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1.
Artigo em Inglês | MEDLINE | ID: mdl-31370099

RESUMO

INTRODUCTION: In high-income countries the majority of pregnancies have a good outcome, and many adverse obstetric outcomes rarely occur. This makes demonstrating clinically relevant and statistically significant effects of new interventions a challenge. The objective of the study was to report incidences of important obstetric outcomes and to calculate sample sizes for tentative studies. MATERIAL AND METHODS: The study was a registry-based study. Data were retrieved from the Danish Medical Birth Registry and included all deliveries in Denmark from 2008 to 2015. The total population included 465 919 deliveries. The study population comprised intended vaginal deliveries with a single fetus in cephalic presentation at term (n = 381 567). Incidences were reported for 20 outcomes considering the relevance for the patients and the severity of the outcomes. We calculated the sample sizes required in tentative obstetric studies to detect risk reductions of 25 and 50%, for tests at the 5% level, using a power of 80 and 90%. For the randomized controlled trials we calculated the sample size required for comparing two proportions with equal-sized groups. For the cohort study we calculated the sample size also required for two proportions but with unequal sized groups. Outcome measures for sample size calculation were neonatal mortality, Apgar score <7 at 5 minutes and emergency cesarean section. RESULTS: The incidence of neonatal mortality, Apgar score <7 at 5 minutes and emergency cesarean section was 0.05, 0.58 and 10.5%, respectively. Using neonatal mortality as the outcome in a tentative randomized controlled trial with an expected risk reduction of 50% and power of 80%, our calculation showed a sample size of 195 036 deliveries. Using Apgar score <7 at 5 minutes or emergency cesarean section as the outcome, 16 254 and 818 deliveries, respectively, were required. In tentative cohort studies, the required sample sizes were larger due to the unequal proportion of exposed/non-exposed women. CONCLUSIONS: Most adverse obstetric outcomes occur rarely; thus, very large sample sizes are required to achieve adequate statistical power in randomized controlled trials. Multicenter studies, international collaborations or alternative study designs to randomized controlled trials could be considered.

2.
Acta Oncol ; 58(12): 1667-1675, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31354000

RESUMO

Background: Due to long-standing concerns that heavy-load lifting could increase the risk of developing lymphedema, breast cancer survivors have been advised to refrain from resistance exercise with heavy loads. This study prospectively evaluated the effect of heavy-load resistance exercise on lymphedema development in women receiving chemotherapy for breast cancer.Material and Methods: Physically inactive women receiving adjuvant chemotherapy for breast cancer (n = 153) were randomized to a HIGH (supervised, multimodal exercise including heavy-load resistance exercise: 85-90% 1 repetition maximum [RM], three sets of 5-8 repetitions) versus LOW (pedometer and one-on-one consultations) 12-week intervention. Outcomes (baseline, 12 and 39 weeks) included lymphedema status (extracellular fluid [bioimpedance spectroscopy] and inter-arm volume % difference [dual-energy X-ray absorptiometry], lymphedema symptoms [numeric rating scale 0-10]), upper-extremity strength (1 RM), and quality of life domains (EORTC- BR23). Linear mixed models were used to evaluate equivalence between groups for lymphedema outcomes (equivalence margins for L-Dex, % difference and symptoms scale: ±5, ±3% and ±1, respectively). Superiority analysis was conducted for muscle strength and quality of life domains.Results: Postintervention equivalence between groups was found for extracellular fluid (0.4; 90% CI -2.5 to 3.2) and symptoms of heaviness (-0.2; -0.6 to 0.2), tightness (-0.1; -0.8 to 0.6) and swelling (0.2; -0.4 to 0.8). Nonequivalence was found for inter-arm volume % difference (-3.5%; -17.3 to 10.3) and pain (-0.7; -1.3 to 0), favoring HIGH. Strength gains were superior in the HIGH versus LOW group (3 kg; 1 to 5, p < .05). Further, clinically relevant reductions in breast (-11; -15 to -7) and arm (-6; -10 to -1) symptoms were found in the HIGH group.Conclusion: Findings suggest that physically inactive breast cancer survivors can benefit from supervised heavy-load resistance exercise during chemotherapy without increasing lymphedema risk. Trial registration: ISRCTN13816000.

3.
Scand J Psychol ; 60(5): 447-455, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31274196

RESUMO

The research literature reveals an ongoing debate regarding the most appropriate conceptualization of psychopathic personality disorder. Specifically, it is discussed to what degree antisocial behavior is part of the conceptualization of the psychopathy construct and what constitutes the best factor model of the Psychopathy Checklist scales. The aim of the present study is to consider the underlying factor structure of the PCL:SV (Psychopathy Checklist Screening Version) in a Danish sample as well as considering the role of antisocial behavior in the psychopathy construct. Data from a Danish forensic patient sample (N = 225) was used and item response theory (IRT), aonfirmatory factor analyses (CFA) and structural equations model (SEM) analyses were carried out. Overall, the findings suggest appropriate item and model fit for the PCL:SV as well as superiority of the three-factor model over the four-factor model. The results are discussed in relation to the broader concept of personality disorder as well as clinical practice in regards to violence risk assessments and treatment of psychopathy.

