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1.
Melanoma Res ; 34(4): 319-325, 2024 Aug 01.
Article in English | MEDLINE | ID: mdl-38578293

ABSTRACT

Surveillance frequency for metastasis is guided by gene expression profiling (GEP). This study evaluated the effect of GEP on time to diagnosis of metastasis, subsequent treatment and survival. A retrospective study was conducted of 110 uveal melanoma patients with GEP (DecisionDx-UM, Castle Biosciences, Friendswood, Texas, USA) and 110 American Joint Committee on Cancer-matched controls. Surveillance testing and treatment for metastasis were compared between the two groups and by GEP class. Rates of metastasis, overall survival and melanoma-related mortality were calculated using Kaplan-Meier estimates. Baseline characteristics and follow-up time were balanced in the two groups. Patients' GEP classification was 1A in 41%, 1B in 25.5% and 2 in 33.6%. Metastasis was diagnosed in 26.4% ( n  = 29) in the GEP group and 23.6% ( n  = 26) in the no GEP group ( P  = 0.75). Median time to metastasis was 30.5 and 22.3 months in the GEP and no GEP groups, respectively ( P  = 0.44). Median months to metastasis were 34.7, 75.8 and 26.1 in class 1A, 1B and 2 patients, respectively ( P  = 0.28). Disease-specific 5-year survival rates were 89.4% [95% confidence interval (CI): 81.0-94.2%] and 84.1% (95% CI: 74.9-90.1%) in the GEP and no GEP groups respectively ( P  = 0.49). Median time to death from metastasis was 10.1 months in the GEP group and 8.5 months in the no GEP group ( P  = 0.40). There were no significant differences in time to metastasis diagnosis and survival outcomes in patients with and without GEP. To realize the full benefit of GEP, more sensitive techniques for detection of metastasis and adjuvant therapies are required.


Subject(s)
Gene Expression Profiling , Melanoma , Neoplasm Metastasis , Uveal Neoplasms , Humans , Melanoma/genetics , Melanoma/pathology , Melanoma/mortality , Uveal Neoplasms/genetics , Uveal Neoplasms/pathology , Uveal Neoplasms/mortality , Male , Female , Middle Aged , Gene Expression Profiling/methods , Retrospective Studies , Aged , Adult , Prognosis , Aged, 80 and over
2.
Scand J Med Sci Sports ; 27(1): 124-135, 2017 Jan.
Article in English | MEDLINE | ID: mdl-26530034

ABSTRACT

Exercise classes are a popular form of physical activity. A greater understanding of the individual difference factors that might influence the outcomes of such classes could help to minimize the high dropout rates associated with exercise. The study explored the effects of dominant attentional style and degree of self-determination on affective, cognitive, and behavioral outcomes following structured exercise classes. Data from 417 female participants revealed that those with a dominant attentional style for association (Associators) reported significantly (P < 0.05) more positive affective, cognitive, and behavioral outcomes than did Dissociators, and were more self-determined. Highly self-determined individuals reported the most positive outcomes. Almost 29% of the variance in participants' affective valence could be explained by Dissociators' behavioral regulations. Results lend support to the notion that attentional style is associated with motivation. The combination of attentional style and degree of self-determination appear to be noteworthy individual difference factors that influence responses to exercise classes and could thus have a bearing on long-term exercise adherence.


Subject(s)
Affect , Attention , Cognition , Exercise , Motivation , Physical Education and Training , Adult , Female , Humans , Middle Aged , Personal Autonomy , Surveys and Questionnaires , Young Adult
3.
Scand J Med Sci Sports ; 21(6): e445-51, 2011 Dec.
Article in English | MEDLINE | ID: mdl-21819448

ABSTRACT

This study examined relationships between beliefs about emotions (meta-emotion beliefs), emotion regulation strategies, and pre-competition emotional states using an instrumental model of emotion regulation. Three hundred and sixty runners reported meta-beliefs about the influence of anxiety and/or anger on performance, completed a short emotion scale, and reported their use of emotion regulation strategies. Results indicated that 55 runners (15%) reported meta-emotion beliefs that strategies aimed at increasing anxiety and/or anger would help performance while 305 runners (85%) reported beliefs that strategies intended to reduce the same emotions before competition would help performance. Multivariate analysis of variance indicated that people who believe that anxiety or anger is good for performance reported high anger, but not anxiety, before performance. They also reported using strategies to increase unpleasant emotions. We suggest that further research is needed to examine relationships between meta-emotion beliefs and the use of emotion regulation strategies in sport.


