FreshRSS

🔒
❌ Acerca de FreshRSS
Hay nuevos artículos disponibles. Pincha para refrescar la página.
AnteayerTus fuentes RSS

Changes in prescription of antidepressants and disability pension due to back pain, compared with other musculoskeletal and other somatic diagnoses: a cohort study in Sweden

Por: Ropponen · A. · Rahman · S. G. · Svedberg · P. · Helgesson · M. · Dorner · T. E. · Mittendorfer-Rutz · E.
Objectives

The aim was to investigate differences in the prescription of antidepressants during the transition to disability pension (DP) comparing DP due to back pain with DP due to other musculoskeletal and DP due to other somatic diagnoses.

Design

A population-based cohort study with follow-up 3 years before and after the event. Estimated prevalence and adjusted ORs with 95% CIs for antidepressant prescription were computed for the 7-year window (ie, t-3 to t+3) around the DP by generalised estimating equations for repeated measures.

Setting and participants

This Swedish population-based nationwide study with registry data included individuals aged 18–64 years, with DP due to back pain (n=2011), DP due to other musculoskeletal (n=3548) or DP due to other somatic diagnoses (n=11 809).

Primary outcome measures

Prescription of antidepressants.

Results

Before DP, the prevalence of prescription of antidepressants was stable in DP due to back pain, but increased for the other DP groups. Similarly, the likelihood of prescription increased only marginally before DP due to back pain (ORs from 0.86 at t-3 to 1.10 at t-1), but clearly in DP due to musculoskeletal (from 0.42 to 1.15) and somatic diagnoses (from 0.29 to 0.98). Both prevalence measures and risks remained at the elevated levels after DP.

Conclusions

Pathways to DP due to musculoskeletal and somatic diagnoses seem to be partly driven by adverse mental health, which remains at a higher level after DP. The increasing prescription of antidepressants prior to DP suggests that special attention should be paid to mental health for prevention of DP. The period after DP needs attention to avoid deterioration of mental health.

Adaptation of the DEMQOL-Proxy for routine use in care homes: a cross-sectional study of the reliability and validity of DEMQOL-CH

Por: Hughes · L. J. · Farina · N. · Page · T. E. · Tabet · N. · Banerjee · S.
Objective

To investigate the routine use of a measure of quality of life (QoL) in care homes and assess its psychometric properties when used by care staff.

Design

A cross-sectional two-phase study.

Setting and participants

Data were collected from care staff in seven care homes in East Sussex, England.

Method

Phase I: The ability of care staff from two care homes to use the DEMQOL-Proxy without interviewer administration was assessed using agreement analysis between a self-administered and interviewer-administered version of the instrument. Based on these findings, DEMQOL-Proxy was adapted into a new version, DEMQOL-CH, for use as a self-administered instrument in care homes. We assessed agreement between the new DEMQOL-CH and DEMQOL-Proxy to ensure DEMQOL-CH was used correctly. Phase II: A preliminary assessment of the psychometric properties of DEMQOL-CH when used routinely was completed in a further five care homes.

Results

Phase I: Nineteen care staff from two care homes completed QoL measurements for residents. Systematic error was identified when staff self-completed the DEMQOL-Proxy without an interviewer. We modified the DEMOoL-Proxy to create DEMQOL-CH; this reduced the error, producing a version that could be used more accurately by care staff. Phase II: Eleven care staff from five care homes rated resident QoL routinely. DEMQOL-CH showed acceptable psychometric properties with satisfactory reliability and validity and a clear factor structure.

Conclusions

The research presents positive preliminary data on the acceptability, feasibility and performance of routine QoL measurement in care homes using an adapted version of DEMQOL-Proxy, the DEMQOL-CH. Results provide evidence to support the concept that routine measurement of QoL may be possible in care homes. Research is needed to refine and test the methodology and instrument further and to explore the potential for benefits to residents, staff and care homes in larger and more representative populations.

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.

Clinical and Cost-effectiveness of a Comprehensive geriatric assessment and management for Canadian elders with Cancer--the 5C study: a study protocol for a randomised controlled phase III trial

Por: Puts · M. T. E. · Hsu · T. · Mariano · C. · Monette · J. · Brennenstuhl · S. · Pitters · E. · Ray · J. · Wan-Chow-Wah · D. · Kozlowski · N. · Krzyzanowska · M. · Amir · E. · Elser · C. · Jang · R. · Prica · A. · Krahn · M. · Beland · F. · Bergman · S. · Koneru · R. · Lemonde · M. · Szumacher
Introduction

Geriatric assessment and management is recommended for older adults with cancer referred for chemotherapy but no randomised controlled trial has been completed of this intervention in the oncology setting.

