Geriatric assessment with management for older patients with cancer receiving radiotherapy: a cluster-randomised controlled pilot study.

BACKGROUND: Geriatric assessment and management (GAM) improve outcomes in older patients with cancer treated with surgery or chemotherapy. It is unclear whether GAM may provide better function and quality of life (QoL), or be cost-effective, in a radiotherapy (RT) setting. METHODS: In this Norwegian cluster-randomised controlled pilot study, we assessed the impact of a GAM intervention involving specialist and primary health services. It was initiated in-hospital at the start of RT by assessing somatic and mental health, function, and social situation, followed by individually adapted management plans and systematic follow-up in the municipalities until 8 weeks after the end of RT, managed by municipal nurses as patients' care coordinators. Thirty-two municipal/city districts were 1:1 randomised to intervention or conventional care. Patients with cancer ≥ 65 years, referred for RT, were enrolled irrespective of cancer type, treatment intent, and frailty status, and followed the allocation of their residential district. The primary outcome was physical function measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (QLQ-C30). Secondary outcomes were overall quality of life (QoL), physical performance, use and costs of health services. Analyses followed the intention-to-treat principle. Study registration at ClinicalTrials.gov ID NCT03881137. RESULTS: We included 178 patients, 89 in each group with comparable age (mean 74.1), sex (female 38.2%), and Edmonton Frail Scale scores (mean 3.4 [scale 0-17], scores 0-3 [fit] in 57%). More intervention patients received curative RT (76.4 vs 61.8%), had higher irradiation doses (mean 54.1 vs 45.5 Gy), and longer lasting RT (mean 4.4 vs 3.6 weeks). The primary outcome was completed by 91% (intervention) vs 88% (control) of patients. No significant differences between groups on predefined outcomes were observed. GAM costs represented 3% of health service costs for the intervention group during the study period. CONCLUSIONS: In this heterogeneous cohort of older patients receiving RT, the majority was fit. We found no impact of the intervention on patient-centred outcomes or the cost of health services. Targeting a more homogeneous group of only pre-frail and frail patients is strongly recommended in future studies needed to clarify the role and organisation of GAM in RT settings.

Cost consequences of task-shifting intravitreal injections from physicians to nurses in a tertiary hospital in Norway.

BACKGROUND: Anti-vascular endothelial growth factor is a medicine administered intravitreally by an injection to maintain visual acuity in patients with a variety of retinal diseases. The demand for this treatment has grown considerably in the westernized world the last two decades and will continue to increase due to an aging population. Because of the high volume, injections seize enormous resources and represent high costs for both hospitals and society. Task-shifting of injections from physicians to nurses may be a means to reduce such costs, however the magnitude of possible savings has been poorly investigated. To this end we investigated changes in the hospital costs per injection, six-year cost projections of physician- versus nurse-administered injections for a Norwegian tertiary hospital and we compared the societal costs per patient per year. METHODS: Patients (n = 318) were randomized to either physician- or nurse administered injections, and data were prospectively collected. Hospital costs per injection were calculated as the sum of training costs, personnel time and running expenses. The number of injections for the years 2014 - 21 from a Norwegian tertiary hospital was combined with age group specific injection prevalence and population projections to calculate cost projections for 2022 - 27. Societal costs per patient were calculated as the sum of hospital costs, transport costs for patients, caregivers' use of time, costs of ophthalmology consultations and community-based homecare. RESULTS: The hospital costs per injection were 5.5 € higher for physicians compared to nurses (281.6 € versus 276.1 €). Cost projections estimated an annual hospital saving of task-shifting of 48 921 € for 2022 - 27. Societal costs per patient did not differ significantly between the two groups (mean 4988 € vs 5418 €, p = 0.398). CONCLUSION: Task-shifting of injections from physicians to nurses can reduce hospital costs and increase the flexibility of physician resources. The annual savings are modest, but increased demand for injections might increase future cost savings. To achieve future savings for society, organizing ophthalmology consultations and injections on the same day to reduce the number of visits might be a solution. TRIAL REGISTRATION: ClinicalTrials.gov NCT02359149 (09/02/2015).

