Construct validity of EQ-5D-5L among patients with inflammatory bowel disease-a study based on real-world data from the Swedish Inflammatory Bowel Disease Registry.

OBJECTIVES: The Swedish Inflammatory Bowel Disease Registry (SWIBREG) includes approximately 84% of all patients with inflammatory bowel disease (IBD) treated with immunomodulators, biologics or surgery in Sweden. Data on health-related quality of life (HRQoL) have been collected using EQ-5D-5L in the registry since 2012. Nevertheless, there are few studies assessing the validity of EQ-5D-5L in this patient population. Thus, the aim of this study was to assess the construct validity of EQ-5D-5L amongst patients with IBD (ulcerative colitis and Crohn's disease). METHODS: Individual-level data on EQ-5D-5L and other disease-specific measures were extracted from SWIBREG. Known-groups validity was assessed by analysing whether the EQ-5D-5L captured expected differences between patient groups with different activity levels of the disease. Convergent validity was assessed by analysing whether the reported problems in the dimensions of EQ-5D-5L, EQ VAS, and the EQ-5D-5L index value correlated, as hypothesized, with the four dimensions in the Short Health Scale, a symptom index question, and the Physician Global Assessment (PGA) score. RESULTS: In total, 9769 patients with IBD were included in the study. Patients with active IBD reported more health problems in the EQ-5D-5L descriptive system than patients being in remission. The effect sizes for the differences in reported problems between patients with active and inactive disease were at least small (≥0.1) or medium (≥0.3) in all dimensions except self-care. Differences in the mean EQ-5D-5L index and EQ-VAS score between patients with active and inactive disease were statistically significant (p < 0.001) and larger than pre-defined cut-offs for minimally important differences (>0.08 for the index and >11.0 for EQ-VAS). The analysis of convergent validity showed that EQ-5D-5L results correlated as expected with the disease-specific measures in 16 of the 21 analyses. In total, 22 (79%) of the 28 hypotheses were supported. CONCLUSION: The findings support the construct validity of EQ-5D-5L amongst patients with IBD and contribute to the scarce literature on the validity of the five-level version of EQ-5D in this patient population. These findings have important implications for the choice of HRQoL measure in routine health care registries like SWIBREG as well as for future clinical or health economic studies considering using EQ-5D-5L as a measure of HRQoL.

Characterizing patient details-related challenges from health information technology-related incident reports from Swedish healthcare.

Introduction: Despite many benefits offered by Health Information Technology (HIT) systems, new technology brings new and unforeseen risks to healthcare quality and patient safety if they're not properly planned, designed, implemented, and managed. This study examined health information technology-related (HIT) incidents to identify patient details-related issues, their association with contributing factors, and outcomes. Methods: Sources of information comprised retrospectively collected incident reports (n = 95) using two sampling methods, i.e., purposive and snowball sampling. The incident reports were analyzed using both the inductive method (thematic analysis) and the deductive approach using an existing framework, i.e., the International Classification for Patient Safety. Results: The studies identified 90 incidents with 120 patient details-related issues-categorized as either information-related (48%) or documentation-related (52%) problems; around two-thirds of the 120 issues were characterized by human factors. Of the total sample, 87 contributing factors were identified, of which "medical device/system" (45%) and "documentation" (20%) were the most common contributing factors. Of 90 incidents, more than half (59%) comprised patient-related outcomes-patient inconvenience (47%) and patient harm (12%) and the remaining 41% (n = 37) included staff or organization-related outcomes. Discussion: More than half of the incidents resulted in patient-related outcomes, namely patient inconvenience and patient harm, including disease risks, severe health deterioration, injury, and even patient death. Incidents associated with patient details can cause deleterious effects; therefore, characterizing them should be a routine part of clinical practice to improve the constantly changing healthcare system.

Health Care Professionals' Experiences in Telerehabilitation: Qualitative Content Analysis.

