Postoperatieve voeding bij patiënten met een schisis
Uitgangsvraag
Welke postoperatieve voedingsadviezen kunnen worden gegeven aan kinderen met een schisis na diverse operaties aan het gehemelte en/of de kaakspleet?
Aanbeveling
Probeer de manier van voeden zoveel mogelijk gelijk te houden als voor de operatie.
Probeer rondom schisis operaties de manier van voeden (fles, borst, lepel) zo min mogelijk te veranderen.
Pas de voedingsadviezen, zoals omschreven in de overzichtstabel, zoveel mogelijk toe.
Adviseer patiënten na een bot in gnatho (BIG) procedure het voedsel gedurende 6 weken niet af te bijten met het front.
Overweeg een beetverhoging aan te brengen indien er contact is tussen boven - en onderfront voor een bot in gnatho BIG procedure.
Evalueer de groei en voedingstoestand zowel pre- als postoperatief en consulteer zo nodig een kinderarts.
Overwegingen
No studies were found that directly compared thin, fluid, soft food or tube feeding with normal/solid food until 6 weeks after palatoplasty, pharyngoplasty or bone graft procedure in children with cleft alveolus and/or palate between 6 months and 11 years old, on the outcomes: wound healing, amount of food intake/nutritional status, moving premaxilla and fistulas.
We will provide an overview of studies that indirectly assessed feeding methods and/or nutritional status in children following cleft palate or bone graft procedure.
Palate repair and different feeding methods
A systematic review by Duarte (2016) compared different feeding methods in children with cleft lip and palate, such as breast feeding, bottle feeding, syringe-, tube-, spoon- or paladai- feeding. For our question only studies that compared feeding methods for soft food (cup, syringe, tube or paladai) with feeding methods for solid food (spoon) in palate repair (associated or not associated with lip repair) were assessed. Bone graft procedures were not included by Duarte (2016). Studies comparing breast feeding/bottle feeding methods were not assessed.
Two studies, included and analysed by Duarte (2016), could be assessed: Hughes (2013) compared tube feeding versus oral food intake and Trettene (2013) compared cup versus spoon feeding. Unfortunately, the studies were focused on the immediate hospital period following palate repair within 24 hours, and not the period 3 to 6 weeks post-surgery.
An overview of study characteristics, taken from the systematic review by Duarte (2016):
Table 1 Study description Hughes (2013) and Trettene (2013) by systematic review of Duarte (2016)
|
Author (year) |
Study design |
Age range |
Isolated cleft palate repair, cleft palate and lip (n, n) |
Comparison |
Assessed period after procedure |
Assessed parameters |
|
Hughes (2013) |
Pilot study of an RCT |
5 to 10 months |
32, 9 |
Feeding tube (n=18) versus. Oral feeding (n=23) |
Until 24 hours after procedure |
Analgesia/pain; number of painful episodes, intravenous fluids and enteral feeding. |
|
Trettene (2013) |
Prospective cross-sectional study |
11 to 18 months |
Not reported |
Cup (n=88) versus. spoon (n=88) |
Until 24 hours after procedure; at 4 different time points |
Coughing, choking, escape; accepted volume. |
Tube versus oral food and cup versus spoon during the postoperative feeding period following surgical repair of cleft palate associated or not associated with lip repair
Source: Duarte (2016)
Table 2 Tube versus oral food during the 24-hour postoperative feeding period following surgical repair of cleft palate
|
|
Nasogastric feeding (n=18) |
Oral feeding (n=23) |
Test statistic |
|
Analgesia/pain: 1) post operative morphine, mean mg/kg (range) 2) paracetamol, mean mg/kg (SD*) 3) ibuprofen, mean mg/kg (SD*) |
1) 0.16 (0.04 to 0.31) 2) 64.4 (13.3) 3) 13.2 (8.23) |
1) 0.16 (0.024 to 0.4) 2) 61.9 (14) 3) 14.6 (4.7) |
1) >0.1 (Mann-Whithney test) 2) >0.1 (Student’s t-test) 3) >0.1 (Student’s t-test) |
|
Number of painful episodes (median, range) |
4.5 (0-13) |
5 (0 to 14) |
> 0.1 (Mann-Whithney test) |
|
Post operative fluids: 1) postoperative fluid and feed in first 24 hours, mean ml/kg (SD*) 2) number requiring postoperative fluids |
1) 147 (55) 2) 9 |
1) 59 (33) 2) 0 |
1) Difference of means (95% CI*) 88 (61.3 to 114.9) 2) Not assessable |
SD= standard deviation, CI=confidence interval
Source: Hughes (2013)
Table 3 Cup versus spoon during the 24-hour postoperative feeding period following surgical repair of cleft palate
|
|
Cup feeding |
Spoon feeding |
Test statistic |
|
Variables related to feeding technique: 1) coughing episodes during food administration (n Yes, %) 2) choking during food administration (n Yes, %) 3) food escape by the commissure (n Yes, %) |
1) 4 (5%) 2) 5 (6%) 3) 67 (76%) |
1) 0 2) 1 (1%) 3) 52 (59%) |
1) 0.121 (Fisher exact test) 2) 0.211 (Fisher exact test) 3) 0.024* (Fisher exact test) |
|
Accepted volume, ml (median, range) |
140,0 |
150,0 |
0.029* (Mann-Whitney test) |
* Significant association (p<0.05)
Source: Trettene (2013)
Hughes (2013) showed that use of analgesia and the number of painful episodes was similar among the tube group (n=18) and the oral food group (n=23) within 24 hours post-surgery. However, the received amount of fluid food volume was higher in the tube feeding group, with less often need for intravenous fluid (Duarte, 2016).
