Patterns of Unnecessary Insurer Prior Authorization Denials in a Complex Surgical Oncology Practice.

INTRODUCTION: Insurance prior authorization (PA) is a determination of need, required by a health insurer for an ordered test/procedure. If the test/procedure is denied, a peer-to-peer (P2P) discussion between ordering provider and payer is used to appeal the decision. The objective of this study was to measure the number and patterns of unnecessary PA denials. METHODS: This was a retrospective review at a quaternary cancer center from October 2021 to March 2022. Included were all patients with outpatient imaging orders for surgical planning or surveillance of gastrointestinal, endocrine, or skin cancer. Primary outcome was unnecessary initial denial (UID) defined as an order that required preauthorization, was initially denied by the insurer, and subsequently overturned by P2P. RESULTS: Nine hundred fifty seven orders were placed and 419 required PA (44%). Of tests requiring authorization, 55/419 (13.1%) were denied. Variability in the likelihood of initial denial was seen across insurers, ranging from 0% to 57%. Following P2P, 32/55 were overturned (58.2% UID). The insurers most likely to have a UID were Aetna (100%), Anthem (77.8%), and Cigna (50.0%). UID was most common for gastrointestinal (58.9%) and endocrine (58.3%) cancers. Average P2P was 33.5 min (interquartile range 28-40). CONCLUSIONS: The majority of imaging studies initially denied were overturned after P2P. If all UIDs were eliminated, this would represent 108 less P2P discussions with an estimated time-savings of 60.3 h annually within a high-volume surgical oncology practice. Combined personnel costs to the health systems and stress on patients with cancer due to image-associated PAs and P2P appear hard to justify.

Facility-Wide Testing for SARS-CoV-2 in Nursing Homes - Seven U.S. Jurisdictions, March-June 2020.

Undetected infection with SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19) contributes to transmission in nursing homes, settings where large outbreaks with high resident mortality have occurred (1,2). Facility-wide testing of residents and health care personnel (HCP) can identify asymptomatic and presymptomatic infections and facilitate infection prevention and control interventions (3-5). Seven state or local health departments conducted initial facility-wide testing of residents and staff members in 288 nursing homes during March 24-June 14, 2020. Two of the seven health departments conducted testing in 195 nursing homes as part of facility-wide testing all nursing homes in their state, which were in low-incidence areas (i.e., the median preceding 14-day cumulative incidence in the surrounding county for each jurisdiction was 19 and 38 cases per 100,000 persons); 125 of the 195 nursing homes had not reported any COVID-19 cases before the testing. Ninety-five of 22,977 (0.4%) persons tested in 29 (23%) of these 125 facilities had positive SARS-CoV-2 test results. The other five health departments targeted facility-wide testing to 93 nursing homes, where 13,443 persons were tested, and 1,619 (12%) had positive SARS-CoV-2 test results. In regression analyses among 88 of these nursing homes with a documented case before facility-wide testing occurred, each additional day between identification of the first case and completion of facility-wide testing was associated with identification of 1.3 additional cases. Among 62 facilities that could differentiate results by resident and HCP status, an estimated 1.3 HCP cases were identified for every three resident cases. Performing facility-wide testing immediately after identification of a case commonly identifies additional unrecognized cases and, therefore, might maximize the benefits of infection prevention and control interventions. In contrast, facility-wide testing in low-incidence areas without a case has a lower proportion of test positivity; strategies are needed to further optimize testing in these settings.

COVID-19 Mortality Among American Indian and Alaska Native Persons - 14 States, January-June 2020.

