Interactive Voice Response Research Articles

Adjuvant pembrolizumab versus placebo in resected stage III melanoma (EORTC 1325-MG/KEYNOTE-054): distant metastasis-free survival results from a double-blind, randomised, controlled, phase 3 trial

The European Organisation for Research and Treatment of Cancer (EORTC) 1325/KEYNOTE-054 trial assessed pembrolizumab versus placebo in patients with resected high-risk stage III melanoma. At 15-month median follow-up, pembrolizumab improved recurrence-free survival (hazard ratio [HR] 0·57 [98·4% CI 0·43-0·74], p<0·0001) compared with placebo, leading to its approval in the USA and Europe. This report provides the final results for the secondary efficacy endpoint, distant metastasis-free survival and an update of the recurrence-free survival results. This double-blind, randomised, controlled, phase 3 trial was done at 123 academic centres and community hospitals across 23 countries. Patients aged 18 years or older with complete resection of cutaneous melanoma metastatic to lymph node, classified as American Joint Committee on Cancer staging system, seventh edition (AJCC-7) stage IIIA (at least one lymph node metastasis >1 mm), IIIB, or IIIC (without in-transit metastasis), and with an Eastern Cooperative Oncology Group performance status of 0 or 1 were eligible. Patients were randomly assigned (1:1) via a central interactive voice response system to receive intravenous pembrolizumab 200 mg or placebo every 3 weeks for up to 18 doses or until disease recurrence or unacceptable toxicity. Randomisation was stratified according to disease stage and region, using a minimisation technique, and clinical investigators, patients, and those collecting or analysing the data were masked to treatment assignment. The two coprimary endpoints were recurrence-free survival in the intention-to-treat (ITT) population and in patients with PD-L1-positive tumours. The secondary endpoint reported here was distant metastasis-free survival in the ITT and PD-L1-positive populations. This study is registered with ClinicalTrials.gov, NCT02362594, and EudraCT, 2014-004944-37. Between Aug 26, 2015, and Nov 14, 2016, 1019 patients were assigned to receive either pembrolizumab (n=514) or placebo (n=505). At an overall median follow-up of 42·3 months (IQR 40·5-45·9), 3·5-year distant metastasis-free survival was higher in the pembrolizumab group than in the placebo group in the ITT population (65·3% [95% CI 60·9-69·5] in the pembrolizumab group vs 49·4% [44·8-53·8] in the placebo group; HR 0·60 [95% CI 0·49-0·73]; p<0·0001). In the 853 patients with PD-L1-positive tumours, 3·5-year distant metastasis-free survival was 66·7% (95% CI 61·8-71·2) in the pembrolizumab group and 51·6% (46·6-56·4) in the placebo group (HR 0·61 [95% CI 0·49-0·76]; p<0·0001). Recurrence-free survival remained longer in the pembrolizumab group 59·8% (95% CI 55·3-64·1) than the placebo group 41·4% (37·0-45·8) at this 3·5-year follow-up in the ITT population (HR 0·59 [95% CI 0·49-0·70]) and in those with PD-L1-positive tumours 61·4% (56·3-66·1) in the pembrolizumab group and 44·1% (39·2-48·8) in the placebo group (HR 0·59 [95% CI 0·49-0·73]). Pembrolizumab adjuvant therapy provided a significant and clinically meaningful improvement in distant metastasis-free survival at a 3·5-year median follow-up, which was consistent with the improvement in recurrence-free survival. Therefore, the results of this trial support the indication to use adjuvant pembrolizumab therapy in patients with resected high risk stage III cutaneous melanoma. Merck Sharp & Dohme.

Mixed-methods economic evaluation of the implementation of tobacco treatment programs in National Cancer Institute-designated cancer centers

BackgroundThe Cancer Center Cessation Initiative (C3I) was launched in 2017 as a part of the NCI Cancer Moonshot program to assist NCI-designated cancer centers in developing tobacco treatment programs for oncology patients. Participating centers have implemented varied evidence-based programs that fit their institutional resources and needs, offering a wide range of services including in-person and telephone-based counseling, point of care, interactive voice response systems, referral to the quitline, text- and web-based services, and medications.MethodsWe used a mixed methods comparative case study design to evaluate system-level implementation costs across 15 C3I-funded cancer centers that reported for at least one 6-month period between July 2018 and June 2020. We analyzed operating costs by resource category (e.g., personnel, medications) concurrently with transcripts from semi-structured key-informant interviews conducted during site visits. Personnel salary costs were estimated using Bureau of Labor Statistics wage data adjusted for area and occupation, and non-wage benefits. Qualitative findings provided additional information on intangible resources and contextual factors related to implementation costs.ResultsMedian total monthly operating costs across funded centers were $11,045 (range: $5129–$20,751). The largest median operating cost category was personnel ($10,307; range: $4122–$19,794), with the highest personnel costs attributable to the provision of in-person program services. Monthly (non-zero) cost ranges for other categories were medications ($17–$573), materials ($6–$435), training ($96–$516), technology ($171–$2759), and equipment ($10–$620). Median cost-per-participant was $466 (range: $70–$2093) and cost-per-quit was $2688 (range: $330–$9628), with sites offering different combinations of program components, ranging from individually-delivered in-person counseling only to one program that offered all components. Site interviews provided context for understanding variations in program components and their cost implications.ConclusionsAmong most centers that have progressed in tobacco treatment program implementation, cost-per-quit was modest relative to other prevention interventions. Although select centers have achieved similar average costs by offering program components of various levels of intensity, they have varied widely in program reach and effectiveness. Evaluating implementation costs of such programs alongside reach and effectiveness is necessary to provide decision makers in oncology settings with the important additional information needed to optimize resource allocation when establishing tobacco treatment programs.

