Implication Of Character Traits In Adherence To Treatment In People With Gout: A Reason For Considering Nonadherence As A Syndrome.

OBJECTIVE: Various aspects of nonadherence to therapy (including medication and lifestyle nonadherence) often appear together. Here we report the association between treatment adherence in gout and the two character traits of patience and obedience, which may explain this observation. METHODS: Data were collected from a cross-sectional study conducted in a French cohort of 1441 adult patients. Patience was assessed using the choice between receiving €1500 in 1 year or €500 immediately. Obedience was evaluated with a single question assessing the use of the seatbelt in the rear seat of a car. Adherence to recommendations for medication, beverage, food and physical activity and smoking status was assessed using self-report questionnaires. RESULTS: Patience and obedience were strong determinants of adherence to medication in multivariate analysis (OR 2.056, 95% CI [1.414-2.989], P< 0.001; OR 1.844, 95% CI [1.273-2.671], P=0.001). In univariate analysis, adherence to medication was also associated with compliance with dietary directives (P<0.001), lower alcohol consumption on an ordinary day (P< 0.001), never consuming soda (P<0.001) or beer (P<0.001), practice of physical activity (P=0.002), being a nonsmoker (P<0.001) and monitoring serum levels of uric acid regularly (P=0.011). Multiple-correspondence analysis illustrated the associations of these different aspects of adherence (medication, diet and exercise, smoking status and monitoring of disease control) with patience and obedience. Finally, we observed a link between patience and obedience (P< 0.001). CONCLUSION: Character traits, which shape preferences, may cause the clustering of different aspects of nonadherence in the form of a syndrome, elucidating the still enigmatic link between nonadherence to placebo and mortality in randomised clinical trials. This concept may also explain, at least in part, the difficulty of improving adherence to long-term therapies and may lead to ethical issues.

Perioperative Opioid-sparing Strategies: Utility of Conventional NSAIDs in Adults.

PURPOSE: Opioids have long been used to treat acute postsurgical and postprocedural pain; however, opioid-related adverse events (AEs) contribute to poor patient outcomes. In addition, perisurgical exposure to opioids can potentially increase the risk for opioid-use disorder. NSAIDs reduce pain and inflammation by a mechanism different from that of opioid analgesics and may be useful in reducing the need for opioid drugs as part of a multimodal analgesia strategy. We conducted this review to assess the effectiveness and tolerability of adjunctive conventional NSAIDs given systemically in the perioperative setting in terms of opioid-sparing effects observed postoperatively. METHODS: Clinical trials published since 2000 that have assessed the opioid-sparing effects of conventional, nonselective NSAIDs were identified by a literature search using the PubMed search engine. Search terms were identified for the treatment of interest, the timing of the intervention, and the drugs of interest (NSAIDs). Data from studies that assessed opioid consumption outcomes with systemic NSAID administration were included in the review; data from studies in which NSAIDs were administered topically or via periarticular injection, local infiltration, or regional block were excluded. FINDINGS: Upon full-text review of the search results, 32 studies were chosen for inclusion in this literature review. These studies included those that assessed diclofenac, ketorolac, ibuprofen, ketoprofen, dexketoprofen, flurbiprofen, lornoxicam, tenoxicam, meloxicam, and piroxicam. In studies in which NSAIDs were associated with opioid-sparing effects within the setting of patient-controlled analgesia, opioid use was reduced by 17%-∼50% with diclofenac, 9%-66% with ketorolac, 22%-46% with ibuprofen, 34%-66% with ketoprofen, 36%-50% with dexketoprofen, 38%-41% with tenoxicam, 36%-54% with lornoxicam, and ∼50% with flurbiprofen. No opioid-sparing effect was noted with meloxicam (1 study). The majority of studies that reported on pain-score changes revealed either pain reductions with NSAIDs versus placebo or similar pain scores between groups, indicating that NSAIDs did not compromise pain control. Although many studies found no difference in the prevalence of AEs in NSAID-treated patients compared with controls, several studies noted lower rates of nausea, vomiting, sedation, and pruritus with NSAIDs versus placebo. Conversely, NSAID-related AEs were few overall but included gastrointestinal bleeding, injection site reactions, transient oliguric renal failure, and dizziness. No surgery-related bleeding complications were observed. IMPLICATIONS: NSAIDs have the potential to play an important role in reducing postoperative opioid requirements. Reducing the amount of opioids used could be expected to reduce opioid-related side effects and contribute to reversing the opioid epidemic.