Subject(s)
Anger , Anxiety/psychology , Athletes/psychology , Athletic Performance/psychology , Adult , Female , Humans , Male , Middle Aged , Multivariate Analysis , Running/psychology , Self Report
4.
J Sports Med Phys Fitness ; 45(2): 208-12, 2005 Jun.
Article in English | MEDLINE | ID: mdl-16355082

ABSTRACT

AIM: The present study investigated the influence of personality on exercise-induced mood changes. It was hypothesised that a) exercise would be associated with significant mood enhancement across all personality types, b) extroversion would be associated with positive mood and neuroticism with negative mood both pre- and post-exercise, and c) personality measures would interact with exercise-induced mood changes. METHODS: Participants were 90 female exercisers (M=25.8 y, SD=9.0 y) who completed the Eysenck Personality Inventory once and the Brunel Mood Scale before and after a 60-min exercise session. Median splits were used to group participants into 4 personality types: stable introverts (n=25), stable extroverts (n=20), neurotic introverts (n=26), and neurotic extroverts (n=19). RESULTS: Repeated measures MANOVA showed significant mood enhancement following exercise across all personality types. Neuroticism was associated with negative mood scores pre- and post-exercise but the effect of extroversion on reported mood was relatively weak. There was no significant interaction effect between exercise-induced mood enhancement and personality. CONCLUSIONS: Findings lend support to the notion that exercise is associated with improved mood. However, findings show that personality did not influence this effect, although neuroticism was associated with negative mood.


Subject(s)
Affect/physiology , Exercise/psychology , Personality , Adolescent , Adult , Emotions/physiology , Extraversion, Psychological , Female , Humans , Introversion, Psychological , Middle Aged , Multivariate Analysis , Neurotic Disorders/psychology , Personality Inventory , Physical Exertion/physiology
5.
J Sports Sci ; 23(4): 409-16, 2005 Apr.
Article in English | MEDLINE | ID: mdl-16089185

ABSTRACT

There have been many examples of contentious points decisions in boxing. Professional boxing is scored subjectively by judges and referees scoring each round of the contest. We assessed whether the probability of a home win (and therefore home advantage) increased when bouts were decided by points decisions rather than knockouts. Overall, we found that bouts ending in points decisions had a significantly higher proportion of home wins than those decided by a knockout, though this effect varied across time, and controlling for relative quality of boxers was only effective when using more recent data. Focusing on these data, again the probability of a home win was higher with a points decision and this effect was consistent as "relative quality" varied. For equally matched boxers ("relative quality" = 0), expected probability of a home win was 0.57 for knockouts, 0.66 for technical knockouts and 0.74 for points decisions. The results of the present study lend general support to the notion that home advantage is more prevalent in sports that involve subjective decision-making. We suggest that interventions should be designed to inform judges to counter home advantage effects.


Subject(s)
Boxing/psychology , Competitive Behavior , Decision Making , Social Environment , Boxing/statistics & numerical data , Chi-Square Distribution , Europe , Humans , Logistic Models , Prejudice , Social Support , Travel/psychology
6.
Br J Sports Med ; 39(6): 351-4; discussion 351-4, 2005 Jun.
Article in English | MEDLINE | ID: mdl-15911606

ABSTRACT

OBJECTIVES: To establish injury rates among a population of elite athletes, to provide normative data for psychological variables hypothesised to be predictive of sport injuries, and to establish relations between measures of mood, perceived life stress, and injury characteristics as a precursor to introducing a psychological intervention to ameliorate the injury problem. METHODS: As part of annual screening procedures, athletes at the Queensland Academy of Sport report medical and psychological status. Data from 845 screenings (433 female and 412 male athletes) were reviewed. Population specific tables of normative data were established for the Brunel mood scale and the perceived stress scale. RESULTS: About 67% of athletes were injured each year, and about 18% were injured at the time of screening. Fifty percent of variance in stress scores could be predicted from mood scores, especially for vigour, depression, and tension. Mood and stress scores collectively had significant utility in predicting injury characteristics. Injury status (current, healed, no injury) was correctly classified with 39% accuracy, and back pain with 48% accuracy. Among a subset of 233 uninjured athletes (116 female and 117 male), five mood dimensions (anger, confusion, fatigue, tension, depression) were significantly related to orthopaedic incidents over the preceding 12 months, with each mood dimension explaining 6-7% of the variance. No sex differences in these relations were found. CONCLUSIONS: The findings support suggestions that psychological measures have utility in predicting athletic injury, although the relatively modest explained variance highlights the need to also include underlying physiological indicators of allostatic load, such as stress hormones, in predictive models.


