Psychometric properties of two implementation measures: Normalization MeAsure Development questionnaire (NoMAD) and organizational readiness for implementing change (ORIC).

Background: Effective interventions need to be implemented successfully to achieve impact. Two theory-based measures exist for measuring the effectiveness of implementation strategies and monitor implementation progress. The Normalization MeAsure Development questionnaire (NoMAD) explores the four core concepts (Coherence, Cognitive Participation, Collective Action, Reflexive Monitoring) of the Normalization Process Theory. The Organizational Readiness for Implementing Change (ORIC) is based on the theory of Organizational Readiness for Change, measuring organization members' psychological and behavioral preparedness for implementing a change. We examined the measurement properties of the NoMAD and ORIC in a multi-national implementation effectiveness study. Method: Twelve mental health organizations in nine countries implemented Internet-based cognitive behavioral therapy (iCBT) for common mental disorders. Staff involved in iCBT service delivery (n = 318) participated in the study. Both measures were translated into eight languages using a standardized forward-backward translation procedure. Correlations between measures and subscales were estimated to examine convergent validity. The theoretical factor structures of the scales were tested using confirmatory factor analysis (CFA). Test-retest reliability was based on the correlation between scores at two time points 3 months apart. Internal consistency was assessed using Cronbach's alpha. Floor and ceiling effects were quantified using the proportion of zero and maximum scores. Results: NoMAD and ORIC measure related but distinct latent constructs. The CFA showed that the use of a total score for each measure is appropriate. The theoretical subscales of the NoMAD had adequate internal consistency. The total scale had high internal consistency. The total ORIC scale and subscales demonstrated high internal consistency. Test-retest reliability was suboptimal for both measures and floor and ceiling effects were absent. Conclusions: This study confirmed the psychometric properties of the NoMAD and ORIC in multi-national mental health care settings. While measuring on different but related aspects of implementation processes, the NoMAD and ORIC prove to be valid and reliable across different language settings.

Why was the study done?: Effective interventions need to be implemented successfully to achieve impact. Reliable measurement instruments are needed to determine if an implementation was successful or not. Two theory-based instruments exist for measuring the effectiveness of implementation strategies and monitor progress. The NoMAD measures aspects of normalization related to sense-making, willingness to implement, the work people do, and reflection. The Organizational Readiness for Implementing Change (ORIC) measures organization members' preparedness for implementing a change. What did we do?: This study examined whether the NoMAD and ORIC measure what they are supposed to measure. We translated the instruments from English to eight languages (Albanian, Danish, Dutch, French, German, Italian, and Spanish/Catalan) We applied various statistical methods to confirm the measurement properties, including correlations of scales, factor structures, test­retest reliability, consistency and floor and ceiling effects. 318 mental health professionals from nine countries participated in the study. What did we find?: For both instruments, total scores can be used as well as the subscale scores. Internal consistency for ORIC was high and for NoMAD adequate. Test­retest reliability was demonstrated, and floor and ceiling effects were rare. What does this mean?: NoMAD and ORIC are reliable instruments for measuring implementation processes and outcomes across mental health care settings in different countries and languages. They measure related but different aspects of implementation processes and outcomes. The measures are brief, and theory supported. However, more work is to be done on interpreting scores in relation to implementation success and regarding changes over time.

Women's perception of future risk following pregnancies complicated by preeclampsia.

OBJECTIVE: To elicit women's personal understanding of future cardiovascular risk, following a pregnancy complicated by preeclampsia, and to identify the postnatal needs of these women. METHODS: Semi-structured interviews with 12 women with a recent history of preeclampsia who had attended a postnatal follow-up clinic. RESULTS: The interviews were held at a median of 47 weeks postpartum (range 24-62 weeks). Family history of cardiovascular disease was associated with a greater awareness of future cardiovascular risk. Women without traditional risk factors found it hard to envisage themselves as being at risk and may not see the relevance of such information. It may take several months after delivery for a woman to be able to fully consider her own health as well as the baby's; a reminder of risk and health information is needed. CONCLUSIONS: Although receptive to follow-up, the situational factors of being a new mother need to be taken into account to engage successfully with this patient group. Further research is needed to help clarify the extent to which a history of preeclampsia is an independent factor for future cardiovascular disease to provide a solid foundation for effective risk communication.

