Abuse in Women and Men with and without Functional Gastrointestinal Disorders

We aimed to investigate the history of abuse in childhood and adulthood and health-related quality of life (HRQL) in women and men with FGID in the general adult population. A cross-sectional study in a random population sample (n = 1,537, 20–87 years) living in Östhammar municipality, Sweden, in 1995 was performed. Persons with FGID (n = 141) and a group of abdominal symptom-free controls (SSF, n = 97) were selected by means of a validated questionnaire assessing gastrointestinal symptoms (the ASQ). Abuse, anxiety and depression (the HADS) and HRQL (the PGWB) were measured. Women with FGID had a higher risk of having a history of some kind of abuse, as compared with the SSF controls (45% vs.16%, OR = 2.0, 95% CI: 1.01–3.9; SSF = 1), in contrast to men (29% vs. 24% n.s.). Women with a history of abuse and FGID had reduced HRQL 91 (95% CI 85–97) as compared with women without abuse history 100 (95% CI 96–104, P = 0.01, “healthy” = 102–105 on PGWB). Childhood emotional abuse was a predictor for consulting with OR = 4.20 (95% CI: 1.12–15.7.7). Thus, previous abuse is common in women with FGID and must be considered by the physician for diagnosis and treatment of the disorder.
Introduction
Maltreatment, threats or violence from another person, often an intimate partner, is psychosocially traumatic and a growing problem in society. During the last decade, 1997–2006, the number of assaults reported to the police in Sweden increased by 40%, to 1,079/100,000 inhabitants, and the number of sexual offences increased by 57% to 137/100,000, of which rapes increased by 142% to 46/100,000. The latter high percentage is partly attributable to a change in the Swedish legislation that lowered the threshold at which sexual offence is classified as rape. For children (0–15 years) the number of assaults reported to the police has increased by 64% to 97/100,000 and the number of rapes has increased during the last decade by 300% to 12/100,000 [1].
About half of the women in Canada and Sweden have been described as having experienced at least one incident of violence by a man since the age of 16 [2, 3], and in a Japanese study three quarters of the women said they had experienced sexual, physical or emotional intimate partner violence [4]. A population survey in Los Angeles reported a childhood (lifetime for age <16 years) sexual assault prevalence of 6.8% in women and 3.8% in men [5], and 10.5% in adults [6].
Functional gastrointestinal disorders (FGIDs) are a group of digestive diseases with a chronic or recurrent course in the absence of organic illness likely to explain the symptoms [7]. The most frequent FGIDs are irritable bowel syndrome (IBS), with an average estimated prevalence of 12%, and functional dyspepsia with a prevalence of 25% in the general adult population, but with a considerable proportion of persons with overlapping symptoms [8]. Most studies on IBS report more sufferers among women than men [9]. The difference in prevalence of dyspepsia between women and men is inconsistent; some studies report a higher prevalence of symptoms of dyspepsia in women than in men [10, 11], whereas others do not find any sex difference [12, 13]. Although FGID is common, only about 50% of people who have symptoms of dyspepsia ever seek medical attention for it [14, 15], while the consulting figures for IBS are somewhat higher [15]. FGIDs constitute about 5% of all consultations in primary care [16], and only a minority is referred to secondary care [17, 18].
Nevertheless, FGID accounts for up to 50% of all gastroenterology consultations [19].
The pathogenesis of FGID is at present often explained using the biopsychosocial model in which biologic and psychosocial factors participate in the origin of symptoms [20].
An overrepresentation of a history of past abuse has been reported in both patients and non-patients with IBS and among non-patients with functional dyspepsia [21, 22]. However, investigating abuse is difficult among patients with abdominal distress, since sexual and physical abuses are seldom reported to doctors by their patients [23].
Our aims were to investigate the occurrence of a history of sexual, physical or emotional abuse experienced in childhood or later in life among women and men with FGID in the general population and the possible association with consultation rate, as compared with subjects free from FGID, controlling for age, sex, education and psychological distress.
Methods
Setting and sampling
A population sample (n = 1,537) drawn from the National Swedish Population Registry in 1995 involved men and women 20–87 years of age, born on day 3, 12 or 24 of each month living in Östhammar municipality. The sampling method is equivalent to random sampling since there is no reason to believe that date of birth is associated with the variables measured. The subjects were sent a validated postal questionnaire, called “The Abdominal Symptom Questionnaire” (ASQ) [24]. The responders (n = 911) in the population sample were classified according to their responses in the ASQ as having either functional gastrointestinal disorder (FGID n = 244), i.e., functional dyspepsia or irritable bowel syndrome, but not predominant symptoms on gastroesophageal reflux, or being strictly symptom free (SSF n = 219), i.e., having reported no gastrointestinal (GI) symptoms and also no GI symptoms reported by subjects who also participated in two previous population studies in 1988–1989 [25].
In 1996, the FGID (n = 244) and SSF (n = 219) sample groups were invited by mail to an appointment at one of their six local health centres. About 187 (77%) with FGID and 156 (71%) SSF accepted the invitation. At the health centre they filled in the ASQ once again together with other questionnaires about health-related quality of life (HRQL) and their abuse history. A nurse assisted only when needed. With the same criteria for FGID applied to this ASQ response, 141 with FGID (IBS and dyspepsia: 99; only dyspepsia: 40; only IBS: 2) and 97 SSF remained, and thus constituted the study groups. Thus the FGID symptomatics were classified as FGID twice, in 1996 and 1995, and the symptom-free SSF group up to four times in 1996, 1995, 1989 and 1988. This sampling procedure assured persistent symptom status in the two study groups, as has been presented earlier [26] and in Fig. 1.
Fig. 1Formation and sampling procedure for the study groups from the population of Östhammar
Questionnaires
The Abdominal Symptom Questionnaire (ASQ) has previously been validated and found reliable and reproducible [27–29]. The definition of FGID used in this study is dyspepsia, IBS or both, as taken from the ASQ. Solitary heartburn and/or regurgitations were symptoms not included in our definition of dyspepsia, which is in agreement with the current ROME III definition [30]. In the Abuse Questionnaire, the questions about sexual abuse were those initially developed for the National Population Survey of Canada [2] from survey questionnaires that fulfill reliability criteria [31]. The questions were translated into Swedish and back-translated into English for validation. Questions were written separately for childhood ≤13 years and adulthood (>13), including six categories of abuse: sexual, physical and emotional, each as a child or as an adult [23].
The Psychological General Well-Being (PGWB) index is a health-related quality of life instrument including 22 items divided into six domains: anxiety, depressed mood, positive well-being, self-control, general health and vitality. Items are scored on a six-grade Likert scale, with higher scores indicating better HRQL. The total score with a high responsiveness and validity for dyspepsia [32] was used in this study. HRQL values varying between 102 and 105 have been observed in a normal healthy population [33]. The total score was dichotomized at the median with a cut-off point 107/108 at the upper 95% CI for functional dyspepsia. Consequently, a good HRQL was considered to be a total score of 108 or more, which was reached by 117 subjects (score 108–132; mean 117.5, SD = 6.3), while a poor HRQL was reached by 120 subjects (score 49–107; mean 90.8, SD = 12.6).
The Hospital Anxiety and Depression Scale (HADS) is a validated, reliable instrument with subscales for measuring anxiety and depression [34–36]. The questionnaire has seven items, graded 0–3, with possible ranges of 0–21 for each subscale (total minimum score of 0, total maximum score of 42). A score of 7 or less on each subscale (out of a maximum of 21) denotes a non-case, 8–10 a doubtful case, and 11 or more a definite case of anxiety or depression. The cut-off point 10/11 was set for identifying sufferers in this study.
All participants per definition completed the ASQ, 231 (97.1%) the Abuse Questionnaire, 237 (99.6%) the PGWB questionnaire and 217 (91.1%) the Hospital Anxiety and Depression Questionnaire.
Educational background was registered at five levels and dichotomized, with low including elementary, comprehensive, secondary level and high upper secondary, university level. Data of previous consultations for GI symptoms and educational background were taken from questions added to the 1995 ASQ.
This study was approved by the Ethics Committee of the Medical Faculty, Uppsala University, on 5 June  1996.