Subject(s)
Athletic Injuries/psychology , Stress, Psychological/etiology , Adolescent , Adult , Affect , Child , Female , Humans , Injury Severity Score , Male , Psychiatric Status Rating Scales , Psychometrics , Queensland , Regression Analysis
7.
Phys Rev E Stat Nonlin Soft Matter Phys ; 67(5 Pt 1): 051406, 2003 May.
Article in English | MEDLINE | ID: mdl-12786151

ABSTRACT

Small-angle neutron scattering experiments have been performed to investigate orientational ordering of a dispersion of rod-shaped ferromagnetic nanoparticles under the influence of shear flow and static magnetic field. In this experiment, the flow and flow gradient directions are perpendicular to the direction of the applied magnetic field. The scattering intensity is isotropic in zero-shear-rate or zero-applied-field conditions, indicating that the particles are randomly oriented. Anisotropic scattering is observed both in a shear flow and in a static magnetic field, showing that both flow and field induce orientational order in the dispersion. The anisotropy increases with the increase of field and with the increase of shear rate. Three states of order have been observed with the application of both shear flow and magnetic field. At low shear rates, the particles are aligned in the field direction. When increasing shear rate is applied, the particles revert to random orientations at a characteristic shear rate that depends on the strength of the applied magnetic field. Above the characteristic shear rate, the particles align along the flow direction. The experimental results agree qualitatively with the predictions of a mean field model.

8.
Br J Sports Med ; 35(6): 390-5, 2001 Dec.
Article in English | MEDLINE | ID: mdl-11726472

ABSTRACT

AIMS: To examine the effects of rapid weight loss on mood and performance among amateur boxers. METHODS: Participants were 16 experienced amateur boxers. In stage 1, structured interviews were used to assess the type of strategies that boxers used to reduce weight and the value of performing at their desired weight in terms of performance. In stage 2, boxers completed a 4 x 2 minute (1 minute recovery) circuit training session. Boxers completed the circuit training session on three different occasions with a week between each. The first test was used to familiarise the boxers with the circuit training task; the second and third tasks were at their training weight and championship weight, respectively. Participants were given one week to reduce their body weight to their championship weight using their preferred weight making strategies; boxers reduced their body weight by an average of 5.16% of body weight. RESULTS: Boxers typically lost weight by restricting fluid and food intake in the week leading to competition. Repeated measures multivariate analysis of variance results indicated that rapid weight loss among boxers was associated with poor performance, increased anger, fatigue, and tension, and reduced vigour. CONCLUSIONS: Strategies used to make weight by boxers are associated with poor performance and a negative mood profile.


Subject(s)
Affect/physiology , Attitude to Health , Boxing/physiology , Boxing/psychology , Task Performance and Analysis , Weight Loss/physiology , Adult , Analysis of Variance , Anger , Body Weight , Boxing/classification , Confusion , Depression , Diet/adverse effects , Fatigue , Humans , Physical Endurance/physiology
9.
J Sports Med Phys Fitness ; 41(4): 539-45, 2001 Dec.
Article in English | MEDLINE | ID: mdl-11687775

ABSTRACT

BACKGROUND: The present study examined the extent to which pre-exercise depressed mood moderated the influence of exercise on changes in other mood dimensions. The study was conducted in an ecologically valid setting using participants with previous experience of aerobic dance exercise. We hypothesized that (a) exercise will be associated with improved mood regardless of depressed mood, (b) the effect of exercise on mood changes would be significantly greater among individuals that reported symptoms of depressed mood before exercise, and (c) that pre-exercise depressed mood will be associated with a mood profile comprising high anger, confusion, fatigue, and tension, with low vigor. METHODS: Participants were 80 (M=27.90 years, SD=4.32 years) exercisers who had attended an exercise class on a regular basis for the previous three months. Participants completed the Profile of Mood States-A 15 minutes before exercise and then immediately after an aerobic dance exercise class. To examine the proposed moderating influence of depressed mood, participants were grouped into either a no-depression group, or a depressed mood group using pre-exercise depression scores. The exercise intervention was an aerobic dance session where participants followed the moves of the instructor. The session lasted for 60 minutes including a warm-up, main session, and cool-down. RESULTS: Repeated measures MANOVA (time x depression/no-depression group) results indicated that anger, confusion, fatigue, tension, and vigor reduced significantly. Thus supporting the notion that exercise reduces negative mood. Results indicated that the reduction in anger, confusion, fatigue, and tension, and increase in vigor was significantly greater in the depressed mood group, hence consistent with theoretical predictions. Results demonstrated that pre-exercise depressed mood was associated with a negative mood profile as hypothesized. CONCLUSIONS: Findings lend support to the notion that exercise is associated with improved mood. However, findings show that this effect was significantly greater among individuals reporting symptoms of depressed mood before exercise.


