Context: Depression and anxiety occur frequently (with reported prevalence rates of around 40%) in individuals with coronary heart disease (CHD), heart failure (HF) or atrial fibrillation (AF) and are associated with a poor prognosis, such as decreased health-related quality of life (HRQoL), and increased morbidity and mortality. Psychological interventions are developed and delivered by psychologists or specifically trained healthcare workers and commonly include cognitive behavioural therapies and mindfulness-based stress reduction. They have been shown to reduce depression and anxiety in the general population, though the exact mechanism of action is not well understood. Further, their effects on psychological and clinical outcomes in patients with CHD, HF or AF are unclear.

To assess the effects of psychological interventions (alone, or with cardiac rehabilitation or pharmacotherapy, or both) in adults who have a diagnosis of CHD, HF or AF, compared to no psychological intervention, on psychological and clinical outcomes.

We included randomised controlled trials (RCTs) comparing psychological interventions with no psychological intervention for a minimum of six months follow-up in adults aged over 18 years with a clinical diagnosis of CHD, HF or AF, with or without depression or anxiety. Studies had to report on either depression or anxiety or both.

Treatment of depression after coronary artery bypass surgery: a randomized controlled trial.

Abstract:
There has been little research on the treatment of depression after coronary artery bypass surgery.

To test the efficacy of 2 nonpharmacological interventions for depression after coronary artery bypass surgery compared with usual care.

A 12-week, randomized, single-blind clinical trial with outcome evaluations at 3, 6, and 9 months.

Outpatient research clinic at Washington University School of Medicine, St Louis, Missouri.

One hundred twenty-three patients who met the DSM-IV criteria for major or minor depression within 1 year after surgery.

Twelve weeks of cognitive behavior therapy or supportive stress management. Approximately half of the participants were taking nonstudy antidepressant medications.

Remission of depression, defined as a score of less than 7 on the 17-item Hamilton Rating Scale for Depression.

Remission of depression occurred by 3 months in a higher proportion of patients in the cognitive behavior therapy (71%) and supportive stress-management (57%) arms than in the usual care group (33%) (chi(2)(2) = 12.22, P = .002). Covariate-adjusted Hamilton scores were lower in the cognitive behavior therapy (mean [standard error], 5.5 [1.0]) and the supportive stress-management (7.8 [1.0]) arms than in the usual care arm (10.7 [1.0]) at 3 months. The differences narrowed at 6 months, but the remission rates differed again at 9 months (73%, 57%, and 35%, respectively; chi(2)(2) = 12.02, P = .003). Cognitive behavior therapy was superior to usual care at most points on secondary measures of depression, anxiety, hopelessness, stress, and quality of life. Supportive stress management was superior to usual care only on some of the measures.

Both cognitive behavior therapy and supportive stress management are efficacious for treating depression after coronary artery bypass surgery, relative to usual care. Cognitive behavior therapy had greater and more durable effects than supportive stress management on depression and several secondary psychological outcomes.

clinicaltrials.gov Identifier: NCT00042198.

Randomised controlled trial of a secondary prevention program for myocardial infarction patients ('ProActive Heart'): study protocol. Secondary prevention program for myocardial infarction patients.

Abstract:
Coronary heart disease (CHD) is a significant cause of health and economic burden. Secondary prevention programs play a pivotal role in the treatment and management of those affected by CHD although participation rates are poor due to patient, provider, health system and societal-level barriers. As such, there is a need to develop innovative secondary prevention programs to address the treatment gap. Telephone-delivered care is convenient, flexible and has been shown to improve behavioural and clinical outcomes following myocardial infarction (MI). This paper presents the design of a randomised controlled trial to evaluate the efficacy of a six-month telephone-delivered secondary prevention program for MI patients (ProActive Heart).

550 adult MI patients have been recruited over a 14 month period (December 2007 to January 2009) through two Brisbane metropolitan hospitals, and randomised to an intervention or control group (n = 225 per group). The intervention commences within two weeks of hospital discharge delivered by study-trained health professionals ('health coaches') during up to 10 x 30 minute scripted telephone health coaching sessions. Participants also receive a ProActive Heart handbook and an educational resource to use during the health coaching sessions. The intervention focuses on appropriate modification of CHD risk factors, compliance with pharmacological management, and management of psychosocial issues. Data collection occurs at baseline or prior to commencement of the intervention (Time 1), six months follow-up or the completion of the intervention (Time 2), and at 12 months follow-up for longer term outcomes (Time 3). Primary outcome measures include quality of life (Short Form-36) and physical activity (Active Australia Survey). A cost-effective analysis of the costs and outcomes for patients in the intervention and control groups is being conducted from the perspective of health care costs to the government.

The results of this study will provide valuable new information about an innovative telephone-delivered cost-effective secondary prevention program for MI patients.

Rationale and design of WEBCARE: a randomized, controlled, web-based behavioral intervention trial in cardioverter-defibrillator patients to reduce anxiety and device concerns and enhance quality of life.

Abstract:
The implantable cardioverter defibrillator (ICD) is generally well accepted, but 25-33% of patients experience clinical levels of anxiety, depression, and impaired quality of life (QoL) following implantation. Few trials in ICD patients have investigated whether behavioral intervention may mitigate the development of these adjustment problems. We present the rationale and study design of the WEB-based distress management program for implantable CARdioverter dEfibrillator patients (WEBCARE) trial.

WEBCARE is a multi-center, multi-disciplinary, randomized, controlled behavioral intervention trial designed to examine the effectiveness of a web-based approach in terms of reducing levels of anxiety and device concerns and enhancing QoL. Consecutive patients hospitalized for the implantation of an ICD will be approached for study participation while in hospital and randomized to the intervention arm (n = 175) versus usual care (n = 175) at baseline (5-10 days post implantation). Patients will complete assessments of patient-centered outcomes at baseline, 14, 26, and 52 weeks after implantation. Patients randomized to the intervention arm will receive a 12-week web-based behavioral intervention starting 2 weeks after implantation. Primary endpoints include (i(i)) patient-centered outcomes (i.e., anxiety, depression, ICD acceptance, QoL); (i(ii)) health care utilization; and (i(iii)) cost-effectiveness. All primary endpoints will be assessed with standardized and validated disease-specific or generic questionnaires. Secondary endpoints include (ii(i)) cortisol awakening response; and (ii(ii)) ventricular arrhythmias.

WEBCARE will show whether a behavioral intervention using a web-based approach is feasible and effective in reducing anxiety and ICD concerns and improving QoL in ICD patients.

http://www.ClinicalTrials.gov. Identifier: NCT00895700.

Evaluating the angina plan in patients admitted to hospital with angina: a randomized controlled trial.

Abstract: The aim of this trial was to evaluate the Angina Plan (AP), a cognitive-behavioral nurse-facilitated self-help intervention against standard care (SC). A randomized controlled trial of 218 patients hospitalized with angina assessed participants predischarge and 6 months later. Data were collected during a structured interview using validated questionnaires, self-report, and physiological measurement to assess between group changes in mood, knowledge and misconceptions, cardiovascular risk, symptoms, quality of life, and health service utilization. The intention-to-treat (ITT) analysis found no reliable effects on anxiety and depression at 6 months. AP participants reported increased knowledge, less misconceptions, reduced body mass index (BMI), an increase in self-reported exercise, less functional limitation, and improvements in general health perceptions and social and leisure activities compared to those receiving SC. Sensitivity analysis excluding participants with high baseline depression revealed a statistical significant reduction in depression levels in AP compared to the SC participants. Analysis excluding participants receiving cardiac surgery or angioplasty removed the ITT effects on physical limitation, self-reported exercise and general health perceptions and the improvements seen in social and leisure activities, while adaptive effects on knowledge, misconceptions and BMI remained and between-group changes in depression approached significance. Initiating the AP in a secondary care setting for patients with new and existing angina produces similar benefits to those reported in newly diagnosed primary care patients. Further evaluation is required to examine the extent of observed effects in the longer term.

Enhanced depression care for patients with acute coronary syndrome and persistent depressive symptoms: coronary psychosocial evaluation studies randomized controlled trial.

Abstract:
Depressive symptoms are an established predictor of mortality and major adverse cardiac events (defined as nonfatal myocardial infarction or hospitalization for unstable angina or urgent/emergency revascularizations) in patients with acute coronary syndrome (ACS). This study was conducted to determine the acceptability and efficacy of enhanced depression treatment in patients with ACS.

A 3-month observation period to identify patients with ACS and persistent depressive symptoms was followed by a 6-month randomized controlled trial. From January 1, 2005, through February 29, 2008, 237 patients with ACS from 5 hospitals were enrolled, including 157 persistently depressed patients randomized to intervention (initial patient preference for problem-solving therapy and/or pharmacotherapy, then a stepped-care approach; 80 patients) or usual care (77 patients) and 80 nondepressed patients who underwent observational evaluation. The primary outcome was patient satisfaction with depression care. Secondary outcomes were depressive symptom changes (assessed with the Beck Depression Inventory), major adverse cardiac events, and death.

At the end of the trial, the proportion of patients who were satisfied with their depression care was higher in the intervention group (54% of 80) than in the usual care group (19% of 77) (odds ratio, 5.4; 95% confidence interval [CI], 2.2-12.9 [P < .001]). The Beck Depression Inventory score decreased significantly more (t(155) = 2.85 [P = .005]) for intervention patients (change, -5.7; 95% CI, -7.6 to -3.8; df = 155) than for usual care patients (change, -1.9; 95% CI, -3.8 to -0.1; df = 155); the depression effect size was 0.59 of the standard deviation. At the end of the trial, 3 intervention patients and 10 usual care patients had experienced major adverse cardiac events (4% and 13%, respectively; log-rank test, chi(2)(1) = 3.93 [P = .047]), as well as 5 nondepressed patients (6%) (for the intervention vs nondepressed cohort, chi(2)(1) = 0.48 [P = .49]).

Enhanced depression care for patients with ACS was associated with greater satisfaction, a greater reduction in depressive symptoms, and a promising improvement in prognosis.

clinicaltrials.gov Identifier: NCT00158054.

