Using mixed methods to select optimal mode of administration for a patient-reported outcome instrument for people with pressure ulcers.

BACKGROUND: When developing new measuring instruments or deciding upon one for research, consideration of the 'best' method of administration for the target population should be made. Current evidence is inconsistent in differentiating superiority of any one method in terms of quantity and quality of response. We trialed a novel mixed methods approach in early scale development to determine the best administration method for a new patient-reported outcome instrument for people with pressure ulcers (the PU-QOL). METHODS: Cognitive interviews were undertaken with 35 people with pressure ulcers to determine appropriateness of a self-completed version of the PU-QOL instrument. Quantitative analysis, including Rasch analysis, was carried out on PU-QOL data from 70 patients with pressure ulcers, randomised to self-completed or interview-administered groups, to examine data quality and differential item functioning (DIF). RESULTS: Cognitive interviews identified issues with PU-QOL self-completion. Quantitative analysis supported these findings with a large proportion of self-completed PU-QOLs returned with missing data. DIF analysis indicated administration methods did not impact the way patients from community care settings responded, supporting the equivalence of both administration versions. CONCLUSIONS: Obtaining the best possible health outcomes data requires use of appropriate methods to ensure high quality data with minimal bias. Mixed methods, with the inclusion of Rasch, provided valuable evidence to support selection of the 'best' administration method for people with PUs during early PRO instrument development. We consider our approach to be generic and widely applicable to other elderly or chronically ill populations or suitable for use in limited samples where recruitment to large field tests is often difficult

Monitoring Immobilized Elderly Patients Using a Public Provider Online System for Pressure Ulcer Information and Registration (SIRUPP): Protocol for a Health Care Impact Study

International Registered Report Identifier (IRRID): DERR1-10.2196/13701However, this body played no part in drafting or revising the paper or in approving the final manuscript. The views expressed in the paper are those of the authors and not necessarily those of the Consejería de Salud y Familias, Junta de Andalucía or of FIBAO.PMID: 31407669Background: Pressure ulcers represent a major challenge to patient safety in the health care context, presenting high incidence (from 7% to 14% in Spain) and increased financial costs (€400-600 million/year) in medical treatment. Moreover, they are a significant predictor of mortality. The prevention of pressure ulcers in long-term care centers and patients’ own homes is proposed as a priority indicator of health care quality. Early stage risk assessment and database recording are both crucial aspects of prevention, classification, diagnosis, and treatment. Objective: This project proposes a 3-year study of immobilized patients residing in the Granada-Metropolitan Primary Healthcare District (DSGM) and monitored via the Pressure Ulcer Information and Registration System (SIRUPP, Spanish initials). The project aims to estimate the incidence of PUs among immobilized elderly patients, analyze the health-related quality of life of these patients by using the Pressure Ulcer Quality of Life (PU-QoL) instrument in a sample of 250 patients, determine the average time to complete wound healing, estimate the rate of pressure ulcers–associated mortality, and assess the predictive value of the Braden and Mini Nutritional Assessment risk measurement scales in a sample of 1700 patients. Methods: The DSGM runs SIRUPP, which is linked to patients’ electronic health records. Currently, 17,104 immobilized patients are monitored under this system. Health-related quality of life will be measured by patient self-reports using the Spanish Pressure Ulcer Quality of Life questionnaire, following cross-cultural adaptation and psychometric validation with respect to the English-language version. Results: The project commenced in June 2017 and is expected to conclude in April 2020. Conclusions: This study addresses two main health outcomes—the time needed for wound healing and the mortality associated with pressure ulcers—both of which might be accounted for by variations in clinical practice and the health-related quality of life of patients with pressure ulcers.The SIRUPP study is funded by Fundación Progreso y Salud-FIBAO (Consejería de Salud y Familias, Junta de Andalucía)

Comparing alternating pressure mattresses and high-specification foam mattresses to prevent pressure ulcers in high-risk patients: the PRESSURE 2 RCT

