Tuberculosis is caused by a Mycobacterium Tuberculosis which is a pathogenic bacterial species in the genus mycobacterium. The treatment of TB usually takes 6 to 12 months depending on how the patient responds. Tuberculosis is a major cause of mortality; it is second only to HIV related complications. “According to the 13th annual tuberculosis report of the World Health Organization (WHO) — published on World TB Day, March 24, 2009 — there were an estimated 9.27 million new cases of tuberculosis worldwide in 2007” (Donald) Ensuring proper patient adherence during this period has proved to be a challenging task for health providers and patients alike. The development of drug resistance has been blamed on laxity of health providers who does very little to ensure that patients adhere strictly to the treatment regimens. Faced with increasing cases of drug resistance medical practitioners and other stake holders are at pains to develop efficient ways of ensuring patient adherence to TB treatment regimen. Why is strict adherence important? During treatment the dose offered is usually aimed at maintaining optimal levels of drug concentration in the body. This is necessary for inhibiting proliferation of the targeted microbial agents. Skipping doses leads to suboptimal drug concentration in the body; this gives an advantage to the microbial agents and may lead to mutation as in the case of TB. The study aims to identify the best methods for ensuring proper patient compliance during the medication of TB. This will go a long way to reduce development of drug resistance.
Literature review
The focus of patient management during TB infection has been to try and prevent dissemination of the infection to others. Little attention has been focused on how the patient utilizes the provided drugs; consequently, cases of patients missing doses have increased leading to higher chances of development of drug resistance. Studies have revealed that lack of proper patient compliance during TB treatment is partly to blame for the rise. Resistance results from the mutation of drug sensitive Mycobacterium Tuberculosis strains. “Resistance to Rifampin (RMP) and Isoniazid (INH), the two most powerful drugs used for first line TB mediation”( Barry) results into Multi-drug resistant Tuberculosis (MDR-TB). “Treatment of tuberculosis is protracted and burdensome. Tuberculosis control is further complicated by the synergy between tuberculosis and HIV/AIDS and by the emergence of multidrug-resistant strains of M. tuberculosis.” (Diacon) Various methods have been used to ensure patient compliance during TB treatment; most of the methods have focused on: home based care and hospital based care where the health officials have developed mechanisms to ensure compliance by visitations and provision of feedback by the patients. The issue of patient compliance is very complex, various patients have their own reasons for not complying with the medication. “Majority of the patients (80%) expresses general concerns about taking medication; previous bad experiences, perceptions that drugs are unnatural or unsafe and are best avoided, and that drugs signify ill health.” (Compliance with Pharmacological Therapy in Hypertension. Can we do better? and How?) Most other patients lack confidence in the health providers and therefore fail to take the issue of compliance seriously. “When tackling the issue of improving patient compliance with medication, the primary focus is not on trying to achieve perfect agreement between prescription and behavior, but rather to achieve a level where the outcome of treatment is improved.” (Compliance with Pharmacological Therapy in Hypertension. Can we do better? and How?)
The methods used to ensure compliance are intended to provide the patient with the best results possible from the treatment regimen.
Statement of the problem and study justification
Cases of drug resistance among TB patients are on the rise. Improper patient compliance has been identified as one the factors contributing to the increase. Poor compliance has been encouraged by: Allowing patients to take medication at home without supervision and clinicians failing to use therapeutic drug monitoring to know whether patients are complying with the treatment regimen.
By identifying the best methods to ensure proper patient compliance to TB treatment regimens, the study will contribute to better patient care and management. This will reduce chances of development of drug resistance.
Hypotheses
- Null hypothesis (HO): There is no relationship between methods of compliance and TB resistance.
- Alternative hypothesis (HA): There is a relationship between methods of compliance and TB resistance.
Researches conducted have associated development of TB drug resistance to poor patient compliance to the treatment regimens. Patient compliance is directly associated with the method used to ensure it. The various methods the study will focus on include: Home based care whereby health officials or practitioners will be assigned patients, who they will be paying regular visits to ensure compliance. In the second method, the patients will be paying regular visits to the hospital to report on his/her progress. In the third method, the need for and importance of compliance will be thoroughly explained to patient at the beginning of the treatment regimen, then the patient will be allowed to go home and left unsupervised. In the fourth type, the patient will be confined to the hospital and drugs will be provided by the health officials each time the patient is required to take them.
