Research Design Considerations Research Articles

Sleep in Neurodevelopmental Disorders.

Individuals with intellectual and developmental disabilities (IDD) experience sleep problems at higher rates than the general population. Although individuals with IDD are a heterogeneous group, several sleep problems cluster within genetic syndromes or disorders. This review summarizes the prevalence of sleep problems experienced by individuals with Angelman syndrome, Cornelia de Lange syndrome, Cri du Chat syndrome, Down syndrome, fragile X syndrome, Prader-Willi syndrome, Smith-Magenis syndrome, Williams syndrome, autism spectrum disorder, and idiopathic IDD. Factors associated with sleep problems and the evidence for sleep treatments are reviewed for each neurodevelopmental disorder. Sleep research advancements in neurodevelopmental disorders are reviewed, including the need for consistency in defining and measuring sleep problems, considerations for research design and reporting of results, and considerations when evaluating sleep treatments.

Research design considerations to ensure detection of all species in an avian community

Summary Recent advances in the estimation of species richness from count data have allowed avian ecologists to incorporate incomplete detectability of species when comparing richness across space or time. Raw counts from single or repeated visits to sample point(s) are nonetheless still used for assessing community composition, and the failure to account for detectability when making these evaluations may lead to incorrect inferences about the community. We estimated detection probabilities (P) for a suite of bird species and used these detection probabilities to determine the minimum number of visits at a single point and the minimum number of points in a grid required to confidently (≥90%) detect the full community of birds for rare, moderately rare, and common species. We used occupancy modelling to estimate the detection probabilities for species from two study sites in Nebraska and Saskatchewan. Some common or highly detectable species were confidently detected in a single visit to a point, whereas others with low detection probabilities (P < 0·20) required more than ten visits to be confidently detected at a point. The grid size required to detect a species in an area varied from a single point for a common highly detectable species to over 30 points for a rare species with low detectability. Detection probabilities of the least detectable species in a study area can be used to determine the number of visits to a single point or the number of points in a grid to be confident that the full community is detected. Biologists can conclude that a species is most likely absent from the community if it remains undetected using the appropriate sampling effort.

Research design considerations for chronic pain prevention clinical trials: IMMPACT recommendations.

Although certain risk factors can identify individuals who are most likely to develop chronic pain, few interventions to prevent chronic pain have been identified. To facilitate the identification of preventive interventions, an IMMPACT meeting was convened to discuss research design considerations for clinical trials investigating the prevention of chronic pain. We present general design considerations for prevention trials in populations that are at relatively high risk for developing chronic pain. Specific design considerations included subject identification, timing and duration of treatment, outcomes, timing of assessment, and adjusting for risk factors in the analyses. We provide a detailed examination of 4 models of chronic pain prevention (ie, chronic postsurgical pain, postherpetic neuralgia, chronic low back pain, and painful chemotherapy-induced peripheral neuropathy). The issues discussed can, in many instances, be extrapolated to other chronic pain conditions. These examples were selected because they are representative models of primary and secondary prevention, reflect persistent pain resulting from multiple insults (ie, surgery, viral infection, injury, and toxic or noxious element exposure), and are chronically painful conditions that are treated with a range of interventions. Improvements in the design of chronic pain prevention trials could improve assay sensitivity and thus accelerate the identification of efficacious interventions. Such interventions would have the potential to reduce the prevalence of chronic pain in the population. Additionally, standardization of outcomes in prevention clinical trials will facilitate meta-analyses and systematic reviews and improve detection of preventive strategies emerging from clinical trials.

Porn architecture

This poster brief describes ongoing research on user taxonomies in free internet pornography, examining tagging and filtering systems in two digital porn bulletin boards on the social network Reddit. These two communities.r/PornVids, a board for mainstream porn, and r/ChickFlixxx, a board for woman-friendly or feminist porn. offer unique insight into not only porn consumption patterns, but also ways of sorting pornography according to distinctly gendered preferences. The researcher concludes by describing future directions for empirical inquiry into internet pornography, making a case for the importance of affective considerations in user research and interface design.

Clinical Studies of Biofield Therapies: Summary, Methodological Challenges, and Recommendations.