Statistical analyses
A Spearman rank correlation test was performed for the variables anxiety, depression and quality of life. A multiple logistic regression analysis was performed with FGID/SSF and consulters/non-consulters as outcome variables, each of the abuse variables as exposure variables and the possible confounding factors: age (−40/40- years), sex (female/male), education level, anxiety (1-HADS subscale >10, 0-HADS subscale <11), depression (1-HADS subscale >10, 0-HADS subscale <11) and HRQL score (1-PGWB >108, 0-PGWB ≤108) as explanatory variables. In order to adjust for the influence of explanatory variables the variables were added one by one with a forward stepwise multiple logistic regression technique [37], and if the variable affected the odds ratios of the outcome variables less than ±10% and with P > 0.10, the variable was eliminated from the model. The Hosmer–Lemeshow goodness-of-fit test was performed for each model, and model improvements were tested with the likelihood-ratio test. Tests for interactions were completed between the abuse variables and age, sex and HRQL. No significant interactions were found. STATA version 9.2 statistical package [38] was used for the analyses.
Results
Demography and sexual, physical and emotional abuse
The distribution of age, sex, education, GI consultation, anxiety, depression, HRQL and sexual, physical and emotional abuse for persons with FGID and SSF is presented in Table 1. Forty-one percent of those with FGID had experienced some kind of abuse, as compared with 20% (P < 0.01) among SSF controls. Impaired anxiety and HRQL were significantly more common among subjects exposed to prior abuse, while depression was not.
Table 1Distribution of age, sex, education, previous GI consultation and abuse for women and men with functional gastrointestinal disorder (FGID) and strictly GI symptom free (SSF) and previous consulters/non-consulters for FGIDFGID (n = 141) n (%) SSF (n = 97) n (%)Statistic PConsulters GI (n = 99) n (%)Non-consulters GI (n = 39) n (%)Statistic PMean age years (SD)b45.7 (14.3)52.4 (15.4)0.000746.7 (13.4)41.4 (14.2)0.041Femalea93 (66.0)51 (52.6)0.038 66 (66.7)26 (66.7)01Completed high schoola66 (47.1)28 (29.5)0.00743 (43.4)23 (60.0)0.100Consulted for GI evera99 (71.7)8 (8.3)<0.001Not relevantNot relevantPsychological general well-beingb96.8114.6<0.000196.896.60.963Anxietya13 (10.0)0 (0.0)0.0025 (7.5)8 (13.1)0.507Depressiona5 (4.8)1 (1.7)0.3193 (5.4)2 (4.3)0.942Childhood abuseChildhood sexual abusea19 (13.9)3 (3.1)0.00616 (16.5)3 (7.9)0.196Childhood physical abusea15 (11.0)3 (3.2)0.02914 (14.4)1 (2.6)0.050Childhood emotional abusea37 (27.4)15 (16.1)0.04632 (33.7)5 (13.2)0.017Any childhood abusea43 (31.4)18 (18.8)0.03137 (38.1)6 (15.8)0.012Adulthood abuseAdult sexual abusea17 (12.4)2 (2.1)0.00514 (14.4)3 (7.9)0.303Adult physical abusea3 (2.2)1 (1.1)0.5133 (3.1)0 (0.0)0.273Adult emotional abusea32 (23.7)5 (5.4)<0.00124 (25.3)8 (21.1)0.608Any adulthood abusea40 (29.2)8 (8.3)<0.00130 (30.9)10 (26.3)0.598Any childhood, not adulthood, abusea16 (14.6)11 (12.4)0.65415 (20.0)1 (3.0)0.022Any adulthood, not childhood, abusea13 (11.8)1 (1.1)0.0038 (10.7)5 (15.2)0.509Any abuse (child or adult)Sexual abusea30 (21.9)4 (4.2)<0.00125 (25.8)5 (13.2)0.113Physical abusea17 (12.4)3 (3.2)0.01416 (16.5)1 (2.6)0.029Emotional abusea48 (35.6)15 (16.1)0.00139 (41.1)9 (23.7)0.060Any abusea56 (40.9)19 (19.8)0.00145 (46.4)11 (29.0)0.064aPearson chi2-test,  b Student’s t-test
Women
There were 144 women, 93 with FGID and 51 SSF in the study. Almost half of the women, 42 out of 93 (45%) with FGID, had a history of abuse, in contrast to the 8 out of 51 (16%, P < 0.01) SSF controls. Women with FGID had a higher prevalence than SSF women for sexual, physical and emotional abuse in childhood and for sexual and emotional abuse in adulthood, as presented in Table 2.
Table 2The number of people and the proportion of individuals (%) with a history of sexual, physical and emotional abuse in women and men with a functional gastrointestinal disorder (FGID) and strictly GI symptom free (SSF). The total number of FGID/SSF for both childhood and adulthood abuse in women was 93/51 and 48/46 in menChildhood abuse number FGID/SSF n(%) PAdulthood abuse number FGID/SSF n(%) PSexualPhysicalEmotionalAnySexualPhysicalEmotionalAnyWomen18(19)/3(6) 0.02711(12)/1(2) 0.04826(28)/5(10) 0.02132(34)/7(14) 0.00614(15)/2(4) 0.0442(2)/0(0) 0.40324(26)/2(4) 0.00131(33)/4(8) <0.001Men1(1)/0(0) 1.004(8)/2(4) 0.87611(23)/10(22) 0.93711(23)/11(24) 1.003(6)/0(0) 0.3311(2)/1(2) 1.008(17)/3(7) 0.3439(19)/4(9) 0.382P value computed with Fisher’s exact two-sided test
Out of the 50 women with a history of abuse, 24 (48%, FGID n = 21, SSF n = 3, P < 0.01) had experienced sexual, physical or emotional abuse both in childhood and as adults. In the FGID group, 42 (46%) women reported abuse in childhood and/or adulthood, as compared with 8 (16%, P < 0.01) in the SSF group. Moreover, in the FGID group, 32 (35%) women had a history of childhood abuse as compared with 7 (14%, P < 0.01) in the SSF group.
Men
In contrast to the women, the men had no significant difference for a history of abuse: 14 out of 48 (29%) men with FGID versus 11 out of 46 (24%, P = 0.69) SSF men. Similarly, no statistically significant difference was found for a history of sexual, physical or emotional abuse in the subgroups childhood and adulthood for men; see Table 2.
Anxiety and depression
Women and men with FGID significantly more often reported anxiety (P < 0.01), consultations for GI problems (P = 0.02), childhood abuse (P < 0.01) and adulthood abuse (P < 0.01) than SSF women and men. In contrast, depression had no significant univariate association with FGID, GI consulting, childhood abuse or adulthood abuse. FGID (OR = 2.1, 95% CI: 1.1–4.0) and anxiety (OR = 10.7, 95% CI: 2.3–51) were the only remaining independent predictors for abuse when adjusted for age, sex, education and depression when tested with the multiple logistic regression technique.
Quality of life
Subjects with FGID had a significant reduction in HRQL, as measured by the PGWB, with a mean value of 97 (95% CI: 94–99), as compared with SSF controls, who scored 115 (95% CI: 112–116). There was no significant difference in HRQL between women and men either for the FGID subjects (women 96; 95% CI: 92–99; men 99; 95% CI: 95–102) or for the SSF group (women 114; 95% CI: 110–117; men 115; 95% CI: 112–119). Women with a history of some kind of abuse and FGID had significantly reduced HRQL, with a mean value of 91 (95% CI: 85–97) as compared with a mean value of 100 (95% CI: 96–104) for women without abuse history. Similarly, men with a history of some kind of abuse and FGID had significantly reduced quality of life, with a mean value of 90 (95% CI: 82–99) as compared with a mean value of 102 (95% CI: 98–105) for men without abuse history.
The HRQL for FGID consulters and non-consulters was the same; both groups had a mean value of 97 with 95% CI 93–100 and 92–102, respectively. However, FGID consulters with a history of abuse had significantly lower HRQL, with a mean value of 92 (95% CI: 86–97), than FGID consulters without a history of abuse with a mean value of 100 (95% CI: 97–104, P < 0.05). There was a significant negative correlation between HRQL and anxiety [r = −0.61 (P < 0.01)] and between HRQL and depression [r = −0.54 (P < 0.01)].