A randomized controlled trial of secondary prevention of anxiety and distress in a German sample of patients with an implantable cardioverter defibrillator.

Abstract:
To evaluate a minimal, easy, accessible intervention targeting anxiety and reduced quality of life in patients with an implantable cardioverter defibrillator (ICD). An estimated 24% to 87% of patients experience anxiety, and 10% to 15% have reduced quality of life.

A total of 119 ICD patients were assigned randomly to usual medical aftercare (n = 63) or additional psychological treatment (n = 56) comprising of written information on medical and psychological consequences of an ICD plus 6 months of individual phone counseling. Treatment efficacy was evaluated by comparing T0 (immediately after implantation) and T1 (6 months later) assessments.

Although 75% of patients considered the program helpful, age moderated treatment efficacy. As indicated by triple interactions, only in the treatment group, anxiety (HADS-Anxiety, p < .01), psychological distress (SCL-K-9, p < .02), and somatic quality of life (SF-36-PCS, p < .01) improved in ICD patients aged <65 years but deteriorated in older patients (age, 65-75 years). Frequency of ICD discharges was associated with a symptom increase from T0 to T1 in all patients (HADS-Depression, CAQ-Avoidance, and ICD-Constraints; all p < .05).

Our findings confirm that psychological treatments cannot be expected to have uniformly positive effects in ICD patients. Our minimal intervention may have adequately addressed ICD-related concerns in younger patients but may have fostered problems in older patients with fewer concerns. Therefore, our findings warrant custom treatment with particular attention to the elderly as well as patients with frequent ICD discharges.

Combined exercise and cognitive behavioral therapy improves outcomes in patients with heart failure.

Abstract:
The purpose of this study is to compare the effectiveness of a combined 12-week home-based exercise (EX)/cognitive behavioral therapy (CBT) program (n=18) with CBT alone (n=19), EX alone (n=20), and with usual care (UC, n=17) in stable New York Heart Association Class II to III heart failure (HF) patients diagnosed with depression.

Depressive symptom severity [Hamilton Rating Scale for Depression (HAM-D)], physical function [6-min walk test (6MWT)], and health-related quality of life (HRQOL) (Minnesota Living with Heart Failure Questionnaire) were evaluated at baseline (T1), after the 12-week intervention/control (T2), and following a 3-month telephone follow-up (T3). A repeated measures analysis of variance was used to determine group differences. Depression severity was dichotomized as minor (HAM-D, 11-14) and moderate-to-major depression (HAM-D, >/=15), and group intervention and control responses were also evaluated on that basis.

The greatest reduction in HAM-D scores over time occurred in the EX/CBT group (-10.4) followed by CBT (-9.6), EX (-7.3), and UC (-6.2), but none were statistically significant. The combined group showed a significant increase in 6-min walk distance at 24 weeks (F=13.5, P<.001). Among all groups with moderate-to-major depression, only those in CBT/EX had sustained lower HAM-D scores at 12 and 24 weeks, 6MWT distances were significantly greater at 12 (P=.018) and 24 (P=.013) weeks, and the greatest improvement in HRQOL also occurred.

Interventions designed to improve both physical and psychological symptoms may provide the best method for optimizing functioning and enhancing HRQOL in patients with HF.

A randomised, feasibility trial of a tele-health intervention for acute coronary syndrome patients with depression ('MoodCare'): study protocol.

Abstract:
Coronary heart disease (CHD) and depression are leading causes of disease burden globally and the two often co-exist. Depression is common after Myocardial Infarction (MI) and it has been estimated that 15-35% of patients experience depressive symptoms. Co-morbid depression can impair health related quality of life (HRQOL), decrease medication adherence and appropriate utilisation of health services, lead to increased morbidity and suicide risk, and is associated with poorer CHD risk factor profiles and reduced survival. We aim to determine the feasibility of conducting a randomised, multi-centre trial designed to compare a tele-health program (MoodCare) for depression and CHD secondary prevention, with Usual Care (UC).

Over 1600 patients admitted after index admission for Acute Coronary Syndrome (ACS) are being screened for depression at six metropolitan hospitals in the Australian states of Victoria and Queensland. Consenting participants are then contacted at two weeks post-discharge for baseline assessment. One hundred eligible participants are to be randomised to an intervention or a usual medical care control group (50 per group). The intervention consists of up to 10 × 30-40 minute structured telephone sessions, delivered by registered psychologists, commencing within two weeks of baseline screening. The intervention focuses on depression management, lifestyle factors (physical activity, healthy eating, smoking cessation, alcohol intake), medication adherence and managing co-morbidities. Data collection occurs at baseline (Time 1), 6 months (post-intervention) (Time 2), 12 months (Time 3) and 24 months follow-up for longer term effects (Time 4). We are comparing depression (Cardiac Depression Scale [CDS]) and HRQOL (Short Form-12 [SF-12]) scores between treatment and UC groups, assessing the feasibility of the program through patient acceptability and exploring long term maintenance effects. A cost-effectiveness analysis of the costs and outcomes for patients in the intervention and control groups is being conducted from the perspective of health care costs to the government.

This manuscript presents the protocol for a randomised, multi-centre trial to evaluate the feasibility of a tele-based depression management and CHD secondary prevention program for ACS patients. The results of this trial will provide valuable new information about potential psychological and wellbeing benefits, cost-effectiveness and acceptability of an innovative tele-based depression management and secondary prevention program for CHD patients experiencing depression.

Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12609000386235.

Short-term effect of motivational interviewing on clinical and psychological outcomes and health-related quality of life in cardiac rehabilitation patients with poor motivation in Hong Kong: a randomized controlled trial.

Abstract:
Motivational interviewing (MI) is effective in promoting behavioural changes in patients with substance abuse and smoking. However, its effectiveness on health outcomes in cardiac rehabilitation patients is unclear.

A randomized controlled trial.

A total of 146 patients assessed as having poor motivation attended a cardiac rehabilitation programme from February 2008 to June 2010. Patients (n = 73) in the control group received usual care while those in the experimental group (n = 73) received usual care plus four sessions of MI, each lasting 30-45 min. Clinical and psychological outcomes and health-related quality of life were measured at baseline and 3 months after entering the programme. Descriptive statistics, independent t-test, Pearson Chi-squared test, and generalized estimating equations models were used to analyse the data.

There was no significant difference between the two groups on clinical outcomes (all p-values >0.05). Patients in the experimental group had higher increases in health-related quality of life (SF-36) scores in the aspects of general health (4.74, 95% CI 0.04-9.44; p = 0.048) and role limitation due to emotional problems (8.80, 95% CI 1.16-16.43; p = 0.024). However, they reported significantly higher increases in anxiety levels (Hospital Anxiety and Depression Scale) than those in the control group (0.96, 95% CI 0.09-1.83; p = 0.030).

The short-term effectiveness of MI on clinical outcomes and health-related quality of life in poorly motivated cardiac rehabilitation patients is limited. MI, however, was shown to increase anxiety levels of patients during the study period (3 months). More evidence is needed to better understand this phenomenon in the future studies.

Dyads affected by chronic heart failure: a randomized study evaluating effects of education and psychosocial support to patients with heart failure and their partners.

Abstract:
Chronic heart failure (CHF) causes great suffering for both patients and their partners. The aim of this study was to evaluate the effects of an integrated dyad care program with education and psychosocial support to patients with CHF and their partners during a postdischarge period after acute deterioration of CHF.

One hundred fifty-five patient-caregiver dyads were randomized to usual care (n = 71) or a psychoeducation intervention (n = 84) delivered in 3 modules through nurse-led face-to-face counseling, computer-based education, and other written teaching materials to assist dyads to develop problem-solving skills. Follow-up assessments were completed after 3 and 12 months to assess perceived control, perceived health, depressive symptoms, self-care, and caregiver burden.

Baseline sociodemographic and clinical characteristics of dyads in the experimental and control groups were similar at baseline. Significant differences were observed in patients' perceived control over the cardiac condition after 3 (P < .05) but not after 12 months, and no effect was seen for the caregivers.No group differences were observed over time in dyads' health-related quality of life and depressive symptoms, patients' self-care behaviors, and partners' experiences of caregiver burden.

Integrated dyad care focusing on skill-building and problem-solving education and psychosocial support was effective in initially enhancing patients' levels of perceived control. More frequent professional contact and ongoing skills training may be necessary to have a higher impact on dyad outcomes and warrants further research.


Context: Cardiovascular diseases (CVDs) are the leading cause of death globally, accounting for almost 18 million deaths annually. People with CVDs have a five times greater chance of suffering a recurrent cardiovascular event than people without known CVDs. Although drug interventions have been shown to be cost-effective in reducing the risk of recurrent cardiovascular events, adherence to medication remains suboptimal. As a scalable and cost-effective approach, mobile phone text messaging presents an opportunity to convey health information, deliver electronic reminders, and encourage behaviour change. However, it is uncertain whether text messaging can improve medication adherence and clinical outcomes. This is an update of a Cochrane review published in 2017.

To evaluate the benefits and harms of mobile phone text messaging for improving medication adherence in people with CVDs compared to usual care.

We included randomised controlled trials (RCTs) with participants with established arterial occlusive events. We included trials investigating interventions using short message service (SMS) or multimedia messaging service (MMS) with the aim of improving adherence to medication for the secondary prevention of cardiovascular events. The comparator was usual care. We excluded cluster-RCTs and quasi-RCTs.

The effect of short message system (SMS) reminder on adherence to a healthy diet, medication, and cessation of smoking among adult patients with cardiovascular diseases.

Abstract:
Cardiovascular Disease is the leading cause of death worldwide. Non-adherence to a recommended regimen among patients with Cardiovascular Diseases represents a significant problem which could lead to an increase in Cardiovascular Diseases.

This study aimed to assess the effects of Short Message System (SMS) reminders on adherence to a healthy diet, medication, and cessation of smoking among adult patients with Cardiovascular Diseases.

