Additional file 1 of Translation and cultural adaptation of the Pregnancy Physical Activity Questionnaire into Danish using the dual-panel approach: comparison with outcomes from an alternative translation approach

Additional file 1. Complete reporting of the translation and cross-cultural adaption of the Pregnancy Physical Activity Questionnaire into Danish

Translation and cultural adaptation of the Pregnancy Physical Activity Questionnaire into Danish using the dual-panel approach: comparison with outcomes from an alternative translation approach

Abstract Objective Physical activity reduces the risk of pregnancy-related complications. However, pregnant women often reduce their physical activity levels and do not follow the WHO’s physical activity recommendations during pregnancy. To support pregnant women in monitoring physical activity, the self-administered Pregnancy Physical Activity Questionnaire was developed in the US. We translated and cross-cultural adapted the questionnaire using the dual approach method. Meanwhile, and without knowing this, another Danish group simultaneously translated the questionnaire using the method described by Beaton et al. The aim is to present our data and discuss the unplanned purpose of comparing the results from using two different translation methods. Results We translated and cross-culturally adapted the Pregnancy Physical Activity Questionnaire to Danish with the following findings. Two additional items for cycling were included. Three items about spending time on a computer, reading, writing or talking on the phone were not feasible in terms of differentiating between them and these were merged into one item. The item ‘Taking care of an older adult’ was found to be irrelevant in a Danish setting and was removed. Adaptions were similar comparing the two methods. Consequently, using the dual-panel and the methods suggested by Beaton et al. yield similar results when translating and cultural adapting the PPAQ

Translation and cultural adaptation of the Pregnancy Physical Activity Questionnaire into Danish using the dual-panel approach: comparison with outcomes from an alternative translation approach

Abstract Objective Physical activity reduces the risk of pregnancy-related complications. However, pregnant women often reduce their physical activity levels and do not follow the WHO’s physical activity recommendations during pregnancy. To support pregnant women in monitoring physical activity, the self-administered Pregnancy Physical Activity Questionnaire was developed in the US. We translated and cross-cultural adapted the questionnaire using the dual approach method. Meanwhile, and without knowing this, another Danish group simultaneously translated the questionnaire using the method described by Beaton et al. The aim is to present our data and discuss the unplanned purpose of comparing the results from using two different translation methods. Results We translated and cross-culturally adapted the Pregnancy Physical Activity Questionnaire to Danish with the following findings. Two additional items for cycling were included. Three items about spending time on a computer, reading, writing or talking on the phone were not feasible in terms of differentiating between them and these were merged into one item. The item ‘Taking care of an older adult’ was found to be irrelevant in a Danish setting and was removed. Adaptions were similar comparing the two methods. Consequently, using the dual-panel and the methods suggested by Beaton et al. yield similar results when translating and cultural adapting the PPAQ

Induced hypothermia in patients with septic shock and respiratory failure (CASS):a randomised, controlled, open-label trial

Animal models of serious infection suggest that 24 h of induced hypothermia improves circulatory and respiratory function and reduces mortality. We tested the hypothesis that a reduction of core temperature to 32-34°C attenuates organ dysfunction and reduces mortality in ventilator-dependent patients with septic shock. In this randomised, controlled, open-label trial, we recruited patients from ten intensive care units (ICUs) in three countries in Europe and North America. Inclusion criteria for patients with severe sepsis or septic shock were a mean arterial pressure of less than 70 mm Hg, mechanical ventilation in an ICU, age at least 50 years, predicted length of stay in the ICU at least 24 h, and recruitment into the study within 6 h of fulfilling inclusion criteria. Exclusion criteria were uncontrolled bleeding, clinically important bleeding disorder, recent open surgery, pregnancy or breastfeeding, or involuntary psychiatric admission. We randomly allocated patients 1:1 (with variable block sizes ranging from four to eight; stratified by predictors of mortality, age, Acute Physiology and Chronic Health Evaluation II score, and study site) to routine thermal management or 24 h of induced hypothermia (target 32-34°C) followed by 48 h of normothermia (36-38°C). The primary endpoint was 30 day all-cause mortality in the modified intention-to-treat population (all randomly allocated patients except those for whom consent was withdrawn or who were discovered to meet an exclusion criterion after randomisation but before receiving the trial intervention). Patients and health-care professionals giving the intervention were not masked to treatment allocation, but assessors of the primary outcome were. This trial is registered with ClinicalTrials.gov, number NCT01455116. Between Nov 1, 2011, and Nov 4, 2016, we screened 5695 patients. After recruitment of 436 of the planned 560 participants, the trial was terminated for futility (220 [50%] randomly allocated to hypothermia and 216 [50%] to routine thermal management). In the hypothermia group, 96 (44·2%) of 217 died within 30 days versus 77 (35·8%) of 215 in the routine thermal management group (difference 8·4% [95% CI -0·8 to 17·6]; relative risk 1·2 [1·0-1·6]; p=0·07]). Among patients with septic shock and ventilator-dependent respiratory failure, induced hypothermia does not reduce mortality. Induced hypothermia should not be used in patients with septic shock. Trygfonden, Lundbeckfonden, and the Danish National Research Foundatio

