiring treatment for troublesome bleeding. Over recent years, wider effects of the condition have been identified in some adults, particularly relating to fatigue and cognitive impairment. In this study, we sought to investigate such effects in a group of children with ITP and further our understanding of their psychological profile. Children attending routine haematology outpatient clinics and their parents were asked to complete standardised questionnaires designed to assess a range of psychological and cognitive factors. Although the majority of children had some scores within the normal range, a significantly high proportion had difficulties with fatigue (70·6%), emotional and behavioural symptoms (25·7%) or executive functioning (19·4%). Quality of life and subjective evaluation of the illness (appraisal) correlated significantly with each of these domains, but bleeding severity and platelet count did not. Our findings provide valuable insight into the broader impact of childhood ITP, which could aid in providing holistic care, potentially contribute to decisions regarding medical treatment, and guide future research.
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Función Ejecutiva/fisiología , Fatiga/etiología , Púrpura Trombocitopénica Idiopática/complicaciones , Púrpura Trombocitopénica Idiopática/psicología , Adolescente , Niño , Preescolar , Femenino , Humanos , MasculinoRESUMEN
Objective: Many patients relapse within one year of completing effective cognitive behavioural therapy (CBT) for depression and anxiety. Residual symptoms at treatment completion have been demonstrated to predict relapse, and so this study used network analyses to improve specificity regarding which residual anxiety and depression symptoms predict relapse. Method: A cohort study identified relapse cases following low- and high-intensity CBT in a stepped care psychological therapy service. The sample included N = 867 "recovered" treatment completers that attended a six-month follow-up review. At follow-up, N = 93 patients had relapsed and N = 774 remained in-remission. Networks of final treatment session depression (PHQ-9) and anxiety (GAD-7) symptoms were estimated for both sub-groups. Results: Qualitatively similar symptom networks were found. Difficulty concentrating was a highly central symptom in the relapse network, whilst of only average centrality in the remission network. In contrast, trouble relaxing was highly central in the remission network, whilst of only average centrality in the relapse network. Discussion: Identification of central residual symptoms holds promise in improving the specificity of prognostic models and the design of evidence-based relapse prevention strategies. The small sample of relapse cases limits this study's ability to draw firm conclusions.
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Ansiedad/terapia , Terapia Cognitivo-Conductual , Depresión/terapia , Adulto , Ansiedad/psicología , Estudios de Cohortes , Depresión/psicología , Femenino , Humanos , Masculino , Persona de Mediana Edad , RecurrenciaRESUMEN
PURPOSE: To evaluate the costs and cost-utility of examination for posterior vitreous detachment (PVD) and treatment of associated pathology, and of managing various other peripheral retinal disorders to prevent retinal detachment (RD). DESIGN: A decision analysis model of cost-utility. PARTICIPANTS: There were no participants. METHODS: Published retrospective data on the natural course of PVD, retinal tears, and lattice degeneration were used to quantitate the visual benefits of examination and treatment. Center for Medicare and Medicaid Services data were used to calculate associated modeled costs in a hospital/facility-based and nonfacility/ambulatory surgical center (ASC)-based setting. Published standards of utility for a given level of visual acuity were used to derive costs and quality-adjusted life years (QALYs). MAIN OUTCOME MEASURES: Cost of evaluation and treatment, utility of defined health states, QALY, and cost per QALY. RESULTS: The modeled cost of evaluation of a patient with PVD and treatment of associated pathology in the facility/hospital (nonfacility/ASC)-based setting was $65 to $190 ($25-$71) depending on whether a single or 2-examination protocol was used. The cost per QALY saved was $255 to $638/QALY ($100-$239/QALY). Treatment of a symptomatic horseshoe tear resulted in a net cost savings of $1749 ($1314) and improved utility, whereas treatment of an asymptomatic horseshoe tear resulted in $2981/QALY ($1436/QALY). Treatment of asymptomatic lattice degeneration in an eye in which the fellow eye had a history of RD resulted in $4414/QALY ($2187/QALY). CONCLUSIONS: Evaluation and management of incident acute PVD (and symptomatic horseshoe tears) offer a low cost and a favorable cost-utility (low $/QALY) as a result of the minimization of the cost and morbidity associated with the development of RD, thus justifying current practice standards.
