Despite a widespread use of pain drawing in the selection of patients for surgical and non-surgic... more Despite a widespread use of pain drawing in the selection of patients for surgical and non-surgical treatment, its value as a predictor of outcome is still not well documented. In a prospective multicentre randomised controlled trial of surgical and non-surgical treatment for chronic low-back pain (CLBP), two hypotheses were tested: (1) Pain drawing predicts outcome of treatment for CLBP, (2) Pain drawing is associated with psychological characteristics of patients with CLBP. Two hundred and sixty-four patients with severe CLBP of long duration completed pain drawings as part of a battery of questionnaires prior to treatment. They were followed up at 2 years post-treatment, with renewed completion of questionnaires. Outcome was measured in three ways: patient global assessment, change of disability/pain, and work status. The pain drawing was analysed by four different methods. The association between the pain drawings and outcomes was analysed. Personality traits and depressive symptoms were evaluated in the psychological assessment. None of the four methods of interpretation of the pain drawings demonstrated any significant association with outcome, in either the surgical or the non-surgical group. The pain drawing was associated with pre-treatment back pain intensity and depressive symptoms. No predictive value of the pain drawing regarding the outcome of treatment of CLPB was demonstrated. The concept of "organic/non-organic" pain in conjunction with chronic low-back pain is not supported by the results of the present study.
Study Design: Observational study of prospectively collected data. Objectives: Patients with chro... more Study Design: Observational study of prospectively collected data. Objectives: Patients with chronic low back pain resistant to nonoperative treatment often face a poor prognosis for recovery. The aim of the current study was to compare the variation and outcome of surgical treatment of degenerative disc disease in the Scandinavian countries based on The International Consortium for Health Outcomes Measurement core spine data sets. Methods: Anonymized individual level data from 3 national registers were pooled into 1 database. At the time of surgery, the patient reports data on demographics, lifestyle topics, comorbidity, and data on health-related quality of life such as Oswestry Disability Index, Euro-Qol-5D, and back and leg pain scores. The surgeon records diagnosis, type of surgery performed, and complications. One-year follow-ups are obtained with questionnaires. Baseline and 1-year follow-up data were analyzed to expose any differences between the countries. Results: A total of 1893 patients were included. At 1-year follow-up, 1315 (72%) patients responded. There were statistically significant baseline differences in age, smoking, comorbidity, frequency of previous surgery and intensity of back and leg pain. Isolated fusion was the primary procedure in all the countries ranging from 84% in Denmark to 76% in Sweden. There was clinically relevant improvement in all outcome measures except leg pain. Conclusions: In homogenous populations with similar health care systems the treatment traditions can vary considerably. Despite variations in preoperative variables, patient reported outcomes improve significantly and clinically relevant with surgical treatment.
Current literature suggests that in the long-term, fusion of the lumbar spine in chronic low back... more Current literature suggests that in the long-term, fusion of the lumbar spine in chronic low back pain (CLBP) does not result in an outcome clearly better than structured conservative treatment modes. This study aimed to assess the long-term outcome of lumbar fusion in CLBP, and also to assess methodological problems in long-term randomized controlled trials (RCTs). A prospective randomized study was carried out. A total of 294 patients (144 women and 150 men) with CLBP of at least 2 years' duration were randomized to lumbar fusion or non-specific physiotherapy. The mean follow-up time was 12.8 years (range 9-22). The follow up rate was 85%; exclusion of deceased patients resulted in a follow-up rate of 92%. Global Assessment (GA) of back pain, Oswestry Disability Index (ODI), visual analogue scale (VAS) for back and leg pain, Zung depression scale were determined. Work status, pain medication, and pain frequency were also documented. Standardized outcome questionnaires were obtained before treatment and at long-term follow-up. To optimize control for group changers, four models of data analysis were used according to (1) intention to treat (ITT), (2) "as treated" (AT), (3) per protocol (PP), and (4) if the conservative group automatically classify group changers as unchanged or worse in GA (GCAC). The initial study was sponsored by Acromed (US$50,000-US$100,000). Except for the ITT model, the GA, the primary outcome measure, was significantly better for fusion. The proportion of patients much better or better in the fusion group was 66%, 65%, and 65% in the AT, PP, and GCAC models, respectively. In the conservative group, the same proportions were 31%, 37%, and 22%, respectively. However, the ODI, VAS back pain, work status, pain medication, and pain frequency were similar between the two groups. One can conclude that from the patient's perspective, reflected by the GA, lumbar fusion surgery is a valid treatment option in CLBP. On the other hand, secondary outcome measures such as ODI and work status, best analyzed by the PP model, indicated that substantial disability remained at long-term after fusion as well as after conservative treatment. The lack of objective outcome measures in CLBP and the cross-over problem transforms an RCT to an observational study, that is, Level 2 evidence. The discrepancy between the primary and secondary outcome measures prevents a strong conclusion on whether to recommend fusion in non-specific low back pain.
costs at one year from ID were € 5'480, 39% RA-related (€ 682 for drugs and 1'444 for hospitalisa... more costs at one year from ID were € 5'480, 39% RA-related (€ 682 for drugs and 1'444 for hospitalisations), € 1'345 for ambulatory care, € 1'016 for other drugs and € 994 for other hospitalisations. ConClusions: Treatment patterns of RA patients in Italy are heterogeneous, with a variety of strategy options reported. More than half of healthcare costs in RA patients are not disease-related, suggesting that management of comorbidities is a cost-driver.