BACKGROUND: The use of digital communication in Swedish health care has increased in an effort to make health care more accessible. At the organizational level, trust in digitalization has stabilized, but a certain degree of skepticism regarding technology appears to exist among health care employees. OBJECTIVE: This study aimed to explore health care professionals' (HCPs) experiences of digital communication with patients and colleagues in a habilitation context. METHODS: Qualitative content analysis was used to analyze data derived from individual interviews. RESULTS: The results revealed that there were mixed feelings regarding the digital format used at the habilitation center. Although some skepticism remained regarding the digital format, there seemed to be a parallel understanding of the motives and benefits of digitalization. Hence, positive aspects, such as increased health care accessibility, were identified. However, emphasis was placed on the considerations required to make digital consultations appropriate for each patient. CONCLUSIONS: Managing a workday influenced by the balance between digital and physical demands forces HCPs to adjust to the digital format and new ways of working. This requires HCPs to consider whether digital means are appropriate for communication in individual patient-specific cases.

Digital consultation in primary healthcare: the effects on access, efficiency and patient safety based on provider experience; a qualitative study.

OBJECTIVE: The objective of the study was to explore the experiences of healthcare staff working with and being part of the implementation of a digital platform for patient-provider consultation across quality dimensions of access, efficiency, and patient safety. DESIGN: The study uses qualitative design to investigate experiences and the views of healthcare professionals. Data collection combined semi-structured individual and focus-group interviews. Content analysis was used to identify categories within the content areas 'access', 'efficiency', and 'patient safety'. SETTING: The basis for the study was an e-consultation platform introduced in three primary healthcare centres in the County of Kalmar in southeast Sweden in 2019. RESULTS: Healthcare staff experienced that the platform offered an open channel for communication with patients in need of frequent contact. This reduced anxiety and therefore the frequency of follow-up appointments. Healthcare staff also noted that the platform offered flexibility in contact benefitting patients with mental health problems. These patients were found to make contact through the platform after closing hours when problems were more acute or intense. However, the risk of digitally illiterate groups being excluded was also noted. Efficiency gains were identified among patients with simple cases which were handled more quickly through the platform. However, low uptake and the experience that the platform did not replace, rather was added on top of other already existing functions and procedures, negatively affected the overall efficiency. Standardized questions in automated medical history-taking contributed to patient safety. CONCLUSION: The findings suggest that text-based e-consultation platforms may bring important quality improvements to primary healthcare service in terms of access, efficiency, and patient safety. Yet, areas where e-consultation does not contribute to quality improvements puts important quality gains at risk.KEY POINTSText based digital consultation improved access for patients in need of frequent appointments and for patients with mental health problems.Efficiency gains among patients with simple cases, and in dealing with patients with mental health problems were noted. However, lack of confidence in platform functions due to low uptake, and limited control over work situation, were perceived as negatively affecting overall efficiency.Health care staff experienced improved patient safety through a standardized set of questions in automated medical history-taking.

Predictors of problems reported on the EQ-5D-3L dimensions among people with impaired vision in northern Portugal.

