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Editorials21 December 1999Handling Hospital Errors: Is Disclosure the Best Defense?Albert W. Wu, MD, MPHAlbert W. Wu, MD, MPHThe Johns Hopkins University School of Medicine; Baltimore, MD 21205 (Wu)Author, Article, and Disclosure Informationhttps://doi.org/10.7326/0003-4819-131-12-199912210-00012 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail Why do patients sue? Bad outcomes and errors in care are obvious factors, but some of the available evidence implicates deficient communication. One attorney explained it to me this way:In over 25 years of representing both physicians and patients, it became apparent that a large percentage of patient dissatisfaction was generated by physician attitude and denial, rather than the negligence itself. In fact, my experience has been that close to half of malpractice cases could have been avoided through disclosure or apology but instead were relegated to litigation. What the majority of patients really wanted was simply an honest ...References1. Green JA. Minimizing malpractice risks by role clarification. The confusing transition from tort to contract. Ann Intern Med. 1988;109:234-41. LinkGoogle Scholar2. Hickson GB, Clayton EW, Githens PB, Sloan FA. Factors that prompted families to file medical malpractice claims following perinatal injuries. JAMA. 1992;267:1359-63. CrossrefMedlineGoogle Scholar3. Levinson W, Roter DL, Mullooly JP, Dull VT, Frankel RM. Physician-patient communication. The relationship with malpractice claims among primary care physicians and surgeons. JAMA. 1997;277:553-9. CrossrefMedlineGoogle Scholar4. Beckman JP. Nursing negligence: analyzing malpractice in the hospital setting. Thousand Oaks, CA: Sage; 1996. Google Scholar5. Brennan TA, Leape LL, Laird NM, Hebert L, Localio AR, Lawthers AG, et al . Incidence of adverse events and negligence in hospitalized patients. Results of the Harvard Medical Practice Study I. N Engl J Med. 1991;324:370-6. CrossrefMedlineGoogle Scholar6. Localio AR, Lawthers AG, Brennan TA, Laird NM, Hebert LE, Peterson LM, et al . Relation between malpractice claims and adverse events due to negligence. Results of the Harvard Medical Practice Study III. N Engl J Med. 1991;325:245-51. CrossrefMedlineGoogle Scholar7. Andrews LB, Stocking C, Krizek T, Gottlieb L, Krizek C, Vargish T, et al . An alternative strategy for studying adverse events in medical care. Lancet. 1997;349:309-13. CrossrefMedlineGoogle Scholar8. Wu AW, Folkman S, McPhee SJ, Lo B. Do house officers learn from their mistakes? JAMA. 1991;265:2089-94. CrossrefMedlineGoogle Scholar9. Wu AW, Cavanaugh TA, McPhee SJ, Lo B, Micco GP. To tell the truth: ethical and practical issues in disclosing medical mistakes to patients. J Gen Intern Med. 1997;12:770-5. CrossrefMedlineGoogle Scholar10. Witman AB, Park DM, Hardin SB. How do patients want physicians to handle mistakes? A survey of internal medicine patients in an academic setting. Arch Intern Med. 1996;156:2565-9. CrossrefMedlineGoogle Scholar11. Grady D. Doctors being urged to admit their mistakes. New York Times. 12 Dec 1997:C9. Google Scholar12. Kraman SS, Hamm G. Risk management: extreme honesty may be the best policy. Ann Intern Med. 1999;131:963-7. LinkGoogle Scholar13. Burstin HR, Johnson WG, Lipsitz SR, Brennan TA. Do the poor sue more? A case–control study of malpractice claims and socioeconomic status. JAMA. 1993;270:1697-701. CrossrefMedlineGoogle Scholar14. Reynolds RA, Rizzo JA, Gonzales ML. The cost of medical professional liability. JAMA. 1987;257:2776-81. CrossrefMedlineGoogle Scholar15. Orenstein A. Apology excepted: incorporating a feminist analysis into evidence policy where you would least expect it. Southwestern University Law Review. 