Methodology
Study Area
The study will be conducted at the Eastern Idaho public hospital. The hospital has a tuberculosis department with a good number of patients seeking treatment services from the hospital.
Study population
The study will include both male and female patients suffering from drug sensitive tuberculosis attending the Eastern Idaho public Hospital. The study population will consist of newly infected TB patients, probably those with an infection of one month or less. The age bracket will be between 18 and 65.
Research design
This will be a prospective study where data will be collected after assigning patients to the different methods of ensuring compliance. correlational study design will be applied whereby different methods of ensuring patient compliance will be applied to different patients and data on effectiveness (ratio of missed doses to the total doses of the treatment regimen) recorded. The methods will then be compared.
Sampling method
A systematic sampling technique will be employed where by equal number of drug sensitive TB patients will be assigned to the different methods of ensuring compliance. The sample size will be calculated by the following formula to obtain a sample that is representative of the target population.
Formula:
Description:
- n = required sample size
- t = confidence level at 95% (standard value of 1.96)
- p = estimated prevalence of malnutrition in the project area
- m = margin of error at 5% (standard value of 0.05)
Study Variables
The dependent variable will be new infection of tuberculosis, probably diagnosed not more than one month earlier (This is to reduce error margin because people infected for longer periods may be used to taking their drugs as required)
The independent variables will be the various methods that can be used to ensure patient compliance. This will include: Home based care whereby a health officials will be assigned patients, who they will be paying regular visits to ensure compliance. In the second method, the patients will be paying regular visits to the hospital to report on his/her progress. In the third method, the need for and importance of compliance will be thoroughly explained to patient at the beginning of the treatment regimen, then the patient will be allowed to go home and left unsupervised. In the fourth type, the patient will be confined to the hospital and drugs will be provided by the health officials each time the patient is required to take them.
Inclusion and Exclusion Criteria
Patients with new drug sensitive TB infections will be included in the study. Patients with other forms of TB, those not suffering from TB and those with drug sensitive infection more than a month old will be excluded.
Ethical Consideration
The permission to carry out the study will be sought from relevant authorities. Consent will be sought from the participants and the study will be carried out using basic ethical principles of autonomy, human dignity, justice and sanctity of life.
Data Collection and analysis and presentation
The study will be carried out for a period of one month during which the number of incidences of patients missing doses for each method used will be recorded. The regimen will be same for all patients. The demographic data will not be collected for the use in this study. The data collected will be tabulated according to the method of ensuring compliance. The number of correctly taken and skipped doses will be entered in the in the table (not specific patients). Chi square will be used to test the hypothesis to ascertain whether there is a relationship between development of resistance and compliance. This will be based on the fact that skipping doses has a chance to cause resistance. The best method will then be selected.
Works cited
Barry, Cliffton. ” Unorthodox Approach to development of new Antituberculosis therapy.” New England Medical Journal;360:397-2405 (2009): n. Pag. Web.
“Calculating Sample size.” Ifad.org, n.d. Web. 2010.
“Compliance with Pharmacological Therapy in Hypertension. Can we do better? and How?” Journal of Human Hypertension (2004). N. pag. Web.
Kombo, Donald and Delno Tromp. Proposal and thesis Writing: An introduction. Nairobi: Paulines Pulications Africa, 2006. Print
Diacon, Andreas., Pym Alexander. “The DiaryQuinolone TC207 for Multidrug-Resistant Tuberculosis.” New England Medical journal 2009;360:2397-2405 (2009). n. Pag. Web.
Donald, Peter and Paul Van Helden. “The Global burden of Turberculosis-Combating Drug Resistance in Difficult Times.” New England Medical Journal;360:2397-2405 (2009). n. Pag. Web.
Walliman, Nicholas. Your Research Project: 2nd Edition. New Delhi: Vistaar Publications, 2006. Print