Reaching hard-to-reach young people: Methodological and ethical considerations in data collection

“Future randomized controlled studies are needed” is a conclusion all too familiar to readers of scientific articles. This statement, distributed liberally in the literature, has come to signify little more than an obligatory admission of a study’s deficiencies. It simultaneously seeks to absolve the authors of any fault from potentially exaggerating the importance of their statistical findings while leaving it to the reader to decide how to apply and disseminate the novel information. The statement also implies that higher quality studies could and should be devised and points to salvation by way of the randomized controlled trial (RCT), the pinnacle of evidence-based medicine.1 Despite this, historical and present-day data show that RCTs are undertaken less frequently in surgery than in other areas of medicine.2–4 This raises concerns about the quality of surgical research, but what can surgeons do about it? Surveys have demonstrated a preponderance of cohort studies and case series in surgical journals, with RCTs accounting for fewer than 10% of publications.5,6 Reasons for lack of quality surgical research have been attributed to unique methodologic, practical, and ethical considerations in evaluating surgical procedures, and surgeon reluctance and lack of experience with surgical trials.3,7,8 Although high-quality RCTs are something to strive for, it is also clear that not all problems in surgery can be evaluated in an RCT. Solomon and McLeod studied 250 research questions in gastrointestinal surgery and concluded that, under ideal conditions, only 38.8% could have been answered with an RCT.9 Rather than attempting to answer every question with an RCT, surgeons should focus on using the best research design for their clinical questions. A variety of study designs can shed important insights if they are applied to the correct problem and conducted with methodologic rigor. The idea, development, exploration, assessment, and long-term study (IDEAL) model is a five-stage framework developed to guide best research practices throughout progressive stages of surgical innovation (Table 1).10,11 Early stages focus on refining the technique and its safety profile, whereas later stages are generally amenable to higher levels of scientific inquiry. With consideration for the stage of development of the surgical technique being investigated, a simple stepwise approach can be applied using the highest feasible level of evidence when choosing a study design. In this article, we outline important concepts and discuss various study designs—RCTs, observational studies with control groups, and case series—with a focus on minimizing biases. We consider various practical and methodologic issues specific to surgical research throughout. Table 1. - IDEAL Stages of Surgical Innovationa Stage Objectives Study Methods 1. Idea Initial technical description of new surgical procedure or technology Case reports, case series 2a. Development Description of early experience with new procedure or technology, including technical modifications and short-term/safety-related outcomes Prospective case series, observational studies 2b. Exploration Larger exploratory study to better define the relevant comparator groups and outcomes, and evaluate feasibility of a future RCT Prospective observational studies, RCTsb 3. Assessment Definitive comparative evaluation against the standard of care RCTs, large prospective observational studiesc 4. Long-term study Collect data for surveillance in real-world practice, identify new complications, and revise indications as needed Registry-based prospective cohort studies or case-control studies, rare case reports aDeveloped from initial description of IDEAL framework by McCulloch P, Altman DG, Campbell WB, et al. No surgical innovation without evaluation: the IDEAL recommendations. Lancet 2009;374:1105–1112.bPerformed when feasible at this stage.cAppropriate when ethical or practical factors preclude performing an RCT. DESIGNING A SURGICAL RESEARCH STUDY A 1994 commentary entitled “The Scandal of Poor Medical Research” was a heated outcry for higher quality research to be performed for a purpose greater than expanding the researcher’s curriculum vitae.12 It pointed to a variety of factors plaguing medical research, including flawed designs, inadequate samples, inappropriate statistical analyses, and misleading interpretation of results. At the heart of the problem was the combination of the “publish or perish” research climate together with a “general failure to appreciate the basic principles underlying scientific research.” Although it is not the goal of this article to review these principles in detail, the concepts of validity, bias, and statistics warrant consideration for our subsequent discussion. Once a question and hypothesis have been established, choosing the study design is the next step. The process should consider ways to maximize validity and minimize bias. Internal validity refers to the accuracy with which the findings reflect true variation in the outcomes measured in the study sample, whereas external validity refers to the extent to which the findings are generalizable to clinical populations encountered in practice.13 The interplay between these concepts is complex. By way of selective inclusion and exclusion criteria, RCTs ensure that groups of patients compared are equivalent in almost all aspects, other than the treatment administered, in striving to achieve a high level of internal validity. This can come at the expense of external validity. For instance, surgeons in real-world practice encounter patients who would not meet the strict inclusion and exclusion criteria of such studies. Biases refer to factors outside of the surgical intervention that systematically influence the results of a study.14 They detract directly from the validity of the study and can occur during study design and preparation, data collection, analysis, and interpretation of results.13,14 Biases are categorized conceptually in terms of their overarching similarities.15 Important conceptual categories are selection biases, observation biases, and confounders (Table 2). Selection biases occur during design of a study and result in unintended differences between comparison groups. They are attributable to systematic flaws in the methodology used to select patients. For instance, in a nonrandomized study investigating a novel surgical procedure compared with nonoperative treatment, patients selected to undergo surgery would likely be healthier, more compliant, and have better access to care than patients treated nonoperatively. These baseline factors stack the odds in favor of surgical outcomes. Observation biases occur during data collection and can be attributed to flaws in the measurement tools used, effects of the study environment on patient behavior, or deferential attitudes of surgeons toward one of the groups. For example, surgeons may be more invested in obtaining favorable outcomes and minimizing complications of surgically treated patients, unintentionally providing better follow-up care. A confounder is any unaccounted for “third variable” responsible for the causal relationship observed in the study. This could be a patient factor, such as smoking, in a study comparing infection rates after different wound care regimens, or a treatment-related factor, such as asymmetry in the duration of postoperative immobilization, in a study comparing different interventions for fractures. Such factors could be more pertinent than the treatments themselves to the outcomes being investigated. Table 2. - Examples of Biases in Surgical Research Bias Description Means of Minimization Selection biases Nonrespondent bias Patients declining to participate in the study differ systematically from those who take part Optimizing communication of objectives, limiting burden of participating