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SMOOTH: Self-Management of Open Online Trials in Health analysis found improvements were needed for reporting methods of internet-based trials

Price A, Vasanthan L, Clarke M, Liew SM, Brice A, Burls A

J Clin Epidemiol, 2019 01;105:27-39.
PMID: 30171901 DOI: 10.1016/j.jclinepi.2018.08.017

BACKGROUND AND OBJECTIVES: The growth of trials conducted over the internet has increased, but with little practical guidance for their conduct, and it is sometimes challenging for researchers to adapt the conventions used in face-to-face trials and maintain the validity of the work. The aim of the study is to systematically explore existing self-recruited online randomized trials of self-management interventions and analyze the trials to assess their strengths and weaknesses, the quality of reporting, and the involvement of lay persons as collaborators in the research process.
STUDY DESIGN AND SETTINGS: The Online Randomized Controlled Trials of Health Information Database was used as the sampling frame to identify a subset of self-recruited online trials of self-management interventions. The authors cataloged what these online trials were assessing, appraised study quality, extracted information on how trials were run, and assessed the potential for bias. We searched out how public and patient participation was integrated into online trial design and how this was reported. We recorded patterns of use for registration, reporting, settings, informed consent, public involvement, supplementary materials, and dissemination planning.
RESULTS: The sample included 41 online trials published from 2002 to 2015. The barriers to replicability and risk of bias in online trials included inadequate reporting of blinding in 28/41 (68%) studies; high attrition rates with incomplete or unreported data in 30/41 (73%) of trials; and 26/41 (63%) of studies were at high risk for selection bias as trial registrations were unreported. The methods for (23/41, 56%) trials contained insufficient information to replicate the trial, 19/41 did not report piloting the intervention. Only 2/41 studies were cross-platform compatible. Public involvement was most common for advisory roles (n = 9, 22%), and in the design, usability testing, and piloting of user materials (n = 9, 22%).
CONCLUSION: This study catalogs the state of online trials of self-management in the early 21st century and provides insights for online trials development as early as the protocol planning stage. Reporting of trials was generally poor and, in addition to recommending that authors report their trials in accordance with CONSORT guidelines, we make recommendations for researchers writing protocols, reporting on and evaluating online trials. The research highlights considerable room for improvement in trial registration, reporting of methods, data management plans, and public and patient involvement in self-recruited online trials of self-management interventions.

Matched MeSH terms: Self Report/standards*
Self reported pain severity among multiethnic older Singaporeans: does adjusting for reporting heterogeneity matter?

Chan A, Malhotra C, Do YK, Malhotra R, Ostbye T

Eur J Pain, 2011 Nov;15(10):1094-9.
PMID: 21646030 DOI: 10.1016/j.ejpain.2011.05.006

The objective of this paper is to test and correct for systematic differences in reporting of pain severity among older adults by age, gender, ethnic group and socio-economic status using anchoring vignettes. Data from a national survey of community-dwelling older Singaporeans (aged 60 years and over) conducted in 2009 was used. Respondents were asked to rate the severity of their own pain as well as that of others described in the vignettes on a five-point scale ranging from none to extreme. An ordered probit model was used to estimate the coefficients of the independent variables (age, gender, ethnic group, education, housing type) on self-reported pain. Reporting heterogeneity in pain severity was then corrected using a Hierarchical Ordered Probit model. The results showed that before correcting for reporting heterogeneity, women, those older, and those of Malay ethnicity reported greater severity of pain, while there was no association of reported pain severity with housing type and education. However, after correcting for reporting heterogeneity, while women and those older were found to have an even greater severity of pain than what they had reported, Malays were found to have a lower severity of pain than what they had reported. We conclude that there are systematic differences in reporting pain severity by age, gender and ethnic group. We propose that pain management may be improved if medical professionals take into account reporting heterogeneity for pain severity among various population sub-groups in Singapore.

