Various Surgical and Non-Surgical Interventions - Research Paper Example

? Ethical issues in treating OSA with exercise independently Introduction: Sleep Apnea (OSA) is one of the most commonly diagnosed sleep disorders (Kline et al., 2011). It is a disease that exposes individuals to immense psychological, mental and physical disorders (Reichmuth et al., 2005; Beebe et al., 2003; Peppard et al., 2000; Ueno LM et al., 2009). OSA is estimated that 12 million people in USA, which is equivalent to 15% of the population, lives with OSA (Institute of Medicine, 2006). The prevalence of OSA increases 2-3 times by age, 6 times by only 10% increasing in weight, and 5 times by sedentary lifestyle (Theorell-Haglow et al., 2005; Resnick et al., 2006; Mannarino et al ., 2012). The increasing in OSA prevalence had motivated researchers to create over 400 studies regarding this disorder in a time frame of five or more years (Vanhecke, 2008). There are various surgical and/or non-surgical interventions which the disorder of OSA can be treated (Kline et al., 2011; Lam et al., 2007). CPAP is the most common non-surgical effective used to treat OSA (Kline et al., 2011). CPAP is considered quite inexpensive in comparison to surgical intervention. However, the problem with CPAP is a poor compliance with CPAP (Kline et al., 2011). Therefore, considering another line for treating OSA may be benefit. Exercise revealed a significant reduction in OSA severity when used as an adjuvant therapy (Netzer et al., 1997; Norman et al., 2000; Giebelhaus et al., 2000; Ackel-D’ Elia et al., 2011). In contrary, exercise alone reported to be less effective in treating OSA comparing with oral appliance as well as one day without use of CPAP and oral compliance reported in worsening the OSA severity (Ferguson et al., 2006; Caples et al., 2010; Kribbs et al., 1993). Despite these evidences recently, few researchers utilized exercise independently to treat OSA in a randomize control trial (Kline et al., 2012; Kline et al., 2011; Sengul el at., 2011). Therefore, maintaining autonomy in obtaining participants’ inform consent and justice in providing a fairly and equal treatment as well as protect both the rights and welfare of participants by engaging them in this study are considered ethical dilemma that researchers are facing in conducting that study. Furthermore, the most important considerations in looking at the ethics of a research study are the magnitude of the potential harm, the significance of the knowledge to be learned, the likelihood that the research will produce such knowledge, and the methods chosen to minimize the potential harm to the subjects. This paper critically discusses and analyzes the ethical considerations for subject’s involvement in research that utilized exercise independently in treating OSA, focusing on autonomy, justice, beneficence, and non-maleficence. Cure of OSA: The effects of ‘Obstructive Sleep Apnea have been evaluated to be harmful today more than ever before”. Patient realizes in severe cases that their controls over his/her sleep or rest condition is growing enfeebled with time. For psychologists it is a major cause of contorted dream pattern and has adverse effects on patient’s personality. Many people are not aware of this disease unless mention and repeated complaint with the partner is made. In severe cases the patient himself feels too much perturbed with the disturbance that cause choking of the breathing. Obstructive Sleep Apnea is akin to the hamsters where calm conditions for rest are not achieved. Obstructive Sleep Apnea is often caused due to the relaxation of the throat’s soft tissue to such a level that it collapses causing airway blockage. The slack which in this type of unconscious can be harmful has been observed with a varying degree of treatments (MacDonald). Accentuating Exercise for the Treatment of OSA: Interestingly, Obstructive Sleep Apnea is linked with snoring because of having same causes as far as physiological construct and disposition is concerned. Many studies have been conducted with proven results. In order to cure Obstructive Sleep Apnea a number of techniques are employed separately, yet eclectic approach is often used for the cure of the disease. About 70 percent of the people with Obstructive Sleep Apnea are found out to be obese and they are recommended and encouraged for multiple physical and throat exercises that help them overcoming the problem. In addition to the weight loss through general exercise and diet control special medication is also used for targeting obesity. In addition to this Nasal Decongestant are also used for the treatment of Obstructive Sleep Apnea. In few cases surgery is helpful and conclusively it improves the air flow through the nose. Position therapy is also employed in most of the cases. In fact this is used as first step that can help not getting expensive treatments in the line. The sleeping posture is important element in most of the cases. Thus learning to sleep through this traditional type of therapy is helpful. This type of therapy is used in low to mild type of Obstructive Sleep Apnea. Where as in severe cases this therapy is left and case of surgery is used for adults. Although adults and children both can be subject to treatment yet common practice and statistical record has suggested that such cure is generally pervasive in adults. Other to these types of treatments is the use of oral appliances. These appliances are like mouth “guards worn for the treatment and obliterating Obstructive