Positive functioning as an outcome in its own right.
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1451 to 1475 of 6,178Witlox L, Schagen SB, de Ruiter MB, Geerlings MI, Peeters PHM, Koevoets EW, van der Wall E, Stuiver M, Sonke G, Velthuis MJ, Palen JAMV, Jobsen JJ, May AM, Monninkhof EM (2019)clinical trialMEDLINE-indexed journal, not yet read by usBMJ open22 citations Effect of physical exercise on cognitive function and brain measures after chemotherapy in patients with breast cancer (PAM study): protocol of a randomised controlled trial.
Introduction: After treatment with chemotherapy, many patients with breast cancer experience cognitive problems. While limited interventions are available to improve cognitive functioning, physical exercise showed positive effects in healthy older adults and people with mild cognitive impairment. The Physical Activity and Memory study aims to investigate the effect of physical exercise on cognitive functioning and brain measures in chemotherapy-exposed patients with breast cancer with cognitive problems.
Methods and analytics: One hundred and eighty patients with breast cancer with cognitive problems 2-4 years after diagnosis are randomised (1:1) into an exercise intervention or a control group. The 6-month exercise intervention consists of twice a week 1-hour aerobic and strength exercises supervised by a physiotherapist and twice a week 1-hour Nordic or power walking. The control group…
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Redfern J, Hyun K, Singleton A, Hafiz N, Raeside R, Spencer L, Carr B, Caterson I, Cullen J, Ferry C, Santo K, Hayes A, Leung RWM, Raadsma S, Swinbourne J, Cho JG, King M, Roberts M, Kok C, Jenkins C, Chow C (2019)clinical trialMEDLINE-indexed journal, not yet read by usBMJ open10 citations ITM support for patients with chronic respiratory and cardiovascular diseases: a protocol for a randomised controlled trial.
Introduction: Simple and scalable strategies are needed to improve 'out-of-hospital' support and management for people living with cardiovascular disease (CVD) and respiratory disease. Text messaging via mobile phones has been shown to be effective in helping promote lifestyle change and is supported by quantitative and qualitative evidence. The aim of this study is to test the effectiveness and implementation of a 6-month text messaging support programme for people with CVD and respiratory disease as an addition to cardiac and pulmonary outpatient rehabilitation.
Methods and analysis: Pragmatic randomised controlled trial (n=310) to test the effectiveness of a 6-month text message support programme on clinical outcomes in people with CVD and chronic respiratory disease who are attending outpatient cardiac and pulmonary rehabilitation. The study includes a nested process evaluation to in…
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Effects of yoga on well-being and healthy ageing: study protocol for a randomised controlled trial (FitForAge).
Introduction: Due to ageing populations worldwide, the burden of disability is increasing. It is therefore important to develop interventions that improve healthy ageing, reduce disability onset and enhance life quality. Physical activity can promote healthy ageing and help maintain independence, yet many older adults are inactive. Yoga is a form of physical activity that aims to improve health and may be particularly suitable for older adults. Research indicates positive effects of yoga on several health-related outcomes; however, empirical studies examining the benefits of yoga on well-being among the elderly remain scarce. This study protocol reports the methodology for a 12-week yoga programme aimed to improve health and well-being among physically inactive older adults.
Methods and analysis: Three group parallel, single-blind randomised controlled trial. Two comparison groups are in…
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Cook G, Royle KL, Pawlyn C, Hockaday A, Shah V, Kaiser MF, Brown SR, Gregory WM, Child JA, Davies FE, Morgan GJ, Cairns DA, Jackson GH (2019)clinical trialMEDLINE-indexed journal, not yet read by usThe Lancet. Haematology91 citations A clinical prediction model for outcome and therapy delivery in transplant-ineligible patients with myeloma (UK Myeloma Research Alliance Risk Profile): a development and validation study.
Background: Tolerability of treatments for multiple myeloma can depend on the characteristics of the patient being treated. We aimed to develop and validate a risk profile, using routinely collected data, that could predict overall survival in patients with multiple myeloma who were ineligible for stem-cell transplantation.
