Naturalistic Clinical Setting Research Articles

Holographic reprocessing: Empirical evidence to reduce posttraumatic cognitions in women veterans with PTSD from sexual trauma and abuse.

Holographic reprocessing (HR) facilitates holistic reappraisal of attributions regarding interpersonal violence and maltreatment. The authors tested the feasibility to train therapists to run a protocol using HR to reduce negative thoughts associated with posttraumatic stress disorder (PTSD) in women veterans who have had sexual trauma or abuse. The study assessed pre- and postscores on the Posttraumatic Cognitions Inventory (PTCI) in a naturalistic clinical setting with 5 therapists. The protocol consisted of screening for PTSD, followed by an average of 9 HR treatment sessions. Twenty-two women were referred to the study; 17 enrolled and completed treatment (0% dropout rate). Significant decreases were found on all scales of the PTCI, with large effect sizes: total negative thoughts, t(16) = 4.42, p < .000, Cohen's d = 1.52, and 47% of the sample had reliable change (decreased negative thoughts; RC < -1.96). These findings suggest that HR is a promising treatment for sexual trauma PTSD. (PsycINFO Database Record (c) 2010 APA, all rights reserved).

Clinical Profile of Botulinum Toxin A in Patients with Chronic Headaches and Cervical Dystonia

Some evidence for the efficacy of botulinum toxin A as a preventive treatment for chronic primary headaches has been reported in randomized, controlled clinical studies. This study investigated the clinical profile of botulinum toxin A in a naturalistic clinical practice setting in a population of patients with cervical dystonia associated with chronic headache and a history of migraine. This was a prospective, open-label, longitudinal study. Following a prospective run-in period, eligible patients were given three sets of botulinum toxin A injections at 8- to 12-week intervals over a 16- to 24-week period and were monitored for 3 months after the final injections. Efficacy was assessed in terms of headache-related disability (using the Migraine Disability Assessment [MIDAS] questionnaire), pain and emotional function (using the Short Pain Inventory [SPI]), quality of life (QOL, using the Short-Form-36 [SF-36] questionnaire) and patient-assessed headache frequency and severity, and medication use and its effectiveness. Safety was assessed as adverse events. The primary endpoint was the change in MIDAS score from baseline following treatment with botulinum toxin A. Twenty-four patients took part in the study and 17 (71%) completed the study. There were significant improvements in headache-related disability (MIDAS score), pain and emotional function (SPI), QOL (SF-36), headache frequency and medication use following treatment with botulinum toxin A (p < 0.05 for all endpoints). An efficacy response occurred within 8 weeks of treatment initiation and was maintained throughout the study duration. Botulinum toxin A was generally well tolerated. This study demonstrated that botulinum toxin A is an effective and well tolerated preventive treatment for chronic headache in patients with cervical dystonia and a history of migraine. These results warrant further investigation in a large, randomized, controlled study.

Mood-Elevating Effects of Opioid Analgesics in Patients With Bipolar Disorder

Mood-Elevating Effects of Opioid Analgesics in Patients With Bipolar Disorder

Expectations and effectiveness of medical treatment and classical homeopathic treatment for patients with hypersensitivity illnesses—One year prospective study

Objective To describe and compare characteristics of adult patients who received treatment for hypersensitivity illnesses by general practitioners (GPs) and classical homeopaths (CHs) over a period of 1 year and examine the statistical predictors of self-reported treatment outcomes. Material and methods We conducted a survey on 151 Danish adult patients with hypersensitivity illnesses, who chose treatment from one of 13 GPs or one of 10 CHs who participated in the project. The treatments were given as individual packages in the naturalistic clinical setting. Patients completed questionnaires at start of treatment, after 6 months and a year after start of treatment. Response rates for the first, second and third questionnaire were respectively 68%, 98%, 95% for the GP patients and 82%, 98%, 94% for the CH patients. Results Patients seeking CH treatment in this study are significantly different in gender and education from patients seeking GP treatment. We did not find significant differences in terms of occupational training, occupation, sickness absence due to hypersensitivity illnesses, diseases other than hypersensitivity illnesses, symptoms severity due to hypersensitivity illnesses before treatment and expectation of the ability of the treatment to alleviate symptoms. Eighty-eight percent of GP and 21% of CH patients were continuing treatment after 1 year. Regression analysis showed that the only significant independent variables to explain the probability of obtaining very positive effect or cure for GPs and CHs were that the patients were in ‘maintenance treatment’, and had high expectation before treatment of the ability of the treatment to relieve their symptoms. Conclusion In this study self-reported very positive effect of GP treatment and very positive effect and cure of CH treatment are associated with the patients’ high expectation of the treatment and continuation of maintenance treatment.

