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Misrepresentation by online study participants-a threat to data integrityAs a group of researchers experienced in collecting health research data using online methods, we have become increasingly concerned with the problem of participants misrepresenting themselves within our studies. Forms of misrepresentation include participants providing false information against inclusion criteria or creating multiple online personas to participate in a study multiple times.
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Using online methods to recruit participants into mental health clinical trials: Considerations and recommendations from the RE-MIND studyBACKGROUND: Ensuring diversity in clinical trials can be a challenge, which may be exacerbated when recruiting vulnerable populations, such as participants with mental health illness. As recruitment continues to be the major cause of trial delays, researchers are turning to online recruitment strategies, e.g. social media, to reach a wider population and reduce recruitment time and costs. There is mixed evidence for the use of online recruitment strategies; therefore, the REcruitment in Mental health trials: broadening the 'net', opportunities for INclusivity through online methoDs (RE-MIND) study aimed to identify evidence and provide guidance for use of online strategies in recruitment to mental health trials, with a focus on whether online strategies can enhance inclusivity. This commentary, as part of the RE-MIND study, focusses on providing recommendations for recruitment strategy selection in future research with the aim to improve trial efficiency. A mixed-methods approach was employed involving three work packages: (I) an evidence review of a cohort of 97 recently published randomised controlled trials/feasibility or pilot studies in mental health to assess the impact of online versus offline recruitment; (II) a qualitative study investigating the experiences of n = 23 key stakeholders on use of an online recruitment approach in mental health clinical trials; (III) combining the results of WP1 and WP2 to produce recommendations on the use of an online recruitment strategy in mental health clinical trials. The findings from WP1 and 2 have been published elsewhere; this commentary represents the results of the third work package. CONCLUSION: For external validity, clinical trial participants should reflect the populations that will ultimately receive the interventions being tested, if proven effective. To guide researchers on their options for inclusive recruitment strategies, we have developed a list of considerations and practical recommendations on how to maximise the use of online recruitment methods.
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Widening participation - recruitment methods in mental health randomised controlled trials: a qualitative studyBACKGROUND: Barriers to mental health research participation are well documented including distrust of services and research; and stigma surrounding mental health. They can contribute to a lack of diversity amongst participants in mental health research, which threatens the generalisability of knowledge. Given the recent widespread use of the internet in medical research, this study aimed to explore the perspectives of key partners on the use of online (e.g. social media) and offline (e.g. in-person) recruitment as an approach to improving diversity in mental health randomised controlled trials (RCTs). METHODS: Face-to-face and online interviews/focus groups with researchers working in mental health and Patient and Public Involvement partners in the United Kingdom. Recordings were transcribed and analysed using a combination of inductive and deductive thematic analysis. RESULTS: Three focus groups and three interviews were conducted with a total N = 23 participants. Four overarching themes were identified: (1) recruitment reach; (2) Demographic factors that affect selection of recruitment method; (3) safety of technology, and; (4) practical challenges. Five main factors were identified that affect the choice of recruitment method: age, complexity of mental health problem and stigma, cultural and ethnicity differences and digital divide. The use of online methods was considered more accessible to people who may feel stigmatised by their mental health condition and with a benefit of reaching a wider population. However, a common view amongst participants was that online methods require closer data monitoring for quality of responders, are not fully secure and less trustworthy compared to offline methods that enable participants to build relationships with health providers. Funding, staff time and experience, organisational support, and technical issues such as spam or phishing emails were highlighted as practical challenges facing online recruitment. All participants agreed that using a hybrid approach tailored to the population under study is paramount. CONCLUSIONS: This study highlighted the importance of offering a flexible and multifaceted recruitment approach by integrating online with offline methods to support inclusivity and widening participation in mental health research. The findings will be used to develop considerations for researchers designing RCTs to improve recruitment in mental health research.
