Lars Gunnar Johnsen

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.

Surgery with disc prosthesis versus rehabilitation in patients with low back pain and degenerative disc: two year follow-up of randomised study

Objective To compare the efficacy of surgery with disc prosthesis versus non-surgical treatment for patients with chronic low back pain. Design A prospective randomised multicentre study. Setting Five university hospitals in Norway. Participants 173 patients with a history of low back pain for at least one year, Oswestry disability index of at least 30 points, and degenerative changes in one or two lower lumbar spine levels (86 patients randomised to surgery). Patients were treated from April 2004 to September 2007. Interventions Surgery with disc prosthesis or outpatient multidisciplinary rehabilitation for 12-15 days. Main outcome measures The primary outcome measure was the score on the Oswestry disability index after two years. Secondary outcome measures were low back pain, satisfaction with life (SF-36 and EuroQol EQ-5D), Hopkins symptom check list (HSCL-25), fear avoidance beliefs (FABQ), self efficacy beliefs for pain, work status, and patients’ satisfaction and drug use. A blinded independent observer evaluated scores on the back performance scale and Prolo scale at two year follow-up. Results The study was powered to detect a difference of 10 points on the Oswestry disability index between the groups at two years. At two years there was a mean difference of −8.4 points (95% confidence interval −13.2 to −3.6) in favour of surgery. In the analysis of prespecified secondary outcomes, there were significant differences in favour of surgery for low back pain (mean difference −12.2, −21.3 to −3.1), patients’ satisfaction (63% (n=46) v 39% (n=26)), SF-36 physical component score (mean difference 5.8, 2.5 to 9.1), self efficacy for pain (mean difference 1.0, 0.2 to 1.9), and the Prolo scale (mean difference 0.9, 0.1 to 1.6). There were no significant differences in return to work, SF-36 mental component score, EQ-5D, fear avoidance beliefs, Hopkins symptom check list, drug use, and the back performance scale. One serious complication of leg amputation occurred during surgical revision of a polyethylene dislodgement. The drop-out rate was 20% (34) and the crossover rate was 6% (5). Conclusions Surgical intervention with disc prosthesis for chronic low back pain resulted in a significantly greater improvement in the Oswestry score compared with rehabilitation, but this improvement did not clearly exceed the prespecified minimally important clinical difference between groups of 10 points, and the data are consistent with a wide range of differences between the groups, including values well below 10 points. The potential risks of surgery and the substantial amount of improvement experienced by a sizeable proportion of the rehabilitation group also have to be incorporated into overall decision making. Trial registration NCT 00394732.

Comparison of the SF6D, the EQ5D, and the oswestry disability index in patients with chronic low back pain and degenerative disc disease

BackgroundThe need for cost effectiveness analyses in randomized controlled trials that compare treatment options is increasing. The selection of the optimal utility measure is important, and a central question is whether the two most commonly used indexes - the EuroQuol 5D (EQ5D) and the Short Form 6D (SF6D) – can be used interchangeably. The aim of the present study was to compare change scores of the EQ5D and SF6D utility indexes in terms of some important measurement properties. The psychometric properties of the two utility indexes were compared to a disease-specific instrument, the Oswestry Disability Index (ODI), in the setting of a randomized controlled trial for degenerative disc disease.MethodsIn a randomized controlled multicentre trial, 172 patients who had experienced low back pain for an average of 6 years were randomized to either treatment with an intensive back rehabilitation program or surgery to insert disc prostheses. Patients filled out the ODI, EQ5D, and SF-36 at baseline and two-year follow up. The utility indexes was compared with respect to measurement error, structural validity, criterion validity, responsiveness, and interpretability according to the COSMIN taxonomy.ResultsAt follow up, 113 patients had change score values for all three instruments. The SF6D had better similarity with the disease-specific instrument (ODI) regarding sensitivity, specificity, and responsiveness. Measurement error was lower for the SF6D (0.056) compared to the EQ5D (0.155). The minimal important change score value was 0.031 for SF6D and 0.173 for EQ5D. The minimal detectable change score value at a 95% confidence level were 0.157 for SF6D and 0.429 for EQ5D, and the difference in mean change score values (SD) between them was 0.23 (0.29) and so exceeded the clinical significant change score value for both instruments. Analysis of psychometric properties indicated that the indexes are unidimensional when considered separately, but that they do not exactly measure the same underlying construct.ConclusionsThis study indicates that the difference in important measurement properties between EQ5D and SF6D is too large to consider them interchangeable. Since the similarity with the “gold standard” (the disease-specific instrument) was quite different, this could indicate that the choice of index should be determined by the diagnosis.

