Prepectoral Two Stage Implant-Based Breast Reconstruction with Poly-4-Hydroxybutyrate (P4HB) for Pocket Control without the use of Acellular Dermal Matrix (ADM): A 4-Year Review.

BACKGROUND: As an alternative to biologic materials, absorbable meshes have been utilized to mitigate the potential drawbacks of ADM based breast reconstruction. Poly-4-hydroxybutyrate has been demonstrated to be a lower cost, safe, and effective alternative to ADM in subpectoral breast reconstruction. The aim of this study is to present the largest long-term observational study to date using P4HB for pocket control and implant support in immediate two stage pre-pectoral breast reconstruction looking at non-integration, capsular contracture, and implant malposition, along with patient comorbidities and risk factors. METHODS: A retrospective review of a single surgeon's (KM) experience was performed over a 4year span for patients who had undergone immediate two-stage prepectoral implant-based breast reconstruction with P4HB mesh. The review examined complications including implant loss, rippling, capsular contracture, malposition, and patient satisfaction throughout follow up. RESULTS: From 2018 to 2022, 105 patients underwent breast reconstruction using P4HBmesh for a total of 194 breasts. P4HBmesh integration was 97%. Overall, 16 breasts (8.2%) experienced minor complications while 10.3% of devices required explantation which was significantly higher in the radiated group at 28.6% (P<0.01). Older patients, higher BMI, active smokers, or increased mastectomy specimen size were more likely to undergo explantation. The rate of capsular contracture was 1.0 %. The overall rate of lateral malposition was also 1.0%. Visible rippling was present in 15.6% of breasts. There was no significant difference between smile mastopexy and inferolateral incision with regards to capsular contracture, lateral malposition, or rippling. Overall, patients demonstrated a high level of satisfaction and there were no significant predictors of capsular contracture, lateral malposition, or visible rippling. CONCLUSIONS: We have shown the safety and efficacy of P4HB in 2-stage pre-pectoral breast reconstruction. There appears to be equal, if not reduced, capsular contracture rates when compared to the published data on the use of ADM. Lastly, this represents a large cost reduction to both the patient and health care system.

Opioid Epidemic or Pain Crisis? Using the Virginia All Payer Claims Database to Describe Opioid Medication Prescribing Patterns and Potential Harms for Patients With Cancer.

PURPOSE: A key challenge regarding the current opioid epidemic is understanding how concerns regarding opioid-related harms affect access to pain management, an essential element of cancer care. In certain regions of the United States where disproportionately high cancer mortality and opioid fatality rates coexist (such as southwest Virginia in central Appalachia), this dilemma is particularly pronounced. METHODS: This longitudinal, exploratory, secondary analysis used the Commonwealth of Virginia All Payer Claims Database to describe prescription opioid medication (POM) prescribing patterns and potential harms for adult patients with cancer living in rural southwest Virginia between 2011 and 2015. Descriptive and inferential statistical analyses were conducted at the patient, prescriber, and prescription levels to identify patterns and predictors of POM prescribing and potential harms. To explore geographic patterns, choropleth and heat maps were created. RESULTS: Of the total sample of patients with cancer (n = 4,324), less than 25% were prescribed a Controlled Substance Schedule II POM at least three times in any study year. More than 60% of patients never received a Controlled Substance Schedule II POM prescription. Six hundred fifty-two patients (15.1%) experienced 1,599 hospitalizations for any reason; 10 or fewer patients were admitted for 11 opioid use disorder-related hospitalizations. The main findings suggest potential undertreatment of cancer-related pain; no difference in risk for opioid-related hospitalization on the basis of frequency of POM prescriptions; and geographic disparities where opioid overdoses are occurring versus where POM prescription use is highest. CONCLUSION: These findings have significant opioid policy and practice implications related to the need for cancer-specific prescribing guidelines, how to optimally allocate health delivery services, and the urgent need to improve data interoperability and access related to POMs.

Vertical Inset of the Latissimus Dorsi Flap Improves Reconstruction Aesthetics by Reducing Scar Burden in the "Social Breast".

