Recent trends in disease-modifying therapy use and associated sickness absence and disability pension among people with multiple sclerosis in Sweden.

BACKGROUND: Disease-modifying therapies (DMTs) have led to improved health and work productivity among people with multiple sclerosis (PwMS). OBJECTIVES: To describe trajectories of recent DMT use and their association with sickness absence and/or disability pension (SADP) among PwMS in Sweden. METHODS: A longitudinal register-based study was conducted among 1395 PwMS with treatment start in 2014/2015. While DMT use over 5 years was assessed using sequence analysis resulting in four clusters, a 7-year (Y-2 toY4) trend of SADP was analyzed using zero-inflated negative binomial regression. RESULTS: Four clusters of DMT use trajectories were identified: long-term non-high-efficacy (483, 34.6%), long-term high-efficacy (572, 41%), escalation (221, 15.8%), and discontinuation (119, 8.5%). Progressive MS and higher expanded disability status scale scores were associated with the escalation, long-term high-efficacy, or discontinuation clusters. PwMS in the long-term high-efficacy and escalation clusters had higher likelihood of being on SADP. However, PwMS initiating high-efficacy DMTs demonstrated steeper decline in SADP than others. CONCLUSION: Using sequence analysis, this study showed recent DMT use trajectories among PwMS where initiation of high-efficacy DMTs has become more common. The trend of SADP was stable and lower in those using non-high-efficacy DMTs and larger improvements were shown in those initiating high-efficacy DMTs.

Health-related quality of life among older adults following acute hospitalization: longitudinal analysis of a randomized controlled trial.

PURPOSE: To describe the longitudinal change of health-related quality of life (HRQoL) over 12 months from acute hospitalization in older adults ≥ 70 years (IMMENSE study), and associated factors, to investigate how a medication optimization intervention influenced this change. METHODS: The EQ-5D-3L was used at discharge and 1, 6 and 12 months after discharge during a randomized controlled trial including 285 participants. Multilevel logistic (EQ-5D-3L dimensions) and mixed model regression (EQ-5D-3L index scores, EQ-VAS) were used to explore the longitudinal change with/without the intervention, and associations with medications, comorbidities, and socioeconomic variables. Subgroup analyses were performed for non-long and long stayers with hospitalizations < or ≥ 14 days. RESULTS: EQ-5D-3L index scores significantly declined after 12 months (ß -0.06 [95% confidence interval (CI:) -0.10--0.02], p = 0.003). Non-long stayers showed significant improvement 1 month from discharge (ß 0.05 [0.00-0.09], p = 0.040). The number of medications and receiving home-care services were the main factors associated with reduced HRQoL. Being home-dwelling was the main factor associated with higher HRQoL. Non-long stayers of the intervention group reported significantly higher EQ-VAS than the control group (ß 4.02 [0.11-7.93], p = 0.044). CONCLUSION: We observed no significant difference in the longitudinal change in HRQoL between the two IMMENSE study groups over 12 months after hospitalization. However, the non-long stayer subgroup analysis indicates that the intervention may have had a long-term effect on HRQoL in some of intervention patients. The number of medications and the ability to live and care for oneself should be taken into consideration when planning future patient care and health-care services. TRIAL REGISTRATION: The trial was registered in clinicaltrials.gov on 28/06/2016 before enrolment started (NCT02816086).

Self-reported restrictions in different life domains and associated factors among people with multiple sclerosis in Sweden.

