No full-text available
To read the full-text of this research,
you can request a copy directly from the authors.
Translation and validation of the Urdu version of the neck pain and disability scale
Disability and Rehabilitation
Abstract
Purpose:
To translate and cross-culturally adapt the neck pain and disability scale (NPDS) into Urdu language (NPDS-U), and to investigate the NPDS-U's psychometric properties in patients with non-specific neck pain (NSNP).
Methods:
The NPDS was translated and cross-culturally adapted into Urdu in accordance with the previously described guidelines. The study included 200 NSNP patients and 50 healthy participants. The NPDS-U, Urdu version of neck disability index (NDI-U), neck Bournemouth questionnaire (NBQ), and numerical pain rating scale (NPRS) were completed by all participants. After three weeks of physiotherapy, the patients completed all of the above-mentioned questionnaires, along with the global rating of change scale. Reliability, factor analysis, validity, and responsiveness were all tested.
Results:
The NPDS-U demonstrated excellent test-retest reliability (ICC2,1=0.92) and high internal consistency (Cronbach's alpha = 0.96). There were no floor or ceiling effects. A three-factor structure was extracted, which explained 70.42% of the total variance. The NPDS-U showed moderate to strong correlations with NPRS, NDI-U, and NBQ (r = 0.67-0.76, p < 0.001). A significant difference in the NPDS-U change scores between the stable and the improved groups (p < 0.001) confirmed its responsiveness.
Conclusion:
The NPDS-U is a reliable, valid, and responsive scale for assessing neck pain and disability in Urdu-speaking patients with NSNP.
ResearchGate has not been able to resolve any citations for this publication.
The estimation of reliability in any research is a very important thing. For us to achieve the goal of the research, we are usually faced with the issue of when the measurements are repeated, are we sure we will get the same result? Reliability is the extent to which an experiment, test, or any measuring procedure yields the same result on repeated trials. If a measure is perfectly reliable, there is no error in measurement, that is, everything we observe is the true score. However, it is the amount/degree of error that indicates how reliable, a measurement is. The issue of sample size determination has been a major problem for researchers and psychometricians in reliability studies. Existing approaches to determining sample size for psychometric studies have been varied and are not straightforward. This has made the psychometric literature contain a wide range of articles that propose a variety of sample sizes. This paper investigated sample sizes in test-retest and Cronbach alpha reliability estimates. The study was specifically concerned with identifying and analyzing differences in test-retest and Cronbach alpha reliability estimate of an instrument using various sample sizes of 20,30,40,50,100,150,200,300, and 400. Four hundred and eight (408) senior secondary school students from thirty-eight (38) public senior secondary schools in Benin metropolis part took in the study. The Open Hemisphere Brain Dominance Scale, by Eric Jorgenson was used for data collection. Data were analyzed using Pearson Product Moment Correlation Coefficient (r) and Cronbach alpha. The findings revealed that the sample sizes of 20 and 30 were not reliable, but the reliability of the instrument became stronger when the sample size was at least 100. The interval estimate (Fisher's confidence interval) gave a better reliability estimate than the point estimate for all samples. Based on the findings, it was, therefore, recommended that for a high-reliability estimate, at least one hundred (100) subjects should be used. Observed or field-tested values should always be used in the estimation of the reliability of any measuring instrument, and reliability should not be reported as a point estimate, but as an interval.
Background
Neck pain is one of the most common musculoskeletal disorders, having an age-standardised prevalence rate of 27.0 per 1000 population in 2019. This literature review describes the global epidemiology and trends associated with neck pain, before exploring the psychological and biological risk factors associated with the initiation and progression of neck pain.
Methods
The PubMed database and Google Scholar search engine were searched up to May 21, 2021. Studies were included that used human subjects and evaluated the effects of biological or psychological factors on the occurrence or progression of neck pain, or reported its epidemiology.
Results
Psychological risk factors, such as long-term stress, lack of social support, anxiety, and depression are important risk factors for neck pain. In terms of the biological risks, neck pain might occur as a consequence of certain diseases, such as neuromusculoskeletal disorders or autoimmune diseases. There is also evidence that demographic characteristics, such as age and sex, can influence the prevalence and development of neck pain, although further research is needed.
Conclusions
The findings of the present study provide a comprehensive and informative overview that should be useful for the prevention, diagnosis, and management of neck pain.
Purpose
Patient-reported outcome measures (PROMs) are increasingly used in clinical settings to inform individual patient care. In-depth understanding of end-users’ experiences may help identify factors that promote or hinder their use in clinical decision-making. We aimed to examine stakeholder perceptions of the utility of using PROMs in clinical practice based on real-life experience.
Methods
Systematic review searching Medline, Embase and PsychINFO from inception to May 2021. Qualitative studies examining patients’ and/or clinicians’ experiences of using PROMs in clinical settings were included. Study screening and data extraction were performed by two independent reviewers. Qualitative data from included studies was analysed thematically.
Results
Of 2388 abstracts retrieved, 52 articles reporting 50 studies met eligibility. Five key benefits were identified: (1) promotes active patient involvement (enables goal setting and discussion of sensitive topics); (2) enhances the focus of consultations (prioritizes patient needs); (3) improves quality of care (enables tailored, holistic care and prompts action); (4) enables standardized monitoring of patient outcomes; and (5) enhances the patient–clinician relationship (provides reassurance). Perceived limitations included the capacity of PROMs to shift the focus of consultations; inaccurately estimate problems; raise unrealistic expectations for care; inhibit patient–clinician interaction; lack clinically meaningful information; and not be suitable for all patients.
Conclusion
Both patients and clinicians reported benefits of using PROMs across diverse health conditions and clinical settings, but also highlighted several limitations. These limitations shed some light on why PROM use may not always improve patient outcomes and provide considerations for the design and implementation of future PROM initiatives.
Introduction: Chronic Neck Pain has become a severe health and socioeconomic problem in modern era. It is a leading cause of physical disability and about 70% of population experience neck pain in their lives. The neck pain is often associated with poor health, social disruption, psychological problems and previous neck injury. Dentists are at higher risk of musculoskeletal pain and disorders as they are vulnerable to mal-postures. There is still not enough data reported regarding prevalence of neck pain in dentists in different districts of Pakistan. The purpose of this study was to determine the prevalence of neck pain in the dentist community of Faisalabad and to report its effect on activities of daily living.
Material & Methods: A cross sectional survey was conducted on 50 dentists working in government and private hospitals and clinics in Faisalabad from January to June 2018. Participants with a history of major trauma, major surgery and other co-morbidities were excluded. Data was collected by using neck pain disability index. The collected data was entered and analyzed by using SPSS 20.
Results: The response rate was 100%, out of 50 dentists 30 (60%) were males and 20 (40%) were females with mean age 35.6 ± 2.00 years (mean ± sd). Our study revealed that 31 (62%) of the dentists in Faisalabad suffered from neck pain and the remaining 19 (38%) had no neck pain. Severity of the pain was reported as 18 (36%) had mild pain and about disability 14 (28%) reported no disability while 24 (48%) had mild disabilities. The study indicated that activities of daily living including to recreational activities were affected differently due to severity of neck pain amongst these dentists.
Conclusion: Dentists in Faisalabad are prone to develop neck pain due to their working poor posture. Male dentists are more vulnerable to developing neck pain compared to their counterparts' female dentists. Long-working hours are the major contributing factors in neck pain amongst dentists.
The purpose of this study was to evaluate the responsiveness of Copenhagen Neck Functional Disability Scale (CNFDS), Neck Disability Index (NDI), Neck Bournemouth Questionnaire (NBQ), Neck Pain and Disability Scale (NPDS) in geriatric patients with non-specific chronic neck pain. A total of 52 geriatric patients with non-specific chronic neck pain were included in the present study. All participants were included in a physical therapy and rehabilitation program for five sessions per week that lasted 3 weeks. All participants were evaluated before and after the treatment. Pain and disability were assessed with the Visual Analog Scale-pain (VAS-pain), VAS-disability, muscle spasm, CNFDS, NDI, NBQ, NPDS scales. Additionally, patient satisfaction scores were questioned both before and after the treatment. Following the 3-week physical therapy and rehabilitation program, significant improvements were detected in the VAS-pain, VAS-disability, muscle spasm, CNFDS, NDI, NBQ, and NPDS scores (p < 0.05). Responsiveness values were found to be as follows: CNFDS [effect size (ES) = 0.78; standardized response mean (SRM) = 0.90], NDI (ES = 0.66; SRM = 1.18), NBQ (ES = 0.82; SRM = 0.97) and NPDS (ES = 0.87; SRM = 0.98). Our study demonstrated that CNFDS, NDI, NBQ, and NPDS are responsive scales in determining treatment-related changes in geriatric patients with non-specific neck pain. These results also suggest that all of these four scales can be used in the assessment of treatment induced changes in geriatric patients with chronic neck pain.