Economic Evaluation of Inpatient Multimodal Occupational Rehabilitation vs. Outpatient Acceptance and Commitment Therapy for Sick-Listed Workers with Musculoskeletal- or Common Mental Disorders.

PURPOSE: To evaluate the cost-effectiveness and cost-benefit of inpatient multimodal occupational rehabilitation (I-MORE) compared to outpatient acceptance and commitment therapy (O-ACT) for individuals sick listed due to musculoskeletal- or common mental disorders during two-years of follow-up. METHODS: We conducted an economic evaluation with a societal perspective alongside a randomized controlled trial with 24 months follow-up. Individuals sick listed 2 to 12 months were randomized to I-MORE (n = 85) or O-ACT (n = 79). The outcome was number of working days. Healthcare use and sick leave data were obtained by registry data. RESULTS: Total healthcare costs during the 24 months was 12,057 euros (95% CI 9,181 to 14,933) higher for I-MORE compared to O-ACT, while the difference in production loss was 14,725 euros (95% CI -1,925 to 31,375) in favour of I-MORE. A difference of 43 (95% CI -6 to 92) workdays, in favour of I-MORE, gave an incremental cost-effectiveness ratio of 278 euros for one workday, less than the cost of one day production (339 euros). Net societal benefit was 2,667 euros during two years of follow-up. CONCLUSION: Despite considerable intervention costs, the lower production loss resulted in I-MORE being cost-effective when compared to O-ACT. Based on economic arguments, I-MORE should be implemented as a treatment alternative for individuals on long-term sick leave. However, more research on subgroup effects and further follow-up of participants' permanent disability pension awards are warranted.

Self-referral to inpatient treatment program in a community mental health Centre in Central Norway: investigating the implementation, professionals' experiences and costs.

BACKGROUND: Self-referral to inpatient treatment (SRIT) is built on user participation and patient autonomy. SRIT was conducted for patients with severe mental disorders in a Norwegian Community Mental Health Centre. The aims of the present study were to describe the implementation of SRIT, explore the professionals' experiences of SRIT and assess the costs entailed. METHODS: Qualitative document analysis, interviews with professionals and quantitative analysis of register data from a randomized controlled trial were used. RESULTS: SRIT seemed to be implemented as intended. According to the professionals, SRIT allowed the patients to cope, be empowered, more active and responsible. Some professionals experienced increased responsibility for patients' medication and for assessing health and suicide risks. SRIT did not reduce hospital costs. The professionals were satisfied with nurse-led SRIT treatment. CONCLUSIONS: SRIT appears to be a high-quality mental health service that empowers and activates patients. Nurse-led treatment may entail more efficient use of professional resources. In future implementations of SRIT, the efficient use of service resources and the administration of beds should be investigated. More flexible availability should be considered in line with the intentions behind SRIT, as well as ensuring adequate professional training in assessing health and suicide risk.

Health-related quality of life in Norwegian adolescents living with chronic fatigue syndrome.

PURPOSE: The primary aim was to measure health related quality of life (HRQoL) in a Norwegian cohort of adolescents with Chronic Fatigue Syndrome (CFS/ME). A secondary aim was to identify factors before diagnosis, at time of diagnosis and after diagnosis that were associated with HRQoL. METHODS: In this cross-sectional population-based study, HRQoL was measured by Pediatric Quality of Life Inventory™ Generic Core scale version 4.0 (PedsQL4.0) in 63 adolescents with CFS/ME. In addition, fatigue was measured by PedsQL Multidimensional Fatigue scale (PedsQL-MFS), depressive symptoms were measured by the Short Mood and Feelings Questionnaire (SMFQ), and disruption in school activities was measured by The De Paul Pediatric Health Questionnaire (DPHQ-N). Data were also collected from medical records and patient interviews. RESULTS: Age at diagnosis was 15 (2) years (mean (SD)), and four out of five participants were female. Time from diagnosis to reply was 39 (22) months. Adolescents with CFS/ME reported PedsQL4.0 score 50 (17), and boys reported a better score than girls (64 vs 47, 95% Confidence Interval (CI) for difference (- 27; - 6)). There were positive associations between overall HRQoL and support from a schoolteacher, school attendance or participation in leisure activities. There were negative associations between overall HRQoL and delayed school progression, having been to rehabilitation stay and depressive symptoms. CONCLUSION: HRQoL in adolescents diagnosed with CFS/ME was low. The associations between reported HRQoL, healthcare previously provided, support from a schoolteacher, school attendance and participation in leisure activity may provide information of value when developing refined strategies for healthcare among adolescents with CFS/ME. Possible causal relationships must however be explored in future studies.

