International Society For Pharmacoeconomics And Outcomes Research Research Articles

(PM-24) TRANSLATION AND CULTURAL ADAPTATION OF THE KAROLINSKA INTERPERSONAL VIOLENCE SCALE INTO BRAZILIAN PORTUGUESE: A METHODOLOGICAL STUDY

Abstract Introduction Interpersonal violence is a global concern with significant implications for mental health and mortality. The Karolinska Institute in Sweden developed the Karolinska Interpersonal Violence Scale (KIVS), a semi-structured interview assessing interpersonal violence experiences as victims or aggressors across childhood and adulthood. Objective Our aim was to translate and culturally adapt the KIVS for use in the Brazilian population. Methods: The translation process involved ten stages based on The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) guidelines. Back-translation was performed by a clinical psychologist unfamiliar with the original scale. The English versions were cross compared by the original instrument author. The consensus version underwent comprehension evaluation by eight participants, comprising four healthcare professionals and four patients from the AISEP - Excessive Sexual Drive and Prevention of Negative Outcomes Related with Sexual Behavior at Instituto de Psiquiatria of Hospital das Clínicas of São Paulo. A 5-point Likert scale assessed participant comprehension, with 80% agreement indicating successful equivalence. Sentences were revised until this consensus was achieved. The finalized translation, incorporating contextual revisions, underwent syntactic and spelling review. Results After application to eight participants (4 women and 4 men), 7 rated with the highest comprehension score (5.0), and 1 with 4.9. A final report documented the entire KIVS translation and validation process. Conclusion The translation and cultural adaptation of the KIVS into Brazilian Portuguese were successful. Minor adjustments were made to enhance comprehension without compromising meaning. This adaptation provides a valuable tool for assessing interpersonal violence in the Brazilian context, with implications for research and clinical practice. Financing FAPESP.

Translation and Cross-Cultural Adaptation into French of the Harris Hip Score and the Modified Harris Hip Score.

The objective of this study was to develop a cross-cultural adaptation and translation into French of the original Harris Hip Score (HHS) and the modified Harris Hip Score (mHHS). The translation and cultural-adaptation of the questionnaire were performed following a 10-step process as recommended by the International Society for Pharmacoeconomics and Outcomes Research (ISPOR). During the cognitive debriefing, each item of the questionnaire has been rated between 1 and 10 according to the comprehension level of 8 patients who underwent total hip arthroplasty. The cross-cultural adaptation process required the modification of the walking distance item by converting the number of blocks into meters but also in walking time (minutes). All the different steps have been performed without any other important changes on the translated questionnaire which has been found highly understandable by interviewed patients (9.6 ± 1.1). This study successfully reports the French version development of the original HHS (HHS-Fr) and its modified patient-reported version (mHHS-Fr), thereby providing to clinicians a standardised version for the evaluation of French-speaking patients suffering from hip osteoarthritis.

(281) Linguistic and Cultural Validation of the Satisfaction Survey for Inflatable Penile Implant (SSIPI) for Brazilian Portuguese and Tri-Continental Spanish Speakers

