- Email: [email protected]
Intensive case management for severe psychotic illness
high quality psychiatric care that they have been providing. Another issue should be considered in judging the (lack of) value of intensive case management. Burns et al do not discuss the implications of their only statistically and clinically significant finding. More people in the intensive group than in the standard care group lost contact with their case manager (13% vs 7·6%, p=0·02). Did this loss occur because the extra input was too intrusive for some patients? Many patients with psychotic illnesses who lost contact with services would not consider requesting help when their health deteriorates. Acceptable monitoring by a case manager is therefore essential. Similarly, when assessing the overall quality of Burns and colleagues’ standard services it is important to consider the needs of patients with severe and enduring mental disorders whom they have previously discharged from secondary care.5 As a spin off from this randomised controlled trial, Burns and colleagues have shown that community care can be highly successful for patients who remain under the care of well functioning community teams. All mental health professionals now have to rise to the challenge of ensuring appropriate care of similar quality to people who are not receiving specialist input and whose illness can prevent them from seeking assistance. *Anthony J Pelosi, G Laing Duncan, Seamus V McNulty Department of Psychiatry, Lanarkshire Primary Care NHS Trust, Hairmyres Hospital, East Kilbride G75 8RG, UK 1
2
3
4
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Burns T, Creed F, Fahy T, et al. Intensive versus standard case management for severe psychotic illnesses: a randomised trial. Lancet 1999; 353: 2185–89. Slade M, Thornicroft G, Loftus L, Phelan M, Wykes T. CAN: Camberwell assessment of need: a comprehensive needs assessment tool for people with severe mental illness. London: Gaskell, 1999. Brewin CR, Wing JK, Mangen SP, Brugha TS, MacCarthy B, Lesage A. Principles and practice of measuring needs in the long-term mentally ill: the MRC Needs for Care Assessment. Psychol Med 1987; 17: 971–81. Bebbington P, Marsden L, Brewin CR. The treatment of psychiatric disorder in the community: report from the Camberwell Needs for Care Survey. J Ment Health 1999; 8: 7–17. Kendrick T, Burns T. Mental health teams should concentrate on psychiatric patients with greatest needs. BMJ 1996; 313: 884–85.
Sir—The design of randomised trials beyond the pharmaceutical arena are fraught with difficulties, and unfortunately Tom Burns and colleagues’ conclusions1 are inappropriate and may misinform policy makers because the
THE LANCET • Vol 354 • October 16, 1999
interpretation of (non-significant) results is flawed. The basic purpose of a controlled clinical trial is to establish and estimate the effects of treatment. In this trial, the treatment is not the type of case management but the interaction of case management, case manager, and case load. Case managers were not randomised to type of case management and randomisation of patients was stratified only by centre and not by centre and type. In effect, standard case management is done by local senior staff (half were senior mental health nurses) at a low case load (22 per case manager vs the expected 30–35 per case manager). By contrast, the intensive case management is done by newly recruited staff (a quarter were senior mental health nurses with 14 per case manager vs the expected 10–15 per case). The investigators state pragmatism for not randomising staff to case management type in three of the four centres. However, results from the fourth centre (St Mary’s), where randomisation was used, differ substantially from the other results. The mean difference in the average number of days in hospital for St Mary’s shows 25 days less for intensive case management compared with 1, 11, and 25 days more for the other centres. The combined centre effects then cancel each other out giving a treatment effect of zero. In short, they found a familiar protocol administered by experienced senior staff shows no difference from a new protocol administered by junior staff working over one and a half times harder. No surprise there. Magnus A McGee MRC Biostatistics Unit, Institute of Public Health, University Forvie Site, Cambridge CB2 2SR, UK 1
Burns T, Creed F, Fahy T, Thompson S, Tyrer P, White I. Intensive versus standard case management for severe psychotic illness: a randomised trial. Lancet 1999; 353: 2185–89.
