Positive functioning as an outcome in its own right.
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776 to 800 of 6,178El-Jawahri A, LeBlanc TW, Kavanaugh A, Webb JA, Jackson VA, Campbell TC, O'Connor N, Luger SM, Gafford E, Gustin J, Bhatnagar B, Walker AR, Fathi AT, Brunner AM, Hobbs GS, Nicholson S, Davis D, Addis H, Vaughn D, Horick N, Greer JA, Temel JS (2021)randomised controlled trialMEDLINE-indexed journal, not yet read by usJAMA oncology151 citations Effectiveness of Integrated Palliative and Oncology Care for Patients With Acute Myeloid Leukemia: A Randomized Clinical Trial.
Importance: Patients with acute myeloid leukemia (AML) receiving intensive chemotherapy experience substantial decline in their quality of life (QOL) and mood during their hospitalization for induction chemotherapy and often receive aggressive care at the end of life (EOL). However, the role of specialty palliative care for improving the QOL and care for this population is currently unknown.
Objective: To assess the effect of integrated palliative and oncology care (IPC) on patient-reported and EOL outcomes in patients with AML.
Design, setting, and participants: We conducted a multisite randomized clinical trial of IPC (n = 86) vs usual care (UC) (n = 74) for patients with AML undergoing intensive chemotherapy. Data were collected from January 2017 through July 2019 at 4 tertiary care academic hospitals in the United States.
Interventions: Patients assigned to IPC were seen by palliativ…
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Miller CB, Gu J, Henry AL, Davis ML, Espie CA, Stott R, Heinz AJ, Bentley KH, Goodwin GM, Gorman BS, Craske MG, Carl JR (2021)randomised controlled trialMEDLINE-indexed journal, not yet read by usJournal of behavior therapy and experimental psychiatry24 citations Feasibility and efficacy of a digital CBT intervention for symptoms of Generalized Anxiety Disorder: A randomized multiple-baseline study.
Background and objectives: Cognitive behavioral therapy (CBT) is a first-line treatment for anxiety, but it is not widely available as clinical guidelines recommend. We examined the feasibility and efficacy of a novel smartphone-based fully automated digital CBT intervention, 'Daylight™', to improve symptoms of Generalized Anxiety Disorder (GAD).
Methods: In this multiple-baseline design, 21 adults (20 F; mean age 43yrs. range 19-65yrs.) with moderate-to-severe symptoms of GAD were randomized to one of three baseline durations (2-, 4-, or 6-weeks) and then received access to digital CBT. Participants completed daily ratings of anxiety and worry, weekly measures of anxiety, depressive symptoms, and sleep, and measures of anxiety, worry, wellbeing, quality of life, CBT skill acquisition, and work performance at initial assessment prior to baseline randomization, post-intervention, and foll…
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Lee WJ, Peng LN, Lin CH, Chen RC, Lin SZ, Loh CH, Kao SL, Hung TS, Chang CY, Huang CF, Tang TC, Huang ST, Wen YW, Hsiao FY, Chen LK, Taiwan Integrated Geriatric Care Study Group (2021)randomised controlled trialMEDLINE-indexed journal, not yet read by usThe lancet. Healthy longevity63 citations Effects of incorporating multidomain interventions into integrated primary care on quality of life: a randomised controlled trial.
Background: Integrating primary prevention into care pathways for older adults is a core strategy of healthy ageing, but evidence remains limited. We aimed to determine whether incorporating a multidomain intervention into primary health care could improve standard value-based health outcomes and quality of life.
Methods: For this Taiwan Integrated Geriatric Care (TIGER) study, a pragmatic randomised controlled trial, we recruited community-dwelling outpatients aged 65 years or older with at least three chronic medical conditions. We excluded people with malignancies undergoing chemotherapy, people with a life expectancy of less than 12 months, or people who were insufficiently able to communicate with study staff. Participants were randomly assigned (1:1) to usual care or to the integrated multidomain intervention using block randomisation. The integrated multidomain intervention entail…
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Efficacy of Zemedy, a Mobile Digital Therapeutic for the Self-management of Irritable Bowel Syndrome: Crossover Randomized Controlled Trial.
