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The limits to patient compliance with directly observed therapy for tuberculosis: a socio-medical study in pakistan

international journal of health planning and management Int J Health Plann Mgmt 2002; 17: 249–267.
Published online in Wiley InterScience ( DOI: 10.1002/hpm.675 The limits to patient compliance with directlyobserved therapy for tuberculosis: asocio-medical study in Pakistan H. Meulemans1*, D. Mortelmans1, R. Liefooghe2, P. Mertens1,S. Akbar Zaidi3, M. Farooq Solangi4 and A. De Muynck51University of Antwerp (UIA), Faculty of Political and Social Sciences, Belgium2Flemish Interuniversity Council (VLIR), Brussels3Independent Consultant, Karachi, Pakistan4Allama Iqbal Open University, Department of Social Sciences, Islamabad5Prince Leopold Institute of Tropical Medicine, Department of Epidemiology, Antwerp Complying with the prescriptions of the directly observed therapy (DOT), one of the compo-nents of the Global Tuberculosis Programme of the WHO, is problematic for many patients.
The factors leading to patient (non-) compliance with DOT are placed in a structural equationmodel.
The study is based on a survey carried out in one general hospital in the Punjab province of Pakistan, amongst all sputum positive pulmonary TB patients (n ¼ 621) who arrived at the TBunit from September 1997 to October 1998.
The tested sequence of manifest variables and latent constructs shows that the social stra- tification perspective has to be extended by the stigmatization perspective. The advantages ofuniversally applying DOT will increase even further when the latter perspective is involved inthe analysis of non-compliance. There is a real danger that the patients reached by selectiveDOT will be stigmatized even more. Copyright # 2002 John Wiley & Sons, Ltd.
key words: compliance; DOTS; stigmatization; TB control; Pakistan Persons who develop tuberculosis have to conquer not only a disease but overcomedeeply entrenched prejudices. Tuberculosis is a chronic infectious disease caused bythe tubercle bacillus. However, tuberculosis has never been merely a biologicalphenomenon. When the first campaigns for eradicating tuberculosis were set up in * Correspondence to: Dr H. Meulemans, University of Antwerp, Faculty of Political and Social Sciences,Universiteitsplein 1, B-2610 Antwerp, Belgium. E-mail: Contract/grant sponsor: Belgian Ministry of Foreign Affairs, Foreign Trade and DevelopmentCooperation.
Contract/grant sponsor: Flemish Interuniversity Council.
Contract/grant sponsor: Research Council of the University of Antwerp.
Contract/grant sponsor: Damien Foundation Brussels.
Copyright # 2002 John Wiley & Sons, Ltd.
the industrialized West in the 19th century, TB was primarily regarded as a socialdisease. Tuberculosis has become an increasing problem around the world in recentyears. The WHO Report on the Global Tuberculosis Epidemic warned about thegravity of the epidemic: between 2.5 and 3.5 million deaths each year, making a totalof 30 million deaths during the 1990s or one quarter of all preventable adult deaths(WHO, 1998; Reichman and Tanne, 2001). It simultaneously alerts us to the dangerthat stigma sends the TB epidemic underground. The present study examines socialbarriers and health beliefs that influence TB patients’ compliance with their treat-ment in Pakistan.
The ‘Directly Observed Treatment, Short-course’ (or DOTS) strategy is a multifa-ceted intervention and not a simple strategy consisting of watching the ingestion ofmedication. This strategy acts as the cornerstone of the Global TB Programme of theWorld Health Organization and is generally considered to be one of the most rapidlyexpanding and successful health interventions of the 1990s (Volmink and Garner,1997; WHO, 1997). It seeks first and foremost to implement a standardized short-course chemotherapy using regimens of 6–8 months, for at least all confirmed smearpositive cases. Good case management includes directly observed therapy (DOT)during the intensive phase for all new sputum smear positive cases, the continuationphase of rifampicin-containing regimens and the whole retreatment regimen. DOT isa practical method for supporting the patient and the family to ensure that the patientadheres to treatment and successfully completes treatment. In addition to applyingDOT, government commitment to sustained TB control, sputum smear microscopyto detect infectious cases, a regular, uninterrupted, supply of quality anti-TB drugsand a monitoring and reporting system to evaluate treatment outcomes, is widelyregarded as the fundamental basis of the DOTS strategy (Raviglione et al., 1995;Raviglione, 2001; Porter and Ogden, 1997; Small and Fujiwara, 2001; Pungrassamiet al., 2002).
A medical regimen is imposed to ensure optimum progression of illness beha- viour, i.e. to ensure that the patient recovers as soon as possible. When patients suc-ceed in conforming their illness behaviour to the medical regimen, they arecompliant. Patient compliance can assume many forms, ranging from demandsfor cooperation in diagnostic procedures despite anxiety and pain, through takingdrugs on schedule and otherwise following a prescribed regimen, to abandonmentof social and familial obligations to the needs of the health system (Hyde, 1988).
