JMIR Research Protocols

Ongoing Trials, Grant Proposals, Formative Research, Methods, Early Results

Designing an Internationally-Accessible Web-based Questionnaire to Discover Risk Factors for Amyotrophic Lateral Sclerosis

Background: Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disease with a typical survival of three to five years. Epidemiological studies using paper-based questionnaires in individual countries or continents have failed to find widely-accepted risk factors for the disease. The many advantages of online versus paper-based questionnaires have been extensively reviewed, but few online epidemiological studies into human neurodegenerative diseases have so far been undertaken. Objective: To design a web-based questionnaire to identify environmental risk factors for ALS and to enable international comparisons of these risk factors. Methods: A web-based epidemiological questionnaire for ALS has been developed, based on experience gained from administering a previous continent-wide paper-based questionnaire for this disease. New and modified questions have been added from our previous paper-based questionnaire, from literature searches, and from validated ALS questionnaires supplied by other investigators. New criteria to allow the separation of familial and sporadic ALS have been included. The questionnaire addresses many risk factors that have already been proposed for ALS, as well as a number that have not yet been rigorously examined. To encourage participation respondents maintain anonymity since no personally-identifying information is requested. The survey is being translated into a number of languages, which will allow most people around the world to read and answer it in their own language. Results: After the questionnaire had been online for 4 months it had 379 respondents, compared to only 46 respondents for the same initial period using a paper-based questionnaire. The questionnaire is soon to be promoted in a number of different countries through ALS associations in these countries and via disease registries. Feedback about the ease of use of the online questionnaire from respondents, including from those with physical disability, has been positive. Conclusions: Web-based questionnaires are a time- and resource-efficient method for performing large epidemiological studies of neurodegenerative diseases such as ALS. The ability to compare risk factors between different countries using the same analysis tool will be of particular value for finding robust risk factors that underlie ALS.

2015-07-01

Thomson Reuters, producer of the Journal Citation Reports and Web of Science and other database products, is creating a new edition of Web of Science; and we are proud to report that JMIR journals have been selected for the content expansion. 

The new Thomson Reuters Web of Science edition, which launches later in 2015, will include influential journals covering a variety of disciplines. "The journals selected have been identified as important to key opinion leaders, funders, and evaluators worldwide.", say a Thomson Reuters communication about the database. "We are proud that the Thomson Reuters team recognizes the influence of the JMIR journals", says Gunther Eysenbach, publisher at JMIR Publications.

The following journals are confirmed to be part of the initial release:

JMIR Publications is working on getting its newer journals such as JMIR Mental Health into the collection as well. JMIR Publications is now publishing over a dozen journals with topics covering innovation in health and technology.

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Journal Description

 

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: 4.7)
  • 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)
 
 

Recent Articles:

  • (cc) Barley et al, CC-BY-SA-2.0, please cite as (http://www.researchprotocols.org/article/viewFile/4280/1/61301).

    The Space From Heart Disease Intervention for People With Cardiovascular Disease and Distress: A Mixed-Methods Study

    Abstract:

    Background: Poor self-management of symptoms and psychological distress leads to worse outcomes and excess health service use in cardiovascular disease (CVD). Online-delivered therapy is effective, but generic interventions lack relevance for people with specific long-term conditions, such as cardiovascular disease. Objective: To develop a comprehensive online CVD-specific intervention to improve both self-management and well-being, and to test acceptability and feasibility. Methods: Informed by the Medical Research Council (MRC) guidance for the development of complex interventions, we adapted an existing evidence-based generic intervention for depression and anxiety for people with CVD. Content was informed by a literature review of existing resources and trial evidence, and the findings of a focus group study. Think-aloud usability testing was conducted to identify improvements to design and content. Acceptability and feasibility were tested in a cross-sectional study. Results: Focus group participants (n=10) agreed that no existing resource met all their needs. Improvements such as "collapse and expand" features were added based on findings that participants’ information needs varied, and specific information, such as detecting heart attacks and when to seek help, was added. Think-aloud testing (n=2) led to changes in font size and design changes around navigation. All participants of the cross-sectional study (10/10, 100%) were able to access and use the intervention. Reported satisfaction was good, although the intervention was perceived to lack relevance for people without comorbid psychological distress. Conclusions: We have developed an evidence-based, theory-informed, user-led online intervention for improving self-management and well-being in CVD. The use of multiple evaluation tests informed improvements to content and usability. Preliminary acceptability and feasibility has been demonstrated. The Space from Heart Disease intervention is now ready to be tested for effectiveness. This work has also identified that people with CVD symptoms and comorbid distress would be the most appropriate sample for a future randomized controlled trial to evaluate its effectiveness.

  • preSANO trial logo.