Background: Patients with irritable bowel syndrome (IBS) experience abdominal pain, altered bowel habits, and defecation-related anxiety, which can result in reduced productivity and impaired health-related quality of life (HRQL). Cognitive behavioral therapy (CBT) has been shown to reduce symptoms of IBS and to improve HRQL, but access to qualified therapists is limited. Smartphone-based digital therapeutic interventions have potential to increase access to guided CBT at scale, but require careful study to assess their benefits and risks.
Objective: The aim of this study was to test the efficacy of a novel app, Zemedy, as a mobile digital therapeutic that delivers a comprehensive CBT program to individuals with IBS.
Methods: This was a crossover randomized controlled trial. Participants were recruited online and randomly allocated to either immediate treatment (n=62) or waitlist control…
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McVary KT, Gittelman MC, Goldberg KA, Patel K, Shore ND, Levin RM, Pliskin M, Beahrs JR, Prall D, Kaminetsky J, Cowan BE, Cantrill CH, Mynderse LA, Ulchaker JC, Tadros NN, Gange SN, Roehrborn CG (2021)randomised controlled trialMEDLINE-indexed journal, not yet read by usThe Journal of urology115 citations Final 5-Year Outcomes of the Multicenter Randomized Sham-Controlled Trial of a Water Vapor Thermal Therapy for Treatment of Moderate to Severe Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia.
Purpose: We present final 5-year outcomes of the multicenter randomized sham-controlled trial of a water vapor therapy (Rezūm™) for treatment of moderate to severe lower urinary tract symptoms due to benign prostatic hyperplasia.
Materials and methods: A total of 197 subjects >50 years of age with International Prostate Symptom Score ≥13, maximum flow rate ≤15 ml/second and prostate volume 30 to 80 cc were randomized and followed for 5 years. From the control arm of 61 subjects, a subset of 53 subjects requalified and after 3 months received treatment as part of the crossover group and were also followed for 5 years. The total number of vapor treatments to each lobe of the prostate was determined by length of prostatic urethra and included middle lobe treatment per physician discretion.
Results: Significant improvement of lower urinary tract symptoms was observed at <3 months post-therma…
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Examining a stepped-care telehealth program for parents of young children with autism: a proof-of-concept trial.
Background: Intervention during the first years of life for children with autism spectrum disorder (ASD) may have the strongest impact on long-term brain development and functioning. Yet, barriers such as a shortage of trained professionals contribute to significant delays in service. The goal of this proof-of-concept study was to explore strategies that support timely and equitable deployment of ASD-specific interventions.
Methods: This 15-week, randomized proof-of-concept study explored the acceptability of a digital parent mediated intervention online reciprocal imitation training (RIT; a naturalistic developmental behavioral intervention) and compared it to a treatment as usual (TAU) control on parent and child outcomes. Eligible children were between 18 and 60 months, met the cutoff for ASD on the Autism Diagnostic Observation Schedule-2nd Edition and demonstrate significant social …
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Application effect of the hospital-community integrated service model in home rehabilitation of stroke in disabled elderly: a randomised trial.
Background: Disabled elderly with stroke usually have difficulty in obtaining professional rehabilitation intervention after being discharged from the hospital, and their self-health management ability is low, so their illness is prone to relapse. The hospital community-integrated service model (HCISM) is a scientific model designed to meet the needs of home care after discharge from the hospital, improve the quality of life of patients after discharge from the hospital, ease the burden on the family, and improve the service capabilities of community medical staff. The purpose of this study is to explore the effect of HCISM in home rehabilitation of stroke disabled elderly.
Methods: From September 2019 to September 2020, 120 the disabled elderly patients with stroke admitted to Affiliated hospital of Jiangnan University were selected and divided into two groups with a random number table…
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Physiotherapy and combined cognitive-behavioural therapy for patients with chronic pelvic pain syndrome: results of a non-randomised controlled feasibility trial.
