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1.
J Clin Oncol ; 37(10): 809-822, 2019 04 01.
Article in English | MEDLINE | ID: mdl-30763176

ABSTRACT

PURPOSE: We evaluated the effect of Internet-based cognitive behavioral therapy (iCBT), with or without therapist support, on the perceived impact of hot flushes and night sweats (HF/NS) and overall levels of menopausal symptoms (primary outcomes), sleep quality, HF/NS frequency, sexual functioning, psychological distress, and health-related quality of life in breast cancer survivors with treatment-induced menopausal symptoms. PATIENTS AND METHODS: We randomly assigned 254 breast cancer survivors to a therapist-guided or a self-managed iCBT group or to a waiting list control group. The 6-week iCBT program included psycho-education, behavior monitoring, and cognitive restructuring. Questionnaires were administered at baseline and at 10 weeks and 24 weeks postrandomization. We used mixed-effects models to compare the intervention groups with the control group over time. Significance was set at P < .01. An effect size (ES) of .20 was considered small, .50 moderate and clinically significant, and .80 large. RESULTS: Compared with the control group, the guided and self-managed iCBT groups reported a significant decrease in the perceived impact of HF/NS (ES, .63 and .56, respectively; both P < .001) and improvement in sleep quality (ES, .57 and .41; both P < .001). The guided group also reported significant improvement in overall levels of menopausal symptoms (ES, .33; P = .003), and NS frequency (ES, .64; P < .001). At longer-term follow-up (24 weeks), the effects remained significant, with a smaller ES for the guided group on perceived impact of HF/NS and sleep quality and for the self-managed group on overall levels of menopausal symptoms. Additional longer-term effects for both intervention groups were found for hot flush frequency. CONCLUSION: iCBT, with or without therapist support, has clinically significant, salutary effects on the perceived impact and frequency of HF/NS, overall levels of menopausal symptoms, and sleep quality.


Subject(s)
Breast Neoplasms/therapy , Cancer Survivors , Cognitive Behavioral Therapy/methods , Internet , Psychotherapy, Group/methods , Adult , Female , Hot Flashes/etiology , Hot Flashes/therapy , Humans , Middle Aged , Neoadjuvant Therapy/adverse effects , Outcome Assessment, Health Care/methods , Outcome Assessment, Health Care/statistics & numerical data , Pilot Projects , Sleep Wake Disorders/etiology , Sleep Wake Disorders/therapy , Surveys and Questionnaires , Sweating
2.
Phys Ther ; 99(4): 428-439, 2019 04 01.
Article in English | MEDLINE | ID: mdl-30690630

ABSTRACT

BACKGROUND: Although the Fitkids Treadmill Test (FTT) has been validated and normative values are available for healthy 6- to 18-year-old children and adolescents, these facts do not automatically imply uptake of the test in routine practice of physical therapists. OBJECTIVE: The objectives of this study were to evaluate the utility of the FTT in different diagnostic groups and to explore potential factors affecting the use of the FTT in clinical practice. DESIGN: Mixed methods with both quantitative and qualitative data were used in this study. METHODS: Outcome parameters from the FTT were retrieved from the Fitkids database. For evaluation of the utility of the FTT, 2 indicators, exercise duration and maximal effort, were used. An online survey was sent to physical therapists in Fitkids practices to identify factors affecting the use of the FTT in clinical practice. RESULTS: The proportion of children and adolescents in each of the diagnostic groups who reached the minimal duration of a maximal exercise test ranged from 94% to 100%. The proportion of participants who reached a peak heart rate ≥180 beats/min ranged from 46% for participants with cognitive, psychological, or sensory disorders to 92% for participants with metabolic diseases. The most important facilitator for use of the FTT was the fact that most physical therapists were convinced of the additional value of the FTT. The main barriers were therapists' attitudes (resistance to change/lack of experience) and, on the environmental level, the absence of a treadmill ergometer in physical therapist practice. LIMITATIONS: Structured interviews would have provided more information on potential factors affecting the use of the FTT in clinical practice. CONCLUSIONS: This study has shown the clinical utility of the FTT in different diagnostic groups in pediatric physical therapist practice. Responding to the factors identified in this study should enable improved uptake of the FTT in clinical practice.