Randomized controlled trial design with three groups was used for this study. A non-probability convenient sample of 160 patients was recruited in this study. The participants were assigned randomly to an experimental group (received SMS regarding adherence to a healthy diet, medication, and smoking cessation), placebo group (received general messages) and control group (routine care). Morisky 8-Item Medication Adherence Scale (MMAS), Mediterranean Diet Adherence Screener (MEDAS), and Readiness to Quit Ladder, were used to assess patients' adherence to medication, adherence to Mediterranean diet, and smoking cessation, respectively. The outcomes were assessed at the beginning of the study and three months later, following completion of the intervention.

One way ANONVA was used to assess the study hypothesis. Significant differences between study groups found in terms of adherence to medication (p=.001) and adherence to a healthy diet (p=.000); however, no significant difference was found between groups, in terms of intention to quit smoking, and/or the number of cigarettes smoked (p= .327), (p=.34), respectively.

It is documented that SMS is effective in improving adherence to a healthy diet and medication. SMS could be a promising solution for management of different chronic diseases.

It is recommended to apply Short Message System (SMS) via cellphone services to improve patient's adherence to a healthy diet and medication. However, further research is needed to support the effectiveness of SMS.

The effectiveness of daily SMS reminders in pharmaceutical care of older adults on improving patients' adherence to antihypertensive medication (SPPA): study protocol for a randomized controlled trial.

Abstract:
Despite a variety of efficient and cost-effective antihypertensive medication, hypertension remains a serious health and economic burden. High consumption of cardiovascular drugs in the Slovak Republic does result neither in better hypertension control nor in significant decrease in cardiovascular mortality. At the same time, Slovakia has alarmingly low patients' adherence to medication intake. Studies have shown the efficiency of short messaging service (SMS) reminders to improve patients' adherence and health outcomes at low costs. Since SMS is popular among Slovaks, this approach may be feasible also in Slovakia. The primary objective is to assess if daily SMS reminders of antihypertensive medication intake provided by pharmacists in addition to the standard pharmaceutical care increase the proportion of adherent older hypertensive ambulatory patients.

The SPPA trial is a pragmatic randomized parallel group (1:1) trial in 300 older hypertensive patients carried out in community pharmacies in Slovakia. Trial pharmacies will be selected from all main regions of Slovakia. Trial intervention comprises daily personalized SMS reminders of medication intake embedded into usual pharmaceutical practice. The primary outcome is a combined adherence endpoint consisting of subjective self-reported medication adherence via the eight-item Morisky Medication Adherence Scale (MMAS-8) and objective pill count rate. Secondary outcomes include: change in the MMAS-8; comparison of adherence rates using pill count; change in systolic blood pressure; and patient satisfaction. Also, direct treatment costs will be evaluated and a cost-effectiveness analysis will be carried out.

The SPPA trial engages community pharmacists and mobile health (mHealth) technologies via evidence-based pharmaceutical care to efficiently and cost-effectively addresses current main healthcare challenges: high prevalence of hypertension; overconsumption of cardiovascular medicines; low adherence to medication treatment; and resulting uncontrolled blood pressure. The results may identify new possibilities and capacities in healthcare with low additional costs and high value to patients.

ClinicalTrials.gov, NCT03105687 . Registered on 07 March 2017.

The Effect of Interactive Text Message Follow-up on Health Promoting Lifestyle of Patients with Acute Coronary Syndrome.

Abstract:
Lifestyle modification is an essential factor in the promotion of health in patients with acute coronary syndrome (ACS). One of the interventions to promote lifestyle is interactive follow-up, which, according to the traditional methods, requires spending significant amount of time and cost. Therefore, this study aimed to determine the effectiveness of interactive text message follow-up on health promoting lifestyle of patients with ACS.

This was a randomized controlled trial among 100 patients suffering from ACS during October-February 2016. The participants were randomly assigned to the experimental and control groups. Collection of data on lifestyle was performed before, 3, and 4 months after the beginning of the intervention using Walker's Health Promoting lifestyle questionnaire. Six messages were sent to the intervention groups each week, and participants asked the questions by sending text message, each week 1 message were sent to the control group for 12 weeks. The statistical analysis of data was performed using independent

Before the intervention, there was no significant difference between the mean score of lifestyle of the two groups, however, 3 months and 4 months after the beginning of the intervention, the mean score of lifestyle in the intervention group was significantly higher than that of the control group (

The interactive text message follow-up is effective in promoting the lifestyle of patients with ACS and can be considered in the planning of follow-up of patients with ACS.

MEDication reminder APPs to improve medication adherence in Coronary Heart Disease (MedApp-CHD) Study: a randomised controlled trial protocol.

Abstract:
The growing number of smartphone health applications available in the app stores makes these apps a promising tool to help reduce the global problem of non-adherence to long-term medications. However, to date, there is limited evidence that available medication reminder apps are effective. This study aims to determine the impact of medication reminder apps on adherence to cardiovascular medication when compared with usual care for people with coronary heart disease (CHD) and to determine whether an advanced app compared with a basic app is associated with higher adherence.

Randomised controlled trial with follow-up at 3 months to evaluate the feasibility and effectiveness of medication reminder apps on medication adherence compared with usual care. An estimated sample size of 156 patients with CHD will be randomised to one of three groups (usual care group, basic medication reminder app group and advanced medication reminder app group). The usual care group will receive standard care for CHD with no access to a medication reminder app. The basic medication reminder app group will have access to a medication reminder app with a basic feature of providing simple daily reminders with no interactivity. The advanced medication reminder app group will have access to a medication reminder app with additional interactive and customisable features. The primary outcome is medication adherence measured by the eight-item Morisky Medication Adherence Scale at 3 months. Secondary outcomes include clinical measurements of blood pressure and cholesterol levels, and medication knowledge. A process evaluation will also be performed to assess the feasibility of the intervention by evaluating the acceptability, utility and engagement with the apps.

Ethical approval has been obtained from the Western Sydney Local Health Network Human Research Ethics Committee (AU/RED/HREC/1/WMEAD/3). Study findings will be disseminated via usual scientific forums.

ACTRN12616000661471; Pre-results.

Using Mobile Health Intervention to Improve Secondary Prevention of Coronary Heart Diseases in China: Mixed-Methods Feasibility Study.

Abstract:
Coronary heart disease (CHD) is the leading cause of cardiovascular mortality worldwide, yet implementation of evidence-based strategies for secondary prevention remains suboptimal.

This study aimed to evaluate the feasibility, specifically the usability and acceptability, and estimate the preliminary effectiveness of a mobile health (mHealth) intervention targeting both physicians and patients to improve adherence to evidence-based medications and lifestyle modifications.

We conducted a 12-week pre-post interventional pilot study at two sites in Shanghai and Hainan, China. Physicians used the app designed in this study to prescribe evidence-based medicines and record patient information. Eligible and consenting patients received automatic text messages or voice calls 4 to 5 times per week for 12 weeks on medication adherence and healthy behaviors. Interviews were conducted among 10 physicians and 24 patients at the two sites for their thoughts on medication adherence and feedback on the usability and acceptability. Questions on usability and acceptability were also asked in a patient follow-up survey. With regard to estimating effectiveness, the primary outcome was medication adherence (as estimated by the Morisky Green Levine Scale) at 12 weeks. Secondary outcomes included physical activity, smoking status, fruits and vegetables consumption, and facility visit frequency.

Interview findings and patient survey showed the good usability and acceptability of the intervention. Among 190 patients who completed the intervention, there was a significant increase in medication adherence (odds ratio [OR] 1.80, 95% CI 1.14-2.85). The study also showed decrease of smokers' percentage (-5%, P=.05), increase of daily vegetables consumption frequency (+0.3/day, P=.01), and community health care center visit frequency (+3 in 3 months, P=.04). The following site-specific differences were noted: medication adherence appeared to increase in Hainan (OR 14.68, 95% CI 5.20-41.45) but not in Shanghai (OR 0.61, 95% CI 0.33-1.12).

Our study demonstrated that the intervention was feasible in both a tertiary care center and an urban community health center in China. Preliminary results from pre-post comparison suggest the possibility that provider and patient-linked mHealth interventions may improve medication adherence and lifestyle modifications among CHD patients, especially in resource-scarce settings. Randomized controlled trials are needed to verify the findings.

Improving Refill Adherence in Medicare Patients With Tailored and Interactive Mobile Text Messaging: Pilot Study.

Abstract:
Nonadherence is a major concern in the management of chronic conditions such as hypertension, cardiovascular disease, and diabetes where patients may discontinue or interrupt their medication for a variety of reasons. Text message reminders have been used to improve adherence. However, few programs or studies have explored the benefits of text messaging with older populations and at scale. In this paper, we present a program design using tailored and interactive text messaging to improve refill rates of partially adherent or nonadherent Medicare members of a large integrated health plan.

The aim of this 3-month program was to gain an understanding of whether tailored interactive text message dialogues could be used to improve medication refills in Medicare patients with one or more chronic diseases.

We used the mPulse Mobile interactive text messaging solution with partially adherent and nonadherent Medicare patients (ie, over age 65 years or younger with disabilities) of Kaiser Permanente Southern California (KP), a large integrated health plan, and compared refill rates of the text messaging group (n=12,272) to a group of partially adherent or nonadherent Medicare patients at KP who did not receive text messages (nontext messaging group, n=76,068). Both groups were exposed to other forms of refill and adherence outreach including phone calls, secure emails, and robo-calls from December 2016 to February 2017.

The text messaging group and nontext messaging group were compared using an independent samples t test to test difference in group average of refill rates. There was a significant difference in medication refill rates between the 2 groups, with a 14.07 percentage points higher refill rate in the text messaging group (P<.001).

The results showed a strong benefit of using this text messaging solution to improve medication refill rates among Medicare patients. These findings also support using interactive text messaging as a cost-effective, convenient, and user-friendly solution for patient engagement. Program outcomes and insights can be used to enhance the design of future text-based solutions to improve health outcomes and promote adherence and long-term behavior change.

The effects of a lifestyle-focused text-messaging intervention on adherence to dietary guideline recommendations in patients with coronary heart disease: an analysis of the TEXT ME study.

