JMIR Publications

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  Non-Randomized Study Protocols and...

  Dec 3, 2019

  Photodynamic Therapy Using a New Painless Light-Emitting Fabrics Device in the Treatment of Extramammary Paget Disease of the Vulva (the PAGETEX Study):...

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  Authors List:

  • Fabienne Lecomte  
  • Elise Thecua  
  • Laurine Ziane  
  • Pascal Deleporte  
  • Alain Duhamel  
  • Cyril Maire  
  • Delphine Staumont-Salle  
  • Serge Mordon  
  • Laurent Mortier  

  Abstract:

  Background: Extramammary Paget disease of the vulva (EMPV) is a rare skin disorder commonly seen in postmenopausal Caucasian females that appears clinically as red, eczematous, pruriginous, and sometimes painful lesions. Although most cases are noninvasive, EMPV may be associated with an underlying or distant adenocarcinoma. EMPV has a chronic and relapsing course. The reference treatment is based on local surgical excision with negative margins. However, disease frequently extends far from the visible lesion, and surgical margins are frequently positive. Topical photodynamic therapy (PDT) is an established treatment modality for various dermatooncologic conditions. For example, red light irradiation with the Aktilite CL 128 and Metvixia (Galderma SA) as a photosensitizing molecule is a conventional protocol approved and widely used in Europe for PDT treatment of actinic keratosis, but this treatment is not yet widely used for EMPV because it has never clearly been demonstrated and is very painful. Objective: The aim of the study is to investigate the efficacy and safety relating to the medical device PAGETEX as a new painless PDT device using Metvixia in the treatment of vulvar Paget disease. The primary end point is the disease control rate at 3 months in 30% of the patients included, defined as stability, partial response, or total response, considering the extent of the lesion. Secondary end points are the disease control rate at 6 months, patient quality of life, level of pain experienced by the patient at each PDT session, severity of erythema, presence of protoporphyrin IX in Paget cells after each PDT session, and overall satisfaction level of the patient. Methods: The trial is an interventional, exploratory, simple group, nonrandomized, and single center (Lille University Hospital) study. Twenty-four patients will be included according to Simon’s optimal plan. Therapeutic procedure is based on a cycle of two PDT sessions with the PAGETEX medical device at 15-day intervals (Metvixia incubation during 30 minutes and 635 nm red light illumination with a low irradiance for 2 hours and 30 minutes for a total fluence of 12 J/cm²). At the assessment session, 3 months after inclusion, if the control of the disease is partial or null, the patient will complete another cycle of two PDT sessions. A final evaluation will be performed in all patients at 6 months. Analyses will be performed using SAS version 9.4 software (SAS Institute Inc). The characteristics of the patients at baseline will be described; qualitative variables will be described by numbers and percentages, and quantitative variables will be described either by the mean and standard deviation for Gaussian distribution or by the median and interquartile range (ie, 25th and 75th percentiles). The normality of the distributions will be tested by a Shapiro-Wilk test and checked graphically by histograms. Results: First patient was included in September 2019 and clinical investigations are planned until August 2022. The final results of this study are expected to be available in January 2023. Conclusions: This clinical trial aims to evaluate the efficacy and safety of a new PDT protocol for the treatment of EMPV. The PAGETEX device could become the treatment of choice if it is effective, painless, and easy to implement and use in hospitals. Clinical Trial: ClinicalTrials.gov NCT03713203; https://clinicaltrials.gov/ct2/show/NCT03713203

  • JMIR Res Protoc 2019;8(12):e15026

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  RCTs - Protocols/Proposals (eHealth)

  Dec 3, 2019

  An App-Delivered Self-Management Program for People With Low Back Pain: Protocol for the selfBACK Randomized Controlled Trial

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  Authors List:

  • Louise Fleng Sandal  
  • Mette Jensen Stochkendahl  
  • Malene Jagd Svendsen  
  • Karen Wood  
  • Cecilie K Øverås  
  • Anne Lovise Nordstoga  
  • Morten Villumsen  
  • Charlotte Diana Nørregaard Rasmussen  
  • Barbara Nicholl  
  • Kay Cooper  
  • Per Kjaer  
  • Frances S Mair  
  • Gisela Sjøgaard  
  • Tom Ivar Lund Nilsen  
  • Jan Hartvigsen  
  • Kerstin Bach  
  • Paul Jarle Mork  
  • Karen Søgaard  