[Quadrivalent influenza vaccine: What is changed and what are the benefits?] / Vaccin grippal quadrivalent : quels changements pour quels bénéfices ?

Currently, circulating viruses responsible for annual seasonal influenza epidemics belong to two influenza A subtypes, A(H1N1) and A(H3N2), and to two antigenically distinct type B lineages, B/Yamagata and B/Victoria lineages. Like diseases due to influenza A virus, influenza B virus diseases may have severe consequences and should be prevented. Until now, in France, the vaccines used to prevent seasonal influenza were trivalent, systematically targeting viruses belonging to both A subtypes and to one or other of the B lineages. The protective efficacy of trivalent vaccines is diminished during the seasons when viruses belonging to both B lineages cocirculated or when the circulating dominant type B virus belonged to a lineage different from that targeted by the vaccine strain. By targeting viruses belonging to both B lineages, quadrivalent vaccines improve the antigenic concordance between circulating and vaccine type B strains. Three inactivated quadrivalent vaccines are authorized for marketing in France and should be available for the 2018-2019 season. It is expected that, by providing enlarged protection, these quadrivalent influenza vaccines will improve vaccine efficacy, the confidence in immunization of the public, the satisfaction of health professionals, and ultimately will help to complete immunization coverage.

Effectiveness and Persistence of Liraglutide Treatment Among Patients with Type 2 Diabetes Treated in Primary Care and Specialist Settings: A Subgroup Analysis from the EVIDENCE Study, a Prospective, 2-Year Follow-up, Observational, Post-Marketing Study.

INTRODUCTION: The objective of this subgroup analysis is to investigate the effectiveness of liraglutide in people with type 2 diabetes (T2D) treated within the primary care physician (PCP) and specialist care settings. METHODS: EVIDENCE is a prospective, observational study of 3152 adults with T2D recently starting or about to start liraglutide treatment in France. We followed patients in the PCP and specialist settings for 2 years to evaluate the effectiveness of liraglutide in glycemic control and body weight reduction. Furthermore, we evaluated the changes in combined antihyperglycemic treatments, the reasons for prescribing liraglutide, patient satisfaction, and safety of liraglutide in these two treatment settings. RESULTS: After 2 years of follow-up, 477 out of 1209 (39.0%) of PCP and 297 out of 1398 (21.2%) of specialist-treated patients still used liraglutide and maintained the glycated hemoglobin (HbA1c) target of <7.0%. Significant reductions from baseline were observed in both PCP- and specialist-treated cohorts in mean HbA1c (-1.22% and -0.8%, respectively), fasting plasma glucose (FPG) concentration (-39 and -23 mg/dL), body weight (-4.4 and -3.8 kg), and body mass index (BMI) (-1.5 and -1.4 kg/m2), all p < 0.0001. Reductions in HbA1c and FPG were significantly greater among PCP- compared with specialist-treated patients, p < 0.0001 for both. Patient treatment satisfaction was also significantly increased in both cohorts. Reported gastrointestinal adverse events were less frequent among PCP-treated patients compared with specialist-treated patients (4.5% vs. 16.1%). CONCLUSION: Despite differences in demography and clinical characteristics of patients treated for T2D in PCP and specialty care, greater reduction in HbA1c and increased glycemic control durability were observed with liraglutide in primary care, compared with specialist care. These data suggest that liraglutide treatment could benefit patients in primary care by delaying the need for further treatment intensification. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT01226966. FUNDING: Novo Nordisk A/S.

Scoring and psychometric validation of the 'Determinants of Intentions to Vaccinate' (DIVA©) questionnaire.

BACKGROUND: Primary care physicians (PCPs) play a key role regarding vaccination in France. The aims of the present study were to define the scoring rules and to assess the measurement properties of the 'Determinants of Intentions to Vaccinate' (DIVA©) questionnaire that aims to assess PCPs' attitudes and beliefs toward vaccination. METHODS: The DIVA questionnaire was derived from a literature review and PCPs focus groups. Scoring and early validation of the DIVA questionnaire were determined during a cross-sectional study conducted in France. During the study, PCPs had to complete the DIVA questionnaire for any of the six vaccine-preventable diseases (VPDs) to which they were randomly assigned (measles, pertussis, pneumococcus infection, seasonal influenza, human papillomavirus -HPV- infection and tetanus). Descriptive analyses of items and the analysis of the grouping of items into domains were conducted. Internal consistency reliability and construct validity was assessed according to each VPD. RESULTS: The DIVA questionnaire was completed by 1,069 PCPs and was well accepted. The 'Commitment of the PCP to the vaccination approach' score showed very good internal consistency reliability (Cronbach's alpha >0.70 overall and for each VPD). The construct validity of the DIVA questionnaire was confirmed. CONCLUSIONS: The DIVA questionnaire is a valid and reliable measure of PCPs' attitudes and beliefs toward vaccination.

