Assessing Patient Eligibility Research Articles

2.5-O4The realities of providing universal health care for patients with chronic conditions in rural trans-border communities: a study in Malawi

Providing long-term care for people living with chronic conditions is a key component of universal health coverage (UHC). To achieve UHC and address social determinants of health, the Malawian government launched the second health sector strategic plan (HSSPII) in 2017. Achieving its targets would require an understanding of contextual factors and mechanisms influencing HSSPII implementation. We explore health stakeholders’ experiences of planning and delivering chronic care services for rural trans-border communities in Malawi. We conducted 15 semi-structured interviews with health stakeholders in Phalombe district, Malawi near the Mozambique border. Respondents were selected through snowballing and purposively to ensure diversity of responses. We applied a thematic approach to data analysis. Respondents reported mixed experiences with implementing the strategy on ‘paper’, with operational difficulties reflecting on-the-ground realities. A key concern for respondents from public facilities was high influx of migrant patients from border communities in Mozambique, due to user-fees charged in their healthcare system. This resulted to acute shortage of medical supplies and continuous pressure on health personnel in healthcare provision, which hindered the effective implementation of UHC. Respondents reported high patient-workload compromised quality of care provided and served as demotivating factors, which posed as major obstacles to UHC attainment. Health providers also experienced difficulties screening and assessing patient eligibility for free healthcare, given the integration of bordering communities. This was attributed to a lack of national identification system, which has severe financial and logistical implications for UHC implementation. While the HSSPII and UHC goals aim to increase coverage and make healthcare services geographical accessible, patient access was crippled by transportation and medication costs in paying health facilities. Health policy makers and planners need to utilise a sector-wide approach that takes into account the operational realities on the ground in implementing UHC, to design innovative interventions that target these findings.

Fecal microbiota transplantation in recurrent Clostridium difficile infection: the first prospective study of 30 patients in Romania

Abstract Introduction: The infection with Clostridium difficile has increased in incidence worldwide and it raises many problems with regard to therapy, resistance to treatment and especially recurrence. Recurrence is frequent in patients treated for Clostridium difficile infection, requiring vancomycin by mouth, with limited alternatives. The literature shows that one of the most efficient treatment methods in Clostridium difficile infection is the transplantation of gut microbiota, also known as fecal microbiota transplantation. Aim: We present our results following FMT performed in patients with recurrent Clostridium difficile infection, and propose a simple and effective protocol for fecal microbiota transplantation. Study design: The study was prospective. The phases of the FMT procedure: assessment of patient eligibility, patient’s consent, identification and screening of donors, discontinuation of antibiotics (vancomycin, metronidazole) 3 days prior to the procedure. Methods: Between 2013 and 2015, FMT was performed in 30 patients with recurrent Clostridium difficile infection, by direct infusion of extensively processed donor fecal matter via colonoscopy. We followed up the patients for 12 months. Results: Immediate post-transplantation outcome in what concerns stool frequency during the follow-up period (7 days) was encouraging in 93.33% of patients. The donors were healthy individuals (53% 1st degree relatives), previously screened for possible infections and infestations. This result was sustained at 6-month and 12-month follow-up. Post-transplantation recurrence occurred in 6.67% (2 patients), which responded well to treatment and did not require a new vancomycin course. Conclusions: Fecal microbiota transplantation via colonoscopy is effective, safe, easy to perform, it yields lasting results and is therefore a good option for recurrent or treatment-resistant Clostridium difficile infection.

Using electronic medical records system to advance cancer survivorship programs.

65 Background: Survivorship care is now being increasingly recognized as an important part of cancer care. The Commission on Cancer (CoC) Standard 3.3 now recommends 100% compliance in the delivery of Survivorship Care Plans (SCP) by 2019 to eligible survivors. However, there are no systematic ways of ensuring compliance of Care Plan delivery and assessing patient eligibility. There are also no standardized methods for documentation or data collection to ensure appropriate consolidation of information from the electronic medical record (EMR) to a SCP, to assess for patient eligibility for survivorship follow up, or to appropriately report on timely delivery and follow-up with Survivorship Programs. Methods: Our survivorship team worked closely with the Cancer Registry Program, nurse navigators, and Information Technology team to optimize our institution owned EPIC electronic medical records system to populate and consolidate information automatically into patient specific care plans. By having electronic care plans, we are able to deliver plans to all members of the care team and to the patients. We also created discrete methods of flagging eligible survivors and automated data reporting and collection to ensure compliance and timeliness of care plan delivery. Results: By optimizing our electronic medical records system and our workflow process for Care Plan delivery, we were able to increase our delivery compliance rate to 100%. We are able to track patients through their care delivery and appropriately refer to our survivorship program and track care plan delivery. Conclusions: The CoC has implemented new standards to encourage appropriate survivorship care delivery and proper communication for ongoing survivorship care and follow up. With these new standards comes the challenge of developing and implementing a system for creating, delivering and evaluating the delivery of SCP. For our team to provide quality survivorship care that is measurable, we have developed data analysis and reports through our EMR with assistance from our IT department. These improvements utilizing our IT and EMR more efficiently has provided us with the ability to achieve 100% care plan delivery compliance.