Can we define success criteria for lumbar disc surgery?: Estimates for a substantial amount of improvement in core outcome measures

Background and purpose A successful outcome after lumbar discectomy indicates a substantial improvement. To use the cutoffs for minimal clinically important difference (MCID) as success criteria has a large potential bias, simply because it is difficult to classify patients who report that they are “moderately improved”. We propose that the criteria for success should be defined by those who report that they are “completely recovered” or “much better”. Methods A cohort of 692 patients were operated for lumbar disc herniation and followed for one year in the Norwegian Registry for Spine Surgery. The global perceived scale of change was used as an external criterion, and success was defined as those who reported that they were “completely recovered” or “much better”. Criteria for success for each of (1) the Oswestry disability index (ODI; score range 0–100 where 0 = no disability), (2) the numerical pain scale (NRS; range 0–10 where 0 = no pain) for back and leg pain, and (3) the Euroqol (EQ-5D; –0.6 to 1 where 1 = perfect health) were estimated by defining the optimal cutoff point on receiver operating characteristic curves. Results The cutoff values for success for the mean change scores were 20 (ODI), 2.5 (NRS back), 3.5 (NRS leg), and 0.30 (EQ-5D). According to the cutoff estimates, the proportions of successful outcomes were 66% for the ODI and 67% for the NRS leg pain scale. Interpretation The sensitivity/specificity values for the ODI and leg pain were acceptable, whereas they were very low for the EQ-5D. The cutoffs for success can be used as benchmarks when comparing data from different surgical units.

Development and delivery of patient treatment in the Trondheim Hip Fracture Trial. A new geriatric in-hospital pathway for elderly patients with hip fracture

BackgroundHip fractures are common among frail elderly persons and often have serious consequences on function, mobility and mortality. Traditional treatment of these patients is performed in orthopedic departments without additional geriatric assessment. However, studies have shown that interdisciplinary geriatric treatment may be beneficial compared to traditional treatment. The aim of the present study is to investigate whether treatment of these patients in a Department of Geriatrics (DG) during the entire hospital stay gives additional benefits as compared to conventional treatment in a Department of Orthopaedic Surgery (DOS).FindingsA new clinical pathway for in-hospital treatment of hip fracture patients was developed. In this pathway patients were treated pre-and postoperatively in DG. Comprehensive geriatric assessment was performed as an interdisciplinary, multidimensional, systematic assessment of all patients focusing on each patient’s capabilities and limitations as recommended in guidelines and systematic reviews. Identification and treatment of co-morbidities, pain relief, hydration, oxygenation, nutrition, elimination, prevention and management of delirium, assessment of falls and osteoporosis were emphasized. Discharge planning started as early as possible. Initiation of rehabilitation with focus on early mobilisation and development of individual plans was initiated in hospital and continued after discharge from hospital. Fracture specific treatment was based upon standard treatment for the hospital, expert opinions and a review of the literature.ConclusionA new treatment program for old hip fracture patients was developed, introduced and run in the DG, the potential benefits of which being compared with traditional care of hip fracture patients in the DOS in a randomised clinical trial.

Minimally invasive decompression versus x-stop in lumbar spinal stenosis: a randomized controlled multicenter study.

Study Design. Prospective randomized controlled multicenter study. Objective. To compare the effect of X-Stop with minimally invasive decompression (MID) in patients with neurogenic intermittent claudication due to lumbar spinal stenosis. Summary of Background Data. Lumbar spinal stenosis is the most common indication for operative treatment in elderly. Laminectomy has been the “gold standard,” but MID is now widely used. Another minimally invasive surgery option is X-Stop showing good result compared with nonoperative treatment, but showing higher reoperation rate than laminectomy. Methods. We enrolled 96 patients aged 50 to 85 years, with symptoms of neurogenic intermittent claudication within 250-m walking distance and 1- or 2-level lumbar spinal stenosis, randomized to either MID or X-Stop. Primary outcome was Zurich Claudication Questionnaire in this intention-to-treat analysis. Secondary outcome was Oswestry Disability Index, EuroQol 5-dimensional questionnaire, numerical rating scale 11 for lower back pain and leg pain, and risk for secondary surgery and complications. Results. No significant differences were found in Zurich Claudication Questionnaire between the groups at any follow-ups. Both groups had a statistical and clinical significant improvement at 6 weeks and throughout the 2-year observation period. The number of patients having secondary surgery due to persistent or recurrent symptoms was significantly higher in the X-Stop group, odds ratio (95% confidence interval) = 6.5 (1.3–31.9). Complication rate was similar and low, but more severe for MID. Conclusion. Both MID and X-Stop led to significant symptom improvements. There were no significant clinical differences in effect between the methods at any of the follow-up time points. X-Stop had significant higher risk of secondary surgery. Complication was more severe for MID. Level of Evidence: 2

Segmental mobility, disc height and patient-reported outcomes after surgery for degenerative disc disease: A prospective randomised trial comparing disc replacement and multidisciplinary rehabilitation