We define the minimal important change (MIC) as a threshold for a minimal within-person change over time above which patients perceive themselves importantly changed. There is a lot of confusion about the concept of MIC, particularly about the concepts of minimal important change and minimal detectable change, which questions the validity of published MIC values. The aims of this study were: (1) to clarify the concept of MIC and how to use it; (2) to provide practical guidance for estimating methodologically sound MIC values; and (3) to improve the applicability of PROMIS by summarizing the available evidence on plausible PROMIS MIC values. We discuss the concept of MIC and how to use it and provide practical guidance for estimating MIC values. In addition, we performed a systematic review in PubMed on MIC values of any PROMIS measure from studies using recommended approaches. A total of 50 studies estimated the MIC of a PROMIS measure, of which 19 studies used less appropriate methods. MIC values of the remaining 31 studies ranged from 0.1 to 12.7 T-score points. We recommend to use the predictive modeling method, possibly supplemented with the vignette-based method, in future MIC studies. We consider a MIC value of 2–6 T-score points for PROMIS measures reasonable to assume at this point. For surgical interventions a higher MIC value might be appropriate. We recommend more high-quality studies estimating MIC values for PROMIS.
Background
Scores on an outcome measurement instrument depend on the type and settings of the instrument used, how instructions are given to patients, how professionals administer and score the instrument, etc. The impact of all these sources of variation on scores can be assessed in studies on reliability and measurement error, if properly designed and analyzed. The aim of this study was to develop standards to assess the quality of studies on reliability and measurement error of clinician-reported outcome measurement instruments, performance-based outcome measurement instrument, and laboratory values.
Methods
We conducted a 3-round Delphi study involving 52 panelists.
Results
Consensus was reached on how a comprehensive research question can be deduced from the design of a reliability study to determine how the results of a study inform us about the quality of the outcome measurement instrument at issue. Consensus was reached on components of outcome measurement instruments, i.e. the potential sources of variation. Next, we reached consensus on standards on design requirements (n = 5), standards on preferred statistical methods for reliability (n = 3) and measurement error (n = 2), and their ratings on a four-point scale. There was one term for a component and one rating of one standard on which no consensus was reached, and therefore required a decision by the steering committee.
Conclusion
We developed a tool that enables researchers with and without thorough knowledge on measurement properties to assess the quality of a study on reliability and measurement error of outcome measurement instruments.
Objective
To use data from the Global Burden of Disease Study between 1990 and 2017 to report the rates and trends of point prevalence, annual incidence, and years lived with disability for neck pain in the general population of 195 countries.
Design
Systematic analysis.
Data source
Global Burden of Diseases, Injuries, and Risk Factors Study 2017.
Main outcome measures
Numbers and age standardised rates per 100 000 population of neck pain point prevalence, annual incidence, and years lived with disability were compared across regions and countries by age, sex, and sociodemographic index. Estimates were reported with uncertainty intervals.
Results
Globally in 2017 the age standardised rates for point prevalence of neck pain per 100 000 population was 3551.1 (95% uncertainty interval 3139.5 to 3977.9), for incidence of neck pain per 100 000 population was 806.6 (713.7 to 912.5), and for years lived with disability from neck pain per 100 000 population was 352.0 (245.6 to 493.3). These estimates did not change significantly between 1990 and 2017. The global point prevalence of neck pain in 2017 was higher in females compared with males, although this was not significant at the 0.05 level. Prevalence increased with age up to 70-74 years and then decreased. Norway (6151.2 (95% uncertainty interval 5382.3 to 6959.8)), Finland (5750.3 (5058.4 to 6518.3)), and Denmark (5316 (4674 to 6030.1)) had the three highest age standardised point prevalence estimates in 2017. The largest increases in age standardised point prevalence estimates from 1990 to 2017 were in the United Kingdom (14.6% (10.6% to 18.8%)), Sweden (10.4% (6.0% to 15.4%)), and Kuwait (2.6% (2.0% to 3.2%)). In general, positive associations, but with fluctuations, were found between age standardised years lived with disability for neck pain and sociodemographic index at the global level and for all Global Burden of Disease regions, suggesting the burden is higher at higher sociodemographic indices.
Conclusions
Neck pain is a serious public health problem in the general population, with the highest burden in Norway, Finland, and Denmark. Increasing population awareness about risk factors and preventive strategies for neck pain is warranted to reduce the future burden of this condition.
Background People with chronic neck pain have impaired proprioception (i.e., sense of neck position). It is unclear whether this impairment involves disruptions to the proprioceptive representation in the brain, peripheral factors, or both. Implicit motor imagery tasks, namely left/right judgements of body parts, assess the integrity of the proprioceptive represention. Previous studies evaluating left/right neck judgements in people with neck pain are conflicting. We conducted a large online study to comprehensively address whether people with neck pain have altered implicit motor imagery performance. Methods People with and without neck pain completed online left/right neck judgement tasks followed by a left/right hand judgement task (control). Participants judged whether the person in the image had their head rotated to their left or right side (neck task) or whether the image was of a left hand or a right hand (hand task). Participants were grouped on neck pain status (no pain;
Background
The Global Burden of Diseases, Injuries, and Risk Factors Study 2017 (GBD 2017) includes a comprehensive assessment of incidence, prevalence, and years lived with disability (YLDs) for 354 causes in 195 countries and territories from 1990 to 2017. Previous GBD studies have shown how the decline of mortality rates from 1990 to 2016 has led to an increase in life expectancy, an ageing global population, and an expansion of the non-fatal burden of disease and injury. These studies have also shown how a substantial portion of the world's population experiences non-fatal health loss with considerable heterogeneity among different causes, locations, ages, and sexes. Ongoing objectives of the GBD study include increasing the level of estimation detail, improving analytical strategies, and increasing the amount of high-quality data.
Methods
We estimated incidence and prevalence for 354 diseases and injuries and 3484 sequelae. We used an updated and extensive body of literature studies, survey data, surveillance data, inpatient admission records, outpatient visit records, and health insurance claims, and additionally used results from cause of death models to inform estimates using a total of 68 781 data sources. Newly available clinical data from India, Iran, Japan, Jordan, Nepal, China, Brazil, Norway, and Italy were incorporated, as well as updated claims data from the USA and new claims data from Taiwan (province of China) and Singapore. We used DisMod-MR 2.1, a Bayesian meta-regression tool, as the main method of estimation, ensuring consistency between rates of incidence, prevalence, remission, and cause of death for each condition. YLDs were estimated as the product of a prevalence estimate and a disability weight for health states of each mutually exclusive sequela, adjusted for comorbidity. We updated the Socio-demographic Index (SDI), a summary development indicator of income per capita, years of schooling, and total fertility rate. Additionally, we calculated differences between male and female YLDs to identify divergent trends across sexes. GBD 2017 complies with the Guidelines for Accurate and Transparent Health Estimates Reporting.
Findings
Globally, for females, the causes with the greatest age-standardised prevalence were oral disorders, headache disorders, and haemoglobinopathies and haemolytic anaemias in both 1990 and 2017. For males, the causes with the greatest age-standardised prevalence were oral disorders, headache disorders, and tuberculosis including latent tuberculosis infection in both 1990 and 2017. In terms of YLDs, low back pain, headache disorders, and dietary iron deficiency were the leading Level 3 causes of YLD counts in 1990, whereas low back pain, headache disorders, and depressive disorders were the leading causes in 2017 for both sexes combined. All-cause age-standardised YLD rates decreased by 3·9% (95% uncertainty interval [UI] 3·1–4·6) from 1990 to 2017; however, the all-age YLD rate increased by 7·2% (6·0–8·4) while the total sum of global YLDs increased from 562 million (421–723) to 853 million (642–1100). The increases for males and females were similar, with increases in all-age YLD rates of 7·9% (6·6–9·2) for males and 6·5% (5·4–7·7) for females. We found significant differences between males and females in terms of age-standardised prevalence estimates for multiple causes. The causes with the greatest relative differences between sexes in 2017 included substance use disorders (3018 cases [95% UI 2782–3252] per 100 000 in males vs s1400 [1279–1524] per 100 000 in females), transport injuries (3322 [3082–3583] vs 2336 [2154–2535]), and self-harm and interpersonal violence (3265 [2943–3630] vs 5643 [5057–6302]).
Interpretation
Global all-cause age-standardised YLD rates have improved only slightly over a period spanning nearly three decades. However, the magnitude of the non-fatal disease burden has expanded globally, with increasing numbers of people who have a wide spectrum of conditions. A subset of conditions has remained globally pervasive since 1990, whereas other conditions have displayed more dynamic trends, with different ages, sexes, and geographies across the globe experiencing varying burdens and trends of health loss. This study emphasises how global improvements in premature mortality for select conditions have led to older populations with complex and potentially expensive diseases, yet also highlights global achievements in certain domains of disease and injury.
Objective:
The purpose of this study was to examine the psychometric properties of the neck disability index (NDI) and numeric pain rating scale (NPRS) in patients with neck pain (NP) without concomitant upper extremity (UE) symptoms.
Design:
A secondary psychometric analysis of 107 patients with NP without UE symptoms. Test-retest reliability, construct validity, area under the curve (AUC), minimum detectable change (MDC), and minimum clinically important difference (MCID) were calculated.
