Effectiveness of cognitive-behavioural therapy for depression in advanced cancer: CanTalk randomised controlled trial

BACKGROUND: Depression is one of the most common mental disorders in people with advanced cancer. Although cognitive-behavioural therapy (CBT) has been shown to be effective for depression in people with cancer, it is unclear whether this is the case for people with advanced cancer and depression. // AIMS: We sought to determine whether CBT is more clinically effective than treatment as usual (TAU) for treating depression in people with advanced cancer (trial registration number ISRCTN07622709). // METHOD: A multi-centre, parallel-group single-blind randomised controlled trial comparing TAU with CBT (plus TAU). Participants (n = 230) with advanced cancer and depression were randomly allocated to (a) up to 12 sessions of individual CBT or (b) TAU. The primary outcome measure was the Beck Depression Inventory-II (BDI-II). Secondary outcome measures included the Patient Health Questionnaire-9, the Eastern Cooperative Oncology Group Performance Status, and Satisfaction with Care. // RESULTS: Multilevel modelling, including complier-average intention-to-treat analysis, found no benefit of CBT. CBT delivery was proficient, but there was no treatment effect (-0.84, 95% CI -2.76 to 1.08) or effects for secondary measures. Exploratory subgroup analysis suggested an effect of CBT on the BDI-II in those widowed, divorced or separated (-7.21, 95% CI -11.15 to -3.28). // CONCLUSIONS: UK National Institute for Health and Care Excellence (NICE) guidelines recommend CBT for treating depression. Delivery of CBT through the Improving Access to Psychological Therapies (IAPT) programme has been advocated for long-term conditions such as cancer. Although it is feasible to deliver CBT through IAPT proficiently to people with advanced cancer, this is not clinically effective. CBT for people widowed, divorced or separated needs further exploration. Alternate models of CBT delivery may yield different results. // DECLARATION OF INTEREST: M.S. is a member of the Health Technology Assessment General Board

Barriers to recruitment when conducting a commissioned randomised controlled trial of medication versus psychological therapy for generalised anxiety disorder: some lessons learned

Background Poor recruitment is the most common reason for premature discontinuation of randomised controlled trials (RCTs). An RCT of medication versus psychological therapy for generalised anxiety disorder (GAD) was discontinued prematurely by the UK National Institute of Health Research funders because of recruitment failure. In order to inform future research studies, this article explores the reasons for poor recruitment and aspects which could have been improved. Methods The trial recruited participants via psychological well-being practitioners (PWPs) employed within local Improving Assess to Psychological Therapies (IAPT) services at four sites in England. For this study, we initially examined the recruitment data to identify reasons why potential participants were reluctant to participate in the trial. We then investigated reasons the PWPs did not identify more potential participants. Finally, we performed retrospective analyses of a computerised clinical records system used by the IAPT services in this study. These analyses aimed to establish the number of potential participants who had not been approached about the trial as well as whether there were additional factors affecting the numbers of people who might be eligible to take part. Data were obtained for all patients assessed during the period from the date on which recruitment commenced until the closure of the trial. Results Three quarters of those patients identified as possibly suitable for the trial declined to take part; the great majority did so because they did not want to be randomly assigned to receive medication. Our retrospective database analyses showed that only around 12% of potentially eligible patients for the trial were identified by the PWPs at the pilot sites. The results also indicated that only 5% of those noted at entry to the IAPT services to have a score of at least 10 on the GAD-7 questionnaire (a self-completed questionnaire with high sensitivity and specificity for GAD) would have been eligible for the trial. Conclusions Our findings suggest that poor recruitment to RCTs can be significantly affected by participants’ treatment preferences and by factors influencing the recruiting clinicians. It may also be important not to include too many restrictions on inclusion criteria for pragmatic trials aiming for generalisable results

Efficacy of once-weekly Isoniazid-Streptomycin in preventing relapse of pulmonary tuberculosis

Two controlled studies were undertaken to assess the efficacy of streptomycin 1 g. or 0.75 g. (by random allocation) plus isoniazid 15 mg./kg. body-weight once-weekly (the SHOW regimen) in the prevention of bacteriological relapse over a 4 year period, in patients with quiescent pulmonary tuberculosis at the end of one year of chemotherapy. In the first study which involved patients with residual cavitation at one year, bacteriological relapse requiring treatment occurred in 3 per cent of 87 patients given the SHOW regimen for 12 months as compared with 21 per cent of 94 patients on a placebo, a high proportion of the relapses in the latter occurred in the 2nd year and with sensitive organisms. In the second study on patients with no residual cavitation at one year, relapse requiring treatment occurred in 2 per cent of 98 patients given the SHOW regimen for 6 months as compared with 1 per cent of 90 patients given isoniazid approximately 4.5 mg./kg. daily for 12 months

Health services research in the public healthcare system in Hong Kong: An analysis of over 1 million antihypertensive prescriptions between 2004-2007 as an example of the potential and pitfalls of using routinely collected electronic patient data

