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Purpose Newborn genomic sequencing (nGS) has great potential to improve pediatric care. Parental interest and concerns about genomics are relatively unexplored. Understanding why parents decline research consent for nGS may reveal implementation barriers. Methods We evaluated parental interest in a randomized trial of nGS in well-baby and intensive care unit nursery settings. Interested families attended an informational enrollment session (ES) with a genetic counselor prior to consenting. Reason(s) for declining participation and sociodemographic associations were analyzed. Results Of 3860 eligible approached families, 10% attended ES, 67% of whom enrolled. Of 1760 families queried for decline reasons, 58% were uninterested in research. Among 499 families considering research, principal reasons for decline prior to ES included burdensome study logistics (48%), feeling overwhelmed postpartum (17%), and lack of interest/discomfort with genetic testing (17%). Decliners after ES more often cited concerns about privacy/insurability (41%) and uncertain/unfavorable results (23%). Conclusion Low interest in research and study logistics were major initial barriers to postpartum enrollment and are likely generic to many postpartum research efforts. Concerns over privacy and result implications were most commonly cited in decliners after ES. Understanding parental concerns around research nGS may inform future integration of nGS into newborn screening, predictive testing, and pediatric diagnostics.

ObjectiveAntireflux surgery can be proposed in patients with GORD, especially when proton pump inhibitor (PPI) use leads to incomplete symptom improvement. However, to date, international consensus guidelines on the clinical criteria and additional technical examinations used in patient selection for antireflux surgery are lacking. We aimed at generating key recommendations in the selection of patients for antireflux surgery.DesignWe included 35 international experts (gastroenterologists, surgeons and physiologists) in a Delphi process and developed 37 statements that were revised by the Consensus Group, to start the Delphi process. Three voting rounds followed where each statement was presented with the evidence summary. The panel indicated the degree of agreement for the statement. When 80% of the Consensus Group agreed (A+/A) with a statement, this was defined as consensus. All votes were mutually anonymous.ResultsPatients with heartburn with a satisfactory response to PPIs, patients with a hiatal hernia (HH), patients with oesophagitis Los Angeles (LA) grade B or higher and patients with Barrett’s oesophagus are good candidates for antireflux surgery. An endoscopy prior to antireflux surgery is mandatory and a barium swallow should be performed in patients with suspicion of a HH or short oesophagus. Oesophageal manometry is mandatory to rule out major motility disorders. Finally, oesophageal pH (±impedance) monitoring of PPI is mandatory to select patients for antireflux surgery, if endoscopy is negative for unequivocal reflux oesophagitis.ConclusionWith the ICARUS guidelines, we generated key recommendations for selection of patients for antireflux surgery.

Purpose One anastomosis/mini gastric bypass (OAGB/MGB) is up to date the third most performed obesity and metabolic procedure worldwide, which recently has been endorsed by ASMBS. The main criticisms are the risk of bile reflux, esophageal cancer, and malnutrition. Although IFSO has recognized this procedure, guidance is needed regarding selection criteria. To give clinicians a daily support in performing the right patient selection in OAGB/MGB, the aim of this paper is to generate clinical guidelines based on an expert modified Delphi consensus. Methods A committee of 57 recognized bariatric surgeons from 24 countries created 69 statements. Modified Delphi consensus voting was performed in two rounds. An agreement/disagreement among ≥ 70.0% of the experts was considered to indicate a consensus. Results Consensus was achieved for 56 statements. Remarkably, ≥ 90.0% of the experts felt that OAGB/MGB is an acceptable and suitable option “in patients with Body mass index (BMI) > 70, BMI > 60, BMI > 50 kg/m 2 as a one-stage procedure,” “as the second stage of a two-stage bariatric surgery after Sleeve Gastrectomy for BMI > 50 kg/m 2 (instead of BPD/DS),” and “in patients with weight regain after restrictive procedures. No consensus was reached on the statement that OAGB/MGB is a suitable option in case of resistant Helicobacter pylori . This is likely as there is a concern that this procedure is associated with reflux and its related long-term complications including risk of cancer in the esophagus or stomach. Also no consensus reached on OAGB/MGB as conversional surgery in patients with GERD after restrictive procedures. Consensus for disagreement was predominantly achieved “in case of intestinal metaplasia of the stomach” (74.55%), “in patients with severe Gastro Esophageal Reflux Disease (GERD)(C,D)” (75.44%), “in patients with Barrett’s metaplasia” (89.29%), and “in documented insulinoma” (89.47%). Conclusion Patient selection in OAGB/MGB is still a point of discussion among experts. There was consensus that OAGB/MGB is a suitable option in elderly patients, patients with low BMI (30–35 kg/m 2 ) with associated metabolic problems, and patients with BMIs more than 50 kg/m 2 as one-stage procedure. OAGB/MGB can also be a safe procedure in vegetarian and vegan patients. Although OAGB/MGB can be a suitable procedure in patients with large hiatal hernia with concurrent hiatal hernia, it should not be offered to patients with grade C or D esophagitis or Barrett’s metaplasia. Graphical abstract