PURPOSE: The skin paddle of the latissimus dorsi flap is typically inset horizontally (HILD) in breast reconstruction. We describe our experience with the vertical inset of the latissimus dorsi (VILD) and its aesthetic benefit. METHODS: We performed a case-control study comparing the most recent cases of both VILD and HILD. Scar, as seen on anterior-posterior photographs, was digitally measured and compared from 3 clinically relevant areas: (1) all visible scarring ("mirror view"), (2) scarring above the nipple ("self-view"), and (3) scarring above or medial to the nipple ("social view"). Demographics and outcomes were statistically compared. EXPERIENCE/RESULTS: Fifty of the most recent patients receiving HILD or VILD were selected for each group. Average patient age was 55.6 and 51.6 years (P = 0.32), and average follow-up was 531.6 and 606.7 days (P = 0.20), respectively. The VILD scar-length ratios were decreased by 17% in the mirror view (P ≤ 0.01), 37% in the self-view (P ≤ 0.01), and 37% in the social view (P ≤ 0.01). There were no statistically significant differences between groups regarding smoking (P = 0.75), diabetes (P = 0.70), body mass index (P = 0.74), seroma (P = 0.46), infection (P = 1.0), or flap necrosis (P = 0.70). CONCLUSIONS: The VILD is safe and reliable. Measurements from anterior-posterior photographs illustrate statistically significant decreases in overall scar burden (mirror view) and statistically significant reductions in the highly visible self-view and social view. Our study is the first to quantify a reduction in scar burden by using VILD technique.

The Contribution of the International Pain Policy Fellowship in Improving Opioid Availability in Georgia.

In the Republic of Georgia, the incidence and prevalence of cancer are increasing, signifying a growing need for palliative care and pain relief, including with controlled opioid medicines. As a signatory to the Single Convention, the Georgian government has a responsibility to ensure the adequate availability of controlled medicines for medical purposes; however, the consumption of morphine is very low, suggesting a high occurrence of unrelieved pain. In Georgia, palliative care development began in the 2000s including the adoption of a policy document in 2005, the creation of the National Palliative Care Coordinator in 2006, and important changes in Georgian legislation in 2007 and 2008, which served to lay a foundation for improving opioid availability. In 2008, a neurologist from the Sarajishvili Institute of Neurology and Neurosurgery in Tbilisi, and member of the Georgia National Association for Palliative Care, was selected to be an International Pain Policy Fellow to focus on improving opioid availability. Working with colleagues, government officials, and international experts, the Fellow contributed to several improvements to opioid availability, such as 1) positive changes to opioid prescribing legislation, 2) clarification of legislative terminology regarding dependence syndrome, 3) initiating the importation of both sustained-release and immediate-release oral morphine, and 4) improvements in the availability of sustained-release morphine. Despite these varied achievements, morphine consumption remains low in Georgia relative to the estimated amounts needed. The Fellow is continuing to study and understand the barriers that are impeding physician's prescription of opioids and patient's acceptance of them.

Can a Quality Collaborative Build Value in Global Surgery? Results From a Single State Experience.

BACKGROUND: Surgery is a critical component of global health care worldwide. Little is known about global surgery participation among surgeons in Connecticut. The goal of this pilot survey project was to determine the breadth of global surgery experience in our state. STUDY DESIGN: An electronic survey was distributed to surgeons in the state of Connecticut via the Connecticut Chapter of the American College of Surgeons (CTACS) and to departments of surgery throughout the state. RESULTS: Seventy-four surgeons and surgical residents completed the online survey from 17 different hospitals. Nineteen (25.7%) of the respondents had participated in global surgery. Most participated in yearly (56.3%), short-term experiences (94.5%). Nearly half of this group reported no formal record of outcomes (52.9%), but 17/19 (89.5%) respondents reported that accurate outcomes measures are beneficial to surgical care in resource-poor areas. Eighty-nine percent reported a willingness to participate in a surgical quality and outcomes database. CONCLUSION: A substantial proportion of surgeons in Connecticut participate in global surgery. Most surgeons value qualityin surgical care, yet outcomes are not routinely measured. This discordance may be addressed through the development of a quality improvement collaborative for global surgery.

Multivariate analysis of countries' government and health-care system influences on opioid availability for cancer pain relief and palliative care: more than a function of human development.

