Validation d’un index méthodologique (MINORS) pour les études non-randomisées

Background. - Because of specific methodological difficulties in conducting randomised trials, surgical research remains based mainly on observational or non-randomised studies. Few validated instruments are available to assess the methodological quality of such studies from the reader’s perspective or within the scope of a meta-analysis. The aim of this study was to develop and validate such an instrument.Methods. - After the first phase of conceptualisation of the methodological index for non-randomised studies (MINORS), a list of 12 items was sent to 100 experts from several surgical specialities for evaluation and was also assessed by 10 clinical methodologists. Subsequent testing of the MINORS involved the assessment of: inter-reviewer reliability, test-retest reliability 2 months later, internal consistency and external validity.Findings. - The final version of MINORS included 12 items (the first eight for non-comparative studies). Clinimetric validation was established owing to good inter-reviewer and test-retest reliabilities with high kappa coefficient, good internal consistency with high Cronbach’s alpha coefficient, and good external validity with the ability of MINORS to recognise excellent trials.Interpretation. - The MINORS is a valid instrument to assess the methodological quality of non-randomised surgical studies (whether comparative or not). The next step will be to study its external validity by a large use and by comparing it with other available instruments.     

Development and validation of the Nasal Obstruction Symptom Evaluation (NOSE) scale.

OBJECTIVE: The study goal was to validate a disease-specific health status instrument for use in patients with nasal obstruction.Design, settings, and patients The study consisted of a prospective instrument validation conducted at 4 academic medical centers with 32 adults with nasal septal deformity. METHODS: Prospective instrument validation occurred in 2 stages. Stage 1 was the development of a preliminary (alpha-version) instrument of potential items. Stage 2 was a test of the alpha-version for item performance, internal consistency, and test-retest reliability; construct, discriminant, criterion validity, and responsiveness; and creation of the final instrument. RESULTS: Items with poor performance were eliminated from the alpha-version instrument. In testing the final instrument, test-retest reliability was adequate at 0.702; internal consistency reliability was also adequate at 0.785. Validity was confirmed using correlation and comparison analysis, and response sensitivity was excellent. CONCLUSIONS: The Nasal Obstruction Symptom Evaluation Scale is a valid, reliable, and responsive instrument that is brief and easy to complete and has potential use for outcomes studies in adults with nasal obstruction.     

Validity and reliability of Swedish WOMAC osteoarthritis index: A self-administered disease-specific questionnaire (WOMAC) versus generic instruments (SF-36 and NHP)

We assessed whether a disease-specific, self-administered questionnaire could replace a generic instrument as an outcome tool after total hip replacement, and tested the validity and reliability of the Swedish WOMAC osteoarthritis index. 58 patients operated on with total hip arthroplasty 2-10 years ago were randomized to the study. All patients were asked to answer one disease-specific questionnaire (WOMAC osteoarthritis index) and two generic instruments (NHP and SF-36) in the same week. The procedure was repeated after 4 weeks. We tested content validity, construct validity, criterion validity, test-retest reliability and internal consistency reliability according to total score, domains and items. We found that both the generic instruments (NHP and SF-36) and the disease-specific test (WOMAC) had a high validity, i.e., measuring what they were supposed to measure (high validity). The questionnaires were also reproducible over time (high reliability). We suggest the Swedish WOMAC to be used after total hip arthroplasty in future studies.     

Validity and reliability of Swedish WOMAC osteoarthritis index: A self-administered disease-specific questionnaire (WOMAC) versus generic instruments (SF-36 and NHP)

We assessed whether a disease-specific, self-administered questionnaire could replace a generic instrument as an outcome tool after total hip replacement, and tested the validity and reliability of the Swedish WOMAC osteoarthritis index. 58 patients operated on with total hip arthroplasty 2-10 years ago were randomized to the study. All patients were asked to answer one disease-specific questionnaire (WOMAC osteoarthritis index) and two generic instruments (NHP and SF-36) in the same week. The procedure was repeated after 4 weeks. We tested content validity, construct validity, criterion validity, test-retest reliability and internal consistency reliability according to total score, domains and items. We found that both the generic instruments (NHP and SF-36) and the disease-specific test (WOMAC) had a high validity, i.e., measuring what they were supposed to measure (high validity). The questionnaires were also reproducible over time (high reliability). We suggest the Swedish WOMAC to be used after total hip arthroplasty in future studies.     