Referral bias Patients referred to clinician and recruited to study have more severe disease Predefined and evidence-based inclusion criteria Channeling bias Patients assigned to interventions based on prognostic factors Randomized studies with allocation concealment, stratification in nonrandomized studies Chronology bias Intervention group compared with historical cohort Using concurrent comparison groups Observation biases Recall bias Inaccurate reporting of treatment response by patients Using prospective design and objective outcome measurements Hawthorne effect Change in behavior as a result of participation in a study Randomization, blinding Performance bias Results influenced by variability in surgical technique or expertise Standardized protocols, different surgeons for different procedures, stratification by surgeon level of expertise Transfer bias Patients lost to follow-up differ from those who completed study By maintaining up-to-date contact information, limiting study burden, issuing reminders Detection bias Outcomes not measured uniformly in comparison groups Concurrent comparison groups, blinding, predefined objective outcomes Conflict of interest Competing interests or secondary gain influence outcomes Mandatory disclosure, randomized blinded designs Misuse of statistics and inappropriate interpretation of statistical findings are other common culprits of poor surgical research. The majority of these issues are attributable to unintentional oversights, but a small proportion are caused by deliberate fraud.16,17 Common statistical errors include inadequate power, selection of inappropriate statistical tests, and inappropriate subgroup analysis.18–20 Complex statistical techniques are often relied on to make up for deficiencies in the study design, such as lack of randomization. Studies also tend to focus on statistical differences without considering clinically important thresholds, leading to exaggeration of the findings. Like strategies to minimize bias, the use of statistics should be planned when designing the study, with primary and secondary outcome variables and the statistical plan specified a priori. A well-designed study can also simplify the statistical methods needed. A thorough understanding of validity, bias, and statistical methods is critical when selecting any of the specific study designs discussed below. RANDOMIZED CONTROLLED TRIALS Now suppose that you have formulated a novel and structurally sound research question and have the resources at your institution to conduct the ideal study. A logical approach would be to start atop the pyramid of evidence and determine whether an RCT could be devised before considering other study types at lower levels of evidence.21 RCTs are generally most appropriate in the exploration or assessment stage of surgical innovation, once the technical aspects and safety profile of the procedure are established. Conducting an RCT requires intensive devotion of resources and time. The Wrist and Radius Injury Surgical Trial, led by the senior author (K.C.C.) to evaluate outcomes of treatments for distal radius fractures, took 10 years to complete and required funding from two National Institutes of Health grants.22 Compared with other types of studies, the same factors that make the RCT a coveted entity can also make it unwieldy in surgical research. Ethical and Practical Considerations A variety of ethical and practical considerations pose challenges for surgical RCTs. Like other comparative studies, RCTs are designed to evaluate a null hypothesis, which requires a control group. Unlike pharmaceutical trials, a methodologically equivalent control in surgery, such as a placebo, is rarely possible. One might be tempted to consider nonoperative treatment to be analogous to the placebo. This common view has been the basis of many surgical trials but is often misguided. In reality, nonoperative treatments are highly variable and difficult to control. They can be interventions such as activity modification, immobilization, physical therapy, injections, or a combination thereof. Patients may also implement their own individualized lifestyle changes, such as specialized diets and fitness regimens. Even if the nonoperative treatment is tightly and reliably controlled, the natural history of the patient’s condition may confound outcomes. In surgical trials, the true equivalent of a placebo would be sham surgery, a notion that transgresses ethical boundaries except in the most selective circumstances.23 In most cases, the use of an RCT to evaluate a surgical procedure mandates clinical equipoise between the surgical treatment being investigated and some other treatment.8 Nevertheless, even the existence of true clinical equipoise does not guarantee the feasibility of an RCT. Randomization and allocation concealment can be difficult to execute.7,8 These attributes strip the patient and physician of the opportunity for shared decision-making. Patients may be uncomfortable with randomized treatment selection without input from the surgeon, or with the notion of being part of an experiment. Patients often arrive at the surgeon’s office with a preference for a particular treatment.24 Even when all of these factors are accounted for, patients who agree to participate in an RCT may differ from patients who do not consent, introducing selection bias.3 Ethical considerations are not limited to the patient. Surgeons conducting the study must strive to treat participants equally to avoid unduly influencing the results of the treatment groups. However, surgeons often have their own preferences for one procedure over another.25 If the same surgeon is performing multiple procedures in the study, he or she may also be more facile in one of the procedures, creating potential for performance bias. This brings forth the issue of blinding, which is generally easier to accomplish in medical trials than in surgical trials. Clearly, the surgeon performing the operation cannot be blinded, but it is also difficult to ensure that patients are blinded to the treatment that they received. Patients may become aware of the surgery that was performed based on the shape of a scar, length of time spent in the operating room, or some other discernible feature. The ethics of withholding information about the surgery from the patient and examiners at follow-up visits are controversial, particularly if difficulties with recovery or complications arise. Cost and challenges recruiting patients and ensuring they return to follow-up are other factors that can make the RCT unfeasible.26 Given some of the ethical and practical factors associated with RCTs, other study designs discussed below may be better options. Minimizing Bias in RCTs Good design is crucial for maximizing validity and minimizing bias. Alarmingly, analyses of all RCTs published in The Journal of Bone and Joint Surgery between 1998 and 2013 showed that trials evaluating surgical procedures (as opposed to nonoperative or medical interventions) and with surgeons as first authors scored significantly lower in quality.27,28 To illustrate features of a well-designed surgical RCT, consider a landmark trial investigating open reduction and internal fixation versus casting for minimally displaced scaphoid waist fractures (the Scaphoid Waist Internal Fixation for Fractures Trial).29 This study sought to answer a timely question that has been a longstanding area of clinical equipoise. Allocation concealment and randomization were used with a remote randomization service that stratified patients based on their pattern of fracture displacement, further minimizing confounders. Sample size was determined based on a priori power analysis, and statistical analyses were performed by a blinded statistician following a strict prespecified plan. Primary and secondary outcomes were stated from the outset, and potentially subjective radiologic tests were evaluated independently by two musculoskeletal radiologists