Choosing Wisely Italy: online survey on opinions and behaviors of 1006 people and 355 volunteers of healthcare advocacy associations.

BACKGROUND: In the framework of 'Doing more does not mean doing better - Choosing Wisely Italy' health professionals, general population and healthcare advocacy associations are widely involved. PartecipaSalute-Mario Negri IRCCS and Altronconsumo organized a survey in order to assess the opinions and behaviors of people toward unnecessary tests and drugs. METHODS: An online survey was distributed by Altroconsumo to a voluntary panel of 6304 Italian citizens covering the whole of the country and by PartecipaSalute-Mario Negri IRCCS through the PartecipaSalute website, e-mail lists, website articles, lay journals and Facebook. RESULTS: In all 1006 people reached by Altroconsumo, and 355 volunteers of healthcare advocacy associations reached by PartecipaSalute responded. Respondents usually decides on their treatment together with the physician, respectively 50% for general population and 64% for volunteers of healthcare advocacy associations. The respondents are aware of the question of over-use of drugs and tests (80%), more often among the volunteers of healthcare advocacy associations (86%). Over-use is considered a problem mostly for economic reasons among the general population, while in the advocacy associations the risks for patients' health is considered more important. CONCLUSION: These findings suggest that patients do not always ask for more, especially if they receive an answer to their questions and clarifications about unnecessary treatments. There is a need for further understanding of the factors influencing decision-making aimed at achieving good care. Engaging the public and patients at all levels of healthcare is essential for a valuable use of health resources.

Homeopathy and health related Quality of Life: a patient satisfaction survey in six European countries and Brazil.

BACKGROUND: Many patients throughout the world consult homeopathic medical doctors. Using a similar methodology as in a first survey published in 2002 a second survey was done including 919 adults receiving homeopathic treatment in six European countries and Brazil aimed to look at who are they, their reasons for consultations and expectations and satisfaction with homeopathy prescribed by a homeopathic doctor after a follow-up time of six months. METHOD: An initial questionnaire included demographic information and questions for assessing health-related Quality of Life (QoL). A follow-up questionnaire collected data on changes in QoL. RESULTS: 77% patients had initially used conventional treatments and 23% other non-conventional treatments. Satisfaction of patients with the medical homeopathic consultation is high. The difference between the final QoL scores after six months and the baseline are positive. Reported differences between baseline and final index range from 3.87 to 10.41 depending on diagnosis. Taking 7% as a reference value for 'minimal clinically significant difference', this is reached for 3 of 8 conditions. Changes in complaint limitations visual scales are positive. Conclusions on clinical impact must be cautious. 6% of the patients experienced side-effects which they attributed to homeopathic treatment. 7.8% of the patients reported significant aggravation at the beginning of the homeopathic treatment and 26.2% slight aggravation of symptoms. CONCLUSIONS: The satisfaction of patients using a medical homeopathic approach is linked to the perceived competence of the doctor homeopath, the perceived improvement of the main complaints limitations and the time dedicated to them by the doctor.

Pediatric homeopathy: a prospective observational survey based on parent proxy-reports of their children's health-related Quality of Life in six European countries and Brazil.

BACKGROUND: Many European citizens regularly consult homeopathic doctors. Especially for children there is very little data available about the reasons they visit a homeopathic doctor. What are the expectations of the parents consulting a Homeopath MD with their child, who are they and last but not least are they satisfied with their initiative? This study including 773 children from six European countries and Brazil is aimed to look at parent-proxy satisfaction with homeopathic treatment prescribed for their children by a homeopathic doctor after a follow-up of two months. The questionnaire was developed from the methodology used in a survey of adults published in 2002. METHOD: An initial questionnaire included demographic information and questions for assessing health-related Quality of Life (QoL). A follow-up questionnaire collected data on changes in QoL. RESULTS: The demographic characteristics of respondents showed more male children (53.1%) but more female parent-proxies (93.4%). 73.7% of respondents had previously tried conventional treatments; 26.3% non-conventional approaches. Satisfaction with the medical homeopathic consultation was high. Reported differences between baseline and final QoL ondexes are positive for all four studied conditions. It range from 3.206 to 10.188. Considering 7% as a reference value for "minimal clinical difference", this is reached for 2 on 4 conditions (8.473 and 10.188). Changes in complaint limitations visual scales are positive, even if uncertain for skin complaints and influenced parents satisfaction. Conclusions on clinical impact must be cautious. 4.2% of patients experienced side-effects which they attribute to homeopathic treatment. 10.1% of patients reported significant aggravation at the beginning of homeopathic treatment, 19% slight aggravation of symptoms. CONCLUSIONS: The satisfaction of parents using a medical homeopathic approach for their children is linked to the perceived competence of the doctor homeopath, the perceived improvement of the main complaint limitations and the completeness of the received information.

EUR-1008 pancreatic enzyme replacement is safe and effective in patients with cystic fibrosis and pancreatic insufficiency.

BACKGROUND: EUR-1008 (Zenpep [pancrelipase]) is a new, enteric-coated, porcine-derived pancreatic enzyme product (PEP) developed for the treatment of cystic fibrosis (CF) patients with malabsorption associated with exocrine pancreatic insufficiency (EPI). Unlike currently marketed PEPs, EUR-1008 contains the label-claimed lipase content. Safety and efficacy were assessed in younger (<7 years) and older (> or =7 years) CF patients with EPI. METHODS: Two multicenter studies were conducted: a randomized, double-blind, placebo-controlled, crossover trial in patients > or =7 years of age (N=34) and a supplemental, open-label study in children <7 years of age (N=19). Use of any medications altering gastric pH/motility was prohibited during the studies. Outcome measures in the randomized trial included changes in the coefficient of fat absorption (CFA), coefficient of nitrogen absorption (CNA), and signs/symptoms of malabsorption for EUR-1008 vs. placebo. Outcome measures in the supplemental study included safety and response (defined as no steatorrhea and no overt signs/symptoms of malabsorption) to EUR-1008 vs. previous enzyme treatment. RESULTS: In the randomized trial, EUR-1008 treatment compared to placebo resulted in a significantly higher mean CFA (88.3% vs. 62.8%, respectively) and CNA (87.2% vs. 65.7%, respectively) (both p<0.001) and reduced the incidence of malabsorption signs and symptoms in 32 evaluable patients. In the supplemental study, 11 of 19 patients met the criteria for responder with EUR-1008 at the end of the study vs. 10 of 19 patients at screening (previous PEP), and improvements in clinical symptoms were reported with EUR-1008 treatment. EUR-1008 was safe and well tolerated, and no serious drug-related AEs were reported in either study. CONCLUSIONS: EUR-1008 was safe, well tolerated, and effective in CF patients of all ages with EPI-associated malabsorption in two clinical trials. Treatment led to clinically and statistically significant improvements in CFA and CNA in the randomized study, and control of malabsorption and clinical symptoms in both studies.