Background
Before beginning a large and complex trial it is considered good practice to run a pilot study to assess the feasibility and acceptability so that quality is maintained and resources are not wasted.Objective
To assesses the feasibility and acceptability of procedures for TOPS: Trial Of Prevention Strategies for low back pain.Design
Randomised controlled pilot trial.Methods
This is a trial of an 8 week, physiotherapist-led group exercise and education program for preventing recurrence of low back pain (LBP) in those recently recovered from LBP. We assessed the feasibility of recruitment and data-collection procedures, acceptability of the trial interventions and loss-to-follow up.Results
The feasibility of recruitment, acceptability of the intervention and feasibility of physical activity data-collection procedures were all below anticipated levels. We enrolled 12 participants over 44 weeks, the adherence rate for the intervention group was 63% and valid physical activity data were obtained for 67% of the measurements. Follow-up methods for collection of LBP recurrence were successful with this information able to be collected for 100% of participants.Conclusion
In response to the pilot, modifications were made to the main trial protocol. We will increase recruitment by relaxing inclusion criteria and expanding recruitment sites to include workplaces, community centres and via social media. We will facilitate compliance by expanding treatment sites to provide more options for participants to access the program and we will limit missing data by checking the validity of baseline physical activity measures prior to enrolment.Trial registration: The study was prospectively registered with the Australian and New Zealand Clinical Trials Registry (ref: ACTRN12614000706673). 相似文献
Introduction
Self-efficacy has been found to have a direct relation with self-care in diabetes. Several tools have been developed and used for evaluating self-efficacy of diabetic patients, the most widely used being the Diabetes Management Self-Efficacy Scale (DMSES). The aim of the present study was to translate, culturally adapt, and validate the Greek DMSES (GR-DMSES) in order for it to be used in the ATTICA pilot study of the SmartCare EU-funded project.Methods
Using standard procedures, the original version of DMSES was translated and culturally adapted into Greek. Content validity was assessed by an expert panel with the calculation of a content validity index of the overall scale. Α convenient sample was recruited to complete the questionnaire. Psychometric testing of the produced instrument included internal consistency test (Cronbach’s alpha), construct validity (factor analysis), and stability (intraclass correlation coefficient).Results
One hundred and sixteen patients, aged 36–86 years, with type 2 diabetes (T2D) participated in the study. There were no items excluded from the original scale after the content validity procedure. The coefficient Cronbach's alpha for the internal consistency was 0.93 and the intraclass correlation coefficient for the stability with a 5-week time interval was 0.87 (P < 0.001). Factor analysis yielded four factors related to diet, medical therapy, medication and feet check, and physical activity.Conclusion
The findings supported that the GR-DMSES was reliable and valid in measuring self-efficacy related to diabetes self-management, thus providing a quick and easy-to-use tool for health professionals dealing with Greek adults with T2D.Background
The aim of the study was to validation of the Tampa Scale for Kinesiophobia for Temporomandibular Disorders (TSK-TMD) for use in patients with painful TMD.Methods
The original TSK-TMD was translated and cross-culturally adaptated following international guidelines. A total of 160 patients with temporomandibular disorders (TMD) were enrolled to fill out the scale. The internal consistency and test-retest methods were used to evaluate the reliability of the TSK-TMD. The validity of the TSK-TMD was analyzed by content validity, construct validity and convergent validity. Construct validity was assessed based on exploratory factor analysis (EFA), and convergent validity by examining the correlation between the global rating of oral health question and TSK-TMD scores.Results
Cronbach’s alpha value for the total TSK-TMD score was 0.919 and the intraclass correlation coefficient (ICC) value for the TSK-TMD was 0.797. Construct validity was assessed by EFA, extracting two factors, accounting for 71.9% of the variance. The factor loadings of all items were higher than 0.40. In terms of convergent validity, the TSK-TMD subscales showed good correlations to the global rating of oral health question.Conclusion
These findings show that the Chinese version of TSK-TMD has satisfactory psychometric properties and is appropriate for use in patients with painful TMD in China.Purpose
