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Validity and interobserver agreement of a new radiographic grading system for intervertebral disc degeneration: Part I. Lumbar spine.

Many different radiographic grading systems for disc degeneration are described in literature. However, only a few of them are tested for interobserver agreement and none for validity. Furthermore, most of them are based on a subjective terminology. The aim of this study, therefore, is to combine these systems to a new one in which all subjective terms are replaced by more objective ones and to test this new system for validity and interobserver agreement. Since lumbar and cervical discs need to be graded differently, this study was divided into the present Part I for the lumbar and a Part II for the cervical spine. The new radiographic grading system covers the three variables "Height Loss", "Osteophyte Formation" and "Diffuse Sclerosis". On lateral and postero-anterior radiographs, each of these three variables first has to be graded individually. Then, the "Overall Degree of Degeneration" is assigned on a four-point scale from 0 (no degeneration) to 3 (severe degeneration). For validation, the radiographic degrees of degeneration of 44 lumbar discs were compared to the respective macroscopic ones, which were defined as "real" degrees of degeneration. The agreement between observers with different levels of experience was determined using the radiographs of 84 lumbar discs. Agreement was quantified using quadratic weighted Kappa coefficients (Kappa) with 95% confidence limits (95% CL). The validation of the new radiographic grading system revealed a substantial agreement between the radiographic and the "real" macroscopic overall degree of degeneration (Kappa=0.714, 95% CL: 0.587-0.841). The radiographic grades, however, tended to be slightly lower than the "real" ones. The interobserver agreement was substantial for all the three variables and for the overall degree of degeneration (Kappa=0.787, 95% CL: 0.702-0.872). However, the inexperienced observer tended to assign slightly lower degrees of degeneration than the experienced one. In conclusion, we believe that the new radiographic grading system is an almost objective, valid and reliable tool to quantify the degree of degeneration of individual lumbar intervertebral discs. However, the user should always remember that the "real" degree of degeneration tends to be underestimated and that slight differences between the ratings of observers with different levels of experience have to be expected.

Adult↗

Establishment of a battery of simple models for facets of bipolar disorder: a practical approach to achieve increased validity, better screening and possible insights into endophenotypes of disease.

The lack of appropriate animal models for bipolar disorder (BPD) hinders the translation of novel molecular and genetic findings into the development of new more efficient treatments. Attempts to develop a comprehensive model for BPD did not result in a practical and valid model and at present most studies utilize a limited number of models for specific components of the disorder. Whereas there is a higher availability of models for the depression pole of BPD, only a few models represent the manic pole with the most frequently used being psychostimulant-induced hyperactivity. This last model had been important in studies of the disease and has some validity but it is clear that by itself cannot be considered to represent mania. Additional models for facets of BPD are needed to allow better screening of new drugs and new mutant mice. Such models may also support the exploration of endophenotypes of BPD and the mechanisms of the disease. An advantage of a battery approach is that each model can be only partially valid when used alone but the combination of a few models may result in strong validity. The present study suggests that such a battery can be based on existing models previously developed in the context of studying normal behavior or other disorders after an initial validation in the context of BPD. An example for this idea is described using the resident-intruder test for aggression. Present results show that 3 weeks oral treatment with 1.2-2.4% lithium (increasing doses), or 20 g/kg daily dose of valproate, significantly reduced aggressive behavior in resident mice without affecting non-aggressive social interactions. Accordingly, it is suggested that the simplified resident-intruder paradigm may model the aggression related to mania as part of a test battery for facets of BPD. It is further speculated that, pending further research, this paradigm can be combined with additional methods to explore changes in the LHPA axis that may be linked to an important endophenotype of BPD.

Animals↗

The Short Form Health Survey (SF-36): translation and validation study of the Iranian version.