American Indian/Alaska Native (AI/AN) persons experienced disproportionate mortality during the 2009 influenza A(H1N1) pandemic (1,2). Concerns of a similar trend during the coronavirus disease 2019 (COVID-19) pandemic led to the formation of a workgroup* to assess the prevalence of COVID-19 deaths in the AI/AN population. As of December 2, 2020, CDC has reported 2,689 COVID-19-associated deaths among non-Hispanic AI/AN persons in the United States.† A recent analysis found that the cumulative incidence of laboratory-confirmed COVID-19 cases among AI/AN persons was 3.5 times that among White persons (3). Among 14 participating states, the age-adjusted AI/AN COVID-19 mortality rate (55.8 deaths per 100,000; 95% confidence interval [CI] = 52.5-59.3) was 1.8 (95% CI = 1.7-2.0) times that among White persons (30.3 deaths per 100,000; 95% CI = 29.9-30.7). Although COVID-19 mortality rates increased with age among both AI/AN and White persons, the disparity was largest among those aged 20-49 years. Among persons aged 20-29 years, 30-39 years, and 40-49 years, the COVID-19 mortality rates among AI/AN were 10.5, 11.6, and 8.2 times, respectively, those among White persons. Evidence that AI/AN communities might be at increased risk for COVID-19 illness and death demonstrates the importance of documenting and understanding the reasons for these disparities while developing collaborative approaches with federal, state, municipal, and tribal agencies to minimize the impact of COVID-19 on AI/AN communities. Together, public health partners can plan for medical countermeasures and prevention activities for AI/AN communities.

Enhanced Surveillance for Coccidioidomycosis, 14 US States, 2016.

Although coccidioidomycosis in Arizona and California has been well-characterized, much remains unknown about its epidemiology in states where it is not highly endemic. We conducted enhanced surveillance in 14 such states in 2016 by identifying cases according to the Council of State and Territorial Epidemiologists case definition and interviewing patients about their demographic characteristics, clinical features, and exposures. Among 186 patients, median time from seeking healthcare to diagnosis was 38 days (range 1-1,654 days); 70% had another condition diagnosed before coccidioidomycosis testing occurred (of whom 83% were prescribed antibacterial medications); 43% were hospitalized; and 29% had culture-positive coccidioidomycosis. Most (83%) patients from nonendemic states had traveled to a coccidioidomycosis-endemic area. Coccidioidomycosis can cause severe disease in residents of non-highly endemic states, a finding consistent with previous studies in Arizona, and less severe cases likely go undiagnosed or unreported. Improved coccidioidomycosis awareness in non-highly endemic areas is needed.

Borrelia mayonii sp. nov., a member of the Borrelia burgdorferi sensu lato complex, detected in patients and ticks in the upper midwestern United States.

Lyme borreliosis (LB) is a multisystem disease caused by spirochetes in the Borrelia burgdorferisensu lato (Bbsl) genospecies complex. We previously described a novel Bbsl genospecies (type strain MN14-1420T) that causes LB among patients with exposures to ticks in the upper midwestern USA. Patients infected with the novel Bbsl genospecies demonstrated higher levels of spirochetemia and somewhat differing clinical symptoms as compared with those infected with other Bbsl genospecies. The organism was detected from human specimens using PCR, microscopy, serology and culture. The taxonomic status was determined using an eight-housekeeping-gene (uvrA, rplB, recG, pyrG, pepX, clpX, clpA and nifS) multi-locus sequence analysis (MLSA) and comparison of 16S rRNA gene, flaB, rrf-rrl, ospC and oppA2 nucleotide sequences. Using a system threshold of 98.3 % similarity for delineation of Bbsl genospecies by MLSA, we demonstrated that the novel species is a member of the Bbsl genospecies complex, most closely related to B. burgdorferisensu stricto (94.7-94.9 % similarity). This same species was identified in Ixodes scapularis ticks collected in Minnesota and Wisconsin. This novel species, Borrelia mayonii sp. nov, is formally described here. The type strain, MN14-1420, is available through the Deutsche Sammlung von Mikroorganismen und Zelkulturen GmbH (DSM 102811) and the American Type Culture Collection (ATCC BAA-2743).

Human Infection with Ehrlichia muris-like Pathogen, United States, 2007-2013(1).

