Abstract
Pandemic and the globally applied restriction measures mainly affect vulnerable population groups, such as patients with opioid use disorders. Towards inhibiting SARS-Cov-2 spread, the medication-assisted treatment (MAT) programs follow strategies targeting the reduction of in-person psychosocial interventions and an increase of take-home doses. However, there is no available instrument to examine the impact of such modifications on diverse health aspects of patients under MAT. The aim of this study was to develop and validate the PANdemic Medication-Assisted Treatment Questionnaire (PANMAT/Q) to address the pandemic effect on the management and administration of MAT. In total, 463 patients under ΜΑΤ participated. Our findings indicate that PANMAT/Q has been successfully validated exerting reliability and validity. It can be completed within approximately 5 min, and its implementation in research settings is advocated. PANMAT/Q could serve as a useful tool to identify the needs of patients under MAT being at high risk of relapse and overdose.
Keywords
Introduction
Patients with opioid use disorders (OUDs) constitute a highly vulnerable population group. Indeed, the restriction and social distancing measures adopted by societies to decelerate the COVID-19 pandemic significantly affect their lives through intensifying medical and psychiatric co-morbidity (Volkow, 2020; Williams et al., 2021). This global public health crisis has induced serious changes in the implemented programs of medication-assisted treatment (MAT), since it led to crucial modifications in the delivery of medical care and in the regimen (i.e., management and administration) of medication for opioid use disorders (MOUD) (Chan et al., 2022; Treitler et al., 2022). In particular, there has been a trend observed by the patients with OUDs to offer and buy illicit substances from the black market (Baillargeon et al., 2021), thus altering the management of MOUD, with craving and misuse being the most serious outcomes (Lambert, 2020). Moreover, economic and health disparities, inadequacy of supportive environment, homelessness, imprisonment, psychological trauma, stigma, and barriers that impede access to treatment due to restrictive measures have resulted in the adoption of unsafe practices that disturb the management and administration of MOUD (Vasylyeva et al., 2020). Consequently, relapse to opioids and further impairment of the already problematic quality of life (QoL) of patients with OUDs have been observed; however, reliable tools for the assessment of such situations under extreme periods, such as the COVID-19 pandemic crisis, are lacking (Leventelis et al., 2020a; Tyndall, 2020).
Several uni- and multidimensional scales and tools have been developed to describe and assess specific problems on the procedure of substance use, such as the desire for using, the disorders due to use, or the severity of health problems contributed to substance use (Marsden et al., 1998; McLellan et al., 1992; Tiffany et al., 1993). However, in most of the cases, the existing tools fail to include in their evaluation all potential dimensions of human behavior (Terwee et al., 2007). Regarding the impact of the pandemic on mental health, diverse tools have been developed for the assessment of psychological destruction (Akan, 2022), fear (Zolotov et al., 2022), anxiety (Chandu et al., 2020), preventive behaviors (Chang et al., 2022), the impact of events (Vanaken et al., 2020), and the QoL (Repišti et al., 2020). Referring to patients with OUDs under MAT, most of the available studies have been focused mainly on the description of the emotional states of the patients affected by COVID-19, creating tools for the detection of worries or fear (i.e., the COVID-19 Worry Index and the Fear of COVID-19 scale), or to assess the forces that promote motivation to substance use (Rogers et al., 2020). Other tools have been built to measure COVID-19-related anxiety and depression (Adinolfi et al., 2022), as well as symptoms of anxiety and depressive disorders, suicidal attitude, and substance use disorders due to COVID-19 (Czeisler et al., 2020).
However, the need for the development of a questionnaire that will consider the alterations in the MAT programs dictated by the pandemic through the incorporation of the appropriate and accurate questions is indisputable. The above-mentioned alterations were implemented under the concept that the spread of COVID-19 should also be prevented in MAT programs to protect the members of the vulnerable population who attend them. Towards this direction, specific adjustments in the MAT administration procedures were made. The most important were the confinement of the daily face-to-face visits of the patients in the MAT programs to take their medication, the enhancement of the number of the take-home doses (i.e., 15 or 30 take-home doses, thus the patients visit the MAT programs only once or twice a month), the reduction of the frequency of drug urine screening for toxic substances, and the constraint of the services that offer psychosocial support to the patients (Corace et al., 2022; Del Pozo & Rich, 2020; Harris et al., 2022; Nunes et al., 2021).
