scholarly journals Improvement of perioperative care of the elderly patient (PeriAge): protocol of a controlled interventional feasibility study

BMJ Open ◽  
2019 ◽  
Vol 9 (11) ◽  
pp. e031837
Author(s):  
Cynthia Olotu ◽  
Lisa Lebherz ◽  
Martin Härter ◽  
Anna Mende ◽  
Lili Plümer ◽  
...  
Keyword(s):  
Postoperative Complications ◽  
Scientific Practice ◽  
Controlled Trial ◽  
The Elderly ◽  
Structured Interviews ◽  
Related Quality ◽  
Registration Number ◽  
Health Related ◽  
Randomised Controlled ◽  
Protocol Study

IntroductionGeriatric patients have a pronounced risk to suffer from postoperative complications. While effective risk-specific perioperative measures have been studied in controlled experimental settings, they are rarely found in routine healthcare. This study aims (1) to implement a multicomponent preoperative and intraoperative intervention, and investigate its feasibility, and (2) exploratorily assess the effectiveness of the intervention in routine healthcare.Methods and analysisFeasibility and exploratory effectiveness of the intervention will be investigated in a monocentric, prospective, non-randomised, controlled trial. The intervention includes systematic information for patients and family about measures to prevent postoperative complications; preoperative screening for frailty, malnutrition, strength and mobility with nutrient supplementation and physical exercise (prehabilitation) as needed. Further components focus on potentially inadequate medication, patient blood-management and carbohydrate loading prior to surgery, retainment of orientation aids in the operating room and a geriatric anaesthesia concept. Data will successively be collected from control, implementation and intervention groups. Patients aged 65+ with impending surgery will be included. A sample size of 240, n=80 per group, is planned. Assessments will take place at inclusion and 2, 30 and 180 days after surgery. Mixed-methods analyses will be performed. Exploratory effectiveness will be assessed using mixed segmented regressions. The primary endpoint is functional status. Secondary endpoints include cognitive performance, health-related quality of life, length of inpatient stay and occurrence of postoperative complications. Feasibility will be assessed through semi-structured interviews with staff and patients and quantitative analyses of the data quality, focussing on practicability, acceptance, adoption and fidelity to protocol.Ethics and disseminationThe study will be carried out in accordance with the Helsinki Declaration and to principles of good scientific practice. The Ethics Committee of the Medical Association Hamburg, Germany, approved the protocol (study ID: PV5596). Results will be disseminated in scientific journals and healthcare conferences.Trial registration numberClinicalTrials.gov Identifier: NCT03325413.

scholarly journals Estimating the minimum important difference in the DEMQOL instrument in people with dementia

2021 ◽  
Author(s):  
Ellen C. Lee ◽  
Jessica Wright ◽  
Stephen J. Walters ◽  
Cindy L. Cooper ◽  
Gail A. Mountain
Keyword(s):  
Quality Of Life ◽  
Controlled Trial ◽  
Minimum Important Difference ◽  
Absolute Change ◽  
People With Dementia ◽  
Related Quality ◽  
Registration Number ◽  
Clinically Significant ◽  
Randomised Controlled

