10.2478/sjph-2020-0003 Zdr Varst. 2020;59(1):18-26 Ratislavovâ K, Stîpkovâ M. The perinatal loss care educational programme and its evaluation. Zdr Varst. 2020;59(1):1-7. doi: 10.2478/sjph-2020-0001 THE PERINATAL LOSS CARE EDUCATIONAL PROGRAMME AND ITS EVALUATION IZOBRAŽEVALNI PROGRAM ZDRAVSTVENE NEGE OB PERINATALNI IZGUBI IN NJEGOVA EVALVACIJA Katerina RATISLAVOVÂ1*, Martina ŠTIPKOVA2 'University of West Bohemia, Nursing and Midwifery, nam. Odboje 18, 32300 Pilsen, Czech Republic 2University of West Bohemia, Faculty of Philosophy, Univerzitni 8, 30100 Pilsen, Czech Republic Received: Jun 17, 2019 Original scientific article Accepted: Sep 17, 2019 ABSTRACT Keywords: perinatal loss care, education, healthcare professionals, blended learning, evaluation research Introduction: Working with bereaved parents is an immense challenge for professionals in the field of perinatal care and requires a high level of knowledge and skill. This article aims to evaluate the effectiveness of the Perinatal Loss Care blended educational programme. Methods: An evaluative assessment was carried out using a scored questionnaire to gather pre- and postprogramme data. Participants were medical and healthcare professionals (n=200) who participated in the programme voluntarily (the Medical Professional/Motivated group and the Others group) or were selected by their employer and for whom attendance was mandatory (the Medical Professional/Non/Motivated group). Results: Participants' perception of their own knowledge and understanding of perinatal bereavement care was significantly higher on completion of the educational programme, proving its effectivity. There was a statistically significant effect on overall score in individual groups of respondents, as well as the whole set (p<0.001), with post-intervention scores higher than pre-intervention scores. No statistically significant differences in overall score were detected before participation in the educational programme in individual groups (p=0.204). Participants from the Medical Professional/Non/Motivated group achieved lower post-intervention scores to a significantly greater extent (p<0.05) and more often perceived the educational programme as being "very difficult" (x2=20.66, df=6, P<0.01) compared to other groups. Conclusions: The educational programme was assessed as effective. Care of bereaved parents has its specifics and healthcare professionals should possess a basic knowledge of how to provide sensitive care during this time. IZVLEČEK Ključne besede: nega ob perinatalni izgubi, izobraževanje, strokovnjaki s področja zdravstvene nege, kombinirano učenje, evalvacija programa Uvod: Delo z žalujočimi starši predstavlja neverjeten izziv za strokovnjake na področju perinatalne nege in zahteva visoko raven znanja in sposobnosti. Prispevek ocenjuje učinkovitost izobraževalnega programa Nege ob perinatalni izgubi. Metode: Z uporabo vprašalnika se je izvajalo ocenjevalno poročilo za zbiranje podatkov pred in po izvajanju programa. Sodelujoči so zdravstveni strokovnjaki in strokovnjaki s področja zdravstvene nege (n = 200), ki so v programu sodelovali prostovoljno (skupina zdravstvenih strokovnjakov/motiviranih in skupina ostalih) ali so jih izbrali njihovi nadrejeni, njihovo sodelovanje pa je bilo obvezno (skupina zdravstvenih strokovnjakov/ nemotiviranih). Rezultati: Dojemanje sodelujočih o svojem lastnem znanju in razumevanje nege ob perinatalni izgubi je bilo po končanem izobraževalnem programu značilno višje, kar dokazuje njegovo učinkovitost. Podan je tudi statistično značilen učinek na splošen izid posameznih skupin anketirancev ter na celoten set (p < 0,001) z višjimi rezultati po izvedbi od rezultatov pred izvedbo izobraževanja. Pri splošnem rezultatu ni zaznati statistično pomembnih razlik pred sodelovanjem v izobraževalnem programu v posameznih skupinah (p = 0,204). Sodelujoči iz skupine zdravstvenih strokovnjakov/nemotiviranih so dosegli nižje rezultate po izvedbi v statistično pomembnem obsegu (p < 0,05) ter so pogosto izrazili, da je izobraževalni program »zelo zahteven« (x2 = 20,66, df = 6, P < 0,01) v primerjavi z drugimi skupinami. Zaključek: Izobraževalni program je ocenjen kot učinkovit. Nega žalujočih staršev ima posebnosti in strokovnjaki s področja zdravstvene nege potrebujejo osnovna znanja, kako v tem času ponuditi občutljivo nego. 'Corresponding author: Tel. + 42 06 079 558 42; E-mail: ratislav@kos.zcu.cz Z Nacionalni inštitut za javno zdravje © Nacionalni inštitut za javno zdravje, Slovenija. 1 10.2478/sjph-2020-0003 Zdr Varst. 2020;59(1):18-26 1 INTRODUCTION Perinatal loss (miscarriage, stillbirth, neonatal death) is a psychologically stressful event and parents endure agonising sorrow following the death of a baby. In the Czech Republic, around 450 women and their families experience perinatal loss every year. For most women experiencing perinatal loss, the quality of care from medical professionals has a direct effect on their psychological health and the grieving process (1-3). Medical professionals refer to stillbirth as one of the most difficult experiences in the field of obstetrics (4) and describe the support and care of bereaved parents as demanding and complicated (5, 6). Working with bereaved parents is an immense challenge for professionals in the field of perinatal care and requires a high level of knowledge and skill. Positive attitudes in healthcare professionals toward care for parents who suffered perinatal loss are associated with previous education in the field of care for bereaved parents, support of a dedicated bereavement team, and hospital policy supporting the care for bereaved parents (7, 8). Most professionals who deal with the experiences of parents after perinatal loss point out the need for evidence-based training in care after perinatal loss using a parent-centred integrated pathway to improve the experience of bereaved parents (3, 7, 9-11). In the Czech Republic, however, education in this field of care is insufficient. This is why the Perinatal Loss Care (PLC) course was created. This article aims to evaluate the effectiveness of the PLC-blended educational programme in the Czech Republic. 2 METHODS The PLC educational programme is intended for medical and healthcare professionals who are involved in the care of bereaved parents. It is designed to incorporate theory and practice and has a duration of 10 weeks. It is based on a holistic approach to perinatal bereavement care with an emphasis on bio-psycho-socio-spiritual elements. A blended learning approach was chosen, as is recommended by Kavanaugh et al. (12) in respect of sensitive and often emotional content associated with grieving and bereavement. The theoretical part of the programme is divided into 10 lectures available to participants in the form of e-learning. Medical professionals consider online learning opportunities as suitable for their working conditions and needs (13). Every week a new lesson of the educational programme is made available to participants. The educational goals of individual lessons are stated in Table 1. Table 1. Learning objectives of the PLC educational programme. 1. To understand the bereavement process after perinatal loss. 2. To define the principles of communicating adverse news to parents. 3. To critically evaluate the plan for the care of women during stillbirth. 4. To critically evaluate the plan for the care of parents during the death of a premature or disabled child. 5. To plan an intervention during the hospitalisation of women after perinatal loss. 6. To describe the main areas of education for women before release from hospital. 7. To understand the prospects of coping with grief after perinatal loss. 8. To distinguish normal and complex bereavement. 9. To describe the prospects of professional and nonprofessional help for parents after perinatal loss. 10. To apply the principles of mental hygiene. Training content is complemented with current research, audio-visual recordings on perinatal palliative care, references to literary resources, and the testimonies of parents who have experienced perinatal loss. During the course, participants are able to discuss individual topics with each other and with tutors. Participant involvement is supported with the allocation of tasks in an interactive online depository. At the end of the e-learning educational programme, participants take a theoretical test. The educational programme is led by two tutors (professionals in the fields of midwifery and psychotherapy). They also participate in leading practical seminars (2x8h classroom activities), which are arranged after the 5th and 10th e-learning lessons. The seminar includes workshops, role plays to resolve model situations, communication skills training, the application of psycho-relaxing exercises, and meetings with parents who have experienced the death of a baby. During the seminars, instructors create a safe place in which participants are able to discuss sensitive topics. Participants voluntarily play various roles in model situations. Personal and professional vulnerabilities are acknowledged and, following the workshops, a clearer understanding of accessible support strategies is gained. The recommended number of participants in the programme is 20-30. Ten weeks for the educational programme was chosen intentionally, as longer educational programmes are known to have a greater chance of changing attitudes toward caring for dying patients than one-off lectures (14). 2 10.2478/sjph-2020-0003 Zdr Varst. 2020;59(1):18-26 The goal of the PLC educational programme is to improve participant knowledge of PLC, therefore, an evaluation was carried out. 2.1 Study Design The PLC educational programme was evaluated quantitatively using pre/post-test, three group design (divided according to occupation and motivation for participation in the educational programme; see Sample). Surveys were administered pre- and post-training to attendees in 2015-2017. These courses were always led by the two same instructors and saw a total of 242 participants. The surveys focused on the perceived level of knowledge in participants, their expectations, and perception of the difficulty of the PLC educational programme. The researchers were able to compare perceived knowledge before and after an intervention due to a baseline of target population established based on surveys (15). 