Using Protection Motivation Theory to develop a survey of over-the-counter decision-making by older adults.

BACKGROUND: Older adults (aged 65+) are responsible for 30% of the over-the-counter (OTC) medication use in the US. Each year, over 175,000 older adults are hospitalized due to OTC-related adverse drug events (ADEs). A major barrier to improving OTC use has been the dearth of actionable research on factors that affect older adult decision-making during OTC selection. Risk perception and health literacy are two such factors known to impact health behavior. However, to date no studies have characterized risk perceptions of OTCs nor how they relate to health literacy in the decision-making processes of older adults. OBJECTIVE: This paper presents the development and validation of a survey instrument to measure older adults' risk perception toward over-the-counter medications. The survey also explores the relation of risk perception to health literacy efficacy. METHODS: The Protection Motivation Theory (PMT) and the Tripartite Risk Perception Model (TRIRISK model) formed the basis for conceptualizing relationships between this study's constructs of interest. The utility of the PMT and the TRIRISK model in the context of OTC medication safety was tested in a survey of 103 older adults; exploratory factor analysis (EFA) and Spearman's correlation coefficients were used to test construct validity. RESULTS: The EFA yielded a 4-factor model of protection motivation, which included deliberative risk perception, emotional risk perception, perceived threat severity, and perceived coping efficacy. The EFA-based item reduction resulted in a final 14-item OTC Protection Motivation survey. CONCLUSION: The survey generated through this study is a tool for characterizing older adult risk perceptions of OTCs. The development of a measure of OTC risk perceptions is a promising step toward designing and evaluating patient-centered interventions to improve older adult medication safety.

Impact of antioxidants in improving semen parameters like count, motility and DNA fragmentation in sub-fertile males: a randomized, double-blind, placebo-controlled clinical trial.

Male infertility is solely responsible for 20-30% of infertility cases. Oxidative damage of sperm DNA is positively linked with oligoasthenoteratozoospermia (OAT), and male infertility. The antioxidants are being explored worldwide to combat OAT, sperm DNA fragmentation and reactive oxygen species. The objective of the study was to assess the effectiveness of an antioxidant blend in improving sperm count, semen parameters and reducing DNA fragmentation index (DFI) in sub-fertile males. A prospective, double-blind, randomized, placebo-controlled trial was conducted in 300 sub-fertile males (25-45 years) from ten study sites in India. Subjects were randomized in either the antioxidant blend treatment group or placebo group. We assessed changes in sperm count, motility, normal morphology, semen volume, and percent DFI before and after treatment (90 days). To further stratify data on different criteria post hoc analysis was performed. Statistical analysis was performed using SPSS 10.0 software. There were improvements in sperm count, semen volume, sperm motility, and sperm normal morphology in the treatment group. There was improvement in sperm count in severe oligospermia subjects (sperm count < 5 million/mL, 5-10 million/mL, 10.1-15 million/mL), and high-extremely higher baseline DFI (20-30%, 31-40% and above 40%), as per post hoc analysis. There was no premature discontinuation and adverse events were reported during the study, indicating safety and well-tolerability of treatment. Study results confirmed the well-researched fact of antioxidants being effective to reduce oxidative stress and thus improve sperm DNA integrity and also improved semen parameters in males aged 40 and above. Trial Registration: Clinical Trials Registry-India Identifier: CTRI/2020/12/029590.

Understanding the Factors Influencing Older Adults' Decision-Making about Their Use of Over-The-Counter Medications-A Scenario-Based Approach.

The potential risks of over-the-counter (OTC) medications are often aggravated in vulnerable populations, such as older adults. The elevated patterns of older-adult OTC medication use do not necessarily translate into a greater understanding of these medications or their safety implications. The objective of this study was to assess how older adults' knowledge, beliefs, and attitudes inform their decision-making regarding OTC use. Situational interviews were conducted in three community pharmacies with 87 older-adult participants to capture how they intended to use an OTC medication. The interviews were transcribed and qualitatively analyzed, generating seven key themes: (1) medication use concerns; (2) following label instructions; (3) wait time until medication effect; (4) responses to medication not working; (5) decision to stop medication; (6) sources of information; and (7) safety implications. This study shows substantial variations in older-adult OTC medication use while providing insight on factors that influence older adults' appropriate OTC medication use and, in some cases, the potential for harmful effects.

Improving Patient-Pharmacist Encounters with Over-The-Counter Medications: A Mixed-Methods Pilot Study.

