scholarly journals A quality indicator set for rehabilitation services for people with rheumatic and musculoskeletal diseases demonstrates adequate responsiveness in a pre–post evaluation

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Anne-Lene Sand-Svartrud ◽  
Gunnhild Berdal ◽  
Maryam Azimi ◽  
Ingvild Bø ◽  
Turid Nygaard Dager ◽  
...  
Keyword(s):  
Health Services ◽  
Musculoskeletal Diseases ◽  
Controlled Trial ◽  
Rehabilitation Services ◽  
Health Care Planning ◽  
Post Intervention ◽  
Bridge Program ◽  
Post Evaluation ◽  
Patient Reported

Abstract Background Quality of care is gaining increasing attention in research, clinical practice, and health care planning. Methods for quality assessment and monitoring, such as quality indicators (QIs), are needed to ensure health services in line with norms and recommendations. The aim of this study was to assess the responsiveness of a newly developed QI set for rehabiliation for people with rheumatic and musculoskeletal diseases (RMDs). Methods We used two yes/no questionnaires to measure quality from both the provider and patient perspectives, scored in a range of 0–100% (best score, 100%). We collected QI data from a multicenter stepped-wedge cluster-randomized controlled trial (the BRIDGE trial) that compared traditional rehabilitation with a new BRIDGE program designed to improve quality and continuity in rehabilitation. Assessment of the responsiveness was performed as a pre–post evaluation: Providers at rehabilitation centers in Norway completed the center-reported QIs (n = 19 structure indicators) before (T1) and 6–8 weeks after (T2) adding the BRIDGE intervention. The patient-reported QIs comprised 14 process and outcomes indicators, measuring quality in health services from the patient perspective. Pre-intervention patient-reported data were collected from patients participating in the traditional program (T1), and post-intervention data were collected from patients participating in the BRIDGE program (T2). The patient groups were comparable. We used a construct approach, with a priori hypotheses regarding the expected direction and magnitude of PR changes between T1 and T2. For acceptable responsivess, at least 75% of the hypotheses needed to be confirmed. Results All eight participating centers and 82% of the patients (293/357) completed the QI questionnaires. Responsiveness was acceptable, with 44 of 53 hypotheses (83%) confirmed for single indicators and 3 of 4 hypotheses (75%) confirmed for the sum scores. Conclusion We found this QI set for rehabilitation to be responsive when applied in rehabilitation services for adults with various RMD conditions. We recommend this QI set as a timely method for establishing quality-of-rehabilitation benchmarks, promoting important progress toward high-quality rehabilitation, and tracking trends over time. Trial registration The study is part of the larger BRIDGE trial, registered at ClinicalTrials.gov (Identifier: NCT03102814).

scholarly journals A Quality Indicator Set for Rehabilitation Services for People With Rheumatic and Musculoskeletal Diseases Demonstrates Adequate Responsiveness in A Pre–Post Evaluation

2020 ◽  
Author(s):  
Anne-Lene Sand-Svartrud ◽  
Gunnhild Berdal ◽  
Maryam Azimi ◽  
Ingvild Bø ◽  
Turid Dager ◽  
...  
Keyword(s):  
Health Services ◽  
Musculoskeletal Diseases ◽  
Controlled Trial ◽  
Rehabilitation Services ◽  
Health Care Planning ◽  
Post Intervention ◽  
Bridge Program ◽  
Post Evaluation ◽  
Patient Reported