    Accuracy of Detecting Residual Disease After Cross Neoadjuvant Chemoradiotherapy for Esophageal Cancer (preSANO Trial): Rationale and Protocol

    Abstract:

    Background: Results from the recent CROSS trial showed that neoadjuvant chemoradiotherapy (nCRT) significantly increased survival as compared to surgery alone in patients with potentially curable esophageal cancer. Furthermore, in the nCRT arm 49% of patients with a squamous cell carcinoma (SCC) and 23% of patients with an adenocarcinoma (AC) had a pathologically complete response in the resection specimen. These results provide a rationale to reconsider and study the timing and necessity of esophagectomy in (all) patients after application of the CROSS regimen. Objective: We propose a “surgery as needed” approach after completion of nCRT. In this approach, patients will undergo active surveillance after completion of nCRT. Surgical resection would be offered only to those patients in whom residual disease or a locoregional recurrence is highly suspected or proven. However, before a surgery as needed approach in oesophageal cancer patients (SANO) can be tested in a randomized controlled trial, we aim to determine the accuracy of detecting the presence or absence of residual disease after nCRT (preSANO trial). Methods: This study is set up as a prospective, single arm, multicenter, diagnostic trial. Operable patients with potentially curable SCC or AC of the esophagus or esophagogastric junction will be included. Approximately 4-6 weeks after completion of nCRT all included patients will undergo a first clinical response evaluation (CRE-I) including endoscopy with (random) conventional mucosal biopsies of the primary tumor site and of any other suspected lesions in the esophagus and radial endo-ultrasonography (EUS) for measurement of tumor thickness and area. Patients in whom no locoregional or disseminated disease can be proven by cytohistology will be offered a postponed surgical resection 6-8 weeks after CRE-I (ie, approximately 12-14 weeks after completion of nCRT). In the week preceding the postponed surgical resection, a second clinical response evaluation (CRE-II) will be planned that will include a whole body PET-CT, followed again by endoscopy with (random) conventional mucosal biopsies of the primary tumor site and any other suspected lesions in the esophagus, radial EUS for measurement of tumor thickness and area, and linear EUS plus fine needle aspiration of PET-positive lesions and/or suspected lymph nodes. The main study parameter is the correlation between the clinical response assessment during CRE-I and CRE-II and the final pathological response in the resection specimen. Results: The first patient was enrolled on July 23, 2013, and results are expected in January 2016. Conclusions: If this preSANO trial shows that the presence or absence of residual tumor can be predicted reliably 6 or 12 weeks after completion of nCRT, a randomized trial comparing nCRT plus standard surgery versus chemoradiotherapy plus “surgery as needed” will be conducted (SANO trial). Trial Registration: Netherlands Trial Register: NTR4834; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4834 (archived by Webcite at http://www.webcitation.org/6Ze7mn67B).

  • (cc) Sooong et al, please cite as (http://www.researchprotocols.org/article/viewFile/4408/1/60745). JMIR EMA methods - mobile phone.

    Using Ecological Momentary Assessment to Study Tobacco Behavior in Urban India: There’s an App for That

    Abstract:

    Background: Ecological momentary assessment (EMA) uses real-time data collection to assess participants’ behaviors and environments. This paper explores the strengths and limitations of using EMA to examine social and environmental exposure to tobacco in urban India among older adolescents and adults. Objective: Objectives of this study were (1) to describe the methods used in an EMA study of tobacco use in urban India using a mobile phone app for data collection, (2) to determine the feasibility of using EMA in the chosen setting by drawing on participant completion and compliance rates with the study protocol, and (3) to provide recommendations on implementing mobile phone EMA research in India and other low- and middle-income countries. Methods: Via mobile phones and the Internet, this study used two EMA surveys: (1) a momentary survey, sent multiple times per day at random to participants, which asked about their real-time tobacco use (smoked and smokeless) and exposure to pro- and antitobacco messaging in their location, and 2) an end-of-day survey sent at the end of each study day. Trained participants, from Hyderabad and Kolkata, India, reported on their social and environmental exposure to tobacco over 10 consecutive days. This feasibility study examined participant compliance, exploring factors related to the successful completion of surveys and the validity of EMA data. Results: The sample included 205 participants, the majority of whom were male (135/205, 65.9%). Almost half smoked less than daily (56/205, 27.3%) or daily (43/205, 21.0%), and 4.4% (9/205) used smokeless tobacco products. Participants completed and returned 46.87% and 73.02% of momentary and end-of-day surveys, respectively. Significant predictors of momentary survey completion included employment and completion of end-of-day surveys. End-of-day survey completion was only significantly predicted by momentary survey completion. Conclusions: This first study of EMA in India offers promising results, although more research is needed on how to increase compliance. End-of-day survey completion, which has a lower research burden, may be the more appropriate approach to understanding behaviors such as tobacco use within vulnerable populations in challenging locations. Compliance may also be improved by increasing the number of study visits, compliance checks, or opportunities for retraining participants before and during data collection.

  • Picture of the ProMove accelerometer and mobile phone app with feedback.

    Effectiveness, Mediators, and Effect Predictors of Internet Interventions for Chronic Cancer-Related Fatigue: The Design and an Analysis Plan of a 3-Armed...

