Development of a patient-reported outcome measure (PROM) and change measure for use in early recovery following hip or knee replacement

Background Hip and knee replacement are effective procedures for end-stage arthritis that has not responded to medical management. However, until now, there have been no validated, patient-reported tools to measure early recovery in this growing patient population. The process of development and psychometric evaluation of the Oxford Arthroplasty Early Recovery Score (OARS), a 14-item patient-reported outcome measure (PROM) measuring health status, and the Oxford Arthroplasty Early Change Score (OACS) a 14-item measure to assess change during the first 6 weeks following surgery is reported. Patients and methods A five-phased, best practice, iterative approach was used. From a literature based starting point, qualitative interviews with orthopaedic healthcare professionals, were then performed ascertaining if and how clinicians would use such a PROM and change measure. Analysis of in-depth patient-interviews in phase one identified important patient-reported factors in early recovery which were used to provide questionnaire themes. In Phase two, candidate items from Phase One interviews were generated and pilot questionnaires developed and tested. Exploratory factor analysis with item reduction and final testing of the questionnaires was performed in phase three. Phase Four involved validation testing. Results Qualitative interviews (n = 22) with orthopaedic healthcare professionals, helped determine views of potential users, and guide structure. In Phase One, factors from patient interviews (n = 30) were used to find questionnaire themes and generate items. Pilot questionnaires were developed and tested in Phase Two. Items were refined in the context of cognitive debrief interviews (n = 34) for potential inclusion in the final tools. Final testing of questionnaire properties with item reduction (n = 168) was carried out in phase three. Validation of the OARS and OACS was performed in phase four. Both measures were administered to consecutive patients (n = 155) in an independent cohort. Validity and reliability were assessed. Psychometric testing showed positive results, in terms of internal consistency and sensitivity to change, content validity and relevance to patients and clinicians. In addition, these measures have been found to be acceptable to patients throughout early recovery with validation across the 6 week period. Conclusions These brief, easy-to-use tools could be of great use in assessing recovery pathways and interventions in arthroplasty surgery

A cross-sectional evidence-based review of pharmaceutical promotional marketing brochures and their underlying studies: Is what they tell us important and true?

BACKGROUND: A major marketing technique used by pharmaceutical companies is direct-to-physician marketing. This form of marketing frequently employs promotional marketing brochures, based on clinical research, which may influence how a physician prescribes medicines. This study's objective was to investigate whether or not the information in promotional brochures presented to physicians by pharmaceutical representatives is accurate, consistent, and valid with respect to the actual studies upon which the promotional brochures are based. METHODS: Physicians in five clinics were asked to consecutively collect pharmaceutical promotional brochures and to send them all to a centralized location. The brochures for any class of medication were collected on a continuous basis until 20 distinct promotional brochures were received by a central location. Once the brochure was received, the corresponding original study was obtained. Two blinded reviewers performed an evidence-based review of the article, comparing data that was printed on the brochure to what was found in the original study. RESULTS: Among the 20 studies, 75% of the studies were found to be valid, 80% were funded by the pharmaceutical company, 60% of the studies and the corresponding brochures presented patient-oriented outcomes, and 40% were compared to another treatment regimen. Of the 19 brochures that presented the data as graphs, 4 brochures presented a relative risk reduction while only 1 brochure presented an absolute risk reduction. 15% of the promotional marketing brochures presented data that was different from what was in the original published study. CONCLUSION: Given the present findings, physicians should be cautious about drawing conclusions regarding a medication based on the marketing brochures provided by pharmaceutical companies

Chinese beliefs in luck are linked to gambling problems via strengthened cognitive biases:A mediation test

10.1007/s10899-017-9690-6Journal of gambling studies3341325-133

Tourism and water inequity in Bali: A social-ecological systems analysis

This paper is a social-ecological systems (SES) analysis of tourism and water inequity in Bali. It uses Elinor Ostrom’s SES model to look at the particular niche of Bali’s tourism and water nexus. Re-analysis of previous qualitative research revealed that the vulnerability of the SES was due to numerous characteristics. In particular, user groups are highly diverse, transient and stratified, thereby inhibiting communication and knowledge sharing. This, in combination with weak governance systems and the economic power of the tourism industry, interact to affect declining water resources and the iniquitous impact of this. Whilst there are obvious indications that Bali’s water resources are over stretched, there is no feedback loop to the institutional structures that would help enable appropriate responses from the user groups or governance system