Background: Pressure ulcers (PUs) are a burden to patients, carers and health-care providers. Specialist mattresses minimise the intensity and duration of pressure on vulnerable skin sites in at-risk patients. Primary objective: Time to developing a new PU of category ≥ 2 in patients using an alternating pressure mattress (APM) compared with a high-specification foam mattress (HSFM). Design: A multicentre, Phase III, open, prospective, planned as an adaptive double-triangular group sequential, parallel-group, randomised controlled trial with an a priori sample size of 2954 participants. Randomisation used minimisation (incorporating a random element). Setting: The trial was set in 42 secondary and community inpatient facilities in the UK. Participants: Adult inpatients with evidence of acute illness and at a high risk of PU development. Interventions and follow-up: APM or HSFM – the treatment phase lasted a maximum of 60 days; the final 30 days were post-treatment follow-up. Main outcome measures: Time to event. Results: From August 2013 to November 2016, 2029 participants were randomised to receive either APM (n = 1016) or HSFM (n = 1013). Primary end point – 30-day final follow-up: of the 2029 participants in the intention-to-treat population, 160 (7.9%) developed a new PU of category ≥ 2. There was insufficient evidence of a difference between groups for time to new PU of category ≥ 2 [Fine and Gray model HR 0.76, 95% confidence interval (CI) 0.56 to 1.04; exact p-value of 0.0890 and 2% absolute difference]. Treatment phase sensitivity analysis: 132 (6.5%) participants developed a new PU of category ≥ 2 between randomisation and end of treatment phase. There was a statistically significant difference in the treatment phase time-to-event sensitivity analysis (Fine and Gray model HR 0.66, 95% CI 0.46 to 0.93; p = 0.0176 and 2.6% absolute difference). Secondary end points – 30-day final follow-up: new PUs of category ≥ 1 developed in 350 (17.2%) participants, with no evidence of a difference between mattress groups in time to PU development, (Fine and Gray model HR 0.83, 95% CI 0.67 to 1.02; p-value = 0.0733 and absolute difference 3.1%). New PUs of category ≥ 3 developed in 32 (1.6%) participants with insufficient evidence of a difference between mattress groups in time to PU development (Fine and Gray model HR 0.81, 95% CI 0.40 to 1.62; p = 0.5530 and absolute difference 0.4%). Of the 145 pre-existing PUs of category 2, 89 (61.4%) healed – there was insufficient evidence of a difference in time to healing (Fine and Gray model HR 1.12, 95% CI 0.74 to 1.68; p = 0.6122 and absolute difference 2.9%). Health economics – the within-trial and long-term analysis showed APM to be cost-effective compared with HSFM; however, the difference in costs models are small and the quality-adjusted life-year gains are very small. There were no safety concerns. Blinded photography substudy – the reliability of central blinded review compared with clinical assessment for PUs of category ≥ 2 was ‘very good’ (kappa statistic 0.82, prevalence- and bias-adjusted kappa 0.82). Quality-of-life substudy – the Pressure Ulcer Quality of Life – Prevention (PU-QoL-P) instrument meets the established criteria for reliability, construct validity and responsiveness. Limitations: A lower than anticipated event rate. Conclusions: In acutely ill inpatients who are bedfast/chairfast and/or have a category 1 PU and/or localised skin pain, APMs confer a small treatment phase benefit that is diminished over time. Overall, the APM patient compliance, very low PU incidence rate observed and small differences between mattresses indicate the need for improved indicators for targeting of APMs and individualised decision-making. Decisions should take into account skin status, patient preferences (movement ability and rehabilitation needs) and the presence of factors that may be potentially modifiable through APM allocation, including being completely immobile, having nutritional deficits, lacking capacity and/or having altered skin/category 1 PU. Future work: Explore the relationship between mental capacity, levels of independent movement, repositioning and PU development. Explore ‘what works for whom and in what circumstances’. Trial registration: Current Controlled Trials ISRCTN01151335. Funding: This project was funded by the National Institute for Health Research Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 52. See the NIHR Journals Library website for further project information

Experimental Zika Virus Infection in the Pregnant Common Marmoset Induces Spontaneous Fetal Loss and Neurodevelopmental Abnormalities.

During its most recent outbreak across the Americas, Zika virus (ZIKV) was surprisingly shown to cause fetal loss and congenital malformations in acutely and chronically infected pregnant women. However, understanding the underlying pathogenesis of ZIKV congenital disease has been hampered by a lack of relevant in vivo experimental models. Here we present a candidate New World monkey model of ZIKV infection in pregnant marmosets that faithfully recapitulates human disease. ZIKV inoculation at the human-equivalent of early gestation caused an asymptomatic seroconversion, induction of type I/II interferon-associated genes and proinflammatory cytokines, and persistent viremia and viruria. Spontaneous pregnancy loss was observed 16-18 days post-infection, with extensive active placental viral replication and fetal neurocellular disorganization similar to that seen in humans. These findings underscore the key role of the placenta as a conduit for fetal infection, and demonstrate the utility of marmosets as a highly relevant model for studying congenital ZIKV disease and pregnancy loss