Relocating patients from a specialist homeless healthcare centre to general practices: a multi-perspective study.

The relocation of formerly homeless patients eligible to transfer from a specialist homeless healthcare centre (SHHC) to mainstream general practices is key to patient integration in the local community. Failure to transition patients conferring eligibility for relocation may also negatively impact on SHHC service delivery. To explore barriers and facilitators of relocation from the perspectives of formerly homeless patients and healthcare staff involved in their care. Qualitative semi-structured face-to-face and telephone interviews conducted in the north east of Scotland. Participants were patients and healthcare staff including GPs, nurses, substance misuse workers, administrative, and local community pharmacy staff recruited from one SHHC, two mainstream general practices, and four community pharmacies. Interview schedules based on the 14 domains of the Theoretical Domains Framework (TDF) were drafted. Transcripts of the interviews were analysed by two independent researchers using a framework approach. Seventeen patients and 19 staff participated. Key barriers and facilitators aligned to TDF domains included: beliefs about consequences regarding relocation; patient intention to relocate; environmental context and resources in relation to the care of the patients and assessing patient eligibility; patient skills in relation to integration; social and professional role and identity of staff and patients; and emotional attachment to the SHHC. Implementation of services, which promote relocation and integration, may optimise patient relocation from SHHCs to mainstream general practices. These include peer support networks for patients, better information provision on the relocation process, and supporting patients in the journey of identifying and adjusting to mainstream practices.

Defining the fracture population in a pragmatic multicentre randomised controlled trial: PROFHER and the Neer classification of proximal humeral fractures.

ObjectivesAccurate characterisation of fractures is essential in fracture management trials. However, this is often hampered by poor inter-observer agreement. This article describes the practicalities of defining the fracture population, based on the Neer classification, within a pragmatic multicentre randomised controlled trial in which surgical treatment was compared with non-surgical treatment in adults with displaced fractures of the proximal humerus involving the surgical neck.MethodsThe trial manual illustrated the Neer classification of proximal humeral fractures. However, in addition to surgical neck displacement, surgeons assessing patient eligibility reported on whether either or both of the tuberosities were involved. Anonymised electronic versions of baseline radiographs were sought for all 250 trial participants. A protocol, data collection tool and training presentation were developed and tested in a pilot study. These were then used in a formal assessment and classification of the trial fractures by two independent senior orthopaedic shoulder trauma surgeons.ResultsTwo or more baseline radiographic views were obtained for each participant. The independent raters confirmed that all fractures would have been considered for surgery in contemporaneous practice. A full description of the fracture population based on the Neer classification was obtained. The agreement between the categorisation at baseline (tuberosity involvement) and Neer classification as assessed by the two raters was only fair (kappa 0.29). However, this disparity did not appear to affect trial findings, specifically in terms of influencing the effect of treatment on the primary outcome of the trial.ConclusionsA key reporting requirement, namely the description of the fracture population, was achieved within the context of a pragmatic multicentre randomised clinical trial. This article provides important guidance for researchers designing similar trials on fracture management.Cite this article: H. H. G. Handoll, S. D. Brealey, L. Jefferson, A. Keding, A. J. Brooksbank, A. J. Johnstone, J. J. Candal-Couto, A. Rangan. Defining the fracture population in a pragmatic multicentre randomised controlled trial: PROFHER and the Neer classification of proximal humeral fractures.Bone Joint Res 2016;5:481–489. DOI: 10.1302/2046-3758.510.BJR-2016-0132.R1.