Validity and reliability of Swedish WOMAC osteoarthritis index: a self-administered disease-specific questionnaire (WOMAC) versus generic instruments (SF-36 and NHP)

We assessed whether a disease-specific, self-administered questionnaire could replace a generic instrument as an outcome tool after total hip replacement, and tested the validity and reliability of the Swedish WOMAC osteoarthritis index. 58 patients operated on with total hip arthroplasty 2-10 years ago were randomized to the study. All patients were asked to answer one disease-specific questionnaire (WOMAC osteoarthritis index) and two generic instruments (NUP and SF-36) in the same week. The procedure was repeated after 4 weeks. We tested content validity, construct validity, criterion validity, test-retest reliability and internal consistency reliability according to total score, domains and items. We found that both the generic instruments (NHP and SF-36) and the disease-specific test (WOMAC) had a high validity, i.e., measuring what they were supposed to measure (high validity). The questionnaires were also reproducible over time (high reliability). We suggest the Swedish WOMAC to be used after total hip arthroplasty in future studies.     

Development and validation of the Overactive Bladder Satisfaction (OAB-S) Questionnaire

AIMS: To develop and validate a measure of patient satisfaction with treatment in overactive bladder: the Overactive Bladder Satisfaction Questionnaire (OAB-S). METHODS: Development of the questionnaire included a comprehensive literature review, development of a conceptual model, item elicitation and cognitive debriefing interviews with US-English and US-Spanish patients, and assessment of the questionnaire's translatability in other languages. Psychometric validation of the questionnaire was run on a longitudinal, non-randomized study involving 201 OAB patients. Analyses included construct validity, concurrent validity, tests of reliability, known-group validity, and responsiveness (exploratory). RESULTS: The OAB-S is a patient-completed questionnaire including five scales: OAB Control Expectations (ten items); Impact on Daily Living with OAB (ten items); OAB Control (ten items); OAB Medication Tolerability (six items); and Satisfaction with Control (ten items) and five single-item overall assessments of patient's fulfillment of OAB medication expectations, interruption of day-to-day life due to OAB, overall satisfaction with OAB medication; willingness to continue OAB medication and improvement in day-to-day life due to OAB medication. The hypothesized structure of the questionnaire was supported by statistical analyses. Internal consistency reliability coefficients (ranging from 0.76 to 0.94) and test-retest reliability coefficients (ranging from 0.72 to 0.87) were good for all dimensions. All dimensions except tolerability discriminated well according to self-reported OAB severity level and incontinence status. CONCLUSION: The OAB-S is a valid, comprehensive instrument to assess satisfaction with treatment of OAB based on independent scales that have demonstrated satisfactory psychometric performance.     

Development of a musculoskeletal extremity health status instrument: The musculoskeletal function assessment instrument

Despite an increasing reliance on the use of health status measures to assess and evaluate medical care, no single instrument is currently available for use with the broad range of patients with musculoskeletal disorders of the extremities that is commonly seen in clinical practice. In this paper, we report on the development of the Musculoskeletal Function Assessment instrument, a 100-item self reported health status instrument that is designed to meet this need. The instrument was developed in two phases During the first phase, items were selected on the basis of interviews with 135 patients and 12 clinicians and from reviews of existing health status instruments. The items then were grouped into categories. During the second phase, the instrument was tested for reliability and content validity using a sample of 327 patients with one of five musculoskeletal disorders of the upper and lower extremities (fractures, soft-tissue injuries, repetitive motion disorders, osteoarthritis, and rheumatoid arthritis). The patients were selected from both community and academic sites. The Musculoskeletal Function Assessment instrument met standards for test-retest reliability and internal consistency. Content validity also was demonstrated, based on a review of item selection procedures, expert opinion, and the distribution of scores on the instrument.     

Validation of an independent living scale for post-acute rehabilitation applications

The Independent Living Scale (ILS) was developed in a post-acute traumatic brain injury (TBI) rehabilitation facility over a 15-year period to assess three main areas: (1) activities of daily living, (2) behaviour, and (3) initiation. The purpose of this study was to examine the psychometric properties of the ILS, including test-retest stability, construct validity, and statistical fit. Statistical analysis was completed on all weekly scores between the years 1986-1995 (n = 5250). A previous study showed ILS inter-rater reliability to be 0.85 and convergent validity 0.82-0.87. This study demonstrated a test-retest stability of 0.72, the Kaiser-Meyer-Olkin Measure of Sampling Adequacy 0.94 (marvelous), and a Bartlett Test of Sphericity result of 'scale items independent'. The ILS was shown to have good construct validity, inter-rater reliability, internal consistency, instrument stability, and convergent validity.     

