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Mealtime challenges in patients with chronic obstructive pulmonary disease: Who is responsible?

Abstract

Aims

To explore experiences of, and practices related to, mealtime challenges in patients with chronic obstructive pulmonary disease (COPD).

Background

Nutritional status is a significant indicator of prognosis and outcome in patients with COPD. Preventing unintended weight loss and helping patients regain weight are important nursing tasks. Dietary supplements have been effective in treating underweight in cases of stable COPD. However, compliance with long‐term interventions is quite low. Improving nutritional intake through knowledge of meal‐related challenges is the key to making further progress in preventing unintended weight loss.

Design

This study employed an ethnographic design using the go‐along method.

Methods

From September 2018–June 2019, 34 hr of meal‐related observations and informal conversations with purposefully selected patients (n = 15) were completed at a Danish respiratory medicine ward and in patients’ homes. We analysed the empirical data using a Ricoeur‐inspired method. Reporting adheres to the COREQ Checklist.

Findings

In this study, we identified the absence of professional responsibility as a main challenge. Mealtimes appeared to be relegated to a matter of nutrition, and common practices surrounding mealtimes were no longer observed. Patients became dependent individuals who had to settle for the food available. In addition, physiological challenges often resulted in patients re‐evaluating the benefits of eating, concluding that it was not worth the effort and therefore not eating. Furthermore, patients were hesitant to communicate their needs, which left a number of nonverbalised challenges unattended.

Conclusions

Overall, meal‐related challenges pose a risk of unintended weight loss, and the health professionals’ work with mealtimes lacks a coordinated, systematic approach. Further research is needed to develop or implement interventions that can accommodate mealtimes.

Relevance to clinical practice

This study contributes valuable knowledge that can be used to improve the quality of nursing care and prevent unintended weight loss in patients with COPD.

Clinical and cost-effectiveness of a guided internet-based Acceptance and Commitment Therapy to improve chronic pain-related disability in green professions (PACT-A): study protocol of a pragmatic randomised controlled trial

Por: Terhorst · Y. · Braun · L. · Titzler · I. · Buntrock · C. · Freund · J. · Thielecke · J. · Ebert · D. · Baumeister · H.
Introduction

Chronic pain is highly prevalent, associated with substantial personal and economic burdens, and increased risk for mental disorders. Individuals in green professions (agriculturists, horticulturists, foresters) show increased prevalence of chronic pain and other risk factors for mental disorders. Available healthcare services in rural areas are limited. Acceptance towards face-to-face therapy is low. Internet and mobile-based interventions (IMIs) based on Acceptance and Commitment Therapy (ACT) might be a promising alternative for this population and may enable effective treatment of chronic pain. The present study aims to evaluate the clinical and cost-effectiveness of an ACT-based IMI for chronic pain in green professions in comparison with enhanced treatment as usual (TAU+).

Methods and analysis

A two-armed pragmatic randomised controlled trial will be conducted. Two hundred eighty-six participants will be randomised and allocated to either an intervention or TAU+ group. Entrepreneurs in green professions, collaborating spouses, family members and pensioners with chronic pain are eligible for inclusion. The intervention group receives an internet-based intervention based on ACT (7 modules, over 7 weeks) guided by a trained e-coach to support adherence (eg, by positive reinforcement). Primary outcome is pain interference (Multidimensional Pain Interference scale; MPI) at 9 weeks post-randomisation. Secondary outcomes are depression severity (Quick Inventory Depressive Symptomology; QIDS-SR16), incidence of major depressive disorder, quality of life (Assessment of Quality of Life; AQoL-8D) and possible side effects associated with the treatment (Inventory for the Assessment of Negative Effects of Psychotherapy; INEP). Psychological flexibility (Chronic Pain Acceptance Questionnaire, Committed Action Questionnaire, Cognitive Fusion Questionnaire) will be evaluated as a potential mediator of the treatment effect. Furthermore, mediation, moderation and health-economic analyses from a societal perspective will be performed. Outcomes will be measured using online self-report questionnaires at baseline, 9-week, 6-month, 12-month, 24-month and 36-month follow-ups.