(436) - Survival and Thrombotic Events in Left Ventricular Assist Device Patients Are Not Influenced by Socioeconomic Status

Purpose: Socioeconomic status (SES) is a well-validated risk factor for poor outcomes among heart failure (HF) and transplant cohorts, but its influence on adverse events and mortality in patients supported with a left ventricular assist device (LVAD) is poorly understood. Furthermore, whether or not SES should be used for preoperative risk stratification prior to LVAD implantation requires clarification, and will be particularly important at public, statesupported, not-for-profit institutions such as ours where there is expansive SES diversity in the advanced HF population. Methods: Data from consecutive patients with a HeartMate II LVAD at our center from 2008-2014 were reviewed and only those with at least 1-year follow-up (n= 120) were included. The Area Deprivation Index (ADI) a validated, geographic-based measure of SES was generated for all individuals using home zip codes. Patient characteristics, implant designation, HF etiology, and INTERMACS profile were also collected. The primary endpoint was a composite of 1yr death, stroke, or pump thrombosis. One-year mortality was also evaluated. Descriptive stats were employed and multivariable models constructed for the outcomes of interest. Results: Seventy-eight percent of study patients were male, 61% white, 54% ischemic, and 68% were implanted as destination therapy (DT). The median ADI was 105.7 (range, 73.9-123.3). Twenty-eight patients (23%) died within 1 year of implant and 40 (33%) reached the primary composite endpoint. On univariate analysis, only lower INTERMACS profile was significantly associated with the primary composite endpoint, while both ischemic etiology (p= 0.04) and lower INTERMACS profile (p= 0.03) were associated with death. There was no significant relationship between ADI and either of the pre-specified endpoints in the unadjusted setting, nor did one exist when ADI was forced into the multivariable models. Conclusion: Despite being a robust predictor of outcomes in the general HF and transplant populations, socioeconomic deprivation was not associated with 1 year death or serious adverse event in our largely DT sample of LVAD patients with diverse SES. It is possible that durable mechanical support may attenuate any potential negative impact of SES and should therefore not be a primary consideration when assessing patient eligibility for device implantation.

Targeted Radionuclide Therapy: Practical Applications and Future Prospects.

In recent years, there has been a proliferation in the development of targeted radionuclide cancer therapy. It is now possible to use baseline clinical and imaging assessments to determine the most effective therapy and to tailor this therapy during the course of treatment based on radiation dosimetry and tumor response. Although this personalized approach to medicine has the advantage of maximizing therapeutic effect while limiting toxicity, it can be challenging to implement and expensive. Further, in order to use targeted radionuclide therapy effectively, there is a need for multidisciplinary awareness, education, and collaboration across the scientific, industrial, and medical communities. Even more important, there is a growing understanding that combining radiopharmaceuticals with conventional treatment such as chemotherapy and external beam radiotherapy may limit patient morbidity while improving survival. Developments in radiopharmaceuticals as biomarkers capable of predicting therapeutic response and targeting disease are playing a central role in medical research. Adoption of a practical approach to manufacturing and delivering radiopharmaceuticals, assessing patient eligibility, optimizing post-therapy follow-up, and addressing reimbursement issues will be essential for their success.

High-frequency ultrasound in carpal tunnel syndrome: assessment of patient eligibility for surgical treatment.

Carpal tunnel syndrome (CTS) is the most common entrapment neuropathy and a frequent cause of sick leaves because of work-related hand overload. That is why an early diagnosis and adequate treatment (conservative or surgical) are essential for optimal patient management.AimThe aim of the study is to assess the usefulness of high-frequency ultrasound in CTS for the assessment of patient eligibility for surgical treatment.Material and methodsThe study involved 62 patients (50 women and 12 men, aged 28–70, mean age 55.2) with scheduled surgeries of CTS on the basis of clinical symptoms, physical examination performed by a neurosurgeon and a positive result of EMG testing. The ultrasound examinations of the wrist were performed in all these patients. On the basis of the collected data, the author has performed multiple analyses to confirm the usefulness of ultrasound imaging in assessing patient eligibility for surgical treatment of CTS.ResultsUS examinations showed evidence of median nerve compression at the level of the carpal tunnel in all of the examined patients. This was further confirmed during surgical procedures. The mean value of the cross-sectional area at the proximal part of the pisiform bone was 17.45 mm2 (min. 12 mm2, max. 31 mm2). Nerve hypoechogenicity proximal to the nerve compression site was visible in all 62 patients (100%). Increased nerve vascularity on the transverse section was present in 50 patients (80.65%).ConclusionsUltrasonography with the use of high-frequency transducers is a valuable diagnostic tool both for assessing patient eligibility for surgical treatment of CTS, and in postoperative assessment of the treatment efficacy.

