[Medical Methods: What Makes them Medically Necessary? Part II: Further Criteria, Overuse, Moving Thresholds, and Grey Zones]. / Medizinische Behandlungsmethoden: Was macht sie medizinisch notwendig? Teil II: Weitere Kriterien, Übermaßverbot, wandernde Grenzen und Grauzonen.

OBJECTIVES: "Medical necessity" (MedN) is a fuzzy term. Our project aims at concretising the concept between medical ethics, social law, and social medicine to support health care regulation, primarily within Germany's statutory health insurance system. In Part I, we identified efficacy, (net)benefit, and the corresponding bodies of evidence as obligatory criteria of MedN. This is the second part suggesting and discussing further criteria. METHODS: See Part I RESULTS: (Part II): As further MedN-criteria we critically assessed a method's effectiveness and acceptance in routine care, its potential beneficiaries, theoretical fundament, cost, and being without alternative as well as patients' self-responsibility, cooperation, and preferences. Since MedN has both lower and upper bounds, we had to consider certain cases of mis- and overuse, due for instance to "indication creep" or "disease mongering". CONCLUSIONS: The additional criteria neither establish MedN (when met singly or together) nor exclude it (when not met). If MedN is rejected in view of the 3 obligatory criteria then further information does not overturn the verdict. If a method is already assessed as being medn then further criteria do not make it "more or less necessary". Though we advocated for a binary MedN-concept (Part I) we are nonetheless convinced that not all medical methods deemed medn are equally medically relevant. Respective differences within the range of MedN could be assessed by techniques to prioritise medical conditions, methods, and aims.

Validation of the "German Inflammatory Bowel Disease Activity Index (GIBDI)": An Instrument for Patient-Based Disease Activity Assessment in Crohn's Disease and Ulcerative Colitis.

INTRODUCTION: Assessment of disease activity in Crohn's disease (CD) and ulcerative colitis (UC) is usually based on the physician's evaluation of clinical symptoms, endoscopic findings, and biomarker analysis. The German Inflammatory Bowel Disease Activity Index for CD (GIBDICD) and UC (GIBDIUC) uses data from patient-reported questionnaires. It is unclear to what extent the GIBDI agrees with the physicians' documented activity indices. METHODS: Data from 2 studies were reanalyzed. In both, gastroenterologists had documented disease activity in UC with the partial Mayo Score (pMS) and in CD with the Harvey Bradshaw Index (HBI). Patient-completed GIBDI questionnaires had also been assessed. The analysis sample consisted of 151 UC and 150 CD patients. Kappa coefficients were determined as agreement measurements. RESULTS: Rank correlations were 0.56 (pMS, GIBDIUC) and 0.57 (HBI, GIBDICD), with p < 0.001. The absolute agreement for 2 categories of disease activity (remission yes/no) was 74.2 % (UC) and 76.6 % (CD), and for 4 categories (none/mild/moderate/severe) 60.3 % (UC) and 61.9 % (CD). The kappa values ranged between 0.47 for UC (2 categories) and 0.58 for CD (4 categories). DISCUSSION: There is satisfactory agreement of GIBDI with the physician-documented disease activity indices. GIBDI can be used in health care research without access to assessments of medical practitioners. In clinical practice, the index offers a supplementary source of information.

Inviting patients with inflammatory bowel disease to active involvement in their own care: a randomized controlled trial.