Mortality prediction in ARDS is important for prognostication and risk stratification. However, no prediction models have been independently validated. A combination of two biomarkers with age and APACHE III was superior in predicting mortality in the NHLBI ARDSNet ALVEOLI trial. We validated this prediction tool in two clinical trials and an observational cohort.Methods
The validation cohorts included 849 patients from the NHLBI ARDSNet Fluid and Catheter Treatment Trial (FACTT), 144 patients from a clinical trial of sivelestat for ARDS (STRIVE), and 545 ARDS patients from the VALID observational cohort study. To evaluate the performance of the prediction model, the area under the receiver operating characteristic curve (AUC), model discrimination, and calibration were assessed, and recalibration methods were applied.Results
The biomarker/clinical prediction model performed well in all cohorts. Performance was better in the clinical trials with an AUC of 0.74 (95% CI 0.70–0.79) in FACTT, compared to 0.72 (95% CI 0.67–0.77) in VALID, a more heterogeneous observational cohort. The AUC was 0.73 (95% CI 0.70–0.76) when FACTT and VALID were combined.Conclusion
We validated a mortality prediction model for ARDS that includes age, APACHE III, surfactant protein D, and interleukin-8 in a variety of clinical settings. Although the model performance as measured by AUC was lower than in the original model derivation cohort, the biomarker/clinical model still performed well and may be useful for risk assessment for clinical trial enrollment, an issue of increasing importance as ARDS mortality declines, and better methods are needed for selection of the most severely ill patients for inclusion.- Implications for Rehabilitation
Program participation is influenced by cultural values and motivational, social and environmental factors.
The meaning and importance of exercise can vary between and within cultures.
Exercise and fall prevention interventions need to be culturally appropriate and utilise the positive influences of social support, especially from physicians and family.
Providing information that falls can be prevented and the reasons why behaviours need to change will be more likely to encourage older people from CALD backgrounds to contemplate participation.
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- NURSES IN A SAME DAY SURGERY (SDs) UNIT used their hospital's quality model to identify a long-term problem, establish a project, analyze the problem, and make recommendations for changes to improve patient care.
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- THE PROCESS included conducting a review of the literature, collecting data about procedure delays and cancellations, making a site visit to another children's hospital, and presenting pertinent findings to the OR committee.
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- THE NURSES initiated a pilot program to bring surgical patients into the SDS area for a preadmission testing visit.
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- DELAYS AND CANCELLATIONS decreased, and satisfaction among nurses working in the SDS unit increased as a result of this program. AORN J 78 (October 2003) 604-617.
Background
Few studies have explored the experiences of low income mothers participating in nurse home visiting programs. Our study explores and describes mothers' experiences participating in the Nurse-Family Partnership (NFP) Program, an intensive home visiting program with demonstrated effectiveness, from the time of program entry before 29 weeks gestation until their infant's first birthday.Methods
A qualitative case study approach was implemented. A purposeful sample of 18 low income, young first time mothers participating in a pilot study of the NFP program in Hamilton, Ontario, Canada partook in one to two face to face in-depth interviews exploring their experiences in the program. All interviews were digitally recorded and transcribed verbatim. Conventional content analysis procedures were used to analyze all interviews. Data collection and initial analysis were implemented concurrently.Results
The mothers participating in the NFP program were very positive about their experiences in the program. Three overarching themes emerged from the data: 1. Getting into the NFP program; 2. The NFP nurse is an expert, but also like a friend providing support; and 3. Participating in the NFP program is making me a better parent.Conclusions
Our findings provide vital information to home visiting nurses and to planners of home visiting programs about mothers' perspectives on what is important to them in their relationships with their nurses, how nurses and women are able to develop positive therapeutic relationships, and how nurses respond to mothers' unique life situations while home visiting within the NFP Program. In addition our findings offer insights into why and under what circumstances low income mothers will engage in nurse home visiting and how they expect to benefit from their participation. 相似文献Background