RISPERIDONE AND OLANZAPNE IN-PATIENT UTILIZATION IN THE UNIVERSITY OF MALAYA MEDICAL CENTRE, KUALA LUMPUR

The objective of this study was to compare in-patient drug use patterns,costs, and outcomes associated with risperidone or olanzapine in a naturalistic clinical setting. Retrospective chart reviews of 92 patients with psychotic disorders were conducted at the University of Malaya Medical Centre (UMMC). Data was collected from patients who were hospitalized and for whom risperidone or olanzapine was the drug of first choice for long-term pharmacologic treatment. Proportion of patients for whom efficacy of the studied treatment could be established(as rated by the treating physician) was higher, but not significantly, with risperidone compared to olanzapine (p = 0.46). The average dose of the studied medication was 2.9 ' 1.0 mg/day for risperidone and 9.7 ' 2.4 mg/day for olanzapine. The total cost was significantly higher (p &lt; 0.0001) for olanzapine (RM140.40; 95% CI: 108.4'181.9) compared to risperidone (RM50.80, 95% CI: 39.5'65.3). The daily cost was also significantly higher for olanzapine (RM19.16; 95% CI: 17.72'20.72) compared to risperidone (RM4.95; 95% CI: 4.46'5.51, p &lt; 0.0001). Analysis of responders showed significantly higher daily and total costs of treatment with olanzapine compared to risperidone. These preliminary data suggest that treatment with risperidone may be more costeffective than treatment with olanzapine. However, a longer duration of study and more data is needed before a proper conclusion on cost-effectiveness is made.

Topiramate monotherapy as broad-spectrum antiepileptic drug in a naturalistic clinical setting

Topiramate was assessed in an open-label trial as broad-spectrum antiepileptic monotherapy, independently from the epilepsy type or syndrome. Adults and children aged 2 years and older, who were diagnosed with epilepsy within the last 5 years, treatment-naive or failing prior treatment with one antiepileptic drug (AED), received individually adjusted doses of topiramate, after escalation to 100mg/day over 4 weeks (maximum 400mg/day) or 3mg/kg/day over 6 weeks (maximum 9 mg/kg/day), respectively. Patients were followed for >or=7 months and optionally up to a maximum of 13 months. Data were analysed for all patients (n=692), as well as for focal (n=421) and generalized epilepsies (n=148). The median topiramate dose used was 125 mg/day in adults and 3.3mg/kg/day in children (<or=12 years). Overall, 80% of patients completed the 7-month study. During this period, 44.3% were seizure-free, while 76.3% achieved >or=50% reduction in mean monthly seizure frequency. Patients with focal and generalized epilepsies alike responded to treatment (73.9 and 83.8% with at least 50% seizure reduction): 39.4% of patients with focal epilepsy and 61.5% of those with generalized epilepsy were seizure-free. The mean monthly seizure frequency was significantly reduced versus baseline at all visits (p<0.001). Similar response rates were obtained from the 237 patients completing the 1-year observation period. During the mandatory 7-month period of study, 8.8% of patients reported insufficient tolerability as a reason for dropout. The most frequent adverse event was paraesthesia. Our results support findings that emerge from controlled studies that topiramate is effective and well tolerated when used as initial or second monotherapy. They also suggest that in a naturalistic setting, overall good retention on treatment and seizure freedom are observed at low doses in a broad spectrum of epilepsies.

Predictive and Treatment Validity of Life Satisfaction and the Quality of Life Inventory

The clinical and positive psychology usefulness of quality of life, well-being, and life satisfaction assessments depends on their ability to predict important outcomes and to detect intervention-related change. These issues were explored in the context of a program of instrument validation for the Quality of Life Inventory (QOLI) involving 3,927 clients from various clinical settings. Clinical norms were also generated that supplement existing nationwide norms. The predictive validity of the QOLI and life satisfaction in a university counseling center was supported in terms of its ability to predict academic retention both by itself and in conjunction with cumulative grade point average 1 to 3 years in advance. The QOLI was also found to be sensitive to treatment-related change in two naturalistic clinical settings and samples. The interpretation and intervention utility of measures of quality of life, well-being, and life satisfaction are discussed with respect to clinical and positive psychology research.