BACKGROUND: Inflammatory bowel diseases impose on patients a broad spectrum of somatic and psychosocial burden. We hypothesized that patients' self-responsibility in planning and initiating adequate usually multimodal health care can be supported by self-assessment and proactive information, thus improving health-related quality of life and social participation. METHODS: We conducted a randomized controlled trial among a random sample of adult members of a German statutory health insurance with Crohn's disease or ulcerative colitis with at least 1 inflammatory bowel diseases-related hospital stay or sick leave in 2009 or 2010. Five hundred fourteen patients completed a postal screening questionnaire inquiring about 22 problems. The intervention group (IG) received an automated data analysis with individualized written advice on appropriate health services, and the control group received usual care. Main outcomes were health-related quality of life and social participation. Secondary outcomes included health care utilization, number of screened problems, and self-management skills. RESULTS: After 12 months, small beneficial effects were seen for all primary outcomes in the IG: EuroQol visual analog scale score (difference between IG and control group: 4.4; 95% confidence interval, 7.7-1.0; P = 0.011), index for measuring participation restriction (IMET) score (difference between IG and control group: 0.4; 95% confidence interval, 0.07-0.62; P = 0.013). The number of disability days improved only in the IG. The IG reported significantly fewer outpatient visits, fewer disease-related problems, and improved self-management skills (health education impact questionnaire scores) with no increase in disease activity, hospital stays, or consultations with allied health professionals. CONCLUSIONS: Our activation and information procedure is effective and beneficial. Further studies might show its usefulness in comprehensive management of patients with inflammatory bowel diseases.

Cohort Profile: a population-based cohort to study non-motor symptoms in parkinsonism (EPIPARK).

Parkinson's disease is increasingly viewed as a complex disorder including a range of typical non-motor symptoms in addition to the cardinal motor signs. This cohort was set up in 2010 to investigate the specificity of non-motor symptoms for Parkinson's disease. For this, we included several control groups with decreasing contrast from Parkinson's disease patients. Group definitions ranged from healthy control subjects to those with suspected early motor signs of parkinsonism. Using a mailed questionnaire, we screened 5838 inhabitants of Lübeck, Germany, out of a target population of 10 000 citizens, enquiring about motor impairment, pain, quality of life, comorbidities, somatization and demographics. Based on this information, participants were assigned to screening groups, and selected participants were invited for in-person examination (n = 623). The examination included cognitive examinations, transcranial ultrasound, a brief psychiatric interview and a standardized motor examination that was used to assign examination groups. In addition, all participants answered questionnaires addressing depression, anxiety, sleep and quality of life. The first-year follow-up examination was performed either in person using the same protocol or via mailed questionnaires. This study is ongoing and publications are in preparation, but you may contact the first author (meike.kasten@neuro.uni-luebeck.de) with suggestions for collaboration or data requests.

[The national public discourse on priority setting in health care in German print media]. / Eine Analyse des nationalen öffentlichen Priorisierungsdiskurses in deutschen Printmedien.

Germany's Central Ethics Committee of the Federal Chamber of Physicians (FCP) and other relevant national actors called for a public discourse on priority setting in health care. Politicians, members of a Federal Joint Committee and health insurance representatives, however, refused to promote or participate in the establishment of a public discussion. A change to that attitude only became apparent after former FCP President Hoppe's opening speech at the annual FCP assembly in Mainz in 2009. The present paper applies the Sociology of Knowledge Approach to Discourse, implemented through Qualitative Content Analysis and elements of Grounded Theory, to examine the development of the national public discourse in leading German print media. It creates a matrix that represents the discourse development between May 2009 and May 2010 and reflects central actors, their "communicative phenomena" and their interactions. Additionally, the matrix has been extended to cover the period until December 2011. Hoppe's arguments for priority setting in health care are faced with a wide opposition assuming opposing prerequisites and thus demanding alternative remedies. The lack of interaction between the different parties prevents any development of the speakers' positions. Incorrect accounts, reductions and left-outs in the media representation add to this effect. Consequently, the public discussion on priority setting is far from being an evolving rational discourse. Instead, it constitutes an exchange of preformed opposing positions.

[Deliberative participation of citizens in the prioritisation debate: what is their contribution?]. / Deliberative Bürgerbeteiligung in der Priorisierungsdebatte: Welchen Beitrag können Bürger leisten?