Objective: To explore feasibility in terms of delivering and evaluating a combination of physiotherapy and psychotherapy for patients with chronic pelvic pain syndrome (CPPS).
Design: Prospective non-randomised controlled pilot study.
Setting: Tertiary care facility with a specialised interdisciplinary outpatient clinic for patients with CPPS.
Participants: A total of 311 patients was approached; 60 participated. 36 patients were included in the intervention group (mean age ±SD 48.6 years±14.8; 52.8% female) and 24 in the control group (mean age ±SD 50.6 years±14.5; 58.3% female). Fourteen participants were lost to follow-up.
Interventions: Participants were non-randomly allocated to the intervention group with two consecutive treatment modules (physiotherapy and cognitive behavioural therapy) with a duration of 9 weeks each or to the control group (treatment as usual).
Main outcome meas…
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Cassarino M, Robinson K, Trépel D, O'Shaughnessy Í, Smalle E, White S, Devlin C, Quinn R, Boland F, Ward ME, McNamara R, Steed F, O'Connor M, O'Regan A, McCarthy G, Ryan D, Galvin R (2021)randomised controlled trialMEDLINE-indexed journal, not yet read by usPLoS medicine40 citations Impact of assessment and intervention by a health and social care professional team in the emergency department on the quality, safety, and clinical effectiveness of care for older adults: A randomised controlled trial.
Background: Older adults frequently attend the emergency department (ED) and experience high rates of adverse events following ED presentation. This randomised controlled trial evaluated the impact of early assessment and intervention by a dedicated team of health and social care professionals (HSCPs) in the ED on the quality, safety, and clinical effectiveness of care of older adults in the ED.
Methods and findings: This single-site randomised controlled trial included a sample of 353 patients aged ≥65 years (mean age = 79.6, SD = 7.01; 59.2% female) who presented with lower urgency complaints to the ED a university hospital in the Mid-West region of Ireland, during HSCP operational hours. The intervention consisted of early assessment and intervention carried out by a HSCP team comprising a senior medical social worker, senior occupational therapist, and senior physiotherapist. The pri…
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Su JJ, Yu DS (2021)randomised controlled trialMEDLINE-indexed journal, not yet read by usInternational journal of nursing studies95 citations Effects of a nurse-led eHealth cardiac rehabilitation programme on health outcomes of patients with coronary heart disease: A randomised controlled trial.
Background: The uptake of and adherence to cardiac rehabilitation remain suboptimal despite its apparent health benefits in modifying risk factors and slowing disease progression. eHealth refers to the use of information and communication technologies for health-related purposes. It is a promising approach for improving participation in cardiac rehabilitation by enabling instant contact, hypermedia information delivery, technology-monitored functionalities and individualised progress monitoring.
Aims: To evaluate the effects of a nurse-led eHealth cardiac rehabilitation (NeCR) system on health behaviours, cardiac self-efficacy, anxiety and depression, health-related quality of life, risk parameters and unplanned use of care services for people with coronary heart disease.
Design: A single-blinded randomised controlled trial design was used.
Methods: The study randomly assigned 146 patien…
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Maguire R, McCann L, Kotronoulas G, Kearney N, Ream E, Armes J, Patiraki E, Furlong E, Fox P, Gaiger A, McCrone P, Berg G, Miaskowski C, Cardone A, Orr D, Flowerday A, Katsaragakis S, Darley A, Lubowitzki S, Harris J, Skene S, Miller M, Moore M, Lewis L, DeSouza N, Donnan PT (2021)randomised controlled trialMEDLINE-indexed journal, not yet read by usBMJ (Clinical research ed.)161 citations Real time remote symptom monitoring during chemotherapy for cancer: European multicentre randomised controlled trial (eSMART).
Objective: To evaluate effects of remote monitoring of adjuvant chemotherapy related side effects via the Advanced Symptom Management System (ASyMS) on symptom burden, quality of life, supportive care needs, anxiety, self-efficacy, and work limitations.
Design: Multicentre, repeated measures, parallel group, evaluator masked, stratified randomised controlled trial.
