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Biomedical subjects

Nicole van der Roer

Publications and source records attributed to Nicole van der Roer.

8 recordsLinked to original sources

Minimally important change determined by a visual method integrating an anchor-based and a distribution-based approach.

BACKGROUND: Minimally important changes (MIC) in scores help interpret results from health status instruments. Various distribution-based and anchor-based approaches have been proposed to assess MIC. OBJECTIVES: To describe and apply a visual method, called the anchor-based MIC distribution method, which integrates both approaches. METHOD: Using an anchor, patients are categorized as persons with an important improvement, an important deterioration, or without important change. For these three groups the distribution of the change scores on the health status instrument are depicted in a graph. We present two cut-off points for an MIC: the ROC cut-off point and the 95% limit cut-off point. RESULTS: We illustrate our anchor-based MIC distribution method determining the MIC for the Pain Intensity Numerical Rating Scale in patients with low back pain, using two conceivable definitions of minimal important change on the anchor. The graph shows the distribution of the scores of the health status instrument for the relevant categories on the anchor, and also the consequences of choosing the ROC cut-off point or the 95% limit cut-off point. DISCUSSION: The anchor-based MIC distribution method provides a general framework, applicable to all kind of anchors. This method forces researchers to choose and justify their choice of an appropriate anchor and to define minimal importance on that anchor. The MIC is not an invariable characteristic of a measurement instrument, but may depend, among other things, on the perspective from which minimal importance is considered and the baseline values on the measurement instrument under study. A balance needs to be struck between the practicality of a single MIC value and the validity of a range of MIC values.

Health Status Indicators↗

Minimal clinically important change for pain intensity, functional status, and general health status in patients with nonspecific low back pain.

STUDY DESIGN: Cohort study. OBJECTIVES: To estimate the Minimal Clinically Important Change (MCIC) of the pain intensity numerical rating scale (PI-NRS), the Quebec Back Pain Disability Scale (QBPDS), and the Euroqol (EQ) in patients with low back pain. SUMMARY OF BACKGROUND DATA: MCIC can provide valuable information for researchers, healthcare providers, and policymakers. METHODS: Data from a randomized controlled trial with 442 patients with low back pain were used. The MCIC was estimated over a 12-week period, and three different methods were used: 1) mean change scores, 2) minimal detectable change, and 3) optimal cutoff point in receiver operant curves. The global perceived effect scale (GPE) was used as an external criterion. The effect of initial scores on the MCIC was also assessed. RESULTS: The MCIC of the PI-NRS ranged from 3.5 to 4.7 points in (sub)acute patients and 2.5 to 4.5 points in chronic patients with low back pain. The MCIC of the QBPDS was estimated between 17.5 to 32.9 points and 8.5 to 24.6 points for (sub)acute and chronic patients with low back pain. The MCIC for the EQ ranged from 0.07 to 0.58 in (sub)acute patients and 0.09 to 0.28 in patients with chronic low back pain. CONCLUSION: Reporting the percentage of patients who have made a MCIC adds to the interpretability of study results. We present a range of MCIC values and advocate the choice of a single MCIC value according to the specific context.

Adult↗

Economic evaluations: a new avenue of outcome assessment in spinal disorders.

The number of economic evaluations in the field of spinal disorders and methodological studies have increased in the last decade. The objective of this paper is to provide an overview of current views on economic evaluations in the field of spinal disorders and to facilitate clinicians to interpret and use results from these studies. A full economic evaluation compares both costs and effects of two or more interventions. Key elements of economic evaluations such as identifying adequate alternatives, analytical perspective, cost methodology, missing values and sensitivity analyses are addressed. Further emphasis is placed on the interpretation of results of economic evaluations conducted alongside randomised clinical trials. Incremental cost-effectiveness ratios, cost-effectiveness planes, acceptability curves and cost-effectiveness thresholds are discussed. The contents may aid in taking the efficacy 'hurdle' in the field of spinal disorders.

Back Pain↗

Management of traumatic thoracolumbar fractures: a systematic review of the literature.

The management of unstable traumatic thoracolumbar fractures without neurological deficits remains controversial. The objective of this study was to compare the effectiveness of operative and conservative treatment of unstable traumatic thoracolumbar fractures. PubMed was used to search for articles published from January 1992 to January 2003 using a variety of keywords. References were checked to identify additional studies. Inclusion criteria were: (1) traumatic lumbar, thoracic or thoracolumbar fractures, (2) unstable fractures without neurological deficits, (3) a comparison between operative and conservative treatment, (4) at least ten patients were included in the study. Seventeen studies were identified; four prospective and 13 retrospective studies. Sample sizes in 15 studies were relatively small (18--100 patients); two studies had larger sample sizes. Comparison among different studies was difficult due to insufficient description of interventions, different outcome measures, and different length of follow-up periods. The current literature does not provide a reliable answer to whether operative or conservative treatment is more effective for unstable traumatic thoracolumbar fractures. High quality randomised controlled trials are direly needed.