The German debate on prioritisation in medicine is getting well under way. This development has raised the question of which substantial and procedural criteria should be used to guide fair and legitimate prioritisation. It seems to be obvious that in a pluralist, democratic society citizens should be involved in such a discussion. But which is the adequate method, and what is the potential of citizen participation? In this paper we compare the results of a regional citizens' conference on prioritisation in medicine with various European reports on principles and criteria for prioritisation, and thereby aim to identify the conference members'contributions to the German debate on prioritisation criteria. The results of this exemplary deliberative event can provide hints towards the general potential of discursive participation. (As supplied by publisher).

Falls prevention for the elderly.

BACKGROUND: An ageing population, a growing prevalence of chronic diseases and limited financial resources for health care underpin the importance of prevention of disabling health disorders and care dependency in the elderly. A wide variety of measures is generally available for the prevention of falls and fall-related injuries. The spectrum ranges from diagnostic procedures for identifying individuals at risk of falling to complex interventions for the removal or reduction of identified risk factors. However, the clinical and economic effectiveness of the majority of recommended strategies for fall prevention is unclear. Against this background, the literature analyses in this HTA report aim to support decision-making for effective and efficient fall prevention. RESEARCH QUESTIONS: The pivotal research question addresses the effectiveness of single interventions and complex programmes for the prevention of falls and fall-related injuries. The target population are the elderly (> 60 years), living in their own housing or in long term care facilities. Further research questions refer to the cost-effectiveness of fall prevention measures, and their ethical, social and legal implications. METHODS: Systematic literature searches were performed in 31 databases covering the publication period from January 2003 to January 2010. While the effectiveness of interventions is solely assessed on the basis of randomised controlled trials (RCT), the assessment of the effectiveness of diagnostic procedures also considers prospective accuracy studies. In order to clarify social, ethical and legal aspects all studies deemed relevant with regard to content were taken into consideration, irrespective of their study design. Study selection and critical appraisal were conducted by two independent assessors. Due to clinical heterogeneity of the studies no meta-analyses were performed. RESULTS: Out of 12,000 references retrieved by literature searches, 184 meet the inclusion criteria. However, to a variable degree the validity of their results must be rated as compromised due to different biasing factors. In summary, it appears that the performance of tests or the application of parameters to identify individuals at risk of falling yields little or no clinically relevant information. Positive effects of exercise interventions may be expected in relatively young and healthy seniors, while studies indicate opposite effects in the fragile elderly. For this specific vulnerable population the modification of the housing environment shows protective effects. A low number of studies, low quality of studies or inconsistent results lead to the conclusion that the effectiveness of the following interventions has to be rated unclear yet: correction of vision disorders, modification of psychotropic medication, vitamin D supplementation, nutritional supplements, psychological interventions, education of nursing personnel, multiple and multifactorial programs as well as the application of hip protectors. For the context of the German health care system the economic evaluations of fall prevention retrieved by the literature searches yield very few useful results. Cost-effectiveness calculations of fall prevention are mostly based on weak effectiveness data as well as on epidemiological and cost data from foreign health care systems. Ethical analysis demonstrates ambivalent views of the target population concerning fall risk and the necessity of fall prevention. The willingness to take up preventive measures depends on a variety of personal factors, the quality of information, guidance and decision-making, the prevention program itself and social support. THE ANALYSIS OF PAPERS REGARDING LEGAL ISSUES SHOWS THREE MAIN CHALLENGES: the uncertainty of which standard of care has to be expected with regard to fall prevention, the necessity to consider the specific conditions of every single case when measures for fall prevention are applied, and the difficulty to balance the rights to autonomous decision making and physical integrity. DISCUSSION AND CONCLUSIONS: The assessment of clinical effectiveness of interventions for fall prevention is complicated by inherent methodological problems (esp. absence of blinding) and meaningful clinical heterogeneity of available studies. Therefore meta-analyses are not appropriate, and single study results are difficult to interpret. Both problems also impair the informative value of economic analyses. With this background it has to be stated that current recommendations regarding fall prevention in the elderly are not fully supported by scientific evidence. In particular, for the generation of new recommendations the dependency of probable effects on specific characteristics of the target populations or care settings should be taken into consideration. This also applies to the variable factors influencing the willingness of the target population to take up and pursue preventive measures. In the planning of future studies equal weight should be placed on methodological rigour (freedom from biases) and transferability of results into routine care. Economic analyses require input of German data, either in form of a "piggy back study" or in form of a modelling study that reflects the structures of the German health care system and is based on German epidemiological and cost data.

