BACKGROUND: The aim was to evaluate data quality and psychometric properties of an instrument for measurement of health-related quality of life: DISABKIDS Chronic Generic Module (DCGM-37) used in school-aged children with cancer.

METHODS: All school-children diagnosed with cancer in Sweden during a two-and-a-half year period were invited to participate in the study. Analysis was performed on combined data from two assessments, two and-a-half and five months after start of cancer treatment (n = 170). The instrument was examined with respect to feasibility, data quality, reliability and construct and criterion-based validity.

RESULTS: Missing items per dimension ranged from 0 to 5.3 percent, with a majority below three percent. Cronbach's alpha values exceeded 0.70 for all dimensions. There was support for the suggested groupings of items into dimensions for all but six of the 36 items of the DCGM-37 included in this study. The instrument discriminated satisfactorily between diagnoses reflecting treatment burden.

CONCLUSIONS: The results indicate satisfactory data quality and reliability of the DCGM-37 when used in children undergoing treatment for cancer. Evaluation of construct validity showed generally acceptable results, although not entirely supporting the suggested dimensionality. Continued psychometric evaluation in a larger sample of children during and after treatment for cancer is recommended.

BACKGROUND: Measurement of person-centred care (PCC) outcomes is underdeveloped owing to the complexity of the concept and lack of conceptual clarity. A framework conceptualizing outpatient PCC in rheumatology nurse-led clinics has therefore been suggested and operationalized into the PCC instrument for outpatient care in rheumatology (PCCoc/rheum).

OBJECTIVE: The aim of the present study was to test the extent to which the PCCoc/rheum represents the underpinning conceptual outpatient PCC framework, and to assess its measurement properties as applied in nurse-led outpatient rheumatology clinics.

METHODS: The 24-item PCCoc/rheum was administered to 343 persons with rheumatoid arthritis from six nurse-led outpatient rheumatology clinics. Its measurement properties were tested by Rasch measurement theory.

RESULTS: Ninety-two per cent of individuals (n = 316) answered the PCCoc/rheum. Items successfully operationalized a quantitative continuum from lower to higher degrees of perceived PCC. Model fit was generally good, including lack of differential item functioning (DIF), and the PCCoc/rheum was able to separate individuals with a reliability of 0.88. The four response categories worked as intended, with the exception of one item. Item ordering provided general empirical support of a priori expectations, with the exception of three items that were omitted owing to multidimensionality, dysfunctional response categories and unexpected ordering. The 21-item PCCoc/rheum showed good accordance with the conceptual framework, improved fit, functioning response categories and no DIF, and its reliability was 0.86.

CONCLUSION: We found general support for the appropriateness of the PCCoc/rheum as an outcome measure of patient-perceived PCC in nurse-led outpatient rheumatology clinics. While in need of further testing, the 21-item PCCoc/rheum has the potential to evaluate outpatient PCC from a patient perspective.

BACKGROUND: Person-centred care (PCC) is considered a key component of effective illness management and high-quality care. However, the PCC concept is underdeveloped in outpatient care. In rheumatology, PCC is considered an unmet need and its further development and evaluation is of high priority. The aim of the present study was to conceptualize and operationalize PCC, in order to develop an instrument for measuring patient-perceived PCC in nurse-led outpatient rheumatology clinics.

METHODS: A conceptual outpatient PCC framework was developed, based on the experiences of people with rheumatoid arthritis (RA), person-centredness principles and existing PCC frameworks. The resulting framework was operationalized into the PCC instrument for outpatient care in rheumatology (PCCoc/rheum), which was tested for acceptability and content validity among 50 individuals with RA attending a nurse-led outpatient clinic.

RESULTS: The conceptual framework focuses on the meeting between the person with RA and the nurse, and comprises five interrelated domains: social environment, personalization, shared decision-making, empowerment and communication. Operationalization of the domains into a pool of items generated a preliminary PCCoc/rheum version, which was completed in a mean (standard deviation) of 5.3 (2.5) min. Respondents found items easy to understand (77%) and relevant (93%). The Content Validity Index of the PCCoc/rheum was 0.94 (item level range, 0.87-1.0). About 80% of respondents considered some items redundant. Based on these results, the PCCoc/rheum was revised into a 24-item questionnaire.

CONCLUSIONS: A conceptual outpatient PCC framework and a 24-item questionnaire intended to measure PCC in nurse-led outpatient rheumatology clinics were developed. The extent to which the questionnaire represents a measurement instrument remains to be tested.

BACKGROUND: Person-centered care (PCC) is a key component to effective illness management and high-quality care but conceptually underdeveloped in outpatient care settings for long-term disorders such as rheumatoid arthritis (RA), and there is a lack of instruments measuring patient perceived PCC.

AIM: To conceptualize and operationalize outpatient PCC as a basis for measuring patient-perceived PCC in nurse-led outpatient rheumatology clinics.

DESIGN: A conceptual outpatient PCC framework was developed based on theory and patient experiences.The resulting framework was operationalizedinto items that were tested regarding their accordancewith the theoretical framework and their measurement properties according to Rasch measurement theory (RMT) using the RUMM2030 software. 

RESULTS: The conceptual framework comprised five intermingled domains (personalization, shared decision-making, empowerment, communication, and social environment) that were operationalized into a 24-item PCC instrument for outpatient care in rheumatology (PCCoc/rheum). RMT analyses found items to successfully map out a quantitative continuum from lower to higher PCC levels, with generally acceptable model fit and a reliability of 0.88. Three items exhibiting multidimensionality, dysfunctional response categories, and/or unexpected hierarchical ordering were omitted. The revised PCCoc/rheum showed good accordance with the conceptual framework, improved fit, functioning response categories, and no DIF; reliability was 0.86.

SUMMARY AND IMPLICATIONS: We found support for the PCCoc/rheum as a conceptually based outcome measure of patient perceived PCC. Results implied minor theoretical reconsiderations, and related scale revisions improved theoretical and clinical clarity. While in need of further testing, the PCCoc/rheum has great potential as a measure of outpatient PCC from a patient perspective.

AIM AND OBJECTIVE: To describe and understand the meaning of living with persistent rheumatoid arthritis.