This was a large population-based study to develop and validate the Iranian version of the Short Form Health Survey (SF-36) for use in health related quality of life assessment in Iran. A culturally comparable questionnaire was developed and pilot tested. Then, the Iranian version of the SF-36 was administered to a random sample of 4163 healthy individuals aged 15 years and over in Tehran. The mean age of the respondents was 35.1 (SD = 16.0) years, 52% were female, mostly married (58%) and the mean years of their formal education was 10.0 (SD = 4.5). Reliability was estimated using the internal consistency and validity was assessed using known groups comparison and convergent validity. In addition factor analysis was performed. The internal consistency (to test reliability) showed that all eight SF-36 scales met the minimum reliability standard, the Cronbach's alpha coefficients ranging from 0.77 to 0.90 with the exception of the vitality scale (alpha = 0.65). Known groups comparison showed that in all scales the SF-36 discriminated between men and women, and old and the young respondents as anticipated (all p values less than 0.05). Convergent validity (to test scaling assumptions) using each item correlation with its hypothesized scale showed satisfactory results (all correlation above 0.40 ranging from 0.58 to 0.95). Factor analysis identified two principal components that jointly accounted for 65.9% of the variance. In general, the Iranian version of the SF-36 performed well and the findings suggest that it is a reliable and valid measure of health related quality of life among the general population.

Adolescent↗

Self-Report Health Screening Tools in Female Athletes: A Systematic Review of Domain Coverage, Validation, and Use Across Participation Levels.

BACKGROUND: Female athlete health encompasses multiple interconnected domains; however, the self-report screening tools used to assess these domains have not been comprehensively synthesised. OBJECTIVE: To systematically identify self-report health screening tools used to assess female athlete health, map domain coverage, determine validation reporting, and describe application across participation levels. METHODS: This systematic review was pre-registered with PROSPERO ( CRD420251056910 ) and conducted in accordance with PRISMA guidelines. Four databases (PubMed, MEDLINE, SPORTDiscus and Web of Science) were searched from inception to January 2026 using female health and screening-related terms. Methodological quality was appraised using Joanna Briggs Institute and National Institutes of Health tools, and findings were synthesised descriptively. Eligible, peer-reviewed studies reported the use, development or validation of self-report health screening tools assessing one or more domains relevant to female health applied in female athlete populations, spanning recreational through elite participation levels. All sports and activities were included. The search was restricted to English language with no date limits. RESULTS: In total, 360 studies (1990-2026) representing 134,506 female participants spanning recreational to elite sport and 273 screening tools were included. Mental health (n = 77, 34.1%), disordered eating (n = 33, 14.6%) and body image (n = 30, 13.3%) predominated. Domains related to female health, including menstrual health, pelvic floor health, pregnancy/postpartum and breast health were comparatively underrepresented. Most studies reported tools were used for risk identification (n = 323, 80.3%). Validation reporting was inconsistent, with half (n = 180, 50%) reporting use of at least one validated tool. Tool use was concentrated in professional and elite sport, with limited inclusion of recreational, masters and disability athlete cohorts. Health literacy constructs were explicitly assessed in 12.5% of studies (n = 45). CONCLUSIONS: Health screening in female athlete populations remains fragmented and uneven in domain coverage, with inconsistent validation reporting. Development of integrated, multi-domain and contextually inclusive screening frameworks is warranted.

Journal Article↗

Audits of nursing care in Britain: a review and a critique of approaches to validating them.

The literature on audits of nursing care shows a strong link between the quality of nursing care and nursing labour force issues. Early attempts to develop a universally applicable formula to set nurse staffing levels on the basis of variations in patient dependency were shown to have been based on unrealistic assumptions about the ability of scientific methods to remove the influence of judgement from such areas of decision-making. The extent to which the validity of audit instruments has been established is reviewed, showing the number of studies to be small, almost exclusively in relation to American instruments, and with inconclusive results. An extension of the concept of validity is discussed, based on House's approach [House, E.R. (1980). Evaluating with Validity. Sage Publications, London, Beverly Hills] towards establishing validity in educational evaluation. This approach explicitly acknowledges the role of judgement in the evaluative enterprise, and widens the debate about how to settle questions of validity for audits of nursing care.

Clinical Protocols↗

A procedure to validate three-dimensional motion assessment systems.