BACKGROUND AND PURPOSE: The heterogeneous symptoms of multiple sclerosis (MS) can considerably impact the lives of people with MS (PwMS). The aim of this study was to describe the extent of restrictions in different life domains that PwMS experience in relation to their symptoms and level of disability. METHODS: A cross-sectional survey was conducted among working-age PwMS in Sweden. The 4052 participants who answered the questions on restrictions in work and private life domains (family, leisure activities, and contact with friends/acquaintances) were included. Predictors of restrictions in the four domains were determined through multinomial logistic regression. RESULTS: Approximately one-third of the PwMS reported no restrictions in the domains of work (35.7%), family (38.7%), leisure activities (31.1%) or contact with friends/acquaintances (40.3%), the remaining participants reported moderate to severe restrictions. Tiredness/fatigue was the most commonly reported most-limiting symptom (49.5%). PwMS with Expanded Disability Status Scale (EDSS) scores of zero reported restrictions in life domains ranging from 39.6% (friends/acquaintances) to 45.7% (leisure activities). Age, sex, education, type of living area, MS type, type of most-limiting symptom, and EDSS score predicted restrictions in work and private life domains. CONCLUSIONS: Most PwMS reported similar levels of restrictions in both their work and private lives. Restrictions in these life domains were also reported by PwMS with low disability levels (EDSS = 0) and were often associated with invisible symptoms such as fatigue. Even in a contemporary MS cohort, close to 90% of PwMS report limitations due to MS.

Cost-effectiveness of implant movement analysis in aseptic loosening after hip replacement: a health-economic model.

OBJECTIVE: To investigate the cost-effectiveness of using Implant Movement Analysis (IMA) to follow up suspected aseptic loosening when the diagnosis after an initial X-ray is not conclusive, compared with a diagnostic pathway with X-ray follow-up. METHODS: A health-economic model in the form of a decision tree was developed using quality-adjusted life years (QALY) from the literature, cost-per-patient data from a university hospital and the probabilities of different events from expert physicians' opinions. The base case incremental cost-effectiveness ratio (ICER) was compared with established willingness-to-pay thresholds and sensitivity analyses were performed to account for assumptions and uncertainty. RESULTS: The base case ICER indicated that the IMA pathway was cost effective (SEK 99,681, compared with the SEK 500,000 threshold). In the sensitivity analysis, the IMA pathway remained cost effective during most changes in parameters. ICERs above the threshold value occurred in cases where a larger or smaller proportion of people receive immediate surgery. CONCLUSION: A diagnostic pathway using IMA after an inconclusive X-ray for suspected aseptic loosening was cost effective compared with a pathway with X-ray follow-up.

Integrating health promotion with and for older people - eHealth (IHOPe) - evaluating remote integrated person-centred care : Protocol of a randomised controlled trial with effectiveness, health economic, and process evaluation.

BACKGROUND: Healthcare and welfare systems worldwide are unprepared to accommodate the growing population of older people. Simultaneously, the cost of reactive care for older people is increasing. However, healthcare systems in many countries are reforming towards integrated and person-centred care with a focus on health promotion and proactive actions. The Integrating Health Promotion with and for Older People - eHealth (IHOPe) project aims to describe and evaluate a person-centred e-support intervention that promotes a sustainable partnership between community-dwelling frail older people and health and social care professionals. METHODS: The IHOPe project is designed as a randomised controlled trial comparing a control group receiving standard care with an intervention group receiving standard care and add-on person-centred care through telephone support and a digital platform. The primary outcome measure is a composite score of changes in general self-efficacy and the need for unscheduled hospital care. The project is conducted in Gothenburg, Sweden. At least 220 participants aged ≥ 75 years will be included after being screened using a frailty instrument. The study design, intervention components, digital platform, and questionnaires were developed in close collaboration with an advisory group of inter-professional researchers, stakeholders, clinicians, and older representatives. Data will mainly be collected through questionnaires at baseline and 3, 6, and 12 months after inclusion in the study. Recruitment is ongoing and should be completed during 2023. Data will be analysed using quantitative and qualitative methods. The evaluation will include effectiveness, process, and health economics. The study was approved by the Regional Ethical Review Board in Gothenburg, Sweden (Dnr 2019-05364, Dnr 2020-03550, Dnr 2021-03255). DISCUSSION: The findings will expand our knowledge of remotely integrated person-centred care for frail older people. Thereby, the IHOPe project is expected to fill highlighted knowledge gaps on intervention evaluations including the triad of person-centred, digital, and integrated care elements, as well as economic evaluations of remote health services for frail older people. The study is ongoing, and the results are not completed but if they turn out to be positive, implementation is not limited to time or location. TRIAL REGISTRATION: ClinicalTrial.gov: NCT04416815. Registered 07/06/2021.