Factors contributing to post-stroke health care utilization and costs, secondary results from the life after stroke (LAST) study.

BACKGROUND: The result from the Life After Stroke (LAST) study showed that an 18-month follow up program as part of the primary health care, did not improve maintenance of motor function for stroke survivors. In this study we evaluated whether the follow-up program could lead to a reduction in the use of health care compared to standard care. Furthermore, we analyse to what extent differences in health care costs for stroke patients could be explained by individual need factors (such as physical disability, cognitive impairment, age, gender and marital status), and we tested whether a generic health related quality of life (HRQoL) is able to predict the utilisation of health care services for patients post-stroke as well as more disease specific indexes. METHODS: The Last study was a multicentre, pragmatic, single-blinded, randomized controlled trial. Adults (age ≥ 18 years) with first-ever or recurrent stroke, community dwelling, with modified Rankin Scale < 5. The study included 380 persons recruited 10 to 16 weeks post-stroke, randomly assigned to individualized coaching for 18 months (n = 186) or standard care (n = 194). Individual need was measured by the Motor assessment scale (MAS), Barthel Index, Hospital Anxiety and Depression Scale (HADS), modified Rankin Scale (mRS) and Gait speed. HRQoL was measured by EQ-5D-5 L. Health care costs were estimated for each person based on individual information of health care use. Multivariate regression analysis was used to analyse cost differences between the groups and the relationship between individual costs and determinants of health care utilisation. RESULTS: There were higher total costs in the intervention group. MAS, Gait speed, HADS and mRS were significant identifiers of costs post-stroke, as was EQ-5D-5 L. CONCLUSION: Long term, regular individualized coaching did not reduce health care costs compared to standard care. We found that MAS, Gait speed, HADS and mRS were significant predictors for future health care use. The generic EQ-5D-5 L performed equally well as the more detailed battery of outcome measures, suggesting that HRQoL measures may be a simple and efficient way of identifying patients in need of health care after stroke and targeting groups for interventions. TRIAL REGISTRATION: https://www.clinicaltrials.govNCT01467206. The trial was retrospectively registered after the first 6 participants were included.

Steam ablation versus stripping of great saphenous varicose veins. / Vanndampbehandling versus stripping av vena saphena magna ved åreknuter.

BACKGROUND: Use of new technology can lead to changes in the treatment course for patients and in treatment costs for the health service. The aim of this study was to compare sickness absence and time to resumption of daily activities, as well as treatment costs, for two surgical treatments for varicose veins: endovenous steam ablation and vein stripping. MATERIAL AND METHOD: This prospective observational study included 46 patients treated with steam ablation and 37 treated with vein stripping in the period 2015-2016. The two groups were matched with respect to age, sex, occupational status and classification. After treatment, patients were interviewed every other week until daily activities had been resumed. Detailed information on expenditure related to personnel, equipment, premises and materials was used to calculate the cost of treatment. RESULTS: Patients treated with steam ablation resumed daily activities after a median of 0 (interquartile range 0-2) days versus 4 (2-7) days for vein stripping (p < 0.001), and sporting activities after 4 (2-9) days versus 11 (3-19) days (p < 0.004). For patients in employment, sickness absence after steam ablation was 2 (2-5) days versus 14 (6-21) for patients treated with vein stripping (p < 0.001). The estimated treatment cost for steam ablation was NOK 5 973, compared with NOK 10 109 for vein stripping. INTERPRETATION: Steam ablation led to shorter convalescence and sickness absence for the patient, and lower costs for the hospital. Reduced sickness absence also implies lower costs for society.

Rights assessment and quality of referrals - rate of agreement between four pain management centres. / Rettighetsvurdering og kvalitet på henvisninger ­ grad av samsvar mellom fire smertesentre.