4.
J Med Internet Res ; 21(6): e10924, 2019 Jun 02.
Artigo em Inglês | MEDLINE | ID: mdl-31199320

RESUMO

BACKGROUND: Individuals with chronic obstructive pulmonary disease (COPD) live with the burden of a progressive life-threatening condition that is often accompanied by anxiety and depression. The severity of the condition is usually considered from a clinical perspective and characterized according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) classification of severity (1-4) and a risk assessment (A through D) that focuses on the patient's symptoms and number of exacerbations, but information about perceived health or ability to manage the condition are rarely included. OBJECTIVE: We evaluated 3 patient-reported outcome measurements (PROMs) to examine how these can be used to report on individuals with COPD who were supported by a digitally assisted intervention that aims to increase the patient's management of their condition to improve their well-being. METHODS: A total of 93 individuals with COPD were enrolled. At baseline and after 6 and 12 months, we measured self-reported self-management (Health Education Impact Questionnaire, heiQ) and health literacy (Health Literacy Questionnaire, HLQ), and physical and mental health (Short Form-36, SF-36) PROMs were collected. The scores of the 19 PROM dimensions were related to COPD severity, that is, GOLD risk assessment, pulmonary function at entry, and number of exacerbations of a period up to 12 months. The initial PROM scores were also compared with pulmonary function, exacerbations, and GOLD risk assessment to predict the number of contacts within the first 90 days. RESULTS: At baseline, 2 dimensions from heiQ and SF-36 Physical health differed significantly between GOLD risk factor groups, indicating more distress and poorer attitudes and health status with increasing severity (GOLD risk assessment). Pulmonary function (FEV1) was negatively associated with the severity of the condition. After 6 months, we observed an increase in heiQ6 (skill and technique acquisition) and a reduction in emotional distress. The latter effect persisted after 12 months, where heiQ4 (self-monitoring and insight) also increased. HLQ3 (actively managing my health) decreased after 6 and 12 months. The number of exacerbations and the GOLD risk factor assessment predicted the number of contacts during the first 90 days. Furthermore, 2 of the PROMS heiQ6 (skill and technique acquisition) and HLQ8 (ability to find good health information) evaluated at baseline were associated with the number of contacts within the first 90 after enrollment. The pulmonary function was not associated with the number of contacts. CONCLUSIONS: Our data suggest that selected dimensions from HLQ, heiQ, and SF-36 can be used as PROMs in relation to COPD to provide researchers and clinicians with greater insight into how this condition affects individuals' ability to understand and manage their condition and perception of their physical and mental health. The PROMs add to the information obtained with the clinical characteristics including the GOLD risk factor assessment. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/resprot.6506.

5.
PLoS One ; 14(4): e0214944, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-30973900

RESUMO

The use of virtual laboratories is growing as companies and educational institutions try to expand their reach, cut costs, increase student understanding, and provide more accessible hands on training for future scientists. Many new higher education initiatives outsource lab activities so students now perform them online in a virtual environment rather than in a classroom setting, thereby saving time and money while increasing accessibility. In this paper we explored whether the learning and motivational outcomes of interacting with a desktop virtual reality (VR) science lab simulation on the internet at home are equivalent to interacting with the same simulation in class with teacher supervision. A sample of 112 (76 female) university biology students participated in a between-subjects experimental design, in which participants learned at home or in class from the same virtual laboratory simulation on the topic of microbiology. The home and classroom groups did not differ significantly on post-test learning outcome scores, or on self-report measures of intrinsic motivation or self-efficacy. Furthermore, these conclusions remained after accounting for prior knowledge or goal orientation. In conclusion, the results indicate that virtual simulations are learning activities that students can engage in just as effectively outside of the classroom environment.