Abstract:
A healthy diet is an important component of secondary prevention of coronary heart disease (CHD). The TEXT ME study was a randomised clinical trial of people with CHD that were randomised into standard care or a text-message programme in addition to standard care. This analysis aimed to: 1) assess the effects of the intervention onadherence to the dietary guideline recommendations; 2) assess the consistency of effect across sub-groups; and 3) assess whether adherence to the dietary guideline recommendations mediated the improvements in objective clinical outcomes.

Dietary data were collected using a self-report questionnaire to evaluate adherence to eight dietary guideline recommendations in Australia, including consumption of vegetables, fruits, fish, type of fat used for cooking and in spreads, takeaway food, salt and standard alcohol drinks. The primary outcome of this analysis was the proportion of patients adhering to ≥ 4 dietary guideline recommendations concomitantly and each recommendation was assessed individually as secondary outcomes. Data were analysed using log-binomial regression for categorical variables and analysis of covariance for continuous variables.

Among 710 patients, 54% were adhering to ≥ 4 dietary guideline recommendations (intervention 53% vs control 56%, p = 0.376) at baseline. At six months, the intervention group had a significantly higher proportion of patients adhering to ≥ 4 recommendations (314, 93%) compared to the control group (264, 75%, RR 1.23, 95% CI 1.15-1.31, p < 0.001). In addition, the intervention patients reported consuming higher amounts of vegetables, fruits, and fish per week; less takeaway foods per week; and greater salt intake control. The intervention had a similar effect in all sub-groups tested. There were significant mediational effects of the increase in adherence to the recommendations for the association between the intervention and LDL-cholesterol (p < 0.001) and body mass index (BMI) at six months follow-up (p = 0.005).

A lifestyle-focused text-message programme improved adherence to the dietary guideline recommendations, and specifically improved self-reported consumption of vegetables, fruits, fish, takeaway foods and salt intake. Importantly, these improvements partially mediated improvements in LDL-cholesterol and BMI. This simple and scalable text-messaging intervention could be used as a strategy to improve diet in people with CHD.

Australia and New Zealand Clinical Trials Registry ACTRN12611000161921 . Registered on 10 February 2011.

Medication reminder applications to improve adherence in coronary heart disease: a randomised clinical trial.

Abstract:
The aim of the MEDication reminder APPs to improve medication adherence in Coronary Heart Disease Study was to evaluate the effectiveness and feasibility of using publicly available high-quality medication reminder applications (apps) to improve medication adherence compared with usual care in patients with coronary heart disease (CHD). An additional aim was to examine whether an app with additional features improved adherence further.

Patients with CHD (n=163) were randomised to one of three groups: (1) usual care, (2) a basic app or (3) an advanced app with interactive/customisable features. The primary analysis compared usual care versus app use on the primary outcome of the 8-item Morisky Medication Adherence Scale (MMAS-8) at 3 months. Secondary outcomes included blood pressure and cholesterol levels.

The mean age was 57.9 years and 87.7% were male. At 3 months, patients using an app had higher adherence (mean MMAS-8 score 7.11) compared with the usual care group (mean MMAS-8 score 6.63) with a mean difference between groups of 0.47 (95% CI 0.12 to 0.82, p=0.008). There was no significant difference in patients using the basic app versus the advanced app (mean difference -0.16, 95% CI -0.56 to 0.24, p=0.428). There were no significant differences in secondary clinical outcome measures.

Patients with CHD who used medication reminder apps had better medication adherence compared with usual care, and using apps with additional features did not improve this outcome further. These data suggest medication apps are likely to help patients with chronic health conditions adhere to medicines, but further examination of whether such benefits are sustained is warranted.

ACTRN12616000661471; Results.

Text messaging support for patients with diabetes or coronary artery disease (SupportMe): protocol for a pragmatic randomised controlled trial.

Abstract:
Low-cost interventions providing self-management support are needed for people with coronary artery disease (CAD) and diabetes. Mobile phone text messaging provides a potential vehicle for this. The SupportMe Trial aims to assess the feasibility of embedding a text messaging programme into routine clinical practice and will determine if this improves cardiovascular risk factor and diabetes control among patients with CAD or type 2 diabetes.

SupportMe is a randomised controlled trial to be conducted within the framework of a health district-wide integrated care programme for people with CAD or type 2 diabetes mellitus. One thousand subjects will be recruited, with at least 500 in each group. Intervention subjects will receive four text messages a week for 6 months, which provide advice, motivation, information and support for disease management and healthy behaviour. The primary outcome is systolic blood pressure at 6 months. Secondary outcomes include body mass index, waist circumference, low-density lipoprotein cholesterol, physical activity levels, dietary intake, quality of life, mood and smoking cessation, and for subjects with diabetes, glycosylated haemoglobin and fasting serum glucose. A process and economic evaluation will also be conducted.

The study has been approved by the Western Sydney Local Health District Human Research Ethics Committee (AU RED HREC/16/WMEAD/331). Results will be disseminated via the scientific forums including peer-reviewed publications and presentations at national and international conferences.

ACTRN12616001689460.

The effect of text message reminders on medication adherence among patients with coronary heart disease: A systematic review and meta-analysis.

Abstract:
To determine the effectiveness of text message reminders (TMR) on medication adherence (MA) and to investigate the effects of TMR on clinical outcomes.

The PubMed, Cochrane library, EMbase, and China Biology Medicine databases were searched for randomized-controlled trials with TMR as the intervention for patients with coronary heart disease. Two reviewers independently extracted data and assessed the risk of bias. Meta-analysis was conducted using Stata 15.0 software.

In total, 1678 patients in 6 trials were included. Compared with the control group, the MA was 2.85 times greater among the intervention group (RR [relative risk] 2.85; 95% confidence interval [CI] 1.07-7.58). TMR reduced systolic blood pressure (BP) (weighted mean difference) = -6.51; 95% CI -9.79 to -3.23), cholesterol (standard mean difference = -0.26; 95% CI -0.4 to -0.12) and increased the number of patients with BP <140/90 mm Hg (RR 1.39; 95% CI 1.26-1.54).

TMR significantly promoted MA and reduced systolic BP, cholesterol level, and body mass index, but had no effect on mortality, diastolic BP, or lipoproteins. However, substantial heterogeneity existed in our analyses.


Context: Active case finding (ACF) refers to the systematic identification of people with tuberculosis in communities and amongst populations who do not present to health facilities, through approaches such as door-to-door screening or contact tracing. ACF may improve access to tuberculosis diagnosis and treatment for the poor and for people remote from diagnostic and treatment facilities. As a result, ACF may also reduce onward transmission. However, there is a need to understand how these programmes are experienced by communities in order to design appropriate services.

To synthesize community views on tuberculosis active case finding (ACF) programmes in low- and middle-income countries.

This review synthesized qualitative research and mixed-methods studies with separate qualitative data. Eligible studies explored community experiences, perceptions, or attitudes towards ACF programmes for tuberculosis in any endemic low- or middle-income country, with no time restrictions.

Knowledge, attitudes and practice concerning tuberculosis in a growing industrialised area in Myanmar.

Abstract:
Factories in industrial zones in Yangon, Myanmar, one of the 22 high tuberculosis (TB) burden countries.

To assess workers' knowledge about TB, their health-seeking behaviour, acceptability of TB screening and predictors for approval of the dismissal of TB patients.

In a cross-sectional survey, structured interviews with 349 factory workers were followed by 27 in-depth interviews and two focus group discussions with employers.

Among 349 workers, 95% perceived TB as being curable, 50% correctly reported air as the main mode of transmission  and 68% were aware of free treatment. Although 88% perceived screening before employment as necessary, only 14% underwent screening; 96% were willing to undergo contact screening for TB, but only 55% could afford it; 33% agreed with the dismissal of workers with TB, which was associated with  lower education, shorter time in employment, not having a history of TB contact and unwillingness to work with an index TB case due to fear and lack of knowledge.

More effective communication strategies towards factory workers are needed to increase workers' knowledge about  transmission and reduce stigma. Employers should be sensitised to protect employees with TB and invest in preventive activities.

Tuberculosis case finding: evaluation of a paper slip method to trace contacts.

Abstract:
South Africa has the third highest tuberculosis (TB) burden in the world. Intensified case finding, recommended by WHO, is one way to control TB.

To evaluate the effectiveness and acceptability of a paper slip method for TB contact tracing.

TB patients were offered paper slips to give to their contacts, inviting them for TB screening. The number of contacts screened and the proportion diagnosed with TB was calculated. Contacts that returned to the clinic after receiving the slips were interviewed. A focus group discussion (FGD) with TB patients was held to determine their acceptability.

From 718 paper slips issued, a 26% TB contact tracing rate was found, with a 12% case detection rate. The majority (68%) of contacts were screened within 2 weeks of receiving the slip. Age and gender were not significantly associated with time to screening. 16% of the contacts screened did not reside with the TB patients. 98% of the contacts said the method was acceptable. FGD findings show that this method is acceptable and may prevent stigma associated with TB/HIV.

This simple, inexpensive method yields high contact tracing and case detection rates and potentially would yield additional benefits outside households.

Patient and community experiences of tuberculosis diagnosis and care within a community-based intervention in Ethiopia: a qualitative study.

Abstract:
The Ethiopian TB control programme relies on passive case finding of TB cases. The predominantly rural-based population in Ethiopia has limited access to health facilities creating barriers to TB services. An intervention package aimed to bring TB diagnosis and treatment services closer to communities has been implemented through partnership with health extension workers (HEWs). They undertook advocacy, communication and social mobilization (ACSM) activities, identified symptomatic individuals, collected sputum, prepared smears and fixed slides at community level. Field supervisors supported HEWs by delivering smeared slides to the laboratory, feeding back results to the HEWs and following up smear-negative cases. Patients diagnosed with TB initiated treatment in the community, they were supported by supervisors and HEWs through the local health post. Case notification increased from 64 to 127/100,000 population/year.

This qualitative study assessed community members' treatment seeking behaviour and their perceptions of the intervention. In-depth interviews (n=36) were undertaken with participants in six districts. Participants were clients of the community-based intervention, currently on TB treatment or those screened negative for TB. Transcripts were translated to English and a thematic analytical framework was developed guided by the different steps symptomatic individuals take within the intervention package. Coding was done and queries run using NVivo software.