Therapeutic Drug Monitoring in a Naturalistic Clinical Setting

Therapeutic Drug Monitoring (TDM) has until now become a routine procedure for many psychopharmacotherapeutical interventions. Its aim is to optimize treatment with antidepressants, neuroleptics and mood stabilizers in the sense of a maximization of the therapeutic effect and a minimization of the toxicity risk. However, data about existing „therapeutic windows“ of psychotropic medications are often obtained from study samples comprised of highly cooperative and selected individuals. Such probands may not be representative for the „average psychiatric patient“ and such studies may thus provide only limited information for the everyday use of psychotropic drugs. Therefore studies with sufficient numbers of unselected patients in a naturalistic clinical setting are of primary importance to clarify the full clinical relevance of TDM in psychopharmacotherapy. To obtain more information about the benefits of TDM under naturalistic conditions, we investigated therapeutic effects and adverse reactions of typical and atypical neuroleptic agents as well as antidepressants in relation to plasma concentrations measured in an unselected collective of patients of a psychiatric university clinic in a standard therapeutical setting. We also examined the influence of gender and age on the clinical response as well as on the frequency of side effects in relation to the plasma levels of the psychotropic drugs. The results of these investigations will be discussed in view of existing data about „therapeutic windows“ in neuroleptics and antidepressants.

Therapeutic Drug Monitoring of Paroxetine in a Naturalistic Clinical Setting

Paroxetine (PXT) is an antidepressant drug first introduced in Sweden in 1991. It is a selective serotonin reuptake inhibitor (SSRI) and during the year 1992–1999, the time for the data collection for this study, the mean DDD/TIND (defined daily dose/thousand inhabitants) in Sweden was 3.16 (±1.17).

Ziprasidone and Methyldihydroziprasidone Kinetics as Displayed in the Naturalistic Clinical Setting by Applying a TDM-Routine

Ziprasidone and Methyldihydroziprasidone Kinetics as Displayed in the Naturalistic Clinical Setting by Applying a TDM-Routine

Motives for investing in TDM and Pharmacogenetic Tests when Treating Patients at Risk

Therapeutic Drug Monitoring (TDM) and pharmacogenetic tests of polymorphic cytochrome P-450 (CYP) isoenzymes (mainly CYP2D6 and CYP2C19 today) are becoming more and more relevant for application in routine clinical psychiatric practice. Hence, the necessity for investigations of TDM- and CYP-determinations when applied in clinical trials phase IV has become an amendable task of further focus for practicing clinical pharmacologists and laboratories offering TDM-services to psychiatry. However, since many of the aspects relevant for the TDM-outcome and its tentative link to CYP-expression are related to e.g. non-compliance issues and prevailing polypharmacy strategies in the everyday clinical practice, such investigations has to assess not only studies based on traditional protocols for phase-IV trials. In the present lecture, therefore, introduction of the concept of TDM-„nouveau“ and its bearing on novel designs for evaluating the basic such pharmacokinetics of newer psychoactive drugs when exposed to the naturalistic clinical setting will be forwarded. The role for this type of TDM as well as evaluation of its implementation with or without pharmacogenetic tests for CYP-polymorphism will be discussed.

A Randomized Trial of Cognitive Group Therapy vs. Waiting List for Patients with Co-Morbid Psychiatric Disorders: Effect of Cognitive Group Therapy after Treatment and Six and Twelve Months Follow-Up

The aim of the study was to assess the effectiveness of cognitive group therapy compared to a waiting list in a sample of patients with heterogeneous non-psychotic disorders. Participants in this study were referred from either the psychiatric in- or outpatient clinic at the psychiatric university hospital in Trondheim, Norway. The patients were assessed with SCID I and SCID II, and randomized either to cognitive group therapy (n=15) or to a waiting list (n=17). Self-report assessments of symptoms and interpersonal difficulties were administered at the start of therapy, after termination of therapy (8 weeks), and at 6 months and 12 months follow-up. Thirty-two patients completed 8 weeks of therapy. Results showed that an 8-week program of CBGT performed better than the waiting list controls, on symptom relief at post-treatment for all patients. The effects of therapy were still upheld at 6 and 12 months follow-up. Cognitive therapy seems to be useful and effective in a group format in naturalistic clinical settings, with patients suffering from various forms of non-psychotic co-morbid psychiatric disorders.

