The reliability and validity of the Norwegian version of the Victorian Institute of Sports Assessment for gluteal tendinopathy questionnaire (VISA-G-Norwegian) for patients with greater trochanteric pain syndrome.

BACKGROUND: Greater Trochanteric Pain Syndrome (GTPS) is a common chronic musculoskeletal condition that may affect physical function, quality of life and sleep. The Victorian Institute of Sport Assessment-Gluteal questionnaire (VISA-G) has been developed as a Patient-Reported Outcome Measurement (PROM) to address pain, everyday activities, physical activities, and difficulty with weight bearing activities. The aim of the study was to test the reliability, validity and floor and ceiling effects of the Norwegian version of the VISA-G (VISA-G-Norwegian) in a population with GTPS in a specialist health care setting. METHODS: This psychometric evaluation of the VISA-G-Norwegian questionnaire were conducted with a prospective observational design. The VISA-G was translated into Norwegian following recommended guidelines. A subgroup repeated the VISA-G-Norwegian a week after the initial submission. For the reliability, the Intraclass Correlation Coefficient (ICC2.1), Standard Error of the Measurement (SEM) and the Smallest Detectable Change (SDC95%) were calculated. Internal consistency was measured using a Cronbach´s alpha. Floor and ceiling effects were evaluated, and construct validity was assessed with three a priori hypotheses. RESULTS: 78 participants were included in the study of which 47 stable participants undertook the test-retest reliability arm of the study. The ICC2.1 for the total score was 0.85 (95% CI 0.68, 0.92), SEM was 6.6 points and SDC95% 18.4 points. Cronbach`s alpha was 0.77 (95% CI 0.69, 0.84). No floor or ceiling effects were found in the total score, but ceiling effect was found in three of the eight items. For construct validity, one of the three hypotheses were confirmed. VISA-G-Norwegian correlated to the modified Harris Hip Score (mHHS), Oswestry Disability Questionnaire (ODI) and Numeric Pain Rating Scale (NPRS), 0.64, -0.75 and - 0.63 respectively. CONCLUSION: The VISA-G-Norwegian has acceptable reliability and validity, despite ceiling effect of individual items. The large SDC95% should be considered when measuring change in similar cohorts with GTPS. For a potential future version, it would be recommended to consider response options for questions with ceiling effect and the comprehensibility of question eight. TRIAL REGISTRATION: Registered at ClinicalTrials.gov the 28/02/2020 (NCT04289922).

Making shoulder pain simple in general practice: implementing an evidence-based guideline for shoulder pain, protocol for a hybrid design stepped-wedge cluster randomised study (EASIER study).

INTRODUCTION: Research suggests that current care for shoulder pain is not in line with the best available evidence. This project aims to assess the effectiveness, cost-effectiveness and the implementation of an evidence-based guideline for shoulder pain in general practice in Norway. METHODS AND ANALYSIS: A stepped-wedge, cluster-randomised trial with a hybrid design assessing clinical effectiveness, cost-effectiveness and the effect of the implementation strategy of a guideline-based intervention in general practice. We will recruit at least 36 general practitioners (GPs) and randomise the time of cross-over from treatment as usual to the implemented intervention. The intervention includes an educational outreach visit to the GPs, a computerised decision tool for GPs and a self-management application for patients. We will measure outcomes at patient and GP levels using self-report questionnaires, focus group interviews and register based data. The primary outcome measure is the patient-reported Shoulder Pain and Disability Index measured at 12 weeks. Secondary outcomes include the EuroQol Quality of Life Measure (EQ5D-5L), direct and indirect costs, patient's global perceived effect of treatment outcome, Pain Self-Efficacy and Brief Illness Perception Questionnaire. We will evaluate the implementation process with focus on adherence to guideline treatment. We will do a cost-minimisation analysis based on direct and selected indirect costs and a cost-utility analysis based on EQ5D-5L. We will use mixed effect models to analyse primary and secondary outcomes. ETHICS AND DISSEMINATION: Ethics approval was granted by the Regional Committee for Medical and Health Research Ethics-South East Norway (ref. no: 2019/104). Trial results will be submitted for publication in a peer-reviewed medical journal in accordance with Consolidated Standards of Reporting Trials. TRIAL REGISTRATION NUMBER: NCT04806191.

Cost-utility analysis of antibiotic treatment in patients with chronic low back pain and Modic changes: results from a randomised, placebo-controlled trial in Norway (the AIM study).