Prior to the intervention many patients with chronic cough did not access TB services. Participants described difficulties they faced in accessing district level health facilities that required travel outside their communities. Giving sputum samples and receiving results from within their home communities was appreciated by all participants. The intervention had a high level of acceptability; particularly clear benefits emerged for poor women and men and those too weak to travel. Some participants appeared to prefer a diagnosis of TB, this is likely because receiving a negative smear microscopy result brought further uncertainty and necessitated seeking further investigation.

There is evidence rural populations with high levels of poverty, and in particular women, are at high risk of unmet health needs and undiagnosed TB. Embedding TB services within communities was an acceptable approach for vulnerable groups experiencing poor access to health facilities. In the Ethiopian context this approach can facilitate early diagnosis and improve treatment outcomes.

Challenges from Tuberculosis Diagnosis to Care in Community-Based Active Case Finding among the Urban Poor in Cambodia: A Mixed-Methods Study.

Abstract:
While community-based active case finding (ACF) for tuberculosis (TB) holds promise for increasing early case detection among hard-to-reach populations, limited data exist on the acceptability of active screening. We aimed to identify barriers and explore facilitators on the pathway from diagnosis to care among TB patients and health providers.

Mixed-methods study. We administered a survey questionnaire to, and performed in-depth interviews with, TB patients identified through ACF from poor urban settlements in Phnom Penh, Cambodia. Additionally, we conducted focus group discussions and in-depth interviews with community and public health providers involved in ACF, respectively.

Acceptance of home TB screening was strong among key stakeholders due to perceived reductions in access barriers and in direct and indirect patient costs. Privacy and stigma were not an issue. To build trust and facilitate communication, the participation of community representatives alongside health workers was preferred. Most health providers saw ACF as complementary to existing TB services; however, additional workload as a result of ACF was perceived as straining operating capacity at public sector sites. Proximity to a health facility and disease severity were the strongest determinants of prompt care-seeking. The main reasons reported for delays in treatment-seeking were non-acceptance of diagnosis, high indirect costs related to lost income/productivity and transportation expenses, and anticipated side-effects from TB drugs.

TB patients and health providers considered home-based ACF complementary to facility-based TB screening. Strong engagement with community representatives was believed critical in gaining access to high risk communities. The main barriers to prompt treatment uptake in ACF were refusal of diagnosis, high indirect costs, and anticipated treatment side-effects. A patient-centred approach and community involvement were essential in mitigating barriers to care in marginalised communities.

Barriers to the diagnosis of childhood tuberculosis: a qualitative study.

Abstract:
In 2012, Peru's National Tuberculosis Program (NTP) reported that children aged 0-14 years accounted for 7.9% of the country's tuberculosis (TB) incidence. This figure is likely an underestimate due to suboptimal diagnosis of childhood TB.

To identify barriers to childhood TB diagnosis in Lima, Peru.

Using semi-structured guides, moderators conducted in-depth interviews with four NTP administrators and five pulmonologists specializing in TB and 10 focus groups with 53 primary care providers, community health workers (CHWs), and parents and/or guardians of pediatric TB patients. Two authors independently performed inductive thematic analysis and identified emerging themes.

Participants identified five barriers to childhood TB diagnosis: ignorance and stigma among the community, insufficient contact investigation, limited access to diagnostic tests, inadequately trained health center staff, and provider shortages.

Recent efforts to increase childhood TB detection have centered on the development of new technologies. However, our findings demonstrate that many diagnostic barriers are rooted in socio-economic and health system problems. Potential solutions include implementing multimedia campaigns and community education to reduce ignorance and stigma, prioritizing contact investigation for high-risk households, and training primary care providers and CHWs to recognize and evaluate childhood TB.

Barriers to tuberculosis care: a qualitative study among Somali pastoralists in Ethiopia.

Abstract:
At the dawn of the third millennium, while the control of the second biggest infectious killer in the world (tuberculosis [TB]) is an international priority, millions of pastoralist communities in the Horn of Africa are struggling to access TB care. Prompt diagnosis and treatment of pastoralist TB patients remain to be a challenge in TB control programs in many countries in this region, where pastoralism is a common means of livelihood. Better understanding of community perceptions of TB and its management could help identify reasons for the delay in diagnosis of TB among pastoral communities. The aim of this study is to explore barriers delaying diagnosis among pastoralist TB patients in the Somali Regional State (SRS) of Ethiopia.

A qualitative study, including 19 respondents was conducted in the SRS of Ethiopia. Participatory Rural Appraisal (PRA) and informal interview techniques were employed to explore pastoralists' migration patterns, their perceptions of TB and their access to TB services. The influence of these factors on the delay of TB patients in receiving biomedical diagnosis was then assessed.

We found that lack of access to formal health services as well as traditional beliefs leading to self treatment were barriers to prompt bio-medical diagnosis of TB among pastoralist TB patients in the SRS of Ethiopia. This study highlights that limited access to TB control programs is the most important barrier in early seeking of biomedical diagnosis of TB among pastoral communities with nomadic pastoralist being the most affected.

Diagnostic and treatment facilities should be established in strategic villages that pastoralist can reach in both dry and wet seasons. Such facilities may alleviate the observed long distance to health facilities and thus long delay in diagnosis of TB. This strategy should be compounded with a community based TB control approach, whereby basic medical training on TB management such as provision of health education, drug distribution and observations is provided to local traditional healers and religious leaders. This approach may improve pastoralists' perceptions of TB, hence eliminating the observed traditional believes associated with TB in pastoralists' context of the SRS.

Comparison of two active case-finding strategies for community-based diagnosis of symptomatic smear-positive tuberculosis and control of infectious tuberculosis in Harare, Zimbabwe (DETECTB): a cluster-randomised trial.

Abstract:
Control of tuberculosis in settings with high HIV prevalence is a pressing public health priority. We tested two active case-finding strategies to target long periods of infectiousness before diagnosis, which is typical of HIV-negative tuberculosis and is a key driver of transmission.

Clusters of neighbourhoods in the high-density residential suburbs of Harare, Zimbabwe, were randomised to receive six rounds of active case finding at 6-monthly intervals by either mobile van or door-to-door visits. Randomisation was done by selection of discs of two colours from an opaque bag, with one disc to represent every cluster, and one colour allocated to each intervention group before selection began. In both groups, adult (≥16 years) residents volunteering chronic cough (≥2 weeks) had two sputum specimens collected for fluorescence microscopy. Community health workers and cluster residents were not masked to intervention allocation, but investigators and laboratory staff were masked to allocation until final analysis. The primary outcome was the cumulative yield of smear-positive tuberculosis per 1000 adult residents, compared between intervention groups; analysis was by intention to treat. The secondary outcome was change in prevalence of culture-positive tuberculosis from before intervention to before round six of intervention in 12% of randomly selected households from the two intervention groups combined; analysis was based on participants who provided sputum in the two prevalence surveys. This trial is registered, number ISRCTN84352452.

46 study clusters were identified and randomly allocated equally between intervention groups, with 55 741 adults in the mobile van group and 54,691 in the door-to-door group at baseline. HIV prevalence was 21% (1916/9060) and in the 6 months before intervention the smear-positive case notification rate was 2·8 per 1000 adults per year. The trial was completed as planned with no adverse events. The mobile van detected 255 smear-positive patients from 5466 participants submitting sputum compared with 137 of 4711 participants identified through door-to-door visits (adjusted risk ratio 1·48, 95% CI 1·11-1·96, p=0·0087). The overall prevalence of culture-positive tuberculosis declined from 6·5 per 1000 adults (95% CI 5·1-8·3) to 3·7 per 1000 adults (2·6-5·0; adjusted risk ratio 0·59, 95% CI 0·40-0·89, p=0·0112).

Wide implementation of active case finding, particularly with a mobile van approach, could have rapid effects on tuberculosis transmission and disease.

Wellcome Trust.

Evaluation of active tuberculosis case finding through symptom screening and sputum microscopy of close contacts in Shandong, China.

Abstract:
To evaluate the effect of active case finding through symptom screening and sputum microscopy of close contacts in a Fidelis (Fund for Innovative DOTS Expansion through Local Initiatives to Stop TB) project.

Secondary data from all 35 counties were collected during implementation and used. They comprised new cases identified, number of close contacts screened and their relationships. Fifty-four in-depth interviews were conducted with staff from key stakeholders.

A total of 13 310 symptomatic contacts of 5255 index cases were screened, and 90 new smear-positive cases were detected with a yield rate of 0.7%. The yield rate of close contacts was positively associated with smear grades of the index cases (P<0.01). Close contacts of cases, such as classmates and workmates, who lived in a closed contained setting, had a higher yield rate than family members (P<0.001). Gaps in project implementation such as training, incentives and sputum collection were identified through in-depth interviews.

The yield rate of close-contact screening of 0.7% was similar to other findings in China. There was a higher yield from screening of close contacts in congregated settings like schools and workshops. Future active case finding projects should provide clear operational guidelines and adequate training.

Model alternative strategies for tuberculosis and Human immune deficiency virus case-finding in hard-to-reach populations in rural Eastern Nigeria.

Abstract:
Since roughly half of all cases of active tuberculosis (TB) and Human immune deficiency virus (HIV) infection currently go undetected, there is a compelling need to pursue research aimed at improving case-finding, particularly among hard-to-reach populations.

To identify and simplify TB/HIV case finding in Eastern Nigeria.

This study involved an extensive pre-intervention Knowledge, Aptitude, Behavioural, Practice (KABP) Survey which revealed the specific limitations to TB/HIV case-finding using semi-structured questionnaires, key informant interviews and focus group discussions. The second component investigated the role of existing strategies and resources in the study area, and identified ways of optimizing these strategies and also provided alternative strategies. The third phase evaluated the performance of the different strategies and the most effective methods of optimizing their use.

The pre- intervention KABP Survey showed that the majority of the population could ill afford the costs imposed by delays in TB/HIV diagnosis and treatment. Most of the patients dropped out completely at any stage on the path to successful treatment due to several reasons. Working at motor parks, accepted stop points and several other ways were found as effective methods of reaching the hard-to-reach population.