Population pharmacokinetic analysis of mirtazapine.

Mirtazapine belongs to the new generation of antidepressants that is commonly used in clinical routine. Therefore, we feel it mandatory to control compliance in the context of non-response, adverse events or other clinical situations by means of plasma concentration measurements. While controlled clinical studies have evaluated the effect of individual covariates on the pharmacokinetics of mirtazapine, our analysis aims to identify covariates within a naturalistic clinical setting. We performed non-linear mixed-effects modelling with data from 65 depressed inpatients whose plasma concentrations were measured weekly during their stay in hospital. Each patient's age, height, weight, co-medication, alcohol, coffee and cigarette consumption, weekly serum creatinine concentrations, liver enzyme activity, blood pressure and pulse was noted. From 49 patients, the genotype of cytochrome P450 (CYP) isoenzymes 2D6, 2C9 and 2C19 was analysed. The clearance of CYP2D6 intermediate metabolisers was reduced by 26% compared with extensive metabolisers. No other factor significantly influenced the clearance of these patients. The variability of mirtazapine plasma concentrations in clinical routine is caused to a relevant degree by CYP2D6. This should be taken into account when therapeutic drug monitoring is carried out to check treatment adherence or when a special clinical situation, such as co-morbidity and add-on medication, demands careful dosing of this drug.

Therapeutic drug monitoring of psychotropic drugs. TDM "nouveau".

TDM applied in psychiatry dates back several decades. The reason for this is that, after the advent of modern clinical psychopharmacology around the middle of the past century, an insight came to common knowledge about the existence of (1) a large interindividual pharmacokinetic (PK) variability for virtually all psychoactive drugs and (2) a worse clinical efficacy not only in inadequate drug concentrations but also in excessively high concentrations. From this concept, the definition of a therapeutic concentration "window" was evidenced for a substantial number of, primarily, antidepressant drugs. However, with the further extensive development of the clinically available pharmacopoeia of psychoactive drugs from the later 1980s until today, the concept of less toxic compounds than before has commonly been launched in the marketing strategies for these newer drugs. This concept also led to the idea that TDM was no longer necessary for the newer types of psychoactive drugs, a position backed up by difficulties in unraveling concentration-effect relationships generally for these drugs in clinical trials. The present survey summarizes the background history for TDM in psychiatry and makes a critical appraisal of why a "lack" of definition of concentration-effect relationships for newer psychoactive drugs is now common. This survey also provides the reader with a novel concept challenging ambient TDM strategies (referred to as TDM "traditionelle") in psychiatry by forwarding a theoretical model called TDM "nouveau." In this model both inter- and intraindividual (over time) PK variation is suggested to be used for dose optimization by TDM in a naturalistic clinical setting. The previous concept of a simple, common concentration "window" existing for all such drugs is questioned by promotion of the use of available PK data merely as "guiding principles" rather than as "reference values" when interpreting the TDM outcome in individual cases.

P.1.005 The serum cytokines and nutritional status after antidepressant treatment in hemodialysis patients

Background: Tiagabine (Gabitril) is a GABA uptake inhibitor recently introduced in the United States as an adjunctive treatment for partial complex seizures. Three published studies have addressed the use of tiagabine for bipolar disorder (BPD); two described positive results and one negative results. We assessed the efficacy of add-on tiagabine in a larger sample of adult BPD outpatients. Methods: Twenty-two adult outpatients with DSM-IV diagnosed BPD of some type who were considered unsatisfactory responders to standard medications for BPD were treated in an open fashion with adjunctive tiagabine in a low-dose range. After baseline demographic data and mood state at the time of entry were documented, each patient was monitored clinically for at least 6 months while the dose of tiagabine was adjusted according to the patient’s clinical status. The subjects were rated using the clinical global impression-bipolar version scale (CGI-BP). Results: After 6 months, eight (36%) of the patients were responders to tiagabine by CGI-BP rating. The dose range of tiagabine for responders was 1–8 mg per day. All 14 nonresponders had to discontinue tiagabine because of unacceptable but reversible side effects; one nonresponder experienced breakthrough absence seizures. Limitations: This study was performed in a nonrandom, open naturalistic clinical setting. The sample size was small. Conclusions: Low-dose tiagabine appears to have mood-stabilizing and antimanic properties as an add-on medication for some adult outpatients who have BPD refractory to standard medications. Tiagabine appears to be safe for most adult BPD outpatients. The results of this preliminary open study await confirmation by double-blind controlled studies.