and a surgeon. Instead of blinding patients and surgeons, the surgical technique and postoperative protocols were left to the discretion of the surgeons, allowing patient-centered care and accounting for differences in surgeons’ technical preference and skill. This practical approach sought to minimize bias while also maximizing external validity, which was important for a trial aiming to inform clinical practice on an international scale. Empiric data support the importance of sound study design on the results of an RCT. Colditz et al. found that the likelihood of an improved outcome from an experimental treatment increased significantly in the absence of randomization.30,31 In a study analyzing 250 controlled trials, treatment effects were increased by 41% when allocation concealment was inadequate and 30% when the extent of concealment was unclear.32 Trials that were not double-blinded yielded treatment effects 17% greater than double-blinded trials. Methodologic problems like these can lead to inaccurate interpretation of findings and distort knowledge found in the published literature. They can be avoided with use of validated quality checklists such as the Consolidated Standards of Reporting Clinical Trials guidelines when planning a study.33 Such frameworks serve as an important quality safeguard and should be familiar to surgeons undertaking RCTs. Grading systems specific to plastic surgery have also been developed.34 OBSERVATIONAL STUDIES WITH A CONTROL GROUP Many questions in surgery cannot be addressed with an RCT but are amenable to other study designs. A nonrandomized study with a control group should be considered when one of the ethical or practical factors discussed above precludes an RCT. Commonly used designs are cohort studies and case-control studies (Fig. 1).15 Although cohort studies are in a higher tier of evidence, both designs have specific indications, methodologic considerations, and biases.Fig. 1.: Observational study designs.Like RCTs, cohort studies can be highly influential in their scope. Because of fewer upfront demands on participants and less stringent inclusion criteria, these studies lend themselves to broader investigations when more knowledge is needed before performing an RCT. For instance, a prospective cohort study was devised to evaluate the effectiveness and safety of immediate implant-based breast reconstruction with or without mesh following mastectomy (Implant Breast Reconstruction Evaluation study).35 This is a current topic of interest for many plastic surgeons, with recent trends toward immediate reconstruction following mastectomy.36 Although previous RCTs evaluating immediate breast reconstruction had been performed, their validity was questioned because of performance biases and low sample size.37–39 The Implant Breast Reconstruction Evaluation study addressed this gap in knowledge with an exploratory design that included more than 2000 patients from 81 participating centers. Patients underwent different variations of breast reconstruction at the discretion of the treating surgeon, eliminating concerns for patient preference that are a major hindrance to RCTs in breast surgery.40 Multiple predefined primary outcomes were evaluated and multivariable logistic regression was used to control for confounders. In addition to eliminating practical hurdles of RCTs, advantages of cohort studies illustrated in this example include obtaining larger samples, evaluating multiple exposures and outcomes at once, and generating new hypotheses for future studies through an exploratory approach. Surgeons must also be aware of the pitfalls of nonrandomized studies. Without randomization, cohort studies have limited ability to account for confounders. A causal relationship is inferred from the chronologic sequence of exposures and outcomes, which is most convincing in prospective studies. Without blinding or allocation concealment, cohort studies are also susceptible to selection biases. Recall bias is a limitation for retrospective cohort studies because of factors such as inaccurate patient recall and reliance on information from patient charts.41 Variability in documentation practices makes the fidelity of large databases particularly concerning. In case-control studies, the inference of causation is especially problematic because comparison groups are selected based on their outcomes and analyzed retrospectively for exposures. Designing an observational study with a control group requires paying special attention to these inherent limitations and must be individualized to the research question. Exposures, outcomes, inclusion criteria, and statistical methods should all be planned in advance, even for studies meant to be “exploratory” or hypothesis-generating. Observational studies should be evaluated using standardized guidelines such as the Strengthening the Reporting of Observational Studies in Epidemiology framework.42,43 Retrospective cohort studies lend themselves to studying rare conditions and procedures, particularly with the availability of large national databases. Vast amounts of data can be extracted and analyzed rapidly. Meanwhile, case-control studies are useful for investigating factors underlying rare outcomes or complications. When using a registry or database, its purpose, completeness, and accuracy should be carefully evaluated.44 If the question would be better suited for an RCT and there are no major practical or ethical barriers, a higher level of evidence design should be pursued. CASE SERIES An appraisal of articles published in the general surgery literature in 1996 compared the preponderance of case series, 46% of all studies, to “comic opera,” pointing to a necessary shift toward higher quality research.6 A similar survey conducted 10 years later found the proportion of case series had decreased to 34%, with 51% of publications being cohort studies.5 Case series, which typically involve a retrospective account of outcomes from a single procedure, often from a single institution and surgeon, remain a common avenue for publishing novel information. The absence of a control group is their primary flaw, as a hypothesis cannot be tested.44 Retrospective case series are also culprits of publication bias, as new procedures with poor outcomes are unlikely to be published.45–47 Furthermore, failure to favorable results of new techniques are unlikely to be concerns about the validity of a case series from a single Case series are for providing for subsequent hypothesis They should be undertaken with specific such as the safety of a novel procedure or rare or complications. The IDEAL model the use of a case series to be appropriate in the or development first with a new procedure are a and are to the surgical To some of the pitfalls discussed prospective series should be performed with protocols for the new procedure and in of conducting the study. studies should also be to publication The use of retrospective series should be but at a involve patients without and a standardized reporting in the case of RCTs and observational studies, validated checklists can be used to minimize bias when reporting novel surgical interventions in a case A simple approach can be used to the best research design for a surgical question. with consideration for the IDEAL stage of the surgery being investigated, the highest level of appropriate for that stage should be evaluated for feasibility before considering designs at lower levels of the evidence RCTs the highest level of but are not suited for many questions. such as observation studies and case series, to be when practical and ethical considerations preclude the use of an RCT. of the study surgical research should quality design and minimize bias. funding from the National Institutes of from and and a research from to study outcomes. has no interest to in to the of this The authors would like to for and to the development of this They appreciate the review and from of at the of

