scholarly journals Oncology patients’ experiences in experimental medicine cancer trials: a qualitative study

BMJ Open ◽  
2021 ◽  
Vol 11 (10) ◽  
pp. e047813
Author(s):  
Chelsea Sawyer ◽  
Laurie Preston ◽  
Sally Taylor ◽  
Michelle Davies ◽  
Louise Carter ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Focus Groups ◽  
Information Needs ◽  
Tertiary Care ◽  
Primary Outcome Measure ◽  
Experimental Medicine ◽  
Trial Participation ◽  
North West ◽  
Trial Treatment ◽  
Regional Cancer Centre

ObjectivesThe study aimed to explore patients’ experiences of experimental cancer medicine (ECM) clinical trials.DesignThe study’s design was qualitative. Two focus groups with patients were undertaken followed by semistructured interviews, to explore patients’ experiences of ECM clinical trials. Interviews and focus groups were audiorecorded and transcribed verbatim. Data were analysed using thematic analysis.SettingA regional cancer centre (tertiary care) in North-West England.ParticipantsTwelve patients (aged 52–79) participated in one of the two focus groups and 22 patients (aged 42–83) participated in interviews.Primary outcome measurePatients’ experiences of an ECM trial.ResultsFour main themes were identified from the analysis: decision making, information needs, the experience of trial participation and impact of trial participation. Subthemes are presented in the manuscript.ConclusionTo make fully informed decisions about trial participation, patients required the simplification of trial information and wanted more information about side effects, their response to trial treatment and the overall trial progress throughout the trial. Patients highlighted the need for improvement for the support provided to their family and friends.

scholarly journals What are the opportunities for cancer care and related research in primary care? A qualitative study of the views of patients, carers, and practice staff

2019 ◽  
Vol 69 (suppl 1) ◽  
pp. bjgp19X703505
Author(s):  
Joseph Clark ◽  
Elvis Amoakwa ◽  
John Blenkinsopp ◽  
Florence Reedy ◽  
Miriam Johnson
Keyword(s):  
Primary Care ◽  
Palliative Care ◽  
Qualitative Study ◽  
Focus Groups ◽  
Cancer Care ◽  
Information Needs ◽  
Controlled Trial ◽  
Unmet Need ◽  
Care Staff ◽  
Trial Participation

BackgroundResearch to identify the role of primary care in cancer care is important. However, trials in primary care are difficult.AimTo understand how patients, families, and primary care clinicians view their role in cancer care and identify opportunities for cancer primary care research.MethodQualitative study embedded within a feasibility cluster randomised controlled trial of a primary care based needs assessment intervention. The Supportive Cancer Needs Survey (SCNS) was the main outcome. In-depth interviews with patients/carers and focus groups with primary care staff explored views on cancer care and trial participation. Data were recorded, transcribed verbatim, and analysed thematically by three independent researchers.ResultsFifteen cancer patients and three carers were interviewed and four focus groups (n = 11) were conducted. Three themes were generated satisfaction with current care; key time-points for improved cancer care; and information and research. Satisfaction with current care among patients was high in spite of 72% reporting at least one moderate-high unmet need at baseline. Most patients undergoing cancer treatment were unsure when to access primary care. Patients and carers highly valued proactive contact from their practice following diagnosis though this was uncommon. Post-oncology discharge was a key time-point for information needs and support for patients. Patients were reluctant to consider palliative care in spite of palliative care needs. Some felt therapeutic benefit from completing study measures.ConclusionPatients are satisfied with cancer primary care despite unmet needs. Palliative care is poorly understood by many who may benefit. Research participation may benefit some patients.

Increasing participation in breast cancer research: (INSPIRE-BrC).

