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1.  Translation and discriminative validation of the STarT Back Screening Tool into Danish 
European Spine Journal  2011;20(12):2166-2173.
The STarT Back Screening Tool (STarT) is a nine-item patient self-report questionnaire that classifies low back pain patients into low, medium or high risk of poor prognosis. When assessed by GPs, these subgroups can be used to triage patients into different evidence-based treatment pathways. The objective of this study was to translate the English version of STarT into Danish (STarT-dk) and test its discriminative validity.
Translation was performed using methods recommended by best practice translation guidelines. Psychometric validation of the discriminative ability was performed using the Area Under the Curve statistic. The Area Under the Curve was calculated for seven of the nine items where reference standards were available and compared with the original English version.
The linguistic translation required minor semantic and layout alterations. The response options were changed from “agree/disagree” to “yes/no” for four items. No patients reported item ambiguity using the final version. The Area Under the Curve ranged from 0.735 to 0.855 (CI95% 0.678–0.897) in a Danish cohort (n = 311) and 0.840 to 0.925 (CI95% 0.772–0.948) in the original English cohort (n = 500). On four items, the Area Under the Curve was statistically similar between the two cohorts but lower on three psychosocial sub-score items.
The translation was linguistically accurate and the discriminative validity broadly similar, with some differences probably due to differences in severity between the cohorts and the Danish reference standard questionnaires not having been validated. Despite those differences, we believe the results show that the STarT-dk has sufficient patient acceptability and discriminative validity to be used in Denmark.
Electronic supplementary material
The online version of this article (doi:10.1007/s00586-011-1911-6) contains supplementary material, which is available to authorized users.
PMCID: PMC3229746  PMID: 21769444
STarT Back Screening Tool; Linguistic; Cultural; Translation; Psychometric; Validation
2.  A Novel Tool for the Assessment of Pain: Validation in Low Back Pain 
PLoS Medicine  2009;6(4):e1000047.
Joachim Scholz and colleagues develop and validate an assessment tool that distinguishes between radicular and axial low back pain.
Adequate pain assessment is critical for evaluating the efficacy of analgesic treatment in clinical practice and during the development of new therapies. Yet the currently used scores of global pain intensity fail to reflect the diversity of pain manifestations and the complexity of underlying biological mechanisms. We have developed a tool for a standardized assessment of pain-related symptoms and signs that differentiates pain phenotypes independent of etiology.
Methods and Findings
Using a structured interview (16 questions) and a standardized bedside examination (23 tests), we prospectively assessed symptoms and signs in 130 patients with peripheral neuropathic pain caused by diabetic polyneuropathy, postherpetic neuralgia, or radicular low back pain (LBP), and in 57 patients with non-neuropathic (axial) LBP. A hierarchical cluster analysis revealed distinct association patterns of symptoms and signs (pain subtypes) that characterized six subgroups of patients with neuropathic pain and two subgroups of patients with non-neuropathic pain. Using a classification tree analysis, we identified the most discriminatory assessment items for the identification of pain subtypes. We combined these six interview questions and ten physical tests in a pain assessment tool that we named Standardized Evaluation of Pain (StEP). We validated StEP for the distinction between radicular and axial LBP in an independent group of 137 patients. StEP identified patients with radicular pain with high sensitivity (92%; 95% confidence interval [CI] 83%–97%) and specificity (97%; 95% CI 89%–100%). The diagnostic accuracy of StEP exceeded that of a dedicated screening tool for neuropathic pain and spinal magnetic resonance imaging. In addition, we were able to reproduce subtypes of radicular and axial LBP, underscoring the utility of StEP for discerning distinct constellations of symptoms and signs.
We present a novel method of identifying pain subtypes that we believe reflect underlying pain mechanisms. We demonstrate that this new approach to pain assessment helps separate radicular from axial back pain. Beyond diagnostic utility, a standardized differentiation of pain subtypes that is independent of disease etiology may offer a unique opportunity to improve targeted analgesic treatment.
Editors' Summary
Pain, although unpleasant, is essential for survival. Whenever the body is damaged, nerve cells detecting the injury send an electrical message via the spinal cord to the brain and, as a result, action is taken to prevent further damage. Usually pain is short-lived, but sometimes it continues for weeks, months, or years. Long-lasting (chronic) pain can be caused by an ongoing, often inflammatory condition (for example, arthritis) or by damage to the nervous system itself—experts call this “neuropathic” pain. Damage to the brain or spinal cord causes central neuropathic pain; damage to the nerves that convey information from distant parts of the body to the spinal cord causes peripheral neuropathic pain. One example of peripheral neuropathic pain is “radicular” low back pain (also called sciatica). This is pain that radiates from the back into the legs. By contrast, axial back pain (the most common type of low back pain) is confined to the lower back and is non-neuropathic.
Why Was This Study Done?
Chronic pain is very common—nearly 10% of American adults have frequent back pain, for example—and there are many treatments for it, including rest, regulated exercise (physical therapy), pain-killing drugs (analgesics), and surgery. However, the best treatment for any individual depends on the exact nature of their pain, so it is important to assess their pain carefully before starting treatment. This is usually done by scoring overall pain intensity, but this assessment does not reflect the characteristics of the pain (for example, whether it occurs spontaneously or in response to external stimuli) or the complex biological processes involved in pain generation. An assessment designed to take such factors into account might improve treatment outcomes and could be useful in the development of new therapies. In this study, the researchers develop and test a new, standardized tool for the assessment of chronic pain that, by examining many symptoms and signs, aims to distinguish between pain subtypes.
What Did the Researchers Do and Find?