Findings from this study can be used for designing appropriate TB/HIV management and case- finding training materials for the training and use of TB/HIV health workers as well as providing information on TB/HIV case finding for National policy. Thorough consideration of the findings and subsequent implementation of them are highly recommended.

High levels of vulnerability and anticipated stigma reduce the impetus for tuberculosis diagnosis in Cape Town, South Africa.

Abstract: Prolonged diagnostic and treatment delays, particularly in settings experiencing concomitant human immunodeficiency virus (HIV) and tuberculosis (TB) epidemics, undermine global TB control efforts. Current TB control policy in South Africa, as organized through the National TB Control Programme (NTP), relies on the voluntary presentation of TB suspects to local clinics for diagnosis, i.e. passive case finding (PCF). In 2005 a participatory study suggested that popular interpretation and perception of TB within eight South African township sites in and around Cape Town, all carrying a high burden of HIV and undiagnosed TB, undermine PCF. Both people's association of TB with dirt and squalor, and the anticipation of HIV-related stigma, combine to impede TB diagnosis. Respondents conveyed TB as unavoidable; this perception is expressed in the context of vulnerability where so much-including dirt-is largely beyond the control of local residents. The lack of control has a disempowering effect, reducing the drive for seeking treatment. In addition, low confidence in patient confidentiality and anticipated HIV-related stigma act as direct deterrents to TB diagnosis and treatment. In conclusion, we wish to draw attention to high levels of disease stigma and vulnerability, and how these undermine PCF. Public health interventions that wish to improve case detection should aim to: (1) emphasize how early treatment improves outcome and can curb ongoing transmission; (2) combat a sense of communal vulnerability to TB; (3) address anticipated HIV-TB stigma; and (4) improve the quality of care provided at local diagnostic services, addressing low levels of patient confidentiality.


Context: People with cancer are 1.4 times more likely to be unemployed than people without a cancer diagnosis. Therefore, it is important to investigate whether programmes to enhance the return-to-work (RTW) process for people who have been diagnosed with cancer are effective. This is an update of a Cochrane review first published in 2011 and updated in 2015.

To evaluate the effectiveness of non-medical interventions aimed at enhancing return to work (RTW) in people with cancer compared to alternative programmes including usual care or no intervention.

We included randomised controlled trials (RCTs) and cluster-RCTs on the effectiveness of psycho-educational, vocational, physical or multidisciplinary interventions enhancing RTW in people with cancer. The primary outcome was RTW measured as either RTW rate or sick leave duration measured at 12 months' follow-up. The secondary outcome was quality of life (QoL).

Improving quality of life in men with prostate cancer: a randomized controlled trial of group education interventions.

Abstract: Men who were recently treated for prostate cancer (N=250) were randomly assigned to a control group, a group education intervention (GE), or a group education-plus-discussion intervention (GED). Both GE and GED increased prostate cancer knowledge. In the year postintervention, men in the GED condition were less bothered by sexual problems than men in the control condition, and they were more likely to remain steadily employed (93.0%) than men in the GE (75.6%) or control (72.5%) conditions. Among noncollege graduates, GED and GE resulted in better physical functioning than the control condition, and GED resulted in more positive health behaviors than the control or GE condition. Among college graduates, controls were comparable with the GE and GED groups in physical functioning and positive health behaviors.

Preoperative biofeedback assisted behavioral training to decrease post-prostatectomy incontinence: a randomized, controlled trial.

Abstract:
We tested the effectiveness of preoperative biofeedback assisted behavioral training for decreasing the duration and severity of incontinence, and improving quality of life in the 6 months following radical prostatectomy.

We performed a prospective, randomized, controlled trial comparing preoperative behavioral training to usual care. The volunteer sample included 125 men 53 to 68 years old who elected radical prostatectomy for prostate cancer. Patients were stratified according to age and tumor differentiation, and randomized to 1 preoperative session of biofeedback assisted behavioral training plus daily home exercise or a usual care control condition, consisting of simple postoperative instructions to interrupt the urinary stream. The main outcome measurements were duration of incontinence (time to continence), as derived from bladder diaries, incontinence severity (the proportion with severe/continual leakage), pad use, Incontinence Impact Questionnaire, psychological distress (Hopkins Symptom Checklist) and health related quality of life (Medical Outcomes Study Short Form Health Survey).

Preoperative behavioral training significantly decreased time to continence (p = 0.03) and the proportion of patients with severe/continual leakage at the 6-month end point (5.9% vs 19.6%, p = 0.04). There were also significant differences between the groups for self-reported urine loss with coughing (22.0% vs 51.1%, p = 0.003), sneezing (26.0% vs 48.9%, p = 0.02) and getting up from lying down (14.0% vs 31.9%, p = 0.04). No differences were found on return to work and usual activities or quality of life measures.

Preoperative behavioral training can hasten the recovery of urine control and decrease the severity of incontinence following radical prostatectomy.

Is education an effective management strategy for reducing cancer-related fatigue?

Abstract:
The use of education is recommended to teach patients self-care behaviours to reduce cancer-related fatigue, however, there is little evidence of its effectiveness or optimal timing. This educationally based cancer-related fatigue intervention trial, CAN-FIT, aimed to reduced severity of fatigue in radiotherapy patients.

One hundred and ten participants aged≥18 years undergoing curative radiotherapy were randomly assigned to receive (1) pre- and post-radiotherapy fatigue education and support (RFES); (2) pre-RFES only; (3) post-RFES only; or (4) no RFES (standard care). Data collection occurred at pre- and post- radiotherapy and at 6-weeks follow-up.

The intervention was not associated with reduction in fatigue levels at any assessment point. Significant changes were seen with secondary activity-based outcomes: Physical activity participation: Pre-RFES was associated with significantly greater increase in vigorous [Assessment (Ax)1-Ax2: 1.05 (0.24, 1.86) p<0.01: Ax2-Ax3: 1.24, (0.44, 2.03) p<0.01] and moderate physical activity participation [Ax1-Ax2: 1.4 (0.53, 2.26) p<0.01]. Post-RFES was associated with significant improvements in walking levels [Ax1-Ax3: 5.82 (0.07, 11.56) p<0.05] compared with no pre-RFES. Paid and unpaid employment: Pre-RFES was associated with slower return to pre-treatment levels of paid work [Ax2-Ax3: -0.72 (-1.41, -0.04) p<0.05] than no pre-RFES. Post-RFES was associated with decreased levels of unpaid work [Ax1-Ax3: 561.79 (51.21, 1,072.37) p<0.05] compared with no post-RFES.

The CAN-FIT programme did not significantly improve the primary outcome, level of fatigue, regardless of when it was delivered, however, significant changes were observed in activity-based outcomes. Further investigations into educationally based programmes should target activity participation rather than changes in underlying fatigue to improve overall patient health.

Effectiveness of a hospital-based work support intervention for female cancer patients - a multi-centre randomised controlled trial.

Abstract:
One key aspect of cancer survivorship is return-to-work. Unfortunately, many cancer survivors face problems upon their return-to-work. For that reason, we developed a hospital-based work support intervention aimed at enhancing return-to-work. We studied effectiveness of the intervention compared to usual care for female cancer patients in a multi-centre randomised controlled trial.

Breast and gynaecological cancer patients who were treated with curative intent and had paid work were randomised to the intervention group (n = 65) or control group (n = 68). The intervention involved patient education and support at the hospital and improvement of communication between treating and occupational physicians. In addition, we asked patient's occupational physician to organise a meeting with the patient and the supervisor to make a concrete gradual return-to-work plan. Outcomes at 12 months of follow-up included rate and time until return-to-work (full or partial), quality of life, work ability, work functioning, and lost productivity costs. Time until return-to-work was analyzed with Kaplan-Meier survival analysis.

Return-to-work rates were 86% and 83% (p = 0.6) for the intervention group and control group when excluding 8 patients who died or with a life expectancy of months at follow-up. Median time from initial sick leave to partial return-to-work was 194 days (range 14-435) versus 192 days (range 82-465) (p = 0.90) with a hazard ratio of 1.03 (95% CI 0.64-1.6). Quality of life and work ability improved statistically over time but did not differ statistically between groups. Work functioning and costs did not differ statistically between groups.

The intervention was easily implemented into usual psycho-oncological care and showed high return-to-work rates. We failed to show any differences between groups on return-to-work outcomes and quality of life scores. Further research is needed to study which aspects of the intervention are useful and which elements need improvement.

Nederlands Trial Register (NTR) 1658.

Case management vocational rehabilitation for women with breast cancer after surgery: a feasibility study incorporating a pilot randomised controlled trial.

Abstract:
There is a paucity of methodologically robust vocational rehabilitation (VR) intervention trials. This study assessed the feasibility and acceptability of a VR trial of women with breast cancer to inform the development of a larger interventional study.

Women were recruited in Scotland and randomised to either a case management VR service or to usual care. Data were collected on eligibility, recruitment and attrition rates to assess trial feasibility, and interviews conducted to determine trial acceptability. Sick leave days (primary outcome) were self-reported via postal questionnaire every 4 weeks during the first 6 months post-surgery and at 12 months. Secondary outcome measures were change in employment pattern, quality of life and fatigue.

Of the 1,114 women assessed for eligibility, 163 (15%) were eligible. The main reason for ineligibility was age (>65 years, n = 637, 67%). Of those eligible, 111 (68%) received study information, of which 23 (21%) consented to participate in the study. Data for 18 (78%) women were analysed (intervention: n = 7; control: n = 11). Participants in the intervention group reported, on average, 53 fewer days of sick leave over the first 6 months post-surgery than those in the control group; however, this difference was not statistically significant (p = 0.122; 95% confidence interval -15.8, 122.0). No statistically significant differences were found for secondary outcomes. Interviews with trial participants indicated that trial procedures, including recruitment, randomisation and research instruments, were acceptable.

Conducting a pragmatic trial of effectiveness of a VR intervention among cancer survivors is both feasible and acceptable, but more research about the exact components of a VR intervention and choice of outcomes to measure effectiveness is required. VR to assist breast cancer patients in the return to work process is an important component of cancer survivorship plans.

