Assessing biopsychosocial status in people living with HIV: validity, reliability, and responsiveness of BETY-BQ

Abstract

Background

Despite the quality of life (QoL) and biopsychosocial model gain importance in the management of people living with HIV (PLWH), there is lack of a suitable tool addressing the current demand. This longitudinal methodological study describes the validity, reliability, and responsiveness of the Bilişsel Egzersiz Terapi Yaklaşımı-Biopsychosocial Questionnaire (BETY-BQ), which was previously designed to assess biopsychosocial characteristics, including pain coping skills, functionality, fatigue, emotional state, sleep, sexuality, and sociability, resulting from chronic diseases in PLWH.

Methods

BETY-BQ was administered to a total of 150 PLWH in the outpatient clinics of two different hospitals. The Short Form-36 (SF-36), the Hospital Anxiety and Depression Scale (HADS), the Clinical Frailty Scale (CFS), and the FRAIL Questionnaire were used for the validity. For both reliability and responsiveness analyses, assessments were conducted in 30 PLWH. Reliability was evaluated by repeating the assessments at 1-week intervals, and responsiveness was assessed by re-administering the same scales at 3-month intervals.

Results

Moderate to high correlations were found between BETY-BQ and SF-36, HADS, CFS, FRAIL. The correlations between BETY-BQ and SF-36 subheadings ranged from rho=-0.497 to rho=-0.650, p < 0.001, while there were correlations with HADS-Anxiety (rho = 0.717, < 0.001), HADS-Depression (rho = 0.653, < 0.001), CFS (rho = 0.467, < 0.001), FRAIL (rho = 0.559, < 0.001). The score distribution refuted floor and ceiling effects. The reliability of BETY-BQ was confirmed by test-retest strategy (ICC = 0.951). The Cronbach’s α value was 0.943 for the test and 0.963 for the retest. The time-dependent change responsiveness of BETY-BQ was moderately correlated with the depression subheading of the HADS.

Conclusions

BETY-BQ is as a valid and reliable instrument by which, multidisciplinary-interdisciplinary healthcare teams can evaluate the biopsychosocial features among PLWH in a holistic and practical manner. Preliminary findings also suggest its potential sensitivity to change, particularly concerning depressive symptoms; however, further studies are needed to establish its responsiveness fully.

Clinical trial number

Not applicable.

Supplementary Information

The online version contains supplementary material available at 10.1186/s12879-026-12526-0.

Background

Human Immunodeficiency Virus (HIV) infection is a global health problem. Despite the achievements in the fight against HIV infection (like antiretroviral therapy (ART) that suppresses viral replication and revitalizes the immune system), chronic inflammation poses a great challenge for people living with HIV (PLWH) [1, 2]. HIV infection and accompanying comorbidities can lead to accelerated aging and bring about many problems [3, 4]. These problems include conditions such as chronic pain [5], fatigue [6], sleep disturbances [7], mental health issues [8], social isolation, high stigmatization and discrimination, and sexual dysfunction [9], all of which result from chronic HIV infection, adverse drug events, and biopsychosocial factors [10]. Moreover, biological markers (such as viral load or CD4 cell count) can barely define well-being. Determining the treatment success should also include biopsychosocial factors with a holistic approach. The biopsychosocial dimensions should be addressed early and comprehensively in order to reach the ultimate ambitious goal of UNAIDS (Joint United Nations Programme on HIV/AIDS) [11–13].

The lack of a proper evaluation instrument to determine the biopsychosocial dimensions is crippling our efforts in reaching the ultimate goal of quality of life (QoL) in PLWH [8]. In a study in which the questionnaires assessing the QoL of PLWH were examined in detail, the commonly used questionnaires were divided into two categories: HIV-specific (World Health Organization Quality-of-life-HIV Bref (WHOQOL-HIV BREF), Medical Outcome Survey-HIV (MOS-HIV), HIV/AIDS Targeted Quality-of-life (HAT-QOL), World Health Organization Quality-of-life Bref (WHOQOL BREF)) and generic (Short Form-36 (SF-36), European Quality-of-life Instrument–5 Dimension (EQ-5D-5 L)). While both HIV-specific and generic scales are valuable based on the study design and intended use, they also have certain disadvantages. HIV-specific QoL instruments vary in the dimensions they measure, making it difficult to choose, while generic scales are limited in assessing factors specific to the nature of HIV. It is also emphasized that as the number of items in the tools, whether generic or HIV specific, increases, the completion percentage decreases [14]. The available tools are time-consuming while PLWH do not want to spend much time in the hospital environment [15]. Therefore, we can assume that the QoL tools to be used in the studies should include both HIV-specific and generic scales, as well as practical tools that measure multiple dimensions of QoL.

