The process and challenges of language translation and cultural adaptation of study instruments: a case study from the NIDA CTN CHOICES-2 trial.

BACKGROUND: As the U.S. grows more diverse, researchers decide how to include non-English speakers. Budget limitations may not allow for translation of all instruments. Study teams must determine which instruments must receive certified translations. This paper describes the procedures utilized in one U.S.-based, multi-site clinical trial to decide which study instruments should undergo certified translation and discusses dialect review procedures. METHODS: The team determined which instruments (n = 31) would be translated using a qualitative evaluation to determine the need to obtain a Spanish-language certified translation: 1) "Could the meaning of these questions change (and potentially elicit a different response) if the translations were not consistent?" and 2) "Is it acceptable to have potential inconsistencies in these data?" Instruments for which question 1 was "yes" and question 2 was "no" (e.g., eligibility, outcomes, safety) were marked for certified translation. A dialect committee reviewed all translated patient-reported outcome measures to ensure that the translations had accounted for different meanings of words based on respondents' countries or regions of origin and recommended changes where necessary. RESULTS: Fourteen interview-based instruments underwent certified forward-only translation into U.S. Spanish. The remaining 2 interview-based instruments were translated via real-time conversation with participants by bilingual staff. Six forms were administrative and not translated. Five out of 9 professionally translated patient-reported outcome measures were amended to better reflect relevant dialects. CONCLUSIONS: In the absence of specific guidance, it is feasible for study team members to 1) determine which instruments should undergo certified translation and 2) incorporate dialect into translations.

The association between E-cigarette use and Kratom use among US adults.

Kratom, an herbal substance with stimulant and opioid-like effects commonly used in capsules or powder to be ingested or brewed as a tea, has been gaining popularity in the United States (US). US e-cigarette use (i.e., vaping) has exponentially increased in recent years. Given the potential risks of kratom (e.g., poisonings) and the increasing prevalence of e-cigarette use, understanding the association between them is important to inform prevention strategies and regulatory policies. We harnessed data from the 2020 National Survey on Drug Use and Health (NSDUH; n = 27,170) to examine past-year kratom use by past-year e-cigarette use among adults. We ran a logistic regression model on kratom use by e-cigarette use adjusting for associated factors with substance use. Among all respondents, the estimated prevalence of past-year kratom use was 0.9% and an estimated 9.7% reported past-year e-cigarette use. Our multivariable model found those with e-cigarette use (vs. not) had 4.80 higher odds of using kratom in the past year (aOR = 4.80; 95% CI = 2.62, 8.80). These findings might help inform the need for continuing education for physicians and healthcare providers related to practice in managing patients with kratom use, future studies for regulatory policies on e-cigarettes (e.g., e-liquids), or other FDA policies related to kratom.

Treatment retention, return to use, and recovery support following COVID-19 relaxation of methadone take-home dosing in two rural opioid treatment programs: A mixed methods analysis.

OBJECTIVES: In March 2020, the Substance Abuse and Mental Health Services Administration permitted Opioid Treatment Programs (OTPs) to relax restrictions on take-home methadone and promoted telehealth to minimize potential exposures to COVID-19. We assessed the effects of COVID-19-related changes on take-home methadone dosing in two OTPs serving five rural Oregon counties. METHODS: We used a mixed-methods convergent design. The OTPs extracted urine drug test (UDT) results, take-home methadone regimens, and treatment retention from the electronic health record (EHR) for patients (n = 377). A mixed-effects negative binomial regression model assessed patient-level differences in take-home doses before and after the COVID-19 policy changes and the associations with treatment discontinuation, and UDT positivity. Semi-structured qualitative interviews (n = 32) explored patient reactions to increased take-home dosing and reduced clinic visits to provide context for quantitative findings. RESULTS: The number of take-home doses increased in the post-COVID-19 period for patients engaged in treatment for more than 180 days (median: 8 vs 13 take-home doses per month, p = 0.011). Take-homes did not increase for patients with fewer days of treatment. Each percentage point increase in take-home dosing above what would be expected without COVID-19 policy changes was negatively associated with the percent of UDT positive for opioids (B = -0.12, CI [-0.21, -0.04], p = 0.005) and the probability of treatment discontinuation (aOR = 0.97, CI [0.95, 0.99], p = 0.003). Qualitative analysis revealed three themes explaining how increased take-home dosing supported recovery: 1) value of feeling trusted with increased responsibility; 2) reduced travel time permitted increased employment and recreation; and 3) reduced exposure to individuals less stable in recovery and potential triggers. CONCLUSIONS: Take-home methadone dose relaxations were associated with increased methadone take-home doses, improved retention, and decreased UDT opioid positive results among clinically stable patients. Qualitative findings suggest that fewer take-home restrictions are feasible and desirable and do not pose safety or public health harms.