Trettene (2013) showed that the spoon technique (n=88) caused less food escape and a higher volume of food received than the cup technique (n=88) within 24 hours post-surgery. It is unclear from this study if the food given with the cup was a different (thinner) consistency than the food with the spoon (Duarte, 2016).
From these studies it remains unclear which food consistency is most effective in week 3 to 6 post surgery, because this was not assessed (the studies did not meet the PICO). It also remains unclear if the food consistency differed among the nasogastric/oral feeding and cup/spoon feeding.
When nasogastric and oral feeding are compared in the first 24 hours, the nasogastric tube led to a higher postoperative fluid volume, however the number of painful episodes and need for analgesia was comparable. How often the tube itself led to pain, discomfort or damage to the repair was not assessed, but one case in which the tube had to be removed due to discomfort was described. Some infants (poor feeders for example) might benefit from nasogastric feeding, but the study of Hughes (2013) does not provide any selection criteria.
When cup and spoon feeding are compared, spoon feeding led to a higher amount of volume accepted and less food escape through the commissure. It could be hypothesized that soft food with the spoon is easier to consume, with less chances for leakage, swallowing or processing problems, than fluid food.
Both studies had a low methodological quality and a small sample size, so results should be interpreted with caution.
Palate repair and influences on eating function
One retrospective single center study from Japan (Fujikawa, 2016) was found that assessed the impact of palate repair surgery on eating function: the amount of a whole meal that was consumed and the food type (fluid food, paste food, soft food and others). Nurses recorded the amount of food intake during the hospital period, and the data was retrieved from medical records. The protocol was made so that patients began with drinking water and taking fluid food and work towards eating food pastes and soft food by postoperative day 7.
A total of 19 patients participated in the study. All patients underwent push back palatoplasty.
The results show that the eating rate increased during the first 6 postoperative days and then stabilized. The amount of fluid foods and pastes decreased over time, and the amount of soft foods and other foods increased. Unfortunately, the study did not assess the 3 to 6 weeks post-surgery period. However, because palatoplasty greatly influences eating function, it could be expected that the energy intake remains insufficient for a longer period.
In case soft food is encouraged, it could be predicted the amount of fluid food and pastes will decrease, however this is largely speculative. From the analysis of Fujikawa (2016) it is also difficult to predict which food types are benefitting patients most in the 3 to 6 weeks post procedure. Because of the lower amount of food intake, and the lower nutritional value of fluid food and food pastes, the authors (Fujikawa 2016) recommend developing a new soft food type which minimizes palatal stress for postoperative cleft management. This study had a low methodological quality and limited amount of study participants, so results should be taken with caution.
Bone graft
No studies were found that assessed bone graft and the impact of different food types or feeding methods.
Advantages and disadvantages of the feeding methods
Infants and children are very susceptible to problems of nutrition. In comparison with adults, they have lower percentages of muscle mass and fat and therefore have fewer caloric reserves in combination with a higher resting energy metabolism. Children are in a growth and developmental phase, with nutritional requirements that are greater and clearly different compared to those of adults and that vary according to the stage of growth. In sick and hospitalized children, malnutrition is associated with increased risk of infection, delayed wound healing, longer hospital stay, and increased morbidity and mortality (Joosten, 2017). In children with cleft lip/palate, feeding is an immediate concern. There is evidence of delay in growth of these children as compared to those without clefts, especially if these were associated with a syndrome or anomaly (Bessell, 2011). For example: Pandya (2001) found an incidence of failure to thrive in Pierre Robin patients of 100%. Therefore, in these children it is very important to evaluate the nutritional status and achieve optimal growth prior to and after surgery. If needed, a dietitian or paediatrician should be consulted.
Operations in the mouth such as in cleft surgery might have considerable impact in the intake of food and sometimes even fluids. Apart from the effect on general wellbeing of the child and his or her parents, food and drinks are crucial for proper wound healing. A balanced and clear protocol for postoperative feeding and feeding methods is therefore important. Unfortunately, the literature shows very little to no evidence for proper food (soft versus solid) or feeding methods in the postoperative period. What we do know is that changes in food or feeding methods, either because the patient cannot or may not eat the food he or she is accustomed to, can lead to stress and loss of weight (Matsunaka, 2015; Madhoun, 2020).
Especially in young children minimizing crying is considered to be the important factor in avoiding tension on the surgical wound. For this reason, the use of a pacifier - to prevent crying - should be allowed as long as the tip of the pacifier does not reach the repair. Changes in feeding methods seems to stress the infants and may cause them to cry, which places tension on the wound (Matsunaka, 2015).
It is assumed that normal feeding with solid food may cause mechanical damage to the wound, but no evidence was found in the literature that endorses this idea. Cohen (1992) conclude in a retrospective analysis of two non-solid food feeding protocols, i.e. tube and syringe feedings versus unrestricted bottle or breast feeding, that there were no wound complications in the unrestricted group. They conclude that immediate unrestricted feeding may be instituted safely, thus improving and simplifying postoperative management after CLA/P repair.
In a prospective randomized study (Kim, 2009) the effect of bottle-feeding versus spoon feeding on early postoperative course after palatoplasty was evaluated. They concluded that bottle-feeding had no adverse effect on wound disruption or fistula formation. Although statistically insignificant, infants in the spoon-feeding group ingested a larger amount of food during the first 3 days and the need for sedatives was lower as compared to the bottle-feeding group. For this reason, it would be wise to encourage parents to introduce spoon feeding as normally advised from the age of 4 months on, to ensure that children can eat well from a spoon after surgery.
