Objective: To prepare a set of statements for randomised clinical trials (RCT) integrity through an international multi-stakeholder consensus. Methods: The consensus was developed via: multi-country multidisciplinary stakeholder group composition and engagement; evidence synthesis of 55 systematic reviews concerning RCT integrity; anonymised two-round modified Delphi survey with consensus threshold based on the average percentage of majority opinions; and, a final consensus development meeting. Prospective registrations: (https://osf.io/bhncy, https://osf.io/3ursn). Results: There were 30 stakeholders representing 15 countries from five continents including triallists, ethicists, methodologists, statisticians, consumer representatives, industry representatives, systematic reviewers, funding body panel members, regulatory experts, authors, journal editors, peer-reviewers and advisors for resolving integrity concerns. Delphi survey response rate was 86.7% (26/30 stakeholders). There were 111 statements (73 stakeholder-provided, 46 systematic review-generated, 8 supported by both) in the initial long list, with eight additional statements provided during the consensus rounds. Through consensus the final set consolidated 81 statements (49 stakeholder-provided, 41 systematic review-generated, 9 supported by both). The entire RCT life cycle was covered by the set of statements including general aspects (n = 6), design and approval (n = 11), conduct and monitoring (n = 19), reporting of protocols and findings (n = 20), post-publication concerns (n = 12), and future research and development (n = 13). Conclusion: Implementation of this multi-stakeholder consensus statement is expected to enhance RCT integrity.
MULTIFILE
The main objective of this report is to analyse and inform about international labour mobility, particularly within Europe, from the perspective of the Dutch Health and Social Care Sector. The report starts by describing the introduction of a new care system in The Netherlands. The government does not participate directly in the actual provision of care. This is a task principally for private care suppliers. Furthermore, the legal position of the Health and Social Care professions, regulated through the Individual Health Care Professions Act, and questions like the international recognition of degrees and the evaluation of foreign diplomas are discussed. This is followed by a clarification of the Dutch education system, particularly, relating to the study of medicine, nursing education and social work education. Subsequently, some core data on the ageing Dutch population are presented. The grey pressure increases and this will have an impact on health spending, health support and the future labour market. Then what follows is a description of the development of employment in the Dutch Health and Social Care Sector, per branch as well as the professions that are engaged in it. The general picture, at this moment, is that the Health and Social Care labour market is reasonably in balance. This trend will continue in the near future; shortages are expected only in the long term. All research done on the subject indicates that international mobility of medical and social professionals is still low in the Netherlands. The question remains whether a more active recruitment policy would be a solution for the expected long term shortages. The report concludes with a look at recruitment policy and some of its developments at the global, national and local level.
Despite the consequences for women’s health, a repeat cesarean section (CS) birth after a previous CS is common in Western countries. Vaginal Birth After Cesarean (VBAC) is recommended for most women, yet VBAC rates are decreasing and vary across maternity organizations and countries. We investigated women’s views on factors of importance for improving the rate of VBAC in countries where VBAC rates are high. We interviewed 22 women who had experienced VBAC in Finland, the Netherlands, and Sweden. We used content analysis, which revealed five categories: receiving information from supportive clinicians, receiving professional support from a calm and confident midwife/obstetrician during childbirth, knowing the advantages of VBAC, letting go of the previous childbirth in preparation for the new birth, and viewing VBAC as the first alternative for all involved when no complications are present. These findings reflect not only women’s needs but also sociocultural factors influencing their views on VBAC.
MULTIFILE