BACKGROUND: Chronic pain is a widespread health problem. The four regional interdisciplinary pain management centres in Norway receive approximately 5 000 referrals from GPs and the specialist health service annually. Equality in service provision requires referrals to be identically assessed. The objective of the study was to evaluate the degree of correspondence between the admission teams in the pain management centres in their assessment of the quality of the referrals received and in their assessment of the patients' right to necessary health care. MATERIAL AND METHOD: Each admission team assessed 40 referrals. They undertook a 'primary assessment' of 10 referrals received in the regular manner and a 'secondary assessment' of 30 referrals sent in the regular manner to the other centres. Each referral was assessed for quality and rights in each centre. The proportion of agreement and the intra-class correlation coefficient (ICC) were used to assess correspondence between the admission teams. RESULTS: The quality of the referrals was deemed 'not good' in 45 % of the primary assessments and 43 % of the secondary assessments. The degree of correspondence varied from low (ICC = 0.19) to moderate (ICC = 0.74). The primary and secondary assessments both granted 63 % of the patients 'the legal right to health care'. The overall degree of correspondence was 69 %, i.e. lower than what is considered 'acceptable agreement' (75 %). INTERPRETATION: The study shows that there is a need for structured referrals, and for the admission teams to harmonise their assessments to a greater degree in order to ensure equality in service provision across the health regions.

Design of a study evaluating the effects, health economics, and stakeholder perspectives of a multi-component occupational rehabilitation program with an added workplace intervention - a study protocol.

BACKGROUND: Recent research has suggested that interventions at the workplace might be the most potent ingredient in return to work interventions, but few studies have investigated the different effects of workplace interventions as part of occupational rehabilitation programs. The comprehensive design described in this article includes effect (on return to work and health outcomes), and health economic evaluations of a workplace intervention added to a multicomponent rehabilitation program. Qualitative and mixed method studies will investigate sick-listed persons', rehabilitation therapists' and employers' perspectives on the usability and outcomes of the rehabilitation program and the workplace intervention. The program and intervention are provided to patients with musculoskeletal, psychological or general and unspecified diagnoses. The program is multi-component and includes Acceptance and Commitment Therapy, physical exercise, patient education and creating a plan for increased work participation. METHODS: Persons who are employed, aged from 18 to 60 years, with a current sick leave status of 50% or more and a diagnosis within the musculoskeletal, psychological or general and unspecified chapters of International Classification of Primary Care-2 (ICPC-2) will be recruited to a researcher-blinded parallel-group randomized controlled trial. All participants take part in an in-patient occupational rehabilitation program, while the intervention group also takes part in an intervention at the workplace. The effect and economic evaluation will investigate the effect of the added workplace intervention. The primary outcome measures will be time until full sustainable return to work and total number of sickness absence days in the 12 months after inclusion. Health economic evaluations will investigate the cost-effectiveness and cost-utility. Qualitative studies will investigate rehabilitation therapists' experiences with working towards return to work within an ACT-approach and stakeholders' experiences with the workplace intervention. A mixed methods study will combine quantitative and qualitative findings on the participants' expectations and motivation for return to work. DISCUSSION: The outline of this comprehensive study could represent an important addition to the standard designs of return to work evaluation. The mixed methods design, with qualitative approaches as well as a rigorous randomized controlled trial, might prove useful to shed light on contextual factors. TRIAL REGISTRATION: ClinicalTrials.gov : NCT02541890 . September 4, 2015.

Motivational interviewing in long-term sickness absence: study protocol of a randomized controlled trial followed by qualitative and economic studies.