BACKGROUND: A considerable number of patients with rheumatoid arthritis live with an ongoing active and symptomatic illness despite access to potent antirheumatic treatment. There is, however, a lack of knowledge about the meaning of living with this severe long-term illness, defined as persistent rheumatoid arthritis.

DESIGN: A descriptive design based on a hermeneutic phenomenological method was used.

METHODS: Ten adults with persistent rheumatoid arthritis and at least five years disease duration were interviewed. The interviews were analysed according to van Manen's method.

RESULTS: Living with persistent rheumatoid arthritis revealed four overall themes: an existence dominated by painful symptoms and treatment, radical changes and limitations in one's life, a continual struggle to cope with one's life and to master the illness, and a dependency on those who are close by and the world around. The lifeworld was affected to a varying extent and in various ways by the illness but also by the dependence on its treatment and care that was not experienced as sufficiently meeting needs in terms of security, access to and coordination of care as well as team and rehabilitation services.

CONCLUSIONS: Persistent rheumatoid arthritis and its treatment entail a radical effect on the person's life and quality of life. Current ordinary rheumatology care does not seem to meet the individual needs of the person with persistent rheumatoid arthritis in an optimal way.

RELEVANCE TO CLINICAL PRACTICE: A greater knowledge about and understanding of the person who lives with persistent rheumatoid arthritis is important for facilitating the development of care and the relief of suffering. A holistic alternative to conventional clinical practice, such as person-centred care, could be tested as an innovative model of care. Our findings might serve as material for educational and counselling purposes for healthcare professionals.

Objective To describe how people with rheumatoid arthritis (RA) experience the care provided by Swedish nurse-led rheumatology outpatient clinics. Methods Eighteen adult people with a diagnosis of RA who had had at least three documented contact sessions with a nurse-led clinic were interviewed. The interviews were analysed with qualitative content analysis. Results Care was expressed in three categories: social environment, professional approach and value-adding measures. A social environment including a warm encounter, a familial atmosphere and pleasant premises was desired and contributed to a positive experience of care. The nurses' professional approach was experienced as empathy, knowledge and skill, as well as support. The care was described as person centred and competent, as it was based on the individual's unique experience of his/her disease and needs. The nurses' specialist knowledge of rheumatology and rheumatology care was highly valued. The offered care represented added value for the participants, instilling security, trust, hope and confidence. It was perceived as facilitating daily life and creating positive emotions. The nurse-led clinics were reported to be easily accessible and provided continuity of the care. These features were presented as fundamental guarantees for health care safety. Conclusion The experiences emphasized the need for a holistic approach to care. In this process, the organization of care and the role and skills of the nurse should be focused on the individual's needs and perspectives. The social environment, professional approach and value-adding measures are particularly relevant for optimal care at nurse-led rheumatology outpatient clinics.

Background Person-centered care (PCC) is increasingly emphasized as a key component of effective illness management and of developing high quality of care. Despite considerable progress of PCC in many areas of care there is currently a gap and a need for means to assess PCC practice in outpatient care. In rheumatology, PCC is considered an unmet need and further development and evaluation of this approach to care is thus of high priority.

Objectives To develop an instrument for measuring person-centered care from the perspective of the person with rheumatoid arthritis (RA) in nurse-led outpatient clinics.

Methods A conceptual framework of PCC in the outpatient context and focusing on the meeting between the person with RA and the nurse and on the patient as an active care partner was undertaken. Based on this framework, qualitative interviews (1,2) and a literature review, a 35-item questionnaire was proposed and qualitatively tested regarding acceptability and content validity among 50 persons with RA attending a nurse-led outpatient clinic. Two versions of the questionnaire were tested: one using four response categories (0 = Totally disagree; 3 = Completely agree), and one using two response categories (0 = Disagree; 1 = Agree). Content validity was estimated by calculating Content Validity Index of the individual items (I-CVI) and of the overall instrument (S-CVI).

Results Respondents found the items easy to understand (77%) and relevant (93%). Seventy-three percent of the respondents preferred the questionnaire version with four response categories. This version took a mean (SD) of 5.3 (2.5) minutes to complete. I-CVI values ranged from 0.87 to 1.00 and S-CVI was 0.94. About 80% of the respondents considered some items to be redundant. This resulted in a reduced 24-item draft questionnaire that yield a total score between 0–72.

Conclusions A preliminary 24-item patient-reported PCC questionnaire was developed. Psychometric testing is needed for validation of this tool before implementation.

Walking difficulties are common in neurological and other disorders, as well as among the elderly. There is a need for reliable and valid instruments for measuring walking difficulties in everyday life since existing gait tests are clinician rated and focus on situation specific capacity. The Walk-12G was adapted from the 12-item multiple sclerosis walking scale as a generic patient-reported rating scale for walking difficulties in everyday life. The aim of this study is to examine the psychometric properties of the Walk-12G in people with multiple sclerosis (MS) and Parkinson’s disease (PD). The Walk-12G was translated into Swedish and evaluated qualitatively among 25 people with and without various neurological and other conditions. Postal survey (MS, n = 199; PD, n = 189) and clinical (PD, n = 36) data were used to test its psychometric properties. Respondents considered the Walk-12G relevant and easy to use. Mean completion time was 3.5 min. Data completeness was good (<5% missing item responses) and tests of scaling assumptions supported summing item scores to a total score (corrected item-total correlations >0.6). Coefficient alpha and test–retest reliabilities were >0.9, and standard errors of measurement were 2.3–2.8. Construct validity was supported by correlations in accordance with a priori expectations. Results are similar to those with previous Walk-12G versions, indicating that scale adaptation was successful. Data suggest that the Walk-12G meets rating scale criteria for clinical trials, making it a valuable complement to available gait tests. Further studies involving other samples and application of modern psychometric methods are warranted to examine the scale in more detail.

Background: SBAR has been suggested as a means to avoid unclear communication between health care professionals and in turn enhance patient safety in the healthcare sector.

Aim: to evaluate hospital-based health care professionals experiences from using the Situation, Background, Assessment and Recommendation (SBAR) communication model.

Methodology: A quantitative, descriptive, comparative pre- and post-intervention questionnaire-based pilot study before and after the implementation of SBAR at surgical hospitals wards. Open comments to questionnaire items were analyzed qualitatively.

Results: The introduction of SBAR increased the experience of having a well-functioning structure for oral communication among health care professionals regarding patients’ conditions. Qualitative findings revealed the categories: Use of SBAR as a structure, Reporting time, Patient safety, and Personal aspects.

