NCT02913950已完成不适用
Pediatric Bristol Stool Scale
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- validation of pediatric Bristol stool scale
研究概览
简要总结
There is a need to develop a stool scale for baby's and toddlers who are not potty-trained yet. The investigators try to get a uniform and approved Bristol stool scale for children who ware diapers.
详细描述
Rationale and background
- There is a need to have an easy way to express the composition aspect of stools. It is known since many years that patients or parents of children just describing what they "see" is very subjective and not reliable for medical use. Because of that need, the Bristol Stool Scale was developed. This is a very easy and reliable way to provide information on stool composition. Seven drawings were made and each drawing corresponds to a precise stool-composition.
- However, this Bristol Stool Scale is developed for adults, or at least for toilet-trained children.
- The group from Amsterdam developed the "Amsterdam Stool Scale", providing additional information on color and volume of the defecations of non-toilet-trained children and infants. However, this scale involved 18 different images, and is too complicated for routine use by parents, nurses and primary health care physicians.
- Because there is "no better", the Bristol Stool Scale is worldwide used to describe the stools of infants and young children. Pediatricians continuously have repeated the idea that "something adapted for young children should be developed". This was recently expressed when a symptom score was developed as awareness tool for cow's milk allergy.
Method so far - what has been done
- The idea is to replace the drawings of adult stools used in the Bristol stool scale with real pictures of real stools of infants and/or young children, not toilet trained, thus wearing diapers.
- The principal investigator asked nurses to take pictures of stools of hospitalized infants and young children during several months. Pictures of hundreds of diapers which contained stools were taken. The principal investigator then selected 28 pictures, in collaboration with the nurses and staff members, best representing the 7 stools described in the Bristol scale.
- These 28 pictures were send out to first core-group (Hania Szajewska (Poland), Annamaria Staiano (Italy), Carmen Ribes-Konickx (Spain), Christophe Dupont (France), Raanan Shamir (Israel)), who selected the seven "best pictures" representing best the original descriptions of the Bristol Stool Scale. These seven pictures were selected with 100 % consensus.
- The principal investigator then mixed the order of the pictures, and send them in combination with the original descriptions of the Bristol Stool Scale to colleague key-opinion leaders, divided over the different parts of the world: Marc Benninga (The Netherlands), Christophe Faure (Canada), Robin Green (South Africa), Badriul Hegar (Indonesia), Roel Lemmens (Belgium), Seksit Osatakul (Thailand), Silvia Salvatore (Italy), Miguel Saps (USA), Mario Vieira (Brazil), Marc Verghote (Belgium), Ioannis Xinias (Greece). Each colleague was asked to put the "best picture" next to each Bristol stool scale descriptions. The result of this was incredibly positive since almost 100 % agreement was reached, if stools are grouped as done in the original Bristol scale:
score 1 and 2: constipation score 3 and 4: normal score 5-7: loose stools score 6-7: diarrhea
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 99 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •all adults who had children with dapers
排除标准
- •adults without children
结局指标
主要结局
validation of pediatric Bristol stool scale
时间窗: 1 year
次要结局
未报告次要终点
研究者
Yvan Vandenplas
principal investigator
Universitair Ziekenhuis Brussel
研究点 (1)
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