The investigation of medication errors in nursing includes both methodological and ethical considerations because it is a sensitive field of research. To present an original research protocol for the investigation of nurses' experiences of medication errors with interpretative phenomenological analysis and the relevant methodological and ethical considerations. A discursive paper which presents an original research protocol about nurses' experiences of medication errors with interpretative phenomenological analysis followed by a literature review and personal reflections about the relevant methodological and ethical considerations. The review included papers published in English from 1990 to February 2019 on PubMed, BNI (British Nursing Index), CINAHL (Cumulative Index to Allied Health Literature), ScienceDirect, and Wiley Online Library. The following methodological considerations were identified: recruitment of participants, data collection, and data analysis, and the ethical considerations included researcher's morality, ethics committees, sensitivity, phrasing of sentences and words, recruitment of participants, location of interviews, type of interviews, emotionality management, medication error incidents' management, researcher, or nurse? By facing as many as possible methodological and ethical considerations and establishing solutions for them, the study's validity, reliability, and rigor are enhanced, and the study is ethically robust. Finally, their understanding enables researchers to uncover nurses' experiences and interpret the meanings they generate in depth.

Purpose This brief report contributes to the small research corpus that focuses on methodological and ethical considerations when adolescents and young people are involved in qualitative research, especially when they have lived experiences of interparental violence. These considerations will be illustrated by an ongoing research project, which examines the active role of adolescent girls and young women and their involvement in processes of intergenerational transmission of violence, agency, and gender. Methods A reconstructive biographical approach using the biographical-narrative interview as the data collection method (Qualitative research practice, 2004) was chosen because it effectively addresses ethical challenges, such as power imbalances and concerns about vulnerability. Results Ethical considerations are of great importance when young people are involved in qualitative research, especially when they might still live in families with IPV. This requires specific attention, particularly concerning informed consent, recruitment, confidentiality, and follow-up support. Conclusion A consequent differentiation between children and youth regarding ethical and methodological aspects in IPV research can lead to a nuanced ethical research practice.