Chronic low back pain is rarely fatal or completely cured but constitutes a considerable sufferin... more Chronic low back pain is rarely fatal or completely cured but constitutes a considerable suffering from those afflicted by it. When conservative treatment fails, lumbar fusion may occasionally be performed in order to reduce pain and decrease disability. Surgical intervention in this patient category is however controversial, and the efficiency is questioned. With the primary objective to compare lumbar fusion with non-surgical treatment in patients with CLBP using a valid scientific approach, the Swedish Lumbar Spine Study Group conducted a multicenter prospective randomized controlled trial with two years follows up by an independent observer.The studies included 294 patients with a mean age of 43 years (range 25-65), men and women in equal proportions. Non-surgical treatment should have been unsuccessful and radiographic changes should be present at L4-L5 and/or L5-S1. Patients were randomized to one of three surgical groups, 1. Posterolateral fusion without instrumentation (PLF n=73), 2. PLF + instrumentation (n=74), 3. Instrumentation + anterior lumbar interbody fusion or posterior lumbar interbody fusion, a so-called "360-degree" fusion (n=75). There were 72 patients randomized to commonly used non-surgical treatments. The primary outcome measurements were the patient's global assessment, pain, disability, and work. The technical measurements were different hospitalization variables, complications and fusion. Costs were evaluated and related to treatment effects, and the patient characteristics were compared with an age and sex matched random sample from the general population.This multicenter randomized controlled study showed that more patients treated with fusion were improved after two years, 63% vs. 29% in the control group (p<0.0001). Pain and disability was reduced by 25-33% vs. 4-8% (p<0.002). Return to work was 36% vs. 13% (p=0.002). The outcome did not differ among the surgical groups, but the power to detect differences was low (<10%). Complications increased significantly with more demanding surgical procedures: PLF- instrumented PLF -"360": 11-22-40% (p=0.0003), but most complications left no sequelae for the patient. The re-intervention rate increased with instrumentation compared with non-instrumented fusion (p=0.020). The cost differences in a societal perspective was of random significance between surgery and conservative treatment after two years: SEK 711 000 ± 48 500 vs. SEK 626 000 ± 81 000 (p=0.104). In a health care perspective, surgery was more costly: SEK 131 000 ± 9 500 vs. 55 000 ± 6 500, (p<0.0001). The direct incremental cost for the health care sector to get one patient back to work using fusion instead of non-surgical treatment was SEK 329 000 ±122 000. The costs for production losses, or indirect costs, for one patient on sick leave was SEK 464 000 ±182 000. The surgical candidates in this study had more severe back pain, but otherwise resembled the average Swedish citizen with back pain. They did not resemble patients in rehabilitation centers and we conclude that our results are probably not generally applicable to every patient with chronic low back pain
A local inflammatory and potentially painful response, of which the ultimate cause is unknown, ha... more A local inflammatory and potentially painful response, of which the ultimate cause is unknown, has been described in nervous tissues in contact with degenerated disc material in patients with low back and leg pain. With the rationale that a possible cause of such inflammation could be bacterial infection, we utilized PCR (polymerase chain reaction) amplification of the 16S rRNA (ribosomal RNA) gene followed by gene sequencing, to investigate whether bacterial DNA might be detected in the degenerative discs of 10 patients operated for disc herniation or post-discectomy syndrome. One patient with disc hernia harbored DNA homologous to Bacillus cereus, and in one patient suffering from post-discectomy syndrome, Citrobacter braakilfreundii DNA was detected. The finding demonstrates that 16S rRNA PCR can be a useful tool in search of bacterial DNA in degenerated discs, which in turn may be indicative of low-grade infection, manifesting itself only as pain rather than as clinical infection.
Objectives: abdominal aortic aneurysm (AAA) is a chronic and progressive disease that often requi... more Objectives: abdominal aortic aneurysm (AAA) is a chronic and progressive disease that often requires surgical repair. The aim of this study was to assess healthcare costs and clinical outcomes of open AAA repair in Spain. MethOds: observational, retrospective, multicenter study of 1-year follow-up. Healthcare resource consumption and associated costs related with the surgical procedure, the inpatient stay and the follow-up period were assessed. Results: ninety patients admitted with asymptomatic AAA who underwent open repair from 2003 to 2009 were recruited at 3 Spanish centers; all patients recruited were male and 70% were over 65 years old. 4 patients (4.4%) died during the first month following the intervention. The mean [SD] procedure time was 292.8 [72.1] minutes, and a mean [SD] of 2.8 [1.1] physicians, 1.3 [0.5] anesthesiologists, 2.3 [0.5] nurses and 1 nursing assistant [non-estimable] were required for the surgical intervention. The mean [SD] inpatient length of stay was 11.4 [5.4] days, of which 2.4 [2.2] days occurred in the intensive care unit (ICU). 32 patients (35.6%) presented in-hospital complications and 3 patients (3.4%) underwent re-intervention during follow-up. The mean overall cost during the study period was € 21,617.98 per patient, of which 42.38% (€ 9,161.59), 52.16% (€ 11,275.39) and 5.46% (€ 1,181) corresponded to the surgical procedure, the inpatient stay and the study follow-up period, respectively. cOnclusiOns: the cost of patients admitted with asymptomatic AAA who underwent open repair in Spain was € 21,617.98 per patient per year. More than half were inpatient stay related costs, driven by hospital length of stay and more than 40% of the costs were associated with the surgical procedure per se, mainly driven by the procedure time related costs. AAA remains a major burden on health systems, so additional efforts comparing the cost of open repair versus the endovascular approach are needed.