The large variation in feeding protocols in the Netherlands after cleft surgery seems to be based on assumptions rather than on scientific evidence. It is evident that a thorough oral hygiene post-surgery, a subject closely related to eating, is very important too. Cleaning the mouth and teeth after feeding might have a positive influence on the possible negative effects of certain food or fluids on the wound. Because this subject was not part of the clinical question, we did not investigate the role of oral hygiene, but we like to mention its importance and relation to feeding.
Values and preferences of patients and their parents or guardians
In our experience a stringent feeding protocol which states soft food for a couple of weeks after cleft surgery seems to be a rather big burden for the cleft patients and their parents. Especially after bonegrafting the alveolar cleft the most important question for the children is often when they can start their normal food again. One of the Dutch cleft teams created therefore a cookbook, written by and for children with a cleft and supervised by students of dietetics. The aim was to create tasty recipes in accordance with a soft diet protocol (https://www.radboudumc.nl/expertisecentra/expertisecentra-zeldzame-aandoeningen/schisis/masterkoekies-kookboek).
One study included in the review of Duarte (2016) states that (little) children who got a gastric feeding tube for 24 hours postoperative needed less pain medication and were dismissed faster. Also, their parents seemed to be more relaxed because they had the feeling their child received enough food and pain medication (Kent, 2009). The possible adverse events of gastric feeding tube are problems with reintroducing oral intake, need for replacement, infections and it might be a burden for the child itself. In general, the nasogastric feeding tube does not seem to be standard practice in the Netherlands unless the oral feeding methods are not successful after a certain amount of time. To prevent mechanical damage to the wound by fingers of the child, it is common to provide arm splints in some countries (the USA for example). This is not routine in The Netherlands because it is believed to discomfort the child by the use of splints.
Costs/Finances
A soft feeding protocol in general does not lead to extra costs. In some occasions supplementary food (i.e. Nutridrink) or a nasogastric feeding tube at home can lead to extra costs which are usually covered by the health care insurance in the Netherlands.
Acceptance, feasibility and implementation
Because no scientific evidence was found to advise a stringent soft food protocol versus a normal diet after cleft surgery, the working group collected the feeding protocols after cleft surgery (especially palate and bone graft procedure) of all the cleft teams in the Netherlands. The large variation in feeding protocols in the Netherlands after cleft surgery seems to be based on assumptions rather than on scientific evidence.
Table 4 shows an overview of the feeding protocols after cleft surgery of all cleft teams in the Netherlands. The results are shown for: closure of hard palate (palatoraphia anterior), pharyngeoplasty, and bone grafting procedure in cleft patients. Only the common recommendations of the different teams are shown. The working group used this overview and the consensus between the feeding protocols as a guidance for the recommentations of this protocol.
The working group created support from all cleft teams through the collection of al feeding protocol, which increases the feasibility of the recommendations. If necessary, adjust nutritional advice to the preferences of the patient within the possibilities of the various protocols used, which are important for recovery and well-being.
Table 4 Overview feeding protocols post cleft surgery of Dutch cleft teams (lip surgery excluded)
|
General recommendations post cleft surgery |
|||
|
Always start with drinking water post-surgery |
day of surgery |
||
|
Always rinse with water after eating |
3 weeks post-surgery |
||
|
Don't use a straw for drinking |
3 weeks post-surgery |
||
|
Do not put hard object into the mouth such as fork, fingers, hard / sharp food such as chips |
3-4 weeks post-surgery |
||
|
No indications to apply nasal gastric feeding tube as standard of care |
|||
|
Surgery |
Age child at operation |
Common recommendations for post-surgical feeding protocol |
Duration of the advice |
|
Bone grafting procedure |
9 to 12 years |
Start with drinking water, then only fluid drinking (tea, apple juice, milk etc.) |
day 1 post-surgery |
|
Thicker fluids: like yogurt, oatmeal, soup |
day 2-7 days post-surgery |
||
|
Soft food: like bread without crusts, mashed food, pasta |
week 2- 6 post-surgery |
||
|
Do not bite or chew with front teeth |
first 6 weeks post-surgery |
||
|
Palatorafia anterior |
variation 3 months to 3 years |
fluids (like apple juice, milk, water) |
day 1 |
|
smooth grinded food (yoghurt, smoothies, Olvarit 4 months) |
day 2 t/m 7 |
||
|
mashed food (like bread without crusts, pasta) |
week 2 and 3 postoperatively |
||
|
no fingers or pacifier or thumb sucking |
until 3 weeks postoperatively |
||
|
avoid orange juice and grapefruit juice |
until 3 weeks postoperatively |
||
|
Pharyngoplasty |
4 to 7years |
fluids (like apple juice, milk, water) |
day 1 |
|
mashed food (like bread without crusts, pasta) |
day 2 - 3 weeks |
||
|
avoid orange juice and grapefruit juice |
until 3 weeks postoperatively |
||
Rationale
Based on the literature summary, the working group is unable to make a statement about the effect of soft food versus normal/ solid food after cleft surgery. Our recommendations are therefore mainly based on the corresponding recommendations in postoperative nutrition of the various cleft teams in the Netherlands and on the expert opinion of the working group members.
Onderbouwing
Achtergrond
After a cleft palate operation (palate repair or palatoplasty or pharyngoplasty) or alveolar bone grafting the patient is advised to drink fluid or eat soft food. The most important reason is to avoid mechanical damage to the wound bed. Following an alveolar bone graft procedure, the idea is to avoid chewing force to the premaxilla bone or front elements. Following a palate repair procedure, the patient is often also advised to avoid citrus fruits.