Abstract Introduction The Satisfaction Survey for Inflatable Penile Implants (SSIPI) has been validated in English. No validated Portuguese and Spanish versions currently exist. Objective We aimed to linguistically validate SSIPI in Portuguese and Spanish to evaluate satisfaction outcomes with a validated instrument. Methods Our methodology adhered to best practices established by the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and involved: forward translation of the 16-item SSIPI into Portuguese and Spanish by 2 independent IPP surgeons, reconciliation, back translation into English by 2 different independent bilingual IPP surgeons, and comparison to the original SSIPI for conceptual equivalence. The translated SSIPI versions underwent in-parallel cognitive debriefing (CD) at the US, Colombia, Spain, and Brazil centers. All interviews were recorded in person or via secure video conference to determine if misunderstandings or modifications were needed. Results 12 and 17 native Portuguese and Spanish speakers, respectively, with IPPs, participated in the CD process for their native language SSIPI. Interviews lasted approximately 1 hour each. The Portuguese SSIPI validation was conducted at 2 different centers in Brazil, resulting in 83% of the patients reporting that the survey was easy to answer. Of 16 questions, only 3 (Q7, Q11, and Q16) raised concerns for 6 patients. 5 patients had issues with the concept of the word “naturalness” and “spontaneity” from Q7 and Q16. One patient struggled with interpreting the word “conceal” in Q11. Regarding the duration taken to answer, 10/12 patients said it was acceptable. The Spanish SSIPI was tested at 4 US, Colombia, and Spain academic centers. 63% indicated the survey was easy to answer. In most cases, replacing a single word in the item with another was proposed. 53% had difficulties comprehending the answer choice options with Q3; however, all participants perceived the time required to complete the SSIPI as reasonable. Conclusions While the Portuguese SSIPI has been demonstrated to be easier to read and interpret than the Spanish SSIPI, with minor changes to wording/phrasing, both versions have the potential to improve IPP outcomes literature globally. Concerning questions will be modified before conducting the final validation steps. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Roman.

Polish Translation and Linguistic Validation of the SCAR-Q.

Introduction Patient-reported outcome measurements (PROMs) are gaining considerable popularity as tools to assess the effectiveness of the treatment in plastic surgery, being a complement to surgical outcomes. The SCAR-Q questionnaire has been recently developed for patients with surgical, traumatic, and burn scars. Aim The study aims to describe the process of translation and linguistic validation of the scar questionnaire (SCAR-Q) for use in Polish patients undergoing scar treatment. Material and methods An official Polish translation and language validation of the SCAR-Q were done in adherence to International Society for Pharmacoeconomics and Outcomes Research (ISPOR) guidelines. The process consisted of four steps: two independent forward translations, a back translation, a review of the back translation, and cognitive participant interviews. Results The field-tested version of the SCAR-Q consisted of 29 items across three scales measuring appearance concerns, symptoms, and the psychosocial impact of the scar. The forward translation was done by two independent translators and revealed specific difficulties in translation to the Polish language (4/29 items). The back translation showed no significant differences compared to the original English version. Cognitive debriefing interviews involved nine Polish patients with postraumatic scars, burn scars, and scars after skin tumor resection. Participants have not reported any major difficulties in understanding the content of the questionnaire. Conclusions The ISPOR provides a straightforward and thorough guideline for the PROMs translation process. The new SCAR-Q is an accessible and efficient PROM that can be implemented in Polish patients to assess the effectiveness of scar treatment.

Culturally adapted translation of LYMPH-Q upper extremity module from English to Mandarin Chinese

BackgroundBreast cancer-related lymphedema (BCRL) is one of the debilitating complications after breast cancer treatment. Several forms of patient-reported outcome measures (PROMs) were developed to evaluate the severity of BCRL based on the patients’ perspective. LYMPH-Q Upper Extremity Module is a newly developed questionnaire for BCRL. This study aimed to demonstrate the process of translation and cultural adaption from English to Mandarin Chinese. Methods and resultsThe translation process followed the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) best-practice guidelines for the translation and cultural adaption of PROM. The process included four steps: forward translation, back translation, back translation review, and patient interviews. In total, five patients with BCRL were recruited for patient interviews.The forward translation step involved two professional translators whose native language was Mandarin Chinese. A reconciled translated version was produced. In the back translation step, the reconciled translated version in Mandarin Chinese was sent to another professional translator whose native language was English. The back-translated version in English was sent back to the developer of LYMPH-Q for review. In this step, 22 items were revised. In the final step of patient interviews, 15 items were revised based on the patients’ feedback. ConclusionThe development of Mandarin Chinese version of LYMPH-Q Upper Extremity Module and its utilization in conjunction with the existing objective measures could provide a more well-rounded picture of the status of patients with BCRL worldwide.

Transcultural Adaptation and Validation of the Spanish Version of the Visual Analogue Scale for the Foot and Ankle (VASFA).