Abstract Background: Quality of care is gaining increasing attention in research, clinical practice, and health care planning. Methods for quality assessment and monitoring, such as quality indicators (QIs), are needed to ensure health services in line with norms and recommendations. The aim of this study was to assess the responsiveness of a newly developed QI set for rehabiliation for people with rheumatic and musculoskeletal diseases (RMDs). Methods: We used two yes/no questionnaires to measure quality from both the provider and patient perspectives, scored in a range of 0%–100% (best score, 100%). We collected QI data from a multicenter stepped-wedge cluster-randomized controlled trial (the BRIDGE trial) that compared traditional rehabilitation with a new BRIDGE program designed to improve quality and continuity in rehabilitation. Assessment of the responsiveness was performed as a pre–post evaluation: Providers at rehabilitation centers in Norway completed the center-reported QIs (n=19 structure indicators) before (T1) and 6–8 weeks after (T2) adding the BRIDGE intervention. The patient-reported QIs comprised 14 process and outcomes indicators, measuring quality in health services from the patient perspective. Pre-intervention patient-reported data were collected from patients participating in the traditional program (T1), and post-intervention data were collected from patients participating in the BRIDGE program (T2). The patient groups were comparable. We used a construct approach, with a priori hypotheses regarding the expected direction and magnitude of PR changes between T1 and T2. For acceptable responsivess, at least 75% of the hypotheses needed to be confirmed. Results: All eight participating centers and 82% of the patients (293/357) completed the QI questionnaires. Responsiveness was acceptable, with 44 of 53 hypotheses (83%) confirmed for single indicators and 3 of 4 hypotheses (75%) confirmed for the sum scores. Conclusion: We found this QI set for rehabilitation to be responsive when applied in rehabilitation services for adults with various RMD conditions. We recommend this QI set as a timely method for establishing quality-of-rehabilitation benchmarks, promoting important progress toward high-quality rehabilitation, and tracking trends over time.Trial registration The study is part of the larger BRIDGE trial, registered at ClinicalTrials.gov (Identifier: NCT03102814)

A Tablet ‐ Based Intervention for Activating Nursing Home Residents with Dementia: Results from a Cluster-Randomised Controlled Trial

2020 ◽  
Author(s):  
Julie Lorraine O'Sullivan ◽  
Sonia Lech ◽  
Paul Gellert ◽  
Ulrike Grittner ◽  
Jan-Niklas Voigt-Antons ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Nursing Home ◽  
Nursing Homes ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Nursing Home Residents ◽  
Cluster Randomised Controlled Trial ◽  
Post Intervention ◽  
Randomised Controlled

Abstract Background: Non-pharmacological interventions (NPI) can improve cognitive and non-cognitive symptoms in nursing home residents living with dementia. However, delivery of suitable NPI can be challenging in everyday nursing home settings. Internet and communication technologies (ICT) may be promising tools for supporting NPI delivery in nursing homes. Methods: A two-arm cluster-randomised controlled trial was conducted to investigate global and momentary effects of a novel ICT-based NPI for nursing home residents with dementia. Ten nursing homes were randomly allocated to the tablet-based intervention (TBI) or conventional activity sessions (CAS) group (each with five nursing homes) between April 2016 and May 2017. A total of N = 162 participants received either regular TBI (n = 80) or CAS (n = 82) over a period of eight weeks. Linear mixed models were used to analyse group differences regarding the primary outcome apathy (AES-I), and secondary outcomes quality of life (QOL-AD, QUALIDEM), neuropsychiatric (NPI-NH, psychotropic medication) and depressive symptoms (GDS). Ecological Momentary Assessments (EMA) of quality of life were also conducted in both groups before and after each activity session.Results: No significant group difference in the change of apathy (AES-I score, primary outcome) was found post intervention (mean group difference: B = .19; 95% CI: -3.90 to 4.28, p = .93). Regarding secondary outcomes, a reduction of psychotropic medication was found for TBI compared to CAS (B = .42; 95% CI: .15 to .69, p < .01). Further analyses revealed a post-intervention improvement of informant-rated quality of life across both groups (B = 3.69; 95% CI: .68 to 6.69, p = .02). Analysis of EMA also rendered short-term post-session improvements of quality of life in the CAS group (B = .43; 95% CI: .30 to .57, p < .001). Conclusions: These findings suggest that NPI involving individually tailored activities have a beneficial impact on quality of life in nursing home residents with dementia. Although we found no clear advantage of TBI compared to CAS, ICT have the potential to support NPI delivery and facilitate regular assessments of fluctuating momentary states in nursing home residents with dementia. Trial registration: The trial was retrospectively registered with the ISRCTN registry (Trial registration number: ISRCTN98947160) on 01/09/2016 http://www.isrctn.com/ISRCTN98947160.