BACKGROUND: Motivational interviewing (MI), mainly used and shown effective in health care (substance abuse, smoking cessation, increasing exercise and other life style changes), is a collaborative conversation (style) about change that could be useful for individuals having problems related to return to work (RTW). The aim of this paper is to describe the design of a randomized controlled trial evaluating the effect of MI on RTW among sick listed persons compared to usual care, in a social security setting. METHODS: The study is a randomized controlled trial with parallel group design. Individuals between 18 and 60 years who have been sick listed for more than 7 weeks, with a current sick leave status of 50-100%, are identified in the Norwegian National Social Security System and invited to participate in the study. Exclusion criteria are no employment and pregnancy. Included participants are randomly assigned to the MI intervention or one of two control groups. The MI intervention consists of two MI sessions offered by caseworkers at the Norwegian Labor and Welfare Service (NAV), while the comparative arms consist of a usual care group and a group that receives two extra sessions without MI content (to control for attentional bias). The primary outcome measure is the total number of sickness absence days during 12 months after inclusion, obtained from national registers. Secondary outcomes include time until full sustainable return to work, health-related quality of life and mental health status. In addition, a health economic evaluation, a feasibility/process evaluation and qualitative studies will be performed as part of the study. DISCUSSION: A previous study has suggested an effect of MI on RTW for sick listed workers with musculoskeletal complaints. The present study will evaluate the effect of MI for all sick listed workers, regardless of diagnosis. The knowledge from this study will potentially be important for policy makers, clinicians and other professionals` practical work. TRIAL REGISTRATION: ClinicalTrials.gov: NCT03212118 (registered July 11, 2017).

A study of unreasonable illegitimate tasks, administrative tasks, and sickness presenteeism amongst Norwegian physicians: an everyday struggle?

BACKGROUND: It has been shown that a recently defined stressor, 'illegitimate tasks', has negative effects on employees' work motivation and health. Better understanding of the illegitimate tasks undertaken by physicians might contribute to a more resource-efficient division of labour within the health care system, with beneficial effects on organisational economics and employee performance. We aimed to investigate the prevalence of unreasonable illegitimate tasks, their associations with workplace variables and their impact on health, in particular sickness presenteeism. METHODS: Cross-sectional data were collected in 2012. A sample of 545 Norwegian physicians answered an online questionnaire. The response rate was high (71.8%). The data were analysed using independent-samples t-tests, ANOVA and logistic regression. RESULTS: About 50.2% of physicians in all clinical positions reported that at least 11% of their everyday tasks could have been done by other hospital personnel. Seven percent of the physicians reported that at least 31% of their daily workload consisted of unreasonable illegitimate tasks. There were no significant differences in unreasonable illegitimate tasks according to clinical position, age or gender. Administrative task load and role conflict were positively associated with unreasonable illegitimate tasks that physicians reported could be reallocated to non-medical professionals. Moreover, unreasonable illegitimate task was associated with a higher probability of sickness presenteeism after controlling for age, gender, role conflict, control over work pace, exhaustion and administrative tasks. CONCLUSIONS: The results confirm that physicians' workload includes a high proportion of unreasonable illegitimate tasks and that this can contribute to sickness presenteeism. Investigation of work environmental factors can provide insight into the mechanisms behind unreasonable illegitimate tasks. Decreasing the amount of administrative tasks and role conflicts faced by physicians should be a priority. These findings could be used to make hospital task management more resource-efficient. Our results indicate that a substantial proportion of physicians' work capacity could be re-allocated to core tasks. Further research is needed into the specific type and content of unreasonable illegitimate tasks undertaken by physicians in order to determine to whom they should be allocated to ensure a healthy and motivated workforce and provision of high quality, resource-efficient health care services.

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.

Effect of Inpatient Multicomponent Occupational Rehabilitation Versus Less Comprehensive Outpatient Rehabilitation on Sickness Absence in Persons with Musculoskeletal- or Mental Health Disorders: A Randomized Clinical Trial.

Purpose To assess effects of an inpatient multicomponent occupational rehabilitation program compared to less comprehensive outpatient rehabilitation on sickness absence in persons with musculoskeletal- or mental health disorders. Methods Randomized clinical trial with parallel groups. Participants were individuals 18-60 years old on sick-leave for 2-12 months with a sick-leave diagnosis within the musculoskeletal, psychological or general and unspecified chapters of ICPC-2, identified in a national register. The inpatient program (4 + 4 days) consisted of Acceptance and Commitment Therapy (ACT), physical training and work-related problem-solving including creating a return to work plan and a workplace visit if considered relevant. The outpatient program consisted primarily of ACT (6 sessions during 6 weeks). Both programs were group based. Primary outcome was cumulated number of sickness absence days at 6 and 12 months follow-up. Secondary outcome was time until sustainable return to work. Results 168 individuals were randomized to the inpatient program (n = 92) or the outpatient program (n = 76). We found no statistically significant difference between the programs in median number of sickness absence days at 6 and 12 months follow-up. In the outpatient program 57% of the participants achieved sustainable return to work (median time 7 months), in the inpatient program 49% (log rank, p = 0.167). The hazard ratio for sustainable return to work was 0.74 (95% CI 0.48-1.32, p = 0.165), in favor of the outpatient program. Conclusions This study provided no support that the more comprehensive 4 + 4 days inpatient multicomponent occupational rehabilitation program reduced sickness absence compared to the outpatient rehabilitation program.