Drug-induced bullous pemphigoid: cases triggered by intravenous iodine and etanercept.

Bullous pemphigoid (BP) is one of the most common acquired immunobullous diseases. Rarely, the development of BP is attributed to drug exposure. We present two cases of BP, one triggered by intravenous iodine, and one associated with etanercept treatment in a patient with psoriasis; the first time, to our knowledge, that either of these associations has been reported. The recognition of occasional cases of drug-induced BP such as ours, with timely cessation of the offending agent, may produce rapid clinical improvement with decreased exposure to potent immunosuppressive therapy.

PRODIGE: a randomized placebo-controlled trial of dalteparin low-molecular-weight heparin thromboprophylaxis in patients with newly diagnosed malignant glioma.

BACKGROUND AND OBJECTIVES: Venous thromboembolism (VTE) occurs in 20-30% of patients with malignant glioma per year of survival. We tested the efficacy of long-term dalteparin low-molecular-weight heparin (LMWH) for prevention of VTE in these patients. PATIENTS/METHODS: Adults with newly diagnosed malignant glioma were randomized to receive dalteparin 5000 anti-Xa units or placebo, both subcutaneously once daily for 6 months starting within 4 weeks of surgery. Treatment continued for up to 12 months. The primary outcome was the cumulative risk of VTE over 6 months. The target sample size was 512 patients. Events were adjudicated by a committee unaware of treatment. RESULTS: The trial began in 2002 and closed in May 2006 because of expiration of study medication. Ninety-nine patients were randomized to LMWH and 87 to placebo. Twenty-two patients developed VTE in the first 6 months: nine in the LMWH group and 13 in the placebo group [hazard ratio (HR) = 0.51, 95% confidence interval (CI): 0.19-1.4, P = 0.29]. At 6 months, there were three major bleeds on LMWH and none on placebo; at 12 months, 5 (5.1%) major bleeds on LMWH and 1 (1.2%) on placebo occurred (HR = 4.2, 95% CI: 0.48-36, P = 0.22). All major bleeds were intracranial and occurred while on study medication. The 12-month mortality rates were 47.8% for LMWH and 45.4% for placebo (HR = 1.2, 95% CI: 0.73-2.0, P = 0.48). CONCLUSIONS: Trends suggesting reduced VTE and increased intracranial bleeding were seen in the LMWH thromboprophylaxis group. The role of long-term anticoagulant thromboprophylaxis in patients with brain tumors remains uncertain.

Facilitation of implant provision in primary care.

OBJECTIVE: To investigate primary care practitioner participation in implant-supported mandibular overdenture (ISOD) provision. DESIGN: Postal questionnaire. SETTING: Primary dental care, North East England 2007. SUBJECTS AND METHODS: Two hundred and ninety-five practitioners in North East England were sent questionnaires presenting a case-based scenario of a patient unable to manage a lower denture on an atrophic ridge. The questionnaire led them through the facilitation stages of ISOD provision, asking them to state their anticipated level of participation at each stage. Demographic details were also collected. RESULTS: Two hundred and seventeen responses were received (74%). Most practitioners would consider the option of provision of ISODs (89%) in this case and all who considered would discuss the option with the patient. Of those offering to facilitate treatment, 66% (122/184) would never deliver themselves, with the majority (60%, 111/184) referring within primary care. Statistical analysis showed associations between demographics and behaviour. CONCLUSIONS: The majority of practitioners in this study area would facilitate ISOD provision in this case. Practitioners who are male and working in a practice where a framework for the provision of implants already exists are most likely to facilitate provision and/or provide an ISOD within primary care.

Methotrexate: prescribing and monitoring practices among the consultant membership of the British Association of Dermatologists.