Setting: Twelve cancer centres in Austria, Greece, Norway, Republic of Ireland, and UK.
Participants: 829 patients with non-metastatic breast cancer, colorectal cancer, Hodgkin's disease, or non-Hodgkin's lymphoma receiving first line adjuvant chemotherapy or chemotherapy for the first time in five years.
Intervention: Patients were randomised to ASyMS (intervention; n=415) or standard care (control; n=414) over six cycles of chemotherapy.
Main outcome measures: The primary outcome was symptom burden (Memorial Symptom Assessme…
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Laird KT, Stanton AL (2021)randomised controlled trialMEDLINE-indexed journal, not yet read by usComplementary therapies in clinical practice6 citations Written expressive disclosure in adults with irritable bowel syndrome: A randomized controlled trial.
Background: The benefits of written expressive disclosure (WED) to health are documented in a variety of healthy and clinical populations. This study investigates the effect of WED on health-related outcomes in irritable bowel syndrome (IBS).
Methods: Adults (N = 189) meeting Rome III criteria for IBS were randomly assigned to write about their: (1) deepest thoughts and feelings about the most stressful life event of the past five years (n = 67), (2) deepest thoughts and feelings about their IBS (n = 61) or (3) daily activities in an objective manner (control condition; n = 61). Participants completed four 20-min writing sessions over 2-6 weeks. Gastrointestinal (GI) symptoms, healthcare utilization, health-related quality of life (HR-QOL), pain catastrophizing, and pain self-efficacy were assessed at baseline, one month post-writing completion, and three months post-writing completion.
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A Mobile-Based Intervention to Increase Self-esteem in Students With Depressive Symptoms: Randomized Controlled Trial.
Background: Depressive symptoms are one of the most common and ever-increasing mental health problems among students worldwide. Conventional treatment options, particularly psychotherapy, do not reach all students in need of help. Internet- and mobile-based interventions are promising alternatives for narrowing the treatment gap.
Objective: In the framework of a randomized controlled trial, we aim to investigate the effectiveness, acceptance, and side effects of a self-help smartphone app (MCT & More) based on cognitive behavioral therapy, mindfulness, acceptance and commitment therapy, and metacognitive training in a sample of students with self-reported depressive symptoms. Furthermore, we were interested in examining the influence of treatment expectations and attitudes toward internet- and mobile-based interventions on treatment adherence and effectiveness.
Methods: A total of 400 st…
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Effect of self-regulatory behaviour change techniques and predictors of physical activity maintenance in cancer survivors: a 12-month follow-up of the Phys-Can RCT.
Background: Current knowledge about the promotion of long-term physical activity (PA) maintenance in cancer survivors is limited. The aims of this study were to 1) determine the effect of self-regulatory BCTs on long-term PA maintenance, and 2) identify predictors of long-term PA maintenance in cancer survivors 12 months after participating in a six-month exercise intervention during cancer treatment.
Methods: In a multicentre study with a 2 × 2 factorial design, the Phys-Can RCT, 577 participants with curable breast, colorectal or prostate cancer and starting their cancer treatment, were randomized to high intensity exercise with or without self-regulatory behaviour change techniques (BCTs; e.g. goal-setting and self-monitoring) or low-to-moderate intensity exercise with or without self-regulatory BCTs. Participants' level of PA was assessed at the end of the exercise intervention and 1…
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Samuel M, Khairy P, Champagne J, Deyell MW, Macle L, Leong-Sit P, Novak P, Badra-Verdu M, Sapp J, Tardif JC, Andrade JG (2021)randomised controlled trialMEDLINE-indexed journal, not yet read by usJAMA cardiology61 citations Association of Atrial Fibrillation Burden With Health-Related Quality of Life After Atrial Fibrillation Ablation: Substudy of the Cryoballoon vs Contact-Force Atrial Fibrillation Ablation (CIRCA-DOSE) Randomized Clinical Trial.
Importance: Patients with atrial fibrillation (AF) have impaired health-related quality of life primarily owing to symptoms related to AF episodes; however, quality of life can be influenced by AF therapies, AF complications, the frequency of follow-up visits and hospitalizations, illness perceptions, and patient factors, such as anxiety or depression.