BACKGROUND AND OBJECTIVES: Over-the-counter (OTC) medication use has increased safety risks for adults older than 65. Most older adults purchase OTC medications from community pharmacies, where the considerable distance or visual obstructions between the prescription area and OTC aisles undermine pharmacists' ability to assist patients with OTC medication decisions. An innovative redesign of an abbreviated medication section specifically for older adults (called the Senior SectionTM ) can facilitate pharmacy staff/patient interaction, potentially improving safe medication selection and use. This study evaluated the impact of the Senior Section on the frequency and content of OTC encounters between pharmacy staff and patients. RESEARCH DESIGN AND METHODS: An intervention mixed-methods design generated data from patient OTC encounters, and interviews with two pharmacists and two technicians, throughout the study. NVivo was used to code interview transcripts, and frequencies and chi-square analyses demonstrated pre/post-intervention comparisons for the OTC encounter variables. RESULTS: After Senior Section implementation, pharmacy staff were more likely to initiate (and be involved in) patient encounters, address more topics or problem/symptoms, provide details about OTC products, discuss appropriateness of OTC use, and discuss medication classes highlighted in the Senior Section. Pharmacy staff were less likely to need to leave the prescription department for extended periods; they also had fewer prolonged encounters or encounters about product location. Importantly, the Senior Section did not impede pharmacy workflow. DISCUSSION AND IMPLICATIONS: The Senior Section prompted more frequent, effective, and efficient engagements between pharmacy staff and patients, which may substantially reduce OTC-related harms among older adults.

Exploring how pharmacists engage with patients about over-the-counter medications.

OBJECTIVE: This study used an innovative information-gathering approach to provide insight into the nature and structure of pharmacy staff encounters with patients seeking over-the-counter (OTC) medications and revealed specific activities of pharmacy staff around these encounters. METHODS: A multistep process was used to develop and standardize an 8-item OTC Encounter Form to document the characteristics of pharmacy staff-patient encounters. The OTC Form contained several domains, including topics discussed and the problems or symptoms identified during the encounter, staff functions during the encounter, and approximate time spent with the patient. Nine pharmacists and 8 technicians used the OTC Form to document patient encounters over 7 consecutive days. Frequency distributions for each OTC Form item are reported. RESULTS: One hundred eleven OTC Forms were completed. Adults aged 65 years or older were involved in 46% of all encounters. Pharmacists provided the only assistance in 41% of encounters and worked in partnership with other pharmacy staff for another 25% of encounters. Many encounters required the pharmacy staff to leave the prescription department, involved discussions about a variety of problems or symptoms, and lasted less than 3 minutes. Although the most prevalent encounter topic was locations of a particular product, about one-third of encounters involved either recommendations about a product or providing information about a product, and 41% involved communications about 2 or more topics. Finally, 11% of encounters generated a nondrug recommendation, and 8% resulted in a referral to a physician. CONCLUSION: Pharmacists play a key role in ensuring that the benefits of OTC medications outweigh the risks, thereby providing an important resource for patient engagement about safe medication selection and use. Examining the features of OTC encounters creates an evidence base to promote best practices for OTC encounters, increasing pharmacists' ability to help people, especially older adults, navigate the intricacies of OTC medication use, without significantly increasing pharmacy staff workload.

Long-term outcomes of pediatric kidney transplant recipients with a pretransplant malignancy.

A childhood malignancy can rarely progress to ESRD requiring a KT. To date, few reports describe long-term outcomes of pediatric KT recipients with a pretransplant malignancy. Between 1963 and 2015, 884 pediatric (age: 0-17 years old) recipients received 1055 KTs at our institution. KT outcomes were analyzed in children with a pretransplant malignancy. We identified 14 patients who had a pretransplant malignancy prior to KT; the majority were <10 years old at the time of KT. Ten (71%) patients received their grafts from living donors, the majority of which were related to the recipient. Wilms' tumor was the dominant type of pretransplant malignancy, seen in 50% of patients. The other pretransplant malignancy types were EBV-positive lymphoproliferative disorders, non-EBV-positive lymphoma, leukemia, neuroblastoma, soft-tissue sarcoma, and ovarian cancer. Ten of the 14 patients received chemotherapy as part of their pretransplant malignancy treatment. Graft survival at 1, 3, and 5 years was 93%, 83%, and 72%, respectively. Patient survival at 1, 5, and 10 years was 100%, 91%, and 83%, respectively. Six (40%) patients suffered AR following KT; half of them had their first episode of AR within 1 month of KT. Our single-center experience demonstrates that pediatric KT recipients with a previously treated pretransplant malignancy did not exhibit worse outcomes than other pediatric KT patients.

Clinical utility of postoperative phosphate recovery profiles to predict liver insufficiency after living donor hepatectomy.

BACKGROUND: Living donor hepatectomy (LDH) is associated with significant postoperative hypophosphatemia. METHODS: From January 1997 through July 2017, we performed 176 LDH and compared donors who developed liver insufficiency (LI) to those that did not within 30 days of LDH. Using smoothing splines, we constructed a mixed-effects model and assessed receiver operating characteristic curves. RESULTS: Of the 176 donors, 161 were included in our study and 10 (6.2%) developed LI. The cohorts differed in minimum observed phosphate levels (1.77 mg/dL, LI cohort; 2.01 mg/dL No LI cohort) at a median nadir of 1.6 days (38 h) postoperatively (p = 0.003). In the ROC analysis, intraoperative time and postoperative phosphate levels best predicted LI (sensitivity, 90%; specificity, 55.6%). CONCLUSION: Mean postoperative phosphate profiles differ significantly between those patients who develop LI and those who do not in the first 38 h after LDH.

Interruptions in community pharmacies: Frequency, sources, and mitigation strategies.