    Abstract:

    Background: Internet interventions offer advantages that especially cancer survivors who suffer from fatigue could benefit from. Given the growing number of such patients, Internet interventions could supplement and strengthen currently available health care. Objective: This paper describes the design and analysis plan that will be used to study 2 Internet interventions aimed at reducing severe fatigue in cancer survivors: a mobile ambulant activity feedback therapy supported through a weekly email by a physiotherapist and a weekly Web- and mindfulness-based cognitive therapy supported online by a psychologist. The data resulting from this trial will be used to (1) investigate the effectiveness, (2) investigate potential mediators of these interventions, and (3) explore participant characteristics that can predict the effect of these interventions. Methods: A 3-armed randomized controlled trial is proposed that compares both Internet interventions with an active control condition that solely consists of receiving psycho-educational emails. The intervention period is 9 weeks for all 3 conditions. Six months after baseline, participants in the control condition can choose to follow 1 of the 2 experimental Internet interventions. Outcomes are measured in terms of fatigue severity, mental health, and self-perceived work ability. All are Web-assessed at baseline, 2 weeks after the intervention period, and at 6 and 12 months after baseline. Fatigue severity, mindfulness, physical activity, expectations and credibility of the intervention, therapeutic working alliance, sleep quality, and sense of control over fatigue are assessed 3 times during the intervention period for identifying mediators of the interventions. Recruitment is performed nationally throughout the Netherlands through patient organizations and their websites, newspapers, and by informing various types of health professionals. All participants register at an open-access website. We aim at including 330 cancer survivors who have finished curative-intent cancer treatment at least 3 months previously, and have been suffering from severe fatigue ever since. All cancer types are included. A detailed analysis plan is described to address the research questions, which allows for individual variation, and fully exploits the longitudinal design. Results: Recruitment started in April 2013 and will proceed until April 2015. Conclusions: This paper describes a systematic trial design for studying 2 different interventions for chronic cancer-related fatigue in order to gain insight into the effectiveness and mediators of the interventions. This design will also be used to identify predictors for the interventions’ effect on fatigue. By publishing our hypotheses and analysis plan before completion of data collection, this paper is a first step in reporting on this trial comprehensively. Clinical Trial: The Netherlands National Trial Register (NTR3483). (Archived by WebCite at http://www.webcitation.org/6NWZqon3o).

  • Photo taken by one of authors.

    Household Transmission of Zoonotic Influenza Viruses in a Cohort of Egyptian Poultry Growers

    Abstract:

    Background: The highly pathogenic avian influenza H5N1 viruses and the low pathogenic H9N2 viruses are enzootic in Egyptian poultry. Several cases of human infection with H5N1 were reported in Egypt. We previously determined that the seroprevalence of H5N1 antibodies in Egyptians exposed to poultry is 2.1% (15/708), suggesting that mild or subclinical infections with this virus occur. We aim to measure the incidence of avian influenza infection in Egyptians exposed to poultry, study risk factors of infection, study the resulting immune response, study household transmission rates, and characterize the viruses causing infections. Objective: The objective of the study is to design a 7-year, prospective, household-based cohort investigation to determine incidence and household transmission of avian influenza viruses in humans exposed to poultry. Methods: At baseline, we will collect sera to measure antibodies against influenza A. Field nurses will visit enrolled subjects at least weekly to check for influenza-like illness symptoms and verify influenza infection by a point of care rapid test. From subjects with influenza infection and their household contacts, we will collect nasal swabs, throat swabs, and nasal washes to characterize the antigenic and genetic makeup of influenza viruses infecting humans. The nurse will also obtain 2x 3-ml blood samples, one for serology, and another for isolating peripheral blood mononuclear cells. Results: Results from this cohort will enhance our understanding of the transmission of avian influenza viruses to humans in a country where such viruses are enzootic. Conclusions: This may enhance public health efforts aimed at reducing this burden.

  • TOC Suriname Health Study.

Interviewer and respondent from the Suriname Health study.
Picture from the

    A National Surveillance Survey on Noncommunicable Disease Risk Factors: Suriname Health Study Protocol

    Abstract:

    Background: Noncommunicable diseases (NCDs) are the leading cause of death in low- and middle-income countries. Therefore, the surveillance of risk factors has become an issue of major importance for planning and implementation of preventive measures. Unfortunately, in these countries data on NCDs and their risk factors are limited. This also prevails in Suriname, a middle-income country of the Caribbean, with a multiethnic/multicultural population living in diverse residential areas. For these reasons, “The Suriname Health Study” was designed. Objective: The main objective of this study is to estimate the prevalence of NCD risk factors, including metabolic syndrome, hypertension, and diabetes in Suriname. Differences between specific age groups, sexes, ethnic groups, and geographical areas will be emphasized. In addition, risk groups will be identified and targeted actions will be designed and evaluated. Methods: In this study, several methodologies were combined. A stratified multistage cluster sample was used to select the participants of 6 ethnic groups (Hindustani, Creole, Javanese, Maroon, Chinese, Amerindians, and mixed) divided into 5 age groups (between 15 and 65 years) who live in urban/rural areas or the hinterland. A standardized World Health Organization STEPwise approach to surveillance questionnaire was adapted and used to obtain information about demographic characteristics, lifestyle, and risk factors. Physical examinations were performed to measure blood pressure, height, weight, and waist circumference. Biochemical analysis of collected blood samples evaluated the levels of glucose, high-density-lipoprotein cholesterol, total cholesterol, and triglycerides. Statistical analysis will be used to identify the burden of modifiable and unmodifiable risk factors in the aforementioned subgroups. Subsequently, tailor-made interventions will be prepared and their effects will be evaluated. Results: The data as collected allow for national inference and valid analysis of the age, sex, and ethnicity subgroups in the Surinamese population. A publication of the basic survey results is anticipated in mid-2015. Secondary results on the effect of targeted lifestyle interventions are anticipated in late 2017. Conclusions: Using the data collected in this study, the national prevalence of NCD risk factors will be approximated and described in a diverse population. This study is an entry point for formulating the structure of NCD prevention and surveillance.