Comprehensive geriatric care for patients with hip fractures: a prospective, randomised, controlled trial.

BACKGROUND: Most patients with hip fractures are characterised by older age (>70 years), frailty, and functional deterioration, and their long-term outcomes are poor with increased costs. We compared the effectiveness and cost-effectiveness of giving these patients comprehensive geriatric care in a dedicated geriatric ward versus the usual orthopaedic care. METHODS: We did a prospective, single-centre, randomised, parallel-group, controlled trial. Between April 18, 2008, and Dec 30, 2010, we randomly assigned home-dwelling patients with hip-fractures aged 70 years or older who were able to walk 10 m before their fracture, to either comprehensive geriatric care or orthopaedic care in the emergency department, to achieve the required sample of 400 patients. Randomisation was achieved via a web-based, computer-generated, block method with unknown block sizes. The primary outcome, analysed by intention to treat, was mobility measured with the Short Physical Performance Battery (SPPB) 4 months after surgery for the fracture. The type of treatment was not concealed from the patients or staff delivering the care, and assessors were only partly masked to the treatment during follow-up. This trial is registered with ClinicalTrials.gov, number NCT00667914. FINDINGS: We assessed 1077 patients for eligibility, and excluded 680, mainly for not meeting the inclusion criteria such as living in a nursing home or being aged less than 70 years. Of the remaining patients, we randomly assigned 198 to comprehensive geriatric care and 199 to orthopaedic care. At 4 months, 174 patients remained in the comprehensive geriatric care group and 170 in the orthopaedic care group; the main reason for dropout was death. Mean SPPB scores at 4 months were 5·12 (SE 0·20) for comprehensive geriatric care and 4·38 (SE 0·20) for orthopaedic care (between-group difference 0·74, 95% CI 0·18-1·30, p=0·010). INTERPRETATION: Immediate admission of patients aged 70 years or more with a hip fracture to comprehensive geriatric care in a dedicated ward improved mobility at 4 months, compared with the usual orthopaedic care. The results suggest that the treatment of older patients with hip fractures should be organised as orthogeriatric care. FUNDING: Norwegian Research Council, Central Norway Regional Health Authority, St Olav Hospital Trust and Fund for Research and Innovation, Liaison Committee between Central Norway Regional Health Authority and the Norwegian University of Science and Technology, the Department of Neuroscience at the Norwegian University of Science and Technology, Foundation for Scientific and Industrial Research at the Norwegian Institute of Technology (SINTEF), and the Municipality of Trondheim.

Nurse-administered intravitreal injections of anti-VEGF: study protocol for noninferiority randomized controlled trial of safety, cost and patient satisfaction.

BACKGROUND: Intravitreal injections (IVI) of anti-vascular endothelial growth factor (anti-VEGF) now improve or stabilize visual acuity in a number of previously untreatable eye diseases, of which the main are age-related macular degeneration, retinal vein occlusion and diabetic macular edema. Most patients require multiple injections over lengthy periods of time and the prevalence of treatable conditions is increasing. Anti-VEGF IVI normally administered by physicians, therefore represent a considerable workload on ophthalmologic clinics and will continue to do so in the near future. Nurse-administered IVI may relieve this workload, but the safety, cost and patient satisfaction of such an extended role for nurses in ophthalmologic clinics has not earlier been investigated. To investigate these outcomes following independent anti-VEGF IVI by trained nurses, a noninferiority randomized controlled trial is being conducted. METHODS/DESIGN: Patients eligible for anti-VEGF treatment, minimum 304, are recruited and randomized to IVI administration by either trained nurses or physicians. The primary outcome is safety, measured by difference in mean change in visual acuity between the two groups during an observation period of 12 months. Secondary outcomes are incidence of ocular adverse events, cost per patient and patient satisfaction. DISCUSSION: This study protocol describes the design of the first randomized controlled trial of nurse-administered IVI of anti-VEGF. The study is designed to examine safety, cost and patient satisfaction during 12 months follow-up. TRIAL REGISTRATION: ClinicalTrials.gov NCT02359149 . Registered February 4, 2015.