Currently, there is no clear evidence for these nutritional instructions, such as the relation between nutrition and disturbance of the soft tissues and bone. Meanwhile, the effort for the child and his/her parents to follow the post operative instructions for feeding seems to be considerable. In addition, there is a lack of evidence and no consensus regarding the duration of the nutritional instructions.
Next to the discussion about the food consistency, there is a discussion about whether or not tube feeding is effective after a palate repair procedure and pharyngoplasty. This discussion is mainly between surgeons and paediatric nurses or paediatricians and a decision that is usually made on individual (patient) basis and team preferences. This is a subquestion which could be interesting to consider.
Because of the fact that lip closure and closure of the soft palate are usually performed in young infants who are bottle or breast fed, these procedures were not included in this module.
Zoeken en selecteren
A systematic review of the literature was performed to answer the following question:
What is the effect of consuming soft food (e.g. liquid food, mashed food or tube feeding) versus solid/normal food after cleft palate repair, pharyngoplasty and bone grafting procedure for children with cleft alveolus and/or palate?
P: patients after cleft palate repair, pharyngoplasty and bone grafting procedure between 6 months and 11 years old;
I: liquid food, mashed food or tube feeding (until 6 weeks post procedure);
C: solid/normal food (until 6 weeks post procedure);
O: no disturbed wound healing, enough food intake, no moving premaxilla, no fistulas.
Relevant outcome measures
The working group considered surgical wound healing and amount of food intake/nutritional status as critical outcome measures for decision making; and moving premaxilla and fistulas as important outcome measures for decision making.
A priori, the working group did not define the outcome measures listed above but used the definitions used in the studies.
The working group defined the criteria for minimal clinically (patient) important difference for the dichotomous outcome measures; RR < 0.80 of > 1.25)
No a priori criteria were set for the continuous outcome measures because it largely depends on its context.
Search and select (Methods)
The databases Medline (via OVID) and Embase (via Embase.com) were searched with relevant search terms until August 20th, 2020. The detailed search strategy is depicted under the tab Methods. The systematic literature search resulted in 331 hits. Studies were selected based on the following criteria:
- Involving patients with a cleft palate procedure or bone graft procedure between 6 months and 11 years old.
- Comparing liquid food, mashed food or tube feeding with solid/normal food 3-6 weeks postoperatively. This module focuses on the nutriotional advice in the first 3 to 6 weeks after a surgical intervention, because it is expected that patients can continue their habitual nutrition intake after 3-6 weeks.
- Assessing surgical wound healing and/or the amount of food intake or nutritional status.
A total of 25 studies were initially selected based on title and abstract screening. After reading the full text, 25 studies were excluded (see the table with reasons for exclusion under the tab Methods) and no studies were included.
Results
No studies were found that answered the question: What is the effect of offering soft food versus solid/normal food after a cleft palate or bone graft procedure for children with cleft alveolus and/or palate? In the justifications a descriptive overview can be found of indirect studies.
Referenties
- Bessell A, Hooper L, Shaw WC, Reilly S, Reid J, Glenny AM. (2011). Feeding interventions for growth and development in infants with cleft lip, cleft palate or cleft lip and palate. Cochrane Database Syst Rev;2011(2):CD003315.
- Cohen M, Marschall MA, Schafer ME. (1992). Immediate unrestricted feeding of infants following cleft lip and palate repair. J Craniofac Surg;3(1):30-2.
- Duarte GA, Ramos RB, Cardoso MC. (2016). Feeding methods for children with cleft lip and/or palate: a systematic review. Braz J Otorhinolaryngol;82(5):602-9.
- Fujikawa H, Wakami S, Motomura H. (2016). The Influence of Palatoplasty on Eating Function. Plast Reconstr Surg Glob Open;4(8):e840.
- Hughes J, Lindup M, Wright S, Naik M, Dhesi R, Howard R, Sommerlad B, Kangesu L, Sury M. (2013). Does nasogastric feeding reduce distress after cleft palate repair in infants? Nurs Child Young People;25(9):26-30.
- Joosten KMF, van Waardenburg D, Kneepkens CMF. (2017). Werkboek Voeding voor zieke Kinderen, Nederlandse Vereniging voor Kindergeneeskunde. ISBN: 978 90 8659 770 3. https://issuu.com/hinke5/docs/werkboek_voeding_def.
- Kent R, Martin V. (2009). Nasogastric feeding for infants who have undergone palatoplasty for a cleft palate. Paediatr Nurs;21(10):24-29.
- Kim EK, Lee TJ, Chae SW. (2009). Effect of unrestricted bottle-feeding on early postoperative course after cleft palate repair. J Craniofac Surg;20 Suppl 2:1886-8.
- Madhoun LL, Crerand CE, O'Brien M, Baylis AL. (2020). Feeding and Growth in Infants With Cleft Lip and/or Palate: Relationships With Maternal Distress. Cleft Palate Craniofac J.:1055665620956873.
- Matsunaka E, Ueki S, Makimoto K. (2019) Impact of breastfeeding and/or bottle-feeding on surgical wound dehiscence after cleft lip repair in infants: A systematic review. J Craniomaxillofac Surg;47(4):570-577.
- Pandya AN, Boorman JG. (2001). Failure to thrive in babies with cleft lip and palate. Br J Plast Surg;54(6):471-5.
- Trettene, Armando dos Santos, Cleide Carolina da Silva Demoro Mondini, and Ilza Lazarini Marques. "Feeding children in the immediate perioperative period after palatoplasty: a comparison between techniques using a cup and a spoon." Revista da Escola de Enfermagem da USP 47.6 (2013): 1298-1304.