Subject(s)
Exercise Test/standards , Physical Fitness/physiology , Physical Therapists , Adolescent , Adult , Child , Chronic Disease/rehabilitation , Female , Humans , Male , Middle Aged
3.
J Sex Marital Ther ; 45(2): 91-102, 2019.
Article in English | MEDLINE | ID: mdl-30040589

ABSTRACT

As part of a larger, randomized controlled trial, we evaluated longitudinally the sexual functioning and relationship satisfaction of 69 partners of breast cancer (BC) survivors who received Internet-based cognitive behavioral therapy (CBT) for sexual dysfunction. The findings suggest that Internet-based CBT positively affects the partners' immediate post-CBT and longer-term overall sexual satisfaction, sexual intimacy, and sexual relationship satisfaction. No sustained changes in other areas of sexual functioning were observed. Our CBT program was focused primarily on the sexual health of the BC survivors. We recommend that future programs include more psychoeducational and behavioral elements targeted at the partners.


Subject(s)
Breast Neoplasms/psychology , Cognitive Behavioral Therapy/methods , Personal Satisfaction , Sexual Partners/psychology , Therapy, Computer-Assisted/methods , Adult , Breast Neoplasms/therapy , Cancer Survivors/psychology , Female , Humans , Internet , Male , Middle Aged
4.
J Sex Marital Ther ; 44(5): 485-496, 2018.
Article in English | MEDLINE | ID: mdl-29297781

ABSTRACT

The study aim was to evaluate the long-term efficacy of Internet-based cognitive behavioral therapy (CBT) for sexual dysfunctions in 84 breast cancer survivors. The positive effects of the intervention on overall sexual functioning, sexual desire, sexual arousal, vaginal lubrication, discomfort during sex, sexual distress, and body image observed immediately posttreatment were maintained at three- and nine-month follow-ups. Although sexual pleasure decreased during follow-up, it did not return to baseline levels. Our findings provide evidence that Internet-based CBT has a sustained, positive effect on sexual functioning and body image of breast cancer survivors with a sexual dysfunction.


Subject(s)
Cancer Survivors/psychology , Cognitive Behavioral Therapy/methods , Libido , Sexual Dysfunction, Physiological/therapy , Sexual Dysfunctions, Psychological/therapy , Adult , Body Image , Female , Humans , Middle Aged , Sexual Behavior , Sexual Dysfunction, Physiological/etiology , Sexual Dysfunction, Physiological/psychology , Sexual Dysfunctions, Psychological/etiology , Sexual Dysfunctions, Psychological/psychology , Surveys and Questionnaires , Treatment Outcome
5.
J Clin Oncol ; 35(12): 1328-1340, 2017 Apr 20.
Article in English | MEDLINE | ID: mdl-28240966

ABSTRACT

Purpose We evaluated the effect of Internet-based cognitive behavioral therapy (CBT) on sexual functioning and relationship intimacy (primary outcomes) and body image, menopausal symptoms, marital functioning, psychological distress, and health-related quality of life (secondary outcomes) in breast cancer survivors (BCSs) with a DSM-IV diagnosis of a sexual dysfunction. Patients and Methods We randomly assigned 169 BCSs to either Internet-based CBT or a waiting-list control group. The CBT consisted of weekly therapist-guided sessions, with a maximum duration of 24 weeks. Self-report questionnaires were completed by the intervention group at baseline (T0), midtherapy (T1), and post-therapy (T2) and at equivalent times by the control group. We used a mixed-effect modeling approach to compare the groups over time. Results Compared with the control group, the intervention group showed a significant improvement over time in overall sexual functioning (effect size for T2 [EST2] = .43; P = .031), which was reflected in an increase in sexual desire (EST1 = .48 and EST2 = .72; P < .001), sexual arousal (EST2 = .50; P = .008), and vaginal lubrication (EST2 = .46; P = .013). The intervention group reported more improvement over time in sexual pleasure (EST1 = .32 and EST2 = .62; P = .001), less discomfort during sex (EST1 = .49 and EST2 = .66; P = .001), and less sexual distress (EST2 = .59; P = .002) compared with the control group. The intervention group reported greater improvement in body image (EST2 = .45; P = .009) and fewer menopausal symptoms (EST1 = .39; P = .007) than the control group. No significant effects were observed for orgasmic function, sexual satisfaction, intercourse frequency, relationship intimacy, marital functioning, psychological distress, or health-related quality of life. Conclusion Internet-based CBT has salutary effects on sexual functioning, body image, and menopausal symptoms in BCSs with a sexual dysfunction.


