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Is mindfulness research methodology improving over time? A systematic review.

ABSTRACT: BACKGROUND:Despite an exponential growth in research on mindfulness-based interventions, the body of scientific evidence supporting these treatments has been criticized for being of poor methodological quality. OBJECTIVES:The current systematic review examined the extent to which mindfulness research demonstrated increased rigor over the past 16 years regarding six methodological features that have been highlighted as areas for improvement. These feature included using active control conditions, larger sample sizes, longer follow-up assessment, treatment fidelity assessment, and reporting of instructor training and intent-to-treat (ITT) analyses. DATA SOURCES:We searched PubMed, PsychInfo, Scopus, and Web of Science in addition to a publically available repository of mindfulness studies. STUDY ELIGIBILITY CRITERIA:Randomized clinical trials of mindfulness-based interventions for samples with a clinical disorder or elevated symptoms of a clinical disorder listed on the American Psychological Association's list of disorders with recognized evidence-based treatment. STUDY APPRAISAL AND SYNTHESIS METHODS:Independent raters screened 9,067 titles and abstracts, with 303 full text reviews. Of these, 171 were included, representing 142 non-overlapping samples. RESULTS:Across the 142 studies published between 2000 and 2016, there was no evidence for increases in any study quality indicator, although changes were generally in the direction of improved quality. When restricting the sample to those conducted in Europe and North America (continents with the longest history of scientific research in this area), an increase in reporting of ITT analyses was found. When excluding an early, high-quality study, improvements were seen in sample size, treatment fidelity assessment, and reporting of ITT analyses. CONCLUSIONS AND IMPLICATIONS OF KEY FINDINGS:Taken together, the findings suggest modest adoption of the recommendations for methodological improvement voiced repeatedly in the literature. Possible explanations for this and implications for interpreting this body of research and conducting future studies are discussed.

SUBMITTER: Goldberg SB

PROVIDER: S-EPMC5663486 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature

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Is mindfulness research methodology improving over time? A systematic review.

Goldberg Simon B SB Tucker Raymond P RP Greene Preston A PA Simpson Tracy L TL Kearney David J DJ Davidson Richard J RJ

PloS one 20171031 10

<h4>Background</h4>Despite an exponential growth in research on mindfulness-based interventions, the body of scientific evidence supporting these treatments has been criticized for being of poor methodological quality.<h4>Objectives</h4>The current systematic review examined the extent to which mindfulness research demonstrated increased rigor over the past 16 years regarding six methodological features that have been highlighted as areas for improvement. These feature included using active cont ...[more]

PMID: 29088283

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Project description:BACKGROUND:Enrolment in a research study requires the participant's informed consent. In the case of minors, informed consent of the respective legal guardian is obtained in conjunction with informed assent of the underage p articipant. Since comprehension of the information provided may be limited, effective interventions to improve understanding should be identified. Thus, it is the objective of this study to review quantitative studies that tested interventions to improve the understanding of information provided during assent processes in health research. The studied population consisted of minors that participated or were willing to participate in research. The primary outcome was the level of comprehension after intervention. METHODS:A systematic search was conducted in eleven databases including regional databases: PubMed, Web of Science, ERIC, PsycINFO, CINAHL, POPLINE, AIM, LILACS, WPRIM, IMSEAR, and IMEMR and included references from inception of the database until July 2018 except PubMed which spanned the period from May 2013 to July 2018. Search terms focused on Informed Consent/Assent, Minors, and Comprehension. To complement the search, reference lists of retrieved publications were additionally searched. We included all quantitative studies that were conducted in minors, tested an intervention, covered assent processes in health research, and assessed comprehension. One reviewer screened titles, abstracts, and full-texts to determine eligibility and collected data on study design, population, intervention, methods, outcome, and for critical appraisal. Interventions comprised enhanced paper forms, interspersed questions, multimedia format, and others. RESULTS:Out of 7089 studies initially identified, 19 studies comprising 2805 participants and conducted in seven countries were included in the review. Fourteen studies (74 %) tested an intervention against control and ten (53 %) were randomized controlled trials. Heterogeneous methodology as well as incomplete outcome and statistical reporting impaired the reliability of the collected data. Positive effects were suggested for use of enhanced paper forms, interspersed questions, use of pie charts, and organizational factors. CONCLUSIONS:Improving assent in health research is an under-researched area with little reliable evidence. While some interventions are proposed to improve understanding in assent processes, further investigation is necessary to be able to give evidence-based recommendations. TRIAL REGISTRATION:PROSPERO ID: 106808.