[German Research Foundation (DFG) Early Career Investigators Workshop in Health Services Research: concept - progress - feedback]. / DFG-Nachwuchsakademie Versorgungsforschung -Konzept - Ablauf - Teilnehmerrückmeldungen.

In December 2010, the Institutes for Social Medicine and Cancer Epidemiology of the University of Lübeck hosted the first Workshop for Early Career Investigators in the area of Health Services Research. This workshop was funded by the Deutsche Forschungsgemeinschaft (DFG, German Research Foundation) with the aim to promote young scientists and researchers that wish to pursue research in the field of Health Services Research in an early phase of their career. The following report addresses the background, concept and progress of the initiative. All applicants had to submit a detailed project proposal and underwent a rigorous selection process. The projects presented at the workshop covered a wide range of topics, such as, for example, access to health care, common elements of mental illnesses and psychosomatic disorders, quality assurance in medical practices (i.e., evaluation of disease management programmes) and targets in rehabilitation. A major subject was migration as a challenge to Health Services Research. The 20 best applicants out of 121 were invited to attend the programme. During five days the participants had the opportunity to present their projects and discuss current issues as well as fundamental themes in study design. At the same time, national and international leading experts gave a series of lectures on current topics of Health Services Research. In numerous discussion groups and topical workshops participants and speakers explored and sought solutions to specific research issues. Following the programme participants are expected to finalise their research proposals and apply for funding to the DFG. To foster networking among early-career researchers, an alumni meeting is scheduled after 12 months. The DFG Workshop for Early Career Investigators was the first of its kind in the field of Health Services Research in Germany. However, evidence of its sustainability will have to be obtained from the future development of the German Health Services Research.

[Quality Association for Acute Stroke Treatment Schleswig-Holstein (QugSS)]. / QugSS - Qualitätsgemeinschaft Schlaganfallversorgung Schleswig-Holstein.

The Quality Association for Acute Stroke Treatment Schleswig-Holstein (QugSS) continues a project which was conducted from 2004 to 2007 as part of a benchmarking programme funded by the German Health Ministry. The implementation of the benchmarking programme in 15 hospitals was intended to improve patient-related outcomes of the inpatient treatment of acute stroke. Regular reports to the Quality Association are complemented by quarterly meetings of the association members to compare and discuss the results of the participating hospitals. Quality indicators developed by the German Stroke Registries Study Group (ADSR) are used. In addition, the meetings serve as a platform for mutual exchange in the form of further training. Between April 2005 and December 2010 approx. 18,000 cases (mean age: 71.9±12.8 years/M±SD, 48.7% females) were documented. From 2008 to 2010, nine out of 12 process indicators improved significantly. Values above the pre-defined target level of the quality indicators were significantly achieved by five indicators (p<.05), almost achieved by three indicators (not significant), and were significantly failed by four indicators.

Informative value of Patient Reported Outcomes (PRO) in Health Technology Assessment (HTA).

