Jens Lauritsen

Twelve-months follow-up in forty-nine patients with acute/semiacute osteoporotic vertebral fractures treated conservatively or with percutaneous vertebroplasty: a clinical randomized study.

Study Design. Clinical randomized study. Objective. Percutaneous vertebroplasty is compared to conservative treatment in patients with acute or subacute osteoporotic vertebral fractures with respect to pain, physical and mental outcomes. The risk of vertebral fractures adjacent to treated levels is assessed. Summary of Background Data. There are some disagreements of the benefits of PVP for the treatment of acute osteoporotic vertebral fractures, but the long-term clinical outcome of PVP compared to conservative treatment has not been evaluated in a randomized study. Methods. The 3-months follow-up of this study has been published previously, and here we report the completed 12-months analysis. About 50 patients (41 females) were included from January 2001 until January 2008. Patients with vertebral fractures less than 8 weeks old were included and randomized to either PVP or conservative treatment. Pain was assessed with a visual analogue scale. Physical and mental outcomes were assessed by validated questionnaires and tests. Tests, questionnaires, and plain radiographs were performed at the inclusion and after 3 and 12 months. Results. Pain score before and after the operation in the PVP group was 7.9 and 2.0, respectively. There was no difference between the groups concerning pain at the 3- and 12-months follow-up. Supplementary assessment of back pain 1 month after discharge from hospital showed a significant lower VAS score in the PVP group over the conservative group. In the study period, 2 adjacent fractures in the PVP group and no adjacent fractures in the conservative group were registered. Conclusion. PVP is a good treatment for some patients with acute/subacute painful osteoporotic vertebral fractures, but the majority of fractures will heal after 8 to 12 weeks of conservative treatment with subsequent decline in pain. The risk of new fractures needs further research.

Helicobacter pylori and risk of ulcer bleeding among users of nonsteroidal anti-inflammatory drugs: A case-control study

BACKGROUND & AIMS Peptic ulcer complications related to use of nonsteroidal anti-inflammatory drugs (NSAIDs) are among the most common serious adverse drug reactions. Whether Helicobacter pylori infection potentiates this gastrointestinal toxicity of NSAIDs is still unresolved. In this study, we investigated the role of H. pylori as a cause of bleeding peptic ulcer among NSAID users. METHODS A case-control study of current users (n = 132) of NSAIDs (including acetylsalicylic acid), admitted because of bleeding peptic ulcer, was performed. Controls were 136 NSAID users without gastrointestinal complications. H. pylori was diagnosed by either increased levels of serum immunoglobulin G or by 13C-urea breath test. RESULTS Fifty-eight (44%) case subjects had a bleeding gastric ulcer, 54 (41%) had a bleeding duodenal ulcer, 12 (9%) had both gastric and duodenal ulcers, and 8 (6%) had hemorrhagic gastritis. H. pylori was present in 75 (57%) cases compared with 59 (43%) controls. The adjusted odds ratio of bleeding peptic ulcer among NSAID users associated with H. pylori infection was 1.81 (95% confidence interval, 1.02-3.21). H. pylori accounted for approximately 24% of bleeding peptic ulcers among elderly NSAID users. CONCLUSIONS NSAID users infected with H. pylori have an almost twofold increased risk of bleeding peptic ulcer compared with NSAID users without H. pylori.

Why has the search for causes of low back pain largely been nonconclusive

Study Design. Cross-sectional data were collected in a postal questionnaire within the framework of a 5-year randomized, controlled, prospective, population-based study. Objectives. To investigate to what extent associations differ or concur when correlates of low back pain are tested against various subdefinitions of low back pain. Summary of Background Data. Numerous factors have been suspected to cause low back pain, but findings have not been constantly reproduced in epidemiologic studies. Methods. Data were collected on 746 people reporting nonspecific low back pain some time during the year preceding the survey. Six correlates of low back pain (age, sex, marital status, attitude to a healthy life-style, self-reported physical activity at work, and smoking) were cross-tabulated against nonspecific low back pain and against four subgroups of low back pain. Results. There was only one statistically significant strong association between the potential risk indicators and the nonspecific definition of low back pain, but several emerged when the low back pain group was split into subgroups. Different subgroups of low back pain did, indeed, relate differently to the various correlates. Conclusions. It is necessary to define some clinically relevant subgroups of low back pain to accelerate the search for causal mechanisms.