An Ehrlichia muris-like (EML) pathogen was detected among 4 patients in Minnesota and Wisconsin during 2009. We characterized additional cases clinically and epidemiologically. During 2004-2013, blood samples from 75,077 patients from all 50 United States were tested by PCR from the groEL gene for Ehrlichia spp. and Anaplasma phagocytophilum. During 2007-2013, samples from 69 (0.1%) patients were positive for the EML pathogen; patients were from 5 states: Indiana (1), Michigan (1), Minnesota (33), North Dakota (3), and Wisconsin (31). Most (64%) patients were male; median age was 63 (range 15-94) years; and all 69 patients reported likely tick exposure in Minnesota or Wisconsin. Fever, malaise, thrombocytopenia, and lymphopenia were the most common symptoms. Sixteen (23%) patients were hospitalized (median 4 days); all recovered, and 96% received doxycycline. Infection with the EML pathogen should be considered for persons reporting tick exposure in Minnesota or Wisconsin.

Alcohol-attributable deaths and years of potential life lost--11 States, 2006-2010.

Excessive alcohol consumption, the fourth leading preventable cause of death in the United States, resulted in approximately 88,000 deaths and 2.5 million years of potential life lost (YPLL) annually during 2006-2010 and cost an estimated $223.5 billion in 2006. To estimate state-specific average annual rates of alcohol-attributable deaths (AAD) and YPLL caused by excessive alcohol use, 11 states analyzed 2006-2010 data (the most recent data available) using the CDC Alcohol-Related Disease Impact (ARDI) application. The age-adjusted median AAD rate was 28.5 per 100,000 population (range = 50.9 per 100,000 in New Mexico to 22.4 per 100,000 in Utah). The median YPLL rate was 823 per 100,000 (range = 1,534 YPLL per 100,000 for New Mexico to 634 per 100,000 in Utah). The majority of AAD (median = 70%) and YPLL (median = 82%) were among working-age (20-64 years) adults. Routine monitoring of alcohol-attributable health outcomes, including deaths and YPLL, in states could support the planning and implementation of evidence-based prevention strategies recommended by the Community Preventive Services Task Force to reduce excessive drinking and related harms. Such strategies include increasing the price of alcohol, limiting alcohol outlet density, and holding alcohol retailers liable for harms related to the sale of alcoholic beverages to minors and intoxicated patrons (dram shop liability).

Utility of minimally invasive endoscopic skull base approaches for the treatment of drug-resistant mesial temporal lobe epilepsy: a review of current techniques and trends.

Mesial temporal lobe epilepsy (mTLE) is an important cause of drug-resistant epilepsy (DRE) in adults and children. Traditionally, the surgical option of choice for mTLE includes a frontotemporal craniotomy and open resection of the anterior temporal cortex and mesial temporal structures. Although this technique is effective and durable, the neuropsychological morbidity resulting from temporal neocortical resections has resulted in the investigation of alternative approaches to resect the mesial temporal structures to achieve seizure freedom while minimizing postoperative cognitive deficits. Outcomes supporting the use of selective temporal resections have resulted in alternative approaches to directly access the mesial temporal structures via endoscopic approaches whose direct trajectory to the epileptogenic zone minimizes retraction, resection, and manipulation of surrounding cortex. The authors reviewed the utility of the endoscopic transmaxillary, endoscopic endonasal, endoscopic transorbital, and endoscopic supracerebellar transtentorial approaches for the treatment of drug-resistant mesial temporal lobe epilepsy. First, a review of the literature demonstrated the anatomical feasibility of each approach, including the limits of exposure provided by each trajectory. Next, clinical data assessing the safety and effectiveness of these techniques in the treatment of DRE were analyzed. An outline of the surgical techniques is provided to highlight the technical nuances of each approach. The direct access to mesial temporal structures and avoidance of lateral temporal manipulation makes endoscopic approaches promising alternatives to traditional methods for the treatment of DRE arising from the temporal pole and mesial temporal lobe. A dearth of literature outlining clinical outcomes, a need for qualified cosurgeons, and a lack of experience with endoscopic approaches remain major barriers to widespread application of the aforementioned techniques. Future studies are warranted to define the utility of these approaches moving forward.

