Clinical course and prognostic factors across different musculoskeletal pain sites: A secondary analysis of individual patient data from randomised clinical trials

Background: Holistic breathlessness services have been developed for people with advanced disease and chronic breathlessness, leading to improved psychological aspects of breathlessness and health. The extent to which patient characteristics influence outcomes is unclear. Aim: To identify patient characteristics predicting outcomes of mastery and distress due to breathlessness following holistic breathlessness services. Design: Secondary analysis of pooled individual patient data from three clinical trials. Our primary analysis assessed predictors of clinically important improvements in Chronic Respiratory Questionnaire mastery scores (+0.5 point), and our secondary analysis predictors of improvements in Numerical Rating Scale distress due to breathlessness (−1 point). Variables significantly related to improvement in univariate models were considered in separate backwards stepwise logistic regression models. Participants: The dataset comprised 259 participants (118 female; mean (standard deviation) age 69.2 (10.6) years) with primary diagnoses of chronic obstructive pulmonary disease (49.8%), cancer (34.7%) and interstitial lung disease (10.4%). Results: Controlling for age, sex and trial, baseline mastery remained the only significant independent predictor of improvement in mastery (odds ratio 0.57, 95% confidence intervals 0.43–0.74; p < 0.001), and baseline distress remained the only significant predictor of improvement in distress (odds ratio 1.64; 95% confidence intervals 1.35–2.03; p < 0.001). Baseline lung function, breathlessness severity, health status, mild anxiety and depression, and diagnosis did not predict outcomes. Conclusions: Outcomes of mastery and distress following holistic breathlessness services are influenced by baseline scores for these variables, and not by diagnosis, lung function or health status. Stratifying patients by levels of mastery and/or distress due to breathlessness appears appropriate for clinical trials and services.

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The effects of immunotherapy with intravenous immunoglobulins versus no intervention, placebo, or usual care in patients with recurrent miscarriages: a protocol for a systematic review with meta-analyses, trial sequential analyses, and individual patient data meta-analyses of randomised clinical trials

Systematic Reviews ◽

10.1186/2046-4053-3-89 ◽

2014 ◽

Vol 3 (1) ◽

Cited By ~ 4

Author(s):

Pia Egerup ◽

Jane Lindschou ◽

Christian Gluud ◽

Ole Bjarne Christiansen

Keyword(s):

Systematic Review ◽

Clinical Trials ◽

Usual Care ◽

Individual Patient Data ◽

Intravenous Immunoglobulins ◽

Patient Data ◽

Randomised Clinical Trials ◽

Recurrent Miscarriages ◽

Meta Analyses ◽

Sequential Analyses

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Development of a Prognostic Factor Prediction Model in Patients with Musculoskeletal Pain Treated with Homeopathy: An Individual Patient Data Meta-Analysis of Three Randomized Clinical Trials

Complementary Medicine Research ◽

10.1159/000508716 ◽

2020 ◽

pp. 1-9

Author(s):

Robbert van Haselen

Keyword(s):

Clinical Trials ◽

Prognostic Factor ◽

Prediction Model ◽

Musculoskeletal Pain ◽

Randomized Clinical Trials ◽

Individual Patient Data ◽

Meta Analysis ◽

Patient Data

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Efficacy of bisphosphonates in specific knee osteoarthritis subpopulations: protocol for an OA Trial Bank systematic review and individual patient data meta-analysis

BMJ Open ◽

10.1136/bmjopen-2018-023889 ◽

2018 ◽

Vol 8 (12) ◽

pp. e023889 ◽

Cited By ~ 2

Author(s):

Leticia A Deveza ◽

Sita M A Bierma-Zeinstra ◽

Willem Evert van Spil ◽

Win Min Oo ◽

Bruno T Saragiotto ◽

...

Keyword(s):

Clinical Trials ◽

Bone Turnover ◽

Knee Osteoarthritis ◽

Individual Patient Data ◽

Meta Analysis ◽

Patient Data ◽

Randomised Clinical Trials ◽

Control Group ◽

Cochrane Central Register ◽

Mineral Density

IntroductionRandomised clinical trials to date investigating the efficacy of bisphosphonates in knee osteoarthritis (OA) have found divergent results, with a recent meta-analysis finding no superiority of these drugs over placebo. Whether particular patient subgroups are more likely to benefit from this therapy than others is still unclear. We aim to investigate the effects of bisphosphonates compared with a control group (placebo, no treatment, another active treatment) on clinical and structural outcomes in specific knee OA subpopulations with possible distinct rates of subchondral bone turnover.Methods and analysisMedline, Embase, Scopus, Web of Sciences and Cochrane Central Register of Controlled Trials will be searched from inception to February 2018. Randomised clinical trials will be eligible if they reported at least one potential treatment effect modifier at baseline: gender, menopausal status, age, body mass index, radiographic stage, knee pain severity, presence of bone marrow lesions, levels of biochemical markers of bone turnover (serum and/or urinary) and systemic bone mineral density status. Authors of original trials will be contacted to obtain individual patient data from each study. Risk of bias will be assessed using the Cochrane Collaboration’s tool. The primary outcomes will include pain and radiographic joint space width loss. Studies using other MRI-based assessment of disease progression will also be eligible. Outcomes will be grouped into short-term (≤3 months), intermediate-term (>3 months; ≤12 months) and long-term (>12 months). Regression models will be used, adding an interaction term for each subgroup of interest to determine possible subgroup effects. There was no source of funding for this study.Ethics and disseminationDissemination of our findings is planned to occur through conference presentations, publication in peer-reviewed journals and social media. No formal ethics approval is generally required as no new data collection will be undertaken.PROSPERO registration numberCRD42018093327.

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