Bone Pain in Multiple Myeloma (BPMM)—A Protocol for a Prospective, Longitudinal, Observational Study

Multiple myeloma (MM) is a bone marrow neoplasia that causes bone pain in 70% patients. While preclinical models of MM have suggested that both nerve sprouting and nerve injury may be causative for the pain, there is a lack of clinical data. Thus, the primary aims of this clinical study are: (1) to provide a deep characterization of the subjective experience of pain and quality of life in MM patients; (2) to investigate disturbances in the bone innervation of MM patients. Secondary aims include exploring correlations between pain and serum inflammatory and bone turnover biomarkers. In a prospective, observational study (clinicaltrials.gov: NCT04273425), patients with suspected MM requiring a diagnostic iliac crest biopsy at Sheffield Teaching Hospital (UK) are invited to participate. Consenting patients answer seven standardized questionnaires assessing pain, quality of life and catastrophizing. Bone turnover biomarkers and inflammatory cytokines are measured in fasting serum samples, and bone innervation is evaluated in diagnostic biopsies. MM patients are invited to a follow-up upon completion of first line treatment. This will be the first deep characterization of pain in MM patients and its correlation with disturbances in bone innervation. Understanding how bone turnover and inflammation correlate to pain in MM is crucial to identify novel analgesic targets for this condition.

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Changes in attitude towards LAI antipsychotic maintenance treatment: A two-year follow-up study

European Psychiatry ◽

10.1016/j.eurpsy.2018.06.002 ◽

2018 ◽

Vol 53 ◽

pp. 58-65 ◽

Cited By ~ 5

Author(s):

Francesco Pietrini ◽

Giulio D’Anna ◽

Lorenzo Tatini ◽

Gabriela Alina Talamba ◽

Costanza Andrisano ◽

...

Keyword(s):

Quality Of Life ◽

Maintenance Treatment ◽

Subjective Experience ◽

Open Label ◽

Sf 36 ◽

Patient Reported ◽

Long Acting ◽

Prospective Longitudinal

AbstractBackground:To present real-world evidence on the effects of switching from oral to long-acting injectable (LAI) antipsychotic maintenance treatment (AMT) in a sample of clinically stable patients with schizophrenia, with regard to subjective experience of treatment, attitude towards drug and quality of life.Methods:50 clinically stable adult schizophrenic outpatients were recruited. At the time of enrolment (T0), all patients were under a stabilized therapy with a single oral second-generation antipsychotic (SGA) and were switched to the equivalent maintenance regimen with the long-acting formulation of the same antipsychotic. 43 patients completed the 24-month prospective, longitudinal, open-label, observational study. Participants were assessed at baseline (T0), after 12 (T1) and 24 months (T2), using psychometric scales (PANSS, YMRS and MDRS) and patient-reported outcome measures (SWN-K, DAI-10 and SF-36).Results:The switch to LAI-AMT was associated with a significant clinical improvement at T1 and T2 compared to baseline (T0). All of the psychometric indexes, as well as patients’ subjective experience of treatment (SWN-K), and quality of life (SF-36) showed a significant improvement after one year of LAI-AMT, with stable results after two years. Patients’ attitude towards drug (DAI-10) increased throughout the follow-up period, with a further improvement during the second year.Conclusions:The switch to LAI-AMT may help to address the subjective core of an optimal recovery in stabilized schizophrenic patients. A sustained improvement in patients’ attitude towards drug may help to achieve patient’s compliance. The size of this study needs to be expanded to produce more solid and generalizable results.

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Myeloma bone disease: from biology findings to treatment approaches

Blood ◽

10.1182/blood-2018-11-852459 ◽

2019 ◽

Vol 133 (14) ◽

pp. 1534-1539 ◽

Cited By ~ 19

Author(s):

Evangelos Terpos ◽

Ioannis Ntanasis-Stathopoulos ◽

Meletios A. Dimopoulos

Keyword(s):

Quality Of Life ◽

Multiple Myeloma ◽

Bone Loss ◽

Bone Turnover ◽

Bone Disease ◽

Osteoclast Activity ◽

Myeloma Bone Disease ◽

Key Players ◽

Skeletal Related Events

Abstract Bone disease is a cardinal complication of multiple myeloma that affects quality of life and survival. Osteocytes have emerged as key players in the development of myeloma-related bone disease. Along with other factors, they participate in increased osteoclast activity, decreased osteoblast function, and immunosuppressed marrow microenvironment, which deregulate bone turnover and result in bone loss and skeletal-related events. Denosumab is a novel alternative to bisphosphonates against myeloma bone disease. Special considerations in this constantly evolving field are thoroughly discussed.