Although emergency medical service (EMS) providers recognize that both male and female paramedics are necessary, Saudi EMSs are currently fully staffed by men. Cultural bias against care provision by male paramedics to female victims in the absence of male guardians underscores the need for female paramedics. Consequently, we explored public perception of female paramedics at King Abdulaziz Medical City (KAMC), Riyadh.Method
This observational, cross-sectional study used convenience sampling to assess the perceptions of patients, visitors, and employees at the emergency rooms in KAMC and King Abdullah Specialized Children’s Hospital via self-administered English- and Arabic-language questionnaires. Questionnaire reliability and validity were assessed in a pilot study.Results
Three hundred twelve respondents completed the survey (67.30% men). The sample included 43.27% medical (40% paramedics, 22% physicians, 12% nurses, and 23% other) and 56.73% nonmedical participants, of whom 53% and 63%, respectively, strongly agreed regarding the importance of female paramedics. Moreover, in the male participant group, 6% of medical and 8% of nonmedical participants strongly disagreed with treatment of their female relatives by male paramedics, and 20% of medical and 30% of nonmedical participants declined medical help because female paramedics were unavailable.Conclusions
Respondents rated the importance of trained female paramedics in the EMS system. Most strongly agreed that female and male paramedics had equal patient-management capabilities and skills.- IMPLICATIONS FOR REHABILITATION
The methods presented in this pilot economic evaluation have large potentials to guide the assessment of future assistive e-health technologies addressing work-disabilities.
The findings show that the web-based tool requires content related improvements with respect to targeting and intensity to enhance employability among work disabled employees.
The findings show that the web-based tool would benefit from improvements related to the study design by more adequately selecting and collecting both outcome measures and cost data.
The burden attributable to large-scale studies and implementation issues were prevented as the outcomes of the pilot economic evaluation did not support the implementation of the web-based tool.
Purpose
This paper aims to assess the psychometric properties of the Chinese version of the MASCC Antiemesis Tool (MAT) for measuring chemotherapy-induced nausea and vomiting (CINV).Methods
This was a psychometric study using a panel of experts and a prospective observational design. Six experts were invited to identify the content validity and face validity of the MAT, and 115 cancer patients were then recruited from three provincial medical centers in Fuzhou, China. The MAT was self-completed by the patients on the first and the fifth day after receiving the most recent chemotherapy, and patients also rated daily the Index of Nausea, Vomiting, and Retching (INVR) during the first 5 days after chemotherapy. Content validity was measured by the index of the content validity (CVI). Construct validity was estimated by the contrasted groups approach. Concurrent validity was measured by exploring the correlations between the INVR and MAT scores. The reliability of the MAT was examined by Cronbach’s alpha and item-to-total correlations.Results
One hundred and eleven subjects returned the completed measures. High content validity was determined. Contrasted groups analysis clearly discriminated the differences on the CINV symptom experiences between different age and gender groups. Excellent concurrent validity was identified, with the Spearman’s correlation coefficient between the MAT total score and the INVR overall total score of 0.94 (P < 0.001). Cronbach’s alpha for the MAT was 0.73, and the item-to-total correlations ranged from 0.50 to 0.71.Conclusions
The MAT Chinese version is a valid, reliable, and convenient instrument for measuring CINV in Chinese cancer patients.- Implications for rehabilitation
A cross-cultural adaptation of the FFI has been done from original version to Chinese.
Consistent results and satisfactory psychometric properties of the Foot Function Index Chinese version have been reported.
For Chinese speaking researcher and clinician FFI-Ch could be used as a tool to assess patients with foot disease.
Aims: To create and pilot test a checklist for appraising methodological validity of a BCT.
Methods: The checklist was created by extracting the most essential elements from the comprehensive set of criteria in the previous paper on BCTs. Also checklists and scientific papers on observational studies and respective systematic reviews were utilized. Ten BCTs published in the Lancet and in the New England Journal of Medicine were used to assess feasibility of the created checklist.