  Abstract:

  Background: Low back pain (LBP) is prevalent across all social classes, in all age groups, and across industrialized and developing countries. From a global perspective, LBP is considered the leading cause of disability and negatively impacts everyday life and well-being. Self-management is a recommended first-line treatment, and mobile apps are a promising platform to support self-management of conditions like LBP. In the selfBACK project, we have developed a digital decision support system made available for the user via an app intended to support tailored self-management of nonspecific LBP. Objective: The trial aims to evaluate the effectiveness of using the selfBACK app to support self-management in addition to usual care (intervention group) versus usual care only (control group) in people with nonspecific LBP. Methods: This is a single-blinded, randomized controlled trial (RCT) with two parallel arms. The selfBACK app provides tailored self-management plans consisting of advice on physical activity, physical exercises, and educational content. Tailoring of plans is achieved by using case-based reasoning (CBR) methodology, which is a branch of artificial intelligence. The core of the CBR methodology is to use data about the current case (participant) along with knowledge about previous and similar cases to tailor the self-management plan to the current case. This enables a person-centered intervention based on what has and has not been successful in previous cases. Participants in the RCT are people with LBP who consulted a health care professional in primary care within the preceding 8 weeks. Participants are randomized to using the selfBACK app in addition to usual care versus usual care only. We aim to include a total of 350 participants (175 participants in each arm). Outcomes are collected at baseline, 6 weeks, and 3, 6, and 9 months. The primary end point is difference in pain-related disability between the intervention group and the control group assessed by the Roland-Morris Disability Questionnaire at 3 months. Results: The trial opened for recruitment in February 2019. Data collection is expected to be complete by fall 2020, and the results for the primary outcome are expected to be published in fall 2020. Conclusions: This RCT will provide insights regarding the benefits of supporting tailored self-management of LBP through an app available at times convenient for the user. If successful, the intervention has the potential to become a model for the provision of tailored self-management support to people with nonspecific LBP and inform future interventions for other painful musculoskeletal conditions. Clinical Trial: ClinicalTrial.gov NCT03798288; https://clinicaltrials.gov/ct2/show/NCT03798288

  • JMIR Res Protoc 2019;8(12):e14720

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  Non-randomized Protocols and Methods...

  Dec 3, 2019

  Defining the Supportive Care Needs and Psychological Morbidity of Patients With Functioning Versus Nonfunctioning Neuroendocrine Tumors: Protocol for a Phase...

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  Authors List:

  • Lisa Guccione  
  • Karla Gough  
  • Allison Drosdowsky  
  • Krista Fisher  
  • Timothy Price  
  • Nick Pavlakis  
  • Mustafa Khasraw  
  • David Wyld  
  • David Ransom  
  • Grace Kong  
  • Megan Rogers  
  • Simone Leyden  
  • John Leyden  
  • Michael Michael  
  • Penelope Schofield  

  Abstract:

  Background: Online information resources and support have been demonstrated to positively influence the well-being of people diagnosed with cancer. This has been explored in past literature for more common cancers; however, for rare cancers, such as neuroendocrine tumors (NETs), there are little to no support or resources available. Despite relatively good prognoses, the quality of life (QoL) of patients with NETs is significantly lower compared with samples of mixed cancer patients and the general population. Patients with NETs also typically report unclear and difficult pathways of disease management and treatment, given the heterogeneity of the diagnosis. There is a vital need to improve the availability of disease-specific information for this patient group and provide supportive care that is tailored to the unique needs of the NET patient population. Objective: This study described the protocol of a study aimed to better understand the outcomes and experiences of patients diagnosed with NETs and to develop and pilot test a nurse-led online and phone-based intervention that will provide tailored supportive care targeted to NET subgroups (functioning vs nonfunctioning). Methods: This is a multisite cohort with 3 phases, incorporating both quantitative and qualitative data collection. Phase 1 is a mixed methods prospective cohort study of NET patients identifying differences in patient experiences and priority of needs between NET subgroups. Phase 2 utilizes results from phase 1 to develop an online and nurse-led phone-based intervention. Phase 3 is to pilot test and evaluate the intervention’s acceptability, appropriateness, and feasibility. Results: Currently, the project is progressing through phase 1 and has completed recruitment. A total of 138 participants have been recruited to the study. To date, patient-reported outcome data from 123 participants at baseline and 87 participants at 6-month follow-up have been collected. Of these, qualitative data from semistructured interviews from 35 participants have also been obtained. Phase 2 and phase 3 of the project are yet to be completed. Conclusions: Limited research for patients with NETs suggests that QoL and patient experiences are significantly impaired compared with the general population. Furthermore, past research has failed to delineate how the clinical variability between those with functioning and nonfunctioning NETs impacts patient supportive care needs. This study will improve on the availability of disease-specific information as well as informing the design of a nurse-led online and phone-based supportive care intervention tailored for the unique needs of the NET patient population.

  • JMIR Res Protoc 2019;8(12):e14361

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  RCTs - Protocols/Proposals (eHealth)

  Dec 2, 2019

  Effects of a 12-Minute Smartphone-Based Mindful Breathing Task on Heart Rate Variability for Students With Clinically Relevant Chronic Pain, Depression, and...

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  Authors List:

  • Muhammad Abid Azam  
  • Vered Valeria Latman  
  • Joel Katz  

  Abstract:

  Background: Mindfulness meditation (MM) is a commonly used psychological intervention for pain, mood, and anxiety conditions, but can be challenging to practice with severe symptoms without proper training. The Mindfulness Meditation app (MMA) is a supportive training tool specifically developed for this study to aid in the practice of mindful breathing using a smartphone. Objective: This study aims to evaluate the psychophysiological effects of the MMA. Specifically, the study will assess parasympathetic functioning using heart rate variability (HRV; primary outcome), pain and mood symptoms, mind-wandering and present moment awareness, and breath focus in groups of undergraduate participants who self-report clinically-relevant symptoms of chronic pain (CP) and depression or anxiety (DA) and condition-free (CF) participants who do not meet either criteria. We hypothesize that use of the MMA by study groups will lead to improved HRV, pain, and mood symptoms compared with groups who do not use the app. Methods: This study is a two-arm randomized controlled trial (RCT) recruiting through a Web-based research participation pool at York University in Toronto, Canada. We are aiming for minimum 60 participants in each of CP, DA, and CF groups. Upon arriving to the laboratory, participants will be prescreened for classification into groups of CP, DA, or CF. Groups will be randomly assigned by a 1:1 ratio to an MMA (MMA+) condition or MM condition without the app (MMA−) after a brief stress induction procedure. In MMA+, participants will practice mindful breathing with a smartphone and press breath or other buttons at the sound of audio tones if their awareness was on breathing or another experience, respectively. HRV and respiration data will be obtained during rest (5 min), stress induction (5 min), and meditation conditions (12 min). Participants will complete psychological self-report inventories before and after the stress induction and after the meditation condition. Separate linear mixed models will be used to examine HRV and self-report inventories comparing groups and treatment conditions. Results: Recruitment for the study began in November 2017 and is expected to be completed in winter of 2019-2020. As of July 2019, 189 participants have been recruited. The study’s main findings are expected to reveal a positive pattern of HRV responses in the CP, DA, and CF groups, such that a significant increase in HRV (P<.05) is detected in those randomized to the MMA+ condition in comparison with those randomized to the MMA− condition. Conclusions: This RCT will contribute to the burgeoning health psychology literature regarding the clinical relevance of HRV in assessment and treatment of psychological and medical conditions. Furthermore, possible ways to inform designs of MM training tools delivered by apps and Web platforms for CP, depression, and anxiety conditions’ treatment will be discussed. Clinical Trial: Clinicaltrials.gov NCT03296007; https://clinicaltrials.gov/ct2/show/NCT03296007.

