Title: Living alone and antidepressant medication use: a prospective study in a working-age population

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1 Author's response to reviews Title: Living alone and antidepressant medication use: a prospective study in a working-age population Authors: Laura Pulkki-Råback (laura.pulkki-raback@helsinki.fi) Mika Kivimäki (mika.kivimaki@helsinki.fi) Kirsi Ahola (kirsi.ahola@ttl.fi) Kaisla Joutsenniemi (kaisla.joutsenniemi@thl.fi) Marko Elovainio (marko.elovainio@thl.fi) Helena Rossi (helena.rossi@ttl.fi) Sampsa Puttonen (sampsa.puttonen@ttl.fi) Seppo Koskinen (seppo.koskinen@thl.fi) Erkki Isometsä (erkki.isometsa@hus.fi) Jouko Lönnqvist (jouko.lonnqvist@thl.fi) Marianna Virtanen (marianna.virtanen@ttl.fi) Version: 2 Date: 16 November 2011 Author's response to reviews: see over

2 COVER LETTER 1(12) 15 November, 2011 To: BMC Public Health Dear Dr. Victoriono Silvestre, Re: Revision of manuscript Living alone and antidepressant medication use: a prospective study in a working-age population by Pulkki-Råback et al. Thank you for the opportunity to revise this manuscript. We would like to thank you and both Reviewers for providing us constructive feedback to improve our manuscript. We have now made the requested revisions; changes are highlighted in yellow in the revised manuscript. We hope that you will be satisfied with the revision and find it suitable for publication in BMC Public Health. Sincerely, Laura Pulkki-Råback, PhD, on behalf of the authors Institute of Behavioral Sciences P.O. Box 9 FI University of Helsinki Finland tel laura.pulkki-raback@helsinki.fi Institute of Behavioral Science, P.O. Box 9), FI University of Helsinki

3 2(12) RESPONSES TO REVIEWER 1: Major Compulsory Revisions COMMENT: This is a reasonably well-written study on an important question. The study questions are clearly stated. The authors examined the relationship between living alone and incident antidepressant use over 7 years in a working-age population and the extent to which psychosocial, socioeconomic, and health behavior factors explain any associations found. The authors used reliable sources of data to answer their research questions. However, I believe that there is some additional work that the authors need to do before their worthwhile article is accepted for publication. RESPONSE: Thank you for this feedback. Please, find below our point-by-point responses to each comment. Methods section COMMENT: 1) Paragraph 2, In the first paragraph under "Measures", the authors need to include the entire question about living situation. Also, if the authors have any data that indicates marital status, it would be helpful if they indicated what percentage of the population was married, although living alone. RESPONSE: Thank you. We have included the entire question about living situation in the Measures section of the revised manuscript. We also ran a cross-tabulation showing how many were married although living alone (please note that many of them might have been separated but not yet divorced). There were 13 such participants in our sample, and we decided to include them in our data. We have described this in the Methods section, under the Measures heading as follows: "Living arrangement was examined at the baseline examination between 15 August, 2000 and 28 February, The participants were asked: How many persons live in your household, including you? Participants were classified as "living alone" if they reported a household size of one person, and "not living alone" if they reported a household size of two or more persons. Validity of this question was examined by cross-tabulating living arrangement with self-reported marital status. Of the 504 persons living alone, 184 were divorced, 25 widows, and 295 lived alone single without a specific reason. There were 13 married persons living alone; we decided to retain these persons among the 504 persons who were classified as living alone as they might have been separated but not yet divorced." p COMMENT: 2) Paragraph 7, The first paragraph under "Data Analysis", there are some additional data analyses that the authors should perform that would allow them to make more of their data. First, even though they found no interaction with gender, it would still be important to know two things. First, was gender related to living alone and was gender related to the outcome varialble, use of antidepressant medications? It would also be helpful to see the actual OR's for