Subject(s)
Affect/physiology , Depression/psychology , Exercise/psychology , Adult , Depression/classification , Depression/physiopathology , Exercise/physiology , Female , Humans , Male , Multivariate Analysis , Stress, Psychological/therapy , Task Performance and Analysis
10.
Insight ; 26(2): 44-8, 2001 Apr.
Article in English | MEDLINE | ID: mdl-11426204

ABSTRACT

Patients with neovascular (wet) age-related macular degeneration, the leading cause of blindness in persons older than 50 years in developed countries, experience severe visual loss due to choroidal neovascularization, the growth of abnormal vessels under the retina. Photodynamic therapy is a new treatment modality that combines an intravenous injection of a photosensitizing drug, such as verteporfin, and nonthermal laser light application, which destroys choroidal neovascularization without damaging normal surrounding tissue. It has led to new challenges for nurses working in the ambulatory laser setting, including medication preparation, drug administration, and education regarding precautions and potential systemic side effects of photodynamic therapy.


Subject(s)
Job Description , Macular Degeneration/therapy , Nurse's Role , Photochemotherapy/nursing , Choroidal Neovascularization/etiology , Critical Pathways , Equipment Safety , Humans , Macular Degeneration/complications , Patient Education as Topic , Photochemotherapy/adverse effects , Photochemotherapy/instrumentation , Photochemotherapy/methods , Photochemotherapy/psychology , Photosensitizing Agents/therapeutic use , Porphyrins/therapeutic use , Practice Guidelines as Topic , Verteporfin
11.
J Sports Sci ; 19(4): 273-8, 2001 Apr.
Article in English | MEDLINE | ID: mdl-11311025

ABSTRACT

In 1999, Wilson and Batterham proposed a new approach to assessing the test-retest stability of psychometric questionnaires. They recommended assessing the proportion of agreement - that is, the proportion of participants that record the same response to an item - using a test-retest design. They went on to use a bootstrapping technique to estimate the uncertainty of the proportion of agreement. The aims of this short communication are (1) to demonstrate that the sampling distribution of the proportion of agreement is well known (the binomial distribution), making the technique of 'bootstrapping' redundant, and (2) to suggest a much simpler, more sensitive method of assessing the stability of a psychometric questionnaire, based on the test-retest differences (within-individuals) for each item. Adopting methods similar to Wilson and Batterham, 97 sport students completed the Social Physique Anxiety Scale on two occasions. Test-retest differences were calculated for each item. Our results show that the proportion of agreement ignores the nature of disagreement. Items 4 and 11 showed similar agreement (44.3% and 43.3% respectively), but 89 of the participants (91.8%) differed by just +/-1 point when responding to item 4, indicating a relatively stable item. In contrast, only 78 of the participants (80.4%) recorded a difference within +/- 1 point when responding to item 11, suggesting quite contrasting stability for the two items. We recommend that, when assessing the stability of self-report questionnaires using a 5-point scale, most participants (90%) should record test-retest differences within a reference value of +/- 1.


Subject(s)
Anxiety Disorders/diagnosis , Body Image , Psychometrics , Sports/psychology , Surveys and Questionnaires , Adult , Female , Humans , Male , Reproducibility of Results , Statistics, Nonparametric
12.
Percept Mot Skills ; 91(2): 649-52, 2000 Oct.
Article in English | MEDLINE | ID: mdl-11065327

ABSTRACT

Examination of the mood and performance relationship in sport has been an important line of investigation in sport psychology for over 20 years. Recent research has challenged the notion that the Profile of Mood States is the instrument of choice. It has also moved away from the notion that successful performance is associated with an 'iceberg' profile (Morgan, 1980), arguing that researchers should consider mood and emotion as distinguishable constructs (Jones, Mace, & Williams, 2000; Lane & Terry, 2000. In the present paper, I expand the discussion on mood research in sport by re-examining some of the findings of Jones, et al. in the light of recent work.


