One or two venous pedicles by anastomoses for free flaps in reconstruction of the lower extremity: A systematic review and meta-analysis.

BACKGROUND: Microsurgical free tissue transfers are a mainstay of lower extremity reconstruction. Despite being a reliable source of soft tissue, complications do arise. Venous congestion is among the most common causes of flap failure in lower extremity reconstruction, an issue that is attributed to venous stasis and impaired venous return in this region. There remains significant debate whether dual venous drainage improves outcomes. The aim of this study was thus to compare one versus two venous anastomoses in lower limb free flap reconstruction. METHODS: A systematic review of Medline, EMBASE, EBSCO CINAHL, SCOPUS, Proquest Dissertations and Theses Global, Cochrane Library, and PROSPERO from inception to May 20, 2020, was conducted. Two independent reviewers screened titles and extracted data. Our primary outcome was total free flap necrosis. Secondary outcomes were partial flap necrosis, minor complications, flap reoperation, venous thrombosis, and amputation. Methodological quality was assessed using the MINORS criteria and level of evidence. RESULTS: Three-hundred and fourteen unique titles were identified. All studies were level VI evidence and had a mean MINORS score of 16.1/24. Seven studies (comprising 1499 patients, 910 single venous anastomoses, and 579 double venous anastomoses) met criteria for inclusion. The mean (SD) patient age was 46.5 (7.1) years. Double venous anastomoses did not reduce the rate of minor complications, flap takeback, venous thrombosis, total flap necrosis, or partial flap necrosis when compared to a single vein (all p > .05). CONCLUSION: In microvascular lower extremity reconstruction, two venous anastomoses did not reduce the rate of minor or major complications.

Sharing longitudinal, non-biological birth cohort data: a cross-sectional analysis of parent consent preferences.

BACKGROUND: Mandates abound to share publicly-funded research data for reuse, while data platforms continue to emerge to facilitate such reuse. Birth cohorts (BC) involve longitudinal designs, significant sample sizes and rich and deep datasets. Data sharing benefits include more analyses, greater research complexity, increased opportunities for collaboration, amplification of public contributions, and reduced respondent burdens. Sharing BC data involves significant challenges including consent, privacy, access policies, communication, and vulnerability of the child. Research on these issues is available for biological data, but these findings may not extend to BC data. We lack consensus on how best to approach these challenges in consent, privacy, communication and autonomy when sharing BC data. We require more stakeholder engagement to understand perspectives and generate consensus. METHODS: Parents participating in longitudinal birth cohorts completed a web-based survey investigating consent preferences for sharing their, and their child's, non-biological research data. Results from a previous qualitative inquiry informed survey development, and cognitive interviewing methods (n = 9) were used to improve the question quality and comprehension. Recruitment was via personalized email, with email and phone reminders during the 14-day window for survey completion. RESULTS: Three hundred and forty-six of 569 parents completed the survey in September 2014 (60.8%). Participants preferred consent processes for data sharing in future independent research that were less-active (i.e. no consent or opt-out). Parents' consent preferences are associated with their communication preferences. Twenty percent (20.2%) of parents generally agreed that their child should provide consent to continue participating in research at age 12, while 25.6% felt decision-making on sharing non-biological research data should begin at age 18. CONCLUSIONS: These finding reflect the parenting population's preference for less project-specific permission when research data is non-biological and de-identified and when governance practices are highly detailed and rigourous. Parents recognize that children should become involved in consent for secondary data use, but there is variability regarding when and how involvement occurs. These findings emphasize governance processes and participant notification rather than project-specific consent for secondary use of de-identified, non-biological data. Ultimately, parents prefer general consent processes for sharing de-identified, non-biological research data with ultimate involvement of the child.

Parental perspectives on consent for participation in large-scale, non-biological data repositories.

BACKGROUND: Data sharing presents several challenges to the informed consent process. Unique challenges emerge when sharing pediatric or pregnancy-related data. Here, parent preferences for sharing non-biological data are examined. METHODS: Groups (n = 4 groups, 18 participants) and individual interviews (n = 19 participants) were conducted with participants from two provincial, longitudinal pregnancy cohorts (AOB and APrON). Qualitative content analysis was applied to transcripts of semi-structured interviews. RESULTS: Participants were supportive of a broad, one-time consent model or a tiered consent model. These preferences were grounded in the perceived obligations for reciprocity and accuracy. Parents want reciprocity among participants, repositories and researchers regarding respect and trust. Furthermore, parents' worry about the interrelationships between the validity of the consent processes and secondary data use. CONCLUSIONS: Though parent participants agree that their research data should be made available for secondary use, they believe their consent is still required. Given their understanding that obtaining and informed consent can be challenging in the case of secondary use, parents agreed that a broad, one-time consent model was acceptable, reducing the logistical burden while maintaining respect for their contribution. This broad model also maintained participant trust in the research and secondary use of their data. The broad, one-time model also reflected parents' perspectives surrounding child involvement in the consent process. The majority of parents felt decision made during childhood were the parents responsibility and should remain in parental purview until the child reaches the age of majority.

Parent perspectives on privacy and governance for a pediatric repository of non-biological, research data.

Research data repositories (RDRs) are data storage entities where data can be submitted, stored, and subsequently accessed for purposes beyond the original intent. There is little information relating to non-biological RDRs, nor considerations regarding pediatric data storage and re-use. We examined parent perspectives on pediatric, non-biological RDRs. Qualitative, descriptive methods including both interviews and focus groups were used. Purposive sampling of adult participants in two provincial birth cohorts yielded 19 interviewees and 18 focus group participants (4 groups). Transcripts were analyzed by thematic content analysis. Parent research participants strongly supported the sharing of their own, and their child's, non-biological research data. Four themes emerged: that altruism has limits, that participants have ongoing privacy concerns, that some participants need the assurance of congruent values between themselves and researchers/research questions, and that opinions diverge for some governance issues. The establishment of RDRs is important and maximizes participants', researchers', and funders' investments. Participants as data donors have concerns relating to privacy, relationships, and governance that must be considered in RDR development.