All these changes may negatively affect the procedure of successful maintenance treatment, thus preventing rehabilitation via increase of craving. Interestingly, methadone and buprenorphine, along with counseling and psychosocial services offered by MAT programs, aim to the high adherence of patients to treatment. In parallel, this MAT practice intends to reduce illegal substance use and overdose mortality rates, as well as to inhibit aggressive and drug-seeking behaviors (Joseph et al., 2021; Treitler et al., 2022). Notwithstanding, because of the loosening of the regulations on MOUD attributed to COVID-19 measures, concerns regarding the diversion of opioids into the black market and the potential surge of harmful health consequences from misuse and overdose of prescribed medications have emerged (Del Pozo & Rich, 2020; Nagelhout et al., 2017; Nunes et al., 2021). To our knowledge, there is no available tool regarding the assessment of the pandemic impact on the management and administration of MOUD and on several health and social parameters that pertain to MAT patients as evaluated by the patients themselves (Harris et al., 2022). This is an important matter, since examined from the patient perspective, a major context for the observed impact of the pandemic-related changes on mental and clinical parameters could guide research and public health policies to address specific issues as they have been stressed by the patients themselves (Harris et al., 2022). In that end, the main objective of the present study was the development and validation of the PANdemic Medication-Assisted Treatment Questionnaire (PANMAT/Q), an instrument for the management and administration of MOUD, namely methadone and buprenorphine, in patients under MAT programs. It is expected that such a questionnaire, which is oriented toward patients under MOUD, will offer valuable insight concerning the impact of restriction measures applied globally in the COVID-19 era, as well as in similar crises that will potentially arise in the future, on the trajectory to retention to maintenance treatment, and, finally, rehab and social reintegration.
Material and methods
The development of the questionnaire
Conceptual framework
After the onset of the COVID-19 pandemic, the Greek Organization against Drugs (OKANA) and other relevant authorities worldwide provided their patients with their take-home doses for an extended period up to a whole month. The concept for this action was to prevent the patients from visiting them every day, thus preventing the coronavirus spread. In compliance with a period of crisis, the Substance Abuse and Human Services Administration (SAMHSA) emphasized on the maintenance of the adherence of MOUD and encouraged providers to communicate two ideas to encourage the success of this modified way to offer medication to patients (Del Pozo & Rich, 2020). The first idea was that methadone and buprenorphine, as agonist MOUD, are a highly integral part of the therapeutic treatment of OUDs (Del Pozo & Rich, 2020). The second idea referred to the fact that access to treatment, even under this regimen, ensures high adherence and protection of the patients against overdose, whereas, although the danger for MOUD diversion and misuse is existent, it is considered less crucial (Del Pozo & Rich, 2020). To that end, the MAT programs were rapidly adapted in the new reality, regarding both the procedures of medication administration and psychosocial support. Nevertheless, enhancement of medication diversion, misuse, and overdose were often noted, highlighting serious issues emerged from the management of MOUD and retention to treatment due to the COVID-19 pandemic (Corace et al., 2022; Del Pozo & Rich, 2020; Harris et al., 2022; Nunes et al., 2021).
Item generation
The main query of this study was to develop a questionnaire that will offer to professionals the ability to evaluate the management and administration of MOUD, namely methadone and buprenorphine, in patients under MAT programs during a period of public health crisis that is the COVID-19 pandemic. On the basis of the theoretical background and the referred concerns, 35 items concerning mood, substance administration, pandemic measures, sociability, accessibility to therapeutic programs, biopsychosocial support, and wellness were created from scratch and were initially proposed. The chosen type of measurement was a 5-point Likert scale ranging from 1 (i.e., not at all) to 5 (i.e., very much). According to the literature, a 5-, 7-, or 10-point Likert scale allows the respondents to adequately express their feelings in a more sensitive manner compared to a scale with two, three, or four response options (Preston & Colman, 2000).