Subject(s)
Breast Neoplasms/therapy , Cognitive Behavioral Therapy/methods , Internet , Sexual Dysfunction, Physiological/therapy , Therapy, Computer-Assisted/methods , Breast Neoplasms/physiopathology , Breast Neoplasms/psychology , Female , Humans , Middle Aged , Self Report , Sexual Behavior/physiology , Sexual Behavior/psychology , Sexual Dysfunction, Physiological/psychology , Survivors , Waiting Lists
6.
Phys Ther ; 96(11): 1764-1772, 2016 Nov.
Article in English | MEDLINE | ID: mdl-27197825

ABSTRACT

BACKGROUND: Recent research has shown that the Fitkids Treadmill Test (FTT) is a valid and reproducible exercise test for the assessment of aerobic exercise capacity in children and adolescents who are healthy. OBJECTIVE: The study objective was to provide sex- and age-related normative values for FTT performance in children and adolescents who were healthy, developing typically, and 6 to 18 years of age. DESIGN: This was a cross-sectional, observational study. METHODS: Three hundred fifty-six children and adolescents who were healthy (174 boys and 182 girls; mean age=12.9 years, SD=3.7) performed the FTT to their maximal effort to assess time to exhaustion (TTE). The least-mean-square method was used to generate sex- and age-related centile charts (P3, P10, P25, P50, P75, P90, and P97) for TTE on the FTT. RESULTS: In boys, the reference curve (P50) showed an almost linear increase in TTE with age, from 8.8 minutes at 6 years of age to 16.1 minutes at 18 years of age. In girls, the P50 values for TTE increased from 8.8 minutes at 6 years of age to 12.5 minutes at 18 years of age, with a plateau in TTE starting at approximately 10 years of age. LIMITATIONS: Youth who were not white were underrepresented in this study. CONCLUSIONS: This study describes sex- and age-related normative values for FTT performance in children and adolescents who were healthy, developing typically, and 6 to 18 years of age. These age- and sex-related normative values will increase the usefulness of the FTT in clinical practice.


Subject(s)
Exercise Test/methods , Physical Fitness/physiology , Adolescent , Child , Cross-Sectional Studies , Female , Humans , Male , Netherlands , Reference Values
7.
Ann Surg Oncol ; 23(1): 30-7, 2016 Jan.
Article in English | MEDLINE | ID: mdl-26486999

ABSTRACT

BACKGROUND: Ultrasound-guided breast-conserving surgery (USS) results in a significant reduction in both margin involvement and excision volumes (COBALT trial). Objective. The aim of the present study was to determine whether USS also leads to improvements in cosmetic outcome and patient satisfaction when compared with standard palpation-guided surgery (PGS). METHODS: A total of 134 patients with T1­T2 invasive breast cancer were included in the COBALT trial (NTR2579) and randomized to either USS (65 patients) or PGS (69 patients). Cosmetic outcomes were assessed by a three-member panel using computerized software Breast Cancer Conservative Treatment cosmetic results (BCCT.- core) and by patient self-evaluation, including patient satisfaction. Time points for follow-up were 3, 6, and 12 months after surgery. Overall cosmetic outcome and patient satisfaction were scored on a 4-point Likert scale (excellent, good, fair, or poor), and outcomes were analyzed using a multilevel, mixed effect, proportional odds model for ordinal responses. RESULTS: Ultrasound-guided breast-conserving surgery achieved better cosmetic outcomes, with 20 % excellence overall and only 6 % rated as poor, whereas 14 % of PGS outcomes were rated excellent and 13 % as poor. USS also had consistently lower odds for worse cosmetic outcomes (odds ratio 0.55, p = 0.067) than PGS. The chance of having a worse outcome was significantly increased by a larger lumpectomy volume (ptrend = 0.002); a volume [40 cc showed odds 2.78-fold higher for a worse outcome than a volume B40 cc. USS resulted in higher patient satisfaction compared with PGS. CONCLUSION: Ultrasound-guided breast-conserving surgery achieved better overall cosmetic outcomes and patient satisfaction than PGS. Lumpectomy volumes[40 cc resulted in significantly worse cosmetic outcomes.