Subject(s)
Affect , Emotions , Sports/psychology , Hockey/psychology , Humans , Personality Inventory
13.
Arch Ophthalmol ; 118(6): 773-8, 2000 Jun.
Article in English | MEDLINE | ID: mdl-10865313

ABSTRACT

OBJECTIVE: To determine if a reduction in proton radiation dose from the standard dose of 70 cobalt gray equivalents (CGE) to 50 CGE would decrease radiation-induced complications, thereby improving visual prognosis, without compromising local tumor control for patients with uveal melanoma at high risk of these complications. DESIGN: Randomized, double-masked clinical trial. PARTICIPANTS: A total of 188 patients with small or medium-sized choroidal melanomas (<15 mm in diameter and <5 mm in height) near the optic disc or macula (within 4 disc diameters of either structure). METHODS: Patients were treated with proton beam therapy at doses of either 50 CGE or 70 CGE between October 1989 and July 1994, and followed up biannually through April 1998. Outcomes included visual acuity, radiation complications, melanoma recurrence, and metastasis. RESULTS: Proportions of patients retaining visual acuity of at least 20/200 were similar in the 2 dose groups at 5 years after radiation (approximately 55%). Similar numbers of patients in each group experienced tumor regrowth (2 patients at 50 CGE vs 3 patients at 70 CGE; P>.99) and metastasis (7 patients at 50 CGE vs 8 patients at 70 CGE;P=.79). Five-year rates of radiation maculopathy also were similar (for both groups, approximately 75% for tumors within 1 disc diameter and 40% for tumors >1 disc diameter from the macula). Rates of radiation papillopathy were nonsignificantly decreased in the 50-CGE treatment group when tumors were located 1 disc diameter or less from the optic disc (P=.20). Patients treated with the lower dose also experienced significantly less visual field loss. CONCLUSIONS: This level of dose reduction did not result in a lesser degree of visual acuity loss. The lower-dose group did experience significantly less visual field loss. Local tumor recurrence and metastatic death rates were similar in both dose groups. Arch Ophthalmol. 2000;118:773-778


Subject(s)
Choroid Neoplasms/radiotherapy , Melanoma/radiotherapy , Radiotherapy Dosage , Adult , Aged , Aged, 80 and over , Choroid Neoplasms/physiopathology , Cobalt Radioisotopes/therapeutic use , Dose-Response Relationship, Radiation , Double-Blind Method , Female , Humans , Male , Melanoma/physiopathology , Middle Aged , Radiation Dosage , Radiation Injuries/prevention & control , Visual Acuity/radiation effects , Visual Fields/radiation effects
14.
Arch Ophthalmol ; 118(3): 327-36, 2000 Mar.
Article in English | MEDLINE | ID: mdl-10721954

ABSTRACT

OBJECTIVE: To evaluate short-term safety and the effects on visual acuity and fluorescein angiography of single or multiple sessions of photodynamic therapy with verteporfin for choroidal neovascularization (CNV) not related to age-related macular degeneration (AMD), including pathologic myopia, the ocular histoplasmosis syndrome, angioid streaks, and idiopathic causes. DESIGN: A nonrandomized, multicenter, open-label, dose-escalation phase 1 and 2 clinical trial. SETTING: Four ophthalmic centers in Europe and North America providing retinal care. PARTICIPANTS: Thirteen patients with subfoveal CNV due to pathologic myopia, the ocular histoplasmosis syndrome, angioid streaks, or idiopathic causes. METHODS: Standardized protocol refraction, visual acuity testing, ophthalmic examinations, color photographs, and fluorescein angiograms were used to evaluate the results of photodynamic therapy treatments with verteporfin. Follow-up ranged from 12 weeks for patients who were treated once to 43 weeks for patients who were treated up to 4 times. RESULTS: Verteporfin therapy was well tolerated in patients with CNV not related to AMD. No deterioration in visual acuity was observed; most patients gained at least 1 line of vision. Reduction in the size of leakage area from classic CNV was noted in all patients as early as 1 week after verteporfin therapy, with complete absence of leakage from classic CNV in almost half of the patients. Improvement in visual acuity after verteporfin therapy was greatest (+6, +8, and +9 lines) in 3 patients with relatively poor initial visual acuity (between 20/200 and 20/800). Up to 4 treatments were found to have short-term safety even with retreatment intervals as short as 4 weeks. CONCLUSIONS: Treatment of CNV not related to AMD with verteporfin therapy achieves short-term cessation of fluorescein leakage from CNV in a small number of patients without loss of vision. Further randomized clinical trials including a larger number of patients are under way to confirm whether verteporfin therapy is beneficial for subfoveal CNV not related to AMD.