One hundred thirty patients with several types of peripheral neuropathic pain and 57 patients with non-neuropathic (axial) low back pain completed a structured interview of 16 questions and a standardized bedside examination of 23 tests. Patients were asked, for example, to choose words that described their pain from a list provided by the researchers and to grade the intensity of particular aspects of their pain from zero (no pain) to ten (the maximum imaginable pain). Bedside tests included measurements of responses to light touch, pinprick, and vibration—chronic pain often alters responses to harmless stimuli. Using “hierarchical cluster analysis,” the researchers identified six subgroups of patients with neuropathic pain and two subgroups of patients with non-neuropathic pain based on the patterns of symptoms and signs revealed by the interviews and physical tests. They then used “classification tree analysis” to identify the six questions and ten physical tests that discriminated best between pain subtypes and combined these items into a tool for a Standardized Evaluation of Pain (StEP). Finally, the researchers asked whether StEP, which took 10–15 minutes, could identify patients with radicular back pain and discriminate them from those with axial back pain in an independent group of 137 patients with chronic low back pain. StEP, they report, accurately diagnosed these two conditions and was well accepted by the patients.
What Do These Findings Mean?
These findings indicate that a standardized assessment of pain-related signs and symptoms can provide a simple, quick diagnostic procedure that distinguishes between radicular (neuropathic) and axial (non-neuropathic) low back pain. This distinction is crucial because these types of back pain are best treated in different ways. In addition, the findings suggest that it might be possible to identify additional pain subtypes using StEP. Because these subtypes may represent conditions in which different pain mechanisms are acting, classifying patients in this way might eventually enable physicians to tailor treatments for chronic pain to the specific needs of individual patients rather than, as at present, largely guessing which of the available treatments is likely to work best.
Additional Information
Please access these Web sites via the online version of this summary at
This study is further discussed in a PLoS Medicine Perspective by Giorgio Cruccu and and Andrea Truini
The US National Institute of Neurological Disorders and Stroke provides a primer on pain in English and Spanish
In its 2006 report on the health status of the US, the National Center for Health Statistics provides a special feature on the epidemiology of pain, including back pain
The Pain Treatment Topics Web site is a resource, sponsored partly by associations and manufacturers, that provides information on all aspects of pain and its treatment for health care professionals and their patients
Medline Plus provides a brief description of pain and of back pain and links to further information on both topics (in English and Spanish)
The MedlinePlus Medical Encyclopedia also has a page on low back pain (in English and Spanish)
PMCID: PMC2661253  PMID: 19360087
3.  Cross-cultural adaptation of the delphi definitions of low back pain prevalence (German DOLBaPP) 
Assessed dimensions of low back pain (LBP) vary in prevalence studies. This may explain the heterogeneity in frequency estimates. To standardize definitions of LBP, an English consensus with 28 experts from 12 countries developed the “Delphi Definitions of Low Back Pain Prevalence” (DOLBaPP). The optimal definition and the shorter minimal definition with the related questionnaires for online, paper, and face-to-face use and telephone surveys are suitable for population-based studies. The definitions have to be adapted to different languages and cultures to provide comparable frequency estimates. The objective was to culturally adapt and pre-test the English definitions and corresponding Delphi DOLBaPP questionnaire forms into German.
The German DOLBaPP adaptation was conducted using the systematic approach suggested by Beaton et al. A pre-test of the Delphi DOLBaPP optimal paper questionnaire including an additional evaluation form was conducted in a sample of 121 employees (mainly office workers). In order to evaluate the comprehensibility, usability, applicability, and completeness of the adapted questionnaire, response to the questionnaire and 6 closed evaluation questions were analyzed descriptively. Qualitative methods were used for the 3 open questions of the evaluation form.
The cultural adaptation of the DOLBaPP for a German-speaking audience required little linguistic adaptation. Conceptual equivalence was difficult for the expression “low back pain”. The expert committee considered the face validity of the pre-final version of the related Delphi DOLBaPP questionnaires as good. In the pre-test, most participants (95%) needed less than 5 minutes to fill in the optimal Delphi DOLBaPP questionnaire. They were generally positive regarding length, wording, diagram, and composition. All subjects with LBP (n = 61 out of 121 – 50.4%) answered the questions on functional limitation, sciatic pain, frequency and duration of symptoms as well as pain severity.
The results indicate that the cross-cultural German adaptation of the DOLBaPP Definitions and the corresponding questionnaires was successful. The definitions can be used in epidemiological studies to measure the prevalence of LBP. Some critical issues were raised regarding the general features of the Delphi DOLBaPP questionnaires. Future research is needed to evaluate these instruments.
Electronic supplementary material
The online version of this article (doi:10.1186/1471-2474-15-397) contains supplementary material, which is available to authorized users.
PMCID: PMC4258005  PMID: 25425047
Questionnaire; Validation; Low back pain; Pre-test; Cross-cultural adaptation; Prevalence; Site; Symptoms; Duration; Functional limitation
4.  Translation and validation of the German version of the Bournemouth questionnaire for low back pain 
Finding the best outcome measures for research and quality assurance purposes in terms of validity, sensitivity to change, length and ease of completion is crucial. The Bournemouth questionnaire for neck pain patients was recently translated and validated into German and found to be more sensitive to change than other commonly used questionnaires. However, the low back pain version is not yet available in German. Therefore the purpose of this study was to translate and validate the Bournemouth Questionnaire (BQ) for low back pain (LBP) into German.
The translation was done in 4 steps, translated and back-translated by two independent people and adapted and approved by an expert committee. Face validity was then done by 30 people who checked the questionnaire for comprehension. Test-retest reliability (reproducibility) was tested using 30 stable back pain patients. Internal consistency was tested using 108 low back patients. External construct validity, external longitudinal validity and responsiveness was tested against the German versions of the Oswestry Disability Index (ODI) and the SF-36 questionnaire using 108 patients from 5 different chiropractic clinics.
The BQ showed high test-retest reliability (ICC > 0.91) for all items and strong internal consistency (Cronbachs alpha = 0.86 at baseline and 0.94 at 4 weeks).
The BQ demonstrated good external construct and longitudinal construct validity with established measures. The effect sizes of the BQ were high and comparable with established measures.
External construct validity and external longitudinal construct validity showed significant correlation for all 7 scales of the BQ with the relevant scales of the other questionnaires with one exception. External responsiveness results showed higher effect sizes for the BQ items and total score indicating better sensitivity to change than the compared measures.
