Reasons for Exclusion of Apparently Healthy Mature Adult and Senior Dogs From a Clinical Trial.
Reasons for Exclusion of Apparently Healthy Mature Adult and Senior Dogs From a Clinical Trial.
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DOI：
10.3389/fvets.2021.651698
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发表时间：
2021
影响因子：
3.2
通讯作者：
Creevy KE
中科院分区：
文献类型：
--
作者：
Gibbs NH;Michalski H;Promislow DEL;Kaeberlein M;Creevy KE
背景资料：旨在维持老年犬健康的干预性临床试验是不寻常的，需要特别注意排除标准。目的：描述排除的原因时，一个成熟的成年和老年犬人口与正常的健康状况。动物：56只伴侣犬被指定用于随机对照试验（RCT）。操作步骤：排除发生在第1阶段（S1）：主人提供的调查信息;第2阶段（S2）：病历审查;和第3阶段（S3）：筛选检查和主人、犬或其他因素类别内。结果：在56只指定犬中，39只分别在S1（n = 19）、S2（n = 5）和S3（n = 15）时被排除。排除犬的主人（n = 4）、犬（n = 27）、其他（n = 6）和并发（主人+犬; n = 2）因素。最常见的排除期为S1（n = 19），体重超出目标范围是该阶段最常见的排除因素（n = 10）。心脏杂音是第二常见的排除因素（S1：n = 1; S3：n = 5）;疑似或确诊的全身性疾病是第三常见的（S1：n = 2; S2：n = 3; S3：n = 2）。在通过S1和S2筛选的犬中（n = 32），15只犬（48%）在S3时因心脏杂音> II/VI级（n = 5）、心律失常（n = 2）和临床病理异常（n = 2）而被排除。结论和临床相关性：由于体型、既往诊断和新发现的心脏异常，排除了被提名用于健康成年犬和老年犬临床试验的犬。对于健康状况正常的成年犬和老年犬的未来干预措施，重要的是要定义预期的年龄相关异常，以确保使用有意义的排除标准。
Background: Interventional clinical trials intended to maintain health in aging dogs are unusual and require particular attention to exclusion criteria. Objectives: To describe reasons for exclusion when a mature adult and senior canine population with normal health status was sought. Animals: Fifty six companion dogs nominated for a randomized controlled trial (RCT). Procedures: Exclusions occurred within Stage 1 (S1): owner-provided survey information; Stage 2 (S2): medical records review; and Stage 3 (S3): screening examination and within Owner, Dog, or Other factor categories. Results: Of 56 nominated dogs, 39 were excluded at S1 (n = 19), S2 (n = 5), and S3 (n = 15), respectively. Dogs were excluded for Owner (n = 4), Dog (n = 27), Other (n = 6), and concurrent (Owner + Dog; n = 2) factors. The most common exclusion period was S1 (n = 19), with weight outside the target range being the most common exclusion factor in that stage (n = 10). Heart murmurs were the second most common exclusion factor (S1: n = 1; S3: n = 5); suspected or confirmed systemic illness was third most common (S1: n = 2; S2: n = 3; S3: n = 2). Among dogs who passed S1 and S2 screening (n = 32), 15 dogs (48%) were excluded at S3, for heart murmur > grade II/VI (n = 5), cardiac arrhythmias (n = 2), and clinicopathologic abnormalities (n = 2). Conclusions and Clinical Relevance: Dogs nominated for a clinical trial for healthy mature adult and senior dogs were excluded for size, previous diagnoses, and newly discovered cardiac abnormalities. For future interventions in mature adult and senior dogs of normal health status, it is important to define expected age-related abnormalities to ensure that meaningful exclusion criteria are used.
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影响因子：
7.8
作者：
Dai DF;Karunadharma PP;Chiao YA;Basisty N;Crispin D;Hsieh EJ;Chen T;Gu H;Djukovic D;Raftery D;Beyer RP;MacCoss MJ;Rabinovitch PS
通讯作者：
Rabinovitch PS
影响因子：
2.5
作者：
Burnell, Matthew;Gentry-Maharaj, Aleksandra;Menon, Usha
通讯作者：
Menon, Usha
DOI：
10.2460/javma.246.1.77
发表时间：
2015-01-01
影响因子：
1.9
作者：
Bellows, Jan;Colitz, Carmen M. H.;Zhang, Jin
通讯作者：
Zhang, Jin
影响因子：
1.3
作者：
Bennell, Paula M.;Whittem, Ted;Tudor, Elizabeth
通讯作者：
Tudor, Elizabeth
影响因子：
5.4
作者：
Creevy, Kate E.;Austad, Steven N.;Promislow, Daniel E. L.
通讯作者：
Promislow, Daniel E. L.