Real-world clinical and cost analysis of CT coronary angiography and CT coronary angiography-derived fractional flow reserve (FFRCT)-guided care in the National Health Service.

AIM: To quantify the real-world clinical and cost impact of computed tomography (CT) coronary angiography (CTCA)-derived fractional flow reserve (FFRCT) in the National Health Service (NHS). MATERIALS AND METHODS: Consecutive clinical CTCA examinations from September to December 2018 with ≥1 stenosis of ≥25% underwent FFRCT analysis. The Heart Team reviewed clinical data and CTCA findings, blinded to FFRCT values, and documented hypothetical consensus management. FFRCT results were then unblinded and hypothetical consensus management re-recorded. Diagnostic waiting times for management pathways were estimated. A per-patient cost analysis for diagnostic certainty regarding coronary artery disease (CAD) management was performed using 2014-2020 NHS tariffs for pre- and post-FFRCT pathways. RESULTS: Two hundred and fifty-one CTCAs were performed during the study period. Fifty-seven percent (145/251) had no CAD or stenosis <25%. One study was non-diagnostic. Of the remaining 42% (105/251), two were ineligible for FFRCT and there was a 5% (5/103) failure rate. FFRCT led to a change in hypothetical management in 65% (64/98; p<0.001) patients with a functional imaging test cancelled in 17% (17/98) and a diagnostic angiogram cancelled in 47% (46/98). FFRCT-guided management had a reduced mean time to definitive investigation compared with CTCA alone (28 ± 4 versus 44 ± 4 days; p=0.004). Using the proposed 2020/21 tariff, CTCA + FFRCT for stenosis ≥50% resulted in a diagnostic pathway £44.97 more expensive per patient than usual care without FFRCT. CONCLUSIONS: In the real-world NHS setting, FFRCT-guided management has the potential to rationalise patient management, accelerate diagnostic pathways, and depending on the stenosis severity modelled, may be cost-effective.

Access to fertility services in Canada for HIV-positive individuals and couples: a comparison between 2007 and 2014.

In the modern era of HIV care, a multitude of clinical needs have emerged; one such need is the growing sub-specialty of HIV and reproductive health. In 2007, a study surveying Canadian fertility clinics found limited access to fertility services for HIV-positive patients. Given the extensive efforts made to address this lack of services, a follow-up assessment was warranted. This study aimed to compare the access to Canadian fertility clinics and services for HIV-positive individuals and couples in 2014 and 2007. Surveys were sent to medical or laboratory directors of assisted reproductive technology (ART) clinics in 2014 and results were compared to those sent in 2007. Main outcome measures included: the proportion of fertility clinics willing to provide ART to people with HIV, the specific services offered, and whether the 2012 Canadian HIV Pregnancy Planning Guidelines were implemented to inform practice. Across Canadian provinces, 20/34 (59%) clinics completed the survey. Ninety-five percent (19/20) of clinics accepted HIV-positive patients for consultation. Only 50% (10/20) of clinics in four provinces offered a full range of ART (defined as including in vitro fertilization [IVF]). Ten clinics (50%) in five provinces were aware that guidelines exist; half (n = 5) having read them and four reporting implementation of all the guidelines' recommendations in their practice. Compared to 2007, more clinics had implemented separate facilities (p = 0.028) to treat HIV-positive individuals, offered IVF (p = 0.013) for HIV-positive female partners, sperm washing (p = 0.033) for HIV-positive male partners, and risk reduction techniques to couples with HIV-positive men and women (p = 0.006). Access to fertility clinics for people with HIV has improved over time but is still regionally dependent and access to full ART remains limited. These findings suggest the need for advocacy targeted towards geographical-specific areas and optimizing access to comprehensive services.

The Neonatal Pain, Agitation and Sedation Scale and the bedside nurse's assessment of neonates.

OBJECTIVE: To determine the reliability of an objective measure of pain, agitation and sedation using the Neonatal Pain, Agitation and Sedation Scale (N-PASS) compared with nursing bedside assessment. STUDY DESIGN: Neonates admitted in neonatal intensive care unit over a 6-month period were eligible. Pain and sedation were assessed with N-PASS, and a subjective questionnaire was administered to the bedside nurse. RESULT: A total of 218 neonates were eligible (median: gestational age 34.6 weeks, age at assessment 7 days). N-PASS pain score correlated significantly with both nurses' pain score (Spearman coefficient (r)=0.37; P<0.001) and agitation score (r=0.56; P<0.001). N-PASS sedation score correlated with nurses' sedation score (r=-0.39; P<0.001). Adjusting for gestational age, day of life, intrauterine drug exposure and use of high frequency ventilation only slightly attenuated the correlations (r=0.36, 0.55 and -0.31, respectively). CONCLUSION: The N-PASS captures nursing assessment of pain, agitation and sedation in this broad population and provides a quantitative assessment of subjective descriptions that often drives patient therapy.

Payment to healthy volunteers in clinical research: the research subject's perspective.