6.
Scand J Trauma Resusc Emerg Med ; 27(1): 3, 2019 Jan 09.
Artigo em Inglês | MEDLINE | ID: mdl-30626404

RESUMO

BACKGROUND: Stroke is a leading cause of death and disability with effective treatment, including thrombolysis or thrombectomy, being time-critical for favourable outcomes. While door-to-needle time in hospital has been optimized for many years, little is known about the ambulance on-scene time (OST). OST has been reported to account for 44% of total alarm-to-door time, thereby being a major time component. We aimed to analyse ambulance OST in stroke patients eligible for thrombolysis and identify potential areas of time optimization. METHODS: A study-specific registration form was developed to record detailed information about OST consumption in cases where the Emergency Medical Services (EMS) suspected a stroke from July 2014-May 2015. Registration forms were completed by ambulance personnel and included details on estimated time spent: 1) localising patient, 2) clinical examination, 3) consulting with the on-call neurologist, 4) mobilising patient to the ambulance, 5) treatment in ambulance before departure. Additionally, estimated total OST was noted. For patients found eligible for further evaluation at a stroke centre, time points were analysed using multivariate Poisson regressions. RESULTS: A total of 520 cases were included. The median OST was 21 min (Interquartile Range (IQR) 16-27). Time consumption was significantly lower (17 vs 21 min, p = 0.0015) when electrocardiography (ECG) was obtained in-hospital instead of on-scene, when intravenous (IV) access was established during transportation instead of before transportation (17 vs 21 min, p < 0.0001), and when the quality of communication with the stroke centres was rated as "good" as opposed to "acceptable/poor" (21 vs 23 min, p = 0.014). Neither the presence of relatives nor ambulance trainees had a significant effect on OST. CONCLUSIONS: In-hospital ECG recording and IV cannulation during transport were found to reduce OST, while "acceptable/poor" communication was found to prolong OST relative to "good" communication. These components of pre-hospital stroke management represent potential opportunities for lowering OST with relatively simple changes, which could ultimately lead to earlier treatment and better patient outcome. TRIAL REGISTRATION: Unique identifier: NCT02191514 .


Assuntos
Ambulâncias , Serviços Médicos de Emergência/organização & administração , Acidente Vascular Cerebral/terapia , Tempo para o Tratamento , Cateterismo , Comunicação , Estudos Transversais , Dinamarca , Eficiência Organizacional , Eletrocardiografia , Humanos
7.
Neurogastroenterol Motil ; 31(4): e13554, 2019 04.
Artigo em Inglês | MEDLINE | ID: mdl-30667131

RESUMO

BACKGROUND: Previous studies indicated delayed gastric emptying in patients with end-stage renal disease (ESRD) using indirect methods. The objective of the current study was to examine gastrointestinal motility using a direct method as well as the role of the incretin hormones and glucagon. METHODS: Patients on chronic hemodialysis and with either normal glucose tolerance, impaired glucose tolerance or type 2 diabetes, and healthy control subjects (N = 8, respectively) were studied. Gastric emptying time was measured by repeated gamma camera imaging for 6 hours after intake of a radioactive labeled standardized mixed solid and liquid meal. Glucagon, glucagon-like peptide-1 (GLP-1), and glucose-dependent insulinotropic polypeptide (GIP) levels were measured. KEY RESULTS: Patients were age, gender and BMI matched with controls. We found significantly higher gastric retention at 15 minutes, prolonged gastric mean emptying time, and gastric half-emptying time of the solid marker in all three groups of ESRD patients compared to controls. Significant differences in mean total area under the concentration curve (AUC) values across the four groups for GIP (P = 0.001), but not for GLP-1 and glucagon. The ESRD group had significant higher total AUC of GIP and glucagon compared to controls (P < 0.001 and P < 0.04) but not for GLP-1 (P = 0.4). No difference in incremental AUC was found. CONCLUSIONS AND INFERENCES: We found altered gastrointestinal motility in dialysis patients, with higher gastric retention and prolonged gastric emptying, and higher total AUC of GIP and glucagon independent of the presence of diabetes or prediabetes.

8.
Scand J Work Environ Health ; 45(4): 356-369, 2019 Jul 01.
Artigo em Inglês | MEDLINE | ID: mdl-30592500

RESUMO

Objectives The aim of this study was to describe the development and the content of the Danish Psychosocial Work Environment Questionnaire (DPQ) and to test its reliability and validity. Methods We describe the identification of dimensions, the development of items, and the qualitative and quantitative tests of the reliability and validity of the DPQ. Reliability and validity of a 150 item version of the DPQ was evaluated in a stratified sample of 8958 employees in 14 job groups of which 4340 responded. Reliability was investigated using internal consistency and test-retest reliability. The factorial validity was investigated using confirmatory factor analysis (CFA). For each multi-item scale, we undertook CFA within each job group and multi-group CFA to investigate factorial invariance across job groups. Finally, using multi-group multi-factor CFA, we investigated whether scales were empirically distinct. Results Internal consistency reliabilities and test-retest reliabilities were satisfactory. Factorial validity of the multi-item scales was satisfactory within each of the 14 job groups. Factorial invariance was demonstrated for 10 of the 28 multi-item scales. The hypothesis that the scales of the DPQ were empirically distinct was supported. The final DPQ version consisted of 119 items covering 38 different psychosocial work environment dimensions. Conclusions Overall, the DPQ is a reliable and valid instrument for assessing psychosocial working conditions in a variety of job groups. The results indicate, however, that questions about psychosocial working conditions may be understood differently across job groups, which may have implications for the comparability of questionnaire-based measures of psychosocial working conditions across job groups.

