3.1 STUDY AREA
Cross River State (CRS) is one of the six states in the south-south geopolitical zone of Nigeria, with Calabar as its state capital. It is bounded in the south by the Atlantic Ocean, east by the Republic of Cameroon, north by Benue state, west by Abia and Akwa Ibom states. According to the 2006 national census figures, CRS has a total population of 2,888,966: 1,492,465 males and 1,396,501 females69. With a total population of 371,022, Calabar comprises two Local Government Areas (LGAs) namely Calabar municipality and Calabar south. These areas are homogenous in socio-cultural and economic activities with political boundaries as the only distinguishing factor.
Calabar is located between latitude 4' 58 North and longitude 8' 17 East, and is within the tropical rain forest. Relative humidity is 84% with mean annual temperature of 79° F and average rainfall of 307.6cm. Calabar is bounded in the north by Odukpani LGA, west by Calabar River, south and east by Qua River. Efik is the most widely spoken language while Christianity is the most predominant religion in the study settings. The main occupations of the respondents are farming, fishing and trading70,71.
There are 21 DOTS centres in the two LGAs that comprise Calabar; 13 government and eight privately owned facilities. Four (all government owned facilities) of these 21 DOTS centres offered both in and out-patient services when this study was conducted. Three centers; Navy Medical Center Calabar, Mount Zion Clinic Calabar and University of Calabar Medical Centre (where pre-testing was done) originally enlisted as study centers in the study proposal were
excluded because they were no longer offering in-patient services during the period this study was conducted.
3.2 STUDY DESIGN
This was a cross sectional, analytical study.
3.3 STUDY POPULATION
Study population comprised in-patients and out-patients that have been diagnosed to have TB (PTB and EPTB) by a clinician or other health personnel and have been commenced on medication in the DOTS treatment centre at least one month before commencement of this study. Study population also included unit heads of the selected DOTS centres.
Inclusion criteria For Clients:
1. Patients who were receiving treatment in the four DOTS treatment centres in Calabar that offered in-patient and out-patient services were recruited during the study period.
2. Clients diagnosed to have TB at least one month before commencement of the study.
One month was arbitrarily chosen because it was felt that clients would have developed a level of satisfaction or dissatisfaction during this period that they would have had at least four clinic appointments.
For heads of DOTS centres
1. All the unit heads of DOTS centres in Calabar who have headed the unit for at least three months before commencement of the study were interviewed.
Exclusion criteria
1. All TB contacts placed on prophylactic Isoniazid treatment.
2. All clients transferred from elsewhere to Calabar to continue treatment in less than one month before the study.
3. All TB clients diagnosed less than one month before commencement of the study.
3.4 SAMPLE SIZE
Desired sample size for a single population study is calculated using the formula given below72:
N = z2 p q d
Where z = standard normal deviate d= degree of accuracy desired p= prevalence of people with TB
q= (1-p) prevalence of people without TB
Prevalence rate of TB in Nigeria is 531/100,000[1]. But, prevalence of people with TB shall be taken to be 33% in conformity with the global prevalence2. This is because Nigeria’s TB prevalence is expressed per number of persons and not in percentage as required in the sample size formula.
Therefore p = 33% = 0.33 q = (1-p) = 0.67 d = 0.05
N = 1.96 x 0.33 x 0.67/ 0.05
= 340
Sample size was adjusted for 10% non response rate giving 380 (340 + 34 = 374) respondents, which was taken as the total minimum sample size.
3.5 SAMPLING TECHNIQUE
Among the 21 DOTS centres in Calabar, four that offered both in-patient and out-patient services at the time of data collection were used; Ebrutu Barrack Medical Center, General Hospital, Lawrence Henshaw Hospital and the University of Calabar Teaching Hospital. All clients who were diagnosed to have TB at least in the last one month before commencement of the study and are on anti-TB medication were recruited for study in the four DOTS centres. All population study was done because there were a total of 116 registered TB clients in the four DOTS centres the month preceding the study, thereby necessitating the recruitment of every client who met the inclusion criteria in order to meet the minimum sample size. Undertaking a probability technique in subject selection would have compromised the required sample size considering the three month duration of the study.