Implementing a new birthing room design: a qualitative study with a care provider perspective.

BACKGROUND: Research shows that interventions to protect the sensitive physiological process of birth by improving the birthing room design may positively affect perinatal outcomes. It is, however, crucial to understand the mechanisms and contextual elements that influence the outcomes of such complex interventions. Hence, we aimed to explore care providers' experiences of the implementation of a new hospital birthing room designed to be more supportive of women's birth physiology. METHODS: This qualitative study reports on the implementation of the new birthing room, which was evaluated in the Room4Birth randomised controlled trial in Sweden. Individual interviews were undertaken with care providers, including assistant nurses, midwives, obstetricians, and managers (n = 21). A content analysis of interview data was conducted and mapped into the three domains of the Normalisation Process Theory coding manual: implementation context, mechanism, and outcome. RESULTS: The implementation of the new room challenged the prevailing biomedical paradigm within the labour ward context and raised the care providers' awareness about the complex interplay between birth physiology and the environment. This awareness had the potential to encourage care providers to be more emotionally present, rather than to focus on monitoring practices. The new room also evoked a sense of insecurity due to its unfamiliar design, which acted as a barrier to integrating the room as a well-functioning part of everyday care practice. CONCLUSION: Our findings highlight the disparity that existed between what care providers considered valuable for women during childbirth and their own requirements from the built environment based on their professional responsibilities. This identified disparity emphasises the importance of hospital birthing rooms (i) supporting women's emotions and birth physiology and (ii) being standardised to meet care providers' requirements for a functional work environment. TRIAL REGISTRATION: ClinicalTrials.gov: NCT03948815, 14/05/2019.

Implementation fidelity of a transition program for adolescents with congenital heart disease: the STEPSTONES project.

BACKGROUND: Although transition programs have been evaluated for adolescents with chronic conditions, these have rarely involved process evaluations. Indeed, outcomes of complex interventions are dependent on how the intervention is implemented in practice and evaluations of implementation process are therefore pivotal. The aim of this study was to evaluate the extent to which a transition program for adolescents with congenital heart disease was delivered as intended. Research questions were 1) to what level of fidelity was the program delivered? and 2) what potential moderating factors affected the delivery of the program and overall fidelity? METHODS: A mixed methods design was used, where a process evaluation was embedded in the STEPSTONES randomized controlled trial in Sweden. The implementation fidelity framework by Carrol (2007) and Hasson (2010) was used to design, collect and analyze data. Quantitative data consisted of intervention records on adherence and were analyzed with descriptive statistics. Qualitative data on moderators affecting fidelity were collected through interviews, log-books and focus group interviews with healthcare professionals implementing the intervention and participatory observations of the implementation process. Data were analyzed with deductive content analysis. Triangulation was used to integrate quantitative and qualitative data within the fidelity framework. RESULTS: Six out of eight components of the transition program were delivered to an extent that adhered to the program theory or achieved a high level of fidelity. However, components involving peer support had a low attendance by the participating sample (32.2%), and the joint transfer meeting was challenging to implement, despite achieving high adherence. Moderators affecting the implementation process were the adolescent's and healthcare professional's engagement in the intervention, contextual factors and a lack of standard operating procedures for all components in the program. CONCLUSION: Barriers and facilitators for a future implementation of transition programs have been illuminated in this study. The use of an implementation fidelity framework in the process evaluation proved successful in providing a comprehensive evaluation of factors affecting the implementation process. However, implementation fidelity must be considered in relation to adaptations to the local and personal prerequisites in order to create interventions that can achieve fit.

A Lifestyle Intervention During Pregnancy and Its Effects on Child Weight 2.5 Years Later.