Subject(s)
Breast Neoplasms/diagnostic imaging , Breast Neoplasms/surgery , Cosmetic Techniques/instrumentation , Mastectomy, Segmental , Patient Satisfaction , Surgery, Computer-Assisted , Ultrasonography, Mammary , Breast Neoplasms/pathology , Female , Follow-Up Studies , Humans , Intraoperative Care , Middle Aged , Neoplasm Invasiveness , Neoplasm Staging , Prognosis , Quality of Life
8.
Med Sci Sports Exerc ; 47(10): 2241-7, 2015 Oct.
Article in English | MEDLINE | ID: mdl-26378949

ABSTRACT

PURPOSE: This study aimed to investigate the validity and reproducibility of a new treadmill protocol in healthy children and adolescents: the Fitkids Treadmill Test (FTT). METHODS: Sixty-eight healthy children and adolescents (6-18 yr) were randomly divided into a validity group (14 boys and 20 girls; mean ± SD age, 12.9 ± 3.6 yr) that performed the FTT and Bruce protocol, both with respiratory gas analysis within 2 wk, and a reproducibility group (19 boys and 15 girls; mean ± SD age, 13.5 ± 3.5 yr) that performed the FTT twice within 2 wk. A subgroup of 21 participants within the reproducibility group performed both FTT with respiratory gas analysis. Time to exhaustion (TTE) was the main outcome of the FTT. RESULTS: V˙O2peak measured during the FTT showed excellent correlation with V˙O2peak measured during the Bruce protocol (r = 0.90; P < 0.01). Backward multiple regression analysis provided the following prediction equations for V˙O2peak (L·min) for boys and girls, respectively: V˙O2peak FTT = -0.748 + (0.117 × TTEFTT) + (0.032 × body mass) + 0.263, and V˙O2peak FTT = -0.748 + (0.117 × TTEFTT) + (0.032 × body mass) [R = 0.935; SEE = 0.256 L·min]. Cross-validation of the regression model showed an R value of 0.76. Reliability statistics for the FTT showed an intraclass correlation coefficient of 0.985 (95% confidence interval, 0.971-0.993; P < 0.001) for TTE. Bland-Altman analysis showed a mean bias of -0.07 min, with limits of agreement between +1.30 and -1.43 min. CONCLUSIONS: Results suggest that the FTT is a useful treadmill protocol with good validity and reproducibility in healthy children and adolescents. Exercise performance on the FTT and body mass can be used to adequately predict V˙O2peak when respiratory gas analysis is not available.


Subject(s)
Exercise Test/methods , Exercise Test/standards , Adolescent , Body Height , Body Mass Index , Child , Female , Humans , Male , Oxygen Consumption , Reproducibility of Results , Respiratory Function Tests
9.
Phys Ther ; 94(9): 1306-18, 2014 Sep.
Article in English | MEDLINE | ID: mdl-24786945

ABSTRACT

BACKGROUND: Children with disabilities have an increased risk for reduced fitness and reduced health-related quality of life (HRQoL). Fitkids, a nationwide exercise therapy program in the Netherlands, was developed to improve fitness and HRQoL in children with disabilities. OBJECTIVE: The study objective was to determine the effects of the Fitkids program on health-related fitness, walking capacity, and HRQoL in children with disabilities or chronic conditions. DESIGN: This was a quasi-experimental single-group longitudinal study. METHODS: Fifty-two children and adolescents who were referred to the Fitkids program participated in this study. Participants received a graded exercise training program for 6 months, with frequencies of 1 hour 2 times per week in the first 3 months and 1 hour per week during months 4 to 6. Health-related fitness (aerobic fitness, anaerobic fitness, and muscle strength), walking capacity, and HRQoL were evaluated at baseline and after 3 and 6 months of training. Multilevel modeling was used to quantify the contributions of repeated measures, participants, and Fitkids centers to variations in health-related fitness, walking capacity, and HRQoL during the intervention period. The models were adjusted for sex, height, and weight. RESULTS: After 6 months of training, significant intervention effects were found for aerobic fitness, anaerobic fitness, and muscle strength. A significant effect also was found for walking capacity. On the HRQoL measure, significant improvements were found for the self-reported and parent-reported physical and emotion domains and for the parent-reported total score for HRQoL. LIMITATIONS: No control group was included in this study. CONCLUSIONS: The Fitkids exercise therapy program has significantly improved health-related fitness, walking capacity, and HRQoL in children and adolescents with chronic conditions or disabilities.


