Health-related quality of life in outpatients with substance dependence: evolution over time and associated factors

doi:10.21203/rs.3.rs-961623/v1

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Health-related quality of life in outpatients with substance dependence: evolution over time and associated factors

https://doi.org/10.21203/rs.3.rs-961623/v1

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Background

Health-related quality of life (HRQoL) is an important element of patient care and clinical research. The aim of this study was to describe HRQoL changes and identify associated factors during a 6-month follow-up among outpatients starting care for alcohol or opioid dependence.

Methods

HRQoL was measured at baseline and 3 and 6 months later using the SF-12. Data on sociodemographics, clinical characteristics and patient levels of anxiety and depression were collected using the Hospital Anxiety and Depression Scale (HADS). Repeated-measures analyses were performed to assess factors associated with global HRQoL differences and evolution of HRQoL in both physical and mental scores (PCS and MCS, respectively).

Results

The mean PCS and MCS scores were initially low at 45.4 (SD=8.6) and 36.0 (SD=10.9), respectively. The improvement in HRQoL was rapid in the first 3-month period, then slower and was even maintained over the subsequent 3-month period. Being employed (p=0.012), having no comorbidities (p=0.0144) and no depression (p=0.0041) were associated with significant differences in the average PCS scores at the 3 time points. Patients who had lower overall HRQoL MCS scores on average were those for whom a medication was initiated (p= 0.0086), as was the case for patients with anxiety (p=0.0001) and depression (p=0.0009). Patients with depression at baseline were also those for whom a significantly greater increase in MCS during the 6 months of follow-up was observed.

Conclusion

Our findings highlight the importance of screening early psychological distress and considering other factors associated with HRQoL changes after the first 3-month period in SUD outpatients.

Health Economics & Outcomes Research

Health-related quality of life

outpatient care

substance dependence

follow-up

Substance dependence produces unstable life patterns, as it impacts many areas of an individual’s global functioning across a broad range of life domains [1–2]. It adversely affects the quality of life of patients, including their working life, interpersonal relationships, social activities, and physical and mental states [3–4]. Based on the Global Burden of Disease (GBD) study, substance abuse was responsible for 20 million disability-adjusted life years at the global level in 2010 [5]. Over the last two decades, self-report measures describing patients’ perspectives and experiences of living have been developed and included in studies examining new interventions or models of care to which participants are subjected [6]. There has been an increased interest in quality of life as an outcome measure in the field of substance abuse care [7–9], and patient-perceived health-related quality of life (HRQoL) has become an important acknowledged indicator of treatment effectiveness, patient care/management and recovery in patients with substance disorders [10–12]. It has been shown that HRQoL is consistently low among individuals with SUD who actively seek treatment compared with individuals without SUD or those with chronic psychiatric conditions [13]. Longitudinal studies help to examine HRQoL changes during care. Follow-up assessments from previous works showed that improvement of HRQoL among outpatients with substance use disorders receiving care was rapid in the first 3 months [4, 14–16] and slower over the later period of 3–8 months when HRQoL assessments were continued [15, 17]. A previous work even reported that the best HRQoL was achieved at 6 months of care during a 1-year observation period [18]. The results from longitudinal studies using the SF-36 or the SF-12 with substance use clinical populations reported more improvement, especially in the mental area over time [14, 19]. Divergent findings were reported in the physical area, with some studies showing small but significant improvements in physical component summary scores [4, 20] whereas others did not [19].

Although the literature has shown that specialized SUD treatment enhances HRQoL for dependent patients [11], findings on factors associated with changes in HRQoL are lacking [21]. However, identifying predictors of HRQoL changes with longitudinal studies would advise clinicians how to improve HRQoL in making more improvement strategies as appropriate interventions during the process of care and thus enable health planners, administrators and policy-makers to plan and deliver more effective and efficient care [22–23]. Some studies revealed that QoL improved with abstinence [20], whereas others showed that there was no correlation between a reduction in substance use and HRQoL [24]. In addition, a published study found that sociodemographic and clinical factors, such as marital status, income and somatic comorbidities, explained differences in HRQoL changes [25]. Conflicting findings have been reported regarding the relationship between HRQoL and the presence of other mental disorders [26]. Some previous works have shown that comorbidities impact HRQoL [7, 27], while other authors did not find relationships between HRQoL and comorbidities and associated impaired HRQoL with variables related to patterns of drug use [19, 28].

Although there are several studies that assess HRQoL in the field of addiction research, there are few evaluating its evolution over time using longitudinal design in outpatient settings. Indeed, in addition to inpatient settings, ambulatory care has increasingly become a focus among researchers aiming to improve addiction care for patients with substance use disorders [3, 29]. Therefore, this study aimed to assess dependent outpatients’ HRQoL changes in a follow-up study at 3 and 6 months after initiating outpatient care and to explore related factors associated with HRQoL evolution during this 6-month follow-up period.