The biopsychosocial model is a theoretical framework that views the individual holistically through biological, psychological, and social dimensions. Bilişsel Egzersiz Terapi Yaklaşımı (BETY) - (Cognitive Exercise Therapy Approach in English) is an innovative exercise model based on physical exercise developed for patients with rheumatism and is an example of a biopsychosocial approach. The BETY approach incorporates the biological component through physical exercise, addresses the psychological aspect by improving coping skills for chronic illness, and promotes social interaction through group-based exercise sessions [16–18]. Bilişsel Egzersiz Terapi Yaklaşımı-Biopsychosocial Questionnaire (BETY-BQ) is created with repetitive statistics based on recovery characteristics of individuals who attended BETY sessions since 2010 [19]. These healing properties stem from the common biopsychosocial problems (pain, functionality, mood, sociability, sexuality, and sleep) that we highlighted earlier, which occur in HIV as in all chronic diseases. BETY-BQ holistically evaluates many biopsychosocial characteristics of the individual, such as pain coping skills, functionality, mood, sociability, sexuality, and sleep [19–26]. The structure of BETY-BQ has been matured upon the feedbacks of individuals with chronic diseases [19]. Considering the parameters it measures, BETY-BQ may offer different perspectives compared to the generic scales commonly used in HIV, such as SF-36 and EQ-5D-5 L. Its distinct structure compared to other generic instruments has the potential to provide researchers with an advantage by enabling them to approach QoL from a different conceptual perspective and to complete the broader picture of QoL assessment, thereby gaining a deeper understanding of PLWH. Another advantage of BETY-BQ is that it is practical and easy to use. Therefore, BETY-BQ differs from its counterparts as it can holistically evaluate aforementioned symptoms in people with chronic diseases in a short time.

We aimed to investigate the validity (construct convergent validity, construct divergent validity, and content validity), reliability and responsiveness of BETY-BQ in PLWH.

Methods

Participants

A total of 157 virologically suppressed PLWH, followed at the outpatient clinics of two hospitals (one tertiary referral university hospital in Ankara, Turkey, and one secondary-level public hospital in Şanlıurfa, Turkey), between May 2022 and May 2023, were invited to participate in the longitudinal methodological study; of these, 150 gave consent. After PLWH who applied to the clinics and met the inclusion criteria were informed about the study in detail, those who accepted were consecutively included, and the purposive sampling method was employed. The inclusion criteria for the study were PLWH over 18 years of age and possessing the ability to read and write in Turkish. The exclusion criteria for the study were lack of informed consent, and illiteracy. A detailed illustration of the participant enrollment flow for the BETY-BQ validation study is presented in Fig. 1. Non-Invasive Research Ethics Committee of Hasan Kalyoncu University reviewed and approved the study protocol (022/025). All the study procedures were performed according to the latest version of the Declaration of Helsinki, and participant names and identifiers were anonymized. All the participants were informed about the study procedures and provided written consent. Furthermore, the study data were collected per the requirements of the Turkish National law (the Law on the Protection of Personal Data) [27]. The study was reported in accordance with the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement for cohort studies to ensure transparency in methodology (https://www.equator-network.org/reporting-guidelines/strobe/). A completed STROBE checklist is included as Supplementary Table 1.

Fig. 1.

Participant Flow Diagram for the Validation of the Bilişsel Egzersiz Terapi Yaklaşımı-Biopsychosocial Questionnaire (BETY-BQ) in People Living with HIV (PLWH)

Study design

Demographic data such as gender, age, body mass index (BMI), disease duration, transmission route, intravenous (IV) drug use, CD4/CD8 count and HIV-RNA values were collected from hospital databases. The number of participants was determined as 150 individuals (at least 5 times the number of 30 items in BETY-BQ) [28]. To minimize potential sources of bias, all paper-based questionnaires were completed by participants under the direct observation of trained researchers (SB, OT, EOS, SDÖ, TDÇ) following standardized administration procedures. The BETY-BQ’s validity, reliability, and responsiveness analyses were conducted per the guidelines of the Consensus-based Standards for the Selection of Health Status Measurement Instruments (COSMIN) [29]. A visual summary of the psychometric evaluation process of the BETY-BQ is shown in Fig. 2. The validity of the BETY-BQ was examined using three methods: construct convergent validity, construct divergent validity, and content validity. To evaluate the construct convergent validity of BETY-BQ, Short Form-36 (SF-36) [30], the Hospital Anxiety and Depression Scale (HADS) [31], Clinical Frailty Scale (CFS) [32], and FRAIL Questionnaire [33], were applied. In addition, age, weight, and height were used to examine construct divergent validity, as they are unlikely to be related to the PLWH’s current condition. High correlations were expected to support convergent validity and low or no correlations would confirm divergent validity. The presence of floor and ceiling effects were assessed for the content validity of BETY-BQ as reported [34].

Fig. 2.