Targeting mitochondrial energetics reverses panobinostat- and marizomib-induced resistance in pediatric and adult high-grade gliomas.

In previous studies, we demonstrated that panobinostat, a histone deacetylase inhibitor, and bortezomib, a proteasomal inhibitor, displayed synergistic therapeutic activity against pediatric and adult high-grade gliomas. Despite the remarkable initial response to this combination, resistance emerged. Here, in this study, we aimed to investigate the molecular mechanisms underlying the anticancer effects of panobinostat and marizomib, a brain-penetrant proteasomal inhibitor, and the potential for exploitable vulnerabilities associated with acquired resistance. RNA sequencing followed by gene set enrichment analysis (GSEA) was employed to compare the molecular signatures enriched in resistant compared with drug-naïve cells. The levels of adenosine 5'-triphosphate (ATP), nicotinamide adenine dinucleotide (NAD)+ content, hexokinase activity, and tricarboxylic acid (TCA) cycle metabolites required for oxidative phosphorylation to meet their bioenergetic needs were analyzed. Here, we report that panobinostat and marizomib significantly depleted ATP and NAD+ content, increased mitochondrial permeability and reactive oxygen species generation, and promoted apoptosis in pediatric and adult glioma cell lines at initial treatment. However, resistant cells exhibited increased levels of TCA cycle metabolites, which required for oxidative phosphorylation to meet their bioenergetic needs. Therefore, we targeted glycolysis and the electron transport chain (ETC) with small molecule inhibitors, which displayed substantial efficacy, suggesting that resistant cell survival is dependent on glycolytic and ETC complexes. To verify these observations in vivo, lonidamine, an inhibitor of glycolysis and mitochondrial function, was chosen. We produced two diffuse intrinsic pontine glioma (DIPG) models, and lonidamine treatment significantly increased median survival in both models, with particularly dramatic effects in panobinostat- and marizomib-resistant cells. These data provide new insights into mechanisms of treatment resistance in gliomas.

Emergence of ciprofloxacin-resistant Neisseria meningitidis in North America.

We report on three cases of meningococcal disease caused by ciprofloxacin-resistant Neisseria meningitidis, one in North Dakota and two in Minnesota. The cases were caused by the same serogroup B strain. To assess local carriage of resistant N. meningitidis, we conducted a pharyngeal-carriage survey and isolated the resistant strain from one asymptomatic carrier. Sequencing of the gene encoding subunit A of DNA gyrase (gyrA) revealed a mutation associated with fluoroquinolone resistance and suggests that the resistance was acquired by means of horizontal gene transfer with the commensal N. lactamica. In susceptibility testing of invasive N. meningitidis isolates from the Active Bacterial Core surveillance system between January 2007 and January 2008, an additional ciprofloxacin-resistant isolate was found, in this case from California. Ciprofloxacin-resistant N. meningitidis has emerged in North America.

Antibiofilm properties of bioactive compounds from Actinomycetes against foodborne and fish pathogens.