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Outcome measures for assessing change over time in studies of symptomatic children with hypermobility: a systematic review

10.21203/rs.3.rs-60935/v1 ◽

2020 ◽

Author(s):

Muhammad Maarj ◽

Andrea Coda ◽

Louise Tofts ◽

Cylie Williams ◽

Derek Santos ◽

...

Keyword(s):

Quality Of Life ◽

Observational Study ◽

Outcome Measures ◽

Joint Hypermobility ◽

Assessment Tools ◽

Post Intervention ◽

Associated Symptoms ◽

Prospective Longitudinal

Abstract Background This study aimed to synthesise outcome measure type and use in interventional or prospective longitudinal studies of children with generalised joint hypermobility (GJH) and associated symptoms. Method Electronic searches of Medline, CINAHL and Embase databases from inception to 16th March 2020 were performed for studies of children with GJH and symptoms between 5-18 years reporting repeated outcome measures collected at least 4 weeks apart. Methodological quality of eligible studies were described using the Downs and Black checklist.Results Six studies comprising of five interventional, and one prospective observational study (total of 388 children) met the inclusion criteria. Interventional study durations were between 2 to 3 months, with up to 10 months post-intervention follow-up, while the observational study spanned 3 years. Three main constructs of pain, function and quality of life were reported as primary outcome measures using 20 different instruments. All but one measure was validated in paediatric populations, but not specifically for children with GJH and symptoms. One study assessed fatigue, reporting disabling fatigue to be associated with higher pain intensity. Conclusions There were no agreed sets of outcome measures for children with GJH and symptoms found. The standardisation of assessment tools across paediatric clinical trials is needed. Four constructs of pain, function, quality of life and fatigue are recommended to be included with agreed upon, validated, objective tools

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Prospective longitudinal study on quality of life in relapsed/refractory multiple myeloma patients receiving second- or third-line lenalidomide or bortezomib treatment

Blood Cancer Journal ◽

10.1038/bcj.2017.20 ◽

2017 ◽

Vol 7 (3) ◽

pp. e543-e543 ◽

Cited By ~ 7

Author(s):

X Leleu ◽

C Kyriakou ◽

I Vande Broek ◽

P Murphy ◽

P Bacon ◽

...

Keyword(s):

Quality Of Life ◽

Multiple Myeloma ◽

Longitudinal Study ◽

Prospective Longitudinal Study ◽

Refractory Multiple Myeloma ◽

Bortezomib Treatment ◽

Third Line ◽

Prospective Longitudinal

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A prospective observational study to assess clinical decision-making, prognosis, quality of life and satisfaction with care in patients with relapsed/refractory multiple myeloma: the CLARITY study protocol

Health and Quality of Life Outcomes ◽

10.1186/s12955-018-0953-4 ◽

2018 ◽

Vol 16 (1) ◽

Cited By ~ 2

Author(s):

Fabio Efficace ◽

Mario Boccadoro ◽

Antonio Palumbo ◽

Maria Teresa Petrucci ◽

Francesco Cottone ◽

...

Keyword(s):

Quality Of Life ◽

Decision Making ◽

Multiple Myeloma ◽

Observational Study ◽

Study Protocol ◽

Prospective Observational Study ◽

Clinical Decision Making ◽

Clinical Decision ◽

Satisfaction With Care

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Physical, emotional and social pain communication by patients diagnosed and living with multiple myeloma

Pain Management ◽

10.2217/pmt-2021-0013 ◽

2021 ◽

Author(s):

Barry Quinn ◽

Heinz Ludwig ◽

Abigail Bailey ◽

Keerun Khela ◽

Andrea Marongiu ◽

...

