What is important for you? A qualitative interview study of living with diabetes and experiences of diabetes care to establish a basis for a tailored Patient-Reported Outcome Measure for the Swedish National Diabetes Register

OBJECTIVES: There is a growing emphasis on the perspective of individuals living with diabetes and the need for a more person-centred diabetes care. At present, the Swedish National Diabetes Register (NDR) lacks patient-reported outcome measures (PROMs) based on the perspective of the patient. As a basis for a new PROM, the aim of this study was to describe important aspects in life for adult individuals with diabetes. DESIGN: Semistructured qualitative interviews analysed using content analysis. SETTING: Hospital-based outpatient clinics and primary healthcare clinics in Sweden. PARTICIPANTS: 29 adults with type 1 diabetes mellitus (DM) (n=15) and type 2 DM (n=14). INCLUSION CRITERIA: Swedish adults (≥18 years) living with type 1 DM or type 2 DM (duration ≥5 years) able to describe their situation in Swedish. Purposive sampling generated heterogeneous characteristics. RESULTS: To live a good life with diabetes is demanding for the individual, but experienced barriers can be eased by support from others in the personal sphere, and by professional support from diabetes care. Diabetes care was a crucial resource to nurture the individual's ability and knowledge to manage diabetes, and to facilitate life with diabetes by supplying support, guidance, medical treatment and technical devices tailored to individual needs. The analysis resulted in the overarching theme 'To live a good life with diabetes' constituting the two main categories 'How I feel and how things are going with my diabetes' and 'Support from diabetes care in managing diabetes' including five different categories. CONCLUSIONS: Common aspects were identified including the experience of living with diabetes and support from diabetes care. These will be used to establish a basis for a tailored PROM for the NDR.

The validity of the 21-item version of the depression anxiety stress scales as a routine outcome measure

Objective: This study aimed to test the validity of the 21-item Depression Anxiety Stress Scales (DASS-21) as a routine clinical outcome measure in the private in-patient setting. We hypothesized that it would be a suitable routine outcome instrument in this setting.

Method: All in-patients treated at a private psychiatric hospital over a period of 24 months were included in the study. Data were collected on demographics, service utilization, diagnosis and a set of four routine measures both at admission and discharge. These measures consisted of the Clinical Global Impressions (CGI) scales, Health of the Nation Outcome Scales (HoNOS), the Mental Health Questionnaire (MHQ-14) and DASS-21. The results of these measures were compared.

Results: Of 786 admissions in total, the number of fully completed (ie paired admission and discharge) data sets for the DASS-21 depression, anxiety and stress subscales were 337, 328 and 347, respectively. All subscales showed statistically significant reductions in mean scores from admission to discharge (P < 0.001) and were significantly correlated with all MHQ-14 subscales and significantly related to CGI scale categories. The total DASS-21 and total HoNOS scores were also significantly correlated.

Conclusions: The findings from the present study support the validity of DASS-21 as a routine clinical outcome measure in the private in-patient setting.

A patient-reported outcome measure to identify occurrence and distress of post-surgery symptoms of WOMen with vulvAr Neoplasia (WOMAN-PRO) - a cross sectional study.

