Surgical Research

“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

Chapter 1: World Views, Paradigms, and the Practice of Social Science Research Case 1. Quantitative Research Case 2. Qualitative Research Thinking about the Foundations and Practice of Research What This Book Is and Is Not About. What Warrants Our Attention? The Traditional Canon Alternative Paradigms New Techniques or New Paradigms? Chapter 2: History and Context of Paradigm Development Positivism: A Response to Metaphysical and Magical Explanations Critical Theory: A Response to Inequities in Society Interpretivism: A Response to the Excesses of Scientific Social Science The Special Cases of Postmodernism and Feminism Chapter 3: Foundational Issues: Postpositivist and Critical Perspectives Social Science Research: The View from the Postpositivist Paradigm Social Science Research: The View from the Critical Theory Paradigm Chapter 4: History and Foundations of Interpretivist Research (1) Nature of Reality. (2) Purpose of Research. (3) Acceptable Methodology/Data. (4) The Meaning of Data (5) Relationship of Research to Practice. The Implications of an Interpretivist Approach What Sorts of Research are Worthwhile? Examples of Interpretive Research Chapter 5: Frameworks for Qualitative Research Postpositivist Research Moments of Qualitative Research Some General Frameworks for Qualitative Research Chapter 6: General Guidelines for Qualitative Research Guidelines for Qualitative Research Situated or Contextual Understanding, Not Truth, is the Purpose of Research Accept Multiple Sources of Influence Take A Foundational Rather Than Technique Perspective Practice Recursive (Iterative ) and Emergent Data Collection and Analysis Use Multiple Sources of Data Think of Research as a Reflective Process The Researcher is the Primary Tool for Data Collection and Analysis An Emphasis on Participatory versus Nonparticipatory Research. Adopt an Open Approach Deal With Bias Directly Select Natural Contexts for Research Research Should be Holistic, Not Atomistic Research Involves More Than Induction and Deduction: Analogical Reasoning, Abduction, and Family Resemblances Alternatives to Postpositivist Criteria for Believability: Validity and Reliability Alternative Approaches to Validity and Reliability: Triangulation and More Conclusions? Aren't They Generalizations? Chapter 7: Methods of Qualitative Research Case 1: Action Research on a Pediatric Surgical Ward Established Qualitative Research Methods Ethnography Case Studies: Another Form of Qualitative Observation Interview Research Historigraphy Historiography: The Research Methods of History Innovative Methods Participatory Qualitative Research Emancipatory Research Critical Emancipatory Action Research Chapter 8: Approaches to Data Analysis and Intepretation The Purpose of Research General Theory Objective Description Hermeneutic (Verstehen) Understanding Story telling/Narrative Data Analysis Families Eyeballing the Data Connoisseurship: A Global Perspective Hermeneutics as a Data Analysis Method Grounded Theory Analytic Induction A Final Topic: The Ethics of Research Chapter 9: 21st Century Social Science: Peering into the Future Will the Cacophony Continue? Why Can't Social Science Converge on The Answer? Competition Linearity Dialog as an Alternative to Competition Three Approaches to Knowing in Greek Thought Plato Aristotle The Humanities Choices 20th Century Social Science Made Suppose We Chose Badly Two Theories That May Help Us Build 21st Century Social Science Poetic Logic Chaos and Complexity Theory: Another Route to a Nonlinea Social Science

Maintaining ethics in research will defend its credibility, usefulness, and impact within society. However, ethics can vary significantly between research paradigms. This is due to the kinds of ontological, epistemological, and methodological philosophies that each possesses. This paper studies research ethics within positivist, interpretivist, and pragmatist paradigms. There is a clear difference between these paradigms. Ethical considerations in the positivist paradigm concentrated on objectivity, reliability, and treating people fairly. Researchers must uphold objectivity, refrain from prejudice, and defend the rights of participants. Getting informed consent, protecting data, and reducing the possibility of harm to research participants during surveys or experiments are important ethical considerations. The interpretivist paradigm places a high value on ethical concerns arising from subjectivity, ethnocentrism, and researcher involvement. Researchers need to manage personal dynamics, engage in reflexivity, and establish trust with participants. Relational ethics values participants’ lived experiences and promotes collaborative knowledge creation, going beyond traditional judgement to ensure ethical engagement. To consolidate both paradigms, a flexible approach is introduced as the pragmatist paradigm. This is distinguished by methodological diversity and practical problem-solving. Pragmatist researchers, therefore, combine qualitative and quantitative methods to observe ethical dilemmas in a situation-appropriate manner. The researcher must critically balance their ethical responsibilities under various approaches to ensure that moral principles are maintained without sacrificing the flexibility of their study. Using a comparative approach, it reviews literature, research ethics guidelines, and philosophical texts to analyse ethical practices within each paradigm, focusing on ontological, epistemological, and axiological beliefs in research ethics. Ethical decisions should be grounded in the study's philosophical and methodological context, promoting responsible and contextually aware research practices. This paper provides researchers and all parties involved with useful information to enhance ethical standards that consider different research traditions.