The main aim of this study is to perform a cross-cultural adaptation and validation of the Visual Analogue Scale for the Foot and Ankle (VASFA) questionnaire, creating a Spanish-language version (VASFA-Sp), and to determine the measurement properties of this instrument. VASFA was cross-culturally translated into Spanish following the guidelines of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR). The study sample was composed of 228 participants who were recruited from February to May 2022. All were at least 18 years old, gave signed informed consent to take part and properly completed the Foot and Ankle Ability Measures-Sp and VASFA-Sp questionnaires. Cronbach's alpha and test/re-test reliability values were calculated. Structural validity was assessed via exploratory factor analysis. The 228 patients included in the final analysis presented the following characteristics: 35.53% were male and 64.47% were female; the mean age was 35.95 (18-81) years; and the mean body mass index was 23.79. Internal consistency was excellent. The Cronbach's alpha for VASFA-Sp was 0.96 and the intraclass correlation coefficient was 0.932 (95% CI; 0.84 to 0.97). Exploratory factor analysis identified one main factor. VASFA-Sp is a reliable, valid and sensitive questionnaire that is suitable for measuring perceived foot and ankle function impairment in a Spanish-speaking population.

OP87 A Roadmap for Increasing The Usefulness And Impact Of Patient Preference Studies In Health Technology Assessment (HTA)

IntroductionThe number of patient preference studies in health has increased dramatically. There is growing use of patient preferences in a wide variety of contexts, including health technology assessment. Patient preference studies can help inform decision makers on the needs and priorities of patients and the tradeoffs they are willing to make about health technologies.MethodsThis International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Task Force included international experts, health preference researchers and others from diverse backgrounds, including regulatory, health technology assessment, medicine, patient advocacy, and the pharmaceutical industry. The report underwent two rounds of written reviews by ISPOR Preferences Special Interest Group members until a final consensus was reached. The Task Force focused on developing a roadmap that would: (i) apply to the wide variety of preference methods, (ii) identify key domains to guide researchers and other stakeholders in making patient preference studies more useful to decision makers, and (iii) detail important questions to guide researchers conducting preference studies and those critically appraising them.ResultsThis Task Force report provides a novel roadmap that invites patient-preference researchers to work with decision makers, patients and other stakeholders to do even more to ensure that studies are useful and impactful. The ISPOR Roadmap consists of five key elements: (i) Context; (ii) Purpose; (iii) Population; (iv) Method; and (v) Impact. In this report, we define these five elements and provide good practices on how patient-preference researchers can actively contribute to increasing the usefulness and impact of patient preference studies in decision-making. We also present a set of key questions that can support researchers and other stakeholders in assessing efforts that promote preference studies’ intended and unintended impact.ConclusionsThis roadmap can help increase the usefulness and impact of patient preference studies in decision-making by challenging researchers to engage and partner with decision makers, patients and others, and together consider the intended and unintended impacts of patient preference studies on decision-making while actively fostering positive impact.

Danish translation and linguistic validation of the LIMB-Q, a PROM for traumatic lower limb injuries and amputations

BackgroundThe LIMB-Q is a newly developed patient-reported outcome measure (PROM), applicable for lower extremity trauma patients requiring fracture treatment, soft tissue debridement, reconstruction, and/or amputation. The aim of this study was to translate and linguistically validate the LIMB-Q from English to Danish.MethodThe translation and linguistic validation were performed by combining guidelines from the World Health Organization (WHO) and the International Society for Pharmacoeconomics and Outcomes Research (ISPOR). This approach involved 2 forward translations, a backward translation, an expert panel meeting, and 2 rounds of cognitive patient interviews. The main goal of these steps was to achieve a conceptual translation with simple and clear items. Feedback from the Danish translation was used in combination with psychometric analyses for item reduction of the final international version of LIMB-Q.ResultsIn the forward translation, 6 items were found difficult to translate into Danish. The two translations were harmonized to form the backward translation. From the backward translation, 1 item was identified with a conceptually different meaning and was re-translated. The revised version was presented at the expert panel meeting leading to revision of 10 items. The cognitive patient interviews led to revision of 11 items. The translation process led to a linguistically validated and conceptually equivalent Danish version of the LIMB-Q.ConclusionThe final Danish LIMB-Q version consisting of 16 scales is conceptually equivalent to the original and ready for field-testing in Denmark.Level of evidence: Not gradable.