BACKGROUND: The EQ-5D index often fails to detect the effect of ophthalmic diseases and sight loss. Investigating predictors of individual EQ-5D health dimensions might reveal the underlying reasons. The aim of this study was to investigate predictors of health dimension ratings obtained with the EQ-5D-3L from participants with impaired vision representing a spectrum of eye diseases. METHODS: Observational cross-sectional study with participants recruited at four public hospitals in Portugal. Outpatients with visual acuity of 0.30 logMAR(6/12) or worse in the better-seeing eye were invited to participate. Participants completed two instruments: the EQ-5D-3L (measures participants' perceived health-related quality-of-life) and the Massof Activity Inventory (measures visual ability-ability to perform vision-related activities). This study used logistic regression models to identify factors associated with responses to the EQ-5D-3L. RESULTS: The study included 492 participants, mean age 63.4 years (range = 18-93), 50% females. The most common diagnosis was diabetic retinopathy (37%). The mean visual acuity in the better seeing eye was 0.65 logMAR (SD = 0.48) and the mean visual ability was 0.62 logits (SD = 2.04), the correlation between the two was r = - 0.511 (p < 0.001). Mobility and self-care were the health dimensions with the fewest problems (1% reported extreme problems), anxiety and depression the dimension with the most problems (24% reported extreme problems). ROC curve analysis showed that the EQ-5D index was a poor predictor of cases of vision impairment whilst visual ability given was a good predictor of cases of vision impairment. Visual ability was an independent predictor of the response for all dimensions, higher ability was always associated with a reduced odds of reporting problems. The odds of reporting problems were increased for females in 3 out of 5 dimensions. Comorbidities, visual acuity and age-category were predictors of the odds of reporting problems for one dimension each. CONCLUSIONS: The odds of reporting problems for the five health dimensions of the EQ-5D-3L were strongly influenced by the ability to perform vision-related activities (visual ability). The EQ-5D index showed poor performance at detecting vision impairment. These findings are informative and relevant for the clinic and for research evaluating the impact of eye diseases and disease treatments in ophthalmology.

Characterizing healthcare incidents in Sweden related to health information technology affecting care management of multiple patients.

This study aimed to examine health information technology-related incidents and identify risks associated with multiple patients' management. Sources of information comprised interviews with healthcare professionals and three small sets of local voluntary incident reports using two sampling strategies, purposive and snowball sampling. Incident reports, in the form of free-text narratives, were aggregated for analysis using the Health Information Technology Classification System and thematic analysis. Of 95 incidents, 176 issues were identified, comprising 77% (n = 136) technical issues, and 23% (n = 40) use or human-related issues. Human issues were over two times more likely to harm patients (OR 2.25, 95% CI 1.01 - 4.98) than technical issues. Incidents that affected multiple patients' care accounted for 70% (n = 66) of the total sample, and large-scale events comprised 39% (n = 26) of the incidents that affected multiple patients' care. Systematically identifying and characterizing such incidents should be prioritized for health information technology implementations.

Digital Health Testbeds in Sweden: An exploratory study.

OBJECTIVE: This study explored the Swedish digital health testbeds through the lens of complexity science. METHODS: The purposive sampling was used to identify 38 digital health testbed organizations to conduct interviews in written or audio-conferencing. The interview responses were aggregated and analyzed using thematic analysis. The themes were mainly generated through complexity theory and the principles of complex adaptive systems. RESULTS: Fifteen testbed organizations responded, comprising 13 written responses and two audio-conferencing. Five main theoretical themes were generated: agents and diversity, connections and communication, adaptation and learning, perturbations, and path dependence. Agents and diversity depicted different types of testbeds, stakeholders and innovation, and the primary function and purpose of the testbeds. Various factors enhancing connections and communications among multiple stakeholders were identified, such as the quality of e-health solutions and the 2030 Agenda for Sustainable Development. Some adaptation and learning factors, such as internal reorganization, sharing and creating learning opportunities, and additional funding, guaranteed the sustainability of testbeds. Perturbations were characterized by two factors: non-linear interactions - lack of commitment and transparency in stakeholders' engagement, and uncertainty about testbed definitions and concepts. Path dependence highlighted the importance of history, such as previous positive and negative experiences. CONCLUSION: This study provided insights into testbeds' organization, their functions, how various aspects were challenged, and how they adapted to overcome and improve the system issues. Identifying the stakeholders and relevant factors, commissioning an evaluation, backing up with a contingency plan, securing adequate funding, and disseminating the findings can improve the testbeds' design and implementation.

A Human, Organization, and Technology Perspective on Patients' Experiences of a Chat-Based and Automated Medical History-Taking Service in Primary Health Care: Interview Study Among Primary Care Patients.