Ethics and dissemination

This study was approved by the Ethics Committee of the University of Ulm, Germany (file no. 453/17—FSt/Sta; 22 February 2018). Results will be submitted for publication in peer-reviewed journals and presented at conferences.

Trial registration number

German Clinical Trial Registration: DRKS00014619. Registered on 16 April 2018.

Influence of socioeconomic status on the referral process to cardiac rehabilitation following acute coronary syndrome: a cross-sectional study

Por: Graversen · C. B. · Johansen · M. B. · Eichhorst · R. · Johnsen · S. P. · Riahi · S. · Holmberg · T. · Larsen · M. L.
Objective

To evaluate the association between socioeconomic status (SES) and referral to cardiac rehabilitation (CR) after incident acute coronary syndrome (ACS) by dividing the referral process into three phases: (1) informed about CR, (2) willingness to participate in CR, (3) and assigned CR setting.

Design

Cross-sectional study.

Setting

Department of Cardiology at a Danish University Hospital from 1 January 2011 to 31 December 2014.

Participants

A total of 1229 patients assessed for CR during hospitalisation with ACS were prospectively registered in the Rehab-North Register from 2011 to 2014. SES was assessed using data from national registers, concerning: personal income, occupational status, educational level and civil status. Patients were excluded if one of the following criteria was fulfilled: (1) missing data on SES, or (2) acceptable reason for not informing patients about CR (treatment with coronary artery bypass grafting, transfer to another hospital, still under treatment or death).

Main outcome measures

Outcomes were defined by dividing the referral process into three phases: (1) informed about CR, (2) willingness to participate, and (3) assigned CR setting (in-hospital/community centre) after ACS.

Results

A total of 854 (69.5 %) patients were referred to CR. After adjustment for age, gender, ACS diagnosis (ST-elevated myocardial infarction, non-ST-elevated myocardial infarction, unstable angina pectoris) and comorbidity, high income had the strongest association of referral to CR in all three phases (informed about CR: OR 2.17, 95% CI 1.01 to 4.64; willingness to participate in CR: OR 1.55, 95% CI 1.02 to 2.35; assigned in-hospital CR: OR 1.47, 95% CI 0.91 to 2.36). Educational level showed similar tendencies, however not statistically significant. The results did not vary according to gender.

Conclusion

This is the first study to investigate the referral process to CR using a three-phase structure. It suggests income and education to influence all phases in the referral process to CR after ACS.

Erythema of the skin after breast radiotherapy: It is not always recurrence

Abstract

Recurrence of breast cancer is a predominant fear for patients who were treated for breast cancer. Acute and late dermatologic effects of radiotherapy are not uncommon and could have similar characteristics to breast cancer recurrence. Thus, it is important to highlight key differences between the clinical and histologic presentations of radiation effects and recurrence. Herein, we present two patients who presented with late dermatologic effects of radiotherapy months to years after treatment, neither of whom had workup consistent with cancer recurrence. We provide clinical and microscopic descriptions of each case and provide a review to differentiate various dermatologic conditions. This report aims to outline potential late dermatologic effects of radiation treatment and emphasise that changes in the breast do not always signal breast cancer recurrence.

Central Sensitisation and functioning in patients with chronic low back pain: protocol for a cross-sectional and cohort study

Por: Ansuategui Echeita · J. · Schiphorst Preuper · H. R. · Dekker · R. · Stuive · I. · Timmerman · H. · Wolff · A. P. · Reneman · M. F.
Introduction

A relevant subsample of patients with chronic low back pain (CLBP) have manifested augmented central pain processing, central sensitisation (CS). Patients with CLBP have limited functioning and participation. Theoretically, physical functioning in patients with CLBP can plausibly be linked to CS; however, evidence to explain such association is scarce. Moreover, there is no gold standard for CS diagnosis. The objectives of the study are: (1) to analyse the association between instruments assessing reference symptoms and signs attributed to CS; (2) to analyse whether reference symptoms and signs attributed to CS are associated with functioning measurement outcomes; and (3) to analyse whether changes (between baseline and discharge) in reference symptoms and signs attributed to CS are related to changes in each of the functioning measurement outcomes.