The automation provided by computer-assisted motion-tracking systems allows for three-dimensional motion and force analysis. These systems combined with mathematical modelling are able to analyse quickly the intricate dynamics of human movement. Understanding the limitations of human motion analysis as performed by the present measurement techniques is essential for proper application of the results. It is necessary to validate the analysis system prior to subject testing. This paper provides a validation of an optoelectric motion-tracking system used in a dynamic knee assessment study. While the validation is shown with one particular system only, it is suggested that all systems used in two- or three-dimensional motion analysis should be tested similarly in the actual configuration used. Three simple mechanical representations of the human knee have been used in this validation. The first model provided an understanding of the source and behaviour of the error introduced to the accuracy of defining a vector between the recorded coordinates of two markers. The other two models investigated the effect of processing methods specific to the knee analysis project. Separating the markers by at least 180 mm is recommended to produce stable vectors. Relative joint angles could be calculated in all three planes of rotation. The error in calculating flexion and longitudinal rotation was less than 2.0 degrees, while calculating adduction introduced errors of 4.0 degrees. Force calculations were found to be within 8%. The system behaviour was found to be consistent within the calibrated volume about the force platform. Simple mechanical models combined with straightforward procedures can provide validation in terms of clinically relevant parameters.

Algorithms↗

Evaluation of research studies. Part IV: Validity and reliability--concepts and application.

The concepts of validity and reliability are defined within the context of applied clinical research. Validity concerns what an instrument measures and how well it does so. Reliability concerns the faith that one can have in the data obtained from use of an instrument, that is, the degree to which any measuring tool controls for random error. The researcher selects a measure that demonstrates content, criterion, or construct validity, according to the intended use of the measurement tool. Similarly, the researcher selects a measure that demonstrates a degree of reliability that is needed for its application. It is possible to have reliability without validity, but it is logically impossible to demonstrate that an unreliable test is valid.

Bias↗

A new measure of quality of life in depression: testing the reliability and construct validity of the QLDS.

Our previous paper described the development of a new quality of life scale for use with people suffering from depression; the Quality of Life in Depression Scale (QLDS). This paper reports on the testing of the scale for reliability and construct validity. Reliability was assessed by giving the questionnaire to the same set of patients on two occasions 2 weeks apart. This test-retest technique yielded a correlation of 0.94, with high internal consistency at both time 1 and time 2. A test of split-half reliability also indicated very high reliability. Construct validity was measured by comparing scores on the QLDS with those on an established scale of well-being from the same group of patients. The results gave a correlation between the two measures of 0.79, giving a satisfactory validity. It is concluded that the QLDS is a reliable and valid measure which is easy to use and acceptable to patients. Further tests of discriminative, concurrent and criterion validity are planned.

Depression↗

University validation of Project 2000 courses.

The need for academic validation of Project 2000 courses has implications for schools/colleges who intend to offer such courses. These include not only academic aspects of the course curriculum, but also the development of students and the need for joint validation. In this paper, these aspects are discussed from the particular perspective of university accreditation, but it is probable that most of the issues raised will be relevant irrespective of the validating body. The issues will have been the concern of nurse educators in the past, and the intention here is to place these issues in the context of academic validation. The paper is based on the writers' experience of taking part in the validation of such a course, as a university lecturer who has also worked in a school of nursing.

Accreditation↗

Validation of a quality of life questionnaire for use in clinical trials for treatment of patients with inoperable lung cancer.

In order to assess the quality of life of patients with inoperable lung cancer, a questionnaire for patient self-administration with 29 variables was designed including the following subjects: psychosocial well-being, medical side-effects, activities of daily living and physical performance. The questionnaire was validated by using a semistructured interview. Thirty-one patients treated for inoperable lung cancer with either radiotherapy (42%), chemotherapy (42%) or a combination of these two treatment modalities (16%) were included in the study. The multitrait-multimethod matrix (MTMM) was used in the analysis of the construct validity. The present validation study showed a high degree of validity for the majority of the items studied. Some of the items showed a low degree of validity, and are subject to future analysis in large scale studies.

Activities of Daily Living↗

Development and validation of the PCQ: a questionnaire to measure the psychological consequences of screening mammography.