Multivariate risk modeling
Persons with FGID had higher odds ratio 2.2 (95% CI: 1.1–4.4) of a history of some kind of abuse (in childhood or adulthood, sexual, physical or emotional) as compared with the SSF controls adjusted for age, sex and HRQL (main model, adding the variable anxiety or education did not improve the model). Some kind of abuse in adulthood had odds ratio 2.8 (95% CI: 1.1–7.1) with the same strategy. Emotional abuse in adulthood had the highest (and only significant) odds ratio 3.1 (95% CI: 1.0–9.4), while sexual abuse did not reach significance. In childhood, physical abuse seems to have the highest odds ratio 2.9 (95% CI: 0.7–12) for future FGID, although significance was not reached in this study (data not shown).
With the main model, women had significantly high odds ratios for FGID: from some kind of abuse 3.13 (95% CI: 1.21–8.10), emotional abuse 3.66 (95% CI: 1.22–11.0), physical abuse 5.07 (95% CI: 0.55–47.1) and sexual abuse 3.03 (95% CI: 0.89–10.3); the latter two types of abuse did not reach significance, as presented in Table 3. There were significant high odds ratios in women with the crude model for FGID from all types of abuse in childhood and adulthood, except adult physical abuse (probably owing to the small number of observations). Similarly, with the main model, there were high odds ratios in women, but they did not reach significance, see Table 3.
Table 3Odds ratio and 95% confidence interval (CI) for having a functional gastrointestinal disorder (FGID) (logistic regression) in different groups of abuse, women and men, in crude model and main model adjusted for age and HRQLVariableCrude modelMain model (adjusted for age and HRQL)WomenMenWomenMenChildhood abuseNo childhood sexual abuse11Childhood sexual abuse3.95 (1.10–14.1)*2.44 (0.60–10.0)*No childhood physical abuse1111Childhood physical abuse 6.88 (0.86–54.9)1.95 (0.34–11.2)4.93 (0.53–46.3)1.61 (0.21–12.3)No childhood emotional abuse1111Childhood emotional abuse 3.71 (1.32–10.4)1.00 (0.38–2.68)2.71 (0.87–8.4)1.14 (0.37–3.55)No childhood abuse1111Any childhood abuse3.41 (1.38–8.43)0.94 (0.36–2.47)2.50 (0.91–6.85)1.10 (0.36–3.38)Adulthood abuseNo adult sexual abuse111Adult sexual abuse4.45 (0.97–20.5)*3.20 (0.60–16.9)1.51 (0.53–4.29)No adult physical abuse11Adult physical abuse *0.93 (0.06–15.4)*0.84 (0.03–25.3)No adult emotional abuse1111Adult emotional abuse 8.86 (2.00–39.3)2.74 (0.67–11.1)3.42 (0.70–16.9)2.78 (0.55–14.0)No adulthood abuse1111Any adulthood abuse6.07 (2.00–18.4)2.43 (0.69–8.57)3.10 (0.92–10.3)2.41 (0.55–10.5)Any abuse (child or adult)No sexual abuse111Sexual abuse3.57 (1.34–9.5)*3.03 (0.89–10.3)1.49 (0.52–4.24)No physical abuse1111Physical abuse7.59 (0.96–60.2)2.5 (0.46–13.6)5.07 (0.55–47.1)1.84 (0.26–13.0)No emotional abuse1111Emotional abuse5.83 (2.11–16.1)1.26 (0.48–3.28)3.66 (1.22–11.0)1.31 (0.43–3.95)No abuse1111Any abuse4.61 (1.95–10.9)1.31 (0.52–3.32)3.13 (1.21–8.10)1.32 (0.45–3.90)1 = Reference, * too few observations
In contrast, men did not have the same elevation of odds ratio for FGID from any type of abuse as compared to women. The highest odds ratio in men for FGID was for some kind of adulthood abuse and was 2.41 (95% CI: 0.55–10.5), while adult emotional abuse was 2.78 (95% CI: 0.55–14.0), but neither were significant; see Table 3.
Consulters and non-consulters with FGID
Consulters with FGID more often (46% of them) had a history of abuse as compared with non-consulters (29%, P = 0.06), although it did not reach significance as shown in Table 1. Some kind of abuse in childhood was more prevalent: 38% in consulters versus 16% in non-consulters (P = 0.01) and correspondingly for childhood emotional abuse 34% and 13% (P = 0.02) and for childhood physical abuse 14% and 3% (P = 0.05). Moreover, there was a significantly higher prevalence of physical abuse in childhood or adulthood in consulters, 17%, versus non-consulters, 3%, P = 0.03. Female consulters with a history of some kind of abuse had an odds ratio of 2.47 (95% CI: 0.92–6.7), and with a history of childhood emotional abuse this was significant, 4.20 (95% CI: 1.12–15.7.7), in contrast to male consulters, with an odds ratio of 1.66 (95% CI: 0.37–7.50) for some kind of abuse and 2.10 (95% CI: 0.37–12.0) for childhood emotional abuse.
Discussion
Women, but not men, with longstanding FGID often have a history of abuse. Women with FGID reported past sexual, physical or emotional abuse in 45% of the cases, as compared with 16% for women without FGID, 29% in men with FGID and 25% in men without FGID. In this study emotional and sexual abuse are the most common type of threats to women’s health related to FGID. This study also shows that childhood emotional abuse is a predictor for consulting for GI problems. Moreover, longstanding FGID is associated with a significantly reduced HRQL, and a history of abuse further reduces the HRQL in women and men. The findings reveal that a history of abuse is an important psycho-social factor linked to FGID in women. In contrast, the association in men is less clear, although men with a history of some kind of abuse and FGID had significantly reduced HRQL as compared with men with FGID without any history of abuse.
Our study does not support the idea that consulters with FGID generally have a poorer HRQL than non-consulters, but a history of abuse had a negative effect on HRQL for consulters with FGID.
Most studies that investigate FGID use a technique that implies questioning the subjects of the experiment at a single point in time. One of the strengths of this study is the repetitive sampling procedure, which makes it possible to compare individuals with longstanding FGID with persistently symptom-free individuals in the same population. We consider that our findings can be generalized to the general population, as the study groups were sampled from a well-defined and thoroughly investigated population [24, 26]. The individuals answered the abuse questionnaire in a quiet, safe environment, in reality anonymously, with the support of a nurse only when needed, which was an advantage since patients tend to underreport abuse when asked face to face by a doctor [23].
The abuse questionnaire has not been thoroughly validated in a Swedish population, but the questions are straightforward and the questionnaire was translated into Swedish and back-translated into English. The definition of functional dyspepsia and IBS used is not exactly the same as the now recommended Rome III criteria [39]. The definitions of dyspepsia and IBS used in this study were those used in the original study from 1988 [25], before current recommendations were available. We opted to retain our original study definition since our IBS definition was in accordance with the Rome III criteria and our definition of dyspepsia was more restricted in terms of symptoms, but wider in terms of abdominal location. We consider the overall prevalence of FGID in this study and the concordance on an individual level to be applicable within the current definition [39], and thus we consider our results conclusive.
Previous studies in the field have reported that about half the patients referred to a gastroenterology clinic had a history of sexual or physical abuse [23, 40]. Moreover, 71% of women who reported domestic violence to the police had FGID according to Perona et al. [41]. In the literature, a history of childhood or adult abuse characterizes patients who present with a variety of functional symptoms apart from FGID [42]: headaches [43], pelvic pain [44], panic disorders [45], non-epileptic attack disorders [46] and back pain [47]. Psychological factors such as anxiety [48], as well as physiological factors such as enhanced visceral sensitivity, all contributed to a poor health outcome [42]. Only a few studies have focused on abuse and FGID in the general population, where Koloski et al. [22] found abuse to be significantly associated with IBS and/or functional dyspepsia, but less important when psychosocial factors were controlled for, a finding confirmed by others [49, 50].