3.6 DOTS MODEL OF THIS STUDY
Figure 3.1: Impact of the environment (external and internal) on the functionality (input, process and output) of DOTS centers.
DOTS STRATEGIC ELEMENTS
Sustained political commitment
Access to quality assured microscopy
Recording and reporting Access to
short-course chemotherapy
Uninterrupted supply of anti-TB drugs
DOTS CENTERS
INPUT FACTORS
PROCESS FACTORS
OUTCOME
Figure 1 shows a lay out of the model which was developed by the researcher in this study based. The model has as its core functional elements the DOTS strategic component outlined by the WHO1. It clearly depicts how the five elements of DOTS are meant to enhance the input and process factors in such a way as to improve satisfaction of clients with respect to the services provided in DOTS centres.
3.7 RESEARCH ASSISTANTS
Central training was conducted for five working days for three community health officers (CHOs) who assisted the principal investigator in the data collection. In order to be able to interview respondents who do not speak English, the Efik version of the interviewer-administered semi-structured questionnaire (Appendix II) for clients was obtained by doing forward translation from English to Efik language (the most predominant local language spoken in study area) and backward translation from Efik to English language during the central training. The aim of the training was to collect uniform information from the respondents to avoid subject and interviewer biases in order to enhance validity and repeatability of the research findings.
3.8 DATA COLLECTION
3.8.1 Pretesting
All study tools including the Efik version of the interviewer-administered semi-structured questionnaire for the clients were pre-tested at the University of Calabar medical centre which offered in-patient and out-patient services at the time of the pretesting. This was to enhance comprehensibility, validity, reliability and sensitivity of questions, and for average duration of administration. All corrections were made before final data collection.
3.8.2 Interview process for TB clients
Prior to the interview, the TB clients were adequately informed (Appendix V) of the purpose of the study as they exited the TB clinics. Other information included: indirect benefit to the participants, the right to decline participation or to withdraw from the study at any point during the interview, no risks of harm or injury to the participants during and after the conduct of the study, the maintenance of confidentiality by keeping the identity of the respondents anonymous and by keeping the data secure and making them available to only members of the research team who needed them for the purpose of the research. Written individual informed consent (Appendix VII) was obtained from the clients who voluntarily agreed to participate in the study after which interviews were conducted. In order to ensure privacy of the clients, interviews were conducted in consulting rooms separate from the TB clinics to which only members of the research team had access.
3.8.3 Data collection tools
Three tools were used for data collection: interviewer-administered semi-structured questionnaire for clients (Appendices I and II), self-administered semi-structured questionnaire for head of DOTS centres (Appendix III) and structured observation checklist for facilities in the DOTS centres (Appendix IV). The interviewer-administered semi-structured questionnaire contained information on respondents’ socio-demographic characteristics, household characteristics/assets and dimensions of satisfaction with medical care received. The questions on client satisfaction which was a measure of outcome were adapted from PSQ-18 questionnaire68. In order to enhance validity of the study, the interviewers administered the Efik version of the client questionnaires to the respondents who did not understand English.
The self-administered semi-structured questionnaire for the heads of DOTS centres contained information on the following variables: type of health facility, category of qualified health staff and routine services offered in the DOTS centres.
The structured observation checklist contained information on the expected weighted input factors scoring system as outlined in the explicit criteria against which the quantitative assessment of observed input factors in the DOTS centres were scored. Through direct observation, only the researcher assigned observed scores to input and process factors in the four DOTS centres in order to avoid inter-observer variation.
3.9 MEASUREMENT OF STUDY VARIABLES
In the Zimbabwean study45, an attempt was made to correct for data deficiencies usually encountered in retrospective studies, so an estimation of qualityof in-patient services by using prospective patient-specificmethods was used. This study in Calabar, though cross sectional by its design but maintaining the Donabedian’s structure–process–outcome paradigm, adapted the methodology used in the Zimbabwean study that measured quality performance by use of quantitative weighted scores for specified aspects of care. The weight reflected the relative importance ofeach factor to the total quality score. Providers were then ranked and compared among themselves according to their total scores, and also compared against an expected yardstick quality score73. A provider performance index (PPI) is an example of such a total score74,75.