Recent literature contains a number of synonyms for the term ‘compliance’(Volmink and Garner, 1997). Some authors now use the term ‘adherence’ to empha-size the fact that the following of a medical regimen is the independent choice of thepatient. Sometimes the term ‘concordance’ is used to stress the active exchange ofinformation, negotiation and spirit of cooperation in the relationship between illnessbehaviour and medical regimen. Since the treatment of tuberculosis does not alwaysimply an independent choice of the patient and an active exchange of informationbetween patient and health professional cannot be taken for granted, we prefer the Copyright # 2002 John Wiley & Sons, Ltd.
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term ‘compliance’ in this context. As long as patients act as they should and conformto therapeutic prescriptions, they can continue to function socially without any pro-blems. However, as soon as the threshold of acceptable norms is crossed, deviantbehaviour replaces legitimate illness behaviour and society’s integrative capacitiesgradually disappear.
There are many ways to deviate from the medical regimen prescribed by the DOTS strategy. People can ignore TB symptoms and fail to seek treatment. Treat-ment can be postponed until the disease has become very severe indeed. However,there are also other, less radical ways to be non-compliant and to reduce the likeli-hood of a cure. It is quite easy, for example, to forget to go to the doctor or be care-less about keeping appointments. Some people adapt medication to suit themselvesand simplify the treatment plan. The supervision, which forms an intrinsic part of theDOTS strategy, can be changed coincidentally or systematically.
According to Bayer and Wilkinson (1995), it is essential to take into account the socio-cultural context in which this dysfunctional behaviour is displayed. Not every-one feels strongly about missing an appointment, adjusting medication or avoidingsupervision. Patients may have to contend with side-effects, such as nausea and slee-piness. Many fail to take their medicine on time because they are either homeless ormentally ill, as a result of alcohol or drug abuse, or because they are refugees. Therisk of non-compliance remains even if intermittent treatment increases the patient’scomfort. According to Weber (1996), the main reason for failing to keep up the regi-men is quite clear: patients who commence treatment become non-infectious andalready start to feel better after a few weeks. As a result, they tend to weigh the costsof continuing treatment and opportunity costs differently, more in favour of short-term interests, and they no longer feel the need to endure the discomforts of the treat-ment, thereby increasing the growth of multidrug-resistant TB, so that treatmentnearly always fails and patients almost certainly suffer a relapse of the disease.
Another important reason for the non-compliant behaviour of TB patients is related to their stigmatization (Liefooghe et al., 1995; Liefooghe et al., 1999;Meulemans, 2001). Stigmatization occurs when people are given a negative sociallabel that identifies them as deviant, not because their behaviour violates norms butbecause they have personal or social characteristics that lead others to exclude them(Mason et al., 2001; Johnson, 1995). Goffman (1990) distinguished three differenttypes of stigma. First there are abominations of the body, the various physical defor-mities. Next there are blemishes of individual character perceived as weak will,domineering or unnatural passions, treacherous and rigid beliefs and dishonesty.
Finally, there are the tribal stigmas of race, nation and religion, these being stigmasthat can be transmitted through lineage and equally contaminate all members of afamily. These three types of stigma can be said to occur in the medical sphere.
Examples are the tangible social tensions surrounding TB as a result of its infec-tiousness, making everyone at risk, the coughing fits, sweat attacks, phlegm, andthe emaciated ‘skin and bone’ body. The contagiousness of TB is an important factorfor fear and thus stigmatization, because having a TB patient around can potentiallydestroy many more people in the family as they catch TB as well. However, althoughtuberculosis patients are stigmatized by their disease, it does not mean there are noother apparent sources of stigmatization. The power of the concept ‘stigmatization’ Copyright # 2002 John Wiley & Sons, Ltd.
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is such that it targets all social spheres where negative social labels can be assignedto discredit behaviour and turn people into outcasts. The stigmatization caused bythe disease immediately breaks out of the medical sphere and is influenced by allareas of life from that point on. Research, furthermore, reveals that stigmatizationeven continues to complicate the lives of the stigmatized even as treatment improvestheir symptoms and functioning. The stigma does not disappear with the disease. It isperpetuated by other sources (Fife and Wright, 2000; Link et al., 1997). In this studythe factors leading to patient (non-) compliance with TB treatment will be integratedinto a model and we will examine the way these factors affect the behaviour of TBpatients attending a general hospital in the Punjab province of Pakistan.
The setting for this study was the Bethania Hospital in Sialkot, Pakistan (Figure 1).
The hospital is situated in the Punjab province at the east of the Islamabad–Lahoreaxis. Since its founding in 1964 by Flemish Capuchin Fathers as a mission hospital,Bethania Hospital has made an enormous effort to detect and treat tuberculosispatients from the region. It is currently a 215-bed front-line and referral hospital, pro-viding medical and surgical services. One hundred beds are reserved for a specializedTB unit. It has a ward for men and a ward for women, its own outpatient department,sputum laboratory, dispensary and registration unit. About 75% of patients arerecruited from a catchment area of 50 km around the centre of the city of Sialkot.