Results: The appraised studies seem to have several methodological limitations, some of which could be avoided in planning, conducting and reporting phases of the studies.
Conclusions: The checklist can be used for planning, conducting, reporting, reviewing, and critical reading of observational intervention studies. However, the piloted checklist should be validated in further studies.
- Key messages
Benchmarking Controlled Trial (BCT) is a concept which covers all observational studies aiming to assess impact of interventions or health care system features to patients and populations.
This paper presents a checklist for appraising methodological validity of BCTs and pilot-tests the checklist with ten BCTs published in leading medical journals. The appraised studies seem to have several methodological limitations, some of which could be avoided in planning, conducting and reporting phases of the studies.
The checklist can be used for planning, conducting, reporting, reviewing, and critical reading of observational intervention studies.
Background
There has been much debate by both academics and clinical agencies about the motivations and abilities of nurse graduates to work in mental health nursing. The aim of this study was to recruit student nurses from a dedicated mental health nursing program in the United Kingdom (UK) and a comprehensive nursing program in Australia and illuminate their motivations towards considering mental health nursing as a career choice.Methods
This study comprised of two UK and four Australian Schools of Nursing within Universities. A 12 item survey was developed for the purpose of this study and was checked for face validity by experienced mental health nurses. Convenience sampling was used and 395 responses were received.Results
The comprehensive program represented by the Australian sample, revealed a third of respondents indicated that mental health nursing was definitely not a career option, while only 8 % of the UK specialised program reported mental health nursing was not seven for them. In both groups a higher level of motivation to work in mental health emanated from personal experience and/or work experience/exposure to mental health care.Conclusions
A greater focus on clinical exposure in comprehensive programs could enhance professional experience needed to increase student motivations for mental health nursing.Background
Between 75 and 89% of residents living in long-term care facilities have limited mobility. Nurses as well as other licensed and unlicensed personnel directly involved in resident care are in a key position to promote and maintain the mobility of care-dependent persons. This requires a certain level of competence. Kinaesthetics is a training concept used to increase nursing staff’s interaction and movement support skills for assisting care-dependent persons in their daily activities. This study aims to develop and test an observation instrument for assessing nursing staff’s competences in kinaesthetics.Methods
The Kinaesthetics Competence (KC) observation instrument was developed between January and June 2015 based on a literature review, a concept analysis and expert meetings (18). The pilot instrument was evaluated with two expert panels (n?=?5, n?=?4) regarding content validity, usability and inter-rater agreement. Content validity was assessed by determining the content validity index (CVI). The final instrument was tested in a cross-sectional study in three nursing homes in the German-speaking part of Switzerland between July 2015 and February 2016. In this study nursing staff (n?=?48) was filmed during mobilization situations. Based on this video data two observers independently assessed nursing staff’s competences in kinaesthetics with the KC observation instrument. Inter-rater reliability and inter-rater agreement was evaluated using the intra-class correlation coefficient (ICC) and percentage of agreement. Construct validity was assessed by a discriminating power analysis. Internal consistency was evaluated using Cronbach’s alpha coefficient and item analysis.Results
The final version of the KC observation instrument comprised of four domains (interaction, movement support of the person, nurses’ movement, environment) and 12 items. The final instrument showed an excellent content validity index of 1.0. Video sequences from 40 persons were analysed. Inter-rater reliability for the whole scale was good (ICC 0.73) and the percentage of inter-rater agreement was 53.6% on average. Cronbach’s alpha coefficient for the whole instrument was 0.97 and item-total correlations ranged from 0.76 to 0.90. The construct validity of the instrument was supported by a significant discrimination of the instrument between nursing staff with no or basic and with advanced kinaesthetics training for the total score and 3 of 4 subscales.Conclusions
The KC observation instrument showed good preliminary psychometric properties and can be used to assess nursing staff’s competences in mobility care based on the principles of kinaesthetics.OBJECTIVE