1999;28:221-79. Google Scholar16. Beyond MICRA: new ideas for liability reform. American College of Physicians. Ann Intern Med. 1995; 122:466-73. Google Scholar17. Sundhedsministeriet. Betænkning om revision af lov om patientforsikring. Betænkning nr. 1346. København, Denmark; 1997. www.sum.dk/publika/forsikr/. Google Scholar18. Brennan TA, Rosenthal M. Medical malpractice reform: the current proposals. J Gen Intern Med. 1995;10:211-8. CrossrefMedlineGoogle Scholar19. Wadlington W. Medical injury compensation. A time for testing new approaches [Editorial]. JAMA. 1991;265:2861. CrossrefMedlineGoogle Scholar Author, Article, and Disclosure InformationAuthors: Albert W. Wu, MD, MPHAffiliations: The Johns Hopkins University School of Medicine; Baltimore, MD 21205 (Wu)Corresponding Author: Albert W. Wu, MD, MPH, Health Services Research and Development Center, 624 North Broadway, Baltimore, MD 21205; e-mail, awu@jhsph.edu. For reprint orders in quantities exceeding 100, please contact the Reprints Coordinator; phone, 215-351-2657; e-mail, reprints@mail.acponline.org. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetailsSee AlsoRisk Management: Extreme Honesty May Be the Best Policy Steve S. 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Decomposing the Effect of Apologies on Medical Malpractice Payments Using State Apology LawsDoes sorry work? The impact of apology laws on medical malpracticeAre Temporary Staff Associated with More Severe Emergency Department Medication Errors?National Study on the Frequency, Types, Causes, and Consequences of Voluntarily Reported Emergency Department Medication ErrorsWhich medical error to disclose to patients and by whom? Public preference and perceptions of norm and current practiceCase 34-2010Doctors' views of attitudes towards peer medical errorDoes Sorry Work? The Impact of Apology Laws on Medical MalpracticeGetting to the Root of Medication ErrorsStudent and Faculty CasesDisclosing Harmful Medical Errors to PatientsAnálisis a fondo de los errores de medicaciónGetting to the root of medication errorsProportionality and the View from Below: Analysis of Error DisclosureClinical risk management and the ethics of open disclosureImprovements in the safety of patient care can help end the medical malpractice crisis in the United StatesBibliographyFinding a Liability-free Space in Which Personalized Medicine can BloomA proposed partnership for investigating device-related accidentsMaking Sense of Failure: A Motivated Model of Hindsight BiasChapter 20. Disclosing Medication Errors to Patients and FamiliesDisclosure of Medical ErrorsEmergency Physicians and Disclosure of Medical ErrorsWill Saying "I'm Sorry" Prevent a Malpractice Lawsuit?Disclosing errors and adverse events in the intensive care unit*Residents?? Responses to Medical Error: Coping, Learning, and ChangeDisclosing Adverse Events to PatientsDoctors' responses to medical errorsAchieving closure through disclosure:Taking the High RoadDoes Full Disclosure of Medical Errors Affect Malpractice Liability? The Jury Is Still OutUnanticipated Harm to Patients: Deciding When to Disclose OutcomesPatient Safety and Medical Malpractice: A Case StudyTroyen A. Brennan, MD, JD, MPH and Michelle M. Mello, JD, PhD, MPhil*HUMAN ERROR IN HEALTH CARE SYSTEMS: BIBLIOGRAPHYOuality Toolbox: Approaches for Improving Patient Safety Through a Safety ClearinghouseMedication misadventure in cancer careMedical Mistakes and Older Patients: Admitting Errors and Improving CareShrinking Medication Errors Down to SizeA risk management program based on full disclosure and trust: Does everyone win?Adverse drug events and near misses: who's counting?Human error in medicine: Promise and pitfalls, part 2 21 December 1999Volume 131, Issue 12Page: 970-972KeywordsDisclosureHospitalizationsInpatientsInsuranceMotivationPrimary care physiciansProspective studiesQuality improvementRisk managementSerious adverse events ePublished: 15 August 2000 Issue Published: 21 December 1999 Copyright & PermissionsCopyright © 1999 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...

