Engaging Patients in Health System Transformation: The experience of the Maine Health Access Foundation\u27s (MeHAF) Advancing Payment Reform Initiative

In 2001, the Institute of Medicine (IOM) identified patient centeredness as one of six essential aims of “a new health care system for the 21st century”.1 Since that time, we have begun a gradual shift from a professionally driven system toward one that is more “patient centered” or “consumer centered,” recognizing and incorporating patients’ perspectives in decisions in clinical care, delivery system, and policies. As the health care system responds to new payment approaches and positions itself to achieve the Triple Aim (i.e. better care, lower cost, enhanced patient experience), it is important to assess how organizations that are moving to advance health care service delivery and payment reform are integrating patient engagement into the health system transformation process. Since 2011, the Maine Health Access Foundation’s Advancing Payment Reform initiative has funded 13 health system transformation projects. Diverse in their approach, each has undertaken efforts to achieve greater patient engagement ranging from involving patients and families as informed and active participants in their own health care (e.g. shared decision making, self-management) to involving patients at the organizational or policy-level through consumer advisory boards and other means to provide guidance for health system transformation. This brief summarizes the experience of these grantees in developing and implementing strategies to engage patients in payment reform and delivery system redesign.2 The purpose is to identify common themes and lessons within and across these initiatives to inform future patient engagement efforts

The Role of Organizational Change in Health System and Payment Reform

The Maine Health Access Foundation (MeHAF) has awarded grants to 14 Maine health organizations to date to mitigate the increasing cost of health care in Maine through innovative delivery system and payment reform strategies that preserve access, improve quality, and offer better value. As part of the evaluation of this initiative, the University of Southern Maine Muskie School of Public Service (Muskie School) is producing a series of issue briefs that capture common themes and challenges across grantees in achieving payment reform and health system delivery change to assess lessons learned. This is the first issue brief which describes our evaluation approach and presents an analysis of the role of organizational change among grantees engaged in delivery system and payment reform

Health Data and Financing and Delivery System Reform: Is the Glass Half Full or Half Empty?

In 2011, the Maine Health Access Foundation (MeHAF) launched its Advancing Payment Reform initiative to stimulate innovative payment and delivery system reform strategies in Maine. This policy paper reports on the health data experience of the 14 program grantees, using interviews conducted in 2013-14 and other information garnered from the evaluation of the initiative. The paper focuses on the role and impact of health data in supporting implementation and monitoring of specific components of the projects’ reform strategies; the data infrastructure challenges the projects have faced and how those have been addressed; and the generalizable lessons learned so far for improving data usefulness, access, analysis, and integration to support payment and delivery system reform. Support for this policy paper was provided by the Maine Health Access Foundation

Peripheral nerve field stimulation for otalgia: A novel therapy for refractory deep ear pain

Refractory otalgia or deep ear pain is a complex clinical problem that poses significant challenges to the physicians. Here we report a case of a 39 year old female who presented to us with deep right ear pain which started following cholesteatoma excision 11 years ago. Since onset of right ear pain, she had multiple ear surgeries including microvascular decompression and excision of right temporal bone before presentation. Following neuropsychological assessment and excluding underlying depression/anxiety, she underwent peripheral nerve field stimulation (PFNS) trial. She had a successful PFNS trial and underwent permanent implantation of PFNS and pulse generator. She had >50% reduction in her pain intensity on VAS and pain medications. She required explantation due to superficial infection; however she was satisfied with her therapy and looking forward for reimplantation. We report the first case of successful management of refractory deep ear pain using PFNS with a review of pertinent literature

Longitudinal cerebellar diffusion tensor imaging changes in posterior fossa syndrome

Posterior fossa syndrome is a severe transient loss of language that frequently complicates resection of tumors of the cerebellum. The associated pathophysiology and relevant anatomy to this language deficit remains controversial. We performed a retrospective analysis of all cerebellar tumor resections at Seattle Children's Hospital from 2010 to 2015. Diffusion tensor imaging was performed on each of the patients as part of their clinical scan. Patients included in the study were divided into groups based on language functioning following resection: intact (N = 19), mild deficit (N = 19), and posterior fossa syndrome (N = 9). Patients with posterior fossa syndrome showed white matter changes evidenced by reductions in fractional anisotropy in the left and right superior cerebellar peduncle following resection, and these changes were still evident 1-year after surgery. These changes were greater in the superior cerebellar peduncle than elsewhere in the cerebellum. Prior to surgery, posterior fossa patients did not show changes in fractional anisotropy however differences were observed in mean and radial diffusivity measures in comparison to other groups which may provide a radiographic marker of those at greatest risk of developing post-operative language loss

Bioequivalence Studies of Sildenafil Citrate Orodispersible Film Administered with and without Water vs ViagraⓇ Film-Coated Tablets in Healthy Male Volunteers