Results:
The NDI exhibited excellent reliability (ICC = 0.88; [0.63 to 0.95]), while the NPRS exhibited moderate reliability (ICC = 0.67; [0.27 to 0.84]). The AUC for both the NDI (0.86; [0.79 to 0.93]) and NPRS (0.81 [0.73 to 0.90]) was acceptable. The MDC for the NDI was 6.9, and the MCID for the NDI was 5.5(Sn = 0.83; Sp = 0.79). For the NPRS, the MDC was 2.6, and the MCID was 1.5(Sn = 0.93; Sp = 0.64).
Conclusion:
The threshold for MCID for the NDI and NPRS in patients without UE symptoms is lower (NDI = 5.5; NPRS = 1.5) than that of patients with UE/radicular symptoms (NDI = 8.5 points; NPRS = 2.2). Knowledge of these cut-scores in each presentation of NP is needed for successful research and clinical treatment. Additional outcomes may be warranted for patients with UE symptoms.
Correlation in the broadest sense is a measure of an association between variables. In correlated data, the change in the magnitude of 1 variable is associated with a change in the magnitude of another variable, either in the same (positive correlation) or in the opposite (negative correlation) direction. Most often, the term correlation is used in the context of a linear relationship between 2 continuous variables and expressed as Pearson product-moment correlation. The Pearson correlation coefficient is typically used for jointly normally distributed data (data that follow a bivariate normal distribution). For nonnormally distributed continuous data, for ordinal data, or for data with relevant outliers, a Spearman rank correlation can be used as a measure of a monotonic association. Both correlation coefficients are scaled such that they range from -1 to +1, where 0 indicates that there is no linear or monotonic association, and the relationship gets stronger and ultimately approaches a straight line (Pearson correlation) or a constantly increasing or decreasing curve (Spearman correlation) as the coefficient approaches an absolute value of 1. Hypothesis tests and confidence intervals can be used to address the statistical significance of the results and to estimate the strength of the relationship in the population from which the data were sampled. The aim of this tutorial is to guide researchers and clinicians in the appropriate use and interpretation of correlation coefficients.This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.
The task of developing a new questionnaire or translating an existing questionnaire into a different language might be overwhelming. The greatest challenge perhaps is to come up with a questionnaire that is psychometrically sound, and is efficient and effective for use in research and clinical settings. This article provides guidelines for the development and translation of questionnaires for application in medical fields, with a special emphasis on perioperative and pain medicine. We provide a framework to guide researchers through the various stages of questionnaire development and translation. To ensure that the questionnaires are psychometrically sound, we present a number of statistical methods to assess the reliability and validity of the questionnaires.
Background
Despite the wide use of the neck disability index (NDI) for assessing disability in patients with neck pain, the NDI has not yet been translated and validated in Urdu. The first purpose of the present study was to translate and cross-culturally adapt the NDI into the Urdu language (NDI-U). The second purpose was to investigate the reliability, validity and responsiveness of the NDI-U in Urdu-speaking patients experiencing chronic mechanical neck pain (CMNP). Methods
Translation and cross-cultural adaptation of the original version of the NDI were carried out using previously described procedures. Seventy-six patients with CMNP and thirty healthy participants were recruited for the study. NDI-U and visual analogue scales for pain intensity (VASpain) and disability (VASdisability) were administered to all the participants at baseline and to the patients 3 weeks after receiving physiotherapy intervention. The global rating of change scale (GROC) was also administered at this time. Test-retest reliability and internal consistency were carried out on forty-six randomly selected patients two days after they completed the NDI-U. The NDI-U was evaluated for factor analysis, content validity, construct validity (discriminative and convergent validity) and responsiveness. ResultsAn intra-class correlation coefficient (ICC2,1) revealed excellent test-retest reliability for all items (ICC2,1 = 0.86–0.98) and total scores (ICC2,1 = 0.99) of the NDI-U. The NDI-U was found internally consistent with a Cronbach’s alpha of 0.90 and a fair to good correlation between single items and the NDI-U total scores (r = 0.34 to 0.89). Factor analysis of the NDI-U produced two factors explaining 66.71% of the variance. Content validity was good, as no floor or ceiling effects were detected for the NDI-U total score. To determine discriminative validity, an independent t-test revealed a significant difference in the NDI-U total scores between the patients and healthy controls (P < 0.001). For convergent validity, Pearson’s correlation coefficient showed a strong correlation between NDI-U and VASdisability (r = 0.83, P < 0.001) and a moderate correlation between NDI-U and VASpain (r = 0.62, P < 0.001). To measure responsiveness, an independent t-test showed a significant difference in the NDI-U change scores between the stable and the improved groups (P < 0.001). Furthermore, moderate correlations were found between the NDI-U change scores and the GROC (r = 0.50, P < 0.001), VASdisability change scores (r = 0.58, P < 0.001) and VASpain change scores (r = 0.55, P < 0.001). Conclusion
The results showed that the NDI-U is a reliable, valid and responsive questionnaire to measure disability in Urdu-speaking patients with CMNP.
The overarching goals of treatments for orthopedic conditions are generally to improve or restore function and alleviate pain. Results of clinical trials are generally used to determine whether a treatment is efficacious; however, a statistically significant improvement may not actually be clinically important, i.e., meaningful to the patient. To determine whether an intervention has produced clinically important benefits requires a two-step process: first, determining the magnitude of change considered clinically important for a particular measure in the relevant population and, second, applying this yardstick to a patient¿s data to determine whether s/he has benefited from treatment. Several metrics have been devised to quantify clinically important differences, including the minimum clinically important difference (MCID) and clinically important difference (CID). Herein, we review the methods to generate the MCID and other metrics and their use and interpretation in clinical trials and practice. We particularly highlight the many pitfalls associated with the generation and utilization of these metrics that can impair their correct use. These pitfalls include the fact that different pain measures yield different MCIDs, that efficacy in clinical trials is impacted by various factors (population characteristics, trial design), that the MCID value is impacted by the method used to calculate it (anchor, distribution), by the type of anchor chosen and by the definition (threshold) of improvement. The MCID is also dependent on the population characteristics such as disease type and severity, sex, age, etc. For appropriate use, the MCID should be applied to changes in individual subjects, not to group changes. The MCID and CID are useful tools to define general guidelines to determine whether a treatment produces clinically meaningful effects. However, the many pitfalls associated with these metrics require a detailed understanding of the methods to calculate them and their context of use. Orthopedic surgeons that will use these metrics need to carefully understand them and be aware of their pitfalls.
A prospective study.
To evaluate the reliability and validity of the adapted Korean version of the Neck Pain and Disability Scale (NPDS).
The validity of Korean version of NPDS has not been completely demonstrated yet.
Translation/retranslation of the English version of NPDS was conducted, and all steps of the cross-cultural adaptation process were performed. The Korean version of the visual analog scale (VAS) measure of pain, NPDS and the previously validated Short Form-36 (SF-36) were mailed to 91 patients, who had been surgically treated for degenerative cervical disease. Eighty-one patients responded to the first mailing of questionnaires and 69 of the first time responder returned their second survey. Factor analysis and reliability assessment by kappa statistics of agreement for each item, the intraclass correlation coefficient and Cronbach's α were conducted. Concurrent and construct validity were also evaluated by comparing the responses of NPDS with the results of VAS and responses of SF-36.
Factor analysis extracted 3 factors. All items had a kappa statistics of agreement greater than 0.6. The NPDS showed excellent test/re-test reliability. Internal consistency of Cronbach's α was found to be very good. The NPDS was correlated with the VAS. The Korean version of NPDS showed good significant correlation with SF-36 total score and with single SF-36 domains scores.
The adapted Korean version of the NPDS was successfully translated and is considered suitable for outcome assessments in the Korean-speaking patients with neck pain.
Purpose
To investigate relevant change on the Neck Pain and Disability Scale (NPAD) and Neck Disability Index (NDI) and which questionnaire is the most responsive in patients with non-specific chronic neck pain (CNP).
Methods
Seventy-six patients with non-specific CNP in an outpatient tertiary rehabilitation setting were dichotomized into “improved” and “stable” based on global perceived effect (GPE) scores. To investigate relevant change minimal detectable change (MDC) and minimal important change (MIC) with the receiver operator characteristic (ROC) cut-off point were assessed. Comparison of responsiveness was performed using areas under the ROC curve (AUC) and correlations between change scores of NPAD and NDI, and GPE.
Results
MDC and MIC on NPAD (scale 0–100) were 31.7 and 11.5 points, respectively. MDC and MIC on NDI (scale 0–50) were 8.4 and 3.5 points, respectively. Changes should exceed this MDC or MIC cut-off to be interpreted as relevant. AUC was 0.75 for both NPAD and NDI. Correlations between change scores of NPAD and NDI, and GPE were, respectively, 0.48 (95 % CI 0.29–0.64) and 0.49 (95 % CI 0.30–0.64).
Conclusions
Relevant change on both NPAD and NDI assessed with MDC and MIC resulted in different cut-offs and consequently with different amounts of certainty that the patient is improved. Responsiveness of NPAD and NDI was similar.
Clinical outcome measures are important tools to monitor patient improvement during treatment as well as to document changes for research purposes. The short-form Bournemouth questionnaire for neck pain patients (BQN) was developed from the biopsychosocial model and measures pain, disability, cognitive and affective domains. It has been shown to be a valid and reliable outcome measure in English, French and Dutch and more sensitive to change compared to other questionnaires. The purpose of this study was to translate and validate a German version of the Bournemouth questionnaire for neck pain patients.