Introduction: This paper discusses the ethical considerations involved in conducting qualitative non-therapeutic research on people suffering from obsessive–compulsive disorder (OCD), a topic covered in few, if any, prior studies. Methods: The study summarizes in depth the existing literature on ethical aspects of conducting qualitative and nursing research with psychiatric patients. It constructs an overview of the most important points that should be taken into account when conducting non-therapeutic qualitative research on individuals with this disorder. Results: This paper draws attention to three ethical considerations: (1) informed consent; (2) OCD sufferer’s competence to give consent; and (3) aspects of the relationship that arises between the researcher and participant. Conclusions: This paper argues that those with OCD remain capable of giving consent, notwithstanding the continuing debates around their cognitive condition. It also provides an informative overview of aspects concerning their competence and insight, and suggests precautions to be followed when conducting interviews, paying attention to several factors that may determine the nature of the interview. Keywords: qualitative research, non-therapeutic research, ethical considerations, obsessive–compulsive disorder.

Surgical trials have always been difficult to conduct and have often been criticized both for the quality and the quantum compared with non-surgical specialties. There have been no studies to analyze the status of surgical research in India. We performed a study to evaluate the proportion and the quality of surgical research registered with the trial’s registry in the country. The Clinical Trials Registry of India (CTRI)—a public registry was accessed to understand the number of surgical trials registered since its inception in July 2007 to April 2018. We defined surgical trials as any trial done to assess and/or compare distinct surgical procedures or devices, surgical techniques, and addition of another treatment to surgery. Different characteristics of these studies including registration year, specialty, study design, sample size, and funding were analyzed. Among 13,301 trials registered in the study period, only 373 (2.8%) were surgical trials. Most of the surgical trials were RCTs (n = 224, 60%), followed by observational studies (n = 120, 32%). Oncology-related surgical trials constituted only 10% (n = 39/373), with the majority being RCTs (n = 25, 64%). Surgical trials were performed most often in surgical gastroenterology (n = 74, 19.8%) and ophthalmology (n = 72, 19.3%). Funding for surgical trials was mostly through institutional funds and only a few trials received extramural funding (n = 56, 15%). Surgical trials constituted less than 3% of all trials registered with CTRI. However, the majority of them were RCT’s and mostly funded by intramural funding. The reasons for these small numbers could be many.

Methodologists recommend member checking (MC) to increase the credibility of results from qualitative studies. In this procedure, the researcher’s categories, hypotheses and interpretations can be verified or corrected by respondents, and the latter can add information. Various methods are available for conducting this procedure. However, in addition to methodological issues, MC also raises ethical questions. In this article, we investigate which member check method (MCM) is most appropriate for a particular study from an ethical perspective. Based on a literature review about ethical issues in different MCMs and ethical principles contained in guidelines for research ethics, we develop seven decision criteria that can facilitate an ethically reflected decision for a particular MCM. Accordingly, we consider the principles of beneficence, justice, scientific quality, informed consent and avoiding harm, which are widely accepted in research ethics. In addition, we recommend that participants’ wishes and concerns regarding the MC be inquired about and considered.

Research ethics guidelines grew out of several infamous episodes where research subjects were exploited. There is significant international synchronization of guidelines. However, indigenous groups in New Zealand, Canada and Australia have criticized these guidelines as being inadequate for research involving indigenous people and have developed guidelines from their own cultural perspectives. Whilst traditional research ethics guidelines place a lot of emphasis on informed consent, these indigenous guidelines put much greater emphasis on interdependence and trust. This article argues that traditional guidelines are premised on relationships of equal power, and that often the researcher has more power that is not fully equalized by providing information. Where there is a relationship of unequal power, then focusing on interdependence and trust is more likely to achieve ethical safety. We illustrate this thesis by describing the detail of a research project looking at the use of interpreters, where we video-recorded live consultations and then interviewed the patient, interpreter and doctor. We conclude by suggesting that mainstream research ethics guidelines should pay more attention to the development of a trustworthy relationship between subject and researcher, and that, following the lead from clinical medicine, we should develop a culturally competent ethical framework for research on human subjects.

