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BMC Medical Research Methodology

Bridie Angela Evans, Alison Porter, Helen Snooks, Vanessa Burholt
BACKGROUND: Public and patient involvement is a routine element of health services research methods to produce better designed and reported studies. Although co-production is recommended when involving people in research, methods for involving people are usually designed and managed by researchers and there is little evidence about methods to co-produce models for effective public and patient involvement. We report the method used by a group of patient and carer service users to develop and implement a model for involving public members in research...
February 15, 2019: BMC Medical Research Methodology
Katarina Maticic, Marina Krnic Martinic, Livia Puljak
BACKGROUND: Reporting quality of systematic reviews' (SRs) abstracts is important because this is often the only information about a study that readers have. The aim of this study was to assess adherence of SR abstracts in the field of anesthesiology with the reporting checklist PRISMA extension for Abstracts (PRISMA-A) and to analyze to what extent will the use of PRISMA-A yield concordant ratings in two raters without prior experience with the checklist. METHODS: We analyzed reporting quality of SRs with meta-analysis of randomized controlled trials of interventions published in the field of anesthesiology from 2012 to 2016 by using 12-item PRISMA-A checklist...
February 14, 2019: BMC Medical Research Methodology
Isao Yokota, Yutaka Matsuyama
BACKGROUND: In some clinical situations, patients experience repeated events of the same type. Among these, cancer recurrences can result in terminal events such as death. Therefore, here we dynamically predicted the risks of repeated and terminal events given longitudinal histories observed before prediction time using dynamic pseudo-observations (DPOs) in a landmarking model. METHODS: The proposed DPOs were calculated using Aalen-Johansen estimator for the event processes described in the multi-state model...
February 14, 2019: BMC Medical Research Methodology
Hisashi Noma, Kazushi Maruo, Masahiko Gosho, Stephen Z Levine, Yair Goldberg, Stefan Leucht, Toshi A Furukawa
BACKGROUND: Mixed effects models have been widely applied in clinical trials that involve longitudinal repeated measurements, which possibly contain missing outcome data. In meta-analysis of individual participant data (IPD) based on these longitudinal studies, joint synthesis of the regression coefficient parameters can improve efficiency, especially for explorations of effect modifiers that are useful to predict the response or lack of response to particular treatments. METHODS: In this article, we provide a valid and efficient two-step method for IPD meta-analyses using the mixed effects models that adequately addresses the between-studies heterogeneity using random effects models...
February 14, 2019: BMC Medical Research Methodology
Kimberley White, Rachel Potter, Shilpa Patel, Vivien P Nichols, Kirstie L Haywood, Siew Wan Hee, Dipesh Mistry, Dawn Carnes, Stephanie J C Taylor, Martin Underwood, Manjit S Matharu
BACKGROUND: Self-management support programmes are effective in a range of chronic conditions however there is limited evidence for their use in the treatment of chronic headaches. The aim of this study was to test the feasibility of four key aspects of a planned, future evaluative trial of a new education and self-management intervention for people with chronic headache: 1) recruiting people with chronic headache from primary care; 2) a telephone interview for the classification of chronic headaches; 3) the education and self-management intervention itself; and 4) the most appropriate patient reported outcomes (PROMS)...
February 11, 2019: BMC Medical Research Methodology
Magne Thoresen
BACKGROUND: It is common in applied epidemiological and clinical research to convert continuous variables into categorical variables by grouping values into categories. Such categorized variables are then often used as exposure variables in some regression model. There are numerous statistical arguments why this practice should be avoided, and in this paper we present yet another such argument. METHODS: We show that categorization may lead to spurious interaction in multiple regression models...
February 7, 2019: BMC Medical Research Methodology
Nicklaus Redenius, Youngwon Kim, Wonwoo Byun
BACKGROUND: Recent advances in sensor technologies have promoted the use of consumer-based accelerometers such as Fitbit Flex in epidemiological and clinical research; however, the validity of the Fitbit Flex in measuring sedentary behavior (SED) and physical activity (PA) has not been fully determined against previously validated research-grade accelerometers such as ActiGraph GT3X+. Therefore, the purpose of this study was to examine the concurrent validity of the Fitbit Flex against ActiGraph GT3X+ in a free-living condition...