The National Tuberculosis Control Programme in Pakistan (Directorate of Tuberculosis Control, 1995) proposes short-course chemotherapy for all sputumpositive cases for a duration of 8 months. The guidelines distinguish three maincategories of patients: category I patients are new AFB smear positive cases;category II refers to smear positive relapses and failures after 8 months short-coursechemotherapy; while category III refers to sputum smear negative and extra-pulmon-ary cases, and to children who cannot produce sputum. The guidelines recommend Copyright # 2002 John Wiley & Sons, Ltd.
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for category I patients a daily treatment of four drugs during the intensive phase of 2months (HRZE), followed by a 6 month daily intake of two drugs (HT).y Given thelimited availability of thioacetazone in Pakistan, many centres replace it by etham-butol or streptomycin. The recommended treatment schedule for category II patientscontains five drugs during the initial phase (HRZES), extends the initial phase with 1month (HRZE) and adds rifampicin during the whole duration of the continuationphase (HRT). Category III patients receive three drugs daily during the first 2 months(HRZ) followed by two drugs daily for the next 6 months (HT). Sometimes etham-butol is substituted for thioacetazone. Although efforts have been made lately todisseminate and apply these guidelines more broadly, Pakistan is still notorious forits poor TB control, absence of a policy supporting the WHO DOTS strategy, muchmalpractice in private practice and a poorly accessible low-quality public health caresystem (Khan et al., 2000; Ghaffar et al., 2000; Uplekar et al., 2001; Sen and Sen,1998; Zaidi, 1999; Zaidi, 2001; Thaver et al., 1998; Green et al., 1997).
In the treatment regimen applied in Bethania Hospital, hospitalization is empha- sized during the intensive phase of treatment. Ambulatory patients had bi-monthlyfollow-up visits during the intensive phase of 2 months. All patients were treated onan ambulatory basis during the continuation phase and had monthly appointments tocollect their drugs and for a check-up. Patients living within 15 km of the hospitalwere visited by the field worker if they were late for more than 2 days. Those resid-ing beyond this distance were invited by a letter to visit the hospital to collect theirdrugs.
The study is based on face-to-face interviews carried out at Bethania Hospital,amongst all sputum positive pulmonary TB patients (n ¼ 621) who presented them-selves at the TB unit from September 1997 to October 1998. The patients were inter-viewed at three fixed moments: at the start of the treatment, after 1 month, after 2months and followed-up until the end of the treatment. Every interview was per-formed by a social worker belonging to a team of four. Since the duration of thetreatment was 8 months, the last patients finished their treatment by the end of June1999. During the interviews, based on questionnaires consisting predominantly ofclosed questions and a small number of open questions, information was gatheredabout the demographical and socio-economic profile of the patients, social supportprovided by different networks, the patients’ key values, their knowledge of TB andtheir perception of the curability of the disease, stigmatization and compliance.
The proposed model could be described as a two-step model. First, an explanation issought for the ways in which TB patients are stigmatized. In our model (Figure 2) we yE, ethambutol; H, isoniazid; R, rifampicin; S, streptomycin; T, thiacetazone; Z, pyrazinamid.
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Figure 2. Model of stigmatization and compliance for TB outline four variables based on past research. First, we hypothesize that olderpatients are more stigmatized than younger ones, and second that women are morestigmatized than men (Connolly and Nunn, 1996). Third, we include a latent con-struct ‘support from family’. The basic hypothesis is that a decrease of support froma patient’s family will be associated with an increase in stigmatization. Lastly, thefourth factor is a knowledge-related construct. It is assumed that the less one agreesthat TB is a curable disease, the more one will be stigmatized.
The second step in the model is the causal explanation of compliance (Burman et al., 1997). The model distinguishes three factors. The first factor, i.e. intake med-icine, concerns compliance to therapeutic standards solely with regard to the use ofmedicine. This factor divides patients into two groups after answering the question‘Have you ever, since the last visit, forgotten to take your medicines, even for oneday?’ with a yes or no. The second factor, i.e. regularity of treatment, refers to theregularity with which patients comply with their obligations in the successive stagesof their treatment. This factor is measured by adding the number of missed (late formore than 2 days) appointments with a health professional during the first 2 monthsof treatment. Patients are classified as irregular if they have missed at least oneappointment. The third factor, i.e. the duration of therapy, refers to the potentialto persevere and complete these stages until full recovery. Patients are classified intothree categories to express the level of deviation from the 8 months norm. Defaulterslie under the norm since they interrupted their treatment. Patients whose treatmentwas compulsorily extended because their therapy failed, are classed over the norm.
Those who adhered to the therapy for the full 8 months are the norm.
The outcome variable compliance is viewed from a dichotomous viewpoint.