Subject(s)
Disabled Children/rehabilitation , Exercise Therapy/methods , Physical Fitness/physiology , Quality of Life , Adolescent , Child , Female , Humans , Male , Netherlands , Program Evaluation , Treatment Outcome
10.
Pediatr Phys Ther ; 25(1): 7-13, 2013.
Article in English | MEDLINE | ID: mdl-23208224

ABSTRACT

PURPOSE: To describe the demographics, medical diagnoses, and initial aerobic fitness levels of children participating in Fitkids: an exercise therapy program for children with chronic conditions or disabilities in the Netherlands. METHODS: We reviewed data of children who were in the program on September 2010. RESULTS: In total, 2482 children from 105 Fitkids centers were included. Results showed the large heterogeneity of the population regarding demographic characteristics and medical diagnoses. Significantly reduced scores on the 6-minute walk test and half Bruce treadmill test were observed. CONCLUSION: The Fitkids population has great heterogeneity. In addition, a plethora of fitness tests were used, and registration of data in the Fitkids database was suboptimal. Moreover, this study showed the impaired aerobic fitness of children participating in Fitkids. Future research should investigate the effectiveness of the Fitkids program.


Subject(s)
Exercise Therapy/statistics & numerical data , Exercise , Physical Fitness , Program Evaluation/statistics & numerical data , Adolescent , Child , Demography , Female , Humans , Male , Netherlands
11.
Lancet Oncol ; 14(1): 48-54, 2013 Jan.
Article in English | MEDLINE | ID: mdl-23218662

ABSTRACT

BACKGROUND: Breast-conserving surgery for palpable breast cancer is associated with tumour-involved margins in up to 41% of cases and excessively large excision volumes. Ultrasound-guided surgery has the potential to resolve both of these problems, thereby improving surgical accuracy for palpable breast cancer. We aimed to compare ultrasound-guided surgery with the standard for palpable breast cancer-palpation-guided surgery-with respect to margin status and extent of healthy breast tissue resection. METHODS: In this randomised controlled trial, patients with palpable T1-T2 invasive breast cancer were recruited from six medical centres in the Netherlands between October, 2010, and March, 2012. Eligible participants were randomly assigned to either ultrasound-guided surgery or palpation-guided surgery in a 1:1 ratio via a computer-generated random sequence and were stratified by study centre. Patients and investigators were aware of treatment assignments. Primary outcomes were surgical margin involvement, need for additional treatment, and excess healthy tissue resection (defined with a calculated resection ratio derived from excision volume and tumour diameter). Data were analysed by intention to treat. This trial is registered at http://www.TrialRegister.nl, number NTR2579. FINDINGS: 134 patients were eligible for random allocation. Two (3%) of 65 patients allocated ultrasound-guided surgery had tumour-involved margins compared with 12 (17%) of 69 who were assigned palpation-guided surgery (difference 14%, 95% CI 4-25; p=0·0093). Seven (11%) patients who received ultrasound-guided surgery and 19 (28%) of those who received palpation-guided surgery required additional treatment (17%, 3-30; p=0·015). Ultrasound-guided surgery also resulted in smaller excision volumes (38 [SD 26] vs 57 [41] cm(3); difference 19 cm(3), 95% CI 7-31; p=0·002) and a reduced calculated resection ratio (1·0 [SD 0·5] vs 1·7 [1·2]; difference 0·7, 95% CI 0·4-1·0; p=0·0001) compared with palpation-guided surgery. INTERPRETATION: Compared with palpation-guided surgery, ultrasound-guided surgery can significantly lower the proportion of tumour-involved resection margins, thus reducing the need for re-excision, mastectomy, and radiotherapy boost. By achieving optimum resection volumes, ultrasound-guided surgery reduces unnecessary resection of healthy breast tissue and could contribute to improved cosmetic results and quality of life. FUNDING: Dutch Pink Ribbon Foundation, Osinga-Kluis Foundation, Toshiba Medical Systems.