Objective: To determine the association between change in AF burden and quality of life in the year following ablation.
Design, setting, and participants: The current study is a secondary analysis of a prospective, parallel-group, multicenter, single-masked randomized clinical trial (Cryoballoon vs Irrigated Radiofrequency Catheter Ablation: Double Short vs Standard Exposure Duration [CIRCA-DOSE] study), which took place at 8 Canadian centers. Between September 2014 and July 2017, 346 patients older than 18 years with symptomatic, primaril…
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Telemedicine in postoperative follow-up of STOMa PAtients: a randomized clinical trial (the STOMPA trial).
Background: A stoma has severe impact on the patient's quality of life (QoL). Postoperative home community follow-up by teleconsultation (TC) and stoma nurses may reduce the burden of travel and improve QoL.
Methods: A university hospital and five district medical centres participated. Patients with a stoma were randomized to follow-up by either TC (intervention) or hospital (control). Stoma nurses performed the clinical examination at the TC studio, aided remotely by hospital nurses and surgeons. The primary endpoint was the EQ-5D™ index score; secondary endpoints were the Stoma Quality-of-Life Scale, the OutPatient Experiences Questionnaire, and use of hospital resources.
Results: A total of 110 patients were randomized to hospital (58 patients) or TC (52) follow-up; 64 patients (hospital 38, TC 26) were followed for more than 12 months and 246 consultations (hospital 151, TC 95) were …
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Holland AE, Corte T, Chambers DC, Palmer AJ, Ekström MP, Glaspole I, Goh NSL, Hepworth G, Khor YH, Hoffman M, Vlahos R, Sköld M, Dowman L, Troy LK, Prasad JD, Walsh J, McDonald CF (2020)randomised controlled trialMEDLINE-indexed journal, not yet read by usBMJ open19 citations Ambulatory oxygen for treatment of exertional hypoxaemia in pulmonary fibrosis (PFOX trial): a randomised controlled trial.
Introduction: Interstitial lung diseases are characterised by scarring of lung tissue that leads to reduced transfer of oxygen into the blood, decreased exercise capacity and premature death. Ambulatory oxygen therapy may be used to treat exertional oxyhaemoglobin desaturation, but there is little evidence to support its efficacy and there is wide variation in clinical practice. This study aims to compare the clinical efficacy and cost-effectiveness of ambulatory oxygen versus ambulatory air in people with fibrotic interstitial lung disease and exertional desaturation.
Methods and analysis: A randomised, controlled trial with blinding of participants, clinicians and researchers will be conducted at trial sites in Australia and Sweden. Eligible participants will be randomised 1:1 into two groups. Intervention participants will receive ambulatory oxygen therapy using a portable oxygen conc…
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Müller-Riemenschneider F, Petrunoff N, Yao J, Ng A, Sia A, Ramiah A, Wong M, Han J, Tai BC, Uijtdewilligen L (2020)randomised controlled trialMEDLINE-indexed journal, not yet read by usThe international journal of behavioral nutrition and physical activity49 citations Effectiveness of prescribing physical activity in parks to improve health and wellbeing - the park prescription randomized controlled trial.
Background: Programs promoting population health through physical activity (PA) and exposure to nature are popular, but few have been evaluated in randomized-controlled trials (RCTs).
Objective: To investigate the effectiveness of a park prescription intervention (PPI) for improving total moderate-to-vigorous PA (MVPA), other PA related behaviors, quality of life (QoL) and cardio-metabolic health among adults.
