scholarly journals 488Trial design and statistical considerations for a trial comparing group and individual treatments

2021 ◽  
Vol 50 (Supplement_1) ◽  
Author(s):  
Moleen Dzikiti ◽  
Mark Cotton ◽  
Lawrence Mbuagbaw ◽  
Lehana Thabane

Abstract Focus of Presentation A randomized clinical trial is considered the best experimental study design for comparing the effect of an intervention against a control. Selecting a trial design depends on the trial objective, a better choice would be a design that provides optimal estimation of the intervention effect, i.e. a design that yields smaller variance for the estimated intervention effect and giving stable estimates. The choice of analysis method depends on trial design aspects, reasonable assumption on the underlying probabilistic model generating the data and the credibility of findings depend on the appropriateness of the analysis method used. Here, we describe a planned randomized standard of care-controlled trial on interactive weekly mobile text messaging added to a motivational interviewing intervention aimed at sustaining continued breastfeeding among women living with HIV in South Africa. Under the “findings” heading, we highlight some of the trial design and statistical issues for discussion at the early career workshop, to gain insights on possible approaches to address the methods issues. Methods and trial design: Women from peri-urban informal settlements and a rural setting will be invited to participate within 24 hours of giving birth at selected primary healthcare facilities. Eligible women will be individually randomized to intervention or control arm after providing written informed consent. The intervention will consist of a weekly text message encouraging women to exclusively breastfeed and inquiring if they have any problems breastfeeding their infants. In addition to text messaging, women assigned to the intervention arm must visit the research site where a research nurse or counsellor will conduct an individual motivational interview, at weeks 2, 6, and 10 post-delivery. Women assigned to the control arm will be counselled by the standard of care service, i.e. primary healthcare nurses and trained counsellors will counsel women to exclusively breastfeed for the first six months through group educational infant feeding counselling sessions. Study participation will not change standard of care of participants, so women assigned to the intervention arm will receive the standard of care service, in line with provincial guidelines applicable in the sector during the study period. The primary outcomes are 1) number of women who are exclusively breastfeeding at week 24 post-delivery and 2) number of women reporting any breastfeeding at week 24 post-delivery. Findings or trial design and statistical issues Although women are individually randomly assigned to intervention and control arms, the standard of care at the primary health care facility may induce a dependency between these participants, also called the group therapy effect. For example, promotion of exclusive breastfeeding in HIV-infected women may be enhanced through positive feedback from women who follow this practice or vice versa. The standard of care will be clustered within group infant feeding counselling session, where participants (both assigned to the control and intervention arm) will receive the standard of care in groups. Women assigned to the intervention arm will receive individual motivational interview and the text messages will be send separately, to each woman’s mobile phone. Implications The trial objective will be to determine whether at week 24 following delivery, weekly text message added to motivational interview leads to better adherence to exclusive breastfeeding and leads to extended breastfeeding than standard of care. Trial design and statistical issues to discuss during the workshop will include a discussion around: 1) the appropriateness of invoking the standard experimental design to address the study objectives, and possible alternatives 2) Sample size estimation for a trial comparing group and individual treatments? 3) Reasonable assumption on the underlying probabilistic model generating the outcome data and 4) Candidate statistical models. Key messages Use of sound statistical principles of experimental design established for clinical trials allow objective and unbiased comparisons.

2019 ◽  
Author(s):  
Megan Partch ◽  
Cass Dykeman

Mental health treatment providers seek high-impact and low-cost means of engaging clients in care. As such, text messaging is becoming more frequently utilized as a means of communication between provider and client. Research demonstrates that text message interventions increase treatment session attendance, decrease symptomology, and improve overall functioning. However, research is lacking related to the linguistic make up of provider communications. Text messages were collected from previously published articles related to the treatment of mental health disorders. A corpus of 39 mental health treatment text message interventions was composed totaling 286 words. Using Linguistic Inquiry and Word Count (LIWC) software, messages were analyzed for prevalence of terminology thought to enhance client engagement. Clout, demonstrating the writer’s confidence and expertise, and positive Emotional Tone were found to be at a high level within the corpus. Results demonstrated statistical significance for five linguistic variables. When compared with national blog norms derived from Twitter, Clout, Emotional Tone, and use of Biological terminology were found to be at higher rates than expected. Authenticity and Informal terminology were found at significantly lesser rates.