Sleep Apnea” and snoring with their use. They work as they help in the positioning the lower jaw slightly forward than the usual position during the sleep (ASAA). “Exercises have proven to have far reaching effects” with varying degree of effects. Research conducted in Brazil and UK to evaluate the effects and impacts of these exercises have eulogized the use of this treatment. They are used with the basic idea of strengthening the muscles and thus removing the slack that causes obstruction type of Sleep Apnea. These exercises include pressing of tongue flat against the floor of mouth and brushing top and sides etc. With the development of physiotherapy and therapeutically medication for such diseases, they are with some ethical issues during the course of treatment. The paper aims at these ethical issues that confront the use of exercise for the treatment of Obstructive Sleep Apnea (Helpguide.org). Preface to ethics for the use of exercise for the treatment of OSA: “Ethics in treatment procedures can be stated as intentional measures” and programs that are used by an organization, team, or physician to prevent any unethical behaviour and to promote best accepted practices, mechanisms structure or pronouncements intended to foster, guide and regulate behaviour (Boone, 2011). Ethics at any moot are explicitly pronounced to be mandatory for practice in letter and spirit. This not only fulfils the requirements that are requisite of any procedure, but also helps in regulating the ethical behaviour. In terms of medical sciences, professionalism and professional development that is unique to this profession is exercised for better performance and reliability of schedules that are followed in medical science. In the case of exercise that are prescribed for treatment, the ethical issues and their due implementation is a newer field that encompasses moral, beneficent and standardized procedures. They are required to minimize harms and risk factor at first place and making the whole process up-board and candid for society on the whole. Code of Ethics for Exercise Physiologists/ Nursing Staff: For the treatment through exercise first the defined code of conduct that has been prescribed in many organizations and intervention centres should be studied. Secondly, the modification of this code of conduct specifically for the treatment of OSA through exercise will be done in this research paper. The code that provides with the guidance for decisions those are to be taken for the conduct of exercises should cover following basic requirements. To adhere to the conduct shall be mandatory so that ethical practices may not be violated in any case. The code should regulate the intervention process and be critically evaluated before the practice. Following measures shall provide for the basic requirements that are generally expected for interventions based on exercises. Communicating about the objectives and clear delivery of assurance should be made as accurate as possible. The risks, harms or any change in future behavioural and thought or cognitive patterns regarding any domain should be conveyed in order to make the procedure clear to the patient or its custodians. Accountability and responsiveness along with the responsibility should be taken for the outcome in case except prognosis or any deterioration occurs. There can be lawful protection in case for unseen scenarios yet the process should be experimental or apprehending to the subject, without prior notification and acceptance by both the parties. Maintaining high quality ambiance and professionalism with utmost competence throughout the course of study of the case and its treatment should be made. This not only curtails problems and unforeseen issues during the techniques employed. Further it helps in prevention and rehabilitation of the patient or subject who is subjected to the exercise. The prior aspects to the intervention should be well plied upon or simulated in order to observe the recognized legal, scientific, and professional standard related. Another thing that is very important in the intervention and even before it is the problems related to privacy, rights, respect and dignity of the subjects by not disclosing them. Further the health and fitness, rehabilitation, and other such research information shall not be made open source unless lawful protection and consensus or any allowance by the subject is achieved. It can sprout problem and severe unethical issues that can be challenged in any court of law. “Integrity of the profession as related to the patient nurse or physician transference or interference should be preserved”. This is regulatory aspect that helps in abiding by clear lines for the sake of utmost professionalism and good ethical conduct. General information related to such exercises should be made public and concealment in an unethical and ex-normative ways should be contained. It provides public and specialized professional critics to evaluate and propose their perspectives and research. This is also an ethical issue where the said interventions are kept closed for any criticism (ASEP.org). Basic Principles of Medical Ethics: For a medical practice to be considered as ethical it should include all four principle of bioethics they are “AUTONOMY, JUSTICE, BENEFICENCE and NON-MALEFICENCE”. The use of reproductive technology and physical therapy mainly in psychological and physiological treatment has started of this debate extensively. The principle of autonomy mandated a patient to have independence of