German translation and back translation into English of the BQN was done independently by four persons and overseen by an expert committee. Face validity of the German BQN was tested on 30 neck pain patients in a single chiropractic practice. Test-retest reliability was evaluated on 31 medical students and chiropractors before and after a lecture. The German BQN was then assessed on 102 first time neck pain patients at two chiropractic practices for internal consistency, external construct validity, external longitudinal construct validity and sensitivity to change compared to the German versions of the Neck Disability Index (NDI) and the Neck Pain and Disability Scale (NPAD).
Face validity testing lead to minor changes to the German BQN. The Intraclass Correlation Coefficient for the test-retest reliability was 0.99. The internal consistency was strong for all 7 items of the BQN with Cronbach α's of .79 and .80 for the pre and post-treatment total scores. External construct validity and external longitudinal construct validity using Pearson's correlation coefficient showed statistically significant correlations for all 7 scales of the BQN with the other questionnaires. The German BQN showed greater responsiveness compared to the other questionnaires for all scales.
The German BQN is a valid and reliable outcome measure that has been successfully translated and culturally adapted. It is shorter, easier to use, and more responsive to change than the NDI and NPAD.
To investigate the validity of the Neck Pain and Disability Scale Dutch Language Version (NPAD-DLV) and the Neck Disability Index (NDI)-DLV.
NPAD-DLV, NDI-DLV, Short-Form-36 Health Survey (SF-36)-DLV, visual analog scale (VAS)(pain) and VAS(disability) were administered to 112 patients with non-specific chronic neck pain in an outpatient tertiary rehabilitation setting. Twenty seven hypotheses were formulated regarding validity. NPAD-DLV and NDI-DLV were evaluated for content validity (normal distribution total scores, missing items, floor and ceiling effects), internal consistency (Cronbach's alpha and Spearman Item-total correlations), construct validity (Pearson correlations with SF-36 domains, VAS(pain) and VAS(disability) and Pearson correlation between total scores of NPAD-DLV and NDI-DLV).
NPAD-DLV and NDI-DLV scores were distributed normally. Missing items were negligible. Floor and ceiling effects were absent in NPAD-DLV and in NDI-DLV two items had floor effects and one item had a ceiling effect. Cronbach's alpha of NPAD-DLV was 0.93 and of NDI-DLV 0.83. Item-total correlations ranged for NPAD-DLV from 0.45 to 0.73 and for NDI-DLV from 0.40 to 0.64. The correlation between, respectively, NPAD-DLV and NDI-DLV and: SF-36 domains ranged from -0.36 to -0.70 and from -0.34 to -0.63; VAS(pain) was 0.54 and 0.43; VAS(disability) was 0.57 and 0.52. The correlation between the total scores of NPAD-DLV and NDI-DLV was 0.77. Twenty six hypotheses were not rejected and one hypothesis was rejected.
The NPAD-DLV and NDI-DLV are valid measures of self-reported neck-pain related disability.
Until recently, no Japanese versions have existed of the more popular, patient-reported disability questionnaires for neck pain. This study aimed to test the reliability, validity, and responsiveness of the Japanese version of the Neck Pain and Disability Scale (NPDS), one of the most widely used questionnaires in patients with neck pain.
In this validation study, 167 outpatients with neck pain participated. Patients received the NPDS and the Medical Outcome Study Short Form 36-item Health Survey (SF-36), and used Visual Analog Scales (VASs) to assess pain and global health. To examine test-retest reliability, patients who were considered stable by clinicians were given the NPDS 2 weeks after baseline. To examine responsiveness, patients who had not undergone treatment at the time of the first data collection or had no change in treatment over 3 months were studied again 2 weeks after starting a new medication or physical therapy.
Of the 167 participants, 143 completed the questionnaires (85.6%). Factor analysis showed two factors, defined as neck-pain-related disability (factor 1) and neck-related pain (factor 2). Cronbach's α coefficient for factor 1, factor 2, and total score was 0.94, 0.93, and 0.96. The intra-class correlation coefficients for the 19 more stable patients were 0.79, 0.88, and 0.87. For concurrent validity, the correlation between NPDS subscales and total score and SF-36 subscale scores ranged from r = -0.54 to -0.22 (p < 0.01). Correlations between the NPDS subscales and total score and VAS of pain ranged from 0.56 to 0.77 (p < 0.01) and those for VAS of global health ranged from 0.48 to 0.63 (p < 0.01). The NPDS subscales and total scores of the 41 patients retested after treatment were significantly improved.
The Japanese version of the NPDS is a useful scale with reliability, validity, and responsiveness in assessing patients suffering from neck pain.
Several disease-specific questionnaires to measure pain and disability in patients with neck pain have been translated. However, a simple translation of the original version doesn't guarantee similar measurement properties. The objective of this study is to critically appraise the quality of the translation process, cross-cultural validation and the measurement properties of translated versions of neck-specific questionnaires.
Bibliographic databases were searched for articles concerning the translation or evaluation of the measurement properties of a translated version of a neck-specific questionnaire. The methodological quality of the selected studies and the results of the measurement properties were critically appraised and rated using the COSMIN checklist and criteria for measurement properties.
The search strategy resulted in a total of 3641 unique hits, of which 27 articles, evaluating 6 different questionnaires in 15 different languages, were included in this study. Generally the methodological quality of the translation process is poor and none of the included studies performed a cross-cultural adaptation. A substantial amount of information regarding the measurement properties of translated versions of the different neck-specific questionnaires is lacking. Moreover, the evidence for the quality of measurement properties of the translated versions is mostly limited or assessed in studies of poor methodological quality.
Until results from high quality studies are available, we advise to use the Catalan, Dutch, English, Iranian, Korean, Spanish and Turkish version of the NDI, the Chinese version of the NPQ, and the Finnish, German and Italian version of the NPDS. The Greek NDI needs cross-cultural validation and there is no methodologically sound information for the Swedish NDI. For all other languages we advise to translate the original version of the NDI.
The first aim of this study was to translate the Neck Pain and Disability Scale (NPAD) from English into Dutch producing the NPAD-Dutch Language Version (DLV). The second aim was to analyze test-retest reliability and agreement of the NPAD-DLV and the Neck Disability Index (NDI)-DLV. The NPAD was translated according to established guidelines. Thirty-four patients (mean age 37.5 years, 68% female) with chronic neck pain (CNP), within an outpatient rehabilitation setting, participated in this study. The NPAD-DLV and the NDI-DLV were filled out twice with a mean test-retest interval of 18 days. The intraclass correlation coefficient of the NPAD-DLV was 0.76 (95% confidence interval (CI) 0.57-0.87) and of the NDI-DLV 0.84 (95% CI 0.69-0.92). The limits of agreement of the NPAD-DLV and the NDI-DLV were, respectively, ±20.9 (scale 0-100) and ±6.5 (scale 0-50). The reliability of the NPAD-DLV and the NDI-DLV was acceptable for patients with CNP. The variation ('instability') in the NPAD-DLV total scores was relatively large and larger than the variation of the NDI-DLV.
The COSMIN checklist (COnsensus-based Standards for the selection of health status Measurement INstruments) was developed in an international Delphi study to evaluate the methodological quality of studies on measurement properties of health-related patient reported outcomes (HR-PROs). In this paper, we explain our choices for the design requirements and preferred statistical methods for which no evidence is available in the literature or on which the Delphi panel members had substantial discussion.
The issues described in this paper are a reflection of the Delphi process in which 43 panel members participated.
The topics discussed are internal consistency (relevance for reflective and formative models, and distinction with unidimensionality), content validity (judging relevance and comprehensiveness), hypotheses testing as an aspect of construct validity (specificity of hypotheses), criterion validity (relevance for PROs), and responsiveness (concept and relation to validity, and (in) appropriate measures).
We expect that this paper will contribute to a better understanding of the rationale behind the items, thereby enhancing the acceptance and use of the COSMIN checklist.
Aim of the COSMIN study (COnsensus-based Standards for the selection of health status Measurement INstruments) was to develop a consensus-based checklist to evaluate the methodological quality of studies on measurement properties. We present the COSMIN checklist and the agreement of the panel on the items of the checklist.
A four-round Delphi study was performed with international experts (psychologists, epidemiologists, statisticians and clinicians). Of the 91 invited experts, 57 agreed to participate (63%). Panel members were asked to rate their (dis)agreement with each proposal on a five-point scale. Consensus was considered to be reached when at least 67% of the panel members indicated 'agree' or 'strongly agree'.
Consensus was reached on the inclusion of the following measurement properties: internal consistency, reliability, measurement error, content validity (including face validity), construct validity (including structural validity, hypotheses testing and cross-cultural validity), criterion validity, responsiveness, and interpretability. The latter was not considered a measurement property. The panel also reached consensus on how these properties should be assessed.
The resulting COSMIN checklist could be useful when selecting a measurement instrument, peer-reviewing a manuscript, designing or reporting a study on measurement properties, or for educational purposes.
