key: cord-0823852-jarov49f authors: Nadort, Els; Rijkers, Nadine; Schouten, Robbert W.; Hoogeveen, Ellen K.; Bos, Willem J.W.; Vleming, Louis Jean; Westerman, Michiel; Schouten, Marcel; Dekker, Marijke J.E.; Smets, Yves F.C.; Shaw, Prataap Chandie; Farhat, Karima; Dekker, Friedo W.; van Oppen, Patricia; Siegert, Carl E.H.; Broekman, Birit F.P. title: Depression, anxiety and quality of life of hemodialysis patients before and during the COVID-19 pandemic date: 2022-04-14 journal: J Psychosom Res DOI: 10.1016/j.jpsychores.2022.110917 sha: c3cd800a894abd907525e5497f7634e594590190 doc_id: 823852 cord_uid: jarov49f Objective To investigate the impact of the coronavirus pandemic on mental health in hemodialysis patients, we assessed depression, anxiety and quality of life with valid mental health measures before and after the start of the pandemic. Methods Data were used from 121 hemodialysis patients from the ongoing prospective multicenter DIVERS-II study. COVID-19 related stress was measured with the Perceived Stress Scale – 10, depression with the Beck Depression Inventory – second edition (BDI-II)), anxiety with the Beck Anxiety Inventory (BAI) and quality of life with the Short Form – 12 (SF-12). Scores during the first and second COVID-19 wave in the Netherlands were compared to data prior to the pandemic with linear mixed models. Results No significant differences were found in BDI-II, BAI and SF-12 scores between before and during the pandemic. During the first wave, 33% of participants reported COVID-19 related stress and in the second wave 37%. These patients had higher stress levels (mean difference (MD) 4.7 (95%CI 1.5; 8.0), p = 0.005) and BDI-II scores (MD 4.9 (95%CI 0.7; 9.0), p = 0.021) and lower SF-12 mental component summary scores (MD -5.3 (95%CI -9.0, −1.6), p = 0.006) than patients who did not experienced COVID-19 stress. These differences were already present before the pandemic. Conclusion The COVID-19 pandemic does not seem to influence mental health in hemodialysis patients. However, a substantial subgroup of patients with pre-existent mental health problems may be more susceptible to experience COVID-19 related stress. The impact of the coronavirus disease 2019 (COVID-19) pandemic on mental health among the general population becomes more evident as the pandemic is continuing. Previous studies show that symptoms of depression, anxiety and stress are common reactions to the COVID-19 pandemic. [1] [2] [3] [4] older age, previous psychiatric history, pre-existent physical or mental health problems, economic insecurity, and accompanying chronic disease including renal disease. [9] [10] [11] [12] [13] Only a limited number of studies investigating mental health during the COVID-19 pandemic among patients with chronic diseases have been performed. This is important as this group of patients are already vulnerable due to high levels of physical and mental distress. Indeed, in dialysis patients, symptoms of depression and anxiety are highly prevalent and associated with adverse clinical outcomes such as decreased quality of life, increased hospitalization and mortality. [14] [15] [16] [17] [18] [19] Perceived stress during the COVID-19 pandemic could increase the burden of these symptoms in these patients. Research investigating mental health problems in dialysis patients during the COVID-19 pandemic could therefore aid in assessing risk factors for and prevention of increased stress levels in these patients. The association between the COVID-19 pandemic and mental health problems in dialysis patients has been investigated in three studies, however, two studies did not compare results during the pandemic with pre-pandemic data. [20] [21] [22] Only the study by Bonenkamp and colleagues compared mental health before and during the COVID-19 pandemic and found no significant difference in mental health related quality of life (HRQoL) and mental health-related symptoms measured with single items from the Dialysis Symptom Index among peritoneal and hemodialysis patients during the COVID-19 pandemic compared to pre-pandemic data. 20 To the best of our knowledge, no studies have investigated the symptom severity of depression, anxiety and perceived stress in hemodialysis patients before and during the COVID-19 pandemic. The aim of this article is first to investigate symptom levels of depression, anxiety and HRQoL in hemodialysis patients during the first and second wave of the COVID-19 pandemic compared to the pre-pandemic era. And second to explore whether depression, anxiety and HRQoL are associated to COVID-19 related stress. J o u r n a l P r e -p r o o f Journal Pre-proof To compare depression, anxiety, quality of life and perceived stress in hemodialysis patients before and during the COVID-19 pandemic in both the first and second wave in the Netherlands, data were used from the ongoing multicenter prospective DIVERS-II study which consists of a randomized