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Best practice guidelines for citizen science in mental health research: Systematic review and evidence synthesisPartnering with people most affected by mental health problems can transform mental health outcomes. Citizen science as a research approach enables partnering with the public at a substantial scale, but there is scarce guidance on its use in mental health research. To develop best practise guidelines for conducting and reporting research, we conducted a systematic review of studies reporting mental health citizen science research. Documents were identified from electronic databases (n = 10), grey literature, conference proceedings, hand searching of specific journals and citation tracking. Document content was organised in NVIVO using the ten European Citizen Science Association (ECSA) citizen science principles. Best practise guidelines were developed by (a) identifying approaches specific to mental health research or where citizen science and mental health practises differ, (b) identifying relevant published reporting guidelines and methodologies already used in mental health research, and (c) identifying specific elements to include in reporting studies. A total of 14,063 documents were screened. Nine studies were included, from Australia, Belgium, Canada, Denmark, Netherlands, Spain, the UK, and the United States. Citizen scientists with lived experience of mental health problems were involved in data collection, analysis, project design, leadership, and dissemination of results. Most studies reported against some ECSA principles but reporting against these principles was often unclear and unstated. Best practise guidelines were developed, which identified mental health-specific issues relevant to citizen science, and reporting recommendations. These included citizen science as a mechanism for empowering people affected by mental health problems, attending to safeguarding issues such as health-related advice being shared between contributors, the use of existing health research reporting guidelines, evaluating the benefits for contributors and impact on researchers, explicit reporting of participation at each research stage, naming the citizen science platform and data repository, and clear reporting of consent processes, data ownership, and data sharing arrangements. We conclude that citizen science is feasible in mental health and can be complementary to other participatory approaches. It can contribute to active involvement, engagement, and knowledge production with the public. The proposed guidelines will support the quality of citizen science reporting.
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A fundamental change is needed for appraising placebo responses in psychiatry - author's replyMatthew Burke makes an important argument that a better biopsychosocial understanding of placebo responses in randomised controlled trials is required. More detailed design and reporting requirements for placebos in randomised controlled trials might also be informative. In addition to an assessment of the adequacy of blinding, measurement of expectancy and hope associated with the intervention, and effects on core or target symptoms as well as total score on symptom and function measures throughout the randomised controlled trials might aid interpretation.1 The distinction between active placebo (some common factors with the active treatment) and passive placebo (no common factors)2 could be useful. A discussion might be included of the nature of the placebo, its functionality, context, and how the efforts to ensure blinding might have compromised the trial in terms of demonstrating efficacy or effectiveness. These effects might be better understood with quantitative and qualitative data collection alongside the trial. In neuromodulation studies of depression, hope and expectancy might be high since access to novel forms of neuromodulation might be restricted. All neuromodulation interventions require participants to start a regular routine of use at home or attendance outside the home. Setting a daily goal and structuring the day are components of some effective psychological treatments for depression such as behavioural activation and cognitive behaviour therapy.3 Therefore, sham neuromodulation might be considered an active placebo with a potentially larger, more variable effect on depression than the additional therapeutic effect from neuromodulation. Furthermore, the design of the study to ensure blinding might compromise both the efficacy of an intervention and the generalisability of the findings. For instance, a fixed low dose of cranial electrostimulation that was subsensory, was employed in the Alpha-Stim trial to ensure double blinding.4 However, in clinical practice, the ability to personalise the dose and use higher currents might improve its effectiveness. RM was chief investigator on a grant from the UK National Institute for Health and Care Research (NIHR) Applied Research Collaboration (ARC) East Midlands. RM has received other NIHR funding for research on interventions for depression and has received funding from Novartis to serve on a data management and ethics committee for two trials on the treatment of depression.
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Design decisions and data completeness for experience sampling methods used in psychosis: systematic reviewBackground: The experience sampling method (ESM) is an intensive longitudinal research method. Participants complete questionnaires at multiple times about their current or very recent state. The design of ESM studies is complex. People with psychosis have been shown to be less adherent to ESM study protocols than the general population. It is not known how to design studies that increase adherence to study protocols. A lack of typology makes it is hard for researchers to decide how to collect data in a way that allows for methodological rigour, quality of reporting, and the ability to synthesise findings. The aims of this systematic review were to characterise the design choices made in ESM studies monitoring the daily lives of people with psychosis, and to synthesise evidence relating the data completeness to different design choices. Methods: A systematic review was conducted of published literature on studies using ESM with people with psychosis. Studies were included if they used digital technology for data collection and reported the completeness of the data set. The constant comparative method was used to identify design decisions, using inductive identification of design decisions with simultaneous comparison of design decisions observed. Weighted regression was used to identify design decisions that predicted data completeness. The review was pre-registered (PROSPERO CRD42019125545). Results: 38 studies were included. A typology of design choices used in ESM studies was developed, which comprised three superordinate categories of design choice: Study context, ESM approach and ESM implementation. Design decisions that predict data completeness include type of ESM protocol used, length of time participants are enrolled in the study, and if there is contact with the research team during data collection. Conclusions: This review identified a range of design decisions used in studies using ESM in the context of psychosis. Design decisions that influence data completeness were identified. Findings will help the design and reporting of future ESM studies. Results are presented with the focus on psychosis, but the findings can be applied across different mental health populations.