Efficacy of task-specific circuit training on physical activity levels and mobility of stroke patients: A randomized controlled trial

2020 ◽  
Vol 47 (4) ◽  
pp. 451-462
Author(s):  
Júlia Caetano Martins ◽  
Sylvie Nadeau ◽  
Larissa Tavares Aguiar ◽  
Aline Alvim Scianni ◽  
Luci Fuscaldi Teixeira-Salmela ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Physical Activity ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Post Intervention ◽  
Randomized Controlled ◽  
Secondary Outcomes ◽  
Experimental Group

BACKGROUND: Impaired mobility is related to low physical activity (PA) levels observed after stroke. Therapeutic approaches, such as task-specific circuit training (TSCT), used to improve mobility in individuals with stroke, could also improve PA levels. OBJECTIVE: To investigate the efficacy of TSCT, focused on both upper (UL) and lower (LL) limbs, in improving PA levels and mobility (primary outcomes), as well as muscle strength, exercise capacity, and quality of life (secondary outcomes) in subjects with stroke. METHODS: A randomized controlled trial with 36 subjects with chronic stroke was conducted. Experimental group: TSCT, involving both UL and LL. Control group: global stretching, memory exercises, and education sessions. Both groups received 60 minute sessions/week over 12 weeks. Outcomes were measured at baseline, post-intervention and 16 week follow-up. RESULTS: No changes were found for primary and secondary outcomes (0.11≤p≤0.99), except for quality of life, which improved in the experimental group post-intervention and 16 week follow-up (p = 0.02). CONCLUSION: TSCT focused on both UL and LL was not effective on PA levels and mobility of individuals with chronic stroke, however, improvements in quality of life were observed. Since this is the first study to investigate this combined training aimed at improving PA levels, future studies are necessary to better understand the impact of this type of intervention.

scholarly journals Matrix-Augmented Bone Marrow Stimulation With a Polyglycolic Acid Membrane With Hyaluronan vs Microfracture in Local Cartilage Defects of the Femoral Condyles: A Multicenter Randomized Controlled Trial

2020 ◽  
Vol 8 (5) ◽  
pp. 232596712092293
Author(s):  
Johannes Glasbrenner ◽  
Wolf Petersen ◽  
Michael J. Raschke ◽  
Matthias Steiger ◽  
René Verdonk ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Polyglycolic Acid ◽  
Tissue Formation ◽  
Bone Marrow Stimulation ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Patient Reported

Background: Microfracture (MF) is an established operative treatment for small, localized chondral defects of the knee joint. There is evidence from animal studies that matrix augmentation of bone marrow stimulation (m-BMS) can improve the quality of the repair tissue formation. Purpose: To evaluate the therapeutic outcome of a matrix made of polyglycolic acid and hyaluronan as compared with a conventional MF technique. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: Patients between the ages of 18 and 68 years who had an articular femoral cartilage defect of 0.5 to 3 cm2 in the weightbearing area of the femoral condyles with indication for MF were included in this study. Patients were randomized and treated with either MF or m-BMS with Chondrotissue. Defect filling, as assessed on magnetic resonance imaging (MRI), at postoperative 12 weeks was defined as the primary outcome measure, with follow-up MRI at weeks 54 and 108. Follow-up data were also collected at 12, 54, and 108 weeks after surgery and included patient-reported clinical scores: visual analog scale for pain, Knee injury and Osteoarthritis Outcome Score (KOOS), International Knee Documentation Committee score, and 36-Item Short Form Health Survey. Results: MRI scans confirmed cartilage repair tissue formation in both groups 12 weeks after treatment. There was no significant difference between the m-BMS and MF groups in the percentage of defect filling at 12, 54, and 108 weeks postoperatively. No significant difference was found in terms of patient-reported clinical scores. Both groups showed significant improvement in 4 KOOS subscales—Pain, Activities of Daily Living, Sport and Recreation, and Quality of Life—at 54 and 108 weeks after treatment. Conclusion: This is the first randomized controlled trial comparing m-BMS with a polyglycolic acid matrix with hyaluronan with MF. The use of the Chondrotissue implant in m-BMS has been proven to be a safe procedure. No difference was found between m-BMS and MF in terms of patient-reported outcome scores and MRI assessment until postoperative 2 years. Long-term follow-up studies including histological assessment are desirable for further investigation. Registration: EUCTR2011-003594-28-DE (EU Clinical Trials Register).

Automatic inpatient palliative care consultation (PCC): Too little, too late to impact quality of life for advanced cancer patients?

