Informing the development of the SUCCEED reporting guideline for studies on the scaling of health interventions: A systematic review.

BACKGROUND: Quality reporting contributes to effective translation of health research in practice and policy. As an initial step in the development of a reporting guideline for scaling, the Standards for reporting stUdies of sCaling evidenCEd-informED interventions (SUCCEED), we performed a systematic review to identify relevant guidelines and compile a list of potential items. METHODS: We conducted a systematic review according to Cochrane method guidelines. We searched the following databases: MEDLINE, Embase, PsycINFO, Cochrane Library, CINAHL, Web of Science, from their respective inceptions. We also searched websites of relevant organizations and Google. We included any document that provided instructions or recommendations, e.g., reporting guideline, checklist, guidance, framework, standard; could inform the design or reporting of scaling interventions; and related to the health sector. We extracted characteristics of the included guidelines and assessed their methodological quality using a 3-item internal validity assessment tool. We extracted all items from the guidelines and classified them according to the main sections of reporting guidelines (title, abstract, introduction, methods, results, discussion and other information). We performed a narrative synthesis based on descriptive statistics. RESULTS: Of 7704 records screened (published between 1999 and 2019), we included 39 guidelines, from which data were extracted from 57 reports. Of the 39 guidelines, 17 were for designing scaling interventions and 22 for reporting implementation interventions. At least one female author was listed in 31 guidelines, and 21 first authors were female. None of the authors belonged to the patient stakeholder group. Only one guideline clearly identified a patient as having participated in the consensus process. More than half the guidelines (56%) had been developed using an evidence-based process. In total, 750 items were extracted from the 39 guidelines and distributed into the 7 main sections. CONCLUSION: Relevant items identified could inform the development of a reporting guideline for scaling studies of evidence-based health interventions. This and our assessment of guidelines could contribute to better reporting in the science and practice of scaling.

A New Era for Firearm Violence Prevention Research.

This Viewpoint discusses the expansion of firearm injury research that involves diverse disciplinary perspectives that could potentially lead to lifesaving policy innovation.

Online questionnaire on genetic testing for intractable diseases in Japan: response to and issues associated with the revised medical care act.

In Japan, most genetic testing for intractable diseases has been conducted in research laboratories in the past. However, since the Revised Medical Care Act came into effect on December 1, 2018, genetic testing in compliance with this act has become a major issue. To collect information on this topic, we conducted an online survey of members of the research groups for intractable diseases, which play a central role in medical care and research on intractable diseases with the support of the Ministry of Health, Labor and Welfare, five months after the enactment of the act. We separated the surveyed facilities into those that conducted genetic testing in their own laboratories ("testing facilities") and those that outsourced genetic testing ("outsourcing facilities"). Ninety-five and 66 responses regarding genetic testing were obtained from the testing and outsourcing facilities, respectively. Genetic analysis was the most commonly conducted genetic testing method, accounting for 60% or more of the tests. At the testing facilities that conducted comprehensive analysis with a next-generation sequencer, the number of target diseases for genetic testing was observed to be higher. In these testing facilities, more than 70% were research laboratories. In contrast, at the outsourcing facilities, testing was outsourced to registered clinical laboratories in many cases or to research laboratories. The proportion of genetic testing covered by public medical insurance at the outsourcing facilities was two times higher than that at the testing facilities. The importance of quality control for genetic testing was generally well acknowledged, but there was apprehension regarding the increased cost and burden on staff of quality control assurance, and many testing facilities viewed genetic testing as difficult. The research groups could handle the examination and interpretation of the genetic testing results, and many groups gathered and registered patient information. Within the intractable disease medical support network, there was a relatively large number of collaborations, with studies supported by the Japan Agency for Medical Research and Development (AMED) and Initiative on Rare and Undiagnosed Diseases (IRUD) projects. There were many requests for genetic testing to be covered by public medical insurance. In the future, the implementation of genetic testing using a next-generation sequencer at clinical laboratories with guaranteed quality control and the development of a system for collaboration with research groups will be necessary.

Two sets of qualitative research reporting guidelines: An analysis of the shortfalls.