The same research team [51] found that past sexual, physical and emotional abuse was not a significant predictor for seeking health care, in contrast to our finding that a history of childhood emotional abuse was associated with consulting, and anxiety and FGID were independent predictors for previous abuse. It is clear from our study that many subjects with traumatic memories and uncomfortable symptoms never seek health care and that when they do it is important to take a thorough medical history.
There is a bi-directional communication between the gut and the brain through the autonomic nervous system and the hypothalamic–pituitary–adrenal axis [51] that can mediate an emotional trauma such as previous abuse. Common links suggested are neuroticism [49], generally diminished pain threshold [52] and current depression [53]. There is a higher incidence of childhood abuse reported for women than for men in this study as in others [5]. This could explain the significant relation of consulting and childhood emotional abuse for women, but not for men found in this study, suggesting that FGID in some patients might be a sequel of previous abuse. The treatments available to date for FGIDs are of limited value. Creed et al. [54] have reported that psychological treatment and antidepressants are effective in patients with IBS and a history of sexual abuse, which stresses the importance of discovering past abuse in patients with FGID. Future studies must focus on how the knowledge of a patient’s previous exposure to different kinds of abuse and the effects of different kind of psychotherapy can improve the treatment for at least a subset of FGID sufferers.
Conclusions
We conclude that women with longstanding FGID in many cases have a history of physical, emotional or sexual abuse in childhood or adulthood, which is associated with a poor HRQL and increased health care seeking. This is important for physicians to consider when diagnosing and treating FGID in women.

functional gastrointestinal disorders
irritable bowel syndrome
abused women
child abuse


A rare case of complete C2–C3 dislocation with mild neurological symptoms

The authors report a rare case of complete C2–C3 dislocation with unexpectedly mild neurological symptoms in a 57 year old man involved in a motor vehicle accident, who had previously undergone posterior laminectomy from C3 through C7. A retrospective chart analysis and a thorough radiographic review were performed. X-rays and CT of the cervical spine demonstrated a complete dislocation at the C2–C3 level. Computed tomographic angiography revealed disruption of both vertebral arteries; however, blood flow was evident in the basilar artery. After radiologically guided placement in cervical traction with tongs that reduced the subluxation by approximately 50% the patient had spontaneous eye opening and was able to follow commands. A two-stage 360o stabilization and fusion was performed and the patient was finally discharged 24 days after admission with his neurological status essentially unchanged. In conclusion, our patient presented with surprisingly mild neurological symptoms. The previously performed laminectomy could have both predisposed to injury as well as protected his spinal cord from potentially fatal trauma.
Introduction
Subluxation of the cervical spine in adults usually occurs at its lower segments (C4–C7) [12, 14]; 50% of anterior subluxation of the neck has been reported to involve the highly mobile C5–C6 junction [11, 14]. In the pediatric population (up to 9 years old), the upper cervical spine is more susceptible to injury due to the anatomical differences in the developing spine [3]. Subluxation at the C2–C3 level is a particularly uncommon injury. We report a case of complete dislocation at the C2–C3 level in a patient involved in a motor vehicle accident who presented with surprisingly mild neurological symptoms.
Case report
A 57 year old African American man under the influence of alcohol and benzodiazepines was involved in a severe motor vehicle accident including one fatality. The patient was wearing a seat belt. He was transferred to our clinic via ambulance from a community hospital, fully immobilized with a hard cervical collar on, while the spinal cord injury solumedrol protocol had been initiated. On arrival to our Emergency Department, the patient had a Glascow Coma Scale (GCS) score of 11 and was thrashing all extremities. He responded to pain. He was intubated and thorough radiologic evaluation was undertaken.
The CT of the brain revealed a slender tentorial subdural hematoma not requiring surgical evacuation. X-rays and CT of the cervical spine revealed a complete dislocation at the C2–C3 level with acute angulation between the two cervical vertebral segments (Fig. 1). Additionally, the imaging studies demonstrated multi-level degenerative spondylosis, anterior bridging osteophytes from C3 through C7 consistent with Forestier’s disease and extensive previously performed posterior laminectomy from C3 to C7. Laminectomy was performed, according to the patient, because of underlying degenerative disease. Computed tomographic angiography (CTA) revealed disruption of the vertebral arteries bilaterally at the level of C2–C3 (Fig. 2). However, flow was identified in the basilar artery indicating a patent posterior circle of Willis providing back flow to the basilar artery and the posterior circulation. No MRI could be obtained due to the presence of a previously implanted cardiac pacemaker.
Fig. 1Plain lateral X-rays of the cervical spine demonstrating a complete C2–C3 dislocation upon the patient’s admissionFig. 2Computed tomographic angiography obtained at patient’s admission demonstrating bilateral complete disruption of vertebral arteries
The patient was placed in cervical traction with tongs under radiologic guidance for verifying alignment. The weight applied was gradually increased up to twelve pounds; at that point, fluoroscopic imaging demonstrated a significant improvement in the angulation of the two separate segments and a reduction of the degree of subluxation. However, a subluxation of approximately 50% of the cervical spine vertebral body length was still present (Fig. 3). Upon reversal of sedation, the patient had spontaneous eye opening and was able to follow commands. His upper and lower extremities’ muscle strength was 3/5. The treatment plan for this patient consisted of a two stage 360o stabilization and fusion.
Fig. 3Plain lateral X-rays of the cervical spine on the same patient obtained after applying external traction via tongs, demonstrating sub-optimal realignment of his cervical spine
Shortly after his arrival to our hospital, the patient started to experience respiratory difficulties, leading the authors to the decision to delay surgery until the respiratory condition of the patient was stabilized. Two days after his admission, anterior cervical discectomy and fusion (ACDF) with the standard Smith-Robinson technique and bone allograft was performed at the C2–C3 level. A 24 mm Synthes (Paoli, PA, USA) statue plate was utilized after appropriate bending in order to contour the curvature of the cervical spine. Intraoperatively, disruption of the anterior longitudinal ligament at the C2–C3 level as well as fracture of the anterior osteophytic bony bridges, were evident. The vertebral endplates of the vertebral bodies at that level were severely degenerated. At the conclusion of the case, adequate reduction, satisfactory alignment and stabilization of the anterior cervical spine were accomplished. A halo vest was applied post-operatively for additional stabilization, necessary for the aggressive physical therapy that the patient’s respiratory condition demanded. Post-operative X-rays demonstrated reduction of the dislocation of C2 with respect to C3 and anatomic alignment of the structures of the cervical spine.
The patient’s neurological condition remained unchanged during the following days. Respiratory distress was however noted, and a few days later, the patient was diagnosed with pneumonia. Appropriate treatment with antibiotics was initiated and it was decided to delay the second, posterior surgical approach until the patient’s respiratory condition was stabilized and his pneumonia resolved. Eighteen days after the initial operation, a second, posterior approach was employed. Under general endotracheal anesthesia, through a midline skin incision, a posterior cervical fusion and instrumentation (Synthes, Paoli, PA, USA) with pedicle screws at C2 level (20 mm long and 4 mm in diameter) and lateral mass screws (12 mm in length and 3.5 mm in diameter) at C3 level was undertaken. After optimal position of the screws was fluoroscopically verified, a 40 mm rod was used, which was attached and secured on a C2 and a C3 screw. Allograft bone chips were then appropriately placed (Fig. 4). The patient was placed back in the halo post-operatively due to his age and some concerns regarding osteoporosis. The halo vest was kept for four weeks after the second operation. He was finally discharged from the hospital to a rehabilitation clinic 24 days after admission. His neurologic status was essentially unchanged, with a muscle strength 3/5 in the upper and lower extremities.
Fig. 4Post-operative lateral X-rays on the same patient after completion of anterior and posterior fusion
The patient was followed at a different institution. At the last follow-up visit, 12 months postoperatively, his neurological status showed improvement with muscle strength of 4/5 in the upper and lower extremities.(Fig. 5a, b)
Fig. 5a Post-operative CT (3D reformatted midsagittal image) of the cervical spine demonstrating adequate anatomical alignment at the C2–C3 level. b Post-operative CT (3D reformatted midsagittal image) of the cervical spine demonstrating adequate anatomical alignment at the C2–C3 level
Discussion
Injury of the cervical spine is a potentially fatal and debilitating incident due to the risk of damage of the cervical spinal cord. Although the degree of subluxation does not necessarily correlate with clinical symptoms and neurological signs, one would agree that the patient described above presented with unusually mild symptomatology in regards to the complete dislocation of the cervical vertebrae of the C2–C3 level, evident in his radiological examination.
