Select an epidemiology-related topic that interests you and specify a research question.
1. Provide a short literature review of your topic and explain the topic’s importance to health care, public health, etc.
2. Specify the study design that you will use to answer your research question and justify your rationale for choosing that design. Be sure to discuss the advantages and disadvantages of your design relative to other possible study designs. Note: do not simply provide a generic list of advantages and disadvantages. Tailor the discussion to your specific research question. (For example, if you are proposing a case-control study to investigate the association between some exposure and coronary heart disease (CHD) in a hospital setting, then citing the rare disease assumption as an advantage of case-control studies would not be applicable to your specific circumstances because CHD is not a rare disease.)
3. Explain your criteria for enrolling participants (e.g., must be disease-free upon enrollment, each matched control must have the same age and sex as the corresponding case, etc.).
4. Explain how you will measure your exposure and disease (outcome) variables (e.g., score on a specialized scale, clinical diagnostic or screening test result, etc.). Specify your measure of association.
5. Describe the types of biases that might affect your study and outline the strategies that you will employ to minimize these biases.Note: Tailor the discussion to your specific research question and study design.
6. What variables might be potential effect modifiers or confounders in your study? How will you assess effect modification and control for confounding? Note: Tailor the discussion to your specific research question and study design.
7. Tables and figures are not necessary, but you may add up to two tables and two figures.
Principles of Epidemiology
Readmission rates are higher in patients with chronic obstructive pulmonary disease (COPD). Effective self-awareness and self-management proved effective in reducing readmission rates in the COPD patients. COPD conditions like exacerbations and deterioration are first being recognised by the patients. However, it is evident that patients are not able to use medical terminologies for exacerbations and related conditions. Moreover, patients are unable to understand meaning of exacerbation; however, patients are aware of the forthcoming exacerbations1.
It is necessary for the patients to recognise early symptoms of exacerbations because it can produce significant physical and emotional distress in these patients. Hence, interventions useful in the stable state might not be effective in patients, who experienced these symptoms previously2. Few of the studies also criticised exacerbations as subjective experience due to indistinctness in its definition. It is very important for the patients to identify exacerbations accurately and demonstrate its experience to the healthcare provider. It is evident that, patients are unenthusiastic to bring exacerbations to the notice of healthcare providers and visit healthcare provider when it become serious. It has been found that patient use clinical markers for the identification of COPD exacerbations3. Patients not only use visible symptoms for the identification of exacerbations but also use self-experience like chest sensations, breathlessness and bodily changes for the identification of the exacerbations. Self-experience and experimental knowledge about the disease condition proved helpful in self-management and seeking help from the healthcare professional in long term disease condition like COPD. It is very important for the COPD patients to corelate physical limitations with the respiratory symptoms. From the previous studies, it is evident that objective symptom like change in the colour of the sputum is also a driving force for the patients to contact healthcare professionals. Identification of symptoms of exacerbations produces emotional fear in COPD patients. Emotional fear make COPD patients understand that something is wrong with them and drive them to approach to healthcare professional. From the earlier studies, it is evident that in the initial stage, patients try to manage their condition to reduce symptoms. However, if it is not successful, they try to reach healthcare professionals. COPD patients consider that self-management of symptoms is a way of life and they do not consider that these symptoms would remain with them for considerable duration. Patients mentioned that they manage their conditions on various levels like self-medication, self-monitoring of symptoms and non-pharmacological management of the symptoms4,5.
Hospital support is necessary for the patients for the self-management of the COPD symptoms. Incorporation of self-management education in the discharge plan of the COPD patients proved successful in improved outcome of these patients. It is evident that self-management of COPD proved effective in reducing hospital readmissions and mortality rate. In the previous studies, it has also been reported that early identification and management of COPD exacerbations proved successful in improving secondary outcomes by progressing health related quality of life. However, most of the trials are inadequately reported and these are associated with biasness6,7. Short term follow-up is the significant limitation of most of the earlier trials. Hence, current trial needs to be planned with longer duration follow-up.
