Assessment Of Health Status In Patients Research Articles

A phase II trial of cemiplimab alone or in combination with standard of care chemotherapy in locally advanced or metastatic penile carcinoma (EPIC trial).

TPS14 Background: Penile cancer is rare, <1% of male malignancies diagnosed each year, but its incidence is increasing with an 18% increase over the last decade projected to rise a further 9% in the next 10 years. Patients with locally advanced/metastatic penile cancer (la/mPC) have very few treatment options and there is a lack of clinical trial data to guide management. Cisplatin containing combination chemotherapy regimens are regarded as the standard of care (SOC) in this setting. However, with response rates of 50% or less there is a need to further improve treatment outcomes. PDL1 is upregulated in 40–60% of PC cases and is correlated with poor prognosis making a case for immunotherapy as a treatment for la/mPC. The PD-1 inhibitor cemiplimab is approved for patients with locally advanced or metastatic cutaneous squamous cell carcinoma (SCC) suggesting efficacy against penile SCC. The EPIC trial was set up to evaluate the benefit and safety of cemiplimab alone, or, in combination with SOC chemotherapy in patients with la/mPC. Methods: This is a non-randomised, 2 arm, phase II multi-centre trial. Arm 1 cemiplimab + SOC chemotherapy (local site choice of cisplatin/5FU, TPF or TIP regimes); Arm 2 single agent cemiplimab. The choice of arm decided by the investigator site based on chemotherapy eligibility. 47 patients will be recruited from 10 UK centres: 29 patients into ARM 1 who will receive 4 cycles of cemiplimab 350mg IV q3 weekly + SOC chemotherapy, followed by single agent cemiplimab x 30 cycles (24 months total). 18 patients into ARM 2 who will receive single agent cemiplimab 350mg IV q3 weekly x 34 cycles (24 months total). The primary endpoint is clinical benefit rate (CBR) of cemiplimab: objective response rate (ORR) plus stable disease as assessed radiologically (RECIST 1.1) at 12 weeks from first dose in patients with la/mPC. Secondary end-points include safety, tolerability, CBR at 1, 2 and 3 years, ORR, progression-free survival, overall survival and assessment of patient health status and quality of life using the patient reported outcome measures EQ-5D-5L and EORTC QLQ-C30. Each arm will be analysed separately as a Fleming A’Hern study α=0.05 + power (1-β)=0.8. Arm 1 assumes 25% meeting the clinical end point is a poor treatment (p0=0.25) and 50% is a good treatment (p1=0.5). Arm 2 assumes 5% meeting the clinical end point is a poor treatment (p0=0.05) and 25% is a good treatment (p1=0.25). Progress: By February 2023 10 UK sites had been opened to recruitment. The first patient entered the trial in November 2021 and to date 25 patients have been recruited into Arm 1 and 10 into Arm 2. Opening sites was slower than anticipated following emergence from the COVID pandemic. However, a recruitment rate of 1-2 patients per month has shown the feasibility of running a trial for this rare patient population. Clinical trial information: ISRCTN95561634 .

A phase II trial of cemiplimab alone or in combination with standard of care chemotherapy in locally advanced or metastatic penile carcinoma (EPIC Trial).

TPS5094 Background: Penile cancer (PC) is rare but its incidence is increasing, with an increase of 21% over the last decade. The rarity of this cancer means a paucity of large prospective clinical trial data to guide the management of locally advanced/metastatic penile cancer (la/mPC). Cisplatin containing combination chemotherapy regimens are widely regarded as the standard of care (SOC) in this setting. However, with response rates of about 50% there is a need to further improve treatment outcomes. PDL1 is upregulated in 40–60% of PC cases and is correlated with poor prognosis making a case for immunotherapy as a treatment for la/mPC. Currently there are ongoing clinical trials exploring immunotherapy on penile carcinoma, however, none of these trials are looking at the combination of immunotherapy and chemotherapy. The novel immune checkpoint inhibitor cemiplimab has been approved for locally advanced and metastatic cutaneous squamous cell carcinoma (mcSCC). In view of this, we sought to evaluate the benefit and safety of cemiplimab alone, or, in combination with SOC chemotherapy in patients with la/mPC. Methods: This is a non-randomised, open label, two arm phase II multi-centre trial of single agent cemiplimab versus cemiplimab + SOC chemotherapy in la/mPC, choice of arm decided by the investigator site based on chemotherapy eligibility. Eligibility includes patients with la/mPC who are candidates for immunotherapy +/- SOC chemotherapy (local UK centre choice of cisplatin/5FU or TPF or TIP regimes). 47 patients will be recruited from 10 UK centres: 29 patients into ARM 1 who will receive 4 cycles of cemiplimab 350mg IV q3 weekly + SOC chemotherapy, followed by single agent cemiplimab x 30 cycles (24 months total). 18 patients into ARM 2 who will receive single agent cemiplimab 350mg IV q3 weekly, up to 34 cycles (24 months total). The primary endpoint is clinical benefit rate (CBR) of cemiplimab: objective response rate (ORR) plus stable disease as assessed radiologically (RECIST 1.1) post cycle 4 in patients with la/mPC. Secondary end-points include safety, tolerability, CBR at 1, 2 and 3 years, ORR, progression-free survival, overall survival and assessment of patient health status and quality of life using the patient reported outcome measures EQ-5D-5L and EORTC QLQ-C30. Each arm will be analysed separately as a Fleming A’Hern study α = 0.05 + power (1-β) = 0.8. Arm 1 assumes 25% meeting the clinical end point is a poor treatment (p0 = 0.25) and 50% is a good treatment (p1 = 0.5). Arm 2 assumes 5% meeting the clinical end point is a poor treatment (p0 = 0.05) and 25% is a good treatment (p1 = 0.25). To date, 4 patients have been recruited from 2 centres with the aim to open all UK centres to recruitment by June 2022. The EPIC trial is NCRN badged. Clinical trial information: 95561634.