AIM: The aim of this study was to evaluate if overweight and obesity in the offspring is reduced by a low-intensity antenatal primary care intervention with focus on diet and physical activity for pregnant women with obesity, comparing children to mothers receiving the intervention with children to mothers who did not. METHODS: This study is a follow-up of children 2.5 years of age after their mothers' participation in a non-randomised controlled intervention intending to limit gestational weight gain. All study participants received standard antenatal care. The intervention group received lifestyle support via motivational talks with midwife and support from dietician. Data on child weight were collected by medical records, letter and phone. RESULTS: There was no significant difference between the groups 2.5 years after intervention (International Obesity Task Force ISO-BMI 25 (child BMI corresponding to adult BMI of 25): 20% vs. 21%; ISO-BMI 30: 4.6% vs. 1.3%). The mother's BMI at the beginning of pregnancy significantly influenced child BMI at 2.5 years (r = 0.13, p = 0.014, r2 = 0.017). For each unit of increase in maternal BMI at enrollment, the probability of child ISO-BMI ≥ 25 increased by 7.5% (p = 0.021) and of ≥ 30, by 12.9% (p = 0.017). CONCLUSION: The frequency of overweight and obesity of the children at 2.5 years of age was significantly correlated to the mother's BMI, but not correlated to the mothers' participation in the antenatal lifestyle intervention. Thus, it seems important to address obesity and lifestyle issues before and between pregnancies. Trial registration The study has been registered at ClinicalTrials.gov, Identifier: NCT03147079.

Cost effectiveness of a controlled lifestyle intervention for pregnant women with obesity.

BACKGROUND: The Mighty Mums antenatal lifestyle intervention is a person-centered behavioral intervention focusing on nutrition and physical activity for pregnant women with obesity (body mass index [BMI] ≥30). The aim of this study was to evaluate the costs and clinical outcomes of adding the Mighty Mums intervention to standard antenatal care. METHODS: Participants in the intervention group (n = 434) received motivational talks with their midwife and a selection of physical and/or nutritional activities in addition to antenatal care. Control participants (n = 867) from adjacent geographic areas received standard antenatal care. Costs for staff, unit costs for specific activities, and registered costs for specialized antenatal care were analyzed for associations with gestational weight gain and self-reported health. Results are reported for the intention-to-treat (ITT) population and a per protocol (PP) population identified by participation in the intervention. Analyses included bootstrapped linear regressions adjusted for background characteristics that differed significantly between groups. RESULTS: The average costs were SEK 9727 higher (95% confidence interval [CI]: 6677 to 12,777) among participants in the intervention group than in the control ITT population and SEK 8655 (95% CI 4586 to 12,724) higher than in the PP population. The cost increase per 1 kg reduction in gestational weight gain was SEK 12,369 in the ITT population and SEK 7209 for the PP population. CONCLUSION: Participation in the Mighty Mums intervention was associated with higher costs, but also reduced gestational weight gain. The cost per kilogram reduction in gestational weight gain was low, particularly in the PP population. A future decision to implement this behavioral intervention in standard care should take into account society's willingness to pay per unit reduction in gestational weight gain. TRIAL REGISTRATION: The study is registered at ClinicalTrials.gov , Identifier: NCT03147079 .

Mechanisms of impact and experiences of a person-centred transition programme for adolescents with CHD: the Stepstones project.

BACKGROUND: During the past decade there has been some evaluation of transition programmes for adolescents with chronic conditions. However, this has rarely involved process evaluations focusing on mechanisms leading to outcomes, thus hampering implementation of these complex interventions. Our aim was to (I) describe adolescents' and parents' experiences of participating in a person-centred transition programme aiming to empower them in transition to adulthood and (II) explore the mechanisms of impact. METHODS: A qualitative process evaluation was performed, embedded in a randomized controlled trial evaluating the effectiveness of a transition programme for adolescents with congenital heart disease in Sweden. A purposive sample of 14 adolescents and 12 parents randomized to the intervention group were interviewed after participation in the programme. Data were analysed deductively and inductively in NVivo v12. RESULTS: Experiences of participation in the transition programme were generally positive. Meeting a transition coordinator trained in person-centred care and adolescent health and embarking on an educational process based on the adolescents' prerequisites in combination with peer support were considered key change mechanisms. However, support to parents were not sufficient for some participants, resulting in ambivalence about changing roles and the unmet needs of parents who required additional support. CONCLUSIONS: Participants experienced increased empowerment in several dimensions of this construct, thus demonstrating that the transition programme was largely implemented as intended and the evidence-based behaviour-change techniques used proved effective in reaching the outcome. These findings can inform future implementation of transition programmes and illuminate challenges associated with delivering a complex intervention for adolescents with chronic conditions.