2.2 Sample The PLC educational programme was offered to hospitals in the Czech Republic via e-mail, and an offer of the course was available on the "Empty Cradle" website - that of a group of parents who have experienced perinatal loss. A total of two hundred participants were incorporated into the evaluation research, all of whom agreed to take part in the research and all of whom completed the pre- and post-intervention tests. For the purposes of data analysis, participants were divided into three groups. The first group (Medical Professionals/Motivated) consisted of medical professionals who chose to participate in the educational programme as a part of their lifelong education and who wanted to actively deepen their knowledge in the field of the care of bereaved parents. The second group (Medical Professionals/Non/Motivated) consisted of employees from a gynaecology-obstetrics clinic in the Czech Republic whose employer paid for the educational programme and whose attendance on the course was compulsory. The goal was a blanket training of the staff of one workplace and the seminars took place at the gynaecology-obstetrics clinic. The third group (Others) consisted of participants in the educational programme from various occupations, who were in one way or another involved in the care of bereaved parents and who were interested in obtaining new knowledge and skills in this field. Seminars for the Medical Professionals/Motivated and Others groups were held collectively (in mixed groups) at an educational centre in Prague. 2.3 Data Collection Tool and Process The construction of the evaluation questionnaire was inspired by the UBET tool (16). The evaluation questionnaire that was used comprised of questions focusing on the perceived level of knowledge of the respondents before and after the completion of the educational programme (see Table 2). Table 2. Pre- and post-test and points rating. Questions Possibilities/ Scales Points How much do you know about the psychosocial care of parents after perinatal loss? I know the rules on communicating information about the death of a baby to parents. How would you intervene in the physical contact of a woman with her stillborn baby? I am able to recognise cases in which the grieving process of a woman has become complex and she needs professional psychological help. I know effective tools of mental-hygiene and I know how to use them in practice. 1-10 1-10 No - more likely no - more likely yes - yes 0-3 a) I would recommend the woman see and hold the baby. 0-3 b) I would provide information on how the woman could physically say goodbye to the baby. c) I would not recommend the woman physical contact with the stillborn baby. d) I would ask the woman if she wanted to see or hold her baby. No - more likely no - more likely yes - yes 0-3 No - more likely no - more likely yes - yes 0-3 Total 1-22 3 10.2478/sjph-2020-0003 Zdr Varst. 2020;59(1):18-26 The questionnaire was always completed before the start of the educational programme and, after its completion, respectively before the final practical seminar, in which further questions could be asked or further information added. Within the framework of a mathematical-statistical analysis, the shift in the perceived level of respondent knowledge was measured using applied standard scales in a Paired T-Test. The degree of compliance was also tested using a Pearson Chi-Square test. Testing was performed using the SPSS and SASD programmes, version 1.5.6. The Medical Professionals/Motivated, Medical Professionals/ Non/Motivated and Others groups were tested separately and, subsequently, the entire set together. 3 RESULTS 3.1 Demographic Data A total of 200 participants met the criteria of the study. Their demographic characteristics are represented in Table 3. All categories were strongly dominated by women, who made up 93% in total. The first group (designated Medical Professionals/Motivated) consisted of 74 participants, of whom 53 were midwives, 9 neonatal nurses, 2 obstetricians, and 10 neonatologists. The second group (designated Medical Professionals/ Non/Motivated) included 27 midwives, 51 neonatal nurses, and 9 neonatologists, with 87 participants in total. The third group (designated Others) contained 39 participants, including psychologists, social workers, doulas, counsellors, priests, crisis interveners etc. Table 4. Results of pre and post-tests scores by category of attendants and in total. Group Mean pre-test scores (SD) Mean post-test scores (SD) Medical Professionals/ Motivated 9.76 (3.28) 18.00 (1.90) Medical Professionals/ Non/Motivated 9.05 (3.20) 17.32 (2.34) Others 10.05 (3.33) 18.41 (1.81) Total 9.51 (3.28) 17.79 (2.13) Min. 1 point, max.22 points No statistically significant differences in total score before the completion of the educational programme in individual groups were identified (p=0.204). However, significant differences in total score were identified in individual groups after the course. Participants from the Medical Professionals/Non/Motivated group achieved lower scores to a significantly greater extent, and participants from the Others group achieved higher scores to a significantly greater extent (p<0.05). During the analysis of individual answers from the evaluation questionnaire, some significant differences between individual groups of respondents were identified. To the question "How would you intervene in the physical contact of a woman with her stillborn baby?" a statistically significant shift in the choice of possible answer was unequivocally proven (see Table 5). Table 3. Descriptive statistics (mean and SD or relative frequency) by group. Medical Medical Others Total Professionals/ Professionals/ Motivated Non/Motivated Gender 90.54 (women %) Age 37.84 (8.65) N 74 95.4 92.31 93 39.13 36.95 38.23 (7.7) (7.64) (8.06) 87 39 200 3.2 Evaluation A statistically significant effect in the total score was observed in individual groups of respondents, as well as in the whole set (p<0.001) with post-intervention scores higher than pre-intervention scores (see Table 4). 4 10.2478/sjph-2020-0003 Zdr Varst. 2020;59(1):18-26 Table 5. The evaluation of the question "How would you intervene in the physical contact of a woman with her stillborn baby?" in pre- and post-test. "How would you intervene in the Medical Professionals/ Medical Professionals/Non/ Others physical contact of a woman with Motivated Motivated her stillborn baby?" pre-test post-test pre-test post-test pre-test post-test % % %% %% a) I would recommend the woman see 23.0 and hold the baby. b) I would provide information on how 44.6 the woman could physically say goodbye to the baby. c) I would not recommend the woman 0 physical contact with the stillborn baby. d) I would ask the woman if she wanted 32.4 to see or hold her baby. 36.5 24.1 48.3 23.1 17.9 60.8 46.0 46.0 53.8 82.1 0 0 0 0 0 2.7 29.9 5.7 23.1 0 In the whole set, and in the groups of medical professionals (Motivated and Non/Motivated), the shift was proven at the level of p<0.001, in the group of Others at the level of p<0.05. After completion of the course, in all cases, a statistically significant decrease was observed in the choice of answer d) "I would ask the woman if she wanted to see or hold her baby," and a statistically significant increase was observed in the choice of answer b) "I would provide information on how the woman could physically say goodbye to the baby," (with the exception of the Medical Professionals/Non/Motivated group, where the choice of answer b) did not change). The choice of answer a) "I would recommend the woman see and hold the baby," also saw a statistically significant increase, with the exception of the Others group. Before the completion of the PLC educational programme, respondents anticipated that during the programme they would improve their knowledge and secure more assurance in the psycho-social care of bereaved parents, meaning they would, therefore, be better able to cope with the situation of perinatal loss. Participants' expectations of the PLC educational programme were 83.8% fully met in the Medical Professionals/Motivated group, 52.9% in the Medical Professionals/Non/Motivated group, and 84.6% in the Others group. Participants mostly perceived the programme as being "moderately challenging" (58.1%). Participants from the Medical Professionals/Non/ Motivated group assessed the course as statistically significantly more often as "very challenging" (x2=20.66, df=6, P<0.01). 4 DISCUSSION Participants' perception of their own knowledge and understanding of perinatal bereavement care was significantly higher after the completion of the PLC educational programme, proving its effectiveness. The effectiveness of the course could be affected by the combination of extremely efficient teaching methods. The blended learning method was chosen for the course, with online asynchronous e-learning on the one hand and personal meetings on the other, where elements of psycho-social training were used for the development of communication skills and the use of therapeutic techniques in the care of bereaved families. Positive effects of the course manifested in all three groups of participants (Motivated and Non/Motivated Medical professionals and Others). Each group, however, exhibited their own specific features. The Medical Professionals/ Non/Motivated group received the lowest scores in the post-test. These participants attended the course at their employer's behest; some exhibited an interest in education in this field, while others felt coerced into participating and felt that they had never encountered the situation of the death of a baby in practice. Their need for competence and autonomy, therefore, remained unfulfilled, which probably led to a negative impact on their learning experience and the satisfaction they obtained. One question that remained unanswered in this research was whether the various medical professions benefitted from the course to the same extent. Participants in the PLC educational programme were predominantly midwives and neonatal nurses; only 2 male obstetricians were present, with no female obstetricians at all. 5 10.2478/sjph-2020-0003 Zdr Varst. 