Authors’ reply Sir—Dermot McGovern and Andrew Owen fail to grasp the rationale for our study.1 We know the long debate around differing forms of case management. A sharp distinction between ACT and intensive case management has no empirical basis. The expert consensus cited is just that—the opinions of experts about what constitutes the essence of ACT. Terminology may be as much determined by health-care traditions as by practice differences.2 The most recent review of case management research does not support any gulf between the practice of ACT
and intensive case management, and its superiority over standard services is now small,3 because standard services have been improving. In the UK such services routinely offer care from a community-based multidisciplinary team. In the USA, at the time the superiority of ACT was shown, there were major deficiencies in such routine care.4 In previous studies, it is difficult to identify which of several stated differences between experimental and control services may have had an effect. We aimed to test rigorously one essential component of both ACT and intensive case management (ICM), low case-load size. The strength of the study was that this variable was tested across four services with local variations. Owen and McGovern criticise the model of care in our experimental group, and cite “personal communication with the investigators” to characterise it. Their conclusions are mistaken. All four experimental services were based in multidisciplinary teams, three had a psychiatrist as an integral member, two had total control over admissions and discharges, and two negotiated control. No services offered 24-h cover internally, but Owen and McGovern should examine what 24-h cover means in publications on ACT— eg, simply the availability of an answerphone and even “collaboration with the local CMHC emergency services”.5 All our services were part of comprehensive mental-health programmes with integral 24-h emergency services, but not restricted to intensive case management. Anthony Pelosi and colleagues’ comments on our use of CAN are undoubtedly correct. We chose this measure, rather than the MRC Needs for Care Assessment Schedule, because of its brevity, current use in clinical settings, and the increasing attention being given to patients’ own assessments of their needs. We have also speculated about intensity of contact being too intrusive, leading to patients discharging themselves. However, because of the degree of uncertainty surrounding how disengagement is determined in standard services, we feel it would be premature to draw firm conclusions. Patients previously identified in primary care were clinically very different from those in our trial. Magnus McGee’s calculation about the comparative case-load size overlooks that some of the standard-casemanagement staff continued to care for patients not in the study, yielding figures of 14 versus 32, not 22. The staff in both services were equally experienced— McGee overlooks the levels of seniority
1385
of non-nursing staff and focuses exclusively on G grade nurses whose imbalance was not significant (p=0·11). We did not focus on individual site results since the estimated effect of ICM did not differ between the four centres (p=0·31), nor was the estimated effect in any individual centre significant. Community psychiatry research has been bedevilled by over-interpretation and we restricted ourselves to conclusions appropriate to the study design. It is difficult to do a community psychiatry trial in which only one factor is varied, and we believe we have been reasonably successful. Real progress will be made when the essential ingredients in complex interventions are indvidually subject to equally rigorous evaluation. *Tom Burns, Tom Fahy, Simon Thompson, Peter Tyrer, Ian White Department of General Psychiatry, St George’s Hospital Medical School, University of London, Cranmer Terrace, London SW17 0RE, UK (e-mail: [email protected]) 1
UK700 Group, Creed F, Burns T, Butler T, et al. Comparison of intensive and standard case management for patients with psychosis: rationale of the trial. Br J Psychiatry 1999; 174: 74–78. 2 Burns T. Case management, care management and care programming. Br J Psychiatry 1997; 24: 37–74. 3 Mueser KT, Bond GR, Drake RE, Resnick SG. Models of community care for severe mental illness: a review of research on case management. Schizophr Bull 1998; 24: 37–74. 4 Lehman AF, Steinwachs DM. Patterns of usual care for schizophrenia: initial results from the Schizophrenia Patient Outcomes Research Team (PORT) Client Survey. Schizophr Bull 1998; 24: 11–20. 5 Stein LI, Santos BA. Assertive community treatment of persons with severe mental illness. New York: WW Norton & Company Inc, 1998.