Purpose To evaluate the predictive precision of the Dialogue Support, a tool for additional help ... more Purpose To evaluate the predictive precision of the Dialogue Support, a tool for additional help in shared decision-making before surgery of the degenerative spine. Methods Data in Swespine (Swedish national quality registry) of patients operated between 2007 and 2019 found the development of prediction algorithms based on logistic regression analyses, where socio-demographic and baseline variables were included. The algorithms were tested in four diagnostic groups: lumbar disc herniation, lumbar spinal stenosis, degenerative disc disease and cervical radiculopathy. By random selection, 80% of the study population was used for the prediction of outcome and then tested against the actual outcome of the remaining 20%. Outcome measures were global assessment of pain (GA), and satisfaction with outcome. Results Calibration plots demonstrated a high degree of concordance on a group level. On an individual level, ROC curves showed moderate predictive capacity with AUC (area under the curve) values 0.67-0.68 for global assessment and 0.6-0.67 for satisfaction. Conclusion The Dialogue Support can serve as an aid to both patient and surgeon when discussing and deciding on surgical treatment of degenerative conditions in the lumbar and cervical spine. Level of evidence I.
Spinal cord stimulation (SCS), a minimally invasive treatment option for long-term neuropathic pa... more Spinal cord stimulation (SCS), a minimally invasive treatment option for long-term neuropathic pain, has been shown to be effective in patients with persisting neuropathic pain after spine surgery. However, little is known about the longterm cost and quality-of-life (QoL) patterns in SCS-treated patients. The aim is to describe the use of SCS, costs, pre-spinesurgery and post-spine-surgery QoL, and reported pain intensity, in patients who have undergone spine surgery and subsequent SCS implantation. The results will be related to outcome and cost in spine surgery patients in general. Materials and Methods: A research database comprised from six Swedish national and regional registers, and the spine surgery quality-of-care register Swespine was utilized. Two cohorts were identified: all patients who had spine surgery (N = 73,765) and patients who had spine surgery and subsequent SCS implantation (N = 239). Costs were analyzed before and after spine surgery for both cohorts, as well as before and after SCS implantation for the second cohort. QoL was explored by estimating patient-reported outcome measures such as pain intensity, Oswestry Disability Index, and EuroQol-5Dimensions from spine surgery up to five years post-spine surgery. Results: In spine surgery patients, mean QoL and pain intensity levels improved following surgery. Patients subsequently treated with SCS had lower reported QoL and higher costs before the initial spine surgery, and spine surgery did not lead to any substantial improvements, however, costs decreased following SCS implantation in these patients.
Background The EQ VAS component of the EQ-5D questionnaire has been used to assess patients’ valu... more Background The EQ VAS component of the EQ-5D questionnaire has been used to assess patients’ valuation of their own health besides its use for self-reporting of overall health status. The objective of the present study was to identify patients’ valuation of EQ-5D-3L health states using the EQ VAS in different patient groups over time and in comparison to the general population. Methods Data were obtained from patients from nine National Quality Registers (n = 172,070 patients) at baseline and at 1-year follow-up and compared with data from the general population (n = 41,761 participants). The correlation between EQ VAS scores and EQ-5D-3L index based on the Swedish experience-based VAS value set was assessed. Ordinary least squares (OLS) regression models were used to determine the association between EQ-5D-3L dimensions and EQ VAS valuation. Results EQ VAS scores showed consistency with severity of health states both at baseline and at 1-year follow-up in the nine selected EQ-5D-3L...
Journal of Bone Joint Surgery British Volume, Sep 1, 2012
Background Balloon kyphoplasty (BKP) is a minimally invasive cementing procedure, occasionally us... more Background Balloon kyphoplasty (BKP) is a minimally invasive cementing procedure, occasionally used in patients with painful vertebral compression fractures (VCF). In this multicenter Swedish RCT, we evaluated the cost-effectiveness of BKP compared with standard medical treatment, Control, in osteoporotic patients with acute/sub-acute VCF ( Results Between February 2003 and December 2005, 70 patients were randomized to BKP (n=35) or to standard medical treatment (n=35). Three patients in the Control group declined to participate in an economic evaluation, and only patients answering EQ-5D at all FU occasions (1-3-6-12-24 months) were included in the analyses, leaving in all 63 patients, BKP=32, Control=31. Baseline data were similar. The mean age in the BKP group was 72 years (71% women) vs. 75 years (78% women) in the Control group. Baseline difference in QoL was adjusted for using statistical methods. There were no cross overs. Four patients in the BKP group and three patients in the Control group died within two years of causes not related to the VCF. Costs were collected using “cost diaries” in mailed questionnaires after 1-3-6-12-18-24 months. Costs and EQ-5D values (0 at FU after death) were carried forward. Total mean societal cost per patient for BKP and Control was SEK 160,017 (SD 151,083) and SEK 84,816 (SD 40,954), respectively. The difference was significant 75,198 (95% CI 16,037 to 120,104). The accumulated mean difference in QALYs was 0.085 (−0.132 to 0.306) units in favour of BKP. Cost per QALY gained using BKP was SEK 884,682 (EURO 92,154) with high uncertainty assessed using the bootstrapping technique, and demonstrated on the cost-effectiveness plane and on the acceptability curve. When the EQ-5D values from all patients in the FREE trials were included in a sensitivity analysis, cost/QALY was SEK 359,146 (EURO 37,411) Conclusion: Costs were significantly higher for BKP compared with standard medical treatment, with no significant difference in QALYs gained. In this selected patient population with vertebral compression fracture due to osteoporosis, BKP could not be concluded as cost-effective after two years
PurposeTo examine the association between COMT and OPRM1 gene polymorphisms and pain and disabili... more PurposeTo examine the association between COMT and OPRM1 gene polymorphisms and pain and disability at baseline and long-term follow-up in patients treated for chronic low back pain (LBP).Methods371 of 767 unrelated European patients recruited from four randomised trials underwent genetic analyses at mean 11.4 years follow-up. 274 patients had fusion and 97 had non-operative treatment. Association analyses included disability, pain, five single nucleotide polymorphisms (SNPs) in the COMT gene, and one SNP in the OPRM1 gene. Analyses were adjusted for age, gender, smoking, analgesics and treatment.ResultsDisability at baseline was significantly associated with COMT SNPs rs4818 (p = 0.02), rs6269 (p = 0.007), rs4633 (p = 0.04) rs2075507 (p = 0.009), two haplotypes (p < 0.002), age, gender and smoking (p ≤ 0.002). No significant associations with clinical variables were observed for OPRM1, or for COMT at long-term follow-up.ConclusionsResults suggest that genetic factors are partly responsible for the variation in disability levels in patients presenting with chronic LBP being considered for surgery; in contrast, genetics has no influence on the long-term outcome of treatment.