BACKGROUND: The use of e-visits in health care is progressing rapidly worldwide. To date, studies on the advantages and disadvantages of e-consultations in the form of chat services for all inquiries in primary care have focused on the perspective of health care professionals (HCPs) rather than those of end users (patients). OBJECTIVE: This study aims to explore patients' experiences using a chat-based and automated medical history-taking service in regular, tax-based, not-for-profit primary care in Sweden. METHODS: Overall, 25 individual interviews were conducted with patients in the catchment areas of 5 primary care centers (PCCs) in Sweden that tested a chat-based and automated medical history-taking service for all types of patient inquiries. The semistructured interviews were transcribed verbatim before content analysis using inductive and deductive strategies, the latter including an unconstrained matrix of human, organization, and technology perspectives. RESULTS: The service provided an easily managed way for patients to make written contact with HCPs, which was considered beneficial for some patients and issues but less suitable for others (acute or more complex cases). The automated medical history-taking service was perceived as having potential but still derived from what HCPs need to know and how they address and communicate health and health care issues. Technical skills were not considered as necessary for a mobile phone chat as for handling a computer; however, patients still expressed concern for people with less digital literacy. The opportunity to take one's time and reflect on one's situation before answering questions from the HCPs was found to reduce stress and prevent errors, and patients speculated that it might be the same for the HCPs on the other end of the system. Patients appreciated the ability to have a conversation from almost anywhere, even from places not suitable for telephone calls. The asynchronicity of the chat service allowed the patients to take more control of the conversation and initiate a chat at any time at their own convenience; however, it could also lead to lengthy conversations where a single issue in the worst cases could take days to close. The opportunity to upload photographs made some visits to the PCC redundant, which would otherwise have been necessary if the ordinary telephone service had been used, saving patients both time and money. CONCLUSIONS: Patients generally had a positive attitude toward e-visits in primary care and were generally pleased with the prospects of the digital tool tested, somewhat more with the actual chat than with the automated history-taking system preceding the chat. Although patients expect their PCC to offer a range of different means of communication, the human, organization, and technology analysis revealed a need for more extensive (end) user experience design in the further development of the chat service.

Swedish translation and cross-cultural adaptation of eight pediatric item banks from the Patient-Reported Outcomes Measurement Information System (PROMIS)®.

BACKGROUND: This study is part of the Swedish initiative for the establishment of standardized, modern patient-reported measures for national use in Swedish healthcare. The goal was to translate and culturally adapt eight pediatric Patient-Reported Outcomes Measurement Information System (PROMIS®) item banks (anger, anxiety, depressive symptoms, family relationships, fatigue, pain interference, peer relationships and physical activity) into Swedish. METHODS: Authorization to translate all currently available pediatric PROMIS item banks (autumn, 2016) into Swedish was obtained from the PROMIS Health Organization. The translation followed the Functional Assessment of Chronic Illness Therapy translation recommendations with one major modification, which was the use of a bilingual multi-professional review workshop. The following steps were applied: translation, reconciliation, a two-day multi professional reviewer workshop, back translation, and cognitive debriefing with eleven children (8-17 years) before final review. The bilingual multi-professional review workshop provided a simultaneous, in-depth assessment from different professionals. The group consisted of questionnaire design experts, researchers experienced in using patient-reported measures in healthcare, linguists, and pediatric healthcare professionals. RESULTS: All item banks had translation issues that needed to be resolved. Twenty-four items (20.7%) needed resolution at the final review stage after cognitive debriefing. The issues with translations included 1. Lack of matching definitions with items across languages (6 items); 2. Problems related to language, vocabulary, and cultural differences (6 items); and 3. Difficulties in adaptation to age-appropriate language (12 items). CONCLUSIONS: The translated and adapted versions of the eight Swedish pediatric PROMIS item banks are linguistically acceptable. The next stage will be cross-cultural validation studies in Sweden. Despite the fact that there are cultural differences between Sweden and the United States, our translation processes have successfully managed to address all issues. Expert review groups from already-established networks and processes regarding pediatric healthcare throughout the country will facilitate the future implementation of pediatric PROMIS item banks in Sweden.

