Nutritional Supplementation For Prevention Of Pressure Ulcers In Hip-Fracture Patients

Study Design

How the nutritional supplement could suppress the occurrence of pressure ulcers ( PU) in patients who has been suffering from hip- fracture?

It has been seen that PU development is more frequent in the health care centers of Netherlands. The author suggests that malnutrition is the major factor for the development of PU. A study suggests that the indices of the malnutrition and PU are interrelated. Since Netherland is a developing country, so the nutritional status among the people is very inadequate, so the malnutrition occurs at a very high rate thus resulting in the occurrence of pressure ulcers especially among the patients who has suffered the hip fracture. Many studies have been carried out showing that the percentage of PU is much higher in the non- malnourished patients than the malnourished one. So the author plans to conduct randomly, double-blind placebo-controlled experiment to see the effect of PU on the patients. He chose the randomization process of the experiment as to avoid the biases among the patients and to have the desired effect of the supplements.

Randomized, the double-blind placebo-controlled type was the idea of the study which was designed by the author to conduct the experiment. This study is involved in a medical trial treatment where the number of patients is divided in to two groups . One is the experimental or treatment group and the other is the controlled or placebo group. The underlying difference between these two groups is in the giving of supplements. The desired nutritional supplement is given to the experimental group which shows the affect and normal lookalike supplement without any nutrients is given to the controlled group to see the desired results. In this type of study, both the patients as well as the assessors are blind fold which means neither the patients nor the assessors know what supplement is given to them until the end of the study. Out of the total sample population the patients are divided randomly into the experimental and placebo group.

The source of the population was the three medical centers of Netherlands .Further this study was approved by all the participating centers of the Committee of Medical Ethical.

The population study for this research was 103 patients. The patients who had hip fracture were also eligible for this study.

The study was recruited by the Dutch Consensus Meeting where a score was allotted for the risk of PU. If the PU risk score was above eight  according to the risk assessment tool of CBO, then those patients were eligible to be included in the study. At the time of the study, ten points were kept in mind like temperature , medication, intake and status of nutrition, mental and neurological condition, incontinence and diabetes. These points are needed for the recruitment of the patients to include in the study. These are the vital factors which determine the initial characteristics of the patients before the start of any experiment. By In a clinical experiment, the inclusion and exclusion criteria are the vital factors which must be specified for the participation of the patients in the experiment.  Inclusion factors refer to those which must be possessed by the patients to enter in to the experiment. For the present study, the inclusion factors are sex, age, weight, height, hemoglobin, operation duration of stay and the type of surgery performed.

Results

The exclusion factors refer to the which disqualify the patient’s inclusion factors in the study. For this study, the exclusion factors are the metastatic hip fracture, care at terminal level, insulin- dependent diabetes, the renal disease where the creatinine level was more than 176mmol/l, the morbid condition of obesity with a basal metabolic index of more than 40 and liver disease.

These factors also play an important role in determining the outcome of the experiment because based on these factors the p-values are calculated which significance in the experiment.

To prove his point that mal nutrition may be the risk factor for developing PU and also to see the effects of supplements whether they can lead to the suppression of PU in hip fracture patients, Houwing designed his study to give supplements of two different types of both the groups in the experiment. To the treatment or the experimental group, he provided the supplement which was loaded with high proteinaceous nutrients like zinc, arginine, and anti-oxidants. In contrast, to the placebo group, the supplement provided was a normal water- based drink, non- caloric in nature which contained only sweeteners, coloring and flavoring agents. It was in actual not a supplement but a replica of supplement devoid of nutrients, only containing sweetening agents.

Both the supplements’ look, texture, and taste were not similar, but they were given in some identical packages where the difference could not be made. This was done to mask the difference between both groups so to avoid biases among the patients. If the patient comes to know that what supplement are given to them then they might be intentionally or unintentionally influenced which could have an effect on the outcomes of the interpreted data.