February 7, 2019: BMC Medical Research Methodology
Ala'a Alkerwi, Jessica Pastore, Nicolas Sauvageot, Gwenaëlle Le Coroller, Valéry Bocquet, Marylène d'Incau, Gloria Aguayo, Brice Appenzeller, Dritan Bejko, Torsten Bohn, Laurent Malisoux, Sophie Couffignal, Stephanie Noppe, Charles Delagardelle, Jean Beissel, Anna Chioti, Saverio Stranges, Jean-Claude Schmit
BACKGROUND: It is challenging to manage data collection as planned and creation of opportunities to adapt during the course of enrolment may be needed. This paper aims to summarize the different sampling strategies adopted in the second wave of Observation of Cardiovascular Risk Factors (ORISCAV-LUX, 2016-17), with a focus on population coverage and sample representativeness. METHODS: Data from the first nationwide cross-sectional, population-based ORISCAV-LUX survey, 2007-08 and from the newly complementary sample recruited via different pathways, nine years later were analysed...
February 4, 2019: BMC Medical Research Methodology
Emma F France, Maggie Cunningham, Nicola Ring, Isabelle Uny, Edward A S Duncan, Ruth G Jepson, Margaret Maxwell, Rachel J Roberts, Ruth L Turley, Andrew Booth, Nicky Britten, Kate Flemming, Ian Gallagher, Ruth Garside, Karin Hannes, Simon Lewin, George W Noblit, Catherine Pope, James Thomas, Meredith Vanstone, Gina M A Higginbottom, Jane Noyes
AIMS: The aim of this study was to provide guidance to improve the completeness and clarity of meta-ethnography reporting. BACKGROUND: Evidence-based policy and practice require robust evidence syntheses which can further understanding of people's experiences and associated social processes. Meta-ethnography is a rigorous seven-phase qualitative evidence synthesis methodology, developed by Noblit and Hare. Meta-ethnography is used widely in health research, but reporting is often poor quality and this discourages trust in and use of its findings...
January 31, 2019: BMC Medical Research Methodology
Heather Ames, Claire Glenton, Simon Lewin
BACKGROUND: In a qualitative evidence synthesis, too much data due to a large number of studies can undermine our ability to perform a thorough analysis. Purposive sampling of primary studies for inclusion in the synthesis is one way of achieving a manageable amount of data. The objective of this article is to describe the development and application of a sampling framework for a qualitative evidence synthesis on vaccination communication. METHODS: We developed and applied a three-step framework to sample studies from among those eligible for inclusion in our synthesis...
January 31, 2019: BMC Medical Research Methodology
Amy Rogers, Robert W V Flynn, Isla S Mackenzie, Thomas M MacDonald
BACKGROUND: Recruitment to clinical trials can be challenging. Methods that improve the efficiency of trial recruitment are needed to increase successful study completions. The aim of this study was to ascertain whether sending an audio-visual presentation on a digital versatile disc (DVD), along with usual study invitation materials, would improve recruitment to the Febuxostat versus Allopurinol Streamlined Trial (FAST), a clinical trial in patients with established gout. METHODS: Potential participants for the FAST study who were identified by searches of GP records in Scottish primary care practices between August 2013 and July 2014 were included in this study...
January 30, 2019: BMC Medical Research Methodology
Lasse H Jakobsen, Therese M-L Andersson, Jorne L Biccler, Tarec C El-Galaly, Martin Bøgsted
BACKGROUND: Within cancer care, dynamic evaluations of the loss in expectation of life provides useful information to patients as well as physicians. The loss of lifetime function yields the conditional loss in expectation of life given survival up to a specific time point. Due to the inevitable censoring in time-to-event data, loss of lifetime estimation requires extrapolation of both the patient and general population survival function. In this context, the accuracy of different extrapolation approaches has not previously been evaluated...
January 28, 2019: BMC Medical Research Methodology
Michael J Grayling, Adrian P Mander
BACKGROUND: Gehan's two-stage design was historically the design of choice for phase II oncology trials. One of the reasons it is less frequently used today is that it does not allow for a formal test of treatment efficacy, and therefore does not control conventional type-I and type-II error-rates. METHODS: We describe how recently developed methodology for flexible two-stage single-arm trials can be used to incorporate the hypothesis test commonly associated with phase II trials in to Gehan's design...
