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Smartwatch and fitness band wearable consumer electronics can passively measure pulse rate from the wrist using photoplethysmography (PPG). Identification of pulse irregularity or variability from these data has the potential to identify atrial fibrillation or atrial flutter (AF, collectively). The rapidly expanding consumer base of these devices allows for detection of undiagnosed AF at scale. The Apple Heart Study is a prospective, single arm pragmatic study that has enrolled 419,093 participants (NCT03335800). The primary objective is to measure the proportion of participants with an irregular pulse detected by the Apple Watch (Apple Inc, Cupertino, CA) with AF on subsequent ambulatory ECG patch monitoring. The secondary objectives are to: 1) characterize the concordance of pulse irregularity notification episodes from the Apple Watch with simultaneously recorded ambulatory ECGs; 2) estimate the rate of initial contact with a health care provider within 3 months after notification of pulse irregularity. The study is conducted virtually, with screening, consent and data collection performed electronically from within an accompanying smartphone app. Study visits are performed by telehealth study physicians via video chat through the app, and ambulatory ECG patches are mailed to the participants. The results of this trial will provide initial evidence for the ability of a smartwatch algorithm to identify pulse irregularity and variability which may reflect previously unknown AF. The Apple Heart Study will help provide a foundation for how wearable technology can inform the clinical approach to AF identification and screening.

Objective To assess the efficacy of modest non-financial incentives on immunisation rates in children aged 1-3 and to compare it with the effect of only improving the reliability of the supply of services.Design Clustered randomised controlled study. Setting Rural Rajasthan, India.Participants 1640 children aged 1-3 at end point.Interventions 134 villages were randomised to one of three groups: a once monthly reliable immunisation camp (intervention A; 379 children from 30 villages); a once monthly reliable immunisation camp with small incentives (raw lentils and metal plates for completed immunisation; intervention B; 382 children from 30 villages), or control (no intervention, 860 children in 74 villages). Surveys were undertaken in randomly selected households at baseline and about 18 months after the interventions started (end point).Main outcome measures Proportion of children aged 1-3 at the end point who were partially or fully immunised.Results Among children aged 1-3 in the end point survey, rates of full immunisation were 39% (148/382, 95% confidence interval 30% to 47%) for intervention B villages (reliable immunisation with incentives), 18% (68/379, 11% to 23%) for intervention A villages (reliable immunisation without incentives), and 6% (50/860, 3% to 9%) for control villages. The relative risk of complete immunisation for intervention B versus control was 6.7 (4.5 to 8.8) and for intervention B versus intervention A was 2.2 (1.5 to 2.8). Children in areas neighbouring intervention B villages were also more likely to be fully immunised than those from areas neighbouring intervention A villages (1.9, 1.1 to 2.8). The average cost per immunisation was $28 (1102 rupees, about £16 or €19) in intervention A and $56 (2202 rupees) in intervention B.Conclusions Improving reliability of services improves immunisation rates, but the effect remains modest. Small incentives have large positive impacts on the uptake of immunisation services in resource poor areas and are more cost effective than purely improving supply.Trial registration IRSCTN87759937.

Medical conditions are often complicated by major depression, with consequent additional impairment of quality of life. We aimed to compare the effectiveness of an integrated treatment programme for major depression in patients with cancer (depression care for people with cancer) with usual care. SMaRT Oncology-2 is a parallel-group, multicentre, randomised controlled effectiveness trial. We enrolled outpatients with major depression from three cancer centres and their associated clinics in Scotland, UK. Participants were randomly assigned in a 1:1 ratio to the depression care for people with cancer intervention or usual care, with stratification (by trial centre) and minimisation (by age, primary cancer, and sex) with allocation concealment. Depression care for people with cancer is a manualised, multicomponent collaborative care treatment that is delivered systematically by a team of cancer nurses and psychiatrists in collaboration with primary care physicians. Usual care is provided by primary care physicians. Outcome data were collected up until 48 weeks. The primary outcome was treatment response (≥50% reduction in Symptom Checklist Depression Scale [SCL-20] score, range 0–4) at 24 weeks. Trial statisticians and data collection staff were masked to treatment allocation, but participants could not be masked to the allocations. Analyses were by intention to treat. This trial is registered with Current Controlled Trials, number ISRCTN40568538. 500 participants were enrolled between May 12, 2008, and May 13, 2011; 253 were randomly allocated to depression care for people with cancer and 247 to usual care. 143 (62%) of 231 participants in the depression care for people with cancer group and 40 (17%) of 231 in the usual care group responded to treatment: absolute difference 45% (95% CI 37–53), adjusted odds ratio 8·5 (95% CI 5·5–13·4), p<0·0001. Compared with patients in the usual care group, participants allocated to the depression care for people with cancer programme also had less depression, anxiety, pain, and fatigue; and better functioning, health, quality of life, and perceived quality of depression care at all timepoints (all p<0·05). During the study, 34 cancer-related deaths occurred (19 in the depression care for people with cancer group, 15 in the usual care group), one patient in the depression care for people with cancer group was admitted to a psychiatric ward, and one patient in this group attempted suicide. None of these events were judged to be related to the trial treatments or procedures. Our findings suggest that depression care for people with cancer is an effective treatment for major depression in patients with cancer. It offers a model for the treatment of depression comorbid with other medical conditions. Cancer Research UK and Chief Scientist Office of the Scottish Government.