Purpose of study: The determination of the etiology of persistent pain after lumbar interbody fus... more Purpose of study: The determination of the etiology of persistent pain after lumbar interbody fusion is often difficult, especially with metallic interbody constructs. Our study evaluates a unique discogram technique for determination of interbody fusion status. We evaluate the rate of concordant pain response on injection of interbody fusion constructs. We also determine the results of revision surgery after discogram evidence of failed fusion. Methods used: Twenty-four patients were referred for evaluation of lumbar interbody fusion and adjacent levels by discogram technique. Referrals noted appearance of solid fusion on standard radiographic studies but persistent low back pain. Adjacent levels were evaluated in addition to the level of interbody fusion. Presenting symptom was predominantly low back pain (nϭ24) with variable lower extremity symptoms. Pseudarthrosis was dramatically documented when dye flowed around and through interbody cages or surrounded allograft arthrodesis. Solid arthrodesis was documented with inability to inject dye or with dye flowing around solid construct. A retrospective review of prereferral studies noted the appearance of fusion with lack of halo formation, appearance of bone incorporating into the vertebral bodies and less than 5 degrees of motion on flexion-extension lateral radiographs. When pseudarthrosis with concordant response was documented, patients were given the option of revision surgery. Clinical response to revision surgery was evaluated independently by a questionnaire completed by the patient. A minimum of 2-year follow-up postoperatively was required for study inclusion. Summary of findings: Twenty-four patients (16 women, 8 men) with persistent postoperative low back pain and appearance of solid fusion on standard radiographs underwent discogram evaluation of interbody fusion and adjacent levels. All patients were sent a back pain questionnaire by an independent reviewer with a 79% (17 of 24) response. Average time from fusion to the discogram study was 17 months. Pseudarthrosis was demonstrated in 58% (14 of 24) of the patients evaluated. Concordant pain response was seen in only one level that was documented solid on interbody discogram. Any level with pseudarthrosis was always accompanied by a concordant pain response (pϽ.0001). Adjacent level concordant pain response was seen in 8% (2 of 24) of patients with a solid fusion. All but one (13 of 14) of the pseudarthrosis group elected to have revision surgery. One of the adjacent levels response group also elected further surgery. Symptomatic improvement in pain was found in 79% (11 of 14) of the surgical revisions of patients with concordant pain response. Relationship between findings and existing knowledge: Studies have noted pseudarthrosis intraoperatively in levels noted solid on standard radiographic studies. McAfee demonstrated a wide variation in techniques used to document solid fusion. We provide an additional technique to evaluate lumbar interbody fusion. Overall significance of findings: The interbody fusion discogram provides a dramatic demonstration of pseudarthrosis in patients with persistent low back pain, despite appearance of solid fusion on standard radiographs. There is a strong statistical correlation of concordant pain response and discogram documentation of pseudarthrosis. Interbody fusion discogram technique allows demonstration of pseudarthrosis, documents response at adjacent levels and predicts successful outcome with revision surgery. Disclosures: No disclosures. Conflict of interest: No conflicts.
Purpose Lumbar spinal stenosis (LSS) can be surgically treated, with variable outcome. Studies ha... more Purpose Lumbar spinal stenosis (LSS) can be surgically treated, with variable outcome. Studies have linked socioeconomic factors to outcome, but no nationwide studies have been performed. This register-based study, including all patients surgically treated for LSS during 2008-2012 in Sweden, aimed to determine predictive factors for the outcome of surgery. Methods Clinical and socioeconomic factors with impact on outcome in LSS surgery were identified in several high-coverage registers, e.g., the national quality registry for spine surgery (Swespine, FU-rate 70-90%). Multivariate regression analyses were conducted to assess their effect on outcome. Two patient-reported outcome measures, Global Assessment of leg pain (GA) and the Oswestry Disability Index (ODI), as well as length of sick leave after surgery were analyzed. Results Clinical and socioeconomic factors significantly affected health outcome (both GA and ODI). Some predictors of a good outcome (ODI) were: being born in the EU, reporting no back pain at baseline, a high disposable income and a high educational level. Some factors predicting a worse outcome were previous surgery, having had back pain more than 2 years, having comorbidities, being a smoker, being on social welfare and being unemployed. Conclusions The study highlights the relevance of adding socioeconomic factors to clinical factors for analysis of patientreported outcomes, although the causal pathway of most predictors' impact is unknown. These findings should be further investigated in the perspective of treatment selection for individual LSS patients. The study also presents a foundation of case mix algorithms for predicting outcome of surgery for LSS. Graphical abstract These slides can be retrieved under Electronic Supplementary Material.