Abstract Purpose The Dementia-Related Quality of Life (DEMQOL) measure and the DEMQOL-Utility Score (DEMQOL-U) are validated tools for measuring quality of life (QOL) in people with dementia. What score changes translate to a clinically significant impact on patients’ lives was unknown. This study establishes the minimal important differences (MID) for these two instruments. Methods Anchor-based and distribution-based methods were used to estimate the MID scores from patients enrolled in a randomised controlled trial. For the anchor-based method, the global QOL (Q29) item from the DEMQOL was chosen as the anchor for DEMQOL and both Q29 and EQ-5D for DEMQOL-U. A one category difference in Q29, and a 0.07 point difference in EQ-5D score, were used to classify improvement and deterioration, and the MID scores were calculated for each category. These results were compared with scores obtained by the distribution-based methods. Results A total of 490 people with dementia had baseline DEMQOL data, of these 386 had 8-month data, and 344 had 12-month DEMQOL data. The absolute change in DEMQOL for a combined 1-point increase or decrease in the Q29 anchor was 5.2 at 8 months and 6.0 at 12 months. For the DEMQOL-U, the average absolute change at 8 and 12 months was 0.032 and 0.046 for the Q29 anchor and 0.020 and 0.024 for EQ-5D anchor. Conclusion We present MID scores for the DEMQOL and DEMQOL-U instruments obtained from a large cohort of patients with dementia. An anchored-based estimate of the MID for the DEMQOL is around 5 to 6 points; and 0.02 to 0.05 points for the DEMQOL-U. The results of this study can guide clinicians and researchers in the interpretation of these instruments comparisons between groups or within groups of people with dementia. Trial Registration Number and date of registration: ISRCTN17993825 on 11th October 2016.

scholarly journals The ‘Cancer Home-Life Intervention’: A randomised controlled trial evaluating the efficacy of an occupational therapy–based intervention in people with advanced cancer

2018 ◽  
Vol 32 (4) ◽  
pp. 744-756 ◽  
Author(s):  
Marc Sampedro Pilegaard ◽  
Karen la Cour ◽  
Lisa Gregersen Oestergaard ◽  
Anna Thit Johnsen ◽  
Line Lindahl-Jacobsen ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Advanced Cancer ◽  
Controlled Trial ◽  
Health Related Quality ◽  
Home Life ◽  
Everyday Activities ◽  
Related Quality ◽  
Health Related ◽  
Randomised Controlled

Background: People with advanced cancer face difficulties with their everyday activities at home that may reduce their health-related quality of life. To address these difficulties, we developed the ‘Cancer Home-Life Intervention’. Aim: To evaluate the efficacy of the ‘Cancer Home Life-Intervention’ compared with usual care with regard to patients’ performance of, and participation in, everyday activities, and their health-related quality of life. Design and intervention: A randomised controlled trial ( ClinicalTrials.gov NCT02356627). The ‘Cancer Home-Life Intervention’ is a brief, tailored, occupational therapy–based and adaptive programme for people with advanced cancer targeting the performance of their prioritised everyday activities. Setting/participants: Home-living adults diagnosed with advanced cancer experiencing functional limitations were recruited from two Danish hospitals. They were assessed at baseline, and at 6 and 12 weeks of follow-up. The primary outcome was activities of daily living motor ability. Secondary outcomes were activities of daily living process ability, difficulty performing prioritised everyday activities, participation restrictions and health-related quality of life. Results: A total of 242 participants were randomised either to the intervention group ( n = 121) or the control group ( n = 121). No effect was found on the primary outcome (between-group mean change: −0.04 logits (95% confidence interval: −0.23 to 0.15); p = 0.69). Nor was any effect on the secondary outcomes observed. Conclusion: In most cases, the ‘Cancer Home-Life Intervention’ was delivered through only one home visit and one follow-up telephone contact, which not was effective in maintaining or improving participants’ everyday activities and health-related quality of life. Future research should pay even more attention to intervention development and feasibility testing.

Acupuncture for pain, mandibular function and oral health‐related quality of life in patients with masticatory myofascial pain: A randomised controlled trial

2020 ◽  
Vol 47 (10) ◽  
pp. 1193-1201
Author(s):  
Franklin Teixeira Salles‐Neto ◽  
Janice Simpson Paula ◽  
João Gabriel de Azevedo José Romero ◽  
Camila Megale Almeida‐Leite
Keyword(s):  
Quality Of Life ◽  
Oral Health ◽  
Randomised Controlled Trial ◽  
Myofascial Pain ◽  
Controlled Trial ◽  
Health Related Quality ◽  
Related Quality ◽  
Health Related ◽  
Randomised Controlled
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