In reviewing the possible parameters related to this patient’s favorable outcome, attention should be drawn to the posterior cervical laminectomy previously performed on our patient due to underlying degenerative disease. It is quite likely that the lack of dorsal spinal elements of the C3 level, provided for adequate space for the posterior dislocation of the spinal cord to occur without sustaining the anticipated injury due to compression. This must have been of great importance both during the injury itself, as well as, after the dislocation had been established.
Interestingly, Fountas et al. [5] noted in their study using postmyelogram computed tomographic measurements, that the cervical spinal cord might be smaller than considered. Specifically, they found that the diameter of the cervical spinal cord was 15–20% smaller than has been reported by autopsy studies. A smaller cervical spinal cord would also be less susceptible to injury due to compression. Although this is an interesting point that should perhaps be taken into consideration when referring to compression of the cervical spinal cord, its role in our case of a complete dislocation of the cervical spine could not have been, by itself, determinant without the history of previous laminectomy.
On the other hand, the removal of the posterior arc of the vertebral bone may have predisposed for the development of such a complete dislocation. Hansen-Schwartz et al. [7] observed that 26% of patients developed static subluxation at the cervical spine 7.7±0.6 years after cervical laminectomy. Cusick et al [2], in a cadaveric study examining the biomechanical responses of the cervical spine to laminectomy, concluded that multilevel cervical laminectomy induces increases in total column flexibility, allowing additional motion in the flexion-extension plane. This observation may well describe the mechanism of injury in our case in which extension of C2–C3 induced a posterior dislocation and was not limited to a severe sprain. Likewise, Hong-Wan et al. [8] noted in their biomechanical study a significant increase in intersegmental motions following cervical laminectomy. Furthermore, Fields et al. [4] observed in their randomized study comparing the effects of laminectomy and laminoplasty in the rabbit, that laminectomized animals had poorer clinical outcome at 3 months post-operatively, associated with statistically significant angular deformity. Similarly, Baisden et al. [1], using a goat model, concluded that laminoplasty is superior to laminectomy in maintaining sagittal cervical alignment and preventing spinal deformities. The removal of bony and ligamentous structures of the posterior cervical spine might alter the biomechanics of the vertebral column and predispose to instability. The involvement of the C2–C3 level in our patient which coincides with the transition from non-laminectomized to laminectomized segments raises further suspicion regarding the putative role of laminectomy in the mechanism of injury in our case. Finally, the presence of osteophytes in the anterior cervical column in our patient (Forestier’s disease) could predispose to injury; more severe neurologic deficits have been described in patients with diffuse idiopathic skeletal hyperostosis even following minor trauma [15].
It is interesting to note that our patient had no signs of posterior fossa infarction despite the fact that both of his vertebral arteries were disrupted at the C2–C3 level. We assume that this is because of the presence of fetal circulation in this patient providing back flow to the basilar artery as this was demonstrated in his CTA, thus maintaining adequate perfusion of the posterior fossa [9].
Treatment of subaxial cervical spinal injury remains controversial. Both the anterior and posterior procedures have serious advantages and disadvantages [6, 10, 13]. In our case, we decided to perform a combined anterior and posterior surgical procedure, since both the anterior and posterior longitudinal ligaments were disrupted and we felt that a circumferential approach would sufficiently restore the lost stability. Furthermore, the presence of disc fragments compromising the spinal canal could not be ruled out, due to the inability to obtain an MRI in our patient. A posterior approach, thus, without anterior stabilization was considered to harbor an increased risk of spinal cord compromise. It needs to be emphasized that further multiinstitutional prospective clinical studies are required in order to establish guidelines for the management of subaxial cervical spine injury.
Conclusion
In conclusion, we have reported a rare case of complete C2–C3 dislocation with unexpectedly mild neurological symptoms in a patient who had previously undergone a C3–C7 laminectomy. The previously performed laminectomy might have both predisposed and protected the patient’s spinal cord from severe injury.

dislocation
fusion
upper cervical
anteroposterior stabilization
post-laminectomy


The “Essential Levels of Care” in Italy: when being explicit serves the devolution of powers

The definition of an explicit health benefit package in Italy has gained importance because of devolution of powers from the national level to the regions. The set of services to be guaranteed by the public sector are defined at national level, while regions are accountable for their provision. This contribution discusses the entitlements and the decision criteria adopted by Italian policy-making bodies. Entitlements to services are clearly defined for few sectors (mainly outpatient specialist care); for hospital care the benefit catalogue is vague. The definition of the health benefit package in Italy is an essential element of the relationship between the central government and the regions. It is argued that adequate monitoring systems and accountability procedures are still needed to make the essential levels of care an effective pivotal element of the Italian National Health Service.
Italy has a National Health Service based on principles of universalism and comprehensiveness [1, 2]. Established in 1978, the Italian National Health Service (INHS) absorbs 76.4% of total health care expenditure and it is financed by general taxation (OECD health data, 2005). As a consequence most care is provided free of charge at point of delivery, although user charges apply for outpatient services and procedures and, to a lesser extent, on pharmaceuticals [3].
A major critical feature of the INHS rests on the distribution of powers between the central government and the regions. Mainly created to reverse the concentration of state power occurring during the Fascist regime, the 20 regions are the emerging institutional tier of the country as they benefit from a substantial, although controversial, devolution of powers from the State. They have almost full control over approx. 200 Local Health Units and 100 Independent INHS Hospitals and they are expected to cover their deficit [4]. The Italian Constitution, revised in 2001, reserves to the central government the exclusive power to set the so-called “essential levels of care” (Livelli Essenziali di Assistenza, LEAs), which must be guaranteed to all residents. Regions have virtually exclusive powers over regulation, organization, administration, and funding of publicly financed healthcare.
The Italian Constitution of 1948 specifies the citizen’s right to health. This constitutional guarantee is expressed in very general terms. Article 32 of the Constitution says that “The Republic protects health as a fundamental right of the individual and as a concern of collectivity and guarantees free care to the indigent.” The principle of a package of benefits available to all citizens irrespective of age, social condition, or income was stated later, in the law introducing the INHS in 1978. The expression “levels of care” was mentioned for the first time with the objective to guarantee equal health care coverage throughout the country: “the State is to set objectives for eliminating geographical differences in social and health care conditions” (Art. 2) and “and to determine levels of care to be guaranteed to all citizens” (Art. 3). The same legislation also introduced another major feature of the INHS: the patient’s right to choose “provider and place of treatment.”
Although the 1978 reform listed the areas in which treatments are to be delivered under the INHS, it did not define the benefits to be included and excluded in detail. The concept of levels of care gained prominence in the legislation reforming the INHS in 1992–1993. The delegation of new powers to regions was coupled with tighter accountability systems. On the provision side the regions must deliver uniform levels of care, while on the funding side regions are mandated to cover any deficit required to provide the LEAs and to use their own resources to provide services above those guaranteed by national laws.
The reform laid out a new logical framework, but it took time to establish the LEAs. Significant progress was made in the late 1990s with the approval of the National Health Plan 1998–2000 and a new reform approved in 1999. These emphasized the importance of the principle of equality in the access of care and introduced LEA system; they also clearly stated the criteria that should inform their definition: human dignity, effectiveness, appropriateness, and efficiency.