BACKGROUND: Many international governmental and nongovernmental organizations regard unrelieved cancer pain as a significant global public health problem. Although opioids such as morphine are considered essential medicines in the provision of palliative care and for treating cancer pain, especially when the pain is severe, low- and middle-income countries often lack such medications. AIM: The primary aim of this study was to examine countries' government and health-care system influences on opioid availability for cancer pain and palliative care, as a means to identify implications for improving appropriate access to prescription opioids. DESIGN: A multivariate regression of 177 countries' consumption of opioids (in milligrams/death from cancer and AIDS) contained country-level predictor variables related to public health, including Human Development Index, palliative care infrastructure, and health system resources and expenditures. RESULTS: Results were highly explanatory (adjusted R(2) = 82%) and Human Development Index was the most predictive variable when controlling for all other factors in the statistical model (B = 11.875, confidence interval = 10.216, 13.534, p < 0.0001). CONCLUSIONS: Study findings demonstrate that a limited number of predictor variables characterizing a country's government and health-care system infrastructure can explain its opioid consumption level, with the greatest influence being very high Human Development Index. However, Human Development Index is not the most policy-relevant factor, and this finding should be reconciled against the reality that many countries with low or medium Human Development Index have succeeded in creating and sustaining a health-care system to strengthen cancer pain care and palliative care, including through the appropriate use of essential prescription opioids.

Opioid pharmacotherapy for chronic non-cancer pain in the United States: a research guideline for developing an evidence-base.

UNLABELLED: This document reports the consensus of an interdisciplinary panel of research and clinical experts charged with reviewing the use of opioids for chronic noncancer pain (CNCP) and formulating guidelines for future research. Prescribing opioids for chronic noncancer pain has recently escalated in the United States. Contrasting with increasing opioid use are: 1) The lack of evidence supporting long-term effectiveness; 2) Escalating misuse of prescription opioids including abuse and diversion; and 3) Uncertainty about the incidence and clinical salience of multiple, poorly characterized adverse drug events (ADEs) including endocrine dysfunction, immunosuppression and infectious disease, opioid-induced hyperalgesia and xerostomia, overdose, falls and fractures, and psychosocial complications. Chief among the limitations of current evidence are: 1) Sparse evidence on long-term opioid effectiveness in chronic pain patients due to the short-term time frame of clinical trials; 2) Insufficiently comprehensive outcome assessment; and 3) Incomplete identification and quantification of ADEs. The panel called for a strategic interdisciplinary approach to the problem domain in which basic scientists and clinicians cooperate to resolve urgent issues and generate a comprehensive evidence base. It offered 4 recommendations in 3 areas: 1) A research strategy for studying the effectiveness of long-term opioid pharmacotherapy; 2) Improvements in evidence-generation methodology; and 3) Potential research topics for generating new evidence. PERSPECTIVE: Prescribing opioids for CNCP has outpaced the growth of scientific evidence bearing on the benefits and harms of these interventions. The need for a strong evidence base is urgent. This guideline offers a strategic approach to creating a comprehensive evidence base to guide safe and effective management of CNCP.

Opioid analgesics for pain control: wisconsin physicians' knowledge, beliefs, attitudes, and prescribing practices.

OBJECTIVE: Opioid analgesics are the drugs of choice for the treatment of moderate to severe acute and cancer pain. Although their role in the management of chronic pain not related to cancer is controversial, there is increasing evidence for their benefit in certain patient populations. DESIGN: A 32-item survey to assess Wisconsin physicians' knowledge, beliefs, and attitudes toward opioid analgesic use was mailed to 600 randomly selected licensed physicians, resulting in a 36% response rate. RESULTS: Half of the respondents considered diversion a moderate or severe problem in Wisconsin. A majority considered addiction to be a combination of physiological and behavioral characteristics, rather than defining it solely as a behavioral syndrome. Most physicians felt it lawful and acceptable medical practice to prescribe opioids for chronic cancer pain, but only half held this view if the pain was not related to cancer. Fewer physicians considered such prescribing as lawful and generally accepted medical practice if the patient had a history of substance abuse. About two-thirds of physicians were not concerned about being investigated for their opioid prescribing practices, but some admitted that fear of investigation led them to lower the dose prescribed, limit the number of refills, or prescribe a Schedule III or IV rather than a Schedule II opioid. CONCLUSION: Wisconsin physicians who responded to this survey held many misconceptions about the prescribing of opioids. Such views, coupled with a lack of knowledge about laws and regulations governing the prescribing of controlled substances, may result in inadequate prescribing of opioids with resultant inadequate management of pain.