The Prevalence of Low Back Pain in the Literature A Structured Review of 26 Nordic Studies From 1954 to 1993

Study Design. A systematic review was done for all prevalence studies on low back pain in the Nordic population between 1954 and 1992 that could be identified. Objective. To investigate the homogeneity of data. Summary of Background Data. Costs resulting from low back pain are steadily increasing, but it is not known whether this has been caused by changes in healthcare behavior or whether there is art underlying increase in the occurrence of low back pain in the general population. The prevalence rate of low back pain has been continually estimated over the last 40 years, but are the studies sufficiently homogeneous to allow pooling of data? Methods. Twenty-six population-based epidemiologic surveys on the occurrence of low back pain in the Nordic countries were assessed for the following criteria: quality or the report according to a checklist related to the representativeness of the study sample, quality of data, and definition of low back pain; study design (study population, definition of low back pain, and recall periods); poolability of data, taking into account the quality of the report, the definition of low back pain, type of population, age, and sex. Results. Only 10 studies fulfilled a minimum of 75% of the methodologic criteria. There were large differences between studies regarding study design, and the poolability of data was limited to a few studies, none of which fulfilled all of the above criteria. Conclusion. A more stringent, systematic, and uniform methodologic approach to studying the prevalence (or incidence) of back pain is needed.

Decreasing incidence of hip fracture in the Funen County, Denmark

Background Hip fracture incidence rates are high, and increase with increasing age. Previous studies have predicted a continued increase in both crude and age-standardized rates. Method We estimated incidence rates, based on a complete and validated register containing verified and individually sequenced hip fractures from 1996–2003, for a population of 500,000 people in Funen County, Denmark. Results The verified number of the first hip fractures was 6,676, with 520 subsequent fractures. Between 1996 and 2003, the incidence rate of first hip fracture fell by 2.4% per year for males (p = 0.02) and by 1.8% per year for females (p = 0.004). The highest decrease of 3.4% per year (p = 0.02) was seen in 80–84-year-old women. Interpretation The incidence rate of the first hip fracture has fallen in both sexes. In most age groups, the actual number of fractures has also decreased. The findings emphasize the need for valid projection studies which should include both demographic projections and modeling of the effects of different levels of prevention.

Incidence of unintentional injuries in farming based on one year of weekly registration in Danish farms.

BACKGROUND In Denmark, farming ranks as the industry with the highest incidence rate of fatal injuries. For nonfatal injuries, insufficient registration practices prevent valid comparisons between occupations. This study examines the occurrence of farm accidents and injuries, as well as work-specific factors, via weekly registration in a representative sample of 393 farms in one county during 1 year. METHODS From a random sample of 794 farms, (10% of farms in the county of Ringkoebing, Denmark) 393 farms with 1,597 residents and employees participated in a 1-year self-registration of work-related unintentional incidents. The procedure included a detailed registration of hours spent on all main working tasks. Weekly recording of incident occurrence or nonoccurrence resulted in the completion of 19,782 registration forms. Three months after incident occurrence, a telephone interview was conducted about the related work situation and resulting injuries. RESULTS During the 12-month period, 479 occupational accidents were reported, of which 389 resulted in an injury. The absolute number of injuries increased with number of work hours, but there was no relative increase of incidence by work hours. Persons below the age of 50 had slightly less than a doubled risk compared with those over 50 years of age. No other marked, reliable age effect was found. There was, however, a seasonal variation, with summer and autumn having a double relative incidence compared with winter and spring. Among farm owners, 35% experienced at least one injury per year, while this was the case for 17% of farm laborers. When adjusting for work hours, the increased frequency of injuries among farm owners was reduced to a factor of 1.5. Animal-related work was the most common injury mechanism. Repair and maintenance work was found to be the most dangerous task relative to the number of task-specific work hours. Subgroups of tasks with a markedly increased injury rate were moving animals within the farm, veterinary procedures, and repair of field machinery and stable equipment. CONCLUSIONS Farm injuries occur among 32% of full-time farmers and farm laborers each year. A quarter of these require professional treatment. This area calls for preventive action.

Exposure to antiepileptic drugs and the risk of hip fracture: A case-control study

Purpose:  To investigate whether the use of antiepileptic drugs (AEDs) increases the risk of hip fracture.

Quality of data entry using single entry, double entry and automated forms processing--an example based on a study of patient-reported outcomes.