OBJECTIVE: To evaluate the cost-utility of 100 days of antibiotics in patients with chronic low back pain (LBP) and type I or II Modic changes included in the Antibiotic treatment In patients with chronic low back pain and Modic changes (AIM) study. DESIGN: A cost-utility analysis from a societal and healthcare perspective alongside a double-blinded, parallel group, placebo, multicentre trial. SETTING: Hospital outpatient clinics at six hospitals in Norway. The main results from the AIM study showed a small effect in back-related disability in favour of the antibiotics group, and slightly larger in those with type I Modic changes, but this effect was below the pre-defined threshold for clinically relevant effect. PARTICIPANTS: 180 patients with chronic LBP, previous disc herniation and Modic changes type I (n=118) or type II (n=62) were randomised to antibiotic treatment (n=89) or placebo-control (n=91). INTERVENTIONS: Oral treatment with either 750 mg amoxicillin or placebo three times daily for 100 days. MAIN OUTCOME MEASURES: Quality-adjusted life years (QALYs) by EuroQoL-5D over 12 months and costs for healthcare and productivity loss measured in Euro (€1=NOK 10), in the intention-to-treat population. Cost-utility was expressed in incremental cost-effectiveness ratio (ICER). RESULTS: Mean (SD) total cost was €21 046 (20 105) in the amoxicillin group and €19 076 (19 356) in the placebo group, mean difference €1970 (95% CI; -3835 to 7774). Cost per QALY gained was €24 625. In those with type I Modic changes, the amoxicillin group had higher healthcare consumption than the placebo group, resulting in €39 425 per QALY gained. Given these ICERs and a willingness-to-pay threshold of €27 500 (NOK 275 000), the probability of amoxicillin being cost-effective was 51%. Even when the willingness-to-pay threshold increased to €55 000, the probability of amoxicillin being cost-effective was never higher than 53%. CONCLUSIONS: Amoxicillin treatment showed no evidence of being cost-effective for people with chronic LBP and Modic changes during 1-year follow-up. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov NCT02323412.

Changes in the rate of publicly financed knee arthroscopies: an analysis of data from the Norwegian patient registry from 2012 to 2016.

OBJECTIVE: To examine rates of publicly financed knee arthroscopic surgery in Norway between 2012 and 2016. DESIGN: Analysis of anonymised data from the National Patient Registry. INTERVENTIONS: Beginning in 2012, South-Eastern Norway Regional Health Authority implemented administrative measures to bring down rates of knee arthroscopy. Similar measures were not introduced in the other three Regional Health Authorities. MAIN OUTCOME MEASURES: We analysed annual national rates of publicly financed knee arthroscopies in 2012 and 2016. We compared the rates in South-Eastern Norway Regional Health Authority with corresponding rates in the rest of the country. Variations by county, public hospital versus publicly reimbursed private hospital, gender and age were also assessed. RESULTS: The overall annual rate of arthroscopic procedures declined by 33% from 2012 to 2016, from 310 to 207 per 100 000 inhabitants, respectively. Hospitals in South-Eastern Norway Regional Health Authority reported a 48% reduction, compared with mean 13% in the other three Regional Health Authorities. In public hospitals, rates decreased nationally by 42%, while rates in publicly reimbursed private hospitals increased by 12%. Rates in publicly reimbursed private hospitals decreased by 30% in South-Eastern Norway Regional Health Authority but increased by 63% in the other Regional Health Authorities. The proportion of patients ≥50 years (excluding meniscal repairs) in Norway was 54% in 2012 and fell to 46% in 2016. Average rates per county varied by a factor of 3:1. CONCLUSION: We report a marked overall reduction of knee arthroscopic procedures from 2012 to 2016 in publicly funded hospitals. The largest decrease was reported in South-Eastern Norway Regional Health Authority, and this coincides in time with implemented administrative measures. The results suggest that the trend of increasing rates of knee arthroscopies can be reversed through purposeful professional and administrative interventions.

Antibiotic treatment In patients with chronic low back pain and Modic changes (the AIM study): study protocol for a randomised controlled trial.

