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PubMed2006

Six methodological steps to build medical data warehouses for research.

PURPOSE: We propose a simple methodology for heterogeneous data collection and central repository-style database design in healthcare. Our method can be used with or without other software development frameworks, and we argue that its application can save a relevant amount of implementation effort. Also, we believe that the method can be used in other fields of research, especially those that have a strong interdisciplinary nature. BACKGROUND: The idea emerged during a healthcare research project, which consisted among others in grouping information from heterogeneous and distributed information sources. We developed this methodology by the lessons learned when we had to build a data repository, containing information about elderly patients flows in the UK's long-term care system (LTC). DESIGN: We explain thoroughly those aspects that influenced the methodology building. The methodology is defined by six steps, which can be aligned with various iterative development frameworks. We describe here the alignment of our methodology with the RUP (rational unified process) framework. The methodology emphasizes current trends, as early identification of critical requirements, data modelling, close and timely interaction with users and stakeholders, ontology building, quality management, and exception handling. RESULTS: Of a special interest is the ontological engineering aspect, which had the effects with the highest impact after the project. That is, it helped stakeholders to perform better collaborative negotiations that brought better solutions for the overall system investigated. An insight into the problems faced by others helps to lead the negotiators to win-win situations. We consider that this should be the social result of any project that collects data for better decision making that leads finally to enhanced global outcomes.

Computer Communication Networks↗

PubMed2006

New methodology to determine the rate-limiting adsorption kinetics mechanism from experimental dynamic surface tension data.

We present a new methodology to determine the rate-limiting adsorption kinetics mechanism (diffusion-controlled vs mixed diffusion-barrier controlled), including deducing the kinetics parameters (the diffusion coefficient, D, and the energy-barrier parameter, beta), from the experimental short-time dynamic surface tension (DST) data. The new methodology has the following advantages over the existing procedure used to analyze the experimental DST data: (a) it does not require using a model for the equilibrium adsorption isotherm, and (b) it only requires using the experimental short-time DST data measured at two initial surfactant bulk solution concentrations. We apply the new methodology to analyze the experimental short-time DST data of the following alkyl poly(ethylene oxide), CiEj, nonionic surfactants: C12E4, C12E6, C12E8, and C10E8 measured using the pendant-bubble apparatus. We find that for C12E4 and C12E6, the effect of the energy barrier on the overall rate of surfactant adsorption can be neglected for surfactant bulk solution concentrations below their respective critical micelle concentrations (CMCs), and therefore, that the rate-limiting adsorption kinetics mechanism for C12E4 and C12E6 is diffusion-controlled at any of their premicellar surfactant bulk solution concentrations. On the other hand, for C12E8 and C10E8, we find that their respective CMC values are large enough to observe a significant effect of the energy barrier on the overall rate of surfactant adsorption. In other words, for C12E8 and C10E8, the rate-limiting adsorption kinetics mechanism shifts from diffusion-controlled to mixed diffusion-barrier controlled as their premicellar surfactant bulk solution concentrations increase. We test the new methodology by predicting the short-time DST profiles at other initial surfactant bulk solution concentrations, and then comparing the predicted DST profiles with those measured experimentally. Very good agreement is obtained for the four CiEj nonionic surfactants considered. We also compare the results of implementing the new methodology with those of implementing the existing procedure, and conclude that using a model for the equilibrium adsorption isotherm can lead not only to different values of D and beta, but it can also lead to a completely different determination of the rate-limiting adsorption kinetics mechanism. Since the new methodology proposed here does not require using a model for the equilibrium adsorption isotherm, we conclude that it should provide a more reliable determination of the rate-limiting adsorption kinetics mechanism, including the deduced kinetics parameters, D and beta.

Journal Article↗

PubMed2004

The Health Technology Assessment-disease management instrument reliably measured methodologic quality of health technology assessments of disease management.

OBJECTIVE: Systematic reviews aim to summarize the evidence in a particular topic area, giving attention to the identified methodologic quality of published research. Because research in a specific area may be susceptible to specific biases, it is assumed that the methodologic quality of Health Technology Assessment (HTA) of disease management cannot properly be measured with the existing methodologic quality assessment instruments. The purpose of this study was to describe to what extent existing instruments are useful in assessing the methodologic quality of HTA of disease management. STUDY DESIGN AND SETTING: An inventory was made of the problems that arise when assessing the methodologic quality of six HTAs of disease management with three different instruments. Based on these findings, a new instrument is proposed and validated. RESULTS: Problems mainly concern the items related to the study design, criteria for selection and restriction of patients, baseline and outcome measures, blinding of patients and providers, and the description of (co)-interventions. CONCLUSION: With its more specific characteristics, the HTA-DM addresses the problems mentioned. The HTA-DM is a reliable instrument for methodologic quality assessment of HTA of disease management in comparison with the other three instruments.