2020;59(1):18-26 Therefore, they cannot be statistically compared. It can, however, be assumed that the attitude of the obstetricians toward bereavement care will differ. A qualitative study by Montero et al. (17, p. 1409) includes a statement by one of the obstetricians: "I don't believe that education is necessary, because we know intuitively how to manage these situations." In general, very little is known about obstetricians' reactions to perinatal death. Feelings of guilt and failure in obstetricians who care for women after perinatal loss (10, 17), sorrow and high emotional tension, which can lead to considerations of leaving the profession (11), are primarily mentioned. Withdrawal from the situation, "a conspiracy of silence" and denial, attention to the physical aspects of care, and immersion in administrative tasks were common reactions among healthcare personnel to perinatal death (9, 18, 19). These reactions may lead to a lower quality of care for the bereaved parents and the possibility of an avoidance of education in the field of the care of bereaved parents, or to resistance to compulsory attendance of the course. Therefore, it can be assumed that a higher attendance of obstetricians of the course could help to improve the quality of care, as well as their own well-being. During discussions and personal meetings, participants supported each other and shared common painful stories, which in itself could have had an effect on the general sense of belonging and group support. Discussion and innovative methods during teaching tend to support the creation of opinions, attitudes and skills in the care of bereaved parents (20) and have a positive impact on the nurses' attitudes toward death by helping them better understand the significance of the experience of suffering (21). Meetings of individuals from various support and health professions also lead to an understanding of the role, as well as an appreciation of the roles of other professionals in the care of parents after perinatal loss (22). A patriarchal approach in the field of healthcare, including care during childbirth, is still prevalent among medical professionals in the Czech Republic (23). This manifested itself in answers to the question "How would you intervene in the physical contact of a woman with her stillborn child?" Many studies state that the approach of carers and their communication with parents can have a significant effect on whether or not parents see or hold their deceased baby. Therefore, during the educational programme, great attention was paid to the rituals of bidding farewell to a deceased baby. Among other things, participants learnt that it is not recommended to ask bereaved parents the question, "Do you want to see your child?" but parents' natural compulsion to see and hold their deceased baby should be reflected (24, 25). Therefore, after the completion of the PLC course, the preference of the answer, "I would ask the woman if she wanted to see or hold her baby," significantly decreased (29.5% of respondents chose this answer in the pre-test, with only 3.5% in the post-test). The positive attitude of the respondents toward the rituals of bidding farewell to a stillborn baby (none of the respondents preferred the answer, "I would not recommend the woman physical contact with her stillborn child," in pre- nor post-test) was one positive outcome of the research. Holding and seeing a deceased baby is valuable for most but not all women (26). Who should decide what would be best for a particular woman/parent? Can the healthcare professionals recommend physical contact with a deceased baby to all women? It is currently preferred to allow the parents to decide for themselves as to which solution is the best for them. Healthcare professionals should, therefore, inform the parents verbally and in written form of the opportunities available to them to bid farewell to their deceased baby, discuss their feelings, and give them time to decide before the birth. The answer, "I would provide information on how the woman could physically say goodbye to the child," was chosen by 47% of respondents in the pre-test and 58.5% of respondents in the post-test. In our research, in the group of Medical Professionals (Motivated and Non/Motivated), the preference for the answer "I would recommend the woman see and hold the baby," increased in the posttest (compared to the pre-test). In the Others group, on the other hand, preference for this answer decreased in the post-test (compared to the pre-test). Even though some parents need increased guidance in making difficult decisions after a diagnosis of stillbirth (27), medical professionals should not take a dominant position and make the decision on the parents' behalf. It is important for them to use their communication skills to maximum effect and to further educate themselves in the field of communication with patients, principally in emotionally demanding situations. Limitations of the study include the fact that data was only collected immediately after the educational programme. Only a brief evaluation tool was used and one which was not validated. 5 CONCLUSION The PLC educational programme was evaluated as effective. Training using blended learning proved to be successful and can be recommended primarily for the education of working medical professionals who are fully experienced in practice. E-learning can be constantly updated and fine-tuned to the expectations of course participants. Workshops during personal meetings enable the development of communication skills in the care of bereaved parents, as well as self-care and mental hygiene. 6 10.2478/sjph-2020-0003 Zdr Varst. 2020;59(1):18-26 These are the two areas in which participants in the PLC educational programme required the most improvement. The care of bereaved parents has its own specifics and medical professionals should possess a basic knowledge of how to provide sensitive care during this period. Not all medical professionals, however, are motivated to educate themselves further in this field. In the Czech Republic, the creation of perinatal bereavement teams, in which professionals with an empathy and deep understanding of palliative care would work, is deemed to be essential. CONFLICTS OF INTEREST The authors have no conflict of interest to declare. FUNDING This research did not receive any specific grant from funding agencies in the public, commercial, or not-forprofit sectors. ETHICAL APPROVAL All of the respondents of the research completed the questionnaire voluntarily, were acquainted with the goals and the method of processing the questionnaire and agreed to participate in the evaluation of the educational programme. 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VALUATION OF EQ-5D-3L HEALTH STATES IN SLOVENIA: VAS BASED AND TTO BASED VALUE SETS VREDNOTENJE ZDRAVSTVENIH STANJ EQ-5D-3L V SLOVENIJI: VREDNOSTI ZDRAVSTVENIH STANJ, PRIDOBLJENE Z METODAMA VAS IN TTO Valentina PREVOLNIK RUPEL1*, Andrej SRAKAR1, Kim RAND2 'Institute for Economic Research, Kardeljeva ploščad 17, 1000 Ljubljana, Slovenia 2Health Services Research Unit, Akershus University Hospital, L0renskog, Norway Received: May 21, 2019 Original scientific article Accepted: Sep 26, 2019 ABSTRACT Keywords: EQ-5D-3L, Slovenia, quality-adjusted life-years, social value set, utility Introduction: The two primary objectives of this paper were (a) to develop first logically consistent TTO based EQ-5D-3L value sets for Slovenia and (b) to revisit earlier developed VAS based EQ-5D-3L value sets. Methods: Between September 2005 and April 2006, face-to-face interviews with 225 individuals in Slovenia were conducted. Protocols from the Measurement and Value of Health study were followed closely. Each respondent valued 15 health states out of a total of 23. Model selection was informed by the criteria monotonicity/logical consistency. Predictive accuracy was assessed in terms of mean square difference between out-of-sample predictions and corresponding observed means, as well as Lin's Concordance Correlation Coefficient. Results: Modelling was based on 2,717 VAS and 2,831 TTO values elicited from 225 respondents. A 6-parameter constrained regression model with a supplementary power term was selected for VAS and TTO value sets, as it produces monotonic values, and proved superior in terms of out-of-sample predictive accuracy over the tested alternatives. Conclusion: This is the first EQ-5D-3L TTO based value set in Slovenia and the second in Central and Eastern Europe (besides Poland). It is also the first monotonic and logically consistent VAS value set in Central and Eastern Europe. Comparisons with Polish and UK TTO values show considerable differences, mostly due to mobility with having a substantially greater weight in Slovenia. The UK value set generally produces lower values and the Polish value set higher values for mild states. IZVLEČEK Ključne besede: EQ-5D-3L, Slovenija, kakovostno prilagojena leta življenja, vrednostni set VAS, koristnost Uvod: Dva osnovna cilja raziskave sta (a) prikazati prvi logično konsistentni vrednostni set EQ-5D-3L za Slovenijo, ki temelji na metodi časovne izmenjave, (b) izboljšati prejšnji vrednostni set EQ-5D-3L za Slovenijo, ki temelji na vrednostni lestvici (VAS-metodi). Metode: Od septembra 2005 do aprila 2006 je bilo opravljenih 225 osebnih intervjujev s posamezniki iz 40 slovenskih občin. Študija je natančno sledila protokolu študije MVH o merjenju in vrednotenju zdravja, ki je bila izvedena v Združenem kraljestvu. Vsak anketiranec je ocenil 15 od skupno 23 zdravstvenih stanj. Izbira modela za izračun