Patient reported adverse effects when switching from oral to subcutaneous administration of methotrexate – a prospective, multi-centre, paired cohort study

2021 ◽  
Author(s):  
Diernæs JEF ◽  
Kromann CB ◽  
Boel M ◽  
Bygum A ◽  
Jemec GBE
Keyword(s):  
Cohort Study ◽  
Adverse Effects ◽  
Subcutaneous Administration ◽  
Patient Reported

scholarly journals Subjective symptoms and serum methadone concentrations: what should guide dose adjustments in methadone maintenance treatment? A naturalistic cohort study from Norway

2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Fatemeh Chalabianloo ◽  
Lars Thore Fadnes ◽  
Gudrun Høiseth ◽  
Christian Ohldieck ◽  
Jørn Henrik Vold ◽  
...  
Keyword(s):  
Substance Use ◽  
Cohort Study ◽  
Adverse Effects ◽  
Methadone Maintenance Treatment ◽  
Maintenance Treatment ◽  
Methadone Maintenance ◽  
Opioid Withdrawal ◽  
Withdrawal Symptoms ◽  
Serum Concentrations ◽  
Patient Reported

Abstract Background There is little evidence-based guidance on how to optimize methadone dosages among patients with opioid addiction undergoing methadone maintenance treatment (MMT). This study aims to investigate whether self-perceived opioid withdrawal symptoms, adverse effects, and self-reported substance use in patients on MMT are related to serum methadone concentrations and the role that these variables could play in clinical decisions on dose adjustments. Methods This naturalistic prospective cohort study included clinical and laboratory measurements from 83 patients undergoing MMT in outpatient clinics in Bergen, Norway, from May 2017 to January 2020. Information on age, gender, methadone daily doses and serum concentrations, subjective opioid withdrawal symptoms using 16 items Subjective Opioid Withdrawal Scale (SOWS) questionnaire, self-reported adverse effects, and substance use was obtained. Linear mixed modelling was used for analyzing the data. Results The mean age of the participants was 45 years, and 33% were women. Almost half reported mild to moderate subjective opioid withdrawal symptoms, and all had experienced at least one subjective adverse effect. The use of at least one substance was reported by 88% of the participants. Serum concentration-to-dose ratios were lower among those who had reported subjective opioid withdrawal symptoms (p) = 0.039). The total SOWS score (p < 0.001); the specific subjective withdrawal symptoms of anxiety (p = 0.004), bone and muscle aches (p = 0.003), restlessness (p = 0.017), and (slightly) shaking (p = 0.046), also use of heroin (p = 0.015) and alcohol (p = 0.011) were associated with lower methadone concentrations. Cannabis use was slightly related to higher methadone concentrations (p = 0.049). Conclusions The findings suggest that the patient’s self-perceived symptoms and current clinical condition are related to the serum concentrations of methadone. This interpretation supports dose adjustments based on patient-reported symptoms. In some aberrant cases, measurement of serum concentrations together with other individual assessments may be considered to support the clinical decision.

scholarly journals The INTREST registry: protocol of a multicenter prospective cohort study of predictors of women’s response to integrative breast cancer treatment

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Heidemarie Haller ◽  
Petra Voiß ◽  
Holger Cramer ◽  
Anna Paul ◽  
Mattea Reinisch ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Cohort Study ◽  
Cancer Treatment ◽  
Prospective Cohort Study ◽  
Cancer Care ◽  
Prospective Cohort ◽  
Breast Cancer Treatment ◽  
Cancer Data ◽  
Patient Reported

