Outcome Measures In Clinical Practice Research Articles

Achieving consensus on patient-reported outcome measures in clinical practice for inflammatory skin disorders

International Dermatology Outcome Measures and the American Academy of Dermatology recently agreed on a physician-reported global severity measure to demonstrate quality of care in inflammatory dermatoses. Because patient-reported outcome measures are also important, we aimed to achieve consensus on 1 of these measures for clinical practice. Patients and providers participated in a consensus-building study involving a modified-Delphi technique. Voting was focused on identifying a minimal set of assessments for clinical practice, patientglobal assessments (PtGAs), Skindex instruments, and final instrument selection for quality improvement. Among 53 stakeholders, >70% agreed that identification of patient goals, assessment of treatment harm, and assessment of the adequacy of treatment response were the minimal assessments needed for clinical practice. The most preferred PtGA was a 5-point PtGA (scale 0-4; 0=clear, 4=severe) having an optional check-box for worst ever. A new metric to assess change since treatment initiation, which we called a trajectory measure, was proposed. Stakeholders preferred Skindex instruments over PtGAs and a trajectory measure for clinical practice. A small number of patients and caregivers were involved and a consensus was not reached on all items. PtGAs as standalone measures do not adequately capture the patient's assessment of disease severity or the effect of care. The combination of a PtGA with a Skindex instrument or another measure of health-related quality of life might provide a more comprehensive evaluation of patients in clinical practice.

Patient-reported outcome measures in benign gynecologic surgery: updates and selected tools.

Use of patient-reported outcome measures in clinical practice and research is becoming more prevalent and reflects initiatives to center the patient in healthcare delivery and outcomes assessment. The purpose of this review is to provide a summary description of selected, validated tools used to assess outcomes related to several benign gynecologic conditions: abnormal uterine bleeding, fibroids and endometriosis. Given the availability of several validated instruments to assess patient outcomes in benign gynecology, there is still significant heterogeneity in tools used in trials. Patient outcomes assessment should be an integral part of clinical practice and research in order to treat the whole patient and address any health-related impacts on quality of life. More attention is needed to increase standardization of tools used in research to facilitate assessment of comparative efficacy between treatments.

Prosthetic Limb User Experiences With Crossover Feet: A Pilot Focus Group Study to Explore Outcomes That Matter

ABSTRACT Introduction Many different prosthetic feet are available to meet the diverse needs of people with lower-limb amputation. Current methods used to assess comparative effectiveness of prosthetic feet may not align with outcomes that are most important to people with lower-limb amputation. User participation in qualitative research is one approach to guide selection of outcome measures for clinical practice and quantitative research studies. This pilot study examined outcomes of importance to people who have used both energy storing and crossover prosthetic feet. Materials and Methods An in-person focus group of people with lower-limb amputation was conducted. Inclusion criteria were as follows: 18 years of age or older, lower-limb amputation, previous use of an energy storing foot and crossover foot, and a minimum of 1 year prosthesis use. Results Five participants with lower-limb amputation (4 males/1 female), aged 41 to 59 years (mean, 45.6 ± 7.7 years), participated in the focus group. Three participants had unilateral transtibial amputations; one had bilateral transtibial amputations; and another had bilateral involvement with a transtibial and partial-foot amputation. All participants reported daily use of a prosthesis (mean, 15.2 ± 1.1 hours). Three categories of themes arose from this focus group: direct outcomes, external influences, and indirect outcomes. Direct outcomes included balance and stability, endurance and sustained gait quality, and naturalness. External influences included peer and prosthetist interactions. Indirect outcomes included increased confidence and expanded mobility. Outcome measures available to assess identified constructs were suggested. Conclusions Engagement of prosthesis users through qualitative research methods can inform the choice of outcome measures used to assess clinical outcomes or evaluate the effectiveness of prosthetic devices.