Compliant patients completed their therapy in full and as a general rule also under-went, at the end of treatment, a test confirming them as sputum smear negative. Non-compliant patients did not complete their therapy so a sputum test was not carriedout. When implementing DOT, these variables become very important, because thesystem explicitly requires the strict intake of medicine, regular visits to health Copyright # 2002 John Wiley & Sons, Ltd.
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professionals and an effort sustained over many months. It would be interesting toexamine the other factors affecting compliance such as the quality of interactionbetween patients and staff. It is important to include this kind of interaction in thestudy when comparing, for example, the effect of DOT on the success of tuberculosistreatment with that of self-supervised treatment. Although our research focused oncompliance with DOT, research designs should also be drawn up for self-supervisedpatients (Zwarenstein et al., 1998).
Manifest variables. The model to be estimated is a non-standard model (Hatcher,1994: 423). It consists of several manifest variables that account for a part of thestructural portion of the model. In other words, we assume that these manifestvariables are perfect measures for the constructs they express. Before we turn ourattention to the latent constructs in the model, we first want to give an overview of itsmanifest variables.
There are three exogenous manifest variables. Sex and age are measured in a straightforward way: men and women on the one hand, and a patient’s age expressedin years on the other. Occupation is measured on an ordinal scale. All occupationsare placed on a social stratification scale thus allowing them to be situated on ahigher or lower societal level. At the lower range of the scale are housewives,unskilled and skilled workers. In the middle range are cottage industry workers,tenant farmers, civil servants, white-collar workers and small business owners.
Finally, at the higher end of the scale are land-owning farmers and large businessowners. The ordinal character of the scale might pose some problems since struc-tural equation modelling requires interval measurement. However, we includedthe occupations scale for two reasons. The first is theoretical: we suspected thatoccupation would be an important determinant in the model we proposed. Second,the scale was developed in Pakistan and fits the specific situation very well, however,we were not able to prove equal and exact distances in the scale.
Latent constructs. In the model we used four latent constructs. Before discussingthe measurement model in more detail, we concentrated on the different items foreach endogenous construct. The family is an important factor in the socialenvironment of the TB patient. Therefore, we tried to include the support of thefamily within the model. Since most patients were married (62%), we had to dealwith both the family and the family-in-law.
Support from the family-in-law was not included extensively in the research. We could only include a latent factor ‘support from family-in-law’ based on two indi-cator variables. We are aware that the latent construct is not firmly measured in thisway. However, the results of the measurement model (Table 1) are acceptable (scalecomposite reliability, c ¼ 0.67). The indicator variables from the construct are mea-sured on a five-point scale (no influence at all–strong influence).
The second latent construct is the support a patient receives from his own family (scale composite reliability, c ¼ 0.52). This construct is based on three indicatorvariables, the first two rated on a five-point scale (strongly discourage–stronglyencourage), the third asking about financial support (No, Yes).
Copyright # 2002 John Wiley & Sons, Ltd.
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Copyright # 2002 John Wiley & Sons, Ltd.
Int J Health Plann Mgmt 2002; 17: 249–267.
A six-point scale (don’t agree at all–strongly agree) was used to rate seven state- ments about stigmatization both at the onset of the treatment (first time) and after 2months’ treatment (second time). The statements were as follows: 1. If someone has TB, he/she avoids talking about it with other persons.
2. If a young person catches TB, he/she will experience the consequences for the 3. It is difficult to earn your living after recovering from TB.
4. People who are treated for TB, should talk to others about it.
5. After recovering from TB, everyone treats you in the same way as before.
6. It is a disgrace for the family to have a family member with TB.
7. Even your best friends sometimes desert you when you have an infectious Two of these statements were most appropriate for measuring latent construct stigmatization (scale composite reliability, c ¼ 0.64), i.e. statement 6, which scoredboth at the onset of the treatment (first time) and after 2 months’ treatment (secondtime), and statement 7, scored after 2 months’ treatment (second time). Again, thefamily plays an important role in this construct. If a person agreed strongly withstatement 6, it is assumed that he feels stigmatized by his family. The same goesfor stigmatization by friends (statement 7). The respondents could indicate whetherthey agreed with the premise that very good friends left them because of their dis-ease. The more they agreed, the more stigmatized they were.
The questionnaire also included questions which tested the TB patient’s medical knowledge, such as ‘Can you give the name of your disease?’, ‘Can you explain howa person gets TB?’, ‘How long do you believe it will take before you can have anormal life again?’ However, the explanatory value of these knowledge-relatedquestions was very limited and became interesting only when questions wereselected which expressed willingness to act as circumstances dictated. The last latentconstruct in the model therefore expresses the patient’s belief in the curability of thedisease and in knowing how to handle its complexity (scale composite reliability,c ¼ 0.68). It is a factor consisting of three indicator variables in which patients wereasked to give their opinion on the complexity of their situation. All indicators weremeasured on a five-point scale (strongly disagree–strongly agree). The indicatorstatements dealt with the opinion on the curability of TB (TB is easy to cure), thecommonness of TB (TB is a common disease) and with the difficulty of TB as adisease itself (TB is a difficult disease and hard to cure).
