Measuring the Effect of the Early assessment Team (MEET) for patients referred to outpatient mental health care: a study protocol for a randomised controlled trial.

BACKGROUND: Referrals to specialised mental health care (such as community mental health centres; CMHC) have increased over the last two decades. Patients often have multifaceted problems, which cannot only be solved by such care. Resources are limited, and triaging is challenging. A novel method which approaches patients early and individually upon referral to a CMHC-possibly with a brief intervention-is an Early assessment Team (EaT). In an EaT, two therapists meet the patient early in the process and seek to solve the present problem, often involving community services, primary health care, etc.; attention is paid to symptoms and functional strife, rather than diagnoses. This is in contrast to treatment as usual (TAU), where the patient (after being on a waiting list) meets one therapist, who focuses on history and situation to assign a diagnosis and eventually start a longitudinal treatment. The aim of this study is to describe and compare EaT and TAU regarding such outcomes as work and social adjustment, mental health, quality of life, use of health services, and patient satisfaction. The primary outcome is a change in perceived function from baseline to 12-month follow-up, measured by the Work and Social Adjustment Scale. METHOD: Patients (18 years and above; n = 588) referred to outpatient health care at a CMHC are randomised to EaT or TAU. Measures (patient self-reports and clinician reports, patients' records, and register data) are collected at baseline, after the first and last meeting, and at 2, 4, 8, 12, and 24 months after inclusion. Some participants will be invited to participate in qualitative interviews. TRIAL DESIGN: The study is a single-centre, non-blinded, RCT with two conditions involving a longitudinal and mixed design (quantitative and qualitative data). DISCUSSION: This study will examine an intervention designed to determine early on which patients will benefit from parallel or other measures than assessment and treatment in CMHC and whether these will facilitate their recovery. Findings may potentially contribute to the development of the organisation of mental health services. TRIAL REGISTRATION: ClinicalTrials.gov NCT05087446. Registered on 21 October 2021.

Pembrolizumab with or Without Lenvatinib as First-line Therapy for Patients with Advanced Urothelial Carcinoma (LEAP-011): A Phase 3, Randomized, Double-Blind Trial.

BACKGROUND: Pembrolizumab plus lenvatinib has shown antitumor activity and acceptable safety in patients with platinum-refractory urothelial carcinoma (UC). OBJECTIVE: To evaluate pembrolizumab plus either lenvatinib or placebo as first-line therapy for advanced UC in the phase 3 LEAP-011 study. DESIGN, SETTING, AND PARTICIPANTS: Patients with advanced UC who were ineligible for cisplatin-based therapy or any platinum-based chemotherapy were enrolled. INTERVENTION: Patients were randomly assigned (1:1) to pembrolizumab 200 mg intravenously every 3 wk plus either lenvatinib 20 mg or placebo orally once daily. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Dual primary endpoints were progression-free survival (PFS) and overall survival (OS). An external data monitoring committee (DMC) regularly reviewed safety and efficacy data every 3 mo. RESULTS AND LIMITATIONS: Between June 25, 2019 and July 21, 2021, 487 patients were allocated to receive lenvatinib plus pembrolizumab (n = 245) or placebo plus pembrolizumab (n = 242). The median time from randomization to the data cutoff date (July 26, 2021) was 12.8 mo (interquartile range, 6.9-19.3). The median PFS was 4.5 mo in the combination arm and 4.0 mo in the pembrolizumab arm (hazard ratio [HR] 0.90 [95% confidence interval {CI} 0.72-1.14]). The median OS was 11.8 mo for the combination arm and 12.9 mo for the pembrolizumab arm (HR 1.14 [95% CI 0.87-1.48]). Grade 3-5 adverse events attributed to trial treatment occurred in 123 of 241 patients (51%) treated with lenvatinib plus pembrolizumab and in 66 of 242 patients (27%) treated with placebo plus pembrolizumab. This trial was terminated earlier than initially planned based on recommendation from the DMC. CONCLUSIONS: The benefit-to-risk ratio for first-line lenvatinib plus pembrolizumab was not considered favorable versus pembrolizumab plus placebo as first-line therapy in patients with advanced UC. PATIENT SUMMARY: Lenvatinib plus pembrolizumab was not more effective than pembrolizumab plus placebo in patients with advanced urothelial carcinoma.