We have developed a reliable and valid questionnaire to measure the psychological consequences of screening mammography. The questionnaire measures the effect of screening on an individual's functioning on emotional, social, and physical life domains. Content validity was ensured by extensive review of the relevant literature, discussion with professionals and interviews with attenders at a pilot Breast X-ray Screening Program in Melbourne, Australia. Discriminant validity was assessed by having expert judges sort items into dimensions which they appeared to be measuring. Acceptable levels of concordance (above 80%) with a priori classifications were found. Concurrent validity was demonstrated by comparison of subscale scores of 53 attenders at the Breast X-ray Program with an independent interview assessment of dysfunction on each of the emotional, social and physical dimensions. There was over 79% agreement between interview scores and questionnaire scores for each dimension. Construct validity was confirmed by showing that subscale scores varied in predicted ways. For women who were recalled for further investigation, scores on each subscale measuring negative consequences, were higher at the recall clinic than at screening clinic (emotional: t = -7.28; df = 70; P less than 0.001; physical: t = -2.53; df = 70; P = 0.014; social: t = -2.49; df = 70; P = 0.015). The internal consistency of all subscales was found to be acceptable. This questionnaire is potentially useful for assessing the psychological consequences of the screening process and should have wide application.

Female↗

Validity of transfer-function representation of input-output relation in allosteric models.

A transfer-function representation of reaction velocity is devised to describe analytically and approximately an input-output response of allosteric enzyme around a steady state. The transfer function is derived on assuming an exponential change in reaction velocity for the indicial response to substrate influx rate. The validity of the representation with variation in the kinetic parameters and flow rates is examined for the response of Koshland-Nemethy-Filmer (KNF) and Monod-Wyman-Changeux (MWC) dimeric models by comparing with the exact response obtained from the computer simulation, that is, by numerical integration of the rate equation. The representation has a wider valid region with a decrease in influx rate than with an increase. For the KNF model the representation is valid for negative cooperativity, but invalid for positive cooperativity. For the MWC model the validity decreases with stronger cooperativity. With the transfer functions valid for the Michaelis-Menten and allosteric reactions, we may derive the transfer-function representation for many metabolic pathways.

Allosteric Regulation↗

Increasing the reliability and validity of pain intensity measurement in chronic pain patients.

This study examined the effects of increasing the number of assessments on the reliability and validity of measures of average pain intensity. Two hundred chronic pain patients completed 2 weeks of hourly pain ratings. A series of regression analyses were performed, and test-retest stability, internal consistency and validity coefficients were computed to address 4 questions. (1) Are chronic pain patients' reports of pain similar from one day to another? (2) What is the reliability and validity of a single rating of pain intensity when used as an indicant of average pain? (3) How many assessments (data points) are required to obtain estimates of average pain intensity with adequate to excellent psychometric properties? (4) How important is it to sample pain from different days? The results were consistent with predictions based on patients' self-reports of their pain and on psychometric theory. First, the majority of patients did not report similar levels of pain from one day to another, and average pain scores calculated from ratings obtained from a single day were less stable than those calculated from ratings obtained from multiple days. Also, and as expected, the results indicate that a single rating of pain intensity is not adequately reliable or valid as a measure of average pain. However, a composite pain intensity score calculated from an average of 12 ratings across 4 days demonstrated adequate reliability and excellent validity as a measure of the average pain in this sample of chronic pain patients.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗

Low Back Pain Rating scale: validation of a tool for assessment of low back pain.

Low Back Pain Rating scale is an index scale which includes measurements of pain intensity, disability, and physical impairment. The scale was designed to monitor the outcome of clinical trials of low back pain treatment. It has been validated in 58 patients following first-time discectomy. The scale rating can be rapidly carried out and requires no special aids. With slight modification it can be used in office and telephone interviews, as well as postal questionnaires. These modifications only slightly reduce the quantity of information gathered. In the study, a high rater agreement (97.7%) was found without level difference between two observers using the scale. The validation process included: construct validity, criterion-related validity and item bias, relative to Global Assessments pronounced by the patient and an experienced clinician. Low Back Pain Rating scale hs been shown to be valid and reliable in the assessment of low back pain.

Adult↗

A new analogue scale for assessing children's pain: an initial validation study.