Abstract Background Cancer registries usually assess data of conventional treatments and/or patient survival. Beyond that, little is known about the influence of other predictors of treatment response related to the use of complementary therapies (CM) and lifestyle factors affecting patients’ quality and quantity of life. Methods INTREST is a prospective cohort study collecting register data at multiple German certified cancer centers, which provide individualized, integrative, in- and outpatient breast cancer care. Patient-reported outcomes and clinical cancer data of anticipated N = 715 women with pTNM stage I-III breast cancer are collected using standardized case report forms at the time of diagnosis, after completing neo−/adjuvant chemotherapy, after completing adjuvant therapy (with the exception of endocrine therapy) as well as 1, 2, 5, and 10 years after baseline. Endpoints for multivariable prediction models are quality of life, fatigue, treatment adherence, and progression-based outcomes/survival. Predictors include the study center, sociodemographic characteristics, histologic cancer and comorbidity data, performance status, stress perception, depression, anxiety, sleep quality, spirituality, social support, physical activity, diet behavior, type of conventional treatments, use of and belief in CM treatments, and participation in a clinical trial. Safety is recorded following the Common Terminology Criteria for Adverse Events. Discussion This trial is currently recruiting participants. Future analyses will allow to identify predictors of short- and long-term response to integrative breast cancer treatment in women, which, in turn, may improve cancer care as well as quality and quantity of life with cancer. Trial registration German Clinical Trial Register DRKS00014852. Retrospectively registered at July 4th, 2018.

scholarly journals Australia IBD Microbiome (AIM) Study: protocol for a multicentre longitudinal prospective cohort study

BMJ Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. e042493
Author(s):  
Astrid-Jane Williams ◽  
Ramesh Paramsothy ◽  
Nan Wu ◽  
Simon Ghaly ◽  
Steven Leach ◽  
...  
Keyword(s):  
Cohort Study ◽  
Environmental Factors ◽  
Prospective Cohort Study ◽  
Clinical Data ◽  
Prospective Cohort ◽  
Response To Therapy ◽  
Psychological State ◽  
Local Health ◽  
Microbial Composition ◽  
Patient Reported

IntroductionCrohn’s disease and ulcerative colitis are common chronic idiopathic inflammatory bowel diseases (IBD), which cause considerable morbidity. Although the precise mechanisms of disease remain unclear, evidence implicates a strong multidirectional interplay between diet, environmental factors, genetic determinants/immune perturbations and the gut microbiota. IBD can be brought into remission using a number of medications, which act by suppressing the immune response. However, none of the available medications address any of the underlying potential mechanisms. As we understand more about how the microbiota drives inflammation, much interest has focused on identifying microbial signals/triggers in the search for effective therapeutic targets. We describe the establishment of the Australian IBD Microbiota (AIM) Study, Australia’s first longitudinal IBD bioresource, which will identify and correlate longitudinal microbial and metagenomics signals to disease activity as evaluated by validated clinical instruments, patient-reported surveys, as well as biomarkers. The AIM Study will also gather extensive demographic, clinical, lifestyle and dietary data known to influence microbial composition in order to generate a more complete understanding of the interplay between patients with IBD and their microbiota.MethodsThe AIM Study is an Australian multicentre longitudinal prospective cohort study, which will enrol 1000 participants; 500 patients with IBD and 500 healthy controls over a 5-year period. Assessment occurs at 3 monthly intervals over a 24-month period. At each assessment oral and faecal samples are self-collected along with patient-reported outcome measures, with clinical data also collected at baseline, 12 and 24 months. Intestinal tissue will be sampled whenever a colonoscopy is performed. Dietary intake, general health and psychological state will be assessed using validated self-report questionnaires. Samples will undergo metagenomic, transcriptomic, proteomic, metabolomic and culturomic analyses. Omics data will be integrated with clinical data to identify predictive biomarkers of response to therapy, disease behaviour and environmental factors in patients with IBD.Ethics and disseminationEthical approval for this study has been obtained from the South Eastern Sydney Local Health District Research Ethics Committee (HREC 2019/ETH11443). Findings will be reported at national and international gastroenterology meetings and published in peer-reviewed journals.Trial registration numberACTRN12619000911190.

scholarly journals What are the prevalence and predictors of psychosocial healthcare among patients with heart disease? A nationwide population-based cohort study

BMJ Open ◽  
2020 ◽  
Vol 10 (10) ◽  
pp. e037691
Author(s):  
Line Zinckernagel ◽  
Annette Kjær Ersbøll ◽  
Teresa Holmberg ◽  
Susanne S Pedersen ◽  
Helle Ussing Timm ◽  
...  
Keyword(s):  
Cohort Study ◽  
Heart Disease ◽  
Labour Force ◽  
Disease Onset ◽  
Psychosocial Rehabilitation ◽  
Female Gender ◽  
Population Based ◽  
Multivariable Logistic Regression Analysis ◽  
Patient Reported ◽  
Patients Experience