Subject(s)
Breast Neoplasms/surgery , Mastectomy, Segmental/methods , Ultrasonography, Mammary , Adult , Aged , Breast Neoplasms/pathology , Female , Humans , Intraoperative Period , Middle Aged , Neoplasm Staging , Palpation , Treatment Outcome
12.
J Clin Oncol ; 30(33): 4124-33, 2012 Nov 20.
Article in English | MEDLINE | ID: mdl-23045575

ABSTRACT

PURPOSE: The purpose of our study was to evaluate the effect of cognitive behavioral therapy (CBT), physical exercise (PE), and of these two interventions combined (CBT/PE) on menopausal symptoms (primary outcome), body image, sexual functioning, psychological well-being, and health-related quality of life (secondary outcomes) in patients with breast cancer experiencing treatment-induced menopause. PATIENTS AND METHODS: Patients with breast cancer reporting treatment-induced menopausal symptoms (N=422) were randomly assigned to CBT (n=109), PE (n=104), CBT/PE (n=106), or to a waiting list control group (n=103). Self-report questionnaires were completed at baseline, 12 weeks, and 6 months. Multilevel procedures were used to compare the intervention groups with the control group over time. RESULTS: Compared with the control group, the intervention groups had a significant decrease in levels of endocrine symptoms (Functional Assessment of Cancer Therapy-Endocrine Symptoms; P<.001; effect size, 0.31-0.52) and urinary symptoms (Bristol Female Lower Urinary Tract Symptoms Questionnaire; P=.002; effect size, 0.29-0.33), and they showed an improvement in physical functioning (36-Item Short Form Health Survey physical functioning subscale; P=.002; effect size, 0.37-0.46). The groups that included CBT also showed a significant decrease in the perceived burden of hot flashes and night sweats (problem rating scale of the Hot Flush Rating Scale; P<.001; effect size, 0.39-0.56) and an increase in sexual activity (Sexual Activity Questionnaire habit subscale; P=.027; effect size, 0.65). Most of these effects were observed at both the 12-week and 6-month follow-ups. CONCLUSION: CBT and PE can have salutary effects on endocrine symptoms and, to a lesser degree, on sexuality and physical functioning of patients with breast cancer experiencing treatment-induced menopause. Future work is needed to improve the design and the planning of these interventions to improve program adherence.


Subject(s)
Breast Neoplasms/psychology , Breast Neoplasms/therapy , Cognitive Behavioral Therapy/methods , Exercise/psychology , Menopause/physiology , Menopause/psychology , Breast Neoplasms/drug therapy , Female , Hot Flashes/drug therapy , Humans , Middle Aged , Prospective Studies , Quality of Life , Retrospective Studies , Surveys and Questionnaires , Treatment Outcome
13.
BMC Surg ; 11: 8, 2011 Mar 16.
Article in English | MEDLINE | ID: mdl-21410949

ABSTRACT

BACKGROUND: Breast-conserving surgery for breast cancer was developed as a method to preserve healthy breast tissue, thereby improving cosmetic outcomes. Thus far, the primary aim of breast-conserving surgery has been the achievement of tumour-free resection margins and prevention of local recurrence, whereas the cosmetic outcome has been considered less important. Large studies have reported poor cosmetic outcomes in 20-40% of patients after breast-conserving surgery, with the volume of the resected breast tissue being the major determinant. There is clear evidence for the efficacy of ultrasonography in the resection of nonpalpable tumours. Surgical resection of palpable breast cancer is performed with guidance by intra-operative palpation. These palpation-guided excisions often result in an unnecessarily wide resection of adjacent healthy breast tissue, while the rate of tumour-involved resection margins is still high. It is hypothesised that the use of intra-operative ultrasonography in the excision of palpable breast cancer will improve the ability to spare healthy breast tissue while maintaining or even improving the oncological margin status. The aim of this study is to compare ultrasound-guided surgery for palpable tumours with the standard palpation-guided surgery in terms of the extent of healthy breast tissue resection, the percentage of tumour-free margins, cosmetic outcomes and quality of life. METHODS/DESIGN: In this prospective multicentre randomised controlled clinical trial, 120 women who have been diagnosed with palpable early-stage (T1-2N0-1) primary invasive breast cancer and deemed suitable for breast-conserving surgery will be randomised between ultrasound-guided surgery and palpation-guided surgery. With this sample size, an expected 20% reduction of resected breast tissue and an 18% difference in tumour-free margins can be detected with a power of 80%. Secondary endpoints include cosmetic outcomes and quality of life. The rationale, study design and planned analyses are described. CONCLUSION: The COBALT trial is a prospective, multicentre, randomised controlled study to assess the efficacy of ultrasound-guided breast-conserving surgery in patients with palpable early-stage primary invasive breast cancer in terms of the sparing of breast tissue, oncological margin status, cosmetic outcomes and quality of life. TRIAL REGISTRATION NUMBER: Netherlands Trial Register (NTR): NTR2579.