Prospects of returning to work after lumbar spine surgery for patients considering disability pension: a nationwide study based on data from the Norwegian Registry for Spine Surgery.

OBJECTIVES: To assess the odds for not returning to work (non-RTW) 1 year after treatment among patients who had applied for or were planning to apply for disability pension (DP-applicant) prior to an operation for degenerative disorders of the lumbar spine. METHODS: This population-based cohort study from the Norwegian Registry for Spine surgery included 26 688 cases operated for degenerative disorders of the lumbar spine from 2009 to 2020. The primary outcome was RTW (yes/no). Secondary patient-reported outcome measures (PROMs) were the Oswestry Disability Index, Numeric Rating Scales for back and leg pain, EuroQoL five-dimension and the Global Perceived Effect Scale. Logistic regression analysis was used to investigate associations between being a DP-applicant prior to surgery (exposure), possible confounders (modifiers) at baseline and RTW 12 months after surgery (outcome). RESULTS: The RTW ratio for DP-applicants was 23.1% (having applied: 26.5%, planning to apply 21.1%), compared with 78.6% among non-applicants. All secondary PROMs were more favourable among non-applicants. After adjusting for all significant confounders (low expectations and pessimism related to working capability, not feeling wanted by the employer and physically demanding work), DP-applicants with under 12 months preoperative sick leave had 3.8 (95% CI 1.8 to 8.0) higher odds than non-applicants for non-RTW 12 months after surgery. The subgroup having applied for disability pension had the strongest impact on this association. CONCLUSION: Less than a quarter of the DP-applicants returned to work 12 months after surgery. This association remained strong, also when adjusted for the confounders as well as other covariates related RTW.

Who Returns to work? Exploring the Role of Interpersonal Problems in Occupational Rehabilitation.

PURPOSE: Current interventions designed to facilitate return to work (RTW) after long-term sick leave show weak effects, indicating the need for new approaches to the RTW process. The importance of social relationships in the workplace is widely recognized in existing RTW literature, but very little is known about the role of the interpersonal problems of the returning worker. Current research indicates that a subset of these - hostile-dominant interpersonal problems - give particular disadvantages in several life areas. This prospective cohort study aims to test whether higher levels of interpersonal problems predict lower likelihood of RTW when controlling for symptom levels (H1); and whether higher levels of hostile-dominant interpersonal problems specifically predict lower likelihood of RTW (H2). METHODS: 189 patients on long-term sick leave completed a 3½-week transdiagnostic RTW program. Before treatment, self-reported interpersonal problems, chronic pain, insomnia, fatigue levels, anxiety and depression were collected. RTW data for the following year were collected from the Norwegian Labour and Welfare Administration. RESULTS: A multivariable binary logistic regression analysis found that (H2) hostile-dominant interpersonal problems significantly predicted RTW (OR = 0.44, [95% CI: 0.19, 0.98], p = .045), while a corresponding analysis (H1) found that general interpersonal problems did not. CONCLUSION: Hostile-dominant interpersonal problems negatively predict RTW after long-term sick leave, suggesting an overlooked factor in the field of occupational rehabilitation. The findings could open up new avenues for research and interventions entailed to individuals in the field of occupational rehabilitation.

Return to Work after Surgical Clipping versus Endovascular Treatment of Unruptured Intracranial Aneurysms: A Nationwide Registry-Based Study.