The measurement model shown in Table 1 provides a reasonable fit to the data.
The 2 test of exact fit is significant, where the objective is to achieve a non-significant p-value. However, Hatcher (1994: 289) indicates that a significant 2does not make the measurement model inadequate. The 2 ratio shows that the ratioof the 2 value and the degree of freedom is lower than 2 (1.7). This indicates that the2 test is within acceptable limits (Marsh et al., 1988). In terms of validity of theconstructs, convergent validity is evidenced by the large and significant loadingsof the items on their posited indicators. Further evidence of convergent validity isshown in Table 2. None of the correlations between the latent constructs are too highto challenge the convergent validity of the constructs.
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Table 2 also indicates the discriminant validity, because the confidence interval ( Æ 2 standard errors) around the correlation estimate between any two latent con-structs never includes 1.0 (Anderson and Gerbing, 1988: 416). The VarianceExtracted Test also shows the discriminant validity of our constructs. This test com-pares the variance extracted from two latent constructs with the square of the corre-lation between these two constructs (Fornell and Larcker, 1981). Discriminantvalidity is shown when the explained variance is greater than the squared correlation.
We compared all pairs of factors and they all showed an acceptable varianceextracted.
The 621 patients were composed of 56.5% men and 43.5% women. Almost sevenpatients out of ten were younger than 40 (Table 3). As far as the nuclear family isconcerned, 62% of patients were married, 31% were single, 5% widowed and 2% Table 3. Frequency distributions of age, gender and occupation of the TB patients Age (mean ¼ 34.8; std dev ¼ 16.3; min ¼ 15; max ¼ 90; p < 0.001) Occupation (mean ¼ 3.1; std dev ¼ 1.4; min ¼ 1; max ¼ 6; p < 0.001) Copyright # 2002 John Wiley & Sons, Ltd.
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divorced. The skills-base of the patients was very low: more than half did not receiveany formal education and the problem of illiteracy among older female patients wasparticularly acute.
During the first month of treatment, 80% of patients were hospitalized; during the second month this number dropped to only 48%. One out of three regarded hospi-talization as problematic. This group’s dissatisfaction was rooted both in economicand medical causes: they had to contend with financial problems, absenteeism, trans-port costs, found themselves in dire straits, doctors were considered as incompetent,the drag of life in the ward, etc.
One-third of patients were the family breadwinner. Remarkably, only one-fifth of patients came from a household with more than three economically active persons,considering that roughly 70% of households consisted of six and often more mem-bers. The small number of economically active persons within the extended familiescannot be attributed to a large number of children, because roughly half of thepatients had fewer than three children and 20% of households did not have any chil-dren under 12.
Throughout the analysis, the operationalization of belief in the curability of the disease often appeared as a variable with serendipity characteristics. This variablemeasures the confidence sick people have in solving their problem situation. Trustenables the complexity of a social system to be reduced: without further ado, the sickcan rely on their partner, family, health professionals etc., to channel their medicalregimen. It is clear that precisely this confidence is shattered by the TB stigma,thereby reducing belief in the curability of TB in general.
Correctly assessing the treatment’s duration is characteristic for patients who strongly believe in the curability of their disease. However, this element of informa-tion is certainly not common knowledge when the treatment starts. Only one in threepatients is aware that the treatment will last several months. However, after 1 monththis number doubles and after 2 months it increases even further. We established thatpatients with the lowest socio-economic status often did not possess the most rudi-mentary, objective, medical knowledge. On the other hand, persons who did notmind regular check-ups, a strict regimen of medication and the costs involved,who thought it would all be worthwhile and were confident their treatment wouldresult in a cure, were not necessarily more skilled or had a higher professional rank.
It would seem that another phenomenon or mechanism is active as far as belief in thecurability of TB is concerned. Thinking exclusively in terms of social stratificationor ‘lumping techniques of rejection together as ways of dealing with marginal cate-gories’ (Douglas, 1994: 85) does not suffice to gain a better understanding of theideal treatment conditions.
Compliance has to be viewed not only from the social stratification perspective but also from the stigmatization perspective. At the onset of the treatment and after 2months’ treatment seven statements concerning stigmatization (see Latent con-structs) were presented to the patients. The statement most people (more than80%) agreed with, both at the onset of the treatment and 2 months afterwards,was: ‘If someone has TB, he/she avoids talking about it with other persons’. If some-one contracts TB it is best to keep quiet about it. The statement only a minority (oneout of four patients) agreed with, both at the onset of the treatment and after 2 Copyright # 2002 John Wiley & Sons, Ltd.
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months, was: ‘It is difficult to earn your living after recovering from TB’. The factthat only very few regarded their TB problem in terms of income is related to the factthat during this life-threatening situation, the treatment has absolute priority andtakes precedence over all other forms of need.