Cross-Cultural Adaptation and Validation of a Marathi Version of the Versus Arthritis Musculoskeletal Health Questionnaire (MSK-HQ).

Introduction Musculoskeletal (MSK) well-being plays a crucial role in determining one's quality of life. Musculoskeletal Health Questionnaire (MSK-HQ) score is a tool recently developed by the Versus Arthritis group of Oxford University in English to measure MSK health. Marathi is a regional language in western India spoken by more than 100 million people. There is a scarcity of valid and reliable tools to measure MSK health in this language. Hence, we decided to cross-culturally adapt and translate MSK-HQ to Marathi. Method We translated MSK-HQ score to Marathi (MSK-HQ-Ma) as per the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) guidelines. We tested its internal consistency, construct validity and reproducibility. It was compared with other health status scores EQ-5D-5L and overall health using the Visual Analogue Scale (VAS). Test-retest reliability was tested in those subjects who were having stable MSK health after two weeks. Results We recruited 158 consecutive subjects attending musculoskeletal clinics who had Marathi as their native language. Mean age was 44.8±17 years, females were 78 (49%).It showed good internal consistency (Cronbach's alpha = 0.95). For construct validity we found a strong correlation between MSK-HQ-Ma and EQ-5D-5L values (Spearman's r = 0.82, p<0.001). There was also a good correlation between MSK-HQ-Ma and overall health by VAS (Spearman's r = 0.76, p<0.001). An excellent test-retest reliability (Spearman's r = 0.94, p<0.001) was seen in 105 subjects who had stable MSK condition after two weeks of first appearance. Conclusion The MSK-HQ-Ma instrument has demonstrated good consistency, reliability and construct validity when evaluating the musculoskeletal health of individuals who can understand the Marathi language. Hence it can be used as a validated tool for the evaluation of musculoskeletal health in western India where Marathi is a commonly used language.

Cross-Cultural Adaptation, Reliability, and Validity Tests of the Thai Version of the Manchester-Oxford Foot Questionnaire in Individuals with Chronic Foot Pain

Objective: To adapt cross-culturally and examine the reliability and validity of the Thai version of MOXFQ (Thai-MOXFQ) among individuals with chronic foot pain. Material and Methods: The Thai-MOXFQ was successfully adapted cross-culturally from the original version with minor changes according to the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) guidelines. Its reliability and construct validity were then investigated in individuals with chronic foot pain. The test-retest reliability was evaluated among 30 participants by calculating the intraclass correlation coefficient (ICC 3,1). Meanwhile, the internal consistency of the Thai-MOXFQ was studied in 100 participants by computing Cronbach’s alpha. Additionally, the construct validity was analyzed via Spearman’s rank correlation analysis to determine the relationship between the Thai-MOXFQ, Foot and Ankle Ability Measure (FAAM), 36-item Short-Form Health Survey (SF-36), and Visual Analogue Scale (VAS). Results: The Thai-MOXFQ demonstrated a good level of test-retest reliability (ICC of 0.763 to 0.885) and an acceptable level of internal consistency (Cronbach’s alpha of 0.738 to 0.871) when used in individuals with chronic foot pain. Moreover, the Thai-MOXFQ was shown to have moderate to strong relationships with FAAM, SF-36, and VAS (p-value&lt;0.05, Spearman rank correlation coefficients of 0.543 to 0.711). Furthermore, the results of the construct validity of the Thai version were in line with the original English and other translated versions. Conclusion: The Thai-MOXFQ is a reliable and valid, foot-specific, patient-reported outcome measurement (PROM) for assessing outcomes in individuals with chronic foot pain.

