JMIR Formative Research

Process evaluations, early results, and feasibility/pilot studies of digital and non-digital interventions

Editor-in-Chief:

Amaryllis Mavragani, PhDc, Scientific Editor at JMIR Publications, Canada


Impact Factor 2.0

JMIR Formative Research (JFR, ISSN 2561-326X, Impact Factor 2.2publishes peer-reviewed, openly accessible papers containing results from process evaluations, feasibility/pilot studies and other kinds of formative research and preliminary results. While the original focus was on the design of medical- and health-related research and technology innovations, JFR publishes studies from all areas of medical and health research.

Formative research is research that occurs before a program is designed and implemented, or while a program is being conducted. Formative research can help

  • define and understand populations in need of an intervention or public health program
  • create programs that are specific to the needs of those populations
  • ensure programs are acceptable and feasible to users before launching
  • improve the relationship between users and agencies/research groups
  • demonstrate the feasibility, use, satisfaction with, or problems with a program before large-scale summative evaluation (looking at health outcomes)

Many funding agencies will expect some sort of pilot/feasibility/process evaluation before funding a larger study such as a Randomized Controlled Trial (RCT).

Formative research should be an integral part of developing or adapting programs and should be used while the program is ongoing to help refine and improve program activities. Thus, formative evaluation can and should also occur in the form of a process evaluation alongside a summative evaluation such as an RCT.

JFR fills an important gap in the academic journals landscape, as it publishes sound and peer-reviewed formative research that is critical for investigators to apply for further funding, but that is usually not published in outcomes-focused medical journals aiming for impact and generalizability.

Summative evaluations of programs and apps/software that have undergone a thorough formative evaluation before launch have a better chance to be published in high-impact flagship journals; thus, we encourage authors to submit - as a first step - their formative evaluations in JFR (and their evaluation protocols to JMIR Research Protocols). 

In 2023, JMIR Formative Research received an inaugural Journal Impact Factor™ of 2.2 (Source: Journal Citation Reports™ from Clarivate, 2023)JFR is indexed in PubMed, PubMed CentralDOAJ, Scopus, Sherpa/Romeo, EBSCO/EBSCO Essentials, and the Emerging Sources Citation Index (Clarivate).

Recent Articles

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Formative Evaluation of Digital Health Interventions

The potential of artificial intelligence (AI) chatbots, particularly ChatGPT with GPT-4 (OpenAI), in assisting with medical diagnosis is an emerging research area. However, it is not yet clear how well AI chatbots can evaluate whether the final diagnosis is included in differential diagnosis lists.

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Pilot studies (non-ehealth)

Multidisciplinary clinics (MDCs) provide benefits to patients with amyotrophic lateral sclerosis (ALS) and their caregivers, but MDC visits are information-heavy and can last 4 hours, with patients and caregivers meeting with multiple specialists within each MDC visit. There are questions about the effectiveness of current methods of sharing information from MDCs with patients. Video recordings are a promising new method of sharing information that may allow patients and caregivers to revisit the MDC and remind them of clinical recommendations and conversations.

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Pilot studies (non-ehealth)

Age-related vision changes significantly contribute to fatal crashes at night among older drivers. However, the effects of lighting conditions on age-related vision changes and associated driving performance remain unclear.

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Formative Evaluation of Digital Health Interventions

Meaning in life is positively associated with health, well-being, and longevity, which may be partially explained by engagement in healthier behaviors, including physical activity (PA). However, promoting awareness of meaning is a behavior change strategy that has not been tested in previous PA interventions.

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Development and Evaluation of Research Methods, Instruments and Tools

Accelerated digitalization in the health sector requires the development of appropriate evaluation methods to ensure that digital health technologies (DHTs) are safe and effective. Software as a medical device (SaMD) is a commonly used DHT by clinicians to provide care to patients. Traditional research methods for evaluating health care products, such as randomized clinical trials, may not be suitable for DHTs, such as SaMD. However, evidence to show their safety and efficacy is needed by regulators before they can be used in practice. Clinical simulation can be used by researchers to test SaMD in an agile and low-cost way; yet, there is limited research on criteria to assess the robustness of simulations and, subsequently, their relevance for a regulatory decision.

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Pilot studies (ehealth)

Large-scale crisis events such as COVID-19 often have secondary impacts on individuals’ mental well-being. University students are particularly vulnerable to such impacts. Traditional survey-based methods to identify those in need of support do not scale over large populations and they do not provide timely insights. We pursue an alternative approach through social media data and machine learning. Our models aim to complement surveys and provide early, precise, and objective predictions of students disrupted by COVID-19.

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Development and Evaluation of Research Methods, Instruments and Tools

Measurement-based care in behavioral health uses patient-reported outcome measures (PROMs) to screen for mental health symptoms and substance use and to assess symptom change over time. While PROMs are increasingly being integrated into electronic health record systems and administered electronically, paper-based PROMs continue to be used. It is unclear if it is feasible to administer a PROM on paper when the PROM was initially developed for electronic administration.

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Formative Evaluation of Digital Health Interventions

Timely detection of stress in people with dementia and people with an intellectual disability (ID) may reduce the occurrence of challenging behavior. However, detecting stress is often challenging as many long-term care (LTC) residents with dementia and residents with ID have communication impairments, limiting their ability to express themselves. Wearables can help detect stress but are not always accepted by users and are uncomfortable to wear for longer periods. Integrating sensors into clothing may be a more acceptable approach for users in LTC. To develop a sensor system for early stress detection that is accepted by LTC residents with dementia and residents with ID, understanding their perceptions and requirements is essential.

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Formative Evaluation of Non-Ehealth Innovations

The longevity of the world population can contribute to an increase in hospitalizations and, consequently, to the emergence of functional limitations, resulting in the need for family caregivers. Hospitalized older adults may become dependent and require more care, increasing the burden on family caregivers. Thus, the nursing team in the hospital environment faces a new situation: an increase in the number of older adults occupying hospital beds and the presence of their family caregivers.

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Formative Evaluation of Digital Health Interventions

Mobile health (mHealth) apps have proven useful for people with multiple sclerosis (MS). Thus, easy-to-use digital solutions are now strongly required to assess and monitor cognitive impairment, one of the most disturbing symptoms in MS that is experienced by almost 43% to 70% of people with MS. Therefore, we developed DIGICOG-MS (Digital assessment of Cognitive Impairment in Multiple Sclerosis), a smartphone- and tablet-based mHealth app to self-assess cognitive impairment in MS.

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Early Results in Infodemiology and Infoveillance

The Mediterranean diet has been linked to reduced risk for several cardiometabolic diseases. The lack of a clear definition of the Mediterranean diet in the scientific literature and the documented proliferation of nutrition misinformation on the internet suggest the potential for confusion among consumers seeking web-based Mediterranean diet information.

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Formative Evaluation of Digital Health Interventions

Chronic pain is prevalent in our society, with conditions such as fibromyalgia being notably widespread. The gold standard for aiding individuals dealing with chronic pain involves interdisciplinary approaches rooted in a biopsychosocial perspective. Regrettably, access to such care is difficult for most of the people in need. Information and communication technologies (ICTs) have been used as a way of overcoming access barriers (among other advantages).

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Preprints Open for Peer-Review

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