Out of 103 patients involved in the experiment, 52 patients were randomized to get placebo treatment and 51 patients were given the normal treatment. After receiving the supplementation, it was seen that 57% patients were diagnosed with PU and 23% patients were diagnosed with stage II PU. If the results of both the groups are taken individually, then it was seen that the occurrence of the pressure ulcers were 59% which was higher than the group which was given the supplement whose number was 55%. When the results of the stage II  PU was taken into consideration then also the placebo group had the higher value than the other. The placebo  group had 28% development of PU where as the group provided with the nutritional supplement had 18% PU development. Though the results dint showed any significant difference in the statistics.

External and Internal Validity

The analysis of the results showed that the supplement which is enriched with nutrients might not cure PU, but it suppresses the progression symptoms of the PU disease in the hip fracture patients. The placebo group was a controlled one where no nutrient based supplement was given, and they showed the higher percentages of PU development.

There are certain factors which are needed for all the experiments to give its validation proof. The two most important tools for the validation of the experiment are the external validity and internal validity. These tools, in general, generalize the effects of the experiment and also to draw inferences on the casual relationships between the variables.

External validity is an integral tool for any experiment.  It is required as the basic tool to design any experiment. There are two main criteria of the external validity- first being the generalization and the other being the results. Generalization refers to the process of the experiment where as the results which are being collected from the grouping of the sample, surroundings of the laboratory gives an idea about how long it can be further extended and also to make predictions about the whole population. Generalizability gives the answer to external validity regarding the questions asked about the setting of the experiment, populations, variables involved, treatments, and the outcome measures. The effect of generalizability is studied by this. Moreover, external validity can be categorized into the validity of the population and the validity of the ecology and both these parameters are involved in evaluating the strength of any experiment. External validity also paves a way for concern whether the same result would be found in other settings or not. In an experiment of science, there are mainly two approaches by which generalization characteristics could be understood. First is the sampling model where that population is identified which needs to generalize; then a fair sample is drawn from the above sample and the research is done, and finally we can generalize the results back to the population because the sample itself is the population representative. The second method is the model of proximal similarity. This is applicable for those situations where different sections in term of their similarities are to be taken like as those of times and places.  By using this model we can generalize the results regarding places, persons or time. 

Internal validity refers to the approximate value which accounts for the validation of the two variables relationship when they are inferred. The inference of this should be the casual one. To have such results, the internal validity is obtained through the control techniques and design features. Experimental designs are the best features of the design, and the assignments of the randomization are the best techniques of control. The casual inferences of the internal validity are important because it helps us to improve further in that experimental world. The internal validity helps to make a conclusion that whether the applied treatment made any difference or not in the experiment as it also helps in the reduction of the score and in the symptoms of the disease. Internal validity also accounts for the generalizability of zero scores. Internal validity in the experiment gives the evidence that the experiment has been carried out, and even the outcomes have also occurred. It does not account whether the experiment which we wanted to construct that has been done or not. An experiment with high validation of internal validity let the researchers choose a definite explanation with much more confidence and it leads to avoidance of many confounding factors.

Fig: image showing the process of internal validity

There are some tools which determine the efficiency of the internal validity by seeing the casual inferences drawn from the experiment. The tools are temporal precedence, elimination process, and covariation.

A temporal precedence is an important tool which determines the strength of the cause of the internal validity and also its effect on the experiment. This tool says that the cause of the experiment has happened before the effect of the experiment comes into play.

Covariation says that both the cause and the effect of the experiment is inter-related for the variables. It says that when the experiment has been done then, some measurable outcome has to be there.

The elimination process of the causality factor is one of the most simple and easiest ways to prove that a particular experiment has a high internal validity. It does so by eliminating the confounding effects of the variables.