9.
Lung Cancer ; 126: 125-132, 2018 12.
Artigo em Inglês | MEDLINE | ID: mdl-30527176

RESUMO

INTRODUCTION: Little is known about the optimal amount and timing of exercise strain in concern of the operation wound and with regard improvement of physical function and quality of life (QOL) after surgery for lung cancer. On this background, we decided to investigate the effect of early vs. late initiated postoperative rehabilitation in patients with operable lung cancer on exercise capacity, functional capacity, muscle strength, and QOL. METHODS: The study was designed as a two-armed randomized controlled trial with randomization to either early initiated postoperative rehabilitation (14 days after surgery (ERG)) or a control arm with late initiated postoperative rehabilitation (14 weeks after surgery (LRG)). The primary endpoint was a change in maximum oxygen consumption (VO2peak) from baseline to post intervention 26 weeks following lung resection. Fatigue was measured with EORTC QLQ C30 LC13. RESULTS: From April 2013 to June 2016, 582 patients with operable NSCLC were screened for eligibility. With 119 patients randomized in the early rehabilitation group (ERG) and 116 randomized to late rehabilitation group (LRG). There was no significant difference from baseline to 26 weeks between ERG and LRG (p = 0.926). There was a significant difference from baseline to 14 weeks between groups (p = 0.0018). There was a significant difference from 14 weeks to 26 weeks between the two groups (p < 0.001). We found no significant differences in QOL but we found a significant difference between ERG and LRG from baseline to 14 weeks in fatigue level in favour of ERG. CONCLUSION: This is the first randomized controlled trial to investigate the effects of early vs. late initiated postoperative rehabilitation in patients with lung cancer. There is no difference in the commencement (early vs. late) of a postoperative exercise program for patients with lung cancer on exercise capacity. But to reduce fatigue patients should be recommended to initiate early exercise programs.


Assuntos
Carcinoma Pulmonar de Células não Pequenas/reabilitação , Fadiga/prevenção & controle , Neoplasias Pulmonares/reabilitação , Cuidados Pós-Operatórios/métodos , Idoso , Carcinoma Pulmonar de Células não Pequenas/complicações , Carcinoma Pulmonar de Células não Pequenas/cirurgia , Exercício , Terapia por Exercício/métodos , Fadiga/complicações , Feminino , Humanos , Neoplasias Pulmonares/complicações , Neoplasias Pulmonares/cirurgia , Masculino , Pessoa de Meia-Idade , Qualidade de Vida , Testes de Função Respiratória , Fatores de Tempo
10.
Qual Life Res ; 2018 Nov 19.
Artigo em Inglês | MEDLINE | ID: mdl-30456715

RESUMO

PURPOSE: The psychometric properties of the shoulder pain and disability index (SPADI) have been extensively evaluated using classical test theory, but very few studies have applied Rasch analysis. The purpose of this study was to validate the Danish version using Rasch analysis. METHODS: Responses to the SPADI from 229 patients (48% female, mean age 54.5) were included in the Rasch analysis. Overall fit, individual item fit, local response dependence, dimensionality, targeting, reliability, and differential item functioning (DIF) were examined. RESULTS: After iterative analyses, good fit to the Rasch model was observed, with acceptable targeting and uni-dimensionality. SPADI should be reported as two separate subscales: Pain and Functional Disability. The pain subscale initially demonstrated misfit due to local dependence and DIF, but a log linear Rasch model showed good fit to the Rasch model with acceptable targeting and uni-dimensionality. A six-item version of the disability subscale exhibited adequate fit in the Danish version. The same items were also found to fit the Rasch model in the English version. CONCLUSIONS: The measurement properties of the Danish SPADI are similar to those of the English version. SPADI should be reported as two separate subscales. For the pain subscale, DIF with respect to age was disclosed, but the impact was small. The eight-item disability subscale did not fit the Rasch model. A six-item version of the disability subscale exhibited adequate fit in the Danish version. The same items were also found to fit the Rasch model in the English version.

11.
Health Qual Life Outcomes ; 16(1): 97, 2018 May 16.
Artigo em Inglês | MEDLINE | ID: mdl-29769073

RESUMO

BACKGROUND: The experience of menopausal symptoms is common and an adequate patient-reported outcome measure is crucial in studies where women are treated for these symptoms. The aims of this study were to identify a patient-reported outcome measure for bothersome menopausal symptoms and, in the absence of an adequate tool, to develop a new measure with high content validity, and to validate it using modern psychometric methods. METHODS: The literature was reviewed for existing questionnaires and checklists for bothersome menopausal symptoms. Relevant items were extracted and subsequently tested in group interviews, single interviews, and pilot tests. A patient-reported outcome measure was drafted and completed by 1504 women. Data was collected and psychometrically validated using item-response theory Rasch Models. RESULTS: All questionnaires identified in the literature lacked content validity regarding bothersome menopausal symptoms and none were validated using item-response theory. Our content validation resulted in a draft measurement encompassing 122 items across eight domains. Following psychometrical validation, the final version of our patient-reported outcome measure, named the MenoScores Questionnaire, encompassed 51 items, including one single item, covering 11 scales. CONCLUSION: Menopausal symptoms are multidimensional with some symptoms unquestionably related to the menopausal transition. We identified four constructs of importance: hot flushes, day-and-night sweats, general sweating, and menopausal-specific sleeping problems. The MenoScores Questionnaire is condition-specific with high content validity and adequate psychometrical properties. It is designed to measure bothersome menopausal symptoms and all scales are developed and psychometrically validated using item-response theory Rasch Models. TRIAL REGISTRATION: Approved by the Danish Data Agency (J.nr. 2015-41-4057). Ethics Committee approval was not required.


