Exploring womens' experiences and decision making about physical activity during pregnancy and following birth: a qualitative study.

BACKGROUND: Physical activity (PA) tends to decline during pregnancy, and remains low in the early postpartum period, despite the known physical and psychological benefits. This study aimed to explore: (1) women's experiences of PA during pregnancy and following birth; and (2) decision-making processes related to PA during this time. METHODS: Semi-structured telephone interviews were conducted with 16 women who were either pregnant or had recently given birth. Interviews were transcribed verbatim and analysed using thematic analysis. RESULTS: There were two over-arching themes: (1) ownership of body, which consisted of the sub-themes: others try to take ownership, important to maintain fitness into pregnancy and motherhood, expectations of PA, and pressure to conform; and (2) unknown territory, which consisted of the sub-themes: engaging in PA with caution, and unclear advice. Decision-making about PA during pregnancy was influenced by: pressure from others who felt responsible to protect the woman from coming to harm; pressure from social media to lose weight postpartum; participant's beliefs about the benefits of maintaining fitness and participants expectations of how active they thought they would be able to be during pregnancy. Participants felt that pregnancy was an 'unknown territory' in terms of the unfamiliar feelings in their body and the inability to continually monitor their baby for reassurance of baby's health. Advice received from midwives was often lacking, or not tailored to the individual. Advice from friends and family was often regarded as incorrect, but still caused doubt and fear of PA during pregnancy. CONCLUSIONS: These findings contribute to the understanding of women's experiences of PA during pregnancy and post-partum, and their decision-making processes about PA during pregnancy. Developing accurate and tailored advice as part of midwifery care, that considers the physical and psychological aspects of engaging in PA during pregnancy, will help to ensure that women are supported to make informed decisions about their PA behaviour

Patient-reported outcome measures in presbyopia: a literature review

Presbyopia is the age-related loss of near-distance focusing ability. The aim of this study was to identify patient-reported outcome measures (PROMs) used in clinical trials and quality-of-life studies conducted in individuals with presbyopia and to assess their suitability for use in individuals with phakic presbyopia. Literature searches were performed in Medline and Embase up until October 2017. Specific search terms were used to identify presbyopia studies that included a PROM. All clinical trials with PROM-supported endpoints in presbyopia were identified on ClinicalTrials.gov. Further searches were conducted to retrieve articles documenting the development and psychometric evaluation of the PROMs identified. A total of 703 records were identified; 120 were selected for full-text review. Twenty-one clinical trials employed PROMs to support a primary or secondary endpoint. In total, 13 PROMs were identified; a further 23 publications pertaining to the development and validation of these measures were retrieved. Most PROMs were developed prior to release of the Food and Drug Administration (FDA) 2009 patient-reported outcome guidance and did not satisfy regulatory standards. The Near Activity Visual Questionnaire (NAVQ) was identified as the most appropriate for assessing near-vision functioning in presbyopia. While the NAVQ was developed in line with the FDA guidance, the items do not reflect changes in technology that have occurred since the questionnaire was developed in 2008 (eg, the increase in smartphone use), and the measure was not validated in a purely phakic presbyopia sample. Further research is ongoing to refine the NAVQ to support trial endpoints related to changes in near-vision functioning associated with phakic presbyopia

Social Media Listening to Understand the Lived Experience of Presbyopia:Systematic Search and Content Analysis Study

