A handheld device for intra-cavity and ex vivo fluorescence imaging of breast conserving surgery margins with 5-aminolevulinic acid.

BACKGROUND: Visualization of cancer during breast conserving surgery (BCS) remains challenging; the BCS reoperation rate is reported to be 20-70% of patients. An urgent clinical need exists for real-time intraoperative visualization of breast carcinomas during BCS. We previously demonstrated the ability of a prototype imaging device to identify breast carcinoma in excised surgical specimens following 5-aminolevulinic acid (5-ALA) administration. However, this prototype device was not designed to image the surgical cavity for remaining carcinoma after the excised lumpectomy specimen is removed. A new handheld fluorescence (FL) imaging prototype device, designed to image both excised specimens and within the surgical cavity, was assessed in a clinical trial to evaluate its clinical utility for first-in-human, real-time intraoperative imaging during index BCS. RESULTS: The imaging device combines consumer-grade imaging sensory technology with miniature light-emitting diodes (LEDs) and multiband optical filtering to capture high-resolution white light (WL) and FL digital images and videos. The technology allows for visualization of protoporphyrin IX (PpIX), which fluoresces red when excited by violet-blue light. To date, n = 17 patients have received 20 mg kg bodyweight (BW) 5-ALA orally 2-4 h before imaging to facilitate the accumulation of PpIX within tumour cells. Tissue types were identified based on their colour appearance. Breast tumours in sectioned lumpectomies appeared red, which contrasted against the green connective tissues and orange-brown adipose tissues. In addition, ductal carcinoma in situ (DCIS) that was missed during intraoperative standard of care was identified at the surgical margin at <1 mm depth. In addition, artifacts due to the surgical drape, illumination, and blood within the surgical cavity were discovered. CONCLUSIONS: This study has demonstrated the detection of a grossly occult positive margin intraoperatively. Artifacts from imaging within the surgical cavity have been identified, and potential mitigations have been proposed. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01837225 (Trial start date is September 2010. It was registered to ClinicalTrials.gov retrospectively on April 23, 2013, then later updated on April 9, 2020, to reflect the introduction of the new imaging device.).

Cost-effectiveness of Fibrinogen Concentrate vs Cryoprecipitate for Treating Acquired Hypofibrinogenemia in Bleeding Adult Cardiac Surgical Patients.

Importance: Excessive bleeding requiring fibrinogen replacement is a serious complication of cardiac surgery. However, the relative cost-effectiveness of the 2 available therapies-fibrinogen concentrate and cryoprecipitate-is unknown. Objective: To determine cost-effectiveness of fibrinogen concentrate vs cryoprecipitate for managing active bleeding in adult patients who underwent cardiac surgery. Design, Setting, and Participants: A within-trial economic evaluation of the Fibrinogen Replenishment in Surgery (FIBERS) randomized clinical trial (February 2017 to November 2018) that took place at 4 hospitals based in Ontario, Canada, hospitals examined all in-hospital resource utilization costs and allogeneic blood product (ABP) transfusion costs incurred within 28 days of surgery. Participants included a subset of 495 adult patients from the FIBERS trial who underwent cardiac surgery and developed active bleeding and acquired hypofibrinogenemia requiring fibrinogen replacement. Interventions: Fibrinogen concentrate (4 g per dose) or cryoprecipitate (10 units per dose) randomized (1:1) up to 24 hours postcardiopulmonary bypass. Main Outcomes and Measures: Effectiveness outcomes included number of ABPs administered within 24 hours and 7 days of cardiopulmonary bypass. ABP transfusion (7-day) and in-hospital resource utilization (28-day) costs were evaluated and a multivariable net benefit regression model built for the full sample and predefined subgroups. Results: Patient level costs for 495 patients were evaluated (mean [SD] age 59.2 [15.4] years and 69.3% male.) Consistent with FIBERS, ABP transfusions and adverse events were similar in both treatment groups. Median (IQR) total 7-day ABP cost was CAD $2280 (US dollars [USD] $1697) (CAD $930 [USD $692]-CAD $4970 [USD $3701]) in the fibrinogen concentrate group and CAD $2770 (USD $1690) (IQR, CAD $1140 [USD $849]-CAD $5000 [USD $3723]) in the cryoprecipitate group. Median (interquartile range) total 28-day cost was CAD $38 180 (USD $28 431) $(IQR, CAD $26 350 [USD $19 622]-CAD $65 080 [USD $48 463]) in the fibrinogen concentrate group and CAD $38 790 (USD $28 886) (IQR, CAD $26 180 [USD $19 495]-CAD $70 380 [USD $52 409]) in the cryoprecipitate group. After exclusion of patients who were critically ill before surgery (11%) due to substantial variability in costs, the incremental net benefit of fibrinogen concentrate vs cryoprecipitate was positive (probability of being cost-effective 86% and 97% at $0 and CAD $2000 (USD $1489) willingness-to-pay, respectively). Net benefit was highly uncertain for nonelective and patients with critical illness. Conclusions and Relevance: Fibrinogen concentrate is cost-effective when compared with cryoprecipitate in most bleeding adult patients who underwent cardiac surgery with acquired hypofibrinogenemia requiring fibrinogen replacement. The generalizability of these findings outside the Canadian health system needs to be verified.

