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People-Centered Tuberculosis Care Verses Standard Directly Observed Therapy: Study Protocol For a Cluster Randomized Controlled Trial
This study involved reviewed a program to determine the effectiveness of a program to control drug sensitive TB by improving the treatment adherence of patients. The study compared the results of a patient program involving education and counseling of the patient and family members followed by Text messages and phone calls to remind them to take medications and monitor treatment and side effects. This is compared to the WHO recommended treatment of requiring the patient to make daily visits to TB outpatient centers for drug administration.
Causality Criteria Criteria to Evaluate Studies
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Outcomes are classified as cured, completed treatment, dead, failed, defaulted, and transferred. Treatment is successful only if the outcome is cured. Secondary Outcomes include patient knowledge, depression status, and quality of life.
What was the Study Design:
The study was designed as an open-label, stratified cluster randomized controlled superiority trial with two parallel equal arms (intervention and control). TB outpatient centers defined the clusters, with equal numbers of clusters assigned to intervention and control arms.
What was the Study Population?
Drug-sensitive tuberculosis patients in the continuation phase of treatment in the intervention arm and their family members.
What was the Main Result?
Improvement in TB treatment strategies can have a significant public health and economic impact.
Internal Validity
Observation bias
Recall bias
Confounding
Chance Internal Validity (Non-Causal Factors)?
This is not relevant to the study as the study is observation of patients already infected and studies outcome results not infection methods.
Are the results likely to be affected by observation bias?
No, the results are self-reported by patients on questionnaires during interviews with medical staff.
Are results likely to be affected by recall bias?
Potentially. For the study group, taking medications was self-reported after text and phone call reminders, so no medical staff witnessed medication administration. Secondary outcomes such as
The CDC website provides ample educational information regarding tuberculosis. It gives a detail description of what Tuberculosis is, the testing used and how it works. The website also addresses the risk factors of tuberculosis and warns that traveling to countries such as Africa, Asia and Central America puts them in a higher risk of contracting TB. In addition, it provides people with preventive measures to avoid being infected. They advise against close proximity with infected, and to be cautious around people working in health care facilities, prisons, shelter or an over populate area and advise to refrain from consuming unpasteurized milk products. In addition, the Website provides Data and Statistics, which can help support previous
Due to the transmission that TB is spread, through the air from one person to another coughing, sneezing, and speaking. It is vital that those who have TB disease are treated, complete the medicine regimen, and take the medications exactly as prescribed. If one was to discontinue the medications without completion, they can become ill again and if they do not take the drugs correctly, the TB bacteria that are still alive may become resistant to those medications. TB must be treated by taking antibiotics, the exact drugs and length of treatment depend on your age, overall health, possible drug resistance, the form of TB, latent or active, and the location
A resolution was introduced by the Minister of Health ”Through this Framework, the federal government will focus its efforts on reducing the burden of tuberculosis within those populations by: Optimizing and enhancing current efforts to prevent and control active tuberculosis disease, facilitating the identification and treatment of latent tuberculosis infection for those at high risk of developing active tuberculosis disease, and championing collaborative action to address the underlying risk factors for tuberculosis.” (The Honourable Rona Ambrose, P.C., M.P Minister of Health). In 2004, total tuberculosis-related expenditures in Canada were estimated at $74 million dollars, with the average cost of treating a case of active tuberculosis being approximately $47 thousand dollars. Treatment for latent TB infection, on the other hand, is estimated to be less than $1000 per
The new TB drugs have eliminated most of the dangerous aspects that involved in TB patient care, but the new role of nurse is more difficult because of increased responsibility, the success of treatment for TB depends on the patients regularly following the medication for a long period just like Hypertension and it is the duty of R.N’s to make certain
a patient with a new case of TB can be treated at home. Others will enter the
I – Empower nurses with new evidence based practices and redirect their nursing practice skills towards early diagnosis of TB disease. Educate the society to be aware of TB disease and encourage them to seek medical help when experiencing any signs of TB. And provide resources to patients on Anti-TB Drugs to help them adherence with their medication.
