scholarly journals Impact of Automated Digital Navigation Program on Bowel Preparation Quality and Patient Satisfaction for Colonoscopy: A Comparative Study Across Multiple Sites

Iproceedings ◽  
10.2196/15270 ◽  
2019 ◽  
Vol 5 (1) ◽  
pp. e15270
Author(s):  
Natalie Bishop ◽  
Sarthak Kakkar ◽  
Shashank Garg ◽  
Andy Pfau ◽  
Melody Burgo ◽  
...  
Keyword(s):  
Patient Satisfaction ◽  
Usual Care ◽  
Bowel Preparation ◽  
Patient Engagement ◽  
Cost Of Care ◽  
Navigation Program ◽  
American Gastroenterology Association ◽  
Mount Sinai ◽  
The Impact

Background Nearly 1 in 5 patients suffers from inadequate or poor bowel preparation in advance of a colonoscopy. Prior studies have shown that this leads to a decrease in adenoma detection rate, increased time spent in completing efficiency in endoscopy suite, as well as an overall increase in cost of care from 13-20%. With the shift to value-based care in the American healthcare system, there is an urgent need for solutions that can automate pre-procedure guidance and post-procedure follow up. Objective As part of the American Gastroenterology Association digital transformation network, we sought to automate and improve pre-procedure navigation for colonoscopy using connected health technologies (specifically digital navigation). At Arizona Center for Digestive Health (AZCDH), we assessed the impact of digital navigation on bowel preparation quality, patient engagement, and patient satisfaction. We also sought to assess the reproducibility of outcomes seen at AZCDH at additional sites that have implemented digital navigation for endoscopic procedures as part of the American Gastroenterology Association network, including Yale New Haven Hospital (YNHH) and three Mount Sinai Hospital locations. Methods At AZCDH, we compared two cohorts of patients (usual care versus digital navigation) scheduled for colonoscopy. The digital navigation cohort received usual care in addition to time based messages and education content pathways on smartphones and delivered through Rx.Health’s digital medicine platform. Bowel preparation quality was then assessed, as well as patient satisfaction with the digital navigation intervention. Patient engagement and satisfaction were then compared with initial data from other sites within the network. Results Of the 217 patients prescribed the digital navigation program at AZCDH, 93 completed the procedure to date and had bowel preparation results documented in the electronic endoscopic record system. After implementing the digital navigation program the rate of aborted procedures decreased from 2.2% at baseline to 1.07%. In a follow up survey, 93% of respondents “strongly agreed” or “agreed” that the digital navigation program was helpful in preparing for their colonoscopy. At other locations to date, 433 patients have been prescribed the pathway at YNHH along with 213 patients at Mount Sinai locations. One hundred percent and 94% of respondents “strongly agreed” or “agreed” that the digital navigation program was helpful in preparing for their procedure at YNHH and Mount Sinai locations, respectively. Conclusions Our single-site study at AZCDH paved the way to implementing digital navigation pathways at YNHH and Mount Sinai endoscopy locations by demonstrating that colonoscopy instructions are well received by patients, can reduce the rate of aborted procedures and can result in higher patient satisfaction as well as a higher quality of bowel preparation. Further, patient engagement rates and satisfaction with the program was consistent at all sites across the US where the digital navigation program has been implemented. In the future, we plan to report on patient outcomes (including reduction in no shows, poor bowel preparation) to allow benchmarking on a national scale.

scholarly journals An Automated Text Message Navigation Program Improves the Show Rate for Outpatient Colonoscopy

2019 ◽  
Vol 46 (6) ◽  
pp. 942-946 ◽  
Author(s):  
Nadim Mahmud ◽  
Sahil D. Doshi ◽  
Mary S. Coniglio ◽  
Michelle Clermont ◽  
Donna Bernard ◽  
...  
Keyword(s):  
Patient Satisfaction ◽  
Usual Care ◽  
Bowel Preparation ◽  
Text Message ◽  
Text Messages ◽  
Perceived Usefulness ◽  
High Patient Satisfaction ◽  
Appointment Adherence ◽  
Navigation Program ◽  
A Prospective Study