SIESTA - Home sleep study with BresoDx for obstructive sleep apnea: a randomized controlled trial.

STUDY OBJECTIVES: The objectives of this study were to evaluate (1) the accuracy of the clinical diagnosis of obstructive sleep apnea (OSA) informed by the home sleep study with a Type 4 portable monitor BresoDx® versus Type 1 polysomnography (PSG); and (2) agreement of the apnea-hypopnea index (AHI) compared between BresoDx and PSG. MATERIAL AND METHODS: This was a randomized, parallel, multicentre, single-blind, pragmatic controlled trial enrolling adults referred to three Ontario sleep clinics for suspected OSA. Participants were randomized to BresoDx followed by PSG (one-night apart) or PSG followed by BresoDx sleep testing sequence arms. The primary outcomes included the accuracy of clinical diagnosis and OSA severity measured by AHI between tests. RESULTS: In sum, 233 participants completed both sleep studies and 206 completed physician consultation visits. The agreement between clinical diagnosis informed by PSG versus BresoDx was fair (Cohen's kappa coefficient = 0.28). The sensitivity of BresoDx-informed clinical diagnosis against PSG was between 0.86 and 0.89, and the specificity between 0.38 and 0.44. For AHI cut-off of ≥5 events/hour the sensitivity, specificity and positive and negative predictive values were 0.85, 0.48, 0.81 and 0.54. CONCLUSIONS: Home sleep apnea testing with BresoDx can be used in a referral population with a high pretest probability of OSA similar to other Type IV devices. This study complements the existing body of evidence suggesting that home testing with portable devices plays a valuable role for diagnosing of OSA in a variety of settings. SIESTA TRIAL REGISTRATION: www.clinicaltrials.gov (Identifier: NCT02003729).

Diagnostic accuracy of level IV portable sleep monitors versus polysomnography for obstructive sleep apnea: a systematic review and meta-analysis.

PURPOSE: Obstructive sleep apnea (OSA) is the most common sleep-related breathing disorder. In-laboratory, overnight type I polysomnography (PSG) is the current "gold standard" for diagnosing OSA. Home sleep apnea testing (HSAT) using portable monitors (PMs) is an alternative testing method offering better comfort and lower costs. We aimed to systematically review the evidence on diagnostic ability of type IV PMs compared to PSG in diagnosing OSA. METHODS: Participants: patients ≥16 years old with symptoms suggestive of OSA;intervention: type IV PMs (devices with < 2 respiratory channels); comparator: in-laboratory PSG; outcomes: diagnostic accuracy measures;studies: cross-sectional, prospective observational/experimental/quasi-experimental studies; information sources: MEDLINE and Cochrane Library from January 1, 2010 to May 10, 2016. All stages of review were conducted independently by two investigators. RESULTS: We screened 6054 abstracts and 117 full-text articles to select 24 full-text articles for final review. These 24 studies enrolled a total of 2068 patients with suspected OSA and evaluated 10 different PMs with one to six channels. Only seven (29%) studies tested PMs in the home setting. The mean difference (bias) between PSG-measured and PM-measured apnea-hypopnea index (AHI) ranged from - 14.8 to 10.6 events/h. At AHI ≥ 5 events/h, the sensitivity of type IV PMs ranged from 67.5-100% and specificity ranged from 25 to 100%. CONCLUSION: While current evidence is not very strong for the stand-alone use of level IV PMs in clinical practice, they can potentially widen access to diagnosis and treatment of OSA. Policy recommendations regarding HSAT use should also consider the health and broader social implications of false positive and false negative diagnoses.