Quality of life after restorative proctocolectomy for ulcerative colitis: different questionnaires lead to different interpretations

BACKGROUND: According to some researchers, health-related quality-of-life scores for patients who undergo restorative proctocolectomy (RPC) for ulcerative colitis (UC) are comparable to those of healthy control subjects. Other studies show evidence that patients who undergo RPC experience a health-related quality of life similar to patients with mild UC or UC in remission. HYPOTHESIS: The discrepancy in health-related quality-of-life scores among studies may be due to different health-related quality-of-life analyses. DESIGN: Cross-sectional study. SETTING: Outpatient clinic of a tertiary care center. PATIENTS: In the first phase of the study, we consecutively enrolled 24 patients with UC, 24 patients with Crohn disease, and 24 healthy controls. In the second phase of the study, 40 patients who underwent RPC, 43 patients with UC, and 44 controls were consecutively enrolled. INTERVENTIONS: We administered an Italian version of the Cleveland Global Quality of Life (CGQL) instrument, the Padova Inflammatory Bowel Disease Quality of Life instrument, and the Italian 36-Item Short-Form Health Survey. MAIN OUTCOME MEASURES: We evaluated the construct validity, internal consistency, test-retest reliability, sensitivity to change, and discriminant ability of the Italian CGQL instrument. We compared its discriminative ability with that of the Padova Inflammatory Bowel Disease Quality of Life instrument. RESULTS: The Italian CGQL instrument obtained good construct validity, internal consistency, test-retest reliability, and sensitivity to change. The Italian CGQL score did not distinguish patients who underwent RPC from healthy controls and those with mild UC or UC in remission, while the Padova Inflammatory Bowel Disease Quality of Life instrument reported similar scores for patients who underwent RPC and those with mild UC or UC in remission, and showed a difference vs healthy controls. CONCLUSIONS: We validated an Italian version of the CGQL score. The different results obtained with the CGQL and the Padova Inflammatory Bowel Disease Quality of Life instruments can be attributed to the different discriminative ability of the 2 questionnaires.     

Reliability of an osteoporosis-targeted quality of life survey instrument for use in the community: OPTQoL

A brief Osteoporosis-Targeted Quality of Life (OPTQoL) questionnaire was previously developed as a cross-sectional survey instrument to assess the community impact of osteoporosis on quality of life in women. The initial development process involving item generation through focus groups, item reduction, and content and construct validation yielded a 36-item questionnaire with three domains (physical difficulty, adaptations and fears) and 10 health-related questions. In the present study, test-retest reliability and internal consistency of the questionnaire were assessed in a mail-based study with two clinical sites. Two hundred women (50 with severe osteoporosis, 50 with osteopenia, 50 with normal bone mineral density (BMD) and 50 with osteoarthritis and normal BMD), aged 43–84 years, completed the self-administered questionnaire initially and again about 2 weeks later. Using weighted kappas, agreement between questionnaire administrations ranged from 0.60 to 0.80 for most of the individual items. Intraclass correlation coefficients to assess reliability for the domain scores were 0.93 (physical difficulty), 0.82 (adaptations) and 0.88 (fears). Internal consistency of each of the domains was also high, with Cronbach’s alpha coefficients ranging from 0.89 to 0.91. Four items were dropped from the 36-item questionnaire due to high percentage of ‘not applicable’ responses. Results of the analyses support the validity and reliability of this instrument as a cross-sectional survey tool for assessing the impact of osteoporosis on quality of life in women living in the community. The questionnaire has been translated and culturally adapted into seven languages to allow cross-cultural studies of the community impact of osteoporosis.     

The General Function Score: a useful tool for measurement of physical disability. Validity and reliability