Methadone is an effective treatment for opioid dependence. When people who are receiving methadone maintenance treatment for opioid dependence are incarcerated in prison or jail, most US correctional facilities discontinue their methadone treatment, either gradually, or more often, abruptly. This discontinuation can cause uncomfortable symptoms of withdrawal and renders prisoners susceptible to relapse and overdose on release. We aimed to study the effect of forced withdrawal from methadone upon incarceration on individuals' risk behaviours and engagement with post-release treatment programmes. In this randomised, open-label trial, we randomly assigned (1:1) inmates of the Rhode Island Department of Corrections (RI, USA) who were enrolled in a methadone maintenance-treatment programme in the community at the time of arrest and wanted to remain on methadone treatment during incarceration and on release, to either continuation of their methadone treatment or to usual care—forced tapered withdrawal from methadone. Participants could be included in the study only if their incarceration would be more than 1 week but less than 6 months. We did the random assignments with a computer-generated random permutation, and urn randomisation procedures to stratify participants by sex and race. Participants in the continued-methadone group were maintained on their methadone dose at the time of their incarceration (with dose adjustments as clinically indicated). Patients in the forced-withdrawal group followed the institution's standard withdrawal protocol of receiving methadone for 1 week at the dose at the time of their incarceration, then a tapered withdrawal regimen (for those on a starting dose >100 mg, the dose was reduced by 5 mg per day to 100 mg, then reduced by 3 mg per day to 0 mg; for those on a starting dose >100 mg, the dose was reduced by 3 mg per day to 0 mg). The main outcomes were engagement with a methadone maintenance-treatment clinic after release from incarceration and time to engagement with methadone maintenance treatment, by intention-to-treat and as-treated analyses, which we established in a follow-up interview with the participants at 1 month after their release from incarceration. Our study paid for 10 weeks of methadone treatment after release if participants needed financial help. This trial is registered with ClinicalTrials.gov, number NCT01874964. Between June 14, 2011, and April 3, 2013, we randomly assigned 283 prisoners to our study, 142 to continued methadone treatment, and 141 to forced withdrawal from methadone. Of these, 60 were excluded because they did not fit the eligibility criteria, leaving 114 in the continued-methadone group and 109 in the forced-withdrawal group (usual care). Participants assigned to continued methadone were more than twice as likely than forced-withdrawal participants to return to a community methadone clinic within 1 month of release (106 [96%] of 110 in the continued-methadone group compared with 68 [78%] of 87 in the forced-withdrawal group; adjusted hazard ratio [HR] 2·04, 95% CI 1·48–2·80). We noted no differences in serious adverse events between groups. For the continued-methadone and forced-withdrawal groups, the number of deaths were one and zero, non-fatal overdoses were one and two, admissions to hospital were one and four; and emergency-room visits were 11 and 16, respectively. Although our study had several limitations—eg, it only included participants incarcerated for fewer than 6 months, we showed that forced withdrawal from methadone on incarceration reduced the likelihood of prisoners re-engaging in methadone maintenance after their release. Continuation of methadone maintenance during incarceration could contribute to greater treatment engagement after release, which could in turn reduce the risk of death from overdose and risk behaviours. National Institute on Drug Abuse and the Lifespan/Tufts/Brown Center for AIDS Research from the National Institutes of Health.

BackgroundColonoscopy is among the standard tests for colorectal cancer (CRC) screening. However, uptake varies, and alternatives such as colon capsule endoscopy (CCE) are available. The uptake and detection rate of clinically significant neoplasia with CCE, compared with colonoscopy, remain unclear in this setting.ObjectiveThe primary objective of this study was to compare the detection rates of advanced neoplasia between CCE and colonoscopy, using a pathway in which the study group could choose between the two procedures, while the control group was offered only colonoscopy.DesignA randomised, intention-to-treat trial was conducted among Danish CRC screening participants who tested positive with a faecal immunochemical test (FIT). The trial compared the detection rate of advanced neoplasia (primary outcome) and the uptake rate of both approaches between the two arms.ResultsA total of 473 684 invitations were sent to 396 676 individuals, with 62.6% returning the test. Among them, 11 075 tests were positive (4.5%), with no significant differences between the two study groups. Among FIT-positive cases, the uptake for colonoscopy was 91.1% in the control arm and 91.7% in the study arm, where participants had a choice of methods. In the study arm, 45.8% preferred CCE, 11.4% preferred colonoscopy and 42.8% had no preference and underwent colonoscopy. Ultimately, 69.9% of patients who initially opted for CCE were later referred for colonoscopy. The rate of advanced neoplasia detection was similar between the groups: 0.67% in the study arm versus 0.64% in the control arm.ConclusionOffering CCE as an alternative to colonoscopy did not significantly alter the detection rate of advanced neoplasia, nor did it increase uptake in a screening programme with high adherence to colonoscopy following a positive FIT test. Instead, it led to a very high rate of secondary colonoscopies. Therefore, CCE cannot be recommended in this setting.Trial registration number NCT04049357 (ClinicalTrials.gov)