  • JMIR Res Protoc 2019;8(12):e14119

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  RCTs - Protocols/Proposals (funded,...

  Nov 28, 2019

  Delivering a Post-Partum Weight Loss Intervention via Facebook or In-Person Groups: Protocol for a Randomized Feasibility Pilot Trial

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  Authors List:

  • Molly E Waring  
  • Brooke A Libby  
  • Tiffany A Moore Simas  
  • Madison L Bracken  
  • Jessica L Bibeau  
  • Valeria Herrera  
  • Justin Wang  
  • Sherry L Pagoto  

  Abstract:

  Background: Postpartum weight retention contributes to long-term weight gain and obesity for many women. Lifestyle interventions with numerous visits are logistically challenging for many postpartum women. Delivering a lifestyle intervention via social media may overcome logistic challenges to participation in in-person weight loss programs. Objective: The objective of this study is to conduct a randomized feasibility pilot trial of a 6-month postpartum weight loss intervention delivered via Facebook or in-person groups with 72 postpartum women with overweight or obesity. Methods: Women with overweight or obesity who are 8 weeks to 12 months postpartum (N=72) will be recruited from the Hartford, Connecticut community. Eligible participants must also own an iPhone or Android smartphone and be an active Facebook user. Participants will receive a 6-month postpartum weight loss intervention based on the Diabetes Prevention Program lifestyle intervention and adapted for postpartum women. Participants will be randomized to receive the intervention via a private Facebook group or in-person group meetings. Assessments will occur at baseline, weekly during the intervention, at 6 months (at the end of the intervention), and at 12 months. Primary feasibility outcomes are recruitment, sustained participation, contamination, retention, and feasibility of assessment procedures including measurement of costs to deliver and receive the intervention. We will describe 6- and 12-month weight loss as an exploratory outcome. Results: Recruitment began in September 2018. The first wave of the intervention began in February 2019, and the second wave of the intervention is expected to begin in fall 2019. We anticipate completing follow-up assessments in fall 2020, and results will be analyzed at that time. Conclusions: Results will inform the design of a large randomized controlled trial to assess whether delivering a postpartum weight loss intervention via Facebook is noninferior for weight loss and more cost-effective than delivering the intervention via traditional in-person groups.

  • JMIR Res Protoc 2019;8(11):e15530

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  Non-randomized Protocols and Methods...

  Nov 28, 2019

  Development of an Early Warning System to Prevent Crises in the Palliative Home Care Setting of Patients and Their Informal Caregivers: Protocol for a Mixed...

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  Authors List:

  • André Fringer  
  • Eleonore Arrer  
  • Edith Maier  
  • Wilfried Schnepp  
  • Tom Ulmer  

  Abstract:

  Background: Most people wish to die at home, but most people in Switzerland die in hospitals or nursing homes. Family caregivers often offer support so patients with palliative care needs can stay at home for as long as possible. However, crises and unplanned hospital admissions often occur in this setting because of family caregiver strain and symptom severity in patients. The so-called smart devices such as wearables or smartphones offer the opportunity to continuously monitor certain parameters and recording symptom deteriorations. By providing professionals with this information in a timely manner, crises in the home could be avoided. Objective: The aim of this interdisciplinary study is to explore the symptom burden of people with palliative care needs who are cared for at home and to understand the development of crises in the home care setting. On the basis of the findings from this study, we will develop an early warning system to stabilize the home care situation and to prevent critical events from happening, thereby reducing avoidable hospitalizations. Methods: A mixed method study is being conducted consisting of 4 main consecutive phases: (1) developing the monitoring system; (2) pretesting the system and adapting it to user needs; (3) conducting the study in the palliative home care setting with approximately 40 patients; and (4) distinguishing symptom patterns from the collected data specific to crisis emergence, followed by the development of an early warning system to prevent such crises. In study phase 3, each patient will receive an upper arm sensor and a symptom diary to assess symptom burden related to patients and family caregivers. A within-case analysis will be conducted for each patient’s situation followed by a cross-case comparison to identify certain symptom patterns that may predict symptom deterioration (study phase 4). Results: The collaboration with the local mobile palliative care team for participant recruitment and data collection has been established. Recruitment is forthcoming. Conclusions: We expect the findings of this study to provide holistic insight into symptom burden and the well-being of patients with palliative care needs and of their family caregivers. This information will be used to develop an early warning system to avoid the occurrence of potential crises, thereby improving palliative care provision at home.