Evidence tabellen
Table of excluded studies
|
Author and year |
Reason for exclusion |
|
Augsornwan, 2013 |
Wrong comparison: breast feeding/bottle versus spoon/syringe after lip repair |
|
Assunção, 2005 |
Wrong comparison: bottle versus spoon/syringe after cheiloplasty |
|
Bannister, 2017 |
Wrong comparison: description of postoperative care following first stage cleft closure |
|
Beluci, 2012 |
Wrong comparison: nutritional status before and after mandibular surgery. Comparison between nutritional status before surgery and 5 days after surgery. |
|
Bessell, 2011 |
Studies on feeding methods, e.g. breast, bottle, spoon, maxillary plate etc. No direct comparison solid versus soft food. More recent SR = Duarte 2016. Wrong comparison: breastfeeding versus spoon feeding, rigid versus squeezable bottle and maxillary plate versus no maxillary plate |
|
Blough, 2019 |
Wrong intervention: risk factor analysis for wound complications during palatoplasty |
|
Burianova, 2017 |
Wrong participants: baby's in first 2 weeks of life. |
|
De Vries, 2014 |
Wrong intervention: analysis of occurrence of feeding difficulties in cleft palate children |
|
Duarte, 2016 |
Wrong comparison: different methods of feeding, not soft versus solid food. This study was used for the justifications. |
|
Farronato, 2014 |
Wrong design: narrative review/background article |
|
Fujikawa, 2016 |
No comparison: no comparison soft versus solid food. But a description how the amount of fluid, paste and soft food increased over the time course of one-week post operation palatoplasty |
|
Gopinath, 2013 |
Wrong comparison: nutritional intake of CLP children versus children without CLP |
|
Harris, 2010 |
Wrong comparison: safety of cleft lip repair in babies |
|
Hughes, 2013 |
Wrong comparison: nasogastric feeding versus oral feeding after palate repair. N.B. This study was used for the justifications. |
|
Kaye, 2019 |
Wrong comparison: differences in weight loss and recovery between CLP (lip) and CP (palate) repair children |
|
Kim, 2009 |
Wrong comparison: breast feeding/bottle versus spoon/syringe after palatoplasty |
|
Kent, 2009 |
Wrong comparison: nasogastric feeding versus bottle feeding after palate repair |
|
Matsunaka, 2015 |
Wrong design: protocol of Matsunaka 2019 (see under) |
|
Matsunaka, 2019 |
Wrong participants: cleft lip repair, exclusion of cleft palate repair. Wrong comparison: breast/bottle feeding versus other feeding methods after cleft lip repair |
|
Onyekwelu, 2016 |
Wrong comparison: omitting intravenous fluids as a postoperative routine versus no intravenous fluids after lip/palate repair |
|
Prahl, 2005 |
Wrong comparison: maxillary plate versus no maxillary plate in first year of life in infants with complete unilateral cleft lip and palate |
|
Rajamani, 2007 |
Wrong comparison: nerve block versus intravenous fentanyl during cleft lip surgery in children |
|
Robin, 2006 |
Wrong study design: narrative review. No information on feeding after palate repair or bone surgery. |
|
Selber, 2014 |
Wrong participants: Pharyngoesophageal (PE) reconstruction. |
|
Worley, 2018 |
Wrong design: narrative review/background article |
Verantwoording
Autorisatiedatum en geldigheid
Laatst beoordeeld : 26-11-2021
Laatst geautoriseerd : 26-11-2021
Geplande herbeoordeling : 01-01-2027
The Board of the Dutch Society for Plastic and Reconstructive Surgery (NVPC) will assess whether this guideline module is still up-to-date in 2026 at the latest. If necessary, a new working groupwill be appointed to revise the guideline module. The validity of the guideline or modules of the guideline may lapse earlier when new developments arise. As the holder of this guideline, the NVPC is chiefly responsible for keeping the guideline up to date.
|
Module1 |
Responsible party2 |
Year of autorisation |
Next assessment of actuality guideline3 |
Frequency of assessement of actuality4 |
Supervisor of actuality5 |
Relevant factors for changes in recommendations6 |
|
Postoperative nutritional care |
NVPC |
2021 |
2026 |
every 5 years |
NVPC |
None |
|
[1] Name of module 2 Responsible party for the module 3 maximum of 5 years 4 half a year, every (other,..) year 5 supervising party or parties 6 Current reseach, changes in organizations/restitions, new available rescourses |
||||||
Other scientific organizations participating in the guideline or users of the guideline share the responsibility to inform the chiefly responsible party (NVPC) about relevant developments within their fields.
Algemene gegevens
The revision of this guideline module was supported by Knowledge Institute Federation of Medical Specialists (https://www.demedischspecialist.nl/kennisinstituut) and was financed by the Quality Foundation of the Dutch Medical Specialists (SKMS). The funding organization did not have any influence on the content of the guideline in any way.
Doel en doelgroep
Objectives of the guideline
The aim of this guideline is to improve the care of children/patients with CLA/Ps in The Netherlands ranging from prenatal detection to young adulthood, substantiated by scientific knowledge from research where possible. ‘Improving’ also means providing insight in the differences in practices between cleft teams and discriminating between wanted and unwanted (i.e. scientifically based or non-scientifically based) practice variation. This resulted in recommentations for a more uniform treatment. However, the lack of high-quality studies and evidence remains a serious limiting factor and forced the working group to define some conclusions in a more generalized way than was wished for at the start.
Specific attention will be given to the following aspects:
- reducing undesirable/unfounded practice variation in the working method and treatment protocols of the Dutch cleft teams, without hampering custom work, innovation or research;
- making objective / evidence-based information about the treatment of CLA/Ps available and accessible to healthcare providers, patients, parents and other parties;
- determine to what extent the existing organisation of care needs to be changed in order to meet the requirements regarding “state of the art” treatment of a child or adult with CLA/Psand the follow-up to this treatment.