Methods and analysis

A cross-sectional and longitudinal observational study is performed with measurements taken at baseline and discharge of an interdisciplinary rehabilitation programme. A sample size of 110 adult patients with CLBP has been calculated for the study. CS measurements are: Central Sensitisation Inventory, quantitative sensory testing and heart rate variability. Functioning measurements are: lifting capacity, maximal aerobic capacity, accelerometry and reported functioning. Statistical analyses to be performed are: (1) correlation between CS measurements, (2) multiple regression between functioning (dependent variable) and CS measurements (independent variable), and (3) multiple regression between changes in scores of functioning (dependent variable) and CS measurements (independent variable), and corrected for sex and age.

Ethics and dissemination

The study obtained the clearance to its implementation from the Medical Research Ethics Committee of the University Medical Center Groningen in July 2017. The results will be disseminated through scientific publications in peer-reviewed journals, presentations at relevant conferences, and reports to stakeholders.

Trial registration number

NTR7167/NL6980.

Prospective, observational study to evaluate the relation between patient-reported outcomes and component rotation in total knee replacement: protocol for the CRACK study

Por: van Jonbergen · H.-P. · Landman · E. · Horst · M. · Westerbeek · R. · Kleinlugtenbelt · Y.
Introduction

Total knee replacement (TKR) for osteoarthritis results in a satisfactory outcome in the majority of patients, although up to one in five patients may be dissatisfied with the outcome. Persistent pain is a main contributor to patient dissatisfaction, and femoral and tibial component malrotation have been identified as a potential cause for both persistent pain and patellofemoral problems. Based on the assumption that component malrotation is the causative factor for persistent pain, early revision for patients with symptomatic malrotated components has been advocated in the literature. However, convincing evidence that component malrotation indeed results in less than optimal outcomes is lacking. This study aims to assess the relation between knee prosthesis component rotation and patient-reported outcomes in a large group of patients and to determine the range of femoral, tibial and combined rotation that results in the best clinical outcomes.

Methods and analysis

In this single-centre, prospective observational cohort study, a total of 500 patients will undergo TKR. All patients will have a 3D-CT assessment of femoral and tibial component rotation within 8 weeks after surgery. Outcome measures will include the Oxford Knee Score, the Knee Injury and Osteoarthritis Outcome Score, EQ-5D, visual analogue scale for pain, the American Knee Society Score and the knee joint range of motion. We will assess the relation between femoral, tibial and combined component rotation and patient-reported outcome measures at 8 weeks and 1 year of follow-up, and we will determine the range of femoral, tibial and combined rotation that results in the best clinical outcomes.

Ethics and dissemination

Ethical approval for this study has been granted by the Isala Hospital ethics committee. The results will be published in a peer-reviewed journal and presented at relevant meetings.

Trial registration number

NL7635.

Heart Rehabilitation in patients awaiting Open heart surgery targeting to prevent Complications and to improve Quality of life (Heart-ROCQ): study protocol for a prospective, randomised, open, blinded endpoint (PROBE) trial

Por: Hartog · J. · Blokzijl · F. · Dijkstra · S. · DeJongste · M. J. L. · Reneman · M. F. · Dieperink · W. · van der Horst · I. C. C. · Fleer · J. · van der Woude · L. H. V. · van der Harst · P. · Mariani · M. A.
Introduction

The rising prevalence of modifiable risk factors (eg, obesity, hypertension and physical inactivity) is causing an increase in possible avoidable complications in patients undergoing cardiac surgery. This study aims to assess whether a combined preoperative and postoperative multidisciplinary cardiac rehabilitation (CR) programme (Heart-ROCQ programme) can improve functional status and reduce surgical complications, readmissions and major adverse cardiac events (MACE) as compared with standard care.