Keyword(s):

Quality Of Life ◽

Multiple Myeloma ◽

Bone Pain ◽

Social And Emotional ◽

Pain Communication ◽

Questionnaire Version ◽

Related Quality ◽

Reported Data ◽

Pain Symptoms

Aim: To describe physical, social and emotional aspects of pain self-reported by patients with multiple myeloma (MM), and patient–physician communication of physical pain. Materials & methods: We analyzed self-reported data from 330 adults receiving anti-MM therapy in Germany and Italy on health-related quality of life (European Organisation for Research and Treatment of Cancer Quality of Life Core-30 Questionnaire version 3, -MY20) and bone pain symptoms. Results: Patients experienced clinically important physical (69%), emotional (58%) and social (22%) pain. Less than three-quarters of physicians’ records matched patients’ perception of bone pain (71.5%), with bone pain not recorded in 19.7% of patients experiencing it. Nearly half of physicians underestimated bone pain severity. Conclusion: Patients with MM experience physical, social and emotional pain. Discordance regarding bone pain symptoms and severity was observed, suggesting the need for improved communication.

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Quality of life in patients with multiple myeloma treated with percutaneous vertebroplasty

Coluna/Columna ◽

10.1590/s1808-185120141301rc105 ◽

2014 ◽

Vol 13 (1) ◽

pp. 53-56 ◽

Cited By ~ 1

Author(s):

Omar Jamit Bohsain

Keyword(s):

Quality Of Life ◽

Multiple Myeloma ◽

Bone Pain ◽

Hematological Malignancies ◽

Percutaneous Vertebroplasty ◽

Average Weight ◽

Initial Symptom ◽

Analog Scale ◽

Self Sufficiency

OBJECTIVE: To determine the quality of life in patients with multiple myeloma treated with vertebroplasty. Multiple myeloma has a prevalence of 1% in all neoplastic diseases and 10% of hematological malignancies. Bone pain is the initial symptom in most cases. METHODS: A series of cases study was conducted. Patients were assessed by the Karnofsky scale to measure its functionality, the WHO analgesic scale to assess the type of analgesic and visual analog scale (VAS) and the Oswestry questionnaire for pain. RESULTS: Of 24 patients, 10 were cases (vertebroplasty) (41.7%) and 14 were controls (conservative) (58.3%), 13 (54.2%) were female and 11 (45.8%) male, with an average age of 60 years (SD = 12) and 63 kg of average weight (SD = 12), mean height of 1.59 cm (SD = 9) and mean body mass index of 24.8 (SD = 3.7). Survival was obtained from the time of diagnosis to death, and 2 (8.3%) patients died within the first 2 years and 1 (4.2%) after 3 years. CONCLUSIONS: Patients with MM who have vertebral fractures are excellent candidates to undergo vertebroplasty, because this represents a greater benefit in their quality of life, which has a direct impact on their level of functionality, giving them greater self-sufficiency and reducing their pain because of the benefits of the thermogenic effect of vertebroplasty.

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Outcome measures for assessing change over time in studies of symptomatic children with hypermobility: a systematic review

BMC Pediatrics ◽

10.1186/s12887-021-03009-z ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Muhammad Maarj ◽

Andrea Coda ◽

Louise Tofts ◽

Cylie Williams ◽

Derek Santos ◽

...

Keyword(s):

Quality Of Life ◽

Observational Study ◽

Outcome Measures ◽

Prospective Observational Study ◽

Joint Hypermobility ◽

Assessment Tools ◽

Post Intervention ◽

Prospective Longitudinal

Abstract Background Generalised joint hypermobility (GJH) is highly prevalent among children and associated with symptoms in a fifth with the condition. This study aimed to synthesise outcome measures in interventional or prospective longitudinal studies of children with GJH and associated lower limb symptoms. Methods Electronic searches of Medline, CINAHL and Embase databases from inception to 16th March 2020 were performed for studies of children with GJH and symptoms between 5 and 18 years reporting repeated outcome measures collected at least 4 weeks apart. Methodological quality of eligible studies were described using the Downs and Black checklist. Results Six studies comprising of five interventional, and one prospective observational study (total of 388 children) met the inclusion criteria. Interventional study durations were between 2 and 3 months, with up to 10 months post-intervention follow-up, while the observational study spanned 3 years. Three main constructs of pain, function and quality of life were reported as primary outcome measures using 20 different instruments. All but one measure was validated in paediatric populations, but not specifically for children with GJH and symptoms. One study assessed fatigue, reporting disabling fatigue to be associated with higher pain intensity. Conclusions There were no agreed sets of outcome measures used for children with GJH and symptoms. The standardisation of assessment tools across paediatric clinical trials is needed. Four constructs of pain, function, quality of life and fatigue are recommended to be included with agreed upon, validated, objective tools.

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