SU‐C‐BRA‐06: Developing Clinical and Quantitative Guidelines for a 4DCT‐Ventilation Functional Avoidance Clinical Trial

Purpose:4DCT‐ventilation is an exciting new imaging modality that uses 4DCTs to calculate lung ventilation. Because 4DCTs are acquired as part of routine care, calculating 4DCT‐ventilation allows for lung function evaluation without additional cost or inconvenience to the patient. Development of a clinical trial is underway at our institution to use 4DCT‐ventilation for thoracic functional avoidance with the idea that preferential sparing of functional lung regions can decrease pulmonary toxicity. The purpose of our work was to develop the practical aspects of a 4DCT‐ventilation functional avoidance clinical trial including: 1.assessing patient eligibility 2.developing trial inclusion criteria and 3.developing treatment planning and dose‐function evaluation strategies.Methods:96 stage III lung cancer patients from 2 institutions were retrospectively reviewed. 4DCT‐ventilation maps were calculated using the patient's 4DCTs, deformable image registrations, and a density‐change‐based algorithm. To assess patient eligibility and develop trial inclusion criteria we used an observer‐based binary end point noting the presence or absence of a ventilation defect and developed an algorithm based on the percent ventilation in each lung third. Functional avoidance planning integrating 4DCT‐ventilation was performed using rapid‐arc and compared to the patient's clinically used plan.Results:Investigator‐determined clinical ventilation defects were present in 69% of patients. Our regional/lung‐thirds ventilation algorithm identified that 59% of patients have lung functional profiles suitable for functional avoidance. Compared to the clinical plan, functional avoidance planning was able to reduce the mean dose to functional lung by 2 Gy while delivering comparable target coverage and cord/heart doses.Conclusions:4DCT‐ventilation functional avoidance clinical trials have great potential to reduce toxicity, and our data suggest that 59% of lung cancer patients have lung function profiles suitable for functional avoidance. Our study used a retrospective evaluation of a large lung cancer patient database to develop the practical aspects of a 4DCT‐ventilation functional avoidance clinical trial.(R.C., E.C., T.G.), NIH Research Scientist Development Award K01‐CA181292 (R.C.), and State of Colorado Advanced Industries Accelerator Grant (Y.V.).

Abstract 967: Massively parallel sequencing of clinical FFPE cancer specimens enables comprehensive genomic assessment of patient eligibility for targeted therapy

Abstract Molecular diagnostics are growing in importance to clinical oncology as an increasing number of therapies targeting specific molecular alterations become available. This trend has led to a proliferation of focused biomarker tests delivered using a variety of technologies, which are generally restricted in their breadth of mutational status assessment and constrained by scarce tissue material. We deployed massively parallel sequencing (or “NGS”) technology to develop a pan-cancer, comprehensive genomic profiling assay interrogating 189 relevant cancer genes, using minimal DNA from fixed surgical or biopsy specimens. With this assay we identify all classes of DNA alterations (base substitutions, insertions and deletions, copy number alterations and rearrangements at specific loci) in a single test with high sensitivity and specificity. To assess the potential for comprehensive genomic profiling to inform clinical decisions, we sequenced 58 archival FFPE tumor specimens, including 16 breast, 16 colon, 14 lung, and 12 renal cell cancers to an average of depth of 850x and considered the resultant mutation profiles in the context of current treatment guidelines and clinical trial information. In total, 121 mutations and 30 copy number alterations were identified, of which less than one third could be identified by traditional “hotspot” analysis. The observed mutation frequencies were consistent with published studies for these tissue types: 56% of breast cancers carried TP53 mutations, 38% had PIK3CA mutations, and 13% harbored HER2 amplifications. In colon cancers, 75% and 63% carried APC and TP53 mutations, while 38%, 31%, and 25% harbored KRAS, BRAF, and PIK3CA mutations respectively. Finally, 57% and 42% of NSCLCs carried mutations in TP53 and KRAS, while 17% of RCCs had mutations in VHL. Nearly 70% of the 58 cases carried one or more mutations that could plausibly confer sensitivity or resistance to approved or experimental targeted therapies. Of these potentially clinically actionable mutations, 57% occurred at known sites of oncogene activation, 27% involved gene amplification or deletion, 14% resulted in tumor suppressor loss, and one resulted in the EML4-ALK fusion gene. Our results demonstrate technical feasibility of comprehensive cancer gene characterization through massively parallel sequencing in clinical FFPE specimens. The prevalence and diversity of potentially actionable mutations we observed highlights the benefits of adopting this approach. As massively-parallel sequencing is the only practical means to detect all classes of somatic mutation in a small, clinically relevant sample, we suggest that this type of testing will be an essential ingredient in bringing targeted therapies to cancer patient care. Citation Format: {Authors}. {Abstract title} [abstract]. In: Proceedings of the 103rd Annual Meeting of the American Association for Cancer Research; 2012 Mar 31-Apr 4; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2012;72(8 Suppl):Abstract nr 967. doi:1538-7445.AM2012-967