Despite a widespread use of pain drawing in the selection of patients for surgical and non-surgic... more Despite a widespread use of pain drawing in the selection of patients for surgical and non-surgical treatment, its value as a predictor of outcome is still not well documented. In a prospective multicentre randomised controlled trial of surgical and non-surgical treatment for chronic low-back pain (CLBP), two hypotheses were tested: (1) Pain drawing predicts outcome of treatment for CLBP, (2) Pain drawing is associated with psychological characteristics of patients with CLBP. Two hundred and sixty-four patients with severe CLBP of long duration completed pain drawings as part of a battery of questionnaires prior to treatment. They were followed up at 2 years post-treatment, with renewed completion of questionnaires. Outcome was measured in three ways: patient global assessment, change of disability/pain, and work status. The pain drawing was analysed by four different methods. The association between the pain drawings and outcomes was analysed. Personality traits and depressive symptoms were evaluated in the psychological assessment. None of the four methods of interpretation of the pain drawings demonstrated any significant association with outcome, in either the surgical or the non-surgical group. The pain drawing was associated with pre-treatment back pain intensity and depressive symptoms. No predictive value of the pain drawing regarding the outcome of treatment of CLPB was demonstrated. The concept of "organic/non-organic" pain in conjunction with chronic low-back pain is not supported by the results of the present study.
Study Design: Observational study of prospectively collected data. Objectives: Patients with chro... more Study Design: Observational study of prospectively collected data. Objectives: Patients with chronic low back pain resistant to nonoperative treatment often face a poor prognosis for recovery. The aim of the current study was to compare the variation and outcome of surgical treatment of degenerative disc disease in the Scandinavian countries based on The International Consortium for Health Outcomes Measurement core spine data sets. Methods: Anonymized individual level data from 3 national registers were pooled into 1 database. At the time of surgery, the patient reports data on demographics, lifestyle topics, comorbidity, and data on health-related quality of life such as Oswestry Disability Index, Euro-Qol-5D, and back and leg pain scores. The surgeon records diagnosis, type of surgery performed, and complications. One-year follow-ups are obtained with questionnaires. Baseline and 1-year follow-up data were analyzed to expose any differences between the countries. Results: A total of 1893 patients were included. At 1-year follow-up, 1315 (72%) patients responded. There were statistically significant baseline differences in age, smoking, comorbidity, frequency of previous surgery and intensity of back and leg pain. Isolated fusion was the primary procedure in all the countries ranging from 84% in Denmark to 76% in Sweden. There was clinically relevant improvement in all outcome measures except leg pain. Conclusions: In homogenous populations with similar health care systems the treatment traditions can vary considerably. Despite variations in preoperative variables, patient reported outcomes improve significantly and clinically relevant with surgical treatment.
Current literature suggests that in the long-term, fusion of the lumbar spine in chronic low back... more Current literature suggests that in the long-term, fusion of the lumbar spine in chronic low back pain (CLBP) does not result in an outcome clearly better than structured conservative treatment modes. This study aimed to assess the long-term outcome of lumbar fusion in CLBP, and also to assess methodological problems in long-term randomized controlled trials (RCTs). A prospective randomized study was carried out. A total of 294 patients (144 women and 150 men) with CLBP of at least 2 years&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39; duration were randomized to lumbar fusion or non-specific physiotherapy. The mean follow-up time was 12.8 years (range 9-22). The follow up rate was 85%; exclusion of deceased patients resulted in a follow-up rate of 92%. Global Assessment (GA) of back pain, Oswestry Disability Index (ODI), visual analogue scale (VAS) for back and leg pain, Zung depression scale were determined. Work status, pain medication, and pain frequency were also documented. Standardized outcome questionnaires were obtained before treatment and at long-term follow-up. To optimize control for group changers, four models of data analysis were used according to (1) intention to treat (ITT), (2) &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;quot;as treated&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;quot; (AT), (3) per protocol (PP), and (4) if the conservative group automatically classify group changers as unchanged or worse in GA (GCAC). The initial study was sponsored by Acromed (US$50,000-US$100,000). Except for the ITT model, the GA, the primary outcome measure, was significantly better for fusion. The proportion of patients much better or better in the fusion group was 66%, 65%, and 65% in the AT, PP, and GCAC models, respectively. In the conservative group, the same proportions were 31%, 37%, and 22%, respectively. However, the ODI, VAS back pain, work status, pain medication, and pain frequency were similar between the two groups. One can conclude that from the patient&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39;s perspective, reflected by the GA, lumbar fusion surgery is a valid treatment option in CLBP. On the other hand, secondary outcome measures such as ODI and work status, best analyzed by the PP model, indicated that substantial disability remained at long-term after fusion as well as after conservative treatment. The lack of objective outcome measures in CLBP and the cross-over problem transforms an RCT to an observational study, that is, Level 2 evidence. The discrepancy between the primary and secondary outcome measures prevents a strong conclusion on whether to recommend fusion in non-specific low back pain.
costs at one year from ID were € 5'480, 39% RA-related (€ 682 for drugs and 1'444 for hospitalisa... more costs at one year from ID were € 5'480, 39% RA-related (€ 682 for drugs and 1'444 for hospitalisations), € 1'345 for ambulatory care, € 1'016 for other drugs and € 994 for other hospitalisations. ConClusions: Treatment patterns of RA patients in Italy are heterogeneous, with a variety of strategy options reported. More than half of healthcare costs in RA patients are not disease-related, suggesting that management of comorbidities is a cost-driver.