Humans↗

What is the most cost-effective treatment for patients with low back pain? A systematic review.

Economic evaluations of the various interventions available for low back pain will help clinicians and policymakers to identify the most beneficial treatment. This chapter aims to evaluate the most cost-effective treatments for patients with non-specific low back pain. Pubmed, Embase and the Cochrane library were used to search for articles published from 1966 to July 2004 using a variety of keywords. References were checked to identify additional studies. The consensus health economic criteria (CHEC) list was used to assess the methodological quality of the studies. We found 17 studies; six of these concluded that the intervention of interest was superior to the control intervention. However, definite conclusions about the most cost-effective intervention could not be drawn because of the heterogeneity of interventions, controls and study populations. More high-quality economic evaluations are needed before such a conclusion can be made.

Cost-Benefit Analysis↗

Direct medical costs of traumatic thoracolumbar spine fractures.

BACKGROUND: The costs and cost-effectiveness of treatment of thoracolumbar fractures are poorly known. METHODS: We estimated the costs of hospital care and outpatient visits for patients with traumatic thoracolumbar spine fractures. RESULTS: Stable fractures without neurological deficits were treated nonoperatively and the costs were EUR 5,100. Unstable fractures without neurological deficits were treated either nonoperatively, with an average of 29 hospitalization days and average cost of EUR 12,500 (86% of which represented hospitalization costs), or operatively with 24 hospitalization days and average cost of EUR 19,700 (48% of which represented hospitalization costs and 42% surgery costs). Unstable fractures with neurological deficits were usually operated (average costs EUR 31,900). INTERPRETATION: For all patients, the costs of hospitalization days were the main cost driver. Although the length of stay for patients with unstable fractures and without neurological deficit who were treated operatively was shorter than for patients treated nonoperatively, the total costs were higher due to the additional costs of surgery. Surgical treatment must therefore be shown to give a better outcome in order to outweigh the costs. Future research should focus on the cost-effectiveness of operative and nonoperative treatment of patients with unstable vertebral fractures who have no neurological deficits, and take indirect costs and quality of life into account.

Adolescent↗

Cost-effectiveness of an intensive group training protocol compared to physiotherapy guideline care for sub-acute and chronic low back pain: design of a randomised controlled trial with an economic evaluation. [ISRCTN45641649].

BACKGROUND: Low back pain is a common disorder in western industrialised countries and the type of treatments for low back pain vary considerably. METHODS: In a randomised controlled trial the cost-effectiveness and cost-utility of an intensive group training protocol versus physiotherapy guideline care for sub-acute and chronic low back pain patients is evaluated. Patients with back pain for longer than 6 weeks who are referred to physiotherapy care by their general practitioner or medical specialist are included in the study. The intensive group training protocol combines exercise therapy with principles of behavioural therapy ("graded activity") and back school. This training protocol is compared to physiotherapy care according to the recently published Low Back Pain Guidelines of the Royal Dutch College for Physiotherapy. Primary outcome measures are general improvement, pain intensity, functional status, work absenteeism and quality of life. The direct and indirect costs will be assessed using cost diaries. Patients will complete questionnaires at baseline and 6, 13, 26 and 52 weeks after randomisation. DISCUSSION: No trials are yet available that have evaluated the effect of an intensive group training protocol including behavioural principles and back school in a primary physiotherapy care setting and no data on cost-effectiveness and cost-utility are available.

Absenteeism↗

Cost-effectiveness of hip protectors in frail institutionalized elderly.

A randomized controlled trial was performed to examine the cost-effectiveness of external hip protectors in the prevention of hip fractures. Since the hip protectors were not effective in preventing hip fractures in our study, the main objective became to examine whether the use of hip protectors results in lower average costs per participant in the hip protector group as compared with the control group. In addition, the average costs of a hip fracture and subsequent rehabilitation in frail, institutionalized elderly were calculated. Residents from apartment houses for the elderly, homes for the elderly and nursing homes with a high risk for hip fractures were randomized to the hip protector group (n=276) or control group (n=285). Costs were calculated for the hip fracture and subsequent rehabilitation until 1 year after the fracture. Six months after each hip fracture, a nurse was interviewed and after 12 months, a questionnaire was sent to the general practitioner or nursing home physician to determine the utilization of health care resources. Differences in costs between the groups were analyzed using non-parametric bootstrapping. Eighteen hip fractures occurred in the intervention group and 20 hip fractures (in 19 persons) in the control group (log rank P-value=0.86). The average costs per participant, including the costs of the intervention, were Euro 913 in the intervention group and Euro 502 in the control group (cost difference of Euro -411; 95% confidence interval: -723; 57). The average costs of a hip fracture and subsequent rehabilitation were Euro 8100 (95% CI: 6716-10,010). The use of hip protectors was not associated with lower costs. In addition, the average costs of a hip fracture and subsequent rehabilitation in the first year after the fracture were estimated at Euro 8100 in institutionalized elderly.

Aged↗