Methods: We used patient data from two randomised controlled trials done in patients with newly diagnosed multiple myeloma who were ineligible for stem-cell transplantation (the NCRI Myeloma XI study [NCRI-XI, n=1852] and the MRC Myeloma IX study [MRC-IX, n=520]), to develop the UK Myeloma Research Alliance Risk Profile (MRP) for overall survival. We used multivariable Cox regression with a least absolute shrinkage and selection operator penalty term. Multiple imputation by chained equations was used to account for missing data in the development and internal validati…
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Evaluation of a structured skills training group for adolescents with attention deficit/hyperactivity disorder (ADHD) - study protocol of a randomised controlled trial.
Background: Attention deficit/hyperactivity disorder (ADHD) has a negative impact on several domains of life. However, there is a shortage of evidence-based non-pharmacological treatments for adolescents with ADHD. A structured skills training group (SSTG) based on dialectical behaviour therapy (DBT) has been used in adult patients with ADHD with some promising results, although the treatment has not yet been adapted or evaluated for adolescents with ADHD. This study protocol describes how this treatment was adapted for an adolescent population and how the efficacy of the SSTG will be evaluated using a randomised controlled trial (RCT) design.
Methods: A sample of 184 adolescents (15-18 years of age) with a diagnosis of ADHD has been recruited from seven child and adolescent psychiatric outpatient units and randomised to either the SSTG or an active control group based on psychoeducation…
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Sánchez-Villegas A, Cabrera-Suárez B, Molero P, González-Pinto A, Chiclana-Actis C, Cabrera C, Lahortiga-Ramos F, Florido-Rodríguez M, Vega-Pérez P, Vega-Pérez R, Pla J, Calviño-Cabada MJ, Ortuño F, Navarro S, Almeida Y, Hernández-Fleta JL (2019)clinical trialMEDLINE-indexed journal, not yet read by usBMC psychiatry32 citations Preventing the recurrence of depression with a Mediterranean diet supplemented with extra-virgin olive oil. The PREDI-DEP trial: study protocol.
Background: The role of dietary patterns in the prevention of unipolar depression has been analyzed in several epidemiological studies. The primary aims of this study are to determine the effectiveness of an extra-olive oil-enriched Mediterranean diet in reducing the recurrence of depression and improving the symptoms of this condition.
Methods: Multicenter, two-arm, parallel-group clinical trial. Arm 1, extra-virgin olive oil Mediterranean diet; Arm 2, control group without nutritional intervention. Dieticians are in charge of the nutritional intervention and regular contact with the participants. Contacts are made through our web platform ( https://predidep.es/participantes/ ) or by phone. Recurrence of depression is assessed by psychiatrists and clinical psychologists through clinical evaluations (semi-structured clinical interviews: Spanish SCID-I). Depressive symptoms are assessed w…
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Emergency Medicine Palliative Care Access (EMPallA): protocol for a multicentre randomised controlled trial comparing the effectiveness of specialty outpatient versus nurse-led telephonic palliative care of older adults with advanced illness.
Introduction: Emergency department (ED)-initiated palliative care has been shown to improve patient-centred outcomes in older adults with serious, life-limiting illnesses. However, the optimal modality for providing such interventions is unknown. This study aims to compare nurse-led telephonic case management to specialty outpatient palliative care for older adults with serious, life-limiting illness on: (1) quality of life in patients; (2) healthcare utilisation; (3) loneliness and symptom burden and (4) caregiver strain, caregiver quality of life and bereavement.
Methods and analysis: This is a protocol for a pragmatic, multicentre, parallel, two-arm randomised controlled trial in ED patients comparing two established models of palliative care: nurse-led telephonic case management and specialty, outpatient palliative care. We will enrol 1350 patients aged 50+ years and 675 of their car…
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Study protocol for a feasibility study of an internet-administered, guided, CBT-based, self-help intervention (ENGAGE) for parents of children previously treated for cancer.
Introduction: A subgroup of parents of children previously treated for cancer report long-term psychological distress after end of treatment. However, needs for psychological support are commonly unmet and there is a lack of evidence-based treatments tailored to the specific needs of this population. An internet-administered, guided, cognitive-behavioural therapy-based, self-help intervention (ENGAGE) for parents of children previously treated for cancer may provide a solution. The aim is to examine the feasibility and acceptability of the intervention ENGAGE and the study procedures for a future controlled trial.