Findings from qualitative research may make valuable contributions to the evidence informing healthcare practice. Qualitative research methodologies and methods, however, are less familiar to health researchers and research consumers when compared with quantitative methods. Qualitative research reporting guidelines and their merit have been hotly debated for at least two decades. Herein I discuss two sets of qualitative research reporting guidelines endorsed by many high tiered health research journals: Consolidated criteria for reporting qualitative research and Standards for reporting qualitative research. Six aspects of the two sets of guidelines are compared. The first aspect is the focus of the guidelines. The latter five aspects are items included in the guidelines: reflexivity, participant sampling and saturation, data collection, member checking, and data analysis. Except for reflexivity, these items were selected for comparison as they include features of, or strategies to, enhance the rigor of qualitative research that are applicable within some but not all qualitative methodologies. Reflexivity, a central feature of rigor within all qualitative research, is discussed for its suboptimal representation in both sets of reporting guidelines. Without regular and critical review of reporting guidelines, efforts to promote the design, conduct, and reporting of rigorous qualitative health research to support evidence-informed practice may be undermined. Moreover, for qualitative research reporting guidelines to be useful, they must be applied appropriately and in a flexible manner by researchers and reviewers. This paper has implications for researchers, journal editors, reviewers, and research consumers.

Cenário epidemiológico da Covid-19 no estado do Rio de Janeiro Período de Análise: março/2020 a abril/2021 / Epidemiological scenario from Covid-19 in the state of Rio de Janeiro Analysis Period: March/2020 to April/2021

O Estado do Rio de Janeiro vem monitorando a evolução das variantes da Covid-19 por meio de três processos de seleção de amostras. O primeiro é o monitoramento realizado pelos municípios que notifica e solicita o sequenciamento, seguindo os critérios e fluxos descritos na Nota técnica da SES-RJ Nº 09/2021. O segundo faz parte da Vigilância Genômica organizada pelo Ministério da Saúde, onde três amostras aleatórias são enviadas pelo Lacen/RJ para FUNED/MG, de acordo com os critérios estabelecidos pela SVS/ FUNED. O terceiro é através de um estudo com financiamento da Fundação de Amparo à Pesquisa do Estado do Rio de Janeiro (FAPERJ) que iniciou em março de 2021 e irá realizar a genotipagem de um total de 4.800 amostras nos próximos seis meses, sendo 400 a cada 15 dias. Por fim, a Secretaria de Estado de Saúde tem envidado esforços em ações de redução de risco, como a vacinação, ampliação de testagem, monitoramento genômico e promoção de saúde em todo o estado do Rio de Janeiro. E é recomendado manter as medidas de proteção à vida: como evitar aglomeração, usar de máscara, lavar as mãos e fazer higienização das mãos com álcool 70°.

Partners in care.

This festschrift contribution, written for my colleague and mentor John Graham, reflects on geneticist-genetic counselor interactions in clinical care, samples of alternative models of care for pediatric and general genetic counselors, and avenues for expanding access to genetic healthcare services utilizing genetic counselors.

Asian American Pacific Islander Representation in Outcomes Research: NSQIP Scoping Review.

BACKGROUND: If Asian American and Pacific Islanders (AAPIs) are not recognized within patients in health services research, we miss an opportunity to ensure health equity in patient outcomes. However, it is unknown what the rates are of AAPIs inclusion in surgical outcomes research. STUDY DESIGN: Through a scoping review, we used Covidence to search MEDLINE, EMBASE, PsycINFO, Web of Science, Scopus, and CINAHL for studies published in 2008-2018 using NSQIP data. NSQIP was chosen because of its national scope, widespread use in research, and coding inclusive of AAPI patients. We examined the proportion of studies representing AAPI patients in the demographic characteristics and Methods, Results, or Discussion section. We then performed multivariable logistic regression to examine associations between study characteristics and AAPI inclusion. RESULTS: In 1,264 studies included for review, 62% included race. Overall, only 22% (n = 278) of studies included AAPI patients. Of studies that included race, 35% represented AAPI patients in some component of the study. We found no association between sample size or publication year and inclusion. Studies were significantly more likely to represent AAPI patients when there was a higher AAPI population in the region of the first author's institution (lowest vs highest tercile; p < 0.001). Studies with a focus on disparities were more likely to include AAPI patients (p = 0.001). CONCLUSIONS: Our study is the first to examine AAPI representation in surgical outcomes research. We found < 75% of studies examine race, despite availability within NSQIP. Little more than one-third of studies including race reported on AAPI patients as a separate group. To provide the best care, we must include AAPI patients in our research.

Sharing Patient-Controlled Real-World Data Through the Application of the Theory of Commons: Action Research Case Study.