Chronic low back pain is rarely fatal or completely cured but constitutes a considerable sufferin... more Chronic low back pain is rarely fatal or completely cured but constitutes a considerable suffering from those afflicted by it. When conservative treatment fails, lumbar fusion may occasionally be performed in order to reduce pain and decrease disability. Surgical intervention in this patient category is however controversial, and the efficiency is questioned. With the primary objective to compare lumbar fusion with non-surgical treatment in patients with CLBP using a valid scientific approach, the Swedish Lumbar Spine Study Group conducted a multicenter prospective randomized controlled trial with two years follows up by an independent observer.The studies included 294 patients with a mean age of 43 years (range 25-65), men and women in equal proportions. Non-surgical treatment should have been unsuccessful and radiographic changes should be present at L4-L5 and/or L5-S1. Patients were randomized to one of three surgical groups, 1. Posterolateral fusion without instrumentation (PLF n=73), 2. PLF + instrumentation (n=74), 3. Instrumentation + anterior lumbar interbody fusion or posterior lumbar interbody fusion, a so-called "360-degree" fusion (n=75). There were 72 patients randomized to commonly used non-surgical treatments. The primary outcome measurements were the patient's global assessment, pain, disability, and work. The technical measurements were different hospitalization variables, complications and fusion. Costs were evaluated and related to treatment effects, and the patient characteristics were compared with an age and sex matched random sample from the general population.This multicenter randomized controlled study showed that more patients treated with fusion were improved after two years, 63% vs. 29% in the control group (p&lt;0.0001). Pain and disability was reduced by 25-33% vs. 4-8% (p&lt;0.002). Return to work was 36% vs. 13% (p=0.002). The outcome did not differ among the surgical groups, but the power to detect differences was low (&lt;10%). Complications increased significantly with more demanding surgical procedures: PLF- instrumented PLF -"360": 11-22-40% (p=0.0003), but most complications left no sequelae for the patient. The re-intervention rate increased with instrumentation compared with non-instrumented fusion (p=0.020). The cost differences in a societal perspective was of random significance between surgery and conservative treatment after two years: SEK 711 000 ± 48 500 vs. SEK 626 000 ± 81 000 (p=0.104). In a health care perspective, surgery was more costly: SEK 131 000 ± 9 500 vs. 55 000 ± 6 500, (p&lt;0.0001). The direct incremental cost for the health care sector to get one patient back to work using fusion instead of non-surgical treatment was SEK 329 000 ±122 000. The costs for production losses, or indirect costs, for one patient on sick leave was SEK 464 000 ±182 000. The surgical candidates in this study had more severe back pain, but otherwise resembled the average Swedish citizen with back pain. They did not resemble patients in rehabilitation centers and we conclude that our results are probably not generally applicable to every patient with chronic low back pain
A local inflammatory and potentially painful response, of which the ultimate cause is unknown, ha... more A local inflammatory and potentially painful response, of which the ultimate cause is unknown, has been described in nervous tissues in contact with degenerated disc material in patients with low back and leg pain. With the rationale that a possible cause of such inflammation could be bacterial infection, we utilized PCR (polymerase chain reaction) amplification of the 16S rRNA (ribosomal RNA) gene followed by gene sequencing, to investigate whether bacterial DNA might be detected in the degenerative discs of 10 patients operated for disc herniation or post-discectomy syndrome. One patient with disc hernia harbored DNA homologous to Bacillus cereus, and in one patient suffering from post-discectomy syndrome, Citrobacter braakilfreundii DNA was detected. The finding demonstrates that 16S rRNA PCR can be a useful tool in search of bacterial DNA in degenerated discs, which in turn may be indicative of low-grade infection, manifesting itself only as pain rather than as clinical infection.
Objectives: abdominal aortic aneurysm (AAA) is a chronic and progressive disease that often requi... more Objectives: abdominal aortic aneurysm (AAA) is a chronic and progressive disease that often requires surgical repair. The aim of this study was to assess healthcare costs and clinical outcomes of open AAA repair in Spain. MethOds: observational, retrospective, multicenter study of 1-year follow-up. Healthcare resource consumption and associated costs related with the surgical procedure, the inpatient stay and the follow-up period were assessed. Results: ninety patients admitted with asymptomatic AAA who underwent open repair from 2003 to 2009 were recruited at 3 Spanish centers; all patients recruited were male and 70% were over 65 years old. 4 patients (4.4%) died during the first month following the intervention. The mean [SD] procedure time was 292.8 [72.1] minutes, and a mean [SD] of 2.8 [1.1] physicians, 1.3 [0.5] anesthesiologists, 2.3 [0.5] nurses and 1 nursing assistant [non-estimable] were required for the surgical intervention. The mean [SD] inpatient length of stay was 11.4 [5.4] days, of which 2.4 [2.2] days occurred in the intensive care unit (ICU). 32 patients (35.6%) presented in-hospital complications and 3 patients (3.4%) underwent re-intervention during follow-up. The mean overall cost during the study period was € 21,617.98 per patient, of which 42.38% (€ 9,161.59), 52.16% (€ 11,275.39) and 5.46% (€ 1,181) corresponded to the surgical procedure, the inpatient stay and the study follow-up period, respectively. cOnclusiOns: the cost of patients admitted with asymptomatic AAA who underwent open repair in Spain was € 21,617.98 per patient per year. More than half were inpatient stay related costs, driven by hospital length of stay and more than 40% of the costs were associated with the surgical procedure per se, mainly driven by the procedure time related costs. AAA remains a major burden on health systems, so additional efforts comparing the cost of open repair versus the endovascular approach are needed.