A new instrument was designed to provide a practical clinical measure for assessing children's pain intensity and pain affect. The pocket size measure includes a Coloured Analogue Scale (CAS) to assess intensity and a facial affective scale to assess the aversive component of pain. Both scales have numerical ratings on the back, so that the person administering it can quickly note the numbers that represent a child's pain. This study was conducted to determine the validity of the new instrument by evaluating the psychophysical properties of the intensity scale and by evaluating the discriminant validity of the intensity and affective scales. Since visual analogue scales (VAS) are valid and reliable measures for assessing children's pain, children's ability to use the new analog scale was compared with their performance on a VAS. Children's ability to rate pain affect using an affective scale, in which the 9 faces on a Facial Affective Scale (FAS) are presented in an ordered sequence from least to most distressed, was compared to their performance on the original FAS, in which the same faces were presented in a random order. Using a parallel groups design, 104 children (5-16 years; 60 female, 44 male; 51 healthy and 53 with recurrent headaches) were randomized into two groups: CAS or VAS. Children used the assigned scale to complete a calibration task, in which they rated the sizes of 7 circles varying in area (491, 804, 1385, 2923, 3848, 5675 and 7854 mm2). The psychophysical function relating perceived circle size to actual physical size was determined for the CAS and VAS. Children's CAS and VAS responses on the calibration task yielded similar mathematical relationships: psi cas = 0.035I0.87, psi vas = 0.027I0.89, where psi = perceived magnitude and I = stimulus intensity. The R2 values were 0.921 and 0.922 for the CAS and VAS groups, respectively. Analyses of covariance revealed no significant differences in the characteristics of these relationships, i.e., R2, slope, or y intercept, by scale type. Children used the same scale to complete the Children's Pain Inventory (CPI), in which they rated the intensity and affect of 16 painful events (varying in nature and extent of tissue damage). Children's CAS and VAS responses on the CPI were similar. Analyses of covariance indicated that there were no differences in either intensity or affective ratings by scale type. However, the mean number of painful events experienced by children increased significantly with age (P = 0.0001). Intensity ratings decreased significantly with age (P = 0.002), but affective ratings did not vary with age. The new instrument has equivalent psychometric properties to a 165 mm VAS. However, the CAS was rated as easier to administer and score than the VAS, so it may be more practical for routine clinical use. Since the CAS has fulfilled the first two criteria for a pain measure (psychophysical properties and discriminant validity), it is ethical to proceed with the formal definitive test for construct validity, in which children from various clinical populations use the CAS scale to assess their own pain.

Adolescent↗

The body image detection device versus subjective measures of weight dissatisfaction: a validity comparison.

Several procedures have been developed to measure body image distortion. A recently developed device is the Body Image Detection Device (BIDD), which includes a measure of perceptual size distortion (BPI) and subjective ratings of relative weight (SRI). Initial studies have supported the validity and reliability of the BIDD BPI and SRI in mainly bulimic patients, though studies which question the validity of the BIDD (especially the BPI) have appeared. One purpose of the present study was to examine the BIDD's validity in anorectic as well as bulimic patients and to compare both to a psychiatric control group. A second purpose of the study was to compare the validity of the BIDD to alternative measures. Thus, this study also compared the BIDD indices with simple measures of body weight dissatisfaction. The results did not support the validity of the BIDD BPI as a measure of body image disturbance, moderately supported the SRI, and did support the measures of weight dissatisfaction.

Adult↗

A comprehensive method validation strategy for bioanalytical applications in the pharmaceutical industry--2. Statistical analyses.

The first paper in this two-part series described [Lang and Bolton, J. Pharm. Biomed. Anal. 9, 357-361 (1991)] an overall validation strategy for bioanalytical methods. This second paper focuses on the statistical analyses performed on the validation data that will allow the analyst to evaluate the reliability and reproducibility of a bioanalytical method. Based on the validation results, acceptance criteria for the quality control concentrations are established and used during the study proper to determine if the analytical run is valid. After analysing the clinical study samples and accepting the analytical runs, the quality control results are incorporated into databases to update their acceptance limits. This continuous validation process enables the analyst to monitor the method's performance over time and be confident that accurate sample concentrations are being reported. It is important to emphasize that the statistical analyses of the data provide information that should be considered from a practical point of view by the analyst. The analyst should use sound judgement in evaluating the reliability of the method.

Analysis of Variance↗

Practical computer validation for pharmaceutical laboratories.

Computer validation should address the scientific correctness of the application software, the business objectives of the organisation, and the concerns of regulatory agencies. It is a balance between a practical and cost effective system that must develop the confidence that the system is under control. This paper gives an overview of computer validation from the following perspectives. What is computer validation? Why can a computer system not be completely validated? Why and how should computer systems be validated? The principles outlined in this paper should be adapted to a specific system on a case by case basis depending on its scope and complexity.

Chemistry, Pharmaceutical↗