Evaluating the Safety of Endoscopy During Pregnancy: The Robust Statistical Power vs Limitations of a National Registry Study

Objective The global surge in adolescent suicide necessitates the development of innovative and efficacious preventive measures. Traditionally, various approaches have been used, but with limited success. However, with the rapid advancements in artificial intelligence (AI), new possibilities have emerged. This paper reviews the potentials and challenges of integrating AI into suicide prevention strategies, focusing on adolescents. Method: This narrative review assesses the impact of AI on suicide prevention strategies, the strategies and cases of AI applications in adolescent suicide prevention, as well as the challenges faced. Through searches on the PubMed, web of science, PsycINFO, and EMBASE databases, 19 relevant articles were included in the review. Results: AI has significantly improved risk assessment and predictive modeling for identifying suicidal behavior. It has enabled the analysis of textual data through natural language processing and fostered novel intervention strategies. Although AI applications, such as chatbots and monitoring systems, show promise, they must navigate challenges like data privacy and ethical considerations. The research underscores the potential of AI to enhance future suicide prevention efforts through personalized interventions and integration with emerging technologies. Conclusion: AI possesses transformative potential for adolescent suicide prevention by offering targeted and adaptive solutions, while they also raise crucial ethical and practical considerations. Looking forward, AI can play a critical role in mitigating adolescent suicide rates, marking a new frontier in mental health care.

Surgical research: from comic opera to IDEAL and collaborative symphonies The role of the editor of a medical journal is not only to select papers for publication, but also to question current dogma and be provocative. Richard Horton, Editor of The Lancet, did just that in his commentary: Surgical research or comic opera: questions, but few answers (The Lancet 1996; 437: 984). His commentary was not without evidence. He had evaluated the first edition of nine general surgery journals in 1996 and found that of the 215 articles, only 7% were randomized trials and 46% case series. His challenge to the surgical community sent vibrations through the academic surgical departments of the UK, ‘only when the quality of publications in the surgical literature has improved will surgeons reasonably be able to rebut the charge that as much as half of the research they undertake is misconceived’. Indeed, reference was made to Horton's challenge at the Annual Scientific Congress of the RACS in Brisbane in May 2016, at the plenary session on ‘Innovation – learning from the next generation’. Three academic surgeons from the UK praised and thanked Horton for precipitating change in surgical research. Derek Alderson and Dion Morton focused on developments within the Royal College of Surgeons (RCS) in the formation of the three pillars of the RCS Research Department: Research Fellowships and Awards, Clinical Effectiveness Unit and the Surgical Trials Initiative. Whereas Ravinder Vohra described the proliferation of research collaboratives driven by trainees, particularly in his region through the West Midlands Research Collaborative (www.wmresearch.org.uk), with studies such as ROSSINI, evaluating wound protection in reducing surgical site infection, and DREAMS, the influence of dexamethasone on reducing postoperative nausea. These presentations can be accessed through the Annual Scientific Congress virtual congress (https://asc.surgeons.org/virtual-congress). Similar research collaboratives now exist throughout all regions and NHS trusts in the UK and Ireland. The great potential of these collaboratives is the ability to recruit thousands of patients to be able to satisfy the power calculation necessary to provide results with statistically significant outcomes. The progress that has been made was acknowledged in The Lancet commentary: The struggle for better research in surgery (The Lancet 2016; 387: 1970) with specific reference to the IDEAL collaboration, developed indirectly as a consequence of Horton's challenge, an initiative to improve the quality of research in surgery (www.ideal-collaboration.net). The collaboration is an international network that grew out of a collection of methodologists and clinicians who held a series of conferences in Balliol College, Oxford, between 2007 and 2009. It is a model that describes the stages of innovation in surgery: idea, development, exploration, assessment and long-term study. A set of recommendations at each stage of the model have been developed by experts in evidence-based surgery. The IDEAL collaboration is directed by an international steering group of surgeons and researchers in surgery, and other innovative, complex interventions, coordinated from the University of Oxford, Nuffield Department of Surgical Sciences, including two representatives from Australia, Guy Madden from Adelaide and Paul Glasziou from Brisbane. The five domains of the IDEAL collaboration are: Idea (stage 1 in innovation). The goal is a proof of concept. Reporting should be in the form of a structured case report, for example, perioral endoscopic myotomy for oesophageal achalasia. Development (stage 2A). The goal is to refine the technique by extending it to more patients, usually around 30, where ethical approval is required, with outcomes reflecting the safety and success of the procedure, including negative results. Reporting should be in the form of prospective development studies. Exploration (stage 2B). The goal is to build upon the technique established in stage 2A, and expand through a patient base of 100s, where the studies should be prospective, being a precursor to the randomized control study such as prospective collaborative study. Assessment (stage 3). The goal is to compare the innovation to the current standard or other alternatives using randomized trials. Long-term studies (stage 4). The goal is surveillance to monitor long-term effects. The majority of these studies should be in the form of a registry. The other significant function of the IDEAL collaboration is to coordinate the trainee research collaboratives, referred to above, under the banner of the Academic Surgical Collaborative, a trainee research collaborative working on methodology outcomes and reporting issues within surgery. A recent example is the National Appendicectomy Audit involving 95 centres (BJS 2013; 100: 1240). There are 27 regional collaboratives, including the West Midlands Research Collaborative mentioned above. So, Horton's ‘comic opera’ challenge has been answered, loud and clear from the ‘orchestra pits’ of the RCS and the IDEAL collaboration. Probably, what Horton did not predict was the willingness of surgeons in the UK and internationally to collaborate and the power of collaboration to not only generate sufficient statistical power but also better patient outcomes. Something RACS could emulate?

