What information and the extent of information research participants need in informed consent forms: a multi-country survey

Background: The use of lengthy, detailed, and complex informed consent forms (ICFs) is of paramount concern in biomedical research as it may not truly promote the rights and interests of research participants. The extent of information in ICFs has been the subject of debates for decades; however, no clear guidance is given. Thus, the objective of this study was to determine the perspectives of research participants about the type and extent of information they need when they are invited to participate in biomedical research. Methods: This multi-center, cross-sectional, descriptive survey was conducted at 54 study sites in seven Asia-Pacific countries. A modified Likert-scale questionnaire was used to determine the importance of each element in the ICF among research participants of a biomedical study, with an anchored rating scale from 1 (not important) to 5 (very important). Results: Of the 2484 questionnaires distributed, 2113 (85.1%) were returned. The majority of respondents considered most elements required in the ICF to be \u27moderately important\u27 to \u27very important\u27 for their decision making (mean score, ranging from 3.58 to 4.47). Major foreseeable risk, direct benefit, and common adverse effects of the intervention were considered to be of most concerned elements in the ICF (mean score = 4.47, 4.47, and 4.45, respectively). Conclusions: Research participants would like to be informed of the ICF elements required by ethical guidelines and regulations; however, the importance of each element varied, e.g., risk and benefit associated with research participants were considered to be more important than the general nature or technical details of research. Using a participant-oriented approach by providing more details of the participant-interested elements while avoiding unnecessarily lengthy details of other less important elements would enhance the quality of the ICF

Manobra de Epley repetida em uma mesma sessão na vertigem posicional paroxística benigna Epley’s maneuver in the same session in benign positional paroxysmal vertigo

OBJETIVO: Avaliar se a repetição de manobras de Epley em uma mesma sessão resulta em um menor número de sessões para abolir o nistagmo de posicionamento do que uma única manobra por sessão. MÉTODO: A manobra de Epley foi realizada em 123 pacientes com VPPB unilateral por ductolitíase do canal posterior. O grupo I foi composto por 75 pacientes submetidos a uma única manobra de Epley por sessão semanal e o grupo II foi constituído por 48 pacientes submetidos a quatro manobras na primeira sessão. RESULTADOS: O grupo II apresentou latência e duração do nistagmo maiores do que o grupo I (p<0,05). A média e o desvio-padrão do número de sessões apresentados pelo grupo I foram maiores do que no grupo II (p=0,008). Observou-se associação significante entre a distribuição do número de sessões e o grupo (p=0,039). O grupo II apresentou 21,4% a mais de pacientes que necessitaram apenas de uma sessão (IC 95% [7,7% - 35,1%]). CONCLUSÃO: A repetição de manobras de Epley em uma mesma sessão resulta em um menor número de sessões para abolir o nistagmo de posicionamento do que uma única manobra por sessão.<br>AIM: To assess whether more than one Epley’s maneuver in the same session, compared to a single one, decreases the number of sessions necessary to suppress positional nystagmus. METHOS: Epley’s maneuver was done in 123 patients with BPPV due to unilateral posterior semicircular canal canalolithiasis. The number of sessions for positional nystagmus suppression was compared in two groups of patients. Group I consisted of 75 patients submitted to a single Epley’s maneuver on weekly sessions and group II consisted of 48 patients that were submitted to four Epley’s maneuvers during the first session. RESULTS: Group II showed greater nystagmus latency and duration than group I (p<0.05). The number of sessions and standard deviation showed by group I was greater than in group II (p=0.008). We observed a significant association between number of sessions and group (p=0.039) studied. Group II had 21.4% more nystagmus-free patients following only one session (CI95% [7.7% - 35.1%]). CONCLUSION: Repeated Epley’s maneuvers in less sessions rendered more positional nystagmus-free patients when compared to those submitted to more sessions of single maneuvers