Assuntos
Menopausa/fisiologia , Menopausa/psicologia , Medidas de Resultados Relatados pelo Paciente , Qualidade de Vida , Adulto , Estudos Transversais , Feminino , Fogachos/etiologia , Humanos , Pessoa de Meia-Idade , Psicometria , Pesquisa Qualitativa , Reprodutibilidade dos Testes
12.
J Med Internet Res ; 20(5): e178, 2018 May 10.
Artigo em Inglês | MEDLINE | ID: mdl-29748163

RESUMO

BACKGROUND: To achieve full potential in user-oriented eHealth projects, we need to ensure a match between the eHealth technology and the user's eHealth literacy, described as knowledge and skills. However, there is a lack of multifaceted eHealth literacy assessment tools suitable for screening purposes. OBJECTIVE: The objective of our study was to develop and validate an eHealth literacy assessment toolkit (eHLA) that assesses individuals' health literacy and digital literacy using a mix of existing and newly developed scales. METHODS: From 2011 to 2015, scales were continuously tested and developed in an iterative process, which led to 7 tools being included in the validation study. The eHLA validation version consisted of 4 health-related tools (tool 1: "functional health literacy," tool 2: "health literacy self-assessment," tool 3: "familiarity with health and health care," and tool 4: "knowledge of health and disease") and 3 digitally-related tools (tool 5: "technology familiarity," tool 6: "technology confidence," and tool 7: "incentives for engaging with technology") that were tested in 475 respondents from a general population sample and an outpatient clinic. Statistical analyses examined floor and ceiling effects, interitem correlations, item-total correlations, and Cronbach coefficient alpha (CCA). Rasch models (RM) examined the fit of data. Tools were reduced in items to secure robust tools fit for screening purposes. Reductions were made based on psychometrics, face validity, and content validity. RESULTS: Tool 1 was not reduced in items; it consequently consists of 10 items. The overall fit to the RM was acceptable (Anderson conditional likelihood ratio, CLR=10.8; df=9; P=.29), and CCA was .67. Tool 2 was reduced from 20 to 9 items. The overall fit to a log-linear RM was acceptable (Anderson CLR=78.4, df=45, P=.002), and CCA was .85. Tool 3 was reduced from 23 to 5 items. The final version showed excellent fit to a log-linear RM (Anderson CLR=47.7, df=40, P=.19), and CCA was .90. Tool 4 was reduced from 12 to 6 items. The fit to a log-linear RM was acceptable (Anderson CLR=42.1, df=18, P=.001), and CCA was .59. Tool 5 was reduced from 20 to 6 items. The fit to the RM was acceptable (Anderson CLR=30.3, df=17, P=.02), and CCA was .94. Tool 6 was reduced from 5 to 4 items. The fit to a log-linear RM taking local dependency (LD) into account was acceptable (Anderson CLR=26.1, df=21, P=.20), and CCA was .91. Tool 7 was reduced from 6 to 4 items. The fit to a log-linear RM taking LD and differential item functioning into account was acceptable (Anderson CLR=23.0, df=29, P=.78), and CCA was .90. CONCLUSIONS: The eHLA consists of 7 short, robust scales that assess individual's knowledge and skills related to digital literacy and health literacy.

13.
Trials ; 19(1): 154, 2018 Mar 02.
Artigo em Inglês | MEDLINE | ID: mdl-29499710

RESUMO

BACKGROUND: Subacromial impingement syndrome (SIS) is a painful, and often long lasting, shoulder condition affecting patient function and quality of life. In a recent study, we observed major strength impairments in shoulder external rotation and abduction (~30%) in a population of patients with pronounced and long-lasting SIS. However, the current rehabilitation of such strength impairments may be inadequate, with novel rehabilitation programmes including exercise therapy only improving external rotation strength by 4-13%. As these previous studies are the basis of current practice, this suggests that the strengthening component could be inadequate in the rehabilitation of these patients, and it seems likely that more emphasis should be placed on intensifying this part of the rehabilitation. The purpose of this study is to investigate the effectiveness of a programme consisting of progressive home-based resistance training using an elastic band, aimed at improving shoulder external rotation and abduction strength, added to usual care and initiated shortly after diagnosis has been established. METHODS: A pragmatic randomised controlled superiority trial will be conducted, including 200 patients with pronounced and long-lasting SIS, diagnosed using predefined criteria. Participants will be randomised to receive either an add-on intervention of progressive home-based resistance training using an elastic band in addition to usual care or usual care alone in a 1:1 allocation ratio. The randomisation sequence is computer generated, with permuted blocks of random sizes. The primary outcome will be change in Shoulder Pain And Disability Index (SPADI) score from baseline to 16 weeks follow-up. Outcome assessors are blinded to group allocation. Intervention receivers will be kept blind to treatment allocation through minimal information about the content of the add-on intervention and control condition until group allocation is final. Analyses are performed by blinded data analysts. DISCUSSION: If effective, the simple shoulder strengthening exercise programme investigated in this trial could easily be added to usual care. The usefulness of the trial is further supported by the magnitude of the problem, the information gained from the study and the pragmatism, patient centeredness and transparency of the trial. TRIAL REGISTRATION: The trial is pre-registered at ClinicalTrials.gov with the ID NCT02747251 on April 19, 2016.