Background: Although chronic obstructive pulmonary disease (COPD) is a life-limiting disease with a significant symptom burden, the patients are more often referred to nursing homes (NH), than to specialist palliative care (SPC) at the end of life (EOL). This study aimed to compare patients with COPD in SPC with those in NH and to compare the care provided.Methods: A national register study was carried out where the Swedish National Airway Register and the Swedish Register of Palliative Care were merged. COPD patients who died in NHs or short-term facilities were included in the NH group (n = 415) and those who died in SPC were included in the SPC group (n = 355). Demographic and clinical variables were included from the Swedish National Airway Register and variables concerning EOL care from the Swedish Register of Palliative Care.Results: Symptom prevalence was similar in NHs and SPC, but symptom assessment (32% vs 20%), symptom relief medication (93-98% in SPC vs 74-90% in NH), EOL discussions (88% vs 66%), and bereavement support (94% vs 67%) were more likely in SPC (in all comparisons p < 0.001). Younger age and co-habiting increased the probability of dying in SPC (p < 0.001).Conclusion: Despite similar symptom prevalence, older persons are more likely to be referred to NHs. If applying a palliative care philosophy in NHs, routine symptom assessment and prescription of rescue medication for frequent symptoms, would be more likely. Promoting advance care planning and EOL discussions at an earlier stage would result in more prepared patients and families.

Objective. To investigate the antenatal health and demographic factors as well as pregnancy and delivery outcomes in women with intellectual disability (ID) in Sweden. Design. A population-based register study. Setting. The National Patient Register (NPR) linked to the Medical Birth Register (MBR). Sample. Women with ID classified as International Classification of Diseases (ICD) 8–10 who gave birth in 1999–2007 (n = 326), identified from the NPR linked to the MBR, were compared with all first-time, singleton mothers without ID or any other psychiatric diagnoses during this period in Sweden (n = 340 624). Methods. Population-based data were extracted from the NPR and the MBR. Main outcome measures. Health and socio-demography at first antenatal visit, mode of delivery, pain relief during labor, preterm birth and discharge from hospital. Results. A higher proportion of women with ID were teenagers (18.4 vs. 3.3%), obese (20.1 vs. 8.6%) and single (36.6 vs. 6.2%) compared with women without ID, and women with ID smoked more often (27.9 vs. 7.9%). Women with ID had more often a preterm birth (12.2 vs. 6.1%), a cesarean section (CS) (24.5 vs. 17.7%) and used less nitrous oxide as pain relief during labor (59.5 vs. 75.8%). Women with ID had a higher risk for preterm birth [odds ratio (OR) 1.68], CS (OR1.55), non-use of nitrous oxide (OR 1.89) and discharge from hospital to a place other than home (OR 2.24). Conclusion. Pregnant women with ID should be considered a risk group suggesting that better tailored pre- and intrapartum care and support are needed for these women.