BACKGROUND: A previous randomised controlled trial (RCT) of patients with chronic low back pain (LBP) and vertebral bone marrow (Modic) changes (MCs) on magnetic resonance imaging (MRI), reported that a 3-month, high-dose course of antibiotics had a better effect than placebo at 12 months' follow-up. The present study examines the effects of antibiotic treatment in chronic LBP patients with MCs at the level of a lumbar disc herniation, similar to the previous study. It also aims to assess the cost-effectiveness of the treatment, refine the MRI assessment of MCs, and further evaluate the impact of the treatment and the pathogenesis of MCs by studying genetic variability and the gene and protein expression of inflammatory biomarkers. METHODS/DESIGN: A double-blinded RCT is conducted at six hospitals in Norway, comparing orally administered amoxicillin 750 mg, or placebo three times a day, over a period of 100 days in patients with chronic LBP and type I or II MCs at the level of a MRI-confirmed lumbar disc herniation within the preceding 2 years. The inclusion will be stopped when at least 80 patients are included in each of the two MC type groups. In each MC type group, the study is designed to detect (ß = 0.1, α = 0.05) a mean difference of 4 (standard deviation 5) in the Roland Morris Disability Questionnaire score between the two treatment groups (amoxicillin or placebo) at 1-year follow-up. The study includes cost-effectiveness measures. Blood samples are assessed for security measures and for possible inflammatory mediators and biomarkers at different time points. MCs are evaluated on MRI at baseline and after 12 months. A blinded intention-to-treat analysis of treatment effects will be performed in the total sample and in each MC type group. DISCUSSION: To ensure the appropriate use of antibiotic treatment, its effect in chronic LBP patients with MCs should be re-assessed. This study will investigate the effects and cost-effectiveness of amoxicillin in patients with chronic LBP and MCs at the level of a disc herniation. The study may also help to refine imaging and characterise the biomarkers of MCs. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT02323412 . Registered on 21 November 2014.

Cost-effectiveness of total disc replacement versus multidisciplinary rehabilitation in patients with chronic low back pain: a Norwegian multicenter RCT.

STUDY DESIGN: Randomized clinical trial with 2-year follow-up. OBJECTIVE: To evaluate the cost-effectiveness of total disc replacement (TDR) versus multidisciplinary rehabilitation (MDR) in patients with chronic low back pain (CLBP). SUMMARY OF BACKGROUND DATA: The existing studies on CLBP report cost-effectiveness of fusion surgery versus disc replacement and fusion versus rehabilitation. This study evaluated the cost-effectiveness of TDR versus MDR. METHODS: Between April 2004 and May 2007, 173 patients with CLBP (>1 yr) were randomized to TDR (n = 86) or MDR (n = 87). Treatment effects (Euro Qol 5D [EQ-5D] and Short Form 6D [SF-6D]) and relevant direct and indirect costs at 6 weeks and at 3, 6, 12, and 24 months after treatment were assessed. Gain in quality-adjusted life years (QALYs) after 2 years was estimated. Cost-effectiveness was expressed as an incremental cost-effectiveness ratio. RESULTS: The mean QALYs gained (standard deviation) using EQ-5D was 1.29 (0.53) in the TDR group and 0.95 (0.52) in the MDR group, a significant difference of 0.34 (95% confidence interval 0.18-0.50). The mean total cost per patient in the TDR group was &OV0556;87,622 (58,351) compared with &OV0556;74,116 (58,237) in the MDR group, which was not significantly different (95% confidence interval: -4041 to 31,755). The incremental cost-effectiveness ratio for the TDR procedure varied from &OV0556;39,748 using EQ-5D (TDR cost-effective) to &OV0556;128,328 using SF-6D (TDR not cost-effective). The dropout rate was 20% (15% TDR group, 24% MDR group). Five patients moved from the MDR to the TDR group, whereas 9 patients randomized to TDR declined surgery. Using per-protocol analysis instead of intention-to-treat analysis indicated that TDR was not cost-effective, irrespective of the use of EQ-5D or SF-6D. CONCLUSION: In this study, TDR was cost-effective compared with MDR after 2 years when using EQ-5D for assessing QALYs gained and a willingness to pay of &OV0556;74,600 (kr500,000/QALY). TDR was not cost-effective when SF-6D was used; therefore, our results should be interpreted with caution. Longer follow-up is needed to accurately assess the cost-effectiveness of TDR. LEVEL OF EVIDENCE: 2.

A health economic evaluation of screening and treatment in patients with adolescent idiopathic scoliosis.