HTLV-I-associated infective dermatitis Sir—Angela Manns and colleagues (June 5, p 1957)1 discuss human Tlymphotrophic virus (HTLV)-Iassociated diseases, including infective dermatitis. We report a patient with infective dermatitis who we treated with continuous co-trimoxazole sulphamethoxazole/trimethoprim 5/1 therapy. A boy (aged 7 years) who was born in the Dominican Republic was referred because of severe relapsing pyoderma since age 6 months. He had a history of numerous, almost continuous, flares of pyoderma involving external ears, anterior nares, eyelids, scalp, gluteal crease, and axillae, as well as chronic nasal discharge. Various oral antibiotics had been given during flares, with good short-term results, but relapses
1386
occurred soon after oral therapy was stopped. The most severe flares resulted in numerous absences from school. The child had been breastfed until age 1 year. On examination, he appeared chronically ill, and had disseminated pyoderma and small papules on the nose. HIV serological test was negative, but testing for HTLV-I was positive by western blot with high titres of specific antibodies in the patient and his mother. His white blood cell count was normal with no abnormal lymphoid cells. His CD4-cell count was 2520/L (CD4/CD8 ratio 3·6). Although HTLV-I provirus (cosmopolitan subtype A) was detectable by PCR in peripheral blood mononuclear cells, clonal integration of HTLV-1 was not detected by Southern blot analysis of the same DNA. Cultures of cutaneous lesions grew meticillinsensitive Staphylococcus aureus that was sensitive to co-trimoxazole, and Proteus mirabilis. Polymorphonuclear neutrophils from the patient’s blood showed normal ex-vivo function, including oxidative burst (measured by tetrazolium nitroblue reduction and chemiluminescence), myeloperoxidase activity, phagocytosis of white staphylococci and agarose migration capability (spontaneous as well as C5a and formyl methionine-leucinephenylalanine-induced chemotaxis). Therapeutic trials with several topical compounds (fusidic acid or tetracycline ointments, antiseptics, dermatocorticoids) did not prevent relapse. However, after starting continuous therapy with oral co-trimoxazole (trimethoprim 3 mg/kg daily, sulphamethoxazole 15 mg/kg daily), he had only three disease flares in the next 18 months: one severe flare was coincident with the discontinuation of co-trimoxazole, and two flares were mild. Between the flares, the patient had no skin disease. The child is now 9 years old, is in good general health, and has good school attendance. Until now, treatment of infective dermatitis has consisted of short-term administration of oral antibiotics during flares, which results in transient improvement but does not prevent relapses.1–3 The putative immunological defect underlying this disease is unknown.1 The predominance of S aureus infection, similar to that in chronic granulomatous disease, 4 prompted us to study the function of this patient’s polymorphonuclear cells. Oxidative burst, which is dramatically diminished in cells from patients with chronic granulomatous disease, was normal in this case. Co-trimoxazole has been shown to be the agent of choice for
the prevention of sepsis in chronic granulomatous disease, owing to its activity on S aureus, safety profile, lack of selection of resistant strains, ease of administration, and low cost.5 Our case indicates that it may also be useful in infective dermatitis, especially in severe cases that interfere with normal activity. The low cost and wide availability of cotrimoxazole make it suitable for developing countries where the disease is particularly prevalent. A Mahé, S Chollet-Martin, *A Gessain Unité de Dermatologie, Centre Hospitalier Universitaire de Pointe-à-Pitre, Guadeloupe, France; Laboratoire d”Hématologie et d’Immunologie Biologique, INSERM U479, CHU, Bichat, Paris; and *Unité d’Oncologie Virale, Département des Rétrovirus, Institut Pasteur, 75724 Paris (e-mail: [email protected]) 1
Manns A, Hisada M, La Grenade L. Human T-lymphotropic virus type I infection. Lancet 1999; 353: 1951–58. 2 La Grenade L, Hanchard B, Fletcher V, Cranston B, Blattner W. Infective dermatitis of Jamaican children: a marker for HTLV-I infection. Lancet 1990; 336: 1345–47. 3 La Grenade L. HTLV-I-associated infective dermatitis: past, present, and future. J Acquir Immune Defic Syndr 1993; 13 (suppl 1): S46–49. 4 Fischer A, Segal AW, Serger R, Weening RS. The management of chronic granulomatous disease. Eur J Pediatr 1993; 152: 896–98. 5 Weening RS, Kabel P, Pijman P, Roos D. Continuous therapy with sulfamethoxazole trimethoprim in patients with chronic granulomatous disease. J Pediatr 1983; 103: 127–30.