One-year health and care costs after hip fracture for home-dwelling elderly patients in Norway: Results from the Trondheim Hip Fracture Trial.

AIM: The aim of this study was to estimate the one-year health and care costs related to hip fracture for home-dwelling patients aged 70 years and older in Norway, paying specific attention to the status of the patients at the time of fracture and cost differences due to various patient pathways after fracture. METHODS: Data on health and care service provision were extracted from hospital and municipal records and from national registries; data on unit costs were collected from the municipalities, hospital administrations and previously published studies. Four different patient pathways were identified and the total costs for subgroups of patients according to age, sex, fracture type and instrumental activity of daily living at fracture incidence were calculated. Descriptive statistics were used to identify cost estimates. RESULTS: The mean total one-year costs per patient were EUR 68,376 and the costs for patients alive one year after hip fracture were EUR 71,719. The patients' age and pre-fracture functional status contributed most to the total cost. CONCLUSIONS: On average, care costs accounted for more than 50% of the total cost; even for patients with good functional status before hip fracture, care costs accounted for 40% of the total cost compared with hospital costs of 38%. To reduce the financial costs of hip fractures in the care sector, the results point to the importance of preventive programmes to reduce the risk of hip fracture, but also to the importance of comprehensive geriatric care in the initial phase after a hip fracture.

Occupational rehabilitation programs for musculoskeletal pain and common mental health disorders: study protocol of a randomized controlled trial.

BACKGROUND: Long-term sick leave has considerably negative impact on the individual and society. Hence, the need to identify effective occupational rehabilitation programs is pressing. In Norway, group based occupational rehabilitation programs merging patients with different diagnoses have existed for many years, but no rigorous evaluation has been performed. The described randomized controlled trial aims primarily to compare two structured multicomponent inpatient rehabilitation programs, differing in length and content, with a comparative cognitive intervention. Secondarily the two inpatient programs will be compared with each other, and with a usual care reference group. METHODS/DESIGN: The study is designed as a randomized controlled trial with parallel groups. The Social Security Office performs monthly extractions of sick listed individuals aged 18-60 years, on sick leave 2-12 months, with sick leave status 50% - 100% due to musculoskeletal, mental or unspecific disorders. Sick-listed persons are randomized twice: 1) to receive one of two invitations to participate in the study or not receive an invitation, where the latter "untouched" control group will be monitored for future sick leave in the National Social Security Register, and 2) after inclusion, to a Long or Short inpatient multicomponent rehabilitation program (depending on which invitation was sent) or an outpatient cognitive behavioral therapy group comparative program. The Long program consists of 3 ½ weeks with full rehabilitation days. The Short program consists of 4 + 4 full days, separated by two weeks, in which a workplace visit will be performed if desirable. Three areas of rehabilitation are targeted: mental training, physical training and work-related problem solving. The primary outcome is number of sick leave days. Secondary outcomes include time until full sustainable return to work, health related quality of life, health related behavior, functional status, somatic and mental health, and perceptions of work. In addition, health economic evaluation will be performed, and the implementation of the interventions, expectations and experiences of users and service providers will be investigated with different qualitative methods. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01926574.

Developing a Program Costs Checklist of Digital Health Interventions: A Scoping Review and Empirical Case Study.