SUMMARY OF BACKGROUND DATA: Adolescent idiopathic scoliosis can progress and affect the health related quality of life of the patients. Research shows that screening is effective in early detection, which allows for bracing and reduced surgical rates, and may save costs, but is still controversial from a health economic perspective. STUDY DESIGN: Model based cost minimisation analysis using hospital's costs, administrative data, and market prices to estimate costs in screening, bracing and surgical treatment. Uncertainty was characterised by deterministic and probabilistic sensitivity analyses. Time horizon was 6 years from first screening at 11 years of age. OBJECTIVE: To compare estimated costs in screening and non-screening scenarios (reduced treatment rates of 90%, 80%, 70% of screening, and non-screening Norway 2012). METHODS: Data was based on screening and treatment costs in primary health care and in hospital care settings. Participants were 4000, 12-year old children screened in Norway, 115190 children screened in Hong Kong and 112 children treated for scoliosis in Norway in 2012. We assumed equivalent outcome of health related quality of life, and compared only relative costs in screening and non-screening settings. Incremental cost was defined as positive when a non-screening scenario was more expensive relative to screening. RESULTS: Screening per child was € 8.4 (95% CrI 6.6 to10.6), € 10350 (8690 to 12180) per patient braced, and € 45880 (39040 to 55400) per child operated. Incremental cost per child in non-screening scenario of 90% treatment rate was € 13.3 (1 to 27), increasing from € 1.3 (-8 to 11) to € 27.6 (14 to 44) as surgical rates relative to bracing increased from 40% to 80%. For the 80% treatment rate non-screening scenario, incremental cost was € 5.5 (-6 to 18) when screening all, and € 11.3 (2 to 22) when screening girls only. For the non-screening Norwegian scenario, incremental cost per child was € -0.1(-14 to 16). Bracing and surgery were the main cost drivers and contributed most to uncertainty. CONCLUSIONS: With the assumptions applied in the present study, screening is cost saving when performed in girls only, and when it leads to reduced treatment rates. Cost of surgery was dominating in non-screening whilst cost of bracing was dominating in screening. The economic gain of screening increases when it leads to higher rates of bracing and reduced surgical rates.

Costs of shoulder pain and resource use in primary health care: a cost-of-illness study in Sweden.

BACKGROUND: Painful shoulders pose a substantial socioeconomic burden. A prospective cost-of-illness study was performed to assess the costs associated with healthcare use and loss of productivity in patients with shoulder pain in primary health care in Sweden. METHODS: The study was performed in western Sweden, in a region with 24 000 inhabitants. Data were collected during six months from electronic patient records at three primary healthcare centres in two municipalities. All patients between 20 and 64 years of age who presented with shoulder pain to a general practitioner or a physiotherapist were included. Diagnostic codes were used for selection, and the cases were manually controlled. The cost for sick leave was calculated according to the human capital approach. Sensitivity analysis was used to explore uncertainty in various factors used in the model. RESULTS: 204 (103 women) patients, mean age 48 (SD 11) years, were registered. Half of the cases were closed within six weeks, whereas 32 patients (16%) remained in the system for more than six months. A fifth of the patients were responsible for 91% of the total costs, and for 44% of the healthcare costs. The mean healthcare cost per patient was €326 (SD 389) during six months. Physiotherapy treatments accounted for 60%. The costs for sick leave contributed to 84% of the total costs. The mean annual total cost was €4139 per patient. Estimated costs for secondary care increased the total costs by one third. CONCLUSIONS: The model applied in this study provides valuable information that can be used in cost evaluations. Costs for secondary care and particularly for sick leave have a major influence on total costs and interventions that can reduce long periods of sick leave are warranted.

Physical and mental health in young adults operated on for idiopathic scoliosis.

In this study, physical and mental health were investigated in 30 young adults who were operated on for idiopathic scoliosis, 2-3 years after surgery, and the results compared to an age- and sex-matched control group of 40 individuals. We used the short form of the 36 health survey (SF-36 version 1.2), which is a 36-item questionnaire measuring health functioning on eight scales: physical functioning, role limitations due to physical functioning, bodily pain, general health perceptions, vitality, social functioning, emotional role limitation, and general mental health. The patient scores indicated lower than the controls in physical health but higher in mental health. Otherwise, there were no significant differences between the two groups. Overall, this study showed that young adults operated on for idiopathic scoliosis were satisfied, and that their mental health was even better than the normal group, but their physical health was somewhat poorer. Thus, the surgical procedure was well tolerated and had not traumatized the patient.