Study population

Data for this study were derived from the SUBstance Users Satisfaction and Quality Of Life (SUBUSQOL) study, a prospective multicentric cohort study on HRQoL and satisfaction with care in substance dependence (ClinicalTrials.gov ID: NCT02894476). Inclusion criteria were being aged over 18, having alcohol dependence or opioid dependence according to the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) [30], and beginning care in one of four French specialized addiction treatment investigator centers. The participants were recruited by clinicians who were certified in addiction pathologies and were familiar with the DSM-IV. Treatment included individual motivation enhancement, supportive therapy, pharmacotherapy and assessments of somatic and mental health achieved by multidisciplinary staff, including psychiatrists, psychologists, social workers and specialized nurses.

Data collection

Sociodemographic and clinical data were collected at inclusion (T0), 3 months (T1) and 6 months (T2) after medical interviews and clinical testing. Self-report questionnaires were used to assess anxiety and depression levels at T0 and self-reported quality of life at T0, T1 and T2 (Figure 1).

Sociodemographic and medical data

Patients’ sociodemographic and medical characteristics were collected, such as sex, age, marital status, educational level, occupational status, type of substance dependence, duration of illness, presence of psychiatric and/or somatic comorbidity, medication introduced and origin of the care request. Data related to the physician, including sex, academic qualifications and years of clinical practice, were also reported.

Health-related quality of life

Health-related quality of life was assessed by the validated French version of the SF-12 questionnaire [32]. The questionnaire was completed as part of routine care at inclusion and 3 and 6 months later. The SF-12 includes a subset of 12 items from the earlier SF-36 that covers eight domains: physical functioning, role-physical (that is, role limitations due to physical problems), bodily pain, general health, vitality, social functioning, role-emotional (that is, role limitations due to emotional problems) and mental health [31]. The French version yields valid and reliable clinical assessments of self-reported quality of life among substance users [32]. A physical health component summary (PCS) and a mental health component summary (MCS) were calculated from all 12 items. All scores are transformed into standardized 0–100 scores. Higher scores indicate better self-reported health status.

Anxiety and depression

The French version of the Hospital Anxiety and Depression Scale (HADS) was used to assess symptoms of anxiety and depression [33]. The HADS consists of 14 items, with 7 items assessing the level of anxiety and 7 items assessing depression [34]. Each item is rated on a 4-point Likert scale, and all the scores for both subscales range from 0 to 21. For each subscale, the score is obtained by summing the respective 7 items (the subscale scores range from 0–21). Each subscale has three ranges using cutoff scores indicating severity of distress levels: 0–7 (noncases), 8–10 (mild severity), and 11–21 (moderate or severe severity) [35].

Statistical analyses

Sample description analyses

Continuous variables are described by the means and standard deviations. Medians are used to dichotomize variables where applicable. Categorical variables are described by percentages.

Evolution of SF-12 scores over time

ANOVAs with two factors (patient and time) were used to compare HRQoL scores between 0, 3 and 6 months, and a Bonferroni correction was applied for 2 by 2 comparisons.

Factors associated with SF-12 scores over time

To analyze the associations between sociodemographic and clinical data and HRQoL evolution after 6 months of care, bivariable and multivariable repeated-measures ANOVAs were used (within and between effects). Variables with a p value <0.1 in bivariable analysis were candidates for the multivariable model. Beforehand, the lake of collinearity was verified. No selection procedure was applied in the multivariable model. Finally, Bonferroni tests were used to compare HRQoL scores 2 by 2. Analyses were performed using SAS 9.4 (SAS Inst., Cary, NC, USA).

Ethics approval and consent to participate

Ethics approval was granted by the Institutional Review Board (Comité National Informatique et Liberté DR-2013-156) and ensured the confidentiality of the data collected. Potential participants were informed of the research’s purpose and aims and received guidance about how they could withdraw consent at any point. Consent forms were signed in the presence of a researcher and were kept in the main study site file.

Patient characteristics

Sociodemographic and clinical characteristics are presented in Table 1. Overall, 126 patients were included in the study; 80.2% were men, and 19.8% were women. The mean age was 39.6 years (SD=10.1). In total, 46.3% of the patients were single, 32.5% were married, and 21.2% were separated, divorced or widowed. A little less than one-third of the sample (32%) reported full-time work, and 20% had a high school level of education. Of the sample, 81 (64.3%) patients suffered from opioid dependence, and 45 (35.7%) patients exhibited alcohol dependence according to the DSM-IV criteria. The mean duration of the disorder was 15.7 years (SD=11.0), and 36.5% (n=46) presented somatic and/or psychiatric comorbidity. The baseline mean HADS score for the depression subscale was 8.3 (SD=4.3), and the mean HADS score for the anxiety subscale was 10.5 (SD=4.7). In total, 67.5% had moderate or severe anxiety, and 58.2% had moderate or severe depression.

