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

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

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

Validity of rating scale measures of voice quality

The validity of perceptual measures of vocal quality has been neglected in studies of voice, which focus more commonly on rater reliability. Validity depends in part on reliability, because an unreliable test does not measure what it is intended to measure. However, traditional measures of rating reliability only partially represent interrater agreement, because they cannot reflect variations or patterns of agreement for specific voice samples. In this paper the likelihood that two raters would agree in their ratings of a single voice is examined, for each voice in five previously gathered data sets. Results do not support the continued assumption that traditional rating procedures produce useful indices of listeners' perceptions. Listeners agreed very poorly in the midrange of scales for breathiness and roughness, and mean ratings in the midrange of such scales did not represent the extent to which a voice possesses a quality, but served only to indicate that listeners disagreed. Techniques like analysis by synthesis or judgment of similarity avoid decomposing quality into constituent dimensions, and do not require a listener to compare an external stimulus to an unstable internal representation, thus decreasing the error in measures of quality. Modeling individual differences in perception can increase the variance accounted for in models of quality, further reducing the error in perceptual measures. Thus such techniques may provide valid alternatives to current approaches

Evaluating rehabilitation following lumbar fusion surgery (REFS): study protocol for a randomised controlled trial

BACKGROUND: The rate of lumbar fusion surgery (LFS) is increasing. Clinical recovery often lags technical outcome. Approximately 40% of patients undergoing LFS rate themselves as symptomatically unchanged or worse following surgery. There is little research describing rehabilitation following LFS with no clear consensus as to what constitutes the optimum strategy. It is important to develop appropriate rehabilitation strategies to help patients manage pain and recover lost function following LFS. METHODS/DESIGN: The study design is a randomised controlled feasibility trial exploring the feasibility of providing a complex multi-method rehabilitation intervention 3 months following LFS. The rehabilitation protocol that we have developed involves small participant groups of therapist led structured education utilising principles of cognitive behavioral therapy (CBT), progressive, individualised exercise and peer support. Participants will be randomly allocated to either usual care (UC) or the rehabilitation group (RG). We will recruit 50 subjects, planning to undergo LFS, over 30 months. Following LFS all participants will experience normal care for the first 3 months. Subsequent to a satisfactory 3 month surgical review they will commence their allocated post-operative treatment (RG or UC). Data collection will occur at baseline (pre-operatively), 3, 6 and 12 months post-operatively. Primary outcomes will include an assessment of feasibility factors (including recruitment and compliance). Secondary outcomes will evaluate the acceptability and characteristics of a limited cluster of quantitative measures including the Oswestry Disability Index (ODI) and an aggregated assessment of physical function (walking 50 yards, ascend/descend a flight of stairs). A nested qualitative study will evaluate participants' experiences. DISCUSSION: This study will evaluate the feasibility of providing complex, structured rehabilitation in small groups 3 months following technically successful LFS. We will identify strengths and weakness of the proposed protocol and the usefulness and characteristics of the planned outcome measures. This will help shape the development of rehabilitation strategies and inform future work aimed at evaluating clinical efficacy. TRIAL REGISTRATION: ISRCTN60891364, 10/07/2014

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 surgery

The area-based social patterning of injuries among 10 to 19 year olds Changes over time in the Stockholm County

<p>Abstract</p> <p>Background</p> <p>Area-based studies of childhood injuries strongly suggest that neighborhood socio-demographic and economic circumstances impact on various – though not all – types of injuries. The primary aim of this study was to investigate the stability over time of the association between area characteristics and childhood injuries of various causes.</p> <p>Methods</p> <p>Register-based and ecological, the study encompassed Stockholm County's 138 parishes, and considered two time periods (1993–95; 2003–05). Two indices were measured: economic deprivation and social fragmentation, and parishes were allocated to their respective quintile on each index. Data on both unintentional and intentional injuries for children (boys and girls) aged 10–14 and 15–19 respectively were gathered from the County Council's hospital inpatient register. For each period and index, gender, age and cause-specific comparisons were made to assess the rate ratios (with 95% confidence intervals) of being injured using parishes belonging to the best index level as a comparison group. A series of simple and partial Pearson correlations were also calculated to assess the independent contribution of each index.</p> <p>Results</p> <p>Regardless of time period, there were rather few significant rate ratios and, when they occurred, there were both under and excess risks. For instance, in each period, boys from both age groups living in parishes with the highest levels of economic deprivation had lower rate of injury as a motor vehicle rider. Most strikingly, intentional injuries were more frequent during the second time period and in considerable excess among girls aged 15–19 from more economically deprived areas. Also, during that last period, none of the injury causes correlated significantly with the index of social fragmentation after adjustment for economic deprivation (partial correlation).</p> <p>Conclusion</p> <p>Over a ten-year period, differential economic deprivation among parishes has widened more than social fragmentation in Stockholm County. The correlation between those indices is high in both periods of time whilst the association between the levels of each index and injury rates varies depending on group of injuries or time period considered. It is of concern that intentional injuries have increased numerically and are significantly and positively correlated with economic deprivation (net of social fragmentation), in particular among girls.</p