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e20565-e20565
Author(s):  
Gabrielle Betty Rocque ◽  
Toby Christopher Campbell ◽  
Anne Elizabeth Barnett ◽  
Renae M Quale ◽  
Jens C. Eickhoff ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Health Services ◽  
Cancer Patients ◽  
Advanced Cancer ◽  
Primary Outcome ◽  
Intervention Group ◽  
Control Group ◽  
Patient Reported ◽  
Small Patient Population

e20565 Background: Patients with advanced cancer who are hospitalized have high symptom burden and a short life expectancy, which may warrant PCC. Methods: Using sequential cohorts, we prospectively assessed implementation of automatic PCC for hospitalized cancer patients. The primary outcome was hospice utilization. Secondary outcomes included evaluation of changes in quality of life (FACIT-PAL), symptoms (ESAS), satisfaction (FAMCARE), and anxiety and depression (HADS). Surveys were administered at baseline, 2 weeks and 3 months post-hospitalization. Chart abstraction was utilized to assess demographics, resource use, and survival information. Results: Patients were evaluated consecutively (65 in the control group, 70 in the intervention). At admission, 91% reported uncontrolled symptoms: 52% pain; 15% dyspnea. 60% of intervention patients received PCC during their first admission. 54 patients completed surveys (29 control group, 25 PCC group), 64 patients declined or were unable to complete surveys, 16 patients were excluded due to language barriers, physician preference, or not receiving surveys. Using an intent-to-treat analysis, there was no difference between patients in the control and the intervention group in FACIT-PAL (119 ± 29 vs 123 ± 30, p = 0.68 ), ESAS (28 ± 14 vs 26 ± 15, p = 0.74) HADS (13 ± 6.6 vs. 12.± 4.7, p = 0.58), or FAMCARE (58 ± 9.1 vs 59 ± 8.6, p = 0.61). In both groups, patients had modest worsening of symptoms and quality of life over the course of the study. Survival and Health Services data analysis, including hospice referral, is proceeding. Conclusions: Automatic PPC had little impact on patient-reported symptoms and quality of life. Limitations included: small patient population; high rate of incomplete surveys, likely due to illness burden; penetration of the PCC was limited to 60% by patient or provider preference and consultant availability. Our primary outcome analysis (hospice utilization) is forthcoming, as are data on survival and Health Services outcomes.

Feasibility of olanzapine at reduced dose in highly emetogenic chemotherapy: A randomised controlled trial against aprepitant in triple therapy (FORESIGHT).

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 12087-12087
Author(s):  
Michelle Chen ◽  
Isabelle Baron ◽  
Stephanie Beaulieu ◽  
Annick Dufour ◽  
Nathalie Letarte ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Large Scale ◽  
Controlled Trial ◽  
Complete Response ◽  
Research Centre ◽  
Highly Emetogenic Chemotherapy ◽  
Patient Reported ◽  
Delayed Phase ◽  
Drug Prophylaxis

12087 Background: Olanzapine is used as an adjunct antiemetic in oncology as salvage therapy and in four-drug prophylaxis. Growing literature supports its effectiveness in initial three-drug prophylaxis in highly emetogenic chemotherapy (HEC). Methods: This prospective, multi-centre, open-label study evaluated the feasibility of a large-scale randomized controlled trial comparing the effectiveness and tolerability of 5 mg olanzapine once daily for four days (starting the night before chemotherapy) versus standard dose aprepitant (in tritherapy with standard ondansetron and dexamethasone) in treatment-naive patients receiving the first cycle of a HEC. Secondary outcomes included: complete response (no nausea, no emesis, no use of rescue medication), complete remission (no emesis, no rescue medication), intensity of patient-reported nausea and emesis on a visual analog scale, quality of life (scored with the Functional Living Index Emesis [FLIE]), and incidence of adverse events. Results: We randomized 30 patients in an intent-to-treat analysis. The large-scale trial was deemed not feasible without support from a research centre. Complete response rates were significantly higher in the olanzapine group in the delayed phase (24-120h post-chemotherapy) (86,7% v 21,4%, p < 0,001) and overall phase (0-120h post-chemotherapy) (60,0% v 21,4%, p = 0,04). Similar results were observed for complete remission. Intensity of patient-reported nausea was significantly lower in the olanzapine group in the delayed phase (p = 0,001). FLIE scores were significantly lower for the nausea domain (mean 62,3 v 60,9, p = 0,004) and overall score (124,3 v 108,8, p = 0,006). Depression on the ESAS-R was more common in the aprepitant group (0% v 38%, p = 0,01). Other adverse events were not significantly different. Conclusions: Support from a research centre must be ensured for study feasibility. Tritherapy olanzapine significantly improved complete response and remission in the delayed and overall phases post-chemotherapy among patients receiving HEC. It was also associated with higher quality of life and a reassuring safety profile. This feasibility trial, despite its small sample size, is one of the first prospective randomised trials to suggest similar efficacy of 5 mg olanzapine to aprepitant and to measure a difference in patient quality of life with this regimen. Clinical trial information: NCT04075955 .