The involvement of young Indigenous people in research is a key emphasis in current approaches to both sociology of childhood and Indigenous research. This article discusses how the two research methodologies, both of which emphasise participation rights, intersect in research focusing on the participation and perspectives of Indigenous children and young people in education. The article examines ethical requirements of Indigenous and childhood research and institutional ethics procedures, along with methodological considerations, potential constraints and opportunities in undertaking research that aims to facilitate children and young people's participation. Drawing on empirical data it discusses how these processes have shaped participative research studying the views of Aboriginal and Torres Strait Islander students learning Indigenous knowledge and perspectives in New South Wales schools.

A few weeks ago, we published an editorial discussion on whether artificial intelligence applications should be authors of academic articles [1] . We were delighted to receive more than one interesting reply letter to this editorial in a short time [2, 3] . We hope that opinions on this

Healthcare researchers are increasingly using ethnographic methods to understand the social dynamics and cultural contexts of specific groups, such as clinical teams in hospitals and community clinics. Critical ethnography is a subtype of ethnography that mobilizes critical social theory to expose and challenge group inequities and power dynamics shaped by broader social, economic, and political conditions. Critical ethnography is particularly useful for understanding how providers interact with one another in complex and high-acuity environments such as emergency rooms and intensive care units. Given the varied approaches to critical theory and ethnographic methods, this critical review summarizes how critical ethnography has been conceptualized and applied to study providers in acute care settings. After conducting a comprehensive cross-database search, we extracted the following information from the 27 reviewed publications: paradigm, theoretical framework, axiology, positionality, data collection and analysis methods, approach to rigor, and research ethics considerations. After synthesizing key trends in literature, we identified and critically interpreted several themes, contradictions, and tensions present across the studies. Drawing on social science commentary on theoretical and methodological coherence, axiology, and citational practices in critical theory, this article provides several conceptual, ethical, and methodological considerations for the use of critical ethnography in healthcare research.