Fourteen patients required care while undergoing legally mandated addiction treatment. All of the physicians were currently working with patients with substance dependence, and 83 outpatients were screened by a junior physician (65.9%).In 40.5% of all cases, the patient and physician were of the same gender. After 6 months, the average number of medical sessions completed was 13.9 (SD=5.4), and positive changes in substance use behavior were observed for 103 (82.4%) outpatients.

Evolution of HRQOL over time

Scores on the SF-12 over time are shown in Table 2. At T0, the mean SF-12 scores were 45.4 (SD=8.6) and 36.0 (SD=10.9) for the PCS and MCS domains, respectively. The HRQoL scores improved significantly from T0 to T2 (<0.0001 for PCS and MCS after Bonferroni correction), and different patterns of change emerged according to the HRQoL domain. For the PCS, the score improved between T0 and T1 and then reached a plateau by T2, while the score for the MCS still increased from T0 to T2.

Factors associated with average HRQoL during the 6-month follow-up

The associations between sociodemographic and clinical data and global average HRQoL during the 6-month period of care are presented in Tables 3 and 4. Table 3 shows significant associations between the HRQoL average scores on the physical domain and 3 variables: occupational status, comorbidity axis I diagnosis and HADS depression score. Patients who were employed (p=0.012), those with no health problems other than their addictive disorder (p=0.0144) and those with no depression on the HADS questionnaire (HADS depression <8) (p=0.0041) had an average higher overall HRQoL during 6 months of follow-up than the others. No factor interacted with time.

The results for MCS scores are presented in Table 4. Patients who had an average lower overall HRQoL scores were those for whom medication was initiated during the 6-month follow-up (p=0.0086), as was the case for patients with anxiety (p=0.0001) and depression (p=0.0009) at baseline on the HADS.

Factors associated with HRQoL changes over time at the 6-month follow-up

A single significant interaction with time was observed with the HADS depression score, indicating that a difference was found in the magnitude of change in the MCS regardless of the HADS depression score at baseline (Figure 2). Patients with depression at inclusion were those for whom a significantly greater increase in MCS during the 6 months of follow-up was observed.

In this 6-month follow-up study, we investigated longitudinal associations between sociodemographic, clinical and health-related status at baseline and HRQoL changes over time. First, this study indicated seriously impaired HRQoL at baseline, mainly affecting the mental domain. This finding corroborates previous works, which showed that the HRQoL was consistently low among patients with SUD compared with the general population or individuals with other chronic health conditions [11,13,36]. Second, consistent with other studies [14,37] and given repeated assessments of generic HRQoL instruments, this study also found that improvement in HRQoL was rapid in the first 3-month period and then slowed and was maintained over the subsequent 3-month period [38-40]. In contrast to findings about the relationship between treatment for SUD and changes in physical HRQoL [37], our study found significant improvement between the mean SF-12 physical component summary scores during care, particularly during the first 3 months. Even if significant improvement in SF-12 scores was seen, our study’s participants in both the physical and mental domains still had longer recoveries than the European general norms [41].

Among the baseline sociodemographic characteristics, occupational status was the only parameter associated with an average higher overall HRQoL in the physical domain during the 6-month follow-up period. Regarding occupational status, it is well known that being employed is consistently associated with better HRQoL scores [42-43]. In our study, neither length of substance dependence nor changes in alcohol and/or opioid consumption were significantly associated with quality of life functioning during the 6-month follow-up, in line with previous work [7, 44]. This result highlights that other factors may play an important role in the HRQoL for individuals with substance disorders beyond just abstinence or reduction in substance use and that a restricted focus on drug-related issues will only have a limited impact on HRQoL. Therefore, the impact of comorbid disorders on HRQoL is a point of interest in this study, as the presence of self-perceived high levels of anxiety and depression has the largest impact on patients’ HRQoL scores. First, the study found no association between axis I comorbidity and HRQoL scores except on the physical dimension of the SF-12, though the self-perceived high levels of anxiety and depression on the HADS have been shown to affect HRQoL scores. Only one-third of the sample had a comorbidity axis I diagnosis reported by the physician, while more than half of the sample expressed moderate or severe levels of anxiety and depression on the HADS. As previously reported [26], this discrepancy might reflect an important difference in the methodological approach to measuring comorbidity, in particular psychiatric comorbidity for these patients with substance disorders: clinician-based diagnosis vs. structured interviews. Furthermore, it should be noted that the study was conducted in a drug addiction treatment setting, and other prevalence rates could probably be observed in mental health settings. The cooccurrence of SUD and other psychopathologies has been observed in previous works, especially mental disorders [45-46]. The relationships among these disorders are complex and may take three different forms: SUD may be a primary disorder that determines the development of other disorders; SUD may develop as a consequence of other psychopathological disorders; and SUD and other psychopathological disorders may develop together [47].