Whose Experiences Do We Understand? Generalizability Considerations When Analyzing Data about Massive Open Online Courses

Massive Open Online Courses (MOOCs) have generated considerable excitement and considerable skepticism since their recent inception (e.g., Kim, 2014; Perna et al., 2014). By fall 2015, approximately 35 million people had participated in 4200 courses offered by over 550 institutions (Shah, 2015). In addition to MOOCs’ potential for expanding access to higher education offerings, scholars have touted their potential for facilitating research about online learning (Eichhorn & Matkin, 2016; Haywood, 2016). However, many questions remain about what participants are actually learning from MOOCs and how researchers can best make use of the huge amount of data the courses generate. In Fall 2014, Oregon State University launched its first Massive Open Online Course (MOOC), Supporting English Language Learners Under New Standards. Funded by the Oregon Department of Education and created in partnership with Stanford University, this course was designed to provide K-12 teachers with specific professional development on fostering English learners’ skills in argumentation, a key practice emphasized in new education standards. As we have worked to understand what participants learned from this MOOC, we have encountered methodological issues that likely impact a wide variety of research on MOOCs. Specifically, because many participants in our MOOC began but did not complete the course, analyzing data collected at the end of the course provides information about a potentially nonrepresentative sample of participants that likely does not generalize to the full group who started the course. After describing the generalizability issues that arose in our own research, we describe potential approaches for addressing these issues in MOOC research more broadly

“Give us the tools!” - development of knowledge transfer tools to support the involvement of patient partners in the development of clinical trial protocols with patient-reported outcomes (PROs), in accordance with SPIRIT-PRO extension

Objectives (a) To adapt the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT)-patient-reported outcome (PRO) Extension guidance to a user-friendly format for patient partners and (b) to codesign a web-based tool to support the dissemination and uptake of the SPIRIT-PRO Extension by patient partners.Design A 1-day patient and public involvement session.Participants Seven patient partners.Methods A patient partner produced an initial lay summary of the SPIRIT-PRO guideline and a glossary. We held a 1-day PPI session in November 2019 at the University of Birmingham. Five patient partners discussed the draft lay summary, agreed on the final wording, codesigned and agreed the final content for both tools. Two additional patient partners were involved in writing the manuscript. The study compiled with INVOLVE guidelines and was reported according to the Guidance for Reporting Involvement of Patients and the Public 2 checklist.Results Two user-friendly tools were developed to help patients and members of the public be involved in the codesign of clinical trials collecting PROs. The first tool presents a lay version of the SPIRIT-PRO Extension guidance. The second depicts the most relevant points, identified by the patient partners, of the guidance through an interactive flow diagram.Conclusions These tools have the potential to support the involvement of patient partners in making informed contributions to the development of PRO aspects of clinical trial protocols, in accordance with the SPIRIT-PRO Extension guidelines. The involvement of patient partners ensured the tools focused on issues most relevant to them

Experiences of colorectal cancer survivors in returning to primary coordinated healthcare following treatment

Background. Advances in screening and treatments for colorectal cancer (CRC) have improved survival rates, leading to a large population of CRC survivors. Treatment for CRC can cause longterm side-effects and functioning impairments. General practitioners (GPs) have a role in meeting survivorship care needs of this group of survivors. We explored CRC survivors’ experiences of managing the consequences of treatment in the community and their perspective on the GP’s role in post-treatment care. Methods. This was a qualitative study using an interpretive descriptive approach. Adult participants no longer actively receiving treatment for CRC were asked about: side-effects post-treatment; experiences of GP-coordinated care; perceived care gaps; and perceived GP role in post-treatment care. Thematic analysis was used for data analysis. Results. A total of 19 interviews were conducted. Participants experienced side-effects that significantly impacted their lives; many they felt ill-prepared for. Disappointment and frustration was expressed with the healthcare system when expectations about preparation for posttreatment effects were not met. The GP was considered vital in survivorship care. Participants' unmet needs led to self-management, self-directed information seeking and sourcing referral options, leaving them feeling like their own care coordinator. Disparities in post-treatment care between metropolitan and rural participants were observed. Conclusion. There is a need for improved discharge preparation and information for GPs, and earlier recognition of concerns following CRC treatment to ensure timely management and access to services in the community, supported by system-level initiatives and appropriate interventions