Mycophenolate mofetil in IBD patients Sir—We have reported1 a favourable outcome for five of six patients with severe Crohn’s disease (Crohn’s disease activity index [CDAI] >300) treated with mycophenolate mofetil, an immunosuppressant with uncompetitive and reversible inhibitory activity against inosine monophosphate dehydrogenase, which decreases de novo guanosine nucleotide synthesis in T and B lymphocytes. Three patients had perianal disease, which responded favourably. 1 Furthermore, Philip Lowry and colleagues’ commentary 2 on mycophenolate mofetil noted a more favourable outcome for mycophenolate mofetil-treated patients with severe Crohn’s disease during the first month of 6 months’ observation versus azathioprine-treated patients in the only reported randomised trial.3 We studied the same and additional patients (eight women and seven men, with inflammatory bowel disease), 11 of whom had Crohn’s, and all with severe disease (CDAI >300) and unresponsive or intolerant of azathioprine and
THE LANCET • Vol 354 • October 16, 1999
2
3
4
5
Burns T, Creed F, Fahy T, et al. Intensive versus standard case management for severe psychotic illnesses: a randomised trial. Lancet 1999; 353: 2185–89. Slade M, Thornicroft G, Loftus L, Phelan M, Wykes T. CAN: Camberwell assessment of need: a comprehensive needs assessment tool for people with severe mental illness. London: Gaskell, 1999. Brewin CR, Wing JK, Mangen SP, Brugha TS, MacCarthy B, Lesage A. Principles and practice of measuring needs in the long-term mentally ill: the MRC Needs for Care Assessment. Psychol Med 1987; 17: 971–81. Bebbington P, Marsden L, Brewin CR. The treatment of psychiatric disorder in the community: report from the Camberwell Needs for Care Survey. J Ment Health 1999; 8: 7–17. Kendrick T, Burns T. Mental health teams should concentrate on psychiatric patients with greatest needs. BMJ 1996; 313: 884–85.
Sir—The design of randomised trials beyond the pharmaceutical arena are fraught with difficulties, and unfortunately Tom Burns and colleagues’ conclusions1 are inappropriate and may misinform policy makers because the
THE LANCET • Vol 354 • October 16, 1999
interpretation of (non-significant) results is flawed. The basic purpose of a controlled clinical trial is to establish and estimate the effects of treatment. In this trial, the treatment is not the type of case management but the interaction of case management, case manager, and case load. Case managers were not randomised to type of case management and randomisation of patients was stratified only by centre and not by centre and type. In effect, standard case management is done by local senior staff (half were senior mental health nurses) at a low case load (22 per case manager vs the expected 30–35 per case manager). By contrast, the intensive case management is done by newly recruited staff (a quarter were senior mental health nurses with 14 per case manager vs the expected 10–15 per case). The investigators state pragmatism for not randomising staff to case management type in three of the four centres. However, results from the fourth centre (St Mary’s), where randomisation was used, differ substantially from the other results. The mean difference in the average number of days in hospital for St Mary’s shows 25 days less for intensive case management compared with 1, 11, and 25 days more for the other centres. The combined centre effects then cancel each other out giving a treatment effect of zero. In short, they found a familiar protocol administered by experienced senior staff shows no difference from a new protocol administered by junior staff working over one and a half times harder. No surprise there. Magnus A McGee MRC Biostatistics Unit, Institute of Public Health, University Forvie Site, Cambridge CB2 2SR, UK 1
Burns T, Creed F, Fahy T, Thompson S, Tyrer P, White I. Intensive versus standard case management for severe psychotic illness: a randomised trial. Lancet 1999; 353: 2185–89.