Health Care Professionals' Experience of a Digital Tool for Patient Exchange, Anamnesis, and Triage in Primary Care: Qualitative Study.

BACKGROUND: Despite a growing body of knowledge about eHealth innovations, there is still limited understanding of the implementation of such tools in everyday primary care. OBJECTIVE: The objective of our study was to describe health care staff's experience with a digital communication system intended for patient-staff encounters via a digital route in primary care. METHODS: In this qualitative study we conducted 21 individual interviews with staff at 5 primary care centers in Sweden that had used a digital communication system for 6 months. The interviews were guided by narrative queries, transcribed verbatim, and subjected to content analysis. RESULTS: While the digital communication system was easy to grasp, it was nevertheless complex to use, affecting both staffing and routines for communicating with patients, and documenting contacts. Templates strengthened equivalent procedures for patients but dictated a certain level of health and digital literacy for accuracy. Although patients expected a chat to be synchronous, asynchronous communication was extended over time. The system for digital communication benefited assessments and enabled more efficient use of resources, such as staff. On the other hand, telephone contact was faster and better for certain purposes, especially when the patient's voice itself provided data. However, many primary care patients, particularly younger ones, expected digital routes for contact. To match preferences for communicating to a place and time that suited patients was significant; staff were willing to accept some nuisance from a suboptimal service-at least for a while-if it procured patient satisfaction. A team effort, including engaged managers, scaffolded the implementation process, whereas being subjected to a trial without likely success erected barriers. CONCLUSIONS: A digital communication system introduced in regular primary care involved complexity beyond merely learning how to manage the tool. Rather, it affected routines and required that both the team and the context were addressed. Further knowledge is needed about what factors facilitate implementation, and how. This study suggested including ethical perspectives on eHealth tools, providing an important but novel aspect of implementation.

Associations of Psychosocial Factors with Multiple Health Behaviors: A Population-Based Study of Middle-Aged Men and Women.

Background: The health behaviors smoking, risky alcohol consumption, insufficient physical activity, and poor diet constitute the main contributors to non-communicable diseases. Clustering of risk behaviors is common and increases the risk of these diseases. Despite health benefits, it is difficult to change health behaviors. Psychosocial factors could play a role in health behavior change, with research showing relationships between unfavorable psychosocial factors and health risk behaviors. However, many studies only investigated one or two health behaviors at a time. The present study, therefore, aimed to investigate associations between a broad range of psychosocial factors and multiple health risk behaviors in a general middle-aged population in Sweden. Methods: A cross-sectional design was used to investigate a random sample from the general population in Sweden (n = 1007, 45-69 years, 50% women). Questionnaire data on health behaviors (smoking, alcohol consumption, physical activity, and fruit/vegetable intake) and psychosocial factors, with both psychological and social resources (social integration, emotional support, perceived control, self-esteem, sense of coherence and trust) and psychological risk factors (cynicism, vital exhaustion, hopelessness and depressiveness), were analyzed. Logistic and ordinal logistic regression were used to analyze associations between psychosocial factors and multiple (0-1, 2 or 3-4) health risk behaviors. Results: A total of 50% of the sample had two health risk behaviors and 18% had three health risk behaviors. After adjusting for age, sex, education, employment status, and immigrant status, eight out of 10 psychosocial factors (exceptions: social integration and self-esteem) showed significant odds ratios (ORs) in the expected directions; low levels of psychosocial resources and high levels of psychosocial risk factors were associated with multiple risk behaviors. The strongest associations with multiple risk behaviors were seen for vital exhaustion (adjusted (adj.) OR 1.28; confidence interval (CI) 1.11-1.46), depressiveness (adj. OR 1.32, CI 1.14-1.52), and trust (adj. OR 0.80, CI 0.70-0.91). When controlling for all psychosocial factors in the same model, only the association with trust remained statistically significant (adj. OR 0.89, CI 0.73-1.00, p = 0.050). Associations with individual health behaviors were fewer and scattered, with no psychosocial factor being related to all four behaviors. Conclusions: Examining associations between a broad range of psychosocial factors and multiple health risk behaviors revealed consistent and significant associations for almost all psychosocial factors. These associations were stronger compared to associations to single health risk behaviors. Our findings support the relevance of considering psychosocial aspects in interventions aimed at health behavior change, especially for people with multiple health risk behaviors.