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Data Ethics Club: Creating a collaborative space to discuss data ethicsAwareness and management of ethical issues in data science are becoming crucial skills for data scientists. Discussion of contemporary issues in collaborative and interdisciplinary spaces is an engaging way to allow data-science work to be influenced by those with expertise in sociological fields and so improve the ability of data scientists to think critically about the ethics of their work. However, opportunities to do so are limited. Data Ethics Club is a fortnightly discussion group about data science and ethics whose community-generated resources are hosted publicly online. These include a collaborative list of materials around topics of interest and guides for leading an online data-ethics discussion group. Our meetings and resources are designed to reduce the barriers to learning, reflection, and critique on data science and ethics, with the broader aim of building ethics into the cultural fabric of quality data-science work.
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The value of qualitative methods to public health research, policy and practiceThis article reviews the role and use of qualitative methods in public health research.'Signs of quality' are introduced to help guide potential authors to publish their qualitative research in public health journals. We conclude that high-quality qualitative research offers insights that quantitative research cannot. It is time for all public health journals to recognise the value of qualitative research and increase the amount that they publish.
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Proportionate translation of study materials and measures in a multinational global health trial: methodology development and implementationOBJECTIVESCurrent translation guidelines do not include sufficiently flexible translation approaches for different study materials. We aimed to develop a proportionate methodology to inform translation of all types of study materials in global health trials.DESIGNThe design included three stages: (1) categorisation of study materials, (2) integration of existing translation frameworks and (3) methodology implementation (Germany, India, Israel, Tanzania and Uganda) and refinement.PARTICIPANTSThe study population comprised 27 mental health service users and 27 mental health workers who were fluent in the local language in stage 7 (pretesting), and 54 bilingual mental health service users, aged 18 years or over, and able to give consent as judged by a clinician for step 9 (psychometric evaluation).SETTINGThe study took place in preparation for the Using Peer Support in Developing Empowering Mental Health Services (UPSIDES) randomised controlled trial (ISRCTN26008944).PRIMARY OUTCOME MEASUREThe primary outcome measure was the Social Inclusion Scale (SIS).RESULTSThe typology identifies four categories of study materials: local text, study-generated text, secondary measures and primary measure. The UPSIDES Proportionate Translation Methodology comprises ten steps: preparation, forward translation, reconciliation, back translation, review, harmonisation, pretesting, finalisation, psychometric evaluation and dissemination. The translated primary outcome measure for the UPSIDES Trial (SIS) demonstrated adequate content validity (49.3 vs 48.5, p=0.08), convergent validity and internal consistency (0.73), with minimal floor/ceiling effects.CONCLUSIONThis methodology can be recommended for translating, cross-culturally adapting and validating all study materials, including standardised measures, in future multisite global trials. The methodology is particularly applicable to multi-national studies involving sites with differing resource levels. The robustness of the psychometric findings is limited by the sample sizes for each site. However, making this limitation explicit is preferable to the typical practice of not reporting adequate details about measure translation and validation.TRAIL REGISTRATION NUMBERISRCTN26008944.
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Assessing the value of a novel "Recovery and Collaborative Care Planning Cafe" initiative for co-designing improvements through a shared learning experience with service users, carers, and practitionersObjective: This paper ascertains the value of a novel approach to creating a participative social learning space with service users, carers, and practitioners to develop recovery-oriented conversations and the experience of collaborative care planning. Methods: A participatory method “World Café” was utilized with taught masterclasses on recovery principles. Evidenced-based practice was a central feature drawn from service user research. The Model for Improvement: Plan-Do-Study-Act (PDSA) framed the sessions to generate and test ideas. Results: Service user and carer attendance was low at the start, although this increased after testing ideas using PDSA cycles to improve this. Shared learning grew over time, which led to ideas to create improved participation in care planning. Conversations also developed towards becoming more recovery oriented after participants incorporated a framing set of recovery concepts into the sessions. Conclusions: The café design proved it was possible to both create a social learning space and change conversations leading to a greater focus on recovery through using CHIME (a conceptual framework incorporating connectedness, hope, identity, meaning, and empowerment). The café successfully generated improvement ideas and created a participative learning space.