Content validity
For the validation of the proposed PANMAT/Q, 10 expert scientists in the fields of addiction, psychiatry, nursing, psychology, and questionnaire development evaluated whether the introduced 35 items with a 4-point Likert scale could lead to the desired outcome. After three rounds, 26 items with a content validity index (CVI) > .9 were selected. A CVI ≥ .8 is considered acceptable (Zamanzadeh et al., 2015). The readability of the questionnaire was reviewed by a Greek linguist. Then, 50 patients were invited to assess the language clarity and readability of the items and to identify potential difficulties with questionnaire completion.
Convergent validity
To assess convergent validity, the PANMAT/Q was correlated with the Nottingham Health Profile (NHP) and the Heroin Craving Questionnaire (HCQ). The NHP is a self-administered tool and has been used to evaluate the impact of the COVID-19 pandemic on the QoL of patients under MAT. It evaluates the discomfort of an individual who suffers from various health problems and their effects on his everyday activities. The validity and reliability of the Greek version were high with test-retest reliability coefficients, Spearman's r-value in the range of .77–.86 (Leventelis et al., 2020a). The HCQ is a multidimensional self-administered instrument and has been used to measure the cravings of opioid-addicted patients during the COVID-19 pandemic. The reliability of the HCQ is high as indicated by the value of Cronbach's α = .9 (Leventelis et al., 2020b)
Participants and procedure
Based on the literature, the appropriate number of participants is recommended to be equal to 10 times the number of the items of the questionnaire (DeVellis, 2017). In our case, 260 participants are an adequate population. For the needs of the study, considering a percentage of dropout (usually 10%), 550 patients randomly chosen using an electronic software, who participated in 54 MAT programs of OKANA, received the questionnaire. A total of 463 questionnaires were returned and used for the analysis. All patients were completely informed about the purpose and objectives of the experiment. The confidentiality of personal data was fully ensured, whereas each patient signed a consensus form before participating in the study. According to the inclusion criteria, the patients should be aged over 20 years, they should be long-term users of opioid substances experiencing physical and mental dependence, and they should be active members in MAT programs during at least two quarantine periods during the COVID-19 pandemic. Patients with severe psychopathology and serious pathological problems, which impaired attending the program, were excluded from the study. All patients completed the three above-mentioned instruments, i.e., PANMAT/Q, HCP, and NHP, to assess the effects of the pandemic on the management and administration of MOUD, on craving, and on their QoL.
Administration of MAT
The patients were under either methadone hydrochloride solution (10 mg/mL) or buprenorphine tablets (2–8 mg). Mean doses of methadone and buprenorphine were equal to 72.15 mg/24 h and 15.6 mg/24 h, respectively. According to the literature, daily doses of methadone in the range of 40–100 mg and buprenorphine in the range of 12–14 mg are considered effective (Saxon et al., 2013).
Ethical considerations
The present study was performed in line with the European Union guidelines under the 1975 Helsinki Declaration as revised in 2013 and was approved by the Nursing Department of the University of Peloponnese, Tripoli, Greece and the scientific committee of OKANA.
Statistical analysis
Quantitative variables were expressed as mean values ± standard deviation (SD), and qualitative variables were expressed as absolute and relative frequencies. Exploratory factor analysis was carried out to evaluate construct validity, disclose underlying structures, and reduce the number of variables in the impact of PANMAT/Q. Principal component analysis (PCA) was chosen as an extraction method using Varimax rotation. The Kaiser-Meyer-Olkin procedure for measuring sample adequacy was applied. The cutoff point for factor loadings was .40 and for eigenvalues it was 1.00. Internal consistency reliability was determined by the calculation of Cronbach's α coefficient. Scales with reliabilities greater than or equal to .70 were considered acceptable. Convergent validity was assessed with the association of PANMAT/Q impact factors with NHP and HCQ subscales via Pearson's correlational analysis (r). Discriminant construct validity was evaluated by comparing COVID-19 impact questionnaire factors between the two substitutes using the Student t-test. All reported p values are two-tailed. Statistical significance was set at p < .05 and analyses were conducted using SPSS statistical software (version 22.0).