OBJECTIVE The aim of the study was to describe the (a) symptom experience of women with vulvar intraepithelial neoplasia and vulvar cancer (vulvar neoplasia) during the first week after hospital discharge, and (b) associations between age, type of disease, stage of disease, the extent of surgical treatment and symptom experience. METHODS This cross-sectional study was conducted in eight hospitals in Germany and Switzerland (Clinical Trial ID: NCT01300663). Symptom experience after surgical treatment in women with vulvar neoplasia was measured with our newly developed WOMAN-PRO instrument. Outpatients (n=65) rated 31 items. We used descriptive statistics and regression analysis. RESULTS The average number of symptoms reported per patient was 20.2 (SD 5.77) with a range of 5 to 31 symptoms. The three most prevalent wound-related symptoms were 'swelling' (n=56), 'drainage' (n=54) and 'pain' (n=52). The three most prevalent difficulties in daily life were 'sitting' (n=63), 'wearing clothes' (n=56) and 'carrying out my daily activities' (n=51). 'Tiredness' (n=62), 'insecurity' (n=54) and 'feeling that my body has changed' (n=50) were the three most prevalent psychosocial symptoms/issues. The most distressing symptoms were 'sitting' (Mean 2.03, SD 0.88), 'open spot (e.g. opening of skin or suture)' (Mean 1.91, SD 0.93), and 'carrying out my daily activities' (Mean 1.86, SD 0.87), which were on average reported as 'quite a bit' distressing. Negative associations were found between psychosocial symptom experience and age. CONCLUSIONS WOMAN-PRO data showed a high symptom prevalence and distress, call for a comprehensive symptom assessment, and may allow identification of relevant areas in symptom management.

The Responsiveness, Content Validity, and Convergent Validity of the Measure Yourself Concerns and Wellbeing (MYCaW) Patient-Reported Outcome Measure

Objective Measure Yourself Concerns and Wellbeing (MYCaW) is a patient-centred questionnaire that allows cancer patients to identify and quantify the severity of their ‘Concerns’ and Wellbeing, as opposed to using a pre-determined list. MYCaW administration is brief and aids in prioritising treatment approaches. Our goal was to assess the convergent validity and responsiveness of MYCaW scores over time, the generalisability of the existing qualitative coding framework in different complementary and integrative healthcare settings and content validity. Methods Baseline and 6-week follow-up data (n=82) from MYCaW and FACIT-SpEx questionnaires were collected for a service evaluation of the ‘Living Well With The Impact of Cancer’ course at Penny Brohn Cancer Care. MYCaW construct validity was determined using Spearman's Rank Correlation test, and responsiveness indices assessed score changes over time. The existing qualitative coding framework was reviewed using a new dataset (n=158) and coverage of concern categories compared to items of existing outcome measures. Results Good correlation between MYCaW and FACIT-SpEx score changes were achieved (r= -0.57, p≥0.01). MYCaW Profile and Concern scores were highly responsive to change: SRM=1.02 and 1.08; effect size=1.26 and 1.22. MYCaW change scores showed the anticipated gradient of change according to clinically relevant degrees of change. Categories including ‘Spirituality’, ‘weight change’ and ‘practical concerns’ were added to the coding framework to improve generalisability. Conclusions MYCaW scores were highly responsive to change, allowing personalized patient outcomes to be quantified; the qualitative coding framework is generalisable across different oncology settings and has broader coverage of patient-identified concerns compared with existing cancer-related patient-reported outcome measures.

Health-related quality of life in portuguese SLE patients: an outcome measure independent of disease activity and cumulative damage

PURPOSE: To evaluate quality of life in Portuguese patients with Systemic Lupus Erithematosus (SLE) and its correlation with disease activity and cumulative damage. METHODS: We included consecutive SLE patients, fulfilling the 1997 ACR Classification Criteria for SLE and followed at the Rheumatology Department of the University Hospital of Coimbra, Portugal at time of visit to the outpatient clinic. Quality of life was evaluated using the patient self-assessment questionnaire Medical Outcomes Survey Short Form-36 (SF-36) (validated Portuguese version). The consulting rheumatologist fulfilled the SLE associated indexes for cumulative damage (Systemic Lupus International Collaborating Clinics- Damage Index: SLICC/ACR-DI) and disease activity (Systemic Lupus Erythematosus Disease Activity Index: SLEDAI 2000). Correlation between SLEDAI and SLICC and SF-36 was tested with the Spearman Coefficient. Significant level considered was 0.05. RESULTS: The study included 133 SLE patients (90.2% female, mean age - 40.7 years, mean disease duration - 8.7 years). Most patients presented low disease activity (mean SLEDAI = 4.23) and limited cumulative damage (mean SLICC = 0.76). Despite that, SF-36 mean scores were below 70% in all eight domains of the index. Physical function domains showed lower scores than mental function domains. The QoL in this group of patients is significantly impaired when compared with the reference Portuguese population (p<0.05 in all domains). There was no correlation between clinical activity or cumulative damage and quality of life. CONCLUSION: QoL is significantly compromised in this group of SLE patients, but not related with disease activity or damage. These findings suggest that disease activity, cumulative damage and QoL are independent outcome measures and should all be used to assess the full impact of disease in SLE patients.