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Dr QI - A quality improvement (QI) approach to designing and delivering QI trainingAims To develop and implement a QI training programme for trainees, Trust grade doctors and Consultants in Nottinghamshire Healthcare NHS Trust (NHFT) to enable them to deliver change in practice through acquisition of new knowledge and practical application of skills in QI projects using Model for Improvement. Background QI is crucial to improve patient care. Doctors are uniquely placed to input into patient safety and service delivery of healthcare. The skills required to be future clinical leaders and undertake improvement work are not innate and formal teaching and support is required. What is DrQI? DrQI is a trainee-led QI teaching programme developed in collaboration with Trainees improving patient safety through QI (TIPSQI) in North West deanery. Method A pre-implementation survey amongst doctors in NHFT in February 2019 (33 responses) suggested that 90% of doctors were interested in learning QI and about 48% preferred face-face workshops with support from the QI team. A list of change ideas were created using a driver diagram with QI education and project support identified as key primary drivers. PDSA cycles Nine interactive workshops teaching key QI concepts (based on model for improvement) in NHFT, training more than 100 doctors. A workshop in Derbyshire Healthcare NHS Foundation Trust (70 doctors) and Nottingham University Hospital (20 doctors). Workshops were continually adapted based on qualitative and quantitative feedback. Different formats were tried including virtual sessions, game-based and problem-based learning approaches using small group activities. Result Pre-course and post-course questionnaires were used to assess change in understanding of individual components of QI methodology (SMART Aim, Driver diagram, PDSA cycles, outcome and process measures and run charts). Mean pre-course self-assessment score collated from seven QI workshops in NHFT (2019-2020) was 3.3 and mean post-course score was 7.68, showing an improvement in understanding of QI methodology. Participants were asked to score the relevance (8.4) and quality of teaching (8.4) and the support from the QI team (7.4) on a scale of 1-10 (1 = poor and 10 = excellent). Additional free text feedback was obtained to help us improve the teaching programme. Conclusion Collaborative leadership trainee-led initiative to increase the QI capacity. A bottom up approach to complement the top down approach from the Trust QI team. Future steps include further collaboration and expansion of the scheme to other Trusts, Train the trainer sessions and building a network of QI champions.
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Cochrane Schizophrenia Group's study-based register of randomized controlled trials: Development and content analysisBackground: Study-based registers facilitate systematic reviews through shortening the process for review team and reducing considerable waste during the review process. Such a register also provides new insights about trends of trials in a sub-specialty. This paper reports development and content analysis of Cochrane Schizophrenia Group’s Study-Based Register. Methods: The randomized controlled trials were collected through systematic searches of major information sources. Data points were extracted, curated and classified in the register. We report trends using regression analyses in Microsoft Excel and we used GIS mapping (GunnMap 2) to visualize the geographical distribution of the origin of schizophrenia trials. Results: Although only 17% of trials were registered, the number of reports form registered trials is steadily increasing and registered trials produce more reports. Clinical trial registers are main source of trial reports followed by sub-specialty journals. Schizophrenia trials have been published in 23 languages from 90 countries while 105 nations do not have any reported schizophrenia trials. Only 9.7% of trials were included in at least one Cochrane review. Pharmacotherapy is the main target of trials while trials targeting psychotherapy are increasing in a continuous rate. The number of people randomized in trials is on average 114 with 60 being the most frequent sample size. Conclusions: Curated datasets within the register uncover new patterns in data that have implications for research, policy, and practice for testing new interventions in trials or systematic reviews.
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Are researchers getting the terms used to denote different types of recreational cannabis right?-a user perspectiveBACKGROUND: While current cannabis research has advanced our understanding into the effects of its individual components, there is a pressing need to identify simple terminology that is understood in the same way by researchers and users of cannabis. Current categorisation in research focuses on the two main cannabinoids: delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD); and two different species of cannabis: indica and sativa. Recreational cannabis has also been categorised by researchers as 'skunk' or 'hash'. Focusing on individuals who use cannabis frequently, this study aimed to identify views on current terms used to denote different types of cannabis and to identify terms validated by participants. These views were extracted from responses of the Cannabis Experiences Questionnaire (CEQ), a widely used instrument in the literature. METHODS: We qualitatively analysed 236 free-text responses from Question 23 of the CEQ survey (using Iterative Categorisation) relating to categorization and consumption methods. Data was used from a previous study (Sami et al., Psychol Med 49:103-12, 2019), which recruited a convenience sample of 1231 participants aged 18 years and above who had previously used cannabis. RESULTS: Regarding type of cannabis used, specific strain names (n = 130), concentrates (n = 37), indica/sativa (n = 22) and THC/CBD terms (n = 22) were mentioned. Other terms used were hybrids (n = 10), origins of specific strains (n = 17), edibles (n = 8), and herbal cannabis (n = 7). Regarding problems with specific terms, participants were skeptical about terms such as skunk and super skunk (n = 78) preferring terms like THC/CBD, indica/sativa, specific marketed strains and references to preparation methods. CONCLUSIONS: The results suggest a disparity between the common terms used by researchers in academia and those used by cannabis consumers. While there are advantages and limitations of using these terms to bridge views of researchers and individuals who use cannabis, this study underscores the importance of formally assessing chemical constituents rather than relying on self-report data and of incorporating cannabis user views on current terms used in research, potentially also incorporating descriptors of preparation and consumption methods.