vrednosti zdravstvenih stanj je temeljila na dveh osnovnih merilih: monotonosti in logični doslednosti vrednosti. Napovedno moč smo vrednotili s povprečno kvadrirano razliko med napovedmi izven vzorca in pripadajočimi ocenjenimi povprečji ter s pomočjo Linovega konkordančnega korelacijskega koeficienta. Rezultati: Izbrana modela temeljita na vrednostih zdravstvenih stanj 2,717 VAS in 2,831 TTO, ki smo jih pridobili v 225 osebnih intervjujih. Za oceno vrednosti VAS in TTO smo izbrali šestparametrski regresijski model z omejitvami in dodanim potenčnim faktorjem, saj se je izkazalo, da so ocenjene vrednosti na temelju tega modela monotone in imajo boljšo napovedno moč ocen izven vzorca kot vsi drugi ocenjevani modeli. Zaključek: V študiji smo prikazali prvi slovenski vrednostni set EQ-5D, ki temelji na metodi TTO, hkrati pa je to drugi set, izračunan v srednji in vzhodni Evropi (poleg Poljske). Gre tudi za prvi monotoni in logično dosledni vrednostni VAS-set tako v Sloveniji kot srednji in vzhodni Evropi. Primerjave z vrednostmi poljskega in britanskega TTO kažejo precejšnje razlike med vrednostmi posameznih zdravstvenih stanj, predvsem zaradi dimenzije pokretnosti, ki ima bistveno večjo težo v Sloveniji. Vrednosti TTO v Združenem Kraljestvu so na splošno nižje za manj težavna zdravstvena stanja, poljske vrednosti zdravstvenih stanj pa so na splošne višje. Corresponding author: Tel. + 386 1 478 6870; E-mail: katkarupel@yahoo.com; katka.rupel@gmail.com IVI 117 Nacionalni inštitut IMIJb za javno zdravje © Nacionalni inštitut za javno zdravje, Slovenija. 8 10.2478/sjph-2020-0003 Zdr Varst. 2020;59(1):18-26 1 INTRODUCTION Slovenia passed the regulation that required economic evaluation to inform drug and health technology reimbursement decision-making in the 1990s. Health technologies are assessed by various bodies (1, 2). The latest evaluation guidelines by the Health Insurance Institute of Slovenia recommend that the benefits of the treatment are expressed as quality-adjusted life years (QALYs). QALY is a measure that encapsulates a treatment's impact on a patient's life length and also on their health-related quality of life (HRQOL), which is recognized as a key indicator of treatment outcomes (3). The QALY requires data that expresses health-related quality of life (HRQOL) in the form of a single value, sometimes known as a health state utility value, which is scored on a scale that assigns a value of 1 to a state equivalent to full health and 0 to a state equivalent to death (4). Weinstein and Stason (1977) connected QALYs with utilities, specifically expected utility, rather than the "weights" of the earlier literature; and this connection has remained although, not everybody agrees with the concession of the term "quality" to refer only to expected utility-based measures (5). Anyhow, in health economics, utilities (values) are typically combined with survival estimates and aggregated across individuals to generate quality-adjusted life years (QALYs) for use in cost-utility analyses of healthcare interventions (6). There are many methods available regarding how the health states can be valued and grouped into two broad categories of measures: direct and indirect methods of measurement. The direct valuation methods include standard gamble (SG), time trade-off (TTO), DCE (discrete choice experiment), rating scales, equivalence technique, ratio scaling and person trade-off. The SG approach is the classic method of measuring preferences in economics under conditions of uncertainty, and is based on von Neumann Morgenstern utility theory (7). The theoretical underpinnings of all other methods are less clear. TTO valuation methodology does not conform to utility-under-uncertainty requirements under expected utility theory, but is still a dominant method in the valuation sets across countries (8). Regarding VAS values, there are a lot of criticisms and opposing views on their suitability for use in cost utility analysis. Mostly, criticisms consist of VAS values not being choice based and their lack of theoretical foundation (5). Due to these issues, most health economists would recommend a choice-based value set, derived from TTO or DCE data, especially for economic studies where cost-utility analysis is anticipated. If a choice-based value set is not available for the country/region, a choice-based value set can be selected from a country/region that most closely approximates the country where the study is being conducted. Alternatively, a VAS-based value set can be used if that is available for the country/region (9). Due to these issues, most health economists would recommend a choice-based value set, derived from TTO or discrete choice experiment (DCE) data to be used in studies that estimate the value of health states of any population. If a choice-based value set is not available for the country/ region, a choice-based value set can be selected from a country/region that most closely approximates the country where the study is being conducted. Alternatively, a VAS-based value set can be used if that is available for the country/region (9). Utilities (values representing preferences) for healthcare priority setting are typically obtained indirectly by asking the general population (or patients) to fill in a questionnaire and attach value to hypothetical heath state, later on converting the results to a value set for all health states, using population (or patient) values. There are at least two advantages that contributed to the popularity of the indirect methods: the pool of health states is already defined and so are their values (value set). When a patient defines his own health state in subsequent studies, a value can thus be attached to his/ her health state from the value set. Some of the established questionnaires are the Health Utility Index, the Short Form 6D, 15D instrument, Assessment of Quality of Life (AQOL) and the EuroQol 5D (EQ-5D). The EQ-5D is a prominent example of preference-based measures developed by the EuroQol Group (9). It has been suggested that these are the most widely used preference-based measures in the world (10). To improve the instrument's sensitivity and to reduce ceiling effect, EuroQoL Group developed a new version in 2009, called EQ-5D-5L. The new version kept its original 5 dimensions, but expanded the response options from 3 to 5 levels. As there are a lot of existing 3L value sets in many countries, for comparison reasons a non-parametric model was set up to transform any EQ-5D-3L values into EQ-5D-5L values. In this way, 5L values can also be used in cases when 5L preferences directly elicited from representative general population samples are not yet available (11). The EQ-5D-3L descriptive system has been formally translated and validated into the Slovenian language in 1999/2000 (12). The two primary objectives of this paper were (a) to develop first logically consistent EQ-5D-3L TTO-based value sets for Slovenia and (b) to revisit earlier developed VAS-based EQ-5D-3L value sets for Slovenia (13). Some issues that went undetected with the previous VAS value set have been identified, and methodological advances seem to make it possible to improve on earlier modelling. 9 10.2478/sjph-2020-0003 Zdr Varst. 2020;59(1):18-26 2 METHODS 2.1 Study Overview The study was a multicentre, population-based study, using face-to-face interviews. The sample was prepared by the Statistical Office of Slovenia using the Central Population Register. In the sample, 1,000 individuals aged 18+ from 40 Slovenian municipalities were included. At the first level, 40 municipalities were randomly selected and later on 25 individuals were selected from each municipality. Each person carried a name, last name, address, house number, postcode, municipality, age and gender. The investigators started the interviews in September 2005 and finished in April 2006. Participant recruitment was conducted primarily through landline telephone numbers for each participant in the sample. 225 participants agreed to participate in the survey. Interviews were conducted by three interviewers, who underwent one-day training on the health state valuations, the purpose of the interviews and TTO procedures. To facilitate the training, the interview book prepared by Gudex (14) was translated into Slovenian language and used for training of the interviewers and in the pilot training. Each investigator conducted 5 test interviews. 2.2 EQ-5D EQ-5D consists of a descriptive system and EQ visual analogue scale (EQ-VAS). The EQ-5D descriptive system consists of 5 dimensions: mobility (MO), self-care (SC), usual activities (UA), pain/discomfort (PD), and anxiety/ depression (AD). Each dimension has 3 levels: no problems, some problems, and extreme problems (9). The respondent is asked to indicate his or her health state by ticking the box that marks the most appropriate level of problems in each dimension. A unique health state can be described by using a 5-digit vector formed according to the responses to the 5 questions. For example, no problems in MO and SC, some problems in UA and PD and extreme problems in AD can be referred to as "11223." Health states defined in this way may be converted into a single summary index by applying a formula that attaches values to each of the levels in each dimension. A total of 243 possible health states can be defined. 