4 3(12) men and women separately and to know if when age and gender are considered together, that made a difference. I think that that this is a big enough data set to allow a more detailed look into the age-gender variable. RESPONSE: Thank you for this comment. We ran additional analyses stratified by gender and added Table 1 and Table 4 to show these results. First, we examined whether the predictor (living arrangement) or the outcome (antidepressant medication use) differed by gender, and the findings are shown in Table 1. Gender was not related to living arrangement but, as expected, antidepressant consumption was greater in women compared to men. Table 1 also reports gender differences in the potential explanatory sociodemographic, psychosocial, and behavioral variables. Table 1 Characteristics of the study participants. The Health 2000 Study, n=3471. n (%) Men Women All P for gender n=1695 n=1776 n=3471 difference Number of participants living alone 244 (14.4) 260 (14.6) 504 (14.5) Number of antidepressant users: At baseline 75 (4.4) 140 (7.9) 215 (6.2) <0.001 During 7-year follow-up 235 (13.9) 362 (20.4) 597 (17.2) <0.001 Incident users during 7-year follow-up 175 (10.3) 245 (13.8) 420 (12.1) Psychosocial factors: Poor job climate 622 (36.7) 604 (34.0) 1226 (35.3) Lack of support at the workplace 618 (36.5) 551 (31.0) 1169 (33.7) Lack of social support in private life 600 (35.4) 626 (35.2) 1226 (35.3) High cynical hostility 455 (26.8) 466 (26.2) 921 (26.5) Sociodemographic factors: Low occupational grade (blue-collar) 753 (44.4) 431 (24.3) 1184 (34.1) <0.001 Lack of secondary education 387 (22.8) 384 (21.6) 771 (22.2) Low income (<50% of national median 182 (10.7) 213 (12.0) 395 (11.4) Temporarily outside working life 122 (7.2) 170 (9.6) 292 (8.4) Urban residency 1058 (62.4) 1193 (67.2) 2251 (64.9) Living at rent 379 (22.4) 402 (22.6) 781 (22.5) Poor housing conditions 152 (9.0) 185 (10.4) 337 (9.7) Health behaviors: Daily smoking 490 (28.9) 380 (21.4) 870 (25.1) <0.001 Heavy alcohol use 241 (14.2) 135 (7.6) 376 (10.8) <0.001 Infrequent physical activity 336 (19.8) 424 (23.9) 760 (21.9) Obesity (BMI 30) 310 (18.3) 340 (19.1) 650 (18.7) 0.519

5 4(12) An excerpt from the first paragraph of the Results section reporting these findings: "Women had greater prevalence and incidence of antidepressant use than men did. Compared to women, men had less social support at work and lower occupational grade than women, lived more often in rural areas, smoked more often, and used alcohol more heavily than women." p. 8. The association between living arrangement and antidepressant medication was examined separately for men and women and the results are shown in Table 4. The unadjusted ORs were rather similar in men and women (suggesting that living alone was associated with greater risk of antidepressant use in both genders), but the explaining factors were somewhat different. These analyses are described in the revised manuscript in the Methods section. The results are reported as follows: "There was no statistical evidence to suggest that gender modifies the association between living arrangement and antidepressant use (P-values for gender living arrangement interactions were 0.618, 0.673, and 0.984). However, the underlying mechanisms can be gender-specific. Thus, we ran the analyses shown for the total cohort in Table 2 stratified by gender to examine whether the contributing factors differed between men and women. Table 4 shows that in men psychosocial factors had the greatest contributing effect to the association between living arrangement and antidepressant use (attenuations were 31%, 21%, and 15%). In women, sociodemographic factors stood out as the major contributors showing attenuations of 24%, 27%, and 31%." p. 9. The gender-specific findings are also commented in the Discussion, please see excerpts below: First paragraph of the Discussion, page 10: "This study suggested that living alone is associated with prospective use of antidepressant medication in a nationally representative Finnish working-age sample. Those who lived alone had 80% higher risk of initiating antidepressant use during the 7-year follow-up compared with participants who did not live alone. Socioeconomic adversity explained part of this relationship, especially in women. Psychosocial factors, including lack of social support, were important explanatory factors in men. Health behaviors had only a marginal contribution to the association between living alone and antidepressant use among men and women, with the exception of heavy alcohol use in men. This is in agreement with a