Subject(s)
Breast Neoplasms/diagnostic imaging , Breast Neoplasms/surgery , Mastectomy, Segmental/methods , Palpation , Ultrasonography, Mammary , Adult , Aged , Breast Neoplasms/pathology , Breast Neoplasms/psychology , Clinical Protocols , Cosmetic Techniques , Female , Humans , Mastectomy, Segmental/instrumentation , Middle Aged , Prospective Studies , Quality of Life , Treatment Outcome
14.
Int J Nurs Stud ; 36(5): 387-96, 1999 Oct.
Article in English | MEDLINE | ID: mdl-10519683

ABSTRACT

Caring, the theoretical foundation of nursing, is identified as one of the core values by Hospital Authorities world-wide to be actualised in clinical practice. Exactly how caring attributes relate to nurses' professional self image and quality nursing service in the context of a contemporary technological environment have yet to be operationalised. In total, 1957 Registered Nurses from 11 different countries were involved in the study which aimed to: develop an understanding of and compare the responses to items relating to caring, professional self concept and technological influences. To collect data an instrument containing 104 Likert items was administered to RNs working in general hospitals. The instrument contained sections which examined professional self concept, technological influences and caring attributes. Descriptive and inferential statistics revealed that many of the Asian nurses in the sample were younger, had less experience yet were more qualified than their 'western' colleagues. The mean scores for the caring attributes for nurses from the Philippines, Sweden and South Africa were significantly higher than those from China (Beijing), Korea, China (Hong Kong) and Scotland. The Korean sample demonstrated the lowest mean score for professional self concept while the New Zealand sample the highest. The Australian, Canadian, NZ, Scotland and Swedish samples were strongly of the opinion that the increase in technology has not brought about the any more spare time in nursing and generally had a more negative opinion about the influence of technology when compared to those from China (Beijing), Philippines, China (Hong Kong) and Singapore. The results are discussed in the light of the cultural differences in the sample and recommendations for future research are considered.


Subject(s)
Cross-Cultural Comparison , Empathy , Medical Laboratory Science , Nurses/psychology , Self Concept , Adult , Demography , Female , Humans , Nurses/statistics & numerical data , Pilot Projects , Reproducibility of Results , Surveys and Questionnaires
15.
Zhonghua Hu Li Za Zhi ; 31(5): 288-90, 1996 May.
Article in Chinese | MEDLINE | ID: mdl-8945141
17.
Arch Ophthalmol ; 106(11): 1543-7, 1988 Nov.
Article in English | MEDLINE | ID: mdl-3190538

ABSTRACT

The visual function of 100 eyes with low visual acuity of 100 patients with age-related macular degeneration was examined using measurements of visual acuity, peak contrast sensitivity, and the ability to read, to tell time, and to distinguish colors, products, and facial expressions. Visual acuity and peak contrast sensitivity were correlated (r = .62); however, a range of peak contrast sensitivities was observed at each level of acuity. When considered individually, visual acuity and peak contrast sensitivity were related to the ability to perform each of the tasks. When multivariate methods were applied, both visual acuity and peak contrast sensitivity contributed independently to the ability to read and tell time. Among patients with the same contrast sensitivity, visual acuity had little or no relationship to the ability to identify colors, products, and faces.