Background The clinical and scientific usage of patient-reported outcome measures is increasing in the health services. Often paper forms are used. Manual double entry of data is defined as the definitive gold standard for transferring data to an electronic format, but the process is laborious. Automated forms processing may be an alternative, but further validation is warranted. Methods 200 patients were randomly selected from a cohort of 5777 patients who had previously answered two different questionnaires. The questionnaires were scanned using an automated forms processing technique, as well as processed by single and double manual data entry, using the EpiData Entry data entry program. The main outcome measure was the proportion of correctly entered numbers at question, form and study level. Results Manual double-key data entry (error proportion per 1000 fields = 0.046 (95% CI: 0.001–0.258)) performed better than single-key data entry (error proportion per 1000 fields = 0.370 (95% CI: 0.160–0.729), (p = 0.020)). There was no statistical difference between Optical Mark Recognition (error proportion per 1000 fields = 0.046 (95% CI: 0.001–0.258)) and double-key data entry (p = 1.000). With the Intelligent Character Recognition method, there was no statistical difference compared to single-key data entry (error proportion per 1000 fields = 6.734 (95% CI: 0.817–24.113), (p = 0.656)), as well as double-key data entry (error proportion per 1000 fields = 3.367 (95% CI: 0.085–18.616)), (p = 0.319)). Conclusions Automated forms processing is a valid alternative to double manual data entry for highly structured forms containing only check boxes, numerical codes and no dates. Automated forms processing can be superior to single manual data entry through a data entry program, depending on the method chosen.

Assessment of the global trigger tool to measure, monitor and evaluate patient safety in cancer patients: reliability concerns are raised

Background Countries around the world are currently aiming to improve patient safety by means of the Institute for Healthcare Improvement global trigger tool (GTT), which is considered a valid tool for evaluating and measuring patient safety within organisations. So far, only few data on the measurement properties and utility of the GTT have been published. Aims To determine and evaluate the effect of interrater variation between review teams on the standard outcome measures of the GTT and to assess and quantify measurement error of the GTT. Methods Retrospective chart reviews were conducted on identical charts by two independent review teams in 2010 at a department of oncology in a university hospital. Standard GTT outcome measurements were obtained and compared between teams using statistical process control (SPC) charts. A Bland–Altman plot assessed measurement error and limits of agreement. Results Only 31% of adverse events (AE) were identified by both teams, and further differences in categorisation of identical events was found. Moderate interrater agreement (κ=0.45) between teams gave rise to different conclusions on the patient safety process when monitoring using SPC charts. The Bland–Altman plot suggests little systematic error but large random error. Conclusions Review teams may identify different AE and reach different conclusions on the safety process when using the GTT on identical charts. Tracking true change in the safety level is difficult due to measurement error of the GTT. The results do not encourage further use of the GTT until additional evaluation studies on the measurement properties of the GTT have been conducted.

Collecting core data in severely injured patients using a consensus trauma template: an international multicentre study

IntroductionNo worldwide, standardised definitions exist for documenting, reporting and comparing data from severely injured trauma patients. This study evaluated the feasibility of collecting the data variables of the international consensus-derived Utstein Trauma Template.MethodsTrauma centres from three different continents were invited to submit Utstein Trauma Template core data during a defined period, for up to 50 consecutive trauma patients. Directly admitted patients with a New Injury Severity Score (NISS) equal to or above 16 were included. Main outcome variables were data completeness, data differences and data collection difficulty.ResultsCentres from Europe (n = 20), North America (n = 3) and Australia (n = 1) submitted data on 965 patients, of whom 783 were included. Median age was 41 years (interquartile range (IQR) 24 to 60), and 73.1% were male. Median NISS was 27 (IQR 20 to 38), and blunt trauma predominated (91.1%). Of the 36 Utstein variables, 13 (36%) were collected by all participating centres. Eleven (46%) centres applied definitions of the survival outcome variable that were different from those of the template. Seventeen (71%) centres used the recommended version of the Abbreviated Injury Scale (AIS). Three variables (age, gender and AIS) were documented in all patients. Completeness > 80% was achieved for 28 variables, and 20 variables were > 90% complete.ConclusionsThe Utstein Template was feasible across international trauma centres for the majority of its data variables, with the exception of certain physiological and time variables. Major differences were found in the definition of survival and in AIS coding. The current results give a clear indication of the attainability of information and may serve as a stepping-stone towards creation of a European trauma registry.