Determination of Serum Reboxetine Enantiomers in Patients on Chronic Medication With Racemic Reboxetine

The chiral compound reboxetine is used as a selective noradrenaline reuptake inhibitor (NARI) for the treatment of major depressive disorders. The pharmacokinetic variability of the enantiomers of the drug (S,S- and R,R-reboxetine) was studied using stereoselective high-performance liquid chromatography with mass spectrometric detection in a controlled clinical monotherapy situation (trial I) and a naturalistic clinical setting (trial II). Trial I included patients receiving racemic reboxetine as 6-month monotherapy for treatment of major depressive disorder. Trough level serum samples in steady state were analyzed for the concentration of the reboxetine enantiomers in study weeks 4, 12, and 24. In a therapeutic drug monitoring setting (trial II), 47 patients on doses ranging from 4 to 16 mg daily, including much polypharmacy, trough level steady-state serum samples were analyzed by the same bioanalytical method. Data from trials I and II were assessed to determine the inter- and intraindividual pharmacokinetic outcomes. The results showed that the median S,S/R,R ratio in steady state was 0.5 and ranged from 0.22 to 0.88. It was also shown that women have an approximately 30% higher S,S/R,R ratio than men. The S,S/R,R ratios of reboxetine were not found to correlate with reboxetine concentrations. To investigate the NARI activity of a circulating serum reboxetine concentration, a recalculation of the determined enantiomeric concentrations to previously demonstrated experimental NARI potencies of the drug enantiomers was performed. This partly novel concept of estimating pharmacodynamic activity showed that the serum NARI activity in women tended to be higher than in men at a given reboxetine concentration. In conclusion, the variability in the NARI activity per nmol/L reboxetine and the variability in the concentration outcome of the reboxetine enantiomers may justify the use of enantioselective drug monitoring in the clinic. The gender aspects of the drug have to be further assessed.

A Swiss retrospective naturalistic outcome study comparing risperidone and olanzapine in the treatment of schizophrenic inpatients

Atypical anti-psychotics such as clozapine, risperidone and more recently olanzapine have become the cornerstone of the treatment of schizophrenia. These drugs have superior efficacy and tolerability and a better compliance than conventional anti-psychotics, translating into lower relapse and rehospitalisation rates. The RODOS program (Risperidone Olanzapine Drugs Outcome studies in Schizophrenia) was designed to provide outcomes data for risperidone and olanzapine used in a naturalistic clinical setting. This international retrospective study was conducted on 1901 inpatients. The present paper compares the drug-usage pattern and the costs and outcomes associated with the treatment of schizophrenia or schizo-affective disorders with either risperidone or olanzapine in Switzerland. Retrospective chart reviews were carried out in five Swiss hospitals, for inpatients for whom either risperidone or olanzapine was the drug of first intention for long-term treatment. Patients selected were aged ≤65 years and diagnosed with schizophrenia or schizo-affective disorder. Sociodemographic data and clinical information were collected in patients' files, as well as hospitalisation information and usage pattern of all drugs used during the stay in hospital. Treatment efficacy was recorded, as well as time to efficacy, time to discharge, treatment discontinuation and spontaneously reported side effects. Treatment was rated as or ineffective according to the patient's file as noted by the treating physician. Drug prices (including concomitant medication) were calculated and expressed in local currency at the level of the hospital pharmacy purchasing price. The total population comprised 312 patients, 154 receiving risperidone and 158 receiving olanzapine. The two treatment groups did not have significant differences regarding sociodemographic characteristics, history of schizophrenia and use of previous anti-psychotics. The risperidone and olanzapine groups were comparable in terms of number of days before efficacy was established, proportion of patients with effective treatment (83 vs 85%, p = 0.67), number of patients with symptom improvement, discontinuation rate and time to discharge (median 31 vs 41 days, p = 0.32). Mean dosage at the end of treatment for those patients who were discharged was 3.8 mg for risperidone and 14.9 mg for olanzapine. The average daily cost of the study medication was significantly higher for olanzapine than for risperidone (geometric mean: 11.33 vs 4.15 CHF, p <0.0001). The total cost of the treatment drug was also significantly higher for olanzapine compared to risperidone (geometric mean: 289.0 vs 92.0 CHF, respectively, p <0.0001). During the treatment period, 47 patients (31%) treated with risperidone and 49 patients (31%) treated with olanzapine experienced adverse events. These results show that both treatments have comparable efficacy and short-term side-effect profile, with an almost three times lower cost for risperidone. This is true in all comparisons: all inpatients drugs or study medication only, total population or responding patients, whole hospitalisation or treatment period only. Thus, assuming the same effectiveness for risperidone and olanzapine, but higher costs for the latter drug, the cost-effectiveness ratio of risperidone is to be considered more favourable.