Danish translation, cross-cultural adaptation, and electronic migration of the World Endometriosis Research Foundation Endometriosis Phenome and Biobanking Harmonisation Project Endometriosis Patient Questionnaire.

This study aims to translate and cross-culturally adapt the standard version of the World Endometriosis Research Foundation (WERF) EPHect Endometriosis Patient Questionnaire (EPQ) into Danish and to ensure equivalence of a Danish electronic version. The translation, cultural adaption, and electronic migration followed recommendations from the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and the Critical Path Institute. Ten women with endometriosis were enrolled for cognitive debriefing of the paper version (pEPQ) after translation and back translation. The questionnaire was then migrated into an electronic version (eEPQ) and subsequently tested for usability and measurement equivalence by five women with endometriosis. Cross-cultural alterations were needed for medical terms, response options for ethnicity, the educational system, and measurement units. Thirteen questions were altered after back translation, while 21 underwent minor changes after cognitive debriefing. After testing the eEPQ, 13 questions were altered. Questions tested for measurement equivalence across the two modes of administration were found comparable. The median time-to-complete the pEPQ and eEPQ was 62 min (range: 29-110) and 63 min (range: 31-88), respectively. General comments included the questionnaire being relevant but long and repetitive. We find the the Danish pEPQ and eEPQ similar and comparable to the original English instrument. However, attention must be drawn to questions regarding measurement units, ethnicity, and educational systems before cross-country comparison. The Danish pEPQ and eEPQ are suitable for obtaining subjective data on women with endometriosis.

[Artículo Traducido] Traducción, adaptación cultural y validación de la versión española del Teenagers’ Quality of Life (T-QoL): cuestionario para adolescentes con enfermedades de la piel

BackgroundTeenagers’ Quality of Life (T-QoL) is an age-specific measure to assess QoL of teenagers suffering from different skin diseases. A validated Spanish language version is lacking. We present the translation, cultural adaptation and validation of the T-QoL into Spanish. MethodsA prospective study with 133 patients (between 12 and 19 years old), attended at the dermatology department of Toledo University Hospital, Spain (September 2019–May 2020), was carried out for the validation study. The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) guidelines were used for the translation and cultural adaptation. We evaluated the convergent validity with the Dermatology Life Quality Index (DLQI), the Children's Dermatology Life Quality Index (CDLQI) and with a Global Question (GQ) on self-assessed disease severity. We also analysed internal consistency and reliability of the T-QoL tool and confirmed its structure with a factor analysis. ResultsGlobal T-QoL scores significantly correlated with the DLQI and the CDLQI (r = 0.75) and with the GQ (r = 0.63). The confirmatory factor analysis showed optimal fit for the bi-factor model and an adequate fit for the correlated three-factor model. Reliability indicators were high (Cronbach's α = 0.89; Guttman's Lambda 6 index = 0.91; Omega ω = 0.91) and test–retest showed a high stability (ICC = 0.85). The results were consistent with those found by the authors of the original test. ConclusionOur Spanish version of the T-QoL tool is valid and reliable to assess QoL of Spanish-speaking adolescents with skin diseases.

German translation of the PROMIS® pediatric anxiety, anger, depressive symptoms, fatigue, pain interference and peer relationships item banks