Efficacy of liposomal bupivacaine and bupivacaine hydrochloride vs bupivacaine hydrochloride alone as a periarticular anesthetic for patients undergoing knee replacement : a randomized clinical trial

Importance: Over half of patients report significant acute post-operative pain following knee replacement. Objective: To evaluate the clinical and cost effectiveness of peri-articular liposomal bupivacaine (LB) for recovery and pain following knee replacement. Design, Setting and Participants: This multi-centre, patient-blinded, pragmatic, randomized controlled superiority trial (RCT) involved 533 participants at 11 institutions within the National Health Service in England. Adults undergoing primary unilateral knee replacement for symptomatic end-stage osteoarthritis were enrolled between March 29th, 2018 and February 29th, 2020 and followed up for one year after surgery. Interventions: LB (266mg) admixed with bupivacaine hydrochloride (100mg) compared to bupivacaine hydrochloride (100mg) alone (control) administered by peri-articular injection at the time of surgery. Main Outcome and Measures: The co-primary outcomes were Quality of Recovery 40 (QoR-40) score at 72hours and pain visual analogue score (VAS) area under the curve (AUC) 6 to 72hours. Secondary outcomes included: QoR-40 and mean pain VAS at days 0 (evening of surgery), 1, 2 and 3, cumulative opioid consumption over 72hours, functional outcomes and quality of life at 6weeks, 6months and 1year, and cost-effectiveness over 1year. Adverse Events and Serious Adverse Events up to 12months post-randomization were also assessed. Results: 533 participants, mean age 69years were randomized with baseline characteristics balanced between arms. There was no difference in QoR-40 at 72hours nor pain VAS AUC 6 to 72hours between LB and control arm (adjusted mean difference for QoR-40: 0.54 (97.5% CI -2.05 to 3.13, p=0.643); pain VAS AUC -21.5 (97.5% CI -46.8 to 3.8; p=0.057)). Analyses of pain VAS and QoR-40 scores demonstrated only one statistically significant difference, with the LB arm having lower pain scores the evening of surgery (day 0; adjusted difference -0.54, 97.5% CI - 1.07 to -0.02; p=0.021). No difference in cumulative opioid consumption and functional outcomes was detected. LB was not cost-effective compared to control. No difference in adverse or serious adverse events was found between LB and control arms. Conclusion and Relevance: This study found no difference in post-operative recovery associated with the use of peri-articular LB compared to bupivacaine hydrochloride alone. This study does not support the use of peri-articular LB for knee replacement. Trial Registration: ISRCTN 54191675, registered on 14 November 2017. http://www.isrctn.com/ISRCTN5419167

Isolation of Oct4-Expressing Extraembryonic Endoderm Precursor Cell Lines

BACKGROUND:The extraembryonic endoderm (ExEn) defines the yolk sac, a set of membranes that provide essential support for mammalian embryos. Recent findings suggest that the committed ExEn precursor is present already in the embryonic Inner Cell Mass (ICM) as a group of cells that intermingles with the closely related epiblast precursor. All ICM cells contain Oct4, a key transcription factor that is first expressed at the morula stage. In vitro, the epiblast precursor is most closely represented by the well-characterized embryonic stem (ES) cell lines that maintain the expression of Oct4, but analogous ExEn precursor cell lines are not known and it is unclear if they would express Oct4. METHODOLOGY/PRINCIPAL FINDINGS:Here we report the isolation and characterization of permanently proliferating Oct4-expressing rat cell lines ("XEN-P cell lines"), which closely resemble the ExEn precursor. We isolated the XEN-P cell lines from blastocysts and characterized them by plating and gene expression assays as well as by injection into embryos. Like ES cells, the XEN-P cells express Oct4 and SSEA1 at high levels and their growth is stimulated by leukemia inhibitory factor, but instead of the epiblast determinant Nanog, they express the ExEn determinants Gata6 and Gata4. Further, they lack markers characteristic of the more differentiated primitive/visceral and parietal ExEn stages, but exclusively differentiate into these stages in vitro and contribute to them in vivo. CONCLUSIONS/SIGNIFICANCE:Our findings (i) suggest strongly that the ExEn precursor is a self-renewable entity, (ii) indicate that active Oct4 gene expression (transcription plus translation) is part of its molecular identity, and (iii) provide an in vitro model of early ExEn differentiation