The BQ for LBP was successfully translated and adapted into German. It was successfully tested for validity, consistency, and responsiveness against the German versions of the ODI and the SF-36. It is shorter, covers more domains than the ODI and is more sensitive to change than the other questionnaires.
PMCID: PMC3849369  PMID: 24295339
Bournemouth questionnaire; Outcome assessment; Low back pain; Chiropractic; Validity of results
5.  The effectiveness of a stratified group intervention using the STarTBack screening tool in patients with LBP - a non randomised controlled trial 
Low back pain (LBP) is costly to society and improving patient outcomes is a priority. Stratifying LBP patients into more homogenous groups is advocated to improve patient outcome. The STarT Back tool, a prognostic screening tool has demonstrated efficacy and greater cost effectiveness in physiotherapy settings. The management of LBP patients in groups is common but to date the utility of the STarT Back tool in group settings has not been explored. The aim of this study is to determine if the implementation of ‘stratified care’ when delivered in a group setting will lead to significantly better physical and psychological outcomes and greater cost effectiveness in LBP patients compared to a bestcare historical control group.
This study is a non randomised controlled trial. Low back pain patients recruited from the Waterford Primary Care area (population = 47,000) will be stratified into low, medium or high risk of persisting symptoms using the STarT Back Tool. Low risk patients will be offered a single one off education/exercise class offering positive messages on LBP management in line with recommended guidelines. Medium risk patients will be offered a 12 week group exercise/education intervention addressing their dominant physical obstacles to recovery. A 12 week group cognitive behavioural approach will be delivered to the high risk patients, characterised by the presence of high levels of psychosocial prognostic factors. These patients will be compared with a historical control group where therapists were blinded as to the risk stratification of patients and a generic group intervention was delivered to all patients, irrespective of their initial risk stratification. The primary outcome measure will be disability (Roland Morris Disability Questionnaire). Secondary outcomes will include back pain intensity (Visual Analogue Scale), distress (Distress and Risk Assessment Method), back beliefs (Back Beliefs Questionnaire), health status (Euroqol), global benefit (7 point likert scale), satisfaction (7 point likert scale), cost effectiveness and functional status. Outcome will be measured at baseline, 12 weeks and 6 months.
This paper details the rationale, design, methods, planned analysis and operational aspects of a study examining the utility of the STarT Back Tool as a ‘stratification tool for targeted treatment’ in a group intervention.
Trial registration
Current controlled trials: ACTRN12613000431729.
PMCID: PMC4029484  PMID: 24308746
Low back pain; Stratification; STarTBack tool; Group exercise/education Intervention
6.  The Brazilian version of STarT Back Screening Tool - translation, cross-cultural adaptation and reliability *  
Psychosocial factors are not routinely identified in physical therapy assessments, although they can influence the prognosis of patients with low back pain. The "STarT Back Screening Tool" (SBST) questionnaire aids in screening such patients for poor prognosis in the primary care setting and classifies them as high, medium, or low risk based on physical and psychosocial factors.
This study sought to translate and cross-culturally adapt the SBST to the Brazilian Portuguese language and test the reliability of the Brazilian version.
The first stage of the study consisted of the translation, synthesis, and back-translation of the original version of the STSB, including revision by the Translation Group, pretest of the translated version, and assessment by an expert panel. The pre-final Brazilian version was applied to 2 samples comprising 52 patients with low back pain; these patients were of both genders and older than 18 years of age. To assess the instrument's reliability, an additional sample comprising 50 patients was subjected to 2 interviews, and the results were assessed using the quadratic weighted kappa value. The instrument's internal consistency was assessed using Cronbach's alpha (n=105), and the standard error of measurement was also calculated (n=50).
Translation and back-translation attained consensus, and only item 6 required changes; the reformulated version was applied to an additional sample comprising 52 individuals who did not report any doubts related to this item. The reliability of the SBST-Brazil was 0.79 (95% confidence interval: 0.63-0.95), the internal consistency was 0.74 for the total score and 0.72 for the psychosocial subscale, and the standard error of measurement was 1.9%.
The translated and cross-culturally adapted SBST-Brazil proved to be reliable for screening patients according to their risk of poor prognosis and the presence of psychosocial factors.
PMCID: PMC4228631  PMID: 25372008
low back pain; questionnaire; STarT Back Screening Tool; rehabilitation; reliability
7.  Subgrouping low back pain: A comparison of the STarT Back Tool with the Örebro Musculoskeletal Pain Screening Questionnaire 
Clinicians require brief, practical tools to help identify low back pain (LBP) subgroups requiring early, targeted secondary prevention. The STarT Back Tool (SBT) was recently validated to subgroup LBP patients into early treatment pathways.
To test the SBT’s concurrent validity against an existing, popular LBP subgrouping tool, the Örebro Musculoskeletal Pain Screening Questionnaire (ÖMPSQ), and to compare the clinical characteristics of subgroups identified by each tool.
Two hundred and forty-four consecutive ‘non-specific’ LBP consulters at 8 UK GP practices aged 18–59 years were invited to complete a questionnaire. Measures included the ÖMPSQ and SBT, disability, fear, catastrophising, pain intensity, episode duration and demographics. Instruments were compared using Spearman’s correlations, tests for subgroup agreement and discriminant analysis of subgroup characteristics according to reference standards.
Completed SBT (9-items) and ÖMPSQ (24-items) data was available for 130/244 patients (53%). The correlation of SBT and ÖMPSQ scores was ‘excellent (rs = 0.80). Subgroup characteristics were similar across the low, medium and high subgroups, but, the proportions allocated to ‘low’, ‘medium’ and ‘high’ risk groups were different, with fewer patients in the SBT’s high risk group. Both instruments similarly discriminated for reference standards such as disability, catastrophising, fear, comorbid pain and time off work. The ÖMPSQ was better at discriminating pain intensity, while the SBT was better for discriminating bothersomeness of back pain and referred leg pain.
The SBT baseline psychometrics performed similarly to the ÖMPSQ, but the SBT is shorter and easier to score and is an appropriate alternative for identifying high risk LBP patients in primary care.