controlled trial (RCT) and a parallel observational cohort. , 2020, and data-treatment-completers. A timeline of the data-collection is presented in Figure 1 . The primary outcomes were the severity of symptoms of depression and anxiety, measured with the BDI-II and the Beck Anxiety Inventory (BAI), respectively. [24] [25] [26] Both questionnaires consist of 21 items each, in which respondents are asked how much these symptoms have bothered them in the past two weeks, on a scale ranging from 0 (not at all) to 3 (severely), with a total score between 0 and 63 where higher scores indicate more severe depression and anxiety. BDI-II and BAI scores were analyzed as continuous scores. Both the BDI-II and the BAI are validated in various cohorts of patients with chronic somatic diseases. [26] [27] [28] The minimum clinically important difference (MCID) in symptom score on the BDI-II and BAI which we used was a difference of at least 5 points. 29 The secondary outcome of HRQoL was measured with the Short Form-12 (SF-12), a validated questionnaire developed for patients with chronic conditions and frequently used in dialysis patients. 30 The SF-12 consists of a Mental Component Summary (MCS) score and a Physical Component Summary (PCS) score, on a scale of 0 to 100, where higher scores reflect better HRQoL. 31 We used a MCID of at least 5 points difference on PCS and MCS scores. 32 The secondary outcome of COVID-19 related stress was measured during the pandemic by the Perceived Stress Scale-10 (PSS-10). This is a widely used and validated questionnaire which measures the global levels of stress in the last month by asking to which degree persons find their lives unpredictable, uncontrollable and overloaded. 33, 34 The Dutch version of the PSS-10 translated by the Longitudinal Aging Study Amsterdam (LASA) was used. 35 The 10 questions were answered on a five point Likert scale from "never" (0) to "very often" (4), with a total score between 0 and 40. The scale consists of six negatively worded items and four positively worded items, from which a negative subscale with a score between 0 and 24 and a positive subscale with a score between 0 and 16 can be calculated. We consider 4 points difference as MCID. 36 To determine if perceived stress was related to COVID-19, the following question was added to the PSS-10: "In the last month, how often have you felt that the tensions or "stress", as answered by you in the above questions, were caused by the corona outbreak?" If patients answered "never" or "almost never", their stress was considered J o u r n a l P r e -p r o o f Journal Pre-proof COVID-19 unrelated. Patients who answered "sometimes", "fairly often" of "very often" were considered to experience COVID-19 related stress. At baseline, sociodemographic and clinical data were collected through self-reported questionnaires and electronic patient files. The primary cause of kidney disease was classified according to the European Renal Association-European Dialysis and Transplant Association (ERA-EDTA) coding system and divided into four groups (renal vascular disease, diabetic nephropathy, glomerulonephritis and other). 37 The Davies comorbidity index was used to define the level of comorbidity. 38 This index is based on the presence or absence of seven comorbid conditions, where patients without comorbidities are classified as low risk, with one or two comorbidities as medium risk and with three or more comorbidities as high risk. Follow-up data on COVID-19 PCR test results and COVID-19 related hospitalization and mortality was extracted from electronic patient files. Standard descriptive statistics were used to present baseline characteristics. J o u r n a l P r e -p r o o f The patient flow is presented in Figure 2 . A total of 121 patients were included in the analysis of the first wave and 50 patients in the analysis of the second wave. Baseline characteristics are summarized in Table 1 . The majority of the patients were male (69%), mean age was 67 years, median dialysis vintage was 23 months and ten percent of the patients had a history of depression. In the first wave, a SARS- This study aimed to investigate depression, anxiety and HRQoL in hemodialysis patients during the COVID-19 pandemic compared to the pre-pandemic era and to explore whether depression, anxiety and HRQoL are related to COVID-19 related stress. Overall, no clinically significant differences in severity of symptom levels of depression, anxiety and HRQoL in hemodialysis patients were found between the pre-pandemic era and during the first and second COVID-19 wave in the Netherlands. We did find higher levels of depression and anxiety and lower mental health related quality of life scores in women than in men, which is consistent with literature from the general population. 