1.9:

In an experiment, the study design is an important factor but the main important thing is the results of the experiments. The clinical, as well as the statistical data, are very helpful in determining the efficiency of the experiment conducted. In an experiment, a significance level is selected so that it gives the probability of neglecting any hypothesis which is null but this does not prove that the hypothesis is false. The statistics are significant because it helps to make a prediction that the results which were obtained are not due to by chance. With the rapid progress in the field of science, it has become mandatory that the focus should be given on both the statistical significance and also the magnitude of the experiment. The magnitude of the experiment is important because it helps to predict the scores and also to make the comparison between the scores obtained. So for the proper evaluation of the result and to avoid any underestimation of the errors it always preferable to check magnitude and statistical significance of the experiment .

Yes, the participants were assigned randomly to the group because the experiment itself was a double blind placebo one where the treatment group was given the supplement and the placebo group was given a normal supplement.

Yes, the allocation sequence concealed because the author randomly divided the patients into two group and supplements were The two groups of the experiment conducted – the experimental group and the placebo group were similar at the start of the experiment because they were divided randomly to receive the respective supplements. The two groups were similar in the type of the treatment they received. They may only differ in the significant values of the two groups that are their p-values.

Yes, the participants were blind to their following study group since it was a randomized experiment where the patients dint know to which group they were placed in. They just followed their assessors in the terms of the supplements and the dosages provided by them.

The assessors of the outcomes were not blind to the participant group study because they knew which group of patients was receiving what type of treatment and supplements. The assessors kept a daily record of the dosages given to each and every patient and how they were reacting to it. The nurses kept a daily track for the presence of pressure ulcers in the areas of patient’s buttocks, bones of a tail, heels and other areas of the body. Thus, by seeing the above statement, it can be said that the assessors might not be blind to the participants in the study group.

From the statistical figures, it could be seen that there were very little differences in the P-values of the characteristics of the patients. Though the occurrence of the PU was seen in the patients receiving the placebo treatment the P- values dint showed any marked difference. Thus by keeping the p- values in mind it could be said that the measured outcomes were not reliable as per the expectations of the assessors.

As per the experiment, all the participants were properly accounted for the conclusion of the study but the follow up of the patients was also done properly by keeping all the inclusion and in mind. The follow up as done by keeping the tracks of the dosages of the supplements given to the patients, the analysis of the various body parts to check for the development of pressure ulcers. So it could be said that proper follow up of the patients were done by the assessors in the experiment.

Intention to treat analysis is atype of analysis which includes all patients who have been randomly assigned  irrespective of their criteria of adherence at the entry level. It does take into account the type of treatment involved with the patients and even the withdrawal treatment from the protocol.

In this experiment , intention to treat analysis was used. As this experiment was a randomized one, so the assessors themselves dint knew that which patients has been assigned  to which group.

As per the author, this experiment dint had any many participants to conduct the study. The minimum number of patients required to conduct this type of experiment is 350 but in this experiment, the number of patients was 103. So hence it could be said that this study dint had as much of the required participants.

In the field of epidemiology, experimental event rate is being defined as the measure of how frequent a particular event of statistics such as a response to some medications, death or any adverse situations occurs within the experimental group and this rate is compared to the non-experimental group. The value of the experimental event is an important one because it gives the of the risk to patients or the benefits of therapeutic agent in the treatment groups. It is an important factor because based on this value the other three factors absolute risk reduction, relative risk reduction and number needed to treat depends on.

In the given experiment,

In the experimental group. 55% of the patients developed PU.

>

EVENTS	YES	NO
EXPOSED	56.65	46.35
NON-EXPOSED	46..35	56.65

So the experimental event rate is a/a+b, then according to the table, the value of a= 56.65 and b=46.35 for the exposed group.

So the calculation is 56.65/56.65+46.35

The value is 0.55.

In the placebo group, 59% of the patient developed PU.

EVENTS	YES	NO
EXPOSED	60.77	42.23
NON EXPOSED	42.23	60.77

 So the experimental event rate is a/a+b, then according to the table a=  60.77 and b=42.23 for the exposed group.