Summary of Psychometric Analyses of the Bilişsel Egzersiz Terapi Yaklaşımı–Biopsychosocial Questionnaire (BETY-BQ) in People Living with HIV (PLWH)

Scores up to 10% of BETY-BQ’s score were considered as minimum (0–12 points), while scores of 90% and higher were considered as maximum (108–120 points). Floor and ceiling effects were considered relevant if > 30% of the PLWH had scores at the limits of the scale [34]. For the reliability analyses, test and retest evaluations were repeated with the same tests on 30 individuals at 1-week intervals. Before the second administration of the BETY-BQ (at 1 week), participants were asked if they had experienced any noticeable changes in their general health status. Only those who reported no changes were included in the test–retest reliability analysis. To determine longitudinal invariance, the same scales were reapplied to the same 30 individuals after 3 months. While the number of participants selected for reliability and responsiveness analyses was based on the number of items in the BETY-BQ, the time intervals (7 days for reliability and 3 months for responsiveness) were chosen to ensure consistency with the methodology used in previous validation studies of the BETY-BQ [19–26]. According to a study by Bujang et al., the minimum number of individuals required for the reliability analysis of a questionnaire is thirty. The selection of 30 PLWH for the reliability and responsiveness analyses of BETY-BQ aligns with the findings of Bujang et al. [35], and this same concept has already been implemented in other validation studies of BETY-BQ [19–26]. In addition, since 30 PLWH were identified for the responsiveness analysis and were required to receive an intervention, following the initial assessment, these 30 individuals participated in BETY group exercise sessions administered via telerehabilitation for a total of 36 sessions over 12 weeks. The intervention content is described in the study by Damar-Örenler et al., where preliminary results are presented [36]. The difference between the results of the two measurements was calculated, and the correlation of the measurements with the time-dependent changes of the scales was analyzed. For the responsiveness of BETY-BQ, the time-dependent measurement correlations of the scales were examined. Measurement error was assessed by calculating the Standard Error of Measurement (SEM) and the Minimal Detectable Change at the 95% confidence level (MDC95). While the ICC was utilized to calculate the SEM, the SEM was used to determine the MDC at 95% confidence limits. SEM was calculated using the formula SEM = Standard Deviation × (square root of (1-ICC)), and MDC95 was derived using the formula MDC95 = 1.96 × SEM × square root of 2.

Instruments

The BETY-BQ was created based on feedback from individuals with various chronic diseases, who expressed the improvements they experienced after participating in BETY group exercise sessions for many years. Unlike traditional methods, BETY-BQ was developed based on patient experiences and comprises 30 items that reflect 30 recovery characteristics as expressed by these patients. BETY-BQ includes questions that reflect these healing characteristics, about pain coping skills, functionality, mood, sociability, sexuality, and sleep. These features are common biopsychosocial problems associated with chronic diseases [19–26]. BETY-BQ has been previously validated in various chronic diseases. BETY-BQ utilizes a 5-point Likert scale (0 = No, never, 1 = Yes, rarely, 2 = Yes, sometimes, 3 = Yes, often, and 4 = Yes, always) and is scored from 0 to 120 points. Higher scores indicate a more unfavorable biopsychosocial status [19]. (The English translation of the BETY-BQ, carried out using the Beaton procedure, is available in Supplementary Fig. 1.)

SF-36, a generic QoL scale, evaluates physical functioning (PF), role limitations due to physical complaints (PR), role limitations due to emotional problems (ER), energy-vitality (EV), mental health (MH), social functioning (SF), bodily pain (BP), general health perception (GH). Each parameter is scored independently, and higher scores indicate a higher QoL [30].

HADS evaluates anxiety (HADS-A) and depression (HADS-D) levels of individuals. A greater score indicates elevated levels of anxiety and depression [31].

CFS evaluates items such as comorbidity, cognitive impairment, and disability. A frailty score is given from 1 to 9, with 1 being ‘very fit’ and 9 ‘terminally ill’. A score of 5 and above is considered fragile [32, 37].

FRAIL is a 5-item scale developed by Morley et al. to detect frailty. Each question is scored 0 or 1 point. The total score can be at least 0 and at most 5 (0 point = Fit, 1–2 points = Pre-Fragility, 3–5 points = Fragile) [33, 38].

Statistical analysis

The statistical analyses were performed using the IBM SPSS Statistics 23.0 (International Business Machines, the Statistical Package for the Social Sciences 23.0) analysis software. Data normality was assessed using visual (histograms and probability plots) and analytical methods (Kolmogorov-Smirnov and Shapiro-Wilk tests). Accordingly, descriptive statistics for quantitative variables are presented as mean ± standard deviation (Mean (SD)) or median and interquartile range (IQR, 25th/75th percentiles) based on distribution characteristics, while categorical variables are summarized using frequency (n) and percentage (%).