Subject(s)
Angioid Streaks/complications , Choroidal Neovascularization/drug therapy , Eye Infections, Fungal/complications , Histoplasmosis/complications , Myopia/complications , Photochemotherapy , Photosensitizing Agents/therapeutic use , Porphyrins/therapeutic use , Adult , Aged , Aged, 80 and over , Capillary Permeability , Choroidal Neovascularization/etiology , Female , Fluorescein Angiography , Fundus Oculi , Humans , Male , Middle Aged , Safety , Verteporfin , Visual Acuity
15.
J Sports Sci ; 17(11): 861-72, 1999 Nov.
Article in English | MEDLINE | ID: mdl-10585166

ABSTRACT

The aim of this study was to develop and validate a shortened version of the Profile of Mood States suitable for use with adolescents. The Profile of Mood States-Adolescents (POMS-A) was administered to 1693 participants from two populations: school children and young athletes. Confirmatory factor analysis supported the factorial validity of a 24-item six-factor model using both independent and multi-sample analyses. Correlations of POMS-A scores with previously validated inventories, which were consistent with theoretical predictions, provided evidence of criterion validity. It is proposed that the POMS-A is a valid instrument for the assessment of mood in adolescents.


Subject(s)
Affect/physiology , Personality Tests/standards , Sports/psychology , Adolescent , Adolescent Behavior , Female , Humans , Male , Reproducibility of Results , Sensitivity and Specificity , United Kingdom
16.
J Sports Sci ; 17(9): 713-24, 1999 Sep.
Article in English | MEDLINE | ID: mdl-10521002

ABSTRACT

Equivocal results of the psychophysical effects of music have been explained in part by the insensitivity of researchers to important personal and situational variables when selecting music. The aim of the present study was to operationalize a conceptual framework for the prediction of psychophysical responses to music into a music rating inventory to assess the motivational qualities of music in exercise and sport environments. An initial item pool was developed and administered to 334 aerobics instructors. Exploratory factor analysis produced a 13-item, four-factor structure (association, musicality, cultural impact and rhythm response), which accounted for 59.2% of the variance. This model demonstrated acceptable fit indices when tested using confirmatory factor analysis on 314 exercise-to-music participants, and was better than an alternative two-factor model. When cross-validated using multisample confirmatory factor analysis, the model also showed an acceptable fit overall, although some invariance in the rhythm response factor was evident that can be attributed to the exclusive use of synchronous music by aerobics instructors. The Brunel Music Rating Inventory appears to be a valid and reliable tool for both researchers and practitioners to assess the motivational qualities of music in exercise and sport environments.


Subject(s)
Exercise/psychology , Motivation , Music , Surveys and Questionnaires/standards , Adult , Analysis of Variance , Chi-Square Distribution , Factor Analysis, Statistical , Humans , Psychometrics , Sports/psychology
17.
Arch Ophthalmol ; 117(9): 1161-73, 1999 Sep.
Article in English | MEDLINE | ID: mdl-10496388

ABSTRACT

OBJECTIVE: To evaluate the safety and short-term visual and fluorescein angiographic effects of a single photodynamic therapy treatment with verteporfin with the use of different dosage regimens in patients with choroidal neovascularization (CNV) from age-related macular degeneration. DESIGN: Nonrandomized, multicenter, open-label, clinical trial using 5 dosage regimens. SETTING: Four ophthalmic centers in North America and Europe providing retinal care. PARTICIPANTS: Patients with subfoveal CNV caused by age-related macular degeneration. METHODS: Standardized protocol refraction, visual acuity testing, ophthalmic examination, color photographs, and fluorescein angiograms were used to evaluate the effects of a single treatment of photodynamic therapy with verteporfin. Follow-up was planned through 3 months in 97 patients and for less than 3 months in 31 other patients. RESULTS: The mean visual acuity change (and range of change) from baseline at the follow-up examination at week 12 after a single treatment with regimens 1 through 5 was -0.2 (-3 to +2), -0.9 (-9 to +5), -1.6 (-9 to +2), +0.4 (-8 to +7), and +0.1 (-8 to +9) lines, respectively. Only the highest light dose (150 J/cm2) in regimens 2 and 3, which produced angiographic nonperfusion of neurosensory retinal vessels, caused marked vision loss. Some cessation of fluorescein leakage from CNV was achieved without loss of vision when the light dose used was less than 150 J/cm2. Systemic adverse events were rare. Cessation of fluorescein leakage from CNV was noted in all regimens by 1 week after photodynamic therapy. Fluorescein leakage from at least a portion of the CNV reappeared by 4 to 12 weeks after treatment in almost all cases. Progression of classic CNV beyond the area of CNV identified before treatment was noted in 42 (51%) of the 83 eyes with classic CNV followed up for 3 months after a single treatment. Eyes in which the area of any CNV leakage at 12 weeks was less than at baseline had a significantly better visual acuity outcome (+0.8 line) than eyes in which CNV leakage progressed (-0.8 line). CONCLUSIONS: Photodynamic therapy with verteporfin achieved short-term cessation of fluorescein leakage from CNV without loss of vision or growth of classic CNV in some patients with age-related macular degeneration. Except for nonperfusion of neurosensory retinal vessels at a light dose of 150 J/cm2, no other adverse events were of concern. Randomized clinical trials to investigate whether this new modality can preserve vision in patients with CNV secondary to age-related macular degeneration are justified.