BACKGROUND: "Patient-Reported Outcome" (PRO) is used as an umbrella term for different concepts for measuring subjectively perceived health status e. g. as treatment effects. Their common characteristic is, that the appraisal of the health status is reported by the patient himself. In order to describe the informative value of PRO in Health Technology Assessment (HTA) first an overview of concepts, classifications and methods of measurement is given. The overview is complemented by an empirical analysis of clinical trials and HTA-reports on rheumatoid arthritis and breast cancer in order to report on type, frequency and consequences of PRO used in these documents. METHODS: For both issues systematic reviews of the literature have been performed. The search for methodological literature covers the publication period from 1990 to 2009, the search for clinical trials of rheumatoid arthritis and breast cancer covers the period 2005 to 2009. Both searches were performed in the medical databases of the German Institute of Medical Documentation and Information (DIMDI). The search for HTA-reports and methodological papers of HTA-agencies was performed in the CRD-Databases (CRD = Centre for Reviews and Dissemination) and by handsearching the websites of INAHTA member agencies (INAHTA = International Network of Agencies for Health Technology Assessment). For all issues specific inclusion and exclusion criteria were defined. The methodological quality of randomized controlled trials (RCT) was assessed by a modified version of the Cochrane Risk of Bias Tool. For the methodological part information extraction from the literature is structured by the report's chapters, for the empirical part data extraction sheets were constructed. All information is summarized in a qualitative manner. RESULTS: Concerning the methodological issues the literature search retrieved 158 documents (87 documents related to definition or classification, 125 documents related to operationalisation of PRO). For the empirical analyses 225 RCT (rheumatoid arthritis: 77; breast cancer: 148) and 40 HTA-reports and method papers were found. The analysis of the methodological literature confirms the role of PRO as an umbrella term for a variety of different concepts. The newest classification system facilitates the description of PRO measures by construct, target population and the method of measurement. Steps of operationalisation involve defining a conceptual framework, instrument development, exploration of measurement properties or, possibly, the modification of existing instruments. Seven out of 59 RCT analysing the effects of antibody therapy for rheumatoid arthritis define PRO as the primary endpoint, 38 trials utilize composite measures (ACR, DAS) and ten trials report clinical or radiological parameters as the primary endpoint. Six out of 123 chemotherapy trials for breast cancer define PRO as the primary endpoint, while 98 trials report clinical endpoints (survival, tumour response, progression) in their primary analyses. Discrepancies in the number of trials result from inaccurate specifications of endpoints in the publications. This distribution is reflected in the HTA-reports: while almost all reports on rheumatoid arthritis refer to PRO, this is only the case in about half of the reports on breast cancer. CONCLUSIONS: As definition and classification of PRO are concerned, coherent concepts are found in the literature. Their operationalisation and implementation must be guided by scientific principles. The type and frequency of PRO used in clinical trials largely depend on the disease analysed. The HTA-community seems to pursue the utilization of PRO proactively - in case of missing data the need for further research is stated.

Individual health services and the limits to service provision in insurance registered German medical practices: patient experiences.

BACKGROUND: Persons with statutory health insurance (SHI) in Germany increasingly report being denied medical services and being asked to purchase individual health services (IHS). We performed a population-based survey to study the prevalence of this practice, patients' attitudes toward it, and any potential regional differences. METHODS: Systematic samples were drawn from the population registries of Lübeck and Freiburg. First, a postal screening survey explored the one-year and lifetime prevalence of IHS and medical service denial among 2448 persons in Lübeck and 2450 in Freiburg. In a second postal survey, the 915 SHI respondents reporting IHS and/or service denial in the past year were asked for further details of their experiences. RESULTS: The response rates were 53.2 % (screening survey) and 75.4 % (detailed questionnaire); more persons responded in Lübeck than in Freiburg, and women and older persons responded more commonly than men and younger persons. There was no regional difference in prevalence. Among the 1899 members of SHI that had consulted a physician in the past year, 41.7 % said they had been offered IHS, and 20.5% reported being denied medical services. In this group, 43.3% later had the denied service offered to them as an IHS. CONCLUSIONS: These population-based data on IHS and the denial of medical services in German medical practices confirm and extend the findings of earlier studies.

The population-based oncological health care study OVIS - recruitment of the patients and analysis of the non-participants.