  • JMIR Res Protoc 2019;8(11):e13933

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  Development of Instruments and Surveys

  Nov 27, 2019

  Group Sex Events Among Cisgender Men Who Have Sex With Men: Cross-Sectional and Longitudinal Survey Study to Explore Participation and Risk-Taking Behaviors

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  Authors List:

  • Lauren R Violette  
  • Lisa A Niemann  
  • Vanessa M McMahan  
  • David A Katz  
  • Pollyanna R Chavez  
  • Hollie A Clark  
  • Andy Cornelius-Hudson  
  • Steven F Ethridge  
  • Sarah J McDougal  
  • George Ure II  
  • Joanne D Stekler  
  • Kevin P Delaney  

  Abstract:

  Background: Group sex events (GSEs) are common among cisgender men who have sex with men (MSM), pose a unique risk profile for HIV and sexually transmitted disease (STD) transmission, and may be on the rise, in part because of Web-based networking platforms. However, collecting data on GSEs can be challenging, and many gaps exist in our knowledge about GSE participation among MSM. Objective: The objective of this study was to develop survey questions addressing aggregate and partner-specific group sex behaviors to measure prevalence of GSEs and associated risks in persons participating in Project Diagnostic Evaluation To Expand Critical Testing Technologies (DETECT), including MSM seeking HIV and STD testing at a public clinic in Seattle, Washington. Methods: We developed a computer self-assisted survey that included questions about participant demographics, sexual history, and risk behaviors, including group sex, as a part of Project DETECT, a Centers for Disease Control and Prevention–funded study evaluating point-of-care HIV tests. Aggregate and partner-specific questions asked about participation in all GSEs, threesomes, and four-or-more-somes including questions about number and HIV status of sex partners and condom use during the events. To evaluate question performance, we assessed the discrepancies in reporting between the aggregate and partner-specific questions, quantified question refusal rates, and calculated the additional time required to answer the GSE questions. Information about network density (number of partnerships of overlapping duration) was estimated and compared for MSM who did and did not report GSEs. Results: Among 841 visits by 690 MSM who were asked any group sex survey question, participation in a GSE of any type in the past 3 months was reported at 293 visits (293/841, 34.8%). We found that 9.0% (76/841) of MSM in the sample reported ≥1 four-or-more-some in the partner-specific questions but did not report in the aggregate. The proportion of refusals on any given aggregate GSE-related question ranged from 0% (0/273) to 10.6% (15/141) (median 2.6%) and partner-specific questions ranged from 0% (0/143) to 22% (5/23) (median 3.0%), with questions about four-or-more-somes having the highest proportions of refusals. Completing the aggregate group sex questions added 1 to 2 minutes and the partner-specific questions added an additional 2 to 4 minutes per partner to the total survey length. As expected, the partner-specific GSE questions documented higher density of sexual networks that was not captured by asking about total partner counts and overlap of specific partnerships. Conclusions: We found that the Project DETECT survey was able to obtain nuanced information about GSEs. The question skip patterns and consistency checks were effective, and survey fatigue was minimal. More research is needed on GSEs, and our survey represents a promising data collection tool to help fill gaps in knowledge about the subject.