  • © LilliDay, purchased from iStock (http://www.istockphoto.com/photo/pen-with-blood-test-results-8302229).

    Rural Versus Urban Health Service Utilization and Outcomes for Renal Patients in New South Wales: Protocol for a Data Linkage Study

    Abstract:

    Background: Kidney disease is a significant burden on health systems globally, with the rising prevalence of end stage kidney disease in Australia mirrored in many other countries. Approximately 25% of the Australian population lives in regional and rural areas and accessing complex tertiary services is challenging. Objective: We aim to compare the burden and outcomes of chronic kidney disease and end stage kidney disease in rural and urban regions of New South Wales (Australia’s most populous state) using linked health data. Methods: This is a retrospective cohort study and we have defined two cohorts: one with end stage kidney disease and one with chronic kidney disease. The end stage kidney disease cohort was defined using the Australia and New Zealand Dialysis and Transplant Registry, identifying all patients living in NSW receiving renal replacement therapy at any time between 01/07/2000 and 31/07/2010. The chronic kidney disease cohort used the NSW Admitted Patient Data Collection (APDC) to identify patients with a diagnostic code relating to chronic renal failure during any admission between 01/07/2000 and 31/07/2010. Both cohorts were linked to the NSW APDC, the Registry of Births, Deaths and Marriages, and the Central Cancer Registry allowing derivation of outcomes by categories of geographical remoteness. Results: To date, we have identified 10,505 patients with 2,384,218 records in the end stage kidney disease cohort and 159,033 patients with 1,599,770 records in the chronic kidney disease cohort. Conclusions: This study will define the geographical distribution of end stage and chronic kidney disease and compare the health service utilization between rural and urban renal populations.

  • This is a royalty free image by David Castillo Dominici (http://www.freedigitalphotos.net/images/Family_g212-Young_Mother_And_Daughter_p65236.html).

    Internet-Based Birth-Cohort Studies: Is This the Future for Epidemiology?

    Abstract:

    Background: International collaborative cohorts the NINFEA and the ELF studies are mother-child cohorts that use the internet for recruitment and follow-up of their members. The cohorts investigated the association of early life exposures and a wide range of non-communicable diseases. Objective: The objective is to report the research methodology, with emphasis on the advantages and limitations offered by an Internet-based design. These studies were conducted in Turin, Italy and Wellington, New Zealand. Methods: The cohorts utilized various online/offline methods to recruit participants. Pregnant women who became aware volunteered, completed an online questionnaire, thus obtaining baseline information. Results: The NINFEA study has recruited 7003 pregnant women, while the ELF study has recruited 2197 women. The cohorts targeted the whole country, utilizing a range of support processes to reduce the attrition rate of the participants. For the NINFEA and ELF cohorts, online participants were predominantly older (35% and 28.9%, respectively), highly educated (55.6% and 84.9%, respectively), and were in their final trimester of pregnancy (48.5% and 53.6%, respectively). Conclusions: Internet-based cohort epidemiological studies are feasible, however, it is clear that participants are self-selective samples, as is the case for many birth cohorts. Internet-based cohort studies are potentially cost-effective and novel methodology for conducting long-term epidemiology research. However, from our experience, participants tend to be self-selective. In marked time, if the cohorts are to form part of a larger research program they require further use and exploration to address biases and overcome limitations.

  • From the University of Michigan Health System (UMHS) media bank: http://mediabank.med.umich.edu/category/General/19671691
All rights to all images in this database belong to UMHS or one of its units. All available images may be used for any official UMHS or U-M purpose. Images may be shared with the news media and external organizations.

    The Effect of Health Information Technology on Health Care Provider Communication: A Mixed-Method Protocol

    Abstract:

    Background: Communication failures between physicians and nurses are one of the most common causes of adverse events for hospitalized patients, as well as a major root cause of all sentinel events. Communication technology (ie, the electronic medical record, computerized provider order entry, email, and pagers), which is a component of health information technology (HIT), may help reduce some communication failures but increase others because of an inadequate understanding of how communication technology is used. Increasing use of health information and communication technologies is likely to affect communication between nurses and physicians. Objective: The purpose of this study is to describe, in detail, how health information and communication technologies facilitate or hinder communication between nurses and physicians with the ultimate goal of identifying how we can optimize the use of these technologies to support effective communication. Effective communication is the process of developing shared understanding between communicators by establishing, testing, and maintaining relationships. Our theoretical model, based in communication and sociology theories, describes how health information and communication technologies affect communication through communication practices (ie, use of rich media; the location and availability of computers) and work relationships (ie, hierarchies and team stability). Therefore we seek to (1) identify the range of health information and communication technologies used in a national sample of medical-surgical acute care units, (2) describe communication practices and work relationships that may be influenced by health information and communication technologies in these same settings, and (3) explore how differences in health information and communication technologies, communication practices, and work relationships between physicians and nurses influence communication. Methods: This 4-year study uses a sequential mixed-methods design, beginning with a quantitative survey followed by a two-part qualitative phase. Survey results from aim 1 will provide a detailed assessment of health information and communication technologies in use and help identify sites with variation in health information and communication technologies for the qualitative phase of the study. In aim 2, we will conduct telephone interviews with hospital personnel in up to 8 hospitals to gather in-depth information about communication practices and work relationships on medical-surgical units. In aim 3, we will collect data in 4 hospitals (selected from telephone interview results) via observation, shadowing, focus groups, and artifacts to learn how health information and communication technologies, communication practices, and work relationships affect communication. Results: Results from aim 1 will be published in 2016. Results from aims 2 and 3 will be published in subsequent years. Conclusions: As the majority of US hospitals do not yet have HIT fully implemented, results from our study will inform future development and implementation of health information and communication technologies to support effective communication between nurses and physicians.

  • Hep B screenshot.

    Development of a Culturally Appropriate Bilingual Electronic App About Hepatitis B for Indigenous Australians: Towards Shared Understandings

    Abstract:

    Background: Hepatitis B is endemic in Indigenous communities in Northern Australia; however, there is a lack of culturally appropriate educational tools. Health care workers and educators in this setting have voiced a desire for visual, interactive tools in local languages. Mobile phones are increasingly used and available in remote Indigenous communities. In this context, we identified the need for a tablet-based health education app about hepatitis B, developed in partnership with an Australian remote Indigenous community. Objective: To develop a culturally appropriate bilingual app about hepatitis B for Indigenous Australians in Arnhem Land using a participatory action research (PAR) framework. Methods: This project was a partnership between the Menzies School of Health Research, Miwatj Aboriginal Health Corporation, Royal Darwin Hospital Liver Clinic, and Dreamedia Darwin. We have previously published a qualitative study that identified major knowledge gaps about hepatitis B in this community, and suggested that a tablet-based app would be an appropriate and popular tool to improve this knowledge. The process of developing the app was based on PAR principles, particularly ongoing consultation, evaluation, and discussion with the community throughout each iterative cycle. Stages included development of the storyboard, the translation process (forward translation and backtranslation), prelaunch community review, launch and initial community evaluation, and finally, wider launch and evaluation at a viral hepatitis conference. Results: We produced an app called “Hep B Story” for use with iPad, iPhone, Android tablets, and mobile phones or personal computers. The app is culturally appropriate, audiovisual, interactive, and users can choose either English or Yolŋu Matha (the most common language in East Arnhem Land) as their preferred language. The initial evaluation demonstrated a statistically significant improvement in Hep B-related knowledge for 2 of 3 questions (P=.01 and .02, respectively) and overwhelmingly positive opinion regarding acceptability and ease of use (median rating of 5, on a 5-point Likert-type scale when users were asked if they would recommend the app to others). Conclusions: We describe the process of development of a bilingual hepatitis B-specific app for Indigenous Australians, using a PAR framework. The approach was found to be successful with positive evaluations.

  • (c) PC Koekkoek.

    Cognitive Impairment in Diabetes: Rationale and Design Protocol of the Cog-ID Study

    Abstract:

    Background: Cognitive impairment frequently co-occurs with type 2 diabetes but is often undiagnosed. Cognitive impairment affects self-management leading to treatment-related complications. Objective: The aim of this study is to develop a stepped diagnostic procedure, consisting of a screening test complemented by an evaluation by a general practitioner (GP), to detect undiagnosed cognitive impairment in older people with type 2 diabetes. Methods: The accuracy of two self-administered cognitive tests, the “Test Your Memory” (TYM) and “Self-Administered Gerocognitive Examination” (SAGE) alone, and in combination with an evaluation by a GP will be assessed. A diagnosis of mild cognitive impairment (MCI) or dementia at a memory clinic will serve as reference standard. This cognitive impairment in diabetes (Cog-ID) study will include 513 people from primary care facilities aged ≥70 with type 2 diabetes. The participants will first fill out the TYM and SAGE tests, followed by a standardized GP evaluation for cognitive impairment, including a mini mental state examination (MMSE). Subsequently, participants suspected of cognitive impairment (on either test or the GP assessment) and a random sample of 15% (65/435) of participants without suspected cognitive impairment will be referred to the memory clinic. At the memory clinic, a medical examination, neuropsychological examination, and magnetic resonance imaging (MRI) of the brain will be performed. Participants will also fill out questionnaires assessing health status and depressive symptoms at baseline and after 6 and 24 months. Results: This research obtained funding and ethical approval. Enrolment started in August, 2012, and all study-related activities will be completed in September, 2016. Conclusions: With the results from this study, physicians will be able to detect cognitive impairment affecting type 2 diabetes patients through case-finding, and can use tailored care to reduce associated complications. Additionally, the results may stimulate discussions about cognitive impairment and whether early recognition is desirable.