Rural opioid treatment program patient perspectives on take-home methadone policy changes during COVID-19: a qualitative thematic analysis.

BACKGROUND: In the United States, methadone for opioid use disorder (OUD) is highly regulated. Federal agencies announced guidelines in March 2020 allowing for relaxation of take-home methadone dispensing at opioid treatment programs (OTPs) to improve treatment access and reduce COVID-19 transmission risk during the public health emergency. We explored patient perspectives at three OTPs serving rural communities on how take-home policy changes were received and implemented and how these changes impacted their addiction treatment and recovery. METHODS: We completed semi-structured individual qualitative interviews in 2 phases: (1) August-October 2020 and (2) November 2020-January 2021 (total n = 46), anticipating possible policy changes as the pandemic progressed. We interviewed patients with OUD enrolled at 3 rural OTPs in Oregon. Participants received varying take-home methadone allowances following the COVID-19-related policy changes. All interviews were conducted via phone, audio-recorded, and transcribed. We conducted a thematic analysis, iteratively coding transcripts, and deductively and inductively generating codes. RESULTS: The 46 participants included 50% women and 89% had Medicaid insurance. Three main themes emerged in the analysis, with no differences between study phases: (1) Adapting to changing OTP policies throughout the pandemic; (2) Recognizing the benefits, and occasional struggles, with increased take-home methadone dosing; and (3) Continuing policies and procedures post-pandemic. Participants described fears and anxieties around ongoing methadone access and safety concerns prior to OTP policy changes, but quickly adapted as protocols soon seemed "natural." The majority of participants acknowledged significant benefits to increased take-homes independent of reducing COVID-19 infection risk including feeling "more like a normal person," improved recovery support, reduced time traveling, and having more time with family and for work. Looking to a post-pandemic future, participants thought some COVID-19-related safety protocols should continue that would reduce risk of other infections, make OTP settings less stressful, and result in more individualized care. CONCLUSIONS: As the pandemic progressed, study participants adapted to rapidly changing OTP policies. Participants noted many unanticipated benefits to increased take-home methadone and other COVID-19 protocols including strengthened self-efficacy and recovery and reduced interpersonal conflict, with limited evidence of diversion. Patient perspectives should inform future policies to better address the ongoing overdose epidemic.

Measurement Invariance of the Short Version of the Problematic Mobile Phone Use Questionnaire (PMPUQ-SV) across Eight Languages.

The prevalence of mobile phone use across the world has increased greatly over the past two decades. Problematic Mobile Phone Use (PMPU) has been studied in relation to public health and comprises various behaviours, including dangerous, prohibited, and dependent use. These types of problematic mobile phone behaviours are typically assessed with the short version of the Problematic Mobile Phone Use Questionnaire (PMPUQ⁻SV). However, to date, no study has ever examined the degree to which the PMPU scale assesses the same construct across different languages. The aims of the present study were to (i) determine an optimal factor structure for the PMPUQ⁻SV among university populations using eight versions of the scale (i.e., French, German, Hungarian, English, Finnish, Italian, Polish, and Spanish); and (ii) simultaneously examine the measurement invariance (MI) of the PMPUQ⁻SV across all languages. The whole study sample comprised 3038 participants. Descriptive statistics, correlations, and Cronbach's alpha coefficients were extracted from the demographic and PMPUQ-SV items. Individual and multigroup confirmatory factor analyses alongside MI analyses were conducted. Results showed a similar pattern of PMPU across the translated scales. A three-factor model of the PMPUQ-SV fitted the data well and presented with good psychometric properties. Six languages were validated independently, and five were compared via measurement invariance for future cross-cultural comparisons. The present paper contributes to the assessment of problematic mobile phone use because it is the first study to provide a cross-cultural psychometric analysis of the PMPUQ-SV.