We developed a 12-item questionnaire for completion by patients having shoulder operations other than stabilisation. A prospective study of 111 patients was undertaken before operation and at follow-up six months later. Each patient completed the new questionnaire and the SF36 form. Some filled in the Stanford Health Assessment Questionnaire (HAQ). An orthopaedic surgeon assessed the Constant shoulder score.
The single score derived from the questionnaire had a high internal consistency. Reproducibility, examined by test-retest reliability, was found to be satisfactory. The validity of the questionnaire was established by obtaining significant correlations in the expected direction with the Constant score and the relevant scales of the SF36 and the HAQ. Sensitivity to change was assessed by analysing the differences between the preoperative scores and those at follow-up. Changes in scores were compared with the patients’ responses to postoperative questions about their condition. The standardised effect size for the new questionnaire compared favourably with that for the SF36 and the HAQ. The new questionnaire was the most efficient in distinguishing patients who said that their shoulder was much better from all other patients.
The shoulder questionnaire provides a measure of outcome for shoulder operations which is short, practical, reliable, valid and sensitive to clinically important changes.
To translate and assess the reliability and the construct validity of 3 functional disability scales for neck pain.
Reliability and validity study.
Tertiary care teaching hospital and outpatient clinic.
One hundred one patients (mean age, 49 y).
French translations were obtained by using the "translation-backward translation" method. Adaptations were made after a pilot study.
Impairment outcome measures (visual analog scale [VAS] pain, neck range of motion, morning stiffness, score of neck sensitivity, radiologic score of Kellgren) and patients' perceived handicap (VAS) were recorded at the baseline visit. Three functional disability scales (Neck Disability Index [NDI], Neck Pain and Disability Scale [NPDS], Northwick Park Neck Pain Questionnaire [NPQ]) were recorded twice, at baseline visit and 24 hours later. Reliability was assessed by using the intraclass correlation coefficient (ICC) and the Bland and Altman method. Construct (convergent and divergent) validity was investigated by using the Spearman rank correlation coefficient and a factor analysis was performed.
Test-retest was excellent for the NPDS and NDI (ICC =.91,.93, respectively) and good for the NPQ (ICC =.84). The Bland and Altman method showed no systematic trend. Expected convergent and divergent validity were observed only for the NPDS; 3 main factors were extracted by factor analysis and explained 78% of the cumulative variance.
The 3 translated scales are valid, but the NPDS seems to have the best construct validity.
To assess the sensitivity to change of three algofunctional scales for neck pain.
Observational, prospective study. Patients with neck disorders were included. Pain and patients' perceived handicap assessed on visual analogue scales (VAS Pain, VAS Handicap), and functional disability measures (Neck Disability Index, Neck Pain and Disability Scale, Northwick Park Neck Pain Questionnaire) were recorded twice, at baseline and at an 11-month follow-up assessment. Sensitivity to change was assessed using the effect size (ES) and the standardised response mean (SRM), and the non-parametric Spearman's rank correlation coefficient (r) was used to assess the correlation between quantitative variable changes and patients' overall opinion. Analysis of variance (ANOVA) followed by a Tukey-test was performed to determine if the scales distinguished improved, stable, and deteriorated patients.
Seventy-one patients (43 women, mean age 49 years) were included and evaluated twice at an interval of 11 +/- 2 months. The three scales showed good sensitivity to change. The ANOVA showed a group effect, and individual changes in the scales scores were statistically different in two-by-two comparisons (improved, stable or deteriorated patients). Changes in NPDS scores had the highest correlation with patient's overall assessment (r = 0.592).
The three scales can detect changes in patients with neck disorders. Changes in NPDS score had the best correlation with patients' overall opinion concerning their neck disorder and this questionnaire should be given preference in clinical trials.
Reproducibility concerns the degree to which repeated measurements provide similar results. Agreement parameters assess how close the results of the repeated measurements are, by estimating the measurement error in repeated measurements. Reliability parameters assess whether study objects, often persons, can be distinguished from each other, despite measurement errors. In that case, the measurement error is related to the variability between persons. Consequently, reliability parameters are highly dependent on the heterogeneity of the study sample, while the agreement parameters, based on measurement error, are more a pure characteristic of the measurement instrument.
Using an example of an interrater study, in which different physical therapists measure the range of motion of the arm in patients with shoulder complaints, the differences and relationships between reliability and agreement parameters for continuous variables are illustrated.
If the research question concerns the distinction of persons, reliability parameters are the most appropriate. But if the aim is to measure change in health status, which is often the case in clinical practice, parameters of agreement are preferred.
To assess the reliability and validity of the Neck Pain and Disability Scale (NPAD) translated into Hindi.
Following a pilot study to ascertain uncertainties with existing terminology in the NPAD scale, a cervical radiculopathy patient cohort (n = 63) was assessed with the translated NPAD. Reliability was assessed by regression analysis for test-retest and by item-factor and factor-total score correlations. Face validity was compared in a cross-sectional design study with an asymptomatic group (n = 38). Convergent and divergent validity were investigated by correlating the NPAD scores with the Numerical Pain Rating Scale (NPRS) for neck and arm pain, and 10 cm long VAS Activity and VAS Depression scales.
ICC values for test-retest NPAD total and factor scores were >0.92 and R2 values >0.912. Pearson product moment correlation of item vs. factor scores varied from 0.17 - 0.91 and for factor vs. total scores 0.72 - 0.91. Differences in NPAD scores between the patient and the asymptomatic group were significant (t = 30.90, p < 0.05). Convergent validity was explained when Factor 2 (minus item 20) was correlated (r = 0.67) with NPRS maximum value scores. Divergent validity was illustrated by low correlation with VAS Activity (r = 0.15) and negative correlation with VAS Depression (r = -0.80) scores.
Based on the results of this study, the Hindi version of the NPAD is a reliable and valid instrument for the assessment of pain and disability in cervical radiculopathy patients.
Recently, an increasing number of systematic reviews have been published in which the measurement properties of health status questionnaires are compared. For a meaningful comparison, quality criteria for measurement properties are needed. Our aim was to develop quality criteria for design, methods, and outcomes of studies on the development and evaluation of health status questionnaires.
Quality criteria for content validity, internal consistency, criterion validity, construct validity, reproducibility, longitudinal validity, responsiveness, floor and ceiling effects, and interpretability were derived from existing guidelines and consensus within our research group.
For each measurement property a criterion was defined for a positive, negative, or indeterminate rating, depending on the design, methods, and outcomes of the validation study.
Our criteria make a substantial contribution toward defining explicit quality criteria for measurement properties of health status questionnaires. Our criteria can be used in systematic reviews of health status questionnaires, to detect shortcomings and gaps in knowledge of measurement properties, and to design validation studies. The future challenge will be to refine and complete the criteria and to reach broad consensus, especially on quality criteria for good measurement properties.
Importance
US health care spending has continued to increase and now accounts for 18% of the US economy, although little is known about how spending on each health condition varies by payer, and how these amounts have changed over time.
Objective
To estimate US spending on health care according to 3 types of payers (public insurance [including Medicare, Medicaid, and other government programs], private insurance, or out-of-pocket payments) and by health condition, age group, sex, and type of care for 1996 through 2016.
Design and Setting
Government budgets, insurance claims, facility records, household surveys, and official US records from 1996 through 2016 were collected to estimate spending for 154 health conditions. Spending growth rates (standardized by population size and age group) were calculated for each type of payer and health condition.
Exposures
Ambulatory care, inpatient care, nursing care facility stay, emergency department care, dental care, and purchase of prescribed pharmaceuticals in a retail setting.
Main Outcomes and Measures
National spending estimates stratified by health condition, age group, sex, type of care, and type of payer and modeled for each year from 1996 through 2016.
Results
Total health care spending increased from an estimated $1.4 trillion in 1996 (13.3% of gross domestic product [GDP]; $5259 per person) to an estimated $3.1 trillion in 2016 (17.9% of GDP; $9655 per person); 85.2% of that spending was included in this study. In 2016, an estimated 48.0% (95% CI, 48.0%-48.0%) of health care spending was paid by private insurance, 42.6% (95% CI, 42.5%-42.6%) by public insurance, and 9.4% (95% CI, 9.4%-9.4%) by out-of-pocket payments. In 2016, among the 154 conditions, low back and neck pain had the highest amount of health care spending with an estimated $134.5 billion (95% CI, $122.4-$146.9 billion) in spending, of which 57.2% (95% CI, 52.2%-61.2%) was paid by private insurance, 33.7% (95% CI, 30.0%-38.4%) by public insurance, and 9.2% (95% CI, 8.3%-10.4%) by out-of-pocket payments. Other musculoskeletal disorders accounted for the second highest amount of health care spending (estimated at $129.8 billion [95% CI, $116.3-$149.7 billion]) and most had private insurance (56.4% [95% CI, 52.6%-59.3%]). Diabetes accounted for the third highest amount of the health care spending (estimated at $111.2 billion [95% CI, $105.7-$115.9 billion]) and most had public insurance (49.8% [95% CI, 44.4%-56.0%]). Other conditions estimated to have substantial health care spending in 2016 were ischemic heart disease ($89.3 billion [95% CI, $81.1-$95.5 billion]), falls ($87.4 billion [95% CI, $75.0-$100.1 billion]), urinary diseases ($86.0 billion [95% CI, $76.3-$95.9 billion]), skin and subcutaneous diseases ($85.0 billion [95% CI, $80.5-$90.2 billion]), osteoarthritis ($80.0 billion [95% CI, $72.2-$86.1 billion]), dementias ($79.2 billion [95% CI, $67.6-$90.8 billion]), and hypertension ($79.0 billion [95% CI, $72.6-$86.8 billion]). The conditions with the highest spending varied by type of payer, age, sex, type of care, and year. After adjusting for changes in inflation, population size, and age groups, public insurance spending was estimated to have increased at an annualized rate of 2.9% (95% CI, 2.9%-2.9%); private insurance, 2.6% (95% CI, 2.6%-2.6%); and out-of-pocket payments, 1.1% (95% CI, 1.0%-1.1%).