Purpose To evaluate the predictive precision of the Dialogue Support, a tool for additional help ... more Purpose To evaluate the predictive precision of the Dialogue Support, a tool for additional help in shared decision-making before surgery of the degenerative spine. Methods Data in Swespine (Swedish national quality registry) of patients operated between 2007 and 2019 found the development of prediction algorithms based on logistic regression analyses, where socio-demographic and baseline variables were included. The algorithms were tested in four diagnostic groups: lumbar disc herniation, lumbar spinal stenosis, degenerative disc disease and cervical radiculopathy. By random selection, 80% of the study population was used for the prediction of outcome and then tested against the actual outcome of the remaining 20%. Outcome measures were global assessment of pain (GA), and satisfaction with outcome. Results Calibration plots demonstrated a high degree of concordance on a group level. On an individual level, ROC curves showed moderate predictive capacity with AUC (area under the curve) values 0.67-0.68 for global assessment and 0.6-0.67 for satisfaction. Conclusion The Dialogue Support can serve as an aid to both patient and surgeon when discussing and deciding on surgical treatment of degenerative conditions in the lumbar and cervical spine. Level of evidence I.
Spinal cord stimulation (SCS), a minimally invasive treatment option for long-term neuropathic pa... more Spinal cord stimulation (SCS), a minimally invasive treatment option for long-term neuropathic pain, has been shown to be effective in patients with persisting neuropathic pain after spine surgery. However, little is known about the longterm cost and quality-of-life (QoL) patterns in SCS-treated patients. The aim is to describe the use of SCS, costs, pre-spinesurgery and post-spine-surgery QoL, and reported pain intensity, in patients who have undergone spine surgery and subsequent SCS implantation. The results will be related to outcome and cost in spine surgery patients in general. Materials and Methods: A research database comprised from six Swedish national and regional registers, and the spine surgery quality-of-care register Swespine was utilized. Two cohorts were identified: all patients who had spine surgery (N = 73,765) and patients who had spine surgery and subsequent SCS implantation (N = 239). Costs were analyzed before and after spine surgery for both cohorts, as well as before and after SCS implantation for the second cohort. QoL was explored by estimating patient-reported outcome measures such as pain intensity, Oswestry Disability Index, and EuroQol-5Dimensions from spine surgery up to five years post-spine surgery. Results: In spine surgery patients, mean QoL and pain intensity levels improved following surgery. Patients subsequently treated with SCS had lower reported QoL and higher costs before the initial spine surgery, and spine surgery did not lead to any substantial improvements, however, costs decreased following SCS implantation in these patients.
Background The EQ VAS component of the EQ-5D questionnaire has been used to assess patients’ valu... more Background The EQ VAS component of the EQ-5D questionnaire has been used to assess patients’ valuation of their own health besides its use for self-reporting of overall health status. The objective of the present study was to identify patients’ valuation of EQ-5D-3L health states using the EQ VAS in different patient groups over time and in comparison to the general population. Methods Data were obtained from patients from nine National Quality Registers (n = 172,070 patients) at baseline and at 1-year follow-up and compared with data from the general population (n = 41,761 participants). The correlation between EQ VAS scores and EQ-5D-3L index based on the Swedish experience-based VAS value set was assessed. Ordinary least squares (OLS) regression models were used to determine the association between EQ-5D-3L dimensions and EQ VAS valuation. Results EQ VAS scores showed consistency with severity of health states both at baseline and at 1-year follow-up in the nine selected EQ-5D-3L...
Journal of Bone Joint Surgery British Volume, Sep 1, 2012
Background Balloon kyphoplasty (BKP) is a minimally invasive cementing procedure, occasionally us... more Background Balloon kyphoplasty (BKP) is a minimally invasive cementing procedure, occasionally used in patients with painful vertebral compression fractures (VCF). In this multicenter Swedish RCT, we evaluated the cost-effectiveness of BKP compared with standard medical treatment, Control, in osteoporotic patients with acute/sub-acute VCF ( Results Between February 2003 and December 2005, 70 patients were randomized to BKP (n=35) or to standard medical treatment (n=35). Three patients in the Control group declined to participate in an economic evaluation, and only patients answering EQ-5D at all FU occasions (1-3-6-12-24 months) were included in the analyses, leaving in all 63 patients, BKP=32, Control=31. Baseline data were similar. The mean age in the BKP group was 72 years (71% women) vs. 75 years (78% women) in the Control group. Baseline difference in QoL was adjusted for using statistical methods. There were no cross overs. Four patients in the BKP group and three patients in the Control group died within two years of causes not related to the VCF. Costs were collected using “cost diaries” in mailed questionnaires after 1-3-6-12-18-24 months. Costs and EQ-5D values (0 at FU after death) were carried forward. Total mean societal cost per patient for BKP and Control was SEK 160,017 (SD 151,083) and SEK 84,816 (SD 40,954), respectively. The difference was significant 75,198 (95% CI 16,037 to 120,104). The accumulated mean difference in QALYs was 0.085 (−0.132 to 0.306) units in favour of BKP. Cost per QALY gained using BKP was SEK 884,682 (EURO 92,154) with high uncertainty assessed using the bootstrapping technique, and demonstrated on the cost-effectiveness plane and on the acceptability curve. When the EQ-5D values from all patients in the FREE trials were included in a sensitivity analysis, cost/QALY was SEK 359,146 (EURO 37,411) Conclusion: Costs were significantly higher for BKP compared with standard medical treatment, with no significant difference in QALYs gained. In this selected patient population with vertebral compression fracture due to osteoporosis, BKP could not be concluded as cost-effective after two years
PurposeTo examine the association between COMT and OPRM1 gene polymorphisms and pain and disabili... more PurposeTo examine the association between COMT and OPRM1 gene polymorphisms and pain and disability at baseline and long-term follow-up in patients treated for chronic low back pain (LBP).Methods371 of 767 unrelated European patients recruited from four randomised trials underwent genetic analyses at mean 11.4 years follow-up. 274 patients had fusion and 97 had non-operative treatment. Association analyses included disability, pain, five single nucleotide polymorphisms (SNPs) in the COMT gene, and one SNP in the OPRM1 gene. Analyses were adjusted for age, gender, smoking, analgesics and treatment.ResultsDisability at baseline was significantly associated with COMT SNPs rs4818 (p = 0.02), rs6269 (p = 0.007), rs4633 (p = 0.04) rs2075507 (p = 0.009), two haplotypes (p < 0.002), age, gender and smoking (p ≤ 0.002). No significant associations with clinical variables were observed for OPRM1, or for COMT at long-term follow-up.ConclusionsResults suggest that genetic factors are partly responsible for the variation in disability levels in patients presenting with chronic LBP being considered for surgery; in contrast, genetics has no influence on the long-term outcome of treatment.