In nature, bacteria can form biofilms, multi-layered structures that adhere microbial populations to solid surfaces by exopolysaccharides, proteins, and nucleic acids. In addition to causing foodborne infections, biofilms can be a major problem in aquaculture. Actinomycetes extracts have previously demonstrated antibiofilm activity against multiple foodborne and fish pathogens, and further characterization of these extracts is needed. In this study, we identified the chemical structures and antibiofilm properties of four extracts and determined the genetic similarity of the isolates to known Streptomyces isolates. We found that several extracts contained multiple antibiofilm compounds, and the antibiofilm activities of all extracts were most stable at pH 6. Furthermore, the antibiofilm inhibition and destruction activities of the isolates were stable at different temperatures. All of crude extracts demonstrated activity against biofilms formed by foodborne and fish pathogens on the surface of stainless-steel coupons as well as polystyrene that commonly used in industrial equipment. Using PCR 16S-rRNA gene and DNA sequencing analysis, the four Actinomycetes isolates were found to be 99% (1 AC), 97% (20 PM), 95% (16 PM), and 85% (18 PM) similar to Streptomyces. Biofilm structure were analyzed using Scanning Electron Microscopy coupled with Energy-Dispersive Spectrometry analysis. Coniine/(S)-2-propylpiperidine was the most active fraction of the crude extracts of the 1 AC, 20 PM, and 16 PM isolates, and piperidine, 2-(tetrahydro-2-furanyl) was most active in the 18 PM isolate.

Epidemiology of Hepatitis C virus infection among incarcerated populations in North Dakota.

This retrospective cohort study was conducted to determine the prevalence of HCV infections among individuals incarcerated in a state prison system and identify potential contributing factors to HCV infection. North Dakota Department of Corrections and Rehabilitation (NDDOCR) data from 2009 to 2018 was used and period prevalence was calculated for this 10-year time period. The period prevalence of HCV infection was (15.13% (95% CI 14.39-15.90) with a marginally significant (p-value: 0.0542) increasing linear trend in annual prevalence over this period. Multivariate logistic regression analysis was used to identify risk factors associated with HCV infection. The main significant independent risk factors for HCV infection in this incarcerated population were age >40 years [OR: 1.78 (1.37-2.32)]; sex [OR: 1.21 (1.03-1.43)]; race/ethnicity [OR: 1.97 (1.69-2.29)]; history of intravenous drug use (IVDU) [OR: 7.36 (6.41-8.44)]; history of needle or syringe sharing [OR: 7.57 (6.62-8.67)]; and alcohol use [OR: 0.87 (0.77-0.99)]. Study limitations include uncollected information on sexual history, frequency or duration of injection drug use and blood transfusion history of the incarcerated population. Considering the high prevalence of HCV infection and its associated risk factors, it is important to implement prevention programs such as syringe/needle exchanges and counsel with imprisoned IVD users.

Screening and characterization of cellulolytic molds from empty fruit bunches and soils in palm oil plantation area in Indonesia.

OBJECTIVE: This research was aimed to isolate cellulolytic molds in empty fruit bunches of oil palm (EFBOP) and soils from palm oil plantation area and identify their enzyme activities to digest EFBOP. RESULTS: A total of seven molds were successfully isolated and screened for their enzyme activities from EFBOP and the soils. The enzymes from each isolate were produced in submerged culture using Mineral Mandels and 3% of alkali pretreated pollard in triplicates. The results indicated that all of the isolates were able to hydrolyze Carboxymethyl Cellulose (CMC), Whatmann No. 1 filter paper, and also EFBOP to sugars with reducing ends that reacted to 3,5-Dinitrosalicylic acid (DNS). The CMCase activity of isolate X showed the highest while the lowest was found for isolate MT8. Filter paperase (FPase) activity of isolate X performed the highest wile the lowest were found from isolate MT3 and MT6. The saccharification activity of isolate P showed the highest while MT6 performed the lowest activity.

Epidemiology of West Nile virus in the highly epidemic state of North Dakota, 2002-2007.

OBJECTIVES: West Nile virus (WNV) continues to cause seasonal epidemics of neuroinvasive disease and febrile illness, which have been most dramatic in the central plains states. We studied the epidemiology of WNV disease in North Dakota (ND), a highly epidemic state, six years following its first appearance in the state. METHODS: We analyzed information from cases of WNV disease reported to the ND Department of Health during August 2002 through December 2007. RESULTS: A total of 1246 cases of WNV disease were reported in ND; 183 cases experienced neuroinvasive disease, including meningitis, encephalitis, or acute flaccid paralysis. Risk factors associated with developing neuroinvasive disease rather than West Nile fever included older age, male gender, and residence in a rural area. Annual cumulative incidence of neuroinvasive disease in ND ranged from 0.3 per 100,000 population to 14.6 per 100,000 population. CONCLUSIONS: Annual cumulative incidence rates of West Nile neuroinvasive disease suggest that this region offers favorable conditions for its continued enzootic transmission, which highlights the need for improved targeted prevention measures, particularly for rural areas of the state.