[The commitment of French general practitioners to vaccination: the DIVA study (Determinants of Vaccination Intentions)]. / L’engagement des médecins généralistes français dans la vaccination : l’étude DIVA (Déterminants des Intentions de Vaccination).

OBJECTIVES: Vaccination is an effective way to reduce morbidity and mortality related to infectious diseases. In France, primary care physicians are the main administrators of vaccines. Our objective was to conduct an exploratory qualitative study with primary care physicians to identify determinants of their commitment to vaccination. METHODS: A qualitative research study was conducted with 36 primary care physicians from different geographical regions in France. Six focus group discussions, following a semi-structured interview guide, were held. Qualitative analysis based on coding of the transcribed discussions was performed to identify the factors influencing primary care physicians' attitudes toward vaccination. These factors were then organized into themes. Saturation was also evaluated. RESULTS: Diphtheria, tetanus, poliomyelitis, measles, mumps, rubella, hepatitis B, tuberculosis, pneumococcal infections, meningococcus, human papillomavirus, rotavirus, pertussis, varicella and flu vaccinations were all discussed in each focus group. Saturation was reached from the fourth focus group. Forty identified determinants were divided into six themes: vaccine characteristics, disease characteristics, primary care physicians' past experience, practical aspects, expected benefits and primary care physician-patient relationship. CONCLUSIONS: This study identified the behavioural and organizational determinants influencing primary care physicians' attitudes toward vaccination. These attitudes and determinants varied according to diseases and vaccines. The identified determinants and themes were used as a basis for the development of a questionnaire evaluating the Determinant of Vaccination Intentions (DIVA) of primary care physicians.

Evaluation of the long-term cost-effectiveness of liraglutide therapy for patients with type 2 diabetes in France.

OBJECTIVES: The present study aimed to compare the projected long-term clinical and cost implications associated with liraglutide, sitagliptin and glimepiride in patients with type 2 diabetes mellitus failing to achieve glycemic control on metformin monotherapy in France. METHODS: Clinical input data for the modeling analysis were taken from two randomized, controlled trials (LIRA-DPP4 and LEAD-2). Long-term (patient lifetime) projections of clinical outcomes and direct costs (2013 Euros; €) were made using a validated computer simulation model of type 2 diabetes. Costs were taken from published France-specific sources. Future costs and clinical benefits were discounted at 3% annually. Sensitivity analyses were performed. RESULTS: Liraglutide was associated with an increase in quality-adjusted life expectancy of 0.25 quality-adjusted life years (QALYs) and an increase in mean direct healthcare costs of €2558 per patient compared with sitagliptin. In the comparison with glimepiride, liraglutide was associated with an increase in quality-adjusted life expectancy of 0.23 QALYs and an increase in direct costs of €4695. Based on these estimates, liraglutide was associated with an incremental cost-effectiveness ratio (ICER) of €10,275 per QALY gained vs sitagliptin and €20,709 per QALY gained vs glimepiride in France. CONCLUSION: Calculated ICERs for both comparisons fell below the commonly quoted willingness-to-pay threshold of €30,000 per QALY gained. Therefore, liraglutide is likely to be cost-effective vs sitagliptin and glimepiride from a healthcare payer perspective in France.

Effectiveness and Persistence with Liraglutide Among Patients with Type 2 Diabetes in Routine Clinical Practice--EVIDENCE: A Prospective, 2-Year Follow-Up, Observational, Post-Marketing Study.