BACKGROUND: The ageing of the population is expected to bring an enormous growth in demand for oncological health care. In order to anticipate and respond to future trends, cancer care needs to be critically evaluated. The present study explores the possibility of conducting representative and population-based research on cancer care on the basis of data drawn from the Cancer Registry. METHODS: A population-based state-wide cohort study (OVIS) has been carried out in Schleswig-Holstein, Germany. All patients with malignant melanoma, breast, or prostate cancer were identified in the Cancer Registry. Epidemiological data were obtained for all the patients and screened for study eligibility. A postal questionnaire requesting information on diagnosis, therapy, QoL and aftercare was sent to eligible patients. RESULTS: A total of 11,489 persons diagnosed with the cancer types of interest in the period from January 2002 to July 2004 were registered in the Cancer Registry. Of the 5,354 (47%) patients who gave consent for research, 4,285 (80% of consenters) completed the questionnaire. In terms of relevant epidemiological variables, participants with melanoma were not found to be different from non-participants with the same diagnosis. However, participants with breast or prostate cancer were slightly younger and had smaller tumours than patients who did not participate in our study. CONCLUSION: Population-based cancer registry data proved to be an invaluable resource for both patient recruitment and non-participant analysis. It can help improve our understanding of the strength and nature of differences between participants and non-respondents. Despite minor differences observed in breast and prostate cancer, the OVIS-sample seems to represent the source population adequately.

Guideline-compatible treatment of breast cancer patients: the status quo in schleswig-holstein.

INTRODUCTION: It is unclear whether the care of breast cancer patients complies with the German breast cancer guideline and achieves the appropriate standard of care. For this reason the guideline's requirements were compared with the empirically determined health care provision in the German state of Schleswig-Holstein. METHODS: The OVIS-study is based on a postal questionnaire survey of medical care in 1927 breast cancer patients between 02/2003 to 02/2005. Statements such as "should be carried out" and "mandatory procedure" were cross-referenced with specific reference ranges. RESULTS: Locally invasive tumors were rare (pT 3/4: 8%). Preoperatively, 95% of patients received mammography, 78% breast ultrasound, 92% a chest x-ray, and 81% an abdominal ultrasound. 71% of all patients had breast conserving treatment, of whom 96% had irradiation of the remaining breast tissue. Axilla lymph node dissection was reported for 91%, axillary irradiation for 36%, and a systemic therapy for 95%. DISCUSSION: Local quality indicators comply in general with the German guideline. The high rate of axillary irradiation could be viewed as inadequate provision.

Minimally invasive surgical procedures for the treatment of lumbar disc herniation.