Effects of the COVID-19 pandemic on the sexual and mental health of adolescent and adult men who have sex with men and transgender women participating in two PrEP cohort studies in Brazil: COBra study protocol

IntroductionThe COVID-19 pandemic and its control measures have impacted health and healthcare provision in various levels. Physical distancing measures, for instance, may affect sexual health, impacting access to HIV prevention...

Health-related quality of life in patients with microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer treated with first-line pembrolizumab versus chemotherapy (KEYNOTE-177): an open-label, randomised, phase 3 trial

In the KEYNOTE-177 study, pembrolizumab monotherapy provided statistically significant and clinically meaningful improvements in progression-free survival versus chemotherapy as first-line treatment in patients with microsatellite instability-high or mismatch repair-deficient metastatic colorectal cancer. To further support the efficacy and safety findings of the KEYNOTE-177 study, results of the health-related quality of life (HRQOL) analyses are reported here. KEYNOTE-177 is an open-label, randomised, phase 3 trial being done at 192 cancer centres in 23 countries, in patients aged 18 years and older with microsatellite instability-high or mismatch repair-deficient metastatic colorectal cancer, with an Eastern Cooperative Oncology Group performance status of 0 or 1, and who had not received previous systemic therapy for metastatic disease. Eligible patients were randomly assigned (1:1) centrally by use of interactive voice response or integrated web response technology to receive pembrolizumab 200 mg intravenously every 3 weeks or investigator's choice chemotherapy (mFOLFOX6 [leucovorin, fluorouracil, and oxaliplatin] or FOLFIRI [leucovorin, fluorouracil, and irinotecan] intravenously every 2 weeks with or without intravenous bevacizumab or cetuximab). Patients and investigators were not masked to treatment assignment. The primary endpoints were progression-free survival (previously reported) and overall survival (data to be reported at the time of the final analysis). HRQOL outcomes were evaluated as prespecified exploratory endpoints. The analysis population comprised all randomly assigned patients who received at least one dose of study treatment and completed at least one HRQOL assessment. HRQOL outcomes were mean change from baseline to prespecified week 18 in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and EORTC Quality of Life Questionnaire-Colorectal 29 (EORTC QLQ-CR29) scale and item scores, and in the EuroQoL 5 Dimensions 3 Levels (EQ-5D-3L) visual analogue scale and health utility scores; the proportion of patients with improved, stable, or deteriorated scores from baseline to prespecified week 18 in EORTC QLQ-C30 scales and items; and time to deterioration in EORTC QLQ-C30 global health status/quality of life (GHS/QOL), physical functioning, social functioning, and fatigue scores and EORTC QLQ-CR29 urinary incontinence scores. The threshold for a small and clinically meaningful mean difference in EORTC QLQ-C30 score was 5-8 points. This study is registered with ClinicalTrials.gov, NCT02563002 and is ongoing; recruitment is closed. Between Feb 11, 2016, and Feb 19, 2018, 307 patients were enrolled and randomly assigned to receive pembrolizumab (n=153) or chemotherapy (n=154). The HRQOL analysis population comprised 294 patients (152 receiving pembrolizumab and 142 receiving chemotherapy). As of Feb 19, 2020, median time from randomisation to data cutoff was 32·4 months (IQR 27·7-37·8). Least squares mean (LSM) change from baseline to prespecified week 18 showed a clinically meaningful improvement in EORTC QLQ-C30 GHS/QOL scores with pembrolizumab versus chemotherapy (between-group LSM difference 8·96 [95% CI 4·24-13·69]; two-sided nominal p=0·0002). Median time to deterioration was longer with pembrolizumab versus chemotherapy for GHS/QOL (hazard ratio 0·61 [95% CI 0·38-0·98]; one-sided nominal p=0·019), physical functioning (0·50 [95% CI 0·32-0·81]; one-sided nominal p=0·0016), social functioning (0·53 [95% CI 0·32-0·87]; one-sided nominal p=0·0050), and fatigue scores (0·48 [95% CI 0·33-0·69]; one-sided nominal p<0·0001). Pembrolizumab monotherapy led to clinically meaningful improvements in HRQOL compared with chemotherapy in patients with previously untreated microsatellite instability-high or mismatch repair-deficient metastatic colorectal cancer. These data, along with the previously reported clinical benefits, support pembrolizumab as a first-line treatment option for this population. Merck Sharp & Dohme, a subsidiary of Merck & Co, Kenilworth, NJ, USA.