  • Hepatitis C virus (HCV) disease progression in people who inject drugs (PWID): protocol for a systematic review and meta-analysis.

    Hepatitis C Virus Disease Progression in People Who Inject Drugs: Protocol for a Systematic Review and Meta-Analysis

    Abstract:

    Background: Most hepatitis C virus (HCV) infections in the United States occur following non-sterile injection drug use. However, the majority of people who inject drugs (PWID) with chronic HCV are not currently receiving care. Objective: This paper presents our protocol for the systematic review and meta-analysis of data on the natural history of HCV among PWID and will inform modeling of the impact and cost-effectiveness of HCV management among this population. This study is conducted as part of the HCV Synthesis Project, which is funded to develop recommendations for HCV control strategies in the United States. Methods: This protocol describes the methods used for a systematic review and meta-analysis of published and unpublished data on the natural history of HCV among PWID including viral clearance, fibrosis progression, and the incidence of compensated cirrhosis (CC), decompensated cirrhosis (DC), hepatocellular carcinoma (HCC), and liver-related mortality. Results: Final results are anticipated by December 2016. Conclusions: Methods used for the synthesis of data on disease progression among HCV mono-infected PWID are presented. Data from the systematic review and meta-analysis will be used to inform simulations of the natural history of HCV and to model the effects of prevention and treatment strategies to reduce disease burden and the associated costs to society and individual patients.

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  • Designing an Internationally-Accessible Web-based Questionnaire to Discover Risk Factors for Amyotrophic Lateral Sclerosis

    Date Submitted: Jul 1, 2015

    Open Peer Review Period: Jul 1, 2015 - Jul 10, 2015

    Background: Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disease with a typical survival of three to five years. Epidemiological studies using paper-based questionnaires in i...

    Background: Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disease with a typical survival of three to five years. Epidemiological studies using paper-based questionnaires in individual countries or continents have failed to find widely-accepted risk factors for the disease. The many advantages of online versus paper-based questionnaires have been extensively reviewed, but few online epidemiological studies into human neurodegenerative diseases have so far been undertaken. Objective: To design a web-based questionnaire to identify environmental risk factors for ALS and to enable international comparisons of these risk factors. Methods: A web-based epidemiological questionnaire for ALS has been developed, based on experience gained from administering a previous continent-wide paper-based questionnaire for this disease. New and modified questions have been added from our previous paper-based questionnaire, from literature searches, and from validated ALS questionnaires supplied by other investigators. New criteria to allow the separation of familial and sporadic ALS have been included. The questionnaire addresses many risk factors that have already been proposed for ALS, as well as a number that have not yet been rigorously examined. To encourage participation respondents maintain anonymity since no personally-identifying information is requested. The survey is being translated into a number of languages, which will allow most people around the world to read and answer it in their own language. Results: After the questionnaire had been online for 4 months it had 379 respondents, compared to only 46 respondents for the same initial period using a paper-based questionnaire. The questionnaire is soon to be promoted in a number of different countries through ALS associations in these countries and via disease registries. Feedback about the ease of use of the online questionnaire from respondents, including from those with physical disability, has been positive. Conclusions: Web-based questionnaires are a time- and resource-efficient method for performing large epidemiological studies of neurodegenerative diseases such as ALS. The ability to compare risk factors between different countries using the same analysis tool will be of particular value for finding robust risk factors that underlie ALS.

  • A cross-sectional study on ‘Attitudes to and Understanding of Risk of Acquisition of HIV’ (AURAH) study: Design, Methods and Participant Characteristics.

    Date Submitted: Jun 28, 2015

    Open Peer Review Period: Jun 28, 2015 - Jul 12, 2015

    Background: The annual number of new HIV infections in the UK among men who have sex with men has risen year on year and, among heterosexuals remains high. Increasing HIV transmission among men who ha...

    Background: The annual number of new HIV infections in the UK among men who have sex with men has risen year on year and, among heterosexuals remains high. Increasing HIV transmission among men who have sex with men is consistent with evidence of ongoing sexual risk behaviour in this group and targeted prevention strategies for this population are needed. Methods/Design: The AURAH study (Attitudes to and Understanding of Risk of Acquisition of HIV) was designed to investigate and assess knowledge of, and attitudes to, HIV transmission risks, as well as physical and mental health, lifestyle and behaviours in HIV negative or undiagnosed people in the UK. It aimed to recruit a large sample of sexually active people, with a focus on key demographic subgroups affected by HIV in the UK, men who have sex with men and black African men and women. Participants that attended 20 sexual health clinics across the UK in 2013-2014 were invited to participate and complete a confidential, self-administered pen and paper questionnaire. Consent also included an option to provide details for future contact about further research, specifically an online prospective cohort study called AURAH2, which commenced in March 2015. Discussion: The study researchers approached a total of 4393 patients in the 20 clinics and obtained 2630 (60%) completed questionnaires over a 17 month period. Of those who participated 2036 (77%) were in the key subgroups of interest, 590 were black Africans (331 females and 259 males) and 1473 were MSM - with 27 in both these categories. 766 MSM participants from AURAH who provided contact details have been invited to join the follow-on web-based prospective cohort questionnaire study, AURAH2. The results from AURAH will be a significant resource to understand the attitudes and sexual behaviour of those at risk of acquisition of HIV within the UK. This will inform future prevention efforts and targeted health promotion initiatives in the HIV negative population.