PURPOSE: To assess return to work following the treatment of unruptured intracranial aneurysms (UIAs). MATERIALS AND METHODS: This retrospective, nationwide registry-based study included all adult patients of working age treated for a UIA in Norway between 2008 and 2018 who had a record of sickness leave on the day of treatment. Data from The Norwegian Patient Registry and The Norwegian Labour and Welfare Administration were linked on an individual level. Daily sickness and recipiency of disability benefits, as an indirect measure of working status, from 1 year before treatment to 1 year after treatment were analyzed. Return to work after endovascular treatment and surgical clipping was compared. RESULTS: In total, 412 patients were included. Of patients who worked 1 year before treatment, 83% returned to work 1 year after treatment. The number of days from treatment to the first day back at work in a continuous 3-month working period was lower in patients who underwent endovascular treatment than in those treated with surgical clipping (median, 69 days; 95% confidence interval [CI], 51-87; vs 201 days, 95% CI, 163-239; P < .001). Return to work was more likely in patients who underwent endovascular treatment at 3 months after treatment (hazard ratio, 3.53; 95% CI, 2.54-4.93; P < .001). There was no difference in return to work at 6 and 12 months after treatment. CONCLUSIONS: The treatment of UIAs affects patients' postoperative working status. Patients treated endovascularly return to work earlier than those who undergo open surgery.

Return to work after surgery for degenerative cervical myelopathy: a nationwide registry-based observational study.

BACKGROUND: Few studies of high quality exist on return to work (RTW) rate after surgery for degenerative cervical myelopathy (DCM). This study aims to examine the RTW rate in patients undergoing surgery for DCM. METHODS: Nationwide prospectively collected data were obtained from the Norwegian Registry for Spine Surgery and the Norwegian Labour and Welfare Administration. The primary outcome was return to work, defined as being at work at a given time postoperatively without any medical income-compensation benefits. Secondary endpoints included the neck disability index (NDI) and quality of life measured by EuroQol-5D (EQ-5D). RESULTS: Among 439 patients operated for DCM between 2012 and 2018, 20% of the patients received a medical income-compensation benefit one year before surgery. This number increased steadily towards the operation at which timepoint 100% received benefits. By 12 months after surgery, 65% had returned to work. By 36 months, 75% had returned to work. Patients that returned to work were more likely to be non-smokers and to have a college education. They had less comorbidity, more were without benefit 1-year pre-surgery, and significantly more patients were employed at operation date. Average days of sick leave in the year before surgery were significantly less in the RTW group, and they had a significantly lower baseline NDI and EQ-5D All PROMs reached statistical significance at 12 months, in favor of the group that achieved RTW. CONCLUSION: At 12 months following surgery, 65% had returned to work. At the end of the 36-month follow-up period, 75% had returned to work, 5% less than the working percentage in the beginning of the follow-up period. This study demonstrates that a large percentage of patients return to work after surgical treatment for DCM.

Health-Related Quality of Life Outcomes With Two Different Starting Doses of Lenvatinib in Combination With Everolimus for Previously Treated Renal Cell Carcinoma.

BACKGROUND: Preserving health-related quality of life (HRQOL) is an important goal during renal cell carcinoma treatment. We report HRQOL outcomes from a phase II trial (NCT03173560). PATIENTS AND METHODS: HRQOL data were collected during a multicenter, randomized, open-label phase II study comparing the safety and efficacy of 2 different starting doses of lenvatinib (18 mg vs. 14 mg daily) in combination with everolimus (5 mg daily), following one prior vascular endothelial growth factor-targeted treatment. HRQOL was measured using 3 different instruments-FKSI-DRS, EORTC QLQ-C30, and EQ-5D-3L-which were all secondary endpoints. Change from baseline was assessed using linear mixed-effects models. Deterioration events for time to deterioration (TTD) analyses were defined using established thresholds for minimally important differences in the change from baseline for each scale. TTD for each treatment arm was estimated using the Kaplan-Meier method. RESULTS: Baseline characteristics of the 343 participants randomly assigned to 18 mg lenvatinib (n = 171) and 14 mg lenvatinib (n = 172) were well balanced. Least-squares mean estimates for change from baseline were favorable for the 18 mg group over the 14 mg group for the FKSI-DRS and most EORTC QLQ-C30 scales, but differences between treatments did not exceed the minimally important thresholds. Median TTD was longer among participants in the 18 mg group than those in the 14 mg group for most scales. CONCLUSIONS: Participants who received an 18 mg lenvatinib starting dose had favorable HRQOL scores and longer TTD on most scales compared with those who received a 14 mg starting dose.