An open case series on the utility of tiagabine as an augmentation in refractory bipolar outpatients

Background: Tiagabine (Gabitril) is a GABA uptake inhibitor recently introduced in the United States as an adjunctive treatment for partial complex seizures. Three published studies have addressed the use of tiagabine for bipolar disorder (BPD); two described positive results and one negative results. We assessed the efficacy of add-on tiagabine in a larger sample of adult BPD outpatients. Methods: Twenty-two adult outpatients with DSM-IV diagnosed BPD of some type who were considered unsatisfactory responders to standard medications for BPD were treated in an open fashion with adjunctive tiagabine in a low-dose range. After baseline demographic data and mood state at the time of entry were documented, each patient was monitored clinically for at least 6 months while the dose of tiagabine was adjusted according to the patient’s clinical status. The subjects were rated using the clinical global impression-bipolar version scale (CGI-BP). Results: After 6 months, eight (36%) of the patients were responders to tiagabine by CGI-BP rating. The dose range of tiagabine for responders was 1–8 mg per day. All 14 nonresponders had to discontinue tiagabine because of unacceptable but reversible side effects; one nonresponder experienced breakthrough absence seizures. Limitations: This study was performed in a nonrandom, open naturalistic clinical setting. The sample size was small. Conclusions: Low-dose tiagabine appears to have mood-stabilizing and antimanic properties as an add-on medication for some adult outpatients who have BPD refractory to standard medications. Tiagabine appears to be safe for most adult BPD outpatients. The results of this preliminary open study await confirmation by double-blind controlled studies.

Therapeutic drug monitoring data on olanzapine and its N-demethyl metabolite in the naturalistic clinical setting.

Olanzapine (Zyprexa) was approved for general prescription in Sweden in November 1996, and an HPLC-based therapeutic drug monitoring (TDM) routine for serum olanzapine (OLA) and its major metabolite, N-demethylolanzapine (DMO) was established in February 1997. During 1997 to 1999, a total of 753 TDM requests for a total of 545 Swedish patients was analyzed. Additional patient information on certain clinical variables was collected on specifically designed TDM request forms. After the exclusion process, samples from 194 patients were found to be eligible for further scrutiny. The concentration-to-dose (C/D) ratio for OLA varied 25-fold and that of DMO 22-fold. Women had a higher (P < 0.01) median C/D ratio for OLA than men (median, 7.2 nmol/L/mg vs 5.2 nmol/L/mg). Nonsmokers had a higher (P < 0.001) C/D ratio for OLA than smokers (median, 9.2 nmol/L/mg vs 4.0 nmol/L/mg). Smokers got higher prescribed (P < 0.05) doses of OLA than nonsmokers did. In the group with reported side effects, the median serum OLA concentration was 22% higher (P < 0.05) than in the group without side effects. Patients co-medicated with carbamazepine had a 71% lower median C/D ratio for OLA than patients on OLA monotherapy. The present TDM-based follow-up suggests that the influence of gender, smoking habits, and certain drug interactions may need to be considered for optimal dosage of OLA. TDM may be used for this purpose more readily in the future.

A follow-up study of the use of a patient-held record in mental health

Aims and MethodPatient-held records have been introduced in mental health over the past 2 decades. This follow-up study aimed to evaluate one pilot project 5 years after the records were introduced. All patients initially interviewed 4 years previously were approached and asked about their use and opinion of the record.ResultsOf the 19 people interviewed, 12 were still using the record and had a positive opinion of its usefulness. Of all community mental health team contacts, 72% were recorded in the patient-held notes.Clinical ImplicationsPatient-held records are sustainable in a naturalistic clinical setting over the period of 5 years.