The Swedish Spine Register: development, design and utility

The Swedish Spine Register enables monitoring of surgical activities focusing on changes in trends over time, techniques utilized and outcome, when implemented in general clinical practice. Basic requirements for a prosperous register are unity within the profession, mainly patient-based documentation and a well functioning support system. This presentation focuses on the development and design of the register protocol, problems encountered and solutions found underway. Various examples on how the results can be presented and utilized are given as well as validation. Register data demonstrate significant gender differences in lumbar disc herniation surgery with females having more pain, lower quality of life and more pronounced disability preoperatively while improvement after surgery is similar between genders. Quality of life after surgery for degenerative disorders is significantly improved for disc herniation, stenosis, spondylolisthesis and disc degenerative disorders. Over the last 10 years, surgical treatment for spinal stenosis has increased gradually while disc herniation surgery decreases regarding yearly number of procedures. An added function to the register enables more complex prospective clinical studies to include register data together with data suitable for the individual study. A common core set of demographic, surgical and outcome parameters would enable comparisons of clinical studies within and between nations

To What Extent do Fiscal Regimes Equalize Opportunities for Income Acquisition Among Citizens?

This project employs the theory of equality of opportunity, described in Roemer's book (Equality of Opportunity, Harvard University Press, 1998), to compute the extent to which tax-and-transfer regimes in ten countries equalize opportunities among citizens for income acquisition. Roughly speaking, equality of opportunity for incomes has been achieved in a country when it is the case that the distributions of post-fisc income are the same for different types of citizen, where a citizen's type is defined by the socioeconomic status of his parents. Intuitively, a country will have equalized opportunity if the chances of earning high (or low) income are equal for citizens from all family backgrounds. Of course, pre-fisc income distributions, by type, will not be identical, as long as the educational system does not entirely make up for the disadvantage that children, who come from poor families face, but the tax-and-transfer system can play a role in rectifying that inequality. We include, in our computation, two numbers that summarize the extent to which each country's current fiscal regime achieves equalization of opportunities for income, and the deadweight loss that would be incurred by moving to the regime that does.

A prospective cohort study of surgical treatment for back pain with degenerated discs; study protocol

BACKGROUND: The diagnosis of discogenic back pain often leads to spinal fusion surgery and may partly explain the recent rapid increase in lumbar fusion operations in the United States. Little is known about how patients undergoing lumbar fusion compare in preoperative physical and psychological function to patients who have degenerative discs, but receive only non-surgical care. METHODS: Our group is implementing a multi-center prospective cohort study to compare patients with presumed discogenic pain who undergo lumbar fusion with those who have non-surgical care. We identify patients with predominant low back pain lasting at least six months, one or two-level disc degeneration confirmed by imaging, and a normal neurological exam. Patients are classified as surgical or non-surgical based on the treatment they receive during the six months following study enrollment. RESULTS: Three hundred patients discogenic low back pain will be followed in a prospective cohort study for two years. The primary outcome measure is the Modified Roland-Morris Disability Questionnaire at 24-months. We also evaluate several other dimensions of outcome, including pain, functional status, psychological distress, general well-being, and role disability. CONCLUSION: The primary aim of this prospective cohort study is to better define the outcomes of lumbar fusion for discogenic back pain as it is practiced in the United States. We additionally aim to identify characteristics that result in better patient selection for surgery. Potential predictors include demographics, work and disability compensation status, initial symptom severity and duration, imaging results, functional status, and psychological distress

Cost effectiveness of disc prosthesis versus lumbar fusion in patients with chronic low back pain: randomized controlled trial with 2-year follow-up