Methods: Healthy individuals aged 40 to 65 years were recruited through community health screenings and randomly assigned to 1) PPI: face-to-face Park Prescription + invitation to weekly exercise sessions in parks, or 2) control: standard PA materials. After the six-month intervention, participants completed accelerometer assessments, questionnaires on health behaviors and QoL, and health screenings. Independent sample t-tests were used to compare outcomes between groups, with seco…
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Korfage IJ, Carreras G, Arnfeldt Christensen CM, Billekens P, Bramley L, Briggs L, Bulli F, Caswell G, Červ B, van Delden JJM, Deliens L, Dunleavy L, Eecloo K, Gorini G, Groenvold M, Hammes B, Ingravallo F, Jabbarian LJ, Kars MC, Kodba-Čeh H, Lunder U, Miccinesi G, Mimić A, Ozbič P, Payne SA, Polinder S, Pollock K, Preston NJ, Seymour J, Simonič A, Thit Johnsen A, Toccafondi A, Verkissen MN, Wilcock A, Zwakman M, van der Heide A, Rietjens JAC (2020)randomised controlled trialMEDLINE-indexed journal, not yet read by usPLoS medicine101 citations Advance care planning in patients with advanced cancer: A 6-country, cluster-randomised clinical trial.
Background: Advance care planning (ACP) supports individuals to define, discuss, and record goals and preferences for future medical treatment and care. Despite being internationally recommended, randomised clinical trials of ACP in patients with advanced cancer are scarce.
Methods and findings: To test the implementation of ACP in patients with advanced cancer, we conducted a cluster-randomised trial in 23 hospitals across Belgium, Denmark, Italy, Netherlands, Slovenia, and United Kingdom in 2015-2018. Patients with advanced lung (stage III/IV) or colorectal (stage IV) cancer, WHO performance status 0-3, and at least 3 months life expectancy were eligible. The ACTION Respecting Choices ACP intervention as offered to patients in the intervention arm included scripted ACP conversations between patients, family members, and certified facilitators; standardised leaflets; and standardised ad…
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Campo G, Tonet E, Chiaranda G, Sella G, Maietti E, Bugani G, Vitali F, Serenelli M, Mazzoni G, Ruggiero R, Villani G, Biscaglia S, Pavasini R, Rubboli A, Campana R, Caglioni S, Volpato S, Myers J, Grazzi G (2020)randomised controlled trialMEDLINE-indexed journal, not yet read by usHeart (British Cardiac Society)61 citations Exercise intervention improves quality of life in older adults after myocardial infarction: randomised clinical trial.
Objective: To establish the benefits of an early, tailored and low-cost exercise intervention in older patients hospitalised for acute coronary syndrome (ACS).
Methods: The study was a multicentre, randomised assessment of an exercise intervention in patients with ACS ≥70 years with reduced physical performance (as defined by the short physical performance battery (SPPB), value 4-9). The exercise intervention included four supervised sessions (1, 2, 3, 4 months after discharge) and home-based exercises. The control group attended a health education programme only. The outcomes were the 6-month and 1-year effects on physical performance, daily activities, anxiety/depression and quality of life. Finally, 1-year occurrence of adverse events was recorded.
Results: Overall, 235 patients with ACS (median age 76 (73-81) years) were randomised 1 month after ACS. Exercise and control groups were …
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Isolating the role of time in bed restriction in the treatment of insomnia: a randomized, controlled, dismantling trial comparing sleep restriction therapy with time in bed regularization.
Study objectives: Sleep restriction therapy (SRT) is one of the most effective treatments for insomnia. Restriction of time in bed (TIB) is assumed to be the central mechanism through which SRT improves sleep consolidation and reduces insomnia symptoms. This hypothesis has never been directly tested. We designed a randomized, controlled, dismantling trial in order to isolate the role of TIB restriction in driving both clinical and polysomnographic sleep outcomes.
Methods: Participants aged 25-55 who met diagnostic criteria for insomnia disorder were block-randomized (1:1) to 4 weeks of SRT or time in bed regularization (TBR), a treatment that involves the prescription of a regular but not reduced TIB. The primary outcome was assessed with the insomnia severity index (ISI) at baseline, 4-, and 12-weeks post-randomization. Secondary outcomes included sleep continuity (assessed via polysomn…
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The presence of a caregiver is associated with patient outcomes in patients with Parkinson's disease and atypical parkinsonisms.