ISRCTN29666484.

Effect of Low-Intensity Physical Activity and Moderate- to High-Intensity Physical Exercise During Adjuvant Chemotherapy on Physical Fitness, Fatigue, and Chemotherapy Completion Rates: Results of the PACES Randomized Clinical Trial.

Abstract:
We evaluated the effectiveness of a low-intensity, home-based physical activity program (Onco-Move) and a moderate- to high-intensity, combined supervised resistance and aerobic exercise program (OnTrack) versus usual care (UC) in maintaining or enhancing physical fitness, minimizing fatigue, enhancing health-related quality of life, and optimizing chemotherapy completion rates in patients undergoing adjuvant chemotherapy for breast cancer.

We randomly assigned patients who were scheduled to undergo adjuvant chemotherapy (N = 230) to Onco-Move, OnTrack, or UC. Performance-based and self-reported outcomes were assessed before random assignment, at the end of chemotherapy, and at the 6-month follow-up. We used generalized estimating equations to compare the groups over time.

Onco-Move and OnTrack resulted in less decline in cardiorespiratory fitness (P < .001), better physical functioning (P ≤ .001), less nausea and vomiting (P = .029 and .031, respectively) and less pain (P = .003 and .011, respectively) compared with UC. OnTrack also resulted in better outcomes for muscle strength (P = .002) and physical fatigue (P < .001). At the 6-month follow-up, most outcomes returned to baseline levels for all three groups. A smaller percentage of participants in OnTrack required chemotherapy dose adjustments than those in the UC or Onco-Move groups (P = .002). Both intervention groups returned earlier (P = .012), as well as for more hours per week (P = .014), to work than the control group.

A supervised, moderate- to high-intensity, combined resistance and aerobic exercise program is most effective for patients with breast cancer undergoing adjuvant chemotherapy. A home-based, low-intensity physical activity program represents a viable alternative for women who are unable or unwilling to follow the higher intensity program.

[Effects of a Phone-Based Follow-Up Care After Inpatient Rehabilitation for Breast Cancer Patients - A Randomized Controlled Trial].

EMLA reduces acute and chronic pain after breast surgery for cancer.

Abstract:
A significant percentage of women undergoing breast surgery for cancer may develop neuropathic pain in the chest, and/or ipsilateral axilla and/or upper medial arm, with impairment in performing daily occupational activities. We designed this study to determine if the perioperative application of EMLA (eutectic mixture of local anesthetics; AstraZeneca) cream in the breast and axilla area reduces analgesic requirements, as well as the acute and chronic pain after breast surgery.

Forty-six female patients scheduled for breast surgery received randomly 5 g of EMLA or placebo on the sternal area 5 minutes before surgery, and 15 g on the supraclavicular area and axilla at the end of the operation. Treatment with EMLA cream (20 g) or placebo was also applied daily on the 4 days after surgery. In the postanesthesia care unit (PACU), 3, 6, 9, and 24 hours after surgery, and on the second to sixth day postoperatively, pain was assessed by visual analogue scale (VAS) at rest and after movement, and postoperative analgesic requirements were recorded. Three months later, patients were asked if they had pain in the chest wall, axilla and/or medial upper arm, decreased sensation, if they required analgesics at home, and for the intensity of pain.

Acute pain at rest and with movement did not differ between the EMLA and control groups, and the analgesics consumed during the first 24 hours were the same for the EMLA and control groups. However, time to the first analgesia requirement was longer (P = .04), and codeine and paracetamol consumption during the second to fifth days was less (P = .001, and P = .004, respectively) in the EMLA versus the control group. Three months postoperatively, pain in the chest wall, axilla, and the total incidence and the intensity of chronic pain were significantly less in the EMLA versus the control group (P = .004, P = .025, P = .002 and P = .003, respectively). The use of analgesics at home and abnormal sensations did not differ between the 2 groups.

The application of EMLA to patients undergoing breast surgery for cancer reduced the postoperative analgesic requirements and the incidence and intensity of chronic pain.

Sentinel lymph node biopsy results in less postoperative morbidity compared with axillary lymph node dissection for breast cancer.

Abstract:
This study was designed to compare the postoperative morbidity and socioeconomic impact of sentinel lymph node biopsy (SLNB) with axillary lymph node dissection (ALND) in patients with early stage breast cancer.

A prospective, nonrandomized, controlled study was designed to include patients who underwent breast conservation surgery and SLNB +/- ALND. Group A consisted of patients who had a negative SLNB and did not go on to completion ALND. Group B consisted of patients who underwent a SLNB followed by a completion ALND because either (1) their sentinel node contained cancer or (2) they were within the validation phase of our institution's sentinel lymph node protocol. Patients were evaluated with a questionnaire and underwent a standardized physical examination to determine arm circumference.

Data were obtained from 96 patients with a mean follow-up period of 15 months (range 8 to 29). Significant differences were seen in subjective measurements of arm complaints and arm numbness (P <0.001), with fewer complaints reported in group A. The difference in mid-bicep and antecubital fossa circumferences was significant when comparing the ratio of the procedure arm with the nonprocedure arm and when subtracting the nonprocedure arm from the procedure arm (P <0.003 and P <0.016, respectively) in favor of group A. Axillary surgery was performed as an outpatient procedure in 88% of group A patients, compared with 15% in group B (P <0.001). Furthermore, 71% of group A patients returned to "normal activity" in less than 4 days, in comparison with 7% of group B (P <0.001).

SLNB results in less postoperative morbidity in terms of subjective arm complaints and mid-arm swelling. Expeditious return to work or normal activity after SLNB has potentially significant socioeconomic consequences.

"Between men": patient perceptions and priorities in a rehabilitation program for men with prostate cancer.

Abstract: The objective of the study is to compare consumer aspects of an informative, a physical, and a combined informative and physical rehabilitation program included in the "Between men" project for newly diagnosed prostate cancer patients. A consecutive series of patients was randomized. Programs were especially developed for prostate cancer patients. The format was 7 weekly sessions. The results show that the perceived benefits of relaxation was greater in the combination group than in the physical training group only. In comparison with the physical group more patients in the informative groups (information and information+physical training) rated the knowledge received as very important. The majority of patients (90%) was of the opinion that the "Between men" programs, should be continued. Independent of the actual program given, patients opted for the combination program or information alone but not the physical training alone program.


Context: Admission avoidance hospital at home provides active treatment by healthcare professionals in the patient's home for a condition that would otherwise require acute hospital inpatient care, and always for a limited time period. This is the fourth update of this review.

To determine the effectiveness and cost of managing patients with admission avoidance hospital at home compared with inpatient hospital care.

Randomised controlled trials recruiting participants aged 18 years and over. Studies comparing admission avoidance hospital at home with acute hospital inpatient care.

Hospital in the home: a randomised controlled trial.

Abstract:
To compare treatment of acute illness at home and in hospital, assessing safety, effect on geriatric complications, and patient/carer satisfaction.

Randomised controlled trial.

A tertiary referral hospital affiliated with the University of New South Wales.

100 patients (69% older than 65 years) with a variety of acute conditions, who were assessed in the emergency department as requiring admission to hospital.

Patients were allocated at random to be treated by a hospital-in-the-home (HIH) service in their usual residence or to be admitted to hospital.

Geriatric complications (confusion, falls, urinary incontinence or retention, faecal incontinence or constipation, phlebitis and pressure areas), patient/carer satisfaction, adverse events, and death.

There was a lower incidence of confusion (0 v. 20.4% [95% CI, 9.1%-31.7%]; P = 0.0005), urinary complications (incontinence or retention) (2.0% [95% CI, -1.8%, 5.8%] v. 16.3% [95% CI, 6.0%, 26.6%]; P = 0.01), and bowel complications (incontinence or constipation) (0 v. 22.5% [95% CI, 10.7%, 34.1%]; P = 0.0003) among HIH-treated patients. No significant difference in number of adverse events and deaths (to 28 days after discharge) in the two groups was found (although numbers were small). Patient and carer satisfaction was significantly higher in the HIH group.

Home treatment appears to provide a safe alternative to hospitalisation for selected patients, and may be preferable for some older patients. We found high levels of both patient and carer satisfaction with home treatment.

Randomised controlled trial of effectiveness of Leicester hospital at home scheme compared with hospital care.

Abstract:
To compare effectiveness of patient care in hospital at home scheme with hospital care.

Pragmatic randomised controlled trial.

Leicester hospital at home scheme and the city's three acute hospitals.

199 consecutive patients referred to hospital at home by their general practitioner and assessed as being suitable for admission. Six of 102 patients randomised to hospital at home refused admission, as did 23 of 97 allocated to hospital.

Hospital at home or hospital inpatient care.

Mortality and change in health status (Barthel index, sickness impact profile 68, EuroQol, Philadelphia geriatric morale scale) assessed at 2 weeks and 3 months after randomisation. The main process measures were service inputs, discharge destination, readmission rates, length of initial stay, and total days of care.

Hospital at home group and hospital group showed no significant differences in health status (median scores on sickness impact profile 68 were 29 and 30 respectively at 2 weeks, and 24 and 26 at 3 months) or in dependency (Barthel scores 15 and 14 at 2 weeks and 16 for both groups at 3 months). At 3 months' follow up, 26 (25%) of hospital at home group had died compared with 30 (31%) of hospital group (relative risk 0. 82 (95% confidence interval 0.52 to 1.28)). Hospital at home group required fewer days of treatment than hospital group, both in terms of initial stay (median 8 days v 14.5 days, P=0.026) and total days of care at 3 months (median 9 days v 16 days, P=0.031).

Hospital at home scheme delivered care as effectively as hospital, with no clinically important differences in health status. Hospital at home resulted in significantly shorter lengths of stay, which did not lead to a higher rate of subsequent admission.

Economic evaluation of hospital at home versus hospital care: cost minimisation analysis of data from randomised controlled trial.

Abstract:
To compare the costs of admission to a hospital at home scheme with those of acute hospital admission.

Cost minimisation analysis within a pragmatic randomised controlled trial.

Hospital at home scheme in Leicester and the city's three acute hospitals.