BackgroundThe number of interventions to improve recruitment and retention of participants in trials is rising, with a corresponding growth in randomised Studies Within Trials (SWATs) to evaluate their (cost-)effectiveness. Despite recognised challenges in conducting trials involving adults who lack capacity to consent, until now, no individual-level recruitment interventions have focused on this population. Following the development of a decision aid for family members making non-emergency trial participation decisions on behalf of people with impaired capacity, we have designed a SWAT to evaluate the decision aid in a number of host trials (CONSULT). Unlike in recruitment SWATs to date, the CONSULT intervention is aimed at a ‘proxy’ decision-maker (a family member) who is not a participant in the host trial and does not receive the trial intervention. This commentary explores the methodological and ethical considerations encountered when designing such SWATs, using the CONSULT SWAT as a case example. Potential solutions to address these issues are also presented.DiscussionWe encountered practical issues around informed consent, data collection, and follow-up which involves linking the intervention receiver (the proxy) with recruitment and retention data from the host trial, as well as issues around randomisation level, resource use, and maintaining the integrity of the host trial. Unless addressed, methodological uncertainty about differential recruitment and heterogeneity between trial populations could potentially limit the scope for drawing robust inferences and harmonising data from different SWAT host trials. Proxy consent is itself ethically complex, and so when conducting a SWAT which aims to disrupt and enhance proxy consent decisions, there are additional ethical issues to be considered.ConclusionsDesigning a SWAT to evaluate a recruitment intervention for non-emergency trials with adults lacking capacity to consent has raised a number of methodological and ethical considerations. Explicating these challenges, and some potential ways to address them, creates a starting point for discussions about conducting these potentially more challenging SWATs. Increasing the evidence base for the conduct of trials involving adults lacking capacity to consent is intended to improve both the ability to conduct these trials and their quality, and so help build research capacity for this under-served population.

Resumo Compromissos éticos em estudos envolvendo seres humanos têm sido considerados há poucas décadas. No entanto, preocupações a que comumente se restringem os pesquisadores são entendidas como típicas de ética denominada formal (e.g. anonimato, consentimento informado e ausência de fraudes). Neste artigo, enquanto defendemos que esse tipo de ética, também denominada burocrática, precisa ser superada, compartilhamos e ilustramos um exemplo materializado de ética defendida na pesquisa em humanas, nomeadamente, ética emancipatória. Esse exemplo é fornecido pela tese doutoral da primeira autora, sob orientação da segunda, e apresentado com considerações de ordens epistemológicas, ontológicas, metodológicas e éticas do início do processo investigativo ao seu final. Princípios da pesquisa emancipatória (CAMERON et al ., 1992), do cuidado com o outro (NODDINGS, 1984) e, ainda, considerações éticas e metodológicas de Denzin (1997) e Christians (2006) para pesquisas sociais e humanas fundamentam este texto. Em suma, este artigo visa demonstrar formas de distribuição de poder e incorporação das vozes dos participantes em prática de pesquisa.

Greater inclusion of people living with dementia (PLWD) and their caregivers in research is a global research priority and an expressed priority of dementia advocacy organizations. Absent inclusion of PLWD and caregivers, our understanding of dementia-related experiences and optimization of care and caregiving interventions is stymied. Qualitative interviewing techniques constitutes a primary method for obtaining PLWD and caregivers’ perspectives. Yet, there is little guidance on use of qualitative interviewing techniques among PLWD and caregivers or discussion of potential challenges encountered, despite unique vulnerabilities faced throughout the research process, which may be further heightened among historically excluded groups. Meaningful progress toward inclusion of PLWD and their caregivers in dementia research necessitates broader examination of associated methodological and ethical considerations that arise in the conduct of interviews. Drawing from a large multi-site qualitative study of dementia caregivers with exposure to high levels of social disadvantage, we used a multiple-triangulation qualitative approach across interview transcripts, memos, and interviewer discussions to identify methodological and ethical challenges that arose during the interviewing process. Challenges were identified across all phases of research, and included relational concerns with PLWD and family members due to disclosure of sensitive information, risk of re-traumatization in discussing past experiences, multiple roles of caregivers with conflicting perspectives, variable recall capacity, limited prior appraisal of caregiving, and request of interviewers for medical advice or selecting services . We outline events evidencing these challenges and proposed strategies (i.e. use of research consults, interview debriefing) to strengthen research capacity to anticipate and respond to them.