Conclusions: SBAR is perceived as effective to get a structure of the content in patient reports, which may facilitate patient safety.

AIM: To evaluate the psychometric properties of a questionnaire addressing psychosocial consequences of false-positive mammographic screening.

BACKGROUND: The Consequences of Screening - Breast Cancer and Lung Cancer questionnaires target psychosocial consequences of false-positive cancer screening. The Consequences of Screening - Breast Cancer questionnaire and ten items not considered lung cancer specific from the Lung Cancer questionnaire have been adapted for use in mammographic screening in Sweden, but remain psychometrically untested.

DESIGN: Instrument development paper with psychometric cross-sectional and test-retest design.

METHODS: Twelve scales of a Swedish questionnaire version were tested by the Rasch model and traditional psychometric methods. Women with false-positive (Group I, n = 640) and negative (Group II, n = 802) screening mammography responded to the study questionnaire and the Nottingham Health Profile during 2009-2011.

RESULTS: Iterative analyses resulted in nine scales demonstrating Rasch model fit, but all scales exhibited poor targeting with relatively large floor effects. Corrected item-total correlations exceeded the recommended criterion. Score differences between Groups I and II and correlations with Nottingham Health Profile sections followed an expected pattern. Cronbach's α and test-retest reliability was acceptable for group-level assessments for ten and seven scales, respectively.

CONCLUSIONS: Five scales (Sense of dejection, Anxiety, Behavioural, Sleep and Existential values) of the Swedish questionnaire version demonstrated the best psychometric properties. Other scales should be used more cautiously. Although filling an important gap, causes of concern were identified across scales. The questionnaire should therefore be considered for group-level assessments rather than for measurement of individual degrees of psychosocial consequences.

Introduction: Magnetic resonance imaging (MRI) is an important modality in diagnostics and treatment follow-up. However, MRI can be perceived as unpleasant even though the examination is non-invasive. Patients' knowledge of the MRI procedure is usually scarce, which may enhance patient anxiety at ex- amination. We investigated the effects on anxiety and satisfaction with an information booklet on MRI compared to a placebo booklet delivered to adult patients prior to their first MRI examination. Methods: This randomized, single-blind, placebo-controlled trial included 197 patients. The intervention group (n 1⁄4 95) received a booklet about MRI prior to the examination, whereas the control group (n 1⁄4 102) received a placebo booklet of the same size and layout but containing general information. The State Trait Anxiety Inventory with supplementary questions from the Quality from the Patient's Perspective questionnaire were used as patient-reported outcome measures.Results: Anxiety did not differ between the groups, either prior to MRI or during the examination, but those who received the placebo booklet were at higher risk of experiencing high anxiety prior to the MRI examination (odds ratio 2.64; P 1⁄4 0.029). The intervention group was more satisfied with the infor- mation received (P 1⁄4 0.044), and a majority of participants in both groups (!87%) considered it important to obtain information on the MRI procedure.Conclusion: Written MRI information decreases the risk of high anxiety levels before MRI and improves patient satisfaction with the information. Further research is needed to investigate whether written information prior to MRI is beneficial not only from the perspective of the patient but may also be cost- effective.Implications for practice: Written MRI information prior to the examination is recommended in radiog- raphy care.

BACKGROUND: Cancer screening aims to detect cancer at an asymptomatic stage, although side effects from screening also occur. We investigated the prevalence, longitudinal development, and predictors of psychosocial consequences of false-positive breast cancer screening.

METHODS: Three hundred ninety-nine women with false-positive screening mammography responded to the Consequences of Screening-Breast Cancer (COS-BC) questionnaire immediately after a negative diagnosis (free from breast cancer) following recall examination(s) (baseline), and 6 and 12 months later. Age-matched controls (n = 499) with a negative mammogram responded to the COS-BC at the same occasions. Five COS-BC scales (Sense of dejection, Anxiety, Behavioral, Sleep, and Existential values) were used as outcome measures.

RESULTS: Women with false-positive mammography had consistently higher prevalence of all five consequences compared with controls (P < 0.001). The prevalences decreased between baseline and 6 months (P < 0.001) but were stable between 6 and 12 months (P ≥ 0.136). Early recall profoundly predicted long-term consequences for all five outcomes (OR, 3.05-10.31), along with dissatisfaction with information at recall (OR, 2.28-2.56), being foreign-born (OR, 2.35-3.71), and lack of social support (OR, 1.13-1.25).

CONCLUSION: This 1-year longitudinal study shows that women experience psychosocial consequences of false-positive screening mammography. Early recall should be performed cautiously, and provision of information as well as social support may reduce psychosocial consequences.

IMPACT: Although delivery of population-based screening reduces breast cancer mortality, it also raises the issue of its impact on the psychosocial well-being of healthy women. Our findings identify predictors that can be targeted in future efforts to reduce the side effects of mammographic screening.

The aim was to develop and evaluate a preparatory information booklet for adult patients undergoing magnetic resonance imaging (MRI). The booklet was developed based on pertinent literature and clinical experience. After ethical approval, it was then evaluated qualitatively in 10 people who had received the booklet before their first ever MRI scan. All patients expressed the need for written preparatory information and seven had experienced prescan anxiety and discomfort. Participants found the booklet informative and easily understood, and expressed appreciation related to procedural, behavioral, and sensory information. A few minor misunderstandings were revealed. The impressions by previously MRI-naive participants in this study indicate that the information booklet was successful in providing procedural, behavioral, and sensory information. Minor booklet modifications should provide means to circumvent current misunderstandings. The process used to develop and evaluate the information booklet for this study illustrates an easily implemented strategy to meet patients' needs for preparatory information in clinical practice.

Rationale:  Experiencing a false-positive screening mammography can cause considerable psychosocial distress. The Consequences of Screening – Breast Cancer questionnaire (COS-BC parts 1 and 2), recently developed in Denmark, is the only condition-specific questionnaire for measuring short- and long-term psychosocial consequences of false-positive mammographic screening. Additional studies are needed to further test the COS-BC before use across cultures. Furthermore, studies have suggested that the consequences of false-positive screening results are partly common across cancer screening settings, although this hypothesis remains largely untested.