Acute myeloid leukemia (AML) is primarily a disease of older adults, for whom optimal treatment strategies remain controversial. Because of the concern for therapeutic resistance and, in particular, excessive toxicity or even treatment-related mortality, many older or medically unfit patients do not receive AML-directed therapy. Yet, evidence suggests that outcomes are improved if essentially all of these patients are offered AML therapy, ideally at a specialized cancer center. Medical fitness for tolerating intensive chemotherapy can be estimated relatively accurately with multiparameter assessment tools; this information should serve as basis for the assignment to intensive or non-intensive therapy. Until our accuracy in predicting the success of individual therapies improves, all patients should be considered for participation in a randomized controlled trial. Comparisons between individual trials will be facilitated once standardized, improved response criteria are developed, and standard treatment approaches have been defined against which novel therapies can be tested.

BackgroundMore effective recruitment strategies like alternative approaches to consent are needed to facilitate adequately powered trials. Witholding Enteral feeds Around Transfusion was a multicentre, randomised, pilot trial that compared withholding and continuing feeds around transfusion. The primary clinical outcome was necrotising enterocolitis. The trial used simplified opt-out consent with concise parent information and no consent form.ObjectiveTo explore the views and experiences of parents and health professionals on the acceptability and feasibility of opt-out consent in randomised comparative effectiveness trials.MethodsA qualitative, descriptive interview-based study nested within a randomised trial. Semistructured interview transcripts were analysed using inductive thematic analysis.SettingEleven neonatal units in England.ParticipantsEleven parents and ten health professionals with experience of simplified consent.ResultsFive themes emerged: ‘opt-out consent operationalised as verbal opt-in consent’, ‘opt-out consent normalises participation while preserving parental choice’, ‘opt-out consent as an ongoing process of informed choice’, ‘consent without a consent form’ and ‘choosing to opt out of a comparative effectiveness trial’, with two subthemes: ‘wanting “normal care”’ and ‘a belief that feeding is better’.ConclusionIntroducing a novel form of consent proved challenging in practice. The principle of a simplified, opt-out approach to consent was generally considered feasible and acceptable by health professionals for a neonatal comparative effectiveness trial. The priority for parents was having the right to decide about trial participation, and they did not see opt-out consent as undermining this. Describing a study as ‘opt-out’ can help to normalise participation and emphasise that parents can withdraw consent.

Purpose General consensus of patient selection criteria for outpatient joint arthroplasty is lacking, which is paramount to prevent prolonged hospital stay, adverse events and/or readmissions. This review highlights patient selection criteria for OJA based on the current literature and expert opinion. Methods A search of the English and International electronic healthcare databases including MEDLINE/PubMed, EMBASE, AMED and the Cochrane library was performed in November 2015 to include studies published during the last 10 years. Furthermore, a survey of physicians from different specialties was performed. Results Fourteen studies described results regarding outpatient joint arthroplasty. Studies on outpatient hip and/or knee arthroplasty resulted in similar outcome in preselected patients. Patients who are able and willing to participate, with a low ASA classification (II), bleeding disorders, poorly controlled and/or severe cardiac (e.g. heart failure, arrhythmia) or pulmonary (e.g. embolism, respiratory failure) comorbidities, uncontrolled DM (type I or II), a high BMI (>30 m 2 /kg), chronic opioid consumption, functional neurological impairments, dependent functional status, chronic/end-stage renal disease and/or reduced preoperative cognitive capacity should be excluded from outpatient joint arthroplasty. The expert opinion-based selection criteria were comparable to literature with a further extension of exclusion for patients with practical issue’s, urologic medical history and/or severe mobility disorders. Conclusion Based on the current literature, the presented patient selection criteria provide a basis for outpatient joint arthroplasty and can be useful when selecting patients. Together with a change in mindset, a multidisciplinary approach and literature-based protocols, outpatient joint arthroplasty can be applied in daily orthopaedic practice while ensuring patients’ safety. Level of evidence Clinical review, Level III.

