Assessing meaningful change over time in quality of life: A user's guide for clinicians

e20635 Background: Osseous metastases in patients suffering from cancer, is a multifactor symptom which affects quality of life. Methods: The Samarium group (SG) n=53 patients received a single bolus infusion of (153)Sm (37 MBq/kg), and we compared with a Control group(CG) n=37. Both groups of patients who had metastatic bone cancer requiring analgesia answered the following questionnaires: Greek Brief Pain Inventory (GBPI), Brief Multidimensional Life Satisfaction Scale (BMLSS), Hospital Anxiety Depression Scale (HADS), ECOG/WHO/Zubrod score and Hospital Satisfaction Scale (HSS),day 0 and 30±3 days after the intervention start.There was no statistically significant(SS) difference for the variables(V-) sex, age, pain’s localization and lodging. Results: Pain severity and pain interference change over time was the same for both groups P= 0.0005. For the V- HADS-anxiety, SG showed no SS improvementP= 0.397, something which was achieved for the CG,P= 0.031. The V- HADS improved SS for both groups P= 0.031 and P= 0.003 respectively which changed over time with the same way. This may show the strong relation between pain and depression. The V- ECOG also changed over time in the same way for both SG(P=0.005) and CG (P=0.014). The percentage of patients who changed scale towards improvement for their quality of life was 24,3% for the CG and 15,1% for the SG. The V-BMLSS change over time was similar for both groups. There was no SS difference for the V-HSS towards medical and nursing personnel for both groups (P=1.000). Myelotoxicity for the SG was moderate and reversible, as well as the side effects for the CG. Finally an equivalence test between the two groups, showing that both treatment regimens were equivalent for all variables: Pain severity=0.034, Pain interference=0.009, HAD-anxiety P=0.048, HAD-depression=0.033, BMLSS=0.016, ECOG=0.0005. During our study among the patients of the SG in some cases the stabilization of bone lesions was observed, and in one case partial and/or complete remission. Conclusions: Administration of (153)Sm is another equivalent option for those patients who are intolerant or resistant to medication treatment having a better cost-effectiveness result.

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Ultramicronized Palmitoylethanolamide (um-PEA) as Add-on Treatment in Fibromyalgia Syndrome (FMS): Retrospective Observational Study on 407 Patients

CNS & Neurological Disorders - Drug Targets ◽

10.2174/1871527318666190227205359 ◽

2019 ◽

Vol 18 (4) ◽

pp. 326-333 ◽

Cited By ~ 9

Author(s):

Vittorio Schweiger ◽

Alvise Martini ◽

Paola Bellamoli ◽

Katia Donadello ◽

Carlo Schievano ◽

...

Keyword(s):

Quality Of Life ◽

Observational Study ◽

Fibromyalgia Syndrome ◽

Fibromyalgia Impact Questionnaire ◽

Retrospective Observational Study ◽

Visual Analogue Scale Pain ◽

Change Over Time ◽

Ultramicronized Palmitoylethanolamide ◽

Over Time

Background: Fibromyalgia syndrome is a chronic multifaceted disease characterized by widespread pain, muscle stiffness, fatigue, unrefreshing sleep and cognitive disorders. To date, no medication has been shown to significantly improve pain, associated symptoms and Quality of Life in fibromyalgic patients. Methods: In this retrospective observational study, we analyzed data regarding 407 patients with diagnosis of fibromyalgia syndrome who between 2013 and 2016 have been prescribed orally ultramicronized palmitoylethanolamide tablets (Normast® Epitech Group SpA, Saccolongo, Italy) regardless of the concomitant pharmacological therapy (add-on treatment). Results: Regarding efficacy, in the 359 analyzed patients, the change over time in Visual Analogue Scale pain score was statistically significant, ranging from 75.84 (±15.15) to 52.49 (±16.73) (p<0.001). Regarding quality of life, the change over time in Fibromyalgia Impact Questionnaire score was statistically significant, ranging from 68.4 (±14.1) to 49.1 (±19.6) (p<0.001). In the treated population, only 36 patients (13,7%) reported Adverse Events predominantly of gastrointestinal type (diarrhea, dyspepsia, bloating, constipation, vomiting). Globally, 151 patients (57,63%) left the treatment due to inefficacy. Conclusion: The results of ultramicronized palmitoylethanolamide treatment in this retrospective analysis represent an important step for the development of a new and well-tolerated therapy for fibromyalgia syndrome, mostly suitable for these patients who need long-term treatments. Further methodologically stronger studies will be necessary to validate our observation.

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Symptom burden, health-related quality of life, and treatment preference over time as reported by patients with metastatic colorectal cancer (mCRC).

Journal of Clinical Oncology ◽

10.1200/jco.2015.33.29_suppl.82 ◽

2015 ◽

Vol 33 (29_suppl) ◽

pp. 82-82

Author(s):

Amy Little Jones ◽

Nrupen Anjan Bhavsar ◽

Amy Pickar Abernethy ◽

Yousuf Zafar

Keyword(s):

Quality Of Life ◽

Pilot Study ◽

Life Expectancy ◽

Symptom Burden ◽

Treatment Preference ◽

Change Over Time ◽

Limited Life Expectancy ◽

Limited Life ◽

Over Time

82 Background: Clinicians have difficulty predicting longitudinal changes in patient symptom burden and quality of life, and then how those changes might affect treatment preference. The primary aim of this pilot study was to investigate how self-reported symptom burden, quality of life, and treatment preference change over time in mCRC patients with limited life expectancy. Methods: Eligible mCRC patients had incurable disease, received chemotherapy at Duke or Duke Raleigh, were > = 18 years old, and spoke English. Patients were surveyed at each clinic visit and followed for up to 3.8 years on study. Measures included FACT-C (Functional Assessment of Cancer Therapy-Colorectal), PCM (Patient Care Monitor; a validated, 87-item review of systems survey; items measured on a 0-10 scale), and QQQ (Quality-Quantity Questionnaire; a validated, 8-item measure of cancer patient preference for quantity vs. quality of life; items measured on a 1-5 Likert scale). Demographic, disease, and treatment data were abstracted from the medical record. Results: The 56 patients were primarily male (68%) and Caucasian (79%) with a mean age of 55 at diagnosis of metastatic disease. Patients answered surveys a mean of 6.8 times each, with a median 364 days between first and last surveys. Over time, patients reported most symptoms improved or stayed the same (72%, n = 63 symptoms). Mean symptom scores that improved the most from first to last survey were fatigue (3.92 to 3.03) and nausea (2.1 to 1.4), while pain (1.9 to 2.5) and cough (0.4 to 0.7) worsened the most. Decision making about treatment preference also did not change over time, with mean QQQ scores from first survey (22, n = 28) to last survey (22, n = 16) remaining stable. Mean QQQ length and quality scores likewise were unchanged (12.9 to 12.8; 12.4 to 12.2 respectively). Conclusions: In this pilot study of mCRC patients with limited life expectancy, reported symptom burden scores remained stable or modestly improved over time, while preferences for quality vs. quantity of life remained stable. These findings suggest that patients with advanced cancer might perceive symptom burden differently over the course of their treatment.

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