The LEAs notion was at risk of remaining an abstract concept as political costs and implementation difficulties of clarifying and limiting INHS coverage were paramount. However, substantial progress in the definitions of LEAs was necessary to make sense of the overall strategy of redistribution of powers between the central government and the regions. This progress was made with the agreement between the regions and the central government on 8 August 2001 which was followed by a governmental decree (the LEA decree). At present this decree is the pivotal element of the Italian health benefit catalogue (Fig. 1). It defines the main areas of healthcare services to be guaranteed by the INHS (positive list), those completely excluded by public coverage (negative list), and those partially covered (only available for specific clinical conditions).Fig. 1 Decision making on benefits in Italy
The positive list is based on the recognition and systematization of current legislation (other decrees, laws, guidelines, etc.), i.e., it includes all the services that the INHS is actually providing categorized in three macrolevels of care: (a) public health services, (b) community care, and (c) hospital care (Fig. 2). Table 1 displays the main elements of LEA decree and of the other benefit-defining laws and decrees currently in force in Italy. The present contribution focuses on curative services.Fig. 2 DPCM, 29 November 2001. Definition of national standards of care (LEAs). MoH Ministry of HealthTable 1 Benefit-defining laws/decrees and catalogues for curative care services in Italy (LEAs DPCM, 29 November 2001, “Definition of Essential Levels of Care”; Specialist DM, 22 July 1996, “Specialist outpatient services”;
NPF National Pharmaceutical Formulary; Prostheses DM 332/1999: “Prosthetic devices, tariffs and provision modalities”; Rehab Guidelines on Rehabilitative Care adopted on May 7th 1998;
Primary National Contract for Primary Care)LEAsSpecialistNPFaProsthesesaRehabaPrimaryInpatient curative care+–––––Day cases curative care+–––––Primary care+––––+Outpatient dental care+–––––Specialist outpatient care++––––Alternative medicine+–––––Rehabilitative care+–––+–Long-term nursing care+–––––Clinical laboratory–+–––Emergency rescue+–––––Pharmaceuticals+–+–––Therapeutic devices+––+––Prevention and public health services+–––––Legal statusLegislative decreeMinistry DecreeAgency administrative actLegislative decreeLawPresidential decreeDecision makerPermanent State-Regions Conference; MoHMinistry of HealthNational Drug AgencyMinistry of HealthMinistry of healthMinistry of health; Trade-Unions of GPsOriginal purposeEntitlementsFee-schedulePositive listFee-scheduleGuidelinesEntitlementsPositive/negative definition of benefitsP and NPPPPPDegree of explicitnessb233311/2If itemized: goods, procedures only; linked to indicationsVaries by area of careProcedures, sometimes linked to indicationsGoods, for certain categories specific indications (prescription notes)GoodsNoPartiallyUpdatingForeseenNo at national level; regular at regional levelRegularly (annually)No (foreseen)NoEvery 2–3 yearsCriteria––––––  Need+––+–+  Costs++++––  Effectiveness–++––+  Cost-effectiveness––––––  Budget+––––+  Appropriateness+–––++aThese sections (noncurative care services) are not discussed in detail in the present contributionb1, “all necessary”; 2, areas of care; 3, items
The decree also defined a system for monitoring LEA implementation across the country. Responsibility for this was assigned to a special technical body established in April 2002 and composed of representatives of the Ministry of Health, the Treasury, and the regional governments. The main objective of the commission is to “monitor and evaluate the actual provision of services included in the LEAs and their costs.”
In 2004 a new technical body (the National LEA Commission) was established to update LEAs on the basis of scientific, technological, and economic evidence (Ministry decree of 25 February 2005). The Commission is set up of 14 members: 6 experts of healthcare management, planning, and organizational sciences are nominated by the Ministry of Health, 7 are regional representatives, and one is appointed by the Treasury.
Services of curative care in the health benefit basket
Inpatient curative care
Traditionally the services to be provided in hospital settings were never explicitly defined by the INHS. It has been rather implicitly recognized that all types of services deemed to be appropriately delivered at hospital level must be available to citizens. The LEA decree defines seven chapters as broad categories of services to be delivered in the hospital: (a) emergency services, (b) ordinary admissions (including rehabilitative and long-term inpatient care), (c) day hospital, (d) day surgery, (e) curative home-care, (f) collection, diffusion, control of blood-components and transfusion services, and (g) organ and tissue transplantation services. In addition, it is explicitly recognized that some benefits are available in hospitals although not included in the positive list of outpatient services provided under public coverage (e.g., certain pharmaceuticals or diagnostic tests).
While the detailed spectrum of services to be provided by the hospitals is not explicitly defined, national and regional fee-schedules regulate their funding. Since January 1995 Italian hospitals have been financed mainly according to nationally predetermined rates based on classification into diagnosis-related groups (DRGs) [4, 5, 6]. Regions are free to modify the rates according to their own standards but must take the national rate as the maximum level [1]. To a certain extent DRG lists may be interpreted as the catalogue of hospital services and benefits covered by the INHS. This interpretation, however, should be done with some caution. DRGs are divided in two major groups: surgical and medical. The interventions to which surgical DRGs refer are expected to be offered and funded. Therefore surgical DRGs define a sort of list of services available to patients. For medical DRGs the situation is different as the classification includes all possible diagnoses, including those for which hospital admissions may not been appropriate. Therefore medical DRGs do not define a list of services to be guaranteed but rather economic constraints according to which providers act. Thus, although implicitly, the tariff values assigned to DRGs influence the specific content of the services provided in each diagnosis category.
In Italy as well as in other countries, determining tariffs for specific diagnosis and treatments is seen as detrimental to the adoption of innovative technologies. Fixed and outdated tariffs may discourage the adoption of new expensive technologies and may force hospitals to look for alternative source of funding, often resulting in wide disparities of their availability to citizen. Regional authorities may react to the deficiencies in national policy with a variety of measures as it is illustrated in the case of Drug Eluting Stents (DES). Since their introduction into the European market in 2002, DES have been gradually implemented in clinical practice in Italy, mainly by hospitals in the north of the country. Several position papers and recommendations have been provided by scientific societies (e.g., Italian Group for Heamodynamics Studies, GISE), study groups, local committees (e.g., Emilia-Romagna Cardiology-Cardiosurgery Committee) in order to guide the adoption of DES. Early updating of reimbursement policies has been advocated by Italian cardiologists, hospital administrators, and patients to allow this technology to be economically sustainable by the hospitals [7]. Faced with continuously growing clinical and economic evidence, some regional authorities started to adopt different policy measures [8]. In 2002 the Lombardy Region revolutionized its DRG classification by creating three new DRGs to cover stent reimbursement and to encourage utilization. Other regions (Emilia Romagna, Lazio, Marche, Puglia) allowed for particular DRG tariff increase while the Campania Region established a special regional fund for DES reimbursement. In addition, Emilia-Romagna and recently Sicily established a regional registry to monitor the rate of adoption of the new technology and its effectiveness in real-life conditions. The final aim is to identify the target populations for which the new technology would be most beneficial. Most of the regions still have not updated in any way their reimbursement policies, thus limiting to certain extent the diffusion of the device on their territory.
The example on DES illustrates the existence of wide variations across the regions concerning how to fund innovative technologies. Similar situations may be found in other sectors of health care. However, the issue is not that simple when we consider that one of the fundamental rights of Italian citizens is the “freedom of choice of provider and place of care” [9], making regions responsible for the cost of treatment provided to their residents in other regions.
Day cases of curative care
Services available in day hospital regime are defined as “diagnostic, rehabilitation, and curative care, delivered as alternative to ordinary hospitalization, when the services to be provided require, due to their nature or complexity of provision, medical or/and nurse continuous assistance, not available in the outpatient (ambulatory) setting” (Presidential decree, 20 October 1992). Regarding inpatient care services available in day hospital are not explicitly defined, but rather there are specific criteria for the service to be considered appropriately delivered in this regime. Guidelines are defined at national level and they refer mostly to organizational aspects of services’ provision rather than their specific types (i.e., number of beds assigned for day hospital services must be at least 10% of the total).