Authors’ reply Sir—Dermot McGovern and Andrew Owen fail to grasp the rationale for our study.1 We know the long debate around differing forms of case management. A sharp distinction between ACT and intensive case management has no empirical basis. The expert consensus cited is just that—the opinions of experts about what constitutes the essence of ACT. Terminology may be as much determined by health-care traditions as by practice differences.2 The most recent review of case management research does not support any gulf between the practice of ACT
and intensive case management, and its superiority over standard services is now small,3 because standard services have been improving. In the UK such services routinely offer care from a community-based multidisciplinary team. In the USA, at the time the superiority of ACT was shown, there were major deficiencies in such routine care.4 In previous studies, it is difficult to identify which of several stated differences between experimental and control services may have had an effect. We aimed to test rigorously one essential component of both ACT and intensive case management (ICM), low case-load size. The strength of the study was that this variable was tested across four services with local variations. Owen and McGovern criticise the model of care in our experimental group, and cite “personal communication with the investigators” to characterise it. Their conclusions are mistaken. All four experimental services were based in multidisciplinary teams, three had a psychiatrist as an integral member, two had total control over admissions and discharges, and two negotiated control. No services offered 24-h cover internally, but Owen and McGovern should examine what 24-h cover means in publications on ACT— eg, simply the availability of an answerphone and even “collaboration with the local CMHC emergency services”.5 All our services were part of comprehensive mental-health programmes with integral 24-h emergency services, but not restricted to intensive case management. Anthony Pelosi and colleagues’ comments on our use of CAN are undoubtedly correct. We chose this measure, rather than the MRC Needs for Care Assessment Schedule, because of its brevity, current use in clinical settings, and the increasing attention being given to patients’ own assessments of their needs. We have also speculated about intensity of contact being too intrusive, leading to patients discharging themselves. However, because of the degree of uncertainty surrounding how disengagement is determined in standard services, we feel it would be premature to draw firm conclusions. Patients previously identified in primary care were clinically very different from those in our trial. Magnus McGee’s calculation about the comparative case-load size overlooks that some of the standard-casemanagement staff continued to care for patients not in the study, yielding figures of 14 versus 32, not 22. The staff in both services were equally experienced— McGee overlooks the levels of seniority
1385
of non-nursing staff and focuses exclusively on G grade nurses whose imbalance was not significant (p=0·11). We did not focus on individual site results since the estimated effect of ICM did not differ between the four centres (p=0·31), nor was the estimated effect in any individual centre significant. Community psychiatry research has been bedevilled by over-interpretation and we restricted ourselves to conclusions appropriate to the study design. It is difficult to do a community psychiatry trial in which only one factor is varied, and we believe we have been reasonably successful. Real progress will be made when the essential ingredients in complex interventions are indvidually subject to equally rigorous evaluation. *Tom Burns, Tom Fahy, Simon Thompson, Peter Tyrer, Ian White Department of General Psychiatry, St George’s Hospital Medical School, University of London, Cranmer Terrace, London SW17 0RE, UK (e-mail: [email protected]) 1
UK700 Group, Creed F, Burns T, Butler T, et al. Comparison of intensive and standard case management for patients with psychosis: rationale of the trial. Br J Psychiatry 1999; 174: 74–78. 2 Burns T. Case management, care management and care programming. Br J Psychiatry 1997; 24: 37–74. 3 Mueser KT, Bond GR, Drake RE, Resnick SG. Models of community care for severe mental illness: a review of research on case management. Schizophr Bull 1998; 24: 37–74. 4 Lehman AF, Steinwachs DM. Patterns of usual care for schizophrenia: initial results from the Schizophrenia Patient Outcomes Research Team (PORT) Client Survey. Schizophr Bull 1998; 24: 11–20. 5 Stein LI, Santos BA. Assertive community treatment of persons with severe mental illness. New York: WW Norton & Company Inc, 1998.
HTLV-I-associated infective dermatitis Sir—Angela Manns and colleagues (June 5, p 1957)1 discuss human Tlymphotrophic virus (HTLV)-Iassociated diseases, including infective dermatitis. We report a patient with infective dermatitis who we treated with continuous co-trimoxazole sulphamethoxazole/trimethoprim 5/1 therapy. A boy (aged 7 years) who was born in the Dominican Republic was referred because of severe relapsing pyoderma since age 6 months. He had a history of numerous, almost continuous, flares of pyoderma involving external ears, anterior nares, eyelids, scalp, gluteal crease, and axillae, as well as chronic nasal discharge. Various oral antibiotics had been given during flares, with good short-term results, but relapses