This prospective multicentre study was undertaken to determine segmental movement, disc height and sagittal alignment after total disc replacement (TDR) in the lumbosacral spine and to assess the correlation of biomechanical properties to clinical outcomes.A total of 173 patients with degenerative disc disease and low back pain for more than one year were randomised to receive either TDR or multidisciplinary rehabilitation (MDR). Segmental movement in the sagittal plane and disc height were measured using distortion compensated roentgen analysis (DCRA) comparing radiographs in active flexion and extension. Correlation analysis between the range of movement or disc height and patient-reported outcomes was performed in both groups. After two years, no significant change in movement in the sagittal plane was found in segments with TDR or between the two treatment groups. It remained the same or increased slightly in untreated segments in the TDR group and in this group there was a significant increase in disc height in the operated segments. There was no correlation between segmental movement or disc height and patient-reported outcomes in either group.In this study, insertion of an intervertebral disc prosthesis TDR did not increase movement in the sagittal plane and segmental movement did not correlate with patient-reported outcomes. This suggests that in the lumbar spine the movement preserving properties of TDR are not major determinants of clinical outcomes.

Comparing cost-effectiveness of X-Stop with minimally invasive decompression in lumbar spinal stenosis: a randomized controlled trial.

Study Design. Randomized clinical trial with 2-year follow-up. Objective. To compare the cost-effectiveness of X-stop to minimally invasive decompression in patients with symptomatic lumbar spinal stenosis. Summary of Background Data. Lumbar spinal stenosis is the most common indication for operative treatment in elderly. Although surgery is more costly than nonoperative treatment, health outcomes for more than 2 years were shown to be significantly better. Surgical treatment with minimally invasive decompression is widely used. X-stop is introduced as another minimally invasive technique showing good results compared with nonoperative treatment. Methods. We enrolled 96 patients aged 50 to 85 years, with symptoms of neurogenic intermittent claudication within 250-m walking distance and 1- or 2-level lumbar spinal stenosis, randomized to either minimally invasive decompression or X-stop. Quality-adjusted life-years were based on EuroQol EQ-5D. The hospital unit costs were estimated by means of the top-down approach. Each cost unit was converted into a monetary value by dividing the overall cost by the amount of cost units produced. The analysis of costs and health outcomes is presented by the incremental cost-effectiveness ratio. Results. The study was terminated after a midway interim analysis because of significantly higher reoperation rate in the X-stop group (33%). The incremental cost for X-stop compared with minimally invasive decompression was &OV0556;2832 (95% confidence interval: 1886–3778), whereas the incremental health gain was 0.11 quality-adjusted life-year (95% confidence interval: −0.01 to 0.23). Based on the incremental cost and effect, the incremental cost-effectiveness ratio was &OV0556;25,700. Conclusion. The majority of the bootstrap samples displayed in the northeast corner of the cost-effectiveness plane, giving a 50% likelihood that X-stop is cost-effective at the extra cost of &OV0556;25,700 (incremental cost-effectiveness ratio) for a quality-adjusted life-year. The significantly higher cost of X-stop is mainly due to implant cost and the significantly higher reoperation rate. Level of Evidence: 2

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

Adjacent level degeneration and facet arthropathy after disc prosthesis surgery or rehabilitation in patients with chronic low back pain and degenerative disc: second report of a randomized study.

Study Design. Randomized clinical trial with 2-year follow-up. Objective. To assess the development of adjacent level degeneration (ALD) and index level facet arthropathy (FA) in patients treated with disc prosthesis compared with patients treated with rehabilitation. Summary of Background Data. There is controversy about the natural history of disc degeneration and the development of ALD and FA in patients who undergo disc prosthesis surgery. Methods. The study included 116 patients with a history of low back pain for at least 1 year, Oswestry Disability Index 30 points or more, and degenerative changes in 1 or 2 lower lumbar spine levels. Magnetic resonance imaging was performed before treatment and at the 2-year follow-up. ALD and index level FA were determined on the basis of the majority assessment of 3, independent, experienced radiologists. ALD was assessed by evaluating Modic changes, posterior high intensity zone in the disc, nucleus pulposus signal, disc height, disc contour, and FA. Data were analyzed with Fischer exact test and t test. Results. ALD developed with similar frequencies in patients who were (n = 59) and were not (n = 57) treated with surgery. In patients treated with surgery, index level FA appeared or increased in 20 patients (34%) and decreased in 1 patient. In patients treated with rehabilitation, 2 (4%) had new or increased FA at the index/degenerated disc level and 1 had decreased FA (P < 0.001). The development of ALD and FA was not related to clinical outcome. Conclusion. In this first study that compared the courses of degeneration after treatment with disc prosthesis surgery or rehabilitation, ALD was observed at similar frequencies at the 2-year follow-up. However, the surgery group had increased FA at the implant level.