The situation is very similar as regards day surgery care. National guidelines provide a list of possible interventions that may be performed in day care setting, as an alternative to normal hospital care. The list includes about 780 interventions, itemized by service delivered and grouped according to the organ or system of organs they refer to (e.g., respiratory system interventions, cardiovascular system interventions)
Outpatient curative care: primary care
All patients in Italy are registered with a general practitioner (GP) or a pediatrician who is in charge for providing most primary care, referring to specialists, and prescribing diagnostic interventions and drugs. The citizen’s can freely choose his or her own GP, given the limit of maximum number of enrolled patients. Primary care services provided by GPs are outlined broadly in the National Contract for General Practitioners, which is the most important document regulating various aspect of primary care. The National Contract is a result of negotiations between the government and representatives of general practitioners organized in various trade unions. Once reached, the content of the National Contract is legislated through a Decree approved by the Ministry of Health (i.e., the agreement is a binding by law). Regions are autonomous in establishing further agreements (Accordi Integrativi Regionali) aimed mainly at identifying the most appropriate organizational arrangements for the provision of services set at national level. The regional agreements may define additional services to be provided in primary care. The categories of services that primary care physicians are obliged to provide under the National Contract are defined broadly as: (a) essential services: acute and chronic disease management, in line with best practice indications and in agreement with the patient; (b) health promotion activities; (c) patient management within programmed and integrative domiciliary care coordinated with providers of specialist and rehabilitative care services; and (d) community services defined on the basis of regional agreements. The National Contract also encourages various forms of integration between primary care physicians and district services such as social and home care. Additionally, the National Contract obliges Local Health Units to guarantee continuity of care, i.e., primary care services 24 h a day, 7 days a week. Organizational arrangements are decided at regional level.
Outpatient dental care
Public coverage of dental care services has always been a debated issue in the Italian NHS. Current legislation explicitly excludes almost all types of dental services from the nationally defined benefit package. Some limited care is available to special groups of patients defined according to age and to specific clinical conditions. This explicit and rather broad exclusion of dental care services at national level had an impact on regional health policies. Numerous regions have adopted measures to guarantee some types of dental care services to citizens. An example of regionally defined benefit catalogue for dental care services is that in Veneto region, defined by Regional decree 2227/02. The regional decree defines the list of services available free of charge or subject to copayment for special patient categories. The list of services is available under set conditions only for the residents of Veneto Region, while nonresidents are fully charged. Beneficiaries are identified according to age, income, employment status, and presence of specific disease criteria: (a) dental health care in developmental age (0–16 years): preventive, diagnostic, and curative services for patients under the age of 16 years, orthodontic care for patients under the age of 12, nonsurgical treatment of paradental pathology for patients under age 16; (b) dental and prosthetic care to very low-income residents (<€ 8,500 per year) affected by chronic (e.g., cardiac insufficiency, psychosis) and rare (e.g., metabolic diseases, immunodeficiency) conditions; and (c) specialist curative care (excluding prosthetics) for anthalgic emergency cases caused by infections of caries and of paradental pathologies of traumatic events.
Specialized outpatient care
Specialized ambulatory services, including specialist visits, diagnostic, and curative interventions, are provided either by LHUs or by accredited public and private facilities. Patients are allowed to access specialist care only after approval by their general practitioner, who is responsible for the referral. Once the general practitioner has authorized the visit or the procedure, the patient is free to choose any provider among those accredited by the NHS anywhere in Italy. A list of outpatient services, including diagnostic procedures, specialist visits and laboratory tests was drawn up in 1996, and its original purpose was to define reimbursement fees of providers. Since then the national list of services has not been updated. However, regional authorities have often revised their fee schedules. The main criteria including services are effectiveness (based on solid scientific evidence) and costs. The benefits are classified in three different sections: (a) specialist outpatient care (including clinical laboratory and diagnostic imaging) provided under INHS coverage (a positive list of services, explicitly defined and enumerated, mainly without specific link to clinical conditions); (b) specialist services available only for specific indications (positive list of services limited to special patient categories); and (c) specialist outpatient care not covered by the INHS (negative list).
Regions are free to deliver additional services for which they are financially responsible. These services should be marked separately in the fee schedule and added to the list in accordance with the coding system in place. The positive list of specialist outpatient services is itemized by service delivered. The items (approx. 2,000) are grouped into 16 categories on the basis of system of organs the intervention refers to (e.g., respiratory system interventions). Each category is further divided according to the specific organ (e.g., trachea and larynges interventions). Finally, each subcategory contains a list of specific services (e.g., laryngoscope). Some services in the positive list are limited to special settings (e.g., where special equipments are available). Services that are available only to special patients categories (i.e., limited for specific clinical conditions) include about 20 items, mainly laboratory and diagnostic examinations that are very costly (e.g., positron emission tomography) or in some way controversial (palliative pain treatments).
All other outpatient curative care
Numerous services of physiotherapy are excluded from the national benefit package. Many regions, however, have approved their inclusion in the regional benefits so to generate substantial variability across the country. Lombardy, for example, includes all services listed on the national negative list while Veneto and Friuli Venezia Giulia authorize “water rehabilitation.” Almost all regions provide anthalgic electrotherapy, ultrasound therapy, mesotherapy, and laser therapy. The national benefit package explicitly excludes all types of alternative and complementary medicine, leaving it to the regions to decide whether to provide some of these services to their citizens. Only 4 of 21 the regions have invested in this category of services: (a) acupuncture is available in Piedmont, Valle d’Aosta, Umbria, and Tuscany; (b) homeopathy is available in Valle d’Aosta (limited to specific clinical conditions); and (c) chiropractic services are available in Valle d’Aosta only for spinal cord pathologies. Spa treatment is available for a limited number of pathologies, identified as those for which thermal treatment may provide actual benefits (based on scientific evidence). The list of pathologies is explicitly defined in a Ministry decree (1994) and includes: rheumatic diseases (e.g., osteoarthrosis and other degenerative forms, extrajoint rheumatisms), respiratory diseases (e.g., chronic pulmonary diseases), and dermatological diseases (e.g., psoriasis).
Discussion
Almost 40 year since its inception, the Italian NHS has an explicit system of national services guaranteed to all its citizens. The concept of providing a limited set of services under the INHS is now well established. Entitlements to services in particular areas (mainly outpatient care) are now clearly defined, and some services (e.g., dental and thermal care) are explicitly excluded. In the area of hospital care entitlements remain broad and general, although a strong reference to appropriateness criteria and the use of DRGs contribute to make benefits more explicit in this setting as well.
As in other countries, in Italy a clear definition of the benefits provided by the statutory system is thought to be beneficial for several reasons: it can contribute to a better allocation of resources, help to reassure patients about their rights and responsibilities, and facilitate the development of supplementary insurance [9]. In addition, the definition of the health benefit package in Italy is also an essential element in the relationship between the central government and the regions. The system of LEAs is the means to keep management and policy powers at regional level while assuring national guarantees. In this sense the basic package is primarily a policy devise to keep regions accountable to national standards.
A constitutional reform aimed at a new redistribution of powers between the central and regional authorities is presently under parliamentary discussion. This specifies that powers on health matters are exclusively in the hands of regions, provided that national principles are respected. If this reform is approved, the basic package would gain even more importance. Therefore we foresee the need for substantial investments to further specify the content of the package and, more importantly, to develop adequate monitoring systems and accountability procedures.
In our opinion, two issues are particularly critical in this respect. First, the coherence between benefits and resources made available requires an adequate governance system. At present Italy does not have a higher Chamber (it may be introduced in the Constitution reform under discussion) in which regions are represented, and where negotiations between them and the central government can take place within an appropriate institutional framework. At present, the devolution process lacks adequate rules to govern negotiations and conflicts. The risk of institutional conflicts, endless negotiations, legal disputes, and lack of coordination is very real and hitherto affects mainly the health care sector. It should be clear that without adequate governance mechanisms conflicts between the two central and regional authorities and between the regions themselves may result in further acceleration of the fragmentation of the INHS. The second issue concerns an adequate infrastructure to sustain the national government as guarantor of health care rights. Without an appropriate information system and new jurisdictional powers the national tier cannot ensure its guarantor role. To implement effective national guarantees the central government needs to develop the benefit package, to implement an effective monitoring system, and to design appropriate rules to force regions to act adequately. On the other hand, these conditions are also needed to ensure that resources available to the regions are compatible with the cost of the provision of services included in the benefit package [10].