Background. Numerous barriers to outpatient colonoscopy completion exist, causing undue procedure cancellations and poor bowel preparation. We piloted a text message navigation program to improve colonoscopy adherence. Method. We conducted a prospective study of patients aged 18 to 75 years scheduled for outpatient colonoscopy at an urban endoscopy center in April 2018. An intervention arm consisting of bidirectional, automated text messages prior to the procedure was compared with a usual care arm. We enrolled 21 intervention patients by phone and randomly selected 50 controls. Outcomes included colonoscopy appointment adherence, bowel preparation quality, and colonoscopy completion. Results. The arms had similar demographics and comorbidities. Intervention patients had higher colonoscopy appointment adherence (90% vs. 62%, p = 0.049). There were no significant differences in preparation quality or procedure completeness. Poststudy surveys indicated high patient satisfaction and perceived usefulness of the program. Conclusion. A bidirectional, automated texting navigation program improved colonoscopy adherence rates as compared with usual care.

Abstract 225: A Depression Quality Program and Cardiovascular Disease: Assessing the Impact on Care

2017 ◽  
Vol 10 (suppl_3) ◽  
Author(s):  
Linda Gordon ◽  
Amanda Malecky ◽  
Andrew Althouse ◽  
Nicole Ansani
Keyword(s):  
Usual Care ◽  
Goal Attainment ◽  
Intervention Group ◽  
Phone Call ◽  
Categorical Variables ◽  
Care Group ◽  
Control Group ◽  
Surrogate Outcome ◽  
The Impact

Background: Data demonstrate an adverse association between depression and coronary artery disease prognosis. Therefore, a depression screening program was initiated in the catheterization (cath) lab. The goals were to improve HEDIS depression compliance rates and determine the impact on clinical outcomes. Methods: Adult patients in an inpatient cath lab from 3 cardiology practices were screened for enrollment in a randomized controlled trial. All cath lab patients received a PHQ-9 depression screener. Those who screened positive for depression (score ≥ 10) were randomized to intervention or usual care. The usual care group received a follow-up phone call to re-administer the PHQ-9 at 6-8 weeks and within 210 days of discharge. The intervention group was administered the PHQ-9 and received intensive education at baseline, 6-8 weeks, and within 210 days of discharge. Education included targeted depression information with a mental health care provider and comprehensive disease management education with a cardiovascular nurse practitioner. Outcomes included: differences in HEDIS depression goal attainment; depression response/remission rates; and cardiovascular goals. Differences between groups were tested using chi-squared tests (categorical variables) and t-tests (continuous variables). Results: Baseline characteristics were similar between control (N=43) and intervention (N=40) groups, with the exception of significantly fewer African American patients in the control group (N=2, 4.7%) vs intervention (N=9, 22.5%). Changes in HEDIS goal attainment show that patients in the intervention group were slightly more likely to be referred to a provider to address depression (95.0% vs 86.0%, p=0.314), or receive meds for depression (65.0% vs 51.2%, p=0.219), but these differences are not statistically significant. More patients in the intervention group refused meds for depression compared to control (15.0% vs. 2.3%, p=0.041); have received blood work (65.0% vs 41.9%, p=0.030); and have received follow-up within 210 days (82.5% vs 46.5%, p<0.001). Treatment adjustment rate was higher in the intervention group compared to control (85.0% vs. 65.1%, p=0.037). Hospital readmission rate was similar between groups (p=0.896) and there was no difference in depression remission or response rates (p=0.426). Further, no differences were seen in cardiovascular surrogate outcome parameters, including cholesterol, A1c, CRP, or BNP between groups; except SGOT was significantly different between groups (-5.0 intervention vs 2.0 control p=0.045). Conclusions: These data demonstrate improvements in attaining a surrogate outcome measure of quality (HEDIS goals); however, this does not appear to translate to a significant clinical impact. Quality measures may need to be continuously reassessed to ensure efficiency and effectiveness of care.

scholarly journals Patient Satisfaction With Extended International Normalized Ratio Follow-up Intervals in a Veteran Population

2019 ◽  
Vol 54 (5) ◽  
pp. 442-449
Author(s):  
Rebecca R. Schoen ◽  
Michael W. Nagy ◽  
Andrea L. Porter ◽  
Amanda R. Margolis
Keyword(s):  
Patient Satisfaction ◽  
Focus Group ◽  
International Normalized Ratio ◽  
Limited Data ◽  
Participant Satisfaction ◽  
Small Effect Size ◽  
The Mean ◽  
The Impact ◽  
Improve Patient