INTRODUCTION: The aim of this study was to investigate whether the efficacy of liraglutide observed in randomized controlled trials translates into therapeutic benefits in the French population during routine clinical practice. METHODS: This observational, prospective, multicenter study included 3152 adults with type 2 diabetes who had recently started or were about to start liraglutide treatment. During 2 years of follow-up, an evaluation of the reasons for prescribing liraglutide, maintenance dose of liraglutide, changes in combined antidiabetic treatments, level of glycemic control, change in body weight and body mass index (BMI), patient satisfaction with diabetes treatment and safety of liraglutide were investigated. The primary study endpoint was the proportion of patients still receiving liraglutide and presenting with HbA1c <7.0% after 2 years of follow-up. RESULTS: At the end of the study, 29.5% of patients maintained liraglutide treatment and reached the HbA(1c) target. Mean (±SD) HbA(1c), fasting plasma glucose concentration, body weight and BMI were significantly reduced from baseline [8.46% (±1.46) to 7.44% (±1.20); 180 (±60) to 146 (±44) mg/dL; 95.2 (±20.0) to 91.1 (±19.6) kg; 34.0 (±7.2) to 32.5 (±6.9) kg/m(2); respectively, all P < 0.0001]. Patient treatment satisfaction increased, with the mean diabetes treatment satisfaction questionnaire status version score increasing from 22.17 (±7.64) to 28.55 (±5.79), P < 0.0001. The main adverse event type was gastrointestinal, with a frequency of 10.9%, and the percentage of patients suffering ≥1 hypoglycemic episode decreased from 6.9% to 4.4%. CONCLUSION: The results of the EVIDENCE study suggest that the effectiveness of liraglutide in real-world clinical practice is similar to that observed in randomized controlled trials. FUNDING: Novo Nordisk A/S. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT01226966.

General Practitioners' intention to prescribe and prescribing patterns in selected European settings: The OTCSOCIOMED project.

The aim of this paper is to explore general practitioners' (GPs) prescribing intentions and patterns across different European regions using the Theory of Planned Behavior (TPB). A cross-sectional study was undertaken in selected geographically defined Primary Health Care areas in Cyprus, Czech Republic (CZ), France, Greece, Malta, Sweden and Turkey. Face-to-face interviews were conducted using a TPB-based questionnaire. The number of GP participants ranged from 39 to 145 per country. Possible associations between TPB direct measures (attitudes, subjective norms (SN) and perceived behavioral control (PBC)) and intention to prescribe were assessed by country. On average, GPs thought positively of, and claimed to be in control of, prescribing. Correlations between TPB explanatory measures and prescribing intention were weak, with TPB direct measures explaining about 25% of the variance in intention to prescribe in Malta and CZ but only between 3% and 5% in Greece, Sweden and Turkey. SN appeared influential in GPs from Malta; attitude and PBC were statistically significant in GPs from CZ. GPs' prescribing intentions and patterns differed across participating countries, indicating that country-specific interventions are likely to be appropriate. Irrational prescribing behaviors were more apparent in the countries where an integrated primary care system has still not been fully developed and policies promoting the rational use of medicines are lacking. Demand-side measures aimed at modifying GPs prescribing behavior are deemed necessary.

Irrational prescribing of over-the-counter (OTC) medicines in general practice: testing the feasibility of an educational intervention among physicians in five European countries.

BACKGROUND: Irrational prescribing of over-the-counter (OTC) medicines in general practice is common in Southern Europe. Recent findings from a research project funded by the European Commission (FP7), the "OTC SOCIOMED", conducted in seven European countries, indicate that physicians in countries in the Mediterranean Europe region prescribe medicines to a higher degree in comparison to physicians in other participating European countries. In light of these findings, a feasibility study has been designed to explore the acceptance of a pilot educational intervention targeting physicians in general practice in various settings in the Mediterranean Europe region. METHODS: This feasibility study utilized an educational intervention was designed using the Theory of Planned Behaviour (TPB). It took place in geographically-defined primary care areas in Cyprus, France, Greece, Malta, and Turkey. General Practitioners (GPs) were recruited in each country and randomly assigned into two study groups in each of the participating countries. The intervention included a one-day intensive training programme, a poster presentation, and regular visits of trained professionals to the workplaces of participants. Reminder messages and email messages were, also, sent to participants over a 4-week period. A pre- and post-test evaluation study design with quantitative and qualitative data was employed. The primary outcome of this feasibility pilot intervention was to reduce GPs' intention to provide medicines following the educational intervention, and its secondary outcomes included a reduction of prescribed medicines following the intervention, as well as an assessment of its practicality and acceptance by the participating GPs. RESULTS: Median intention scores in the intervention groups were reduced, following the educational intervention, in comparison to the control group. Descriptive analysis of related questions indicated a high overall acceptance and perceived practicality of the intervention programme by GPs, with median scores above 5 on a 7-point Likert scale. CONCLUSIONS: Evidence from this intervention will estimate the parameters required to design a larger study aimed at assessing the effectiveness of such educational interventions. In addition, it could also help inform health policy makers and decision makers regarding the management of behavioural changes in the prescribing patterns of physicians in Mediterranean Europe, particularly in Southern European countries.