Effects of Person-Centered Care Using a Digital Platform and Structured Telephone Support for People With Chronic Obstructive Pulmonary Disease and Chronic Heart Failure: Randomized Controlled Trial.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) and chronic heart failure (CHF) are characterized by severe symptom burden and common acute worsening episodes that often require hospitalization and affect prognosis. Although many studies have shown that person-centered care (PCC) increases self-efficacy in patients with chronic conditions, studies on patients with COPD and CHF treated in primary care and the effects of PCC on the risk of hospitalization in these patients are scarce. OBJECTIVE: The aim of this study is to evaluate the effects of PCC through a combined digital platform and telephone support for people with COPD and CHF. METHODS: A multicenter randomized trial was conducted from 2018 to 2020. A total of 222 patients were recruited from 9 primary care centers. Patients diagnosed with COPD, CHF, or both and with internet access were eligible. Participants were randomized into either usual care (112/222, 50.5%) or PCC combined with usual care (110/222, 49.5%). The intervention's main component was a personal health plan cocreated by the participants and assigned health care professionals. The health care professionals called the participants in the intervention group and encouraged narration to establish a partnership using PCC communication skills. A digital platform was used as a communication tool. The primary end point, divided into 2 categories (improved and deteriorated or unchanged), was a composite score of change in general self-efficacy and hospitalization or death 6 months after randomization. Data from the intention-to-treat group at 3- and 6-month follow-ups were analyzed. In addition, a per-protocol analysis was conducted on the participants who used the intervention. RESULTS: No significant differences were found in composite scores between the groups at the 3- and 6-month follow-ups. However, the per-protocol analysis of the 3-month follow-up revealed a significant difference in composite scores between the study groups (P=.047), although it was not maintained until the end of the 6-month follow-up (P=.24). This effect was driven by a change in general self-efficacy from baseline. CONCLUSIONS: PCC using a combined digital platform and structured telephone support seems to be an option to increase the short-term self-efficacy of people with COPD and CHF. This study adds to the knowledge of conceptual innovations in primary care to support patients with COPD and CHF. TRIAL REGISTRATION: ClinicalTrials.gov NCT03183817; http://clinicaltrials.gov/ct2/show/NCT03183817.

Factors affecting adolescents' participation in randomized controlled trials evaluating the effectiveness of healthcare interventions: the case of the STEPSTONES project.

BACKGROUND: Recruitment of adolescents to intervention studies is a known challenge. For randomized controlled trials (RCT) to be generalizable, reach must be assessed, which means ascertaining how many of the intended population actually participated in the trial. The aim of this study was to evaluate the reach and representativeness of an RCT evaluating the effectiveness of a complex intervention for adolescents with chronic conditions. METHODS: A mixed methods sequential explanatory design was employed. Firstly, quantitative cross-sectional data from the RCT, patient registries and medical records were collected and analysed regarding baseline differences between participants and non-participants in the trial. Secondly, qualitative data on their reasons for participating or not were collected and analysed with content analysis to explain the quantitative findings. RESULTS: Participants showed larger differences in effect sizes and a significantly more complex chronic condition than non-participants. No other statistically significant differences were reported, and effect sizes were negligible. Reasons for declining or accepting participation were categorized into three main categories: altruistic reasons, personal reasons and external reasons and factors. CONCLUSIONS: Integration of quantitative and qualitative findings showed that participation in the RCT was affected by disease complexity, the perceived need to give back to healthcare and research and the adolescents' willingness to engage in their illness. To empower adolescents with chronic conditions and motivate them to participate in research, future intervention studies should consider developing tailored recruitment strategies and communications with sub-groups that are harder to reach.