Background: For highly stable warfarin patients, limited data exists regarding patient satisfaction on extended international normalized ratio (INR) follow-up intervals and how this population compares with patients on a direct oral anticoagulant (DOAC). Objective: To assess the impact on patient satisfaction of extending INR follow-up intervals. Methods: Veterans on stable warfarin doses had extended INR follow-up intervals up to 12 weeks in a single-arm prospective cohort study for 2 years. This analysis included participants who completed at least 2 Duke Anticoagulation Satisfaction Scales (DASS). The primary outcome was the change in the DASS. A focus group described participant experiences. Participant satisfaction was compared to patients on a DOAC. Results: Of the 51 participants, 48 were included in the warfarin extended INR follow-up group. Compared with baseline, the mean DASS score (42.9 ± 12.08) was worse at 24 months (46.82 ± 15.2, P = 0.0266), with a small effect size (Cohen’s d = 0.29). The 8 participants in the focus group were satisfied with the extended INR follow-up interval but would be uncomfortable extending follow-up past 2 to 3 months. The extended INR follow-up interval study had similar DASS scores as the 33 participants included on DOAC therapy (46.8 ± 15.1, P = 0.9970) but may be limited by differing populations using DOACs. Conclusion and Relevance: For patients currently stable on warfarin therapy, extending the INR follow-up interval up to 12 weeks or changing to a DOAC does not appear to improve patient satisfaction.

scholarly journals Clinical effectiveness of the START (STrAtegies for RelaTives) psychological intervention for family carers and the effects on the cost of care for people with dementia: 6-year follow-up of a randomised controlled trial

2019 ◽  
Vol 216 (1) ◽  
pp. 35-42 ◽  
Author(s):  
Gill Livingston ◽  
Monica Manela ◽  
Aidan O'Keeffe ◽  
Penny Rapaport ◽  
Claudia Cooper ◽  
...  
Keyword(s):  
Health Research ◽  
Psychological Intervention ◽  
Care Home ◽  
Clinical Effectiveness ◽  
Cost Of Care ◽  
Research Centre ◽  
Family Carers ◽  
People With Dementia ◽  
The Impact

BackgroundThe START (STrAtegies for RelaTives) intervention reduced depressive and anxiety symptoms of family carers of relatives with dementia at home over 2 years and was cost-effective.AimsTo assess the clinical effectiveness over 6 years and the impact on costs and care home admission.MethodWe conducted a randomised, parallel group, superiority trial recruiting from 4 November 2009 to 8 June 2011 with 6-year follow-up (trial registration: ISCTRN 70017938). A total of 260 self-identified family carers of people with dementia were randomised 2:1 to START, an eight-session manual-based coping intervention delivered by supervised psychology graduates, or to treatment as usual (TAU). The primary outcome was affective symptoms (Hospital Anxiety and Depression Scale, total score (HADS-T)). Secondary outcomes included patient and carer service costs and care home admission.ResultsIn total, 222 (85.4%) of 173 carers randomised to START and 87 to TAU were included in the 6-year clinical efficacy analysis. Over 72 months, compared with TAU, the intervention group had improved scores on HADS-T (adjusted mean difference −2.00 points, 95% CI −3.38 to −0.63). Patient-related costs (START versus TAU, respectively: median £5759 v. £16 964 in the final year; P = 0.07) and carer-related costs (median £377 v. £274 in the final year) were not significantly different between groups nor were group differences in time until care home (intensity ratio START:TAU was 0.88, 95% CI 0.58–1.35).ConclusionsSTART is clinically effective and this effect lasts for 6 years without increasing costs. This is the first intervention with such a long-term clinical and possible economic benefit and has potential to make a difference to individual carers.Declarations of interestG.L., Z.W. and C.C. are supported by the UCLH National Institute for Health Research (NIHR) Biomedical Research Centre. G.L. and P.R. were in part supported by the National Institute for Health Research (NIHR) Collaboration for Leadership in Applied Health Research and Care (CLAHRC) North Thames at Bart's Health NHS Trust. The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health. Z.W. reports during the conduct of the study; personal fees from GE Healthcare, grants from GE Healthcare, grants from Lundbeck, other from GE Healthcare, outside the submitted work.

