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Critique and FEEDBACK NEEDED only to help me identify what I need to improve in my research paper

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Critique and FEEDBACK NEEDED only to help me identify what I need to improve in my research paper. I conducted and wrote the research below. I need an expert in statistics to help provide detailed feedback on my research paper. I need to know from an statistical/epidemiological standpoint if I'm missing and key points, data, information, etc. any and all comments and feedback to help improve the paper below is appreciated. Research Problem and Purpose ? Humans can heal themselves. At a healthy early age, we seem almost impervious to scrapes and bruises. Even common cuts and burns take only days to fully heal. As we get older, the ability to self-heal becomes weaker and we rely on clinical intervention. The standard of care for a wound is to make sure it is clean and dressed. The dressing should be changed often, and topical antibiotics can be used to prevent infection. A wound becomes chronic and non-healing if the standard of care does not work. Chronic non-healing wounds have been called a "Silent epidemic" (Lindholm, 2016). A research problem we will investigate is the effectiveness of wound care. "Prevalence surveys in the UK and Denmark indicate that there are about three to four people with one or more wounds per 1000 population" (Lindholm, 2016). Wounds affect a sizable portion of the population because they occur frequently from surgical intervention, pressure, or underlying diseases such as vascular disease or diabetes. It is estimated that "around 15% of wounds remain unresolved 1 year after presentation" (Lindholm, 2016). A substantial portion of wounds remain for an extended period which in turn costs the affected person both financially and physically. "There are estimated to be around 1.5-2 million people living with a chronic wound across Europe. In the USA, chronic wounds affect around 6.5 million people at any one time" (Lindholm, 2016). The research purpose is to find an effective care for chronic non-healing wounds. Effective chronic wound care must meet requirements. The treatment must be efficient. The chronic wound should heal in a timely manner and require minimal dressings to show that the treatment is cost effective. "The cost of treating pressure ulcers alone in the USA is estimated to be $11 billion/year" (Sen, 2009) and "in Europe, the cost of managing DFUs is estimated to be €4-6 billion/year (Posnett, 2009). Each reapplication of a treatment or changing of a dressing raises the cost of wound care. Literature Review Research on wound healing. The healing process of a wound has four stages haemostatis, inflammation, proliferation, and remodeling (Zhao, 2016). Haemostatis is the initial blood clot formation around a wound while inflammation is the breakdown of dead tissue and foreign microorganisms by our immune system. Our body then goes into the proliferation stage where we make new tissue. The new tissue is then remodeled, and the wound is healed. Inflammatory response can be variable due to the severity of the wound. Excessive inflammation is the biomarker for chronic non-healing wounds (Zhao, 2016). In chronic wounds our own immune system can block healing by prolonged inflammation. Lowering the inflammatory response could result in better wound healing. Chronic wounds most commonly affect the elderly. The older population has a higher prevalence of vascular disease leading to ischemia, poor circulation and neuropathy, loss of neural innervation (Zhao, 2016). Research on chronic wounds. Chronic wounds fall into 3 main categories venous ulcers, pressure ulcers, diabetic ulcers. Venous ulcers come from complications in circulation. Pressure ulcers come from immobility. Continuous pressure on an area leads to tissue becoming ischemic and neurotic. When left untreated the area becomes an ulcer. Diabetes mellitus is one of the leading causes of death, with over 382 million people living with the disease worldwide (Zhao, 2016). Diabetic ulcers are a common and severe problem for the population. Diabetics have weakened muscle and tissue from neuropathy of their extremities along with ischemia. Since diabetics are unable to absorb glucose there is significant oxidative stress on the body's circulatory system. The damage to vessels leads to ischemia of areas of the body. Currently 30% of treated diabetic foot ulcers result in chronic wounds (Lullove, 2021). The chronic wounds are at risk of infection that could lead to amputation if spread throughout the extremity. Patients that have undergone an amputation are more at risk of death in the next 4-5 years. Minor amputations have a 45% 4-year mortality rate and a major amputation have a 65% 4-year mortality rate (Lullove). Diabetic foot ulcers are associated with death and currently the standard of care (SOC) is inadequate to heal them in a timely manner. The percentage of wounds healed with SOC therapy is 24.2% by 12 weeks and 30.9% after 20 weeks (Lindholm, 2016). Research on treatment. A treatment that is becoming common in chronic wound care is skin grafts. Skin grafts can come from human placental tissue, allograft, or from a different species, xenograft. Fish skin grafts (FSG) have unique properties that could make them an effective treatment for chronic wounds. FSG are developed from Atlantic cod and require minimal processing. The fish skin graft also has a shelf life of 3 years (Krisner, 2020). The less processing leaves the tissue with increased structural integrity. Fish skin grafts contain poly-unsaturated omega-3 fatty acids. Omega 3 fatty acids have been shown to have anti-inflammatory properties (Lullove, 2021). In comparison with amnion/chorion membrane products, the acellular FSG structure is porous rather than dense. This porous structure facilitates 3D wound cell ingrowth (Lullove, 2021). The porous structure also facilitates the diffusion of omega 3 fatty acids to the affected area. The omega-3 fatty acids contain polyunsaturated fats like elcosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) that reduce the inflammatory response and stimulate wound healing (Lullove, 2021). Placental tissue treatment is on average 76% more expensive than fish skin treatment. The costs were determined from average sales price per square cm. Placental tissue was $160 USD/ per square cm while fish skin was $80 USD/ per square cm (Krisner, 2020). FSG could be an effective treatment for chronic wounds. FSG are more cost effective than other alternative treatments and possess anti-inflammatory properties that speed up the healing process. Research questions Research questions. Can FSG be an effective treatment for chronic wounds? Do fish skin grafts speed up the closure of a chronic wound? FSG more efficient than the current SOC used in wound healing? Variables The study will measure wound closure percentage over 20 weeks to research if there is a correlation between wound healing and fish skin grafts. Participants will be given two treatments, current standard of care acting as a control and fish skin graft application. Independent Variables. Participant demographics (age, sex, race), time (weeks), treatment (standard of care or fish skin graft) Dependent Variables. Average wound closure percentage measured weekly over 20 weeks. Hypotheses Null Hypothesis. There is no significant change in the average wound closure percentage between the SOC and FSG. There is no significant change in the wound healing rate between SOC and FSG. Hypotheses. FSG applicant leads to significant increase in wound closure percentage compared to SOC. Denoted as H1. FSG heals wounds faster than SOC. Denoted as H2. H1 could be accepted showing FSG can be an effective wound healing treatment or rejected demonstrating that FSG are not an effective treatment. Previous studies indicate that SOC treatments heal 70% of wounds in 20 weeks (Lindholm, 2016). There must be a significant increase in the percentage of the participants healed at 20 weeks to accept H1. To accept H2 participants with FSG application must show a greater average wound closure percentage throughout the study compared with the SOC application. Both hypotheses will have a p-value of 0.05 and will be used to test if the difference is an actual difference in the two treatments or due to chance (Tikah, 2022). If the probability of chance decreases the difference is more significant. A p-value less than 0.05 is significant and we will accept our hypotheses. A p-value greater than or equal to 0.05 will show there is no significant difference and the hypotheses will be rejected. Materials and Methods Study Design and Participants. The study will be a quantitative study focusing on how treatment affects average wound closure percentage over 20 weeks. The study will be a randomized controlled, double-blinded, comparative, clinical trial. Recruitment will take place in the surrounding area of Miami over a 2-month period. Volunteers will be excluded if they are suffering from immunodeficiency, vascular disease, and neuropathy to eliminate preexisting conditions as a source of error. Women who are pregnant or breast feeding will also be excluded from the trial. The use of healthy patients will simulate chronic wounds without additional variables. Each participant will receive two 10mm circular wounds on the same arm created with a standard 10mm biopsy tool. Participants act as their own control. One wound will be randomly selected for FSG treatment and the other will be treated with SOC. A team of wound care professionals blinded to the treatment will access the wounds