<b>Objectives</b> Increasing use is being made of routinely collected electronic patient data in health services research. The aim of the present study was to evaluate the potential usefulness of a comprehensive database used routinely in the public healthcare system in Hong Kong, using antihypertensive drug prescriptions in primary care as an example.<p></p> <b>Methods</b> Data on antihypertensive drug prescriptions were retrieved from the electronic Clinical Management System (e-CMS) of all primary care clinics run by the Health Authority (HA) in the New Territory East (NTE) cluster of Hong Kong between January 2004 and June 2007. Information was also retrieved on patients’ demographic and socioeconomic characteristics, visit type (new or follow-up), and relevant diseases (International Classification of Primary Care, ICPC codes). <p></p> <b>Results</b> 1,096,282 visit episodes were accessed, representing 93,450 patients. Patients’ demographic and socio-economic details were recorded in all cases. Prescription details for anti-hypertensive drugs were missing in only 18 patients (0.02%). However, ICPC-code was missing for 36,409 patients (39%). Significant independent predictors of whether disease codes were applied included patient age > 70 years (OR 2.18), female gender (OR 1.20), district of residence (range of ORs in more rural districts; 0.32-0.41), type of clinic (OR in Family Medicine Specialist Clinics; 1.45) and type of visit (OR follow-up visit; 2.39). <p></p> In the 57,041 patients with an ICPC-code, uncomplicated hypertension (ICPC K86) was recorded in 45,859 patients (82.1%). The characteristics of these patients were very similar to those of the non-coded group, suggesting that most non-coded patients on antihypertensive drugs are likely to have uncomplicated hypertension. <p></p> <b>Conclusion</b> The e-CMS database of the HA in Hong Kong varies in quality in terms of recorded information. Potential future health services research using demographic and prescription information is highly feasible but for disease-specific research dependant on ICPC codes some caution is warranted. In the case of uncomplicated hypertension, future research on pharmaco-epidemiology (such as prescription patterns) and clinical issues (such as side-effects of medications on metabolic parameters) seems feasible given the large size of the data set and the comparability of coded and non-coded patients

Fluorescence properties of a potential antitumoral benzothieno[3,2-b]pyrrole in solution and lipid membranes

Fluorescence properties of the antitumoral methyl 3-(benzo[b]thien-2-yl)-benzothieno[3,2-b]pyrrole-2-carboxylate (BTP) were studied in solution and in lipid bilayers of dipalmitoyl phosphatidylcholine (DPPC), dioleoyl phosphatidylethanolamine (DOPE) and egg yolk phosphatidylcholine (Egg-PC). BTP presents good fluorescence quantum yields in all solvents studied (0.20 ≤ ΦF ≤ 0.32) and a bathochromic shift in polar solvents. The results indicate an ICT character of the excited state, with an estimated dipole moment of μe = 7.38 D. Fluorescence (steady-state) anisotropy measurements of BTP incorporated in lipid membranes of DPPC, DOPE and Egg-PC indicate that this compound is deeply located in the lipid bilayer, feeling the difference between the rigid gel phase and fluid phases. BTP inhibits the growth of three human tumour cell lines, MCF-7 (breast adenocarcinoma), SF-268 (glioma) and NCI-H460 (non-small cell lung cancer), being significantly more potent against the NCI-H460 tumour cells.European Communitarian Fund (FEDER)Fundação para a Ciência e a Tecnologia (FCT) – projecto SeARCH (ref. REEQ/443/EEI/2005), bolsa SFRH/BPD/24548/2005, projecto PTDC/QUI/81238/200

The Role of Primary Care in Service Provision for People with Severe Mental Illness in the United Kingdom

Severe mental illness is a serious and potentially life changing set of conditions. This paper describes and analyses patient characteristics and service usage over one year of a representative cohort of people with a diagnosis of severe mental illness across England, including contacts with primary and secondary care and continuity of care

Arthralgia in South Indian patients with pulmonary tuberculosis during treatment with pyrazinamide and rifampicin

Arthralgia was the major adverse reaction encountered in a clinical trial of the treatment of pulmonary tuberculosis with three short-course regimens containing pyrazinamide in South Indian patients. The first regimen was of rifampicin, streptomycin, isoniazid and pyrazinamide given daily for three months; the second was of the same four drugs daily for three months followed by streptomycin, isoniazid and pyrazinamide twice-weekly for two months, and the third was the same as the second except that rifampicin was not administered. Arthralgia was reported in 36% of 353 rifampicin patients and 66% of 179 non-rifampicin patients, a highly significant difference (p<0.001). The onset of arthralgia was mostly during the first two months of chemotherapy. The knees were affected in about 90% followed by the ankles in about 50% of the patients with arthralgia, and about 60% of these patients had one or more of the signs, swelling, tenderness and limitation of joint movement. Chemotherapy was modified in 10 rifampicin and 15 non-rifampicin patients; the rest of the patients were managed with symptomatic treatment with analgesics. There was a two to three fold increase in serum uric acid concentrations by the end of the first month and the concentrations were more or less stationary throughout the rest of the daily phase of treatment. The mean concentration during the daily phase of treatment in patients with arthralgia (0.482 mmoles/litre) was similar to that in those without arthralgia (0.484 mmoles/litre), while that in the rifampicin patients (0.476 mmoles/litre) was significantly lower (p=0.03) than that in the non-rifampicin patients (0.495 mmoles/litre)