2.3 Health State Selection In the valuation task, each investigator had 3 sets of health states, and investigators decided randomly which set to use with each respondent. The sets were named A, B and C. Each set contained 15 health states. Some health states were included in all three sets, but some were not. Health states in each set represent the complete scale of health states, from worst to best health states. Sets B and C were developed in 2000 (16). The number of all various directly valued health states in all three sets is 23 plus unconscious and dead. These states are 11211, 11111, 21111, 12111, 11112, 11121, 11122, 11113, 11131, 11133, 11312, 13311, 32211, 22222, 21232, 22323, 22233, 32223, 32313, 23232, 33321, 33323, 33333, unconscious and dead. Health states can also be divided into mild, moderate and severe states (17) in such a way that all the categories were represented in all three sets. 2.4 Interview Process The questionnaire consists of four parts. In the first part, the respondent indicated his/her own health state on the day of the interview using an EQ-5D descriptive system. Furthermore, the respondent marks how good or bad his/her health state is on a visual analogue scale (VAS) from 0 to 100 (where 0 represents the worst health state imaginable and 100 represents the best health state imaginable). The second part of the questionnaire is a valuation of the 15 selected health states. Once the respondent had familiarised himself/herself with the health states by reading them, he/she ranked the selected states from worst to best. After ranking he/she attached the value from 0 to 100 to all 15 health states. The third part of the interview is the valuation of the same selected 15 health states using time trade off (TTO) method. The interviewers follow the adapted Measurement and Value of Health study (MVH) protocol (14). The MVH study was a large exercise, in which 3,395 respondents valued 13 different health states. Because of the limited budget, we included 23 health states altogether. Out of 23 health states, we made three different sets of 15 health states (sets A, B and C) as described in Chapter 2.3. The objective of the TTO is to determine the length of lifetime the respondent would be willing to forego to live in a better health state (typically 'full health') and to avoid living in a bad health state. This is achieved by presenting respondents with a series of choice tasks, each involving two alternative hypothetical lives. The two lives are presented so that the respondent is forced to choose between a longer life in the health state of interest and a shorter life in better health (15). The last part of the interview collects social demographic data: gender, age, education, work experience, smoking habits, experience with illness and postcode. 2.5 Preference Elicitation Techniques In the TTO procedure, the interviewers used a TTO board and a set of health state cards. A TTO board was made of three layers of thick cardboard and incorporated a sliding scale from 0 to 10 years. Both sides of the board were used, one for states better than dead and the other for health states worse than dead. The respondent was taken through each of 15 health states to be valued, 10 10.2478/sjph-2020-0003 Zdr Varst. 2020;59(1):18-26 one at a time, with the interviewer moving the scale as appropriate. The respondent needed to make a series of choices between two hypothetical lives: one involving x years of healthy life, followed by death (Life A) and the other involving t years in a worse health state (where x0.05). 2.3 Statistical Analysis Descriptive statistics were used to analyse study sample characteristics. The prevalence and 95% confidence interval (CI) of self-medication among males and females was calculated separately. The crude odds ratio (OR) with 95% confidence interval (CI) was used to analyse univariate associations between the independent (potential explanatory) variables with the dependent variable ("self-medication with tranquillizers and sleeping pills"). Variables found to be significantly associated with self-medication in the univariate analysis were included in the multivariate logistic regression models. The multivariate logistic regression analysis identified potential, gender-related, predictors of self-medication with tranquillizers and sleeping pill using an adjusted odds ratio (aOR) with 95% CI. Statistical significance in all analyses was deemed likely if the computed probability value was <0.05. Data analysis was performed by using Statistical Package for Social Sciences (SPSS) software (SPSS 18.0 for Windows, SPSS Inc., Chicago, IL, USA). 49 10.2478/sjph-2020-0003 Zdr Varst. 2020;59(1):18-26 Table 1. Prevalence of self-medication with tranquillizers and sleeping pills in the Serbian female population and association with selected socio-demographic, health, and healthcare system characteristics, n=7,570. Female population characteristics Prevalence of TSP self-medication, (%) 95% CI Crude OR 95% CI Female TSP users 5.6 5.0-6.1 Age (years) 15-24 1.0 0.4-1.7 - 25-34 2.4 1.5-3.2 2.20 1.07-4.54 35-44 4.0 2.9-5.1 3.85 1.96-7.60 45-54 6.6 5.2-8.0 6.51 3.40-12.49 55-64 10.2 8.6-11.8 10.43 5.53-19.67 65-74 7.0 5.3-8.7 6.94 3.58-13.44 >75 6.6 4.9-8.3 6.53 3.34-12.76 Employment status Employed 4.1 3.2-4.9 - Unemployed 6.0 5.1-6.9 1.49 1.14-1.96 Pupil/Student 1.1 0.4-1.9 0.28 0.14-0.57 Retiree 7.9 6.7-9.0 2.01 1.53-2.63 Education No formal education/ Primary school 6.6 5.7-7.5 - Secondary school 5.3 4.6-6.0 0.79 0.64-0.97 Undergraduate/Postgraduate studies 3.9 2.8-5.0 0.58 0.42-0.80 Self-assessment of health status Very good/Good/Fair 4.6 4.1-5.1 - Poor/Very poor 9.5 8.0-11.0 2.16 1.75-2.67 Presence of chronic disease No 1.8 1.3-2.2 - Yes 8.2 7.4-9.0 4.98 3.74-6.64 Exposure to stress during four weeks prior to the interview No/Yes, not more than others 4.3 3.8-4.8 - Yes, more than others/Yes, unbearable 13.4 11.4-15.4 3.48 2.81-4.30 Physical pain during four weeks prior to the interview No/Very mild 3.4 2.8-3.9 - Mild/Moderate 7.3 6.2-8.4 2.26 1.79-2.85 Severe/Very severe 9.4 7.8-11.0 2.97 2.30-3.83 Unmet healthcare needs in the past 12 months due to a long waiting time for health service No 5.9 5.2-6.6 - No need for healthcare 2.5 1.7-3.3 0.41 0.30-0.57 Yes 8.6 6.9-10.2 1.49 1.17-1.91 Unmet healthcare needs in the past 12 months due to distance or transportation barriers No 6.1 5.4-6.7 - No need for healthcare 2.7 2.0-3.5 0.44 0.32-0.60 Yes 10.6 7.5-13.7 1.83 1.30-2.58 Satisfaction with public health service Very satisfied/Satisfied 5.3 4.6-6.0 - Neither satisfied nor dissatisfied 5.8 4.8-6.9 1.11 0.88-1.41 Dissatisfied/Very dissatisfied 6.3 5.1-7.5 1.21 0.94-1.56 Satisfaction with private health service Very satisfied/Satisfied 4.7 4.0-5.5 - Neither satisfied nor dissatisfied 5.6 4.2-7.0 1.20 0.87-1.64 Dissatisfied/Very dissatisfied 7.1 4.3-9.9 1.55 0.98-2.43 Notes: significant findings where p<0.05 are marked in bold: Abbreviations: TSP- tranquillizers and sleeping pills, CI - Confidence Interval, OR- Odds Ratio 50 10.2478/sjph-2020-0003 Zdr Varst. 2020;59(1):51-26 Table 2. Prevalence of self-medication with tranquillizers and sleeping pills in the Serbian male population and association with selected socio-demographic, health, and healthcare system characteristics, n=7,053. Female population characteristics Prevalence of TSP self-medication, (%) 95% CI Crude OR 95% CI Female TSP users 2.2 1.9-2.6 Age (years) 15-24 0.4 0.1-0.7 - - 25-34 0.9 0.4-1.5 2.72 0.82-9.04 35-44 2.0 1.2-2.8 5.86 1.91-18.07 45-54 2.8 1.8-3.7 8.31 2.77-24.99 55-64 3.1 2.2-4.1 9.34 3.14-27.78 65-74 4.1 2.7-5.6 12.54 4.15-37.86 >75 3.3 1.8-4.9 10.09 3.20-31.80 Employment status Employed 1.4 1.0-1.8 - - Unemployed 2.9 2.1-3.7 2.08 1.37-3.16 Pupil/Student 0.5 0.1-0.9 0.29 0.09-1.00 Retiree 3.6 2.7-4.5 2.63 1.76-3.91 Education No formal education/ Primary school 2.0 1.3-2.6 - - Secondary school 2.4 2.0-2.9 1.25 0.84-1.87 Undergraduate/Postgraduate studies 2.0 1.2-2.8 1.00 0.58-1.72 Self-assessment of health status Very good/Good/Fair 1.6 1.3-1.9 - Poor/Very poor 6.9 5.1-8.6 4.52 3.24-6.30 Presence of chronic disease No 0.6 0.3-0.9 - Yes 4.0 3.3-4.7 6.73 4.30-10.53 Exposure to stress during four weeks prior to the interview No/Yes, not more than others 1.5 1.2-1.8 - Yes, more than others/Yes, unbearable 8.5 6.4-10.6 6.03 4.32-8.40 Physical pain during four weeks prior to the interview No/Very mild 1.0 0.7-1.2 - Mild/Moderate 5.2 4.0-6.3 5.57 3.87-8.03 Severe/Very severe 5.7 3.8-7.6 6.18 3.95-9.66 Unmet healthcare needs in the past 12 months due to a long waiting time for health service No 2.5 2.0-3.0 - No need for healthcare 0.7 0.3-1.0 0.27 0.16-0.45 Yes 6.4 4.6-8.3 2.72 1.89-3.92 Unmet healthcare needs in the past 12 months due to distance or transportation barriers No 2.8 2.3-3.3 - No need for healthcare 0.6 0.3-0.9 0.22 0.13-0.38 Yes 10.2 6.1-14.4 4.00 2.48-6.47 Satisfaction with public health service Very satisfied/Satisfied 2.0 1.5-2.5 - Neither satisfied nor dissatisfied 2.5 1.8-3.2 1.25 0.86-1.82 Dissatisfied/Very dissatisfied 3.4 2.3-4.4 1.68 1.13-2.50 Satisfaction with private health service Very satisfied/Satisfied 2.6 2.0-3.3 - Neither satisfied nor dissatisfied 2.2 1.3-3.1 0.82 0.51-1.33 Dissatisfied/Very dissatisfied 4.0 1.9-6.1 1.53 0.85-2.77 Notes: significant findings where p<0.05 are marked in bold: Abbreviations: TSP- tranquillizers and sleeping pills, CI - Confidence Interval, OR- Odds Ratio 10.2478/sjph-2020-0003 Zdr Varst. 