BACKGROUND: Presbyopia is defined as the age-related deterioration of near vision over time which is experienced in over 80% of people aged 40 years or older. Individuals with presbyopia have difficulty with tasks that rely on near vision. It is not currently possible to stop or reverse the aging process that causes presbyopia; generally, it is corrected with glasses, contact lenses, surgery, or the use of a magnifying glass. OBJECTIVE: This study aimed to explore how individuals used social media to describe their experience of presbyopia with regard to the symptoms experienced and the impacts of presbyopia on their quality of life. METHODS: Social media sources including Twitter, forums, blogs, and news outlets were searched using a predefined search string relating to symptoms and impacts of presbyopia. The data that were downloaded, based on the keywords, underwent manual review to identify relevant data points. Relevant posts were further manually analyzed through a process of data tagging, categorization, and clustering. Key themes relating to symptoms, impacts, treatment, and lived experiences were identified. RESULTS: A total of 4456 social media posts related to presbyopia were identified between May 2017 and August 2017. Using a random sampling methodology, we selected 2229 (50.0%) posts for manual review, with 1470 (65.9%) of these 2229 posts identified as relevant to the study objectives. Twitter was the most commonly used channel for discussions on presbyopia compared to forums and blogs. The majority of relevant posts originated in Spain (559/1470, 38.0%) and the United States (426/1470, 29.0%). Of the relevant posts, 270/1470 (18.4%) were categorized as posts written by individuals who have presbyopia, of which 37 of the 270 posts (13.7%) discussed symptoms. On social media, individuals with presbyopia most frequently reported experiencing difficulty reading small print (24/37, 64.9%), difficulty focusing on near objects (15/37, 40.5%), eye strain (12/37, 32.4%), headaches (9/37, 24.3%), and blurred vision (8/37, 21.6%). 81 of the 270 posts (30.0%) discussed impacts of presbyopia-emotional burden (57/81, 70.4%), functional or daily living impacts (46/81, 56.8%), such as difficulty reading (46/81, 56.8%) and using electronic devices (21/81, 25.9%), and impacts on work (3/81, 3.7%). CONCLUSIONS: Findings from this social media listening study provided insight into how people with presbyopia discuss their condition online and highlight the impact of presbyopia on individuals' quality of life. The social media listening methodology can be used to generate insights into the lived experience of a condition, but it is recommended that this research be combined with prospective qualitative research for added rigor and for confirmation of the relevance of the findings

Evaluation of the content validity of patient-reported outcome (PRO) instruments developed for use with individuals with phakic presbyopia, including the Near Activity Visual Questionnaire-presbyopia (NAVQ-P) and the near vision correction independence (NVCI) instrument

Background: Presbyopia is the age-related deterioration in the ability to focus on close objects. In order to develop a patient-reported outcome (PRO) instrument to assess near vision functioning, the Near Activity Visual Questionnaire (NAVQ) was adapted to incorporate modern technology (e.g. smartphones) and to be appropriate for use in phakic presbyopia, leading to the development of the NAVQ-Presbyopia (NAVQ-P). Additional single-item instruments of near vision correction independence (NVCI), correction preference (NVCP), and vision satisfaction (NVS) were also developed. The study aimed to evaluate the content validity of the NAVQ-P and additional instruments in individuals with phakic presbyopia. Methods: Participants in the US (n = 15), Germany (n = 10) and France (n = 10) took part in face-to-face, qualitative, cognitive debriefing interviews. Seven healthcare professionals (HCPs) were also interviewed to assess the clinical relevance of the PRO instruments. Interviews started with open-ended qualitative concept elicitation questioning; participants then completed the PRO instruments on an electronic tablet using a “think-aloud” process and were asked about their understanding and relevance of each item, instruction, response scale and recall period. Interviews were conducted in two rounds allowing for modifications between rounds. Results: The participants interpreted the majority of the PRO instruments and recall period correctly and consistently. They were able to select an appropriate response option without difficulty. Minor modifications were made to the PRO instruments based on interview findings. Instruction/item wording was modified to include reference to use of a magnifying glass, in addition to glasses and contact lenses. Two items were added to assess difficulty with precision tasks (e.g. sewing) and taking longer to adjust from distance to near vision. HCPs confirmed the relevance of the concepts being measured for presbyopia and recommended the addition of an item assessing contrast sensitivity. Conclusions: Developed in accordance with the FDA PRO Guidance, the findings support content validity of the NAVQ-P as a suitable, well-understood instrument of relevant near vision functioning concepts in individuals with phakic presbyopia. The NVCI and additional PRO instruments are appropriate to assess near vision correction independence, correction preference, and vision satisfaction. Future work will assess the psychometric properties of the NAVQ-P and additional PRO instruments

Understanding the visual function symptoms and associated functional impacts of phakic presbyopia