When the onset of the treatment is compared with the situation 2 months later, there are no shifts in the statement’s ranking order. Only two statementspoint to a possible evolution during the first 2 months, but they do not really disruptthe ranking order in any significant way. This refers to the statement ‘People whoare treated for TB should talk to others about it’: 68% agreed at the onset of thetreatment, and 78% after 2 months’ treatment. Whilst 54% agreed at the beginningof the treatment with the statement ‘Even your best friends sometimes desert youwhen you have an infectious disease, like TB’, this dropped to 45% after 2 months’treatment.
To render more precise the model as a whole, we will also focus on the single frequency distribution of the three variables in the tail of the model, i.e. intake med-icine, regularity of therapy and duration of therapy, and of the outcome variablecompliance. After subtracting from the 621 patients the number of patients who havedied (6%), those who have transferred to another treatment centre (2%), and the tinygroup of patients where the treatment failed (1%), 563 patients remained. Accordingto our definition, 77% of the latter group were compliant and 23% were non-compliant. The number of missed appointments was used to indicate the regularityof the treatment: 48% of patients did not miss a single appointment, 34% missedonly one and 18% missed various appointments. As far as the duration of the therapyis concerned, the norm of 8 months is achieved by 55% of patients; the norm is notachieved (<8 months) by 33% of patients and the norm is exceeded (>8 months) by12% of patients. Compared with the results of previous research (Liefooghe et al.,1995; Meulemans, 2000) the compliance rate in Bethania Hospital is gradually evol-ving towards the WHO target to cure 85% of the sputum smear positive tuberculosiscases detected (Raviglione, 2001).
Comparison of the scores of compliant and non-compliant patients on the stigma- tization statements, yields significant results: 72% of patients who agreed with thestatement ‘It is a disgrace for the family to have a family member with TB’, werecompliant. Those who did not agree had a compliance rate of 82%. Other statementsproduced similar findings, for example, ‘Even your best friends sometimes desertyou when you have an infectious disease, like TB’. Those who agreed had a com-pliance rate of 83%. Those who did not had a compliance rate of 89%.
The social workers who conducted the interviews, did their utmost to keep the non-response rate as low as possible. Out of a total group of 621 patients selectedfor the study on the basis of the positive result of their sputum test, everyone parti-cipated in the first interview, i.e. the interview that took place when the treatmentstarted. Their number dropped to 568 patients after 1 month (second interview)and to 528 after 2 months (third interview). Consequently, the chances of samplebias as a result of refusals has been kept to a minimum and can be attributed tothe phenomenon of defaulting or the gradual outflow of patients initially includedin the population. The amount of missing data for the variables used in the modelis also limited.
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The proposed structural model in Figure 2 was tested by using conventional maxi-mum likelihood estimation techniques. The model was fitted to the covariancematrix. In order to avoid the scale indeterminacy problem, each latent constructhas one observed reference variable (which factor loading has been fixed at 1). Itis recommended to use the observed variable that represents the latent constructthe best (Jo¨reskog and So¨rbom, 1993: 173). In our case this meant: Famlaw1 forthe construct ‘Support from family-in-law’, Fam1 for the construct ‘Support family’,Stigma2 for the ‘Stigmatization’ construct and Belief1 for the ‘Belief in curability ofTB’ construct. The model showed an acceptable fit. Again the 2 test of exact fit issignificant but the 2 ratio is lower than two (0.7). All of the path coefficients aresignificant. Anderson and Gerbing (1988) recommend a 2 difference test (CDT)in order to enhance the confidence in the structural part of the model. The CDT com-pares the structural model (which is a restricted theoretical model MT) with anunconstrained alternative model (MU). Since the relevant test statistics lead to anon-significant CDT, the restricted theoretical model MT (Figure 3) is preferred tothe theoretical uncorrelated model MU.
Since most of the test-statistics show an acceptable model, we can look at the results of the two-step model presented earlier. First, we tried to model the influenceson the degree of stigmatization of a patient. These influences come from very dif-ferent sources. The most important factors determining stigmatization are sex andage. Women feel more stigmatized than men. This also holds for older people. Fromthe latent factors, support from the family is the most important. The more onereceives support from one’s family, the less one is stigmatized. Another influenceon stigmatization comes from belief in the curability of the TB construct. The moreone believes that TB is curable, the less one is stigmatized. These results suggest thata robust position within society prevents a person from being stigmatized.
We then tried to link the stigmatization of the TB patients and their compliance with the directly observed therapy. The restricted theoretical model reveals thatthe influence of stigmatization on compliance only becomes clearly visible after Figure 3. Structural model of compliance and TB Significance (p-value): * ¼ 0.05 ** ¼ 0.01 *** ¼ 0.001. Fit statistics for structural model:2ð122Þ ¼ 175:26, p ¼ 0.00; GFI ¼ 0.96; RMR ¼ 0.041; CFI ¼ 0.97; PNFI ¼ 0.72; NNFI ¼0.96; RMSEA ¼ 0.039.
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introducing the regularity and the duration of the therapy as intervening variables.