INTRODUCTION: In up to 30% of patients undergoing lumbar disc surgery for herniated or protruded discs outcomes are judged unfavourable. Over the last decades this problem has stimulated the development of a number of minimally-invasive operative procedures. The aim is to relieve pressure from compromised nerve roots by mechanically removing, dissolving or evaporating disc material while leaving bony structures and surrounding tissues as intact as possible. In Germany, there is hardly any utilisation data for these new procedures - data files from the statutory health insurances demonstrate that about 5% of all lumbar disc surgeries are performed using minimally-invasive techniques. Their real proportion is thought to be much higher because many procedures are offered by private hospitals and surgeries and are paid by private health insurers or patients themselves. So far no comprehensive assessment comparing efficacy, safety, effectiveness and cost-effectiveness of minimally-invasive lumbar disc surgery to standard procedures (microdiscectomy, open discectomy) which could serve as a basis for coverage decisions, has been published in Germany. OBJECTIVE: Against this background the aim of the following assessment is: Based on published scientific literature assess safety, efficacy and effectiveness of minimally-invasive lumbar disc surgery compared to standard procedures. To identify and critically appraise studies comparing costs and cost-effectiveness of minimally-invasive procedures to that of standard procedures. If necessary identify research and evaluation needs and point out regulative needs within the German health care system. The assessment focusses on procedures that are used in elective lumbar disc surgery as alternative treatment options to microdiscectomy or open discectomy. Chemonucleolysis, percutaneous manual discectomy, automated percutaneous lumbar discectomy, laserdiscectomy and endoscopic procedures accessing the disc by a posterolateral or posterior approach are included. METHODS: In order to assess safety, efficacy and effectiveness of minimally-invasive procedures as well as their economic implications systematic reviews of the literature are performed. A comprehensive search strategy is composed to search 23 electronic databases, among them MEDLINE, EMBASE and the Cochrane Library. Methodological quality of systematic reviews, HTA reports and primary research is assessed using checklists of the German Scientific Working Group for Health Technology Assessment. Quality and transparency of cost analyses are documented using the quality and transparency catalogues of the working group. Study results are summarised in a qualitative manner. Due to the limited number and the low methodological quality of the studies it is not possible to conduct metaanalyses. In addition to the results of controlled trials results of recent case series are introduced and discussed. RESULTS: The evidence-base to assess safety, efficacy and effectiveness of minimally-invasive lumbar disc surgery procedures is rather limited: PERCUTANEOUS MANUAL DISCECTOMY: Six case series (four after 1998)AUTOMATED PERCUTANEOUS LUMBAR DISCECTOMY: Two RCT (one discontinued), twelve case series (one after 1998)CHEMONUCLEOLYSIS: Five RCT, five non-randomised controlled trials, eleven case seriesPERCUTANEOUS LASERDISCECTOMY: One non-randomised controlled trial, 13 case series (eight after 1998)ENDOSCOPIC PROCEDURES: Three RCT, 21 case series (17 after 1998) There are two economic analyses each retrieved for chemonucleolysis and automated percutaneous discectomy as well as one cost-minimisation analysis comparing costs of an endoscopic procedure to costs for open discectomy. Among all minimally-invasive procedures chemonucleolysis is the only of which efficacy may be judged on the basis of results from high quality randomised controlled trials (RCT). Study results suggest that the procedure maybe (cost)effectively used as an intermediate therapeutical option between conservative and operative management of small lumbar disc herniations or protrusions causing sciatica. Two RCT comparing transforaminal endoscopic procedures with microdiscectomy in patients with sciatica and small non-sequestered disc herniations show comparable short and medium term overall success rates. Concerning speed of recovery and return to work a trend towards more favourable results for the endoscopic procedures is noted. It is doubtful though, whether these results from the eleven and five years old studies are still valid for the more advanced procedures used today. The only RCT comparing the results of automated percutaneous lumbar discectomy to those of microdiscectomy showed clearly superior results of microdiscectomy. Furthermore, success rates of automated percutaneous lumbar discectomy reported in the RCT (29%) differ extremely from success rates reported in case series (between 56% and 92%). The literature search retrieves no controlled trials to assess efficacy and/or effectiveness of laser-discectomy, percutaneous manual discectomy or endoscopic procedures using a posterior approach in comparison to the standard procedures. Results from recent case series permit no assessment of efficacy, especially not in comparison to standard procedures. Due to highly selected patients, modi-fications of operative procedures, highly specialised surgical units and poorly standardised outcome assessment results of case series are highly variable, their generalisability is low. The results of the five economical analyses are, due to conceptual and methodological problems, of no value for decision-making in the context of the German health care system. DISCUSSION: Aside from low methodological study quality three conceptual problems complicate the interpretation of results. Continuous further development of technologies leads to a diversity of procedures in use which prohibits generalisation of study results. However, diversity is noted not only for minimally-invasive procedures but also for the standard techniques against which the new developments are to be compared. The second problem refers to the heterogeneity of study populations. For most studies one common inclusion criterion was "persisting sciatica after a course of conservative treatment of variable duration". Differences among study populations are noted concerning results of imaging studies. Even within every group of minimally-invasive procedure, studies define their own in- and exclusion criteria which differ concerning degree of dislocation and sequestration of disc material. There is the non-standardised assessment of outcomes which are performed postoperatively after variable periods of time. Most studies report results in a dichotomous way as success or failure while the classification of a result is performed using a variety of different assessment instruments or procedures. Very often the global subjective judgement of results by patients or surgeons is reported. There are no scientific discussions whether these judgements are generalisable or comparable, especially among studies that are conducted under differing socio-cultural conditions. Taking into account the weak evidence-base for efficacy and effectiveness of minimally-invasive procedures it is not surprising that so far there are no dependable economic analyses. CONCLUSIONS: Conclusions that can be drawn from the results of the present assessment refer in detail to the specified minimally-invasive procedures of lumbar disc surgery but they may also be considered exemplary for other fields where optimisation of results is attempted by technological development and widening of indications (e.g. total hip replacement). Compared to standard technologies (open discectomy, microdiscectomy) and with the exception of chemonucleolysis, the developmental status of all other minimally-invasive procedures assessed must be termed experimental. To date there is no dependable evidence-base to recommend their use in routine clinical practice. To create such a dependable evidence-base further research in two directions is needed: a) The studies need to include adequate patient populations, use realistic controls (e.g. standard operative procedures or continued conservative care) and use standardised measurements of meaningful outcomes after adequate periods of time. b) Studies that are able to report effectiveness of the procedures under everyday practice conditions and furthermore have the potential to detect rare adverse effects are needed. In Sweden this type of data is yielded by national quality registries. On the one hand their data are used for quality improvement measures and on the other hand they allow comprehensive scientific evaluations. Since the year of 2000 a continuous rise in utilisation of minimally-invasive lumbar disc surgery is observed among statutory health insurers. Examples from other areas of innovative surgical technologies (e.g. robot assisted total hip replacement) indicate that the rise will probably continue - especially because there are no legal barriers to hinder introduction of innovative treatments into routine hospital care. Upon request by payers or providers the "Gemeinsamer Bundesausschuss" may assess a treatments benefit, its necessity and cost-effectiveness as a prerequisite for coverage by the statutory health insurance. In the case of minimally-invasive disc surgery it would be advisable to examine the legal framework for covering procedures only if they are provided under evaluation conditions. While in Germany coverage under evaluation conditions is established practice in ambulatory health care only ("Modellvorhaben") examples from other European countries (Great Britain, Switzerland) demonstrate that it is also feasible for hospital based interventions. (ABSTRACT TRUNCATED)