Project description:In phenylketonuria (PKU), natural protein tolerance is defined as the maximum natural protein intake maintaining a blood phenylalanine (Phe) concentration within a target therapeutic range. Tolerance is affected by several factors, and it may differ throughout a person's lifespan. Data on lifelong Phe/natural protein tolerance are limited and mostly reported in studies with low subject numbers. This systematic review aimed to investigate how Phe/natural protein tolerance changes from birth to adulthood in well-controlled patients with PKU on a Phe-restricted diet. Five electronic databases were searched for articles published until July 2020. From a total of 1334 results, 37 articles met the eligibility criteria (n = 2464 patients), and 18 were included in the meta-analysis. The mean Phe (mg/day) and natural protein (g/day) intake gradually increased from birth until 6 y (at the age of 6 months, the mean Phe intake was 267 mg/day, and natural protein intake was 5.4 g/day; at the age of 5 y, the mean Phe intake was 377 mg/day, and the natural protein intake was 8.9 g/day). However, an increase in Phe/natural protein tolerance was more apparent at the beginning of late childhood and was >1.5-fold that of the Phe tolerance in early childhood. During the pubertal growth spurt, the mean natural protein/Phe tolerance was approximately three times higher than in the first year of life, reaching a mean Phe intake of 709 mg/day and a mean natural protein intake of 18 g/day. Post adolescence, a pooled analysis could only be performed for natural protein intake. The mean natural protein tolerance reached its highest (32.4 g/day) point at the age of 17 y and remained consistent (31.6 g/day) in adulthood, but limited data were available. The results of the meta-analysis showed that Phe/natural protein tolerance (expressed as mg or g per day) increases with age, particularly at the beginning of puberty, and reaches its highest level at the end of adolescence. This needs to be interpreted with caution as limited data were available in adult patients. There was also a high degree of heterogeneity between studies due to differences in sample size, the severity of PKU, and target therapeutic levels for blood Phe control.

Project description:BackgroundQ-methodology is an approach to studying complex issues of human 'subjectivity'. Although this approach was developed in the early twentieth century, the value of Q-methodology in healthcare was not recognised until relatively recently. The aim of this review was to scope the empirical healthcare literature to examine the extent to which Q-methodology has been utilised in healthcare over time, including how it has been used and for what purposes.MethodsA search of three electronic databases (Scopus, EBSCO-CINAHL Complete, Medline) was conducted. No date restriction was applied. A title and abstract review, followed by a full-text review, was conducted by a team of five reviewers. Included articles were English-language, peer-reviewed journal articles that used Q-methodology (both Q-sorting and inverted factor analysis) in healthcare settings. The following data items were extracted into a purpose-designed Excel spreadsheet: study details (e.g., setting, country, year), reasons for using Q-methodology, healthcare topic area, participants (type and number), materials (e.g., ranking anchors and Q-set), methods (e.g., development of the Q-set, analysis), study results, and study implications. Data synthesis was descriptive in nature and involved frequency counting, open coding and the organisation by data items.ResultsOf the 2,302 articles identified by the search, 289 studies were included in this review. We found evidence of increased use of Q-methodology in healthcare, particularly over the last 5 years. However, this research remains diffuse, spread across a large number of journals and topic areas. In a number of studies, we identified limitations in the reporting of methods, such as insufficient information on how authors derived their Q-set, what types of analyses they performed, and the amount of variance explained.ConclusionsAlthough Q-methodology is increasingly being adopted in healthcare research, it still appears to be relatively novel. This review highlight commonalities in how the method has been used, areas of application, and the potential value of the approach. To facilitate reporting of Q-methodological studies, we present a checklist of details that should be included for publication.

Project description:BackgroundThere have been notable investments in large multi-partner research programmes across the agriculture-nutrition-health (ANH) nexus. These studies often involve human participants and commonly require research ethics review. These ANH studies are complex and can raise ethical issues that need pre-field work, ethical oversight and also need an embedded process that can identify, characterise and manage ethical issues as the research work develops, as such more embedded and dynamic ethics processes are needed. This work builds on notions of 'ethics in practice' by developing an approach to facilitate ethical reflection within large research programmes. This study explores the application of a novel 'real-time research ethics approach' (RTREA) and how this can support ethical mindfulness. This involves embedding ethical analysis and decision-making within research implementation, with a continuous dialogue between participants and researchers. The aim is to improve ethical responsiveness and participant experience, which in turn may ethically support adherence and retention. In this case study, a bioethics team (BT) was embedded in a community-based randomised, controlled trial conducted in rural Malawi, titled the 'Addressing Hidden Hunger with Agronomy'. To identify ethical issues, the researchers conducted ten focus group discussions, fourteen in-depth interviews with key informants, two workshops, observed two sensitisation and three activity meetings conducted by the trial team, and analysed fifteen reports from pre-trial to trial implementation.ResultsThe RTREA facilitated the identification of social and ethical concerns and made researchers aware of participants' 'lived research experience'. To address concerns and experiences, the BT worked with researchers to facilitate conversation spaces where social and ethical issues were discussed. Conversation spaces were designed to create partnerships and promote participatory methods to capture trial participants' (TPs) perspectives and experiences.ConclusionsThe use of RTREA showed the value of real-time and continuous engagement between TPs and researchers. These real-time processes could be embedded to complement traditional ethical guidance and expert opinions. A deeper engagement appeared to support greater operationalising of principles of inclusion, empowerment, and participant autonomy and supported researchers 'ethical mindfulness' which in turn may support instrumental outcomes of high recruitment, retention, and adherence levels.

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Is mindfulness research methodology improving over time? A systematic review.

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Is mindfulness research methodology improving over time? A systematic review.

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