Development and validation of the ankle fracture outcome of rehabilitation measure (A-FORM)

Study Design Delphi panel and cohort study. Objective To develop and refine a condition-specific, patient-reported outcome measure, the Ankle Fracture Outcome of Rehabilitation Measure (A-FORM), and to examine its psychometric properties, including factor structure, reliability, and validity, by assessing item fit with the Rasch model. Background To our knowledge, there is no patient-reported outcome measure specific to ankle fracture with a robust content foundation. Methods A 2-stage research design was implemented. First, a Delphi panel that included patients and health professionals developed the items and refined the item wording. Second, a cohort study (n = 45) with 2 assessment points was conducted to permit preliminary maximum-likelihood exploratory factor analysis and Rasch analysis. Results The Delphi panel reached consensus on 53 potential items that were carried forward to the cohort phase. From the 2 time points, 81 questionnaires were completed and analyzed; 38 potential items were eliminated on account of greater than 10% missing data, factor loadings, and uniqueness. The 15 unidimensional items retained in the scale demonstrated appropriate person and item reliability after (and before) removal of 1 item (anxious about footwear) that had a higher-than-ideal outfit statistic (1.75). The “anxious about footwear” item was retained in the instrument, but only the 14 items with acceptable infit and outfit statistics (range, 0.5–1.5) were included in the summary score. Conclusion This investigation developed and refined the A-FORM (Version 1.0). The A-FORM items demonstrated favorable psychometric properties and are suitable for conversion to a single summary score. Further studies utilizing the A-FORM instrument are warranted. J Orthop Sports Phys Ther 2014;44(7):488–499. Epub 22 May 2014. doi:10.2519/jospt.2014.4980

A tool to measure progress and outcome in recovery

Recovery and the use of routine outcome measurement tools are key topics for mental health nurses. This article reports on research carried out to assess the usability of an outcome measure designed to assess recovery in clinical practice. Results indicate that the Individual Recovery Outcomes Counter (I.ROC) is both easy to use and well liked by services users.

Validation of an Australian sign language instrument of outcome measurement for adults in mental health settings

Objective: There are currently no adult mental health outcome measures that have been translated into Australian sign language (Auslan). Without a valid and reliable Auslan outcome measure, empirical research into the efficacy of mental health interventions for sign language users is unattainable. To address this research problem the Outcome Rating Scale (ORS), a measure of general functioning, was translated into Auslan and recorded on to digital video disk for use in clinical settings. The purpose of the present study was therefore to examine the reliability, validity and acceptability of an Auslan version of the ORS (ORS-Auslan). Method: The ORS-Auslan was administered to 44 deaf people who use Auslan as their first language and who identify as members of a deaf community (termed ‘Deaf’ people) on their first presentation to a mental health or counselling facility and to 55 Deaf people in the general community. The community sample also completed an Auslan version of the Depression Anxiety Stress Scale-21 (DASS-21). Results: t-Tests indicated significant differences between the mean scores for the clinical and community sample. Internal consistency was acceptable given the low number of items in the ORS-Auslan. Construct validity was established by significant correlations between total scores on the DASS-21-Auslan and ORS-Auslan. Acceptability of ORS-Auslan was evident in the completion rate of 93% compared with 63% for DASS-21-Auslan. Conclusions: This is the only Auslan outcome measure available that can be used across a wide variety of mental health and clinical settings. The ORS-Auslan provides mental health clinicians with a reliable and valid, brief measure of general functioning that can significantly distinguish between clinical and non-clinical presentations for members of the Deaf community.