PMCID: PMC2809923  PMID: 19223271
Low back pain; Classification; Primary care; Early identification; Psychological factors
8.  The psychometric profile of chiropractic patients in Norway and England: using and comparing the generic versions of the STarT Back 5-item screening tool and the Bournemouth Questionnaire 
Musculoskeletal pain and low back pain (LBP) in particular is one of the more costly health challenges to society. The STarT Back Tool (SBT) has been developed in the UK with a view to identifying subgroups of LBP patients in order to guide more cost effective care decisions. The Bournemouth Questionnaire (BQ) is a validated multidimensional patient reported outcome measure (PROM) that is widely used in routine clinical practice settings. This study sets out to describe and compare SBT and BQ scores within and between populations of patients presenting for chiropractic care in Norway and Great Britain.
Patient demographics, BQ and the 5-item generic condition SBT data were collected from patients presenting with musculoskeletal pain to 18 Norwegian and 12 English chiropractors. Analysis of correlation between groups was achieved using a 1-way Chi2 approximation (p < 0.05).
Eleven percent of Norwegian LBP patients (n = 214) and 24% of English LBP patients (n = 186) were “distressed by their condition” (SBT > 4). By comparison, Norwegian chiropractic patients are: somewhat younger, have lower BQ scores, are less distressed by the condition and score significantly lower on items relating to catastrophisation and depression than English patients. There was an apparent association between total BQ and SBT scores (correlation 0.59, p < .0001) and patients who scored higher than 45 (IQR 39–58) on BQ were more likely to respond “distressed by condition” (>4) on SBT. Furthermore, patients in “distressed by condition” SBT category who had marked the “low mood” question on SBT also had a high score on the “depression” question of BQ (>6 (IQR 4–8), correlation 0.54, p < .0001).
The BQ and SBT appear to identify the same subgroups in some, but not all of the measured items. It appears that unknown factors result in variations between patients seeking chiropractic care for comparable complaints in primary care in England vs Norway. Comparison of populations from Norway and UK demonstrate that extrapolating and pooling of data in relation to different populations should be done with caution, in regard to these stratification tools.
PMCID: PMC4176988  PMID: 24268179
Start back tool; Bournemouth questionnaire; Musculoskeletal pain; Screening tools
9.  Translation and validation of the German version of the Bournemouth Questionnaire for Neck Pain 
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.
PMCID: PMC3398331  PMID: 22273038
Bournemouth Questionnaire; Outcome Assessment; Neck Pain; Chiropractic; Validity of Results
10.  Reliability and validity of the cross-culturally adapted French version of the Core Outcome Measures Index (COMI) in patients with low back pain 
European Spine Journal  2011;21(1):130-137.
To conduct a cross-cultural adaptation of the Core Outcome Measures Index (COMI) into French according to established guidelines.
Seventy outpatients with chronic low back pain were recruited from six spine centres in Switzerland and France. They completed the newly translated COMI, and the Roland Morris disability (RMQ), Dallas Pain (DPQ), adjectival pain rating scale, WHO Quality of Life, and EuroQoL-5D questionnaires. After ~14 days RMQ and COMI were completed again to assess reproducibility; a transition question (7-point Likert scale; “very much worse” through “no change” to “very much better”) indicated any change in status since the first questionnaire.
COMI whole scores displayed no floor effects and just 1.5% ceiling effects. The scores for the individual COMI items correlated with their corresponding full-length reference questionnaire with varying strengths of correlation (0.33–0.84, P < 0.05). COMI whole scores showed a very good correlation with the “multidimensional” DPQ global score (Rho = 0.71). 55 patients (79%) returned a second questionnaire with no/minimal change in their back status. The reproducibility of individual COMI 5-point items was good, with test–retest differences within one grade ranging from 89% for ‘social/work disability’ to 98% for ‘symptom-specific well-being’. The intraclass correlation coefficient for the COMI whole score was 0.85 (95% CI 0.76–0.91).
In conclusion, the French version of this short, multidimensional questionnaire showed good psychometric properties, comparable to those reported for German and Spanish versions. The French COMI represents a valuable tool for future multicentre clinical studies and surgical registries (e.g. SSE Spine Tango) in French-speaking countries.
Electronic supplementary material
The online version of this article (doi:10.1007/s00586-011-1992-2) contains supplementary material, which is available to authorized users.
PMCID: PMC3252438  PMID: 21881865
Low back pain; Outcome measure; Questionnaire; Cross-cultural adaptation
11.  Linguistic validation of translation of the self-assessment goal achievement (saga) questionnaire from English 
A linguistic validation of the Self-Assessment Goal Achievement (SAGA) questionnaire was conducted for 12 European languages, documenting that each translation adequately captures the concepts of the original English-language version of the questionnaire and is readily understood by subjects in the target population.
Native-speaking residents of the target countries who reported urinary problems/lower urinary tract problems were asked to review a translation of the SAGA questionnaire, which was harmonized among 12 languages: Danish, Dutch, English (UK), Finnish, French, German, Greek, Icelandic, Italian, Norwegian, Spanish, and Swedish. During a cognitive debriefing interview, participants were asked to identify any words that were difficult to understand and explain in their own words the meaning of each sentence in the questionnaire. The qualitative analysis was conducted by local linguistic validation teams (original translators, back translator, project manager, interviewer, and survey research expert).
Translations of the SAGA questionnaire from English to 12 European languages were well understood by the participants with an overall comprehension rate across language of 98.9%. In addition, the translations retained the original meaning of the SAGA items and instructions. Comprehension difficulties were identified, and after review by the translation team, minor changes were made to 7 of the 12 translations to improve clarity and comprehension.
Conceptual, semantic, and cultural equivalence of each translation of the SAGA questionnaire was achieved thus confirming linguistic validation.