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Costos de la Atención en Salud , Terapia por Láser/economía , Desprendimiento de Retina/economía , Curvatura de la Esclerótica/economía , Agudeza Visual , Vitrectomía/economía , Desprendimiento del Vítreo/economía , Anciano , Análisis Costo-Beneficio , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Años de Vida Ajustados por Calidad de Vida , Desprendimiento de Retina/etiología , Desprendimiento de Retina/prevención & control , Estudios Retrospectivos , Estados Unidos , Desprendimiento del Vítreo/complicaciones , Desprendimiento del Vítreo/cirugíaRESUMEN
PURPOSE: To present ophthalmic patient time-tradeoff vision utilities for quantifying vision-related quality-of-life when the fellow eye still has good vision. These utilities are important for performing reliable cost-utility analyses. DESIGN: Consecutive time-tradeoff vision utilities were obtained from ophthalmic patients with good vision (20/20-20/25) in one eye and vision ranging from 20/20 to no light perception in the fellow eye over a 15-year period from 2000 through 2014. PARTICIPANTS: Five hundred eighty-six ophthalmic participant interviews from Wills Eye Hospital, New York Eye and Ear Hospital, and ophthalmology office practices in Pennsylvania and New Jersey. METHODS: Participants underwent a full ophthalmic examination, after which time-tradeoff vision utilities were obtained by personal interview by the authors using a standardized, validated instrument. MAIN OUTCOME MEASURES: Time-tradeoff vision utilities. RESULTS: Mean time-tradeoff vision utilities were as follows in participants with good vision (20/20-20/25) in at least one eye and the following visions in the fellow eyes: no light perception, 0.79; counting fingers to light perception, 0.87; 20/200 to 20/400, 0.88; 20/60 to 20/100, 0.88; 20/30 to 20/50, 0.87; and 20/20 to 20/25, 0.94. CONCLUSIONS: In people with good vision (20/20-20/25) in one eye, the associated mean time-tradeoff vision utility is a remarkably consistent 0.87 to 0.88 when vision in the fellow eye ranges from 20/30 to light perception. Vision of 20/20 to 20/25 in the fellow eye results in a significantly higher associated utility of 0.94 (P < 0.01), whereas vision of no light perception in the fellow eye results in a significantly lower utility of 0.079 (P < 0.01). These utilities are important for calculating reliable patient value (quality-adjusted life-year) gains in ophthalmic cost-utility analysis populations in which there is unilateral and bilateral disease involvement.
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Análisis Costo-Beneficio , Oftalmopatías/fisiopatología , Calidad de Vida , Visión Binocular/fisiología , Visión Monocular/fisiología , Visión Ocular/fisiología , Agudeza Visual/fisiología , Anciano , Actitud Frente a la Salud , Estudios Transversales , Femenino , Estado de Salud , Humanos , Masculino , Persona de Mediana Edad , Años de Vida Ajustados por Calidad de Vida , Encuestas y CuestionariosRESUMEN
PURPOSE: The Argus II Retinal Prosthesis System (Second Sight Medical Products, Inc, Sylmar, CA) was developed to restore some vision to patients blind as a result of retinitis pigmentosa (RP) or outer retinal degeneration. A clinical trial was initiated in 2006 to study the long-term safety and efficacy of the Argus II System in patients with bare or no light perception resulting from end-stage RP. DESIGN: Prospective, multicenter, single-arm clinical trial. Within-patient controls included the nonimplanted fellow eye and patients' native residual vision compared with their vision with the Argus II. PARTICIPANTS: Thirty participants in 10 centers in the United States and Europe. METHODS: The worse-seeing eye of blind patients was implanted with the Argus II. Patients wore glasses mounted with a small camera and a video processor that converted images into stimulation patterns sent to the electrode array on the retina. MAIN OUTCOME MEASURES: The primary outcome measures were safety (the number, seriousness, and relatedness of adverse events) and visual function, as measured by 3 computer-based, objective tests. Secondary measures included functional vision performance on objectively scored real-world tasks. RESULTS: Twenty-four of 30 patients remained implanted with functioning Argus II Systems at 5 years after implantation. Only 1 additional serious adverse event was experienced after the 3-year time point. Patients performed significantly better with the Argus II on than off on all visual function tests and functional vision tasks. CONCLUSIONS: The 5-year results of the Argus II trial support the long-term safety profile and benefit of the Argus II System for patients blind as a result of RP. The Argus II is the first and only retinal implant to have market approval in the European Economic Area, the United States, and Canada.