Results
In total, 463 patients under MAT (76.8% men), whose characteristics are presented in Table 1, voluntarily participated in this study. Their mean age was 44.8 years, their nationality was almost exclusively (97.4%) Greek, and most of them had health insurance (68.5%) and were not married (64.7%). In addition, 41.6% of the participants were high school graduates and 63.8% were unemployed. The mean age at first use was 17.8 years and the mean duration both in MAT programs and of drug use was 7.5 and 16.8 years, respectively. Moreover, 1.5% of the participants had been diagnosed positive for COVID-19, and 6% had been in touch with a case of COVID-19. Furthermore, 39.2% of the volunteers were living in a high-risk area for COVID-19, and 75.2% received buprenorphine as a MOUD (24.8% were under methadone treatment).
The characteristics of the participants.
Note. Values are given as n (%) or mean ± SD. COPD = chronic obstructive pulmonary disease; HCQ = Heroin Craving Questionnaire; NHP = Nottingham Health Profile.
The items of the PANMAT/Q are described in detail in Table 2. Exploratory factor analysis was conducted with Varimax rotation, suggesting six factors, as presented in Table 3. The KMO value was .54 and Bartlett's criterion was statistically significant (p < .001). All loadings were above .4, thus all items were included in a factor. All six factors combined explained 80.23% of the variance. The factor “Mood” included three items and explained 13.72% of the variance. In addition, the factor “Substance administration and pandemic measures” included six items and explained 16.55% of the variance. The factor “Sociability” included five items and explained 13.26% of the variance. Moreover, the factor “Accessibility to therapeutic programs” included three items and explained 9.52% of the variance. The factor “Biopsychosocial support from therapeutic programs” included six items and explained 16.34% of the variance. Furthermore, the factor “Wellness” included three items and explained 10.84% of the variance.
The items of the Pandemic Medication-Assisted Treatment Questionnaire.
Note. Values are given as n (%). MAT = medication-assisted treatment.
The results of the exploratory factor analysis with Varimax rotation and descriptive statistics of the factors emerged.
Corrected item-total correlations and internal consistency reliability of the PANMAT/Q factors.
Note. PANMAT/Q = Pandemic Medication-Assisted Treatment Questionnaire.
Corrected item-total correlations and Cronbach's alpha, if an item was deleted per factor, are presented in Τable 4. All corrected item-total correlations were above .4. The internal consistency reliability was acceptable for all factors. More specifically, Cronbach's alpha was .98 for “Mood”, .83 for “Substance administration and pandemic measures”, .85 for “Sociability”, .76 for “Accessibility to therapeutic programs”, .88 for “Biopsychosocial support from therapeutic programs”, and .86 for “Wellness”.
Correlations of PANMAT/Q factors with NHP and HCQ factors are presented in Table 5. Only “Sociability” was positively correlated with “Energy level” of NHP and “Anticipation of relief from withdrawal or dysphoria” and” Lack of control over use” of HCQ. All other factors were not significantly associated with NHP and HCQ factors.
Pearson's correlation coefficients of PANMAT/Q factors with NHP and HCQ factors.
Note. HCQ = Heroin Craving Questionnaire; NHP = Nottingham Health Profile; PANMAT/Q = Pandemic Medication-Assisted Treatment Questionnaire.
Bold numbers: Statistical significance (p<.05) between the dimension “Sociability” of PANMAT/Q with the dimension “Energy level” of NHP and the dimensions “Anticipation of relief from withdrawal or dysphoria” and “Lack of control over use” of HCQ.