Controlled event rate of the experiment is defined as the measure of the outcome for the non-controlled group in the experiment. It is very much identical to the experimental event rate in all terms except that it is used in the calculation for the non-exposed groups in the experiment.

So from the above table it could be seen that in the experimental group, the non-exposed group has the value of c= 46.35 and value of d=56.65.

Therefore, the formula to calculate the control event rate is c/c+d. Then according to the given table, the value is 46.35/46.35+56.65

The value is 0.45

Similarly, for the placebo group, it could be seen that for the non-exposed group the value of c= 42.23 and the value of d=60.77therfore the formula to calculate the control event rate is c/c+d. Then according to the table, the value is 42.23/42.23+60.77

Relative risk is defined as the ratio of comparing the events which have occurred in the experimental group to the events occurred in the non- experimental group. It includes two important criteria: risk comparison between two events of exposure and second being the proper denominators value in related to the exposure.

The formula to calculate the relative risk is EER/CER. That means it is the ratio of the experimental event rate to the controlled event rate.

So from the above calculation, the value of experimental event rate for the experimental group is 0.55 and for the placebo group is 0.59.

On the other hand, the value of the controlled event rate for the experimental group is 0.45 and for the placebo group is 0.41.

Then the relative risk for the experimental group is 0.55/0.45 and the value is 1.22.

Also, the relative risk for the placebo group is 0.59/0.41 and the value turns out to be 1.43.

Rate ratio or risk ratio can be differentiated by the value obtained in the relative ratio. If the relative ratio is more than 1, then it could be said that the concerned event is less likely to occur in the controlled group, and its chance of occurrence is more in the experimental group.

If the relative risk is less than 1, then it could be said that the concerned event is less likely to occur in the experimental group, and its chance of occurrence is more in the placebo group.

So from the above calculations, it could be seen that the relative risk for both the experimental and the placebo group is more tan one, so the experiment could be said as the rate ratio.

Absolute risk difference in the field of epidemiology is defined as the change in the risk of the outcome of the experiment employed in the experiment. It is inversely proportion to the number needed the treat. It also helps in making the comparison between the occurrence of the events in the experimental and controlled reactions.

So the formula for the calculation of the absolute risk reduction is CER-EER.

So from the above values, the absolute risk reduction could be calculated.

For the experimental group, EER is 0.55 and CER are 0.45, then the absolute risk reduction is (0.45-0.55) which is -0.1

For the placebo group, EER is 0.59 and CER are 0.41, then the absolute risk reduction value is (0.41-0.59) which is -0.18

3.6:

NNT or number needed to treat is calculated by the formula 1/AAR.

So for the experimental group, ARR is -0.1, so the number need to treat would be 1/0.1 and the value comes out to be 10.

So for the experimental group, the NNT value is 10.

Similarly, for the placebo group, ARR is 0.18, so the number needed to treat would be 1/0.18 and the value comes out to be 5.

NNT or number needed to treat is defined as the number of patients needed who are needed for the treatment to prevent any disastrous outcome. It helps in giving the idea to the health care centers as how many patients need treatment. It is the inversely proportional to the absolute risk reduction and if the NNT value is one, then it means that with the defined treatment all the patient improves and no one gets the benefit from the controlled treatment.

The main research proposal involved in the study of this hypothesis is the clinical measures which have been taken for the diabetic patients with foot ulcers. The statistical data which have been identified through the hypothesis includes that many people are the sufferers of the disease. The main question arisesthat why irrespective of age, sex, smoking status, the ulcer site and the severity of the patients has increased with a potential increment. The primary and the secondary care of the patients could be provided with extra care awareness, which would help the patients to recover from the respective disease. The hypothesis also measures the causes and the factor that are disease related.