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Ceguera/cirugía , Retina/patología , Retinitis Pigmentosa/complicaciones , Agudeza Visual , Prótesis Visuales , Personas con Daño Visual/rehabilitación , Adulto , Anciano , Ceguera/etiología , Ceguera/fisiopatología , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Diseño de Prótesis , Retina/fisiopatología , Retinitis Pigmentosa/fisiopatología , Retinitis Pigmentosa/cirugía , Factores de Tiempo , Resultado del TratamientoRESUMEN
PURPOSE: The purpose of this study was to use a cross-sectional prevalence-based health care economic survey to ascertain the annual, incremental, societal ophthalmic costs associated with neovascular age-related macular degeneration. METHODS: Consecutive patients (n = 200) with neovascular age-related macular degeneration were studied. A Control Cohort included patients with good (20/20-20/25) vision, while Study Cohort vision levels included Subcohort 1: 20/30 to 20/50, Subcohort 2: 20/60 to 20/100, Subcohort 3: 20/200 to 20/400, and Subcohort 4: 20/800 to no light perception. An interviewer-administered, standardized, written survey assessed 1) direct ophthalmic medical, 2) direct nonophthalmic medical, 3) direct nonmedical, and 4) indirect medical costs accrued due solely to neovascular age-related macular degeneration. RESULTS: The mean annual societal cost for the Control Cohort was $6,116 and for the Study Cohort averaged $39,910 (P < 0.001). Study Subcohort 1 costs averaged $20,339, while Subcohort 4 costs averaged $82,984. Direct ophthalmic medical costs comprised 17.9% of Study Cohort societal ophthalmic costs, versus 74.1% of Control Cohort societal ophthalmic costs (P < 0.001) and 10.4% of 20/800 to no light perception subcohort costs. Direct nonmedical costs, primarily caregiver, comprised 67.1% of Study Cohort societal ophthalmic costs, versus 21.3% ($1,302/$6,116) of Control Cohort costs (P < 0.001) and 74.1% of 20/800 to no light perception subcohort costs. CONCLUSION: Total societal ophthalmic costs associated with neovascular age-related macular degeneration dramatically increase as vision in the better-seeing eye decreases.
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Costo de Enfermedad , Atención a la Salud/economía , Costos de la Atención en Salud , Oftalmología/economía , Degeneración Macular Húmeda/economía , Anciano , Anciano de 80 o más Años , Cuidadores/economía , Análisis Costo-Beneficio , Estudios Transversales , Economía Médica , Femenino , Recursos en Salud/estadística & datos numéricos , Humanos , Masculino , Persona de Mediana Edad , Prevalencia , Calidad de Vida , Factores Socioeconómicos , Encuestas y Cuestionarios , Estados Unidos , Agudeza Visual , Degeneración Macular Húmeda/diagnóstico , Degeneración Macular Húmeda/terapiaRESUMEN
PURPOSE: To assess the incremental, comparative effectiveness (patient value gain) and cost effectiveness (financial value gain) associated with 0.3-mg intravitreal ranibizumab injection therapy versus sham therapy for diabetic macular edema (DME). DESIGN: Value-Based Medicine (Center for Value-Based Medicine, Flourtown, PA) 14-year, cost-utility analysis using patient preferences and 2012 United States real dollars. PARTICIPANTS: Published data from the identical Ranibizumab Injection in Subjects with Clinically Significant Macular Edema with Center Involvement Secondary to Diabetes Mellitus (RISE and RIDE) clinical trials. METHODS: An incremental cost-utility analysis was performed using societal and third-party insurer cost perspectives. Costs and outcomes were discounted with net present value analysis at 3% per annum. MAIN OUTCOME MEASURES: The incremental comparative effectiveness was measured in: (1) quality-adjusted life year (QALY) gain and (2) percent patient value (quality-of-life) gain. Cost effectiveness was quantified with the cost-utility ratio (CUR) measured as $/QALY. RESULTS: The 14-year, incremental patient value gain conferred by intravitreal ranibizumab therapy for diabetic maculopathy was 0.9981 QALY, equating to an 11.6% improvement in quality of life. The direct, ophthalmic medical cost for ranibizumab therapy in 1 eye was $30 116, whereas for 2 eyes it was $56 336. The direct, nonophthalmic, medical costs saved from decreased depression, injury, skilled nursing facility admissions, nursing home admissions, and other vision-associated costs totaled $51 758, resulting in an overall