BackgroundAlthough increasingly recognised as valuable within sexual and reproductive health (SRH) research and service improvement, examples of patient and public involvement (PPI) are underdocumented, including specific issues relating to young...

BackgroundSeveral typologies and guidelines are available to address the methodological and practical considerations required in mental health research. However, few studies have actually attempted to systematically identify and synthesise these considerations. This paper provides an integrative review that identifies and synthesises the available research evidence on mental health research methodological considerations.MethodsA search of the published literature was conducted using EMBASE, Medline, PsycINFO, CINAHL, Web of Science, and Scopus. The search was limited to papers published in English for the timeframe 2000–2018. Using pre-defined inclusion and exclusion criteria, three reviewers independently screened the retrieved papers. A data extraction form was used to extract data from the included papers.ResultsOf 27 papers meeting the inclusion criteria, 13 focused on qualitative research, 8 mixed methods and 6 papers focused on quantitative methodology. A total of 14 papers targeted global mental health research, with 2 papers each describing studies in Germany, Sweden and China. The review identified several methodological considerations relating to study design, methods, data collection, and quality assurance. Methodological issues regarding the study design included assembling team members, familiarisation and sharing information on the topic, and seeking the contribution of team members. Methodological considerations to facilitate data collection involved adequate preparation prior to fieldwork, appropriateness and adequacy of the sampling and data collection approach, selection of consumers, the social or cultural context, practical and organisational skills; and ethical and sensitivity issues.ConclusionThe evidence confirms that studies on methodological considerations in conducting mental health research largely focus on qualitative studies in a transcultural setting, as well as recommendations derived from multi-site surveys. Mental health research should adequately consider the methodological issues around study design, sampling, data collection procedures and quality assurance in order to maintain the quality of data collection.

Background In April 2019, our hospital transitioned to an electronic patient record system and patient portal (MyGOSH). MyGOSH enables young people aged 12 years or older and their parents to access results, documentation, appointments, and to communicate with their care team. Aims A focus group was conducted to explore the ethical and legal considerations of young people and their parents using a patient portal from the perspective of hospital Ethics Committee members. Participants and research context Members of the hospital Paediatric Bioethics Centre were recruited ( n = 7). Written informed consent was provided by all participants. Research design The focus group discussion was recorded, transcribed verbatim and analysed using thematic analysis. Ethical considerations Health Research Authority Research Ethics Committee (REC) Approval was granted by London Southeast REC (IRAS Project ID: 248793; REC Reference: 18/LO/1945). Results Four themes, and sub-themes, were identified: (1) granting access – complexities of assessing competence/capacity, exclusion from MyGOSH due to non-disclosure of diagnosis, and truth-telling; (2) inequalities resulting in inequities – complexities of inequity in access; (3) responding to change – providing support and managing expectations; (4) engagement, empowerment and understanding – data safety, empowering young people to take ownership of their health data, a one-size fits all system may not meet the needs of all families, and early engagement with young people/parents. Discussion Giving families portal access can increase engagement, empowering them to be more involved in care, yet poses challenges for all. Complexities exist in the assessment for portal access, and supporting and managing user expectations whilst providing an equitable service. Conclusions Ongoing support is required for all stakeholders following patient portal implementation to navigate the ethical and legal complexities, and to promote equity and portal utility for patient benefit.