2021 ◽  
Vol 10 (1) ◽  
Author(s):  
Katarina Åsberg ◽  
Marcus Bendtsen

Abstract Background Evidence suggests that unhealthy lifestyle behaviours are modifiable risk factors for postoperative complications. Digital behaviour change interventions (DBCIs), for instance text messaging programs and smartphone apps, have shown promise in achieving lifestyle behaviour change in a wide range of clinical populations, and it may therefore be possible to reduce postoperative complications by supporting behaviour change perioperatively using digital interventions. This scoping review was conducted in order to identify existing research done in the area of perioperative DBCIs for reducing alcohol consumption, improving dietary intake, increasing physical activity and smoking cessation. Main text This scoping review included eleven studies covering a range of surgeries: bariatric, orthopaedic, cancer, transplantation and elective surgery. The studies were both randomised controlled trials and feasibility studies and investigated a diverse set of interventions: one game, three smartphone apps, one web-based program and five text message interventions. Feasibility studies reported user acceptability and satisfaction with the behaviour change support. Engagement data showed participation rates ranged from 40 to 90%, with more participants being actively engaged early in the intervention period. In conclusion, the only full-scale randomised controlled trial (RCT), text messaging ahead of bariatric surgery did not reveal any benefits with respect to adherence to preoperative exercise advice when compared to a control group. Two of the pilot studies, one text message intervention, one game, indicated change in a positive direction with respect to alcohol and tobacco outcomes, but between group comparisons were not done due to small sample sizes. The third pilot-study, a smartphone app, found between group changes for physical activity and alcohol, but not with respect to smoking cessation outcomes. Conclusion This review found high participant satisfaction, but shows recruitment and timing-delivery issues, as well as low retention to interventions post-surgery. Small sample sizes and the use of a variety of feasibility outcome measures prevent the synthesis of results and makes generalisation difficult. Future research should focus on defining standardised outcome measures, enhancing patient engagement and improving adherence to behaviour change prior to scheduled surgery.


2018 ◽  
Vol 23 (6) ◽  
pp. 219-225
Author(s):  
Nicole J. Chimera ◽  
Monica R. Lininger ◽  
Meghan Warren

Clinical Question: Can text message be used for epidemiologic data collection and accurate injury reporting in recreational and club sport participation? Clinical Bottom Line: Text message may be advantageous for injury surveillance in recreational exercise and club sport participation. This novel method may provide a more complete understanding of injury rates as this tool allows for more immediate recall of injury exposures and incidences. Further, data suggest that injuries are reported more often via text message compared to those reported to health care personnel.


Author(s):  
Joy Waughtal ◽  
Phat Luong ◽  
Lisa Sandy ◽  
Catia Chavez ◽  
P Michael Ho ◽  
...  

Abstract Almost 50% of patients with cardiovascular diseases face challenges in taking medications and increased morbidity and mortality. Text messaging may impact medication refill behavior and can be delivered at scale to patients by texting mobile phones. To obtain feedback from persons with chronic conditions on the design of interactive text messages and determine language of message for making messages that can motivate patients to refill medications on time. We purposively sampled 35 English and Spanish speaking patients with at least one chronic condition from three large healthcare delivery systems to participate in N-of-1 video-based synchronous interviews. Research assistants shared ideas for theory-informed text messages with content intended to persuade patients to refill their medication. We transcribed recorded interviews and conducted a content analysis to identify strategies to employ generating a dynamic interactive text message library intended to increase medication refill. Those interviewed were of diverse age and race/ethnicity and typical of persons with multiple chronic conditions. Several participants emphasized that personally tailored and positively framed messages would be more persuasive than generic and/or negative messages. Some patients appreciated humor and messages that could evoke a sense of social support from their providers and rejected the use of emojis. Messages to remind patients to refill medications may facilitate improvements in adherence, which in turn can improve chronic care. Designing messages that are persuasive and can prompt action is feasible and should be considered given the ease with which such messages can be delivered automatically at scale.


2021 ◽  
Author(s):  
Reham Shalaby ◽  
Marianne Hrabok ◽  
Pamela Spurvey ◽  
Rabab M. Abou El-Magd ◽  
Michelle Knox ◽  
...  