  • Mamma Mia: From theory to intervention – Mapping the development of an internet intervention for postpartum depression

    Date Submitted: Jun 24, 2015

    Open Peer Review Period: Jun 28, 2015 - Jul 12, 2015

    Background: 10–15% of new mothers experience depression postpartum. An internet-based intervention (‘Mamma Mia’) was developed with the primary aims of preventing depressive symptoms and enhanci...

    Background: 10–15% of new mothers experience depression postpartum. An internet-based intervention (‘Mamma Mia’) was developed with the primary aims of preventing depressive symptoms and enhancing subjective well-being among pregnant and postpartum women. A secondary aim of Mamma Mia was to ease the transition of becoming a mother by providing knowledge, techniques, and support during pregnancy and after birth. Objective: The aim of the current article is to provide a systematic and comprehensive description of the intervention rationale and the development of Mamma Mia. Methods: For this purpose, we used Intervention Mapping (IM) protocol as descriptive tool, which consists of six steps: 1) a needs assessment, 2) definition of change objectives, 3) selection of theoretical methods and practical strategies, 4) development of program components, 5) planning adoption and implementation, and 6) planning evaluation. For this purpose, we used Intervention Mapping (IM) protocol as descriptive tool, which consists of six steps: 1) a needs assessment, 2) definition of change objectives, 3) selection of theoretical methods and practical strategies, 4) development of program components, 5) planning adoption and implementation, and 6) planning evaluation. Results: Mamma Mia is a fully automated internet intervention available for computers, tablets, and smartphones. It starts in gestational week 18–24 and lasts to the baby is about 6 months, and applies a tunneled design to guide the woman through the program in a step-by-step fashion in accordance with the psychological preparations of becoming a mother. The intervention is delivered by e-mail and interactive websites, combining text, pictures, pre-recorded audio files, and user input. It targets risk and protective factors for postpartum depression such as pre- and postpartum attachment, couple satisfaction, social support, and subjective well-being, as identified in the needs assessment. The plan is to implement Mamma Mia directly to users and as part of ordinary services at well-baby clinics, and to evaluate the effectiveness of Mamma Mia in a randomized controlled trial and assess users’ experiences with the program. Conclusions: The Intervention Mapping of Mamma Mia has made clear the rationale for the intervention, and linked theories and empirical evidence to program contents and materials. This meets the recent calls for intervention descriptions and may inform future studies, development of interventions, and systematic reviews.

  • Digital gaming used to improve the functioning of people with traumatic brain injury: a feasibility study

    Date Submitted: Jun 22, 2015

    Open Peer Review Period: Jun 23, 2015 - Jul 7, 2015

    Traumatic brain injury (TBI) is a critical public health problem. Treatment of TBI is long lasting, which incurs economic cost to health systems. The recovery process for people with brain damage is t...

    Traumatic brain injury (TBI) is a critical public health problem. Treatment of TBI is long lasting, which incurs economic cost to health systems. The recovery process for people with brain damage is typically slow and dependent on complex and intensive assisted rehabilitation programs. The aim of this study is to evaluate the effects and feasibility of digital games for cognitive functioning and general well-being among people with traumatic brain injury. This feasibility study includes a pragmatic, randomised controlled trial with three arms, and will recruit patients from the Turku University Hospital, Division of Clinical Neurosciences in Finland. To be included in the study, participants must meet the following inclusion criteria: a Finnish speaking adult, aged 18 – 65; diagnosed with a traumatic brain injury (diagnostic criteria ICD-10, S06.X, T90.5) in the University Hospital, has access to a TV screen, a computer and the internet at home; not an active digital gamers (5 hours or less a week); and willing to participate in the study. Participants must have been discharged from the neurologic treatment period for traumatic brain injury for over 12 months before the commencement of the trial, and they may not have actively participated in cognitive rehabilitation during the 3 months prior to the trial. Written informed consent given by each potential participant will be mandatory for acceptance into the trial. Potential participants will not be admitted to the study if they have any of the following exclusion criteria: sensory, cognitive or physical impairment (e.g. severe cognitive impairment), deficiency restricting the use of computers or computer game control system unaided (e.g. impairment in vision, severe astigmatism, hemiplegia, disorder in visuospatial perception, dysfunction of the central vestibular system), apathy identified in previous neuropsychological evaluations, or diagnosed severe mental disorders (e.g. schizophrenia or severe depressive disorders to be identified in medical records as the secondary diagnosis). The intervention comprises three parts: 1) the rehabilitation game, Lumosity, with a web-based cognitive training platform will be used. The game tasks are divided into different sections targeting memory, attention, speed, flexibility, and problem solving. Participants can select at least one game out of 52 in different sections; 2) commercial digital games designed for Sony Playstation 3 (PS3) consoles will be used. Each participant in this group can select one game out of eight; and 3) the ‘as usual’ group will not have gaming activities organised by the project. The primary outcome will show processing speeds and visuomotor activities. The secondary outcomes will reveal levels of attention, working memory, depression, self-efficacy and executive functions (the instruments filled out in three times; at baseline, after 8 weeks, and 6 months). Feasibility will be assessed by patient adherence (patient participation/refusal of the study, dropout for any reason; involvement in the intervention (for 8 weeks period), usability, satisfaction and desire to participate the intervention in the future. The calculation of the sample size was powered by the assessments of primary (speed and visuomotor activities) and secondary (depression) outcomes. The study cohort will be obtained from medical records of patients who have been treated at the University Hospital 12 months before the recruitment. For speed and visuomotor activities, assuming a 15% effect size, we would have 85% power with an ICC of 0.05 (with a score of 71, and a mean change of 30 in the scores during the follow-up, SD is 53). The difference between measurements could be expected to be significant (with a power of 85% on a significant level of 0.05) if the sample size in each group is 30 subjects. For the secondary outcomes, the average level of the PHQ-9 score can be 10 and the mean change in the scores during the follow-up is 3 (SD 5). The difference could be expected to be significant (with a power of 85% on significant level of 0.05) if the sample size in each group is 27 subjects. All participants will be analysed at baseline, after 8 weeks (when the intervention has been finalized), and at 8 weeks, on all the scales. Paired t-tests, or Chi-square tests, will be performed to detect significant differences before and after treatment in one group. Significant differences between groups will be evaluated applying the unpaired Student’s t-test using the conventional 95% level of confidence. The cumulative monitoring data during the 8-week period regarding gaming will be calculated for the total number of received parameters(frequency, timing, time). Information available for feasibility will also be calculated (participation/refusal rate, measurement instrument filled, drop-outs, acceptability, usability, satisfaction, willingness) and compared to the highest possible representative numbers (100% participation rate; measurement instrument filled, drop-out rate 0%, acceptability 100%, usability 100%, satisfaction 100%, willingness to use games as treatment or intervention in the future 100%). The clinical trial registration number: NCT02425527