Measuring psychosocial factors in health surveys using fewer items.

The present study investigated the possibility of reducing length of psychosocial scales, while maintaining validity, using easily manageable techniques. Data were collected 2003-2004 in a Swedish general population; n = 1007, ages 45-69, 50% women. Eight psychosocial scales were reduced from 6-20 to 3-7 items maintaining Cronbach's alpha >0.7 and correlation coefficients between full and reduced scales > 0.85. Relationships to biomarkers for inflammation, self-rated health and 8-year incidence of coronary heart disease showed no difference between full and reduced scales. It was possible, using these easily manageable methods, to reduce scale length without threatening validity for use in population surveys.

SF-36 predicts 13-year CHD incidence in a middle-aged Swedish general population.

PURPOSE: To study the predictive ability of each of the eight scales of SF-36 on 13-year all-cause mortality and incident coronary heart disease (CHD) in a general middle-aged population. METHODS: The population-based, longitudinal "Life-conditions, Stress and Health" study, in 2003-2004 enrolled 1007 persons aged 45-69 years (50% female), randomly sampled from the general population in Östergötland, Sweden. Variables at baseline included the SF-36 (health-related quality of life, HRQoL) and self-reported disease. Incident CHD (morbidity and mortality) and all-cause mortality data for the study population during the first 13 years from baseline were obtained from national Swedish registries. RESULTS: Seven of the eight SF-36 scales predicted CHD (sex- and age-adjusted Hazard Ratios up to 2.15; p ≤ 0.05), while only the Physical Functioning scale significantly predicted all-cause mortality. Further adjustments for presence of (self-reported) disease did not, in most cases, alter these significant predictions. CONCLUSION: Low SF-36 scores predict risk of CHD, also after adjustment for present disease, supporting the biopsychosocial model of health and disease. Measures of HRQoL yield important information and can add to the cardiopreventive toolbox, including primary prevention efforts, as it is such a simple and relatively inexpensive tool.

Pediatric food allergy-related household costs are influenced by age, but not disease severity.

OBJECTIVE: The economic burden of food allergy on households is poorly understood. We evaluated the household costs associated with specialist-diagnosed pediatric food allergy, with focus on age and disease severity. STUDY DESIGN: A cross-sectional study of 70 Swedish case-control pairs (59% boys) was conducted using Food Allergy Economic questionnaire. Household costs were analyzed between age- and gender-matched cases (children aged 0-17 years, with specialist-diagnosed food allergy) and controls (non-food allergic households). RESULTS: Parents were predominantly university-educated and employed full-time. Most cases had parent-reported previous anaphylaxis. Mean total annual household costs were comparable between cases and controls. However, compared to controls, cases had significantly higher direct medical-, and non-medical related costs; higher indirect medical-related costs, and higher intangible costs (all p < 0.05). In a sensitivity analyses of only cases aged 0-12 years, direct household costs, including lost earnings due to child's hospitalization, were significantly higher than controls. Results from only children with severe disease paralleled those of all cases vs. controls. CONCLUSIONS: Although pediatric food allergy is not associated with higher total annual household costs, these households have significantly higher direct medical-related, indirect and intangible costs vs. non-food allergic households. Higher household costs were identified amongst younger children, but not disease severity.

Health-related quality of life worsens by school age amongst children with food allergy.