This randomized controlled health economic study assesses the cost-effectiveness of the concept of total disc replacement (TDR) (Charité/Prodisc/Maverick) when compared with the concept of instrumented lumbar fusion (FUS) [posterior lumbar fusion (PLF) /posterior lumbar interbody fusion (PLIF)]. Social and healthcare perspectives after 2 years are reported. In all, 152 patients were randomized to either TDR (n = 80) or lumbar FUS (n = 72). Cost to society (total mean cost/patient, Swedish kronor = SEK, standard deviation) for TDR was SEK 599,560 (400,272), and for lumbar FUS SEK 685,919 (422,903) (ns). The difference was not significant: SEK 86,359 (−45,605 to 214,332). TDR was significantly less costly from a healthcare perspective, SEK 22,996 (1,202 to 43,055). Number of days on sick leave among those who returned to work was 185 (146) in the TDR group, and 252 (189) in the FUS group (ns). Using EQ-5D, the total gain in quality adjusted life years (QALYs) over 2 years was 0.41 units for TDR and 0.40 units for FUS (ns). Based on EQ-5D, the incremental cost-effectiveness ratio (ICER) of using TDR instead of FUS was difficult to analyze due to the “non-difference” in treatment outcome, which is why cost/QALY was not meaningful to define. Using cost-effectiveness probabilistic analysis, the net benefit (with CI) was found to be SEK 91,359 (−73,643 to 249,114) (ns). We used the currency of 2006 where 1 EURO = 9.26 SEK and 1 USD = 7.38 SEK. It was not possible to state whether TDR or FUS is more cost-effective after 2 years. Since disc replacement and lumbar fusion are based on different conceptual approaches, it is important to follow these results over time

What comprises a good outcome in spinal surgery? A preliminary survey among spine surgeons of the SSE and European spine patients

Standardized and validated self-administered outcome-instruments are broadly used in spinal surgery. Despite a plethora of articles on outcome research, no systematic evaluation is available on what actually comprises a good outcome in spinal surgery from the patients' and surgeons' perspective, respectively. However, this is a prerequisite for improving outcome instruments. In performing a cross-sectional survey among spine patients from different European regions and spine surgeons of the SSE, the study attempted (1) to identify the most important domains determining a good outcome from a patients' as well as a surgeon's perspective, and (2) to explore regional differences in the identified domains. For this purpose, a structured interview was performed among 30 spine surgeons of the SSE and 353 spine surgery patients (representing Northern, Central and Southern Europe) to investigate their criteria for a good outcome. A qualitative and descriptive approach was used to evaluate the data. Results revealed a high agreement on what comprises a good outcome among surgeons and patients, respectively. The main parameters determining good outcome were achieving the patients' expectations/satisfaction, pain relief, improvement of disability and social reintegration. Younger patients more often expected a complete pain relief, an improved work capacity, and better social life participation. Patients in southern Europe more often wanted to improve work capacity compared to those from central and northern European countries. No substantial differences were found when patients' and surgeons' perspective were compared. However, age and differences in national social security and health care system ("black flags”) have an impact on what is considered a good outcome in spinal surger

To what extent do fiscal regimes equalize opportunities for income acquisition among citizens?.

This paper employs the theory of equality of opportunity, described in Roemer’s book (Equality of Opportunity, Harvard University Press, 1998), to compute the extent to which tax-and-transfer regimes in 11 countries equalize opportunities among citizens for income acquisition. Roughly speaking, equality of opportunity for incomes has been achieved in a country when it is the case that the distributions of post-fisc income are the same for different types of citizen, where a citizen’s type is defined by the socio-economic status of his parents. Intuitively, a country will have equalized opportunity if the chances of earning high (or low) income are equal for citizens from all family backgrounds. Of course, pre-fisc income distributions, by type, will not be identical, as long as the educational system does not entirely make up for the disadvantage that children, who come from poor families face, but the tax-and-transfer system can play a role in rectifying that inequality. We include, in our computation, two numbers that summarize the extent to which each country’s current fiscal regime achieves equalization of opportunities for income, and the deadweight loss that would be incurred by moving to the regime that does.Fiscal regimes; Equal opportunities; Income acquisition;

Report of the International Evaluation of the National Institute for Health and Welfare

THL is an extraordinary institution that any country would be very proud to have as a government agency for public health and welfare and as a source of expertise, evidence, counsel for policy making and the capacity to address Finland’s current challenges in health, welfare, inequalities therein, health threats and health and social care delivery as well as unanticipated future challenges. Both THL leadership and staff and the International Evaluation Group also recognize that Finland faces economic constraints and THL’s budget will need to reflect such circumstances. The IEG feels that efficiencies can be achieved in THL management and consolidation and that strategic planning with priority setting can properly target other areas for diminished emphasis and activity that can be cost-saving. However we urge the Government of Finland and the MSAH to carefully undertake such cost-saving and restructuring efforts to ensure that one of its component “jewels” maintains its excellence and critical capacity such that it continues to be able to provide the highest level of service to Finland and the health and well-being of the Finnish people. The final Report will be published later this year