A national research centre for the evaluation and implementation of person-centred care: Content from the first interventional studies.

BACKGROUND: Person-centred care (PCC) has been suggested as a potential means to improve the care of patients with chronic and long-term disorders. In this regard, a model for PCC was developed by the University of Gothenburg Centre for Person-Centred Care (GPCC). OBJECTIVE: The present study aimed to explore the theoretical frameworks, designs, contexts and intervention characteristics in the first 27 interventional studies conducted based on the ethics for person-centredness provided by the GPCC. DESIGN: Cross-sectional study. SETTING AND PARTICIPANTS: A questionnaire to the principal investigators of the 27 intervention studies financed by the GPCC and conducted between 2010 and 2016. MAIN OUTCOME MEASURES: Theoretical frameworks, contexts of studies, person-centred ethic, and outcome measures. RESULTS: Most of the interventions were based on the same ethical assumptions for person-centredness but theories and models in applying the interventions differed. All studies were controlled; 12 randomized and 15 quasi-experimental. Hospital in- and outpatient and primary care settings were represented and the outcome measures were related to the specific theories used. A complexity in designing, introducing and evaluating PCC interventions was evident. CONCLUSION: The frameworks, designs and interventions in the studies were in line with the established ethical basis of PCC, whereas outcome measures varied widely. Consensus discussions among researchers in the field are needed to make comparisons between studies feasible. PATIENT OR PUBLIC CONTRIBUTIONS: Patients or the public made no direct contributions, although most of the studied projects included such initiatives.

Cognitive function is a major determinant of income among multiple sclerosis patients in Sweden acting independently from physical disability.

BACKGROUND: In multiple sclerosis (MS), various aspects of cognitive function can be detrimentally affected, thus patients' employment and social functioning is commonly impacted. OBJECTIVE: To analyse income among MS patients in relation to cognitive function, assessed with the Symbol Digit Modalities Test (SDMT). METHODS: A cross-sectional study including 2080 MS patients was conducted linking national register-based data. Descriptive statistics and a two-part model were used to estimate differences in earnings and social benefits. RESULTS: MS patients in the highest SDMT score quartile earned more than twice annually compared to patients in the lowest quartile, whereas patients in the lowest quartile received three times more income through social benefits. The difference in earnings and benefits across the SDMT performance quartiles remained statistically significant after adjusting for various clinical and socio-demographic variables, including physical disability. The corrected prevalence ratios for MS patients in the highest quartile for having income from earnings and benefits were 1.40 (95% confidence interval (CI): 1.29-1.49) and 0.81 (95% CI: 0.71-0.90), respectively, when compared to the patients in the lowest quartile. CONCLUSION: Cognitive function affects the financial situation of MS patients negatively and independently of physical disability. This warrants cognitive testing as a routine measure in health care services for MS patients.

Economic evaluation of a person-centred care intervention in head and neck oncology: results from a randomized controlled trial.

PURPOSE: Head and neck cancer and its treatment deteriorate quality of life, but symptoms improve with person-centred care. We examined the cost-effectiveness of a person-centred care intervention versus standard medical care. METHODS: In this randomized clinical trial of a person-centred intervention, patients were planned for outpatient oncology treatment in a Swedish university hospital between 2012 and 2014 and were followed during 1 year. Annual healthcare costs were identified from medical records and administrative register data. Productivity costs were calculated from reported sick leave. Health-related quality of life was collected using the EuroQol Group's five-dimension health state questionnaire. RESULTS: Characteristics were similar between 53 patients in the intervention group and 39 control patients. The average total cost was Euro (EUR) 55,544 (95% confidence interval: EUR 48,474-62,614) in the intervention group and EUR 57,443 (EUR 48,607-66,279) among controls, with similar health-related quality of life. CONCLUSIONS: This person-centred intervention did not result in increased costs and dominated the standard medical care. TRIAL REGISTRATION: ClinicalTrials.gov (registration number: NCT02982746).