Can health care utilization explain the association between socioeconomic status and back pain?

STUDY DESIGN: Cross-sectional population-based study. OBJECTIVES: To assess whether the association between socioeconomic status and severe back pain can be explained by the preceding health care utilization for back pain. SUMMARY OF BACKGROUND DATA: The ways in which socioeconomic status affects the occurrence of back pain are unclear. METHODS: Age- and gender-adjusted odds ratios with 95% confidence intervals for the association between indicators of socioeconomic status and severe current back pain (high intensity and/or high disability: no/yes) were investigated in an interview among 770 study participants out of 1113 study participants with a recent history of back pain in a survey among 2731 adults. RESULTS: The point prevalence of severe current back pain (39.8%) was related to educational level and health insurance status. Prior health care utilization for back pain was about 2-fold more prevalent in adults with severe current back pain. Members of private health insurance (odds ratio 0.60, 95% confidence interval 0.37-0.99) were less likely to report prior consultation of a general practitioner for back pain. Members of sick funds for white-collar workers (odds ratio 2.81, 95% confidence interval 1.43-5.51) and private insurance (odds ratio 2.81, 95% confidence interval 1.02-6.24) and individuals with intermediate educational level (odds ratio 1.76, 95% confidence interval 1.05-2.95) utilized more physical therapy for the treatment of back pain. After additionally adjusting for health care utilization, the associations between educational level or health insurance status and severe current back pain remained unchanged. CONCLUSIONS: The data suggest that education, health insurance status, and health care utilization are independently associated with severe current back pain in a society with universal access to health care.