Trial design

A two-group parallel single blind multi-centre randomised trial with a companion trial-based economic evaluation from both payer and societal perspectives with process evaluation.

Participants

A total of 350 participants aged 70+, diagnosed with a solid tumour, lymphoma or myeloma, referred for first/second line chemotherapy, who speak English/French, have an Eastern Collaborative Oncology Group Performance Status 0–2 will be recruited. All participants will be followed for 12 months.

Intervention

Geriatric assessment and management for 6 months. The control group will receive usual oncologic care. All participants will receive a monthly healthy ageing booklet for 6 months.

Objective

To study the clinical and cost-effectiveness of geriatric assessment and management in optimising outcomes compared with usual oncology care.

Randomisation

Participants will be allocated to one of the two arms in a 1:1 ratio. The randomisation will be stratified by centre and treatment intent (palliative vs other).

Outcome

Quality of life.

Secondary outcomes

(1) Cost-effectiveness, (2) functional status, (3) number of geriatric issues successfully addressed, (4) grades3–5 treatment toxicity, (5) healthcare use, (6) satisfaction, (7) cancer treatment plan modification and (8) overall survival.

Planned analysis

For the primary outcome we will use a pattern mixture model using an intent-to-treat approach (at 3, 6 and12 months). We will conduct a cost-utility analysis alongside this clinical trial. For secondary outcomes 2–4, we will use a variety of methods.

Ethics and dissemination

Our study has been approved by all required REBs. We will disseminate our findings to stakeholders locally, nationally and internationally and by publishing the findings.

Trial registration number

NCT03154671.

Cardiovascular, antidepressant and immunosuppressive drug use in relation to risk of cutaneous melanoma: a protocol for a prospective case-control study

Por: Berge · L. A. M. · Andreassen · B. K. · Stenehjem · J. S. · Larsen · I. K. · Furu · K. · Juzeniene · A. · Roscher · I. · Heir · T. · Green · A. · Veierod · M. B. · Robsahm · T. E.
Introduction

The incidence of cutaneous melanoma (hereafter melanoma) has increased dramatically among fair-skinned populations worldwide. In Norway, melanoma is the most rapidly growing type of cancer, with a 47% increase among women and 57% among men in 2000–2016. Intermittent ultraviolet exposure early in life and phenotypic characteristics like a fair complexion, freckles and nevi are established risk factors, yet the aetiology of melanoma is multifactorial. Certain prescription drugs may have carcinogenic side effects on the risk of melanoma. Some cardiovascular, antidepressant and immunosuppressive drugs can influence certain biological processes that modulate photosensitivity and immunoregulation. We aim to study whether these drugs are related to melanoma risk.

Methods and analysis

A population-based matched case–control study will be conducted using nation-wide registry data. Cases will consist of all first primary, histologically verified melanoma cases diagnosed between 2007 and 2015 identified in the Cancer Registry of Norway (14 000 cases). Ten melanoma-free controls per case (on date of case melanoma diagnosis) will be matched based on sex and year of birth from the National Registry of Norway. For the period 2004—2015, and by using the unique personal identification numbers assigned to all Norwegian citizens, the case–control data set will be linked to the Norwegian Prescription Database for information on drugs dispensed prior to the melanoma diagnosis, and to the Medical Birth Registry of Norway for data regarding the number of child births. Conditional logistic regression will be used to estimate associations between drug use and melanoma risk, taking potential confounding factors into account.

Ethics and dissemination

The project is approved by the Regional Committee for Medical Research Ethics in Norway and by the Norwegian Data Protection Authority. The study is funded by the Southeastern Norway Regional Health Authority. Results will be published in peer-reviewed journals and disseminated further through scientific conferences, news media and relevant patient interest groups.

Cost-effectiveness of cell salvage and donor blood transfusion during caesarean section: results from a randomised controlled trial

Por: McLoughlin · C. · Roberts · T. E. · Jackson · L. J. · Moore · P. · Wilson · M. · Hooper · R. · Allard · S. · Wrench · I. · Beresford · L. · Geoghegan · J. · Daniels · J. · Catling · S. · Clark · V. A. · Ayuk · P. · Robson · S. · Gao-Smith · F. · Hogg · M. · Lanz · D. · Dodds · J. · Khan · K.
Objectives

To evaluate the cost-effectiveness of routine use of cell salvage during caesarean section in mothers at risk of haemorrhage compared with current standard of care.