BACKGROUND: Food allergy is negatively associated with health-related quality of life (HRQL). Although differences exist between parents and children, less is known about age-specific differences amongst children. As such, we aimed to identify if age, as well as other factors, are associated with food allergy-specific HRQL in an objectively defined population of children. METHODS: Overall, 63 children (boys: n = 36; 57.1%) with specialist-diagnosed food allergy to 1 + foods were included. Parents/guardians completed the Swedish version of a disease-specific questionnaire designed to assess overall- and domain-specific HRQL. Descriptive statistics and linear regression were used. RESULTS: The most common food allergy was hen's egg (n = 40/63; 63.5%). Most children had more than one food allergy (n = 48; 76.2%). Nearly all had experienced mild symptoms (e.g. skin; n = 56/63; 94.9%), and more than half had severe symptoms (e.g. respiratory; 39/63; 66.1%). Compared to young children (0-5 years), older children (6-12 years) had worse HRQL (e.g. overall HRQL: B = 0.60; 95% CI 0.05-1.16; p < 0.04.). Similarly, multiple food allergies, and severe symptoms were significantly associated with worse HRQL (all p < 0.05) even in models adjusted for concomitant allergic disease. No associations were found for gender or socioeconomic status. CONCLUSION: Older children and those with severe food allergy have worse HRQL.

The Swedish RAND-36 Health Survey - reliability and responsiveness assessed in patient populations using Svensson's method for paired ordinal data.

BACKGROUND: The Short Form 36-Item Survey is one of the most commonly used instruments for assessing health-related quality of life. Two identical versions of the original instrument are currently available: the public domain, license free RAND-36 and the commercial SF-36.RAND-36 is not available in Swedish. The purpose of this study was threefold: to translate and culturally adapt the RAND-36 into Swedish; to evaluate its reliability and responsiveness using Svensson's method for paired ordered categorical data; and to assess the usability of an electronic version of the questionnaire.The translation process included forward and backward translations and reconciliation. Test-retest reliability was examined during a period of two-weeks in 84 patients undergoing dialysis for chronic kidney disease. Responsiveness was examined in 97 patients before and 2 months after a cardiac rehabilitation program. Usability tests and cognitive debriefing of the electronic questionnaire were carried out with 18 patients. RESULTS: The Swedish translation of the RAND-36 was conceptually equivalent to the English version. Test-retest reliability was supported by non-significant relative position (RP) values among dialysis patients for all RAND-36 subscales (range - 0.02 to 0.10; all confidence intervals (CI) included zero). Responsiveness was demonstrated by significant improvements in RP values among cardiac rehabilitation patients for all subscales (range 0.22-0.36; lower limits of all CI > 0.1) except two subscales (General health, RP -0.02; CI -0.13 to 0.10; and Role functioning/emotional, RP 0.03; CI -0.09 to 0.16). In cardiac rehabilitation patients, sizable individual variation (RV > 0.2) was also shown for the Pain, Energy/fatigue and Social functioning subscales.The electronic version of RAND-36 was found easy and intuitive to use. CONCLUSIONS: Our results provide evidence supporting the reliability and responsiveness of the newly translated Swedish RAND-36 and the user-friendliness of the electronic version. Svensson's method for paired ordinal data was able to characterize not only the direction and size of differences among the patients' responses at different time points but also variations in response patterns within groups. The method is therefore, besides being suitable for ordinal data, also an important and novel tool for gaining insights into patients' response patterns to treatment or interventions, thus informing individualized care.

The joint subclinical elevation of CRP and IL-6 is associated with lower health-related quality of life in comparison with no elevation or elevation of only one of the biomarkers.