Return to Work After Surgery for Cervical Radiculopathy: A Nationwide Registry-based Observational Study.

STUDY DESIGN: An observational multicenter study. SUMMARY OF BACKGROUND DATA: Return to work (RTW) is increasingly used to assess the standard, benefit, and quality of health care. OBJECTIVE: The aim of this study was to evaluate sick leave patterns among patients undergoing surgery for cervical radiculopathy and identify predictors of successful RTW using two nationwide databases. MATERIALS AND METHODS: Data from the Norwegian Registry for Spine Surgery (NORspine) and the Norwegian Labour and Welfare Administration were linked on an individual level. We included patients between 18 and 60 years of age registered in NORspine from June 2012 through December 2019 that were temporarily out of the labor force for medical reasons at the time of surgery. We assessed types and grades of sickness benefits before and after surgery and conducted logistic regression analyses. RESULTS: Among 3387 patients included in the study, 851 (25.1%) received temporary benefits one year before surgery. The proportion of recipients increased steadily towards surgery. Postoperatively the medical benefit payment decreased rapidly, and half of the patients had already returned to work by four months. The rate of RTW reached a plateau at one year. By the end of the third year, 2429 patients (71.7%) had returned to work. The number of sick days, categorized as 90 or less, during the year before surgery had the most powerful association with RTW at two years (odds ratio: 4.54, 95% CI: 3.42-6.03, P <0.001). Improvement in neck-related disability was the second strongest predictor (odds ratio: 2.17, 95% CI: 1.69-2.78, P <0.001). CONCLUSION: RTW after cervical radiculopathy surgery occurs primarily during the first year. The strongest predictor of RTW was fewer sick days before surgery. The clinical improvement after surgery had a lesser impact. LEVEL OF EVIDENCE: 2.

Return to work after surgical clipping versus endovascular treatment for ruptured intracranial aneurysms - A nationwide registry-based study.

OBJECTIVES: The aim of this study was to assess return to work following aneurysmal subarachnoid haemorrhage (SAH) and compare working status after open surgical clipping and endovascular treatment. METHODS: This nationwide registry-based study included all adult patients in working age treated for a ruptured intracranial aneurysm in Norway between 2008 and 2018 who had a record of sickness leave on the day of treatment. Data from The Norwegian Patient Registry and The Norwegian Labour and Welfare Administration were linked on an individual level. Daily sickness and disability benefits recipiency one year preoperatively to one year postoperatively was analysed. Return to work after endovascular treatment and surgical clipping was compared. RESULTS: 183 patients were included in the study. Among patients who worked at one year preoperatively, 57% had returned to work one year after treatment. Mean number of days from treatment to the first day back at work in a continuous 3-month working period was 298 (95% CI: 276-321) vs. 319 (95% CI: 299-339) for patients who underwent endovascular treatment compared to patients treated with clipping (p = 0.365). Older patients were less likely to return to work after treatment (hazard ratio 0.977 per year of age, 95% CI 0.956-1.000, p = 0.046). There was no significant association between return to work and patient sex or location of the aneurysm. CONCLUSIONS: Aneurysmal SAH profoundly affects patient working status. This study found no significant difference in time to return to work after treatment between patients treated with endovascular techniques compared to patients undergoing open surgery.

Assessing the Safety and Efficacy of Two Starting Doses of Lenvatinib Plus Everolimus in Patients with Renal Cell Carcinoma: A Randomized Phase 2 Trial.