Design

Model-based cost-effectiveness evaluation alongside a multicentre randomised controlled trial. Three main analyses were carried out on the trial data: (1) based on the intention-to-treat principle; (2) based on the per-protocol principle; (3) only participants who underwent an emergency caesarean section.

Setting

26 obstetric units in the UK.

Participants

3028 women at risk of haemorrhage recruited between June 2013 and April 2016.

Interventions

Cell salvage (intervention) versus routine care without salvage (control).

Primary outcome measures

Cost-effectiveness based on incremental cost per donor blood transfusion avoided.

Results

In the intention-to-treat analysis, the mean difference in total costs between cell salvage and standard care was £83. The estimated incremental cost-effectiveness ratio (ICER) was £8110 per donor blood transfusion avoided. For the per-protocol analysis, the mean difference in total costs was £92 and the ICER was £8252. In the emergency caesarean section analysis, the mean difference in total costs was £55 and the ICER was £13 713 per donor blood transfusion avoided. This ICER is driven by the increased probability that these patients would require a higher level of postoperative care and additional surgeries. The results of these analyses were shown to be robust for the majority of deterministic sensitivity analyses.

Conclusions

The results of the economic evaluation suggest that while routine cell salvage is a marginally more effective strategy than standard care in avoiding a donor blood transfusion, there is uncertainty in relation to whether it is a less or more costly strategy. The lack of long-term data on the health and quality of life of patients in both arms of the trial means that further research is needed to fully understand the cost implications of both strategies.

Trial registration number

ISRCTN66118656.

Profile of a population-based diabetic macular oedema study: the Liverpool Eye and Diabetes Study (Sydney)

Por: Liew · G. · Wong · V. W. · Saw · M. · Tsang · T. E. · Nolan · T. · Ong · S. · Ho · I.-V.
Purpose

The population prevalence of diabetic macular oedema (DME) is unclear. Previous estimates have depended on photographic grading of clinically significant macular oedema, which is subjective and has resulted in widely varying estimates. With the advent of optical coherence tomography (OCT), the presence and severity of DME can now be assessed objectively and accurately.

Methods

The Liverpool Eye and Diabetes Study (LEADS) is a cross-sectional population-based study of patients with type 1 and type 2 diabetes in a multi-ethnic region of Sydney, Australia, to determine the population prevalence of OCT-defined DME, how this varies by ethnicity and association with systemic factors. This report describes the rationale, methodology and study aims.

Results

To date 646 patients out of an expected sample size of 2000 have been recruited. Baseline data are presented for patients with type 1 (n=75, 11.8%) and type 2 (n=562, 88.2%) diabetes recruited to date. Patients with type 1 diabetes were younger (39.5vs60.7 years), with longer duration of diabetes (18.1vs11.7 years), slightly worse glycaemic control (HbA1c 9.0vs8.3), and less likely to have hypertension (30.7vs71.4%), hypercholesterolaemia (33.3vs74.6%) and obesity (31.1vs51.5%, respectively, all p

Conclusions

The LEADS will provide objective estimates of the population prevalence of DME, how this varies with ethnicity and associations with systemic disease.

Effects of exercise interventions on cardiovascular health in individuals with chronic, motor complete spinal cord injury: protocol for a randomised controlled trial [Cardiovascular Health/Outcomes: Improvements Created by Exercise and education in SCI (C

Por: Krassioukov · A. V. · Currie · K. D. · Hubli · M. · Nightingale · T. E. · Alrashidi · A. A. · Ramer · L. · Eng · J. J. · Ginis · K. A. M. · MacDonald · M. J. · Hicks · A. · Ditor · D. · Oh · P. · Verrier · M. C. · Craven · B. C.
Introduction

Recent studies demonstrate that cardiovascular diseases and associated complications are the leading cause of morbidity and mortality in individuals with spinal cord injury (SCI). Abnormal arterial stiffness, defined by a carotid–to-femoral pulse wave velocity (cfPWV) ≥10 m/s, is a recognised risk factor for heart disease in individuals with SCI. There is a paucity of studies assessing the efficacy of conventional training modalities on arterial stiffness and other cardiovascular outcomes in this population. Therefore, this study aims to compare the efficacy of arm cycle ergometry training (ACET) and body weight-supported treadmill training (BWSTT) on reducing arterial stiffness in individuals with chronic motor complete, high-level (above the sixth thoracic segment) SCI.