BACKGROUND Peer support (PS) is emotional, social, and practical help that is provided by non-professionals to assist others in sustaining health behaviours. PS is valued in recovery-oriented models of mental health and is becoming implemented increasingly at the organizational level. Text messaging is a relatively low cost, high impact, and easily scalable program that uses existing technology, is devoid of geographic barriers, and is easily accessible to end users. OBJECTIVE This study aims to evaluate the effect of an innovative peer support system plus supportive text messaging program on the recovery of discharged patients from acute psychiatric care. METHODS This is a prospective, rater-blinded, pilot randomized controlled trial, including 180 patients discharged from acute psychiatric care. Patients were randomized to one of four conditions: treatment as usual (follow-up care), daily supportive text messages, peer-support only, or peer-support plus daily supportive text messages. A standardized self-report measure of recovery (Recovery Assessment Scale; RAS) was completed at baseline, six weeks, three months, and six months. Descriptive analysis, One-Way ANOVA, and repeated measures MANCOVA were deployed to examine the changes in RAS among the study groups and over the follow-up time points. RESULTS Sixty-five patients completed assessments at each time-point. For the overall sample, higher scores were found for the peer-support plus text message condition compared to the text message only and treatment as usual condition on several scales (i.e., Willingness to ask for help and Personal Confidence and Hope) and total score on the RAS. CONCLUSIONS Peer support plus supportive text messaging results in improved recovery compared to other interventions. It is advisable to incorporate the two interventions as a part of routine practice for patients with psychiatric disorders upon their hospital discharge. CLINICALTRIAL The study received ethical approval from the Health Ethics Research Board of the University of Alberta (Ref # Pro00078427) and operational approval from the Alberta Health Services regional health authority. All patients provided written informed consent. The study was registered with clinicaltrials.gov (Trial registration number NCT03404882).


Author(s):  
Beverly Plester ◽  
Clare Wood ◽  
Samantha Bowyer

The authors present three investigations into pre-teen children’s text message language and measures of their standard literacy abilities. The children translated sentences, from standard English into text, and from text into standard English , and wrote text messages appropriate to a set of scenarios. They categorised text abbreviations used and calculated the proportion of abbreviations to total words. The children completed a questionnaire about their mobile phone use. Text messaging facility was positively associated with verbal reasoning, vocabulary, school achievement in English, and reading ability across the three studies. Texting provides opportunity for children to communicate in writing without the constraints of standard English, and we propose that the playful variants on words that they use in texting, and their ability to encode spoken slang graphically, show not a lack of knowledge of English, but a light hearted use of phonological and alphabetic decoding principles that also underpin standard English.


2019 ◽  
Vol 7 (3_suppl) ◽  
pp. 2325967119S0004
Author(s):  
Xochitl Mellor ◽  
Matthew J. Buczek ◽  
J. Todd Lawrence ◽  
Theodore J. Ganley ◽  
Alexander J. Adams ◽  
...  

Background: Patient-reported outcome (PRO) instruments measure a patient’s health status in a variety of domains, including physical, mental and social well-being. The delivery of such instruments has become an integral part of healthcare, commonly employed to assess treatment efficacy and outcomes in sports medicine. With the proliferation of mobile phones, administration of PROs across patient-friendly platforms (e.g. apps, text messaging) may increase completion rates, particularly among younger patients. The purpose of this study was to validate the collection of common knee PROs with text messaging in sports medicine, by correlating text messaging responses with traditional paper delivery in adolescents and young adults. Methods: Patients presenting to a hospital-based pediatric orthopaedic sports medicine clinic with a knee injury were enrolled in this prospective investigation. Patients were excluded if they were undergoing a same-day office procedure, underwent surgery within the previous 90 days, and/or had no access to a mobile phone. Paper versions of the Pediatric International Knee Documentation Committee (Pedi-IKDC) Subjective Knee Evaluation Form and the Pediatric Functional Activity Brief Scale (Pedi-Fab Scale) questionnaires were completed during the patients’ initial clinic visit. Over the next 72 hours, the patients subsequently completed the mobile phone portion of the study outside of the clinic (Figure 1), which included text message delivery of the Pedi-IKDC and Pedi-Fab Scale, assigned in a random order. Correlations between paper and text message delivery of the two PROs were assessed. Secondary analyses were conducted to examine overall completion time and associations between patient demographics and text compliance. Results: Of the 91 patients (Age M=16.0 ±2.0 years; 48% female) initially enrolled in the study, 55 (60.4%) completed the text Pedi-Fab Scale, 48 (52.7%) completed the text Pedi-IKDC, and 39 (42.9%) completed both PROs. Among the evaluable sample, the intraclass correlation coefficient (ICC) between the paper and mobile phone delivery of the Pedi-Fabs was 0.95 (95% CI, 0.91-0.97). The ICC between the paper and mobile phone delivery of the Pedi-IKDC was 0.96 (95% CI, 0.93-0.98). Average Pedi-Fab scores on paper (M=12.7) and mobile phone (M=12.3) were not significantly different (p=0.52). Similarly, average Pedi-IKDC scores on paper (M=68.8) and mobile phone (M=67.7) were not significantly different (p=0.41). A Bland-Altman plot and linear regression revealed there was no proportional bias between the mean and difference for the Pedi-Fab scores (p=0.55) and Pedi-IKDC scores (p=0.56). The average completion time for the text delivered Pedi-Fab and Pedi-IKDC were 102±224 minutes and 159±155 minutes, respectively. For Pedi-Fab, there were no patient demographics that were significantly associated with text completion. However, high school students (p=0.025), female sex (p=0.036), and race (p=0.002), were significantly associated with the text completion of Pedi-IKDC. In addition, order of the delivery of the questionnaires and paper scores were not associated with text completion for either survey. Conclusion: Text message delivery using mobile phones permits valid assessment of Pedi-IKDC and Pedi-Fabs scores in this prospective observational study. Questionnaire delivery by automated text messaging allows asynchronous response and may increase compliance among high school students while also reducing the labor cost of collecting PROs.