6 5(12) previous register-based study showing a strong link between living alone and alcoholrelated mortality [1].." p. 10. "...In our study, urban living, poor housing conditions and living at rent, contributed to the association between living alone and antidepressant use. Their effect was more pronounced in women than men." p. 10 "...Lack of social support, poor job climate, and a hostile personality were among the psychosocial factors that were associated with living alone and antidepressant use. Lack of supportive social contacts at work and in private life explained part of the association between living alone and antidepressant use in men. " p. 10 Discussion, the Conclusion section, page 13: "...We found evidence to suggest that the explanatory factors may be gender-specific, with lack of social support playing a greater role in men and socioeconomic disadvantage in women. These finding suggest that improving the quality of social relations and material circumstances should be important targets in mental health promotion..." COMMENT: Next, seven years is a long followup period. As the authors rightly point out later in the paper, they do not really know what the living situation of anyone in their study is when they actually start to use antidepressant medications. So, I suggest that the authors do some analysis to see if most of the incident use happens in the first year of followup or the first two years of followup, etc. RESPONSE: The Reviewer is correct. We conducted two types of analyses to examine this issue. First, we examined whether incident use of antidepressants peaked at some point of the follow-up period. The findings, gathered in Annex table 1, show that there were 49 to 69 new users each year, corresponding to a steady 1% to 2% annual incidence rate. Thus, incidence was equally distributed over the follow-up period as shown in the table:

7 6(12) Annex table 1 (on-line supplement) Prevalence and incidence of antidepressant use according to follow-up year. The Health 2000 Study, n=3471. Prevalence New users a Follow-up year n (%) n (%) (5.4) 65 (1.9) (6.1) 69 (2.0) (6.9) 58 (1.7) (6.9) 49 (1.4) (7.3) 53 (1.5) (7.7) 57 (1.6) (8.9) 69 (2.0) a Indicates first-time users who had no previous purchases of antidepressants at any year. To further examine the effect of the length of the follow-up, we repeated the main analyses by using the 2-year follow-up period instead of the 7-year one. We found similar, although weaker (as expected), associations between living arrangement and antidepressant medication in these analyses with a more proximal outcome. These results are described in the Results and shown in Annex table 2. An excerpt from the Results section, page 9: " Finally, we conducted a sensitivity analysis to examine whether the associations were dependent of the length of the follow-up period. We repeated the analyses between living arrangement and antidepressant use using a 2-year follow-up period instead of a 7- year follow-up period. The association was directionally similar but slightly weaker than in the main analysis (Annex Table 2). The contributing factors were similar in magnitude to those in the main analysis, with sociodemographic factors having the greatest contribution and health behaviours the least contribution to the greater antidepressant use of participants living alone." p. 9.

8 7(12) Finally, we have noted this point as a limitation in the Discussion: Second, we were unable to examine whether changes in living arrangements had an effect on antidepressant use. As we had no data on living status at follow-up, some misclassification is possible due to changes in living status after baseline, that is, someone who originally was living alone may have been co-habiting at the time of purchase of antidepressants. Although the main findings were replicated in sensitivity analyses over a shorter time-span when a change in living status was less likely, this question remains to be examined in further studies. p.11. Results section COMMENT: 3)The authors need to add the actual OR's for the association between living alone and antidepressant use that are related to sociodemographic factors, psychosocial factors and health behaviors instead of just including the percentages that these factors attenuate the relationship. The figures are in Table 2, but it would be important for the reader to see the adjusted OR's in the text. RESPONSE: As suggested, we added these ORs in the Results section: Sociodemographic factors attenuated these associations by 18%, 21%, and 20%. As shown in Table 3, the ORs adjusted for sociodemographic factors were 1.48 (CI= ) for baseline antidepressant use, 1.64 (CI= ) for 7-year use, and 1.57 (CI= ) for incident antidepressant use. Psychosocial factors attenuated the associations by 30%, 12%, and 6% with the adjusted ORs being 1.43 (CI= ) for baseline use, 1.71 (CI= ) for 7-year use, and 1.67 (CI= ) for incident antidepressant use. Finally, health behaviors had only marginal effect on the associations between living arrangement and antidepressant use with adjusted ORs 1.58 (CI= ), 1.74 (CI= ), and 1.64 (CI= ), corresponding to a contribution of 5% to 9% owing mainly to heavy alcohol use. p.8-9. Discussion section COMMENT: 4) The discussion section includes the necessary points, but needs to be written much more crisply. It also needs to more clearly state that the authors do not know if when members of the study population started to use antidepressants after baseline, their living situation could have been different. The fact that the followup period is so long, makes the possiblity fairly likely that the antidepressant use could have happened when someone living alone at baseline was living with others when they purchased the antidepressants. This fact makes it difficult to know exactly what to make of the study findings.