Improving state pain policies: recent progress and continuing opportunities.

The National Institutes of Health reports that 100 million Americans suffer from chronic pain, including pain associated with the disease of cancer. Painful conditions can strike anyone, including cancer patients and cancer survivors. Unrelieved severe pain can limit a person's functioning and sometimes even destroy the will to live. When the quality of pain relief provided is inadequate, it is usually the result of failures to apply existing knowledge about pain and its treatment, including the appropriate use of opioids. But pain relief also can be affected by the regulatory environment and fear of being investigated for excessive prescribing. The importance of evaluating and improving policies governing pain management has been recognized by national and international authorities, including the Institute of Medicine and the World Health Organization. A pilot examination of state laws and regulatory policies demonstrated that they contained a number of outdated medical concepts and prescribing restrictions and did not contain key elements of law that can make pain management a priority for licensed medical practitioners. The Pain & Policy Studies Group developed a research program to evaluate US federal and state policy governing the medical use of pain medication. This article describes 3 national policy evaluations and how the results are being used to document improvements in state pain policies. An emerging role for clinicians and their professional organizations to improve their state's pain policies is discussed.

Progress to achieve balanced state policy relevant to pain management and palliative care: 2000-2003.

State laws and regulatory policies govern healthcare practice, including the prescribing, dispensing, and administering of opioid analgesics to treat pain. A number of national healthcare and law enforcement organizations have identified drug regulatory policy as a potential barrier to pain relief and palliative care, and have called for evaluation and removal. This article summarizes and discusses the results of an innovative evaluation methodology that was used to produce three policy analysis tools, including one report that graded and ranked states based on the quality of their policies related to pain management and palliative care (called a Progress Report Card [PRC]). The PRC development and implementation was a first-of-a-kind study that compared pain policies in all states over a three year period according to the same evaluation criteria. Results demonstrate significant progress to improve policy in a number of states during the study period, but also showed that most state policies are characterized by a lack "balance." In addition to providing examples of policy change in particular states, the relevance of these findings to current policy issues, including the importance of communicating and implementing new policies is discussed. The need for partnerships between the healthcare and law enforcement communities is emphasized to create a more positive regulatory environment for pain relief and palliative care, which ultimately will benefit patient care.

U.S. policies relevant to the prescribing of opioid analgesics for the treatment of pain in patients with addictive disease.

Undertreatment of pain is likely to occur among patients with active addiction or those who have a history of addiction. One of the factors that can contribute to the inadequate treatment of pain in this patient population is the presence of laws and regulations that, when implemented, could impede effective pain management. This article describes the current status of federal and state policy governing the medical use of opioid analgesics for pain management with patients who have an addictive disease in the U.S. Three types of policy barriers are discussed: (1) those that can affect pain management in any patient, (2) those that can lead to patients in pain being classified as "addicts," and (3) those that relate specifically to patients with a high risk of addiction. Also presented are recent policy initiatives that can improve the use of controlled substances to treat pain and, thus, ultimately enhance pain relief for patients with an addictive disease.

Pain management, controlled substances, and state medical board policy: a decade of change.

Physicians' concerns about regulatory scrutiny and the possibility of unwarranted investigation by regulatory agencies negatively affect their prescribing of opioid analgesics to treat pain. Indeed, some state medical boards have rejected prescribing practices that are considered acceptable by today's standards. This article describes a ten-year program of research, education, and policy development implemented by the Pain & Policy Studies Group aimed at updating and clarifying state medical board policies on the use of opioid analgesics to treat pain, including cancer and chronic noncancer pain. Following surveys of medical board members and educational workshops, state medical board policies began an initial period of change, drawing on guidelines from other states, particularly in California. The next phase of policy development was marked by the introduction of Model Guidelines by the Federation of State Medical Boards of the U.S. The Model Guidelines address professional standards for the appropriate prescribing of opioid analgesics for pain management, as well as physicians' fears of regulatory scrutiny. Although most state medical boards have adopted regulations, guidelines, or policy statements relating to controlled substances and pain management, to date ten boards have adopted the Model Guidelines, while ten more have adopted the Model Guidelines in part. Further actions are recommended so that state medical boards can address inadequate pain management and physician concerns about regulatory scrutiny.