The General Function Score (GFS) is a disease-specific instrument consisting of nine items focusing on strict physical activities of daily living. It is intended as an alternative to the more complex scores of disability (such as the Oswestry Disability Index), serving as a complement to the quality of life instruments in the study of low back pain (LBP). It was developed from an original 17-item questionnaire, of which 11 of the items were tested for criterion validity in an observer-supervised performance test. Two items were excluded from further analysis because of too low a validity. The remaining nine-item GFS was tested for construct validity, reliability, feasibility and responsiveness in six different cohorts: 297 patients with chronic low back pain (cohort 1), an age- and sex-matched control group of 287 randomly allocated Swedish citizens (cohort 2), three separate groups of patients admitted for surgery due to low back disorders (cohorts 3-5) and outpatients with spinal disorders (cohort 6). Correlations were tested with the Spearman Rank correlation coefficient, differences between groups with the Mann-Whitney test and the internal consistency with the Cronbach's coefficient alpha. The GFS total scores showed correlations of 0.78, 0.81 and 0.88 in the three aspects of the performance test. The response rate was 98.3-100%. The mean time to complete the questionnaire was 1.2 min. The internal consistency was 0.69 and 0.86 in cohorts 1 and 2 respectively. The test-retest correlation was 0.88. The GFS showed a high responsiveness to difference and change. The effect size was 0.82-0.96 in surgically treated disc herniation and 0.55-0.85 in spondylolisthesis. The GFS is a highly valid and reliable instrument with good responsiveness and feasibility, useful for evaluation of physical disability.     

痴呆生活质量量表中文版的修订及信效度检测

目的建立痴呆生活质量量表(Dementia Quality of Life,DQoL)中文版,并检测信度和效度,以期为中国痴呆患者的生活质量测评提供有效工具。方法将DQoL翻译成中文,最终形成包括3个测试问题,29个条目,以及1项生活质量总体评价的5级量表。对简易精神状态检查量表(MMSE)筛选的40例轻中度痴呆患者进行生活质量评定,检测量表的信度和效度,并选取22例患者于4周后重测。结果 DQoL中文版Cronbach′sα系数为0.856;重测信度系数为0.726;内容效度指数(S-CVI)为0.986;量表5个维度间的相关系数为-0.133～0.694。结论 DQoL中文版具有较好的信度,效度略低,仍需扩大样本进行更深入的研究。     

Reliability and validity of the Malay version of the Health-Related Quality of Life instrument in a Malaysian population

OBJECTIVE: To validate the Malay version of the Health-Related Quality of Life (Mal-HRQOL-20) questionnaire in patients with and without urinary symptoms in a Malaysian population. PATIENTS AND METHODS: The validity and reliability of the Mal-HRQOL-20 were assessed in patients with and without lower urinary tract symptoms (LUTS). The reliability was evaluated using the test-retest method and the internal consistency using Cronbach's alpha. Sensitivity to change was expressed as the effect size in the score before and after intervention in additional patients with LUTS who underwent transurethral resection of the prostate. RESULTS: The internal consistency was excellent; there was a high degree of internal consistency for each of the 20 items and for the overall score (Cronbach's alpha > or = 0.57 and 0.79, respectively) in the population study. The test-retest correlation coefficient for the 20 item scores was highly significant. The intra-class correlation coefficient was high (> or = 0.55). The sensitivity and specificity were high for the effects of treatment. There was a very significant agreement between scores before and after treatment across all domains in the treatment cohort, but not in the control group. CONCLUSION: The Mal-HRQOL-20 is suitable, reliable, valid and sensitive to clinical change in the Malaysian population.     

EDITS: development of questionnaires for evaluating satisfaction with treatments for erectile dysfunction

OBJECTIVES: To develop Patient and Partner versions of a psychometrically sound questionnaire, the EDITS (Erectile Dysfunction Inventory of Treatment Satisfaction), to assess satisfaction with medical treatments for erectile dysfunction. METHODS: Treatment satisfaction differs from treatment efficacy as it focuses on a person's subjective evaluation of treatment received. Twenty-nine items representing the domain of treatment satisfaction for men and 20 representing partner satisfaction were generated. Two independent samples of 28 and 29 couples completed all items at two points in time. Spearman rank-order correlations were derived to assess test-retest reliability and couple coefficients of validity. Internal consistency coefficients were calculated for both Patient and Partner versions and a content validity panel was used to analyze content validity. RESULTS: Only items that met all the following criteria were selected to comprise the final questionnaires: (a) range of response four or more out of five; (b) test-retest reliability greater than 0.70; (c) ratings by at least 70% of the content validity panel as belonging in and being important for the domain; and (d) significant correlation between the subjects' and partners' responses. Eleven patient items met criteria and formed the Patient EDITS; five partner items met criteria and formed the Partner EDITS. Scores on the two inventories were normally distributed with internal consistencies of 0.90 and 0.76, respectively. Test-retest reliability for the Patient EDITS was 0.98; for the Partner EDITS, it was 0.83. CONCLUSIONS: Reliability and validity were well established, enabling the EDITSs to be used to assess satisfaction with treatment modalities for erectile dysfunction and to explore the impact of patient and partner satisfaction on treatment continuation.     