Objectives:  This study (i) assesses content validity of a Swedish version of the COS-BC, (ii) tests whether items expressing long-term consequences of false-positive lung cancer screening results are relevant in a breast cancer screening context and (iii) explores the usefulness of taking results from Rasch analyses of the source version as an aid in questionnaire translation and adaptation.

Methods:  Following dual-panel translation, content validity was assessed through qualitative interviews with representatives of the target population and the content validity index (CVI). Item locations and Rasch model fit of the source questionnaires were considered in the translation and assessment process.

Results:  The COS-BC items were generally found relevant and provided coverage of the target construct. Content validity was supported also for nine of 10 lung cancer screening items. Scale CVI values were ≥0.81. Previous Rasch data were useful in facilitating translation and assessing item content validity. The resulting Swedish version of the COS-BC parts 1 and 2 consists of 34 and 23 items, respectively.

Conclusion:  This study illustrates the value of methodological triangulation and use of data from previous Rasch analyses in questionnaire translation and adaptation. We found support for the hypothesis that consequences of false-positive screening are common across cancer screening settings. Psychometric properties of the Swedish COS-BC remain to be established.

Aims and objectives To explore coping with the perceived psychosocial consequences of a false-positive screening mammography. Background Mammographic screening has been found effective to decrease breast cancer (BC) mortality, yet there are adverse effects. Psychosocial consequences of false-positive mammographic screening have mainly been investigated from a population-based perspective. A call for qualitative studies to further explore these consequences has thus been postulated. To date, qualitative studies have elucidated women's experiences following their recall breast examinations, but their coping with perceived psychosocial consequences of a false-positive screening mammography has not yet been explored. Design An explorative qualitative study. Methods Face-to-face interviews were held with a purposive heterogeneous sample of 13 Swedish-speaking women with a false-positive screening mammography. The transcripts were analysed by the use of an inductive content analysis. Results Coping with the perceived psychosocial consequences of a false-positive screening mammography implied a roller coaster of emotion and sense. Women described how they imagined the worst and were in a state of uncertainty feeling threatened by a fatal disease. Conversely, they felt protected, surrounded by their families and being professionally taken care of, which together with perceived sisterhood and self-empowerment evoked strength and hope. Being aware of family responsibility became a crucial matter. Experiencing false-positive screening raised thoughts of thankfulness and reappraisal of life, although an ounce of BC anxiety remained. Consequently, gained awareness about BC screening and values in life surfaced. Conclusions Experiencing a false-positive screening mammography triggers agonising experiences evoking a variety of coping strategies. Provision of screening raises the issue of responsibility for an impact on psychosocial well-being among healthy women. Relevance to clinical practice Gained knowledge might provide a basis for interventions to prevent psychosocial consequences of false-positive mammographic screening and provide support for women with a potentially compromised ability to overcome such consequences.

Five parkinsonian patients were transplanted bilaterally into the putamen and caudate nucleus with human embryonic mesencephalic tissue from between seven and nine donors. To increase graft survival, the lipid peroxidation inhibitor tirilazad mesylate was administered to the tissue before implantation and intravenously to the patients for 3 days thereafter. During the second postoperative year, the mean daily L-dopa dose was reduced by 54% and the UPDRS (Unified Parkinson's Disease Rating Scale) motor score in 'off' phase was reduced by a mean of 40%. At 10-23 months after grafting, PET showed a mean 61% increase of 6-L-[(18)F]fluorodopa uptake in the putamen, and 24% increase in the caudate nucleus, compared with preoperative values. No obvious differences in the pattern of motor recovery were observed between these and other previously studied cases with putamen grafts alone. The amount of mesencephalic tissue implanted in each putamen and caudate nucleus was 42 and 50% lower, respectively, compared with previously transplanted patients from our centre. Despite this reduction in grafted tissue, the magnitudes of symptomatic relief and graft survival were very similar. These findings suggest that tirilazad mesylate may improve survival of grafted dopamine neurons in patients, which is in agreement with observations in experimental animals.

Objective: To identify and describe experiences that people with PD and their relatives after participation inthe self-management intervention NPS (National Parkinson School) find valuable for managing daily life.

Background: A self-management program called NPS was developed as a collaboration of healthcare providers, researchers and patient organizations. NPS is aiming to provide tools and strategies for people with PD and their relatives to increase ability to manage symptoms and consequences of disease and thereby improving conditions for a good life. Self-monitoring and self-management are central concepts. NPS focuses on life with PD, which via 7 sessions consisting of education/lectures and group discussions are mediated. Home assignments make participants practice the new skills in their own life.

Methods: The last session, evaluation of the NPS, was audio recorded in its whole and transcribed verbatim. Data was collected from five separate clinics and analysed both inductively and deductively using Thematic Analysis and by applying the Self-and Family management theory.

Results: Through inductive analysis three themes; Exchanging experiences and feeling support, Adjustment and acceptance of PD for managing daily life and Promoting life satisfaction, were identified and described. The themes are capturing the meaning, value and experience of being a participant of NPS. Deductive analysis indicated thatthe Self-and Family management theory was useful and valid for this group of patients and generated a modified framework applicable for patients with PD and their families [figure1].

Conclusions: Living with PD affects patients as well as relatives. Meeting others in the same situation gives support and strengthen their self- image. Having the opportunity sharing experiences and practical advices showed that there was a hopeful future to come. Techniques to accept and manage life with PD included seeking information about disease and treatments, self-monitoring in order to adjust to new situations and improve symptoms of disease and having a positive mind-set. Living an active life, participating in enjoyable social, cultural, and physical activities were important to feel happy and satisfied with life. Participation in NPS covered many areas of importance for the ability of self-management in PD. The framework for self-management in chronic disease was found relevant also for the PD population

BACKGROUND: Parkinson's disease (PD) is a progressive neurodegenerative condition that is expected to double in prevalence due to demographic shifts. Value-based healthcare is a proposed strategy to improve outcomes and decrease costs. To move towards an actual value-based health care system, condition-specific outcomes that are meaningful to patients are essential.

OBJECTIVE: Propose a global consensus standard set of outcome measures for PD.

METHODS: Established methods for outcome measure development were applied, as outlined and used previously by the International Consortium for Health Outcomes Measurement (ICHOM). An international group, representing both patients and experts from the fields of neurology, psychiatry, nursing, and existing outcome measurement efforts, was convened. The group participated in six teleconferences over a six-month period, reviewed existing data and practices, and ultimately proposed a standard set of measures by which patients should be tracked, and how often data should be collected.