Chiropractors\u2019 views on the use of patient-reported outcome measures in clinical practice: a qualitative study

BackgroundPatient-reported outcome measures (PROMs) are widely available for use in musculoskeletal care. However, there is little research exploring the implementation of PROMs in clinical practice. This qualitative study explored chiropractors’ views on PROMs to identify any barriers and facilitators to implementing PROMs in chiropractic care and the training needs of chiropractors regarding the use of PROMs.MethodsA qualitative study of chiropractors’ views on PROMs was undertaken as part of a larger project to address the feasibility of conducting a randomised controlled trial of PROM use in chiropractic clinics for patients with low back pain. Contact was made with chiropractors working in chiropractic companies with multiple clinic sites. Semi-structured interviews were conducted with eight chiropractors, either face-to-face at their place of work or over the telephone. The interviews were transcribed verbatim and analysed using thematic analysis. The data were coded inductively by two authors.ResultsChiropractors discussed their knowledge and engagement with PROMs in clinical practice, identifying reasons for their use, such as understanding clinic performance, clinical practice, and research. They also discussed how they used PROMs within their clinical practice and the benefits of using them with individual patients, for example during the consultation, identifying yellow flags, and tracking patient progress. Chiropractors voiced concerns about patient engagement with PROMs, questioning if patients find them burdensome, and the appropriate PROMs to use with patients with pain. Finally, chiropractors acknowledged the organisational barriers and facilitators to using PROMs within their practice, such as busy practices, electronic systems, and use of reception staff.ConclusionsUsing participating chiropractors’ views of PROMs, the study identified barriers and facilitators to implementing PROMs in chiropractic care, such as clinician knowledge, engagement, and organisational concerns and identified the potential training needs of chiropractors regarding PROMs. The results from the study suggested chiropractors use PROMs with their individual patients, but PROMs should be meaningful to patients and chiropractors to improve engagement.

Validation of an inertial measurement unit to determine countermovement jump height

BackgroundVertical jump highs are used to quantify performance in the lower extremities. The aim of this study was to validate a wearable inertial measurement unit (IMU) for purpose of estimating countermovement jump height using the following methods: numerical double integration (NDI), takeoff velocity (TOV) and flight-time (FT). MethodsFifteen students each performed three jumps in two different sessions, four weeks apart. Jump-heights calculated from motion capture and force plate were used as gold standard for global IMU position and center of mass (CoM) displacement, respectively. ResultsThe NDI method showed higher estimates for global position (1.39 cm, p = 0.025), and for CoM displacement (4.20 cm, p < 0.001). Narrow limits of agreements (LoA) were found (<4.8 cm). Further, a low tolerance level of determining equivalence (delta) between the two sessions regarding both global and CoM displacement (±2.80 and ± 2.90 cm) suggesting reasonable test-retest reliability.Similar bias was found for TOV and FT (p < 0.015) and wide LoAs were found for global position and for CoM displacement (TOV: ±7.05 and ± 9.36 cm, AT: ±9.27 and ± 8.49 cm). Further, high delta between the two sessions (TOV: ±3.50 cm, FT ±4.00 cm) showed poor test-retest reliability. ConclusionEstimation of countermovement jump height using an IMU leads to the most accurate measurements applying the NDI-method. Countermovement jump estimated with an IMU can reliably evaluate functional performance in the lower extremities in young or in sports active patients after surgery or after rehabilitation. Countermovement jump with an IMU allows performing the test without a force plate and thus serves as an objective outcome measure in clinical practice.

Head and Neck Cancer: Improving Patient-Reported Outcome Measures for Clinical Practice.

Head and neck cancer includes a wide range of tumors that occur in several areas of the upper aerodigestive tract. Most head and neck cancer patients report treatment-related late effects (both physical and psycho-social). High-quality and patient-centered care in head and neck cancer depend on the understanding of the continuum patient's experience-the disease pathway. Healthcare has been improved by involving patients more actively in the disease process, and a few reports support that patient-reported outcomes-built around the patient's experience-given in a timely manner to oncologists are extremely valuable in oncology clinical care. Implementation and clinical use of patient-reported outcomes requires some procedures involving head and neck cancer patients, clinicians, researchers, and institutional leaders The unified and integrated vision is still absent and some current concerns are being discussed to optimize benefits of patient-reported outcomes use in clinical practice. The inclusion of all first-line caregivers, team formation and training, continuous monitoring improvement, and analysis are critical success factors to consider. Our team developed a broader and inclusive understanding of patient-reported outcomes. Patient-reported outcome (Health-Related Quality of Life) assessment is implemented as a systematic and routine process in Head and Neck Unit. Head and neck cancer patients consider the questionnaire administration as part of the clinical approach. We are currently working in a program (PROimp) using mathematical models to identify common head and neck cancer patterns and building prognostic predictive models, to predict future outcomes, to appraise risk/benefit of treatments (standard or new), and to estimate patient's risk of future disease development. It is our aim to better comprehend the singular and unexpected perceptions to really provide directed and personalized cancer care defining the patient pathway. The future holds promising for PROs that are ascending as a nuclear outcome in head and neck oncology.