To perform the first comprehensive psychometric evaluation of the Hypoglycemia Fear Survey-II (HFS-II), a measure of the behavioral and affective dimensions of fear of hypoglycemia, using modern test-theory methods, including item-response theory (IRT).RESEARCH DESIGN AND METHODS
Surveys completed in four previous studies by 777 adults with type 1 diabetes were aggregated for analysis, with 289 subjects completing both subscales of the HFS-II and 488 subjects completing only the Worry subscale. The aggregated sample (53.3% female, 44.4% using insulin pumps) had a mean age of 41.9 years, diabetes duration of 23.8 years, HbA1c value of 7.7%, and 1.4 severe hypoglycemic episodes in the past year. Data analysis included exploratory factor analysis using polychoric correlations and IRT. Factors were analyzed for fit, trait-level locations, point-measure correlations, and separation values.RESULTS
Internal and test-retest reliability was good, as well as convergent validity, as demonstrated by significant correlations with other measures of psychological distress. Scores were significantly higher in subjects who had experienced severe hypoglycemia in the past year. Factor analyses validated the two subscales of the HFS-II. Item analyses showed that 12 of 15 items on the Behavior subscale, and all of the items on the Worry subscale had good-fit statistics.CONCLUSIONS
The HFS-II is a reliable and valid measure of the fear of hypoglycemia in adults with type 1 diabetes, and factor analyses and IRT support the two separate subscales of the survey.The Hypoglycemia Fear Survey (HFS), first published in 1987 (1), originally was developed to measure behaviors and worries related to fear of hypoglycemia (FOH) in adults with type 1 diabetes. Both the original HFS (HFS-I) and the revised version (HFS-II) are composed of two subscales, the Behavior (HFS-B) and Worry (HFS-W). HFS-B items describe behaviors in which patients may engage to avoid hypoglycemic episodes and/or their negative consequences (e.g., keeping blood glucose [BG] levels above 150 mg/dL, making sure other people are around, and limiting exercise or physical activity). HFS-W items describe specific concerns that patients may have about their hypoglycemic episodes (e.g., being alone, episodes occurring during sleep, or having an accident). Since it was first published, the HFS, in its original form and subsequent revisions, has been used in >60 published studies and numerous clinical trials and has been translated into over 50 languages. The survey also is commonly used in studies of people with type 2 diabetes to better understand their experiences of hypoglycemia (2). In addition, the authors have developed alternative versions of the HFS for use with pediatric patients with type 1 diabetes and their parents, as well as spouses and significant others of adults with diabetes (3–5).Despite its widespread use, the only comprehensive study to address the psychometric properties of the U.S. HFS was published >15 years ago and focused on the HFS-I, which is no longer in use (6). Since then, based on subsequent studies, the scale has been significantly revised, leaving only 18 of 33 items unchanged from the original version from 1987. Although there is some evidence for the reliability and validity of the HFS-II (2,7), no comprehensive study of its psychometric properties has been conducted with a large sample. In addition, psychometric results of previous studies included only classical test-theory methods that have not acknowledged the categorical nature of HFS data. Modern test procedures, such as item-response theory (IRT), are better suited to analyze categorical data and can provide valuable information about item quality, including response option use, fit, and endorsement difficulty (8).For researchers and clinicians interested in using the HFS-II, this lack of supporting psychometric data presents many obstacles not the least of which is the inability to interpret scores in a clinically meaningful way. The purpose of the current study was to conduct a comprehensive psychometric investigation of the HFS-II U.S. English adult version using a large aggregate sample of data collected at our laboratory over the past decade and using modern test-theory methods. The following were the hypotheses tested: 1) that the HFS-II is a reliable and valid measure of FOH and 2) that factor analysis will yield a two-factor structure reflecting the two subscales of the survey. 相似文献Implications for Rehabilitation
The Participation Scale can be used to measure restrictions in social participation.
The Participation Scale showed consistent structural validity across many different cultural settings and target groups.
A shorter version of the scale was developed, namely the Participation Scale Short.
The Participation Scale Short needs field testing before application to test its reliability, validity, reduction in administration time and usefulness.