BACKGROUND: Lenvatinib (18 mg) plus everolimus (5 mg) is approved for patients with advanced renal cell carcinoma (RCC) after one or more prior antiangiogenic therapies. OBJECTIVE: To assess whether a lower starting dose of lenvatinib has comparable efficacy with improved tolerability for patients with advanced RCC treated with lenvatinib plus everolimus. DESIGN, SETTING, AND PARTICIPANTS: A randomized, open-label, phase 2 global trial was conducted in patients with advanced clear cell RCC and disease progression after one prior vascular endothelial growth factor-targeted therapy (prior anti-programmed death-1/programmed death ligand-1 therapy permitted). INTERVENTION: Patients were randomly assigned 1:1 to the 14- or 18-mg lenvatinib starting dose, both in combination with everolimus 5 mg/d. Patients in the 14-mg arm were to be uptitrated to lenvatinib 18 mg at cycle 2, day 1, barring intolerable grade 2 or any grade ≥3 treatment-emergent adverse events (TEAEs) requiring dose reduction occurring in the first 28-d cycle. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary efficacy endpoint was investigator-assessed objective response rate (ORR) as of week 24 (ORRwk24); the noninferiority threshold of the 14- versus 18-mg arm was p ≤ 0.045. The primary safety endpoint was the proportion of patients with intolerable grade 2 or any grade ≥3 TEAEs within 24 wk of randomization. RESULTS AND LIMITATIONS: The ORRwk24 for the 14-mg arm (32% [95% confidence interval {CI} 25-39]) was not noninferior to the ORRwk24 in the 18-mg arm (35% [95% CI 27-42]; odds ratio: 0.88; 90% CI 0.59-1.32; p = 0.3). The proportion of intolerable grade 2 or any grade ≥3 TEAEs was similar between the two arms (14 mg, 83% vs 18 mg, 80%; p = 0.5). The secondary endpoints of overall ORR, progression-free survival, and overall survival numerically favored the 18-mg arm. A limitation of this study was that the study design did not allow for a full comparison of progression-free survival between treatment arms. CONCLUSIONS: The study findings support the approved dosing regimen of lenvatinib 18 mg plus everolimus 5 mg daily for patients with advanced RCC. PATIENT SUMMARY: In this report, we examined two doses of lenvatinib (the approved 18-mg dose and a lower dose of 14 mg) in people with advanced renal cell carcinoma to determine whether the lower dose (which was increased to the approved 18-mg dose after the first treatment cycle) could improve safety without affecting efficacy. The results showed that the efficacy of the lower lenvatinib dose (14 mg) was not the same as that of the approved (18 mg) dose, although safety results were similar, so the approved lenvatinib 18-mg dose should still be used.

Participants' experiences from group-based treatment at multidisciplinary pain centres - a qualitative study.

OBJECTIVES: The aim of the study was to explore the experiences of participants in non-pharmacological group-based treatments delivered as part of a randomised controlled trial at Norwegian tertiary care pain centres. METHODS: Individual semi-structured interviews with 15 persons were conducted. The data were analysed with a descriptive thematic cross-case analysis based on the method of systematic text condensation. RESULTS: All participants talked about some aspects of the group-based treatments as a positive experience, but mainly the outcome was in line with their expectations; they hoped it would reduce their pain but did not expect it. There were no clear-cut differences in the experiences between the participants from the two different intervention groups. The content was experienced as both relevant and interesting but also to introduce concepts that were difficult to grasp and understand. Similarly, the experiences of participating in a group-based treatment were mostly stimulating but could also be challenging because of an expectancy of sharing personal stories. Although experiencing few changes to their pain they came away with techniques and lessons that were valuable to them. CONCLUSIONS: In this study, taking part in group-based treatment was perceived as giving positive and valuable lessons, due to relevant content and learning from the professionals and fellow participants, but without any clear indication of reduced pain. Approval from ethical committee number 10260 REK Midt. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov NCT04057144.