9 8(12) RESPONSE: We agree with the Reviewer that absence of follow-up data regarding changes in living situation may obscure our findings. However, it is likely that, compared to people not living alone at baseline, a greater proportion of those living alone at baseline also do so at follow-up and, conversely, that a greater proportion of persons not living alone at baseline do so at follow-up as compared to those who lived alone at baseline. Some misclassification is likely, as we have acknowledged in the revised manuscript (please, see our previous response), but a major bias seems unlikely. In order to assess potential misclassification bias arising from this study design, we have conducted additional analyses and reported them in Annex tables 1 and 2 in the revised manuscript. We have also re-written parts of the Discussion and tackled these concerns. An example from the Discussion, p.9: Second, we were unable to examine whether changes in living arrangements had an effect on antidepressant use. As we had no data on living status at follow-up, some misclassification is possible due to changes in living status after baseline, that is, someone who originally was living alone may have been co-habiting at the time of purchase of antidepressants. Although the main findings were replicated in sensitivity analyses over a shorter time-span when a change in living status was less likely, this question remains to be examined in further studies. p.11. COMMENT: 5) Regarding the first paragraph under Discussion: This is a good succinct summation of the study findings. However, the authors need to spend more time in the discussion section writing about the fact that the association they found between living situation and antidepressant use is not totally explained by the sociodemographic factors, psychosocial factors, and health behaviors explored in their study. It would be helpful if the authors described what factors unmeasured in the present study might explain their findings. I suggest that the authors add some of their ideas about what the relevant unmeasured variables might be. RESPONSE: We have noted this briefly in the first paragraph of the Discussion and added a more detailed paragraph in the Conclusion section (as suggested by the Reviewer). Please, see the following parts of the revised manuscript: First paragraph of the Discussion, page 10:... All the factors included in this study explained 46% of the associations, thus leaving the majority of the association between living alone and antidepressant use unexplained. Discussion, the Conclusion part on page 10: Further research is needed as over half of the association between living alone and antidepresant use remained unexplained by the variables included in this study. Further insights may arise for example from assessments that cover social capital (that is, feelings of alienation and lack of trust in the society), critical life-events and their accumulation over

10 9(12) time, and childhood circumstances giving rise to psychological vulnerabilities in adulthood. p.13. COMMENT: 6) Abstract section: I recommend that the authors add the adjusted OR's to the results section of the abstract. These are the OR's regarding the relationship between living situation and antidepressant use when sociodemographic factors and psychosocial factors and behaviors are adjusted for. RESPONSE: We have added the adjusted ORs in the Abstract of the revised manuscript. COMMENT: 7) The conclusion in the abstract should be differerent. First, because of the limitations of the study, the opening sentence should say that "...people living alone may be more at risk for developing mental health problems than people not living alone." In other words the conclusion should be a little less strong. RESPONSE: Thank you, we did as the Reviewer suggested here. COMMENT: 8) Since one of the study questions was about whether or not sociodemographic, psychosocial factors and health behaviors explain the relationship between living situation and antidepressant use, I think in the conclusion there should be a recommendation for more studies to be conducted to try to identify the unmeasured factors that might explain the relationship. This sentence could go right before the concluding sentence. RESPONSE: We added such a paragraph in the Discussion. This is the last paragraph of the Conclusion section on page 13. We placed this paragraph in the end of the Conclusion but we may change its place if recommended by the Reviewer. Further research is needed as over half of the association between living alone and antidepresant use remained unexplained by the variables included in this study. Further insights may arise for example from assessments that cover social capital (that is, feelings of alienation and lack of trust in the society), critical life-events and their accumulation over time, and childhood circumstances giving rise to psychological vulnerabilities in adulthood. p.13. Minor Essential Revisions COMMENT: 1) Background section, Paragraph 1, line 3. It now says "...households constitute..." should be "will constitute" or "will include." RESPONSE: Revised as suggested. COMMENT: 2) Paragraph 3, line 6. It now says..."is a risk for mental health". It should say "is a risk for developing mental health problems." RESPONSE: Thank you, we did this correction. COMMENT: 3) Paragraph 4, line 4. "...antidepressant use over during." The author should say, either "over" or "during" but not both.