Structure and characteristics of community-based multidisciplinary wound care teams in Ontario: an environmental scan.

Multidisciplinary team approach is an essential component of evidence-based wound management in the community. The objective of this study was to identify and describe community-based multidisciplinary wound care teams in Ontario. For the study, a working definition of a multidisciplinary wound care team was developed, and a two-phase field evaluation was conducted. In phase I, a systematic survey with three search strategies (environmental scan) was conducted to identify all multidisciplinary wound care teams in Ontario. In phase II, the team leads were surveyed about the service models of the teams. We identified 49 wound care teams in Ontario. The highest ratio of Ontario seniors to wound team within each Ontario health planning region was 82,358:1; the lowest ratio was 14,151:1. Forty-four teams (90%) participated in the survey. The majority of teams existed for at least 5 years, were established as hospital outpatient clinics, and served patients with chronic wounds. Teams were heterogeneous in on-site capacity of specialized diagnostic testing and wound treatment, team size, and patient volume. Seventy-seven percent of teams had members from three or more disciplines. Several teams lacked essential disciplines. More research is needed to identify optimal service models leading to improved patient outcomes.

Quantitative patient preference evidence for health technology assessment: a case study.

OBJECTIVES: We conducted a systematic review of quantitative research regarding patients' preferences, perspectives and values for ventilation among chronic obstructive pulmonary disease (COPD) patients. Our objective was to explore the feasibility and desirability of incorporating patient preferences within the health technology assessment (HTA) process by working through a case study. METHODS: Medical and economic databases were searched for studies published in English from 1990 through March 4, 2011. Studies were selected based on title and abstract. Due to the heterogeneity of the studies, data were analyzed using a narrative synthesis approach. RESULTS: Among 1833 identified citations, twelve studies met our inclusion criteria. Ten of these studies pertained to COPD patient preferences for ventilation. Results indicate that a significant proportion of COPD patients are willing to forgo ventilation, particularly when it is expressed as "indefinite life support" (60-78 percent) rather than as temporary modality. Results indicate that patient preferences for mechanical or noninvasive ventilation cannot be predicted by covariates (e.g., age, quality of life) or by others who are frequently called upon to make decisions are their behalf. CONCLUSIONS: We found that it is indeed feasible to conduct a systematic review of quantitative preference-related evidence for an HTA topic. However, the process of conducting this preference-related case study also revealed several challenges because there is a high degree of variation in taxonomy, instrumentation, and study design. Therefore, we do not recommend it as a routine part of the HTA process, but we suggest that it is a promising area to pursue for preference-sensitive technological decisions.

Preventing pressure ulcers in long-term care: a cost-effectiveness analysis.

BACKGROUND: Pressure ulcers are common in many care settings, with adverse health outcomes and high treatment costs. We evaluated the cost-effectiveness of evidence-based strategies to improve current prevention practice in long-term care facilities. METHODS: We used a validated Markov model to compare current prevention practice with the following 4 quality improvement strategies: (1) pressure redistribution mattresses for all residents, (2) oral nutritional supplements for high-risk residents with recent weight loss, (3) skin emollients for high-risk residents with dry skin, and (4) foam cleansing for high-risk residents requiring incontinence care. Primary outcomes included lifetime risk of stage 2 to 4 pressure ulcers, quality-adjusted life-years (QALYs), and lifetime costs, calculated according to a single health care payer's perspective and expressed in 2009 Canadian dollars (Can$1 = US$0.84). RESULTS: Strategies cost on average $11.66 per resident per week. They reduced lifetime risk; the associated number needed to treat was 45 (strategy 1), 63 (strategy 4), 158 (strategy 3), and 333 (strategy 2). Strategy 1 and 4 minimally improved QALYs and reduced the mean lifetime cost by $115 and $179 per resident, respectively. The cost per QALY gained was approximately $78 000 for strategy 3 and $7.8 million for strategy 2. If decision makers are willing to pay up to $50 000 for 1 QALY gained, the probability that improving prevention is cost-effective is 94% (strategy 4), 82% (strategy 1), 43% (strategy 3), and 1% (strategy 2). CONCLUSIONS: The clinical and economic evidence supports pressure redistribution mattresses for all long-term care residents. Improving prevention with perineal foam cleansers and dry skin emollients appears to be cost-effective, but firm conclusions are limited by the available clinical evidence.