Background:Cancer and circulatory diseases are overrepresented among the annual deaths in Sweden. Specialized palliative care (SPC) is considered complex, especially by cancer patients who have undergone long-term treatment. Relatives caring for a person with cancer within the home are faced with many demanding tasks.Purpose:To describe and map relatives’ experiences of the end-of-life care given in specialized palliative home care from a Swedish national perspective.Methods:A register study was conducted with a mixed-method design using qualitative and quantitative descriptive data from relatives (n = 563). Reflexive thematic analysis was used for the qualitative data, followed by a quantifying process inspired by Sandelowski.Findings:Two main themes were identified, with related themes and subthemes: “Home—a safe, dignified, and good place for dying” and “Home—a challenging, lonely, and unworthy place for dying.” As a place of dying during SPC, home provided both security and challenging events. It offered security for the family and upheld their dignity with the presence and support of competent healthcare professionals (HCPs). Conversely, challenging events emphasized how the relatives were unprepared for their loved one’s death and struggled to cope with the end-of-life situation. Some relatives felt that too much of the responsibility was left to them. However, the quantitative data showed that 99.1% of the relatives knew where to find urgent help during the last week of life, and the quantified qualitative data showed that HCPs were often available and supportive.Conclusion:Specialized palliative home care must strive to minimize challenging events that relatives experience during their loved one’s end of life and reinforce protective factors such as the presence of HCPs. As the end-of-life period is challenging for families, adequate support and competencies must be secured. Otherwise, there is a risk of increased family suffering and relatives having difficulties with grief after the death.

AimsTo investigate liver-related and all-cause mortality among amphetamine users with hepatitis C virus (HCV) infection and compare this with opioid users with HCV infection and the uninfected general population.MethodsIn this national register study of mortality in persons notified with HCV infection 1990–2015 and a substance-related diagnosis in Sweden, amphetamine users (n = 6,509) were compared with opioid users (n = 5,739) and a matched comparison group without HCV infection/substance use (n = 152,086).ResultsAmphetamine users were observed for 91,000 years and 30.1% deceased. Crude liver-related mortality was 1.8 times higher in amphetamine users than opioid users (crude mortality rate ratio 1.78, 95% CI 1.45–2.19), but there was no significant difference when adjusting for age and other defined risk factors. An alcohol-related diagnosis was associated with liver-related death and was more common among amphetamine users. Crude and adjusted liver-related mortality was 39.4 and 5.8 times higher, respectively, compared with the uninfected group. All-cause mortality was lower than in opioid users (adjusted mortality rate ratio 0.78, 95% CI 0.73–0.84), but high compared with the uninfected group. External causes of death dominated in younger ages whereas liver-related death was more common among older individuals.ConclusionsThis national register study presents a higher crude risk of liver-related death among HCV-infected amphetamine users compared with opioid users or the uninfected general population. The higher risk of liver-related death compared with opioid users may be explained by lower competing death risk and higher alcohol consumption. Treatment of HCV infection and alcohol use disorders are needed to reduce the high liver-related mortality.

To assess the fetal loss rate following amniocentesis and chorionic villus sampling (CVS). This was a national registry-based cohort study, including all singleton pregnant women who had an amniocentesis (n = 32 852) or CVS (n = 31 355) in Denmark between 1996 and 2006. Personal registration numbers of women having had an amniocentesis or a CVS were retrieved from the Danish Central Cytogenetic Registry, and cross-linked with the National Registry of Patients to determine the outcome of each pregnancy. Postprocedural fetal loss rate was defined as miscarriage or intrauterine demise before 24 weeks of gestation. The miscarriage rates were 1.4% (95% CI, 1.3-1.5) after amniocentesis and 1.9% (95% CI, 1.7-2.0) after CVS. The postprocedural loss rate for both procedures did not change during the 11-year study period, and was not correlated with maternal age. The number of procedures a department performed had a significant effect on the risk of miscarriage. In departments performing fewer than 500 amniocenteses, the odds ratio for fetal loss was 2.2 (95% CI, 1.6-3.1) when compared to departments performing more than 1500 procedures during the 11-year period. For CVS the risk of miscarriage was 40% greater in departments performing 500-1000 and 1001-1500 as compared to those performing more than 1500 procedures. The miscarriage rates (i.e. spontaneous loss and procedure-related loss) after amniocentesis and CVS were 1.4% and 1.9%, respectively. This difference may be explained by the difference in gestational age at the time of the procedures. The miscarriage rate was inversely correlated with the number of procedures performed in a department.