Disease Management↗

PubMed2005

ARAMIS project: a comprehensive methodology for the identification of reference accident scenarios in process industries.

In the frame of the Accidental Risk Assessment Methodology for Industries (ARAMIS) project, this paper aims at presenting the work carried out in the part of the project devoted to the definition of accident scenarios. This topic is a key-point in risk assessment and serves as basis for the whole risk quantification. The first result of the work is the building of a methodology for the identification of major accident hazards (MIMAH), which is carried out with the development of generic fault and event trees based on a typology of equipment and substances. The term "major accidents" must be understood as the worst accidents likely to occur on the equipment, assuming that no safety systems are installed. A second methodology, called methodology for the identification of reference accident scenarios (MIRAS) takes into account the influence of safety systems on both the frequencies and possible consequences of accidents. This methodology leads to identify more realistic accident scenarios. The reference accident scenarios are chosen with the help of a tool called "risk matrix", crossing the frequency and the consequences of accidents. This paper presents both methodologies and an application on an ethylene oxide storage.

Accidents, Occupational↗

PubMed2002

The TEAM methodology for the evaluation of information systems in biomedicine.

The TEAM evaluation methodology for information systems in biomedicine (Total Evaluation and Acceptance Methodology) is a unifying methodology for any computer-based information system based on a three dimensional framework; these dimensions being Role, Time and Structure. The theory is derived from how the information system relates to the general system where it should operate, the properties of information flow within a general system and the relation between a system and its models. As a system can in theory be modelled from many perspectives, a perspective to be modelled is built up by formulating criteria relevant to that perspective which can be evaluated by quantitative and qualitative assessment methods. Key characteristics of the methodology include the insistence on a global rather than partial approach to the evaluation of information systems, also the dynamic nature of an information system which is continually in modification as it more successfully deals with the inherent complexity of the environment in which it is operating. The role dimension identifies four main categories, designer, specialist user, end user and stakeholder from which several sub-categories may be identified. The time dimension has four main phases towards relative stability of the information system. The structural dimension distinguishes strategic, tactical or organisational and operational levels that often are confused together with risk of dilution in current approaches. It is believed that this framework and methodology can provide a basis for future standardisation of evaluation methodologies.

Evaluation Studies as Topic↗

PubMed2005

Association between methodological characteristics and outcome in health technology assessments which included case series.

OBJECTIVES: Case series constitute a weak form of evidence for effectiveness of health technologies. However, for a variety of reasons, such studies may be included in health technology assessments. There are no clear criteria for assessing the quality of case series. We carried out an empirical investigation of the association between outcome frequency and methodological characteristics in a sample of health technology assessments. METHODS: Systematic reviews of functional endoscopic sinus surgery for nasal polyps, spinal cord stimulation for chronic back pain, and percutaneous transluminal coronary angioplasty and coronary artery bypass grafting for chronic stable angina were identified as containing more than forty case series. Data were extracted by one reviewer and checked by a second on population characteristics, outcomes, and the following methodological features: sample size, prospective/retrospective approach, consecutive recruitment, multi- or single-center organization, length of follow-up, independence of outcome measurement, and date of publication. Association between methodological features and outcome were explored in univariate and multivariate analyses using parametric and nonparametric tests and robust regression or analysis of variance/analysis of covariance, as appropriate. RESULTS: Included reviews contained between forty-two and seventy-six case series studies, involving 5 to 172,283 participants. Reporting of methodological features was poor and limited the analyses. In general, we found little evidence of any association between methodological characteristics and outcome. Sample size is used as an inclusion criterion in many reviews of'case series but was consistently shown to have no relationship to outcome in all analyses. A prospective approach was not associated with outcome. Insufficient data were available to explore consecutive recruitment. Mixed results were shown for length of follow-up, independence of outcome measurement, and publication date. CONCLUSIONS: We found little evidence to support the use of many of the factors included in tools used for quality assessment of case series. Importantly, we found no relationship between study size and outcome across the four examples studied. Isolated examples of a potentially important relationship between other methodological factors and outcome were shown, for example, blinding of outcome measurement, but these examples were not shown consistently across the small number of examples studied. Further research into the determinants of quality in case series studies is required to support health technology assessment.