1386
occurred soon after oral therapy was stopped. The most severe flares resulted in numerous absences from school. The child had been breastfed until age 1 year. On examination, he appeared chronically ill, and had disseminated pyoderma and small papules on the nose. HIV serological test was negative, but testing for HTLV-I was positive by western blot with high titres of specific antibodies in the patient and his mother. His white blood cell count was normal with no abnormal lymphoid cells. His CD4-cell count was 2520/L (CD4/CD8 ratio 3·6). Although HTLV-I provirus (cosmopolitan subtype A) was detectable by PCR in peripheral blood mononuclear cells, clonal integration of HTLV-1 was not detected by Southern blot analysis of the same DNA. Cultures of cutaneous lesions grew meticillinsensitive Staphylococcus aureus that was sensitive to co-trimoxazole, and Proteus mirabilis. Polymorphonuclear neutrophils from the patient’s blood showed normal ex-vivo function, including oxidative burst (measured by tetrazolium nitroblue reduction and chemiluminescence), myeloperoxidase activity, phagocytosis of white staphylococci and agarose migration capability (spontaneous as well as C5a and formyl methionine-leucinephenylalanine-induced chemotaxis). Therapeutic trials with several topical compounds (fusidic acid or tetracycline ointments, antiseptics, dermatocorticoids) did not prevent relapse. However, after starting continuous therapy with oral co-trimoxazole (trimethoprim 3 mg/kg daily, sulphamethoxazole 15 mg/kg daily), he had only three disease flares in the next 18 months: one severe flare was coincident with the discontinuation of co-trimoxazole, and two flares were mild. Between the flares, the patient had no skin disease. The child is now 9 years old, is in good general health, and has good school attendance. Until now, treatment of infective dermatitis has consisted of short-term administration of oral antibiotics during flares, which results in transient improvement but does not prevent relapses.1–3 The putative immunological defect underlying this disease is unknown.1 The predominance of S aureus infection, similar to that in chronic granulomatous disease, 4 prompted us to study the function of this patient’s polymorphonuclear cells. Oxidative burst, which is dramatically diminished in cells from patients with chronic granulomatous disease, was normal in this case. Co-trimoxazole has been shown to be the agent of choice for
the prevention of sepsis in chronic granulomatous disease, owing to its activity on S aureus, safety profile, lack of selection of resistant strains, ease of administration, and low cost.5 Our case indicates that it may also be useful in infective dermatitis, especially in severe cases that interfere with normal activity. The low cost and wide availability of cotrimoxazole make it suitable for developing countries where the disease is particularly prevalent. A Mahé, S Chollet-Martin, *A Gessain Unité de Dermatologie, Centre Hospitalier Universitaire de Pointe-à-Pitre, Guadeloupe, France; Laboratoire d”Hématologie et d’Immunologie Biologique, INSERM U479, CHU, Bichat, Paris; and *Unité d’Oncologie Virale, Département des Rétrovirus, Institut Pasteur, 75724 Paris (e-mail: [email protected]) 1
Manns A, Hisada M, La Grenade L. Human T-lymphotropic virus type I infection. Lancet 1999; 353: 1951–58. 2 La Grenade L, Hanchard B, Fletcher V, Cranston B, Blattner W. Infective dermatitis of Jamaican children: a marker for HTLV-I infection. Lancet 1990; 336: 1345–47. 3 La Grenade L. HTLV-I-associated infective dermatitis: past, present, and future. J Acquir Immune Defic Syndr 1993; 13 (suppl 1): S46–49. 4 Fischer A, Segal AW, Serger R, Weening RS. The management of chronic granulomatous disease. Eur J Pediatr 1993; 152: 896–98. 5 Weening RS, Kabel P, Pijman P, Roos D. Continuous therapy with sulfamethoxazole trimethoprim in patients with chronic granulomatous disease. J Pediatr 1983; 103: 127–30.
Mycophenolate mofetil in IBD patients Sir—We have reported1 a favourable outcome for five of six patients with severe Crohn’s disease (Crohn’s disease activity index [CDAI] >300) treated with mycophenolate mofetil, an immunosuppressant with uncompetitive and reversible inhibitory activity against inosine monophosphate dehydrogenase, which decreases de novo guanosine nucleotide synthesis in T and B lymphocytes. Three patients had perianal disease, which responded favourably. 1 Furthermore, Philip Lowry and colleagues’ commentary 2 on mycophenolate mofetil noted a more favourable outcome for mycophenolate mofetil-treated patients with severe Crohn’s disease during the first month of 6 months’ observation versus azathioprine-treated patients in the only reported randomised trial.3 We studied the same and additional patients (eight women and seven men, with inflammatory bowel disease), 11 of whom had Crohn’s, and all with severe disease (CDAI >300) and unresponsive or intolerant of azathioprine and
THE LANCET • Vol 354 • October 16, 1999