January 28, 2019: BMC Medical Research Methodology
Gian Luca Di Tanna, Joshua K Porter, Richard B Lipton, Alan Brennan, Stephen Palmer, Anthony J Hatswell, Sandhya Sapra, Guillermo Villa
BACKGROUND: Health economic models are critical tools to inform reimbursement agencies on health care interventions. Many clinical trials report outcomes using the frequency of an event over a set period of time, for example, the primary efficacy outcome in most clinical trials of migraine prevention is mean change in the frequency of migraine days (MDs) per 28 days (monthly MDs [MMD]) relative to baseline for active treatment versus placebo. Using these cohort-level endpoints in economic models, accounting for variation among patients is challenging...
January 23, 2019: BMC Medical Research Methodology
Yanli Hu, Lay Hwa Tiew, Fan Li
BACKGROUND: Spiritual care is defined as recognizing and responding to the needs of the human spirit when the individual is facing trauma, illness, or sadness. Providing spiritual care is one of the core aspects of holistic care, as it is significantly associated with patients' quality of life. The provision of optimal spiritual care requires good understanding by the nurses. Therefore, it is important to assess this understanding by using a proven, well-validated instrument. The Spiritual Care-Giving Scale (SCGS) is designed to measure nurses' perceptions of spirituality and spiritual care in Singapore...
January 23, 2019: BMC Medical Research Methodology
Judith J M Rijnhart, Jos W R Twisk, Iris Eekhout, Martijn W Heymans
BACKGROUND: Logistic regression is often used for mediation analysis with a dichotomous outcome. However, previous studies showed that the indirect effect and proportion mediated are often affected by a change of scales in logistic regression models. To circumvent this, standardization has been proposed. The aim of this study was to show the relative performance of the unstandardized and standardized estimates of the indirect effect and proportion mediated based on multiple regression, structural equation modeling, and the potential outcomes framework for mediation models with a dichotomous outcome...
January 21, 2019: BMC Medical Research Methodology
Graham M Wheeler, Adrian P Mander, Alun Bedding, Kristian Brock, Victoria Cornelius, Andrew P Grieve, Thomas Jaki, Sharon B Love, Lang'o Odondi, Christopher J Weir, Christina Yap, Simon J Bond
INTRODUCTION: The continual reassessment method (CRM) is a model-based design for phase I trials, which aims to find the maximum tolerated dose (MTD) of a new therapy. The CRM has been shown to be more accurate in targeting the MTD than traditional rule-based approaches such as the 3 + 3 design, which is used in most phase I trials. Furthermore, the CRM has been shown to assign more trial participants at or close to the MTD than the 3 + 3 design. However, the CRM's uptake in clinical research has been incredibly slow, putting trial participants, drug development and patients at risk...
January 18, 2019: BMC Medical Research Methodology
Michael P Schnetz, Harry S Hochheiser, David J Danks, Douglas P Landsittel, Keith M Vogt, James W Ibinson, Steven L Whitehurst, Sean P McDermott, Melissa Giraldo Duque, Ata M Kaynar
BACKGROUND: Mean arterial pressure (MAP), bispectral index (BIS), and minimum alveolar concentration (MAC) represent valuable, yet dynamic intraoperative monitoring variables. They provide information related to poor outcomes when considered together, however their collective behavior across time has not been characterized. METHODS: We have developed the Triple Variable Index (TVI), a composite variable representing the sum of z-scores from MAP, BIS, and MAC values that occur together during surgery...
January 14, 2019: BMC Medical Research Methodology
Svenja E Seide, Christian Röver, Tim Friede
BACKGROUND: Standard random-effects meta-analysis methods perform poorly when applied to few studies only. Such settings however are commonly encountered in practice. It is unclear, whether or to what extent small-sample-size behaviour can be improved by more sophisticated modeling. METHODS: We consider likelihood-based methods, the DerSimonian-Laird approach, Empirical Bayes, several adjustment methods and a fully Bayesian approach. Confidence intervals are based on a normal approximation, or on adjustments based on the Student-t-distribution...
January 11, 2019: BMC Medical Research Methodology
Sung Mu Heo, Justine M Naylor, Ian A Harris, Timothy R Churches
BACKGROUND: Patient reported outcomes are increasingly used to assess the success of surgical procedures. Patient reported complications are often included as an outcome. However, these data must be validated to be accurate and useful in clinical practice. METHODS: This was a retrospective descriptive study of 364 patients who had completed their six-month follow-up review questionnaire in the Arthroplasty Clinical Outcomes Registry, National (ACORN), an Australian orthopaedic registry...
January 11, 2019: BMC Medical Research Methodology
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