Factors Associated With Opting Out of Automated Text and Telephone Messages Among Adult Members of an Integrated Health Care System

Health care systems deliver automated text or telephone messages to remind patients of appointments and to provide health information. Patients who receive multiple messages may demonstrate message fatigue by opting out of future messages. To assess whether the volume of automated text or interactive voice response (IVR) telephone messages is associated with the likelihood of patients requesting to opt out of future messages. This retrospective cohort study was conducted at Kaiser Permanente Colorado (KPCO), an integrated health care system. All adult members who received 1 or more automated text or IVR message between October 1, 2018, and September 30, 2019, were included. Receipt of automated text or IVR messages. Message volume and opt-out rates obtained from messaging systems over 1 year. Of the 428 242 adults included in this study, 59.7% were women, and 66.5% were White; the mean (SD) age was 52.3 (17.7) years. During the study period, 84.1% received 1 or more text messages (median, 4 messages; interquartile range, 2-8 messages) and 67.8% received 1 or more IVR messages (median, 3 messages; interquartile range, 1-6 messages). A total of 8929 individuals (2.5%) opted out of text messages, and 4392 (1.5%) opted out of IVR messages. In multivariable analyses, individuals who received 10 to 19.9 or 20 or more text messages per year had higher opt-out rates for text messages compared with those who received fewer than 2 messages per year (adjusted odds ratio [aOR]: 10-19.9 vs <2 messages, 1.27 [95% CI, 1.17-1.38]; ≥20 vs <2 messages, 3.58 [95% CI, 3.28-3.91]), whereas opt-out rates increased progressively in association with IVR message volume, with the highest rates among individuals who received 10.0 to 19.9 messages (aOR, 11.11; 95% CI, 9.43-13.08) or 20.0 messages or more (aOR, 49.84; 95% CI, 42.33-58.70). Individuals opting out of text messages were more likely to opt out of IVR messages (aOR, 4.07; 95% CI, 3.65-4.55), and those opting out of IVR messages were more likely to opt out of text messages (aOR, 5.92; 95% CI, 5.29-6.61). In this cohort study among adult members of an integrated health care system, requests to discontinue messages were associated with greater message volume. These findings suggest that, to preserve the benefits of automated outreach, health care systems should use these messages judiciously to reduce message fatigue.

Switching to riociguat versus maintenance therapy with phosphodiesterase-5 inhibitors in patients with pulmonary arterial hypertension (REPLACE): a multicentre, open-label, randomised controlled trial

Riociguat and phosphodiesterase-5 inhibitors (PDE5i), approved for the treatment of pulmonary arterial hypertension (PAH), act on the same pathway via different mechanisms. Riociguat might be an alternative option for patients with PAH who do not respond sufficiently to treatment with PDE5i, but comparisons of the potential benefits of riociguat and PDE5i in these patients are needed. The aim of this trial was to assess the effects of switching to riociguat from PDE5i therapy versus continued PDE5i therapy in patients with PAH at intermediate risk of 1-year mortality. Riociguat rEplacing PDE5i therapy evaLuated Against Continued PDE5i thErapy (REPLACE) was an open-label, randomised controlled trial in 81 hospital-based pulmonary hypertension centres in 22 countries. The study enrolled patients aged 18-75 years with symptomatic PAH at intermediate risk of 1-year mortality (based on the European Society for Cardiology-European Respiratory Society guideline thresholds for WHO functional class and 6-min walk distance [6MWD]) who were receiving treatment with a PDE5i with or without an endothelin receptor antagonist for at least 6 weeks before randomisation. Patients were excluded if they had been previously treated with riociguat, had used prostacyclin analogues or prostacyclin receptor agonists within 30 days before randomisation, had clinically significant restrictive or obstructive parenchymal lung disease, or had left heart disease. Patients were randomly assigned (1:1) to remain on PDE5i treatment (oral sildenafil [≥60 mg per day] or oral tadalafil [20-40 mg per day]; the PDE5i group) or to switch to oral riociguat (up to 2·5 mg three times per day; the riociguat group), using an interactive voice and web response system, stratified by cause of PAH. The primary endpoint was clinical improvement by week 24, defined as an absence of clinical worsening and prespecified improvements in at least two of three variables (6MWD, WHO functional class, and N-terminal prohormone of brain natriuretic peptide), analysed using last observation carried forward in all randomly assigned patients with observed values at baseline and week 24 who received at least one dose of study medication (the full analysis set). Secondary endpoints included clinical worsening events. The trial has been completed and is registered with ClinicalTrials.gov, NCT02891850. Between Jan 11, 2017, and July 31, 2019, 293 patients were screened, of which 226 patients were randomly assigned to the riociguat group (n=111) or to the PDE5i group (n=115). 211 patients completed the study and 14 patients discontinued (seven in each group). One patient assigned to the PDE5i group did not receive treatment, so 225 patients were included in the safety analysis, and one further patient in the PDE5i group had missing components of the composite primary endpoint at baseline, so 224 patients were included in the full analysis set. The primary endpoint was met by 45 (41%) of 111 patients in the riociguat group and 23 (20%) of 113 patients in the PDE5i group; odds ratio [OR] 2·78 (95% CI 1·53-5·06; p=0·0007). Clinical worsening events occurred in one (1%) of 111 patients in the riociguat group (hospitalisation due to worsening PAH) and 10 (9%) of 114 patients in the PDE5i group (hospitalisation due to worsening PAH [n=9]; disease progression [n=1]; OR 0·10 [0·01-0·73]; p=0·0047). The most frequently occurring adverse events were hypotension (15 [14%]), headache (14 [13%]), and dyspepsia (10 [9%]) in the riociguat group, and headache (eight [7%]), cough (seven [6%]), and upper respiratory tract infection (seven [6%]) in the PDE5i group. Serious adverse events were reported in eight (7%) of 111 patients in the riociguat group and 19 (17%) of 114 patients in the PDE5i group. During the study, four patients died in the PDE5i group, one of them during the safety follow-up period. Switching to riociguat from PDE5i treatment, both of which act via the nitric oxide-soluble guanylate cyclase-cyclic guanosine monophosphate pathway, could be a strategic option for treatment escalation in patients with PAH at intermediate risk of 1-year mortality. Bayer AG, Merck Sharp & Dohme.