Using Outcome and Quality Measures to Drive Improvement in Care

Strategies to improve the quality of the health care system often are based on measuring performance. Psychiatry has lagged behind other disciplines in using quality standards. Participants will learn the value and methods of integrating quality and patient outcome measures in clinical practice and how such measures can be used to direct efforts to enhance patient care.

Starting from scratch: implementing outcome measurement in clinical practice.

Outcome measurement is becoming increasingly important in palliative care both in research as well as clinical care. Regular ongoing assessments in palliative care clinical practice have the potential to enable monitoring of the patient's situation, assess the effectiveness of interventions, assess symptoms accurately and focus on patients' priorities. Implementing routine outcome measurement into clinical practice remains a challenge. Therefore, the aim of this article is to describe the process of implementing routine outcome measurement into daily clinical work in a university palliative care unit. According to the recommendations of Antunes, the following steps were used to implement routine outcome measurement in clinical care in a university palliative care unit. (I) Selection of outcomes of interest by the clinical leads and head of department: most prevalent symptoms; psychological, practical and spiritual concerns, functional status, carer burden; (II) selection of outcome measures: Integrated Palliative Care Outcome Scale (IPOS), phase of illness, Australian Karnofsky Performance Status; (III) educational component about the measure and how to use results: team meetings and team retreat with introduction of outcome measurement in palliative care, chosen measures and role plays with use of measures; (IV) selection of responsible consultant on the ward as coordinator and facilitator for outcome measurement; (V) who applies the measure and its periodicity. Implementation of outcome measurement in clinical routine is feasible following a structured process. Nevertheless, it is a time consuming and long-lasting process which needs continuous attention. However, the benefits outweigh the burden of implementation and it is a task worthwhile undertaking.

Establishing Minimal Important Differences for the VR-12 and SANE Scores in Patients Following Treatment of Rotator Cuff Tears.

Background:Minimal important differences (MIDs) for the Veterans RAND 12-Item Health Survey (VR-12) and the Single Assessment Numeric Evaluation (SANE) have not been reported in patients following treatment for rotator cuff tears (RCTs).Purpose:To determine the MIDs for the VR-12 and SANE among patients with RCT after treatment.Study Design:Cohort study (diagnosis); Level of evidence, 2.Method:A total of 222 patients diagnosed with RCT completed the VR-12 and SANE at baseline and then received surgical or nonsurgical treatment. After 64 weeks, 160 patients completed the VR-12, the SANE, and a global change questionnaire. We applied a distribution-based approach to estimate the MIDs for the SANE and for the physical component score (PCS) and mental component score (MCS) of the VR-12. We then used the global rating score as an anchor for 20 patients who perceived a minimal improvement, and we applied an anchor-based approach. One-half standard deviation of the baseline score was used in the distribution-based approach. Linear regression analyses and backward model selection were conducted to evaluate the associations between patients’ characteristics and the anchor-based MIDs.Results:The MIDs derived from distribution-based method estimates for the VR-12 PCS, MCS, and SANE scores were 4.94, 5.99, and 11.80, respectively. The MIDs estimated using the anchor-based method for the PCS, MCS, and SANE scores were 2.57 (90% CI, –1.62 to 6.76), 1.87 (90% CI, –2.07 to 5.80), and 27.25 (90% CI, 16.17 to 38.33), respectively. The final regression model for significant predictors of the MID on the PCS included baseline PCS (P < .001), body mass index (P = .014), symptom duration (P = .011), diabetes (P = .009), and surgery (P = .089). The final model for the MID on the MCS included baseline MCS (P < .001), patient sex (P = .027), and diabetes (P = .083). The final model for the MID on SANE included baseline SANE score (P = .059) and diabetes (P = .050).Conclusion:This is the first study to assess the MIDs for the VR-12 and SANE scores in patients with rotator cuff disease. The estimates of MID will facilitate the interpretation and application of these outcome measures in clinical practice and research.

