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Harbin consensus conference and quality of infertility trials: reflections of a scientist on the Italian experience.

ABSTRACT: During the days August 22-24, 2013 has been held in Harbin (China) an International Consensus Conference aimed to improve the quality and the reporting of the randomized controlled trials (RCTs) in infertility and subfertility field. I, as Italian scientist with experience in clinical infertility trials, was invited to have a speech on the Italian experience in RCTs, with particular regard for the surgical trials. Considerations on this subject were particularly interesting to highlight pitfalls and triumphs of research in Italy.

SUBMITTER: Palomba S

PROVIDER: S-EPMC3843534 | biostudies-literature | 2013

REPOSITORIES: biostudies-literature

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Harbin consensus conference and quality of infertility trials: reflections of a scientist on the Italian experience.

Palomba Stefano S

Journal of ovarian research 20131120 1

During the days August 22-24, 2013 has been held in Harbin (China) an International Consensus Conference aimed to improve the quality and the reporting of the randomized controlled trials (RCTs) in infertility and subfertility field. I, as Italian scientist with experience in clinical infertility trials, was invited to have a speech on the Italian experience in RCTs, with particular regard for the surgical trials. Considerations on this subject were particularly interesting to highlight pitfalls ...[more]

PMID: 24257071

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Project description:BackgroundControversy exists regarding many aspects of decision making pertaining to same-day versus staged bilateral TKA (BTKAs), including patient selection, perioperative management decisions, and other important choices.Questions/purposesIn the absence of suitable randomized trials, we sought to determine areas of consensus among national experts on the following questions: (1) What are the comparative risks of same-day BTKAs compared with unilateral TKA (UTKA) and staged BTKAs? (2) Who should be considered an appropriate candidate for same-day BTKAs? (3) What constitutes appropriate workup and perioperative management for BTKAs? (4) What is the optimal time between procedures if same-day BTKAs are not deemed appropriate? (5) Are there orthopaedic or rehabilitation considerations for BTKAs that might outweigh medical contraindications?MethodsIn the setting of a consensus conference of national experts in orthopaedic surgery, anesthesiology, perioperative medicine, and epidemiology, the major questions surrounding same-day BTKAs were addressed by using an extensive literature review and the modified Delphi process. The process concluded with a meeting of participants and formulation of consensus statements.ResultsEighty-one percent of participants agreed that BTKAs are more invasive and complex procedures associated with increased risk for perioperative adverse events compared with UTKA in an unselected group of patients. The consensus group agreed that physicians and hospitals should consider using more restrictive patient selection criteria and exclude those with a modified cardiac risk index greater than 3 to mitigate the potentially increased risk. The majority of the group agreed that perioperative assessment and management should reflect the higher level of acuity of same-day BTKAs. Eighty-one percent of participants agreed that if a patient is not deemed a candidate for same-day BTKAs, a second TKA should be scheduled no sooner than 3 months after the first. The entire group agreed that when there is a conflict between the orthopaedic need and the medical adequacy of same-day BTKAs, the medical concern for the patient's safety should prevail over the orthopaedic need.ConclusionsExperts perceived that same-day BTKAs increase medical risk, and thus a systematic approach to the management of patients should be taken to minimize complications.

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Harbin consensus conference and quality of infertility trials: reflections of a scientist on the Italian experience.

Publications

Harbin consensus conference and quality of infertility trials: reflections of a scientist on the Italian experience.

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