weekly. Measurements at each visit will allow the team to know the visit where full closure occurred. Randomization. All participants will be given a randomized number. The randomization of the number dictates if the FSG will be applied to the medial or lateral wound. If the number is even the FSG will be applied to the medial wound. If odd the FSG will be applied to the lateral wound. The trial physician applying the treatments will have access to the even/odd randomization design. Surgery and Schedule. Local anesthesia is applied to the posterior lateral aspect of the arm superior to the elbow joint. Two 10mm wounds 4 mm apart are applied. Treatment was applied according to the randomization sequence. After application, the wounds were dressed in a damp, antimicrobial, waterproof, transparent plastic film with a central gauze pad. Participants are instructed not to remove the treatment or get the area wet. Over 20 weeks, participants were instructed to come to the clinic once per week to allow physicians to collect data on the status of their wounds. Wounds will be assessed for infection, pain, bleeding, and measured to determine wound closure percentage. A Physican will determine if a wound is healed or not healed. No material will be removed, and no new material will be applied. Photographs of the wounds will be taken weekly and will be used to determine if the wound is healed. Statistical Analysis A table of outcomes (healed vs non healed) and wound closure percentage will be produced for each week of the trial. To estimate if the differences are significant between the two treatments a mixed-effects Cox proportional hazard model will be used (Krisner, 2020). The model will combine a fixed effect for the treatment, a random participant effect to account for a participant to receive both wounds, and a random wound effect to account for variance for different reviewers of the wound (Krisner, 2020). A correlation analysis testing will be performed in R version 3.4.1 (). The confidence interval for the percentage of wounds healed with each treatment will be estimated with the bootstrap method using 2 million simulations (Krisner, 2020). Model parameters are estimated using the "coxme" package in R (Krisner, 2020). A chi-squared test will be used to check for the difference in healing in lateral vs medial wounds. A paired t-test will be used for cost analysis. Comparing the cost averages for the two treatments. Discussion The discussion will be the area where we can discuss the findings of the study. If the data shows that there is a significant increase in wound closure percentage in FSG compared to the SOC, we would accept the hypothesis and reject the null hypothesis. This would show that FSG are effective in healing a wound faster and more efficiently than SOC. If the data shows that there is no significant increase in wound closure percentage in FSG compared to SOC, then we would reject our hypothesis and accept the null hypothesis. If we reject the hypothesis, then the data shows FSG are not a more effective treatment than SOC. If the chi-squared test results in a p-value higher than 0.05 then there was no significant difference in wound healing in a medial or lateral placed wound. If the p-value is lower than 0.05, the wound's placement significantly affected healing. If that is true, we would need to reevaluate and change the study. The paired t-test for cost analysis will compare the cost between the two treatments. If the FSG application is more cost effective the mean cost will be lower than SOC. The test will show if fish skin grafts are a cost-effective treatment. Implications, Limitations, Future Research Implications. If the participant's wounds healed significantly more with the application of a FSG than SOC, then this would show that FSG would be an effective care for wound healing. Vice versa if the wounds did not heal significantly more with the application of a FSG compared to SOC, then FSG would not be an effective care for wound healing. Limitations. The study does not take into account chronic wound care. Patients with chronic wounds may need reapplication of the fish skin graft treatment and have a higher incidence of infection. The research proposal does not reflect how FSG treats chronic wounds. Future Research. If FSG proves to be an effective wound care, additional research is needed to test FSG as a treatment for chronic wound care. If FSG proves to be an effective treatment for chronic wounds that would further validate this study. Conclusion Based on the results of the study we can conclude if FSG is an effective treatment for wounds. FSG could be an effective treatment for wound care if they show significant superiority over the SOC used to treat wounds. FSG could be used in future studies to test their effectiveness as a treatment for chronic wound cases.