thoughts, intentions and his decision making ability for the procedures that may be carried out for this treatment. The decision making by the patient cannot be forced and full acknowledgement by the patient is mandatory for the procedure to start off. (Stanford.org) The aspect of justice is the experimental methods and distribution of case study burdens in the case of OSA patients should be distributed equally amongst the group rather concentrating them on a single subject. Further the outcome of the case study or trial shall be equally available for the other patients in case it proves to be beneficent with minimum risk. In the aspect of Beneficence, the procedure is required to provide with the intent of doing good to the patient with no maleficent intent. For a patient to be in the now is the Good Clinical Practice (GCP) as per the recommendation of international committees on Health. The health care providers in the domain of developing exercises for OSA are deemed to maintain skills and knowledge and continually update trainings. The non-maleficence aspect the procedural harms or any threat is cautioned and determinedly stopped from occurring. The assistive programs are also scrutinized so that any harmful aspect of the procedure shall not be let happen. Ethics applicable to treatment of OSA through Exercise: Answer to Why? General rules of conduct revolve around program (intervention) effectiveness, professional conduct for treatment, standing of the intervention, moral credibility, acknowledgement and other professional and legal issues. To do justice with the profession and the stream of action taken for the treatment of the subject, is actually regulated by the law. Doctors and Medical staff are subject to the supervision of subject’s trial and medico-legal oversight. If “handling of a case results in harm, the intervener is subject to be taken to task for malpractice or negligence”, or something criminal negligence. A consistent and enduring ethical behavior can lead to a more effective program which is actual objective of the treatment (Rabinowitz). Considering the code, moral credibility, leads to all inclusive insight used during the treatment. Standing in the community and reliability as acknowledged and that reposes confidence by the similar patients suffering from obstructive sleep disorders. In a research work named, “Ethical Issues in the Conduct of Clinical Trials in Obstructive Sleep Apnea” Devin L. Brown and his workgroup have given a case study for the use of Continuous Positive Airway Pressure (CPAP) emphasized on vital medical aspects. The end points chosen for the case study are myocardial infarction, cardiac arrhythmias, Attacks, humanity, fist, and cognitive purposes (Brown, et al., 2011). In the US, federal rules have been defined for the protection of the human subjects. These rules are used be researcher for the conduct of research, studies and interventions. The code of federal regulations requires that the risk that may come to the subject can only be said reasonable if the outcome benefits and the risk are thinned to a minimum level. Further to aid this legislation moot that was arranged in Helsinki was international and first of its king to document and promulgate a declaration. World medical Association has subjected the declaration to several amendments. The use of placebos has also been subjected to come under the law. The tradeoff of risks has only be taken in juxtaposing the benefits and effectiveness of the methodology that is tested those that are currently best prophylactic, diagnostic, and therapeutic methods. Further to the research and benefit and risk analysis the CPAP for OSA, rest treatments are subject to severe criticism and are not allowed in many cases. Clinical Equipoise (Trials Compulsions): For clinical trials to be considers according to the code of conduct or ethical, there are several requirements that are emphasized. The investigator should be qualified, value and validity of the trail, just and non coercive patient, ratio of risk to benefit should be in acceptable limits according to the law, independent review, clued-up approval, respect for potential and enrolled patients and other such merits should be taken into account Other important considerations include perception of the patient or subject that the exercise is uncomfortable. This is because to adverse effects that may include exposure for repugnant techniques or oddity in the procedure. Informed Consent: The patient and doctor’s relationship should be kept different from the investigative or experimental study relationship. In such relationships the patient hesitates and is not able to comply with the advice better. It should be noted that the clinical trial is not a treatment rather research in the intervention exercise that may be effective. The declaration of Helsinki also mentions that the case of a doctor-patient relationship should be research and covert observatory. Further the knowledge and consent for the exercise that may help in minimizing and finally obliterating of the suffrage of the patient should be kept as aim. Poor outcomes are also due to non compliance with the informed consent code of conduct. In clinical trials there are some special considerations that are important for taking up of the trial. They are actually setting up of a resource restricted environment. The procedure for setting up of an ambiance can be same as that used in natural settings or designed setting in psychological case studies. But the procedures are