Clothes encounter: patient perception of nursing attire in a behavioral health unit.

BACKGROUND: In an acute behavioral health unit, patients' perceptions of nurses can be influenced by the type of clothing they wear. OBJECTIVES: The purposes of this study were to determine if mental health patients had preferences related to nursing attire, to determine if patient preference varied with age, and to determine if nursing attire affected patients' thoughts on approachability, competence, and professionalism. STUDY DESIGN: A six-question survey was distributed to patients who met specific criteria between August and December 2008. RESULTS: Overall, patients did not have a preference for the type of attire worn by staff. Identification of nurses was a concern for many. More than half of the respondents indicated approachability was not affected by attire; however, 29% said that street clothes made the nurse less approachable. Attire did not affect patient perception of competence or professionalism. CONCLUSION: As behavioral health care changes, staff attire may need to be reconsidered.

Photo-fragmentation cross-section of gaseous 2,4,6-trinitrotoluene at different ultraviolet wavelengths.

The photo-fragmentation cross-section of 2,4,6-trinitrotoluene (TNT) vapor at room temperature was determined at different ultraviolet wavelengths (254, 300, 340, and 400 nm) by measuring the concentration of NO molecule with cavity ring down spectroscopy and correcting for the photo-fragmentation cross-section of NO(2). Nitric oxide (NO) molecules are produced by the TNT photo-fragmentation processes via an intermediate production of NO(2). Our results reveal that the photo-fragmentation cross-section of TNT changes appreciably with change in wavelength with xenon arc lamp illumination, increasing with decreasing excitation wavelength. The maximum value of cross-section was observed at the shortest photo-fragmentation wavelength studied (254 nm), which is closest to the wavelength of an absorption peak of TNT near 220 nm.

Effects of social approval bias on self-reported fruit and vegetable consumption: a randomized controlled trial.

BACKGROUND: Self-reports of dietary intake in the context of nutrition intervention research can be biased by the tendency of respondents to answer consistent with expected norms (social approval bias). The objective of this study was to assess the potential influence of social approval bias on self-reports of fruit and vegetable intake obtained using both food frequency questionnaire (FFQ) and 24-hour recall methods. METHODS: A randomized blinded trial compared reported fruit and vegetable intake among subjects exposed to a potentially biasing prompt to that from control subjects. Subjects included 163 women residing in Colorado between 35 and 65 years of age who were randomly selected and recruited by telephone to complete what they were told would be a future telephone survey about health. Randomly half of the subjects then received a letter prior to the interview describing this as a study of fruit and vegetable intake. The letter included a brief statement of the benefits of fruits and vegetables, a 5-A-Day sticker, and a 5-a-Day refrigerator magnet. The remainder received the same letter, but describing the study purpose only as a more general nutrition survey, with neither the fruit and vegetable message nor the 5-A-Day materials. Subjects were then interviewed on the telephone within 10 days following the letters using an eight-item FFQ and a limited 24-hour recall to estimate fruit and vegetable intake. All interviewers were blinded to the treatment condition. RESULTS: By the FFQ method, subjects who viewed the potentially biasing prompts reported consuming more fruits and vegetables than did control subjects (5.2 vs. 3.7 servings per day, p < 0.001). By the 24-hour recall method, 61% of the intervention group but only 32% of the control reported eating fruits and vegetables on 3 or more occasions the prior day (p = 0.002). These associations were independent of age, race/ethnicity, education level, self-perceived health status, and time since last medical check-up. CONCLUSION: Self-reports of fruit and vegetable intake using either a food frequency questionnaire or a limited 24-hour recall are both susceptible to substantial social approval bias. Valid assessments of intervention effects in nutritional intervention trials may require objective measures of dietary change.