  • The development of an online support program for parents of children with a chronic kidney disease using Intervention Mapping: a study design article

    Date Submitted: Jun 17, 2015

    Open Peer Review Period: Jun 23, 2015 - Jul 7, 2015

    Background: The care for children with a chronic kidney disease (CKD) is complex. Parents of these children experience high levels of stress in managing their child’s disease, leading to negative ef...

    Background: The care for children with a chronic kidney disease (CKD) is complex. Parents of these children experience high levels of stress in managing their child’s disease, leading to negative effects on their child’s health outcomes. Although the experienced problems are well known, adequate (online) support for these parents is lacking. Objective: The aim of this paper is to describe the systematic development of an online support program for parents of children with CKD, and how this program will be evaluated Methods: Intervention Mapping (IM) was used for the development of the program. After conducting a needs assessment, defining the program objectives, searching for theories and selecting behavioural change objectives, the online program e-Powered Parents was developed. E-Powered Parents consist of an online community and an online training platform. The online community includes a chat room, a forum and information about CKD and its treatment. The online training platform consists of four training modules: managing stress, setting limits, communication and coping with emotions. In an explorative randomized controlled trial with 120 parents the potential effectiveness and effect size of e-Powered Parents will be evaluated. The outcomes will be the child’s quality of life, parental stress and fatigue, family management and self-efficacy in communication with healthcare professionals. A process evaluation will provide insight in parents’ experiences and how the program supported them. Results: Not applicable Conclusions: Although the development of e-Powered Parents using IM was time-consuming, IM has been a useful protocol. IM provided us a framework to structure the development process, and the decision of the targeting behaviour and the behaviour change applications. The participatory planning group was valuable as well; knowledge, experiences and visions were shared, ensuring us that the program is supported by parents and healthcare professionals. Clinical Trial: NTR4808 (Dutch Trial Register: www.trialregister.nl)

  • Systematic development of a self-regulation eHealth intervention to increase health behaviour through general practice

    Date Submitted: Jun 17, 2015

    Open Peer Review Period: Jun 23, 2015 - Jul 7, 2015

    This study describes the systematic development of an eHealth intervention ‘MyPlan’ with the aim to promote physical activity and fruit and vegetable intake among adults who visit their general pr...

    This study describes the systematic development of an eHealth intervention ‘MyPlan’ with the aim to promote physical activity and fruit and vegetable intake among adults who visit their general practitioner. The Intervention Mapping Protocol was used to develop a dynamic computer-tailored programme that targets motivational, volitional and self-regulation processes. Innovative behavioural change methods (e.g. goal-setting, problem-solving, implementation-intentions) were applied and tablet computers were used for delivery in general practice. To facilitate implementation of the intervention in general practice, GPs were involved from the beginning of the development. The effect of the intervention on physical activity and fruit and vegetable intake will be evaluated in a three-arm clustered quasi-experimental design in general practice. Using the Intervention Mapping protocol ensures that a goal directed, theory and evidence based intervention protocol is developed that has optimal prospects for effectiveness. When the intervention is found to be effective, a dynamic eHealth programme for the promotion of healthy lifestyle will be available for use in general practice.