Humans↗

PubMed2001

Systematic reviews of diagnostic research. Considerations about assessment and incorporation of methodological quality.

The aim of this paper is to provide a theoretical background for performing and reading systematic reviews of diagnostic studies. We first discuss items for assessment of methodological quality in diagnostic studies and then present methods on how to incorporate these quality measures in systematic reviews. The items of internal validity determine whether the presented results of the individual studies are unbiased and can be trusted. Items of external validity determine to what extent the results are applicable outside the population in which the study was performed. The issues concern the adequacy of the study population, the performance and interpretation of the diagnostic tests and the presentation of the results. Several methods exist for incorporation of issues of methodological quality into systematic reviews, such as subgroup analyses, meta-regression analysis, and methodological scores. Publications of diagnostic studies should provide sufficient information to enable assessment of the methodological quality. Furthermore, publication of results of subgroup analyses should be promoted. Methodological criteria lists might help to improve the quality of systematic reviews of diagnostic research. With the items of methodological quality in mind the general practitioner might be better equipped to critically read and interpret diagnostic reviews.

Epidemiologic Studies↗

PubMed2000

Studies of surgical outcome after patellar tendinopathy: clinical significance of methodological deficiencies and guidelines for future studies. Victorian Institute of Sport Tendon Study Group.

Patellar tendinopathy is often treated surgically after failure of conservative treatment but clinical experience suggests that results are not uniformly excellent. The aim of this review was to (i) identify the different surgical techniques that have been reported and compare their success rates, and (ii) critically assess the methodology of studies that have reported surgical outcomes. Twenty-three papers and two abstracts were included in the review. Surgical procedures were categorized and outcomes summarized. Using ten criteria, an overall methodology score was derived for each paper. Criteria for which scores were generally low (indicating methodological deficiency) concerned the type of study, subject selection process and outcome measures. We found a negative correlation between papers' reported success rates and overall methodology scores (r= -0.57, P<0.01). There was a positive correlation between year of publication and overall methodology score (r=0.68, P<0.001). We conclude that study methodology may influence reported surgical outcome. We suggest practical guidelines for improving study design in this area of clinical research, as improved study design would provide clinicians with a more rigorous evidence-base for treating patients who have recalcitrant patellar tendinopathy.

Bias↗

PubMed2006

[Feasibility of prismatic correction of microesotropia using the measuring and correcting methodology by H.-J. Haase].

BACKGROUND: The "Measuring and Correcting Methodology after H.-J. Haase" is based on the assumption that a minute deviation from the orthovergence position (fixation disparity) indicates a difficulty to overcome a larger "vergence angle of rest". Objective recordings have, however, revealed that the subjective tests applied in the "Measuring and Correcting Methodology after H.-J. Haase" can mislead to the assumption of a fixation disparity, although both eyes are aligned exactly to the fixation point. QUESTION: How do patients with an inconspicuously small, yet objectively verified strabismus react to the "Measuring and Correcting Methodology by H.-J. Haase"? METHODS: Eight patients with a microesotropia between 0.5 and 3 degrees were subjected to the "Measuring and Correcting Methodology after H.-J. Haase. RESULTS: In all 8 patients, the prisms determined with the Cross-, Pointer- and Rectangle Tests increased the angle of squint, without reaching a full correction: the original angle prevailed. In the Stereobalance Test, prisms did not reduce the 100 % preponderance of the non-squinting eye. The stereoscopic threshold was between 36 and 1170 arcsec in 7 out of the 8 subjects, and above 4000 arcsec in 1 subject. CONCLUSIONS: (1) In all 8 patients, prisms determined with the "Measuring and Correcting Methodology by H.-J. Haase" increased the angle of strabismus, without reaching bifoveal vision. This uniform result suggests that primary microesotropia cannot be corrected with the "Measuring and Correcting Methodology after H.-J. Haase" (2) A lacking contribution of the strabismic eye to the recognition of a lateral offset between stereo objects, as determined with the Stereobalance Test, does not imply a lack of binocular stereopsis.

Adolescent↗

PubMed2000

Improved spatial allocation methodology for on-road mobile emissions.