To measure the construct validity of BETY-BQ in PLWH, its correlations with SF-36, HADS, CFS and FRAIL were analyzed. The distribution in the data was analyzed with the Kolmogorov–Smirnov test. The Pearson’s correlation coefficient was used when a linear relationship was present between the variables, and the Spearman’s correlation coefficient was used when the relationship was not linear or when the data were not normally distributed. Based on the correlation coefficients (r), the correlation levels were classified as very high for 0.80 < r < 1, high for 0.60 < r < 0.80, moderate for 0.40 < r < 0.60, weak for 0.20 < r < 0.40, and no correlation for 0.00 < r < 0.20 [39]. For scale reliability, the test–retest method was preferred, and the intraclass correlation coefficient (ICC) was calculated. ICC values vary between 0 and 1, and scores in the range of 0.60–0.80 indicate good reliability, whereas those above 0.80 indicate excellent reliability [40]. The Cronbach’s Alpha (α) coefficient, ranging between 0 and 1, was calculated to evaluate the internal consistency of the scale. The Cronbach’s α values were interpreted as acceptable when between 0.7–0.8, good when between 0.8–0.9, and excellent when > 0.9 [41]. The statistical significance level (p) was accepted as < 0.05. In another study on BETY-BQ [20], the ICC value was found to be 0.833. Accordingly, the sample size that needed to be adopted in this study was calculated. Using an F test with a significance level of 0.05, a sample size of 27 participants with 2 observations per participant has 81% power to detect an intraclass correlation of 0.83 under the alternative hypothesis when the intraclass correlation under the null hypothesis is 0.60. For the responsiveness analysis, a ‘change score’ was derived from the difference between the baseline scores of 30 BETY session participants and their scores 3 months later. Effect size (ES) indicates the mean change divided by the standard deviation of the baseline score, while standardized response mean (SRM) represents the mean change divided by the standard deviation of the change score. Values of < 0.20, ≥ 0.20 to < 0.50, ≥ 0.50 to < 0.80 and ≥ 0.80 for the SRM were considered to represent no, small, moderate and large responsiveness, respectively [42]. For ES, values between 0.20 and 0.50 were considered a small effect, 0.51–0.80 a moderate effect, and values higher than 0.80 a significant effect [43].

Results

Demographics

To determine the validity, reliability, and responsiveness of BETY-BQ, a total of 150 PLWH, 33 (22%) female, 114 (76%) male and 3 (%2) transgender PLWH, were included. The age range of the volunteers ranged from 19 to 77 years, with a mean age of 40.18 ± 13.19 years. The mean body weight, mean height, and mean body mass index (BMI) of the participants were 75.61 ± 12.85 kg, 172.15 ± 8.01 cm, and 25.47 ± 3.84 kg/m², respectively. The mean duration HIV infection of the participants was 6.08 ± 5.48 years. Table 1 shows the detailed sociodemographic and clinical characteristics of the participants.

Table 1.

Clinical characteristics of PLWH

	PLWH (N = 150)
Gender n, (%)
Female	33 (22.0)
Male	114 (76.0)
Trans-women	3 (2.0)
Age (year) Mean (SD)	40.18 ± 13.19
Body Mass Index (kg/m2) Mean (SD)	25.47 ± 3.84
Time from diagnosis (year) Mean (SD)	6.08 ± 5.48
CD4 count (IQR)	610.93 (361.0/807.0)
CD8 count (IQR)	696.50 (488.0/964.0)
HIV-RNA value	undetectable
Transmission route n, (%)
Heterosexual	56 (37.3)
Homosexual	48 (32.0)
People who inject	0 (0.0)
Perinatal infection	1 (0.7)
Blood, blood products	3 (2.0)
Unknown	40 (26.7)
Did not disclose	2 (1.3)
Antiretroviral Therapy Regimens n, (%)
TDF/FTC/DTG	47 (31.3)
TAF/FTC/BIC	47 (31.3)
3TC/DTG	29 (19.3)
ABC/3TC/DTG	16 (10.7)
TXF/FTC/ELV/c	7 (4.7)
DTG/DRV/r	3 (2.0)
TDF/FTC/RAL	1 (0.7)

PLWH, people living with HIV; 3TC, lamivudine; ABC, abacavir; BIC, bictegravir; c, cobicistat; DTG, dolutegravir; DRV, darunavir; ELV, elvitegravir; FTC, emtricitabine; r, low-dose ritonavir; RAL, raltegravir; TAF, tenofovir alafenamide; TDF, tenofovir disoproxil fumarate; TXF, tenofovir alafenamide or disoproxil; N, number of participants; IQR, interquartile range

Descriptive statistics of the BETY-BQ and criterion measures

Descriptive statistics for the total score of the BETY-BQ and criterion measures are provided in Table 2. According to the CFS, the distribution of frailty scores was as follows: Very fit – 45.3%, Fit – 33.3%, Managing well – 10.0%, Living with very mild frailty – 5.3%, Living with mild frailty – 3.3%, Living with moderate frailty – 0.7%, Living with severe frailty – 0.0%, Living with very severe frailty – 1.3%, and Terminally ill – 0.7%.