The study highlighted that patients with depression on the HADS had higher impaired HRQoL than those with no depression on the HADS at baseline but also that they were those for whom a significantly greater increase in the HRQoL mental domain was observed, in particular during the first 3 months. The beginning of the process of care allowed individuals with a likely dual diagnosis to reduce rapidly accommodating behaviors, thus alleviating the burden of illness. The large impact of self-perceived mental status on HRQoL changes suggests the need not only for an early systematic psychiatric screening of persons presenting for substance abuse treatment [48] but also to set up more targeted psychological interventions during care to manage emotional problems and reduce anxiety and depression [49].

This study had some limitations that should be considered when interpreting the results. A primary limitation of this study is the small size of the sample. The patients were recruited from French specialty treatment services, and as a result, the generalizability of these results is limited to other patients in other countries with different recruitment processes or settings. This study is also limited by the fact that we used a generic HRQoL instrument that may not be relevant to patients with SUD due to the specific and different expectations that outpatients may have. However, no specific instrument has yet been developed to assess changes in HRQoL in individuals with SUD [50]. The small R2 of our model suggests that the common HRQoL changes we examined explain only a portion of the variance in change in HRQoL. This finding suggests that other factors not captured in epidemiologic data, such as coping or other psychosocial adaptations to chronic illness, may be related to changes in HRQoL over time [51].

However, one of the major strengths of the study is the prospective design. In light of our results, more research is needed to determine the impacts of various comorbid disorders in SUD patients. To our knowledge, this is the first study applying a multivariate design to assess the independent impact of various demographic-, psychosocial-, substance use- and health-related determinants on HRQoL among outpatients starting care over time and found that the depression score on HADS at baseline was associated with a great improvement in the HRQoL mental domain, especially during the first 3 months. Consequently, beyond health-related aspects in line with psychological distress and the SUD, it appears necessary to pay attention to issues such as housing, social support, and aspects of life that are meant to enhance individuals’ HRQoL over time. Furthermore, as patients with SUD are increasingly treated in ambulatory settings, the factors associated with HRQoL improvements may become of paramount importance. Finally, in this context of outpatient settings, our demonstration of longitudinal associations between health status at baseline and changes in HRQoL indicates that patients are aware of changes in symptoms and daily functioning and can reliably report them on PRO instruments. Including HRQoL in clinical practice may prove useful for monitoring the impact of SUD care on daily functioning.

We found substantially lower HRQOL in outpatients with SUD entering care, especially in their mental HRQOL. A rapid improvement was seen in HRQoL by month 3, which was then maintained over time. Knowledge of the factors associated with HRQoL changes over time in these SUD outpatients is of interest. Taking into consideration these associated factors, such as occupational status, anxiety and depression status, will contribute to the design of comprehensive therapeutic planning. Treatment approaches considering HRQOL are likely to be more effective in patients with SUD as they track anxiety and depression symptoms. Our findings supported the usefulness of both generic HRQoL and mental disorder measurements as evidence benefitting the recovery process in the SUD field.

DSM IV: Diagnostic and Statistical Manual of Mental Disorders, fourth edition; HADS: Hospital Anxiety and Depression Scale; HRQoL: Health related quality of life; QoL: Quality of life; SF-12: Short-Form 12 questionnaire; SUBUSQOL: SUBstance Users Satisfaction and Quality Of Life; SUD: Substance use disorders.

Acknowledgments

The authors gratefully acknowledge the study team and all the care workers for their contributions. We are also grateful to SETHS for supporting this work and to CIC-EC-Inserm CIC1433, particularly to Ms. Pierrez for her assistance.

Authors’ Contributions

SB-B and CB designed the study protocol. AS, PDP, MB, and SV collected the data used in the current manuscript. HR performed the statistical analysis. AS participated in the discussion and writing of the paper. SB-B and CB oversaw the drafting of the manuscript. All authors contributed to reading and critically revising the paper and agree to be accountable for all aspects of the work.

Role of the Funding Source

Nothing declared.

Availability of data and materials

Data will not be shared to protect the participants’ anonymity.

Ethics approval and consent to participate

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and national research committee (Comité National Informatique et Liberté DR-2013-156) and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.
Informed consent was obtained from all individual participants included in the study. Consent forms were signed in the presence of a researcher and kept in the main study site file.

Consent for publication

All authors gave consent for publication.

Conflict of Interest

The authors of this paper declare that they have no conflicts of interest.

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Health-related quality of life in outpatients with substance dependence: evolution over time and associated factors

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