BACKGROUND: Technological advances have radically changed the opportunities for individuals with chronic conditions to practice self-care and to coproduce health care and research. Digital technologies enable patients to perform tasks traditionally carried out by health care professionals in a more convenient way, at lower costs, and without compromising quality. Patients may also share real-world data with other stakeholders to promote individual and population health. However, there is a need for legal frameworks that enable patient privacy and control in such sharing of real-world data. We believe that this need could be met by the conceptualization of patient-controlled real-world data as knowledge commons, which is a resource shared by a group of people. OBJECTIVE: This study aimed to propose a conceptual model that describes how patient-controlled real-world data can be shared effectively in chronic care management, in a way that supports individual and population health, while respecting personal data privacy and control. METHODS: An action research approach was used to develop a solution to enable patients, in a self-determined way, to share patient-controlled data to other settings. We chose the context of cystic fibrosis (CF) care in Sweden, where coproduction between patients, their families, and health care professionals is critical in the introduction of new drugs. The first author, who is a lawyer and parent of children with CF, was a driver in the change process. All coauthors collaborated in the analysis. We collected primary and secondary data reflecting changes during the time period from 2012 to 2020, and performed a qualitative content analysis guided by the knowledge commons framework. RESULTS: Through a series of changes, a national system for enabling patients to share patient-controlled real-world data to different stakeholders in CF care was implemented. The case analysis resulted in a conceptual model consisting of the following three knowledge commons arenas that contributed to patient-controlled real-world data collection, use, and sharing: (1) patient world arena involving the private sphere of patients and families; (2) clinical microsystem arena involving the professional sphere at frontline health care clinics; and (3) round table arena involving multiple stakeholders from different settings. Based on the specification of property rights, as presented in our model, the patient can keep control over personal health information and may grant use rights to other stakeholders. CONCLUSIONS: Health information exchanges for sharing patient-controlled real-world data are pivotal to enable patients, health care professionals, health care funders, researchers, authorities, and the industry to coproduce high-quality care and to introduce and follow-up novel health technologies. Our model proposes how technical and legal structures that protect the integrity and self-determination of patients can be implemented, which may be applicable in other chronic care settings as well.

Realizing the Promise of Learning Organizations to Transform Mental Health Care: Telepsychiatry Care As an Exemplar.

To address the global mental health crisis exacerbated by the COVID-19 pandemic, an urgent need has emerged to transform the accessibility, efficiency, and quality of mental health care. The next suite of efforts to transform mental health care must foster the implementation of "learning organizations," that is, organizations that continuously improve patient-centered care through ongoing data collection. The concept of learning organizations is highly regarded, but the key features of such organizations, particularly those providing mental health care, are less well defined. Using telepsychiatry care as an example, the authors of this Open Forum concretely describe the key building blocks for operationalizing a learning organization in mental health care to set a research agenda for services transformation.

Assessment of the quality and trend of reporting of health economic evaluation research in India.

Objectives: This study was conducted to assess the reporting quality of health economic evaluation studies using Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement along with an analysis of their trend in India.Methods: Following ethical review exemption, PubMed and Google scholar were searched for Indian studies published in 5 years (2014-2019). Keywords used were cost-effectiveness, cost-benefit, cost-utility, and cost-minimization analysis, economic evaluation, and India. CHEERS statement was used to assess the reporting quality and trend was studied using variables like a published year, type of analysis, therapy area, intervention. Data were analyzed using descriptive statistics.Results: Of the 39 studies analyzed, 17 scored less than 18 (represents 75% compliance) with a minimum score of 9 and a maximum of 23. The reporting quality was deficient with respect to heterogeneity characterization (25 studies), discount rate (18 studies), model choice, and assumptions (18 studies). Cost - effectiveness was the most common PE analysis (27 studies). The most commonly studied therapy area was infectious disorders (10) followed by oncology (5), and the commonest intervention was drugs (22).Conclusion: Inadequacy in reporting quality of health economic evaluation studies is evident. The trend revealed cost-effectiveness to be the most commonly performed type of analysis.Expert Opinion: Health economic evaluation research has gained considerable importance in healthcare decision making. Reporting quality is critical to enable efficient interpretation of health economic evaluation research. These studies have many elements, each of which have a significant impact on the conduct and outcome of the study. Hence, it is advisable to refer to any of the available guidelines [eg. CHEERS checklist] while preparing the manuscript so as to ensure all crucial elements of the study have been reported.