Olaparib tablets as maintenance therapy in patients with platinum-sensitive relapsed ovarian cancer and a BRCA1/2 mutation (SOLO2/ENGOT-Ov21): a final analysis of a double-blind, randomised, placebo-controlled, phase 3 trial

Olaparib, a poly (ADP-ribose) polymerase (PARP) inhibitor, has previously been shown to extend progression-free survival versus placebo when given to patients with relapsed high-grade serous or endometrioid ovarian cancer who were platinum sensitive and who had a BRCA1 or BRCA2 (BRCA1/2) mutation, as part of the SOLO2/ENGOT-Ov21 trial. The aim of this final analysis is to investigate the effect of olaparib on overall survival. This double-blind, randomised, placebo-controlled, phase 3 trial was done across 123 medical centres in 16 countries. Eligible patients were aged 18 years or older, had an Eastern Cooperative Oncology Group performance status at baseline of 0-1, had histologically confirmed, relapsed, high-grade serous or high-grade endometrioid ovarian cancer, including primary peritoneal or fallopian tube cancer, and had received two or more previous platinum regimens. Patients were randomly assigned (2:1) to receive olaparib tablets (300 mg in two 150 mg tablets twice daily) or matching placebo tablets using an interactive web or voice-response system. Stratification was by response to previous chemotherapy and length of platinum-free interval. Treatment assignment was masked to patients, treatment providers, and data assessors. The primary endpoint of progression-free survival has been reported previously. Overall survival was a key secondary endpoint and was analysed in all patients as randomly allocated. Safety was assessed in all patients who received at least one treatment dose. This trial is registered with ClinicalTrials.gov, NCT01874353, and is no longer recruiting patients. Between Sept 3, 2013 and Nov 21, 2014, 295 patients were enrolled. Patients were randomly assigned to receive either olaparib (n=196 [66%]) or placebo (n=99 [34%]). One patient, randomised in error, did not receive olaparib. Median follow-up was 65·7 months (IQR 63·6-69·3) with olaparib and 64·5 months (63·4-68·7) with placebo. Median overall survival was 51·7 months (95% CI 41·5-59·1) with olaparib and 38·8 months (31·4-48·6) with placebo (hazard ratio 0·74 [95% CI 0·54-1·00]; p=0·054), unadjusted for the 38% of patients in the placebo group who received subsequent PARP inhibitor therapy. The most common grade 3 or worse treatment-emergent adverse event was anaemia (which occurred in 41 [21%] of 195 patients in the olaparib group and two [2%] of 99 patients in the placebo group). Serious treatment-emergent adverse events were reported in 50 (26%) of 195 patients receiving olaparib and eight (8%) of 99 patients receiving placebo. Treatment-emergent adverse events with a fatal outcome occurred in eight (4%) of the 195 patients receiving olaparib, six of which were judged to be treatment-related (attributed to myelodysplastic syndrome [n=3] and acute myeloid leukaemia [n=3]). Olaparib provided a median overall survival benefit of 12·9 months compared with placebo in patients with platinum-sensitive, relapsed ovarian cancer and a BRCA1/2 mutation. Although statistical significance was not reached, these findings are arguably clinically meaningful and support the use of maintenance olaparib in these patients. AstraZeneca and Merck.

Combining Wearable Devices and Mobile Surveys to Study Child and Youth Development in Malawi: Implementation Study of a Multimodal Approach.

BackgroundMultimodal approaches have been shown to be a promising way to collect data on child development at high frequency, combining different data inputs (from phone surveys to signals from noninvasive biomarkers) to understand children’s health and development outcomes more integrally from multiple perspectives.ObjectiveThe aim of this work was to describe an implementation study using a multimodal approach combining noninvasive biomarkers, social contact patterns, mobile surveying, and face-to-face interviews in order to validate technologies that help us better understand child development in poor countries at a high frequency.MethodsWe carried out a mixed study based on a transversal descriptive analysis and a longitudinal prospective analysis in Malawi. In each village, children were sampled to participate in weekly sessions in which data signals were collected through wearable devices (electrocardiography [ECG] hand pads and electroencephalography [EEG] headbands). Additionally, wearable proximity sensors to elicit the social network were deployed among children and their caregivers. Mobile surveys using interactive voice response calls were also used as an additional layer of data collection. An end-line face-to-face survey was conducted at the end of the study.ResultsDuring the implementation, 82 EEG/ECG data entry points were collected across four villages. The sampled children for EEG/ECG were 0 to 5 years old. EEG/ECG data were collected once a week. In every session, children wore the EEG headband for 5 minutes and the ECG hand pad for 3 minutes. In total, 3531 calls were sent over 5 weeks, with 2291 participants picking up the calls and 984 of those answering the consent question. In total, 585 people completed the surveys over the course of 5 weeks.ConclusionsThis study achieved its objective of demonstrating the feasibility of generating data through the unprecedented use of a multimodal approach for tracking child development in Malawi, which is one of the poorest countries in the world. Above and beyond its multiple dimensions, the dynamics of child development are complex. It is the case not only that no data stream in isolation can accurately characterize it, but also that even if combined, infrequent data might miss critical inflection points and interactions between different conditions and behaviors. In turn, combining different modes at a sufficiently high frequency allows researchers to make progress by considering contact patterns, reported symptoms and behaviors, and critical biomarkers all at once. This application showcases that even in developing countries facing multiple constraints, complementary technologies can leverage and accelerate the digitalization of health, bringing benefits to populations that lack new tools for understanding child well-being and development.