PMCID: PMC3349573  PMID: 22525050
SAGA; Validation; Lower urinary tract symptoms; Overactive bladder; Goal achievement; Patient-reported questionnaire
12.  Cross-cultural adaptation and validation of the VISA-A questionnaire for German-speaking Achilles tendinopathy patients 
Achilles tendinopathy is the predominant overuse injury in runners. To further investigate this overload injury in transverse and longitudinal studies a valid, responsive and reliable outcome measure is demanded. Most questionnaires have been developed for English-speaking populations. This is also true for the VISA-A score, so far representing the only valid, reliable, and disease specific questionnaire for Achilles tendinopathy. To internationally compare research results, to perform multinational studies or to exclude bias originating from subpopulations speaking different languages within one country an equivalent instrument is demanded in different languages. The aim of this study was therefore to cross-cultural adapt and validate the VISA-A questionnaire for German-speaking Achilles tendinopathy patients.
According to the "guidelines for the process of cross-cultural adaptation of self-report measures" the VISA-A score was cross-culturally adapted into German (VISA-A-G) using six steps: Translation, synthesis, back translation, expert committee review, pretesting (n = 77), and appraisal of the adaptation process by an advisory committee determining the adequacy of the cross-cultural adaptation. The resulting VISA-A-G was then subjected to an analysis of reliability, validity, and internal consistency in 30 Achilles tendinopathy patients and 79 asymptomatic people. Concurrent validity was tested against a generic tendon grading system (Percy and Conochie) and against a classification system for the effect of pain on athletic performance (Curwin and Stanish).
The "advisory committee" determined the VISA-A-G questionnaire as been translated "acceptable". The VISA-A-G questionnaire showed moderate to excellent test-retest reliability (ICC = 0.60 to 0.97). Concurrent validity showed good coherence when correlated with the grading system of Curwin and Stanish (rho = -0.95) and for the Percy and Conochie grade of severity (rho 0.95). Internal consistency (Cronbach's alpha) for the total VISA-A-G scores of the patients was calculated to be 0.737.
The VISA-A questionnaire was successfully cross-cultural adapted and validated for use in German speaking populations. The psychometric properties of the VISA-A-G questionnaire are similar to those of the original English version. It therefore can be recommended as a sufficiently robust tool for future measuring clinical severity of Achilles tendinopathy in German speaking patients.
PMCID: PMC2776582  PMID: 19878572
13.  Brazilian Portuguese translation and cross-cultural adaptation of the “Caregiver Priorities and Child Health Index of Life with Disabilities” (CPCHILD©) questionnaire 
BMC Pediatrics  2014;14:30.
Consideration of the quality of life in relation to individual health status is crucial for planning and maintaining a system of patient-centered care. Until recently, there have been no suitable instruments to assess health-related quality of life (HRQoL,) of children and adolescents with severe, non-ambulant cerebral palsy (GMFCS functional levels IV and V). The “Caregiver Priorities and Child Health Index of Life with Disabilities Questionnaire” (CPCHILD©) was developed in English specifically for this population, and has been validated in Canada. The aim of this study was to translate and adapt the CPCHILD© Questionnaire into Brazilian Portuguese, thus permitting researchers in Brazil to access this important tool for measuring HRQoL in this population, as well as the possibility of making comparisons with other studies that use the same questionnaire in other languages.
The cross-cultural adaptation included two forward translations by independent translators, their synthesis, two back-translations by independent translators, an assessment of the versions by an expert committee and the development of a pre-final version, which was tested on 30 caregivers of children (5 -18) with severe cerebral palsy (GMFCS IV & V).
Despite the relative equivalence between the two translations, some items required adaptations for the synthesized version. Certain modifications were necessary in the pre-final version to achieve idiomatic equivalence. The modifications were required to account for the socioeconomic and cultural levels of the target population.
The translation and cross-cultural adaptation of the CPCHILD© questionnaire provides a Brazilian Portuguese equivalent to measure the HRQoL of children with severe developmental disabilities, with the potential to measure the benefits of various procedures that are indicated for these patients. This adaptation exhibited a satisfactory level of semantic equivalence between the Portuguese target and the original English source versions. The validity of the Brazilian version of the instrument must be established in the future by assessing its psychometric properties on Brazilian epidemiological samples.
PMCID: PMC3915619  PMID: 24485229
Translation; Adaptation; Questionnaire; Assessment; Health-related quality of life; Developmental disabilities
14.  Validation of the Brazilian-Portuguese Version of the Gesture Behavior Test for Patients with Non-Specific Chronic Low Back Pain 
Clinics (Sao Paulo, Brazil)  2009;64(2):83-90.
To develop a Brazilian version of the gesture behavior test (GBT) for patients with chronic low back pain.
Translation of GBT into Portuguese was performed by a rheumatologist fluent in the language of origin (French) and skilled in the validation of questionnaires. This translated version was back-translated into French by a native-speaking teacher of the language. The two translators then created a final consensual version in Portuguese. Cultural adaptation was carried out by two rheumatologists, one educated patient and the native-speaking French teacher. Thirty patients with chronic low back pain and fifteen healthcare professionals involved in the education of patients with low back pain through back schools (gold-standard) were evaluated. Reproducibility was initially tested by two observers (inter-observer); the procedures were also videotaped for later evaluation by one of the observers (intra-observer). For construct validation, we compared patients’ scores against the scores of the healthcare professionals.
Modifications were made to the GBT for cultural reasons. The Spearman’s correlation coefficient and the intra-class coefficient, which was employed to measure reproducibility, ranged between 0.87 and 0.99 and 0.94 to 0.99, respectively (p < 0.01). With regard to validation, the Mann-Whitney test revealed a significant difference (p < 0.01) between the averages for healthcare professionals (26.60; SD 2.79) and patients (16.30; SD 6.39). There was a positive correlation between the GBT score and the score on the Roland Morris Disability Questionnaire (r= 0.47).
The Brazilian version of the GBT proved to be a reproducible and valid instrument. In addition, according to the questionnaire results, more disabled patients exhibited more protective gesture behavior related to low-back.
PMCID: PMC2666487  PMID: 19219312
Low back pain; Behavior; Patient education; Back school; Validation studies
15.  Development and validation of a Greek language version of the Manchester Foot Pain and Disability Index 
The Manchester Foot Pain and Disability Index (MFPDI) is a 19 item questionnaire used to assess the severity and impact of foot pain. The aim of this study was to develop a Greek-language version of the MFPDI and to assess the instrument's psychometric properties.