Evaluation of a multiple ecological level child obesity prevention program: Switch® what you Do, View, and Chew

<p>Abstract</p> <p>Background</p> <p>Schools are the most frequent target for intervention programs aimed at preventing child obesity; however, the overall effectiveness of these programs has been limited. It has therefore been recommended that interventions target multiple ecological levels (community, family, school and individual) to have greater success in changing risk behaviors for obesity. This study examined the immediate and short-term, sustained effects of the Switch program, which targeted three behaviors (decreasing children's screen time, increasing fruit and vegetable consumption, and increasing physical activity) at three ecological levels (the family, school, and community).</p> <p>Methods</p> <p>Participants were 1,323 children and their parents from 10 schools in two states. Schools were matched and randomly assigned to treatment and control. Measures of the key behaviors and body mass index were collected at baseline, immediately post-intervention, and 6 months post-intervention.</p> <p>Results</p> <p>The effect sizes of the differences between treatment and control groups ranged between small (Cohen's <it>d </it>= 0.15 for body mass index at 6 months post-intervention) to large (1.38; parent report of screen time at 6 months post-intervention), controlling for baseline levels. There was a significant difference in parent-reported screen time at post-intervention in the experimental group, and this effect was maintained at 6 months post-intervention (a difference of about 2 hours/week). The experimental group also showed a significant increase in parent-reported fruit and vegetable consumption while child-reported fruit and vegetable consumption was marginally significant. At the 6-month follow-up, parent-reported screen time was significantly lower, and parent and child-reported fruit and vegetable consumption was significantly increased. There were no significant effects on pedometer measures of physical activity or body mass index in the experimental group. The intervention effects were moderated by child sex (for fruit and vegetable consumption, physical activity, and weight status), family involvement (for fruit and vegetable consumption), and child body mass index (for screen time). The perception of change among the experimental group was generally positive with 23% to 62% indicating positive changes in behaviors.</p> <p>Conclusion</p> <p>The results indicate that the Switch program yielded small-to-modest treatment effects for promoting children's fruit and vegetable consumption and minimizing screen time. The Switch program offers promise for use in youth obesity prevention.</p

As Far as the Eye Can See: Relationship between Psychopathic Traits and Pupil Response to Affective Stimuli

Psychopathic individuals show a range of affective processing deficits, typically associated with the interpersonal/affective component of psychopathy. However, previous research has been inconsistent as to whether psychopathy, within both offender and community populations, is associated with deficient autonomic responses to the simple presentation of affective stimuli. Changes in pupil diameter occur in response to emotionally arousing stimuli and can be used as an objective indicator of physiological reactivity to emotion. This study used pupillometry to explore whether psychopathic traits within a community sample were associated with hypo-responsivity to the affective content of stimuli. Pupil activity was recorded for 102 adult (52 female) community participants in response to affective (both negative and positive affect) and affectively neutral stimuli, that included images of scenes, static facial expressions, dynamic facial expressions and sound-clips. Psychopathic traits were measured using the Triarchic Psychopathy Measure. Pupil diameter was larger in response to negative stimuli, but comparable pupil size was demonstrated across pleasant and neutral stimuli. A linear relationship between subjective arousal and pupil diameter was found in response to sound-clips, but was not evident in response to scenes. Contrary to predictions, psychopathy was unrelated to emotional modulation of pupil diameter across all stimuli. The findings were the same when participant gender was considered. This suggests that psychopathy within a community sample is not associated with autonomic hypo-responsivity to affective stimuli, and this effect is discussed in relation to later defensive/appetitive mobilisation deficits