Conclusions and Relevance
Estimates of US spending on health care showed substantial increases from 1996 through 2016, with the highest increases in population-adjusted spending by public insurance. Although spending on low back and neck pain, other musculoskeletal disorders, and diabetes accounted for the highest amounts of spending, the payers and the rates of change in annual spending growth rates varied considerably.
Objective: The purpose of this systematic review was to critically appraise and synthesize the psychometric properties of the Global Rating of Change (GRoC) scales on the assessment of patients with low back pain (LBP), upper extremity and lower extremity disorders.
Methods: A search was performed in 4 databases (MEDLINE, EMBASE, CINAHL, SCOPUS) until February 2019. Eligible articles were appraised using Consensus-based Standards for the selection of health Measurement Instruments (COSMIN) checklist and the Quality Appraisal for Clinical Measurement Research Reports Evaluation Form.
Results: The 8 eligible studies included participants with orthopedic lumbar spine impairments (n=52,767), patients with work-related musculoskeletal disorders (n=1,944), patients with low back pain (n=183) and individuals with upper extremity disorders (n=151). Risk of bias was ranging from “adequate” to “very good” and quality was found excellent for all studies. Based on pooled data, test-retest reliability of 11-item GRoC for patients with low back pain was found excellent ICC = 0.84, 95% CI: 0.65 to 0.94. Test-retest reliability in patients with shoulder pain was found fair to good ICC of 0.62 in a 15-point GRoC scale. Seven studies (n=7) examined the convergent validity between GRoC and another outcome measure. Minimum important change on the Portuguese version of GPE for patients with LBP was 2.5 points out of 11 points.
Conclusions: The current pool of clinical measurement studies indicates that the GRoC has excellent test-retest reliability for patients with low back pain, shoulder pain and with lumbar spine disorders. However, the validity of it as a reference standard in responsiveness studies or as an accurate overall assessment of change has been questioned. While future studies might provide more insight into its measurement properties, this limitation is unlikely to change. Therefore, we suggest that future responsiveness in 25 the studies that want a global indicator measure need to use an additional measure to mitigate recall bias.
Objectives:
The aim of this study was to translate the Neck Bournemouth Questionnaire into Turkish and to test the reliability and validity of the Turkish version of the Neck Bournemouth Questionnaire (BQc-t).
Patients and methods:
Between June 2014 and July 2015, a total of 97 patients with neck pain (27 males, 70 females; mean age 46.6±10.6 years; range, 18 to 65 years) were included in the study. The patients underwent a physical therapy and rehabilitation program. For translation, the American Association of Orthopedic Surgeons guideline was used. The reliability was measured with internal consistency and test-retest by calculation of the Cronbach alpha and intraclass correlation coefficient (ICC) respectively. Internal construct validity of the BQc-t was analyzed with confirmatory factor analysis. For external construct validity, the correlations between the BQc-t results and the Neck Pain and Disability Scale (NPAD), Modified Neck Disability Index (MNDI), and Short Form-36 (SF-36) were analyzed before and after treatment. Responsiveness was calculated as the effect size (ES) and standardized response mean (SRM). Minimal detectable change (MDC) score was calculated to evaluate interpretability.
Results:
The ICC value for test-retest of total score was 0.945. Pre- and post-treatment Cronbach alpha coefficients were 0.877 and 0.907, respectively, showing that the reliability of the BQc-t was considerably high. Confirmatory factor analysis showed that questions were found to cluster in a single dimension. In terms of the external construct validity, there was a positive statistically significant correlation between the BQc-t questions, except for Question 7, and relevant subscales of the NPAD and MNDI. There was also a negative statistically significant correlation between the BQc-t questions and SF-36 subgroups. The ES and SRM were 1.23 and 1.48, respectively. The MDC was 20.31.
Conclusion:
Our study results show that the BQc-t is reliable, valid, and sensitive to clinical changes.
Background
The evaluation of patient-reported outcome measures for the neck from multiple systematic reviews will provide a broader view of, and may identify potential conflicting or consistent results for, their psychometric properties.
Objectives
The purpose of this study was to conduct an overview of systematic reviews and synthesize evidence to establish the current state of knowledge on psychometric properties of patient-reported outcome measures for patients with neck disorders.
Methods
In this overview of systematic reviews, an electronic search of 6 databases (MEDLINE, Embase, CINAHL, ILC, the Cochrane Central Register of Controlled Trials, and LILACS) was conducted to identify reviews that addressed at least one measurement property of outcome measures for people with neck pain. Only systematic reviews with patient-reported outcome measures were included in the analysis. Risk of bias was assessed with A MeaSurement Tool to Assess systematic Reviews (AMSTAR). Data on measurement properties were extracted from each systematic review.
Results
From 13 systematic reviews, 8 patient-reported outcome measures were evaluated in 2 or more reviews. Risk-of-bias scores ranged from moderate (5–7) to high (4 and lower). Findings on internal consistency, test-retest reliability, construct validity, responsiveness to change, and content and structural validity were synthesized for the Neck Disability Index (NDI) in 11 systematic reviews; the Northwick Park Neck Pain Questionnaire and Neck Pain and Disability scale (NPDS) in 6 systematic reviews; the Copenhagen Neck Functional Disability Scale in 5 systematic reviews; the Neck Bournemouth Questionnaire in 4 systematic reviews; the Core Neck Pain Questionnaire and Patient-Specific Functional Scale in 3 systematic reviews, and the Whiplash Disability Questionnaire in 2 systematic reviews.
Conclusion
High-quality evidence was found of good to excellent internal consistency and moderate to excellent test-retest reliability for the NDI. Moderate-quality evidence was found of good to excellent internal consistency and good test-retest reliability for the Northwick Park Neck Pain Questionnaire. High-quality evidence was found of excellent test-retest reliability and good to strong construct validity with pain scales for the Copenhagen Neck Functional Disability Scale. Moderate-quality evidence was found of unclear to excellent internal consistency and moderate to strong concurrent associations with the NDI and global assessment of change for the Neck Pain and Disability scale. Moderate-quality evidence was found of excellent internal consistency for the Whiplash Disability Questionnaire and of high test-retest reliability for the Patient-Specific Functional Scale
Study Design. The development and testing of a new comprehensive measure of neck pain and disability, the Neck Pain and Disability Scale. Objectives. To provide an initial evaluation of the Neck Pain and Disability Scale’s reliability and validity. Summary of Background data. Although several measures exist for generalized pain and disability, none is specific for neck pain. More specific measurements should improve assessment of treatments and clinical research aimed at cervical pain syndromes. Methods. The Neck Pain and Disability Scale was designed using the Million Visual Analogue Scale as a template and consists of 20 items that assess neck pain. In this study, 100 patients with neck pain, 52 patients with lower back and leg pain, and 27 pain-free volunteers were rated by the Neck Pain and Disability Scale. In addition, a subset of the 47 patients with neck pain were rated by several other established psychometric instruments. Results. An item analysis showed a high degree of internal consistency among the 20 items on the Neck Pain and Disability Scale (r = 0.93), and face validity was established by comparing patients who had neck pain as well as lower back and leg pain with a pain-free group. The Neck Pain and Disability Scale scores correlated with the Oswestry Disability Questionnaire, the Pain Disability Index, and psychological measures of depression and neuroticism. Conclusions. The results suggest a highly reliable instrument for evaluating neck pain with at least four underlying dimensions. Further work to address the predictive validity of this new tool are under way.
To evaluate the responsiveness and minimal important changes (MICs) for the Italian Neck Disability Index (NDI) and Neck Pain Disability Scale (NPDS) as well as which questionnaire was the most responsive in subjects with chronic neck pain (NP).
At the beginning and end of an 8-week rehabilitation programme, 200 patients completed the NDI and NPDS. After the programme, the global perceived effect (GPE) was also evaluated and collapsed to produce a dichotomous outcome (improved vs. stable). Responsiveness was calculated by distribution [effect size (ES); standardised response mean (SRM)] and anchor-based methods (ROC curves; correlations between change scores of NPDS and NDI, and GPE). ROC curves were also used to compute the best cutoff levels between improved and stable subjects (MICs).