In this manner, the guideline offers a tool to create more uniform care in the field of the prenatal and postnatal treatment of a child with CLA/Ps and the implementation of this care in the Netherlands.
Intended users of the guideline
The guideline is primarily intended for all healthcare professionals who are involved in caring for a child with CLA/Ps: general practitioners, midwives, gynaecologists, paediatricians, ENT physicians, plastic surgeons, maxillofacial surgeons, orthodontists, clinical geneticists, specialised nurses, speech therapists, (paediatric) dentists, medical psychologists, remedial educationalists and social workers. The secondary target group involves patients, parents and their surroundings.
Samenstelling werkgroep
A multidisciplinary working group was appointed by the Dutch Society for Plastic and Reconstructive Surgery in October 2019 to update the existing guidelines for clefts of the lip and palate. The original guidelines were initiated by the Dutch Society for Plastic and Reconstructive Surgery and this Society remains responsible for the revisions. The working group subsequently updated both the guideline for prenatal counsellling for clefts of the lip, alveolus, and/or palate (Counseling na prenataal vastgestelde schisis, 2011) and postnatal treatment (Behandeling van patiënten met een schisis, 2018). The working group consisted of representatives from all relevant specialties involved in the care for patients with cleft lip, alveolus and/or palate. Members were mandated by their professional organizations. The working group consisted of a mix of new members and members, who worked on previous editions as well. The group worked on the update of the guideline for two years. The working group is responsible for the full text of this guideline.
Working group
- Dr. A.B. Mink van der Molen, MD, plastic surgeon, Universitair Medisch Centrum Utrecht, (chairman), NVPC
- Dr. M.F. van Dooren, clinical geneticist, Erasmus MC Rotterdam, VKGN
- Dr. M.J.H. van den Boogaard, clinical geneticist, Universitair Medisch Centrum Utrecht, VKGN
- Dr. L.N.A. van Adrichem, MD, plastic surgeon, Universitair Medisch Centrum Utrecht, NVPC
- Dr. H.F.N. Swanenburg de Veye, psychologist, Universitair Medisch Centrum Utrecht/Wilhelmina Kinderziekenhuis, Utrecht, NIP
- Dr. C.J. Bax, MD, gynaecologist, Amsterdam UMC, NVOG
- Prof. dr. C.C. Breugem, MD, plastic surgeon, Amsterdam Medical Center and Meander Medical Center, NVSCA
- Drs. F. Bierenbroodspot, MD, Oral and maxillofacial surgeon, Isala, Zwolle, NVMKA
- Drs. M. Haasnoot, MD, paediatrician, Wilhelmina Kinderziekenhuis, Utrecht, NVK
- Drs. H.H.W. de Gier, MD, otolaryngologist, Erasmus MC Rotterdam, NVKNO
- Dr. M.A.R Kuijpers, orthodontist, Radboud University Medical Center, NVvO
- Dr. M.E.L. Nienhuijs, MD, Oral and maxillofacial surgeon, Radboud University Medical Center, NVSCA
- Dr. D. de Haan, patient representative, Schisis Nederland
Advisory board
- Drs. B. Spaan, dentist, CBT Vogellanden Zwolle, NVvK
- I. Noureldin - Hop, orthopedagogue, NSDSK, NVO
- M. J. Coerts, speech therapist, Amsterdam UMC, NVLF
With methodological support of
- Drs. A.A. Lamberts, senior advisor, Knowledge Institute Federation of Medical Specialists
- Dr. M. den Ouden - Vierwind, advisor, Knowledge Institute Federation of Medical Specialists
Belangenverklaringen
According to the KNMG-code, all members of the working group have declared in writing if, in the last five years, they have held a financially supported position with commercial businesses, organisations or institutions that may have a connection with the subject of the guidelines. Enquiries have also been made into personal financial interests, interests pertaining to personal relationships, interests pertaining to reputation management, interests pertaining to externally financed research, and interests pertaining to valorisation of knowledge. These Declarations of Interest can be requested from the secretariat of the Knowledge Institute of Medical Specialists. See below for an overview.
|
Member |
Profession |
Side jobs |
Declared conflicting interests |
Actions |
|
Dr. A.B. Mink van der Molen |
plastic surgeon, |
None |
None |
No actions |
|
Dr. M.F. van Dooren |
clinical geneticist |
Co-chair VKGN |
None |
No actions |
|
Dr. M.J.H. van den Boogaard |
clinical geneticist |
None |
None |
No actions |
|
Dr. L.N.A. van Adrichem |
plastic surgeon |
DGA van Adrichem Medical B.V. Chairman Concilium plastico chirurgicum Member Raad Opleiding Member BBC NVPC Advisor Hoofdmaatje Chairman Medical Council Equipe Zorgbedrijven Member Medicatie Commissie Equipe Zorgbedrijven Member stuurgroep STW project TU-Twente |
None |
No actions |
|
Dr. H.F.N. Swanenburg de Veye |
psychologist |
None |
None |
No actions |
|
Dr. C.J. Bax |
gynaecologist |
Volunteer hospice Member NIPT consortium Member committee quality documents NVOG Secretary committee Otterlo NVOG Treasurer working group infectious diseases NVOG |
None |
No actions |
|
Dr. C.C. Breugem |
plastic surgeon |
None |
None |
No actions |
|
Drs. F. Bierenbroodspot |
Oral and maxillofacial surgeon |
Working Group Esthetische Aangezichtschirurgie |
None |
No actions |
|
Drs. M. Haasnoot |
paediatrician |
None |
None |
No actions |
|
Dr. J. de Gier |
otolaryngologist |
Board member NVSCA |
None |
No actions |
|
Dr. M. Kuijpers |
orthodontist |
Guideline committee Mondzorg voor jeugdigen preventie diagnostiek behandeling |
None |
No actions |
|
Dr. M. Nienhuijs |
Oral and maxillofacial surgeon |
Boardmember NVSCA |
None |
No actions |
|
Dr. D. de Haan |
patient representative, |
Teacher/ education advisor HU-PABO, Hogeschool Utrecht |
None |
No actions |
Inbreng patiëntenperspectief
Patients were represented by Schisis Nederland. Schisis Nederland is an independent organization representing patients with CLA/Psand their parents in the Netherlands. Representatives from Schisis Nederland participated in the working group. The concept guideline module was presented to Schisis Nederland for their comments.