Background Literature
Research question: Whether knowledge and understanding of COPD symptoms and management will be helpful in improving self-management of COPD.
In this study patient’s knowledge and understanding of COPD symptoms and management will be assessed. Patient’s understanding about both subjective and objective symptoms will be assessed. Moreover, patient’s understanding about self-management will be assessed. Interview based qualitative study will be used as study design in this study. Outcome of the interview based qualitative study design is mainly based on the sampling of the participants8. Using this study design, researcher will be able to observe and understand feelings and experience of participants. Observation and understanding of patient’s experience are important in this study because it provides information related to knowledge and recognition of COPD symptoms and management. Interview based study is useful in getting information about behaviour, opinion or values, feelings, knowledge and demographic information about the patient. Behaviour gives information about a person has done or doing, opinion or values gives information about person’s thinking about the topic, feelings give information about person’s feeling and experience, knowledge gives information about facts about the topic and demographic gives information about person’s age, sex and education.
Content of interview questions will have important impact on the outcome of the study because answers of questions will provide insight of patient’s knowledge. In this study, semi-structured questions will be used because these questions will be prepared according to pure set of instructions and these questions will provide reliable, comparable and qualitative data.
Advantages: Semi-structured interviews comprise of open-ended questions; hence, participants will have freedom to express themselves. Semi-structured interviews are beneficial in gathering more personal and detailed information about the participants. Personal and detailed information related COPD patients is the prerequisite of this study. Accurate data will be collected using this method because participants will not be able to provide false data related to age and gender. This method of data collection will also be helpful in obtaining both verbal and non-verbal ques about the participants. Distractions will be easily avoided and specific focus will be given for the data collection9.
Disadvantage: It is difficult to make sure honesty of participants due to collection of most of the subjective data. Flexibility in interview process might lessen reliability due to biasness of interviewer. It is difficult to analyse open-ended questions because it is difficult to compare answers of questions in the semi-structured interviews. Sample size need to be kept small in this method because more sample size requires a greater number of interviewers9.
This study will be conducted in the District hospital. This study will be conducted for duration of 18 months. Ethical approval will be taken from Research Ethics Committee of the hospital. Written consent will be taken from each participant. Patients eligible to participate in the study will be identified and recruited from the hospital admission records and pulmonary rehabilitation programme by respiratory research nurse. Participants will be recruited using purposeful sampling strategy. Purposeful sampling strategy is also considered as judgemental, selective and subjective sampling. It is a non-probability sampling because recruitment of participants is based on judgement of researcher. Using this sampling techniques, participants with similar characteristics will be recruited. Purposive sampling technique is more applicable in this study because participants with the symptoms of COPD will be recruited in this study. Recruited patients will be of different age, gender, COPD severity, length of diagnosis, frequency and number of exacerbations. In this study participants between the age group 55 to 85 years will be recruited and participants of both the genders will be recruited. Severity of the COPD will be GOLD stage II, III and IV. Patients with duration of symptoms between 2 to 25 years will be recruited in this study.
Research Question and Rationale for Study Design
Inclusion criteria:
- Age >45 years.
- A forced expiratory volume in 1s (FEV1) post-bronchodilator ?82% and predicted ratio of FEV1 to forced vital capacity (FVC) ?0.72.
- History of smoking >15 pack years.
- MRC dyspnoea scale ?
- Willing to give written informed consent.
- Capable to understand English both in writing and verbally.
Exclusion criteria:
- Presence of lung disease other than COPD.
- Presence of chronic heart failure.
- Life expectancy of ?3 months.
Inclusion and exclusion criteria are important aspects of research study because it is useful to define sample universe in the sample selection. It also improves decision making for sample selection. Inclusion and exclusion criteria are useful in identifying patient characteristics like disease severity, potential risk factors and associated risk factors. It is also useful in reducing variability in the research outcome; hence, it gives robust and valid research output.
