JMIR Research Protocols
Ongoing Trials, Grant Proposals, Formative Research, Methods, Early Results
JMIR Research Protocols (ISSN 1929-0748) publishes peer-reviewed, openly accessible research ideas and grant proposals, study and trial protocols, reports of ongoing research, current methods and approaches, and preliminary results from pilot studies or formative research informing the design of medical and health-related research and technology innovations.
JMIR Res Protoc is a new journal spin-off of JMIR, the worlds' leading medical journal in health sciences / health services research and health informatics (Impact Factor 2015: 4.532)
JMIR Res Protoc publishes protocols and grant proposals in all areas of medicine (and their peer-review reports, if available), as well as feasibility studies, early reports and formative/process evaluations of ongoing studies and descriptions of the development and pilot evaluations of innovations and software applications or other interventions
JMIR Res Protoc is fully open access, with full text articles deposited in PubMed Central
Publishing research protocols, grant proposals, pilot/feasibility studies and early reports of ongoing and planned work encourages collaboration and early feedback, and reduces duplication of effort
JMIR Res Protoc will be a valuable ressource for researchers who want to learn about current research methodologies and how to write a winning grant proposal
JMIR Res Protoc creates an early scientific record for researchers who have developed novel methodologies, software, innovations or elaborate protocols
JMIR Res Protoc faciliates subsequent publication of results demonstrating that the methodology has already been reviewed, and reduces the effort of writing up the results, as the protocol can be easily referenced
JMIR Res Protoc demonstrates to reviewers of subsequent results papers that authors followed and adhered to carefully developed and described a-priori methods
Studies whose protocols or grant proposal have been accepted in JMIR Res Protoc are "in principle accepted" for subsequent publication of results in other JMIR journals as long as authors adhere to their original protocol - regardless of study results (even if they are negative), reducing publication bias in medicine
Authors publishing their protocols in JMIR Res Protoc will receive a 20% discount on the article processing fee if they publish their results in another journal of the JMIR journal family (for example, JMIR for ehealth studies, i-JMR for others)
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Latest Submissions Open for Peer-Review:View All Open Peer Review Articles
Epidemiology of patient harms in New Zealand general practices: Records review study
Date Submitted: Sep 25, 2016
Open Peer Review Period: Sep 26, 2016 - Oct 10, 2016
Knowing where and why harm occurs in general practice will assist patients, doctors and others make informed decisions about the risks and benefits of treatment options. Research to date has been un...
Knowing where and why harm occurs in general practice will assist patients, doctors and others make informed decisions about the risks and benefits of treatment options. Research to date has been unable to verify the safety of primary health care and epidemiological research about patient harms in general practice is now a top priority for advancing health systems safety. We therefore aim to study the incidence, distribution, severity, and preventability of the harms patients experience due to their healthcare, from the whole-of-health-system lens afforded by electronic general practice patient records. ‘Harm’ is defined as disease, injury, disability, suffering and death, arising from the health system. The study design is a stratified, two-level cluster, retrospective records review study. Both general practices and patients will be randomly selected so that the study’s results will apply nationally, after weighting. Stratification by practice size and rurality will allow comparisons between six study groups (large, medium-sized, small; urban, and rural practices). Records of equal numbers of patients from each study group will be included in the study because there may be systematic differences in patient harms in different types of practices. Eight general practitioner investigators will review three years of electronic general practice health records (consultation notes, prescriptions, investigations, referrals, and summaries of hospital care) from 9000 patients registered in 60 general practices. Double reviews will check the concordance of reviewers’ assessments. Study data will comprise demographic data of all 9000 patients and reviewers’ assessments of whether patients experienced harm arising from healthcare. Where patient harm is identified, their types, preventability, severity, and outcomes will be coded using MedDRA 18.0 and measured. The design of this complex study is presented with discussion on data collection methods, sampling weightings, power analysis and statistical approach. Lessons from a feasibility study are reported.
The SENSOR Study: A mixed-methods study of SElf-management checks to predict exacerbatioNs of Pseudomonas aeruginosa in patients with long-term reSpiratORy conditions.
Date Submitted: Sep 23, 2016
Open Peer Review Period: Sep 24, 2016 - Oct 8, 2016
There are an estimated three million people in the UK with COPD and the incidence of Bronchiectasis is estimated at around 0.1% but is more common in COPD and severe asthma. Both COPD and Bronchiectas...
There are an estimated three million people in the UK with COPD and the incidence of Bronchiectasis is estimated at around 0.1% but is more common in COPD and severe asthma. Both COPD and Bronchiectasis are characterised by exacerbations in which bacteria play a central role. Pseudomonas aeruginosa (PA) is isolated from sputum samples from 4–15% of adults with COPD and is more likely to be isolated from patients with severe disease. Earlier detection of exacerbations may improve morbidity and mortality by expediting treatment. Aseptika Ltd (Cambridgeshire, UK) has developed a system for patients to self-monitor important physiological measurements including levels of physical activity, peak flow, FEV1 and biomarkers for PA in sputum. We aim to test this system in twenty participants with PA colonisation, and ten controls with Haemophilus influenzae(HI). We plan to recruit 30 adult participants with COPD or non-CF Bronchiectasis who have previously cultured PA or HI during an exacerbation in the last six months. They must produce sputum on most days and should have been stable for four weeks prior to entry. Daily data collected will include symptoms, healthcare usage, medication, weight, FEV1, physical activity level, blood pressure, oxygen saturation and temperature. Sputum and urine samples will be provided daily. These data will be analysed to assess predictive value in detecting upcoming exacerbations. Qualitative data will be gathered through self-administered questionnaires and semi-structured interviews to gather information on participants coping and their use of the technology involved.