2014 ◽  
Vol 32 (26_suppl) ◽  
pp. 53-53
Author(s):  
Brandi Robinson ◽  
Sandra M. Swain
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Primary Outcome Measure ◽  
Test Method ◽  
Trial Participation ◽  
Lower Survival Rate ◽  
Black Patients ◽  
Clinical Trial Enrollment ◽  
The Impact

53 Background: Increasing black patients’ participation in cancer clinical trials is particularly important because of the population’s lower survival rate. Accrual to clinical trials remains low among the general population (1 to 3%), with recruitment of blacks the lowest of all groups at 0.5 to 1.5%. Clinical trials are key to developing new methods to prevent, detect, and treat cancer. INSPIRE-BrC aims to increase trial participation rates among black patients with breast cancer and examine the relationship between the intervention and attitudes/beliefs on the decision to participate. Methods: A sample size of 123 black patients with breast cancer at five MedStar sites will view a 15 minute, culturally tailored video about clinical trials, which targets six cultural and attitudinal barriers to participation. A pre-test/post-test method is used to determine the impact of the video on three variables — likely participation in therapeutic clinical trials; attitudes toward therapeutic clinical trials (assessed based on the 6 barriers); and actual trial enrollment. Expected Findings: We hypothesize that the intervention will increase clinical trial enrollment compared to our 2012 clinical trial enrollment baseline rate of 6% (22/384) for black patients with breast cancer in five MedStar hospitals. The primary outcome measure is the proportion of black patients with breast cancer who agree to participate in a therapeutic clinical trial among those who sign consent to INSPIRE-BrC. Study findings have the potential to increase patient recruitment as a promising tool for rapid dissemination of a theory-driven, evidence-based model to enhance clinical trial accrual among black patients with cancer. [Table: see text]

Seroprevalence of Enterically Transmitted Hepatitis in North West India

2016 ◽  
Vol 1 (2) ◽  
pp. 29
Author(s):  
Rekha Bachhiwal ◽  
Rajni Sharma ◽  
Pooja Gupta ◽  
Jyotsna Shukla
Keyword(s):  
Hepatitis A ◽  
Seasonal Pattern ◽  
Tertiary Care ◽  
Hepatitis E ◽  
Care Hospital ◽  
Subacute Hepatitis ◽  
North West ◽  
Pediatric Age Group ◽  
Male Preponderance ◽  
Current Infection

Introduction: To ascertain the seroprevalence of enterically transmitted Hepatitis A (HAV) and Hepatitis E (HEV) in cases with acute/subacute hepatitis attending a tertiary care hospital in North West India. Methods: A total of 2936 cases were examined for the presence of current infection with HAV and HEV, determined by demonstration of HAV-IgM and HEV-IgM antibodies using ELISA. Results: Overall seroprevalence for enterically transmitted hepatitis was found to be 24.89%. HAV IgM was present in 7.35% and HEV IgM was present in 17.54% of total cases. HAV infection was predominantly found in pediatric age group while HEV infection was mostly seen among adults. Male preponderance was noted. Enteric hepatitis cases occurred throughout the year. No definitive seasonal pattern was observed. Conclusion: Our data demonstrated high seropositivity of enterically transmitted hepatitis indicating the need for improvement in personal and public hygiene, and development of HEV vaccine.

Effect of coronavirus disease in patients with kidney disease in India

2020 ◽  
Vol 11 (SPL1) ◽  
pp. 1255-1259
Author(s):  
Shashi Prabha Singh ◽  
Preeti Sharma ◽  
Durgesh singh ◽  
Pradeep kumar ◽  
Rakesh Sharma ◽  
...  
Keyword(s):  
Chronic Kidney Disease ◽  
Clinical Trials ◽  
Kidney Disease ◽  
Meta Analysis ◽  
Tertiary Care ◽  
Type Ii Diabetes Mellitus ◽  
Asymptomatic Infection ◽  
Type Ii ◽  
Cardiorespiratory Failure ◽  
Inflammatory State