Validation of the hospital anxiety and depression scale and the psychological disorder among premature ejaculation subjects

Premature ejaculation (PE) is a common sexual dysfunction among the general population. PE has often been associated with a psychological state of mind. Hospital Anxiety and Depression Scale (HADS) can be used as an instrument to assess the emotional and psychological state. The present study was designed to assess the reliability and validity of the HADS in a Malaysian population. The validity and reliability were studied in subjects with and without PE. Test-retest methodology was used to assess the reliability whereas Cronbach's alpha was used to assess the internal consistency. In the control and the PE groups, the internal consistency was good and a high degree of internal consistency was observed for all 14 items. In the control group, the Cronbach's alpha values at baseline were from 0.811 to 0.834, whereas for retest, the Cronbach's alpha values were from 0.821-0.838 items. Intraclass correlation coefficient (ICC) was high for the control (0.797-0.868: baseline and 0.805-0.872: retest) and PE group (0.822-0.906: baseline and 0.785-0.887: retest). The high value of ICC and the internal consistency was due to high reliability and consistency of the items at 2-week interval. A degree of significance between the baseline and week-2 scores was observed across all items in the PE group but not in the control group. The HADS is a suitable, reliable, valid and sensitive instrument to measure the clinical change for anxiety and depression in the Malaysian population.     

Reliability and validity of a brief instrument for assessing post-traumatic stress disorder

This study examines the psychometric properties of two versions of the PTSD Sympton Scale (PSS). The scale contains 17 items that diagnose PTSD according to DSM-III-R criteria and assess the severity of PTSD symptoms. An interview and self-report version of the PSS were administered to a sample of 118 recent rape and non-sexual assault victims. The results indicate that both versions of the PSS have satisfactory internal consistency, high test-retest reliability, and good concurrent validity. The interview version yielded high interrater agreement when administred separately by two interviewers and excellent convergent validity with the SCID. When used to diagnose PTSD, the self-report version of the PSS was somewhat more conservative than the interview version.     

Development and validation of a risk assessment scale for pathological scarring

To develop a risk assessment scale for pathological scarring and validate its psychometric properties. This was a methodological study. Researchers developed the scale based on a literature review, qualitative study and Delphi expert consultation. Subsequently, 409 patients participated in the study to test the psychometric properties of the scale. We evaluated construct validity, content validity, internal consistency reliability, and interrater reliability. The researchers developed a scale consisting of three dimensions and 12 items. Factor analysis extracted a total of four common factors that accounted for 62.22% of the total variance. The results revealed that the item-content validity index (I-CVI) ranged from 0.67 to 1, while the scale-content validity index (S-CVI) was 0.82. Internal consistency reliability: Cronbach's α of the items ranged from 0.67 to 0.76, while Cronbach's α of the whole scale was 0.74. Interrater reliability: the Kappa number was 0.73. The final scale showed adequate construct validity, content validity, and reliability. It is appropriate for use in research and clinical practice settings to identify patients with a risk of pathological scarring. Further study is needed to confirm the scale's validity and reliability in other settings and populations.     

Reliability and validity of the Malay version of the International Prostate Symptom Score in the Malaysian population

PURPOSE: We validated the Malay version of the International Prostate Symptom Score in patients with and without urinary symptoms in the Malaysian population. MATERIALS AND METHODS: Validity and reliability were studied in patients with and without lower urinary tract symptoms. Reliability was evaluated using the test-retest method and internal consistency was assessed by Cronbach's alpha. Sensitivity to change was expressed as the effect size in the pre-intervention versus post-intervention score in additional patients with lower urinary tract symptoms who underwent transurethral prostate resection. RESULTS: Internal consistency was excellent. A high degree of internal consistency was observed for each of the 7 items and for the total score (Cronbach's alpha 0.53 and greater, and 0.68, respectively). The test-retest correlation coefficients of the 7 items were highly significant. The intraclass correlation coefficient was high at 0.51 and greater. There was a high degree of sensitivity and specificity to the effects of treatment. Significant change from baseline to posttreatment scores was observed in all 8 items in the treated but not in the control group. CONCLUSIONS: The Malay International Prostate Symptom Score is a suitable, reliable, valid instrument that is sensitive to clinical change in the Malaysian population.