Methods and analysis: The study has an uncontrolled within-group design with an embedded qualitative and quantitative process evaluation. Potential participants are parents of children previously treated for cancer, living in Sweden, recruited via their child's personal identif…
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Nollett C, Lewis C, Kitchiner N, Roberts N, Addison K, Brookes-Howell L, Cosgrove S, Cullen K, Ehlers A, Heke S, Kelson M, Lovell K, Madden K, McEwan K, McNamara R, Phillips C, Pickles T, Simon N, Bisson J (2018)clinical trialMEDLINE-indexed journal, not yet read by usBMC psychiatry10 citations Pragmatic RAndomised controlled trial of a trauma-focused guided self-help Programme versus InDividual trauma-focused cognitive Behavioural therapy for post-traumatic stress disorder (RAPID): trial protocol.
Background: There is good evidence that trauma-focused therapies for Post-Traumatic Stress Disorder are effective. However, they are not always feasible to deliver due a shortage of trained therapists and demands on the patient. An online trauma-focused Guided Self-Help (GSH) programme which could overcome these barriers has shown promise in a pilot study. This study will be the first to evaluate GSH against standard face-to-face therapy to assess its suitability for use in the NHS.
Methods: The study is a large-scale multi-centre pragmatic randomised controlled non-inferiority trial, with assessors masked to treatment allocation. One hundred and ninety-two participants will be randomly allocated to receive either face-to-face trauma-focused cognitive behaviour therapy (TFCBT) or trauma-focused online guided self-help (GSH). The primary outcome will be the severity of symptoms of PTSD ov…
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Quality of life of the Indonesian general population: Test-retest reliability and population norms of the EQ-5D-5L and WHOQOL-BREF.
Objectives: The objective of this study is to obtain population norms and to assess test-retest reliability of EQ-5D-5L and WHOQOL-BREF for the Indonesian population.
Methods: A representative sample of 1056 people aged 17-75 years was recruited from the Indonesian general population. We used a multistage stratified quota sampling method with respect to residence, gender, age, education level, religion and ethnicity. Respondents completed EQ-5D-5L and WHOQOL-BREF with help from an interviewer. Norms data for both instruments were reported. For the test-retest evaluations, a sub-sample of 206 respondents completed both instruments twice.
Results: The total sample and test-retest sub-sample were representative of the Indonesian general population. The EQ-5D-5L shows almost perfect agreement between the two tests (Gwet's AC: 0.85-0.99 and percentage agreement: 90-99%) regarding the five dim…
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Exercise combined with Acceptance and Commitment Therapy (ExACT) compared to a supervised exercise programme for adults with chronic pain: study protocol for a randomised controlled trial.
Background: Acceptance and Commitment Therapy (ACT) is a form of cognitive behavioural therapy, which may be beneficial for people with chronic pain. The approach aims to enhance daily functioning through increased psychological flexibility. Whilst the therapeutic model behind ACT appears well suited to chronic pain, there is a need for further research to test its effectiveness in clinical practice, particularly with regards to combining ACT with physical exercise.
Methods/design: This prospective, two-armed, parallel-group, single-centre randomised controlled trial (RCT) will assess the effectiveness of a combined Exercise and ACT programme, in comparison to supervised exercise for chronic pain. One hundred and sixty patients, aged 18 years and over, who have been diagnosed with a chronic pain condition by a physician will be recruited to the trial. Participants will be individually ra…
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Quality of Life and Compassion Satisfaction in Clinicians: A Pilot Intervention Study for Reducing Compassion Fatigue.
Background: Compassion fatigue (CF) is prevalent in healthcare professionals, particularly in those caring for chronic, acutely ill, and/or those patients who might be moving toward comfort care. Over time, CF can lead to burnout (BO) and secondary traumatic stress and an overall decrease in professional quality of life. In this pilot study, participants completed a resiliency program focused on education about CF and self-awareness of its individualized impact and were expected to develop ongoing self-care practices to prevent/address the untoward effects.
Methods: Healthcare professionals ( N = 15) participated in a formalized educational program consisting of three 90-minute educational sessions held 2 weeks apart. Preassessment and postintervention data were collected electronically in survey format. A postprogram evaluation was also offered.