The patient perspective of alpha-1 antitrypsin deficiency: disease burden and unmet needs.

Three people with alpha-1 antitrypsin deficiency (AATD) share their experiences of living with this rare, genetic condition. They reflect on living with AATD and its impact on their lives including inequality of access to treatment across Europe. https://bit.ly/3rrYS9s.

Barriers and Facilitators for Implementing Motivational Interviewing as a Return to Work Intervention in a Norwegian Social Insurance Setting: A Mixed Methods Process Evaluation.

Purpose The aim of this study was to evaluate potential barriers and facilitators for implementing motivational interviewing (MI) as a return to work (RTW) intervention in a Norwegian social insurance setting. Methods A mixed-methods process evaluation was conducted alongside a randomized controlled trial involving MI sessions delivered by social insurance caseworkers. The study was guided by the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework using focus groups with the caseworkers. MI fidelity was evaluated through audio-recordings of MI sessions and questionnaires to sick-listed participants. Results Lack of co-worker and managerial support, time and place for practicing to further develop MI skills, and a high workload made the MI intervention challenging for the caseworkers. The MI method was experienced as useful, but difficult to master. MI fidelity results showed technical global scores over the threshold for "beginning proficiency" whereas the relational global score was under the threshold. The sick-listed workers reported being satisfied with the MI sessions. Conclusions Despite caseworker motivation for learning and using MI in early follow-up sessions, MI was hard to master and use in practice. Several barriers and facilitators were identified; these should be addressed before implementing MI in a social insurance setting.Trial registration ClinicalTrials.gov: NCT03212118 (registered July 11, 2017).

Metacognitive Beliefs as Predictors of Return to Work After Intensive Return-to-Work Rehabilitation in Patients With Chronic Pain, Chronic Fatigue and Common Psychological Disorders: Results From a Prospective Trial.

BACKGROUND: Metacognitions are associated with work status, but no research has examined to what extent metacognitions before treatment and change in metacognitions following treatment predict return to work (RTW) prospectively. The present study aims to address these two gaps in knowledge. METHODS: 212 patients on long-term sick leave (>8 weeks) with extensive fatigue, chronic pain conditions and/or mental distress received 3.5 weeks of intensive rehabilitation treatment, aimed at returning them to work. Only part of the population (n = 137) had complete follow-up data on metacognitions. Metacognitions were measured with the Metacognitions Questionnaire 30 (MCQ-30), while RTW was measured using official registry data from the Norwegian Labor and Welfare Service. A registry record of participation in competitive work ≥2.5 days (50% work participation) per week, averaging over 14 weeks, was chosen as an outcome reflecting a successful RTW. The registry data spanned a total of 56 weeks per participant. RESULTS: Our results indicated that baseline MCQ scores was not associated with RTW. This was analyzed for the total MCQ score as well as for all subscales. We observed substantial changes in metacognitions following treatment, and a 1-point change in the total sum of metacognitive beliefs was associated with 5% greater odds for successful RTW at all time points (p = 0.040), while a 1-point change on the subscale of beliefs about the need to control thoughts gave 20% greater odds for successful RTW (p = 0.016). CONCLUSION: Metacognitions concerning the need to control thoughts appear to have a significant influence on patients return to work. Here, we observed that a change in these beliefs following treatment substantially affected RTW over the course of 1 year.

Protocol for the EARCO Registry: a pan-European observational study in patients with α1-antitrypsin deficiency.

