Prospective multicenter study of quality of life before and after lower extremity vein bypass in 1404 patients with critical limb ischemia

Abstract Background Cell-based therapy is being explored as an alternative treatment option for critical limb ischemia (CLI), a disease associated with high amputation and mortality rates and poor quality of life. However, therapeutic potential of uncultured adipose-derived stromal vascular fraction (SVF) cells has not been evaluated as a possible treatment. In this pilot study, we investigated the efficacy of multiple injections of autologous uncultured adipose-derived SVF cells to treat patients with CLI. Methods This study included 15 patients, from 35 to 77 years old, with rest pain and ulceration. SVF cells were injected once or twice in the ischemic limb along the arteries. Digital subtraction angiography was performed before and after cell therapy. The clinical follow up was carried out for the subsequent 12 months after the beginning of the treatment. Results Multiple intramuscular SVF cell injections caused no complications during the follow-up period. Clinical improvement occurred in 86.7% of patients. Two patients required major amputation, and the amputation sites healed completely. The rest of patients achieved a complete ulcer healing, pain relief, improved ankle-brachial pressure index and claudication walking distance, and had ameliorated their quality of life. Digital subtraction angiography performed before and after SVF cell therapy showed formation of numerous vascular collateral networks across affected arteries. Conclusion Results of this pilot study demonstrate that the multiple intramuscular SVF cell injections stimulate regeneration of injured tissue and are effective alternative to achieve therapeutic angiogenesis in CLI patients who are not eligible for conventional treatment. Trial registration number at ISRCTN registry, ISRCTN13001382. Retrospectively registered at 26/04/2017.

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Patient Satisfaction and Quality of Life Before and After Treatment of Pancreatic and Periampullary Cancer: A Prospective Multicenter Study

Journal of the National Comprehensive Cancer Network ◽

10.6004/jnccn.2020.7528 ◽

2020 ◽

Vol 18 (6) ◽

pp. 704-711

Author(s):

Tara M. Mackay ◽

Lennart B. van Rijssen ◽

Jurr O. Andriessen ◽

Mustafa Suker ◽

Geert-Jan Creemers ◽

...

Keyword(s):

Quality Of Life ◽

Patient Satisfaction ◽

Multicenter Study ◽

Interpersonal Skills ◽

Information Provision ◽

Satisfaction With Care ◽

Periampullary Cancer ◽

Prospective Multicenter Study ◽

Before And After

Background: This study sought to assess patient satisfaction and quality of life (QoL) before and after treatment of pancreatic and periampullary cancer. Methods: We conducted a prospective multicenter study of patients treated for pancreatic and periampullary cancer. General patient satisfaction was measured using the EORTC satisfaction with care questionnaire (IN-PATSAT32) at baseline and 3 months after treatment initiation, with a 10-point change on the Likert scale considered clinically meaningful. QoL was measured using the EORTC Core Quality of Life Questionnaire (QLQ-C30). The influence of treatment (curative and palliative) on patient satisfaction and QoL was determined. Results: Of 100 patients, 71 completed follow-up questionnaires. General satisfaction with care decreased from 74.3 before treatment to 61.9 after treatment (P<.001), whereas global QoL increased from 68.4 to 71.4 (P=.39). Clinically meaningful reductions were also observed for the reported interpersonal skills of doctors (from 73.4 to 63.3) and exchange of information within the care team (from 63.5 to 52.5). Satisfaction scores were lower for patients treated with curative intent than for those treated with palliative intent regarding interpersonal skills of doctors (P=.01), information provision by doctors (P=.004), information provision by nurses (P=.02), availability of nurses (P=.004), exchange of information within the care team (P=.01), and hospital access (P=.02). In multivariable analysis, clinicopathologic or QoL factors were not independently associated with general patient satisfaction. Conclusions: Satisfaction with care, but not QoL, decreased after pancreatic cancer treatment. Improvements in communication and interpersonal skills are needed to maintain patient satisfaction after treatment.

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Faculty Opinions recommendation of Results of a prospective, multicenter study evaluating quality of life, safety, and efficacy of sacral neuromodulation at twelve months in subjects with symptoms of overactive bladder.

Faculty Opinions – Post-Publication Peer Review of the Biomedical Literature ◽

10.3410/f.725290982.793511674 ◽

2015 ◽

Author(s):

Marcus Drake

Keyword(s):

Quality Of Life ◽

Overactive Bladder ◽

Multicenter Study ◽

Sacral Neuromodulation ◽

Life Safety ◽

Prospective Multicenter Study ◽

Safety And Efficacy

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Critical Limb Ischemia and Its Impact on Patient Health Preferences and Quality of Life—An International Study

International Journal of Angiology ◽

10.1055/s-0032-1324738 ◽

2012 ◽

Vol 21 (03) ◽

pp. 139-146 ◽

Cited By ~ 1

Author(s):

Giovanni Pisa ◽

Thomas Reinhold ◽

Eliot Obi-Tabot ◽

Maria Bodoria ◽

Bernd Brüggenjürgen

Keyword(s):

Quality Of Life ◽

Critical Limb Ischemia ◽

International Study ◽

Limb Ischemia ◽

Patient Health

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Effect of Originator Infliximab Treatment on Disease-Related Hospitalizations, Work Productivity and Activity Impairment, and Health Resource Utilization in Patients with Crohn’s Disease in a Real-Life Setting: Results of a Prospective Multicenter Study in Germany

Inflammatory Intestinal Diseases ◽

10.1159/000512159 ◽

2020 ◽

pp. 1-13

Author(s):

Niels Teich ◽

Michael Bläker ◽

Frank Holtkamp-Endemann ◽

Eric Jörgensen ◽

Andreas Stallmach ◽

...

Keyword(s):

Quality Of Life ◽

Crohn’S Disease ◽

Crohn's Disease ◽

Multicenter Study ◽

Work Productivity ◽

Infliximab Treatment ◽

Prospective Multicenter Study ◽

Hospitalization Rates ◽

The Mean

Introduction: Infliximab (IFX) therapy is efficacious for inducing and maintaining symptomatic remission in patients with Crohn’s disease (CD), but whether this benefit results in reduced hospitalization rates and therefore may improve patients’ quality of life in an economically sensible way is conflicting so far. Methods: We conducted a noninterventional, multicenter, open-label, prospective study to evaluate the effect of originator IFX treatment on patient-reported outcomes and disease-related hospitalizations in adult CD patients in Germany treated for the first time with IFX according to label. Results: Two hundred and ninety-four patients were included in the study. We observed a statistically significant reduction in the number of CD-related hospitalizations from the year before baseline (mean 1.00 per patient, SD ± 0.93) to the mean value of the 1st (0.62, SD ± 0.95) and 2nd year (0.32, SD ± 0.75) of the observation period (p < 0.0001). After 3 months of IFX therapy, work productivity and activity increased by an average of 12.6 and 17.1%, respectively. Patient’s clinical outcome was markedly improved as the total CD activity index (CDAI) sum score continuously decreased from baseline to month 24 and the mean score of the total inflammatory bowel disease questionnaire (IBDQ) changed substantially from 141 at baseline to 172 after 24 months of IFX treatment. Additionally, the number of work incapacity days declined. Recently, no new safety issues of IFX have been identified. Conclusion: In this large, prospective, multicenter study on disease-related hospitalization rates, work productivity, capacity for daily activities, and HRQoL in patients with CD, IFX significantly reduces their hospitalization rates and improves work productivity, daily activity, and quality of life over 24 months.

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