An Interactive Voice Response Software to Improve the Quality of Life of People Living With HIV in Uganda: Randomized Controlled Trial.

BackgroundFollowing the successful scale-up of antiretroviral therapy (ART), the focus is now on ensuring good quality of life (QoL) and sustained viral suppression in people living with HIV. The access to mobile technology in the most burdened countries is increasing rapidly, and therefore, mobile health (mHealth) technologies could be leveraged to improve QoL in people living with HIV. However, data on the impact of mHealth tools on the QoL in people living with HIV are limited to the evaluation of SMS text messaging; these are infeasible in high-illiteracy settings.ObjectiveThe primary and secondary outcomes were to determine the impact of interactive voice response (IVR) technology on Medical Outcomes Study HIV QoL scores and viral suppression at 12 months, respectively.MethodsWithin the Call for Life study, ART-experienced and ART-naïve people living with HIV commencing ART were randomized (1:1 ratio) to the control (no IVR support) or intervention arm (daily adherence and pre-appointment reminders, health information tips, and option to report symptoms). The software evaluated was Call for Life Uganda, an IVR technology that is based on the Mobile Technology for Community Health open-source software. Eligibility criteria for participation included access to a phone, fluency in local languages, and provision of consent. The differences in differences (DIDs) were computed, adjusting for baseline HIV RNA and CD4.ResultsOverall, 600 participants (413 female, 68.8%) were enrolled and followed-up for 12 months. In the intervention arm of 300 participants, 298 (99.3%) opted for IVR and 2 (0.7%) chose SMS text messaging as the mode of receiving reminders and health tips. At 12 months, there was no overall difference in the QoL between the intervention and control arms (DID=0.0; P=.99) or HIV RNA (DID=0.01; P=.94). At 12 months, 124 of the 256 (48.4%) active participants had picked up at least 50% of the calls. In the active intervention participants, high users (received >75% of reminders) had overall higher QoL compared to low users (received <25% of reminders) (92.2 versus 87.8, P=.02). Similarly, high users also had higher QoL scores in the mental health domain (93.1 versus 86.8, P=.008) and better appointment keeping. Similarly, participants with moderate use (51%-75%) had better viral suppression at 12 months (80/94, 85% versus 11/19, 58%, P=.006).ConclusionsOverall, there was high uptake and acceptability of the IVR tool. While we found no overall difference in the QoL and viral suppression between study arms, people living with HIV with higher usage of the tool showed greater improvements in QoL, viral suppression, and appointment keeping. With the declining resources available to HIV programs and the increasing number of people living with HIV accessing ART, IVR technology could be used to support patient care. The tool may be helpful in situations where physical consultations are infeasible, including the current COVID epidemic.Trial RegistrationClinicalTrials.gov NCT02953080; https://clinicaltrials.gov/ct2/show/NCT02953080

English

This study aimed at assessing the level of mobile phone use in Ugandan agricultural extension, and to establish the extent to which mobile phone Viamo&rsquo;s 3-2-1 service, hosted by Airtel Uganda, was being accessed and how the facility can be improved to boost banana productivity. The results of the study indicate that use of mobile phones for increased banana productivity were dependent on age, gender, household size, income and farming experience. Data collected show that the major information source by farmers was extension agents followed by phones and televisions. Focus group discussions revealed that most farmer participants owned phones (94.3%), had Airtel SIM cards and accessed Viamo service (65%). All respondents were aware of the Viamo service and majority got to know about the service through Airtel SMS notifications (83.3%). Farmers indicated that the four most sought after information elements for increasing banana productivity included material on weather forecasts, pest and disease control, fertilizers and their usage, and markets and their location. The study reveals information gaps with respect to pests and disease diagnosis and management, market prices, weather information, mulching and weeding in different terrains, and sources of clean banana planting material. It was concluded that the service is relevant and contributes to improving farmer knowledge on good banana farming practices. A further step will be to scale up use of the 3-2-1 service for agricultural purposes at country and regional levels. Key words: Agricultural information, banana, information technology, innovations, IVR system, smartphones.

Implementation of an Interactive Voice Response System for Cancer Awareness in Uganda: Mixed Methods Study.