Results: Upon completion of the program, …
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Effects of a mindfulness-based intervention on fertility quality of life and pregnancy rates among women subjected to first in vitro fertilization treatment.
Generally, undergoing an in vitro fertilization (IVF) treatment is an emotional and physical burden for the infertile woman, which may negatively influence the treatment outcome. We conducted a study to investigate the effectiveness of a mindfulness-based intervention (MBI) among women subjected to first IVF treatment at a fertility medical center in China. Among infertile women registered for their first IVF treatment, 58 completed the intervention, and 50 were assigned to a control group using a non-randomized controlled study. Standardized measures of mindfulness, self-compassion, emotion regulation difficulties, infertility-related coping strategies and fertility quality of life (FertiQoL) were endorsed pre- and post-MBI, and measure of pregnancy rates at the sixth months after the intervention. Both groups were shown to be equivalent at baseline. By the end of the intervention, wome…
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MYmind: Mindfulness training for Youngsters with autism spectrum disorders and their parents.
Background: Despite the dramatic increase in autism spectrum disorder in youth and the extremely high costs, hardly any evidence-based interventions are available. The aim of this study is to examine the effects of mindfulness training for adolescents with autism spectrum disorder, combined with Mindful Parenting training.
Method: A total of 23 adolescents with autism spectrum disorder, referred to a mental health clinic, received nine weekly sessions of mindfulness training in group format. Their parents (18 mothers, 11 fathers) participated in parallel Mindful Parenting training. A pre-test, post-test, and 9-week follow-up design was used. Data were analyzed using multi-level analyses.
Results: Attendance rate was 88% for adolescents and fathers and 86% for mothers. Adolescents reported an increase in quality of life and a decrease in rumination, but no changes in worry, autism spectru…
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Santonati A, Palermo A, Maddaloni E, Bosco D, Spada A, Grimaldi F, Raggiunti B, Volpe R, Manfrini S, Vescini F, Hypoparathyroidism AME Group (2015)clinical trialMEDLINE-indexed journal, not yet read by usThe Journal of clinical endocrinology and metabolism43 citations PTH(1-34) for Surgical Hypoparathyroidism: A Prospective, Open-Label Investigation of Efficacy and Quality of Life.
Context: Conventional therapy for hypoparathyroidism consists of calcium and calcitriol, but sometimes normal serum calcium cannot be maintained, and/or this approach might lead to nephrocalcinosis, nephrolithiasis, or renal insufficiency.
Objective: The objective of the study was to investigate the effects of 6 months of PTH(1-34) treatment in adult subjects with postoperative hypoparathyroidism and to evaluate quality-of-life changes.
Design: This was a 2-year prospective, open-label study. At baseline and after 6 months of PTH(1-34) treatment, calcium and vitamin D supplementation requirements, serum calcium, phosphate, creatinine, alkaline phosphatase, uric acid, and 24-hour urinary calcium excretion were evaluated. Quality of life was evaluated by the Rand 36-Item Short Form Health Survey covering eight domains of physical and mental health.
Setting: This was an Italian multicentric…
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Assessment of quality of life during gonadotrophin treatment for male hypogonadotrophic hypogonadism.
Objective: The management of male hypogonadotrophic hypogonadism (MHH) with gonadotrophins is effective in promoting genital development and spermatogenesis. We investigated the changes in SF-36 subscales, including physical, social and psychological QOL, during gonadotrophin or testosterone treatment and analysed the factors that are involved in the outcomes of health-related quality of life (HRQOL) in MHH patients.
Patients and design: Thirty-seven MHH patients (mean age: 26.1 years old) who underwent gonadotrophin (n = 31) or testosterone treatment (n = 6), excluding infertility cases, were asked to respond to a SF-36 questionnaire before and every 6 months during the 2-year treatment period. The changes in SF-36 domains and the associations between improvements and patient factors were examined.
Results: The scores in all of the SF-36 domains were lower than in the normal Japanese po…
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Health-related quality of life in pediatric patients after allogeneic SCT: development of the PedsQL Stem Cell Transplant module and results of a pilot study.
