Development and Internal Validation of a Clinical Risk Score to Predict Pain Response After Palliative Radiation Therapy in Patients With Bone Metastases

Velden, Joanne M. van der; Peters, Max; Verlaan, Jorrit‐Jan; Versteeg, Anne; Zhang, Liying; Tsao, May; Danjoux, Cyril; Barnes, Elizabeth; Vulpen, Marco van; Chow, Edward; Verkooijen, Helena M.

doi:10.1016/j.ijrobp.2017.07.029

Cited by 22 publications

(38 citation statements)

References 40 publications

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“…Trials may be conducted in parallel with the cohort and across a wide range of patient and participant groups, as in Western Australia’s ORIGINS Project [ 12 ]; with appropriate consent, a cohort may subsequently provide pre-randomization (e.g., genetic) and some or all outcomes data for trials. A second model has been variously labelled Zelen trials [ 13 ], cohort multiple randomized controlled trials (cmRCTs) [ 3 , 14 ], and Trials Within Cohorts (TWiCS), as in England’s Born in Bradford Better Start cohort [ 7 ]. In TWiCS, cohort participants consent to contribute control data to future unspecified trials at recruitment into the cohort itself, with only participants randomly allocated to the intervention arm then asked for informed consent into any given TWiCs trial.…”

Section: Introductionmentioning

confidence: 99%

“…In TWiCS, cohort participants consent to contribute control data to future unspecified trials at recruitment into the cohort itself, with only participants randomly allocated to the intervention arm then asked for informed consent into any given TWiCs trial. Despite the potential for allocation bias, they can be efficient and achieve valid [ 14 ] and meaningful outcomes [ 15 , 16 ], and can evaluate the impact of ‘stacked’ interventions [ 7 ] approximating how parents and children naturalistically navigate needed services. A third potential model is that of master protocols as above that predefine from the outset and coordinate a set of trials that may occur.…”

Section: Introductionmentioning

confidence: 99%

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Integrating trials into a whole-population cohort of children and parents: statement of intent (trials) for the Generation Victoria (GenV) cohort

Wake

Warren

et al. 2020

BMC Med Res Methodol

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Background Very large cohorts that span an entire population raise new prospects for the conduct of multiple trials that speed up advances in prevention or treatment while reducing participant, financial and regulatory burden. However, a review of literature reveals no blueprint to guide this systematically in practice. This Statement of Intent proposes how diverse trials may be integrated within or alongside Generation Victoria (GenV), a whole-of-state Australian birth cohort in planning, and delineates potential processes and opportunities. Methods Parents of all newborns (estimated 160,000) in the state of Victoria, Australia, will be approached for two full years from 2021. The cohort design comprises four elements: (1) consent soon after birth to follow the child and parent/s until study end or withdrawal; retrospective and prospective (2) linkage to clinical and administrative datasets and (3) banking of universal and clinical biosamples; and (4) GenV-collected biosamples and data. GenV-collected data will focus on overarching outcome and phenotypic measures using low-burden, universal-capable electronic interfaces, with funding-dependent face-to-face assessments tailored to universal settings during the early childhood, school and/or adult years. Results For population or registry-type trials within GenV, GenV will provide all outcomes data and consent via traditional, waiver, or Trials Within Cohorts models. Trials alongside GenV consent their own participants born within the GenV window; GenV may help identify potential participants via opt-in or opt-out expression of interest. Data sharing enriches trials with outcomes, prior data, and/or access to linked data contingent on custodian’s agreements, and supports modeling of causal effects to the population and between-trials comparisons of costs, benefits and utility. Data access will operate under the Findability, Accessibility, Interoperability, and Reusability (FAIR) and Care and Five Safes Principles. We consider governance, ethical and shared trial oversight, and expectations that trials will adhere to the best practice of the day. Conclusions Children and younger adults can access fewer trials than older adults. Integrating trials into mega-cohorts should improve health and well-being by generating faster, larger-scale evidence on a longer and/or broader horizon than previously possible. GenV will explore the limits and details of this approach over the coming years.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Integrating trials into a whole-population cohort of children and parents: statement of intent (trials) for the Generation Victoria (GenV) cohort

Wake

Warren

et al. 2020

BMC Med Res Methodol

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show abstract

“…Although it is well known that histology, performance status, and baseline pain scores are predictive for pain response, our response rates after 3DCRT were higher than those reported in nonoligometastatic patients. 41 This reflects the favorable profile of patients with oligometastatic disease, leaving less room for improvement by SBRT. Furthermore, for the assessment of pain response we excluded all patients with no pain at baseline, which limited the number of patients for analyses.…”