ABSTRACT: Background: Orodispersible film (ODF) formulation offers ease of use, convenience of administration, and other advantages, especially for patients who have difficulty in swallowing or are on liquid restriction compared with conventional oral formulations for the treatment of erectile dysfunction. Objectives: These studies compared the bioequivalence of 50 mg sildenafil citrate ODF formulation (test drug) with the marketed 50 mg sildenafil citrate film-coated tablet (FCT) (ViagraⓇ; Pfizer, New York, NY) (reference drug), with and without water in 2 randomized cross-over studies. Methods: Two randomized cross-over studies were conducted. The first study explored the bioequivalence of test drug administered with and without water compared with the reference drug with water. The second study investigated the bioequivalence of test drug, without water, compared with the reference drug with water. Forty-two and 80 healthy male volunteers were recruited in the first and second study, respectively. All volunteers fasted for 10 hours pre-dose. A 1-day washout period between doses was observed. Blood samples were collected at both before (up to 120 minutes before dosing) and after dosing (at different intervals up to 14 hours) stages. Statistical analyses on pharmacokinetic parameters were performed. Safety and tolerability for both the formulations were evaluated. Results: In the first study, bioequivalence was demonstrated for sildenafil citrate ODF administered with water when compared with the ViagraⓇ FCT. The ratios of adjusted geometric means (90% confidence interval (CI)) were maximum plasma concentration: 1.02 (94.91–108.78) and area under the plasma concentration-time curve: 1.09 (104.49–113.21) for sildenafil citrate ODF administered with water vs ViagraⓇ FCT. These ratios were within the bioequivalence acceptance range of 80% to 125%, indicating that the bioequivalence criteria were met. The pharmacokinetic parameters for the second study also showed bioequivalence for sildenafil citrate ODF (without water) compared with ViagraⓇ FCT. The ratios of adjusted geometric means (90% CI) were maximum plasma concentration: 1.02 (95.47–109.36) and area under the plasma concentration-time curve: 1.06 (103.42–108.40) for sildenafil citrate ODF administered without water vs ViagraⓇ FCT. Adverse events in both the studies occurred at similar rates for the 2 formulations and were mild in intensity. Conclusions: These results suggest that the new ODF formulation can be used interchangeably with the marketed FCT formulation. Sildenafil citrate ODF administered with and without water met bioequivalence criteria compared with ViagraⓇ FCT administered with water under fasted conditions in healthy adult male volunteers. The new ODF formulation can be used as a suitable alternative to the conventional oral solid dosage form

Artificial Intelligence Detection of Diabetic Retinopathy

Objective: To compare general ophthalmologists, retina specialists, and the EyeArt Artificial Intelligence (AI) system to the clinical reference standard for detecting more than mild diabetic retinopathy (mtmDR). Design: Prospective, pivotal, multicenter trial conducted from April 2017 to May 2018. Participants: Participants were aged ≥ 18 years who had diabetes mellitus and underwent dilated ophthalmoscopy. A total of 521 of 893 participants met these criteria and completed the study protocol. Testing: Participants underwent 2-field fundus photography (macula centered, disc centered) for the EyeArt system, dilated ophthalmoscopy, and 4-widefield stereoscopic dilated fundus photography for reference standard grading. Main Outcome Measures: For mtmDR detection, sensitivity and specificity of EyeArt gradings of 2-field, fundus photographs and ophthalmoscopy grading versus a rigorous clinical reference standard comprising Reading Center grading of 4-widefield stereoscopic dilated fundus photographs using the ETDRS severity scale. The AI system provided automatic eye-level results regarding mtmDR. Results: Overall, 521 participants (999 eyes) at 10 centers underwent dilated ophthalmoscopy: 406 by nonretina and 115 by retina specialists. Reading Center graded 207 positive and 792 eyes negative for mtmDR. Of these 999 eyes, 26 eyes were ungradable by the EyeArt system, leaving 973 eyes with both EyeArt and Reading Center gradings. Retina specialists correctly identified 22 of 37 eyes as positive (sensitivity 59.5%) and 182 of 184 eyes as negative (specificity 98.9%) for mtmDR versus the EyeArt AI system that identified 36 of 37 as positive (sensitivity 97%) and 162 of 184 eyes as negative (specificity of 88%) for mtmDR. General ophthalmologists correctly identified 35 of 170 eyes as positive (sensitivity 20.6%) and 607 of 608 eyes as negative (specificity 99.8%) for mtmDR compared with the EyeArt AI system that identified 164 of 170 as positive (sensitivity 96.5%) and 525 of 608 eyes as negative (specificity 86%) for mtmDR. Conclusions: The AI system had a higher sensitivity for detecting mtmDR than either general ophthalmologists or retina specialists compared with the clinical reference standard. It can potentially serve as a low-cost point-of-care diabetic retinopathy detection tool and help address the diabetic eye screening burden