Automated Adherence Reminders for High Risk Children with Asthma: Research Protocol
Date Submitted: Sep 23, 2016
Open Peer Review Period: Sep 23, 2016 - Oct 7, 2016
Background: The use of inhaled corticosteroid (ICS) medications has been shown to improve asthma control and reduce asthma-related morbidity and mortality. Two recent randomized trials demonstrated d...
Background: The use of inhaled corticosteroid (ICS) medications has been shown to improve asthma control and reduce asthma-related morbidity and mortality. Two recent randomized trials demonstrated dramatic improvements in ICS adherence by monitoring adherence with electronic sensors and providing automated reminders to participants to take their ICS medications. Given their lower levels of adherence and higher levels of asthma-related emergency department (ED) visits, hospitalizations, and death, urban minority populations could potentially benefit greatly from these types of interventions. Objective: The principle objective of this study will be to evaluate the feasibility, acceptability, and limited efficacy of a text message reminder intervention to enhance ICS adherence in an urban minority population of children with asthma. We will also assess trajectories of ICS adherence in the two months following asthma hospitalization. Methods: Participants will include children ages 2-13 who are currently admitted to the Children’s Hospital of Philadelphia (CHOP) for asthma and their parent or legal guardian. Participants will be assigned to intervention and control arms using a 1:1 randomization scheme. The intervention arm will receive daily text message reminders for a 30-day intervention phase following hospitalization. This will be followed by a 30-day follow-up phase, in which all participants may choose whether or not to receive the text messages. Feasibility will be assessed by measuring (1) retention of the participants through the study phases and (2) perceived usefulness, acceptability, and preferences regarding the intervention components. Limited efficacy outcomes will include percent adherence to prescribed ICS regimen and change in parent-reported asthma control. We will perform an exploratory analysis to assess for discrete trajectories of adherence using group-based trajectory modeling (GBTM). Results: Study enrollment began in December 2015 and the intervention and follow-up phases are ongoing. Results of the data analysis are expected to be available by December 2016. Conclusions: This study will add to the literature by providing foundational feasibility data on which elements of a mobile health text-message reminder intervention may need to be modified to suit the needs and constraints of high-risk urban minority populations. Clinical Trial: Clinicaltrials.gov: NCT02615743; https://www.clinicaltrials.gov/ct2/show/study/NCT02615743?view=results; archived with WebCite® at http://www.webcitation.org/6ji59rAXN
Cognitive and Psychosocial Assessment After Mechanical Ventilation in Intensive Care - Does an Experience of Delirium Make a Difference: The CAPA Study Protocol
Date Submitted: Sep 17, 2016
Open Peer Review Period: Sep 19, 2016 - Oct 3, 2016
Background: In the Intensive Care Unit (ICU) critical illness delirium occurs in the context of multiple co-morbidities, multi-organ failure, and invasive management techniques, such as mechanical ven...
Background: In the Intensive Care Unit (ICU) critical illness delirium occurs in the context of multiple co-morbidities, multi-organ failure, and invasive management techniques, such as mechanical ventilation, sedation and lack of sleep. Delirium is characterized by an acute confusional state defined by fluctuating mental status, inattention and, either disorganised thinking or an altered level of consciousness. The impact of delirium in ICU on the long-term cognitive and psychosocial function of patients who experience it is of crucial interest. Preliminary data suggest strong association between ICU delirium and long-term cognitive impairment. Objective: We aim to explore the relationship of delirium in ICU to adverse outcomes. We are doing so by following mechanically ventilated patients for a yearafter their ICU discharge. We aim to collect data on their long-term cognition andpsychosocial function. Methods: We are conducting this study by enrolling patients in two tertiary Intensive Care Units in Australia. We aim to recruit 200 patients who have been mechanically ventilated for more than 24 hours. Data is collected at three time points following discharge from ICU: at discharge patients are administered the Mini Mental State Examination (MMSE); at 6 months after ICU discharge they are administered the Impact of Events Scale Revised (IES-R) and the Telephone Inventory for Cognitive Status (TICS); and again at 12 months after ICU discharge patients are administered the TICS and IES-R, as well as the Informant Questionnaire for Cognitive Decline in the Elderly (IQCODE), which is administered Results: We aim to assess long-term cognition and psychosocial function as our primary outcomes. We will investigate mortality as a secondary outcome. The study is enrolling until end of September 2016 and data collection will conclude at the end of September 2017. The analysis and results are expected to be available by March 2018 Conclusions: We aim to assess long-term cognition and psychosocial function as our primary outcomes. We will investigate mortality as a secondary outcome. The study is enrolling until end of September 2016 and data collection will conclude at the end of September 2017. The analysis and results are expected to be available by March 2018. Conclusion: Delirium during mechanical ventilation has been linked with longer ICU and hospital stay and associated financial burden; a higher risk of long-term cognitive impairment, including dementia; poor functional outcomes and quality of life; and decreased survival. Delirium during mechanical ventilation in ICU is not well understood, and this study will advance knowledge of the comprehensive long-term effects on cognitive and psychosocial function. Clinical Trial: Trial Registration: ACTRN12616001116415