ObjectivesPsychosocial healthcare is recommended, but little is known about how patients perceive the level of care and whether subgroups of patients experience less psychosocial healthcare than others. We examined the prevalence of patient-reported psychosocial healthcare and factors predicting patient-reported lack of psychosocial healthcare among patients with heart disease.DesignA cohort study.SettingDenmark, nationwide.ParticipantsA registry-based random sample of 5000 patients with incident heart disease in 2013.MeasuresPatient-reported psychosocial healthcare was obtained from a survey and potential predictors before disease onset from registries. We used multivariable logistic regression analysis to determine predictors of patient-reported lack of care.ResultsWe received responses from 56%; 40% reported lacking information on psychosocial aspects, 51% lacking psychosocial rehabilitation and support and 32% reported lacking both types of psychosocial healthcare. The type of heart disease was the strongest predictor of patient-reported lack of psychosocial healthcare, especially among patients with atrial fibrillation (OR: 3.11–3.98). Older age (OR: 1.48–2.05), female gender (OR: 1.27–1.53) and no contact with general practitioner (OR: 1.47–1.84) also predicted patient-reported lack of psychosocial healthcare. Patients outside the labour force (OR: 1.29) and living in the capital region (OR: 1.50) more frequently reported lacking psychosocial rehabilitation and support, and patients with recent (OR: 1.63) or past (OR: 1.33) anxiety or depression and severe comorbidities (OR: 1.34) more frequently reported lacking both types of psychosocial healthcare.ConclusionsMany patients with heart disease reported lacking psychosocial healthcare. Importantly, patients who most need psychosocial healthcare are not those who report receiving it. Our results call for action to translate guidelines into clinical practice.

scholarly journals Prognosis and Course of Disability in Patients With Chronic Nonspecific Low Back Pain: A 5- and 12-Month Follow-up Cohort Study

2013 ◽  
Vol 93 (12) ◽  
pp. 1603-1614 ◽  
Author(s):  
Karin Verkerk ◽  
Pim A.J. Luijsterburg ◽  
Martijn W. Heymans ◽  
Inge Ronchetti ◽  
Annelies L. Pool-Goudzwaard ◽  
...  
Keyword(s):  
Cohort Study ◽  
Low Back Pain ◽  
Prognostic Factors ◽  
Back Pain ◽  
Short Form ◽  
Low Back ◽  
Multidisciplinary Therapy ◽  
Patient Reported ◽  
Specific Disability

Background Few data are available on the course of and predictors for disability in patients with chronic nonspecific low back pain (CNSLBP). Objective The purpose of this study was to describe the course of disability and identify clinically important prognostic factors of low-back-pain–specific disability in patients with CNSLBP receiving multidisciplinary therapy. Design A prospective cohort study was conducted. Methods A total of 1,760 patients with CNSLBP who received multidisciplinary therapy were evaluated for their course of disability and prognostic factors at baseline and at 2-, 5-, and 12-month follow-ups. Recovery was defined as 30% reduction in low back pain–specific disability at follow-up compared with baseline and as absolute recovery if the score on the Quebec Back Pain Disability Scale (QBPDS) was ≤20 points at follow-up. Potential prognostic factors were identified using multivariable logistic regression analysis. Results Mean patient-reported disability scores on the QBPDS ranged from 51.7 (SD=15.6) at baseline to 31.7 (SD=15.2), 31.1 (SD=18.2), and 29.1 (SD=20.0) at 2, 5, and 12 months, respectively. The prognostic factors identified for recovery at 5 and 12 months were younger age and high scores on disability and on the 36-Item Short-Form Health Survey (SF-36) (Physical and Mental Component Summaries) at baseline. In addition, at 5-month follow-up, a shorter duration of complaints was a positive predictor, and having no comorbidity and less pain at baseline were additional predictors at 12-month follow-up. Limitations Missing values at 5- and 12-month follow-ups were 11.1% and 45.2%, respectively. Conclusion After multidisciplinary treatment, the course of disability in patients with CNSLBP continued to decline over a 12-month period. At 5- and 12-month follow-ups, prognostic factors were identified for a clinically relevant decrease in disability scores on the QBPDS.

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