14.
J Med Internet Res ; 20(2): e36, 2018 Feb 12.
Artigo em Inglês | MEDLINE | ID: mdl-29434011

RESUMO

BACKGROUND: For people to be able to access, understand, and benefit from the increasing digitalization of health services, it is critical that services are provided in a way that meets the user's needs, resources, and competence. OBJECTIVE: The objective of the study was to develop a questionnaire that captures the 7-dimensional eHealth Literacy Framework (eHLF). METHODS: Draft items were created in parallel in English and Danish. The items were generated from 450 statements collected during the conceptual development of eHLF. In all, 57 items (7 to 9 items per scale) were generated and adjusted after cognitive testing. Items were tested in 475 people recruited from settings in which the scale was intended to be used (community and health care settings) and including people with a range of chronic conditions. Measurement properties were assessed using approaches from item response theory (IRT) and classical test theory (CTT) such as confirmatory factor analysis (CFA) and reliability using composite scale reliability (CSR); potential bias due to age and sex was evaluated using differential item functioning (DIF). RESULTS: CFA confirmed the presence of the 7 a priori dimensions of eHLF. Following item analysis, a 35-item 7-scale questionnaire was constructed, covering (1) using technology to process health information (5 items, CSR=.84), (2) understanding of health concepts and language (5 items, CSR=.75), (3) ability to actively engage with digital services (5 items, CSR=.86), (4) feel safe and in control (5 items, CSR=.87), (5) motivated to engage with digital services (5 items, CSR=.84), (6) access to digital services that work (6 items, CSR=.77), and (7) digital services that suit individual needs (4 items, CSR=.85). A 7-factor CFA model, using small-variance priors for cross-loadings and residual correlations, had a satisfactory fit (posterior productive P value: .27, 95% CI for the difference between the observed and replicated chi-square values: -63.7 to 133.8). The CFA showed that all items loaded strongly on their respective factors. The IRT analysis showed that no items were found to have disordered thresholds. For most scales, discriminant validity was acceptable; however, 2 pairs of dimensions were highly correlated; dimensions 1 and 5 (r=.95), and dimensions 6 and 7 (r=.96). All dimensions were retained because of strong content differentiation and potential causal relationships between these dimensions. There is no evidence of DIF. CONCLUSIONS: The eHealth Literacy Questionnaire (eHLQ) is a multidimensional tool based on a well-defined a priori eHLF framework with robust properties. It has satisfactory evidence of construct validity and reliable measurement across a broad range of concepts (using both CTT and IRT traditions) in various groups. It is designed to be used to understand and evaluate people's interaction with digital health services.

15.
Med Sci Sports Exerc ; 50(2): 187-195, 2018 02.
Artigo em Inglês | MEDLINE | ID: mdl-28991039

RESUMO

PURPOSE: Despite a paucity of evidence, prevention guidelines typically advise avoidance of heavy lifting in an effort to protect against breast cancer-related lymphedema. This study compared acute responses in arm swelling and related symptoms after low- and heavy-load resistance exercise among women at risk for lymphedema while receiving adjuvant taxane-based chemotherapy. METHODS: This is a randomized, crossover equivalence trial. Women receiving adjuvant taxane-based chemotherapy for breast cancer who had undergone axillary lymph node dissection (n = 21) participated in low-load (60%-65% 1-repetition maximum, two sets of 15-20 repetitions) and heavy-load (85%-90% 1-repetition maximum, three sets of 5-8 repetitions) upper-extremity resistance exercise separated by a 1-wk wash-out period. Swelling was determined by bioimpedance spectroscopy and dual-energy x-ray absorptiometry, with breast cancer-related lymphedema symptoms (heaviness, swelling, pain, tightness) reported using a numeric rating scale (0-10). Order of low- versus heavy-load was randomized. All outcomes were assessed before, immediately after, and 24 and 72 h after exercise. Generalized estimating equations were used to evaluate changes over time between groups, with equivalence between resistance exercise loads determined using the principle of confidence interval inclusion. RESULTS: The acute response to resistance exercise was equivalent for all outcomes at all time points irrespective of loads lifted, with the exception of extracellular fluid at 72 h after exercise with less swelling after heavy loads (estimated mean difference, -1.00; 95% confidence interval, -3.17 to 1.17). CONCLUSIONS: Low- and heavy-load resistance exercise elicited similar acute responses in arm swelling and breast cancer-related lymphedema symptoms in women at risk for lymphedema receiving adjuvant taxane-based chemotherapy. These represent important preliminary findings, which can be used to inform future prospective evaluation of the long-term effects of repeated exposure to heavy-load resistance exercise.