Background: Presbyopia is defined as the age-related deterioration in the ability to focus on close objects, causing difficulty with near vision tasks. The study aim was to understand the lived experience of phakic presbyopia and identify all relevant visual function symptoms and associated functional impacts. Methods: Fifty individuals with clinician-confirmed phakic presbyopia (US n = 30, France n = 10, Germany n = 10) and seven healthcare professionals (HCPs) participated in in-depth, face-to-face, qualitative concept elicitation interviews. Verbatim transcripts were analyzed using thematic analysis methods. Results: Visual function symptoms reported by participants with phakic presbyopia were categorized as: primary near vision functioning symptoms (impaired near visual acuity, n = 50/50, 100%; difficulty with near vision in dim light, n = 42/50, 84%; difficulty focusing at close distances, n = 30/50, 60%; difficulty seeing things when glare is present, n = 30/50, 60%) and secondary symptoms (eye strain, n = 37/50, 74%; dry eyes, n = 35/50, 70%; headaches, n = 30/50, 60%). Proximal impacts on functional vision included difficulty reading in near vision (n = 49/50, 98%, including printed text and handwriting), seeing objects in near vision n = 48/50, 96%, and performing activities of daily living that require near vision (n = 49/50, 98%, including using a smartphone or computer). Distal impacts on functional vision included emotional, work, financial and social impacts. HCP interviews supported participant findings. Conclusion: Findings provide a comprehensive understanding of the lived experience of phakic presbyopia which informed the development of a presbyopia conceptual model and patient-reported outcome assessments of vision correction independence and near vision functioning. The sample did not include those whose vision cannot be adequately corrected with lenses or surgery

Comparison of Literature Review, Social Media Listening, and Qualitative Interview Research Methods in Generating Patient-Reported Symptom and Functional Impact Concepts of Presbyopia

INTRODUCTION: To compare the insights obtained about the experience of individuals with presbyopia (age-related impaired near vision) across three different sources of qualitative data: a structured targeted literature review, a social media listening (SML) review, and qualitative concept elicitation (CE) interviews with individuals with presbyopia and healthcare professionals (HCPs). The number of concepts identified, depth of data, cost and time implications, and value of the patient insights generated were explored and compared for each method. METHODS: Keyword searches in bibliographic databases and review of abstracts identified 120 relevant publications; in-depth targeted literature review of the qualitative studies identified key symptoms/functioning concepts. SML was conducted using publicly accessible social media sources with focus on ophthalmologic diseases using a pre-defined search string. Relevant posts from individuals with presbyopia (n = 270) were analysed and key concepts identified. Semi-structured CE interviews were conducted with individuals with presbyopia (US n = 30, Germany n = 10, France n = 10), and HCPs (US = 3, France n = 2, Germany n = 1, Japan n = 1) who were experienced in treating presbyopia. Verbatim transcripts were coded using thematic analysis. A conceptual model summarised concepts identified across sources RESULTS: Out of the total of 158 concepts identified across the three sources, qualitative CE interviews yielded the highest number of concepts (n = 151/158, 96%), with SML yielding a third of the concepts (n = 51/158, 32%) and the literature review yielding the fewest concepts (n = 33/158, 21%). Qualitative CE interviews provided greater depth of data than SML and literature reviews. SML and literature reviews were less costly and quicker to run than qualitative CE interviews and also were less burdensome for participants. CONCLUSION: Qualitative CE interviews are considered the gold standard in providing greater depth of understanding of the patient experience, and more robust data. However, research requirements, budget, and available time should be considered when choosing the most appropriate research method. More time and cost-effective SML and literature review methods can be used to supplement qualitative CE interview data and provide early identification of measurement concepts. More research and regulatory guidance into less traditional qualitative methods, however, are needed to increase the value of SML and literature review data

Psychometric evaluation of the near activity visual questionnaire presbyopia (NAVQ-P) and additional patient-reported outcome items