BACKGROUND: Sex and gender differences are often overlooked in research design, study implementation and scientific reporting, as well as in general science communication. This oversight limits the generalizability of research findings and their applicability to clinical practice, in particular for women but also for men. This article describes the rationale for an international set of guidelines to encourage a more systematic approach to the reporting of sex and gender in research across disciplines. METHODS: A panel of 13 experts representing nine countries developed the guidelines through a series of teleconferences, conference presentations and a 2-day workshop. An internet survey of 716 journal editors, scientists and other members of the international publishing community was conducted as well as a literature search on sex and gender policies in scientific publishing. RESULTS: The Sex and Gender Equity in Research (SAGER) guidelines are a comprehensive procedure for reporting of sex and gender information in study design, data analyses, results and interpretation of findings. CONCLUSIONS: The SAGER guidelines are designed primarily to guide authors in preparing their manuscripts, but they are also useful for editors, as gatekeepers of science, to integrate assessment of sex and gender into all manuscripts as an integral part of the editorial process.

For decades, access to essential medicines has been a major priority in global health. The WHO Essential Medicines List (EML) was published over 40 years ago, to address the need for countries to make essential medicines more accessible and affordable to patients, especially in low income countries. Over time, it has become clear that medicines are necessary, but not sufficient to offer quality primary care, prevent outbreaks, and address threats such as antimicrobial resistance and the global epidemic of non-communicable (NCD) diseases. Diagnosis is the first critical step to offer quality healthcare and to contain emergencies. In a ground-breaking move, WHO published the first edition of the WHO Model list of Essential In Vitro Diagnostics (or EDL) on 15 May 2018. By doing so, WHO highlighted the fact that diagnostics are essential components for universal health coverage (UHC), to address health emergencies, and promote healthier populations, which are the three strategic priorities of WHO. The EDL complements the WHO EML and will enhance its impact. After all, medicines work best when they are targeted to the right condition, for the right patient, at the right time. The WHO EDL defines essential diagnostics as those “that satisfy the priority health care needs of the population and are selected with due regard to disease prevalence and public health relevance, evidence of efficacy and accuracy, and comparative cost-effectiveness.” For its first edition, the EDL contains tests that are considered general laboratory tests, and tests that are considered disease-specific, aimed at conditions of public health importance (HIV, tuberculosis, malaria, hepatitis B and C, syphilis and human papilloma virus). The disease-specific tests were selected based on WHO guidelines. The general laboratory tests were selected from other WHO guidance documents on clinical laboratories and pathology, the WHO list of priority medical devices, and disease-specific clinical guidelines. The EDL is in fact a list of categories of tests instead of individual test brands. The EDL groups tests by two major levels of the healthcare delivery system: primary care facilities versus facilities with clinical laboratories. WHO has already begun the process of expanding the list to other areas through a yearly call for submissions of additional categories of tests. Through these calls it will also be possible to submit corrections, clarifications or even deletions. The current call is open to all disease areas but WHO is particularly interested in submission related to IVDs for antimicrobial resistance, neglected tropical diseases, NCDs, outbreaks/emergencies and sepsis. After a pre-submission, screening process, full submissions will be invited, and will require additional information on the tests, performance, quality and impact (with a focus on evidence-based information). These full submissions will be reviewed by WHO and selected experts. The WHO has appointed a Strategic Group of Experts on In Vitro Diagnostics (SAGE IVD) to advise on the development of the EDL. The submissions and the reviews will be posted on the WHO website. The second edition of the EDL is expected to be published in Spring 2019. Additions or changes to the EDL will be done on an annual basis (compared to the 2-year review cycle of the EML). This difference reflects that fact that there is a lot of “catching up” to do to develop a comprehensive EDL but also the fact that the IVD field is very dynamic with a development cycle which is more rapid than for vaccines and medicines. The EDL process will need to be nimble while rigorous to rapidly adapt to technological or policy changes. Although the WHO EDL is a critical step in the right direction, the impact of the EDL will be enhanced when countries adapt the EDL to their own national needs and put in place mechanisms to implement the EDL. One critical area to address is the poor state of laboratories in many low and middle-income countries. In the absence of a strong laboratory network, healthcare providers often rely on empirical therapy, with adverse patient outcomes. Some countries are already working very actively to develop their own EDL, and we hope other countries will follow suit. To help countries develop their own national EDL and strengthen laboratory capacity, WHO is developing a web portal to centralize and thus facilitate access to all WHO documents that support the selection and use of IVDs. This portal is expected to be available later this year and will include IVD and laboratories relevant documents and links on policies & strategic plans, laboratory set up, IVD for primary care setting, human resources, laboratory quality management, regulation and market, procurement and supplies, innovation, as well as global collaborations. In order to improve access to essential IVDs, the EDL is really the first of many steps that need to be done. For procurement, it will be necessary to develop technical specifications for the tests in the list. Regulatory approval of IVDs also needs to be strengthened and harmonized globally to ensure quality and access. Supply and affordability of IVDs on the EDL will also need to improve. For too long, diagnostics have been undervalued in global health. With the publication of the WHO EDL, the tide has finally turned. There is now growing recognition that diagnostics are as important as medicines and vaccines. We call on countries to adapt the WHO EDL and make essential tests accessible within the framework of UHC. All authors were involved in the development of the first WHO Model list of essential in vitro diagnostics. They have no industry or financial conflicts to disclose.