Early prevention of pressure ulcers among elderly patients admitted through emergency departments: a cost-effectiveness analysis.

STUDY OBJECTIVE: Every year, approximately 6.2 million hospital admissions through emergency departments (ED) involve elderly patients who are at risk of developing pressure ulcers. We evaluated the cost-effectiveness of pressure-redistribution foam mattresses on ED stretchers and beds for early prevention of pressure ulcers in elderly admitted ED patients. METHODS: Using a Markov model, we evaluated the incremental effectiveness (quality-adjusted life-days) and incremental cost (hospital and home care costs) between early prevention and current practice (with standard hospital mattresses) from a health care payer perspective during a 1-year time horizon. RESULTS: The projected incidence of ED-acquired pressure ulcers was 1.90% with current practice and 1.48% with early prevention, corresponding to a number needed to treat of 238 patients. The average upgrading cost from standard to pressure-redistribution mattresses was $0.30 per patient. Compared with current practice, early prevention was more effective, with 0.0015 quality-adjusted life-days gained, and less costly, with a mean cost saving of $32 per patient. If decisionmakers are willing to pay $50,000 per quality-adjusted life-year gained, early prevention was cost-effective even for short ED stay (ie, 1 hour), low hospital-acquired pressure ulcer risk (1% prevalence), and high unit price of pressure-redistribution mattresses ($3,775). Taking input uncertainty into account, early prevention was 81% likely to be cost-effective. Expected value-of-information estimates supported additional randomized controlled trials of pressure-redistribution mattresses to eliminate the remaining decision uncertainty. CONCLUSION: The economic evidence supports early prevention with pressure-redistribution foam mattresses in the ED. Early prevention is likely to improve health for elderly patients and save hospital costs.

Support surfaces for intraoperative prevention of pressure ulcers in patients undergoing surgery: a cost-effectiveness analysis.

BACKGROUND: Patients who undergo prolonged surgical procedures are at risk of developing pressure ulcers. Recent systematic reviews suggest that pressure redistribution overlays on operating tables significantly decrease the associated risk. Little is known about the cost effectiveness of using these overlays in a prevention program for surgical patients. METHODS: Using a Markov cohort model, we evaluated the cost effectiveness of an intraoperative prevention strategy with operating table overlays made of dry, viscoelastic polymer from the perspective of a health care payer over a 1-year period. We simulated patients undergoing scheduled surgical procedures lasting ≥90 min in the supine or lithotomy position. RESULTS: Compared with the current practice of using standard mattresses on operating tables, the intraoperative prevention strategy decreased the estimated intraoperative incidence of pressure ulcers by 0.51%, corresponding to a number-needed-to-treat of 196 patients. The average cost of using the operating table overlay was $1.66 per patient. Compared with current practice, this intraoperative prevention strategy would increase slightly the quality-adjusted life days of patients and by decreasing the incidence of pressure ulcers, this strategy would decrease both hospital and home care costs for treating fewer pressure ulcers originated intraoperatively. The cost savings was $46 per patient, which ranged from $13 to $116 by different surgical populations. Intraoperative prevention was 99% likely to be more cost effective than the current practice. CONCLUSION: In patients who undergo scheduled surgical procedures lasting ≥90 min, this intraoperative prevention strategy could improve patients' health and save hospital costs. The clinical and economic evidence support the implementation of this prevention strategy in settings where it has yet to become current practice.

Effects of backrest design on biomechanics and comfort during seated work.

The purpose of this study was to examine the effects of backrest configuration on seatpan and backrest pressure, spinal posture, and comfort. Thirty volunteers (15 male, 15 female) typed a standardized text passage while seated at a computer workstation in five backrest configurations: chair only, chair with a supplementary backrest, and with each of three lumbar pad thicknesses. Pressure, lumbar and cervical angles were collected during 15-min trials. Subjective data were collected during each trial and at the end of the entire protocol. The addition of a supplementary backrest to a standard chair reduced peak and average pressure on the back by 35% and 20%, respectively (P<0.02). Lumbar lordosis was observed only when lumbar pads were used, being greatest with the large pad. Participants preferred backrest configurations that had lower pressure on the back and less lordotic lumbar posture (backrest only or 3 cm lumbar pad), regardless of anthropometrics. Comfort was rated highest in conditions that would not necessarily be considered biomechanically ideal. Further delineation between specific comfort and objective seating variables is required to effectively reduce and prevent low back pain.