Qualitative estimation of possible financial impact under the Wkkgz / Kwalitatieve raming van mogelijke financiële gevolgen in het kader van de Wkkgz
In accordance with the Wet kwaliteit, klachten en geschillen zorg (Wkkgz), a qualitative estimation has been made whether the recommendations in the guideline may lead to substantial financial consequences. In carrying out this assessment, guideline modules were tested in various domains (see the flow chart).
The qualitative estimate shows that there is probably no substantial financial impact, see table below.
|
Module |
Results qualitative estimation |
Elucidation |
|
Module postoperatieve voeding bij patiënten met een schisis |
Likely no substantial financial impact |
The recommendation(s) are not widely applicable (<5,000 patients) and are therefore expected to have no substantial financial consequences for public expenditure. |
Methode ontwikkeling
Evidence based
Implementatie
Guideline implementation and practical applicability of the recommendations was taken into consideration during various stages of guideline development. Factors that may promote or hinder implementation of the guideline in daily practice were given specific attention. The guideline is distributed digitally among all relevant professional groups. The guideline can also be downloaded from the Dutch Society for Plastic and Reconstructive Surgery website: www.nvpc.nl, and the guideline website: www.richtlijnendatabase.nl. The implementation table can be found in the related products.
Werkwijze
AGREE
The guideline has been drafted in accordance with the requirements outlined in the ‘Guidelines 2.0’ report of the Guideline Advisory Committee of the Council on Science, Education and Quality (WOK). This report is based on the AGREE II instrument (Appraisal of Guidelines for Research & Evaluation II) (Brouwers, 2010), an instrument designed to assess the quality of guidelines with broad international support (Brouwers, 2010). The development of a evidence-based guideline module is described step-by-step in “Ontwikkeling van Medisch Specialistische Richtlijnen” of Knowledge Institute for Medical Specialists.
Inventory of the problem areas
During the preparation phase the working group used an inventory to find the problem areas. A report of this inventory can be found in the related products.
Primary questions and outcome measures
Based on the outcomes of the bottleneck analysis, the president and advisor formulated draft primary questions. These were discussed and defined together with the working group. Subsequently, the working groupdetermined which outcome measures were relevant for the patient for each primary question, examining both desired and undesirable effects. The working groupvaluated these outcomes based on their relative importance as crucial, important and unimportant.
Literature search and selection strategy
Specific search terms were used to identify published scientific studies related to each individual primary question in electronic databases like Medline, Cochrane, and Embase. Additionally, the references of the selected articles were screened for additional relevant studies. Studies offering the highest level of evidence were sought out first. Members of the working group selected articles identified by the search based on predetermined criteria. Theselected articles were used to answer the primary question. The searched databases, the search string or terms used during the search and selection criteria applied are listed in the module for each individual primary question.
Quality assessment of individual studies
Individual studies were assessed systematically based on predefined methodological quality criteria in order to assess the risk of biased study results. These assessments may be found in the column ‘Study quality assessment’ in an evidence table.
- AMSTAR - for systematic reviews.
- Cochrane - for randomized controlled trials.
- ACROBAT-NRS - for observational studies.
- QUADAS II - for diagnostic studies.
Summary of the literature
The relevant study results from all selected articles were presented clearly in evidence tables. The key findings from the literature are described in the literature summary. If studies were sufficiently similar in design, data were also summarized quantitatively (meta-analysis) using Review Manager 5.
Assessment of the level of scientific evidence
With regard to intervention questions, the level of scientific evidence was determined using the GRADE method. GRADE is short for ‘Grading Recommendations Assessment, Development and Evaluation’ (see http://www.gradeworkinggroup.org/)
GRADE distinguishes four grades of quality of evidence, i.e. high, moderate, low and very low. These grades indicate the degree of confidence in the conclusions in the literature ((Schünemann, 2013; Hultcrantz, 2017).
|
GRADE |
Definition |
|
High |
|
|
Moderate |
|
|
Low |
|
|
Very low |
|
According to the GRADE methodology the clinical decision threshold should play an important role in assessing the level of evidence (grading) in guidelines (Hultcrantz, 2017). To set the threshold all critical outcomes, and the considerations should be determined. The clinical decision threshold is not exactly the same as the Minimal Clinically Important Difference (MCID). In situations in which an intervention has no important disadvantages and low costs, the clinical decision threshold with regard to the efficiency of an intervention can be lower (closer to zero/ no effect) than MCID (Hultcrantz, 2017).
Formulation of conclusions
For interventions, the conclusion does not refer to one or more articles, but is drawn based on the body of evidence. The working group looked at the net benefits of each intervention. This was done by determining the balance between favourable and unfavourable effects for the patient.
With regard to questions about the value of diagnostic tests, harm or adverse effects, aetiology and prognosis, the scientific evidence is summarized in one or more conclusions, listing the level of evidence for the most relevant data.