The PANMAT/Q factors by MAT are presented in Table 6. Participants under methadone had a significantly greater impact of COVID-19 in almost all sectors (except for “Accessibility to therapeutic programs”) compared to their counterparts under buprenorphine.
PANMAT/Q factors by substitute.
Note. PANMAT/Q = Pandemic Medication-Assisted Treatment Questionnaire.
Discussion
The present study reports for the first time the development and validation of a psychometric instrument (i.e., PANMAT/Q) for the evaluation of pandemic impact on social and clinical parameters of patients under MAT with methadone and buprenorphine. The PANMAT/Q is referred to patients themselves since it is completed by them and considers the modifications in the MOUD programs that are attributed to the restriction and social distancing measures applied in the context of the COVID-19 pandemic. The questionnaire is a concise and friendly-to-use instrument; it can be completed in approximately 5 min, and it covers all major aspects and barriers that mediate in the management and administration of agonists against OUDs in patients who attend MAT programs. According to the factor analysis, six factors are involved in the management and administration of MOUD in MAT patients during the pandemic crisis. These factors are “Mood”, “Substance administration and pandemic measures”, “Sociability”, “Accessibility to therapeutic programs”, “Biopsychosocial support from therapeutic programs”, and “Wellness”.
Research findings indicate that patients with OUDs have experienced the consequences of the COVID-19 pandemic and the subsequent restriction measures to a large extent, facing increased stress, isolation, and sense of insecurity combined with serious health problems due to opioid use (Tracy et al., 2021). Moreover, parameters that exacerbate the negative impact of COVID-19, such as social stigma, lack or confinement in the availability of the services (i.e., medical care and psychosocial support) of MAT programs, and difficulties in the accessibility (e.g., residence in remote areas) of the patients in MAT programs, seem to negatively affect treatment retention and overdose prevention (Corace et al., 2022; Krawczyk et al., 2022; Lister & Lister, 2021; Nunes et al., 2021; Rosenblum et al., 2011).
Mood, stress, craving, and drug use are strongly interrelated as craving seems to be increased in the presence of both stressful conditions and drug cues (Preston et al., 2018). Mood, a parameter that is utterly dependent on the COVID-19 pandemic, is a very sensitive indicator as to whether a patient with OUDs will continue attending the MAT program. This is the case especially for the “negative mood” when we refer to patients under buprenorphine maintenance treatment (BMT) (Panlilio et al., 2019; Preston et al., 2018). It has also been indicated that “negative mood” is related to the medication administration affecting the retention in treatment, and thus potentially may lead to dropout in BMT patients (Hser et al., 2014; Mattick et al., 2014). In addition, recent data have revealed that COVID-19 stress syndrome could highly motivate an individual who belongs to a vulnerable group (e.g., opioid addicts) to use alcohol or drugs to cope with the manifold negative impacts of the COVID-19 pandemic (Taylor et al., 2021); however, there is a lack of evidence regarding patients under MAT. Similarly, individuals who used drugs occasionally before the pandemic crisis increased the dosage to cope with self-isolation induced by the restriction measures (Taylor et al., 2021). Sociability has been associated with substance use mainly in male adults, while it is positively related to the availability of healthcare services (Chen et al., 2019; Pettersen et al., 2019). It should be noted that it has been demonstrated that the social network constitutes a crucial factor regarding the outcome of a therapeutic program, whereas the development of social relations within the therapeutic programs can increase the possibilities for rehabilitation (Neale et al., 2018; Weston et al., 2018). On the contrary, the fact that opioid-addicted patients are a stigmatized and marginalized population, the lack of availability of treatment and the absence of attractive therapeutic programs are considered serious barriers to engagement and retention in treatment (Nunes et al., 2021). Unfortunately, to our knowledge there are no instruments to address the role of these factors on the management of MOUD as pinpointed by the patients themselves.