Table 2.

Descriptive statistics of the BETY-BQ and criterion measures

	min-max	Mean (SD)	Median (IQR)
BETY-BQ (B:0-W:120)	0-110	31.19 (24.08)	25.00 (12.00/43.00)
SF-36 (B:100-W:0)
Physical Functioning	0-100	87.07 (16.90)	95.00 (80.00/100.00)
Role Limitations Due to Physical Complaints	0-100	76.73 (33.72)	100.00 (50.00/100.00)
Role Limitations Due to Emotional Problems	0-100	58.44 (41.22)	66.66 (33.33/100.00)
Energy-Vitality	0-100	58.37 (24.12)	60.00 (40.00/80.00)
Mental Health	8-100	65.77 (21.06)	68.00 (48.00/84.00)
Social Functioning	0-100	73.92 (25.82)	75.00 (50.00/100.00)
Bodily Pain	0-100	75.95 (25.28)	80.00 (57.50/100.00)
General Health Perception	0-100	62.77 (23.36)	65.00 (45.00/80.00)
HADS-Anxiety (B:0-W:21)	0–19	6.13 (4.80)	6.00 (2.00/9.00)
HADS-Depression (B:0-W:21)	0–19	5.27 (4.43)	4.00 (2.00/9.00)
FRAIL (B:0-W:5)	0–3	0.56 (0.73)	0.00 (0.00/1.00)

B: Best; W: Worst; BETY-BQ: Bilişsel Egzersiz Terapi Yaklaşımı-Biopsychosocial Questionnaire; SF-36: Short Form-36; HADS: Hospital Anxiety and Depression Scale; FRAIL; FRAIL Questionnaire

Validity analysis

BETY-BQ highly correlated with the SF-36 dimensions EV, SF, BP, GH, and HADS-A and HADS-D. Additionally, moderate correlations were found between BETY-BQ and the SF-36 parameters of PF, PR, ER, MH, and CFS, and FRAIL (Table 3). Within the scope of divergent validity, the correlations between the BETY-BQ score and age, weight, and height were as follows, respectively: rho = − 0.109, p = 0.189; rho = − 0.034, p = 0.677; and rho = − 0.088, p = 0.283. While 38 out of 150 (25.3%) received minimal points (0–12) for the BETY-BQ score, only one person (0.66%) got a maximum score (108–120). Therefore, these values remained below the 30% limit, and no ceiling and floor effects were observed.

Table 3.

Construct convergent validity correlation analysis

BETY-BQ (N = 150)
rho		p
SF-36		< 0.001*
Physical functioning	-0.556	< 0.001*
Role limitations due to physical complaints	-0.497	< 0.001*
Role limitations due to emotional problems	-0.557	< 0.001*
Energy-vitality	-0.650	< 0.001*
Mental health	-0.557	< 0.001*
Social functioning	-0.614	< 0.001*
Bodily pain	-0.601	< 0.001*
General health perception	-0.642	< 0.001*
HADS-Anxiety	0.717	< 0.001*
HADS-Depression	0.653	< 0.001*
CFS	0.467	< 0.001*
FRAIL	0.559	< 0.001*

BETY-BQ, Cognitive Exercise Therapy Approach-Biopsychosocial Questionnaire; SF 36, Short Form-36; HADS, Hospital Anxiety and Depression Scale; CFS, Clinical Frailty Scale; FRAIL, Frailty Questionnaire; N, number of participants; rho, spearman’s correlation coefficient; * p < 0.001

Reliability analysis

The BETY-BQ scores showed internal consistency (Cronbach’s α values were 0.943 for test and 0.963 for retest). An item-total correlation analysis was conducted for BETY-BQ, and if any item were to be removed from the scale, the Cronbach’s α coefficient would be smaller than the coefficient calculated for the entire scale. As a result, no item was removed from BETY-BQ. The item-total correlation varied between r = 0.342–0.782 (p < 0.001).

A total of 30 patients had a second assessment for reliability analysis. The test–retest reliability displayed an overall ICC of 0.951 (95% CI 0.897 to 0.977).

Responsiveness analysis

30 were re-evaluated 3 months after the initial application. BETY-BQ scores before and after BETY sessions were 47.96 ± 29.90 and 35.76 ± 26.12, respectively. While the SRM showed a large effect (3.22), the ES showed a small effect (-0.40). SEM and MDC95 values obtained for the total score of the BETY-BQ were 4.92 and 13.63, respectively.

A moderate correlation was found between BETY-BQ and HADS-D, and there was no correlation between other parameters (Table 4).