Matched MeSH terms: Self Report/standards
Fulltext Validity of self-reported weight and height: a cross-sectional study among Malaysian adolescents

Kee CC, Lim KH, Sumarni MG, Teh CH, Chan YY, Nuur Hafizah MI, et al.

BMC Med Res Methodol, 2017 Jun 02;17(1):85.
PMID: 28577547 DOI: 10.1186/s12874-017-0362-0

BACKGROUND: Self-reported weight and height are commonly used in lieu of direct measurements of weight and height in large epidemiological surveys due to inevitable constraints such as budget and human resource. However, the validity of self-reported weight and height, particularly among adolescents, needs to be verified as misreporting could lead to misclassification of body mass index and therefore overestimation or underestimation of the burden of BMI-related diseases. The objective of this study was to determine the validity of self-reported weight and height among Malaysian secondary school children.

METHODS: Both self-reported and directly measured weight and height of a subgroup of 663 apparently healthy schoolchildren from the Malaysian Adolescent Health Risk Behaviour (MyAHRB) survey 2013/2014 were analysed. Respondents were required to report their current body weight and height via a self-administrative questionnaire before they were measured by investigators. The validity of self-reported against directly measured weight and height was examined using intraclass correlation coefficient (ICC), the Bland-Altman plot and weighted Kappa statistics.

RESULTS: There was very good intraclass correlation between self-reported and directly measured weight [r = 0.96, 95% confidence interval (CI): 0.93, 0.97] and height (r = 0.94, 95% CI: 0.90, 0.96). In addition the Bland-Altman plots indicated that the mean difference between self-reported and direct measurement was relatively small. The mean difference (self-reported minus direct measurements) was, for boys: weight, -2.1 kg; height, -1.6 cm; BMI, -0.44 kg/m2 and girls: weight, -1.2 kg; height, -0.9 cm; BMI, -0.3 kg/m2. However, 95% limits of agreement were wide which indicated substantial discrepancies between self-reported and direct measurements method at the individual level. Nonetheless, the weighted Kappa statistics demonstrated a substantial agreement between BMI status categorised based on self-reported weight and height and the direct measurements (kappa = 0.76, 95% CI: 0.67, 0.84).

CONCLUSION: Our results show that the self-reported weight and height were consistent with direct measurements and therefore can be used in assessing the nutritional status of Malaysian school children from the age of 13 to 17 years old in epidemiological studies and for surveillance purposes when direct measurements are not feasible, but not for assessing nutritional status at the individual level.

Matched MeSH terms: Self Report/standards*
Standardized questions in English for estimating tinnitus prevalence and severity, hearing difficulty and usage of healthcare resources, and their translation into 11 European languages

Biswas R, Lugo A, Gallus S, Akeroyd MA, Hall DA

Hear Res, 2019 06;377:330-338.
PMID: 30853349 DOI: 10.1016/j.heares.2019.02.008

INTRODUCTION: Prevalence estimates depend largely on the nature of the question asked to define the presence of the health condition, and the literature on the population burden of tinnitus and hearing difficulties is no different in this respect. The lack of standardized questions for data collection limits comparison across studies and across countries. The purpose of this short Technical Note is to report the first attempt to establish a set of standard questions developed for use in population-based surveys, and their adaptation and translation from English into 11 European languages.
METHODS: Four questions and their corresponding response options were adapted from existing population-based surveys to assess tinnitus prevalence, tinnitus symptom severity, use of healthcare resources for tinnitus and hearing difficulty. The translated versions (Bulgarian, French, German, Greek, Italian, Latvian, Polish, Portuguese, Romanian, Russian, and Spanish) were generated using recognized methods to achieve a "world-for-world" translation.
RESULTS: Translated versions were produced with acceptable functional equivalence to the original English-language version, as judged by a small panel of bilingual speakers who participated in the online field testing.
CONCLUSION: This work is the first of its kind to promote multi-national standardization by creating a set of tools that can readily be used across countries. These are currently being used in a European-wide study of tinnitus prevalence, and have wider application across English- and Spanish speaking countries including the Americas and Oceania.

Matched MeSH terms: Self Report/standards*