The recent letter published in The American Journal of Medicine by Mimouni et al entitled “Beall's list removed: what stands between us and the open access predators?”1Mimouni M. Braun E. Mimouni F.B. Mimouni D. Blumenthal E.Z. Beall's list removed: what stands between us and open access predators?.Am J Med. 2017; 130: e371-e372Abstract Full Text Full Text PDF PubMed Scopus (13) Google Scholar raises an important question: are there any alternatives to Beall's List of predatory journals and publishers? After Beall's List was removed from the Internet owing to (as Beall puts it himself) “legal reasons”2Beall J. What I learned from predatory publishers.Biochem Med (Zagreb). 2017; 27: 273-278Crossref PubMed Scopus (144) Google Scholar on January 17, 2017, there has been a vacuum on the publishing market,3Strielkowski W. Predatory journals: Beall's List is missed.Nature. 2017; 544: 416Crossref PubMed Scopus (36) Google Scholar and many questions have been left unanswered. For instance, there is no clear recommendation regarding what to do about the journals that were suspected of predatory practices by Beall and that are also indexed in reputable citation databases, such as Scopus or the Web of Science. Should the researchers publish in them anyway, or should they search for some other blacklists and publishing ethics committees' guidelines? If so, who will appoint these committees, or who will decide which journals are good and which are bad? Quis custodiet ipsos custodes (“Who will guard the guardians”)? The question is troubling, and the decision is uneasy. For instance, there is the well-known case of Multidisciplinary Digital Publishing Institute (MDPI), an open access publishing house from Switzerland. In 2014 MDPI was added to Beall's list. However, an Open Access Scholarly Publishers Association (OASPA) investigation concluded that MDPI met the OASPA membership criteria, and MDPI was subsequently removed from Beall's List on the October 28, 2015.4MDPI Response to Mr. Jeffrey Beall's repeated attacks on MDPI.http://www.mdpi.com/about/announcement/534Date: 2014Date accessed: October 25, 2017Google Scholar Several of MDPI's journals currently appear in the prestigious ABS Academic Journal Guide, and in 2017 MDPI partnered with Wiley, Sage, Springer Nature, and Cambridge University Press to work on Publons, the new initiative intended to encourage reviewers to peer-review academic papers and earn “publons.” Cabell's Blacklist became the most anticipated and long-awaited product(s) on the academic publications market since the disappearance of Beall's List. Cabell's Blacklist is presented by its creators, Cabell's, the scholarly analytics company from Beaumont, Texas, as the “the only blacklist of deceptive and predatory academic journals.”5Cabell's Journal blacklist.http://www.cabells.com/about-blacklistDate: 2017Date accessed: October 25, 2017Google Scholar The Blacklist currently features more than 4000 journals (with more journals under review).6Prasad R. Cabell's: ‘Our journal blacklist differs from Jeffrey Beall‘s’.http://www.thehindu.com/sci-tech/science/cabells-our-journal-blacklist-differs-from-jeffrey-bealls/article19094374.eceDate: 2017Date accessed: October 25, 2017Google Scholar By emphasizing that their product is “the only blacklist,” Cabell's is clearly trying to seize the narrow niche on the tiny market of academics against predatory journals and publishers.7Cabell's The journal blacklist.http://www.cabells.com/about-blacklistDate: 2017Date accessed: October 25, 2017Google Scholar The question is, however, whether they will succeed in doing so. Here are some ideas that, if designed and presented to the academic community in its current form, Cabell's Blacklist might not be, at the moment, a very good replacement of Beall's List. First, there is the issue of money and pricing. Although the Cabell's Blacklist institutional subscription fee is not that high in comparison with such products at Scopus, ScienceDirect, and Web of Science offered by Elsevier and Clarivate Analytics, it might be much too pricy for individuals. Beall's List was available free of charge, and everyone could check it any time. Cabell's is charging hefty sums for their blacklist alternative. According to Cabell's, the 1-year subscription to its Blacklist can be purchased for a $1500 add-on cost with purchase of at least 1 more discipline on the Whitelist (ranging from $1000 to $3600 for 1 set). Unfortunately, Cabell's does not provide the users with an opportunity to at least check the free author profile in the same fashion as Scopus, a respected academic database owned by Elsevier. Second, there are the somewhat misleading metrics used to label a journal as “predatory.” Similar to Beall's List, Cabell's undertakes their scrutiny of the journals hidden from the view of the public and then announces the results, which might be disputed by the publishers and by the academics publishing in the journals, who would suddenly appear on the Blacklist. Third, Cabell's Blacklist is not limited to open access journals (as in the case of Beall's List) and therefore might involve journals published by the large publishing companies. This creates a possibility for potential conflicts of interest, because cases of large publishing companies harboring fake and predatory journals have happened in the past.8Eriksson S. Helgesson G. The false academy: predatory publishing in science and bioethics.Med Health Care Philos. 2017; 20: 163-170Crossref PubMed Scopus (86) Google Scholar All in all, it becomes apparent that Cabell'is trying hard, and their goal of helping the academic community to identify predatory journals and publishers is noble. If the new Blacklist is positioned and priced appropriately, it would at least bring some order to the academic realm that is full of (not only) open access predators.