RESULTS: The standard set applies to all cases of idiopathic PD, and includes assessments of motor and non-motor symptoms, ability to work, PD-related health status, and hospital admissions. Baseline demographic and clinical variables are included to enable case mix adjustment.

CONCLUSIONS: The Standard Set is now ready for use and pilot testing in the clinical setting. Ultimately, we believe that using the set of outcomes proposed here will allow clinicians and scientists across the world to document, report, and compare PD-related outcomes in a standardized fashion. Such international benchmarks will improve our understanding of the disease course and allow for identification of 'best practices', ultimately leading to better informed treatment decisions.

OBJECTIVE: The 22-item Unidimensional Fatigue Impact Scale (U-FIS) provides an index of the impact of fatigue on patients with multiple sclerosis (MS). The objective is to produce eight new language versions of the U-FIS: Canadian-English, Canadian-French, French, German, Italian, Spanish, Swedish, and US-English.

METHODS: The U-FIS was translated via two translation panels. Cognitive debriefing interviews conducted with patients in each country assessed face and content validity. Scaling and psychometric properties were assessed via survey data with patients in each country completing the U-FIS, Nottingham Health Profile (NHP), and demographic questions.

RESULTS: Cognitive debriefing interviews demonstrated U-FIS acceptability. Analysis of postal survey data showed all new language versions to be unidimensional. Reliability was high, with test-retest correlations and internal-consistency coefficients exceeding 0.85. Initial evidence of validity was provided by moderate to high correlations with NHP scales. The U-FIS was able to discriminate between groups based on employment status, perceived MS severity, and general health.

CONCLUSION: The U-FIS is a practical new measure of the impact of fatigue. It was successfully adapted into eight new languages to broaden availability for researchers. Psychometric analyses indicated that the new language versions were unidimensional and reproducible with promising construct validity.

Background: Mastery refers to the degree to which people perceive that they can control factors that influence their life situation, and has been found important for people's quality of life and well-being. It is thus essential to be able to measure mastery in a valid and reliable way. Aim: This study aimed at using the Rasch measurement model to investigate the psychometric properties of a Swedish version of the Pearlin Mastery Scale (Mastery-S). Methods: A sample of 300 healthy individuals and 278 persons with mental illness responded to the Mastery-S. Item responses were Rasch analysed regarding model fit, response category functioning, differential item functioning (DIF) and targeting, using the partial credit model. Results: The Mastery-S items represented a logical continuum of the measured construct but one item displayed misfit. Reliability (Person Separation Index) was 0.7. The response categories did not work as expected in three items, which could be corrected for by collapsing categories. Three items displayed DIF between the two subsamples, which caused a bias when comparing mastery levels between subsamples, suggesting the Mastery-S is not truly generic. Conclusions: The Mastery-S may be used to obtain valid and reliable data, but some precautions should be made. If used to compare groups, new analyses of DIF should first be made. Users of the scale should also consider exempting item 6 from the scale and analyse it as a separate item. Finally, rewording of response categories should be considered in order to make them more distinct and thereby improve score reliability.

This study investigated psychometric properties of an instrument for assessing perceived occupational value, the 26-item OVal-pd. Data from 225 Swedish subjects with and without known mental illness were analysed regarding fit to the Rasch measurement model (partial credit model), differential item functioning (DIF), and functioning of the OVal-pd four-category response scale. The reliability (index of person separation, analogous to Cronbach's alpha) was good (0.92) but there were signs of overall and item level (six items) misfit. There was DIF between people with and without mental illness for three items. Iterative deletion of misfitting items resulted in a new 18-item DIF-free scale with good overall and individual item fit and maintained reliability (0.91). There were no disordered response category thresholds. These observations also held true in separate analyses among people with and without mental illness. Thus, the first steps of ensuring that occupational value can be measured in a valid and reliable way have been taken. Still, occupational value is a dynamic construct and the aspects that fit the construct may vary between contexts. This has implications for, e.g., cross-cultural research and calls for identification of a core set of culture-free items to allow for valid cross-cultural comparisons.

Fatigue has been shown to be a consistent and common problem in Parkinson's disease (PD) in multiple countries and cultures. It is one of the most disabling of all symptoms, including motor dysfunction, and appears early, often predating the onset of motor symptoms. Several studies of the epidemiology of fatigue have been published, often using different scales, but few on treatment. The Movement Disorder Society (MDS) commissioned a task force to assess available clinical rating scales, critique their psychometric properties, summarize their clinical properties, and evaluate the evidence in support of their use in clinical studies in PD. Six clinical researchers reviewed all studies published in peer reviewed journals of fatigue in PD, evaluated the scales' previous use, performance parameters, and quality of validation data, if available. Scales were rated according to criteria provided by the MDS. A scale was "recommended" if it has been used in clinical studies beyond the group that developed it, has been used in PD and psychometric studies have established that it is a valid, reliable and sensitive to change in people with PD. Requiring a scale to have demonstrated sensitivity to change in PD specifically rather than in other areas in order to attain a rating of "recommended" differs from the use of this term in previous MDS task force scale reviews. "Suggested" scales failed to meet all the criteria of a "recommended" scale, usually the criterion of sensitivity to change in a study of PD. Scales were "listed" if they had been used in PD studies but had little or no psychometric data to assess. Some scales could be used both to screen for fatigue as well as to assess fatigue severity, but some were only used to assess severity. The Fatigue Severity Scale was "recommended" for both screening and severity rating. The Fatigue Assessment Inventory, an expanded version of the Fatigue severity Scale, is "suggested" for both screening and severity. The Functional Assessment of Chronic Illness Therapy-Fatigue was "recommended" for screening and "suggested" for severity. The Multidimensional Fatigue Inventory was "suggested" for screening and "recommended" for severity. The Parkinson Fatigue Scale was "recommended" for screening and "suggested" for severity rating. The Fatigue Severity Inventory was "listed" for both screening and severity. The Fatigue Impact Scale for Daily Use, an adaptation of the Fatigue Impact Scale was "listed" for screening and "suggested" for severity. Visual Analogue and Global Impression Scales are both "listed" for screening and severity. The committee concluded that current scales are adequate for fatigue studies in PD but that studies on sensitivity and specificity of the scales are still needed.