Subject(s)
Choroidal Neovascularization/drug therapy , Macular Degeneration/complications , Photochemotherapy , Photosensitizing Agents/therapeutic use , Porphyrins/therapeutic use , Aged , Aged, 80 and over , Capillary Permeability/drug effects , Choroid/blood supply , Choroidal Neovascularization/etiology , Choroidal Neovascularization/metabolism , Choroidal Neovascularization/pathology , Female , Fluorescein/metabolism , Fluorescein Angiography , Follow-Up Studies , Fundus Oculi , Humans , Male , Middle Aged , Refraction, Ocular , Safety , Treatment Outcome , Verteporfin , Visual Acuity
18.
Arch Ophthalmol ; 117(9): 1177-87, 1999 Sep.
Article in English | MEDLINE | ID: mdl-10496389

ABSTRACT

OBJECTIVES: To evaluate safety and short-term visual acuity and fluorescein angiographic effects of photodynamic therapy (PDT) after retreatments with verteporfin for choroidal neovascularization (CNV) in age-related macular degeneration (AMD) that demonstrated fluorescein leakage after at least 1 course of PDT. DESIGN: Nonrandomized, multicenter, open-label phase 1 and 2 clinical trial using 2 different retreatment dosage regimens. SETTING: Four ophthalmic centers in Europe and North America providing retinal care. METHODS: Standardized protocol refraction, visual acuity testing, ophthalmic examinations, color photographs, and fluorescein angiograms were used to evaluate the results of multiple PDT treatments. Two regimens (regimens 2 and 4) for treatment and retreatment were chosen from 5 used in a single-treatment study. Both regimens used a verteporfin dose of 6 mg/m2 infused for 10 minutes. However, regimen 2 used a light dose of 100 J/cm2 applied 20 minutes after the start of the verteporfin infusion, whereas regimen 4 used a light dose of 50, 75, or 100 J/cm2 applied 15 minutes after infusion commenced. Posttreatment evaluations were planned in 31 participants up to 3 months after up to 2 retreatments given at 2- or 4-week intervals after initial PDT treatment. Similar posttreatment evaluations were planned after retreatments in 5 additional participants who were reenrolled some time more than 12 weeks after an initial PDT treatment. RESULTS: The average visual acuity change for the 31 participants who had retreatment within 2 to 4 weeks after the initial treatment and a follow-up examination 16 to 20 weeks after the initial treatment was 0.2 lines (range, -4 to 4 lines) in regimen 2 and -1.0 line (range, -5 to 3 lines) in regimen 4. Similar outcomes were noted in the 5 reenrolled participants. Cessation of fluorescein leakage from classic CNV for at least 1 to 4 weeks could be achieved without loss of visual acuity after at least 2 treatments in 2 (6.5%) of 31 patients. Similar to single-treatment effects, the disappearance of leakage was documented regularly at 1 week after each retreatment. Fluorescein leakage reappeared by 4 to 12 weeks after a retreatment in almost all cases. However, compared with baseline, leakage activity appeared to be reduced after multiple PDT courses. For the 31 patients who had follow-up for 3 months after the last retreatment and had received retreatment 2 to 4 weeks after the initial treatment, progression of CNV beyond the area identified before the retreatment was noted in 10 (48%) of the 21 eyes with classic CNV in regimen 2 and 9 (90%) of 10 eyes in regimen 4. The rate and severity of ocular or systemic adverse events were not increased by multiple applications. CONCLUSIONS: Multiple applications of PDT with verteporfin achieve repetitive, short-term cessation of fluorescein leakage from CNV secondary to AMD, without loss of visual acuity. This strategy can be used in randomized clinical trials investigating the efficacy of verteporfin in PDT for recurrent fluorescein dye leakage from persistent or recurrent CNV, following an initial or subsequent PDT treatment, with maintenance of visual acuity. Retreatments may achieve progressive cessation of leakage and prevent further growth of CNV and subsequent visual loss.