Social science methodologies are increasingly used by conservation organisations to improve social‐ecological outcomes. However, ethnographic approaches seeking to understand organisations themselves and how organisational culture impacts biodiversity and social justice are rarely discussed. By exploring previous studies of the methodological considerations of organisational ethnography in conservation, we provide conservationists and ethnographers with an empirically grounded understanding of the opportunities, challenges and underlying ethical considerations of this approach. We conducted a scoping review of a disparate body of literature where ethnographers were embedded in conservation organisations and discussed their methodology, identifying 26 studies for analysis. We then extracted information on key themes relevant to methodological process and uptake. Our review found such research spanned the globe, with a broad range of methodological and ethical considerations related to how ethnographers and conservationists interact. For example, organisational ethnography was perceived as valuable by conservationists as it allowed tracking progress toward internal goals such as diversification of staff and providing moral and emotional support and valuable information for transforming organisational practices. However, conservationists also worried about ethnographers' presence in their organisations. A key methodological challenge we identify, corroborating with the literature, is how ethnographers can benefit organisations while supplying critique. Based on the results, we provide recommendations and areas of reflection for conservation organisations and ethnographers. Mainstreaming organisational ethnography through attention to certain methodological considerations can be beneficial for the future of conservation organisations and the biodiversity and people they impact.

Two years ago, I began a project based on the question, “If online platforms are providing more access for hate groups to recruit and radicalize members, then is it possible to use online platforms to combat discrimination, racism, and hatred?” Educating public audiences and promoting positive social change were laudable goals, but this article explores the idea of how this was done in ethical ways. There were challenges encountered “along the way” when attempting to create a project from personal stories, including issues of ethical storytelling, respectful data management, community engagement with marginalized communities, complications of “going viral,” and more. In this article, I document the process of how four anti-racist videos were created, some of the challenges encountered along the way, methodological maneuvers, and suggestions for further methodological and ethical consideration. I explore two levels of analysis. First, by looking at methodological considerations, I detail the importance of community consultation, the need for research findings to be accessible, useful, and meaningful to the community, and how the decisions and planning around “going viral,” were further complicated by funder requirements and other ethical considerations. At the second level of analysis, I use autoethnography to explore how my own positionality factored into decisions about the project.

This incident captures some of the issues that I faced when conducting research with children and young people in Zambia looking at how their transitions to adulthood are affected when they have caring responsibilities for sick or disabled parents or relatives. Doing research about and with children and young people is fraught with added layers of complexity and sensitivity compared to research with adults, due to their vulnerability. Since the early 1990s there has been a burgeoning of research in the social sciences on children and young people (Evans 2008), with particularly valuable contributions coming from the field of geography (Holloway and Valentine 2000). The recognition that children and young people are social actors (Duckett et al. 2008) who are ‘competent witnesses to speak for themselves about their experiences of, and perspectives on, the social worlds in which they live’ (Barkerand Weller 2003: 208) has led to greater recognition that children and young people not only have the ‘right to express their views freely’ but ‘have valuable knowledge and understanding’ (Robson et al. 2009: 470) about the issues affecting their lives. Such research is based on being ‘fair and respectful’ to young people and recognizes that they are research ‘subjects’ rather than ‘objects’ (Barker and Weller 2003; Ansell 2005; Greene and Hill 2005; Clacherty and Donald 2007) who rather than having research done ‘on them’ can actively participate and contribute to research studies ‘about them.’ However, with this has grown the recognition that while children and young people can offer a valuable contribution to research, they also occupy a vulnerable and powerless position in society in which they can be manipulated (Morrow and Richards 1996; James et al. 1998; Masson 2000; Evans and Becker 2009). While research can give young people a voice, it can also be an ‘intrusive process’ in which young people are asked to discuss sensitive issues (Lindsay 2000). Ethical considerations are relevant to research regardless of the age of the participant, but it is widely recognized that they need to be more stringent when conducting research with children and young people compared to adults (Scott 2000) and must offer greater protection in research relationships. Therefore, while participation of children and young people in research has been actively encouraged, it has been on the understanding that it should not be at the expense of their protection from additional harm or distress (Evans and Becker 2009). Ethics has therefore become a key part of researching youth, ‘predicated on the expectation that the participants [will] suffer no harm as a result of the research or its outcomes’ (Young and Barrett 2001: 130). This chapter explores my experiences in Zambia, focusing on four elements of my fieldwork in which ethical considerations were a key feature of the planning and execution: identifying the research participants; gaining informed consent and ensuring participant safety; selecting the research methods; and recognizing young people’s participation. I illustrate how ethical considerations influenced my behavior and research practice in the field, as well as some of the challenges that occurred and how I overcame them.