Aim: The aim of this study was to test the psychometric properties of the Salutogenic Health Indicator Scale (SHIS) in an adolescent population. Methods: The investigation was performed among Swedish students aged 13–15 years (n = 817; 58% girls). The SHIS was assessed for respondent acceptability, and its psychometric properties were evaluated according to classical test theory (regarding unidimensionality, targeting, reliability, and external construct validity). Results: The adolescents found it easy to complete the questionnaire, which was completed in an average of 4 minutes. Exploratory factor analysis, which is based on polychoric correlations, identified one factor, supporting the instrument’s unidimensionality. Floor/ceiling effects were ⩽ 3.3%. Reliability estimates yielded a Cronbach’s alpha value of 0.93; the test–retest reliability (n = 50; 2-week interval) coefficients were 0.89 for the total SHIS score and 0.52–0.79 for item scores. Spearman correlations with other variables were based on a priori expectations (self-rated general health, 0.595; depressive symptoms, −0.773; anxiety, −0.577; and sleep problems, 0.519). Conclusions: Our observations support both the acceptability and the psychometric properties of the SHIS as a brief, unidimensional assessment tool for salutogenic health in adolescents. Further studies using modern test theory are needed to better understand the measurement properties of the SHIS, including the functioning of its response categories and its comparability between adolescents and adults.

Våra observationer stöder både acceptansen och de psykometriska egenskaperna för SHIS som ett kort, en-dimensionellt frågeformulär för att mäta salutogen hälsa hos ungdomar.

Objectives

We aimed to investigate whether sleep duration is associated with self-reported overall health, screen time, and nighttime texting among Swedish adolescents.

Methods

This was a cross-sectional survey of students (n = 1518) aged 13 to 15 years (50.7% girls) in southern Sweden.

Results

Fewer than 8 hours sleep duration before a school day was reported by 31% of students. The median time spent watching television and/or at the computer was 3 hours, and 43% of students reported texting at night one or more times per week. Sleeping fewer than 8 hours was significantly associated with poorer self-reported overall health, often being tired at school, increased screen time, and a habit of nighttime texting.

Conclusions

Short sleep duration (<8 hours) was associated with poor self-reported health, increased screen time, and nighttime texting among respondents. These results provide information for parents, educators, and school health professionals to encourage young people to adopt healthy screen habits and sleep hygiene.

Vilka sjukdomsaspekter är väsentligast ur patienternas perspektiv? Vilka mål ska sättas för behandlingen? Livskvalitet, gångförmåga och rörlighet är några av de faktorer som visat sig viktiga att utvärdera.

Among the responses to this month's question, the most common strategy for motivating compliance is providing information. This finding is also supported with the example from Australia, where stoke sufferers are highly compliant with any intervention aimed at prevention of future strokes. In this case, the high level of compliance and (probably) motivation can be explained by the fact that stroke is potentially fatal and highly disabling. Other important issues also were identified in the responses: (a) patients' trust and belief in healthcare professionals in terms of providing information and motivation, and (b) a lack of motivation in some patients who simply do not want to comply and prefer a certain level of seizure activity or other impairments and disabilities over the potential side effects of the treatment. This raises another question that goes beyond the concept of compliance and noncompliance: How does the system comply to the patient? I will leave this topic open, and I welcome comments for a future round of discussion here at Global Views.

The Parkinson's Disease Questionnaire - 39 is the most widely used disease-specific health status questionnaire for Parkinson's disease. Evaluations of various language versions have focused on psychometric properties, whereas documented evaluations regarding linguistic validity, respondent burden and questionnaire content are largely lacking. Work with the Swedish Parkinson's Disease Questionnaire - 39 has taken these aspects into account, which has resulted in a linguistically revised version which is currently being evaluated. Initial observations indicate that the revision rectified linguistic but not nonlinguistic problems, and that its feasibility in terms of respondent burden in more advanced disease can be challenged. There are also indications for the need for content improvements. These experiences are discussed along with their implications.

Parkinson’s disease (PD) is a progressive neurodegenerative disorder characterized by motor as well as non-motor symptoms. While available symptomatic therapy is effective, PD is associated with increasing disability and limitations in performance of activities of daily living (ADL). Maintaining and improving activity performance is therefore a major goal in available symptomatic therapy. The most commonly used rating scale for quantification of ADL outcomes is the ADL section (part II) of the Unified PD Rating Scale (UPDRS). However, the UPDRS II does not only include activity but also impairment items. The consequences of this does not appear to have been addressed from a measurement perspective. This paper describes results from Rasch Measurement Theory analyses of complete UPDRS II (full scale, Activity and Impairment) data (n=675-687). Results show poor fit of the full UPDRS II with, e.g., disordered response thresholds, significant misfit and DIF (reliability, 0.82). The 6 Activity items showed no disordered thresholds, significant misfit or DIF (reliability, 0.86), whereas Impairment items did (reliability, 0.51). In conclusion, dividing the UPDRS II into two scales improves ADL measurement, but alternative approaches are needed and the UPDRS II cannot be recommended for measuring ADL in PD as it may yield misleading outcomes.

Parkinson's disease (PD) is a progressive neurodegenerative disorder associated with increasing disability and limitations in performance of activities of daily living (ADL) despite availability of effective symptomatic therapy. Following an overview of classical test theory (CTT) and Rasch measurement theory (RMT), the case of a clinical PD trial aiming to demonstrate ADL improvements by using the ADL section (part II) of the Unified PD Rating Scale (UPDRS) to measure ADL outcomes is considered and central questions related to its validity and interpretation are addressed. It is found that while CTT did not detect any issues, RMT in combination with conceptual considerations seriously challenged the role of the UPDRS II as an ADL outcome measure. Results are discussed from historical, methodological and clinical perspectives. (C) 2018 Elsevier Ltd. All rights reserved.

This paper reports the interim results of an ongoing systematic review of the available evidence for the effectiveness of nursing care for people with Parkinson's disease (PD). Five clinical and four health-economic evaluations suggest that the clinical and cost effectiveness of nursing care for PD remain inconclusive. This is in contrast to clinical experience and may be due to issues related to study designs, study interventions, and the outcome measures used. More studies are needed and may benefit from considering specific interventions evaluated using outcome measures that are valid and responsive representations of their expected outcomes.