Semistructured in-depth interviews are commonly used in qualitative research and are the most frequent qualitative data source in health services research. This method typically consists of a dialogue between researcher and participant, guided by a flexible interview protocol and supplemented by follow-up questions, probes and comments. The method allows the researcher to collect open-ended data, to explore participant thoughts, feelings and beliefs about a particular topic and to delve deeply into personal and sometimes sensitive issues. The purpose of this article was to identify and describe the essential skills to designing and conducting semistructured interviews in family medicine and primary care research settings. We reviewed the literature on semistructured interviewing to identify key skills and components for using this method in family medicine and primary care research settings. Overall, semistructured interviewing requires both a relational focus and practice in the skills of facilitation. Skills include: (1) determining the purpose and scope of the study; (2) identifying participants; (3) considering ethical issues; (4) planning logistical aspects; (5) developing the interview guide; (6) establishing trust and rapport; (7) conducting the interview; (8) memoing and reflection; (9) analysing the data; (10) demonstrating the trustworthiness of the research; and (11) presenting findings in a paper or report. Semistructured interviews provide an effective and feasible research method for family physicians to conduct in primary care research settings. Researchers using semistructured interviews for data collection should take on a relational focus and consider the skills of interviewing to ensure quality. Semistructured interviewing can be a powerful tool for family physicians, primary care providers and other health services researchers to use to understand the thoughts, beliefs and experiences of individuals. Despite the utility, semistructured interviews can be intimidating and challenging for researchers not familiar with qualitative approaches. In order to elucidate this method, we provide practical guidance for researchers, including novice researchers and those with few resources, to use semistructured interviewing as a data collection strategy. We provide recommendations for the essential steps to follow in order to best implement semistructured interviews in family medicine and primary care research settings.

Thematic analysis is a highly popular technique among qualitative researchers for analyzing qualitative data, which usually comprises thick descriptive data. However, the application and use of thematic analysis has also involved complications due to confusion regarding the final outcome’s presentation as a conceptual model. This paper develops a systematic thematic analysis process for creating a conceptual model from qualitative research findings. It explores the adaptability of the proposed process across various research methodologies, including constructivist methodologies, positivist methodologies, grounded theory, and interpretive phenomenology, and justifies their application. The paper distinguishes between inductive and deductive coding approaches and emphasizes the merits of each. It suggests that the derived systematic thematic analysis model is valuable across multiple disciplines, particularly in grounded theory, ethnographic approaches, and narrative approaches, while also being adaptable to more descriptive, positivist-based methodologies. By providing a methodological roadmap, this study enhances the rigor and replicability of thematic analysis and offers a comprehensive strategy for theoretical conceptualization in qualitative research. The contribution of this paper is a systematic six-step thematic analysis process that leads to the development of a conceptual model; each step is described in detail and examples are given.