BackgroundCancer awareness is crucial for cancer care and prevention. However, cancer awareness in Uganda is low, and access to cancer information is limited.ObjectiveThis study aims to (1) understand the cancer awareness situation in Uganda (perceptions, beliefs, information needs, and challenges to accessing cancer information) and opinions about interactive voice response (IVR) systems; (2) develop cancer awareness messages and implement them in an IVR system; and (3) evaluate user acceptance and use of the IVR system.MethodsA participatory design approach was adopted. To understand cancer awareness needs and challenges, 3 interviews and 7 focus group discussions (FGDs) were conducted with cancer health care providers, patients with cancer, caregivers and survivors, administrators, and lay citizens (n=73). On the basis of the resulting qualitative data, audio messages addressing cancer information needs were developed and implemented in an IVR system. The system and messages were tested with users (n=12) during 2 co-design workshops before final rollout. Finally, the system was evaluated over 6 months after going live, using call records and user feedback from telephone interviews with callers (n=40).ResultsThe cancer information needs included general topics such as what cancer is, what causes it, cancer screening and diagnosis, cancer treatment, and practical information on what to expect during cancer care. There were also myths and misconceptions that need to be addressed, such as that cancer is due to witchcraft and has no treatment. Information on COVID-19 was also sought after following the outbreak. We developed 20 audio cancer messages (approximately 2 minutes each) in English and Luganda, along with 14 IVR navigation instructions. These were implemented in an IVR system with 24/7 availability from all over Uganda via a toll-free multi-channel telephone number. The total number of calls made to the IVR system 6 months after going live was 3820. Of these, 2437 (63.8%) lasted at least 30 seconds and were made from 1230 unique telephone numbers. There were 191 voice messages and 760 calls to live agents, most of which (681/951, 71.6%) were in Luganda. Call volumes peaked following advertisement of the system and lockdowns due to COVID-19. Participants were generally familiar with IVR technology, and caller feedback was largely positive. Cited benefits included convenience, toll-free access, and detailed information. Recommendations for improvement of the system included adding live agents and marketing of the system to target users.ConclusionsIVR technology provides an acceptable and accessible method for providing cancer information to patients and the general public in Uganda. However, a need remains for health system reforms to provide additional cancer information sources and improve cancer care services in general.

Within-subject evaluation of interim buprenorphine treatment during waitlist delays

BackgroundThe effectiveness of opioid agonist treatment for opioid use disorder (OUD) is well established, and delays to treatment are still common, particularly in rural geographic areas. In a randomized 12-week pilot study, we demonstrated initial efficacy of a technology-assisted Interim Buprenorphine Treatment (IBT) vs. continued waitlist control (WLC) for reducing illicit opioid use and other risk behaviors during waitlist delays. Upon completion of that parent trial, WLC participants were given the opportunity to receive 12 weeks of IBT, permitting an additional within-subject examination of IBT effects. MethodsSixteen WLC participants crossed over to receive IBT, involving buprenorphine maintenance with bi-monthly visits, medication administration at home via a computerized device, daily monitoring calls using an Interactive Voice Response (IVR) phone system, and IVR-generated random call-backs. Biochemically-verified illicit opioid abstinence, changes in psychosocial functioning, and HIV + HCV knowledge were examined among participants originally randomized to the WLC phase and who subsequently crossed over to IBT (IBTc). ResultsParticipants submitted a higher percentage of illicit opioid negative specimens at Weeks 4, 8, and 12 during IBT (75 %, 63 %, and 50 %) vs. WLC (0%, 0%, and 0%), respectively (p’s<.01). Participants also demonstrated improvements in anxiety, depression, and HIV and HCV knowledge (p’s<.01). Medication administration, daily IVR call and random call-back adherence and treatment satisfaction were also favorable. ConclusionsThis within-subject evaluation provides additional support for interim buprenorphine’s efficacy in reducing illicit opioid use and improving health outcomes during waitlist delays for more comprehensive treatment.

Effect of Interactive eHealth Interventions on Improving Medication Adherence in Adults With Long-Term Medication: Systematic Review.

BackgroundMedication nonadherence leads to suboptimal treatment outcomes, making it a major priority in health care. eHealth provides an opportunity to offer medication adherence interventions with minimal effort from health care providers whose time and resources are limited.ObjectiveThe aim of this systematic review is twofold: (1) to evaluate effectiveness of recently developed and tested interactive eHealth (including mHealth) interventions on medication adherence in adult patients using long-term medication and (2) to describe strategies among effective interventions.MethodsMEDLINE, EMBASE, Cochrane Library, PsycINFO, and Web of Science were systematically searched from January 2014 to July 2019 as well as reference lists and citations of included articles. Eligible studies fulfilled the following inclusion criteria: (1) randomized controlled trial with a usual care control group; (2) a total sample size of at least 50 adult patients using long-term medication; (3) applying an interactive eHealth intervention aimed at the patient or patient’s caregiver; and (4) medication adherence as primary outcome. Methodologic quality was assessed using the Cochrane risk of bias tool. Selection and quality assessment of studies were performed by 2 researchers (BP and BvdB or JV) independently. A best evidence synthesis was performed according to the Cochrane Back Review Group.ResultsOf the 9047 records screened, 22 randomized clinical trials were included reporting on 29 interventions. Most (21/29, 72%) interventions specified using a (mobile) phone for calling, SMS text messaging, or mobile apps. A majority of all interactive interventions (17/29) had a statistically significant effect on medication adherence (P<.05). Of these interventions, 9 had at least a small effect size (Cohen d ≥ 0.2) and 3 showed strong odds for becoming adherent in the intervention group (odds ratio > 2.0). Our best evidence synthesis provided strong evidence for a positive effect of interventions using SMS text messages or interactive voice response, mobile app, and calls as mode of providing adherence tele-feedback. Intervention strategies “to teach medication management skills,” “to improve health care quality by coordinating medication adherence care between professionals,” and “to facilitate communication or decision making between patients and health care providers” also showed strong evidence for a positive effect.ConclusionsOverall, this review supports the hypothesis that interactive eHealth interventions can be effective in improving medication adherence. Intervention strategies that improve patients’ treatment involvement and their medication management skills are most promising and should be considered for implementation in practice.