On closer examination, compliance would appear to be a rather hybrid concept,which can take various forms and has many depths. Compliance comes clearer tothe fore when regularity and duration are separated. In the model, stigmatizationwith an effect of À 0.16, affects regularity. Subsequently, regularity has a directeffect of 0.10 on compliance, but there is a stronger effect on duration and from thereon compliance. The regularity and the duration of the therapy, therefore, form a tan-dem, which can be brought out of balance by stigmatization and no longer providesany guarantees for compliant behaviour.
The structural model (Figure 3) hinges on the latent construct of stigmatization. Stig-matization affects compliance through the tandem of regularity and duration of ther-apy. Persons who have been strongly stigmatized display more irregular illnessbehaviour and find it more problematic to see the difficult and troublesome treatmentthrough to the end. In this respect it could be said that ending or interrupting theregimen is not due to a lack of organization. On the contrary, non-compliance is amechanism which helps to relieve the pain of stigmatization, ensuring that for awhile, the TB patient does not have to be ashamed and can take a break when thepressure of the medical regimen becomes too much to handle. According toGoffman’s terminology, deviating from the standards of the regimen can be regardedas a technique for controlling information. Deciding whether to confide in someoneor keep quiet, to lie or be truthful, and to whom, how, when, and where, are tricks forstopping the exhausting process of blame by society. They are, in summary, strate-gies for managing a spoiled identity. In the model, three social conditions affect thedegree of stigmatization of TB patients. These conditions have to be taken intoaccount to reduce the limits to patient compliance with DOT.
The first condition is related to the demographical situation of the patient and comprises two variables from the exogenous set, i.e. gender and age. Female patientsfeel more stigmatized than male patients, and older patients feel more stigmatizedthan young persons. Both links are highly significant. As housewives or elderlymembers of the extended family, many have a low socio-economic status. For them,health is above all a question of physical strength. The loss of physical strengththrough tuberculosis, the fact that those who have been stricken with the diseasecan no longer perform hard labour, do the housekeeping, are no longer reproductive,etc., are important contributors to stigmatization. This is all the more so in the coun-tryside, where external signs of vulnerability often do not suffice to relieve peoplefrom their normal social tasks in the family, the village and the community.
The second condition closely concerns the belief of TB patients in the curability of their disease. We already said earlier that this latent construct in our researchdisplayed features of serendipity. It is distinct from strict measurements of rationalmedical knowledge because it emphasises praxis, i.e. implementing knowledge andacting on insights. The higher the socio-economic status, the greater the belief in thecurability of TB. It is impossible to ignore the phenomenon of social stratification Copyright # 2002 John Wiley & Sons, Ltd.
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when analysing illness behaviour of TB patients. Patients with a higher professionalrank, have great faith in the curability of their disease. The opposite also applies inequal measure: unemployment and illiteracy are conducive for non-compliant beha-viour. There is a negative correlation between belief in the curability of TB and thedegree of stigmatization. Persons who are convinced they will soon be cured and arecapable of strictly following the medical regimen, will be less stigmatized.
The third condition is situated at the level of the social networks in which TB patients function. As a general rule it can be said that persons who receive more helpfrom others are less likely to be stigmatized. Roughly six out of ten patients are mar-ried, and for married women, the family-in-law occupies the central position in theirsocial network. The model established a negative relationship between support fromblood relatives and support from the family-in-law. Solidarity with the family-in-lawreduces solidarity with blood relatives. This applies both in general, but also in thespecific framework of help and support in times of illness. The fear married femaleTB patients have of being abandoned by their husbands and of being unable to per-form their domestic tasks, should not be underestimated. The model revealed that theTB patients who received the least support from their family were stigmatized themost. This recalls the relational nature of all types of stigmatization.
In Pakistani society, and particularly in many villages and settlements in the Punjab, social networks and stigmatization are inextricably linked and have an enor-mous influence on community life (Khan et al., 2000). The biraderi, the patriarchalnetwork of kinship, forms the framework for social and community networks. Spe-cial events and rites of passage such as birth, the circumcision of a son, marriage andthe death of an old person, strengthen this solidarity within the biraderi. Thebiraderi uses many other occasions to promote social and community networks,and illness is perhaps one of the most important (Eglar, 1960). When a daughter-in-law becomes seriously ill or is hospitalized, her children are either looked afterby the other daughters of the house or are temporarily housed with other members ofthe biraderi. If the sole breadwinner of a household cannot work because he is ser-iously ill, his nearest relatives and other members of his biraderi provide moral,material and financial support. A TB patient who is admitted to hospital, will initiallybe visited by members of his biraderi. He will usually receive a few hundred rupeesand the traditional fruit. However, as news about the nature of the illness spreadswithin the biraderi, contacts become less frequent. The negative correlation betweenfamily support and stigmatization in case of TB is deeply rooted in Pakistani society.
Stigmatization erodes solidarity within social networks and seriously impairs thecivic status of TB patients. ‘The sociological model of the treatment of infectiousdiseases’ (Douglas, 1994: 85) which is required to make the TB treatment acceptedas a standard of care for all TB patients, can only be developed if we recognize thesesubtle social mechanisms.