Considerations
When making recommendations, scientific evidence was considered together with other key aspects, such as expertise of the group members, patient preferences, costs, availability of facilities and/or organizational aspects. Insofar as they are not part of the systematic literature review, these aspects are listed under ‘Considerations’. The considerations are written using a structured format based on the evidence-to-decision framework of the international GRADE Working Group, and part of the GRADE methodology (Alonso-Coello, 2016a; Alonso-Coello 2016b).
Formulation of recommendations
Recommendations provide an answer to the primary question and are based on the best scientific evidence available and the most important considerations. The level of scientific evidence and the importance given to considerations by the working group jointly determine the strength of the recommendation. In accordance with the GRADE method, a low level of evidence for conclusions in the systematic literature review does not rule out a strong recommendation, while a high level of evidence may be accompanied by weak recommendations (Agoritsas, 2017; Neumann, 2016). The strength of the recommendation is always determined by weighing all relevant arguments.
Preconditions (Organisation of care)
In the analysis of problem areas, the organisation of care (all those aspects that are preconditions for the provision of care) were explicitly taken into account. These aspects include coordination, communication, materials, financial means, work force and infrastructure. Preconditions that are relevant to the answering of a specific clinical question are part of the considerations related to that specific question.
Knowledge gaps
During the development of this guideline, systematic searches were conducted for research contributing to answering the primary questions. For each primary question, the working group determined whether (additional) scientific research is desirable.
Commentary and authorization phase
The draft guideline was submitted to the (scientific) organizations involved for comment. The guideline was also submitted to the following organizations for comment: Dutch College of General Practitioners (NHG), Healthcare Insurers Netherlands (ZN), The Dutch Healthcare Authority (NZA), the National Health Care Institute (ZINL), the Health Care Inspectorate (IGJ), Dutch Organisation of Hospitals (NVZ), Dutch Federation of Academic Hospitals (NFU), Dutch Organisation of Independent Clinics (ZKN), the Netherlands Patients Federation, Dutch Organisation of nurses and caregivers (V&VN), Dutch Association of Physician Assistants, and Collaborating Top Clinical Training Hospitals (STZ). Comments were collected and discussed with the working group. The draft guideline was updated and finalized by the working group based on the comments. The final guideline was submitted for authorization to the (scientific) organizations involved and authorized or approved by them.
Literature
Agoritsas T, Merglen A, Heen AF, Kristiansen A, Neumann I, Brito JP, Brignardello-Petersen R, Alexander PE, Rind DM, Vandvik PO, Guyatt GH. UpToDate adherence to GRADE criteria for strong recommendations: an analytical survey. BMJ Open. 2017 Nov 16;7(11):e018593. doi: 10.1136/bmjopen-2017-018593. PubMed PMID: 29150475; PubMed Central PMCID: PMC5701989.
Alonso-Coello P, Schünemann HJ, Moberg J, Brignardello-Petersen R, Akl EA, Davoli M, Treweek S, Mustafa RA, Rada G, Rosenbaum S, Morelli A, Guyatt GH, Oxman AD; GRADE Working Group. GRADE Evidence to Decision (EtD) frameworks: a systematic and transparent approach to making well informed healthcare choices. 1: Introduction. BMJ. 2016 Jun 28;353:i2016. doi: 10.1136/bmj.i2016. PubMed PMID: 27353417.
Alonso-Coello P, Oxman AD, Moberg J, Brignardello-Petersen R, Akl EA, Davoli M, Treweek S, Mustafa RA, Vandvik PO, Meerpohl J, Guyatt GH, Schünemann HJ; GRADE Working Group. GRADE Evidence to Decision (EtD) frameworks: a systematic and transparent approach to making well informed healthcare choices. 2: Clinical practice guidelines. BMJ. 2016 Jun 30;353:i2089. doi: 10.1136/bmj.i2089. PubMed PMID: 27365494.
Brouwers MC, Kho ME, Browman GP, et al. AGREE Next Steps Consortium. AGREE II: advancing guideline development, reporting and evaluation in health care. CMAJ. 2010;182(18):E839-42. doi: 10.1503/cmaj.090449. Epub 2010 Jul 5. Review. PubMed PMID: 20603348.
Hultcrantz M, Rind D, Akl EA, et al. The GRADE Working Group clarifies the construct of certainty of evidence. J Clin Epidemiol. 2017 Jul;87:4-13. doi: 10.1016/j.jclinepi.2017.05.006. Epub 2017 May 18. PubMed PMID: 28529184.
Medisch Specialistische Richtlijnen 2.0 (2012). Adviescommissie Richtlijnen van de Raad Kwalitieit. http://richtlijnendatabase.nl/over_deze_site/over_richtlijnontwikkeling.html.
Schünemann H, Brożek J, Guyatt G, et al. GRADE handbook for grading quality of evidence and strength of recommendations. Updated October 2013. The GRADE Working Group, 2013. Available from http://gdt.guidelinedevelopment.org/central_prod/_design/client/handbook/handbook.html.
Schünemann HJ, Oxman AD, Brozek J, et al. Grading quality of evidence and strength of recommendations for diagnostic tests and strategies. BMJ. 2008;336(7653):1106-10. doi: 10.1136/bmj.39500.677199.AE. Erratum in: BMJ. 2008;336(7654). doi: 10.1136/bmj.a139. PubMed PMID: 18483053.
Wessels M, Hielkema L, van der Weijden T. How to identify existing literature on patients' knowledge, views, and values: the development of a validated search filter. J Med Libr Assoc. 2016 Oct;104(4):320-324. PubMed PMID: 27822157; PubMed Central PMCID: PMC5079497.
Zoekverantwoording
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