Assessment of Psychological Distress in Adults With Type 2 Diabetes Mellitus Through Technologies: Literature Review.

BackgroundThe use of technological devices can support the self-management of individuals with type 2 diabetes mellitus (T2DM), particularly in addressing psychological distress. However, there is poor consistency in the literature regarding the use of psychological instruments for the web-based screening of patients’ psychological distress and subsequent monitoring of their psychological condition during digital interventions.ObjectiveThis study aims to review previous literature on the types of psychological instruments delivered in digital interventions for assessing depression, anxiety, and stress in patients with T2DM.MethodsThe literature review was conducted using the PsycINFO, CINAHL and PubMed databases, in which the following terms were considered: diabetes mellitus, measure, assessment, self-care, self-management, depression, anxiety, stress, technology, eHealth, mobile health, mobile phone, device, and smartphone.ResultsIn most studies, psychological assessments were administered on paper. A few studies deployed self-reporting techniques employing automated telephonic assessment, a call system for screening and monitoring patients’ conditions and preferences, or through telephone interviews via interactive voice response calls, a self-management support program leveraging tailored messages and structured emails. Other studies used simple telephone interviews and included the use of apps for tablets and smartphones to assess the psychological well-being of patients. Finally, some studies deployed mood rating scales delivered through tailored text message–based support systems.ConclusionsThe deployment of appropriate psychological tools in digital interventions allows researchers and clinicians to make the screening of anxiety, stress, and depression symptoms faster and easier in patients with T2DM. Data from this literature review suggest that mobile health solutions may be preferred tools to use in such digital interventions.

Mobile Phone Automated Messaging Service’s and the Fulfilment of Planned Clinical Appointments: Lessons from an Ebola Clinical Study in Kambia District, Sierra Leone

Introduction: The Ebola vaccine Deployment, Acceptance, and Compliance (EBODAC) project was established to develop a communication and community engagement strategy, including the development of appropriate technology, to maximize Ebola vaccination impact in the targeted population both in support of clinical trials and in the broader vaccination program beyond the clinical trial. EBODAC supported the EBOVAC-Salone trial in Kambia district in Sierra Leone to ensure that the novel prime-boost vaccine regimen is well accepted and successfully used in the context of clinical trials; while also preparing to maximize the impact of the potential deployment of a future Ebola vaccination program. The Mobile Technology for Community Health (MOTECH) platform was utilized and customized to help ensure compliance with the prime-boost vaccination regimen. Its main role was to support the communications and reminders surrounding the Ebola vaccine trial through an automated message service to participants’ mobile phones as Interactive Voice Responses (IVR) and SMS (Short Message Service) messages. Methods: The study was cross-sectional and adopted qualitative and quantitative research methods. The design was constructed to provide a representation of different user segments. The sample size was not constructed to provide statistical differences or detect differences in impact among groups but was simply designed to provide insights into how study participants interacted with the technology. Eligibility criteria involved randomly selecting participants from those that: a) received IVR and SMS and didn’t miss an appointment (booster compliant), b) received IVR and SMS and missed an appointment (booster non-compliant), c) received no IVR and SMS and didn’t miss or missed an appointment (MOTECH non-user). Quantitative information was entered in well-designed data entry templates. All participants’ names were anonymized for data analysis. Results: All the respondents, (n=81) revealed liking both the IVRS and SMS messages and majority of these, 80.2% (n=65) reported that IVR was very easy to understand. Respondents 47.5% (n=45) were comfortable receiving IVR, as opposed to 35.8% (n=29) preferred both text and voice messages. It was also found that 74.1% (n=60) of the respondents who were sent visit reminder messages never missed clinic appointment and 81.5% of those that received information preferred to know how to protect themselves from the disease. Conclusion: The EBOVAC-Salone automated voice messages contributed to valuable learning about areas of improvement for the MOTECH that will be of great importance for future outbreaks and medical interventions.