The distinction made in social policy between universal and selective award of benefits, is also applied at the level of TB control. Weis (1997), for example, distin-guished two treatment policies—universal DOT and selective DOT. Universal DOTis a policy in which it is intended that observed therapy be used for all patients,whereas in selective DOT patients are observed taking medications only if certainselection criteria are satisfied. The criteria may relate to predictive factors such as Copyright # 2002 John Wiley & Sons, Ltd.
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social, housing or economic status; compliance parameters, or drug susceptibilitypatterns. Patients not meeting the selection criteria are placed on traditional self-administered regimens. When studying the determinants of non-adherence to anti-tuberculosis treatment, Dick (1999) wonders whether we use the appropriateresearch methodology. She believes it is particularly important to develop ‘a unifiedconceptual approach’ to adherence in treatment behaviour. In turn, Farmer (1997)argues that often, social scientists mar contributions to an understanding of TB bymaking ‘immodest claims of causality’, regarding its distribution and course. In ourmodel, we focused on stigmatization because it can seriously damage public healthin Pakistan, where taboos concerning tuberculosis are considerable. Other variableshave not been included in the model because it would genuinely pose a risk ofimmodest claims of causality. Nevertheless, the model explicitly confirms theimportance of the patient’s socio-economic status. Although much research will stillbe needed to develop a unified conceptual approach, one thing is already quite clear:economic and cultural determinants are sure to figure most prominently.
Patient compliance with the DOT regimen is an essential condition for combatingthe tuberculosis epidemic both in countries with high and low levels of welfare.
For TB patients, compliance means regularly taking different medicines for a longperiod of time under medical supervision. Many methods are used to make illnessbehaviour as compliant as possible: mass media campaigns, health education andcounselling, mobilization of family members, local liaison persons, volunteers orfield workers as supervisors, ‘chaperones’ for women patients, mailed or telephonereminders of appointments and follow-up to missed appointments, selection of cues(meals, other daily rhythms, etc.) to mentally programme the intake of medicines,serving-up medicines in well-organized containers, financial incentives, etc.
In our research we established that compliance is thwarted by many conditions.
Economic, demographical, geographical, psychological and socio-cultural factorshave an impact on illness behaviour. It is almost impossible to identify which ofthese factors is decisive. Moreover, these factors differ according to the context oftuberculosis. Our empirical material illustrated that the study of compliance isimpossible without the social stratification-perspective. Someone who is economic-ally vulnerable, unskilled and unemployed, poor and socially threatened, will also bethe first to abandon the TB regimen. A low socio-economic status is an importantpredictor of non-compliance and is therefore often used as a criterion for the selec-tive application of DOT.
Furthermore, not only the social stratification perspective, but also the stigmatiza- tion perspective increase insight into the mechanisms of rejection of norms and non-compliance of TB patients. TB patients are stigmatized because their illness disruptstheir lives and causes insecurities. It threatens their social relations and social struc-ture because their illness bears the hallmark of a sub-culture of poverty, weaknessand lack of hygiene. TB gradually and surreptitiously erodes the support afforded bysocial networks. The social network cannot hold out against so much social censure.
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Furthermore, friends fail to muster support and are afraid of becoming ostracized aswell. Completely distraught, patients who are already in a precarious situation fromthe very beginning, are stigmatized even further.
The only way to break this vicious circle, is to develop DOT as the standard of care and a service to all TB patients, rather than being seen as a procedure of last resorts fornon-compliant patients. Although there are usually practical objections against imple-menting a universal DOT regimen, universalism is a powerful driving force, con-stantly encouraging us to consider the target groups which have been reached, andthose which have not. This research has demonstrated that it is essential to perma-nently evaluate DOT and expose possible stigmatization effects. As soon as they havebeen detected, they have to be suppressed by, for example, integrating the programmeinto the primary health care system, available within the most decentralized deliveryunits in Pakistan (tehsils, rural health centres and basic health units), and obviating theneed for hospitalization. Health professionals need to take responsibility for their TBpatients’ compliance with DOT, provide purposeful information, education and takecommunication measures. Different forums such as health committees, women’sclubs, schools and colleges for health promotion and education, and TB associations,are ideally suited for playing an active role. The TB care delivery system needs to belocated as close to the home of the patient as possible, needs to be patient friendly andreliable for the patient, incorporating a complete DOTS strategy.
Financial support from the Belgian Ministry of Foreign Affairs, Foreign Trade andDevelopment Cooperation (DGIS), the Flemish Interuniversity Council (VLIR), theResearch Council of the University of Antwerp (UIA) and the Damien Foundation,Brussels is acknowledged. Suleman Joseph, Bethania Hospital, Sialkot, Pakistan,played an invaluable role in data collection and analysis. We also appreciate theinspiring comments of an anonymous reviewer on an earlier version of this paper.
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