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Principles for the production and dissemination of recruitment material for three clinical trials of an online interventionSome health research studies recruit participants through electronic mechanisms such as the placement of messages on social media platforms. This raises questions for ethics committee oversight, since effective social media campaigns might involve the production and dissemination of hundreds of contemporaneous messages. For the Narrative Experiences Online (NEON) study, we have developed nine principles to control the production and dissemination of promotional material. These have been approved by an ethics committee and enable the audit of our recruitment work. We propose that the drafting for approval of recruitment principles by health research studies may, in many cases, strike an appropriate balance between enabling ethical oversight of online recruitment work and the potential burden of message review.
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Identification of surveys in major biomedical bibliographic databasesThis is a letter to the editor.
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Assessing the quality of meta-analyses in systematic reviews in pharmaceutical research in Iran by 2016: A systematic reviewBackground: Meta-analyses, like all other studies, may be poorly designed and implemented. This study was designed to determine the quality of meta-analyses in systematic reviews in the field of pharmaceutical research in Iran. Methods: Web of Science Core Collection, EMBASE, Ovid Medline, CINAHL, Scopus, and PubMed were systematically searched on June 4, 2017. The search was limited to the researches in the field of pharmaceutical studies. Based on inclusion criteria, 104 systematic reviews with meta-analysis (SRMA) were selected and assessed using quality assessment tools introduced by Higgins. Results: Participants, experimental interventions, and outcomes were reported in all the articles. Comparator intervention and study design were correctly reported in 103 (99.04%) and 101 (97.12%) articles, respectively. The comprehensive search strategy was available only in 48 articles (46.16%), and there was no evidence of a comprehensive search in 56 articles (53.84%). Risk of bias was investigated in 78 articles (75%). Also, funnel plots were the most commonly used method for reporting the bias in 64 articles (46.42%). Conclusion: In many of the meta-analyses, several items of the tool that represented a high-quality meta-analysis were absent. According to the findings, the comprehensive search and quality assessment were not at an appropriate level. Thus, the importance of reproducibility of information and quality assessment of included studies should be emphasized. © Iran University of Medical Sciences.
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Keeping up with studies on covid-19: systematic search strategies and resourcesThe reason I write this letter is to take a small step towards helping readers with evidence based decision making by keeping them up to date with the rapidly growing number of covid-19 studies in PubMed and other resources.1 Many studies are not going to be visible in PubMed or Embase in the next few months because of indexing and content policy in bibliographic databases that avoids indexing preprint and unpublished studies, including registered clinical trials.
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Lessons from COVID-19 to future evidence synthesis efforts: First living search strategy and out of date scientific publishing and indexing industryNussbaumer-Streit et al. [1] reported a timely study on the exclusion of non-English language reports in systematic reviews but cautiously generalized the implications to rapid reviews rather than systematic reviews. The results complement the guidance in the new edition of the Cochrane Handbook [2]. However, the time of publication of this report coincides with the COVID-19 outbreak that introduces a geographical bias toward the inclusion of non-English literature. Although many researchers will try to publish in English, literature in non-English should not be ignored. We also thought it will be an added value to share our other experiences on literature search for evidence synthesis on COVID-19
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Classification of interventions in Traditional Chinese MedicineOBJECTIVETo describe the key systems used for Traditional Chinese Medicine (TCM) classification.METHODSThe TCM classifications used in the International Classification of Diseases-9 Clinical Modification (ICD-9-CM) volume 3, the ICD-10 Procedure Coding System, the International Classification of Health Interventions, and the Medical Subject Headings (MeSH) and Chinese Traditional Medicine and Materia Medica Subject Headings (TCMeSH) thesauruses were compared regarding descriptive terms, structure, and features of TCM interventions.RESULTSThe National Library of Medicine's MeSH thesaurus is ubiquitous. The ICD-9-CM (volume 3), ICD-10 Procedure Coding System, and International Classification of Health Interventions cover insufficient concepts of TCM, and cannot be used directly as classification systems for TCM interventions. In contrast, the TCM contents of the TCMeSH thesaurus are complete, systematic, and detailed, and its hierarchical structure can be used for effective TCM classification.CONCLUSIONTCM classification is very limited and flawed. The MeSH thesaurus helps decrease the detrimental effect of the language barrier. Similarly, the TCMeSH thesaurus can help those without full command of the Mandarin language to access Chinese literature, but the value of searches using TCMeSH could be improved by collaborative working with Information Specialists who are fluent in Mandarin and understand TCM.