Subject(s)
Choroidal Neovascularization/drug therapy , Macular Degeneration/complications , Photochemotherapy , Photosensitizing Agents/therapeutic use , Porphyrins/therapeutic use , Aged , Aged, 80 and over , Capillary Permeability/drug effects , Choroid/blood supply , Choroidal Neovascularization/etiology , Choroidal Neovascularization/metabolism , Choroidal Neovascularization/pathology , Female , Fluorescein/metabolism , Fluorescein Angiography , Follow-Up Studies , Fundus Oculi , Humans , Male , Middle Aged , Photosensitizing Agents/administration & dosage , Porphyrins/administration & dosage , Retreatment , Safety , Treatment Outcome , Verteporfin , Visual Acuity
19.
Ophthalmology ; 106(8): 1571-7; discussion 1577-8, 1999 Aug.
Article in English | MEDLINE | ID: mdl-10442906

ABSTRACT

PURPOSE: To evaluate rates of occurrence and risk factors for radiation maculopathy and radiation papillopathy in patients with choroidal melanoma at high risk for these complications. DESIGN: Cohort study. PARTICIPANTS: A total of 558 patients treated with proton irradiation for choroidal melanoma between 1986 and 1996 with small to moderate sized tumors (less than 5 mm in height and 15 mm in diameter) located within 4 disc diameters of the macula or optic nerve and with a median ocular follow-up of 4 years. METHODS: Annual and cumulative rates of each endpoint were estimated using life table approaches. Prognostic factors were evaluated using the Cox proportional hazards regression. MAIN OUTCOME MEASURES: Radiation maculopathy, radiation papillopathy, and vision loss to worse than 20/100. RESULTS: Cumulative 5-year rates for radiation maculopathy, radiation papillopathy, and vision loss were 64%, 35%, and 68%, respectively. Complication rates rose as a function of radiation exposure to the macula (P for trend = 0.04) or optic disc (P for trend < 0.001), although dose-response patterns were nonlinear. History of diabetes was a significant risk factor for maculopathy (P < 0.001) and optic neuropathy (P = 0.009). CONCLUSIONS: The onset of radiation vasculopathy is determined primarily by the degree of irradiation exposure to the macula and optic disc. Risk may be enhanced among those with underlying vascular disorders.


Subject(s)
Choroid Neoplasms/radiotherapy , Macula Lutea/radiation effects , Melanoma/radiotherapy , Optic Disk/radiation effects , Radiation Injuries/etiology , Retinal Diseases/etiology , Aged , Female , Humans , Male , Middle Aged , Prospective Studies , Protons , Radiotherapy Dosage , Risk Factors , Vision Disorders/etiology
20.
J Sports Sci ; 17(6): 505-12, 1999 Jun.
Article in English | MEDLINE | ID: mdl-10404499

ABSTRACT

The aim of this study was to evaluate the factor structure of the Competitive State Anxiety Inventory-2 (CSAI-2) using confirmatory factor analysis. Volunteer participants (n = 1213) completed the CSAI-2 approximately 1 h before competition and the data were analysed in two samples. The hypothesized model showed poor fit indices in both samples independently (Robust Comparative Fit Index: sample A = 0.82, sample B = 0.84) and simultaneously (Comparative Fit Index = 0.83), suggesting that the factor structure proposed by Martens et al. is flawed. Our findings suggest that a limitation of the Cognitive Anxiety scale derives from phrasing items around the word 'concerned' rather than 'worried'. We suggest that being concerned about an impending performance does not necessarily mean that an athlete is experiencing negative thoughts, but that the athlete is acknowledging the importance and difficulty of the challenge and is attempting to mobilize resources to cope. The present results question the use of the CSAI-2 as a valid measure of competitive state anxiety.


Subject(s)
Anxiety/diagnosis , Competitive Behavior , Personality Inventory/statistics & numerical data , Sports/psychology , Adolescent , Adult , Anxiety/psychology , Factor Analysis, Statistical , Female , Humans , Male , Models, Statistical , Psychometrics , Reproducibility of Results
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