Introduction: Approximately 88% of men and 79% of women with Parkinson's disease (PD) identify an informal caregiver. Although caregivers can play a key role in supporting patients, little is known about how and whether PD patients with and without caregivers differ in terms of physical, cognitive, and mood outcomes. This study explored whether caregiver presence was associated with variations in patient presentation and outcomes in a palliative PD and atypical PD population.
Methods: Secondary data on individuals with PD and their caregivers came from baseline data of a 3-site randomized controlled trial of outpatient palliative care for PD in the US and Canada. Measures included: MDS UPDRS III, Montreal Cognitive Assessment, quality of life (QOL) measures, depression, prolonged grief, spirituality (FACIT SP-12) and Palliative Performance Scale.
Results: Of 210 participants, 175 (83%) h…
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Basnayake C, Kamm MA, Stanley A, Wilson-O'Brien A, Burrell K, Lees-Trinca I, Khera A, Kantidakis J, Wong O, Fox K, Talley NJ, Liew D, Salzberg MR, Thompson AJ (2020)randomised controlled trialMEDLINE-indexed journal, not yet read by usThe lancet. Gastroenterology & hepatology89 citations Standard gastroenterologist versus multidisciplinary treatment for functional gastrointestinal disorders (MANTRA): an open-label, single-centre, randomised controlled trial.
Background: Functional gastrointestinal disorders are common and costly to the health-care system. Most specialist care is provided by a gastroenterologist, but only a minority of patients have improvement in symptoms. Although they have proven to be effective, psychological, behavioural, and dietary therapies are not provided routinely. We aimed to compare the outcome of gastroenterologist-only standard care with multidisciplinary care.
Methods: In an open-label, single-centre, pragmatic trial, consecutive new referrals of eligible patients aged 18-80 years with Rome IV criteria-defined functional gastrointestinal disorders were randomly assigned (1:2) to receive gastroenterologist-only standard care or multidisciplinary clinic care. The multidisciplinary clinic included gastroenterologists, dietitians, gut-focused hypnotherapists, psychiatrists, and behavioural (biofeedback) physiother…
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Medoff Cooper B, Marino BS, Fleck DA, Lisanti AJ, Golfenshtein N, Ravishankar C, Costello JM, Huang L, Hanlon AL, Curley MAQ (2020)randomised controlled trialMEDLINE-indexed journal, not yet read by usPediatrics26 citations Telehealth Home Monitoring and Postcardiac Surgery for Congenital Heart Disease.
Objectives: To test the effect of a 4-month telehealth home monitoring program (REACH), layered on usual care, on postdischarge outcomes in parents of infants recovering from cardiac surgery and their infants.
Methods: Randomized trial of infants discharged from the hospital after cardiac surgery for congenital heart disease. Consecutive infants with complex congenital heart disease undergoing cardiac surgery within 21 days of life were enrolled at 3 university-affiliated pediatric cardiac centers.
Results: From 2012 to 2016, 219 parent-infant dyads were enrolled; 109 were randomly assigned to the intervention group and 110 to the control group. At 4 months postdischarge, parenting stress was not significantly different between groups (total Parenting Stress Index in the intervention group was 220 and in the control group was 215; P = .61). The percentages of parents who met posttraumati…
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Effectiveness of a psycho-educational intervention for expecting parents to prevent postpartum parenting stress, depression and anxiety: a randomized controlled trial.
Background: The first months postpartum can be challenging for parents, leading to elevated symptoms of parenting stress, depression and anxiety. In turn, distressed parents are at higher risk for providing suboptimal quality of caregiving. As psychoeducational interventions can be effective in reducing psychological distress, the goal of this randomized controlled trial was to examine the effectiveness of low-intensity universal psychoeducational program to prevent postpartum parenting stress, and to enhance parental well-being and caregiving quality.
Method: Between 26 and 34 weeks of pregnancy, 138 pregnant women and 96 partners were randomized to the intervention or a waitlist control group. The intervention consisted of a booklet, a video, a home visit, and a telephone call. Information was provided on (1) sensitive responsiveness, adapting to the parental role, and attending to own…
matched on Personal Satisfaction (mesh), well-being (text)