Cell replacement for restoration of neurological functions in patients with movement disorders has been investigated for more than 15 years. Initial attempts used autologous adrenal medulla grafts implanted into the denervated striatum of patients with Parkinson's disease (PD). This approach was soon abandoned in favor of intrastriatal implantation of human embryonic mesencephalic tissue, rich in dopaminergic neurons. Available data from grafted PD patients show long-term (up to 10 years) graft survival and clinical benefits. The pattern and magnitude of symptomatic relief following transplantation, however, are incomplete and the outcome varies among patients. The need for large amounts of human embryonic tissue has to be circumvented and a better understanding of the relationship between graft placement and symptomatic recovery is necessary before this procedure can be offered to larger groups of patients. Clinical trials in Huntington's disease have so far shown inconclusive results. Neural cell replacement therapy is still an experimental procedure, but has the potential to become a future restorative treatment in PD and other movement disorders.

Parkinson’s disease (PD) is a neurodegenerative disorder characterized by motor symptoms such as bradykinesia, rigidity, tremor and postural instability. Available therapy is symptomatic, although several approaches have been investigated as potential disease-modifying therapies. Clinical trial outcomes are typically measured by means of rating scales, of which the Unified PD Rating Scale (UPDRS) is the most commonly used, particularly part III, its motor examination section. Despite its central role, the UPDRS has not been examined regarding its role as a measurement instrument. This paper describes results from an analysis according to Rasch Measurement Theory (RMT) of 804 complete clinical UPDRS III assessments. Results show that the scale exhibits mistargeting, with the vast majority of people being located at the lower half (i.e., less severe symptoms) of its measurement range. Furthermore, evidence suggests multidimensionality as well as redundancy, and problems with the empirical functioning of rating scale categories. It is concluded that the UPDRS represents a clinical assessment tool rather than a measurement instrument, which may contribute to a range of missed opportunities regarding therapeutic developments as well as understanding of the disease itself. Potential remedies include separation into symptom specific scales and reconceptualization in order to expand its range of measurement.

Should boxing be banned? Do the ever-so-obvious risks outweigh everyone's freedom to choose whether to expose oneself to these risks by taking up the sport? On an official level, the RCN in the UK has taken its stand--it does not! So has also the British Medical Association (BMA)--it does! With few exceptions, the responding nurses from Europe, America, and Australia in this month's column seem to agree with the official nursing standpoint in the UK, also emphasizing the importance that any person's choice not only should be free, but also informed. In the United States, where boxing perhaps has its strongest tradition and deepest roots, the whole issue hardly seems to be one of much realistic debate at all. In Australia, however, the debate seems to be similar to that in the UK. What would a total ban on boxing lead to? No more boxing and no more neurological consequences due to boxing? Doubtfully, boxing would probably continue anywhere where there is an interest for it, and a ban might actually increase the attraction to the sport for some people. In this scenario there is also a risk that the safety precautions would be seriously compromised. This month's question exemplifies an area in which it is very important for nurses to make a stand, on a personal as well as on a collective level. As indicated by several of this month's replies, the issue is probably not merely about boxing but also about to what extent people's choices should be controlled by bans and where the line should be drawn. To what extent are people competent to make their own decisions and where/when/how should "big brother" (in this case as represented by, among others, nursing as a profession) be allowed to step in? Anyone who has any further contributions or comments on this issue is welcome to contact me!

Psychometric theory requires unidimensionality (i.e., scale items should represent a common latent variable). One advocated approach to test unidimensionality within the Rasch model is to identify two item sets from a Principal Component Analysis (PCA) of residuals, estimate separate person measures based on the two item sets, compare the two estimates on a person-by-person basis using t-tests and determine the number of cases that differ significantly at the 0.05-level; if ≤5% of tests are significant, or the lower bound of a binomial 95% confidence interval (CI) of the observed proportion overlaps 5%, then it is suggested that strict unidimensionality can be inferred; otherwise the scale is multidimensional. Given its proposed significance and potential implications, this procedure needs detailed scrutiny. This paper explores the impact of sample size and method of estimating the 95% binomial CI upon conclusions according to recommended conventions. Normal approximation, “exact”, Wilson, Agresti-Coull, and Jeffreys binomial CIs were calculated for observed proportions of 0.06, 0.08 and 0.10 and sample sizes from n= 100 to n= 2500. Lower 95%CI boundaries were inspected regarding coverage of the 5% threshold. Results showed that all binomial 95% CIs included as well as excluded 5% as an effect of sample size for all three investigated proportions, except for the Wilson, Agresti-Coull, and JeffreysCIs, which did not include 5% for any sample size with a 10% observed proportion. The normal approximation CI was most sensitive to sample size. These data illustrate that the PCA/t-test protocol should be used and interpreted as any hypothesis testing procedure and is dependent on sample size as well as binomial CI estimation procedure. The PCA/t-test protocol should not be viewed as a “definite” test of unidimensionality and does not replace an integrated quantitative/qualitative interpretation based on an explicit variable definition in view of the perspective, context and purpose of measurement.

The clinical evaluation section of the Core Assessment Program for Intracerebral Transplantations (CAPIT) for Parkinson's disease (PD) was developed to standardize the clinical evaluation in cell transplantation trials, but also has been used in other therapeutic trials for PD. An important part of the CAPIT protocol is the standardized timed tests of motor function. In a recent revision of CAPIT, the Core Assessment Program for Surgical Interventional Therapies in Parkinson's Disease (CAPSIT-PD), the timed tests have been modified. There are some practical considerations that need attention when timed tests are used. They should be performed under the same circumstances with the patient in a defined condition and according to the same instructions from one time to another. Also, the examiner should not assist the patient, either directly or indirectly, by cueing. In addition to quantification of motor function as an outcome measure in therapeutic trials and other clinical research, timed tests also can be used for determining dopaminergic responsiveness in differential diagnosis of parkinsonism. Our experience is that timed tests are valuable quantitative and objective measures in scientific as well as clinical assessments of PD. Practical guidelines for and examples of these areas of use are provided.