It has been suggested that LEAs serve two main policy goals: equality and cost-containment [11]. An explicit definition of the guarantees provided Italians is a major mechanism to promote equality in the access of care, while limiting coverage may be a strong tool to contain costs. In theory the two objectives are compatible as explicitness of coverage can coexist with a different extent of the benefit package. In practice, however, LEAs may results in an overall system to defend the basic principle of the INHS from the risk of poor funding. Should radical policies aimed at reducing the ambitious goals of the INHS prevail, LEAs may become the main pillar of the system.
A few reflections can be made about the criteria adopted in Italy to build the benefit package. Effectiveness (in most cases efficacy), as confirmed by scientific evidence, is the dominant criterion in defining the package. Need criteria have been also used; ailments for minor conditions (cough, sore throat, minor headache), cosmetic surgery, and ritual circumcisions) are excluded on the basis of various interpretations of the need criteria. In general, clinical and organizational appropriateness is promoted as well. As the former requires that treatments and procedures are applied only to patients with particular clinical conditions, the latter tries to assure that patients are treated in the most adequate (and often cheapest) setting. Overall the use of appropriateness criteria suggests that benefit catalogues should be made of detailed lists of services for particular clinical conditions rather than simple lists of services.

italy
health services
health benefit plans
health priorities
national health programs


Measuring quality of life in rheumatic conditions

Musculoskeletal disorders often have associated pain, functional impairment and work disability, and, not surprisingly, are the most common reasons for utilizing healthcare resources. Rheumatoid arthritis (RA) and fibromyalgia (FM) are causes of musculoskeletal pain and disability. Research indicates that there is a widespread impact of RA and FM on physical, psychological and social factors in affected individuals, and thus, outcome measures that encompass multiple aspects of quality of life are needed. Generic measures of quality of life identify associations between physical conditions and mental health and highlight the need to address psychological functioning to ultimately improve the individuals’ quality of life.
Musculoskeletal disorders often have associated pain, functional impairment and work disability, and, not surprisingly, are the most common reasons for utilizing healthcare resources [1, 2]. Rheumatoid arthritis (RA) and fibromyalgia (FM) are among the most common causes of musculoskeletal pain and disability. They are estimated in community studies to affect 0.5–1 and 2–6% of the population, respectively [3–5]. These two conditions differ in a number of ways: In particular, RA has a clear pathophysiology with a range of clinical measures being able to indicate its presence, whereas the biological basis for FM is less defined with no “gold standard” test available. Despite this difference, these two rheumatic conditions share a range of associated outcomes. These include not only pain and fatigue but also difficulties with activities of daily living, ranging from basic and intermediate functions through to more complex tasks such as paid employment and social roles, e.g. child rearing [2, 6]. Further, RA and FM are associated with poor psychological functioning with 20 to 60% reporting depressive symptoms [7–9]. It is clear that there is a widespread impact of RA and FM on physical, psychological and social factors in affected individuals, and thus, outcome measures that encompass multiple aspects of quality of life are needed.
In this volume, Birtane et al. [10] study the use of a generic measure of physical and psychological functioning in patients with RA and FM and thus provide insights on the quality of life outcomes in these disorders. Generic and self-report measures of quality of life provide a wealth of information regarding the experience of individuals with rheumatic conditions that medical and observational measures cannot capture [11]. One such measure is the Medical Outcomes Survey 36 Items (SF-36) [12], which is a self-report multidimensional measure of quality of life that has been used extensively in RA and FM research [13, 14]. The SF-36 includes subscales across eight dimensions of health and well-being, including physical functioning, role physical, role emotional, bodily pain, general health, vitality, social functioning and mental health. Scores for all subscales are expressed on a scale of 0 to 100, with a higher score indicating a better state of health. It has good reliability and validity for both clinical and healthy community-based samples [15].
A generic measure of quality of life can offer a number of insights into the impact of rheumatic conditions on everyday functioning. The SF-36 provides the opportunity for interesting comparisons of the quality of life between healthy individuals and those with rheumatic conditions and other chronic physical conditions. Studies indicate that those with RA and FM, almost invariably, have reduced or compromised quality of life compared to healthy age-matched controls. Both RA and FM have a similar impact on psychological and physical functioning and social roles as other chronic conditions that contribute to the global burden of diseases, such as heart disease, chronic obstructive pulmonary disease and diabetes [10, 16, 17]. These findings have implications on health policy and allocation of funding for both healthcare and research. For instance, musculoskeletal conditions affect more than 17% of the community and 60% of working-aged adults, with projections indicating that arthritis will affect up to 20% of people by 2020 [18]. The prevalence, cost and burden of musculoskeletal disorders indicate that policymakers need to address the impact on economies, healthcare systems and society at large. For instance, if a public health intervention in 2005 enabled the onset of arthritis to be delayed by 10 years, the age-related incidence rates would be reduced by 11.1% before 2020 [18]. The burden of musculoskeletal disorders and issues of impaired quality of life have become an international health priority with initiatives such as the Bone and Joint Decade launched by the World Health Organization (WHO).
Birtane’s use of a generic measure of quality of life highlights the fact that FM, a condition with unclear pathophysiology, is associated with impaired quality of life to a similar extent as RA. This is in keeping with the recent models of quality of life or disability that place less emphasis on disease processes, pathophysiology and/or structural damage. Previous models of outcomes for rheumatic conditions have a strong biomedical focus with many models of disability or quality of life having an implicit assumption that there is a linear relationship between disease processes and disability. Attempting to use such models of disability by reading from left to right has obvious shortcomings because there are many instances such as FM that do not have a fully identifiable disease process [19]. Indeed, focusing on pathophysiology and functional ability in a limited context without consideration of the individual’s everyday tasks and roles sheds little light on the quality of life [20].
Newer approaches to examining disability acknowledge the roles of demographic, physiological, psychological, social and environmental factors acting as buffers and exacerbators of poor outcomes for chronic physical conditions [2]. The International Classification of Functioning (ICF) promoted by the WHO incorporates a broader biopsychosocial framework of disability, health and health-related states [21]. Indeed, the ICF takes a neutral stand with regard to aetiology and allows researchers to arrive at causal inferences using appropriate scientific methods. The ICF attempts to dislodge assumptions that the body level dysfunctioning, classified as impairments, is the fundamental dimension of disability and quality of life [21–23]. In other words, the quality of life in both RA and FM is not contingent on aetiology. The presence of a disability implies a cause, but the cause may not be sufficient to explain the resulting quality of life [21, 24, 25]. Measures such as the SF-36 provide the building blocks to create models of quality of life and study the different perspectives of this process across a range of chronic physical conditions as well as healthy individuals. Within this framework, using generic measures of quality of life can offer opportunities to frame research and interventions that appropriately target the quality of life of individuals with musculoskeletal disorders.
Using this approach, Birtane et al. [10] identified in patients with RA and FM that the incidence of poor physical and psychological functioning is almost invariably greater than for healthy controls. Additionally, higher depression levels are evident in patients with FM compared to those with RA. It is not surprising that FM is associated with the worst psychological functioning, given that depression is often evident in individuals with FM [26]. These observations are consistent with previous findings, which indicate that significant depressive symptoms are reported by up to 60% of individuals with chronic physical conditions. Addressing poor psychological functioning, especially depression, in musculoskeletal conditions is critical due to its impact on the condition itself. Reciprocal relationships can occur between depression and pain and disability leading to a cycle of poor mental and physical health. Depression is related to poor treatment compliance and increased morbidity and mortality in rheumatic conditions [27]. Measures such as the SF-36 clearly identify the associations between chronic physical conditions and mental health and further highlight the importance of addressing psychological functioning in both research and interventions to ultimately improve the individuals’ quality of life.
RA and FM are of course not mutually exclusive. The pathophysiology of each disorder is different, and many patients with RA also have FM, as do many other patients with a variety of chronic rheumatic diseases. The substrate of FM lies in the pain system, which can be functionally activated by distress, a common feature of chronic painful and disabling disorders. How much of the FM mechanism contributes to the low quality of life of RA? Further exploration of the mechanisms causing FM, with its resultant highly significant effect on the quality of life, will have a great impact on the management of not only FM itself but also RA and related musculoskeletal conditions.

quality of life
disability
rheumatoid arthritis
fibromyalgia