Impact of information leaflets on behavior of patients with gastroenteritis or tonsillitis: a cluster randomized trial in French primary care.

OBJECTIVE: To assess the impact of four patient information leaflets on patients' behavior in primary care. DESIGN: Cluster randomized multicenter controlled trial between November 2009 and January 2011. PARTICIPANTS: French adults and children consulting a participating primary care physician and diagnosed with gastroenteritis or tonsillitis. Patients were randomized to receive patient information leaflets or not, according to the cluster randomization of their primary care physician. INTERVENTION: Adult patients or adults accompanying a child diagnosed with gastroenteritis or tonsillitis were informed of the study. Physicians in the intervention group gave patients an information leaflet about their condition. Two weeks after the consultation patients (or their accompanying adult) answered a telephone questionnaire on their behavior and knowledge about the condition. MAIN MEASURES: The main and secondary outcomes, mean behavior and knowledge scores respectively, were calculated from the replies to this questionnaire. RESULTS: Twenty-four physicians included 400 patients. Twelve patients were lost to follow-up (3 %). In the group that received the patient information leaflet, patient behavior was closer to that recommended by the guidelines than in the control group (mean behavior score 4.9 versus 4.2, p < 0.01). Knowledge was better for adults receiving the leaflet than in the control group (mean knowledge score 4.2 versus 3.6, p < 0.01). There were fewer visits for the same symptoms by household members of patients given leaflets (23.4 % vs. 56.2 %, p < 0.01). CONCLUSION: Patient information leaflets given by the physician during the consultation significantly modify the patient's behavior and knowledge of the disease, compared with patients not receiving the leaflets, for the conditions studied.

Baseline observations from the POSSIBLE EU® study: characteristics of postmenopausal women receiving bone loss medications.

SUMMARY: Prospective Observational Scientific Study Investigating Bone Loss Experience in Europe (POSSIBLE EU®) is an ongoing longitudinal cohort study that utilises physician- and patient-reported measures to describe the characteristics and management of postmenopausal women on bone loss therapies. We report the study design and baseline characteristics of 3,402 women recruited from general practice across five European countries. PURPOSE: The POSSIBLE EU® is a study describing the characteristics and management of postmenopausal women receiving bone loss medications. METHODS: Between 2005 and 2008, general practitioners enrolled postmenopausal women initiating, switching or continuing treatment with bone loss treatment in France, Germany, Italy, Spain and the UK. Patients and physicians completed questionnaires at study entry and at 3-month intervals, for 1 year. RESULTS: Of 3,402 women enrolled (mean age 68.2 years [SD] 9.83), 96% were diagnosed with low bone mass; 55% of these using dual energy X-ray absorptiometry. Most women (92%) had comorbidities. Mean minimum T score (hip or spine) at diagnosis was -2.7 (SD 0.89; median -2.7 [interquartile range, -3.2, -2.2]) indicating low bone mineral density. Almost 40% of the women had prior fractures in adulthood, mostly non-vertebral, non-hip in nature, 30% of whom had at least two fractures and more than half experienced moderate/severe pain or fatigue. Bisphosphonates were the most common type of bone loss treatment prescribed in the 12 months preceding the study. CONCLUSIONS: POSSIBLE EU® characterises postmenopausal women with low bone mass, exhibiting a high rate of prevalent fracture, substantial bone fragility and overall comorbidity burden. Clinical strategies for managing osteoporosis in this population varied across the five participating European countries, reflecting their different guidelines, regulations and standards of care.

Assessing the impact of a new delivery method of insulin on glycemic control using a novel trial design.