9-11, 13, 39 Importantly, we found that high depression, anxiety and HRQoL scores were already pre-existent in hemodialysis patients before the COVID-19 outbreak. Cross-sectional studies in dialysis patients during COVID-19 without comparison to pre-pandemic data show a prevalence of depression of 22-27% and a prevalence of anxiety of 12%, but these scores are difficult to interpret as symptoms of depression and anxiety were already highly prevalent in dialysis cohorts before the pandemic. 21 Meta-analyses on self-reported stress among the general population during the COVID-19 pandemic demonstrated similar results (30-40%). 2, 3 In a cross sectional study, 31% of hemodialysis patients experienced high levels of stress during the COVID-19 pandemic using a cut off of ≥ 6 on the PSS-4. 21 We found an even higher prevalence of high stress levels of 38-39% in our cohort using the same cut off score in these four questions from the PSS-10. Although our study does not provide insight in specific reasons for perceived stress during the COVID-19 pandemic, other studies from dialysis populations report that 85% of hemodialysis patients were worried about the risk of infection during the hemodialysis treatment and the transportation to the hospital, and 38% of peritoneal dialysis patients reported that their life was affected by the COVID-19 pandemic because they experienced restriction of activity, fear and panic, restricted hospital access and social isolation. 21, 22 Mortality rates of COVID-19 are known to be higher among patients with pre-existing kidney diseases compared to individuals without pre-existing kidney diseases. 40 , 41 It has been reported that this is one of the reasons that a substantial part of the dialysis patients experiences fear of COVID-19. 20-22 In our cohort, none of the hemodialysis patients were diagnosed with COVID-19 during the first wave and 10% during the second wave. However, observing COVID-19 related disease and mortality of fellowpatients might increase stress in hemodialysis patients. This study has several strengths. First, we compared data on depressive and anxiety symptoms measured with validated questionnaires during the pandemic with data of the pre-pandemic era in hemodialysis patients. Second, this is the first prospective study that reports mental health in hemodialysis patients with additional data from the second wave. This provides longitudinal the current literature on COVID-19 related mental health in dialysis patients with sample sizes of 49 to 177 patients. 20-22 Also, as the upper levels of the 95% confidence intervals we found are still lower than the MCID, it is unlikely that with a larger sample size a clinically relevant difference will be found. Second, selection bias might have occurred since this cohort included patients from an RCT which may play a role in which patients were willing to participate. To address this issue, we offered patients the opportunity to participate in a parallel observational cohort if patients were not willing or motivated to participate in an interventional study. To limit the effect of the intervention on the outcomes of this study, we excluded patients who completed the intervention during the period of the present study from the analysis and performed sensitivity analysis excluding all patients from the intervention group. *Immigrant status is based on country of birth of both patient and biological parents of patient. **Education: Low = primary education, middle = secondary education, high = higher professional education and university. ***Davies comorbidity index: low = no comorbidities, medium = one or two comorbidities, high = three or more comorbidities. ****CVD = acute coronary syndrome, angina pectoris, percutaneous coronary angioplasty, coronary artery bypass surgery, heart failure, peripheral arterial vascular disease, stroke. 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Ann Units in the United States Patientreported outcome measures ( PROMs): making sense of individual PROM scores and changes in PROM scores over time COVID-19 in dialysis patients: outlasting and outsmarting a pandemic COVID-19 Among US Dialysis Patients: Risk Factors and Outcomes From a National Dialysis Provider Note: Values are presented as mean ± standard deviation Note: Before the pandemic and during the first wave COVID-19 related stress n=24 and COVID-19 unrelated stress n=49. During the second wave COVID-19 related stress n=15 and COVID-19 unrelated stress n=25 Analyzed with a linear regression model, adjusted for age, sex, immigrant status and high comorbidity score. Abbreviations: PSS-10 HD, hemodialysis; COVID-19, Corona virus disease 2019; CI, confidence interval The authors are grateful to the participating dialysis centers and the trial team for their precious work. This study is supported by ZonMW [grant number: 843001804] and OLVG hospital in Amsterdam.The funders did not have any role in study design, writing the report, or the decision to submit the report for publication. The authors have no competing interests to report.