Reference values of spirometry for Finnish adults

BackgroundDiagnostic assessment of lung function necessitates up-to-date reference values. The aim of this study was to estimate reference values for spirometry for the Finnish population between 18 and 80years and to compare them with the existing Finnish, European and the recently published global GLI2012 reference values. MethodsSpirometry was performed for 1380 adults in the population-based FinEsS studies and for 662 healthy non-smoking volunteer adults. Detailed predefined questionnaire screening of diseases and symptoms, and quality control of spirometry yielded a sample of 1000 native Finns (387 men) healthy non-smokers aged 18-83years. Sex-specific reference values, which are estimated using the GAMLSS method and adjusted for age and height, are provided. ResultsThe predicted values for lung volumes are larger than those obtained by GLI2012 prediction for the Caucasian subgroup for forced vital capacity (FVC) by an average 62% and 51% and forced expiratory volume in 1s (FEV1) by an average 42% and 30% in men and women, respectively. GLI2012 slightly overestimated the ratio FEV1/FVC with an age-dependent trend. Most reference equations from other European countries, with the exception of the Swiss SAPALDIA study, showed an underestimation of FVC and FEV1 to varying degrees, and a slight overestimation of FEV1/FVC. ConclusionThis study offers up-to-date reference values of spirometry for native Finns with a wide age range. The GLI2012 predictions seem not to be suitable for clinical use for native Finns due to underestimation of lung volumes.Peer reviewe

Repeated Assessments of Informed Consent Comprehension among HIV-Infected Participants of a Three-Year Clinical Trial in Botswana

Informed consent (IC) has been an international standard for decades for the ethical conduct of clinical trials. Yet frequently study participants have incomplete understanding of key issues, a problem exacerbated by language barriers or lack of familiarity with research concepts. Few investigators measure participant comprehension of IC, while even fewer conduct interim assessments once a trial is underway.We assessed comprehension of IC using a 20-question true/false quiz administered in 6-month intervals in the context of a placebo-controlled, randomized trial for the prevention of tuberculosis among HIV-infected adults in Botswana (2004-2009). Quizzes were offered in both Setswana and English. To enroll in the TB trial, participants were required to have ≥ 16/20 correct responses. We examined concepts understood and the degree to which understanding changed over three-years. We analyzed 5,555 quizzes from 1,835 participants. The participants' highest education levels were: 28% primary, 59% secondary, 9% tertiary and 7% no formal education. Eighty percent of participants passed the enrollment quiz (Quiz1) on their first attempt and the remainder passed on their second attempt. Those having higher than primary education and those who took the quiz in English were more likely to receive a passing score on their first attempt (adjusted odds ratios and 95% confidence intervals, 3.1 (2.4-4.0) and 1.5 (1.2, 1.9), respectively). The trial's purpose or procedures were understood by 90-100% of participants, while 44-77% understood randomization, placebos, or risks. Participants who failed Quiz1 on their initial attempt were more likely to fail quizzes later in the trial. Pass rates improved with quiz re-administration in subsequent years.Administration of a comprehension quiz at enrollment and during follow-up was feasible in a large, international collaboration and efficiently determined IC comprehension by trial participants. Strategies to improve understanding of concepts like placebos and randomization are needed. Comprehension assessments throughout a study may reinforce key concepts

Effects of prematurity, intrauterine growth status, and early dexamethasone treatment on postnatal bone mineralisation

AIM—To examine the hypothesis that, apart from prematurity, intrauterine growth status (expressed as gestational age specific birth weight standard deviation scores), neonatal factors, and duration of dexamethasone treatment influence bone mineralisation in early infancy.
METHODS—In this prospective study, groups consisted of 15 preterm small for gestational age infants (SGA group) and 43 preterm appropriate for gestational age infants (AGA group). A reference group contained 17 term infants. Body size is known to affect bone mineral content (BMC), therefore postnatal bone mineralisation was measured when the study infants and controls had attained a similar body size. Bone mineral density (BMD) and BMC were determined by dual energy x ray absorptiometer of the lumbar spine (L2-L4).
RESULTS—Both preterm groups had significantly lower BMC and BMD than the weight matched term reference group, but no difference was found in BMC and BMD between preterm SGA and AGA infants. In stepwise regression analysis, bone area, duration of dexamethasone treatment, weight at examination, and weight gain per week were the most significant factors, explaining 54% of the variance of the BMC values.
CONCLUSION—In particular, weight at examination, prematurity, and possibly dexamethasone treatment, but not intrauterine growth status, affect postnatal bone mineralisation.

SIDCERインフォームドコンセント書式を用いた研究参加者の内容理解改善：8件の臨床試験を用いたインフォームドコンセントのランダム化比較試験

Purpose: This study aimed to test the applicability and effectiveness of the principles and informed consent form (ICF) template proposed by the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER) across multiple clinical trials involving Thai research participants with various conditions. Methods: A single-center, randomized-controlled study nested with eight clinical trials was conducted at Thammasat University Hospital, Thailand. A total of 258 participants from any of the eight clinical trials were enrolled and randomly assigned to read either the SIDCER ICF (n = 130) or the conventional ICF (n = 128) of the respective trial. Their understanding of necessary information was assessed using the post-test questionnaire; they were allowed to consult a given ICF while completing the questionnaire. The primary endpoint was the proportion of the participants who had the post-test score of ?80%, and the secondary endpoint was the total score of the post-test. Results: The proportion of the participants in the SIDCER ICF group who achieved the primary endpoint was significantly higher than that of the conventional ICF group (60.8 vs. 41.4%, p = 0.002). The total score of the post-test was also significantly higher among the participants who read the SIDCER ICF than those who read the conventional ICF (83.3 vs. 76.0%, p < 0.001). Conclusions: The present study demonstrated that the SIDCER ICF was applicable and effective to improve Thai research participants’ understanding of research information in diverse clinical trials. Using the SIDCER ICF methodology, clinical researchers can improve the quality of ICFs for their trials.長崎大学学位論文 学位記番号:博(医歯薬)甲第962号 学位授与年月日:平成29年3月21日Author: Nut Koonrungsesomboon, Thipaporn Tharavanij, Kittichet Phiphatpatthamaamphan, Ratha-korn Vilaichone, Sudsayam Manuwong, Parichat Curry, Sith Siramolpiwat, Thanachai Punchaipornpon, Supakit Kanitnate, Nattapol Tammachote, Rodsarin Yamprasert, Waipoj Chanvimalueng, Ruchirat Kaewkumpai, Soiphet Netanong, Peerapong Kitipawong, Paskorn Sritipsukho, Juntra KarbwangCitation: European Journal of Clinical Pharmacology, 73(2), pp.141-149; 2017Nagasaki University (長崎大学)課程博