The ES was 0.66 and 0.73, and the SRM was 1.09-1.26 for the NDI and NPDS, respectively. The ROC analyses revealed AUCs of 0.96 and 0.91 for the NDI and NPDS, respectively; the MICs were 7-percentage points for the NDI (sensitivity: 98 %; specificity: 81 %) and 10 for NPDS (93; 83 %), showing equivalent responsiveness properties. Baseline NPDS scores did not affect MIC estimate for the NPDS, while, for the NDI, higher MICs were found for patients with worst disability levels. Correlations between change scores of the NDI and NPDS and GPE were, respectively, high (0.71) and moderate (0.59).
The Italian NDI and NPDS were equally sensitive in detecting clinical changes in subjects with chronic NP undergoing rehabilitation. We recommend taking the MICs into account when assessing patient improvement or planning studies in this clinical context.
Evaluation of the psychometric properties of the Neck Pain and Disability Scale (NPDS).
Translating, culturally adapting, and validating the Italian version of the NPDS-I.
Great importance is devoted to validated and comprehensive outcome measures to improve interventions for neck pain. A translated form of a functional scale in patients with neck pain has never been studied within the Italian population.
The Italian version of the NPDS questionnaire was developed involving forward-backward translation and final review by an expert committee to establish multidimensional correspondence with the original English form. Psychometric testing included factor analysis with Varimax rotation, reliability by internal consistency (Cronbach's alpha) and test-retest repeatability (Spearman's rank test), validity by comparing the Italian version of SF-36 to NPDS-I (Pearson's correlation); further subscales comparisons to single SF-36 domains were also conducted.
The authors required a 4-month period before achieving a shared version of the NPDS-I. The form was administered to 157 subjects, presenting good acceptability. Factor analyses demonstrated 3 subscales (63% of explained variance), defined as neck dysfunction related to general activities (subscale 1, 8 items), neck pain and cognitive-behavioral aspects (subscale 2, 8 items), neck dysfunction related to activities of the cervical spine (subscale 3, 4 items). The questionnaire showed high internal consistency (NPDS: 0.942, subscale 1: 0.919, subscale 2: 0.856, subscale 3: 0.889) and good test-retest reliability (P < 0.001). Validity was explained by high correlations with SF-36 total score (r = -0.47, P < 0.001) and with single SF-36 domains scores, highly significant (P < 0.001) with the exception of physical role domain (r = -0.17, P = 0.035). Finally, the 3 subscales demonstrated good correlations when compared with selected SF-36 domains.
The NPDS-I outcome questionnaire was successfully translated into Italian, showing good multidimensional and psychometric properties, supporting the results of the already existing versions of the scale. Its use is recommended in clinical and research practice.
This is a validation study to evaluate validity and reliability of a translated and culturally adapted Neck Pain and Disability Scale (NPAD).
To conduct a cross-cultural adaptation and check the validity and reliability of a Chinese version of NPAD.
Neck pain and its associated disability are very common musculoskeletal problems. NPAD is a reliable evaluation instrument for neck pain and disability, but there is no availability of a published Chinese version.
NPAD was translated into Chinese. To examine the psychometric properties and clinical application of the adapted Chinese NPAD, a survey was conducted in a group of 106 patients. The factor structure of NPAD was analyzed and subscales were defined. Reliability assessment was determined by calculating internal consistency and test-retest repeatability. Validity was decided by comparing the Chinese version of SF-36 to NPAD and conducting subscales comparisons to single SF-36 domains.
Factor analyses demonstrated four subscales for NPAD: "pain," "disability," "neck-specific function," and "emotional and cognitive influences." The internal consistency for "pain," "disability," "neck-specific function," and "emotional and cognitive influences" subscales was 0.935, 0.952, 0.955, and 0.910, respectively. Test-retest reliability was also acceptable for the whole scale (r = 0.813, P < 0.001), as well as for each of the four subscales. Construct validity was established through comparison with SF-36. All the subscales were significantly correlated with the SF-36 domains, except the items associated with Mental Health and Emotional Role.
The authors report the validation of a Chinese version of NPAD for use in China, which is culturally relevant, reliable, repeatable, and psychometrically sound.
Cross-cultural validation of the Neck Disability Index (NDI) and Neck Pain and Disability Scale (NPDS).
To translate and test the psychometric properties of Thai versions of the NDI and NPDS questionnaires.
The NDI and NPDS are questionnaires commonly used to measure neck pain and disability. The original versions of the NDI and NPDS have been translated into many languages but there are no validated Thai versions.
Translation and cross-cultural adaptation of the original English versions of the NDI and NPDS were performed according to published guidelines. A total of 185 patients with neck pain participated in the study and were asked to complete the Neck Disability Index-Thai version (NDI-TH), Neck Pain Disability Scale-Thai version (NPDS-TH), and a visual analogue scale (VAS; 0-10). Psychometric evaluation included factor analysis, internal consistency, test-retest reliability, agreement, and convergent validity. Test-retest reliability for the NDI-TH was examined in 20 patients and in 17 for the NPDS-TH. Patients completed the questionnaires twice with an interval of 48 hours.
Factor analysis revealed a single-factor solution for the NDI-TH and three factor solution for the NPDS-TH. Cronbach α values for the NDI-TH and NPDS-TH were excellent (0.85 and 0.96, respectively). The three NPDS-TH subscales ranged from 0.90 to 0.94. Good to excellent test-retest reliability was demonstrated for all measurements (Intraclass Correlation Coefficient range = 0.74-0.91, P < 0.001). The NDI-TH, NPDS-TH, and NPDS-TH subscales were moderately correlated with the VAS (range, r = 0.61-0.76, P < 0.001). The minimal detectable change was 16.1 points for the NDI-TH (scale range = 0-100) and 21.8 points for NPDS-TH (scale range = 0-100).
The NDI-TH and NPDS-TH seem to be reliable instruments to measure functional limitation and disability in Thai patients with neck pain. However, further research is still needed to determine responsiveness and validity of these questionnaires.
This study's design was a cross-cultural validation of the Neck Disability Index (NDI) and Neck Pain and Disability Scale (NPDS).
To translate and validate Chinese versions of the NDI and the NPDS.
The widely used NDI and NPDS scales have not been translated and validated for Chinese-speaking patients with neck pain.
The translation and cultural adaptation of the original questionnaires were carried out in accordance with the published guidelines. A total of 125 patients with neck pain participated in the study. Patients were asked to complete a questionnaire booklet including the NDI, the NPDS, the SF-36, and a visual analog scale (VAS) of pain. To determine the test-retest reliability, 45 patients were asked to complete the questionnaire booklet a second time within 48 hours of the first completion.
The Cronbach alpha coefficient for the NDI was 0.89, and those for the 3 subscales of the NPDS were found to be satisfactory (0.91, 0.88, and 0.82, respectively). The NDI and the NPDS subscales showed excellent test-retest reliability (the intraclass correlation coefficient ranged from 0.86 to 0.95; P < 0.01). The correlation between the NDI and the NPDS subscales and functional scales of the SF-36 showed desirable results, indicating a good convergent validity (Pearson correlation coefficients ranged from -0.19 to -0.76). The correlation between the NDI and the VAS was 0.75, and that between the NPDS subscales and the VAS ranged from 0.62 to 0.76 (P < 0.01).
The Chinese versions of the NDI and the NPDS are reliable and valid instruments to measure functional status in Chinese-speaking patients with neck pain in China. They are simple and easy to use, and can now be applied in clinical settings and future outcome studies in China and other Chinese-speaking communities.
Injuries to the cervical spine, especially those involving the soft tissues, represent a significant source of chronic disability. Methods of assessment for such disability, especially those targeted at activities of daily living which are most affected by neck pain, are few in number. A modification of the Oswestry Low Back Pain Index was conducted producing a 10-item scaled questionnaire entitled the Neck Disability Index (NDI). Face validity was ensured through peer-review and patient feedback sessions. Test-retest reliability was conducted on an initial sample of 17 consecutive "whiplash"-injured patients in an outpatient clinic, resulting in good statistical significance (Pearson's r = 0.89, p less than or equal to .05). The alpha coefficients were calculated from a pool of questionnaires completed by 52 such subjects resulting in a total index alpha of 0.80, with all items having individual alpha scores above 0.75. Concurrent validity was assessed in two ways. First, on a smaller subset of 10 patients who completed a course of conservative care, the percentage of change on NDI scores before and after treatment was compared to visual analogue scale scores of percent of perceived improvement in activity levels. These scores correlated at 0.60. Secondly, in a larger subset of 30 subjects, NDI scores were compared to scores on the McGill Pain Questionnaire, with similar moderately high correlations (0.69-0.70). While the sample size of some of the analyses is somewhat small, this study demonstrated that the NDI achieved a high degree of reliability and internal consistency.(ABSTRACT TRUNCATED AT 250 WORDS)
Clinicians and researchers without a suitable health-related quality of life (HRQOL) measure in their own language have two choices: (1) to develop a new measure, or (2) to modify a measure previously validated in another language, known as a cross-cultural adaptation process. We propose a set of standardized guidelines for this process based on previous research in psychology and sociology and on published methodological frameworks. These guidelines include recommendations for obtaining semantic, idiomatic, experiential and conceptual equivalence in translation by using back-translation techniques and committee review, pre-testing techniques and re-examining the weight of scores. We applied these guidelines to 17 cross-cultural adaptation of HRQOL measures identified through a comprehensive literature review. The reporting standards varied across studies but agreement between raters in their ratings of the studies was substantial to almost perfect (weighted kappa = 0.66-0.93) suggesting that the guidelines are easy to apply. Further research is necessary in order to delineate essential versus optional steps in the adaptation process.