Biofield therapies are noninvasive therapies in which the practitioner explicitly works with a client's biofield (interacting fields of energy and information that surround living systems) to stimulate healing responses in patients. While the practice of biofield therapies has existed in Eastern and Western cultures for thousands of years, empirical research on the effectiveness of biofield therapies is still relatively nascent. In this article, we provide a summary of the state of the evidence for biofield therapies for a number of different clinical conditions. We note specific methodological issues for research in biofield therapies that need to be addressed (including practitioner-based, outcomes-based, and research design considerations), as well as provide a list of suggested next steps for biofield researchers to consider.

An Ounce of Prevention Is Worth a Pound of Cure: Improving Research Quality Before Data Collection

We rely on classic as well as recently published sources to offer a review of theory, research design, and measurement issues that should be considered prior to conducting any empirical study. First, we examine theory-related issues that should be addressed before research design and measurement considerations. Specifically, we discuss how to make meaningful theoretical progress including the use of inductive and deductive approaches, address an important issue, and conduct research with a practical end in mind. Second, we offer recommendations regarding research design, including how to address the low statistical power challenge, design studies that strengthen inferences about causal relationships, and use control variables appropriately. Finally, we address measurement issues. Specifically, we discuss how to improve the link between underlying constructs and their observable indicators. Our review offers a checklist for use by researchers to improve research quality prior to data collection and by journal editors and reviewers to evaluate the quality of submitted manuscripts.

Situated Research Design and Methodological Choices in Formative Program Evaluation

Design-based implementation research offers the opportunity to rethink the relationships between intervention, research, and situation to better attune research and evaluation to the program development process. Using a heuristic called the intervention development curve, I describe the rough trajectory that programs typically follow as they evolve, and argue that research design considerations and methodological choices are best made in consideration of where interventions are along this curve. Further, I contend that, as programs develop, situational influences play a major role in their evolution and consequently require increased attention to design and methodological considerations. By viewing research as an integral part of a program's development, by making design and methodological choices in consideration of where programs are in their development, and by considering that the situation in which programs evolve as a potential source of change in the nature of the program itself, we alter fundamental perspectives on how research can best contribute to the steady work of building robust programs for educational improvement.

Parenting Intervention Outcome Studies: Research Design Considerations

SYNOPSIS This tutorial provides an overview of major considerations in the design and implementation of research on outcomes of parenting interventions. It is offered in the context of escalating interest in the use of rigorous research designs for determining effective strategies for improving parents’ contributions to the well-being of their children. The tutorial provides guidance on preliminary work for conducting an outcome study, sampling, research designs that permit causal inference, options for comparison conditions, the measurement of implementation fidelity and parent/child outcomes, and basic considerations in outcome analyses.

Voluntary survey completion among team members: Implications of noncompliance and missing data for multilevel research.

We explored whether voluntary survey completion by team members (in aggregate) is predictable from team members' collective evaluations of team-emergent states. In doing so, we reanalyze less-than-complete survey data on 110 teams from a published field study, using so-called traditional and modern missing data techniques to probe the sensitivity of these team-level relationships to data missingness. The multivariate findings revealed that a greater within-team participation rate was indeed related to a higher team-level (mean) score on team mental efficacy (across all four missing-data techniques) and less dispersion among team member judgments about internal cohesion (when the 2 modern methods were used). In addition, results show that a commonly used approach of retaining only those teams with high participation rates produces inflated standardized effect size (i.e., R²) estimates and decreased statistical power. Suggestions include research design considerations and a comprehensive methodology to account for team member data missingness.

Research design considerations for clinical studies of abuse-deterrent opioid analgesics: IMMPACT recommendations

Research design considerations for clinical studies of abuse-deterrent opioid analgesics: IMMPACT recommendations

Does the Time Frame Between Exercise Influence the Effectiveness of Hydrotherapy for Recovery?

An increase in research investigating recovery strategies has occurred alongside the increase in usage of recovery by elite athletes. Because there is inconsistent evidence regarding the benefits of recovery on performance, it is necessary to examine research design to identify possible strategies that enhance performance in different athlete settings. The purpose of this review is to examine available recovery literature specifically related to the time frame between performance assessments to identify considerations for both research design and practical use of recovery techniques.