Methods and analysis

This is a multicentre, randomised, controlled, clinical trial. Eligible participants will be randomly assigned (1:1) into either ACET or BWSTT groups. Sixty participants with chronic (>1 year) SCI will be recruited from three sites in Canada (Vancouver, Toronto and Hamilton). Participants in each group will exercise three times per week up to 30 min and 60 min for ACET and BWSTT, respectively, over the period of 6 months. The primary outcome measure will be change in arterial stiffness (cfPWV) from baseline. Secondary outcome measures will include comprehensive assessments of: (1) cardiovascular parameters, (2) autonomic function, (3) body composition, (4) blood haematological and metabolic profiles, (5) cardiorespiratory fitness and (6) quality of life (QOL) and physical activity outcomes. Outcome measures will be assessed at baseline, 3 months, 6 months and 12 months (only QOL and physical activity outcomes). Statistical analyses will apply linear-mixed modelling to determine the training (time), group (ACET vs BWSTT) and interaction (time x group) effects on all outcomes.

Ethics and dissemination

Ethical approval was obtained from all three participating sites. Primary and secondary outcome data will be submitted for publication in peer-reviewed journals and widely disseminated.

Trial registration number

NCT01718977; Pre-results.

Trial status

Recruitment for this study began on January 2013 and the first participant was randomized on April 2013. Recruitment stopped on October 2018.

Haematological profile of chronic kidney disease in a mixed-ancestry South African population: a cross-sectional study

Por: George · C. · Matsha · T. E. · Erasmus · R. T. · Kengne · A. P.
Objectives

The objectives were to characterise the haematological profile of screen-detected chronic kidney disease (CKD) participants and to correlate the complete blood count measures with the commonly advocated kidney function estimators.

Methods

The current cross-sectional study used data, collected between February 2015 and November 2016, of 1564 adults of mixed-ancestry, who participated in the Cape Town Vascular and Metabolic Health study. Kidney function was estimated using the Modification of Diet in Renal Disease (MDRD) and Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equations. CKD was defined as estimated glomerular filtration rate (eGFR) 2, and anaemia as haemoglobin level

Results

Based on the MDRD and CKD-EPI equations, the crude prevalence of CKD was 6% and 3%. Irrespective of the equation used, median red blood cell (RBC) indices were consistently lower in those with CKD compared with those without CKD (all p

Conclusion

Though it remains unclear whether common kidney function estimators provide accurate estimates of CKD in Africans, the correlation of their estimates with deteriorating RBC profile, suggests that advocated estimators, to some extent approximate kidney function in African populations.

Triangulating abuse liability assessment for flavoured cigar products using physiological, behavioural economic and subjective assessments: a within-subjects clinical laboratory protocol

Por: Wall · C. S. · Bono · R. S. · Lester · R. C. · Hoetger · C. · Lipato · T. · Guy · M. C. · Eissenberg · T. E. · Bickel · W. K. · Barnes · A. J. · Cobb · C. O.
Introduction

In the USA, Food and Drug Administration regulations prohibit the sale of flavoured cigarettes, with menthol being the exception. However, the manufacture, advertisement and sale of flavoured cigar products are permitted. Such flavourings influence positive perceptions of tobacco products and are linked to increased use. Flavourings may mask the taste of tobacco and enhance smoke inhalation, influencing toxicant exposure and abuse liability among novice tobacco users. Using clinical laboratory methods, this study investigates how flavour availability affects measures of abuse liability in young adult cigarette smokers. The specific aims are to evaluate the effect of cigar flavours on nicotine exposure, and behavioural and subjective measures of abuse liability.

Methods and analyses

Participants (projected n=25) are healthy smokers of five or more cigarettes per day over the past 3 months, 18–25 years old, naive to cigar use (lifetime use of 50 or fewer cigar products and no more than 10 cigars smoked in the past 30 days) and without a desire to quit cigarette smoking in the next 30 days. Participants complete five laboratory sessions in a Latin square design with either their own brand cigarette or a session-specific Black & Mild cigar differing in flavour (apple, cream, original and wine). Participants are single-blinded to cigar flavours. Each session consists of two 10-puff smoking bouts (30 s interpuff interval) separated by 1 hour. Primary outcomes include saliva nicotine concentration, behavioural economic task performance and response to various questionnaire items assessing subjective effects predictive of abuse liability. Differences in outcomes across own brand cigarette and flavoured cigar conditions will be tested using linear mixed models.

Ethics and dissemination

The Virginia Commonwealth University Institutional Review Board approved the study (VCU IRB: HM20007848). Dissemination channels for study findings include scientific journals, scientific meetings, and policy briefs.

Trial registration number

NCT02937051.

Electronic PICO Posters Engage Students in Nursing Management

Worldviews on Evidence-Based Nursing, Volume 15, Issue 5, Page 409-410, October 2018.
❌