Early rehabilitation after hospital admission for road trauma using an in-reach multidisciplinary team: a randomised controlled trial

2017 ◽  
Vol 31 (9) ◽  
pp. 1189-1200 ◽  
Author(s):  
Jane Wu ◽  
Steven G Faux ◽  
John Estell ◽  
Stephen Wilson ◽  
Ian Harris ◽  
...  
Keyword(s):  
Length Of Stay ◽  
Usual Care ◽  
Intervention Group ◽  
Psychological Status ◽  
Randomised Control Trial ◽  
Control Group ◽  
Rehabilitation Team ◽  
Secondary Outcomes ◽  
The Impact

Objective: To investigate the impact of an in-reach rehabilitation team for patients admitted after road trauma. Design: Randomised control trial of usual care versus early involvement of in-reach rehabilitation team. Telephone follow-up was conducted by a blind assessor at three months for those with minor/moderate injuries and six months for serious/severe injuries. Setting: Four participating trauma services in New South Wales, Australia. Subjects: A total of 214 patients admitted during 2012-2015 with a length of stay of at least five days. Intervention: Provision of rehabilitation services in parallel with ward based therapy using an in-reach team for the intervention group. The control group could still access the ward based therapy (usual care). Main measures: The primary outcome was acute length of stay. Secondary outcomes included percentage requiring inpatient rehabilitation, function (Functional Independence Measure and Timed Up and Go Test), psychological status (Depression Anxiety and Stress Score 21), pain (Orebro Musculoskeletal Pain Questionnaire) and quality of life (Short Form-12 v2). Results: Median length of stay in acute care was 13 days (IQR 8-21). The intervention group, compared to the control group, received more physiotherapy and occupational therapy sessions (median number of sessions 16.0 versus 11.5, P=0.003). However, acute length of stay did not differ between the intervention and control groups (median 15 vs 12 days, P=0.37). There were no significant differences observed in the secondary outcomes at hospital discharge and follow-up. Conclusion: No additional benefit was found from the routine use of acute rehabilitation teams for trauma patients over and above usual care.

scholarly journals Satisfaction of ottenders and non-attenders with their treatments at psychiatric out-patient clinics

1998 ◽  
Vol 22 (10) ◽  
pp. 612-615 ◽  
Author(s):  
Helen Killaspy ◽  
Julia Gledhill ◽  
Sube Banerjee
Keyword(s):  
Patient Satisfaction ◽  
Statistical Power ◽  
Important Determinant ◽  
Self Report ◽  
Financial Cost ◽  
Patient Dissatisfaction ◽  
Outpatient Appointments ◽  
The Impact

Aims and methodNon-attendance at psychiatric outpatient appointments has a substantial financial cost, and may also have clinical significance. To prevent non-attendance and formulate effective responses, its determinants need to be understood. Patient dissatisfaction with services has been suggested as a reason for non-attendance, we therefore investigated the role of patient satisfaction in attendance at psychiatric out-patients appointments. All patients booked for adult psychiatric out-patient follow-up appointments in a three-month period were studied using a brief, self-report questionnaire.ResultsSixty-three per cent (340/538) of offenders and 54% (118/219) of non-attenders responded. Responders expressed high levels of satisfaction with their treatment (92% offenders, 91% non-attenders) and with the service (96% attenders 92% non-attenders). Despite adequate statistical power, there were no statistically significant differences in satisfaction between the two groups.Clinical implicationsIn conclusion, patient satisfaction with psychiatric out-patient care was reported to be relatively high and did not seem to be an important determinant of non-attendance. Further work is needed to determine the impact of variables such as relapse and social disorganisation on attendance.

scholarly journals Promoting Motivational Interviewing in Primary Care: More Than Intention

PRiMER ◽  
2021 ◽  
Vol 5 ◽  
Author(s):  
Paul J. Hershberger ◽  
Lori S. Martensen ◽  
Timothy N. Crawford ◽  
Dean A. Bricker
Keyword(s):  
Primary Care ◽  
Motivational Interviewing ◽  
Patient Engagement ◽  
Care Setting ◽  
Survey Question ◽  
Patient Interaction ◽  
Widespread Implementation ◽  
Primary Care Clinicians ◽  
The Impact