Data will be collected through in-depth interviews. All the interviews will be conducted by the researcher with extensive experience in the qualitative research methods. Interviews will be lasting for approximately 30 to 60 minutes duration. Participants with communication problem will be allowed to accompany with family members. Field notes will be taken for maintaining context of the interview.
Patients will be interviewed for their knowledge about visible and invisible symptoms. Measurable visible symptoms include physical symptoms and physical limitations. Physical symptoms include cough, sputum colour, viscosity, taste and amount; and cold symptoms. Physical limitations include functional limitations. Subjective invisible symptoms include chest sensation and body knows. Chest sensations include soreness of chest, tight chest, heavy chest and breathlessness. Body knows include lack of energy and knowing right or wrong to the body. Patients will also be interviewed for consumption of medication, use of inhaler techniques, exercise and nutrition after identification of symptoms10. Self-management approaches comprise of self-medication and self-medication strategies, self-monitoring and contact with health-care providers11. Entire interview process will be audio recorded for future reference. Data will be analysed by incorporating multiple steps. Prior to analysis, data will be stored and organised using Microsoft Excel. Audio-recorded data will be transcribed into the verbatim and anonymised transcripts will be imported into the NVIVO 10 (qualitative software data programme). Grounded theory approach and constant comparative method will be used for data analysis. Coding will be implemented in the study to eliminate potential bias in the study12.
After data collection and analysis, patients will be categorised into three categories like high, moderate and low knowledge about symptoms and management strategies. After collection of data, patients in all the categories will be given counselling for self-identification and self-monitoring of COPD. Patients will be monitored and observed for twelve months after the completion of counselling process. During the duration of twelve months, data will be collected for health service utilization, hospital admissions, hospital readmissions, duration of admissions and mortality. During duration of twelve months, secondary outcomes like exacerbations, health related quality of life, anxiety, depression, dyspnea, lung function and self-efficacy will be evaluated13. All the outcome parameters will be calculated in percentage for each category like high, moderate and low-level knowledge about symptoms and management of COPD. Number of participants will be counted in each category like high, moderate and low-level knowledge prior to start of the twelve months. Number of participants in the outcome measure will be counted during duration of twelve months evaluation period.
Self-rating of the subjective characteristics by the participants will lead to potential bias. Prior association of interviewer and participants will lead to probable bias in the data collection14. There will be possibility of biasness in the data analysis because people involved in the data collection might know to the patients. Hence, efforts will be made to improve rigour and validity by implementing coding system. Coding will be done by senior researcher and he/she will not be part of the study. Personal interest of the researcher will lead to bias in the outcome of the interview based qualitative research. Coding of the obtained data will be helpful in reducing this bias. Qualitative research is vulnerable to bias, if standardised methodology is not implemented in the study. Hence, in this study standardised questionnaire will be used for interview process.
Advantages and Disadvantages for Study Design
Management of self-recovery by the patients through monitoring of their COPD symptoms will lead to biasness in the outcome of the study. Patients will decide upon improvement in the COPD conditions based on their willingness to take treatment or visit healthcare professionals. Moreover, patients will not be able to assess accurate improvement in the condition of the patient. If patient will feel improvement in their condition with the existing treatment, they will continue the same treatment for the considerable period of time. However, due to patient’s inability to assess treatment effect in a proper way, there will be continuation of inaccurate treatment. Bias as a result to inaccurate assessment of treatment effect by the patient will be effectively reduced by providing effective education and training. Moreover, continuous observation of the patient’s improvement in the condition will helpful in avoiding this bias18.
During self-management of the COPD condition by the patient, there will be possibility of alteration in the dose of the medicine. Increase in the dose might lead to faster improvement and reduction in the dose might lead to delay in the improvement. However, researcher will not be aware of this dose alteration. Hence, researcher will not consider this change in the dose while analysing data for the particular patient. It will affect overall outcome of the study because accurate assessment of the ability of the patient for self-medication will not be assessed accurately. Variable like change is dose of medicine will be effectively reduced by instructing and guiding the patients to keep record of consumed medicine18.