Assuntos
Neoplasias da Mama/terapia , Remoção/efeitos adversos , Linfedema/etiologia , Treinamento de Resistência , Adulto , Braço , Sobreviventes de Câncer , Quimioterapia Adjuvante , Feminino , Humanos , Pessoa de Meia-Idade , Adulto Jovem
16.
BMJ Open Sport Exerc Med ; 3(1): e000179, 2017.
Artigo em Inglês | MEDLINE | ID: mdl-28761697

RESUMO

BACKGROUND: Children with cancer experience severe reductions in physical fitness and functionality during and following intensive treatment. This may negatively impact their quality of life. PURPOSE: To describe the physical capacity and functionality of children with cancer during and after treatment as well as the feasibility of physical activity intervention in the Rehabilitation including Social and Physical activity and Education in Children and Teenagers with Cancer study. PATIENTS AND METHODS: The study included children diagnosed from January 2013 to April 2016 with paediatric cancer or Langerhans cell histiocytosis, all treated with chemotherapy. Seventy-five of 78 consecutively eligible children (96.2%) were included. Median age was 11 years (range 6‒18). The physical capacity and function were assessed based on testing of physical strength, balance and cardiorespiratory fitness. Children were tested at diagnosis, 3 and 6 months after diagnosis and 1 year after cessation of treatment. The feasibility evaluation was inspired by the criteria for reporting the development and evaluation of complex interventions in healthcare. RESULTS: All children participated in the physical intervention programme with no dropouts. Strenuous physical exercise and physiological testing during paediatric cancer treatment was safe and feasible, with only five minor adverse events during the intervention. Cardiorespiratory fitness was significantly lower in children with cancer than norms for healthy age-matched children at diagnosis (difference 19.1 mL/kg/min, 95% CI 15.4 to 22.7; p <0.0001), during treatment 3 and 6 months from diagnosis (difference 21.0 mL/kg/min, 95% CI 17.4 to 24.6; p <0.0001 and difference 21.6 mL/kg/min, 95% CI 17.3 to 25.8; p <0.0001, respectively) and 1 year after cessation of treatment (difference 6.9 mL/kg/min, 95% CI 1.1 to 12.7; p <0.0072). Furthermore, children with cancer experienced a pronounced decline in physical function. CONCLUSION: This study shows that it is safe and feasible to perform strenuous physical exercise and testing during paediatric cancer treatment and that children with cancer have significantly lower physical capacity and functionality than healthy age-matched norms. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov: NCT01772862.

17.
BMC Res Notes ; 10(1): 213, 2017 Jun 15.
Artigo em Inglês | MEDLINE | ID: mdl-28619041

RESUMO

BACKGROUND: Type 2 diabetes is a progressive chronic illness that will affect more than 500 million people worldwide by 2030. It is a significant cause of morbidity and mortality. Finding the right care management for diabetes patients is necessary to effectively address the growing population of affected individuals and escalating costs. Patient education is one option for improving patient self-management. However, there are large discrepancies in the outcomes of such programs and long-term data are lacking. We assessed the short and long-term outcomes of diabetes patient education using the health education impact questionnaire (HeiQ). METHODS: We conducted a observational cohort study of 83 type 2 diabetes patients participating in patient education programs in Denmark. The seven-scale HeiQ was completed by telephone interview at baseline and 2 weeks (76 participants, 93%) and 12 months (66, 80%) after the patient education ended. Changes over time were assessed using mean values and standard deviation at each time point and Cohen effect sizes. RESULTS: Patients reported improvements 2 weeks after the program ended in 4 of 7 constructs: skills and technique acquisition (ES = 0.59), self-monitoring and insight (ES = 0.52), constructive attitudes and approaches (ES = 0.43) and social integration and support (ES = 0.27). After 12 months, patients reported improvements in 3 of 7 constructs: skills and technique acquisition (ES = 0.66), constructive attitudes and approaches (ES = 0.43), and emotional wellbeing (ES = 0.44). Skills and technique showed the largest short- and long-term effect size. No significant changes were found in health-related activity or positive and active engagement in life over time. CONCLUSION: After 12 months, diabetes patients who participated in patient education demonstrated increased self-management skills, improved acceptance of their chronic illness and decreased negative emotional response to their disease. Applying HeiQ as an outcome measure yielded new knowledge as to what patients with diabetes can obtain by participating in a patient education.