2020;59(1):52-26 3.1 Predictors of Self-Medication with Tranquillizers and Sleeping Pills Multivariate analysis revealed several independent predictors of self-medication with tranquillizers and sleeping pills common for females and males. In both populations, health-related characteristics, including the presence of chronic disease, stress exposure and the presence of physical pain in the four weeks prior to the interview, were significantly associated with an increased likelihood of the use of tranquillizers and sleeping pills without a doctors' prescription (Table 3 and Table 4). However, significant differences in socio-demographic predictors between females and males were shown. The age categories of 45-54, 55-64 and 65-74 years were independent predictors of a higher likelihood for self-medication with tranquillizers and sleeping pills among females, versus males. Concurrently, unemployment status was revealed as an independent predictor of such practices for males, whereas employment was not significantly associated with self-medication with tranquillizers and sleeping pills in females (Table 3, Table 4). Table 3. Potential predictors of self-medication with tranquillizers and sleeping pills among selected socio-demographic, health, and healthcare system characteristics in the Serbian female population, n=7,570. Female population characteristics Adjusted OR 95% CI Age (years) 15-24 - 25-34 1.86 0.71-4.84 35-44 2.63 1.00-6.88* 45-54 3.37 1.30-8.72 55-64 4.75 1.83-12.33 65-74 2.96 1.10-7.97 >75 2.62 0.96-7.14 Employment status Employed - Unemployed 1.14 0.84-1.55 Pupil/Student 1.13 0.40-3.25 Retiree 1.03 0.72-1.48 Education No formal education/Primary school - Secondary school 1.06 0.83-1.35 Undergraduate/Postgraduate studies 0.84 0.58-1.21 Self-assessment of health status Very good/Good/Fair - Poor/Very poor 0.87 0.67-1.13 Presence of chronic disease No - Yes 2.57 1.83-3.61 Exposure to stress in the four weeks prior to interview No/Yes, not more than others - Yes, more than others/Yes, unbearable 2.51 1.99-3.16 Physical pain in the four weeks prior to interview No/Very mild - Mild/Moderate 1.43 1.11-1.83 Severe/Very severe 1.49 1.12-1.99 Unmet healthcare needs in the past 12 months due to a long waiting time for health service - No need for healthcare 0.69 0.33-1.43 Yes 1.09 0.82-1.44 Unmet healthcare needs in the past 12 months due to distance or transportation barriers No - No need for healthcare 1.15 0.78-1.71 Yes 1.07 0.54-2.13 Notes: *p=0.05; significant findings where p<0.05 are marked in bold; all variables significantly associated in univariate analysis were included in multivariate analysis. Abbreviations: OR- Odds Ratio; CI- Confidence Interval 52 10.2478/sjph-2020-0003 Zdr Varst. 2020;59(1):18-26 Table 4. Potential predictors of self-medication with tranquillizers and sleeping pills among selected socio-demographic, health, and healthcare system characteristics in the Serbian male population, n=7,053. Male population characteristics Adjusted OR 95% CI Age (years) 15-24 - 25-34 2.36 0.53-10.56 35-44 3.62 0.81-16.27 45-54 3.66 0.82-16.31 55-64 3.08 0.68-13.85 65-74 3.95 0.80-19.40 >75 3.17 0.62-16.17 Employment status Employed - Unemployed 1.86 1.19-2.91 Pupil/Student 1.65 0.31-8.81 Retiree 1.30 0.69-2.46 Self-assessment of health status Very good/Good/Fair - Poor/Very poor 1.09 0.72-1.64 Presence of chronic disease - Yes 2.32 1.38-3.90 Exposure to stress in the four weeks prior to interview No/Yes, not more than others - Yes, more than others/Yes, unbearable 3.25 2.24-4.73 Physical pain in the four weeks prior to the interview No/Very mild - Mild/Moderate 2.68 1.81-3.99 Severe/Very severe 1.85 1.10-3.12 Unmet healthcare needs in the past 12 months due to the long waiting time for health service - No need for healthcare 1.94 0.52-7.25 Yes 1.43 0.93-2.18 Unmet healthcare needs in the past 12 months due to distance or transportation barriers No - No need for healthcare 0.28 0.08-1.06 Yes 1.55 0.87-2.76 Satisfaction with public health service Very satisfied/Satisfied - Neither satisfied nor dissatisfied 1.09 0.73-1.63 Dissatisfied/Very dissatisfied 0.99 0.64-1.54 Notes: significant findings where p<0.05 are marked in bold; all variables significantly associated in univariate analysis were included in multivariate analysis. Abbreviations: OR- Odds Ratio; CI- Confidence Interval 53 10.2478/sjph-2020-0003 Zdr Varst. 2020;59(1):18-26 4 DISCUSSION Based on our knowledge, this is a rare study highlighting gender differences in predictors of self-medication with tranquillizers and sleeping pills controlled for socio-demographic factors, health status and satisfaction with the healthcare system. Our study has shown that self-medication is a more frequent practice among the female population compared to males in cases of self-medication with tranquillizers and sleeping pills. Health-related factors (chronic disease and physical pain) and environmental stress were revealed as independent predictors of self-medication with observed drugs in both men and women. However, gender differences have been shown through two discriminatory factors, age, and employment status. While an age of above 45 years has been revealed as a strong predictor of self-medication with tranquillizers and sleeping pills in women, a similar effect was not confirmed among males. On the contrary, unemployment has been shown as a significant determinant of self-medication with tranquillizers and sleeping pills in males, but without significant influence in females. Several previous studies investigated the determinants of regularly prescribed medication use for depression, anxiety, stress, and sleep problems in the female population (27, 28). They also found age, stress, and physical pain as predictors of regular use of hypnotics/ anxiolytics/sedatives, as well as other predictors like social tension, hormone replacement therapy, headaches, palpitations, mood swings or increased muscular tension, anger, duration of symptoms lasting longer than one week, consulting a specialist, and mental health-related quality of life. In line with the abovementioned predictive factors, one potential area of intervention may be a focus on timely and proper patient education interventions by healthcare professionals with special warnings about side effects. This may aid in the prevention of future self-medication in women already prescribed drugs for depression, anxiety, stress, or sleeping problems. This study has also shown that self-medication with tranquillizers and sleeping pills is significantly higher in males and females who have reported chronic diseases and physical pain. Since these patients are most likely already prescribed some other medicines, the possibility of drug-drug interactions is increased. This could be of particular concern if an already prescribed drug is a suppressor of the central nervous system (CNS), because of the well-known CNS suppressive effect of tranquillizers and sleeping pills (29, 30). Along with warnings about side effects, patient education interventions should include descriptions of prescribed therapy purposes, with the aim to decrease the rate of therapy duplication or harmful effects. The results of our study have shown that the risks from self-medication in women increase significantly for those over 45 years of age, which coincides with the start of the menopause. This risk reaches a peak at 55-64 years of age when women predominantly cope with unpleasant menopausal symptoms. Additionally, many with symptoms of non-communicable diseases maintain overwhelming amounts of work and family responsibilities with little to no focus on personal health. The decline of risk starts after 65 years of age, which could be linked to the end of women's working engagement and a decrease in the level of family stress, as well as to the end of the menopause. Most middle-aged women suffer from high demands in personal and professional responsibilities and, accordingly, need specialised support. A similar phenomenon may be observed with unemployed males. In spite of Serbia's many modern ways of thinking about traditional gender roles, some traditional elements continue to dominate within Serbian society. One example is the attitude that males are consistently expected to serve as dominant breadwinners in the family. For this reason, the male population requires additional healthcare support in the effects of unstable employment status. Our study directly confirms previous data that self-medication with tranquillizers is not supported by the hypothesis of gender role convergence and expectations (11). Environmental stress is the only modifiable factor revealed as the predictor of self-medication with tranquillizers and sleeping pills in both women and men. Although coping with stress is stressful by itself, psychotherapy, meditation, and other relaxing techniques are showed as helpful (31). However, such techniques are not yet widely accepted in the Serbian population. Concurrently, Santric-Milicevic et al. reported that almost half of the Serbian adult population assessed their mental health as poor and 5% had diagnosed chronic anxiety or depression (32). Accordingly, well-tailored public health actions, specifically targeting middle-aged women and unemployed males and their ability to cope with stress and pressure in healthy ways, could potentially reduce the high level of self-medication with tranquillizers and sleeping tablets and prevent unwanted behaviours and consequences. While previous studies have established the association between unmet healthcare needs and self-medication in general or with self-medication with illicit drugs, our results have not confirmed previous findings (15, 21, 23, 33). Nevertheless, a relatively high prevalence of unmet healthcare needs has been recorded. Unmet healthcare needs due to barriers related to lack of time or geographic accessibility were not potential predictors, perhaps because of the presence of chronic disease that requires continuous monitoring by health professionals. Accordingly, further research should 54 10.2478/sjph-2020-0003 Zdr Varst. 2020;59(1):18-26 explore the relationship between self-medication and the kind of unmet healthcare needs (e.g. prescription of medication, check-up, consultation etc.) and concerning the type of chronic disease condition. This would be of particular benefit for well-targeted preventive measures, especially in developing countries with lower standards and rationalisations of public health expenditures within where the high impacts of unmet healthcare needs could be expected (34). 