  • JMIR Res Protoc 2019;8(11):e15426

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  Proposals (eHealth)

  Nov 27, 2019

  Improving Team-Based Decision Making Using Data Analytics and Informatics: Protocol for a Collaborative Decision Support Design

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  Authors List:

  • Don Roosan  
  • Anandi V Law  
  • Mazharul Karim  
  • Moom Roosan  

  Abstract:

  Background: According to the September 2015 Institute of Medicine report, Improving Diagnosis in Health Care, each of us is likely to experience one diagnostic error in our lifetime, often with devastating consequences. Traditionally, diagnostic decision making has been the sole responsibility of an individual clinician. However, diagnosis involves an interaction among interprofessional team members with different training, skills, cultures, knowledge, and backgrounds. Moreover, diagnostic error is prevalent in the interruption-prone environment, such as the emergency department, where the loss of information may hinder a correct diagnosis. Objective: The overall purpose of this protocol is to improve team-based diagnostic decision making by focusing on data analytics and informatics tools that improve collective information management. Methods: To achieve this goal, we will identify the factors contributing to failures in team-based diagnostic decision making (aim 1), understand the barriers of using current health information technology tools for team collaboration (aim 2), and develop and evaluate a collaborative decision-making prototype that can improve team-based diagnostic decision making (aim 3). Results: Between 2019 to 2020, we are collecting data for this study. The results are anticipated to be published between 2020 and 2021. Conclusions: The results from this study can shed light on improving diagnostic decision making by incorporating diagnostics rationale from team members. We believe a positive direction to move forward in solving diagnostic errors is by incorporating all team members, and using informatics.

  • JMIR Res Protoc 2019;8(11):e16047

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  Non-Randomized Studies (funded,...

  Nov 26, 2019

  Developing Strategies to Reduce Unnecessary Services in Primary Care: Protocol for User-Centered Design Charrettes

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  Authors List:

  • Mandi L Klamerus  
  • Laura J Damschroder  
  • Jordan B Sparks  
  • Sarah E Skurla  
  • Eve A Kerr  
  • Timothy P Hofer  
  • Tanner J Caverly  

  Abstract:

  Background: Overtreatment and overtesting expose patients to unnecessary, wasteful, and potentially harmful care. Reducing overtreatment or overtesting that has become ingrained in current clinical practices and is being delivered on a routine basis will require solutions that incorporate a deep understanding of multiple perspectives, particularly those on the front lines of clinical care: patients and their clinicians. Design approaches are a promising and innovative way to incorporate stakeholder needs, desires, and challenges to develop solutions to complex problems. Objective: This study aimed (1) to engage patients in a design process to develop high-level deintensification strategies for primary care (ie, strategies for scaling back or stopping routine medical services that more recent evidence reveals are not beneficial) and (2) to engage both patients and primary care providers in further co-design to develop and refine the broad deintensification strategies identified in phase 1. Methods: We engaged stakeholders in design charrettes—intensive workshops in which key stakeholders are brought together to develop creative solutions to a specific problem—focused on deintensification of routine overuse in primary care. We conducted the study in 2 phases: a 6.5-hour design charrette with 2 different groups of patients (phase 1) and a subsequent 4-hour charrette with clinicians and a subgroup of phase 1 patients (phase 2). Both phases included surveys and educational presentations related to deintensification. Phase 1 involved several design activities (mind mapping, business origami, and empathy mapping) to help patients gain a deeper understanding of the individuals involved in deintensification. Following that, we asked participants to review hypothetical scenarios where patients, clinicians, or the broader health system context posed a barrier to deintensification and then to brainstorm solutions. The deintensification themes identified in phase 1 were used to guide phase 2. This second phase primarily involved 1 design activity (WhoDo). In this activity, patients and clinicians worked together to develop concrete actions that specific stakeholders could take to support deintensification efforts. This activity included identifying barriers to the actions and approaches to overcoming those barriers. Results: A total of 35 patients participated in phase 1, and 9 patients and 7 clinicians participated in phase 2. The analysis of the deintensification strategies and survey data is currently underway. The results are expected to be submitted for publication in early 2020. Conclusions: Health care interventions are frequently developed without input from the people who are most affected. The exclusion of these stakeholders in the design process often influences and limits the impact of the intervention. This study employed design charrettes, guided by a flexible user-centered design model, to bring clinicians and patients with differing backgrounds and with different expectations together to cocreate real-world solutions to the complex issue of deintensifying medical services.

  • JMIR Res Protoc 2019;8(11):e15618

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  Systematic Review Protocols (funded)

  Nov 26, 2019

  Factors in Randomized Controlled Trials Reported to Impact the Implementation of Patient-Reported Outcome Measures Into Routine Care: Protocol for a...