direct medical cost of $4578. The net mean societal cost for bilateral ranibizumab therapy was -$30 807. Of this total, decreased caregiver costs accrued a $31 406 savings against the direct medical costs, whereas decreased wage losses accrued a $3978 savings. The third-party insurer CUR for bilateral ranibizumab therapy was $4587/QALY. The societal cost perspective for bilateral therapy was -$30 807/QALY, indicating that ranibizumab therapy dominated sham therapy because it conferred both a positive QALY gain of 0.9981 and a financial value gain (positive financial return on investment) of $30 807 referent to the direct ophthalmic medical costs expended. CONCLUSIONS: Intravitreal ranibizumab therapy for the treatment of DME confers considerable patient (human) value gain. It also accrues financial value to patients, public and private insurers, and society.
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Inhibidores de la Angiogénesis/economía , Anticuerpos Monoclonales Humanizados/economía , Análisis Costo-Beneficio , Retinopatía Diabética/economía , Edema Macular/economía , Anciano , Inhibidores de la Angiogénesis/efectos adversos , Inhibidores de la Angiogénesis/uso terapéutico , Anticuerpos Monoclonales Humanizados/efectos adversos , Anticuerpos Monoclonales Humanizados/uso terapéutico , Retinopatía Diabética/tratamiento farmacológico , Femenino , Costos de la Atención en Salud , Humanos , Inyecciones Intravítreas , Edema Macular/tratamiento farmacológico , Masculino , Persona de Mediana Edad , Calidad de Vida , Años de Vida Ajustados por Calidad de Vida , Ensayos Clínicos Controlados Aleatorios como Asunto , Ranibizumab , Factor A de Crecimiento Endotelial Vascular/antagonistas & inhibidores , Agudeza Visual/efectos de los fármacos , Agudeza Visual/fisiologíaRESUMEN
PURPOSE: To assess the character and cause of photopsias in vitreoretinal patients. DESIGN: Cross-sectional study. PARTICIPANTS: A total of 169 consecutive patients (217 eyes) with vitreoretinal disease presenting with a history of photopsias. METHODS: A total of 217 eyes with photopsias in 169 patients were evaluated. Photopsia assessment included (1) laterality (unilateral, bilateral but not simultaneous, bilateral, and simultaneous); (2) morphology (flash, zig-zag, strobe, scintillating scotoma, twinkling, other); (3) color (white, silver, yellow, combination, other); (4) location (temporal, central, other); (5) duration (quick, prolonged, constant, other); (6) frequency; (7) diurnal appearance (day, night, both); (8) stimuli (turning head or eyes, hypoglycemia, hyperglycemia, other); and (9) associated systemic or ocular signs and symptoms (headache, numbness, weakness, vertigo, syncope, diplopia, hypotension, floaters, other). MAIN OUTCOME MEASURES: Clinical photopsia features correlated with the causes of photopsias. RESULTS: Thirty-two photopsia causes were identified. The top 16 included posterior vitreous detachment (PVD) in 39.7% of eyes; retinal tear in 8.9% of eyes; neovascular age-related macular degeneration (AMD) in 7.9% of eyes; rhegmatogenous retinal detachment (RRD) in 7.5% of eyes; classic and ophthalmic migraine in 6.5% of eyes; hypoglycemia in 2.8% of eyes; vertebrobasilar insufficiency in 2.8% of eyes; non-AMD choroidal neovascularization in 2.3% of eyes; retinitis pigmentosa in 1.9% of eyes; severe cough in 1.9% of eyes; central serous chorioretinopathy in 1.4% of eyes; intraocular lens reflections in 0.9% of eyes; blue field entoptic phenomenon in 0.9% of eyes; Charles Bonnet syndrome in 0.9% of eyes; digitalis in 0.9% of eyes; and metastatic adenocarcinoma to the brain in 0.9% of eyes. The photopsias associated with PVD are typically quick (96%), with lightning/flash morphology (96%), white (87%), temporally located (86%), associated with new-onset floaters (85%), preferentially seen in dark (90%) rather than lighted environments (29%), and often initiated by head/eye movements (60%). Retinal detachment had a similar profile, but with more nontemporal photopsias (40%) (P = 0.01). The photopsias from neovascular AMD are more centrally located (83%), quick and repetitive (79%), seen in light (73%) and dark (63%) environments, have no inciting stimuli (84%), and are more likely to be nonwhite (40%). CONCLUSIONS: A pointed history for photopsias can reveal a cause that may not initially seem apparent. Thus, the history can play a key role in management decisions.