Clinical relevance of alerts from a decision support system, PHARAO, for drug safety assessment in the older adults.

BACKGROUND: PHARAO is a decision support system developed to evaluate the risk for a set of either common or serious side-effects resulting from a combination of pharmacodynamic effects from a patient's medications. The objective of this study was to investigate the validity of the risk scores for the common side-effects generated by PHARAO in older patients. METHODS: Side-effects included were sedation, constipation, orthostatic symptoms, anticholinergic and serotonergic effects. The alerts generated by PHARAO were tested in 745 persons ≥65 years old. Dispensed prescriptions retrieved from the Swedish prescribed drug register were used to generate the pharmacological risk scores of patients' medications. Symptoms possibly related to side-effects were extracted from medical records data. RESULTS: The PHARAO system generated 776 alerts, most often for the risk of anticholinergic symptoms. The total specificity estimates of the PHARAO system were 0.95, 0.89 and 0.78 for high, intermediate and low risk alerts, respectively. The corresponding sensitivity estimates were between 0.12 and 0.37. The negative predictive value was 0.90 and the positive predictive value ranged between 0.20-0.25. CONCLUSIONS: The PHARAO system had a high specificity and negative predictive value to detect symptoms possibly associated with the of patients' medications, while the sensitivity and positive predictive value were low. The PHARAO system has the potential to minimise the risk of over-alerts in combination with a drug-drug interaction alert system, but should be used in connection with a medical evaluation of the patient.

Comparing costs of illness of multiple sclerosis in three different years: A population-based study.

BACKGROUND: Little is known about changes in the costs of illness (COI) among multiple sclerosis (MS) patients during recent years. OBJECTIVES: To compare the COI among MS patients and matched controls in 2006, 2009, and 2012, respectively, indicating the costs attributable to the MS disease. METHODS: Three cross-sectional datasets were analyzed, including all MS patients in Sweden aged 20-60 years and five matched controls for each of them. The analyses were based on 10,531 MS patients and 52,655 matched controls for 2006, 11,722 and 58,610 individuals for 2009, and 12,789 and 63,945 for 2012. Nationwide registers, including prescription drug use, specialized healthcare, sick leave, and disability pension, were linked to estimate the prevalence-based COI. RESULTS: Adjusted for inflation, the average difference in COI between MS patients and matched controls were Swedish Krona (SEK) 243,751 (95% confidence interval: SEK 239,171-248,331) in 2006, SEK 238,971 (SEK 234,516-243,426) in 2009, and SEK 225,923 (SEK 221,630-230,218) in 2012. The difference in indirect costs were SEK 170,502 (SEK 166,478-174,525) in 2006, SEK 158,839 (SEK 154,953-162,726) in 2009, and SEK 141,280 (SEK 137,601-144,960) in 2012. CONCLUSION: The inflation-adjusted COI of MS patients was lower in 2012 than in 2006, in particular regarding indirect costs.

Disposable income trajectories of working-aged individuals with diagnosed multiple sclerosis.

OBJECTIVES: The economic situation of individuals diagnosed with multiple sclerosis (MS) is under studied, with the levels and sources of incomes suggested to vary with socio-demographics. We aimed to describe the diversity of disposable income (DI) trajectories among working-aged individuals with incident MS, and investigate the associations of socio-demographic characteristics with identified trajectories. MATERIALS & METHODS: A population-based cohort study of all 1528 individuals first diagnosed with MS in 2008-2009 when aged 25-59, with data linked from three nationwide Swedish registers. DI was defined as net earnings plus net income from benefits. Trajectories of mean annual DI from 7 years prior to 4 years after diagnosis were identified by group-based trajectory modelling. An individual's group membership was determined by individual model-fit estimates from a multinomial logit function. Chi-squared tests and multinomial logistic regressions estimated the associations between trajectory membership and socio-demographic (sex, age, education, birth country, type of living area and family situation) and work disability (sickness absence and disability pension) characteristics. RESULTS: Seven distinct DI trajectories were identified: two consistently low (50.7% of individuals); four increasing (39.0%); and one decreasing (10.3%). Socio-demographic and work disability characteristics were associated with trajectories; the increasing trajectories had older age-profiles and higher proportions of men, while university education was less common in the consistently low trajectories. CONCLUSIONS: We identified high diversity in DI development within the cohort around MS diagnosis. Socio-demographic and work disability characteristics differed between the trajectories. This broader information of the economic situation is important to convey to patients.