2019 ◽  
Vol 76 (6) ◽  
pp. 387-397 ◽  
Author(s):  
Emili Leary ◽  
Murray Brilliant ◽  
Peggy Peissig ◽  
Sara Griesbach

Abstract Purpose As a preliminary evaluation of the outcomes of implementing pharmacogenetic testing within a large rural healthcare system, patients who received pre-emptive pharmacogenetic testing and warfarin dosing were monitored until June 2017. Summary Over a 20-month period, 749 patients were genotyped for VKORC1 and CYP2C9 as part of the electronic Medical Records and Genomics Pharmacogenetics (eMERGE PGx) study. Of these, 27 were prescribed warfarin and received an alert for pharmacogenetic testing pertinent to warfarin; 20 patients achieved their target international normalized ratio (INR) of 2.0–3.0, and 65% of these patients achieved target dosing within the recommended pharmacogenetic alert dose (± 0.5 mg/day). Of these, 10 patients had never been on warfarin prior to the alert and were further evaluated with regard to time to first stable target INR, bleeds and thromboembolic events, hospitalizations, and mortality. There was a general trend of faster time to first stable target INR when the patient was initiated at a warfarin dose within the alert recommendation versus a dose outside of the alert recommendation with a mean (± SD) of 34 (± 28) days versus 129 (± 117) days, respectively. No trends regarding bleeds, thromboembolic events, hospitalization, or mortality were identified with respect to the pharmacogenetic alert. The pharmacogenetic alert provided pharmacogenetic dosing information to prescribing clinicians and appeared to deploy appropriately with the correct recommendation based upon patient genotype. Conclusion Implementing pharmacogenetic testing as a standard of care service in anticoagulation monitoring programs may improve dosage regimens for patients on anticoagulation therapy.


Author(s):  
Nishal Anthony ◽  
Jennifer Molokwu ◽  
Ogechika Alozie ◽  
Diego Magallanes

Introduction: Attendance to clinic appointments and compliance with treatment plans are essential components of HIV/AIDS care. Compliance is especially important in young and minority individuals living with HIV/AIDS. We assessed the effectiveness of a text-based reminder system compared with usual care in improving the attendance to clinic and social work appointments at a Ryan White-funded clinic based in an academic institution. Methods: Convenience sample looking at 2 periods, 6 months before initiation of text messages and 6 months after initiation of text messages. Results: Following a 6-month postintervention period, we found a statistically significant reduction in our no-show rates (individuals failing to keep scheduled appointments) of 24.8% versus 17.7%, P value .05. Conclusion: Using an inexpensive online text messaging system, we were able to significantly decrease no-show rates in a primarily younger, low-income, and uninsured population.


2019 ◽  
Vol 45 (1) ◽  
pp. 3-10 ◽  
Author(s):  
Michaeline Jensen ◽  
Andrea M. Hussong

The ubiquity of digital communication within the high-risk drinking environment of college students raises exciting new directions for prevention research. However, we are lacking relevant constructs and tools to analyze digital platforms that serve to facilitate, discuss, and rehash alcohol use. In the current study, we introduce the construct of alcohol-talk (or the extent to which college students use alcohol-related words in text messaging exchanges) as well as introduce and validate a novel tool for measuring this construct. We describe a closed-vocabulary, dictionary-based method for assessing alcohol-talk. Analyses of 569,172 text messages from 267 college students indicate that this method produces a reliable and valid measure that correlates as expected with self-reported alcohol and related risk constructs. We discuss the potential utility of this method for prevention studies.


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