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Oftalmopatías/diagnóstico , Trastornos de la Percepción/diagnóstico , Fosfenos , Enfermedades de la Retina/diagnóstico , Trastornos de la Visión/diagnóstico , Cuerpo Vítreo/patología , Adulto , Anciano , Anciano de 80 o más Años , Estudios Transversales , Oftalmopatías/complicaciones , Femenino , Humanos , Masculino , Persona de Mediana Edad , Trastornos de la Percepción/etiología , Enfermedades de la Retina/complicaciones , Trastornos de la Visión/etiologíaRESUMEN
PURPOSE: Retinitis pigmentosa (RP) is a group of inherited retinal degenerations leading to blindness due to photoreceptor loss. Retinitis pigmentosa is a rare disease, affecting only approximately 100 000 people in the United States. There is no cure and no approved medical therapy to slow or reverse RP. The purpose of this clinical trial was to evaluate the safety, reliability, and benefit of the Argus II Retinal Prosthesis System (Second Sight Medical Products, Inc, Sylmar, CA) in restoring some visual function to subjects completely blind from RP. We report clinical trial results at 1 and 3 years after implantation. DESIGN: The study is a multicenter, single-arm, prospective clinical trial. PARTICIPANTS: There were 30 subjects in 10 centers in the United States and Europe. Subjects served as their own controls, that is, implanted eye versus fellow eye, and system on versus system off (native residual vision). METHODS: The Argus II System was implanted on and in a single eye (typically the worse-seeing eye) of blind subjects. Subjects wore glasses mounted with a small camera and a video processor that converted images into stimulation patterns sent to the electrode array on the retina. MAIN OUTCOME MEASURES: The primary outcome measures were safety (the number, seriousness, and relatedness of adverse events) and visual function, as measured by 3 computer-based, objective tests. RESULTS: A total of 29 of 30 subjects had functioning Argus II Systems implants 3 years after implantation. Eleven subjects experienced a total of 23 serious device- or surgery-related adverse events. All were treated with standard ophthalmic care. As a group, subjects performed significantly better with the system on than off on all visual function tests and functional vision assessments. CONCLUSIONS: The 3-year results of the Argus II trial support the long-term safety profile and benefit of the Argus II System for patients blind from RP. Earlier results from this trial were used to gain approval of the Argus II by the Food and Drug Administration and a CE mark in Europe. The Argus II System is the first and only retinal implant to have both approvals.