Emissions from automobiles and trucks operating on public roads represent a major portion of the air pollutants included in emission inventories. When emission data are prepared for air quality modeling studies, such as those supporting development of a State Implementation Plan, an emission processor matches the spatial and temporal resolution of the emissions to the requirements of the modeling study. However, the spatial location of vehicular emissions is not known and must be estimated. This paper presents a methodology for determining the spatial distribution of the roads belonging to a road class using geospatial data functions, such as those commonly provided by a geographic information system. Vehicle-miles traveled (VMT) are then allocated to medium-resolution (12 x 12-km) and fine-resolution (4 x 4-km) modeling grids using both this methodology and the existing top-down methodology, which uses population density. The results show a significant difference in the spatial distribution of VMT between these two methodologies. Based upon these results, we recommend using the road class-specific methodology in lieu of the population methodology for spatially allocating vehicular emissions for medium- and finer-resolution modeling grids.

Air Pollution↗

PubMed2006

Understanding the multiple realities of everyday life: basic assumptions in focus-group methodology.

In recent years, there has been a notable growth in the use of focus groups within occupational therapy. It is important to understand what kind of knowledge focus-group methodology is meant to acquire. The purpose of this article is to create an understanding of the basic assumptions within focus-group methodology from a theory of science perspective in order to elucidate and encourage reflection on the paradigm. This will be done based on a study of contemporary literature. To further the knowledge of basic assumptions the article will focus on the following themes: the focus-group research arena, the foundation and its core components; subjects, the role of the researcher and the participants; activities, the specific tasks and procedures. Focus-group methodology can be regarded as a specific research method within qualitative methodology with its own form of methodological criteria, as well as its own research procedures. Participants construct a framework to make sense of their experiences, and in interaction with others these experiences will be modified, leading to the construction of new knowledge. The role of the group leader is to facilitate a fruitful environment for the meaning to emerge and to ensure that the understanding of the meaning emerges independently of the interpreter. Focus-group methodology thus shares, in the authors' view, some basic assumptions with social constructivism.

Focus Groups↗

PubMed2026

Review of regulatory requirements for benefit-risk assessment for medical devices: uncovering existing methodologies.

INTRODUCTION: A positive benefit-risk profile is a prerequisite for the market approval of medical devices. However, regulations are often criticized for providing limited information on benefit-risk assessment (BRA) despite growing expectations for quantitative methods. A clearer understanding of regulatory requirements, existing methodologies, and unresolved issues is needed. AREAS COVERED: Relevant regulatory documents referencing BRA for medical devices were systematically identified, with a primary focus on the European regulation followed by screening to extract BRA‑related requirements and any explicitly or implicitly described methods. The findings were analyzed and consolidated by BRA context, type, objective, methodological description, and implementation, thereby establishing a basis for the BRA methodological landscape. EXPERT OPINION: BRA is not a single concept, but a set of context‑dependent assessments across lifecycle of a medical device. BRA within clinical evaluation framed into BRAs of risk management holds a pivotal role and is supported by the most detailed methodological guidance, although BRAs in other contexts are important. A structured overview of existing BRA requirements clarifies their treatment across regulatory documents. By differentiating BRA contexts, types, objectives, and required methodological detail, the analysis supports a more transparent understanding of BRA and helps identify priorities for methodological refinement and interface clarification.

Risk Assessment↗

PubMed1998

Minimization of CD34+ cell enumeration variability using the ProCOUNT standardized methodology.

The dose of cells expressing the surface antigen CD34 (CD34+) has been shown to be a reliable predictor of the time to engraftment following transplantation of PBPC to support high-dose chemotherapy. However, evaluation of rare cells is complicated by a number of factors, including the variability in operator and technical procedures. Recently, Becton Dickinson Immunocytometry Systems introduced a new CD34+ cell analysis system, the ProCOUNT cell enumeration kit, which automates the analysis of CD34+ cells and minimizes the variabilities of this procedure. We have evaluated the ProCOUNT system in comparison to a standard CD34 cell analysis (based on the Milan approach) using leukapheresis products from patients and normal donors mobilized with chemotherapy plus recombinant human G-CSF (rhG-CSF) or with rhG-CSF alone. In addition, we compared these analyses using CD34+ cell-selected mobilized leukapheresis products with purities of 75% or greater. The standard CD34 cell analysis methodology quantitated the frequency of cells identified as CD45+, low side scatter, and CD34+. A high correlation coefficient was obtained between the ProCOUNT methodology and the standard CD34 cell analysis methodology for cells obtained from leukapheresis products mobilized with chemotherapy plus rhG-CSF (r = 0.98), rhG-CSF alone (r = 0.96), and CD34+-selected mobilized leukapheresis products (r = 0.83). A comparison was also made between technicians using both analysis methods. Whereas the correlation coefficient between two technicians using the standard methodology was r = 0.77, the correlation coefficient was much higher when using ProCOUNT (r = 0.99). These data demonstrate that the use of ProCOUNT is associated with less variability between data analyzed by different operators. Also, ProCOUNT is consistent with existing CD34+ cellular analysis methodologies. An additional advantage is the ability to determine the absolute concentration of CD34+ cells, thereby allowing calculation of total CD34+ cell numbers without using WBC counts, which also have inherent errors. The ProCOUNT system provides an automated analysis procedure that minimizes the variables in CD34+ cell analysis and may be useful for standardization of methodology between laboratories.