Table 4.

Correlation analysis results of BETY-BQ with other scales for responsiveness

	BETY-BQ (N = 30)
	r	rho	p
SF-36
Physical functioning	0.196		0.300
Role limitations due to physical complaints	-0.176		0.352
Role limitations due to emotional problems		-0.102	0.590
Energy-vitality	-0.125		0.511
Mental health	-0.149		0.433
Social functioning	-0.251		0.180
Bodily pain	-0.011		0.954
General health perception		-0.195	0.302
HADS-Anxiety		0.341	0.065
HADS-Depression		0.443	0.014*
CFS		-0.068	0.723
FRAIL		0.068	0.726

BETY-BQ, Cognitive Exercise Therapy Approach-Biopsychosocial Questionnaire; SF 36, Short Form-36; HADS, Hospital Anxiety and Depression Scale; CFS, Clinical Frailty Scale; FRAIL, Frailty Questionnaire; N, number of participants; r, Pearson’s correlation coefficient; rho, Spearman’s correlation coefficient; * p < 0.05

Discussion

In this study, we introduced a brand new measurement tool for determining the effectiveness of QoL interventions in PLWH from a biopsychosocial perspective to the literature. BETY-BQ initially was developed to address the needs of people living with rheumatism where it has widely been accepted and implemented [19–26, 44]. Ongoing inflammation in the setting of HIV infection makes BETY-BQ a promising tool which may also address the needs of physicians targeting the ultimate goal of UNAIDS [13].

Studies investigating comorbidities and their effects on QoL in PLWH are increasing, and there is a need for patient-centered assessments and innovative scales in this area. In line with this point of view, the HIV360 group created a core set of outcome measures to enable the systematic evaluation and comparison of patient reported outcomes (PROs) through scales. They defined the necessary conditions for these outcome measures to be included in the core set, with features such as standardization, holistic perspective, brevity, and ease of application [45]. It is observed that more than one scale is needed in the core outcome set determined by the HIV360 group to evaluate the biopsychosocial impairments of PLWH. In this sense, BETY-BQ, may offer additional options aiding researchers to define QoL in PLWH.

The concepts of validity, reliability and responsiveness are indicators of the quality of the tools implemented [46]. In our study, we evaluated the validity, reliability and responsiveness of BETY-BQ against widely implemented scales i.e. SF-36 [47], HADS [48, 49], CFS and FRAIL [49, 50]. All of the previously developed scales were addressing one single dimension in PLWH, i.e. biological (CFS, FRAIL, and SF-36), psychological (HADS) and social (SF-36). However, BETY-BQ united all those dimensions in a single, easy-to-perform, holistic scale.

In a recent study examining the psychometric properties of health-related QoL scales in PLWH, the SF-36 scale was prioritized to assess QoL [47]. Here we showed that BETY-BQ is highly correlated with EV, SF, BP, GH subheadings of the SF-36 scale. The high correlation found with EV can be explained by the fact that the BETY-BQ items questioning functionality and the questions evaluating the SF-36 EV (questions 23, 27, 29 and 31) have similar content. Question 31 of SF-36 was “Did you feel tired?” while the item 11 of BETY-BQ was “I feel tired.” While BETY-BQ items assessing the emotional state question the person’s positive and negative cognitions by associating them with their illness, the questions assessing MH in SF-36 (questions 24, 25, 26, 28 and 30) evaluate these cognitions without degrading them to disease due to the generic nature of the scale. This difference may have prevented a stronger correlation between BETY-BQ and SF-36 MH. Despite this situation, the moderate correlation obtained between BETY-BQ and SF-36 MH can be explained by the questioning of cognitions related to the disease in other dimensions of BETY-BQ. BETY-BQ’s questions about “social participation” (questions 23–25) and SF section of SF-36 (questions 20 and 32) assess isolation from social life with similar questions. There is a high degree of correlation between BETY-BQ and SF-36 SF. This can be explained by the presence of factors affecting the social status of individuals in other dimensions of BETY-BQ (especially items questioning functionality). Pain status is questioned in the BP section of SF-36 (questions 21 and 22) as the severity of pain and the effect of pain on daily life. BETY-BQ, on the other hand, questions pain (items 1–5) based on the multidimensional characteristics of pain, such as the ability to cope with pain and catastrophization. The fact that the two scales question the subject from different perspectives may explain the relationship between BETY-BQ and SF-36 BP. Although BETY-BQ did not have a question or group of questions that offered general health assessment, the relationship between the total score and the SF-36 GH (questions 1, 33, 34, 35 and 36) was remarkable. It is stated that SF-36, a generic QoL scale, does not give a total score and is not sufficient to detect subtle changes specific to PLWH, including stigma, relationship problems, and comorbidities [47]. It is also noteworthy that, unlike BETY-BQ, which gives a total score, parameters such as sleep and sexuality, among the biopsychosocial impairments of PLWH, are not addressed in the SF-36 content.