Abstract ObjectiveTo evaluate the effect of opt-in compared with opt-out recruitment strategies on response rate and selection bias. DesignDouble blind randomised controlled trial. SettingTwo general practices in England. Participants510 patients with angina. InterventionPatients were randomly allocated to an opt-in (asked to actively signal willingness to participate in research) or opt-out (contacted repeatedly unless they signalled unwillingness to participate) approach for recruitment to an observational prognostic study of patients with angina. Main outcome measuresRecruitment rate and clinical characteristics of patients. Results The recruitment rate, defined by clinic attendance, was 38% (96/252) in the opt-in arm and 50% (128/258) in the opt-out arm (P = 0.014). Once an appointment had been made, non-attendance at the clinic was similar (20% opt-in arm v 17% opt-out arm; P = 0.86). Patients in the opt-in arm had fewer risk factors (44% v 60%; P = 0.053), less treatment for angina (69% v 82%; P = 0.010), and less functional impairment (9% v 20%; P = 0.023) than patients in the opt-out arm. Conclusions The opt-in approach to participant recruitment, increasingly required by ethics committees, resulted in lower response rates and a biased sample. We propose that the opt-out approach should be the default recruitment strategy for studies with low risk to participants.

BackgroundIndividual informed consent from all participants is required for most randomized clinical trials (RCTs). However, some exceptions—for example, emergency research—are widely accepted. MethodsThe literature on various approaches to randomization without consent (RWOC) has never been systematically reviewed. Our goal was to provide a survey and narrative synthesis of published proposals for RWOC. We focused on proposals to randomize at least some participants in a study without first obtaining consent to randomization. This definition included studies that omitted informed consent entirely, omitted informed consent for selected patients (e.g., the control group), obtained informed consent to research but not to randomization, or only obtained informed consent to randomization after random assignment had already occurred. It omitted oral and staged consent processes that still obtain consent to randomization from all participants before randomization occurs. ResultsWe identified ten different proposals for RWOC: two variants of cluster randomization, two variants of the Zelen design, consent to postponed information, two-stage randomized consent, cohort multiple RCT, emergency research, prompted optional randomization trials, and low-risk pragmatic RCTs without consent. ConclusionOf all designs discussed here, only cluster randomized designs and emergency research are routinely used, with the justification that informed consent is infeasible in those settings. Other designs have raised concerns that they do not appropriately respect patient autonomy. Recent proposals have emphasized the importance for RWOC of demonstrating such respect through systematic patient engagement, transparency, and accountability, potentially in the context of learning health care systems.

Background Informed consent is considered to be the standard method for respecting the autonomy of individual participants in research and practices and is thought to be based on several conditions: (1) providing information on the purpose of the research or a specific treatment, what it will entail, (2) the participants being mentally competent to understand the information and weigh it in the balance, and (3) the participants to be free from coercion. While there are studies of informed consent in other countries, especially Low and Middle Income Countries (LMICs), this study explored the experiences of clinicians regarding the process of obtaining informed consent to participate in a Randomised Controlled Trial (RCT) in particular and treatment in general in healthcare settings, both general and mental health, specifically focusing on the tension between individualistic concept of autonomy and collectivist values in cultures such as Pakistan. Methods Qualitative interviews with 20 clinicians from healthcare settings in Pakistan who also served as recruiters in a suicide prevention RCT in Pakistan. The interviews were guided by semi-structured topic guide. All interviews were audio-recorded and transcribed verbatim. Results The interviews revealed that shared decision making was more morally important than individual autonomy, the role of the family played a dominant part in the consent-taking procedure, the decision of the elder and/or family patriarch took prominence, and that clinician-researchers encountered significant challenges in consent process in Pakistan, while recruiting patients into the trial as well as during routine treatment processes in healthcare settings. Four distinct themes emerged which were (1) Family deciding for patients, (2) Benefits of involving family in consent process, (3) Gender disparity in consent process, (4) Challenges experienced by clinician-researchers during consent process in Pakistan. Conclusions The concept of consent is generally considered important in many cultures, however, there are two strands of understanding. There seems to be consensus that participant agreement is necessary to protect the participant but with regards to autonomy there are significant cultural differences whether it is the right for autonomy of the individual (individualistic concept) or family, community, or expert authority in other cultures. In Pakistan clinician-researchers sometimes preferred one approach and sometimes the other as they appreciated the interests of the patient to be.