Administrative data identify sickle cell disease: A critical review of approaches in U.S. health services research.

To identify people living with sickle cell disease (SCD) and study their healthcare utilization, researchers can either use clinical records linked to administrative data or use billing diagnosis codes in stand-alone administrative databases. Correct identification of individuals clinically managed for SCD using diagnosis codes in claims databases is limited by the accuracy of billing codes in outpatient encounters. In this critical review, we assess the strengths and limitations of claims-based SCD case-finding algorithms in stand-alone administrative databases that contain both inpatient and outpatient records. Validation studies conducted using clinical records and newborn screening for confirmation of SCD case status have found that algorithms that require three or more nonpharmacy claims or one inpatient claim plus two or more outpatient claims with SCD codes show acceptable accuracy (positive predictive value and sensitivity) in children and adolescents. Future studies might seek to assess the accuracy of case-finding algorithms over the lifespan.

The first evidence about conceptual vs analytical lean healthcare research studies.

PURPOSE: Several authors have examined the lean healthcare literature, but besides all efforts made, articles comparing conceptual and analytical studies were not found. Thus, a systematic review is conducted aiming to understand the state of the art of lean healthcare by investigating and comparing how conceptual and analytical articles address tools/methods, application fields, implementation barriers and facilitators and positive and negative impacts. DESIGN/METHODOLOGY/APPROACH: Articles in English about lean healthcare, published in journals in the last ten years (2009-2018) and indexed in Web of Science (WoS) or Scopus were examined and assessed by following the Preferred Reporting Items for Systematic Reviews and Meta-Analyzes (PRISMA) protocol. A qualitative content analysis on the eligible articles was conducted, and results from the conceptual and analytical studies were compared. FINDINGS: There is a literature gap regarding tools/methods in both conceptual and analytical approaches once they prioritize for different items. Barriers, facilitators and negative impacts are perceived differently within both categories and might require more extensive analysis. The same items prevail in both conceptual and analytical categories when analyzing healthcare fields and positive impacts. ORIGINALITY/VALUE: There is a lack of articles comparing conceptual and analytical studies concerning lean healthcare. So, this study's relevance is in identifying theoretical and applied research gaps to strengthen the lean healthcare state of the art and to integrate theoretical-applied knowledge. For healthcare professionals, it might provide an overview of the key factors that can promote lean implementation.

Individual, institutional, and scientific environment factors associated with questionable research practices in the reporting of messages and conclusions in scientific health services research publications.

BACKGROUND: Health Services Research findings (HSR) reported in scientific publications may become part of the decision-making process on healthcare. This study aimed to explore associations between researcher's individual, institutional, and scientific environment factors and the occurrence of questionable research practices (QRPs) in the reporting of messages and conclusions in scientific HSR publications. METHODS: We employed a mixed-methods study design. We identified factors possibly contributing to QRPs in the reporting of messages and conclusions through a literature review, 14 semi-structured interviews with HSR institutional leaders, and 13 focus-groups amongst researchers. A survey corresponding with these factors was developed and shared with 172 authors of 116 scientific HSR publications produced by Dutch research institutes in 2016. We assessed the included publications for the occurrence of QRPs. An exploratory factor analysis was conducted to identify factors within individual, institutional, and environmental domains. Next, we conducted bivariate analyses using simple Poisson regression to explore factors' association with the number of QRPs in the assessed HSR publications. Factors related to QRPs with a p-value < .30 were included in four multivariate models tested through a multiple Poisson regression. RESULTS: In total, 78 (45%) participants completed the survey (51.3% first authors and 48.7% last authors). Twelve factors were included in the multivariate analyses. In all four multivariate models, a higher score of "pressure to create societal impact" (Exp B = 1.28, 95% CI [1.11, 1.47]), was associated with higher number of QRPs. Higher scores on "specific training" (Exp B = 0.85, 95% CI [0.77-0.94]) and "co-author conflict of interest" (Exp B = 0.85, 95% CI [0.75-0.97]) factors were associated with a lower number of QRPs. Stratification between first and last authors indicated different factors were related to the occurrence of QRPs for these groups. CONCLUSION: Experienced pressure to create societal impact is associated with more QRPs in the reporting of messages and conclusions in HSR publications. Specific training in reporting messages and conclusions and awareness of co-author conflict of interests are related to fewer QRPs. Our results should stimulate awareness within the field of HSR internationally on opportunities to better support reporting in scientific HSR publications.