RATIONALE AND OBJECTIVES: Alpha-1 antitrypsin deficiency (AATD) is a genetic condition that leads to an increased risk of emphysema and liver disease. Despite extensive investigation, there remain unanswered questions concerning the natural history, pathophysiology, genetics and the prognosis of the lung disease in association with AATD. The European Alpha-1 Clinical Research Collaboration (EARCO) is designed to bring together researchers from European countries and to create a standardised database for the follow-up of patients with AATD. STUDY DESIGN AND POPULATION: The EARCO Registry is a non-interventional, multicentre, pan-European, longitudinal observational cohort study enrolling patients with AATD. Data will be collected prospectively without interference/modification of patient's management by the study team. The major inclusion criterion is diagnosed severe AATD, defined by an AAT serum level <11 µM (50 mg·dL-1) and/or a proteinase inhibitor genotype ZZ, SZ or compound heterozygotes or homozygotes of other rare deficient variants. Assessments at baseline and during the yearly follow-up visits include lung function testing (spirometry, body plethysmography and diffusing capacity of the lung), exercise capacity, blood tests and questionnaires (symptoms, quality of life and physical activity). To ensure correct data collection, there will be designated investigator staff to document the data in the case report form. All data will be reviewed by the EARCO database manager. SUMMARY: The EARCO Registry aims to understand the natural history and prognosis of AATD better with the goal to create and validate prognostic tools to support medical decision-making.

Inpatient multimodal occupational rehabilitation reduces sickness absence among individuals with musculoskeletal and common mental health disorders: a randomized clinical trial.

Objectives This study aimed to investigate whether inpatient multimodal occupational rehabilitation (I-MORE) reduces sickness absence (SA) more than outpatient acceptance and commitment therapy (O-ACT) among individuals with musculoskeletal and mental health disorders. Methods Individuals on sick leave (2-12 months) due to musculoskeletal or common mental health disorders were randomized to I-MORE (N=86) or O-ACT (N=80). I-MORE lasted 3.5 weeks in which participants stayed at the rehabilitation center. I-MORE included ACT, physical exercise, work-related problem solving and creating a return to work plan. O-ACT consisted mainly of 6 weekly 2.5 hour group-ACT sessions. We assessed the primary outcome cumulative SA within 6 and 12 months with national registry-data. Secondary outcomes were time to sustainable return to work and self-reported health outcomes assessed by questionnaires. Results SA did not differ between the interventions at 6 months, but after one year individuals in I-MORE had 32 fewer SA days compared to O-ACT (median 85 [interquartile range 33-149] versus 117 [interquartile range 59-189)], P=0.034). The hazard ratio for sustainable return to work was 1.9 (95% confidence interval 1.2-3.0) in favor of I-MORE. There were no clinically meaningful between-group differences in self-reported health outcomes. Conclusions Among individuals on long-term SA due to musculoskeletal and common mental health disorders, a 3.5-week I-MORE program reduced SA compared with 6 weekly sessions of O-ACT in the year after inclusion. Studies with longer follow-up and economic evaluations should be performed.

Research priorities in α1-antitrypsin deficiency: results of a patients' and healthcare providers' international survey from the EARCO Clinical Research Collaboration.

α1-antitrypsin deficiency (AATD) is a rare and under-recognised genetic condition. Owing to its low prevalence, international initiatives are key for conducting high-quality research in the field. From July 2018 to December 2019, the European Alpha-1 Research Collaboration (EARCO) developed and conducted two surveys, one for healthcare providers and one for patients and caregivers, aiming to identify research priorities and barriers in access to treatment for AATD. A survey on 164 research questions was electronically sent to 230 AATD experts in Europe, and 94 completed surveys from 24 countries were received. The top research areas identified by healthcare providers were causes of variable progression and poor outcomes, improvement in diagnosis, initiation and optimal dosing of augmentation therapy and effectiveness of self-management interventions. During the same period, 438 surveys were completed by patients and caregivers from 26 countries. The top research areas identified were improving knowledge about AATD, in particular among general practitioners, access to AATD specialised centres and access to reliable, easy to understand information about living with AATD. Regarding barriers to treatment, participants from countries where augmentation therapy was reimbursed prioritised improving knowledge in AATD, while respondents in non-reimbursed countries regarded access to AATD augmentation therapy and to specialised centres as the most relevant. The main research and management priorities identified by healthcare providers and patients included understanding the natural history of AATD, improving information to physicians, improving access to specialised reference centres, personalising treatment and having equal opportunities for access to existing therapies.