BACKGROUND: Interruptions constitute a key part of the communication strategy for healthcare providers, including community pharmacy personnel. Previous research in other healthcare environments has shown that interruptions are very common and may present as patient safety hazards. One 1999 study, conducted in community pharmacy settings, found that interruptions were prevalent and associated with dispensing errors. In the last 20 years, pharmacies have expanded patient services and implemented new technology. Yet, it is unknown how these changes have affected interruption sources and frequency. OBJECTIVE: The objective was to characterize the frequency and sources of pharmacist task interruptions that occur in community pharmacies. METHODS: A cross-sectional qualitative study design was used to evaluate the frequency and sources of pharmacist task interruptions in Wisconsin community pharmacies. The participants included 9 pharmacists and 9 technicians working in 2 independently-owned, 2 mass merchandise, and 2 hospital/clinical-affiliated pharmacies. RESULTS: Interruption rates ranged from 3 to 7 per hour across the 6 pharmacies. Sources of interruptions included: patients, technicians, self-initiated interruptions, technology used in the pharmacy, and a second pharmacist. CONCLUSIONS: Interruptions are common in community pharmacies and the causes are multifactorial. Prudent management of interruptions in these work environments may involve improved technician training and better designs of pharmacy technology.

Applying participatory design to a pharmacy system intervention.

BACKGROUND: Stakeholder engagement is an important component of the research process for improving the use and uptake of patient-centered health care innovations. Participatory design (PD), a method that utilizes the involvement of patients and other stakeholders, is well-suited for the design of multifaceted interventions in complex work systems, such as community pharmacies, that have diverse and dynamic end-users. OBJECTIVE: The objective is to describe a blueprint for how to use PD when designing a community pharmacy intervention. This paper outlines the steps of PD and highlights the advantages and disadvantages of this method. METHODS: PD is explained step-wise to underscore the considerations required of researchers unfamiliar with PD. This includes the development of a tailored PD approach, PD session preparatory work, data collection, and intervention development and evaluation. The stakeholders recruited for the community pharmacy intervention were pharmacy staff and older adult patients who received prescriptions at the pharmacy corporation in which the intervention was being implemented. The PD process was a series of six adaptive sessions: (1) problem identification, (2) solution generation, (3) convergence, (4) prototyping, (5) initial evaluation, and (6) formative evaluation. RESULTS: A description of the PD process to design a community pharmacy intervention is provided. The process led to the development of a patient-centered prototype. The advantages of using PD included the opportunity to clarify problems faced by stakeholders, generation of novel solutions to incorporate into the intervention, and the ability to vet and fine-tune stakeholder design ideas in an iterative fashion. The insight gained was unprecedented and invaluable to the researchers. The biggest challenge of employing PD was the time-sensitive and time-intensive nature of developing each session, collecting data, and reflecting on the results in order to design subsequent sessions. CONCLUSIONS: The PD process led to the development of a patient-centered prototype. PD enabled stakeholders to generate creative solutions and provide unique insight on addressing issues faced in healthcare redesign research and specifically in community pharmacies.

Smooth muscle tumour of uncertain malignant potential (SMTUMP) in the nasal cavity: an incidental finding.

Sino-nasal smooth muscle tumours of uncertain malignant potential (SMTUMP) are very rare neoplasms of mesenchymal origin with features in between a benign leiomyoma and a leiomyosarcoma. We report a rare case of SMTUMP in a 44-year-old woman, who presented with vague symptoms of pharyngitis. Nasal endoscopy revealed a smooth mass in left nasal cavity. Contrast-enhanced CT and MRI scans showed features likely to be inverted papilloma or olfactory neuroblastoma or meningioma. Excision was planned and intraoperatively, frozen section revealed a probable spindle cell lesion. Final histopathological report following immunohistochemistry (IHC) & immunofluoresence (IF) confirmed it to be a SMTUMP. This patient underwent complete resection via endoscopic KTP laser assisted, anterior skull base surgery with no recurrence on follow-up.

Identification and characterization of Clostridium sordellii toxin gene regulator.

Toxigenic Clostridium sordellii causes uncommon but highly lethal infections in humans and animals. Recently, an increased incidence of C. sordellii infections has been reported in women undergoing obstetric interventions. Pathogenic strains of C. sordellii produce numerous virulence factors, including sordellilysin, phospholipase, neuraminidase, and two large clostridial glucosylating toxins, TcsL and TcsH. Recent studies have demonstrated that TcsL toxin is an essential virulence factor for the pathogenicity of C. sordellii. In this study, we identified and characterized TcsR as the toxin gene (tcsL) regulator in C. sordellii. High-throughput sequencing of two C. sordellii strains revealed that tcsR lies within a genomic region that encodes TcsL, TcsH, and TcsE, a putative holin. By using ClosTron technology, we inactivated the tcsR gene in strain ATCC 9714. Toxin production and tcsL transcription were decreased in the tcsR mutant strain. However, the complemented tcsR mutant produced large amounts of toxins, similar to the parental strain. Expression of the Clostridium difficile toxin gene regulator tcdR also restored toxin production to the C. sordellii tcsR mutant, showing that these sigma factors are functionally interchangeable.