BackgroundThe present study aimed at the translation and cross-cultural adaptation of six PROMIS® pediatric self- and proxy- item banks and short forms to universal German: anxiety (ANX), anger (ANG), depressive symptoms (DEP), Fatigue (FAT), pain interference (P) and peer relationships (PR).MethodsUsing standardized methodology approved by the PROMIS Statistical Center and in line with recommendations of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) PRO Translation Task Force, two translators for each German-speaking country (Germany, Austria, and Switzerland) commented on and rated the translation difficulty and provided forward translations, followed by a review and reconciliation phase. An independent translator performed back translations, which were reviewed and harmonized. The items were tested in cognitive interviews with 58 children and adolescents from Germany (16), Austria (22), and Switzerland (20) for the self-report and 42 parents and other caregivers (Germany (12), Austria (17), and Switzerland (13)) for the proxy-report.ResultsTranslators rated the translation difficulty of most items (95%) as easy or feasible. Pretesting showed that items of the universal German version were understood as they were intended, as only 14 out of 82 items of the self-report and 15 out of 82 items of the proxy-report versions required minor rewording. However, on average German translators rated the items more difficult to translate (M = 1.5, SD = 0.20) than the Austrian (M = 1.3, SD = 0.16) and the Swiss translators (M = 1.2, SD = 0.14) on a three-point Likert scale.ConclusionsThe translated German short forms are ready for use by researchers and clinicians (https://www.healthmeasures.net/search-view-measures).

A Budget Impact Model of Maintenance Treatment of Chronic Inflammatory Demyelinating Polyneuropathy with IgPro20 (Hizentra) Relative to Intravenous Immunoglobulin in the United States.

Chronic inflammatory demyelinating polyneuropathy (CIDP) is a rare, progressive autoimmune disease causing peripheral nervous system dysfunction. Guidelines recommend immunoglobulin (IG) therapy as an immunomodulatory agent in CIDP. Drawbacks and unmet needs with intravenous immunoglobulin (IVIG) include adverse effects and wear-off effects, along with the burden of administration based on site of care. Subcutaneous administration of Hizentra, a subcutaneous immunoglobulin (SCIG) reduces patient burden by allowing self-administration outside the hospital setting and has fewer adverse events (AEs). We aimed to compare the expected cost of treatment and the budget impact of Hizentra compared with IVIG for maintenance treatment of CIDP in the United States. A decision tree model was developed to estimate the expected budget impact of maintenance treatment with Hizentra for US stakeholders. The model adopts primarily a US integrated delivery network perspective and, secondarily, a commercial perspective over a 1-year time horizon. Pharmacy costs were based on a payment mix of average sales price (73%), wholesale acquisition cost (2%), and average wholesale price (25%). Costs in the model reflect 2022 US dollars. In accordance with the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) guidelines and recommendations for budget impact modeling, no discounting was performed. The PATH clinical study of Hizentra maintenance in CIDP was used to determine clinical inputs for relapse rates at initial assessment (24 weeks) and at 52 weeks for Hizentra. The ICE clinical study of Gamunex maintenance in CIDP was the basis of relapse rates for Gamunex (and other IVIGs). Literature-based estimates were obtained for infusion costs by site of care, costs of IVIG infusion-related complications, and significant IVIG AE rates. Hizentra AE rates from the US Hizentra prescribing information were assessed but were not included in the model as the AEs in CIDP were mild, easily treated, and self-limited. Sensitivity analyses and scenario analyses were conducted to evaluate variations from the base case. The model showed that a Hizentra starting dose of 0.2 g/kg is expected to result in annual cost savings of US$32,447 per patient compared with IVIG. For a hypothetical 25-million-member plan, the budget impact of a 10% market share shift from IVIG to Hizentra is expected to result in savings of US$2,296,235. This analysis projects that Hizentra is likely associated with favorable economic benefit compared with IVIG in managing CIDP.

HARPER — protocol template for real-world trials for evaluating treatment efficacy

The International Society of Pharmacoepidemiology (ISPE) and the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) have created a joint task force, including representatives of key international stakeholders, to create a coordinated protocol template for RWE studies that assess the effect of treatment and is designed to inform decision-making. The template is based on existing transparency efforts and includes the state-of-art ideas regarding the level of detail required to ensure reproducibility of the RWE study. The underlying principle was to achieve sufficient clarity regarding research data, design, analysis and implementation to achieve the three main objectives. Firstly, to help researchers carefully consider and document the choice and justification of the key parameters of the study, secondly, to facilitate decision-making by allowing reviewers to easily assess potential bias associated with the choice, and thirdly, to ensure research reproducibility.