Weaning ward-different from the ICU?

Weaning from mechanical ventilation is generally not the most urgent topic on many ICUs, because acutely endangered patients are usually the staff's main focus. Nevertheless, even these patients whose underlying problem has been mostly solved-whether it was neurologic, internal or surgical-are in need of astructured weaning strategy. The aim of this weaning "road map" is ventilator independence, decannulation and regaining of muscular strength. Achieving of these aims needs awell-educated team of physicians, nurses, respiratory/physical therapists, logopedists and pychologists. Assessment of patient health status, including respiratory muscle function must be part of the overtaking procedure to be able to focus on the main problem that may be causative for the inability to wean so far. Every weaning unit must be able to organize the future treatment of patients (different ward inside the hospital, rehabilitation) or the transfer into a(ventilated) home care situation.

Perceived cognitive decline in multiple sclerosis impacts quality of life independently of depression.

Background/Aim. The aim of this study is to examine the effects of perceived cognitive dysfunction and of depression, on self-reported QoL, in a Greek population sample of MS patients. Methods. One hundred outpatients diagnosed with MS completed the Short-Form-36 Health Survey (SF-36), as well as the Perceived Deficits Questionnaire (PDQ) and the Depression subscale of the Mental Health Inventory (MHI), as part of a clinical evaluation which included the Expanded Disability Status Scale (EDSS) estimation. Multiple linear regression was conducted to determine the best linear combination of age, gender, education, EDSS, depression, attention/concentration, retrospective memory, prospective memory, and planning/organization, for predicting QoL scores. Results. In the multivariate regression analysis models, EDSS (P < 0.05), depression (P < 0.001), perceived planning/organization (P < 0.05), and perceived retrospective memory dysfunction (P < 0.05) independently predict quality of life scores. Age, sex, education level, and perceived attention/concentration dysfunction, as well as perceived prospective memory dysfunction, do not independently predict quality of life scores. Conclusions. Perceived planning/organization impairment and perceived retrospective memory impairment in MS patients predict QoL independently of the severity of disease and the severity of depression and therefore should be considered in the assessment of patient health status as well as in the design of treatment interventions and rehabilitation.

Prescribed drugs and neurological complications

Over the last 2 decades, assessment of patient health status has undergone a dramatic paradigm shift, evolving from a predominant reliance on biochemical and physical measurements to an emphasis upon...

The Stanford Health Assessment Questionnaire: Dimensions and Practical Applications

The ability to effectively measure health-related quality-of-life longitudinally is central to describing the impacts of disease, treatment, or other insults, including normal aging, upon the patient. Over the last two decades, assessment of patient health status has undergone a dramatic paradigm shift, evolving from a predominant reliance on biochemical and physical measurements, such as erythrocyte sedimentation rate, lipid profiles, or radiographs, to an emphasis upon health outcomes based on the patient's personal appreciation of their illness. The Health Assessment Questionnaire (HAQ), published in 1980, was among the first instruments based on generic, patient-centered dimensions. The HAQ was designed to represent a model of patient-oriented outcome assessment and has played a major role in many diverse areas such as prediction of successful aging, inversion of the therapeutic pyramid in rheumatoid arthritis (RA), quantification of NSAID gastropathy, development of risk factor models for osteoarthrosis, and examination of mortality risks in RA.Evidenced by its use over the past two decades in diverse settings, the HAQ has established itself as a valuable, effective, and sensitive tool for measurement of health status. It is available in more than 60 languages and is supported by a bibliography of more than 500 references. It has increased the credibility and use of validated self-report measurement techniques as a quantifiable set of hard data endpoints and has contributed to a new appreciation of outcome assessment. In this article, information regarding the HAQ's development, content, dissemination and reference sources for its uses, translations, and validations are provided.