Biopsychosocial predictors and trajectories of work participation after transdiagnostic occupational rehabilitation of participants with mental and somatic disorders: a cohort study.

BACKGROUND: Group-based transdiagnostic occupational rehabilitation programs including participants with mental and somatic disorders have emerged in clinical practice. Knowledge is sparse on subsequent participation in competitive work. This study aimed to investigate trajectories for (re)entry to work for predefined subgroups in a diagnostically heterogeneous sample of sick-listed participants after completing occupational rehabilitation. METHODS: A cohort of 212 participants aged 18-69 on long-term sick leave (> 8 weeks) with chronic pain, chronic fatigue and/or common mental disorders was followed for one year after completing a 3½-week rehabilitation intervention based on Acceptance and Commitment Therapy. Self-reported, clinical and registry data were used to study the associations between predefined biopsychosocial predictors and trajectories for (re)entry to competitive work (≥ 1 day per week on average over 8 weeks). Generalized estimating equations analysis was used to investigate trajectories. RESULTS: For all biopsychosocial subgroups (re)entry to work increased over time. Baseline employment, partial sick leave and higher expectation of return to work (RTW) predicted higher probability of having (re)entered work at any given time after discharge. The odds of increasing reentry over time (statistical interaction with time) was weaker for the group receiving the benefit work assessment allowance compared with those receiving sickness benefit (OR = 0.92, p = 0.048) or for those on partial sick leave compared with full sick leave (OR 0.77, p < 0.001), but higher for those who at baseline had reported having a poor economy versus not (OR 1.16, p = 0.010) or reduced emotional functioning compared with not (OR 1.11, p = 0.012). Health factors did not differentiate substantially between trajectories. CONCLUSIONS: Work participation after completing a transdiagnostic occupational rehabilitation intervention was investigated. Individual and system factors related to work differentiated trajectories for (re)entry to work, while individual health factors did not. Having a mental disorder did not indicate a worse prognosis for (re)entry to work following the intervention. Future trials within occupational rehabilitation are recommended to pivot their focus to work-related factors, and to lesser extent target diagnostic group.

Randomized Controlled Trial of Adding Telephone Follow-Up to an Occupational Rehabilitation Program to Increase Work Participation.

Purpose Transfer from on-site rehabilitation to the participant's daily environment is considered a weak link in the rehabilitation chain. The main objective of this study is to see if adding boosted telephone follow-up directly after completing an occupational rehabilitation program effects work participation. Methods A randomized controlled study included participants with chronic pain, chronic fatigue or common mental disorders on long-term sick leave. After completing 3½ weeks of acceptance and commitment therapy based occupational rehabilitation, participants were randomized to boosted follow-up or a control group before returning to their daily environment. The intervention was delivered over 6 months by on-site RTW coordinators mainly via telephone. Primary outcome was RTW categorized as participation in competitive work ≥1 day per week on average over 8 weeks. Results There were 213 participants of mean age 42 years old. Main diagnoses of sick leave certification were mental disorders (38%) and musculoskeletal disorders (30%). One year after discharge the intervention group had 87% increased odds (OR 1.87, 95% confidence interval 1.06-3.31, p = 0.031), of (re)entry to competitive work ≥1 day per week compared with the controls, with similar positive results for sensitivity analysis of participation half time (≥2.5 days per week). The cost of boosted follow-up was 390.5 EUR per participant. Conclusion Participants receiving boosted RTW follow-up had higher (re)entry to competitive work ≥1 day per week at 1 year when compared to the control group. Adding low-cost boosted follow-up by telephone after completing an occupational rehabilitation program augmented the effect on return-to-work.