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Ceguera/rehabilitación , Implantación de Prótesis , Retinitis Pigmentosa/cirugía , Baja Visión/rehabilitación , Prótesis Visuales , Adulto , Anciano , Electrodos Implantados , Femenino , Estudios de Seguimiento , Humanos , Masculino , Microelectrodos , Persona de Mediana Edad , Estudios Prospectivos , Reproducibilidad de los Resultados , Retinitis Pigmentosa/fisiopatología , Método Simple Ciego , Agudeza Visual/fisiologíaRESUMEN
UNLABELLED: There is a notable lack of measures of enduring beliefs, which are key etiological factors in Beck's cognitive model of anxiety. The Anxiety Attitude and Belief Scale-2 was developed to address this need. Items from the original AABS were reviewed and revised, and additional items were added to cover the range of constructs identified as reflecting anxiety related expectancies while avoiding the confounding of cognition and affect. Suitability of items was examined using cognitive interviewing (Willis, 2004). The resulting set of 48 items was administered to an index sample of individuals reporting anxiety symptoms and a cross-validation sample of undergraduate students in order to derive a measurement model describing its internal structure. The final, 33-item AABS-2 had a bifactor structure of one general and four specific factors, good fit to the data, common factor content across groups, acceptable precision in measurement, and evidence of construct validity. KEY PRACTITIONER MESSAGE: Measures of enduring beliefs related to anxiety disorders are needed to assess etiological factors within cognitive therapy; while there are numerous measures of automatic thoughts, there are few measures of beliefs. The present study sought to address this gap. The items that originally appeared on ten rationally derived scales drawn from clinical phenomenology of anxiety disorders were eventually grouped into four group factors and one general factor in the course of psychometric analyses. The group factors included ones expected to distinguish groups reporting panic, OCD, and social anxiety symptoms from other anxiety symptom groups, and this prediction was supported. The majority of predictions regarding patterns or correlations were also supported. Further validation research is needed to evaluate the validity of the AABS and its subscales in predicting course and outcome of psychotherapy.
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Trastornos de Ansiedad/psicología , Actitud Frente a la Salud , Encuestas y Cuestionarios/normas , Adulto , Femenino , Humanos , Masculino , Psicometría , Reproducibilidad de los Resultados , Adulto JovenAsunto(s)
Antirreumáticos , Artritis Juvenil , Uveítis , Adalimumab , Análisis Costo-Beneficio , HumanosRESUMEN
PURPOSE OF REVIEW: Although the patient value gain (improvement in quality-of-life and/or length-of-life) has been highlighted in Value-based Medicine cost-utility analyses, the financial value gain associated with healthcare interventions has received less emphasis. It is important for professional healthcare providers to realize their interventions often confer a large financial return-on-investment (ROI) to society. RECENT FINDINGS: The societal costs associated with vitreoretinal and other ophthalmic interventions include: direct ophthalmic medical costs expended (hospital, physician, drug, diagnostic testing and so forth), direct medical costs saved (decreased costs for depression, injury, skilled nursing facility, nursing home and others), direct nonmedical costs saved (decreased costs for caregivers, transportation, residence costs, moving costs, and others), and indirect medical costs saved (improving employment incidence and wages). The financial ROI for direct ophthalmic medical costs expended for ranibizumab therapy for neovascular age-related macular degeneration is 450%, whereas that for cataract surgery is 4500% and for medical open-angle glaucoma therapy is 4000%. Many costs gained add to the Gross Domestic Product and increase the wealth of the nation. SUMMARY: Many vitreoretinal and other ophthalmologic interventions confer considerable patient value, but also result in a large financial ROI to society. This financial ROI increases the wealth of the nation.
Asunto(s)
Economía Médica , Oftalmología/economía , Calidad de Vida/psicología , Años de Vida Ajustados por Calidad de Vida , Anticuerpos Monoclonales Humanizados/economía , Extracción de Catarata/economía , Análisis Costo-Beneficio , Costos Directos de Servicios , Glaucoma de Ángulo Abierto/economía , Humanos , Degeneración Macular/economía , RanibizumabRESUMEN
Interoceptive awareness (IA)--the ability to detect internal body signals--has been linked to various aspects of emotional processing. However, it has been examined mostly as a trait variable, with few studies also investigating state dependent fluctuations in IA. Based on the known positive correlation between IA and emotional reactivity, negative affectivity, and trait anxiety, the current study examined whether IA, as indexed by heartbeat detection accuracy, would change during an anxiety-provoking situation. Participants in the experimental condition, in which they anticipated giving a speech in front of a small audience, displayed significant IA increases from baseline to anticipation. Enhancement in IA was positively correlated with fear of negative evaluation. Implications of the results are discussed in relation to the role of trait and state IA in emotional experience.