11 10(12) RESPONSE: We apologize for this typo and have now corrected it. COMMENT: 3) Discretionary revions. Discussion section. The authors might consider what the effect on their findings related to gender was when so many of the respondents were male with mental health problems were drop outs. RESPONSE: In the revised manuscript, gender differences are discussed in a greater detail. Selective drop out can lead to under- or overestimation of the associations. RESPONSES TO REVIEWER 2:

12 11(12) This study examines the prospective relationship between living alone and antidepressant utilization. The authors employ survey data in addition to medication claims. The approach is novel and the results suggest a strong relationship between living arrangements and antidepressant medication use. I have a few suggestions for revising the paper. COMMENT: 1) In their literature review on pages 3-4, the authors state that they are unaware of any other prospective studies examining the relationship between living arrangements and mental health outcomes. I am aware of one such study that examined the prospective association between living arrangements and depressive symptoms and controlled for social and demographic characteristics of respondents. The study was conducted by Mary Hughes and Linda Waite ( Health in Household Context: Living Arrangements and Health in Late Middle Age, 2002, Journal of Health and Social Behavior). The authors should reference this study in the literature review. RESPONSE: Thank you for this recommendation. We have now read the paper by Mary Hughes and Linda Waite, which we found very interesting and helpful in developing the ideas of our manuscript further. We have cited their paper in the Background section and in the Discussion. Please, see the second paragraph in the Background, page 3: " A prospective study showed that household structure, that is, presence of other people in the same household, was a more important determinant of well-being than marital status in middle-aged people [2]. Please, see also the fourth paragraph of the Discussion on page 12: A large prospective study has shown that under certain circumstances living with other people may be more stressful than living alone [2]. Future studies should examine possible benefits of living alone, and the advantages and disadvantages of having other persons with different statuses in the household. COMMENT: 2) The authors should elaborate on their rationale for collapsing the continuous measures of psychosocial and sociodemographic factors into dichotomous variables. Why was this done? Why were the untransformed continuous measures not used in the analytic model? RESPONSE: We agree with the Reviewer that use of continuous measures would have been an alternative valid analytic strategy. However, we would prefer to use categorised variables, which is another valid strategy. We have used standard categorisations, adopting risk factor cut-points that have been previously shown to be related to depression outcomes. The rationale is that: (1) this approach enables a better comparison with previous studies using similar measures; (2) the assumption underlying the use of continuous variables is that each increment in the distribution equally add risk, but this is not necessarily the case as threshold effects are also possible; (3) our exposure and outcome measures are categorical variables (living alone or not; antidepressant use vs. non-use) rather than a continuum of the duration of

13 12(12) time lived alone or the duration of antidepressant treatment (plus dose), thus using categorical covariates match with our exposure and outcome variables (please, see the Measures section, page 6). COMMENT: 3) The authors should comment on the limitations of their measure of living arrangements (alone versus not-alone). This measure obscures differences between living alone, living with a spouse, living with spouse and children, living with relatives, living with others who are not relatives, etc. RESPONSE: Thank you for this important perspective. We agree that our measure is rather crude and does not allow more specific comparisons of different kinds of living arrangements. Thus, we have now acknowledged this limitation in the Discussion, page 11:... Neither were we able to measure the effect of different household compositions, such as the presence of children, spouse, or elderly relatives, on mental health. A large prospective study has shown that under certain circumstances living with other people may be more stressful than living alone [2]. Future studies should examine possible benefits of living alone, and the advantages and disadvantages of having other persons with different statuses in the household. It is of note that Finland is typically a society with strong nuclear families with 1.7 children in average. Different generations are highly segregated and the extended family typically does not live in the same household (not even when they are old or need to be cared for). It would thus be expected that prevalence of living arrangements including grand-parents or other relatives is small. However, other types of household compositions may be on the rise, such as spouse with children who are not blood-relatives of the primary household member. We plan to examine these important topics in future follow-up examinations of the Health 2000 Study. New references in the manuscript: 1. Herttua K, Martikainen P, Vahtera J, Kivimaki M: Living alone an alcohol-related mortality: a population-based cohort study from Finland. PLoS Med 2011, 8:1-11 (e ). 2. Hughes ME, Waite LJ: Health in houshold context: living arrangements and health in late middle age. Journal of Health and Social Behavior 2002, 43:1-21. END OF RESPONSES

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