In our study, HADS was used to assess the emotional states of PLWH [48, 49]. A high degree of correlation was found between BETY-BQ and both HADS-A and HADS-D. While HADS-A contains items such as tension, anxiety, fear, panic, difficulty in relaxation and restlessness, HADS-D mainly includes items measuring anhedonia [51]. Item 24 of BETY-BQ (“My illness has caused me to withdraw from life.”) not only questions the social status of individuals, but also reflects the state of anhedonia. Item 13 (“Due to the changes my illness has created in my body I feel people are always staring at me.”) of BETY-BQ seems to be related to anxiety and restlessness, item 22 (“I don’t feel comfortable until I’ve completed all of the tasks on my mind.”) to tension and difficulty in relaxation, item 3 (“I am afraid that my pain will get worse.”) to fear and anxiety. The high degree of correlation between a multidimensional scale and a single-dimensional scale can be attributed to the BETY-BQ’s wide-ranging perspective. For instance, questions assessing the sociability parameter also encompass anhedonia, while the questions measuring the pain dimension include catastrophizing.

While current studies suggest integrating frailty assessments in PLWH into clinical practice [52], we explored frailty via CFS and FRAIL scales. FRAIL scale endorsed by the European AIDS Clinical Society (EACS) [53] evaluates frailty primarily in the physical dimension, excluding psychosocial and cognitive factors that are additional drivers of frailty in PLWH [54]. CFS is as a practical screening tool for busy clinics. In CFS, people are categorized according to their functional abilities. Frailty determined by CFS is associated with global cognitive impairment [37]. Here we found moderate correlation between BETY-BQ and both CFS and FRAIL. While CFS evaluates frailty through functional abilities, FRAIL evaluates frailty over parameters such as fatigue, functional loss, concomitant chronic diseases, and weight loss. The questions of BETY-BQ assessing functionality and the parameters in the vulnerability scales overlap. Even at a moderate level, BETY-BQ reflects the dimension of frailty, which is an essential parameter for people living with HIV, and this situation can be considered valuable.

The Cronbach’s α coefficient used in the assessment of internal consistency was found to be high for BETY-BQ (test = 0.943 and retest = 0.963). As a result of the analysis, it was seen that the items that make up the BETY-BQ were internally consistent and maintained their internal consistency regardless of time. In the Turkish validity and reliability studies of other scales used in the study, Cronbach’s α coefficients were found to be 0.792–0.992 for SF-36 parameters, 0.852 for HADS-A, 0.778 for HADS-D, and 0.677–0.822 for FRAIL [30, 31, 33]. In line with this information, it was concluded that BETY-BQ was valid in evaluating the biopsychosocial status of PLWH since it had a better coefficient than other scales. ICC values were calculated using the test-retest method in the analyses performed to evaluate the reliability of BETY-BQ. As part of the test-retest analysis, the data of 30 PLWH who filled out the scales at one-week intervals were evaluated in the categories of very high correlation (r = 0.897, p < 0.001) and excellent ICC (0.951). According to the analysis of ICC values of other scales used in the study (ICC range for SF-36: 0.518 to 0.785, ICC range for HADS-A: 0.696 to 0.725, ICC range for HADS-D: 0.622 to 0.711, ICC for CFS: 0.946, ICC for FRAIL: 1.00), the results were similar to the ICC coefficient of BETY-BQ [30, 31, 33, 55]. As a result, BETY-BQ was thought to be a scale that could be used safely in PLWH since it had better internal consistency than most of the scales recommended for clinical assessment of PLWH.

For responsiveness analysis, the scales were re-administered to 30 PLWH who attended BETY sessions for 3 months. The SRM value was used to evaluate the sensitivity of BETY-BQ, but it could not be compared because the sensitivity of the scales we used was not tested in Turkish validation studies. According to the results of the correlation analysis, a moderate correlation was found between BETY-BQ and HADS-D while there was no correlation between other parameters. However, the lack of significant correlations with other scales may also suggest that the BETY-BQ captures changes not fully represented by traditional measures, highlighting the need for future studies using comparator instruments with known responsiveness. The results obtained suggest that BETY-BQ can more sensitively evaluate the changes in depression, which is the most common neuropsychiatric comorbidity in PLWH [56]. Although the ability of BETY-BQ to detect change is reflected in mood state, it is observed that the same conditions are not valid at the level of frailty scales. This may be due to the fact that psychosocial parameters such as mental health problems, lack of social support and discrimination, which deeply affect PLWH life quality, are not reflected in the frailty scales. Also, future studies may use BETY-BQ to evaluate the effectiveness of different biopsychosocial interventions, as responsiveness analyses are performed after participation in BETY sessions.