BACKGROUND: Many implementation efforts fail, even with highly developed plans for execution, because contextual factors can be powerful forces working against implementation in the real world. The Consolidated Framework for Implementation Research (CFIR) is one of the most commonly used determinant frameworks to assess these contextual factors; however, it has been over 10 years since publication and there is a need for updates. The purpose of this project was to elicit feedback from experienced CFIR users to inform updates to the framework. METHODS: User feedback was obtained from two sources: (1) a literature review with a systematic search; and (2) a survey of authors who used the CFIR in a published study. Data were combined across both sources and reviewed to identify themes; a consensus approach was used to finalize all CFIR updates. The VA Ann Arbor Healthcare System IRB declared this study exempt from the requirements of 38 CFR 16 based on category 2. RESULTS: The systematic search yielded 376 articles that contained the CFIR in the title and/or abstract and 334 unique authors with contact information; 59 articles included feedback on the CFIR. Forty percent (n = 134/334) of authors completed the survey. The CFIR received positive ratings on most framework sensibility items (e.g., applicability, usability), but respondents also provided recommendations for changes. Overall, updates to the CFIR include revisions to existing domains and constructs as well as the addition, removal, or relocation of constructs. These changes address important critiques of the CFIR, including better centering innovation recipients and adding determinants to equity in implementation. CONCLUSION: The updates in the CFIR reflect feedback from a growing community of CFIR users. Although there are many updates, constructs can be mapped back to the original CFIR to ensure longitudinal consistency. We encourage users to continue critiquing the CFIR, facilitating the evolution of the framework as implementation science advances.

The introduction of endoscopy into surgical practice is one of the biggest success stories in the history of medicine. Endoscopy has its roots in the nineteenth century and was initially developed by urologists and internists. During the 1960s and 1970s gynecologists took the lead in the development of endoscopic surgery while most of the surgical community continued to ignore the possibilities of the new technique. This was due in part to the introduction of ever more sophisticated drugs, the impressive results of intensive care medicine, and advances in anesthesia, which led to the development of more radical and extensive operations, or "major surgery." The idea that large problems require large incisions so deeply dominated surgical thinking that there was little room to appreciate the advances of "key-hole" surgery. Working against this current, some general surgeons took up the challenge. In 1976 the Surgical Study Group on Endoscopy and Ultrasound (CAES) was formed in Hamburg. Five years later, on the other side of the Atlantic, the Society of American Gastrointestinal Endoscopic Surgeons (SAGES) was called into being. In 1987 the first issue of the journal Surgical Endoscopy was published, and the following year the First World Congress on Surgical Endoscopy took place in Berlin. The sweeping success of the "laparoscopic revolution" (1989-1990) marked the end of traditional open surgery and encouraged surgeons to consider new perspectives. By the 1990s the breakthrough had been accomplished: endoscopy was incorporated into surgical thinking.

The Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) statement, published in 2009, was designed to help systematic reviewers transparently report why the review was done, what the authors did, and what they found. Over the past decade, advances in systematic review methodology and terminology have necessitated an update to the guideline. The PRISMA 2020 statement replaces the 2009 statement and includes new reporting guidance that reflects advances in methods to identify, select, appraise, and synthesise studies. The structure and presentation of the items have been modified to facilitate implementation. In this article, we present the PRISMA 2020 27-item checklist, an expanded checklist that details reporting recommendations for each item, the PRISMA 2020 abstract checklist, and the revised flow diagrams for original and updated reviews.

