Linguistic and Cultural Validation of Patient-Reported Outcomes Used in Clinical Trials

Althof, Stanley E.; Rosen, Raymond C.; Revicki, Dennis A.

doi:10.1016/j.jsxm.2017.11.017

Cited by 2 publications

(1 citation statement)

References 7 publications

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“…Backward Translation: Accordingly, back-translator(s) should be professionals, native speakers of the source language and fluent in the target language (56,57). Preferably, they should have no prior knowledge of the original instrument (54,58), or any other language version of the instrument to avoid bias (59). In view of this, a naïve bilingual native English speaker was recruited to produce a blind back-translation into English.…”

Section: Methodsmentioning

confidence: 99%

A Cross-Cultural Adaptation and psychometric validation of SISRI-24 among Malaysian Teachers

Ogunsola

Fontaine

Jan

2019

ASSRJ

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The paper is aimed at validating the psychometric properties of SISRI-24 for effective performance among teachers in Malaysia. Through a list-based simple random sampling of 373 teachers, SISRI -24 was translated, adapted and validated. Using TCA procedure, experts validated the translated the instrument from both linguistic structure and semantic point of view. Its internal consistency was validated with Cronbach’s Alpha and CFA. EFA varimax normalized rotation extracted four components. Measure of internal consistency had Cronbach’s Alpha value of 0.911. CFA validated SISRI-19my with χ² / df ratio (354.512 / 141) = 2.514, RMSEA (0.077) and CFI (0.921) as reasonable spiritual intelligence fit model for Malaysian teachers. The adequacy of this paper’s findings is promising, suggesting that the Malaysian version of spiritual Intelligence self-Assessment Inventory scale would provide a valid instrument to develop spiritual intelligence among teachers. Practically, it would stimulate teaching interest irrespective of exigencies. Socially, it models spirited leaders whose role revolves on grooming younger generations towards nation building. Psychological, it acts as catalyst towards improved wellness. Theoretically, it contributes to body of knowledge on spirituality and organizational behaviour. Apart from the study being cross-sectional, it was limited only to private secondary school teachers. Future study may include other strata of teachers to improve SISRI-19my version. The study offers the first to empirically translate, adapt and validate a Malaysian version of SISRI-24.

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Section: Methodsmentioning

confidence: 99%

A Cross-Cultural Adaptation and psychometric validation of SISRI-24 among Malaysian Teachers

Ogunsola

Fontaine

Jan

2019

ASSRJ

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Methodological Challenges in Studying Testosterone Therapies for Hypoactive Sexual Desire Disorder in Women

Rowen

Davis

Parish

et al. 2020

The Journal of Sexual Medicine

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Introduction Testosterone has been studied for its benefits on sexual health for decades. The research regarding testosterone in women has produced evidence that this is a potential treatment for women suffering from female sexual dysfunction. There are several limitations of the testosterone trials that can affect their interpretation and challenges posed by some regulatory agencies that have prevented approval of any testosterone treatment for women in several countries. Aim To summarize the challenges of testosterone trials in terms of study populations, patient-reported outcomes, validated instruments in research, confounders, and regulatory barriers. Methods A thorough review of published data on testosterone for the treatment of women's sexual health problems was undertaken. A detailed evaluation of the limitations of these trials was conducted and incorporated with the published evidence on the regulatory processes involved in moving testosterone from clinical research to drug approval. Main Outcome Measure Main outcome measures are assessment of clinical trial populations, survey tools, confounders, and regulatory barriers. Results There is some heterogeneity of study populations included in testosterone trials in women. Similarly, there have been differences in instruments used to assess patient-reported outcomes and often minimal control for potential confounders. The regulatory agency had posed a challenge to approve any testosterone treatment for women based on unproven concerns and a lack of regulatory guidance for drug developers. Clinical Implications There is strong evidence that shows testosterone is effective for treating sexual health concerns in the women included in clinical trials. Strength & Limitations Strengths include thorough review of published literature and trial design for sexual health concerns. Limitations include being restricted to English Language publications and not having access to unpublished clinical trial data. Conclusions Testosterone trials in women have been limited by homogeneity in the study populations and outcomes measured. Drug development has been hampered by inconsistent regulatory barriers.

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Linguistic and Cultural Validation of Patient-Reported Outcomes Used in Clinical Trials

Cited by 2 publications

References 7 publications

A Cross-Cultural Adaptation and psychometric validation of SISRI-24 among Malaysian Teachers

A Cross-Cultural Adaptation and psychometric validation of SISRI-24 among Malaysian Teachers

Methodological Challenges in Studying Testosterone Therapies for Hypoactive Sexual Desire Disorder in Women

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