Clinical trial rating scale based outcome measures have been criticized of lacking relevance and meaning to end-users, particularly patients. This is concerning since inferences regarding the usefulness of therapies are based on rating scale derived numbers. In order to be meaningful and in accord with their purpose in clinical trials, rating scale based outcome measures should not only be rigorous measures of the variables they intend to quantify, but they also need to represent variables that are important to end-users such as patients and health care professionals. This requires an understanding of what to measure, and state-of-the-art psychometric methods to ensure that rating scale derived data represent meaningful quantitative measures. However, relatively little is known about what variables that people with, e.g. Parkinson’s disease (PD) prioritize for outcome measurement and how this compares to the views of health care professionals. These issues will be discussed and illustrated in view of recent mixed-methods (Group Concept Mapping) studies in PD. Results illustrate similarities in patients’ and health care professionals’ views in that both considered quality of life as the most important outcome variable and both ranked walking/mobility and sleeping problems among the top five outcome variables. This may serve as guidance in designing future clinical trials. However, data also illustrate important differences in conceptual perspectives. Considerations such as those revealed in these studies should be taken into account in order to render clinical trial outcomes more meaningful and interpretable from an end-user perspective.

Context: Previous studies have supported the psychometric properties of the 22-item Zarit Burden Interview (ZBI-22) scale among family caregivers of people with various disorders, including Parkinson´s disease (PD). However, its short-forms have not been psychometrically tested among PD family caregivers, and available psychometric analyses have not accounted for the ordinal nature of item-level data.

Objectives: To assess the psychometric properties of the ZBI-22 and its short forms among family caregivers of people with PD, while taking account for the ordinal nature of data.

Methods: Cross-sectional postal survey ZBI-22 data from 66 family caregiver members (59% women; mean age, 69.6 years) of a local Swedish PD society branch were analysed according to classical test theory methods based on polychoric/polyserial correlations.

Results: Missing item responses were ≤5%. Corrected item-total correlations were ≥0.42 and floor-/ceiling effects were <20%, besides for the briefest (4- and 1-item) short-forms (20% and 40% floor effects, respectively). Reliability was good for all scales (ordinal alpha, 0.89-0.95).  External construct validity was in general accordance with a priori expectations. Short-forms demonstrated good criterion-related validity (r_s 0.87-0.99) and discriminative ability (AUC, 0.91-0.98) relative to the full ZBI-22.

Conclusion: This study provides support for the reliability and validity of the ZBI-22 and its various short forms for use among PD family caregivers. In studies where caregiver burden is a central outcome, either ZBI-22 or -12 is suggested for use; other short-forms can be used when caregiver burden is of less central focus or for clinical screening.

The aim of this work was to evaluate the measurement properties and hierarchical item structure of the Epworth Sleepiness Scale (ESS) in patients with Parkinson's disease (PD). Data were taken from a cross-sectional study regarding fatigue and sleep-related aspects of PD. One hundred and eighteen consecutive patients with neurologist-diagnosed PD without significant co-morbidities (54% men; mean age, 64 years; mean PD duration, 8.4 years) from four Swedish neurological outpatient clinics participated. The ESS displayed good data quality with few missing items (0-2.5%): good reliability (Cronbach's alpha, 0.84), marginal floor and no ceiling effects (1.7% and 0% respectively), and differentiated between those reporting problems staying awake during the past month and those who did not. Item-total correlations, factor and Rasch analyses indicated that items tap a single underlying construct. Rasch analysis supported basic rating scale assumptions and demonstrated an item hierarchy similar to that previously found in patients with other sleep disorders. Gaps in the levels of sleep propensity covered by ESS items and their response options were identified at the higher and lower ends of the underlying sleepiness continuum. This study provides an evidence base for using the ESS in PD by demonstrating good psychometric properties and a stable hierarchical item structure. However, addition of new items and use of Rasch scoring has potential to further enhance the clinical usefulness of the ESS.

Background: The Minimal Insomnia Symptom Scale (MISS) has been suggested as a brief 3-item screening tool for detecting insomnia. Each item has an ordered 5-category (0-4) response scale and the instrument yields a total score between 0-12 (higher scores = more insomnia). Available MISS evaluations have been based on classical test theory (CTT) approaches. Different cut-offs for identifying insomnia have been suggested for adults (aged 20-64) and elderly (aged 65+). For adults, a cut-off of ≥6 has been suggested, while a cut-off of ≥7 has been suggested for the elderly, as determined from applications of the Youden index.

Aim: To test the measurement properties of the MISS using the Rasch measurement model, with special emphasis on Differential Item Functioning (DIF) by age, and to explore implications for the two suggested cut-off scores.

Design: Cross-sectional MISS data from adult (n=1075) and elderly (n=548) populations were analysed by the unrestricted polytomous Rasch measurement model using the RUMM2030 software program. To avoid an inflated type I error rate, sample size was algebraically adjusted to 500 in the calculation of P-values while leaving all other aspects of data (e.g., locations, fit residuals) unaltered.

Results: Mean person location was -1.095 (SD, 1.28), i.e. items tend to represent more severe levels of insomnia than that experienced by the sample. However, for the purpose of screening this may be considered acceptable. There were no statistically significant deviations from model expectations, with a non-significant overall item-trait interaction (χ² = 26.94, P=0.173). Reliability (PSI) was 0.59 suggesting that the MISS can separate approximately two statistically distinct groups of people (1.92 strata). The highest Information Function (IF) was found at -0.2 logits. There were no disordered response category thresholds. There was uniform DIF by age for all three items, which disappeared following adjustment (split by age group) for the most pronounced DIF, suggesting that DIF was artificial for two items. Examination of raw scores-to-location estimates between the two age groups revealed differences at the lower and higher ends of the scale. The raw score cut-off of ≥6 was associated with a smaller logit difference between age groups than the ≥7 cut-off (0.09 vs. 0.23). That is, at a raw score of 6 the two age groups were comparable regarding their logit location estimates. This raw score (representing a logit value of -0.03 for the pooled sample) was also the one closest to the location of the highest IF (i.e., -0.2 logits).

Summary and implications: This study provides general support for the measurement properties of the MISS. However, caution should be exercised in comparing MISS scores between age groups, but applying a ≥6 raw score cut-off appears to allow for valid comparisons between adults and elderly regarding the presence of insomnia. Nevertheless, additional studies are needed to determine the clinically optimal cut-score for identification of insomnia.