Influential methods reports for group-randomized trials and related designs

Background. This article identifies the most influential methods reports for group-randomized trials and related designs published through 2020. Many interventions are delivered to participants in real or virtual groups or in groups defined by a shared interventionist so that there is an expectation for positive correlation among observations taken on participants in the same group. These interventions are typically evaluated using a group- or cluster-randomized trial, an individually randomized group treatment trial, or a stepped wedge group- or cluster-randomized trial. These trials face methodological issues beyond those encountered in the more familiar individually randomized controlled trial. Methods. PubMed was searched to identify candidate methods reports; that search was supplemented by reports known to the author. Candidate reports were reviewed by the author to include only those focused on the designs of interest. Citation counts and the relative citation ratio, a new bibliometric tool developed at the National Institutes of Health, were used to identify influential reports. The relative citation ratio measures influence at the article level by comparing the citation rate of the reference article to the citation rates of the articles cited by other articles that also cite the reference article. Results. In total, 1043 reports were identified that were published through 2020. However, 55 were deemed to be the most influential based on their relative citation ratio or their citation count using criteria specific to each of the three designs, with 32 group-randomized trial reports, 7 individually randomized group treatment trial reports, and 16 stepped wedge group-randomized trial reports. Many of the influential reports were early publications that drew attention to the issues that distinguish these designs from the more familiar individually randomized controlled trial. Others were textbooks that covered a wide range of issues for these designs. Others were “first reports” on analytic methods appropriate for a specific type of data (e.g. binary data, ordinal data), for features commonly encountered in these studies (e.g. unequal cluster size, attrition), or for important variations in study design (e.g. repeated measures, cohort versus cross-section). Many presented methods for sample size calculations. Others described how these designs could be applied to a new area (e.g. dissemination and implementation research). Among the reports with the highest relative citation ratios were the CONSORT statements for each design. Conclusions. Collectively, the influential reports address topics of great interest to investigators who might consider using one of these designs and need guidance on selecting the most appropriate design for their research question and on the best methods for design, analysis, and sample size.

Essential Ingredients and Innovations in the Design and Analysis of Group-Randomized Trials

This article reviews the essential ingredients and innovations in the design and analysis of group-randomized trials. The methods literature for these trials has grown steadily since they were introduced to the biomedical research community in the late 1970s, and we summarize those developments. We review, in addition to the group-randomized trial, methods for two closely related designs, the individually randomized group treatment trial and the stepped-wedge group-randomized trial. After describing the essential ingredients for these designs, we review the most important developments in the evolution of their methods using a new bibliometric tool developed at the National Institutes of Health. We then discuss the questions to be considered when selecting from among these designs or selecting the traditional randomized controlled trial. We close with a review of current methods for the analysis of data from these designs, a case study to illustrate each design, and a brief summary.

Workplace Flexibility

As communication technologies develop and as organizations create policies to deal with global expansion and work−life balance, work practices and organizational lives have shifted, giving rise to a model of work where employment is not restricted to one particular place or to standard work hours. This model, workplace flexibility, has been the topic of many fields including sociology, organizational psychology, industry relations, gender studies, management, and health research. This article brings together influential studies from these fields and identifies key themes and topics of interest: the institutional and organizational forces that drive demand for workplace flexibility, types and practices of flexibility, disparities in the provision, access to, and usage of flexibility, the impact of flexibility on work-, family-, and health-related outcomes, and variation in these outcomes by workers’ characteristics and across contexts. Only articles published in English are included, but great efforts have been made to include as many international and cross-national studies as possible. As will be seen, research findings on workplace flexibility are not always consistent. Indeed, despite a growing literature that praises work flexibility for accommodating employees’ needs to balance work, leisure, and family and for reducing gender inequalities, there are also studies criticizing flexibility for fueling heightened job demands and job insecurity and for enlarging gender inequalities. This contradiction can be partially addressed by realizing that researchers do not always define “workplace flexibility” in the same way (see more discussion in Types of Workplace Flexibility). Unless noted otherwise, this article defines workplace flexibility as the ability of workers to make choices regarding when, where, and for how long they engage in work-related tasks. Flexible work arrangements, therefore, are organizational practices that permit employees to adjust their work schedule or location to better manage demands outside of work. Rigorous studies—through group-randomized trials or natural experiments—show that flexibility can promote employer and employee outcomes, but only through a systematic cultural change in how work is defined and how workers are rewarded. Given the still prevalent ideal worker norms that expect workers to be highly dedicated to work and that use “time at work” as the sole metric to assess productivity, a more profound change is needed to remove the stigma around flexibility so as to provide viable solutions to contemporary employees’ needs.

Optimal designs for group randomized trials and group administered treatments with outcomes at the subject and group level

With group randomized trials complete groups of subject are randomized to treatment conditions. Such grouping also occurs in individually randomized trials where treatment is administered in groups. Outcomes may be measured at the level of the subject, but also at the level of the group. The optimal design determines the number of groups and the number of subjects per group in the intervention and control conditions. It is found by taking a budgetary constraint into account, where costs are associated with implementing the intervention and control, and with taking measurements on subject and groups. The optimal design is found such that the effect of treatment is estimated with highest efficiency, and the total costs do not exceed the budget that is available. The design that is optimal for the outcome at the subject level is not necessarily optimal for the outcome at the group level. Multiple-objective optimal designs consider both outcomes simultaneously. Their aim is to find a design that has high efficiencies for both outcome measures. An Internet application for finding the multiple-objective optimal design is demonstrated on the basis of an example from smoking prevention in primary education, and another example on consultation time in primary care.

A Study on Methodology to Make Team: Methodology — Phase II

Improvement in labor productivity is a common problem in each country. In particular, in Japan where the productive age population is decreasing, it is necessary to steadily advance efforts for the improvement at various sites throughout the entire society. In doing so, in order to make it prevail over broad areas, it is necessary to consider that on-site holding resources can be utilized, that it can be easily introduced, and that it will surely be effective. Therefore, we have focused on improving the way of collaboration from an angle of “person’s personality”. Specifically, we have aimed to build a methodology, for a “team” that is a collaborative form widely introduced and utilized at companies and educational sites, which enhances the effectiveness of team activities. As for the overall structure of the methodology, we have designed it with a three-layer structure in order to clarify separation from other intellectual properties and consideration to ethical aspects. That is, the designed methodology comprises the following three phases. Phase I: a team formation methodology; Phase II: a team management methodology; and Phase III: a team development support methodology. Study results of Phase I were presented at the 26th Design Engineering and System Division Lecture by the Japan Society of Mechanical Engineers (JSME). In this study, we have used the methodology of Phase I to devise, as a method included in Phase II, three Rules for creating a team environment that makes it easy for “introverted” persons in Jungian psychology to express their opinions. Then, we have conducted parallel group randomized trials comparing an intervention group with a control group, analyzed the results by an analysis method such as Data Envelopment Analysis (DEA), and verified the effectiveness of the devised method. As a result, the findings have revealed that teams in which the team management was carried out according to the devised method tends to be more effective and prone to excellent effectiveness.