Are patients with knee osteoarthritis and patients with knee joint replacement as physically active as healthy persons?

BackgroundIt is well documented that patients with knee osteoarthritis (KOA) suffer from reduced physical function and that function of the affected knee is improved after knee joint replacement (KJR). However, it remains uncertain whether patients with KOA are less physically active than healthy people and whether patients increase their level of physical activity after surgery to a level comparable with that of healthy people. The aim of this study was to examine whether patients with KOA are less physically active than healthy participants and whether patients who have undergone KJR show an increased activity and achieve the same level of physical activity as healthy participants 5 years postoperatively. MethodsFifty-four patients with KOA (29 women; mean age 62 ± 8.6; mean body mass index (BMI) 27 ± 5), 52 patients who had KJR due to KOA 5 years earlier (26 women; mean age 66 ± 7.2; mean BMI 30 ± 5) and 171 healthy participants (76 women, mean age 64 ± 9.7, mean BMI 26 ± 5) were included in this cross-sectional study. The level of physical activity was measured over a mean period of 5.5 days with a triaxial accelerometer mounted on the thigh. Number of daily steps, number of daily short walking bouts of <10 s duration and number of daily transfers from sitting to standing position were recorded. Data were analysed using two sample t tests and were adjusted for age, gender and BMI. ResultsPatients with KOA did not differ significantly from healthy participants regarding daily steps (+321, p = 0.50) or daily transfers from sitting to standing (+1.9, p = 0.52) but performed significantly less daily short walking bouts <10 s (−11.9, p = 0.02). Patients after KJR did not differ significantly from healthy participants regarding daily steps (−281, p = 0.60) of transfers from sitting to standing position (−3.2, p = 0.32) but performed significantly less daily short walking bouts <10 s (−21.7, p = 0.001). ConclusionPatients with KOA and KJR showed no significant reduction in number of daily step counts and transfers from sitting to standing position when compared with matched healthy controls. However, the number of short walking bouts was reduced in patients with KOA and by twice as much in patients with KJR. This indicates that KOA and treatment with KJR hardly affect health-related general activity but do affect specific physical activity behaviour potentially indicative of KOA or post-KJR functional limitations. The translational potential of this articleActivity monitoring with an accelerometer-based method gives insights into health-related general activity levels such as total daily steps and specific parameters such as short walking bouts, which may serve as an objective outcome measure in clinical practice.

Test-Retest Reliability of Handgrip Strength as an Outcome Measure in Patients With Symptoms of Shoulder Impingement Syndrome

ObjectiveThe purpose of this study was to investigate the degree of test-retest reliability of grip strength measurement using a hand dynamometer in patients with shoulder impingement syndrome. MethodsA total of 19 patients (10 women and 9 men; mean ± standard deviation age, 33.2 ± 12.9 years; range 18-59 years) with shoulder impingement syndrome were measured using a hand dynamometer by the same data collector in 2 different testing sessions with a 7-day interval. During each session, patients were encouraged to exert 3 maximal isometric contractions on the affected hand and the mean value of the 3 efforts (measured in kilogram-force [Kgf]) was used for data analysis. The intraclass correlation coefficient (ICC2,1) as well as the standard error of measurement (SEM) and Bland-Altman plot were used to estimate the degree of test-retest reliability and the measurement error, respectively. ResultsGrip strength data analysis revealed an ICC2,1 score of 0.94, which, based on the Shrout classification, is considered as excellent test-retest reliability of grip strength measurement. The small values of SEMs reported in both sessions (SEM1, 2.55 Kgf; SEM2, 2.39 Kgf) and the small width of the 95% limits of agreement in the Bland-Altman plot (ranging from −7.39 Kgf to 7.03 Kgf) reflected the measurement precision and the narrow variation of the differences during the 2 testing sessions. ConclusionsResults from this study identified excellent test-retest reliability of grip strength measurement in shoulder impingement syndrome, indicating its potential use as an outcome measure in clinical practice.