Introduction to CRPS Special Issue

The International Association for the Study of Pain (IASP) Special Interest Group on Pain and the Sympathetic Nervous System held a satellite symposium in Cardiff, Wales, ahead of the World Congress in August 2008. Papers presented at this symposium, now edited and updated, are published here. The problems facing the field of complex regional pain syndrome (CRPS) were addressed in general terms by Dr. Donald Manning, summarized below but not published here. Dr. Manning drew on his methodological experience and previewed his contributions to IMMPACT (Dworkin et al. Research design considerations for confirmatory chronic pain clinical trials: IMMPACT recommendations. Pain 2010;140:177–93). Manning pointed out that the state of CRPS research was plagued with methodological issues, with most published studies being inadequate in one or more areas: 1. Definition of CRPS itself has not necessarily been universally accepted. 2. Duration of CRPS (avoiding the terms “acute” and “chronic”) might affect both diagnostic criteria and therapeutic stratagems. 3. Average duration of treatment is usually short. 4. Studies have too few subjects. 5. Double-blind studies are rare, placebo controls are difficult, and statistical analytic methods are controversial. 6. Objective outcome measures are rarely, if ever, used. This results in practical difficulties for clinicians and patients in applying clinical trial data to management of CRPS: 1. How does the physician know which CRPS trial applies to the particular patient? 2. Does information from “acute” CRPS or animal models apply to “chronic” CRPS? 3. How can the clinician and patient assess the risk/cost/benefit of a treatment? 4. How can the clinician and patient assess the risk/cost/benefit of “doing nothing”? 5. Why do the “best” medical centers and research groups appear to have the highest placebo effects? 6. How are CRPS recurrences, relapses, and spread prevented? 7. What are realistic treatment/intervention goals for the individual patient? With these questions in mind, Dr. R. Norman Harden reviewed his studies on …

Hypnosis in the Treatment Of Depression: Considerations in Research Design and Methods

Depressive disorders constitute a serious problem in the United States and around the world. The appearance of practice guidelines and lists of evidenced-based therapies suggests that adequate treatments for depression exist. However, a careful consideration of what is known and not known about the treatment of depression leaves plenty of room for improved approaches to addressing this condition. Although there has been a dearth of research on the treatment of depression using hypnosis, there are several compelling arguments for the inclusion of hypnotic approaches in the array of current strategies for dealing with depression. However, traditional “gold-standard” research methods, namely randomized controlled trials, have many shortcomings for identifying the potential impact of hypnosis on depression. Other strategies, notably single-case design and benchmarking approaches, may offer a more practical solution to the problem of determining “what works for depression.”

Ecological momentary interventions: Incorporating mobile technology into psychosocial and health behaviour treatments

Psychosocial and health behaviour treatments and therapies can be extended beyond traditional research or clinical settings by using mobile technology to deliver interventions to individuals as they go about their daily lives. These ecological momentary interventions (EMIs) are treatments that are provided to people during their everyday lives (i.e. in real time) and in natural settings (i.e. real world). The goal of the present review is to synthesize and critique mobile technology-based EMI aimed at improving health behaviours and psychological and physical symptoms. Twenty-seven interventions using palmtop computers or mobile phones to deliver ambulatory treatment for smoking cessation, weight loss, anxiety, diabetes management, eating disorders, alcohol use, and healthy eating and physical activity were identified. There is evidence that EMI can be successfully delivered, are accepted by patients, and are efficacious for treating a variety of health behaviours and physical and psychological symptoms. Limitations of the existing literature were identified and recommendations and considerations for research design, sample characteristics, measurement, statistical analyses, and clinical implementation are discussed. Mobile technology-based EMI can be effectively implemented as interventions for a variety of health behaviours and psychological and physical symptoms. Future research should integrate the assessment and intervention capabilities of mobile technology to create dynamically and individually tailored EMI that are ecologically sensitive.

Physical Activity, Stress, Disease Activity, and Quality of Life in Adults With Crohn Disease

Physical activity and stress reduction are recognized strategies for chronic disease management. They are recommended for people with a variety of diseases; however, little attention has been paid to the effects of regular physical activity and stress reduction in people with Crohn disease (CD). The aim of this pilot study was to examine the relationship that both physical activity and stress levels have with disease activity (a subscale of a quality of life [QOL] measure). A 2-pronged approach to sampling, using an online Crohn support forum and snowball sampling, was implemented over a period of 3 months to conduct this survey. Seventeen adults with CD completed 3 questionnaires measuring physical activity, stress levels, disease activity, and QOL. Although no significant correlations were found for disease activity with stress or physical activity, significant relationships were revealed for QOL with both stress and physical activity. The direct relationship between physical activity and QOL and the inverse relationship between stress and QOL are noteworthy for persons with CD, as well as their healthcare providers. Suggestions for important research design considerations are presented, along with future research needs.