Antigens, CD34↗

PubMed2002

Doing qualitative research in general practice: methodological utility and engagement.

General practice uses an eclectic range of research methodology. This includes increasing reliance upon qualitative research methods. There seem to be two distinct treatments of qualitative research within primary care and, in particular, within general practice research. The first is characterized by a purely utilitarian and technical focus, using a qualitative method because it is the most appropriate means of realizing the aims of the research, while the second is characterized by in-depth engagement with the philosophical and paradigmatic aspects of qualitative methodology. In-depth engagement with methodology and theory, and theory building, is an important aspect of masterate and doctoral research within social sciences such as education and anthropology, and in the discipline of nursing, but has not been a feature of qualitative research in medicine. A practical difficulty encountered within postgraduate programmes such as the one in which the author teaches is that when innovative qualitative techniques are used by GPs in their postgraduate research dissertations and theses, it is often beyond GP examiners' own knowledge and experience, yet it fails to measure up to standards established in social sciences, particularly in sociology and anthropology where in-depth reflexive engagement with the theory and philosophy of qualitative methodology is expected. This paper suggests that the value of in-depth engagement with methodology when conducting qualitative research results in creative and innovative ways of conducting research that are consonant with the nature of general practice itself, and strengthens research findings. Therefore, as teachers of research methods and supervisors of research theses, it is important to encourage students conducting qualitative research to engage fully with theoretical and methodological issues.

Family Practice↗

PubMed2005

Randomized controlled drug trials on very elderly subjects: descriptive and methodological analysis of trials published between 1990 and 2002 and comparison with trials on adults.

BACKGROUND: Very elderly subjects (VES; aged 80 years or older) constitute a special population as they frequently present multiple diseases (polypathology). Results from trials on general adult populations therefore cannot be extrapolated to VES. We performed a census of randomized controlled trials (RCT) on VES published between 1990 and 2002, and carried out a descriptive and methodological analysis of these RCT/VES, comparing them with matched RCT on general adult populations (control RCT, RCT/C). METHODS: We searched for RCT/VES in two international databases (EMBASE and MEDLINE) and then manually. RCT/C were matched to RCT/VES for disease area and year of publication. The methodological quality of each RCT was assessed with Chalmers' scale. RESULTS: We identified 84 RCT/VES, 63 of which were conclusive and 21, inconclusive. Subjects were institutionalized in 48 RCT, and community dwelling in 11 RCT (unspecified in 25 RCT). Efficacy was the main criterion in 75 RCT; tolerance in 9 RCT. Twenty-six RCT were published by geriatrics journals, and 58 by general medical journals. The RCT/VES covered most of the disease areas of geriatrics. The 84 RCT/VES had a mean methodological quality score of 0.578 +/- 0.157. The matched 84 RCT/C had a mean methodological quality score of 0.592 +/- 0.116 (p = .466). The methodological quality score of RCT/VES increased with the number of included subjects (p = .004) and the year of publication (p = .001). CONCLUSIONS: The methodological quality of RCT/VES is equivalent to that of RCT in general adult populations. Nevertheless, RCT/VES remain very scarce, and neglect certain diseases. RCT/VES and the inclusion of very elderly subjects in RCT on adults should be strongly encouraged.

Adult↗

PubMed2002

Randomized, controlled clinical trials in sepsis: has methodological quality improved over time?