An evaluation of the structural validity of the shoulder pain and disability index (SPADI) using the Rasch model.

The shoulder pain and disability index (SPADI) has been extensively evaluated for its psychometric properties using classical test theory (CTT). The purpose of this study was to evaluate its structural validity using Rasch model analysis. Responses to the SPADI from 1030 patients referred for physiotherapy with shoulder pain and enrolled in a prospective cohort study were available for Rasch model analysis. Overall fit, individual person and item fit, response format, dependence, unidimensionality, targeting, reliability and differential item functioning (DIF) were examined. The SPADI pain subscale initially demonstrated a misfit due to DIF by age and gender. After iterative analysis it showed good fit to the Rasch model with acceptable targeting and unidimensionality (overall fit Chi-square statistic 57.2, p = 0.1; mean item fit residual 0.19 (1.5) and mean person fit residual 0.44 (1.1); person separation index (PSI) of 0.83. The disability subscale however shows significant misfit due to uniform DIF even after iterative analyses were used to explore different solutions to the sources of misfit (overall fit (Chi-square statistic 57.2, p = 0.1); mean item fit residual 0.54 (1.26) and mean person fit residual 0.38 (1.0); PSI 0.84). Rasch Model analysis of the SPADI has identified some strengths and limitations not previously observed using CTT methods. The SPADI should be treated as two separate subscales. The SPADI is a widely used outcome measure in clinical practice and research; however, the scores derived from it must be interpreted with caution. The pain subscale fits the Rasch model expectations well. The disability subscale does not fit the Rasch model and its current format does not meet the criteria for true interval-level measurement required for use as a primary endpoint in clinical trials. Clinicians should therefore exercise caution when interpreting score changes on the disability subscale and attempt to compare their scores to age- and sex-stratified data.

Validation of the Psoriatic Arthritis Impact of Disease (PsAID) Questionnaire and its potential as a single-item outcome measure in clinical practice

ObjectivesThe Psoriatic Arthritis Impact of Disease (PsAID) Questionnaire is a recently developed patient-reported outcome measure (PROM) of disease impact in psoriatic arthritis (PsA). We set out to assess the validity...

P.465 - The reliability and validity of Turkish version of pedsQL multidimensional fatigue scale in Duchenne muscular dystrophy

Fatigue is one of the most common-difficult to evaluate-symptom of Duchenne muscular dystrophy (DMD). However, there is not enough valid and reliable instrument to assess fatigue in neuromuscular disorders in literature. Our aim was to investigate the reliability and validity of pedsQL multidimensional fatigue scale (MFS) Turkish version in DMD. Seventy one DMD children whose ages were between 5–13 years were participated in this study. For the reliability, Turkish PedsQL MFS was applied children and their parents with two weeks interval by same physiotherapist. For the validity assessment, pediatrics quality of life 3.0 Neuromuscular module (PedsQL 3.0-NMM) was used as gold standart. The intraclass correlation coefficent (ICC) and Spearman's correlation coefficients (rho) were used to analyze the reliability and validity, respectively. The mean age of children was 8.57 ± 1.93 years. The ICC values of the scale for children and parents were found 0.87 and 0.91. A positive, moderate, statistically significant correlation was found between PedsQL 3.0-NMM and PedsQL-MFS in children (r:0.62) while positive, strong correlation in parents (r:0.79) (p < 0.05). The Turkish version of PedsQL-MFS is found to be a reliable and valid instrument to measure fatigue in children with DMD. The scale may be used as an outcome measure in clinical practice and trials, as well as a guide to set physiotherapy and home programs.