Data from an RCT of IAPT Norway (\"Prompt Mental Health Care\" [PMHC]) were linked to several administrative registers up to five years following the intervention. The aims were to (1) examine the effects of PMHC compared to treatment-as-usual (TAU) on work-related outcomes and health care use, (2) estimate the cost-benefit of PMHC, and (3) examine whether clinical outcomes at six-month follow-up explained the effects of PMHC on work-/cost-benefit-related outcomes. RCTs with parallel assignment were conducted at two PMHC sites (N = 738) during 2016/2017. Eligible participants were considered for admission due to anxiety and/or depression. We used Bayesian estimation with 90% credibility intervals (CI) and posterior probabilities (PP) of effects in favor of PMHC. Primary outcome years were 2018-2022. The cost-benefit analysis estimated the overall economic gain expressed in terms of a benefit-cost ratio and the differences in overall public sector spending. The PMHC group was more likely than the TAU group to be in regular work without receiving welfare benefits in 2019-2022 (1.27 ≤ OR ≤ 1.43). Some evidence was found that the PMHC group spent less on health care. The benefit-cost ratio in terms of economic gain relative to intervention costs was estimated at 5.26 (90%CI - 1.28, 11.8). The PP of PMHC being cost-beneficial for the economy as a whole was 85.9%. The estimated difference in public sector spending was small. PMHC effects on work participation and cost-benefit were largely explained by PMHC effects on mental health. The results support the societal economic benefit of investing in IAPT-like services.

In 2005, with the goal of reducing the numbers of maternal and neonatal deaths, the Government of India launched Janani Suraksha Yojana (JSY), a conditional cash transfer scheme, to incentivise women to give birth in a health facility. We independently assessed the effect of JSY on intervention coverage and health outcomes. We used data from the nationwide district-level household surveys done in 2002–04 and 2007–09 to assess receipt of financial assistance from JSY as a function of socioeconomic and demographic characteristics; and used three analytical approaches (matching, with-versus-without comparison, and differences in differences) to assess the effect of JSY on antenatal care, in-facility births, and perinatal, neonatal, and maternal deaths. Implementation of JSY in 2007–08 was highly variable by state—from less than 5% to 44% of women giving birth receiving cash payments from JSY. The poorest and least educated women did not always have the highest odds of receiving JSY payments. JSY had a significant effect on increasing antenatal care and in-facility births. In the matching analysis, JSY payment was associated with a reduction of 3·7 (95% CI 2·2–5·2) perinatal deaths per 1000 pregnancies and 2·3 (0·9–3·7) neonatal deaths per 1000 livebirths. In the with-versus-without comparison, the reductions were 4·1 (2·5–5·7) perinatal deaths per 1000 pregnancies and 2·4 (0·7–4·1) neonatal deaths per 1000 livebirths. The findings of this assessment are encouraging, but they also emphasise the need for improved targeting of the poorest women and attention to quality of obstetric care in health facilities. Continued independent monitoring and evaluations are important to measure the effect of JSY as financial and political commitment to the programme intensifies. Bill & Melinda Gates Foundation.

Background Peer support can enable patient engagement with healthcare services, particularly for marginalised populations. In this randomised controlled trial, the efficacy of a peer support intervention at promoting successful engagement with clinical services for chronic hepatitis C was assessed. Methods In London, UK, potential participants were approached through outreach services for problematic drug use and homelessness. Individuals positive for hepatitis C virus (HCV) after confirmatory testing were randomised using an online service to the intervention (peer support) or standard of care. The primary outcome of interest was successful engagement with clinical hepatitis services. The study was non-blinded. Absolute differences were calculated using a generalised linear model and the results compared to logistic regression. Results Three hundred sixty-four individuals consented to participate. One hundred one had chronic hepatitis C and were randomised, 63 to receive the intervention (peer support). A successful outcome was achieved by 23 individuals in this arm (36.5%) and seven (18.4%) receiving the standard of care, giving an absolute increase of 18.1% (95% confidence interval 1.0–35.2%, p value = 0.04). This was mirrored in the logistic regression (odds ratio 2.55 (0.97–6.70), p  = 0.06). No serious adverse events were reported. Conclusions Peer support can improve the engagement of patients with chronic HCV with healthcare services. Trial registration ISRCTN24707359 . Registered 19th October 2012.