According to this study, BETY-BQ provides comprehensive, holistic and multidimensional information about the biopsychosocial characteristics of PLWH, and provides many advantages in terms of presenting them in a short time, in a practical and understandable way. In addition to these advantages, the inclusion of a 5-point Likert system in the questionnaire was thought to allow a more sensitive evaluation of biopsychosocial characteristics and/or changes in these characteristics depending on the interventions given. In addition, BETY-BQ’s questioning of many biopsychosocial features can provide a broad perspective, both in revealing the relationships in evaluation studies and in determining which biopsychosocial parameters an intervention is effective on. We presume that BETY-BQ, among other scales, helps comprehensive evaluation of outcomes in interventional studies.

Our study had some limitations, one of which was the absence of a HIV-specific scale with established validity and reliability for the Turkish population. Although we used the scales recommended for use in HIV studies to analyze validity and responsiveness, these scales were not included in the core set of outcome measures determined by the HIV360 group. However, the core set of outcome measures had not yet been published at the time of this study. Another limitation was that the subgroup used for the test–retest reliability analysis was not randomly selected, as participants were selected based on voluntary participation and availability. Regardless of its limitations, we collected data from two different centers, recruited a sufficient number of participants, and demonstrated that the results of BETY-BQ scale were comparable to those from multi-instrument interventions.

Conclusions

QoL is the ultimate goal of HIV treatment. As Peter Drucker famously stated, “If you can’t measure it, you can’t manage it” [57]. Researchers have a critical need scales to measure the effect of their interventions on the target population. We believe that our scale will address the needs of researchers achieving the ultimate treatment target of UNAIDS. BETY-BQ supports the holistic approach recommended for managing PLWH. BETY-BQ is unique in terms of its biopsychosocial evaluation property, standing out with its advantages such as clarity, brevity, ease of application, quick scoring and change-sensitive features, along with its capability to evaluate various components such as pain coping, functionality, mood, sociability, sexuality and sleep.

Supplementary Information

Below is the link to the electronic supplementary material.

Abbreviations

ART

Antiretroviral Therapy

BETY

Cognitive Exercise Therapy Approach

BETY-BQ

Cognitive Exercise Therapy Approach-Biopsychosocial Questionnaire

BMI

Body Mass Index

BP

Bodily Pain

CFS

Clinical Frailty Scale

EACS

European AIDS Clinical Society

ER

Role Limitations Due to Emotional Problems

ES

Effect size

EV

Energy-vitality

GH

General Health Perception

HADS

Hospital Anxiety and Depression Scale

HADS-A

Hospital Anxiety and Depression Scale-Anxiety

HADS-D

Hospital Anxiety and Depression Scale-Depression

HIV

Human Immunodeficiency Virus

ICC

Intraclass Correlation Coefficient

IV

Intravenous

MH

Mental Health

PF

Physical Functioning

PLWH

People Living with HIV

PR

Role Limitations Due to Physical Complaints

PROs

Patient Reported Outcomes

SF

Social Functioning

SF-36

Short Form-36

SRM

Standardized Response Mean

UNAIDS

Joint United Nations Programme on HIV/AIDS

QoL

Quality of Life

Author contributions

All authors contributed to the study conception and design. SB contributed to investigation, conceptualization, methodology, writing - original draft, writing - review & editing. OT contributed to investigation, conceptualization, methodology, writing - original draft. EOS contributed to investigation, conceptualization, methodology, writing - original draft. SDÖ contributed to investigation, conceptualization, methodology, writing - original draft. TDÇ contributed to investigation, conceptualization, methodology, resources, and supervision. AA contributed to investigation, conceptualization, methodology, writing - original draft. ABT contributed to conceptualization, methodology, writing - review & editing, and supervision. YY contributed to conceptualization, methodology, formal analysis, and writing - review & editing. NBK contributed to investigation, conceptualization, methodology, writing - original draft. MU contributed to investigation, conceptualization, methodology, writing - original draft. MÇS contributed to conceptualization, methodology, writing - review & editing, resources, and supervision. AÇİ contributed to conceptualization, methodology, writing - review & editing, resources, and supervision. SÜ contributed to conceptualization, methodology, writing - review & editing, resources, and supervision. EÜ contributed to conceptualization, methodology, writing - review & editing, and supervision. All authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.

Funding

None declared.

Data availability

The data supporting this study’s findings are available from the corresponding author upon reasonable request.

Declarations

Ethics approval and consent to participate

This study was performed in line with the principles of the Declaration of Helsinki. Non-Invasive Research Ethics Committee of Hasan Kalyoncu University reviewed and approved the study protocol (022/025).

Consent for publication

Not applicable.

Patient consent statement

All the participants were informed about the study procedures and provided written consent. Furthermore, the study data were collected per the requirements of the Turkish National law (the Law on the Protection of Personal Data).

Competing interests

The authors declare no competing interests.