Durable usage of patient-reported outcome measures in clinical practice to monitor health-related quality of life in head and neck cancer patients

PurposeTo investigate the long-term follow-up (5 years) of implementing patient-reported outcome measures (PROMs) in clinical practice to monitor health-related quality of life (HRQOL) in head and neck cancer (HNC) patients.MethodsA mixed method design was used. The usage rate of OncoQuest (a touch screen computer system to monitor HRQOL) and the subsequent nurse consultation was calculated among HNC patients who visited the outpatient clinic for regular follow-up, as well as differences between ever users and never users (sociodemographic and clinical characteristics). The content of the nurse consultation was investigated. Reasons for not using (barriers) or using (facilitators) OncoQuest and the nurse consultation were explored from the perspective of HNC patients, and of head and neck surgeons.ResultsUsage rate of OncoQuest was 67% and of the nurse consultation 79%. Usage of OncoQuest was significantly related to tumor subsite and tumor stage. Topics most frequently (>40%) discussed during the nurse consultation were global quality of life (97%), head and neck cancer related symptoms (82%), other physical symptoms such as pain (61%), and psychological problems such as anxiety (44%). Several barriers and facilitators to implement PROMs in clinical practice were reported by both patients and head and neck surgeons.ConclusionUsage of PROMs in clinical practice and a nurse consultation is durable, even 5 years after the introduction. This study contributes to better insight into long-term follow-up of implementation, thereby guiding future research and projects that aim to implement PROMs in clinical practice to monitor HRQOL among (head and neck) cancer patients.

Using symptom and interference questionnaires to identify recovery among children with anxiety disorders.

Questionnaires are widely used in routine clinical practice to assess treatment outcomes for children with anxiety disorders. This study was conducted to determine whether 2 widely used child and parent report questionnaires of child anxiety symptoms and interference (Spence Child Anxiety Scale [SCAS-C/P] and Child Anxiety Impact Scale [CAIS-C/P]) accurately identify recovery from common child anxiety disorder diagnoses as measured by a ‘gold-standard’ diagnostic interview. Three hundred thirty-seven children (7–12 years, 51% female) and their parents completed the ADIS-IV-C/P diagnostic interview and questionnaire measures (SCAS-C/P and CAIS-C/P) before (Time 1) and after (Time 2) treatment or wait-list. Time 2 parent reported interference (CAIS-P) was found to be a good predictor of absence of any diagnoses (area under the curve [AUC] = .81). In terms of specific diagnoses, Time 2 SCAS-C/P separation anxiety subscale (SCAS-C/P-SA) identified recovery from separation anxiety disorder well (SCAS-C-SA, AUC = .80; SCAS-P-SA, AUC = .82) as did the CAIS-P (AUC = .79). The CAIS-P also successfully identified recovery from social phobia (AUC = .78) and generalized anxiety disorder (AUC = .76). These AUC values were supported by moderate to good sensitivity (.70–.78) and specificity (.70–.73) at the best identified cut-off scores. None of the measures successfully identified recovery from specific phobia. The results suggest that questionnaire measures, particularly the CAIS-P, can be used to identify whether children have recovered from common anxiety disorders, with the exception of specific phobias. Cut-off scores have been identified that can guide the use of routine outcome measures in clinical practice.

The development of an outcome measures toolkit for spinal cord injury rehabilitation.

Spinal cord injury (SCI) is a complex medical condition that can be difficult to monitor. This study aimed to establish a common set of validated outcome measures specifically for SCI clinical practice. In a three-round online Delphi process, experts in SCI care across Canada suggested and ranked outcome measures for clinical practice. The facilitators provided feedback between rounds and determined if consensus (at least 75% agreement) was reached on a single outcome measure per clinical area. One hundred and forty-eight outcome measures were initially considered for inclusion. After three rounds, consensus was reached for 23 out of 30 clinical areas. In the remaining seven, more than one outcome measure was recommended. The final toolkit comprises 33 outcome measures with sufficient measurement properties for use with a SCI population. An outcome measures toolkit validated specifically for SCI should lead to improved identification of best practice and enable clinicians to monitor client progress effectively.