Methods and analysis

Patients (n=350) are randomised to the Heart-ROCQ programme or standard care. The Heart-ROCQ programme consists of a preoperative optimisation phase while waiting for surgery (three times per week, minimum of 3 weeks), a postoperative inpatient phase (3 weeks) and an outpatient CR phase (two times per week, 4 weeks). Patients receive multidisciplinary treatment (eg, physical therapy, dietary advice, psychological sessions and smoking cessation). Standard care consists of 6 weeks of postsurgery outpatient CR with education and physical therapy (two times per week). The primary outcome is a composite weighted score of functional status, surgical complications, readmissions and MACE, and is evaluated by a blinded endpoint committee. The secondary outcomes are length of stay, physical and psychological functioning, lifestyle risk factors, and work participation. Finally, an economic evaluation is performed. Data are collected at six time points: at baseline (start of the waiting period), the day before surgery, at discharge from the hospital, and at 3, 7 and 12 months postsurgery.

Ethics and dissemination

This study will be conducted according to the principles of the Declaration of Helsinki (V.8, October 2013). The protocol has been approved by the Medical Ethical Review Board of the UMCG (no 2016/464). Results of this study will be submitted to a peer-reviewed scientific journal and can be presented at national and international conferences.

Trial registration number

NCT02984449.

Implementation strategies for interventions to improve the management of chronic kidney disease (CKD) by primary care clinicians: protocol for a systematic review

Por: Kamath · C. C. · Dobler · C. C. · Lampman · M. A. · Erwin · P. J. · Matulis · J. · Elrashidi · M. · McCoy · R. G. · Alsawaz · M. · Pajouhi · A. · Vasdev · A. · Shah · N. D. · Murad · M. H. · Thorsteinsdottir · B.
Introduction

There is a considerable implementation gap in managing early stage chronic kidney disease (CKD) in primary care despite the high prevalence and risk for increased morbidity and mortality associated with CKD. This systematic review aims to synthesise the evidence of efficacy of implementation interventions aimed at primary care practitioners (PCPs) to improve CKD identification and management. We further aim to describe the interventions’ behavioural change components.

Methods and analysis

We will conduct a systematic review of studies from 2000 to October 2017 that evaluate implementation interventions targeting PCPs and which include at least one clinically meaningful CKD outcome. We will search several electronic data bases and conduct reference mining of related systematic reviews and publications. An interdisciplinary team will independently and in duplicate, screen publications, extract data and assess the risk of bias. Clinical outcomes will include all clinically meaningful medical management outcomes relevant to CKD management in primary care such as blood pressure, chronic heart disease and diabetes target achievements. Quantitative evidence synthesis will be performed, where possible. Planned subgroup analyses include by (1) study design, (2) length of follow-up, (3) type of intervention, (4) type of implementation strategy, (5) whether a behavioural or implementation theory was used to guide study, (6) baseline CKD severity, (7) patient minority status, (8) study location and (9) academic setting or not.

Ethics and dissemination

Approval by research ethics board is not required since the review will only include published and publicly accessible data. Review findings will inform a future trial of an intervention to promote uptake of CKD diagnosis and treatment guidelines in our primary care setting and the development of complementary tools to support its successful adoption and implementation. We will publish our findings in a peer-reviewed journal and develop accessible summaries of the results.

PROSPERO registration number

CRD42018102441.

Efficacy and safety of cannabidiol followed by an open label add-on of tetrahydrocannabinol for the treatment of chronic pain in patients with rheumatoid arthritis or ankylosing spondylitis: protocol for a multicentre, randomised, placebo-controlled study

Por: Hendricks · O. · Andersen · T. E. · Christiansen · A. A. · Primdahl · J. · Hauge · E. M. · Ellingsen · T. · Horsted · T. I. · Bachmann · A. G. · Loft · A. G. · Bojesen · A. B. · Ostergaard · M. · Lund Hetland · M. · Krogh · N. S. · Roessler · K. K. · Petersen · K. H.
Introduction

Rheumatoid arthritis (RA) and ankylosing spondylitis (AS) are chronic, systemic, inflammatory diseases, primarily in the musculoskeletal system. Pain and fatigue are key symptoms of RA and AS. Treatment presents a clinical challenge for several reasons, including the progressive nature of the diseases and the involvement of multiple pain mechanisms. Moreover, side effects of pain treatment pose an implicit risk. Currently, no well-controlled studies have investigated how medical cannabis affects pain and cognitive functions in RA and AS. The present study aims to evaluate the efficacy and safety of medical cannabis in the treatment of persistent pain in patients with RA and AS with low disease activity.