199 consecutive patients assessed as being suitable for admission to hospital at home for acute care during the 18 month trial period (median age 84 years).

Hospital at home or hospital inpatient care.

Costs to NHS, social services, patients, and families during the initial episode of treatment and the three months after admission.

Mean (median) costs per episode (including any transfer from hospital at home to hospital) were similar when analysed by intention to treat-hospital at home 2569 pounds sterling (1655 pounds sterling), hospital ward 2881 pounds sterling (2031 pounds sterling), bootstrap mean difference -305 (95% confidence interval -1112 to 448). When analysis was restricted to those who accepted their allocated place of care, hospital at home was significantly cheaper-hospital at home 2557 pounds sterling(1710 pounds sterling), hospital ward 3660 pounds sterling (2903 pounds sterling), bootstrap mean difference -1071 (-1843 to -246). At three months the cost differences were sustained. Costs with all cases included were hospital at home 3671 pounds sterling (2491 pounds sterling), hospital ward 3877 pounds sterling (3405 pounds sterling), bootstrap mean difference -210 (-1025 to 635). When only those accepting allocated care were included the costs were hospital at home 3698 pounds sterling (2493 pounds sterling), hospital ward 4761 pounds sterling (3940 pounds sterling), bootstrap mean difference -1063 (-2044 to -163); P=0.009. About 25% of the costs for episodes of hospital at home were incurred through transfer to hospital. Costs per day of care were higher in the hospital at home arm (mean 207 pounds sterling v 134 pounds sterling in the hospital arm, excluding refusers, P<0.001).

Hospital at home can deliver care at similar or lower cost than an equivalent admission to an acute hospital.

Home or hospital? An evaluation of the costs, preferences, and outcomes of domiciliary chemotherapy.

Abstract: This study compares the costs and outcomes of domiciliary and hospital-based chemotherapy, using a prospective randomized cross-over design. Eighty-seven eligible patients were recruited from oncology services at two metropolitan hospitals in Sydney, Australia. Forty patients completed study evaluation requirements, having two months of chemotherapy in each location (home and hospital). The domiciliary service was staffed by hospital-based oncology nurses. Marginal costs of domiciliary treatment over hospital treatment were estimated from the health service perspective. Home-based care was more expensive, largely due to extra nurse time. About half of the eligible patients (n = 87) and 73 percent of the evaluated patients (n = 40) preferred domiciliary care. Most evaluated patients and their informal carers were satisfied with the medical care provided, regardless of location. Patient needs were well met in either location, and no differences were found in quality of life. At current throughput rates, providing chemotherapy in the home was more expensive than providing it in hospital. However, if the demand for chemotherapy were to exceed ward capacity by up to 50 percent, moving chemotherapy into the home could provide a less costly strategy for the expansion of a chemotherapy service without compromising patient outcomes.

The effectiveness of community-based rehabilitation for stroke patients who remain at home: a pilot randomized trial.

Abstract:
To assess the effectiveness of community-based rehabilitation for stroke patients who were not admitted to hospital in South London.

Randomized controlled trial.

Patients' homes in South London.

Stroke patients not admitted to hospital after a stroke.

Rehabilitation at home by rehabilitation team for up to three months or usual care.

The primary outcome measure was the Barthel score. Secondary measures included the Motricity Index, Rivermead ADL, Hospital Anxiety and Depression score and Nottingham Health Profile.

Forty-three patients who remained at home were randomized to rehabilitation team (23) or 'usual' care (20). The mean number of physiotherapy sessions was three (range 1-14) for the rehabilitation team group and two for the usual care group. Patients (with a deficit) in the rehabilitation arm of the trial were more likely to receive occupational, physical and speech therapy than those in the control arm (p = 0.03, 0.01 and 0.008, respectively). For those patients actually receiving therapy, there was no evidence that the amount received differed between the groups. However, the number of patients in each of these comparisons was very small. The outcome for patients in the rehabilitation team arm of the trial was nonsignificantly higher (0.05 < p < 0.2) than for those in the control arm for the areas of Nottingham Health Profile, anxiety, depression, caregiver strain and the proportion of patients living at home. Based on the data observed here, a trial with approximately 150 patients in each arm would be needed to have adequate power to detect a 33% difference between intervention and control groups in these outcomes.

Community therapy support for patients not admitted to hospital is feasible but to determine whether it is cost- or clinically effective would require trials of adequate size.

Myocardial infarction: a comparison between home and hospital care for patients.

Abstract: To compare the results of home and hospital treatment in men aged under 70 years who had suffered acute myocardial infarction within 48 hours 1895 patients were considered for study in four centres in south-west England. Four-hundred-and-fifty patients were randomly allocated to receive care either at home by their family doctor or in hospital, initially in an intensive care unit. The randomised treatment groups were similar in age, history of cardiovascular disease, and incidence of hypotension when first examined. They were followed up for up to a year after onset. The mortality rate at 28 days was 12% for the random home group and 14% for the random hospital group; the corresponding figures at 330 days were 20% and 27%. On average, older patients and those without initial hypotension fared rather better under home care. The patients who underwent randomisation were similar to those whose place of care was not randomised, except that the non-randomised group contained a higher proportion of initially hypotensive patients, whose prognosis was poor wherever treated. These results confirm and extend our preliminary findings. Home care is a proper form of treatment for many patients with acute myocardial infarction, particularly those over 60 years and those with an uncomplicated attack seen by general practitioners.

Initiation of home mechanical ventilation at home: a randomised controlled trial of efficacy, feasibility and costs.

Abstract:
Home mechanical ventilation (HMV) in the Netherlands is normally initiated in hospital, but this is expensive and often a burden for the patient. In this randomised controlled study we investigated whether initiation of HMV at home in patients with chronic respiratory failure is non-inferior to an in hospital based setting.

Seventy-seven patients were included, of which 38 patients started HMV at home. All patients were diagnosed with chronic respiratory failure due to a neuromuscular or thoracic cage disease. Primary outcome was the arterial carbon dioxide (PaCO2) while quality of life and costs were secondary outcomes. Telemonitoring was used in the home group to provide therapeutic information, for example; transcutaneous carbon dioxide, oxygen saturation and ventilator information, to the caregivers. Follow-up was six months.

PaCO2, improved by 0.72 (SE ± 0.16) kPa in the hospital group and by 0.91 (±0.20) in the home group, both improvements being significant and the latter clearly not inferior. There were also significant improvements in quality of life in both groups, again not being inferior with home treatment.

This study is the first to show that initiation of HMV at home in a selective group of patients with chronic respiratory failure is as effective for gas exchange and quality of life as hospital initiation. In addition we found that it is safe, technically feasible and that more than € 3000 per patient can be saved compared to our standard care.

Effectiveness of temporary positive expiratory pressure (T-PEP) at home and at hospital in patients with severe chronic obstructive pulmonary disease.

Abstract:
Temporary positive airway pressure (T-PEP) is a tool recently introduced in the treatment of chronic obstructive pulmonary disease (COPD) or bronchiectasis. It demonstrated encouraging results also in severe COPD patients. The aim of this study is verify if adding T-PEP to best bronchodilator therapy both in clinic and home administering could reduce disease exacerbations and improve lung function in patients with severe COPD.

A total of 142 patients with severe COPD (FEV1 <50%) were enrolled; 120 were randomized in three groups: a group treated with T-PEP at home, a group with T-PEP at hospital and a group with medical therapy only (control group). Number of acute exacerbations COPD (AECOPD) after 1 month and 3 months were the primary outcomes. Secondary outcomes were changes in respiratory function parameters (FVC, FEV1, TLC, RV), arterial blood gases, dyspnea and health status assessment scales (Modified Medical Research Council (MMRC), Breathlessness, Cough and Sputum scale (BCSS) and COPD Assessment Test (CAT). The time of daily use of the T-PEP was registered as well as its acceptance using a Likert scale.

Ninety-nine patients completed the study. Both the groups who used T-PEP showed a statistical lower number of AECOPD after 1 month and 3 months (P<0.01). Some respiratory functional parameters improved in the two groups treated with T-PEP (FVC, FEV1, RV) (P<0.02) and dyspnea and health status assessment scales (MMRC, BCSS, CAT) (P<0.04; P<0.01; P<0.009). The time of daily using was similar in the two T-PEP groups. Patients treated at home showed a greater acceptance than those treated at hospital (Likert scale 4.7

Patients treated with T-PEP showed a lower number of AECOPD. T-PEP improves functional respiratory parameters and improves dyspnea and health status assessment scales. No adherence difference in hospital and home treatment was found. Patients preferred home treatment.

Controlled trial of a home-care service for acute stroke patients.

Abstract: In a controlled trial of a home-care service available for the first 6 months after acute stroke, 440 patients received the new service and 417 patients were in the control group. The trial group used more hospital bed days, had a slightly higher admission rate, and did not show better emotional adjustment to stroke than the control group. There was no difference between the 2 groups in stress on relatives. Functional recovery was equal in the 2 groups. A quarter of patients managed at home in each group were severely disabled. Providing a new service does not necessarily alter clinical decisions in the short term, and care should be taken before expanding domiciliary services to reduce hospital use.

Home initiation of chronic non-invasive ventilation in COPD patients with chronic hypercapnic respiratory failure: a randomised controlled trial.

Abstract:
Chronic non-invasive ventilation (NIV) has become evidence-based care for stable hypercapnic COPD patients. While the number of patients increases, home initiation of NIV would greatly alleviate the healthcare burden. We hypothesise that home initiation of NIV with the use of telemedicine in stable hypercapnic COPD is non-inferior to in-hospital NIV initiation.

Sixty-seven stable hypercapnic COPD patients were randomised to initiation of NIV in the hospital or at home using telemedicine. Primary outcome was daytime arterial carbon dioxide pressure (PaCO

Home NIV initiation was non-inferior to in-hospital initiation (adjusted mean difference in PaCO

This is the first study showing that home initiation of chronic NIV in stable hypercapnic COPD patients, with the use of telemedicine, is non-inferior to in-hospital initiation, safe and reduces costs by over 50%.

NCT02652559.