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  Authors List:

  • Natasha Anne Roberts  
  • Kimberly Alexander  
  • David Wyld  
  • Monika Janda  

  Abstract:

  Background: Patient-reported outcome measures (PROMs) are tools that enable patients to directly report their own assessments of well-being, or symptoms, in a structured and consistent way. Despite the usefulness of PROMs in optimizing health outcomes, their use in clinical practice is not routine. PROMs are complex to integrate into the clinical setting, with many elements potentially impacting on the success of implementation. For this reason, a protocol has been developed to guide a systematic review to collate information on implementation as presented in the randomized controlled trials (RCTs) to date. Objective: The primary objective of this systematic review is to identify and synthesize factors available from RCT data about the fidelity of PROM interventions in clinical practice. The secondary objective will be an assessment of how implementation factors impact fidelity outcomes. Methods: Preferred Reporting Items for Systematic Reviews and Meta-Analyses reporting standards will be followed. MEDLINE, EMBASE, and the Cumulative Index to Nursing and Allied Health Literature via OvidSP will be accessed using a defined search strategy. Grey literature and ClinicalTrials.gov will be reviewed for unpublished studies. Data extraction will be done to identify fidelity and factors impacting implementation, summarized using a narrative synthesis. An evidence-based implementation science framework will assist in identifying potential elements of importance and their effect on the process and outcomes of implementation. A meta-analysis to assess the impact of implementation factors will be attempted. A Cochrane risk of bias tool will be used. Results: This protocol has received funding, and searches of databases will commence at the end of May 2019. It is planned that this systematic review will be finalized for publication in (December) 2019. Conclusions: Applying an implementation science evidence-based framework to the published literature may identify factors present in the data that impact on the implementation of PROMs into routine clinical care. This systematic review aims to improve understanding of how these factors impact the fidelity of this intervention, so that PROMs can be more effectively used in the care of patients. This systematic review can also offer more detailed information about the process and outcomes of successful implementation of PROMs.

  • JMIR Res Protoc 2019;8(11):e14579

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  Grant Proposals (funded, non-ehealth)

  Nov 25, 2019

  Time-Limited Trials Among Critically Ill Patients With Advanced Medical Illnesses to Reduce Nonbeneficial Intensive Care Unit Treatments: Protocol for a...

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  Authors List:

  • Dong Chang  
  • Jennifer Parrish  
  • Nader Kamangar  
  • Janice Liebler  
  • May Lee  
  • Thanh Neville  

  Abstract:

  Background: Invasive intensive care unit (ICU) treatments for patients with advanced medical illnesses and poor prognoses may prolong suffering with minimal benefit. Unfortunately, the quality of care planning and communication between clinicians and critically ill patients and their families in these situations are highly variable, frequently leading to overutilization of invasive ICU treatments. Time-limited trials (TLTs) are agreements between the clinicians and the patients and decision makers to use certain medical therapies over defined periods of time and to evaluate whether patients improve or worsen according to predetermined clinical parameters. For patients with advanced medical illnesses receiving aggressive ICU treatments, TLTs can promote effective dialogue, develop consensus in decision making, and set rational boundaries to treatments based on patients’ goals of care. Objective: The aim of this study will be to examine whether a multicomponent quality-improvement strategy that uses protocoled TLTs as the default ICU care-planning approach for critically ill patients with advanced medical illnesses will decrease duration and intensity of nonbeneficial ICU care without changing hospital mortality. Methods: This study will be conducted in medical ICUs of three public teaching hospitals in Los Angeles County. In Aim 1, we will conduct focus groups and semistructured interviews with key stakeholders to identify facilitators and barriers to implementing TLTs among ICU patients with advanced medical illnesses. In Aim 2, we will train clinicians to use protocol-enhanced TLTs as the default communication and care-planning approach in patients with advanced medical illnesses who receive invasive ICU treatments. Eligible patients will be those who the treating ICU physicians consider to be at high risk for nonbeneficial treatments according to guidelines from the Society of Critical Care Medicine. ICU physicians will be trained to use the TLT protocol through a curriculum of didactic lectures, case discussions, and simulations utilizing actors as family members in role-playing scenarios. Family meetings will be scheduled by trained care managers. The improvement strategy will be implemented sequentially in the three participating hospitals, and outcomes will be evaluated using a before-and-after study design. Key process outcomes will include frequency, timing, and content of family meetings. The primary clinical outcome will be ICU length of stay. Secondary outcomes will include hospital length of stay, days receiving life-sustaining treatments (eg, mechanical ventilation, vasopressors, and renal replacement therapy), number of attempts at cardiopulmonary resuscitation, frequency of invasive ICU procedures, and disposition from hospitalization. Results: The study began in August 2017. The implementation of interventions and data collection were completed at two of the three hospitals. As of September 2019, the study was at the postintervention stage at the third hospital. We have completed focus groups with physicians at each medical center (N=29) and interviews of family members and surrogate decision makers (N=18). The study is expected to be completed in the first quarter of 2020, and results are expected to be available in mid-2020. Conclusions: The successful completion of the aims in this proposal may identify a systematic approach to improve communication and shared decision making and to reduce nonbeneficial invasive treatments for ICU patients with advanced medical illnesses.