Background: The Near Visual Acuity Questionnaire Presbyopia (NAVQ-P) is a patient-reported outcome (PRO) measure that was developed in a phakic presbyopia population to assess near vision function impacts. The study refined and explored the psychometric properties and score interpretability of the NAVQ-P and additional PRO items assessing near vision correction independence (NVCI), near vision satisfaction (NVS), and near vision correction preference (NVCP). Methods: This was a psychometric validation study conducted using PRO data collected as part of a Phase IIb clinical trial (CUN8R44 A2202) consisting of 235 randomized adults with presbyopia from the US, Japan, Australia, and Canada. Data collected at baseline, week 2, and months 1, 2, and 3 during the 3-month trial treatment period were included in the analyses to assess item (question) properties, NAVQ-P dimensionality and scoring, reliability, validity, and score interpretation. Results: Item responses were distributed across the full response scale for most NAVQ-P and additional PRO items. Confirmatory factor analysis supported the pre-defined unidimensional structure and calculation of a NAVQ-P total score as a measure of near vision function. Item deletion informed by item response distributions, dimensionality analyses, item response theory, and previous qualitative findings, including clinical input, supported retention of 14 NAVQ-P items. The 14-item NAVQ-P total score had excellent internal consistency (α = 0.979) and high test-retest reliability (Intraclass Correlation Coefficients > = 0.898). There was good evidence of construct-related validity for all PROs supported by strong correlations with concurrent measures. Excellent results for known-groups validity and ability to detect change analyses were also demonstrated. Anchor-based and distribution-based methods supported interpretation of scores through generation of group-level and within-individual estimates of meaningful change thresholds. A meaningful within-patient change in the range of 8-15-point improvement on the NAVQ-P total score (score range 0–42) was recommended, including a more specific responder definition of 10-point improvement. Conclusions: The NAVQ-P, NVCI, and NVS are valid and reliable instruments which have the ability to detect change over time. Findings strongly support the use of these measures as outcome assessments in clinical/research studies and in clinical practice in the presbyopia population

Expanding the diversity of mycobacteriophages: Insights into genome architecture and evolution

Mycobacteriophages are viruses that infect mycobacterial hosts such as Mycobacterium smegmatis and Mycobacterium tuberculosis. All mycobacteriophages characterized to date are dsDNA tailed phages, and have either siphoviral or myoviral morphotypes. However, their genetic diversity is considerable, and although sixty-two genomes have been sequenced and comparatively analyzed, these likely represent only a small portion of the diversity of the mycobacteriophage population at large. Here we report the isolation, sequencing and comparative genomic analysis of 18 new mycobacteriophages isolated from geographically distinct locations within the United States. Although no clear correlation between location and genome type can be discerned, these genomes expand our knowledge of mycobacteriophage diversity and enhance our understanding of the roles of mobile elements in viral evolution. Expansion of the number of mycobacteriophages grouped within Cluster A provides insights into the basis of immune specificity in these temperate phages, and we also describe a novel example of apparent immunity theft. The isolation and genomic analysis of bacteriophages by freshman college students provides an example of an authentic research experience for novice scientists. © 2011 Hatfull et al

Between a Rock and a Hard Place: Habitat Selection in Female-Calf Humpback Whale (Megaptera novaeangliae) Pairs on the Hawaiian Breeding Grounds

The Au'au Channel between the islands of Maui and Lanai, Hawaii comprises critical breeding habitat for humpback whales (Megaptera novaeangliae) of the Central North Pacific stock. However, like many regions where marine mega-fauna gather, these waters are also the focus of a flourishing local eco-tourism and whale watching industry. Our aim was to establish current trends in habitat preference in female-calf humpback whale pairs within this region, focusing specifically on the busy, eastern portions of the channel. We used an equally-spaced zigzag transect survey design, compiled our results in a GIS model to identify spatial trends and calculated Neu's Indices to quantify levels of habitat use. Our study revealed that while mysticete female-calf pairs on breeding grounds typically favor shallow, inshore waters, female-calf pairs in the Au'au Channel avoided shallow waters (<20 m) and regions within 2 km of the shoreline. Preferred regions for female-calf pairs comprised water depths between 40–60 m, regions of rugged bottom topography and regions that lay between 4 and 6 km from a small boat harbor (Lahaina Harbor) that fell within the study area. In contrast to other humpback whale breeding grounds, there was only minimal evidence of typical patterns of stratification or segregation according to group composition. A review of habitat use by maternal females across Hawaiian waters indicates that maternal habitat choice varies between localities within the Hawaiian Islands, suggesting that maternal females alter their use of habitat according to locally varying pressures. This ability to respond to varying environments may be the key that allows wildlife species to persist in regions where human activity and critical habitat overlap