There is no information available for prior education to the participants about symptoms and management of COPD. Hence, it will be difficult to ensure, whether participants will express accurate knowledge about COPD symptoms. Hence, identification of the symptoms will be confounding factor for the accurate analysis of the outcome related to patient’s knowledge. Stratification will be useful in reducing modifying effect of education about symptoms and self-management of COPD. Confounding variable like varied knowledge of participants about symptoms and self-medication will be effectively reduced by randomisation. Since, there is no consensus on the definition of exacerbations in the COPD patients, it will be difficult to ensure validity and reliability of collected information. Expression and demonstration of COPD exacerbations by the participants will be confounding factor for data analysis15. Multivariate analysis will be used for the control of confounders. Statistical modelling like logistic regression is useful in controlling confounders. Questions incorporated in the interview will be confounding factors. Questions proved suitable at other hospital setting or another set of participants might not be useful in the current study. Standardisation will be useful in minimizing confounding factor related to questions. Questions for interview will be decided based on the relevant literature review and discussion among all the senior researchers in the hospital.
Long term follow-up is necessary in this study; hence, it will be difficult for the researcher to maintain accurate record of healthcare visits by the patient. Few of the patients might visit different healthcare professionals based on their suitability. It will be difficult for the researcher to gather information of patient’s visits to diverse healthcare professionals or hospitals. It will lead to inaccuracy in the recording of number of hospital visits by the patents. Moreover, different healthcare professionals might prescribe different medications. Hence, it will be problematic to assess effectiveness of particular medicine for a specific patient. Problem of inaccurate recording of number of visits by the particular patient will be effectively reduced by instructing the patients to visit the same hospital17,18.
There will be possibility of misinterpretation in reading and understanding of the collected data. Hence, efforts will be made to re-analyse collected data through audio-recorded interview and memo-writing. Memo-writing will be helpful in establishing connection between theoretical aspects and concepts from the collected data16. Analysis of data will be carried out through extensive discussion among all the senior researchers involved in the study. Number of recruited participants will impact outcome of the study. Since, subjective data will be collected in this study; hence, more of number of participants will be helpful in getting statistical significance of the data. Moreover, increase in number of participants will also be helpful in reducing variability collected data. Statistical significance will be achieved and variability will be reduced by recruiting more number participants. In this study, purposeful and theoretical sampling strategy will be used and this sampling strategy will not allow to recruit patients with diverse traits17. However, COPD is a variable disease. Hence, it will be difficult to generalize outcome of this study.
Generalization of obtained data will be avoided by ensuring recruitment of participants with variability. Positive and negative traits of the participants will not be assessed at the initiation of study. Positive and negative traits have potential to impact outcome of the study. It is evident that patients with positive traits will exhibit more adherence to the self-medication and patients with negative traits will exhibit less adherence to the self-medication18. It will be resolved by providing counselling to the recruited patients. Counselling will be given for health and well-being. In this study, multiple variables will be assessing. Self- management of COPD condition is a complex process and in involves various activities like early identification of exacerbations, understanding and consuming medications on regular basis with correct inhaler technique, bronchial clearance technique, management of breathlessness, smoking quitting, consistent exercise to maintain optimum lung function and consumption of healthy diet. Hence, it is necessary for the researcher to be well versed with all the variables related to symptoms and management of COPD. Lack of knowledge of researcher about the symptoms and management might lead to error in the outcome of the study. Hence, error in the outcome of study will be effectively reduced by incorporating researcher with robust experience in the relevant field18.
Experimental or visible symptoms proved more useful in the identification of the COPD patients. Number of years of diagnosis of COPD affects identification of experimental or visible symptoms. However, patients will not be grouped based on the number of years of COPD diagnosis. Hence, validity of data for identification of symptoms will not be ensured due to variability in the baseline characteristics of the patients. However, implementation of various analysis and interpretation methods for different patients will be helpful in minimizing collected data17,18.
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