Spanish Version of Teenagers’ Quality of Life (T-QoL) for Adolescents with Skin Diseases: Translation, Cultural Adaptation and Validation

BackgroundTeenagers’ Quality of Life (T-QoL) is an age-specific measure to assess QoL of teenagers suffering from different skin diseases. A validated Spanish language version is lacking. We present the translation, cultural adaptation and validation of the T-QoL into Spanish. MethodsA prospective study with 133 patients (between 12 and 19 years old), attended at the dermatology department of Toledo University Hospital, Spain (September 2019–May 2020), was carried out for the validation study. The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) guidelines were used for the translation and cultural adaptation. We evaluated the convergent validity with the Dermatology Life Quality Index (DLQI), the Children's Dermatology Life Quality Index (CDLQI) and with a Global Question (GQ) on self-assessed disease severity. We also analysed internal consistency and reliability of the T-QoL tool and confirmed its structure with a factor analysis. ResultsGlobal T-QoL scores significantly correlated with the DLQI and the CDLQI (r=0.75) and with the GQ (r=0.63). The confirmatory factor analysis showed optimal fit for the bi-factor model and an adequate fit for the correlated three-factor model. Reliability indicators were high (Cronbach's α=0.89; Guttman's Lambda 6 index=0.91; Omega ω=0.91) and test–retest showed a high stability (ICC=0.85). The results were consistent with those found by the authors of the original test. ConclusionOur Spanish version of the T-QoL tool is valid and reliable to assess QoL of Spanish-speaking adolescents with skin diseases.

Self-Efficacy to Manage Chronic Disease (SEMCD) scale: translation and evaluation of measurement properties for a swedish version

BackgroundReinforcing self-efficacy in patients is important in person-centered care; therefore, reliable and valid measures of a person’s self-efficacy is of clinical relevance. A questionnaire suitable for self-efficacy and patient engagement that is not limited to a particular condition is the Self-efficacy to Manage Chronic Disease (SEMCD). This study aims to evaluate the measurement properties of a Swedish translation of the SEMCD with a Rasch analysis.MethodsThe translation and cultural adaptation of the SEMCD was performed according to the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) recommendations. Self-reported data was collected from two cohorts: patients with pituitary tumors (n = 86) and patients on sick leave due to common mental disorders (n = 209). Measurement properties were evaluated with a Rasch analysis in RUMM2030.ResultsThe original six-item SEMCD did not fit to a unidimensional scale. Two items, item 5 and item 6, deviated both statistically and conceptually and were removed. A four-item solution, the SEMCD-4 with collapsed thresholds for mid-range response options, showed good targeting and unidimensionality, no item misfit, and a reliability of 0.83.ConclusionIn a Swedish context with a mix of patients with pituitary tumors or common mental disorders, SEMCD-4 showed satisfactory measurement properties. Thus, SEMCD-4 could be used to identify patient self-efficacy in long-term illnesses. This knowledge about patient self-efficacy may be of importance to tailor person-centered support based on each patient´s resources, needs and goals.

Cross-cultural adaptation of the CRS-PRO questionnaire into French

BackgroundChronic rhinosinusitis (CRS), encompasses many different clinical patterns with variable response to treatment. Precise criteria specifying disease severity and control are lacking in the current literature. Our aim was to perform a cross-cultural adaptation of the CRS-PRO, creating a French version for use as a routine questionnaire in the assessment of patients with CRS.MethodsThe CRS-PRO questionnaire was translated according to the recommendations of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) through a three-step procedure including a backward translation.ResultsSeven of 12 items were initially discordant between the three translators before achieving consensus (Step 1). Two of 12 items were discordant between the backward translation and the initial CRS-PRO version regarding the word “mucus”(Step 2). Step 3 allowed the creation of a French proof-read version of the CRS-PRO questionnaire. Thirty patients were included for initial validation, mean age of 49.2 ± 15 years and 63.3% (19/30) male. It took them 67 ± 23 s to complete the questionnaire without any patients requiring more than 2 min.ConclusionThis study presents the French version of the CRS-PRO questionnaire—an adapted, validated, and well-accepted instrument to evaluate the CRS symptoms in the French speaking population.