different because of the physiological intervention. The observation of overt rather than covert type and participant observation is used in the methodology. In this phase, interestingly the no treatment or screening of patients takes place as part of their routine clinical care but their participation can be very useful due to open access to the assessment, monitoring and the therapies that are devised in the form of exercise. This procedure and other relevant items are provided in the guidelines by the Council for International Organizations of Medical Sciences (CIOMS), International Conference for Harmonization’s workshop for better medical Practices (GCP). Study Design (General Designing of Trials): In the phase of designing a trail for study, the possible outcomes that may pertain to risks and benefits are considered. In addition to this the time aspect is also noted for the effectiveness of the treatment. To benefit from the exercise intervention, time is always kept into the evaluation phase as important. Generally the exercises are so designed to keep them up for a fairly long period of time. Control groups are also formed to judge the progress and intermittent intervention. The afore mentioned risks as myocardial infarction, cardiac arrhythmias, stroke, mortality, seizures, and cognitive functions are considered so that the case study may be all inclusive of the points to ponder and conclude by the end of a case study. The subject is kept in the know even after the trial so that ethical value of the final treatment can be ascertained. Few other types of controls are medical therapy or eclectic approaches including “placebo” to treat OSA. They may include placebo controls and CPAP and other such appliances. Use of other low and less effective interventions minimizes the risk factor that is mandatory to the case study as per the ethical and lawful bindings for the treatment (Laredo, Ancoli-Israel & Dimsdale, 2006). The trials are based on duration and the level of severity and thus may not include as many controls as have been described. A physiological base to the hypothesis is that the case study is also dependent upon the severity of OSA. Thus it can be said that greater the severity, more will be the risk. It has been seen that certain failures in intervening of specific exercise may cause risk of stroke and death chances increase on account that OSA is severe and not immediately helped with treatment. To check the level of severity Apnea Hyperpnoea Index AHI is used to design the case study. Conclusion on Ethics for the treatment of OSA through exercise: (Considering the Risk and Benefit Tight Rope) It is well known that “ethical principles are often interconnected”. The beneficence may have to both be considered when making a decision that is to consider both risk and benefit aspects of the treatment. Exercise treatments, particularly in OSA involves some degree of risk. The risk can be seen when the person is not de-conditioned before the initiation of the exercise. This factor increases the risk. A Certified Exercise Physiologist CEP and the nursing staff must see both the benefits and risks of the exercise n an individual. They should be discussed with the subject and his consent must be taken before administering the procedure. If the client chooses not to take the advice additional discussions must be done. Such additional discussion would earn other ethical obligations like compassion and respect (Birnbaum, 2005). Bibliography MacDonald, M. (n.d.). OBSTRUCTIVE SLEEP APNEA EXERCISES: Orofacial Exercises to Cure OSA. Retrieved from http://www.howtocuresleepapnea.net/wp-content/uploads/2013/03/Free-report-Orofacial-Exercises-to-Cure-Sleep-Apnea.pdf ASAA (n.d.). American Sleep Apnea Association | Treatment Options. Retrieved from http://www.sleepapnea.org/diagnosis-and-treatment/treatment-options.html Helpguide.org (n.d.). Sleep Apnea: Symptoms, Treatments, Causes, and Cures. Retrieved from http://www.helpguide.org/life/sleep_apnea.htm Boone, T. (2011). Journal of Professional Exercise Physiology. The Rightness and Wrongness of Sports Supplement Pushers, 9(7). Retrieved from http://www.asep.org/asep/asep/Rightness_Wrongness_Sports_Supplement_Pushers.pdf ASEP.org (n.d.). Standards of Professional Practice | American Society of Exercise Physiologists. Retrieved from http://www.asep.org/services/standards Stanford.org (n.d.). Medical Ethics 101: What are the Basic Principles of Medical Ethics?. Retrieved from http://www.stanford.edu/class/siw198q/websites/reprotech/New%20Ways%20of%20Making%20Babies/EthicVoc.htm Rabinowitz, P. (n.d.). Chapter 19. Choosing and Adapting Community Interventions|Section 5. Ethical Issues in Community Interventions. In The Community Tool Box. Brown, D. L., Anderson, C. S., Chervin, R. D., Kushida, C. A., Lewin, D. S., Malow, B. A., Redline, S., & Goldman, E. B. (2011). Ethical Issues in the Conduct of Clinical Trials in Obstructive Sleep Apnea. Retrieved from American Academy of Sleep Medicine website: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3041615/ Loredo, J. S., Ancoli-Israel, S., & Dimsdale, J. E. (2006, January 5). Effect of Continuous Positive Airway Pressure vs Placebo Continuous Positive Airway Pressure on Sleep Quality in Obstructive Sleep Apnea*. Retrieved from http://www.cebp.nl/vault_public/filesystem/?ID=1888 Birnbaum, L. (2005). Medical Ethics in Exercise Physiology. Journal of Professional Exercise Physiology, 3(10). Retrieved from http://www.exercisephysiologists.com/MedicalEthics/index.html3 Read More