4.1 Strengths and Limitations The current study has strengths and limitations. One limitation of the study was the inability to assess the cause-consequence relationship between the independent and dependent variables. Instead, we explored potential predictors for self-medication with tranquillizers and sleeping pills. Secondly, the survey data may be burdened with biases due to memory recall, which can lead to an over or underestimation of the study findings. In order to maximise the validity of the findings, participants were asked to give information on medication use for a short period of only two weeks prior to the interview, and for a particular disease out of 17 listed conditions or some other. Additionally, the data was collected in 2013, and it may be that the survey results do not reflect actual practices. However, since that time, there has been no national campaign or other similar public health initiatives with regards to decreasing the use of prescription drug use without a prescription, except in the case of antibiotics. Accordingly, we do not currently expect substitutional differences in the practice of tranquillizers and sleeping pills use. Conducting similar analyses of data from the upcoming National Health Survey will be useful since it will reveal the trend of tranquilizers and sleeping pill use and the subpopulations particularly jeopardised by this behaviour. In the representative sample of the Serbian population of 15 years and above, we were able to determine gender differences in the prevalence and predictors of self-medication with tranquillizers and sleeping pills. The data for the survey was extracted from a sample of the general population. Data related to concrete drugs used in self-medication practices were not collected, which left room for participants to potentially misinterpret tranquillizers and sleeping pills. Additionally, the absence of data related to the exact names of drugs made it impossible to conduct a deeper analysis of particular drugs and drug group usage. The results of this study may be utilised to inform the creation of the survey instrument, which sets out to specifically examine illicit/non-prescription drug and drug groups use. Study findings should be interpreted with these limitations and advantages in mind. 5 CONCLUSION The study findings highlighted different predictors of self-medication with tranquillizers and sleeping pills for men and women. Gender-related socio-demographic differences in predictors were shown (higher age in females and unemployment in males), while the same health-related characteristics were shown as predictors in both genders (presence of chronic disease, physical pain, exposure to stress). While revealed practices and predictors may be useful in improving healthcare professionals' consulting practice, observed gender differences may be utilised to inform the design of gender-sensitive surveillance, identification, and prevention of such undesirable practice through well-tailored public health actions. ACKNOWLEDGMENT We are grateful to all participants of the Serbian National Health Survey and to the Ministry of Health of the Republic of Serbia, which made data from the National Health Survey available for further analysis. We are also very grateful to Mr. Ivan Cvorovic, MD and Ms. Nikolina Boskovic, MPH, for editing of the manuscript. CONFLICTS OF INTEREST The authors declare that no conflicts of interest exist. FUNDING This work was supported by the Ministry of Education, Science and Technological Development of Serbia (grant numbers 175087, 41012) which had no role in study design, collection, analysis or interpretation of data, writing the manuscript, or in the decision to submit the article for publication. ETHICAL APPROVAL The Serbian National Health Survey 2013 was approved by the Ethical Board of the National Institute of Public Health of the Republic of Serbia and the Ministry of Health. 55 10.2478/sjph-2020-0003 Zdr Varst. 2020;59(1):18-26 REFERENCES 1. WHO. 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The Editorial Office allows for a maximum of three revisions to be dealt with. If the third revision of the manuscript does not take into account all the comments of the reviewers, the manuscript will be withdrawn from the editorial process. During the editorial process, the secrecy of the contribution content is guaranteed. All the articles are language edited. Author receives in consideration also the first print, but at this stage corrigenda (printing errors) only are to be considered. Proofreading should be returned in three days, otherwise it is considered that the author has no remarks. The journal office strives for rapid editorial process. Authors should adhere to the deadlines set by them in letters; otherwise it may happen that the article will be withdrawn from the editorial process. Any appeal of the authors deals the Editorial Board of the ZV/SJPH. When the manuscript is accepted for publication, the author must assigns copyright ownership of the material to the National Institute of Public Health as a publisher. Any violation of the copyright will be legally persecuted. ZV/SJPH does not have article processing charges (APCs) nor article submission charges. The author receives one copy of the print issue in which the article is published. M 117 Nacionalni inštitut IM 11 b za javno zdravje NAVODILA AVTORJEM Revija: Zdravstveno varstvo (ZV) ISSN 0351-0026 (tiskana izdaja) / Slovenian Journal of Public Health (SJPH) ISSN 1854-2476 (elektronska izdaja) Navodila so v skladu z Uniform Requirements for Manuscripts Submitted to Biomedical Journals. Popolna navodila so objavljena v N Engl J Med 1997; 336: 309-15 in v Ann Intern Med 1997; 126: 36-47 in na spletni strani http://www.icmje.org. ETIČNI STANDARDI Uredništvo sprejema v obdelavo le članke s širšo mednarodno javnozdravstveno tematiko, ki še niso bili in ne bodo objavljeni drugje. Dele članka, ki so povzeti po drugi literaturi (predvsem slike in tabele), mora spremljati dovoljenje avtorja in založnika prispevka, da dovoli naši reviji reprodukcijo. Oddan rokopis morajo prebrati vsi avtorji in se z njegovo vsebino strinjati. Raziskave na ljudeh (vključno s človeškimi materiali in osebnimi podatki) morajo biti izpeljane v skladu s Helsinško deklaracijo in potrjene s strani nacionalne etične komisije. V izjavi na koncu rokopisa morajo avtorji podati izjavo o etiki raziskav na ljudeh, ki mora vsebovati ime etične komisije in referenčno števiko obravnave. Poročanje o raziskavah na ljudeh brez potrdila etične komisije zahteva dodatno razlago v poglavju o metodah dela. Na zahtevo Uredništva je avtor dolžan predložiti vso dokumentacijo o obravnavi raziskovalne etike njegovega rokopisa. Uredništvo si pridržuje pravico, da kontaktira etično komisijo. Prav tako morajo avtorji, ki poročajo o ljudeh ali posredujejo javnosti njihovo slikovno gradivo, pridobiti dovoljenja vseh sodelujočih, da se z vključitvijo v raziskavo strinjajo (v primeru otrok so to starši ali skrbniki). Izjavo o pridobitvi teh dovoljenj morajo avtorji podati v poglavju o metodah dela. Uredništvo si pridržuje pravico vpogleda v to dokumentacijo. Raziskave na živalih morajo biti izpeljane v skladu z navodili "Animal Research: Reporting In Vivo Experiments" (ARRIVE) in potrjene s strani nacionalne etične komisije. V poglavju o metodah dela in v izjavi na koncu rokopisa morajo avtorji podati izjavo o etiki raziskav na živalih z veljavno številko dovoljenja. V izjavi na koncu rokopisa morajo biti zapisani morebitni finančni ali drugi interesi farmacevtske industrije ali proizvajalcev opreme ter inštitucij, povezanih z objavo v ZV/SJPH. Avtorji morajo na koncu rokopisa zapisati sledeče izjave: CONFLICTS OF INTEREST (The authors declare that no conflicts of interest exist.) FUNDING (The study was financed by ... ) ETHICAL APPROVAL (Received from the... ali opis etičnega vidika raziskave) PLAGIATI Kadar uredništvo ugotovi, da je rokopis plagiat, se rokopis takoj izloči iz uredniškega postopka. Plagiatorstvo ugotavljamo s programom za odkrivanje plagiatov CrossCheck plagiarism detection system. ELEKTRONSKA ODDAJA PRISPEVKA Priporočamo uporabo videoposnetka z navodili za avtorje. Prispevke oddajte v elektronski obliki s pomočjo spletne aplikacije Editorial Manager, ki se nahaja na spletnem naslovu http://www.editorialmanager.com/sjph/. V uredništvo sprejemamo po pošti le še Izjave o avtorstvu in avtorskih pravicah, ki zahtevajo lastnoročni podpis. Prosimo, da jih pošljete hkrati z elektronsko oddajo prispevka na naslov: Nacionalni inštitut za javno zdravje, za revijo Zdravstveno varstvo, Trubarjeva 2, 1000 Ljubljana. V spletno uredniško aplikacijo se prijavite kot 'avtor'. Prva prijava zahteva vnos podatkov o avtorju, vse naslednje prijave pa le še vnos podatkov za prijavo, ki jih na svoj elektronski naslov prejmete po prvi prijavi v sistem. Nacionalni inštitut za javno zdravje Trubarjeva 2, 1000 Ljubljana, Slovenija zdrav.var@nijz.si http://www.niiz.si/sl/niiz/reviia-zdravstveno-varstvo ++386 1 2441 543 Po uspešni prijavi izpolnite vsa zahtevana strukturirana polja. Potrdite izjavo, da vaš prispevek še ni bil objavljen ali poslan v objavo kakšni drugi reviji, da so prispevek prebrali in se z njim strinjajo vsi avtorji, da so raziskave na ljudeh oz. živalih opravljene v skladu z načeli Helsinško-Tokijske deklaracije oz. v skladu z etičnimi načeli. Avtorji, ki v objavo pošiljate raziskovalno delo, opravljeno s pomočjo nekega podjetja, to navedite na koncu rokopisa v izjavi o financiranju. Navedete lahko tudi do dva neželena recenzenta. Polje 'Comments' je namenjeno obveznemu predlogu treh recenzentov z imeni, nazivi, e-naslovi in zaposlitvijo. Navedete lahko tudi do dva neželena recenzenta. Podatke o avtorju in soavtorjih vnesite kar se da natančno in popolno. Naveden naj bo korespondenčni avtor (s polnim naslovom, telefonsko številko in elektronskim naslovom), ki bo skrbel za komunikacijo z uredništvom in ostalimi avtorji. Jezik prispevka je angleščina. Objavljamo izvirne znanstvene članke, sistematične pregledne znanstvene članke, metodologije raziskav in vabljene uvodnike. Pri izvirnih, metodoloških in sistematičnih preglednih znanstvenih prispevkih morajo biti naslov, izvleček in ključne besede prevedeni tudi v slovenščino. Naslov, ključne besede in izvleček se oddajajo dvojezično v angleščini in slovenščini v strukturirana polja. Posebno polje za zapis v drugem jeziku obstaja le za izvleček, preostale podatke vnesite v obeh jezikih v ustrezno isto polje. Prvi izvleček je vselej v angleškem jeziku (do 250 besed - sistem vam besede sproti šteje), drugi pa v slovenskem jeziku (razširjen izvleček - do 400 besed). Po vnosu strukturiranih podatkov oddajte še priponko - rokopis (od 1 Uvod naprej), ki ne sme zajemati podatkov, ki ste jih vnesli že pred tem v