PPI was calculatedby dividing the observed scores (OS) by the maximum expected scores (MS). It measures the extent to which hospital care providers performedaccording to explicit
criteria, and takes values from 0 to 1.A value of 1 means total conformity with the quality criteriaand zero reflects total non-conformity45.
The study tools contained information on independent and outcome variables that made it possible to measure the objectives of the study.
Input factors: based on explicit criteria, input factors were scored using the weighted scoring system adopted in the Zimbabwean study45. Actual score of each input component depended on their availability and physical state. Any input component that was not available or was available but not functioning got a score of 0. If input component was available but not in maximal functional condition, it got half the expected score depending on the maximum expected score for that variable. Maximum total expected input score was 25.
Process factors: based on explicit criteria, process factors were scored using the weighted scoring system adopted in the Zimbabwean study45. Process factor had four major components: (I) time of contact with staff since arrival at facility with a score of 1 (II) laboratory services with a score of 6 (III) intensive phase treatment with a score of 8 and (IV) nursing services with a score of 16. Maximum expected process score was 31. Weights were assigned depending on the contribution of variables to the provision of good quality TB services as adapted from explicit criteria used in the Zimbabwean study.
3.9.1 Independent variables
These include education, age, gender, religion, ethnicity, marital status, occupation and socio-economic status (SES).
3.9.2 Outcome variable: For the purpose of doing a logistic regression analysis, the outcome variable was binary in nature - satisfaction or dissatisfaction with overall medical care.
3.10 DATA ANALYSIS
The researcher entered the data using EPI INFO 2000 version 3.3.2 statistical software. Stat transfer software was used to export the database from EPI INFO to STATATM version 10.0 statistical software for data analysis.
3.10.1 Descriptive analysis
Variables were described using mean and relative frequency. Simple relative frequency was used to describe exposure and outcome variables.
3.11.2 Inferential analysis
Level of statistical significance was set at p < 0.05 for bivariate analyses. T-test and ANOVA were used to test for differences and associations among numeric variables. Z-test, Chi-square and Fisher’s exact tests were used to test for differences and associations among categorical variables where applicable. Variables found to be statistically significant with patient satisfaction in the bivariate analyses were built into the multivariate logistic regression model that was used to adjust for potential confounders at 95% (p< 0.05) level of significance in order to accurately determine the predictors of patient satisfaction. Some of the anticipated confounders included socio-economic status, age and education which were measured and controlled for in the following manner:
Socio-economic status of respondents was determined using information on their household possessions and housing characteristics to construct a robust wealth index. The respondents
were categorized into five levels (quintiles) in descending order of socio-economic status from the highest SES: least poor, less poor, poor, more poor and very poor using the principal components analysis technique[76-79].
In order to determine which age group needs to be targeted for policy purpose, age was categorized into three groups: 0-19 years, 20-39 years and 40 years and above. Similarly, educational status of the participants was categorized in ascending order as follows: No education, primary, secondary and tertiary levels.
3.11 STUDY LIMITATIONS
1. The informants (5.3%) who were administered the semi-structured questionnaires on behalf of children (figure 4.10) may have expressed their perceptions which were not reflective of those of the children.
2. There was lack of uniformity from the explicit criteria in the way certain factors were to be measured for the purpose of comparison. For example, certain DOTS centers that had more functional microscopes received the same score as those that had fewer functional microscopes because the explicit criterion which was the standard of judgment did not take into account the differentials in the weighting of the quantity and functionality of certain input and process factors.
3.12 ETHICAL CONSIDERATIONS
1. Ethical clearance to conduct this research was sought and obtained from the University of Benin Teaching Hospital and the Cross River State Government Research Ethics Committees (Appendices IX and X).
2. Informed written consent was obtained from each respondent before interviews were conducted.
3. Confidentiality and privacy of the respondents were respected during the interviews.
4. In order to ensure confidentiality of the respondents, serial numbers rather than names were used to identify the respondents.
5. Respondents were informed that they had the right to decline participation or to withdraw from the study at any time they wished.
6. Respondents were informed that there were no penalties or loss of benefits for refusal to participate in the study or withdrawal from it.
7. There were no risks of harm or injury to the participants during and after the conduct of the study.
8. All data were kept secure and made available to only members of the research team.