Coronavirus disease 19 is a global pandemic which infects over millions of people worldwide in a limited time and changes the lifestyle, clinical spectrum lies from asymptomatic infection to pneumonitis with cardiorespiratory failure and finally death. Higher mortality occurs in senior and who are suffering from co-morbidities like chronic kidney disease, (HTN) hypertension, (DM TYPE II) diabetes mellitus or (CVD) cardiovascular diseases. However, rather than normal individuals, patients with chronic kidney disease (CKD) are under higher risk for infections. The chronic systemic inflammatory state is a significant cause for morbidity and mortality in CKD patients. The objective of this review is to discuss the pathogenesis of COVID-19 in CKD, changes observed in the immune system of CKD patients, COVID-19 infections risk in CKD and therapeutic approach of COVID-19 in CKD patients. From the standpoint of frequent renal co-morbidities in covid19 patients, renal complications were explored in covid19 patients received at level 2 tertiary care Santosh Hospital, Ghaziabad, U.P. Delhi-NCR India during March to August 2020 as per the protocol of Nephrology Society of India. Relevant clinical trials were reviewed in support. Meta-analysis and clinical trials are covered in this review study. Duplicate studies are not taken into account. The outcome of the studies shows that CKD patients are more prone to COVID-19. CKD patients are more likely infected with COVID-19 virus. Whereas in intensive care, CKD occurs more frequent than DM type II and CVD. So,COVID-19 pathogenesis in CKD patients, risk of COVID-19, immunologic changes and therapy COVID-19 in CKD can add support in the effective management of COVID-19.

397 Intra-tumor immunotherapy injections utilizing image guidance in interventional radiology: clinical trial experience at a tertiary care cancer center

2020 ◽  
Vol 8 (Suppl 3) ◽  
pp. A422-A422
Author(s):  
Ravi Murthy ◽  
Rahul Sheth ◽  
Alda Tam ◽  
Sanjay Gupta ◽  
Vivek Subbiah ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Interventional Radiology ◽  
Real Time ◽  
Image Guidance ◽  
Tertiary Care ◽  
Cancer Center ◽  
Imaging Guidance ◽  
Image Guided ◽  
Real Time Image ◽  
Time Image

BackgroundImage guided intra-tumor administration of investigational immunotherapeutic agents represents an expanding field of interest. We present a retrospective review of the safety, feasibility & technical nuances of real-time image guidance for injection & biopsy across a spectrum of extracranial solid malignancies utilizing the discipline of Interventional Radiology.MethodsPatients who were enrolled in image guided intratumoral immunotherapy injection (ITITI) clinical trials over a 6 year period (2013–19) at a single tertiary care cancer center were included in this analysis. Malignancy, location, imaging guidance utilized for ITITI & biopsy for injected (adscopal) & non-injected (abscopal) lesions were determined and categorized. Peri-procedural adverse events were noted.Results262 pts (146 female, 61 yrs median) participating in 29 immunotherapeutic clinical trials (TLR & STING agonists, gene therapy, anti CD-40, viral/bacterial/metabolic oncolytics) met study criteria. Malignancies included melanoma 88, sarcoma 32, colorectal 29, breast 23, lung 17, head & neck 15, ovarian 8, neuroendocrine 7, pancreatic adenocarcinoma 6, 3 each (cholangioCA, endometrial, bladder, GI tract), 2 each (RCC, thymicCA, lymphoma, merkel cell, prostate) & others 1 each (CUP, GIST, dermatofibrosarcoma, DSRT, neuroblastoma, thyroid). All 169 & 93 patients received the intended 1371 ITITI in parietal (abdominal/chest wall, extremity, neck, pelvis) or visceral (liver, lung, peritoneum, adrenal) locations respectively; 83 patients received lymph node injections within either location. Imaging guidance was US in 68% of the cohort (US 161, CT+US 19); CT was used in 30% (81) & MRI in 1 patient. Median diameter of the ITITI lesion was 32 mm (8–230 mm). Median volume of the ITITI therapeutic material/session was 2 ml (1–6.9 ml). Lesions were accessed using a coaxial technique. ITITI delivery needles used at operator preference & tailored to lesion characteristics were either a 21G/22G Chiba, 21G Profusion (Cook Medical), 22G Morrison (AprioMed), 25G hypodermic (BD) & 18G Quadrafuse (Rex Medical). 2840 core biopsies (>18G Tru-cut core, Mission, Bard Medical) were performed in 237 patients during 690 procedures; biopsy sessions were often concurrent & of the ITITI site. 137 patients also underwent biopsy of a non-ITITI site (89 parietal location). Dimensions of the non-ITITI lesion were median 10 mm (7–113 mm); US image guidance was used in 97 patients (72%) to obtain a total of 1257, >18G Tru-core samples. 1.3% of injections resulted in SAE (NCI CTC AE >3) and 0.5% of 4097 biopsies developed major complications (SIR Criteria); both categories were manageable.ConclusionsUtilizing real time image guidance, ITITI to the administration of a myriad of investigational immunotherapeutic agents with concomitant biopsy procedures to date are associated with a high technical success rate & favorable safety profile.AcknowledgementsJoshua Hein, Mara Castaneda, Jyotsna Pera, Yunfang Jiang,Shuang Liu, Holly Liu and Anna LuiTrial RegistrationN/AEthics ApprovalThe study was approved by Institution’s Ethics Board, approval number 2020-0536: A retrospective study to determine the safety, feasibility and technical challenges of real-time image guidance for intra-tumor injection and biopsy across multiple solid tumors.Consent2020-0536 Waiver of Informed ConsentReferenceSheth RA, Murthy R, Hong DS, et al. Assessment of image-guided intratumoral delivery of immunotherapeutics in patients with cancer. JAMA Netw Open 2020;3(7):e207911. doi:10.1001/jamanetworkopen.2020.7911