This study partly deals with this gap in the literature. Indeed, according to the findings reported herein, sociability was related to the dimensions “Anticipation of relief from withdrawal or dysphoria” and “Lack of control over use” presented in HCQ, and with the factor “energy level” of NHP, indicating the relation of energy, as a factor of QoL and wellness, with the sociability and maintenance of social relationships. Crises including the COVID-19 pandemic have been associated with social isolation, depression, and anxiety (Chiappini et al., 2020; Nguyen & Buxton, 2021), factors that potentially lead to the enhancement of vulnerability and a higher risk of substance use (Goldmann & Galea, 2014). These are the main consequences of the pandemic since the psychosocial support offered from MAT programs allows continuous monitoring of the treatment program, especially when the patients visit the premises of relevant organizations daily, which is not the case during the pandemic (Leventelis et al., 2020a). Noteworthy, intense social support has been associated with higher retention and completion of treatment (Dobkin et al., 2002). Based on the findings by factor analysis, accessibility to the therapeutic programs plays a pivotal role affecting opioid maintenance treatment and, in conjunction with negative mood and social distancing, influences the retention in treatment and risk of overdose (Joudrey et al., 2021; Nunes et al., 2021; Ravndal & Amundsen, 2010). Recent data indicate that these three factors result in a greater risk for treatment dropout (Lister & Lister, 2021).
The present study, through the introduction of the PANMAT/Q, aims to offer a tool for the valid and reliable assessment of the role of pandemic crises in general on the efficacy of MAT on patients under buprenorphine and methadone. This becomes necessary since, according to the scarce literature, the results regarding the impact of COVID-19 measures on the management of MOUD by patients themselves are ambiguous. Either a rise in overdose death rates (Kelley et al., 2021) or no effect on the same parameter after an increase of the take-home doses due to pandemic measures has been demonstrated (Brothers et al., 2021; Joseph et al., 2021). It appears to be a fact, though, that SARS-CoV-2 induces inflammation of the central nervous system, leading to the deregulation of the functions of serotonin, dopamine, and glutamate, which are directly linked to the use and misuse of addictive substances (Cisneros & Cunningham, 2021). Furthermore, according to our findings, the pandemic crisis affects patients under methadone maintenance treatment (MMT) to a higher extent than those under BMT in all the PANMAT/Q factors except for the factor “Accessibility”. Research data have demonstrated that BMT patients exhibit a greater increase in “positive mood” (Nunes et al., 2021), while MMT has been associated with a decrease in mortality rates (Nolan et al., 2015).
It must be pointed out that this study comes with the following limitations. First, the PANMAT/Q was developed and validated for patients with OUDs under MAT only and the findings cannot be generalized. Second, even though the theoretical framework behind the PANMAT/Q is considered comprehensive, it has to be mentioned that it was validated herein under the frame of the COVID-19 pandemic. However, given that pandemic crises and the restricted measures adopted may give rise to new factors that are not included in the PANMAT/Q, it is indisputable that in such a situation, its validation should be probably revisited. Finally, this study represents the validation of a promising tool; nevertheless, its strengths and limitations could be modified after the process of revalidation regarding other categories of patients with OUDs.
Conclusion
Given the high potential for fatal overdose in patients experiencing OUDs, an urgent need arises to understand how this population has experienced the changes that have been made following the pandemic crisis in the assessment of addiction treatment. It appears that the PANMAT/Q addresses this matter properly, since it is a multidimensional instrument that displays high reliability and validity, which are necessary elements to export valid results (Polit & Beck, 2008). We report a successful development and validation of PANMAT/Q in MAT patients under methadone and buprenorphine, as the questionnaire demonstrated internal consistency, reliability, and predictive and construct validity reassuring that it can serve as a valuable tool for the assessment of the impact of pandemic on patients in MAT. It can also serve as a useful and comprehensive method for clinicians, helping to better identify patient needs and those being at high risk for relapse and fatal overdose due to extreme social circumstances that will putatively arise in the future.
Footnotes
Data availability
The data used to support the findings of this study are available from the corresponding author upon request.
Declaration of conflicting interests
The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding
The author(s) received no financial support for the research, authorship, and/or publication of this article