With the increase in the number of multinational and multicultural research projects, the need to adapt health status measures for use in other than the source language has also grown rapidly. 1,4,27 Most questionnaires were developed in English-speaking countries, 11 but even within these countries, researchers must consider immigrant populations in studies of health, especially when their exclusion could lead to a systematic bias in studies of health care utilization or quality of life. 9,11 The cross-cultural adaptation of a health status selfadministered questionnaire for use in a new country, culture, and/or language necessitates use of a unique method, to reach equivalence between the original source and target versions of the questionnaire. It is now recognized that if measures are to be used across cultures, the items must not only be translated well linguistically, but also must be adapted culturally to maintain the content validity of the instrument at a conceptual level across different cultures. 6,11‐13,15,24 Attention to this level of detail allows increased confidence that the impact of a disease or its treatment is described in a similar manner in multinational trials or outcome evaluations. The term “cross-cultural adaptation” is used to encompass a process that looks at both language (translation) and cultural adaptation issues in the process of preparing a questionnaire for use in another setting. Cross-cultural adaptations should be considered for several different scenarios. In some cases, this is more obvious than in others. Guillemin et al 11 suggest five different examples of when attention should be paid to this adaptation by comparing the target (where it is going to be used) and source (where it was developed) language and culture. The first scenario is that it is to be used in the same language and culture in which it was developed. No adaptation is necessary. The last scenario is the opposite extreme, the application of a questionnaire in a different culture, language and country—moving the Short Form 36-item questionnaire from the United States (source) to Japan (target) 7 which would necessitate translation and cultural adaptation. The other scenarios are summarized in Table 1 and reflect situations when some translation and/or adaptation is needed. The guidelines described in this document are based on a review of cross-cultural adaptation in the medical, sociological, and psychological literature. This review led to the description of a thorough adaptation process designed to maximize the attainment of semantic, idiomatic, experiential, and conceptual equivalence between the source and target questionnaires. 13 . Further experience in cross-cultural adaptation of generic and diseasespecific instruments and alternative strategies driven by different research groups 18 have led to some refinements
To modify an existing outcome measure (Bournemouth Questionnaire [BQ]) for use in patients with nonspecific neck pain and test its psychometric properties.
Prospective longitudinal study in which the questionnaire was administered on 3 occasions (pretreatment, retest, and posttreatment).
Anglo-European College of Chiropractic outpatient clinic and 8 field chiropractic practices.
Seven core items relating to the biopsychosocial model of pain were included in the original questionnaire (back BQ). The wording of one of these items (disability in activities of daily living) was modified to include activities likely to be affected by neck pain. Testing of the neck BQ was carried out in 102 patients with nonspecific neck pain.
The instrument demonstrated high internal consistency on 3 administrations (Cronbach's alpha = 0.87, 0.91, 0.92). All 7 items were retained on the basis that they each significantly contributed to the total score (item-corrected total score correlations >0.43) and to the instrument's responsiveness to clinical change (item change-corrected total change score correlations >0.42). The instrument was reliable in test-retest administrations in stable subjects (ICC = 0.65). The instrument demonstrated acceptable construct validity and longitudinal construct validity with established external measures. The treatment effect size of the instrument was found to be high (1.67).
The neck BQ covers the salient dimensions of the biopsychosocial model of pain, is quick and easy to complete, and has been shown to be reliable, valid, and responsive to clinically significant change in patients with nonspecific neck pain. Its use as an outcome measure in clinical trials and outcomes research is recommended.
The objective of this study was to test whether a Turkish version of the Neck Pain and Disability Scale retains its reliability and validity of the original English version.
Sixty-one patients with chronic neck pain were enrolled in the study. The Neck Pain and Disability Scale (NPDS), the Pain Disability Index (PDI) and The Hospital Anxiety and Depression Scale (HADS) were filled by all subjects. Reliability was determined by internal consistency. Internal consistency was measured by calculating Cronbach's alpha and item-total correlation. Validity was examined by correlating the NPDS scores to the Visual Analogue Scale (VAS), PDI and HADS scores.
Cronbach's alpha value for NPDS was found to be 0.86 and this was statistically significant (p<0.0001). The item-total correlations of NPDS varied between 0.08 and 0.69. The cross-sectional construct validity coefficients were 0.51 for PDI, 0.45 for VAS, 0.35 and 0.33 for Hospital Anxiety and Depression Scales.
Despite its major limitations, our results seem to support previous findings of the English and French versions of the Neck Pain and Disability Scale, indicating that this functional scale is valid and reliable.
This study's design was a cross-cultural validation of the Neck Disability Index and Neck Pain and Disability Scale.
This study's objective was to translate, culturally adapt, and validate a Brazilian Portuguese version of the Neck Disability Index (NDI-BR) and the Neck Pain and Disability Scale (NPDS-BR).
Although several valid measures exist for measurement of neck pain and functional impairment, these measures have yet been validated in Brazilian Portuguese. Successful linguistic and cultural translation may allow appropriate cross-cultural comparison for clinical and laboratory research analysis.
The NDI-BR and NPAD-BR were culturally and linguistically translated from English into Brazilian Portuguese. The translated version of the instrument was administered to 203 patients at a midsize hospital in southern Brazil. Psychometric evaluation included factor analysis, internal reliability measures, test-retest reliability at 1 and 7 days, and criterion validity comparison with the Brazilian version of the SF-36.
Factor analyses demonstrated a single-factor subscale for the NDI-BR and three subscales for the NPDS-BR. An item analysis showed a high degree of internal consistency for the NDI-BR (r = 0.74) and the three subscales of the NPDS-BR (subscale 1, r = 0.89; subscale 2, r = 0.81; subscale 3, r = 0.72). Test-retest reliability was also acceptable at for the NDI-BR (0.98 at baseline and 0.48 at 7 days) and subset one (0.96 at baseline and 0.91 at 7 days), subset 2 (0.96 at baseline and 0.62 at 7 days), and subset 3 (0.52 at baseline and 0.45 at 7 days) of the NPDS-BR. Construct validity was established during comparison of the Brazilian version of the SF-36. Only items associated with physical role, bodily pain, and emotional role failed significant correlation.
A reliable and valid Portuguese version of the Neck Disability Index and Neck Pain and DisabilityScale was developed, which will facilitate the examination of functional performance within a large patient population, as well as cross-cultural comparisons.
Cohort study.
To develop and establish the psychometric properties of Korean versions of 4 neck pain and disability questionnaires: the Neck Disability Index, Neck Pain and Disability Scale, Functional Rating Index, and Short Form McGill Pain Questionnaire (SFMPQ).
To our knowledge, there are no published Korean language neck pain and disability measures.
Versions of each questionnaire in idiomatic modern Korean were developed with a process involving initial independent translation, synthesis of the translations, independent back translation, and review by an expert committee to achieve equivalence with the original English. Psychometric testing of the questionnaires with 261 subjects was undertaken to examine test-retest reliability, internal consistency, discriminative validity, and longitudinal construct validity.
Test-retest reliability of the translated versions of the 3 disability questionnaires was excellent (intraclass correlation coefficient[2,1] = 0.86-0.90). High internal consistency was found in the 3 disability questionnaires (Cronbach-alpha ranged from alpha = 0.88 for the Functional Rating Index to alpha = 0.96 for the Neck Pain and Disability Scale, and 0.82 for the SFMPQ). The visual analog scale subscale of the SFMPQ was the most responsive of the subscales (effect size = 1.44, standardized response mean = 1.37). The visual analog scale was also the most responsive pain and disability index in internal responsiveness analysis, although disability indexes showed marginally better responsiveness when compared with external standards. No floor or ceiling effects were observed.
We conclude that the questionnaires were successfully translated and show acceptable measurement properties, and, as such, are suitable for use in clinical and research applications.
The effectiveness of spinal surgery as a treatment option is currently evaluated through the assessment of patient-reported outcomes (PROs). The minimum clinically important difference (MCID) represents the smallest improvement considered worthwhile by a patient. The concept of an MCID is offered as the new standard for determining effectiveness of a given treatment and describing patient satisfaction in reference to that treatment.
Our goal is to review the various definitions of MCID and the methods available to determine MCID.
The primary means of determining the MCID for a specific treatment are divided into anchor-based and distribution-based methods. Each method is further subdivided and examined in detail.
The overall limitations of the MCID concept are first identified. The basic assumptions, statistical biases, and shortcomings of each method are examined in detail.
Each method of determining the MCID has specific shortcomings. Three general limitations in the accurate determination of an MCID have been identified: the multiplicity of MCID determinations, the loss of the patient's perspective, and the relationship between pretreatment baseline and posttreatment change scores.
An ideal means of determining the MCID for a given intervention is yet to be determined. It is possible to develop a useful method provided that the assumptions and methodology are initially declared. Our efforts toward the establishment of a MCID will rely on the establishment of specific external criteria based on the symptoms of the patient and treatment intervention being evaluated.