Patient-Reported Outcomes in First-Line Antiretroviral Therapy: Results From NEAT001/ANRS143 Trial Comparing Darunavir/Ritonavir in Combination With Tenofovir/Emtricitabine or Raltegravir

Background: There are few data comparing patient-reported outcomes (PROs) in randomized trials of initial antiretroviral therapy. We present results from a substudy of the NEAT001/ ANRS143 trial. Methods: The randomized trial compared first-line DRV/r 800/100 mg once daily plus RAL 400 mg twice daily and DRV/r plus TDF/ FTC 245/200 mg once daily. Changes in PROs were assessed with 3 questionnaires: EuroQoL 5 domains (EQ-5D), Center for Epidemiologic Studies Depression (CES-D) scale, and HIV Treatment Satisfaction Questionnaire. Major depressive disorder (MDD) was defined as CES-D $16. General estimating equations were used to model change over 96 weeks in PROs from baseline. Results: Of the 805 participants, 797 (99substudy. Baseline PRO data were similar for the 2 randomized groups. Health status improved over time with a mean increase in EQ-5D visual analogue scale (VAS) of 8.0 by W96 [95to 9.4; P, 0.001], and no statistically significant differences between groups (difference of 0.3 on VAS score (95global P value$ 0.05 for all domains over follow-up). There was no significant difference between groups on CES-D [difference of 20.1 (95% CI: 21.3 to 1.1); P = 0.9], or MDD during follow-up, adjusted for baseline MDD (odds ratio = 0.98, 95% CI: 0.82 to 1.18; P = 0.9). RAL + DRV/r group had lower level of convenience (P = 0.03) and fitted less well into patients’ lifestyle (P = 0.007) than the TDF/FTC + DRV/r regimen, and was associated with lower treatment satisfaction [median score: 53 RAL + DRV/r vs 55 TDF/FTC + DRV/r (P = 0.001)]. Conclusion: PROs improved after starting antiretroviral therapy, with no statistically significant difference between groups. The lower satisfaction with RAL + DRV/r may be explained by twicedaily administration

Population pharmacokinetics and pharmacogenetics of ritonavir-boosted darunavir in the presence of raltegravir or tenofovir disoproxil fumarate/emtricitabine in HIV-infected adults and the relationship with virological response : a sub-study of the NEAT001/ANRS143 randomized trial

OBJECTIVES: NEAT001/ANRS143 demonstrated non-inferiority of once-daily darunavir/ritonavir (800/100 mg) + twice-daily raltegravir (400 mg) versus darunavir/ritonavir + tenofovir disoproxil fumarate/emtricitabine (245/200 mg once daily) in treatment-naive patients. We investigated the population pharmacokinetics of darunavir, ritonavir, tenofovir and emtricitabine and relationships with demographics, genetic polymorphisms and virological failure. METHODS: Non-linear mixed-effects models (NONMEM v. 7.3) were applied to determine pharmacokinetic parameters and assess demographic covariates and relationships with SNPs (SLCO3A1, SLCO1B1, NR1I2, NR1I3, CYP3A5*3, CYP3A4*22, ABCC2, ABCC10, ABCG2 and SCL47A1). The relationship between model-predicted darunavir AUC0-24 and C24 with time to virological failure was evaluated by Cox regression. RESULTS: Of 805 enrolled, 716, 720, 347 and 361 were included in the darunavir, ritonavir, tenofovir and emtricitabine models, respectively (11% female, 83% Caucasian). No significant effect of patient demographics or SNPs was observed for darunavir or tenofovir apparent oral clearance (CL/F); coadministration of raltegravir did not influence darunavir or ritonavir CL/F. Ritonavir CL/F decreased by 23% in NR1I2 63396C>T carriers and emtricitabine CL/F was linearly associated with creatinine clearance (P < 0.001). No significant relationship was demonstrated between darunavir AUC0-24 or C24 and time to virological failure [HR (95% CI): 2.28 (0.53-9.80), P = 0.269; and 1.82 (0.61-5.41), P = 0.279, respectively]. CONCLUSIONS: Darunavir concentrations were unaltered in the presence of raltegravir and not associated with virological failure. Polymorphisms investigated had little impact on study-drug pharmacokinetics. Darunavir/ritonavir + raltegravir may be an appropriate option for patients experiencing NRTI-associated toxicity