Increasing return-to-work among people on sick leave due to common mental disorders: design of a cluster-randomized controlled trial of a problem-solving intervention versus care-as-usual conducted in the Swedish primary health care system (PROSA).

BACKGROUND: Common mental disorders affect about one-third of the European working-age population and are one of the leading causes of sick leave in Sweden and other OECD countries. Besides the individual suffering, the costs for society are high. This paper describes the design of a study to evaluate a work-related, problem-solving intervention provided at primary health care centers for employees on sick leave due to common mental disorders. METHODS: The study has a two-armed cluster randomized design in which the participating rehabilitation coordinators are randomized into delivering the intervention or providing care-as-usual. Employees on sick leave due to common mental disorders will be recruited by an independent research assistant. The intervention aims to improve the employee's return-to-work process by identifying problems perceived as hindering return-to-work and finding solutions. The rehabilitation coordinator facilitates a participatory approach, in which the employee and the employer together identify obstacles and solutions in relation to the work situation. The primary outcome is total number of sick leave days during the 18-month follow-up after inclusion. A long-term follow-up at 36 months is planned. Secondary outcomes are short-term sick leave (min. 2 weeks and max. 12 weeks), psychological symptoms, work ability, presenteeism and health related quality of life assessed at baseline, 6 and 12-month follow-up. Intervention fidelity, reach, dose delivered and dose received will be examined in a process evaluation. An economic evaluation will put health-related quality of life and sick leave in relation to costs from the perspectives of society and health care services. A parallel ethical evaluation will focus on the interventions consequences for patient autonomy, privacy, equality, fairness and professional ethos and integrity. DISCUSSION: The study is a pragmatic trial which will include analyses of the intervention's effectiveness, and a process evaluation in primary health care settings. Methodological strengths and challenges are discussed, such as the risk of selection bias, contamination and detection bias. If the intervention shows promising results for return-to-work, the prospects are good for implementing the intervention in routine primary health care. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03346395 Registered January, 12 2018.

Comparing Methods for Estimating Direct Costs of Adverse Drug Events.

OBJECTIVES: To estimate how direct health care costs resulting from adverse drug events (ADEs) and cost distribution are affected by methodological decisions regarding identification of ADEs, assigning relevant resource use to ADEs, and estimating costs for the assigned resources. METHODS: ADEs were identified from medical records and diagnostic codes for a random sample of 4970 Swedish adults during a 3-month study period in 2008 and were assessed for causality. Results were compared for five cost evaluation methods, including different methods for identifying ADEs, assigning resource use to ADEs, and for estimating costs for the assigned resources (resource use method, proportion of registered cost method, unit cost method, diagnostic code method, and main diagnosis method). Different levels of causality for ADEs and ADEs' contribution to health care resource use were considered. RESULTS: Using the five methods, the maximum estimated overall direct health care costs resulting from ADEs ranged from Sk10,000 (Sk = Swedish krona; ~€1,500 in 2016 values) using the diagnostic code method to more than Sk3,000,000 (~€414,000) using the unit cost method in our study population. The most conservative definitions for ADEs' contribution to health care resource use and the causality of ADEs resulted in average costs per patient ranging from Sk0 using the diagnostic code method to Sk4066 (~€500) using the unit cost method. CONCLUSIONS: The estimated costs resulting from ADEs varied considerably depending on the methodological choices. The results indicate that costs for ADEs need to be identified through medical record review and by using detailed unit cost data.