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BACKGROUND: CONSORT guidelines call for precise reporting of behavior change interventions: we need rigorous methods of characterizing active content of interventions with precision and specificity. OBJECTIVES: The objective of this study is to develop an extensive, consensually agreed hierarchically structured taxonomy of techniques [behavior change techniques (BCTs)] used in behavior change interventions. METHODS: In a Delphi-type exercise, 14 experts rated labels and definitions of 124 BCTs from six published classification systems. Another 18 experts grouped BCTs according to similarity of active ingredients in an open-sort task. Inter-rater agreement amongst six researchers coding 85 intervention descriptions by BCTs was assessed. RESULTS: This resulted in 93 BCTs clustered into 16 groups. Of the 26 BCTs occurring at least five times, 23 had adjusted kappas of 0.60 or above. CONCLUSIONS: "BCT taxonomy v1," an extensive taxonomy of 93 consensually agreed, distinct BCTs, offers a step change as a method for specifying interventions, but we anticipate further development and evaluation based on international, interdisciplinary consensus.

BACKGROUND: An integrative theoretical framework, developed for cross-disciplinary implementation and other behaviour change research, has been applied across a wide range of clinical situations. This study tests the validity of this framework. METHODS: Validity was investigated by behavioural experts sorting 112 unique theoretical constructs using closed and open sort tasks. The extent of replication was tested by Discriminant Content Validation and Fuzzy Cluster Analysis. RESULTS: There was good support for a refinement of the framework comprising 14 domains of theoretical constructs (average silhouette value 0.29): 'Knowledge', 'Skills', 'Social/Professional Role and Identity', 'Beliefs about Capabilities', 'Optimism', 'Beliefs about Consequences', 'Reinforcement', 'Intentions', 'Goals', 'Memory, Attention and Decision Processes', 'Environmental Context and Resources', 'Social Influences', 'Emotions', and 'Behavioural Regulation'. CONCLUSIONS: The refined Theoretical Domains Framework has a strengthened empirical base and provides a method for theoretically assessing implementation problems, as well as professional and other health-related behaviours as a basis for intervention development.

BACKGROUND: Choosing a suitable sample size in qualitative research is an area of conceptual debate and practical uncertainty. That sample size principles, guidelines and tools have been developed to enable researchers to set, and justify the acceptability of, their sample size is an indication that the issue constitutes an important marker of the quality of qualitative research. Nevertheless, research shows that sample size sufficiency reporting is often poor, if not absent, across a range of disciplinary fields. METHODS: A systematic analysis of single-interview-per-participant designs within three health-related journals from the disciplines of psychology, sociology and medicine, over a 15-year period, was conducted to examine whether and how sample sizes were justified and how sample size was characterised and discussed by authors. Data pertinent to sample size were extracted and analysed using qualitative and quantitative analytic techniques. RESULTS: Our findings demonstrate that provision of sample size justifications in qualitative health research is limited; is not contingent on the number of interviews; and relates to the journal of publication. Defence of sample size was most frequently supported across all three journals with reference to the principle of saturation and to pragmatic considerations. Qualitative sample sizes were predominantly - and often without justification - characterised as insufficient (i.e., 'small') and discussed in the context of study limitations. Sample size insufficiency was seen to threaten the validity and generalizability of studies' results, with the latter being frequently conceived in nomothetic terms. CONCLUSIONS: We recommend, firstly, that qualitative health researchers be more transparent about evaluations of their sample size sufficiency, situating these within broader and more encompassing assessments of data adequacy. Secondly, we invite researchers critically to consider how saturation parameters found in prior methodological studies and sample size community norms might best inform, and apply to, their own project and encourage that data adequacy is best appraised with reference to features that are intrinsic to the study at hand. Finally, those reviewing papers have a vital role in supporting and encouraging transparent study-specific reporting.