Quality of Life after Balloon Angioplasty versus Stent Implantation in the Superficial Femoral Artery: Findings from a Randomized Controlled Trial

2007 ◽  
Vol 14 (4) ◽  
pp. 431-437 ◽  
Author(s):  
Schila Sabeti ◽  
Alfa Czerwenka-Wenkstetten ◽  
Petra Dick ◽  
Oliver Schlager ◽  
Jasmin Amighi ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Femoral Artery ◽  
Balloon Angioplasty ◽  
Superficial Femoral Artery ◽  
Stent Implantation ◽  
Controlled Trial ◽  
Limb Ischemia ◽  
Post Intervention ◽  
Primary Stenting

Purpose: To investigate whether primary nitinol stenting in the superficial femoral artery (SFA) is beneficial to patients' quality of life (QoL). Methods: One hundred four patients (55 men; mean age 66±19 years) with chronic limb ischemia and SFA disease were randomly assigned to primary stent implantation (n=51) or balloon angioplasty (n=53) with optional stenting for a suboptimal angioplasty result (17 of 53). QoL was measured by the SF-36 questionnaire at baseline and at 3, 6, and 12 months post intervention. Results: QoL was significantly improved post intervention and up to 12 months in both treatment groups. Significant inverse associations were observed between QoL parameters and restenosis. Comparing primary stenting (n=51) versus balloon angioplasty with optional stenting (n=53) by the intention to treat, no significant differences in QoL were observed. Analyses of stented patients (n=68) versus balloon angioplasty (n=36) patients, however, demonstrated significantly improved measures of QoL after stenting. Conclusion: Endovascular revascularization of SFA disease improves QoL, and restenosis negatively affects QoL outcomes. After stent implantation, whether primary or secondary, QoL was significantly ameliorated compared to balloon angioplasty alone. However, it remains to be proven in larger cohorts whether primary stenting yields a QoL benefit compared to balloon angioplasty with optional secondary stenting.

scholarly journals TANGO: effect of tango Argentino on cancer-associated fatigue in breast cancer patients—study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Shiao Li Oei ◽  
Thomas Rieser ◽  
Sarah Becker ◽  
Jessica Groß ◽  
Harald Matthes ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Sleep Quality ◽  
Cancer Patients ◽  
Negative Impact ◽  
Controlled Trial ◽  
Breast Cancer Patients ◽  
Argentine Tango ◽  
Patient Reported

Abstract Background The majority of breast cancer patients suffer from persistent impairments after completion of their primary oncological therapy. Cancer-related fatigue (CRF) in particular is a multidimensional syndrome having a profound negative impact on the quality of life. To counter CRF symptoms, physical activities are suggested as first-line interventions, mind-body therapies have been shown to be effective, and music therapy can also reduce anxiety and stress in breast cancer patients. Tango therapy that combines various elements can have an impact on physical, psychological, and cognitive abilities and could therefore have a beneficial effect on breast cancer patients. The purpose of this study is to investigate whether a 6-week tango module is suited as a therapeutic approach for people after primary breast cancer therapy to favorably influence their quality of life, especially CRF levels. Methods Sixty patients with a diagnosis for stage I–III breast cancer 12–48 months before enrollment and with CRF (age > 18) will be recruited and randomized 1:1 to a tango or a waiting-list group. Movement concepts using elements of Argentine tango (self-awareness, musical and spatial perception, self-perception, playfulness, shared experience) will be examined with the participants during six consecutive weekly 1-h tango sessions. The primary outcome will be the improvement of CRF (German version of the Cancer Fatigue Scale), and the secondary outcomes will be the improvement in sleep quality (Pittsburgh Sleep Quality Index) and quality of life (EORTC-QLQ-C30). Patient-reported outcomes will be measured at baseline and 6 weeks later; follow-up will be performed 6, 12, and 24 months after baseline. An evaluation will be performed by means of descriptive data analyses. Discussion Argentine tango, as a music-based movement therapy, can influence different skills and may improve several outcomes. The therapeutic use of Argentine tango in the care of breast cancer patients has not yet been reported. It is anticipated that participants receiving the tango module will have improved CRF, sleep, and quality of life scores compared to a waitlist control. Trial registration German Clinical Trials Registry (DRKS) DRKS00021601. Retrospectively registered on 21 August 2020

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