With increased survival after pediatric allogeneic hematopoietic SCT health-related quality of life (HRQL) has emerged as an essential health outcome. The impact of transplant and chronic GVHD (cGVHD)-associated morbidity remains a major obstacle. In 2005, the National Institutes of Health (NIH) Consensus Conference on Criteria for Clinical Trials in cGVHD recommended HRQL tools as an independent measure of the impact of disease burden. The NIH recommendations did not provide a cGVHD-specific tool for HRQOL measures in children. This report focuses on the development of an SCT-specific instrument to assess HRQL in children and adolescents. For the assessment of generic HRQL we chose the PedsQL (Pediatric Quality of Life Inventory) Generic Cores Scales, which have been used in a large number of healthy, acutely ill and chronically ill children and adolescents. To capture SCT- and, specifi…
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Internet-delivered acceptance and values-based exposure treatment for fibromyalgia: a pilot study.
Background: Acceptance and commitment therapy (ACT) is a promising treatment option for fibromyalgia (FM). Studies have shown that many cognitive behavioral protocols can be transferred to the Internet with sustained efficacy. However, no study has investigated the effect on an Internet-delivered ACT-based protocol for FM. This study evaluated the efficacy, acceptability, and the health economic effects of an Internet-delivered acceptance and values-based exposure treatment for FM.
Methods: This open pilot trial included 41 self-referred women with a FM diagnosis. The 10-week Internet-delivered treatment included acceptance, mindfulness, work with life-values, and systematic exposure to FM symptoms and FM-related situations. Participants also had regular contact with an assigned online therapist. Assessments were made at pretreatment, post-treatment, and 6-month follow-up.
Results: The t…
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The Glasgow Sleep Impact Index (GSII): a novel patient-centred measure for assessing sleep-related quality of life impairment in Insomnia Disorder.
Objectives: Daytime dysfunction and quality of life impairment are important and salient consequences of poor sleep in those with insomnia. Existing measurement approaches to functional impact tend to rely on non-specific generic tools, non-validated scales, or ad hoc single scale items. Here we report the development and validation of the Glasgow Sleep Impact Index (GSII), a novel self-report measure which asks patients to generate, and assess, three domains of impairment unique to their own individual context. These three patient-generated areas of impairment are ranked in order of concern (1-3; i.e. 1=the most concerning impairment), and then rated on a visual analogue scale with respect to impact in the past two weeks. Patients re-rate these specified areas of impairment, post-intervention, permitting both individual and group-level analyses.
Methods: One-hundred and eight patients (…
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Hegarty KL, O'Doherty LJ, Chondros P, Valpied J, Taft AJ, Astbury J, Brown SJ, Gold L, Taket A, Feder GS, Gunn JM (2013)clinical trialMEDLINE-indexed journal, not yet read by usJournal of interpersonal violence71 citations Effect of type and severity of intimate partner violence on women's health and service use: findings from a primary care trial of women afraid of their partners.
Intimate partner violence (IPV) has major affects on women's wellbeing. There has been limited investigation of the association between type and severity of IPV and health outcomes. This article describes socio-demographic characteristics, experiences of abuse, health, safety, and use of services in women enrolled in the Women's Evaluation of Abuse and Violence Care (WEAVE) project. We explored associations between type and severity of abuse and women's health, quality of life, and help seeking. Women (aged 16-50 years) attending 52 Australian general practices, reporting fear of partners in last 12 months were mailed a survey between June 2008 and May 2010. Response rate was 70.5% (272/386). In the last 12 months, one third (33.0%) experienced Severe Combined Abuse, 26.2% Physical and Emotional Abuse, 26.6% Emotional Abuse and/or Harassment only, 2.7% Physical Abuse only and 12.4% score…
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Schmidt M, Zogheib E, Rozé H, Repesse X, Lebreton G, Luyt CE, Trouillet JL, Bréchot N, Nieszkowska A, Dupont H, Ouattara A, Leprince P, Chastre J, Combes A (2013)clinical trialMEDLINE-indexed journal, not yet read by usIntensive care medicine441 citations The PRESERVE mortality risk score and analysis of long-term outcomes after extracorporeal membrane oxygenation for severe acute respiratory distress syndrome.
Purpose: This study was designed to identify factors associated with death by 6 months post-intensive care unit (ICU) discharge and to develop a practical mortality risk score for extracorporeal membrane oxygenation (ECMO)-treated acute respiratory distress syndrome (ARDS) patients. We also assessed long-term survivors' health-related quality of life (HRQL), respiratory symptoms, and anxiety, depression and post-traumatic stress disorder (PTSD) frequencies.