Subject(s)
Macular Degeneration/physiopathology , Visual Acuity , Aged , Color Perception Tests , Contrast Sensitivity , Female , Humans , Light Coagulation , Macular Degeneration/surgery , Male
18.
Chest ; 94(2): 360-5, 1988 Aug.
Article in English | MEDLINE | ID: mdl-3293930

ABSTRACT

To evaluate whether increased airway reactivity affected the course of patients with cystic fibrosis (CF), we categorized 40 CF patients as to methacholine sensitivity and then evaluated their disease activity and natural history. Twenty methacholine reactors had more severe lung disease (lower S-K clinical scores and more impairment of pulmonary function) than did 16 nonreactive patients, and acute bronchodilator response was greater in the methacholine reactors. Thirty-four patients were followed prospectively over a 17- to 24-month period. Among 19 methacholine reactors, there were more pulmonary exacerbations and a more rapid decline in FEV1. In general, increased obstruction was associated with increased reactivity. Although the data are subject to differing interpretations, they are consistent with the hypothesis that in patients with CF, airway hyperreactivity occurs secondary to bronchial damage, age, is associated with more rapid pulmonary deterioration, and is an unfavorable prognostic finding.


Subject(s)
Cystic Fibrosis/physiopathology , Respiratory Hypersensitivity/physiopathology , Adolescent , Adult , Bronchial Provocation Tests , Child , Cystic Fibrosis/complications , Female , Forced Expiratory Flow Rates , Forced Expiratory Volume , Humans , Male , Methacholine Chloride , Methacholine Compounds , Prospective Studies , Respiratory Hypersensitivity/complications , Respiratory Hypersensitivity/diagnosis , Vital Capacity
19.
Arch Ophthalmol ; 106(3): 357-61, 1988 Mar.
Article in English | MEDLINE | ID: mdl-2449884

ABSTRACT

This study was undertaken to determine whether the treatment benefit reported in randomized trials for patients with extrafoveal choroidal neovascular membranes (NVMs) secondary to age-related macular degeneration (AMD) or the ocular histoplasmosis syndrome (OHS) can be duplicated in other clinical settings. The visual results and recurrence rates in treated extrafoveal NVMs of 70 patients with AMD and 21 patients with OHS were similar to those reported by the Macular Photocoagulation Study Group, in which all treated patients received argon blue-green laser photocoagulation after the administration of retrobulbar anesthesia. In this study, 78% (71/90) of the patients were treated with krypton laser and only 35% (32/90) had retrobulbar anesthesia. These results suggest, but do not prove, that the wavelength of the laser used or the administration of retrobulbar anesthesia may not be critical variables in determining the success of treatment in patients with extra-foveal NVMs.


Subject(s)
Choroid/blood supply , Laser Therapy , Neovascularization, Pathologic/surgery , Argon , Clinical Trials as Topic , Follow-Up Studies , Humans , Krypton , Light Coagulation , Neovascularization, Pathologic/physiopathology , Random Allocation , Recurrence , Visual Acuity
20.
Arch Ophthalmol ; 106(1): 55-7, 1988 Jan.
Article in English | MEDLINE | ID: mdl-3337707

ABSTRACT

Low-contrast charts were used to investigate the possibility that patients with drusen have visual deficits not detected by standard Snellen charts. We compared performance on Regan letter charts between 52 eyes with drusen and Snellen acuity of 20/20 and 27 control eyes. The drusen group read fewer letters than the control group on all of the charts tested. This difference increased as the contrast of the charts decreased. The loss of performance on all of the Regan charts correlated with drusen severity. Twenty-one eyes with drusen and normal Snellen acuity also were tested with a Ginsburg contrast sensitivity chart and compared with age-matched normal controls. The results showed a loss of contrast sensitivity at high spatial frequencies and a loss of peak contrast sensitivity with increasing drusen severity. These results suggest that in patients with drusen, low-contrast charts may be useful for measuring visual loss not detected by standard Snellen charts.


Subject(s)
Macular Degeneration/complications , Vision Disorders/diagnosis , Visual Acuity , Adult , Aged , Humans , Macular Degeneration/physiopathology , Middle Aged , Vision Disorders/etiology , Vision Tests
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