The MFPDI was translated into Greek by three bilingual content experts and two bilingual language experts, and then back-translated into English to assess for equivalence. The final Greek version was administered, along with a questionnaire consisting medical history and the Medical Outcomes Study Short Form 36 (SF-36), to 104 Greek-speaking, community-dwelling people (64 female, 40 male), aged between 64 and 90 years (mean 73.00, SD 5.26) with disabling foot pain.
The Greek translation of the MFPDI was found to have high internal consistency (Cronbach's α= 0.89, and item-total correlation coefficients from 0.33 to 0.72). Principal components analysis revealed a four-factor structure representing the constructs of functional limitation, pain intensity, concern with appearance and activity restriction, which explained 60.8% of the variance, with 38.9% of the variance explained by the first construct (functional limitation). Six items demonstrated different factor loadings to the original English version.
The Greek-language version of the MFPDI appears to be a valid tool in assessing foot pain in Greek-speaking older people. The total MFPDI scores are comparable between the Greek and English version, however due to differences in the factor loadings of some items, between-language comparisons of MFPDI should be undertaken with some caution.
PMCID: PMC2430552  PMID: 18513444
16.  Leicester Cough Questionnaire: translation to Portuguese and cross-cultural adaptation for use in Brazil*  
Jornal Brasileiro de Pneumologia  2014;40(3):213-221.
To translate the Leicester Cough Questionnaire (LCQ) to Portuguese and adapt it for use in Brazil.
Cross-cultural adaptation of a quality of life questionnaire requires a translated version that is conceptually equivalent to the original version and culturally acceptable in the target country. The protocol used consisted of the translation of the LCQ to Portuguese by three Brazilian translators who were fluent in English and its back-translation to English by another translator who was a native speaker of English and fluent in Portuguese. The back-translated version was evaluated by one of the authors of the original questionnaire in order to verify its equivalence. Later in the process, a provisional Portuguese-language version was thoroughly reviewed by an expert committee. In 10 patients with chronic cough, cognitive debriefing was carried out in order to test the understandability, clarity, and acceptability of the translated questionnaire in the target population. On that basis, the final Portuguese-language version of the LCQ was produced and approved by the committee.
Few items were questioned by the source author and revised by the committee of experts. During the cognitive debriefing phase, the Portuguese-language version of the LCQ proved to be well accepted and understood by all of the respondents, which demonstrates the robustness of the process of translation and cross-cultural adaptation.
The final version of the LCQ adapted for use in Brazil was found to be easy to understand and easily applied.
PMCID: PMC4109192  PMID: 25029643
Quality of life; Translations; Questionnaires; Cough
17.  Validation of the Korean version of the Roland–Morris Disability Questionnaire 
European Spine Journal  2011;20(12):2115-2119.
We evaluated the reliability and validity of an adapted Korean version of the Roland–Morris Disability Questionnaire (RMDQ). Translation/retranslation of the English version of RMDQ 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, RMDQ, and the previously validated Oswestry Disability Index (ODI) were mailed to 100 consecutive patients with chronic lower back pain (LBP) of at least 3 months. Eighty-one patients responded to the first mailing of questionnaires and 63 of the first-time responder returned their second survey. The average age of the 63 patients (45 female, 18 male) was 47.8 years. Reliability assessment was determined by estimating kappa statistics of agreement for each item, the intraclass correlation coefficient (ICC), and Cronbach’s α. Concurrent validity was evaluated by comparing the responses of RMDQ with the results of VAS and responses of ODI by using Pearson’s correlation coefficient. The constructed Bland–Altman plot showed a good reliability. All items had a kappa statistics of agreement greater than 0.6. The RMDQ showed excellent test/re-test reliability as evidenced by the high ICC for 2 test occasions (ICC = 0.932, P < 0.001). Internal consistency was found to be very good at both assessments with Cronbach’s α (0.942 and 0.951 at first and second assessments, respectively). The RMDQ was correlated with the VAS (r = 0.692; P = 0.000 and r = 0.668; P = 0.000 at first and second assessments, respectively), and with the ODI (r = 0.789; P = 0.000 and r = 0.802; P = 0.000, respectively). The adapted Korean version of the RMDQ was successfully translated and showed acceptable measurement properties, and as such, is considered suitable for outcome assessments in the Korean speaking patients with LBP.
PMCID: PMC3229737  PMID: 21479853
Low back pain; Roland–Morris Disability Questionnaire; Korean version
18.  Translation and Cross-Cultural Adaptation of the Manchester Orofacial Pain Disability Scale 
The purpose of the present study was to translate and perform a cross-cultural adaptation of Manchester Orofacial Pain Disability Scale to the Portuguese language.
Material and Methods
A synthesis of two independent translations done by bilingual translators whose mother tongue was the Portuguese language began the process of translation. From the synthesis of the translated version and totally blind to the original version, two different non-native English language teachers without dental knowledge translated the questionnaire back to English. The pre-final version was done by an Expert committee: the researchers, two other non-native English language teachers and one native English language speaker. The new questionnaire was then piloted among 8 patients from the target setting that were interviewed to probe it on their perceived meaning of each question. The Manchester Orofacial Pain Disability Scale (MOPDS) thus translated was called Brasil-MOPDS and was validated in 50 patients with Orofacial pain from TMJ and Occlusion clinic ambulatory of São Paulo University School of Dentistry. The Brasil-MOPDS was administered twice by an interviewer (15 - 20 day interval) and once by a second independent interviewer. The Brazilian version of the short form oral health impact profile (OHIP-14) questionnaire and the visual analogue pain scale (VAS) were applied on the same day.
Internal consistency (Cronbach's α = 0.9), inter-observer (ICC = 0.92) and intra-observer (ICC = 0.98) correlations presented high scores. Validity of Brasil-MOPDS compared to OHIP-14 (r = 0.85) and VAS (r = 0.75) shown high correlations.
Brasil-MOPDS was successfully translated and adapted to be applied to Brazilian patients, with satisfactory internal and external reliability.