OBJECTIVE: The purpose of the trial was to examine the impact of inhaled human insulin (INH) on patient or physician willingness to adopt insulin after oral diabetes agent failure. RESEARCH DESIGN AND METHODS: The EXPERIENCE trial was a one-year randomized controlled trial conducted at primary, secondary and tertiary care facilities in Europe and North America. The primary study endpoint was difference in glycated hemoglobin (A(1c)) between randomized groups at 26 weeks, and results from that phase have been reported previously. The present report concerns results from the second 26-week extension phase. We also consider the applicability of the design. The trial recruited 727 patients with type 2 diabetes mellitus who, prior to randomization, were using two or more oral diabetes agents and whose A(1c) was ≥ 8.0%. Patients were randomized to two treatment settings: Group 1 (usual care with the option of INH) or Group 2 (usual care only). Usual care included adjusting oral therapy (optimizing current regimen or adding/deleting agents) and/or initiating subcutaneous (SC) insulin. RESULTS: At baseline, insulin was initiated by more (odds ratio [OR] 6.0;95% confidence interval [CI] 4.2 to 8.8; P < 0.0001) patients in Group 1 (86.2%; 76.7% INH plus 9.5% SC) than in Group 2 (50.7%; SC insulin only). The largest reduction from baseline in A(1c) was in Group 1 (-2.0 ± 1.2%) at Week 12 and in Group 2 (-1.8 ± 1.3%) at Week 26 (P = 0.003). At 52 weeks, 79.8% were on insulin in Group 1 (67.4% INH; 12.4% SC) vs 58.1% (SC only) in Group 2, and mean (SD) changes in A(1c) from baseline were -1.9% (1.2%) and -1.8% (1.3%) in Groups 1 and 2, respectively (P = 0.05). Hypoglycemic event rates per patient month were 0.3 and 0.1 in Groups 1 and 2, respectively (P < 0.0001). CONCLUSION: The EXPERIENCE trial showed that novel delivery technology can accelerate the adoption of insulin although some attenuation of differences is observed over time. And further, that this was achieved in a population of patients who appeared more ready to move to insulin therapy than observed in standard clinical practice, and a group of physicians who appeared more ready to adopt INH than the majority of physicians.

Studying the Hurdles of Insulin Prescription (SHIP): development, scoring and initial validation of a new self-administered questionnaire.

BACKGROUND: Although insulin therapy is well-accepted by symptomatic diabetic patients, it is still often delayed in less severe patients, in whom injectable insulin remains under-used. A better understanding of patients' perception of insulin would eventually help physicians to adopt the most appropriate dialogue when having to motivate patients to initiate or to intensify insulin injection. METHODS: The 'Studying the Hurdles of Insulin Prescription' (SHIP) questionnaire was developed based on a list of concepts derived from three diabetic patients' focus groups, and was included into two cross-sectional studies with similar design: SHIP Oral study and SHIP Premix study. Diabetic patients treated with oral hypoglycaemic agents (OHA; n = 1,494) and patients already treated with insulin (n = 1,150) completed the questionnaire at baseline, 6- and 12 months. Psychometric properties were assessed: 1) structure analysis by Principal Component Analysis (PCA) with Varimax rotation, 2) internal consistency reliability (Cronbach's alpha), and 3) concurrent validity (Spearman correlation coefficients with the Fear of Self-Injecting (FSI) score of the Diabetes Fear of Injecting and Self-testing Questionnaire. Reluctance/motivation towards insulin was assessed. Scores' ability to predict patients' insulin injection reluctance/motivation and initiation/intensification was evaluated with the Area Under the Receiver Operating Characteristic (ROC) Curve (AUC). RESULTS: PCA analysis confirmed the structure of the 14 items grouped into 3 dimensions: 'acceptance and motivation', 'fear and constraints', and 'restraints and barriers' towards insulin injection. Internal consistency reliability was excellent (Cronbach's alpha > 0.70); concurrent validity was good. The three scores were significantly predictive of patients' reluctance/motivation towards insulin injection initiation, as they were of patients' actual switch, except for the 'restraints and barriers' dimension. 'Acceptance and motivation' and 'fears and constraints' dimensions were also significantly predictive of patients' reluctance/motivation towards insulin intensification. By the end of the 12-month study, 179 of the initially OHA-treated patients had started insulin injections; 186 of the patients already treated with insulin had increased their injections. CONCLUSION: The SHIP questionnaire provides reliable and valid assessment of diabetic patients' attitude towards insulin and injections. The predictive power of scores for patients' reluctance/motivation and actual treatment decisions demonstrates encouraging potential for further application in clinical practice.

Real-world trials to answer real-world questions.

Currently, there is a discrepancy between clinical trials designed to assess the efficacy and safety of a new medication under investigation and the real-life questions that need to be addressed regarding the clinical use of the medication by patients, healthcare professionals and society. The data necessary to obtain regulatory approval may be of limited relevance to policy makers when calculating economic parameters such as value for money or cost effectiveness. 'Real-world' studies examine questions relevant to health policy and reimbursement. There are many different forms of clinical trials, but in designing trials incorporating realistic budget impact estimates the important issue is to ensure we are asking a sensible question and attempting to answer it with an appropriate experimental design. As an example, a real-world trial currently underway that examines scenarios of introducing inhaled insulin into clinical practice is described.