BACKGROUND: Many interventions found to be effective in health services research studies fail to translate into meaningful patient care outcomes across multiple contexts. Health services researchers recognize the need to evaluate not only summative outcomes but also formative outcomes to assess the extent to which implementation is effective in a specific setting, prolongs sustainability, and promotes dissemination into other settings. Many implementation theories have been published to help promote effective implementation. However, they overlap considerably in the constructs included in individual theories, and a comparison of theories reveals that each is missing important constructs included in other theories. In addition, terminology and definitions are not consistent across theories. We describe the Consolidated Framework For Implementation Research (CFIR) that offers an overarching typology to promote implementation theory development and verification about what works where and why across multiple contexts. METHODS: We used a snowball sampling approach to identify published theories that were evaluated to identify constructs based on strength of conceptual or empirical support for influence on implementation, consistency in definitions, alignment with our own findings, and potential for measurement. We combined constructs across published theories that had different labels but were redundant or overlapping in definition, and we parsed apart constructs that conflated underlying concepts. RESULTS: The CFIR is composed of five major domains: intervention characteristics, outer setting, inner setting, characteristics of the individuals involved, and the process of implementation. Eight constructs were identified related to the intervention (e.g., evidence strength and quality), four constructs were identified related to outer setting (e.g., patient needs and resources), 12 constructs were identified related to inner setting (e.g., culture, leadership engagement), five constructs were identified related to individual characteristics, and eight constructs were identified related to process (e.g., plan, evaluate, and reflect). We present explicit definitions for each construct. CONCLUSION: The CFIR provides a pragmatic structure for approaching complex, interacting, multi-level, and transient states of constructs in the real world by embracing, consolidating, and unifying key constructs from published implementation theories. It can be used to guide formative evaluations and build the implementation knowledge base across multiple studies and settings.

The general view of descriptive research as a lower level form of inquiry has influenced some researchers conducting qualitative research to claim methods they are really not using and not to claim the method they are using: namely, qualitative description. Qualitative descriptive studies have as their goal a comprehensive summary of events in the everyday terms of those events. Researchers conducting qualitative descriptive studies stay close to their data and to the surface of words and events. Qualitative descriptive designs typically are an eclectic but reasonable combination of sampling, and data collection, analysis, and re-presentation techniques. Qualitative descriptive study is the method of choice when straight descriptions of phenomena are desired.

BACKGROUND: The Framework Method is becoming an increasingly popular approach to the management and analysis of qualitative data in health research. However, there is confusion about its potential application and limitations. DISCUSSION: The article discusses when it is appropriate to adopt the Framework Method and explains the procedure for using it in multi-disciplinary health research teams, or those that involve clinicians, patients and lay people. The stages of the method are illustrated using examples from a published study. SUMMARY: Used effectively, with the leadership of an experienced qualitative researcher, the Framework Method is a systematic and flexible approach to analysing qualitative data and is appropriate for use in research teams even where not all members have previous experience of conducting qualitative research.

As vertebrate genome sequences near completion and research refocuses to their analysis, the issue of effective genome annotation display becomes critical. A mature web tool for rapid and reliable display of any requested portion of the genome at any scale, together with several dozen aligned annotation tracks, is provided at http://genome.ucsc.edu. This browser displays assembly contigs and gaps, mRNA and expressed sequence tag alignments, multiple gene predictions, cross-species homologies, single nucleotide polymorphisms, sequence-tagged sites, radiation hybrid data, transposon repeats, and more as a stack of coregistered tracks. Text and sequence-based searches provide quick and precise access to any region of specific interest. Secondary links from individual features lead to sequence details and supplementary off-site databases. One-half of the annotation tracks are computed at the University of California, Santa Cruz from publicly available sequence data; collaborators worldwide provide the rest. Users can stably add their own custom tracks to the browser for educational or research purposes. The conceptual and technical framework of the browser, its underlying MYSQL database, and overall use are described. The web site currently serves over 50,000 pages per day to over 3000 different users.

The Gene Expression Omnibus (GEO, http://www.ncbi.nlm.nih.gov/geo/) is an international public repository for high-throughput microarray and next-generation sequence functional genomic data sets submitted by the research community. The resource supports archiving of raw data, processed data and metadata which are indexed, cross-linked and searchable. All data are freely available for download in a variety of formats. GEO also provides several web-based tools and strategies to assist users to query, analyse and visualize data. This article reports current status and recent database developments, including the release of GEO2R, an R-based web application that helps users analyse GEO data.

The PRISMA 2020 statement includes a checklist of 27 items to guide reporting of systematic reviews In this article we explain why reporting of each item is recommended, present bullet points that detail the reporting recommendations, and present examples from published reviews We hope that uptake of the PRISMA 2020 statement will lead to more transparent, complete, and accurate reporting of systematic reviews, thus facilitating evidence based decision making on 1 September