Methods: Data from 140 ECMO-treated ARDS patients admitted to three French ICUs (2008-2012) were analyzed. ICU survivors contacted >6 months post-ICU discharge were assessed for HRQL, psychological and PTSD status.
Results: Main ARDS etiologies were bacterial (45%), influenza A[H₁N₁] (26%) and post-operative (17%) pneumonias. Six months post-ICU discharge, 84 (60%) patients were still alive. Based on multivariable logistic regression …
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Outcomes of a weight loss intervention among rural breast cancer survivors.
Obese breast cancer survivors have increased risk of recurrence and death compared to their normal weight counterparts. Rural women have significantly higher obesity rates, thus weight control intervention may be a key strategy for prevention of breast cancer recurrence in this population. This one-arm treatment study examined the impact of a group-based weight control intervention delivered through conference call technology to obese breast cancer survivors living in remote rural locations. The intervention included a reduced calorie diet incorporating prepackaged entrees and shakes, physical activity gradually increased to 225 min/week of moderate intensity exercise, and weekly group phone sessions. Outcomes included anthropomorphic, diet, physical activity, serum biomarker, and quality of life changes. Ninety-one percent of participants (31 of 34) attended >75% of intervention session…
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Identifying patients hospitalized with heart failure at risk for unfavorable future quality of life.
Background: Communicating prognosis to enable shared decision-making is strongly endorsed by heart failure (HF) guidelines. Patients are concerned with both their quantity and quality of life (QoL). To facilitate the recognition of patients at high risk for unfavorable future QoL or death, we created a simple prognostic tool to estimate this combined outcome.
Methods and results: We identified factors associated with 6-month mortality or persistently unfavorable QoL, defined by Kansas City Cardiomyopathy Questionnaire (KCCQ) scores <45 at 1 and 24 weeks after hospital discharge, among 1458 patients from the Efficacy of Vasopressin Antagonism in HF Outcome Study with Tolvaptan (EVEREST). Within 24 weeks of discharge, 478 (32.8%) patients had died and 192 (13.2%) patients had serial KCCQ scores <45. After adjusting for 23 predischarge covariates, independent predictors of the combined end …
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Balboni TA, Paulk ME, Balboni MJ, Phelps AC, Loggers ET, Wright AA, Block SD, Lewis EF, Peteet JR, Prigerson HG (2010)clinical trialMEDLINE-indexed journal, not yet read by usJournal of clinical oncology : official journal of the American Society of Clinical Oncology296 citations Provision of spiritual care to patients with advanced cancer: associations with medical care and quality of life near death.
Purpose: To determine whether spiritual care from the medical team impacts medical care received and quality of life (QoL) at the end of life (EoL) and to examine these relationships according to patient religious coping.
Patients and methods: Prospective, multisite study of patients with advanced cancer from September 2002 through August 2008. We interviewed 343 patients at baseline and observed them (median, 116 days) until death. Spiritual care was defined by patient-rated support of spiritual needs by the medical team and receipt of pastoral care services. The Brief Religious Coping Scale (RCOPE) assessed positive religious coping. EoL outcomes included patient QoL and receipt of hospice and any aggressive care (eg, resuscitation). Analyses were adjusted for potential confounders and repeated according to median-split religious coping.
Results: Patients whose spiritual needs were lar…
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Association of an educational program in mindful communication with burnout, empathy, and attitudes among primary care physicians.
Context: Primary care physicians report high levels of distress, which is linked to burnout, attrition, and poorer quality of care. Programs to reduce burnout before it results in impairment are rare; data on these programs are scarce.
Objective: To determine whether an intensive educational program in mindfulness, communication, and self-awareness is associated with improvement in primary care physicians' well-being, psychological distress, burnout, and capacity for relating to patients.
Design, setting, and participants: Before-and-after study of 70 primary care physicians in Rochester, New York, in a continuing medical education (CME) course in 2007-2008. The course included mindfulness meditation, self-awareness exercises, narratives about meaningful clinical experiences, appreciative interviews, didactic material, and discussion. An 8-week intensive phase (2.5 h/wk, 7-hour retreat) …
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