Socioeconomic inequalities in the quality of life of older Europeans in different welfare regimes

Background: Whether socioeconomic inequalities in health and well-being persist into old age and are narrower in more generous welfare states is debated. We investigated the magnitude of socioeconomic inequality in the quality of life of Europeans in early old age and the influence of the welfare regime type on these relationships.<p></p> Methods: Data from individuals aged 50–75 years (n = 16 074) residing in 13 European countries were derived from Waves 2 and 3 of the Survey of Health, Ageing and Retirement in Europe. Slope indices of inequality (SIIs) were calculated for the association between socioeconomic position and CASP-12, a measure of positive quality of life. Multilevel linear regression was used to assess the overall relationship between socioeconomic position and quality of life, using interaction terms to investigate the influence of the type of welfare regime (Southern, Scandinavian, Post-communist or Bismarckian).<p></p> Results: Socioeconomic inequalities in quality of life were narrowest in the Scandinavian and Bismarckian regimes, and were largest by measures of current wealth. Compared with the Scandinavian welfare regime, where narrow inequalities in quality of life by education level were found in both men (SII = 0.02, 95% CI: −1.09 to 1.13) and women (SII = 1.11, 95% CI: 0.05–2.17), the difference in quality of life between the least and most educated was particularly wide in Southern and Post-communist regimes.<p></p> Conclusion: Individuals in more generous welfare regimes experienced higher levels of quality of life, as well as narrower socioeconomic inequalities in quality of life.<p></p&gt

Comparison of standard fusion with a "topping off" system in lumbar spine surgery: a protocol for a randomized controlled trial

<p>Abstract</p> <p>Background</p> <p>Fusion of lumbar spine segments is a well-established therapy for many pathologies. The procedure changes the biomechanics of the spine. Initial clinical benefits may be outweighed by ensuing damage to the adjacent segments. Various surgical devices and techniques have been developed to prevent this deterioration. "Topping off" systems combine rigid fusion with a flexible pedicle screw system to prevent adjacent segment disease (ASD). To date, there is no convincing evidence that these devices provide any patient benefits.</p> <p>Methods/Design</p> <p>The study is designed as a randomized, therapy-controlled trial in a clinical care setting at a university hospital. Patients presenting to the outpatient clinic with degenerative disc disease or spondylolisthesis will be assessed against study inclusion and exclusion criteria. After randomization, the control group will undergo conventional fusion. The intervention group will undergo fusion with a supplemental flexible pedicle screw system to protect the adjacent segment ("topping off").</p> <p>Follow-up examination will take place immediately after treatment during hospital stay, after 6 weeks, and then after 6, 12, 24 and 36 months. Subsequently, ongoing assessments will be performed annually.</p> <p>Outcome measurements will include quality of life and pain assessments using questionnaires (SF-36™, ODI, COMI). In addition, clinical and radiologic ASD, work-related disability, and duration of work disability will be assessed. Inpatient and 6-month mortality, surgery-related data (e.g., intraoperative complications, blood loss, length of incision, surgical duration), postoperative complications, adverse events, and serious adverse events will be documented and monitored throughout the study. Cost-effectiveness analysis will also be provided.</p> <p>Discussion</p> <p>New hybrid systems might improve the outcome of lumbar spine fusion. To date, there is no convincing published data on effectiveness or safety of these topping off systems. High quality data is required to evaluate the benefits and drawbacks of topping off devices. If only because these devices are quite expensive compared to conventional fusion implants, nonessential use should be avoided. In fact, these high costs necessitate efforts by health care providers to evaluate the effects of these implants. Randomized clinical trials are highly recommended to evaluate the benefits or harm to the patient.</p> <p>Trial Registration</p> <p>ClinicalTrials.gov: <a href="http://www.clinicaltrials.gov/ct2/show/NCT01224379">NCT01224379</a></p