Introduction: Interacting with patients in a manner that furthers self-responsibility for health is an important skill for primary care clinicians. Motivational interviewing (MI) is such an approach to patient engagement, but it remains to be more widely implemented. In a program training health professionals and health professions students in MI, we examined posttraining attitudes and intentions regarding the utilization of MI. Of particular interest was how posttraining intentions were associated with self-reported action 1 month later. Methods: We obtained immediate posttraining and 30-day follow-up data from 209 participants regarding intent to utilize the MI approach (self-reported implementation at the follow-up interval), impact on confidence with patient interaction, and perceived importance of the training. We analyzied frequencies and percentages for all categorical/ordinal variables to describe the participants and the survey question responses. Results: While 91.5% of participants intended to incorporate MI into their approach with patients (to a moderate or great extent) at posttraining, only 48.7% reported that they had actually implemented the MI approach (to a moderate or great extent) 30 days later. However, another 32.1% indicated that they had occasionally utilized MI. Attitudes toward the importance of MI training and the impact of training on confidence remained strong over the 30 days. Conclusion: Achieving more widespread implementation of the MI approach in the primary care setting is likely to be less dependent on convincing clinicians about its importance for patient engagement, but rather on the translation of intent to actual practice and implementation.

scholarly journals Preventing Diagnostic Errors in Ambulatory Care: An Electronic Notification Tool for Incomplete Radiology Tests

2020 ◽  
Vol 11 (02) ◽  
pp. 276-285
Author(s):  
Saul N. Weingart ◽  
Omar Yaghi ◽  
Liz Barnhart ◽  
Sucharita Kher ◽  
John Mazzullo ◽  
...  
Keyword(s):  
Usual Care ◽  
Academic Medical Center ◽  
Intervention Group ◽  
Diagnostic Errors ◽  
Multivariate Logistic Regression Model ◽  
Completion Rates ◽  
Imaging Studies ◽  
The Impact ◽  
Test Completion

Abstract Background Failure to complete recommended diagnostic tests may increase the risk of diagnostic errors. Objectives The aim of this study is to develop and evaluate an electronic monitoring tool that notifies the responsible clinician of incomplete imaging tests for their ambulatory patients. Methods A results notification workflow engine was created at an academic medical center. It identified future appointments for imaging studies and notified the ordering physician of incomplete tests by secure email. To assess the impact of the intervention, the project team surveyed participating physicians and measured test completion rates within 90 days of the scheduled appointment. Analyses compared test completion rates among patients of intervention and usual care clinicians at baseline and follow-up. A multivariate logistic regression model was used to control for secular trends and differences between cohorts. Results A total of 725 patients of 16 intervention physicians had 1,016 delayed imaging studies; 2,023 patients of 42 usual care clinicians had 2,697 delayed studies. In the first month, physicians indicated in 23/30 cases that they were unaware of the missed test prior to notification. The 90-day test completion rate was lower in the usual care than intervention group in the 6-month baseline period (18.8 vs. 22.1%, p = 0.119). During the 12-month follow-up period, there was a significant improvement favoring the intervention group (20.9 vs. 25.5%, p = 0.027). The change was driven by improved completion rates among patients referred for mammography (21.0 vs. 30.1%, p = 0.003). Multivariate analyses showed no significant impact of the intervention. Conclusion There was a temporal association between email alerts to physicians about missed imaging tests and improved test completion at 90 days, although baseline differences in intervention and usual care groups limited the ability to draw definitive conclusions. Research is needed to understand the potential benefits and limitations of missed test notifications to reduce the risk of delayed diagnoses, particularly in vulnerable patient populations.

scholarly journals Improving the Quality of Colonoscopy Bowel Preparation Using an Educational Video

2013 ◽  
Vol 27 (12) ◽  
pp. 696-700 ◽  
Author(s):  
Sateesh R Prakash ◽  
Siddharth Verma ◽  
John McGowan ◽  
Betsy E Smith ◽  
Anjali Shroff ◽  
...  
Keyword(s):  
Colon Cancer ◽  
Patient Satisfaction ◽  
Bowel Preparation ◽  
Video Quality ◽  
Instructional Video ◽  
Limiting Factor ◽  
Colon Preparation ◽  
Colonoscopy Preparation ◽  
The Impact