BACKGROUND: Methotrexate is frequently used in dermatology practice and is potentially toxic. Prescribing and monitoring strategies have evolved over time and many areas of practice remain controversial and without firm evidence base. OBJECTIVES: To document current U.K. prescribing and monitoring practice and to identify variations in practice. METHODS: A postal questionnaire was sent, in a single mailshot, in January 2004 to the entire consultant membership (n = 531) of the British Association of Dermatologists. RESULTS: We received a response rate of 71%. The majority of respondents prescribed for small numbers of patients and 81% reported using a patient information sheet. Almost all monitored full blood count, liver function tests and urea, electrolytes and creatinine, and 71% measured aminoterminal peptide of type III procollagen levels. We identified a wide range of practice in the use of liver biopsy. In terms of adverse events, 12% reported experience of patients developing irreversible liver damage (severity not defined). Forty-nine deaths were reported, of which 18 were due to myelosuppression, six to possible pulmonary fibrosis, two to liver failure in the absence of reported alcohol consumption and four as a consequence of liver biopsy. CONCLUSIONS: We have documented wide variations in methotrexate prescribing and monitoring practice. We compare reported practice with current guidelines and highlight the importance of monitoring for myelosuppression.

Teledermatology in the UK: lessons in service innovation.

BACKGROUND: Teledermatology has the potential to revolutionize the delivery of dermatology services by facilitating access to specialist services at a distance. In the U.K. over the previous decade there have been numerous attempts at introducing and using teledermatology; however, the development of teledermatology as routine service provision remains limited. OBJECTIVES: To identify factors that promote successful use of teledermatology as a part of routine service provision. METHODS: A longitudinal qualitative study of teledermatology, drawing on data from in-depth semistructured interviews; observations of systems in practice; and public meetings. Data were analysed collectively by the research team using established qualitative analytical techniques to identify key thematic categories. The sample consisted of teledermatology services within the U.K. (n = 12) studied over 8 years (1997-2005). Individual participants (n = 68 interviews) were consultant dermatologists, researchers, teledermatology nurses, administrators, patient advocates, general practitioners and technologists. RESULTS: The analysis compared services that did or did not become part of routine healthcare practice to identify features that supported the normalization of teledermatology. Requirements for using and integrating teledermatology into practice included: political support; perceived benefit and relative commitment that outweighs effort; pragmatic approaches to proving efficacy and safety; perception of risk as being 'manageable' on the basis of professional judgement; high levels of flexibility in practice (in terms of individuals, technology and organization); and reconceptualizing professional roles. CONCLUSIONS: Successful implementation of teledermatology as a routine service requires greater understanding of and attention to the interplay between social and technical aspects of teledermatology, and how this is accommodated both by healthcare professionals and the organizations in which they work.

Effectiveness and acceptability of non-pharmacological interventions to reduce wandering in dementia: a systematic review.

BACKGROUND: Wandering occurs in 15-60% of people with dementia. Psychosocial interventions rather than pharmacological methods are recommended, but evidence for their effectiveness is limited and there are ethical concerns associated with some non-pharmacological approaches, such as electronic tracking devices. OBJECTIVE: To determine the clinical and cost effectiveness and acceptability of non-pharmacological interventions to reduce wandering in dementia. DESIGN: A systematic review to evaluate effectiveness of the interventions and to assess acceptability and ethical issues associated with their use. The search and review strategy, data extraction and analysis followed recommended guidance. Papers of relevance to effectiveness, acceptability and ethical issues were sought. RESULTS: (i) Clinical effectiveness. Eleven studies, including eight randomised controlled trials, of a variety of interventions, met the inclusion criteria. There was no robust evidence to recommend any intervention, although there was some weak evidence for exercise. No relevant studies to determine cost effectiveness met the inclusion criteria. (ii) Acceptability/ethical issues. None of the acceptability papers reported directly the views of people with dementia. Exercise and music therapy were the most acceptable interventions and raised no ethical concerns. Tracking and tagging devices were acceptable to carers but generated considerable ethical debate. Physical restraints were considered unacceptable. CONCLUSIONS: In order to reduce unsafe wandering high quality research is needed to determine the effectiveness of non-pharmacological interventions that are practically and ethically acceptable to users. It is important to establish the views of people with dementia on the acceptability of such interventions prior to evaluating their effectiveness through complex randomised controlled trials.

A systematic literature review of the effectiveness of non-pharmacological interventions to prevent wandering in dementia and evaluation of the ethical implications and acceptability of their use.