OBJECTIVE: To systematically evaluate the methodological quality of randomized clinical trials and to determine whether randomized clinical trials of sepsis improved in methodological quality over time. DATA SOURCES: Computerized MEDLINE search of articles published in any language from 1966 to 1998 combined with a manual search of bibliographies of published articles and communication with known experts in the field. STUDY SELECTION: All randomized clinical trials of sepsis, severe sepsis, and septic shock performed in adults and published as full articles. DATA EXTRACTION: Abstracts of all retrieved records were reviewed and the inclusion criteria were applied. All selected articles were classified into (a) trials designed to detect differences in mortality as the primary end point, or (b) trials focusing on surrogate outcome measures (i.e., physiological or biochemical parameters). All retrieved trials were then graded for methodological quality using an objective grading scheme developed specifically for this study. The data selection and extraction process was carried out independently by two of the authors; any disagreement was resolved by discussion. DATA SYNTHESIS: Seventy-four randomized clinical trials involving septic patients qualified for inclusion in this study (40 reporting mortality outcomes, 34 reporting other surrogate outcomes). Trials reporting mortality as the primary outcome had significantly higher quality scores compared with trials reporting surrogate outcome measures (29.6 +/- 1.0 vs. 24.3 +/- 0.8, p =.0006). From 1976 to 1998, trial methodology improved significantly over time (an average of 0.36 points per year, p =.021). Mortality outcome trials improved an average of 0.58 points per year (p =.0011) whereas surrogate outcome trials did not demonstrate an improvement in methodological quality over time (p =.249). CONCLUSION: The methodological limitations identified in this article can help to target further improvement in trial design to enhance the validity of findings from future randomized clinical trials of sepsis.

Adult↗

PubMedDate not supplied

An introduction to the collaborative methodology and its potential use for the management of heart failure.

BACKGROUND: Heart failure (HF) is responsible for significant disease burden in developed countries internationally. Despite significant advances and a strong evidence base in therapies and treatment strategies for HF, access to these therapies continues to remain elusive to a significant proportion of the HF population. The reasons for this are multifactorial and range from the financial cost of treatments to the individual attitudes and beliefs of clinicians. The collaborative methodology, based upon a quality improvement philosophy, has been identified as a potentially useful tool to address this treatment gap. AIM: In this manuscript, we review the published literature on the collaborative methodology and assess the evidence for achieving improvement in the management of HF. METHODS: Searches of electronic databases, the reference lists of published materials, policy documents, and the Internet were conducted using key words including "collaborative methodology," "breakthrough series," "quality improvement," "total quality improvement," and "heart failure." Because of the paucity of high-level evidence, all English-language articles were included in the review. RESULTS: On the basis of the identified search strategy, 43 articles were retrieved. Key themes that emerged from the literature included the following: (1) The collaborative methodology has a significant potential to reduce the treatment gap. (2) Leadership is an important characteristic of the collaborative method. (3) The collaborative methodology facilitates sustainability of the quality improvement process. CONCLUSION: The collaborative methodology, when implemented and conducted according to key conceptual principles, has significant potential to improve the outcomes of patients, particularly those with HF and chronic cardiovascular disease.

Cooperative Behavior↗

PubMed1995

Methodological quality of randomized clinical trials on treatment efficacy in low back pain.

STUDY DESIGN: This was a review of criteria-based meta-analyses. OBJECTIVES: To assess the methodological quality of published randomized clinical trials on the efficacy of commonly used interventions in low back pain. SUMMARY OF BACKGROUND DATA: During the last several decades, the number of published randomized clinical trials regarding low back pain has continued to grow. For some interventions, considerable numbers of trials are available. Trials have been shown to vary substantially regarding their quality. METHODS: A computer-aided search was conducted of published randomized clinical trials into the efficacy of spinal manipulation and mobilization, exercise therapy, back schools, bed rest, orthoses, and traction therapy. There was additional screening of journals not covered by Medline and Embase. The methodological quality of the studies was assessed using a set of predefined criteria. RESULTS: Sixty-nine different randomized clinical trials were identified. Methodological scores varied between 16 and 82 points (maximum was 100 points). Methodological quality tended to be associated with the outcomes of the studies. Methodological shortcomings were frequently found--e.g., small sample sizes, no description of the randomization procedure, no description of drop-outs, no placebo-control group, and lack of blinded outcome assessments. CONCLUSIONS: Although a considerable number of randomized clinical trials have been carried out to evaluate the efficacy of interventions in low back pain, their methodological quality appears to be disappointingly low. Future trials are clearly needed, but much more attention should be paid to the methods of such studies.

Data Interpretation, Statistical↗