Colonoscopy is the preferred modality for colon cancer screening. A successful colonoscopy requires proper bowel preparation. Adequate bowel preparation continues to remain a limiting factor. One hundred thirty-three patients scheduled for an outpatient colonoscopy were prospectively randomized in a single-blinded manner to video or nonvideo group. In addition to written bowel preparation instructions, patients in the video group viewed a brief instructional video. Quality of colon preparation was measured using the Ottawa Bowel Preparation Quality scale, while patient satisfaction with preparation was evaluated using a questionnaire. Statistical analyses were used to evaluate the impact of the instructional colonoscopy video. There were significant differences in the quality of colonoscopy preparation between the video and the nonvideo groups. Participants who watched the video had better preparation scores in the right colon (P = 0.0029), mid-colon (P = 0.0027), rectosigmoid (P = 0.0008), fluid content (P = 0.03) and aggregate score (median score 4 versus 5; P = 0.0002). There was no difference between the two groups with regard to patient satisfaction. Income, education level, sex, age and family history of colon cancer had no impact on quality of colonoscopy preparation or patient satisfaction. The addition of an instructional bowel preparation video significantly improved the quality of colon preparation.

scholarly journals Remote Consultations Versus Standard Face-to-Face Appointments for Liver Transplant Patients in Routine Hospital Care: Feasibility Randomized Controlled Trial of myVideoClinic

10.2196/19232 ◽  
2021 ◽  
Vol 23 (9) ◽  
pp. e19232
Author(s):  
Sarah Damery ◽  
Janet Jones ◽  
Elaine O'Connell Francischetto ◽  
Kate Jolly ◽  
Richard Lilford ◽  
...  
Keyword(s):  
Patient Satisfaction ◽  
Liver Transplant ◽  
Usual Care ◽  
Real Time ◽  
Process Evaluation ◽  
Face To Face ◽  
Transplant Patients ◽  
Qualitative Process Evaluation ◽  
Remote Consultations

Background Using technology to reduce the pressure on the National Health Service (NHS) in England and Wales is a key government target, and the NHS Long-Term Plan outlines a strategy for digitally enabled outpatient care to become mainstream by 2024. In 2020, the COVID-19 response saw the widespread introduction of remote consultations for patient follow-up, regardless of individual preferences. Despite this rapid change, there may be enduring barriers to the effective implementation of remote appointments into routine practice once the unique drivers for change during the COVID-19 pandemic no longer apply, to which pre-COVID implementation studies can offer important insights. Objective This study aims to evaluate the feasibility of using real-time remote consultations between patients and secondary care physicians for routine patient follow-up at a large hospital in the United Kingdom and to assess whether patient satisfaction differs between intervention and usual care patients. Methods Clinically stable liver transplant patients were randomized to real-time remote consultations in which their hospital physician used secure videoconferencing software (intervention) or standard face-to-face appointments (usual care). Participants were asked to complete postappointment questionnaires over 12 months. Data were analyzed on an intention-to-treat basis. The primary outcome was the difference in scores between baseline and study end by patient group for the three domains of patient satisfaction (assessed using the Visit-Specific Satisfaction Instrument). An embedded qualitative process evaluation used interviews to assess patient and staff experiences. Results Of the 54 patients who were randomized, 29 (54%) received remote consultations, and 25 (46%) received usual care (recruitment rate: 54/203, 26.6%). The crossover between study arms was high (13/29, 45%). A total of 129 appointments were completed, with 63.6% (82/129) of the questionnaires being returned. Patient satisfaction at 12 months increased in both the intervention (25 points) and usual care (14 points) groups. The within-group analysis showed that the increases were significant for both intervention (P<.001) and usual care (P=.02) patients; however, the between-group difference was not significant after controlling for baseline scores (P=.10). The qualitative process evaluation showed that—according to patients—remote consultations saved time and money, were less burdensome, and caused fewer negative impacts on health. Technical problems with the software were common, and only 17% (5/29) of patients received all appointments over video. Both consultants and patients saw remote consultations as positive and beneficial. Conclusions Using technology to conduct routine follow-up appointments remotely may ease some of the resource and infrastructure challenges faced by the UK NHS and free up clinic space for patients who must be seen face-to-face. Our findings regarding the advantages and challenges of using remote consultations for routine follow-ups of liver transplant patients have important implications for service organization and delivery in the postpandemic NHS. Trial Registration ISRCTN Registry 14093266; https://www.isrctn.com/ISRCTN14093266 International Registered Report Identifier (IRRID) RR2-10.1186/s13063-018-2953-4

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