Although using the technologies for a variety of chronic health conditions such as personal health record (PHR) is reported to be acceptable and useful, there is a lack of evidence on the associations between the use of the technologies and the change of health outcome and patients' response to a digital health app. This study aimed to examine the impact of the use of PHR and wearables on health outcome improvement and sustained use of the health app that can be associated with patient engagement. We developed an Android-based mobile phone app and used a wristband-type activity tracker (Samsung Charm) to collect data on health-related daily activities from individual patients. Dietary record, daily step counts, sleep log, subjective stress amount, blood pressure, and weight values were recorded. We conducted a prospective randomized clinical trial across 4 weeks on those diagnosed with obstructive sleep apnea (OSA) who had visited the outpatient clinic of Seoul National University Bundang Hospital. The trial randomly assigned 60 patients to 3 subgroups including 2 intervention groups: (1) mobile app and wearable device users (n=20), (2) mobile app-only users (n=20), and (3) controls (n=20). The primary outcome measure was weight change. Body weights before and after the trial were recorded and analyzed during clinic visits. Changes in OSA-related respiratory parameters such as respiratory disturbance, apnea-hypopnea, and oxygenation desaturation indexes and snoring comprised the secondary outcome and were analyzed for each participant. We collected the individual data for each group during the trial, specifically anthropometric measurement and laboratory test results for health outcomes, and the app usage logs for patient response were collected and analyzed. The body weight showed a significant reduction in the 2 intervention groups after intervention, and the mobile app-only group showed more weight loss compared with the controls (P=.01). There were no significant changes in sleep-related health outcomes. From a patient response point of view, the average daily step counts (8165 steps) from the app plus wearable group were significantly higher than those (6034 steps) from the app-only group because they collected step count data from different devices (P=.02). The average rate of data collection was not different in physical activity (P=.99), food intake (P=.98), sleep (P=.95), stress (P=.70), and weight (P=.90) in the app plus wearable and app-only groups, respectively. We tried to integrate PHR data that allow clinicians and patients to share lifelog data with the clinical workflow to support lifestyle interventions. Our results suggest that a PHR-based intervention may be successful in losing body weight and improvement in lifestyle behavior. ClinicalTrials.gov NCT03200223; https://clinicaltrials.gov/ct2/show/NCT03200223 (Archived by WebCite at http://www.webcitation.org/74baZmnCX).

Abstract Background Despite the benefits of self-help resources in several chronic diseases, a knowledge gap exists regarding patients’ and clinicians’ experiences and attitudes toward multimodal self-help resources in inflammatory bowel diseases (IBD). Methods Confidence Optimization through Resources for Education, Engagement, and Empowerment (CORE) was a prospective, convergent parallel mixed-methods study conducted across 5 gastroenterology practices participating in the Crohn’s & Colitis Foundation’s IBD Qorus Learning Health System from 2022 to 2023. Five IBD-specific multimodal self-help resources (workbook, 2 smartphone apps, help center, and peer mentoring) were offered to patients. E-surveys (weeks 0, 6, and 12) and three 60-minute focus groups elicited the perspectives and experiences of patients and providers regarding self-help resources. Univariate, bivariate, and multivariate statistical analyses explored patients’ preferences, acceptability, and utilization of self-help resources. Results Of 536 patients with IBD, only 3.7% previously used self-help resources, yet 80.0% (427/536) selected at least one multimodal self-help resource when offered. Patients with low health confidence in managing IBD (adjusted odds ratio [aOR] 2.5, 95% CI, 1.1-5.6, P = .03) and females (aOR 2.5, 95% CI, 1.2-5.2, P = .02) were more likely to choose self-help resources. After 12 weeks, 75.0% (81/108) used at least 1 self-help resource. Asynchronous resources (books and smartphone apps) were used more often than synchronous resources (help center and peer mentorship). Patients preferred resources suggested by their clinicians, although clinicians expressed a lack of time in the clinic and a lack of knowledge about self-help resources as barriers. Conclusions Few patients with IBD use self-help resources, even though the majority regard multimodal self-help resources as acceptable and feasible to get information, find community and support, and manage living with IBD. Lay Summary Few patients with inflammatory bowel disease (IBD) use self-help resources, even though a majority find them feasible and acceptable for getting information, finding community and support, and managing the physical and psychosocial impacts of IBD. Patients prefer accessible self-help resources suggested by their clinicians. Graphical Abstract Graphical Abstract