A psychosocial intervention for the management of functional dysphonia: complex intervention development and pilot randomised trial.

BACKGROUND: Medically unexplained loss or alteration of voice-functional dysphonia-is the commonest presentation to speech and language therapists (SLTs). Besides the impact on personal and work life, functional dysphonia is also associated with increased levels of anxiety and depression and poor general health. Voice therapy delivered by SLTs improves voice but not these associated symptoms. The aims of this research were the systematic development of a complex intervention to improve the treatment of functional dysphonia, and the trialling of this intervention for feasibility and acceptability to SLTs and patients in a randomised pilot study. METHODS: A theoretical model of medically unexplained symptoms (MUS) was elaborated through literature review and synthesis. This was initially applied as an assessment format in a series of patient interviews. Data from this stage and a small consecutive cohort study were used to design and refine a brief cognitive behavioural therapy (CBT) training intervention for a SLT. This was then implemented in an external pilot patient randomised trial where one SLT delivered standard voice therapy or voice therapy plus CBT to 74 patients. The primary outcomes were of the acceptability of the intervention to patients and the SLT, and the feasibility of changing the SLT's clinical practice through a brief training. This was measured through monitoring treatment flow and through structured analysis of the content of intervention for treatment fidelity and inter-treatment contamination. RESULTS: As measured by treatment flow, the intervention was as acceptable as standard voice therapy to patients. Analysis of treatment content showed that the SLT was able to conduct a complex CBT formulation and deliver novel treatment strategies for fatigue, sleep, anxiety and depression in the majority of patients. On pre-post measures of voice and quality of life, patients in both treatment arms improved. CONCLUSION: These interventions were acceptable to patients. Emotional and psychosocial issues presented routinely in the study patient group and CBT techniques were used, deliberately and inadvertently, in both treatment arms. This CBT "contamination" of the voice therapy only arm reflects the chief limitation of the study: one therapist delivered both treatments. TRIAL REGISTRATION: Registered with the ISRCTN under the title: Training a Speech and Language Therapist in Cognitive Behavioural Therapy to treat Functional Dysphonia - A Randomised Controlled Trial.Trial Identifier: ISRCTN20582523 Registered 19/05/2010; retrospectively registered. http://www.isrctn.com/ISRCTN20582523.

Content Validation of a Home Parenteral Nutrition-Patient-Reported Outcome Questionnaire.

BACKGROUND: Patient-reported outcome (PRO) instruments collect information from patients about health conditions and disease management, including quality of life (QOL). Clinicians acknowledge patient concerns about QOL but need guidance to assess the nature and severity of individually experienced problems. The Home Parenteral Nutrition (HPN)-Patient-Reported Outcome Questionnaire (PROQ) was developed for use during medical appointments or homecare visits to address this gap. The purpose of this research was to provide evidence that the HPN-PROQ items and scale possess content validity. METHODS: A mixed-method study design was used. In phase 1, cognitive interviews (CIs) were conducted with 32 HPN patients. Thematic analysis was used to assess participant understanding of the instructions, items, and response scales and overall utility of the HPN-PROQ. In phase 2, 13 expert clinicians evaluated the relevance of items to the HPN population using the Content Validity Index (CVI) to produce item-level (I-CVI) and scale-level (S-CVI) scores. Items with an I-CVI score ≥0.783 were retained. RESULTS: Fifty-four percent of items were deemed as being comprehensible, acceptable, and clear; 25% were revised; and 11% were deleted. In phase 2, 79% of items were rated highly relevant. The S-CVI score was 0.96. The final HPN-PROQ contains 34 items. CONCLUSION: This study established acceptable content validity of the HPN-PROQ. This PROQ may help foster patient-clinician communication about lifestyle adaptation and QOL.