OBJECTIVES: To determine the effectiveness and cost-effectiveness of non-pharmacological interventions (excluding subjective barriers) in the prevention of wandering in people with dementia, in comparison with usual care, and to evaluate through the review and a qualitative study the acceptability to stakeholders of such interventions and identify ethical issues associated with their use. DATA SOURCES: Major electronic databases were searched up until 31 March 2005. Specialists in the field. REVIEW METHODS: Selected studies were assessed and analysed. The results of two of the efficacy studies that used similar interventions, designs and outcome measures were pooled in a meta-analysis; results for other studies which reported standard deviations were presented in a forest plot. Owing to a lack of cost-effectiveness data, a modelling exercise could not be performed. Four focus groups were carried out with relevant stakeholders (n = 19) including people with dementia and formal and lay carers to explore ethical and acceptability issues in greater depth. Transcripts were coded independently by two reviewers to develop a coding frame. Analysis was via a thematic framework approach. RESULTS: Ten studies met the inclusion criteria (multi-sensory environment, three; music therapy, one; exercise, one; special care units, two; aromatherapy, two; behavioural intervention, one). There was no robust evidence to recommend any non-pharmacological intervention to reduce wandering in dementia. There was some evidence, albeit of poor quality, for the effectiveness of exercise and multi-sensory environment. There were no relevant studies to determine the cost-effectiveness of the interventions. Findings from the narrative review and focus groups on acceptability and ethical issues were comparable. Exercise and distraction therapies were the most acceptable interventions and raised no ethical concerns. All other interventions were considered acceptable except for physical restraints, which were considered unacceptable. Considerable ethical concerns exist with the use of electronic tagging and tracking devices and physical barriers. Existing literature ignores the perspectives of people with dementia. The small number of participants with dementia expressed caution regarding the use of unfamiliar technology. Balancing risk and risk assessment was an important theme for all carers in the management of wandering. CONCLUSIONS: There is no robust evidence so far to recommend the use of any non-pharmacological intervention to reduce or prevent wandering in people with dementia. High-quality studies, preferably randomised controlled trials, are needed to determine the clinical and cost-effectiveness of non-pharmacological interventions that allow safe wandering and are considered practically and ethically acceptable by carers and people with dementia. Large-scale, long-term cohort studies are needed to evaluate the morbidity and mortality associated with wandering in dementia for people both in the community and in residential care. Such data would inform future long-term cost-effectiveness studies.

Serological survey of Babesia bovis and Anaplasma marginale in cattle in Tete Province, Mozambique.

A serological survey of bovine babesiosis and anaplasmosis in communal cattle was conducted in the northwestern province of Tete, Mozambique. Blood was collected from cattle ranging from 4 to 15 months old from randomly selected farms from six districts. Thirty-nine per cent of all 478 calves tested in Tete Province were seropositive to the ELISA for Babesia bovis antibodies and 63% of all calves were seropositive in the card agglutination test for Anaplasma marginale. Seroprevalence of B. bovis ranged from 22.8% in Tete City District to 48.1% in Angonia District. For A. marginale, it ranged from 34.4% in Angonia District to 87.3% in Moatize District. The dominant factor affecting seroprevalence for both haemoparasites was district and there was a trend for higher intensity of tick control to be associated with a higher seroprevalence of B. bovis and a lower seroprevalence of A. marginale. The obvious differences were the low prevalence of B. bovis in Tete City Council District and the low prevalence of A. marginale in Angonia District. The levels of exposure to B. bovis seen in our study are well below any that could be considered to be consistent with endemic stability, yet they are sufficiently high to ensure that clinical disease would be a risk. The seroprevalence of A. marginale, however, suggests that endemic stability with respect to this disease could exist in districts other than Angonia. There was no strong and consistent relationship between the intensity of control and the likelihood of seropositivity to either of the diseases.

Chromoblastomycosis imported from Malta.

Chromoblastomycosis is a chronic fungal infection of the skin and subcutaneous tissues caused by pigmented fungi. It is primarily a disease of the tropics and subtropics. It is uncommon in the UK where it may occur as an imported disease. We describe a 42-year-old lady who developed chromoblastomycosis on her right forearm from Cladosporium, after visiting Malta. The lesion resolved after treatment with itraconazole for 6 months. To our knowledge there are no previous reports of chromoblastomycosis from Malta. We review the clinical course, diagnosis and management of this condition.