PMCID: PMC3886098  PMID: 24422021
orofacial pain; oral health; quality of life; visual analogue pain scale.
19.  Development and validation of a questionnaire assessing volitional competencies to enhance the performance of physical activities in chronic low back pain patients 
Motivation has long been emphasized as the most important determinant of action. However, there is a substantial gap between people's goals and their attainment. Patients may be motivated and yet unable to take action if their volitional competencies are insufficient. One of the important tasks of volition is goal-maintenance. Research has stressed the importance of a volitional tool, the implementation intentions. Implementation intentions indicate where, when, and how the action leading to the goal will be performed. Forming implementation intentions favours the execution of goal-directed efforts, and reinforces the relationship between intentions and behaviours. Results from various studies clearly suggest that volitional competencies and implementation intentions could play a role in low back pain (LBP) patients. However, there is at present no questionnaire allowing assessing the capacity of implementation intentions of physical activities in LBP patients.
This study will develop such a questionnaire, using a 3-step approach. A first qualitative step to build categories and generate items; 30 patients suffering chronic LBP will be invited to participate in semi-structured interviews; verbatim and derived items will then be submitted to a panel of experts, using a Delphi method; a second quantitative step to examine the properties of items, and determine the factorial structure of the questionnaire; 100 patients suffering chronic LBP will be recruited to respond to this phase; and third, preliminary psychometric analyses (item-scale correlations, construct validity, reliability); 180 chronic LBP patients will be recruited for this phase of the study. The relationships between implementation intentions and variables affecting physical activity on chronic LBP patients, i.e. pain, physical capacities, fear-avoidance beliefs, kinesiophobia, work status, and level of physical activity will be considered.
Developing a questionnaire to assess implementation intentions would allow investigating the role of these intentions in the transition from acute to chronic LBP. The results of this study should contribute to the understanding of the psychological processes at stake in the development of chronic LBP, and in particular to the identification of factors eventually favouring patients' participation in and adherence to active physical treatments.
PMCID: PMC3125250  PMID: 21612583
20.  The Prolo Scale: history, evolution and psychometric properties 
The Prolo Scale (PS) is a widely accepted assessment tool for lumbar spinal surgery results. Nevertheless, in the literature there is a dearth of consensus about its application, interpretation and accuracy. The purpose of this review is to investigate the evolution of the PS from its introduction in 1986 to the present, including an analysis of different versions of the scale and research on the existing studies investigating its psychometric properties.
Materials and methods
PubMed, Cochrane Library and PEDro databases were searched. Studies in English, Italian, French, Spanish and German published from 1986 to December 2012 were analyzed.
The original lumbar surgery outcome scale consisted of two Likert-type scales (economic and functional). There are three more versions of the scale: Schnee proposed one consisting of 10 items, Brantigan made one with 20 items and introduced 2 more subscales (pain and medication), and Davis adapted the scale for the cervical spine. PS is often mentioned without any specific reference to the version used; therefore, a homogeneous comparison of studies is difficult to achieve. Several authors agree on the need to embrace a multidimensional measuring system to evaluate low back pain (LBP), but there is still no consensus regarding the most reliable tool. To date, PS has been mostly used as secondary outcome measure in association with validated primary measures for LBP.
The Prolo Scale has been adopted for clinical examination for 20 years because it is easy to administer and useful to compare significant amounts of data from surgical studies carried out at different times. Although several authors demonstrated the scale sensitivity among a battery of tests, no thorough validation study was found in the current literature.
PMCID: PMC3828498  PMID: 23660865
Outcome assessment; Questionnaires; Orthopedic surgery; Spinal fusion; Low back pain
21.  Validation of a Spanish language version of the pain self-perception scale in patients with fibromyalgia 
The Pain Self-Perception Scale (PSPS) is a 24-item questionnaire used to assess mental defeat in chronic pain patients. The aim of this study was to develop a Spanish language version of the PSPS (PSPS-Spanish), to assess the instrument's psychometric properties in a sample of patients with fibromyalgia and to confirm a possible overlapping between mental defeat and pain catastrophizing.
The PSPS was translated into Spanish by three bilingual content and linguistic experts, and then back-translated into English to assess for equivalence. The final Spanish version was administered, along with the Hospital Anxiety Depression Scale (HADS), Pain Visual Analogue Scale (PVAS), Pain Catastrophizing Scale (PCS) and Fibromyalgia Impact Questionnaire (FIQ), to 250 Spanish patients with fibromyalgia.
PSPS-Spanish was found to have high internal consistency (Cronbach's α = 0.90 and the item-total r correlation coefficients ranged between 0.68 and 0.86). Principal components analysis revealed a one-factor structure which explained 61.4% of the variance. The test-retest correlation assessed with the intraclass correlation coefficient, over a 1-2 weeks interval, was 0.78. The total PSPS score was significantly correlated with all the questionnaires assessed (HADS, PVAS, PCS, and FIQ).
The Spanish version of the PSPS appears to be a valid tool in assessing mental defeat in patients with fibromyalgia. In patients with fibromyalgia and Post-Traumatic Stress Disorder (PTSD), PSPS-Spanish correlates more intensely with FIQ than in patients without PTSD. Mental defeat seems to be a psychological construct different to pain catastrophizing.
PMCID: PMC2991283  PMID: 21050485
22.  Feasibility of the STarT back screening tool in chiropractic clinics: a cross-sectional study of patients with low back pain 
The STarT back screening tool (SBT) allocates low back pain (LBP) patients into three risk groups and is intended to assist clinicians in their decisions about choice of treatment. The tool consists of domains from larger questionnaires that previously have been shown to be predictive of non-recovery from LBP. This study was performed to describe the distribution of depression, fear avoidance and catastrophising in relation to the SBT risk groups. A total of 475 primary care patients were included from 19 chiropractic clinics. They completed the SBT, the Major Depression Inventory (MDI), the Fear Avoidance Beliefs Questionnaire (FABQ), and the Coping Strategies Questionnaire. Associations between the continuous scores of the psychological questionnaires and the SBT were tested by means of linear regression, and the diagnostic performance of the SBT in relation to the other questionnaires was described in terms of sensitivity, specificity and likelihood ratios.