Purpose of study: The determination of the etiology of persistent pain after lumbar interbody fus... more Purpose of study: The determination of the etiology of persistent pain after lumbar interbody fusion is often difficult, especially with metallic interbody constructs. Our study evaluates a unique discogram technique for determination of interbody fusion status. We evaluate the rate of concordant pain response on injection of interbody fusion constructs. We also determine the results of revision surgery after discogram evidence of failed fusion. Methods used: Twenty-four patients were referred for evaluation of lumbar interbody fusion and adjacent levels by discogram technique. Referrals noted appearance of solid fusion on standard radiographic studies but persistent low back pain. Adjacent levels were evaluated in addition to the level of interbody fusion. Presenting symptom was predominantly low back pain (nϭ24) with variable lower extremity symptoms. Pseudarthrosis was dramatically documented when dye flowed around and through interbody cages or surrounded allograft arthrodesis. Solid arthrodesis was documented with inability to inject dye or with dye flowing around solid construct. A retrospective review of prereferral studies noted the appearance of fusion with lack of halo formation, appearance of bone incorporating into the vertebral bodies and less than 5 degrees of motion on flexion-extension lateral radiographs. When pseudarthrosis with concordant response was documented, patients were given the option of revision surgery. Clinical response to revision surgery was evaluated independently by a questionnaire completed by the patient. A minimum of 2-year follow-up postoperatively was required for study inclusion. Summary of findings: Twenty-four patients (16 women, 8 men) with persistent postoperative low back pain and appearance of solid fusion on standard radiographs underwent discogram evaluation of interbody fusion and adjacent levels. All patients were sent a back pain questionnaire by an independent reviewer with a 79% (17 of 24) response. Average time from fusion to the discogram study was 17 months. Pseudarthrosis was demonstrated in 58% (14 of 24) of the patients evaluated. Concordant pain response was seen in only one level that was documented solid on interbody discogram. Any level with pseudarthrosis was always accompanied by a concordant pain response (pϽ.0001). Adjacent level concordant pain response was seen in 8% (2 of 24) of patients with a solid fusion. All but one (13 of 14) of the pseudarthrosis group elected to have revision surgery. One of the adjacent levels response group also elected further surgery. Symptomatic improvement in pain was found in 79% (11 of 14) of the surgical revisions of patients with concordant pain response. Relationship between findings and existing knowledge: Studies have noted pseudarthrosis intraoperatively in levels noted solid on standard radiographic studies. McAfee demonstrated a wide variation in techniques used to document solid fusion. We provide an additional technique to evaluate lumbar interbody fusion. Overall significance of findings: The interbody fusion discogram provides a dramatic demonstration of pseudarthrosis in patients with persistent low back pain, despite appearance of solid fusion on standard radiographs. There is a strong statistical correlation of concordant pain response and discogram documentation of pseudarthrosis. Interbody fusion discogram technique allows demonstration of pseudarthrosis, documents response at adjacent levels and predicts successful outcome with revision surgery. Disclosures: No disclosures. Conflict of interest: No conflicts.
Purpose Lumbar spinal stenosis (LSS) can be surgically treated, with variable outcome. Studies ha... more Purpose Lumbar spinal stenosis (LSS) can be surgically treated, with variable outcome. Studies have linked socioeconomic factors to outcome, but no nationwide studies have been performed. This register-based study, including all patients surgically treated for LSS during 2008-2012 in Sweden, aimed to determine predictive factors for the outcome of surgery. Methods Clinical and socioeconomic factors with impact on outcome in LSS surgery were identified in several high-coverage registers, e.g., the national quality registry for spine surgery (Swespine, FU-rate 70-90%). Multivariate regression analyses were conducted to assess their effect on outcome. Two patient-reported outcome measures, Global Assessment of leg pain (GA) and the Oswestry Disability Index (ODI), as well as length of sick leave after surgery were analyzed. Results Clinical and socioeconomic factors significantly affected health outcome (both GA and ODI). Some predictors of a good outcome (ODI) were: being born in the EU, reporting no back pain at baseline, a high disposable income and a high educational level. Some factors predicting a worse outcome were previous surgery, having had back pain more than 2 years, having comorbidities, being a smoker, being on social welfare and being unemployed. Conclusions The study highlights the relevance of adding socioeconomic factors to clinical factors for analysis of patientreported outcomes, although the causal pathway of most predictors' impact is unknown. These findings should be further investigated in the perspective of treatment selection for individual LSS patients. The study also presents a foundation of case mix algorithms for predicting outcome of surgery for LSS. Graphical abstract These slides can be retrieved under Electronic Supplementary Material.
Uploads
Papers by Peter Fritzell