OP41 Facilitating Dialogue Of Real-World Evidence Use In Health Technology Assessment: Taxonomy Of Question/Data Source Pairings To Support A Registry Of Studies

IntroductionThis paper reports the results of the collaboration within the European initiative of new Reimbursement and aCCess Approaches (EUreccA) which is concerned with the use of real-world evidence (RWE) in health technology assessment (HTA) decision-making. The work grew from the observation of a large, very experienced group of HTA practitioners which found that the use of RWE varied depending on the type of question asked and the particulars of the data source(s) used. We set out to examine how RWE is used in HTA decision-making and to make proposals on its facilitation.MethodsLiterature reviews covering earlier reviews of RWE use, academic papers, and HTA agency websites were combined with case studies involving interviews with decision-makers in four countries (England, France, Italy, Sweden) to identify the circumstances of breakdown of RWE use and to build a categorization of the uses of RWE and associated difficulties. This evidence supported the creation of a taxonomy of pairings of data sources and the questions they were used to address. The face validity of the approach was tested at an advisory board of senior HTA practitioners.ResultsIn total, 27 questions were identified and 10 types of data source, giving 270 pairings. These pairings were linked to relevant methods guidance and to examples of their use, itemizing HTA issues and decisions made. Reports are being prepared for publication, covering the detail of the methods of the literature searches; methods of the country case studies; a description of the taxonomy; and guidance on governance.ConclusionsWhen using RWE in HTA decision-making, the detail of the particular data sources and question addressed matter. Recently, both the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and the Real-World Transparency Initiative have argued for a registry of the uses of RWE. The work described here offers a starting classification of the material that should be held in such a registry, and which in itself could be developed by the stakeholders, both agencies and companies, that use it, furthering trust and confidence.

Adaptation and Validation of the Spanish Version of Decisional Conflict Scale in People with Migraine in Spain.

We aimed to validate the Spanish version of the Decisional Conflict Scale (DCS) and analyze its psychometric properties in people with migraine. The DCS validation comprised two phases. First, a translation and cross-cultural adaptation following the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Good Practices: 1-preparation, 2-independent forward translation, 3-reconciliation, 4-back-translation, 5-harmonization, 6-clinical review, and 7-content validation in a group of migraine patients. Second, the analysis of the psychometric properties. The reliability or internal consistency of the DCS scale and subscales was assessed using Cronbach's α value. The item-subscale correlation was also evaluated. A floor and ceiling effects for DCS score was considered when at least 15% of respondents obtained DCS >90 (ceiling) or <10 (floor). The construct validity was studied through the correlation between the DCS subscales and by the correlation between the DCS and other questionnaires (Decision Self-Efficacy Scale [DSES] and 9-item Shared Decision-Making [SDM-Q-9]). Spearman's coefficients were estimated for the correlations. The cross-cultural adaptation was conducted on 17 patients who completed the questionnaire in a mean of 2.4 ±1.1 minutes. Generally, more than 75% of them considered that DCS items were adequate, easy to understand, and relevant. The psychometric properties were evaluated in a sample of n=128 patients. Accordingly, the internal consistency of DCS was high, with a Cronbach's α of 0.97 for the scale and between 0.87 to 0.96 for subscales. Also, a slight floor effect was observed, with 24.2% of patients having DCS scores <10. The correlation between subscales exceeded Spearman's coefficient of 0.7. Whereas the correlation between the DCS and the other questionnaires was generally moderate (Spearman's coefficient >0.4). The Spanish version (Spain) of the DCS has very acceptable psychometric properties (reliability and construct validity) and good potential for assessing decisional conflicts among migraine patients.