strukturirana polja, zlasti ne podatkov o avtorjih. Ime datoteke ne sme vključevati avtorjevih osebnih podatkov, prav tako ne imen ustanov, vključenih v pripravo rokopisa. Grafično in slikovno gradivo je kot ves rokopis v angleškem jeziku. Vključite ga v besedilo na mesto, kamor le-to sodi in ga opremite z naslovom. Oddate torej le en sam dokument, eno priponko. V Wordu uporabite možnost Postavitev strani/Številke vrstic (tako bo na robu vsake vrstice dokumenta dodana številka vrstice). Pri oddaji sledite napotkom, ki vam jih ponuja sistem, pomagate pa si lahko tudi z 'Editorial Manager's Tutorial for Autors'. Sistem najbolje deluje, če uporabljate zadnjo različico Acrobata. Če pri oddajanju rokopisa naletite na nepremostljive težave, se za pomoč obrnite na naslov uredništva: zdrav.var@nijz.si. V nadaljevanju podajamo še nekaj natančnejših napotkov. ROKOPIS Besedila naj bodo napisana z urejevalnikom Word for Windows 97-2003. Robovi naj bodo široki najmanj 25 mm. Znanstveni članki naj imajo naslednja poglavja: uvod, metode, rezultati, razpravljanje in zaključek. Uvodniki in sistematični pregledni članki so lahko zasnovani drugače, vendar naj bo razdelitev na poglavja in podpoglavja jasno razvidna iz velikosti črk naslovov. Poglavja in podpoglavja naj bodo številčena dekadno po standardu SIST ISO 2145 in SIST ISO 690 (npr. 1, 1.1, 1.1.1 itd.). DOLŽINA PRISPEVKOV Zahtevana dolžina prispevka je za vabljen uvodnik od 250 do 1000 besed, za znanstveni članek (originalni, metodološki ali sistematični pregledni) pa od 2000 do 4500 besed s slikovnim gradivom in literaturo vred. Revizija sme obsegati 5000 besed. NASLOV IN AVTORSTVO Naslov v angleškem in slovenskem jeziku naj bo kratek in natančen, opisen in ne trdilen (povedi v naslovih niso dopustne). Navedena naj bodo imena piscev z natančnimi akademskimi in strokovnimi naslovi ter popoln naslov ustanove, inštituta ali klinike, kjer je delo nastalo. Avtorji morajo izpolnjevati pogoje za avtorstvo. Prispevati morajo k zasnovi in oblikovanju oz. analizi in interpretaciji podatkov, rokopis morajo intelektualno zasnovati oz. ga kritično pregledati, strinjati se morajo s končno različico rokopisa. Samo zbiranje podatkov ne zadostuje za avtorstvo. IZVLEČEK IN KLJUČNE BESEDE Izvleček v angleškem in slovenskem jeziku naj bo pri znanstvenem in metodološkem članku strukturiran in naj ne bo daljši od 250 besed v angleščini in 400 besed v slovenščini, izvlečki ostalih člankov so lahko nestrukturirani. Izvleček naj vsebinsko povzema in ne le našteva bistvene vsebine dela. Izogibajte se kraticam in okrajšavam. Napisan naj bo v 3. osebi. Izvleček znanstvenega članka naj povzema namen dela, osnovne metode, glavne izsledke in njihovo statistično pomembnost ter poglavitne sklepe (struktura IMRC - Introduction, Methods, Results, Conclusions). Navedenih naj bo 3-10 ključnih besed, ki nam bodo v pomoč pri indeksiranju. Uporabljajte izraze iz MeSH - Medical Subject Headings, ki jih navaja Index Medicus. KATEGORIJA PRISPEVKA Kategorijo prispevka predlaga z vnosom v ustrezno polje avtor sam, končno odločitev pa sprejme urednik na osnovi predlogov recenzentov. Objavljamo izvirne znanstvene članke, metodološke članke, sistematične pregledne znanstvene članke in vabljene uvodnike. REFERENCE Avtorjem priporočamo, da pregledajo objavljene članke na temo svojega rokopisa v predhodnih številkah naše revije (za obdobje zadnjih pet let). Vsako navajanje trditev ali dognanj drugih morate podpreti z referenco. Reference naj bodo v besedilu navedene po vrstnem redu, tako kot se pojavljajo. Referenca naj bo navedena na koncu citirane trditve. Reference v besedilu, slikah in tabelah navedite v oklepaju z arabskimi številkami ((1), (2, 3), (4-7)). Reference, ki se pojavljajo samo v tabelah ali slikah, naj bodo oštevilčene tako, kot se bodo pojavile v besedilu. Kot referenc ne navajajte izvlečkov in osebnih dogovorov (slednje je lahko navedeno v besedilu). Seznam citirane literature dodajte na koncu prispevka. Literaturo citirajte po priloženih navodilih, ki so v skladu s tistimi, ki jih uporablja ameriška National Library of Medicine v Index Medicus. Uporabljajte numerično citiranje. Imena revij krajšajte tako, kot določa Index Medicus (popoln seznam na naslovu URL: http://www.nlm.nih.gov). Navedite imena vseh avtorjev, v primeru, da je avtorjev šest ali več, navedite prvih šest avtorjev in dodajte et al. Če ima članek/knjiga DOI številko, jo mora avtor navesti na koncu reference. PRIMERI ZA CITIRANJE LITERATURE primer za knjigo: 1. Anderson P, Baumberg P. Alcohol in Europe. London: Institute of Alcohol Studies, 2006. 2. Mahy BWJ. A dictionary of virology. 2nd ed. San Diego: Academic Press, 1997. primer za poglavje iz knjige: 3. Urlep F. Razvoj osnovnega zdravstva v Sloveniji zadnjih 130 let. In: Švab I, Rotar-Pavlič D, editors. Družinska medicina. Ljubljana: Združenje zdravnikov družinske medicine, 2002:18-27. 4. Goldberg BW. Population-based health care. In: Taylor RB, editor. Family medicine. 5th ed. New York: Springer, 1999:32-6. primer za članek iz revije: 5. Florez H, Pan Q, Ackermann RT, Marrero DG, Barrett-Connor E, Delahanty L, et al. Impact of lifestyle intervention and metformin on health-related quality of life: the diabetes prevention program randomized trial. J Gen Intern Med. 2012;27:1594-601. doi: 10.1007/s11606-012-2122-5. primer za članek iz revije, kjer avtor ni znan: 6. Anon. Early drinking said to increase alcoholism risk. Globe. 1998;2:8-10. primer za članek iz revije, kjer je avtor organizacija: 7. Women's Concerns Study Group. Raising concerns about family history of breast cancer in primary care consultations: prospective, population based study. Br Med J. 2001;322:27-8. primer za članek iz suplementa revije z volumnom in s številko: 8. Shen HM, Zhang QF. Risk assessment of nickel carcinogenicity and occupational lung cancer. Environ Health Perspect. 1994;102(Suppl 2):275-82. 9. de Villiers TJ. The role of menopausal hormone therapy in the management of osteoporosis. Climacteric. 2015; 18(Suppl 2):19-21. doi: 10.3109/13697137.2015.1099806. primer za članek iz zbornika referatov: 10. Sugden K, Kirk R, Barry HC, Hickner J, Ebell MH, Ettenhofer T, et al. Suicides and non-suicidal deaths in Slovenia: molecular genetic investigation. In: 9th European Symposium on Suicide and Suicidal Behaviour. Warwick: University of Oxford, 2002:76. primer za magistrske naloge, doktorske disertacije in Prešernove nagrade: 11. Shaw EH. An exploration of the process of recovery from heroin dependence: doctoral thesis. Hull: University of Hull, 2011. primer za elektronske vire: 12. EQ-5D, an instrument to describe and value health. Accessed January 24th, 2017 at: https://euroqol.org/eq-5d-instruments/. TABELE Tabele v angleškem jeziku naj bodo v besedilu prispevka na mestu, kamor sodijo. Tabele naj sestavljajo vrstice in stolpci, ki se sekajo v poljih. Tabele oštevilčite po vrstnem redu, vsaka tabela mora biti citirana v besedilu. Tabela naj bo opremljena s kratkim angleškim naslovom. V legendi naj bodo pojasnjene vse kratice, okrajšave in nestandardne enote, ki se pojavljajo v tabeli. Slike morajo biti profesionalno izdelane. Pri pripravi slik upoštevajte, da gre za črno-beli tisk. Slikovno gradivo naj bo pripravljeno: • črno-belo (ne v barvah!); • brez polnih površin, namesto tega je treba izbrati šrafure (če gre za stolpce, t. i. tortice ali zemljevide); • v linijskih grafih naj se posamezne linije prav tako ločijo med samo z različnim črtkanjem ali različnim označevanjem (s trikotniki, z zvezdicami...), ne pa z barvo; • v grafih naj bo ozadje belo (tj. brez ozadja). Črke, številke ali simboli na sliki morajo biti jasni, enotni in dovolj veliki, da so berljivi tudi na pomanjšani sliki. Ročno ali na pisalni stroj izpisano besedilo v sliki je nedopustno. Vsaka slika mora biti navedena v besedilu. Besedilo k sliki naj vsebuje naslov slike in potrebno razlago vsebine. Slika naj bo razumljiva tudi brez branja ostalega besedila. Pojasniti morate vse okrajšave v sliki. Uporaba okrajšav v besedilu k sliki je nedopustna. Besedila k slikam naj bodo napisana na mestu pojavljanja v besedilu. Fotografijam, na katerih se lahko prepozna identiteta bolnika, priložite pisno dovoljenje bolnika. MERSKE ENOTE Naj bodo v skladu z mednarodnim sistemom enot (SI). KRATICE IN OKRAJŠAVE Kraticam in okrajšavam se izogibajte, izjema so mednarodno veljavne oznake merskih enot. V naslovih in izvlečku naj ne bo kratic. Na mestu, kjer se kratica prvič pojavi v besedilu, naj bo izraz, ki ga nadomešča, polno izpisan, v nadaljnjem besedilu uporabljano kratico navajajte v oklepaju. UREDNIŠKO DELO Prispelo gradivo z javnozdravstveno tematiko mednarodnega pomena posreduje uredništvo po tehnični brezhibnosti v strokovno recenzijo trem mednarodno priznanim strokovnjakom. Recenzijski postopek je dvojno slep. Po končanem uredniškem delu vrnemo prispevek korespondenčnemu avtorju, da popravke odobri in upošteva. Popravljen čistopis vrne v uredništvo po spletni aplikaciji Editorial Manager. Uredništvo dopušča obravnavo največ treh revizij. Če tretja revizija rokopisa ne upošteva vseh pripomb recenzentov, se rokopis umakne iz uredniškega postopka. Sledi jezikovna lektura, katere stroške krije založnik. Med redakcijskim postopkom je zagotovljena tajnost vsebine prispevka. Avtor dobi v pogled tudi prve, t. i. krtačne odtise, vendar na tej stopnji upoštevamo samo še popravke tiskarskih napak. Krtačne odtise je treba vrniti v treh dneh, sicer menimo, da avtor nima pripomb. V uredništvu se trudimo za čim hitrejši uredniški postopek. Avtorji se morajo držati rokov, ki jih dobijo v dopisih, sicer se lahko zgodi, da bo članek odstranjen iz postopka. Morebitne pritožbe avtorjev obravnava uredniški odbor revije. Za objavo članka prenese avtor avtorske pravice na Nacionalni inštitut za javno zdravje kot založnika revije (podpiše Pogodbo o avtorstvu in avtorskih pravicah). Kršenje avtorskih in drugih sorodnih pravic je kaznivo. Prispevkov ne honoriramo in tudi ne zaračunavamo stroškov uredniškega postopka. Avtor dobi izvod tiskane revije, v kateri je objavljen njegov članek.