The sampling was conducted on the patients of October 2001 and February 2003, where the adults were diabetic patients of type

The participants were from the authorities ofnational health serviceof South London. The criteria of the ulceration of the patients suffering from diabetesof  type 1 or type 2 are measurement of the ulceration in the anatomical foot, it also includes the measurement of the ulcer on the foot with a thickness and break in the measurement of 5 mm approximately and the severely injured ischaemic feet with an approximate ratio ranging from greater than 0.5 and 1.5. The area includes the baseline of the ulceration site, the first diabetic ulcer sustaining from last one year, and the effect of the chronicity on the adverse outcome. The treatment studies started from the first three months on the cure. The exclusion criteria include 1) not being fluent in English, 2) independent of comorbid medical conditions and 3) severe mental illness for example schizophrenia, and other psychological disorders.

The exposures of the hypothesis include the people of different parts of south London, which includes the macro vascular complications with respect to myocardial infarct, coronary angioplasty. It determines the presence or absence of major and minor depressive disorders by the diagnosis.

Yes, the exposure was determined accurately, with the association of the symptoms, signs, and the treatment strategies.

he hypothesis includes three outcomes respectively. The first was the amputation, which is          the first ulceration which is noticed in the patients. The patient with the amputation was treated for healing. The amputation undergoes the treatment with the assistance of surgical removal on all parts included in the ulceration. The parts involved in the treatment includes the lower limb, and below the anatomical ankle. The foot ulceration may be defined as the thick break through the epithelial surface with a minimum 5 mm width, or different site including the baseline of the ulceration. The recurrence foot ulceration which is mainly considered due diabetes is treated with excess care.  

Yes, the follow up of the patients were significantly complete and long with the help of the following treatment as described in the respective hypothesis. According to the hypothesis, approximately two hundred sixty-two patients showed their first line of ulceration in the respective study period. Along with the participated people as well as the people who refused to participate were in the total study. The follow up rate as about 100 percent, with respect to the mortality outcome, whereas the about 92.0 percent to 90 percent were for the treatment undergoing amputation and the recurrence. This treatment includes the surgical methods to eliminate the ulceration from the body. The amputation people include lowering shortening of the duration of diabetes in the patients. After that, it was seen that there were about six patients who were having no glycosylated hemoglobin measure at that point of time respectively.

The prognosis which has been highlighted through the respective hypothesis is the study which includes the determination of the patients with high risk of diabetes foot ulceration, and treatment with high care. The opinion was main including the application of the amputation and the reoccurrence on specific patients would help the people to survive with or overcome the life-threatening disease. The limitations of the study emphasis the prognosis that the people who have refused to participate in the study must be diagnosed and treated as early stages as possible.

The main conclusion which has been focused through the hypothesis is the determination and outcome of the people suffering from the first line of the diabetic ulcer, which is followed up by 18 months. This disease was independent of the risk factors irrespective of the age sex, and other parameters which are directly responsible for the disease. In another hand, the diabetes control was one of the preliminary aspects to put a check on the life-threatening disease. He patients who were weak are the majority people who were to be hospitalized frequently. The patients who were under poor control over diabetes includes much severely affected with foot ulceration, etc. Of the greater clinical significance the patients with greater risk of the diabetes foot ulceration, includes moderate ischemia or peripheral arterial disease which is also known as PAD. In the other hand the diseases like coronary, carotid artery disease as well as hyperlipidemia, the PAD is also considered to be the most prevalent one amongst all with the addition of diabetes.

Another conclusion which can be done through the hypothesis is the amputation, which has occurred in few studies and results of the respective hypothesis. The recurrent ulceration was not the fact associated with the depression. Therefore, it can be said that the patients already sufferers of the foot ulcerations is not severe, although have a pain sensation which on no treatment can cause a severe effect on the body. There it is concluded that the severity of the ulcer is the only risk, with the addition to other supports such as PAD, amputation, and the recurrence, etc. The study also emphasizes on the fact to improve the scenario of diabetes in a specific participants, and monitoring the people with specific care and identifying the patients with excessive risk.