Section: [46%]mentioning

confidence: 99%

Patient-Reported Outcomes of Oligometastatic Patients After Conventional or Stereotactic Radiation Therapy to Bone Metastases: An Analysis of the PRESENT Cohort

Ven

Bongard

Pielkenrood

et al. 2020

International Journal of Radiation Oncology*Biology*Physics

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This study shows the paradigm shift toward radical treatment in oligometastastic disease. Survival outcomes of patients with oligometastates are improving, and therefore optimization of palliative care is needed. Clinical local control rates are higher after stereotactic body radiation therapy to bone metastastes compared with conventional radiation therapy, but stereotactic body radiation therapy does not improve pain response or quality of life in oligometastastic patients. Purpose: Stereotactic body radiation therapy (SBRT) has become a widely adopted treatment for patients with oligometastatic disease, despite limited evidence of superiority. We compared pain response and quality of life (QoL) in patients with oligometastatic disease treated with conventionally fractionated 3-dimensional radiation therapy (3DCRT) or SBRT to bone metastases. Methods and Materials: We included patients with oligometastatic disease (5 lesions within 3 organs) treated within the prospective PRESENT cohort. Main outcomes were pain response, clinical local control, and QoL 2, 4, and 8 weeks and 3, 6, and 12 months after treatment. Pain response was assessed only in patients who reported pain at baseline and was defined according to international consensus criteria. Results: Of 131 patients with oligometastatic disease, 66 patients were treated with 3DCRT and 65 patients with SBRT. A pain response was achieved in 81% (3DCRT) versus 84% (SBRT) with a median duration of 23 weeks (range, 1-58) and 24 weeks (range, 0-50), respectively. Reirradiation was needed in 33% versus 5% of the patients, respectively. None of the QoL subscales were significantly different between both groups. Conclusions: In patients with oligometastatic disease, SBRT to bone metastases did not improve pain response or QoL compared with 3DCRT. Reirradiation was less often needed in the SBRT group.

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“…Use of the imputation of variables method has been used previously to account for missing variables and has been reported to eliminate potential selection bias that can arise from using complete case analysis. [41][42][43]…”

Section: Limitations and Strengthsmentioning

confidence: 99%

Preoperative Hyponatremia is a Risk Factor for Adverse 30-Day Outcomes Following Total Hip Arthroplasty

et al. 2020

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The relationship between preoperative hyponatremia and 30-day outcomes following total hip arthroplasty (THA) is currently unknown. The present study used prospectively collected data to quantify the association between preoperative hyponatremia and odds of major morbidity (MM), longer length of stay, readmission, and reoperation within 30 days following THA. Patients who underwent THA between 2012 and 2014 were identified in the National Surgical Quality Improvement Program database using validated Current Procedural Terminology codes. Patients were included if they were either normonatremic or hyponatremic preoperatively. The outcome measures in this study were 30-day MM, hospital length of stay, 30-day readmission, and 30-day reoperation. A unique multivariable logistic regression model was used for each outcome to identify statistically significant associations between hyponatremia and the outcome of interest after adjusting for covariates. From 2012 to 2014, 59,236 THA procedures were recorded in National Surgical Quality Improvement Program, of which 55,611 patients were normonatremic and 3,051 patients were hyponatremic. After adjusting for covariates, preoperative hyponatremia was significantly associated with increased odds of MM (odds ratio [OR] = 1.14; 99% confidence interval [CI]: 1.01–1.30), 30-day reoperation (OR = 1.18; 99% CI: 1.02–1.36), and longer hospital length of stay (OR = 1.20; 99% CI: 1.13–1.27). Hyponatremia was not significantly associated with greater odds of 30-day readmission (OR = 0.91; 99% CI: 0.82–1.01). Preoperative hyponatremia was significantly associated with adverse 30-day outcomes following THA. As the U.S. health care system continues to transition toward value-based reimbursement that emphasizes health care quality, the results of the present study can be used to improve patient selection and preoperative counseling.

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Development and Internal Validation of a Clinical Risk Score to Predict Pain Response After Palliative Radiation Therapy in Patients With Bone Metastases

Cited by 22 publications

References 40 publications

Integrating trials into a whole-population cohort of children and parents: statement of intent (trials) for the Generation Victoria (GenV) cohort

Integrating trials into a whole-population cohort of children and parents: statement of intent (trials) for the Generation Victoria (GenV) cohort

Patient-Reported Outcomes of Oligometastatic Patients After Conventional or Stereotactic Radiation Therapy to Bone Metastases: An Analysis of the PRESENT Cohort

Preoperative Hyponatremia is a Risk Factor for Adverse 30-Day Outcomes Following Total Hip Arthroplasty

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