The entire world population one third is infected by TB. The distribution of this disease is not constancy across the globe. Approximately 80 percent of the population in many African and Asian countries test positive compare to other countries. This isn’t surprising most people who are infected with TB are living in deprived areas. This can become more easily to contract the
In the United States, the incidence rate per year is less than 4 per a population of 100,000. In other countries such as sub-Saharan Africa and Asia the incidence rate is much greater, a few hundred per 100,000. This disease is a very important concern for travelers from the US who travel to places where they might have prolonged exposure to tuberculosis. These travelers or people who plan to spend time in healthcare facilities, correctional facilities, or homeless shelters should receive a 2-step TB skin test. If a person is infected with TB they are encouraged to not travel by commercial airplanes for the risk of spreading the infection. (LoBue, 2015) Tuberculosis is still a leading cause of morbidity and mortality in many developing countries around the globe. Even though there was a declining trend of this disease after the discovery of chemotherapy in the 1940s, this was not the case for developing countries. Tuberculosis was the first infectious disease to be declared a global health emergency by the World Health Organization. Asia and Arica constitute for 86% of the cases in 2007, when they were 9.27 million incident cases of tuberculosis, 13.7 million prevalent cases, 1.32 million death due to tuberculosis in people who were HIV-negative, and 0.45 million deaths in people who were HIV-positive. There are 22 high-burden countries and Bangladesh is ranked number 6. The implementation of directly observed therapy short course (DOTS) was a breakthrough for a way to control TB. It actually covered the whole country of Bangladesh, after being started in 1993. Tuberculosis is also associated with the poorest parts of communities and the highest rates of TB are actually because of poverty. Conditions like, overcrowding in schools, poor nutrition, overcrowded living conditions, as well as poor hygiene habits are likely to
“We cannot win the battle against AIDS if we do not also fight TB. TB is too often a death sentence for people with AIDS. It does not have to be this way. We have known how to cure TB for more than 50 years. What we have lacked is the will and the resources to quickly diagnose people with TB and get them the treatment they need.”
While complicated in practice, the theory portion of tuberculosis management is simple; treat individuals with either active TB or latent TB that is likely to progress to active disease with the appropriate antibiotic regimen (Sloan & Lewis, 2015). Certain countries with a high
In the last few years, a radical change has been witnessed in the way the world responds to tuberculosis. Great strides have been achieved in the treatment and control of the disease. Currently the anti TB drug regimen being followed (DOTS) for drug susceptible tuberculosis has 2 phases, the initial two-month intensive phase where a combination of the four first line drugs (isoniazid, rifampicin, pyrazinamide and ethambutol) are administered followed by a 4-month continuation phase of rifampicin and isoniazid. The 6-month therapy destroys any residual dormant bacilli and the rifampicin resistant mutants that commence replication. Patients are categorized into 4 groups and a combination of the above drugs is administered based on patient compliance, drug susceptibility and disease severity. DOTS-Plus is the strategy used to manage MDR-TB. Treating cases of multidrug resistant TB is a challenge in itself
The goal of this continuing education program is to update knowledge about prevention, assessment, diagnosis, treatment, and follow-up measures for tuberculosis and multi – resistant tuberculosis.
Most cases of TB can be successfully treated with a six-month course of antibiotics, says Mrs Ricketts. But drug-resistant strains of the disease can involve lengthier and more complex treatment with antibiotics and injectable drugs, and often require inpatient care.
Although the epidemiology is concerning, TB is a treatable and curable disease. The WHO has detailed guidelines for the treatment of TB, which specifies that successful TB treatment requires accurate early diagnosis, drug resistance screening, HIV screening, correct drug selection and long-term compliance. (1) The current first line treatment for drug-sensitive TB includes an ‘intensive phase’ of 2 months and a ‘continuation phase’ of 4 to 7 months. The drugs used in the initiation phase include rifampicin (RIF), isoniazid (INH), pyrazinamide (PYR) and ethambutol (EMB), with RIF and INH being continued until MTB is eradicated. (1) This four-drug treatment regimen for drug-sensitive TB disease has been in widespread use for over 20 years, and has achieved cure rates of more than 95% in trial conditions. (5) However, this regimen also has unwanted aspects, which include the lengthy duration of the treatment, the side effects the drugs and, more concerning, the development of drug resistance, have significantly limited its use. (12)
India, the second most populous country with over 1.31 billion people, has the highest burden of tuberculosis (TB) in the world, accounting for 20% of the global incidence of TB, and an even higher share of global incidence of multi–drug resistant (MDR) TB. With an estimated 2 million new cases of TB and 5, 00,000 TB-related deaths in India annually, those who got diagnosed with different forms of DR-TB were 35,385 cases but only 20,753 people started on multidrug-resistant TB (MDR-TB) treatment in 2013. The National Tuberculosis Program was launched in 1962, but suffered heavily continuing TB led mortality. Acknowledging this reality, a Revised National Tuberculosis Control Programme (RNTCP) was launched by the Government of India in 1997, however even today it does not comply with World Health Organization (WHO) recommendations.