Assuntos
Diabetes Mellitus Tipo 2/psicologia , Educação em Saúde/estatística & dados numéricos , Avaliação de Resultados (Cuidados de Saúde)/estatística & dados numéricos , Educação de Pacientes como Assunto , Avaliação de Programas e Projetos de Saúde/estatística & dados numéricos , Idoso , Doença Crônica , Estudos de Coortes , Dinamarca , Diabetes Mellitus Tipo 2/terapia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Qualidade de Vida , Autocuidado , Inquéritos e Questionários
18.
BMC Med Educ ; 17(1): 88, 2017 May 18.
Artigo em Inglês | MEDLINE | ID: mdl-28521768

RESUMO

BACKGROUND: To reduce the incidence of hypoxic brain injuries among newborns a national cardiotocography (CTG) education program was implemented in Denmark. A multiple-choice question test was integrated as part of the program. The aim of this article was to describe and discuss the test development process and to introduce a feasible method for written test development in general. METHODS: The test development was based on the unitary approach to validity. The process involved national consensus on learning objectives, standardized item writing, pilot testing, sensitivity analyses, standard setting and evaluation of psychometric properties using Item Response Theory models. Test responses and feedback from midwives, specialists and residents in obstetrics and gynecology, and medical and midwifery students were used in the process (proofreaders n = 6, pilot test participants n = 118, CTG course participants n = 1679). RESULTS: The final test included 30 items and the passing score was established at 25 correct answers. All items fitted a loglinear Rasch model and the test was able to discriminate levels of competence. Seven items revealed differential item functioning in relation to profession and geographical regions, which means the test is not suitable for measuring differences between midwives and physicians or differences across regions. In the setting of pilot testing Cronbach's alpha equaled 0.79, whereas Cronbach's alpha equaled 0.63 in the setting of the CTG education program. This indicates a need for more items and items with a higher degree of difficulty in the test, and illuminates the importance of context when discussing validity. CONCLUSIONS: Test development is a complex and time-consuming process. The unitary approach to validity was a useful and applicable tool for development of a CTG written assessment. The process and findings supported our proposed interpretation of the assessment as measuring CTG knowledge and interpretive skills. However, for the test to function as a high-stake assessment a higher reliability is required.


Assuntos
Cardiotocografia , Educação Médica , Avaliação Educacional/normas , Comunicação Interdisciplinar , Redação , Dinamarca , Estudos de Viabilidade , Feminino , Humanos , Hipóxia Encefálica/prevenção & controle , Recém-Nascido , Masculino , Psicometria , Reprodutibilidade dos Testes
19.
PLoS One ; 12(5): e0178190, 2017.
Artigo em Inglês | MEDLINE | ID: mdl-28542543

RESUMO

The objective of this study was to develop new scales measuring knowledge and attitude about UVR and sun related behavior, and to examine their association to sun related behavior objectively measured by personal dosimetry. During May-August 2013, 664 Danes wore a personal electronic UV-dosimeter for one week that measured their UVR exposure. Afterwards, they answered a questionnaire on sun-related items. We applied descriptive analysis, linear and logistic regression analysis to evaluate the associations between the questionnaire scales and objective UVR measures. Perceiving protection as routine and important were positively correlated with protective behavior. Knowledge deficit of UV and risk of melanoma, perceived benefits and importance of protection behavior was also correlated with use of protection. 'Knowledge deficit of UV and risk of melanoma and Perceived barrier towards sun avoidance between 12 and 15' were both associated with increased risk of sunburn. Attitude towards tan was associated to both outdoor time and exposure as well as use of protection, but not to sunburn. The results regarding Knowledge deficit of UV and risk of melanoma associated to UVR exposure and Perceived barrier towards sun avoidance between 12 and 15 emphasize the importance of awareness of melanoma risk and the priority of the skin cancer prevention advice. Shifting activities to outside the suns peak-hours could be an approach for structural and campaign preventive measures. Knowledge of items predicting exposure to UVR, use of protection and sunburn are important for planning of preventive interventions and melanoma research.


Assuntos
Atitude Frente a Saúde , Conhecimentos, Atitudes e Prática em Saúde , Queimadura Solar/psicologia , Luz Solar/efeitos adversos , Adolescente , Idoso , Estudos Transversais , Dinamarca , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Queimadura Solar/prevenção & controle , Inquéritos e Questionários , Adulto Jovem
20.
Appl Psychol Meas ; 41(3): 178-194, 2017 May.
Artigo em Inglês | MEDLINE | ID: mdl-29881087

RESUMO

The assumption of local independence is central to all item response theory (IRT) models. Violations can lead to inflated estimates of reliability and problems with construct validity. For the most widely used fit statistic Q3, there are currently no well-documented suggestions of the critical values which should be used to indicate local dependence (LD), and for this reason, a variety of arbitrary rules of thumb are used. In this study, an empirical data example and Monte Carlo simulation were used to investigate the different factors that can influence the null distribution of residual correlations, with the objective of proposing guidelines that researchers and practitioners can follow when making decisions about LD during scale development and validation. A parametric bootstrapping procedure should be implemented in each separate situation to obtain the critical value of LD applicable to the data set, and provide example critical values for a number of data structure situations. The results show that for the Q3 fit statistic, no single critical value is appropriate for all situations, as the percentiles in the empirical null distribution are influenced by the number of items, the sample size, and the number of response categories. Furthermore, the results show that LD should be considered relative to the average observed residual correlation, rather than to a uniform value, as this results in more stable percentiles for the null distribution of an adjusted fit statistic.

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