Use of WHO clinical stage for assessing patient eligibility to antiretroviral therapy in a routine health service setting in Jinja, Uganda

In a routine service delivery setting in Uganda, we assessed the ability of the WHO clinical stage to accurately identify HIV-infected patients in whom antiretroviral therapy should be started.Among 4302 subjects screened for ART, the sensitivity and specificity (95% CI) of WHO stage III, IV against a CD4 count < 200 × 106/l were 52% (50, 54%) and 68% (66, 70%) respectively. Plasma viral load was tested in a subset of 1453 subjects in whom ART was initiated. Among 938 subjects with plasma viral load of 100,000 copies or more, 391 (42%, 95% CI 39, 45%) were at WHO stage I or II.In this setting, a large number of individuals could have been denied access to antiretroviral therapy if eligibility to ART was assessed on the basis of WHO clinical stage. There is an urgent need for greater CD4 count testing and evaluation of the utility of plasma viral load prior to initiation of ART to accompany the roll-out of ART.

Meeting the Challenges of Patient Recruitment

The recruitment rate of adult patients into clinical trials continues to be low. There are a number of barriers to recruitment and, for the most part, these can be classified as patient-, physician-, organisation- or protocolrelated. For practical reasons the process of trial recruitment can be divided into three steps: awareness of the trial, assessment of patient eligibility and the decision to participate. Two key strategies to improve patient recruitment are related to (i) knowledge, information and data management, and (ii) changing the behaviour of physicians and patients. Patient recruitment strategies cover individual services (e.g. call centre, web-based outreach campaigns) or integrated services (e.g. provided by recruitment companies). Unfortunately, there is only limited and inconclusive evidence from randomised or quasi-randomised trials comparing different recruitment strategies.

A Successful System of Scientific Data Audits for Clinical Trials

To report on data collected during on-site audits of source documents in the Cancer and Leukemia Group B (CALGB). A retrospective review of audit reports in four audit cycles. A cooperative group of institutions conducting clinical trials in cancer treatment. Patients taking part in clinical trials at collaborating CALGB institutions, members of the CALGB Data Audit Committee, and group chairmen of CALGB. The results of 691 institutional audits conducted by the CALGB in 1982 through 1992 with comparisons of main CALGB institutions vs affiliates. In four full reviews of all participating institutions in the CALGB, 3787 patients have had their on-site medical records compared with data submitted to the CALGB Data Management Center. Compliance with federal regulations for oversight by an institutional review board improved from a deficiency rate of 28.0% among the main institutions and 49.6% of the affiliate institutions in the first audit cycle to respective figures of 13.3% and 28.2% in the fourth cycle. Consent form deficiencies also dropped overall from 18.5% in the first cycle to 3.9% in the fourth. Patient eligibility was verified by auditors in 94.5%, and assessment of tumor changes in response to treatment was verified in 96.4% in the fourth cycle; both figures were only slightly lower in the first cycle. Two instances of scientific impropriety were discovered for a rate of only 0.28% of all audits. Both occurred prior to 1984, and none have occurred since. Major protocol deviations in drug dosing have held steady at about 11% over four audit cycles. Over the 11-year period of audits, three main institutions and 96 affiliate institutions have discontinued CALGB membership due solely, or at least partly, to unfavorable audit results. Scientific improprieties have occurred very rarely in clinical trials conducted by the CALGB. Protocol compliance in assessing patient eligibility and tumor responses has been high. Attention to administrative matters of consent forms, institutional review board approval, and ancillary data submission has measurably improved in the CALGB, which is at least partly due to the pressure from this on-site peer review of investigator performance.