INTRODUCTION: The rate of development and complexity of digital health interventions (DHIs) in recent years has to some extent outpaced the methodological development in economic evaluation and costing. Particularly, the choice of cost components included in intervention or program costs of DHIs have received scant attention. The aim of this study was to build a literature-informed checklist of program cost components of DHIs. The checklist was next tested by applying it to an empirical case, Mamma Mia, a DHI developed to prevent perinatal depression. METHOD: A scoping review with a structured literature search identified peer-reviewed literature from 2010 to 2022 that offers guidance on program costs of DHIs. Relevant guidance was summarized and extracted elements were organized into categories of main cost components and their associated activities following the standard three-step approach, that is, activities, resource use and unit costs. RESULTS: Of the 3448 records reviewed, 12 studies met the criteria for data extraction. The main cost categories identified were development, research, maintenance, implementation and health personnel involvement (HPI). Costs are largely considered to be context-specific, may decrease as the DHI matures and vary with number of users. The five categories and their associated activities constitute the checklist. This was applied to estimate program costs per user for Mamma Mia Self-Guided and Blended, the latter including additional guidance from public health nurses during standard maternal check-ups. Excluding research, the program cost per mother was more than double for Blended compared with Self-Guided (€140.5 versus €56.6, 2022 Euros) due to increased implementation and HPI costs. Including research increased the program costs to €190.8 and €106.9, respectively. One-way sensitivity analyses showed sensitivity to changes in number of users, lifespan of the app, salaries and license fee. CONCLUSION: The checklist can help increase transparency of cost calculation and improve future comparison across studies.

Estimating program or intervention costs of digital health interventions (DHIs) can be challenging without a checklist. We reviewed scientific literature to identify key cost categories of DHIs: development, research, maintenance, implementation and health personnel involvement. We also summarized relevant information regarding resource use and unit cost for each of the aforementioned categories. Applying this checklist to Mamma Mia, a DHI aimed at preventing perinatal depression, we find that the total cost per user for Mamma Mia Self-Guided is €106.9 and for Mamma Mia Blended is €190.8. Our checklist enhances visibility of DHI cost components and can aid analysts in better estimating costs for economic evaluations.

The healthcare costs of increased body mass index-evidence from The Trøndelag Health Study.

BACKGROUND: Earlier studies have estimated the impact of increased body mass index (BMI) on healthcare costs. Various methods have been used to avoid potential biases and inconsistencies. Each of these methods measure different local effects and have different strengths and weaknesses. METHODS: In the current study we estimate the impact of increased BMI on healthcare costs using nine common methods from the literature: multivariable regression analyses (ordinary least squares, generalized linear models, and two-part models), and instrumental variable models (using previously measured BMI, offspring BMI, and three different weighted genetic risk scores as instruments for BMI). We stratified by sex, investigated the implications of confounder adjustment, and modelled both linear and non-linear associations. RESULTS: There was a positive effect of increased BMI in both males and females in each approach. The cost of elevated BMI was higher in models that, to a greater extent, account for endogenous relations. CONCLUSION: The study provides solid evidence that there is an association between BMI and healthcare costs, and demonstrates the importance of triangulation.

Health service costs and clinical gains of psychotherapy for personality disorders: a randomized controlled trial of day-hospital-based step-down treatment versus outpatient treatment at a specialist practice.

BACKGROUND: Day-hospital-based treatment programmes have been recommended for poorly functioning patients with personality disorders (PD). However, more research is needed to confirm the cost-effectiveness of such extensive programmes over other, presumably simpler, treatment formats. METHODS: This study compared health service costs and psychosocial functioning for PD patients randomly allocated to either a day-hospital-based treatment programme combining individual and group psychotherapy in a step-down format, or outpatient individual psychotherapy at a specialist practice. It included 107 PD patients, 46% of whom had borderline PD, and 40% of whom had avoidant PD. Costs included the two treatment conditions and additional primary and secondary in- and outpatient services. Psychosocial functioning was assessed using measures of global (observer-rated GAF) and occupational (self-report) functioning. Repeated assessments over three years were analysed using mixed models. RESULTS: The costs of step-down treatment were higher than those of outpatient treatment, but these high costs were compensated by considerably lower costs of other health services. However, costs and clinical gains depended on the type of PD. For borderline PD patients, cost-effectiveness did not differ by treatment condition. Health service costs declined during the trial, and functioning improved to mild impairment levels (GAF > 60). For avoidant PD patients, considerable adjuvant health services expanded the outpatient format. Clinical improvements were nevertheless superior to the step-down condition. CONCLUSION: Our results indicate that decisions on treatment format should differentiate between PD types. For borderline PD patients, the costs and gains of step-down and outpatient treatment conditions did not differ. For avoidant PD patients, the outpatient format was a better alternative, leaning, however, on costly additional health services in the early phase of treatment. TRIAL REGISTRATION: Clinical Trials NCT00378248.