scholarly journals A theoretically informed, mixed-methods study of pharmacists’ aspirations and readiness to implement pharmacist prescribing

2021 ◽  
Author(s):  
Derek Stewart ◽  
Abdulrouf Pallivalapila ◽  
Binny Thomas ◽  
Yolande Hanssens ◽  
Wessam El Kassem ◽  
...  
Keyword(s):  
Mixed Methods ◽  
Focus Groups ◽  
Tertiary Care ◽  
Pharmacy Practice ◽  
Principal Component ◽  
Management Support ◽  
Pharmacist Prescribing ◽  
Facilitators And Barriers ◽  
Physician Resistance ◽  
Inner Setting

AbstractBackground Studies have highlighted advancing clinical pharmacy practice in Qatar. Objective To explore pharmacists’ aspirations and readiness to implement pharmacist prescribing. Setting Hamad Medical Corporation (HMC), the main provider of secondary and tertiary care. Method A sequential explanatory mixed-methods design. Questionnaire items were derived from the Consolidated Framework of Implementation Research (CFIR), in domains of: awareness/support; readiness; implementation; and facilitators and barriers. Following piloting, all pharmacists (n = 554) were invited to participate. Questionnaire data were analysed using descriptive and inferential statistics with principal component analysis of attitudinal items. Focus groups were recorded, transcribed and analysed using the Framework Approach. Main outcome measure Aspirations and readiness to implement pharmacist prescribing. Results The response rate was 62.8% (n = 348), with respondents highly supportive of implementation in Qatar (median 4, scale 0–5, extremely supportive). The majority (64.9%, n = 226) considered themselves ready, particularly those more senior (p < 0.05) and classifying themselves innovative (p < 0.01). Outpatient (72.9%, n = 221 agreeing) and inpatient (71.1%, n = 218 agreeing) HMC settings were those perceived as being most ready. PCA identified 2 components, with ‘personal attributes’ being more positive than ‘prescribing support’. Facilitators were access to records, organizational/management support and the practice environment, with physician resistance and scope of practice as barriers. Focus groups provided explanation, with themes in CFIR domains of innovation characteristics, characteristics of individuals and the inner setting. Conclusion HMC pharmacists largely aspire, and consider themselves ready, to be prescribers with inpatient and outpatient settings most ready. CFIR domains and constructs identified as facilitators and barriers should be focus for implementation.

scholarly journals Use of connected digital products in clinical research following the COVID-19 pandemic: a comprehensive analysis of clinical trials

BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e047341
Author(s):  
Caroline Marra ◽  
William J Gordon ◽  
Ariel Dora Stern
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
Outcome Measures ◽  
Remote Monitoring ◽  
Search Algorithm ◽  
Primary Outcome Measure ◽  
Secondary Outcome ◽  
Digital Products ◽  
Clinical Trial Registry ◽  
Before And After

ObjectivesIn an effort to mitigate COVID-19 related challenges for clinical research, the US Food and Drug Administration (FDA) issued new guidance for the conduct of ‘virtual’ clinical trials in late March 2020. This study documents trends in the use of connected digital products (CDPs), tools that enable remote patient monitoring and telehealth consultation, in clinical trials both before and after the onset of the pandemic.DesignWe applied a comprehensive text search algorithm to clinical trial registry data to identify trials that use CDPs for remote monitoring or telehealth. We compared CDP use in the months before and after the issuance of FDA guidance facilitating virtual clinical trials.SettingAll trials registered on ClinicalTrials.gov with start dates from May 2019 through February 2021.Outcome measuresThe primary outcome measure was the overall percentage of CDP use in clinical trials started in the 10 months prior to the pandemic onset (May 2019–February 2020) compared with the 10 months following (May 2020–February 2021). Secondary outcome measures included CDP usage by trial type (interventional, observational), funder type (industry, non-industry) and diagnoses (COVID-19 or non-COVID-19 participants).ResultsCDP usage in clinical trials increased by only 1.65 percentage points, from 14.19% (n=23 473) of all trials initiated in the 10 months prior to the pandemic onset to 15.84% (n=26 009) of those started in the 10 months following (p<0.01). The increase occurred primarily in observational studies and non-industry funded trials and was driven entirely by CDP usage in trials for COVID-19.ConclusionsThese findings suggest that in the short-term, new options created by regulatory guidance to stimulate telehealth and remote monitoring were not widely incorporated into clinical research. In the months immediately following the pandemic onset, CDP adoption increased primarily in observational and non-industry funded studies where virtual protocols are likely medically necessary due to the participants’ COVID-19 diagnosis.

User-centered Requirements for Patient Fluid Intake Monitoring Support

2020 ◽  
Vol 64 (1) ◽  
pp. 736-740
Author(s):  
Ellen J. Bass ◽  
Andrew J. Abbate ◽  
Yaman Noaiseh ◽  
Rose Ann DiMaria-Ghalili
Keyword(s):  
Data Analysis ◽  
Focus Group ◽  
Focus Groups ◽  
Real Time ◽  
Information Needs ◽  
Fluid Intake ◽  
Fluid Consumption ◽  
Registered Dietitians ◽  
Group Data ◽  
Focus Group Data

There is a need to support patients with monitoring liquid intake. This work addresses development of requirements for real-time and historical displays and reports with respect to fluid consumption as well as alerts based on critical clinical thresholds. We conducted focus groups with registered nurses and registered dietitians in order to identify the information needs and alerting criteria to support fluid consumption measurement. This paper presents results of the focus group data analysis and the related requirements resulting from the analysis.

scholarly journals Reducing research waste by promoting informed responses to invitations to participate in clinical trials

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Katie Gillies ◽  
Iain Chalmers ◽  
Paul Glasziou ◽  
Diana Elbourne ◽  
Jim Elliott ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Trial Participation ◽  
Specific Information ◽  
Recruitment And Retention ◽  
Research Waste ◽  
Informed Decisions ◽  
Participation Barriers ◽  
Poor Recruitment

Abstract Poor recruitment to, and retention in, clinical trials is a source of research waste that could be reduced by more informed choices about participation. Barriers to effective recruitment and retention can be wide-ranging but relevance of the questions being addressed by trials and the outcomes that they are assessing are key for potential participants. Decisions about trial participation should be informed by general and trial-specific information and by considering broader assessments of ‘informedness’ and how they impact on both recruitment and retention. We suggest that more informed decisions about trial participation should encourage personally appropriate decisions, increase recruitment and retention, and reduce research waste and increase its value.

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