In this cohort 59% were in the SBT low risk, 29% in the medium risk and 11% in high risk group. The SBT risk groups were positively associated with all of the psychological questionnaires. The SBT high risk group had positive likelihood ratios for having a risk profile on the psychological scales ranging from 3.8 (95% CI 2.3 - 6.3) for the MDI to 7.6 (95% CI 4.9 - 11.7) for the FABQ. The SBT questionnaire was feasible to use in chiropractic practice and risk groups were related to the presence of well-established psychological prognostic factors. If the tool proves to predict prognosis in future studies, it would be a relevant alternative in clinical practice to other more comprehensive questionnaires.
PMCID: PMC3105955  PMID: 21526986
23.  Validation of the Korean Version of the Oxford Knee Score in Patients Undergoing Total Knee Arthroplasty 
Although translated versions of the Oxford Knee Score (OKS) in several languages are available, the absence of a Korean version precludes comparing data from Korea with that from other countries using the OKS.
We therefore evaluated the reliability and validity of the adapted Korean version of the OKS.
We first translated the English version of the OKS into Korean, then back into English, then held expert committee discussions to finalize the Korean version. We then mailed the Korean version of the VAS for pain, OKS, and the previously validated SF-36 to 142 patients who underwent TKAs for knee osteoarthritis. Factor analysis and reliability assessment using the kappa statistic of agreement for each item, the intraclass correlation coefficient, and Cronbach’s alpha were conducted. To determine the subscales of the OKS, we used the factor analysis. We also evaluated concurrent and construct validity by comparing the responses to the OKS with the results of the VAS and SF-36 using Pearson’s correlation coefficient.
All items had a kappa statistic of agreement greater than 0.6. The OKS showed test and retest reliability as follows: OKS, 0.848; Factor 1, 0.867; and Factor 2, 0.819. Internal consistency of Cronbach’s alpha was as follows: OKS, 0.932; Factor 1, 0.907; Factor 2, 0.867. The OKS correlated (r = 0.692) with the VAS. The Korean version of the OKS correlated with the SF-36 total and individual domain (physical functioning, role physical, bodily pain) scores.
The adapted Korean version of the OKS was translated and showed acceptable measurement properties. The data suggest it is suitable for assessing outcomes in Korean-speaking patients having TKAs.
PMCID: PMC3549197  PMID: 22965258
24.  Quality of life after pulmonary embolism: validation of the French version of the PEmb-QoL questionnaire 
The PEmb-QoL is a validated 40-item questionnaire to quantify health-related quality of life in patients having experienced pulmonary embolism (PE). It covers six health dimensions: frequency of complaints, activities of daily living limitations, work-related problems, social limitations, intensity of complaints, and emotional complaints. Originally developed in Dutch and English, we sought to prospectively validate the psychometric properties of a French version of the PEmb-QoL.
We performed a forward and backward translation of the English version of the PEmb-QoL into French. French-speaking consecutive adult patients with an acute, objectively confirmed PE admitted to the emergency department of a Swiss university hospital between 08/2009 and 09/2011 were recruited telephonically. We used standard psychometric tests and criteria to evaluate the acceptability, reliability, and validity of the French version of the PEmb-QoL. We also performed an exploratory factor analysis.
Overall, 102 patients were enrolled in the study. The French version of the PEmb-QoL showed good reliability (internal consistency, item–total and inter-item correlations), reproducibility (test-retest reliability), and validity (convergent, discriminant) in French-speaking patients with PE. The exploratory factor analysis suggested three underlying dimensions: limitations in daily activity (items 4b-m, 5a-d), symptoms (items 1a-h and 7), and emotional complaints (items 9a-f and j).
We successfully validated the French version of the PEmb-QoL questionnaire in patients with PE. Our results show that the PEmb-QoL is a valuable tool for assessing health-related quality of life after PE in French-speaking patients.
Electronic supplementary material
The online version of this article (doi:10.1186/s12955-014-0174-4) contains supplementary material, which is available to authorized users.
PMCID: PMC4260180  PMID: 25464821
25.  Development of a German version of the Oswestry Disability Index. Part 1: cross-cultural adaptation, reliability, and validity 
European Spine Journal  2005;15(1):55-65.
Patient-orientated assessment methods are of paramount importance in the evaluation of treatment outcome. The Oswestry Disability Index (ODI) is one of the condition-specific questionnaires recommended for use with back pain patients. To date, no German version has been published in the peer-reviewed literature. A cross-cultural adaptation of the ODI for the German language was carried out, according to established guidelines. One hundred patients with chronic low-back pain (35 conservative, 65 surgical) completed a questionnaire booklet containing the newly translated ODI, along with a 0–10 pain visual analogue scale (VAS), the Roland Morris Disability Questionnaire, and Likert scales for disability, medication intake and pain frequency [to assess ODI’s construct (convergent) validity]. Thirty-nine of these patients completed a second questionnaire within 2 weeks (to assess test–retest reliability). The intraclass correlation coefficient for the test–retest reliability of the questionnaire was 0.96. In test–retest, 74% of the individual questions were answered identically, and 21% just one grade higher or lower. The standard error of measurement (SEM) was 3.4, giving a “minimum detectable change” (MDC95%) for the ODI of approximately 9 points, i.e. the minimum change in an individual’s score required to be considered “real change” (with 95% confidence) over and above measurement error. The ODI scores correlated with VAS pain intensity (r=0.78, P<0.001) and Roland Morris scores (r=0.80, P<0.001). The mean baseline ODI scores differed significantly between the surgical and conservative patients (P<0.001), and between the different categories of the Likert scales for disability, medication use and pain frequency (in each case P<0.001). Our German version of the Oswestry questionnaire is reliable and valid, and shows psychometric characteristics as good as, if not better than, the original English version. It should represent a valuable tool for use in future patient-orientated outcome studies in German-speaking lands.
PMCID: PMC3454571  PMID: 15856341
Low-back pain; Condition-specific questionnaires; Cross-cultural adaptation; Reliability; Validity

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