Methods and analysis

A double-blinded, randomised, placebo-controlled study of cannabidiol (CBD), followed by an open label add-on of tetrahydrocannabinol (THC) with collection of clinical data and biological materials in RA and AS patients treated in routine care. The oral treatment with CBD in the experimental group is compared with placebo in a control group for 12 weeks, followed by an observational 12-week period with an open label add-on of THC in the primary CBD non-responders. Disease characteristics, psychological parameters, demographics, comorbidities, lifestyle factors, blood samples and serious adverse events are collected at baseline, after 12 and 24 weeks of treatment, and at a follow-up visit at 36 weeks. Data will be analysed in accordance with a predefined statistical analysis plan.

Ethics and dissemination

The Danish Ethics Committee (S-20170217), the Danish Medicines Agency (S-2018010018) and the Danish Data Protection Agency approved the protocol. The project is registered in the European Clinical Trials Database (EudraCT 2017-004226-15). All participants will give written informed consent to participate prior to any study-related procedures. The results will be presented at international conferences and published in peer-reviewed journals.

Feasibility and validity of the Health Status Classification System-Preschool (HSCS-PS) in a large community sample: the Generation R study

Por: Fang · X. · Bai · G. · Windhorst · D. A. · Feeny · D. · Saigal · S. · Duijts · L. · Jaddoe · V. W. V. · Hu · S. · Jin · C. · Raat · H.
Objectives

To evaluate the feasibility, discriminant validity and concurrent validity of the Health Status Classification System-Preschool (HSCS-PS) in children aged 3 years in a large community sample in the Netherlands.

Design/setting

A prospective population-based cohort in Rotterdam, the Netherlands.

Participants

A questionnaire was administrated to a sample of parents of 4546 children (36.7±1.5 months).

Outcome measures

Health-related quality of life (HRQOL) of children was measured by HSCS-PS. The HSCS-PS consists of 10 original domains. Two single-item measures of ‘General health’ and ‘Behavior’ were added. A disability score was calculated by summing up all 10 original domains to describe the overall health status. Feasibility was assessed by the response rate, percentages of missing answers, score distributions and the presence of floor/ceiling effects. Discriminant validity was analysed between subgroups with predefined conditions: low birth weight, preterm birth, wheezing, Ear-Nose-Throat surgical procedures and behaviour problems. In the absence of another HRQOL measure, this study uses the single-items ‘General health’ and ‘Behavior’ as a first step to evaluate concurrent validity of the HSCS-PS.

Results

Feasibility: response rate was 69%. Ceiling effects were observed in all domains. Discriminant validity: the disability score discriminated clearly between subgroups of children born with a ‘very low birth weight’, ‘very preterm birth’, with ‘four or more than four times wheezing’, ‘at least one ear-nose-throat surgical procedures’, ‘behaviour problems present’ and the ‘reference’ group. Concurrent validity: HSCS-PS domains correlated better with hypothesised parallel additional domains than with other non-hypothesised original domains.

Conclusions

This study supports the feasibility and validity of the HSCS-PS among preschoolers in community settings. We recommend developing a utility-based scoring algorithm for the HSCS-PS. Further empirical studies and repeated evaluations in varied populations are recommended.

Using Reflexive Thinking to Establish Rigor in Qualitative Research

imageBackground Reflexivity can be helpful in developing the methodological rigor necessary to attaining trustworthy qualitative study results. Objectives The aim of this study was to evaluate strategies of critical reflexive thinking during a qualitative enquiry rooted in a mixed-methods study. Methods Guided by the questions of Rolfe and colleagues from 2001 (“what,” “so what,” and “now what”), we applied reflexive thinking to all aspects of the investigation. Results Critical reflexive thinking strongly supported our efforts to establish methodological rigor and helped reveal shortcomings. Discussion Effective strategical use of reflexive thinking takes concerted effort. Both time and space are essential to applying reflexive thinking throughout the qualitative research process.
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