  • JMIR Res Protoc 2019;8(11):e16301

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  Systematic Review Protocols

  Nov 25, 2019

  Allegiance Bias and Treatment Quality as Moderators of the Effectiveness of Humanistic Psychotherapy: Protocol for a Systematic Review and Meta-Analysis

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  Authors List:

  • Olivia Schünemann  
  • Alessa Jansen  
  • Ulrike Willutzki  
  • Nina Heinrichs  

  Abstract:

  Background: In many countries, humanistic psychotherapy (HPT) is viewed as a broad psychotherapeutic approach and is accepted in health care systems. To qualify for reimbursement by health insurance in Germany, psychotherapy approaches have to be evaluated positively by the German Scientific Board of Psychotherapy (GSBP). The GSBP examined HPT and its subapproaches based on an application by a number of professional organizations affiliated with HPT (Work Group Humanistic Psychotherapy, WGHPT). The GSBP came to the decision that none of the HPT subapproaches provided sufficient evidence to be evaluated as evidence based. Potential reasons for the discrepancy between international recognition of HPT and GSBP’s decision will be explored: researchers’ allegiance may have led to a risk of bias disadvantaging HPT. Furthermore, the evaluation criteria of the GSBP did not systematically consider whether HPT was conceptualized bona fide and implemented with sufficient treatment integrity in the studies. Objective: This systematic review will re-examine the studies included in the review of the GSBP. Within 2 comparisons (HPT vs control and HPT vs other psychotherapeutic interventions), we will examine moderating effects of treatment quality (bona fide and treatment integrity) and allegiance on the effectiveness of HPT. Methods: This review is based on the prior systematic review by the GSBP. The GSBP examined randomized controlled trials (RCTs) and studies with non-RCTs of HPT interventions for individuals with mental disorders. All studies suggested by the WGHPT were included; moreover, the GSBP conducted searches in standard electronic databases (Cochrane Central Register of Controlled Trials, MEDLINE, PsycINFO, and PSYNDEX) and handsearches in relevant systematic reviews and contacted experts. A total of 2 independent GSBP reviewers performed study screening using a structured form. On the basis of the prior work of the GSBP, all studies that were positively screened by the GSBP will be included in this review. Data will be extracted independently by 4 authors. Standardized mean difference will be calculated, and possible publication bias will be tested using funnel plots and Egger test. A priori defined subgroup or meta-regression analyses will be performed for treatment quality, allegiance, type of nonactive control, study quality, type of subapproach, and target population (children and adolescents or adults). Results: The GSBP identified 115 eligible studies that will be reanalyzed in this systematic review. Conclusions: Results about moderator effects of treatment quality and allegiance will provide important information about their impact on the evaluation of HPT and other psychotherapy approaches and can be used for further evaluation methods.

  • JMIR Res Protoc 2019;8(11):e15140

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