Control of Smart house sensors using Google Assistant

As a result of the research, a working model was created by smart home devices and the Internet of Things using a voice interface. Integrated Google Assistant, Dialogflow, PHP and MQTT. Voice interfaces are closely related not only to the use of smartphones, but also to wearable electronics, autonomous control, speaker speakers and even games. In turn, the Internet of Things today is not only a concept, but also a real movement with its technologies and protocols. Their variety and use of open technologies allows you to flexibly choose the tools for the project you need, taking into account its specifics. Smart lighting control systems are very popular because of the convenience of such solutions (remote on and off, increase and decrease brightness), the ability to collect and analyze data, the ability to make decisions depending on the ratio of external sensors and events. Google Assistant is an artificial intelligence-powered virtual assistant developed by Google that is primarily available on mobile and smart home devices. Unlike the company’s previous virtual assistant, Google Now, the Google Assistant can engage in two-way conversations. Dialogflow is a natural language understanding platform used to design and integrate a conversational user interface into mobile apps, web applications, devices, bots, interactive voice response systems and related uses. The ESP8266 is a low-cost Wi-Fi microchip, with a full TCP/IP stack and microcontroller capability, produced by Espressif Systems in Shanghai, China. The Message Queuing Telemetry Transport (MQTT) is a lightweight, publish-subscribe network protocol that transports messages between devices. The protocol usually runs over TCP/IP; however, any network protocol that provides ordered, lossless, bi-directional connections can support MQTT. It is designed for connections with remote locations where a «small code footprint» is required or the network bandwidth is limited.

Indian Nationalism and its Challenges in the Right-Wing Era of Politics

Background: As a leading cause of morbidity and mortality, Hypertension is a pressing global concern. Adherence to antihypertensive is a cornerstone of effective antihypertensive therapy. However, suboptimal medication adherence is widespread. Mobile health technology i.e. text messaging is a promising tool that can promote medication adherence with a wide-reaching effect on population health. Aims: To critically assess the effectiveness of text-based messaging interventions for improving medication adherence among community-dwelling adults with Hypertension. Methods: Studies were identified through a detailed search of six databases by two independent reviewers: PubMed, Embase, Cochrane, PsycINFO, CINAHL and Scopus. Studies included were: (1) published in English, since 2000; (2) randomised controlled trials; (3) done on community-dwelling adults diagnosed with Primary/ Essential Hypertension; (4) utilised 1 or 2-way text messaging, tailored text messaging, interactive voice response and text-based mobile applications; and (5) with medication adherence-related outcomes. Data extraction was conducted based on the Cochrane Handbook for Systematic Reviews of Intervention, and relevant studies underwent a study appraisal using the Cochrane Risk of Bias Tool. Results: Twelve studies were included in the final review. Text-based messaging interventions exhibited a small statistically significant effect on medication adherence scores and systolic blood pressure reduction while the effect on controlled blood pressure and adherence remains uncertain. Subgroup analyses revealed having a multifaceted content on Hypertension management may be more effective than solely medication adherence content and or reminders. Significance of the study: There is limited evidence that text messaging-based interventions resulted in improved medication adherence and blood pressure control as a result of adherence. With the rise of mobile health, future studies exploring the cost effectiveness and feasibility of tailored and interactive text messaging interventions are warranted to influence the use of public health resources into the development of communication tools as a public health strategy for promoting medication adherence.

Incorporating walking into cognitive behavioral therapy for chronic pain: safety and effectiveness of a personalized walking intervention.

We examined the effectiveness and safety of a walking program offered as part of cognitive behavioral therapy for chronic pain (CBT-CP). Participants were randomized to 10weeks of CBT-CP, delivered either in person or by interactive voice response. Participants reported pedometer-measured step counts daily throughout treatment and received a weekly goal to increase their steps by 10% over the prior week's average. Walking-related adverse events (AEs) were assessed weekly. Participants (n = 125) were primarily male (72%), and white (80%) with longstanding pain (median: 11years). There was no significant difference between treatment groups in rate of change in daily steps, but there was a significant increase in steps from baseline to treatmenttermination in the combined study sample (1648 steps (95% CI 1063-2225)). Participants classified as active doubled. AEs were mostly minor and temporary. Treatment was effective and safe whether the program was delivered in-person or remotely.Trial registration number: clinicaltrials.gov identifier: NCT01025752.

Intermediation Capabilities of Information and Communication Technologies (ICTs) in Ghana’s Agricultural Extension System

Information and communication technologies (ICTs), specifically those that are digital and interactive, present opportunities for enhanced intermediation between actors in Ghana’s agricultural extension system. To understand these opportunities, this study investigates the capabilities of ICTs in support of seven forms of intermediation in the context of agricultural extension: disseminating (information), retrieving (information), harvesting (information), matching (actors to services), networking (among actors), coordinating (actors), and co-creating (among actors). The study identifies the types of ICTs currently functioning in Ghana’s agricultural system, and applies a Delphi-inspired research design to determine the consensus and dissensus of researchers, scientists, and practitioners about the potential of these ICTs to support each of the seven intermediation capabilities. The findings reveal that experts reached consensus that interactive voice response (IVR) technologies currently have the highest potential to support disseminating, retrieving, harvesting, and matching. Meanwhile, social media messaging (SMM) technologies are currently seen as highly capable of supporting coordinating and, to a lesser extent, co-creating, but no consensus is reached on the potential of any of the technologies to support networking.

Safety, Pharmacokinetics, and Pharmacodynamics of Oral Venglustat in Patients With Parkinson's Disease and a &lt;i&gt;GBA&lt;/i&gt; Mutation: Results From Part 1 of the Randomised, Double-Blinded, Placebo-Controlled MOVES-PD Trial

Safety, Pharmacokinetics, and Pharmacodynamics of Oral Venglustat in Patients With Parkinson's Disease and a &lt;i&gt;GBA&lt;/i&gt; Mutation: Results From Part 1 of the Randomised, Double-Blinded, Placebo-Controlled MOVES-PD Trial