BACKGROUND: Measures of health-related quality of life (HRQoL), like the Short Form (SF)-36, have been suggested to correlate with inflammatory biomarkers. It is, however, unclear whether a joint measure of two inflammatory biomarkers would bring additional information in comparison with evaluation of one inflammatory biomarker. OBJECTIVE: To evaluate associations between SF-36 and low-grade inflammation in a Swedish population, with emphasis on a combined measure of C-reactive protein (CRP) and interleukin-6 (IL-6) as a proxy for low-grade inflammation. METHODS: In a randomly selected sample of a middle-aged Swedish general population (n = 905; aged 45-69 years, 50% women), relations between SF-36 parameters and the biomarkers were tested. Regression and correlation analyses were adjusted for sex, age, presence of disease, lifestyle, and psychological factors. RESULTS: After adjustment for sex and age, HRQoL was significantly lower in the group with a joint elevation of CRP and IL-6 in comparison with either the group with no elevation or the groups showing elevation of one of the two biomarkers. Also after full adjustments, the combined measure of elevated CRP and IL-6, with few exceptions, was associated with significantly lower HRQoL in comparison with elevations in one of them, difference ranging from 4 (Mental Health scale) to 18 scale steps (Role-Physical scale). CONCLUSION: This study confirms that there is a relationship between HRQoL and low-grade inflammation. In particular, SF-36 scores are significantly lower in a group with joint elevation of IL-6 and CRP, in comparison with elevation of either one of them.

Psychological factors related to physical, social, and mental dimensions of the SF-36: a population-based study of middle-aged women and men.

BACKGROUND: Measures of health-related quality of life (HRQoL) are increasingly used as patient-reported outcome measures in routine health care. Research on determinants and correlates of HRQoL has, therefore, grown in importance. Earlier studies have generally been patient-based and few of them have examined differences between women and men. The aim of this study was to explore the relationship between psychological factors and physical, social, and mental dimensions of HRQoL, as measured by the Medical Outcome Study Short Form-36 Health Survey (SF-36), in a normal population and to see if observed relations were the same for women and men. METHODS: Relations between scale scores for the eight scales of SF-36 and scale scores for Self-esteem, Sense of Coherence, Perceived Control, Depressed Mood (CES-D), and Cynicism were assessed through partial correlation and multiple linear regression analyses on a sample of 505 women and 502 men (aged 45-69 years), stratified for sex and adjusted for effects of age, presence of disease, back pain, lifestyle, and social support. RESULTS: All psychological factors tested, except Cynicism, were significantly correlated to all scales of the SF-36 for women and men (Pearson product-moment partial correlation coefficient, |r| = 0.11-0.63 and |r| = 0.11-0.60, respectively). The addition of psychological factors into regression models resulted in significant total explained variance (R(2)) changes in all scales of the SF-36 for both sexes. Any discrepancies between women and men pertained more to the strength of relationships rather than the significance of different psychological factors. CONCLUSION: In this population-based study, psychological factors showed significant correlation, for women and men alike, with the physical and social scales of SF-36, as well as the mental scales. These findings suggest that assessments of HRQoL are not merely a measure of absolute function but are also dependent on people's perception of their ability.

Respondent satisfaction regarding SF-36 and EQ-5D, and patients' perspectives concerning health outcome assessment within routine health care.

OBJECTIVE: To investigate respondent satisfaction regarding SF-36 and EQ-5D and patients' perspectives concerning health outcome assessment within routine health care. METHODS: Eighteen Swedish hospitals participated in the study which included 30 patient intervention groups (e.g. education groups for patients with ischemic heart disease or chronic obstructive pulmonary disease). Patients responded to SF-36 and EQ-5D before and after ordinary interventions (n = 463), and then completed an evaluation form. RESULTS: Regarding respondent satisfaction, most patients found both questionnaires easy to understand (70% vs. 75% for SF-36 and EQ-5D respectively), easy to respond to (54% vs. 60%), and that they gave the ability of describing their health in a comprehensive way (68% for both). Health outcome assessment in routine health care was perceived as valuable by 57% of the patients, while 4% disapproved. Most patients (68%) considered both questionnaires equally suitable; 25% preferred SF-36 and 8% EQ-5D. Among those who were more satisfied with a short questionnaire (EQ-5D), several still preferred a longer and more comprehensive questionnaire (SF-36). CONCLUSION: Health outcome assessment within routine health care seems to be acceptable, and even appreciated, by patients. Questionnaire length and ease of response were not found to be crucial arguments in choosing between SF-36 and EQ-5D.