Outcomes of an Evidence-Based, Data Driven-Model Fieldwork Experience for Occupational Therapy Students

Over the past decade, there has been an increased emphasis on evidence-based practice (EBP) and the use of outcome measurement in clinical practice, however, the implementation of evidence into practice remains challenging and irregular. During fieldwork, students often experience a disconnect between the emphasis on EBP in the classroom and lack of use in the clinic. Recognizing the need to develop high-quality, evidence-based and data-driven models of practice for student training, we partnered with local fieldwork educators to develop an innovative program that guides students and simultaneously trains fieldwork educators (FWE) in the use of a systematic data driven decision making (DDDM) process to infuse evidence into practice. Using a pre-post quasi-experimental design, we evaluated the impact of this program on students’ perceived knowledge and skills in use of EBP and DDDM. A focus group with participating fieldwork educators captured their knowledge and attitudes in the use of EBP and DDDM in their clinical sites. Eleven FWEs and twenty four students participated. Results revealed significant change in students’ knowledge and skill in use of EBP and DDDM. FWEs reported the program clarified the role of occupational therapy, enhanced communication, and validated the value of occupational therapy in their clinical site. This program serves as a model for training students to implement evidence and data driven approaches in clinical practice, thus bridging the gap between classroom and clinic.

It's more than dryness and fatigue: The patient perspective on health-related quality of life in Primary Sjögren's Syndrome - A qualitative study.

ObjectivesIn Primary Sjögren’s Syndrome (PSS), there is an apparent lack of data concerning the perspectives of patients, their needs, preferences and difficulties of daily life. This qualitative study was conducted to explore perspectives and needs of patients with PSS that influence health related quality of life (HRQL).MethodsWe recruited 20 PSS patients fulfilling the American-European consensus classification criteria out of the PSS cohort of the Medical University Graz, Austria. In total, 6 focus group sessions (with three to four patients per group) were performed. A modified meaning condensation procedure was used to analyse the data.ResultsThe interview analysis resulted in 484 meaning units, 254 subconcepts and 86 concepts. The identified concepts were grouped into three dimensions: physical dimension, psychological & emotional challenges and social life & daily living. A dependency between the three categories was identified.The concepts most commonly reported by patients were related to the physical dimension: pain and dryness as well as complaints associated with/provoked by these symptoms. Patients also reported shortness of breath, fatigue und constipation.ConclusionsThis qualitative study underpins that HRQL in PSS patients is affected by several factors. The problems are not limited to dryness, pain and fatigue while the complaints secondary to these symptoms are important to patients with PSS significantly affecting physical, psychological and social life components of HRQL. A disease-specific patient related outcome measures for clinical practice and trials should be developed considering the different aspects of HRQL in PSS.

Cross-cultural adaptation and validation of Spanish version of The Foot and Ankle Ability Measures (FAAM-Sp)

BackgroundThe Foot and Ankle Ability Measure (FAAM) is a Patient Reported Outcome (PRO) commonly used to determine the effectiveness of therapeutic interventions for patients with foot and ankle pathologies and associated impairments of body function and structure, activity limitations, and participation restrictions. The aim of this study was to cross-culturally adapt the FAAM into Spanish.MethodsCross-cultural adaptation was performed according to the international guidelines of the International Society for Pharmacoeconomics and Outcomes Research. Cronbach’s alpha, test re-test reliability, and item-total and inter-item correlations were analyzed. Confirmatory factor analysis (CFA) was carried out to test construct validity. Pearson correlations were calculated to assess the convergent validity between FAAM and EuroQol-5.ResultsSpanish data set comprised 194 patients, with a mean age of 38.45 (16.04) and 130 (67.1%) were female, seeing a podiatrist with a wide variety of foot and ankle related disorders. CFA was carried out to test structure matrix (which has three factors). The test–retest reliability was high with global ICC of 0.95 (95% CI: 0.93 to 0.98). A 15 items version of the FAAM-Sp Activities of Daily Living (ADL) obtained the best fit: relative chi-square (x2/df) of 2.46, GFI 0.90 CFI 0.95, NFI 0.93, and RMSEA 0.08 (90% CI 0.04 to 0.09). For exploratory factor analysis for the FAAM-Sp Sport, a one factor solution was obtained, which explained 76.70% of total variance. CFA corroborated this model with an excellent goodness of fit:: relative chi-square (x2/df) of 0.80, GFI 0.99 CFI 1.00, NFI 0.99, and RMSEA 0.00 (90% CI 0.00 to 0.75).ConclusionsThis study validated a new 15-item FAAM-Sp ADL and FAAM-Sp Sport subscales, which can be used as a self-reported outcome measure in clinical practice and research for patients resident in Spain whose main language is Spanish.