Social anxiety disorder: A review of environmental risk factors

Social anxiety disorder (SAD) is a debilitating and chronic illness characterized by persistent fear of one or more social or performance situations, with a relatively high lifetime prevalence of 7% to 13% in the general population. Although the last two decades have witnessed enormous growth in the study of biological and dispositional factors underlying SAD, comparatively little attention has been directed towards environmental factors in SAD, even though there has been much ongoing work in the area. In this paper, we provide a recent review and critique of proposed environmental risk factors for SAD, focusing on traditional as well as some understudied and overlooked environmental risk factors: parenting and family environment, adverse life events, cultural and societal factors, and gender roles. We also discuss the need for research design improvements and considerations for future directions.

Comparison of Three Meta-Analytic Procedures for Estimating Moderating Effects of Categorical Variables

The authors conducted Monte Carlo simulations to compare the Hedges and Olkin, the Hunter and Schmidt, and a refinement of the Aguinis and Pierce meta-analytic approaches for estimating moderating effects of categorical variables. The simulation examined binary moderator variables (e.g., gender—male, female; ethnicity—majority, minority). The authors compared the three meta-analytic methods in terms of their point estimation accuracy and Type I and Type II error rates. Results provide guidelines to help researchers choose among the three meta-analytic techniques based on theory (i.e., exploratory vs. confirmatory research) and research design considerations (i.e., degree of range restriction and measurement error).

Making Sense of New Orleans Flood Trauma Recovery: Ethics, Research Design, and Policy Considerations for Future Disasters

This article details the justification and plans of a research team for studying and helping evacuees of Hurricane Katrina from New Orleans to recover by encouraging experimental participants to disclose information about their related experiences in guided interview sessions. Team members' consideration and practice of ethical principles as researchers dealing with the potentially traumatized victims of a disaster are portrayed. Finally, related recommendations for researchers and policy makers are offered.

Behavioral Headache Research: Methodologic Considerations and Research Design Alternatives

Behavioral headache treatments have garnered solid empirical support in recent years, but there is substantial opportunity to strengthen the next generation of studies with improved methods and consistency across studies. Recently, Guidelines for Trials of Behavioral Treatments for Recurrent Headache were published to facilitate the production of high-quality research. The present article compliments the guidelines with a discussion of methodologic and research design considerations. Since there is no research design that is applicable in every situation, selecting an appropriate research design is fundamental to producing meaningful results. Investigators in behavioral headache and other areas of research consider the developmental phase of the research, the principle objectives of the project, and the sources of error or alternative interpretations in selecting a design. Phases of clinical trials typically include pilot studies, efficacy studies, and effectiveness studies. These trials may be categorized as primarily pragmatic or explanatory. The most appropriate research designs for these different phases and different objectives vary on such characteristics as sample size and assignment to condition, types of control conditions, periods or frequency of measurement, and the dimensions along which comparisons are made. A research design also must fit within constraints on available resources. There are a large number of potential research designs that can be used and considering these characteristics allows selection of appropriate research designs.

Facility Design Considerations for Select Agent Animal Research

The events of September 11, 2001, have piqued US interest and investment in infectious disease research and the facilities that support the research. Since 1999, federal grants for biosafety level (BSL)-3, -3 agricultural (Ag), and -4 research have increased by more than 900%--to 13.1B dollars in the fiscal years 2002 to 2004 compared with 1.2B dollars from 1999 to 2001. This dramatic growth has forced experienced professionals from government agencies, universities, industry, design firms, commissioning firms, and contractors to work together to construct buildings that meet the demanding and unique needs of the research. This discussion pertains primarily to select agent research and provides (1) an overview of the guidelines and standards pertinent to the design and construction of biocontainment research facilities using animals, (2) design considerations appropriate for these facilities, (3) special requirements associated with BSL-3Ag agricultural research, and (4) information to prepare for the use of a state-of-the-art infectious disease research facility.