Although there is much discussion regarding the ethics of making payments to healthy volunteers for participating in clinical research, little data are available from the point of view of the volunteers as to what they would consider to be fair payment. The objectives of this study were to determine healthy volunteers' estimates of appropriate payments for participation in hypothetical clinical trials in order to explore the reasoning behind these estimates and to examine the association between volunteer demographics and payment expectations. Sixty participants with previous experience as healthy volunteers in research studies were presented with four hypothetical studies and interviewed about their impressions of burden and risks involved in the studies. They were also asked to estimate an appropriate payment to the volunteers for each of the studies. For each of the studies, the payment estimates made by the participants varied over a wide range. However, each individual tended to be consistent in estimate placement within this range. No demographic factor was significantly associated with the estimated study payment. Subjects frequently mentioned risk and logistical burden as factors that should determine payment levels. Healthy volunteer subjects appear to have individualized yet consistent methods of arriving at estimates of payments for participating in clinical studies. These estimates are based on each subject's perception of study burden and associated risk.

Fuzzy hidden Markov chains segmentation for volume determination and quantitation in PET.

Accurate volume of interest (VOI) estimation in PET is crucial in different oncology applications such as response to therapy evaluation and radiotherapy treatment planning. The objective of our study was to evaluate the performance of the proposed algorithm for automatic lesion volume delineation; namely the fuzzy hidden Markov chains (FHMC), with that of current state of the art in clinical practice threshold based techniques. As the classical hidden Markov chain (HMC) algorithm, FHMC takes into account noise, voxel intensity and spatial correlation, in order to classify a voxel as background or functional VOI. However the novelty of the fuzzy model consists of the inclusion of an estimation of imprecision, which should subsequently lead to a better modelling of the 'fuzzy' nature of the object of interest boundaries in emission tomography data. The performance of the algorithms has been assessed on both simulated and acquired datasets of the IEC phantom, covering a large range of spherical lesion sizes (from 10 to 37 mm), contrast ratios (4:1 and 8:1) and image noise levels. Both lesion activity recovery and VOI determination tasks were assessed in reconstructed images using two different voxel sizes (8 mm3 and 64 mm3). In order to account for both the functional volume location and its size, the concept of % classification errors was introduced in the evaluation of volume segmentation using the simulated datasets. Results reveal that FHMC performs substantially better than the threshold based methodology for functional volume determination or activity concentration recovery considering a contrast ratio of 4:1 and lesion sizes of <28 mm. Furthermore differences between classification and volume estimation errors evaluated were smaller for the segmented volumes provided by the FHMC algorithm. Finally, the performance of the automatic algorithms was less susceptible to image noise levels in comparison to the threshold based techniques. The analysis of both simulated and acquired datasets led to similar results and conclusions as far as the performance of segmentation algorithms under evaluation is concerned.

Balancing justice and autonomy in clinical research with healthy volunteers.

In clinical research, ethics review generally first examines whether study risks are reasonable in light of benefits provided. Through informed consent, then, prospective subjects consider whether the risk/benefit balance and procedures are reasonable for them. Unique ethics issues emerge in clinical research with healthy volunteers. Certain types of studies only recruit healthy volunteers as participants. Phase 1 studies, for example, including first time in human studies of investigational drugs and vaccines, generally are conducted in healthy volunteers. Although such research carries inherent and often unknown risks, healthy subjects provide the most efficient target population in which to conduct such research, as these volunteers generally are free of concurrent diseases or medications that could confound interpretation of toxicity. Other studies enrolling healthy volunteers often are simply looking for the most scientifically sound population for the study of normal human physiology.

Spinal cord stimulation significantly decreases the need for acute hospital admission for chest pain in patients with refractory angina pectoris.

OBJECTIVE: To assess the impact of spinal cord stimulation (SCS) on the need for acute admissions for chest pain in patients with refractory angina pectoris. DESIGN: Retrospective analysis of case records. PATIENTS: 19 consecutive patients implanted for SCS between 1987 and 1997. All had three vessel coronary disease, and all were in New York Heart Association functional group III/IV. METHODS: Admission rates were calculated for three separate periods: (1) from initial presentation up until last revascularisation; (2) from last revascularisation until SCS implantation; (3) from SCS implantation until the study date. Post-revascularisation rates were then compared with post-SCS rates, without including admissions before revascularisation, as this would bias against revascularisation procedures. RESULTS: Annual admission rate after revascularisation was 0.97/patient/year, compared with 0.27 after SCS (p = 0.02). Mean time in hospital/patient/year after revascularisation was 8.3 days v 2.5 days after SCS (p = 0.04). No unexplained new ECG changes were observed during follow up and patients presented with unstable angina and acute myocardial infarction in the usual way. CONCLUSIONS: SCS is effective in preventing hospital admissions in patients with refractory angina, without masking serious ischaemic symptoms or leading to silent infarction.

Strategic options for hospitals based on ownership type.

Strategic planning for hospitals is difficult in this era of healthcare reform. This article offers strategy options based on an analysis of the strengths, weaknesses, opportunities, and threats of three types of hospitals.