Process evaluation of complex interventions in chronic and neglected tropical diseases in low- and middle-income countries-a scoping review protocol.

BACKGROUND: The use of process evaluations is a growing area of interest in research groups working on complex interventions. This methodology tries to understand how the intervention was implemented to inform policy and practice. A recent systematic review by Liu et al. on process evaluations of complex interventions addressing non-communicable diseases found few studies in low- and middle- income countries (LMIC) because it was restricted to randomized controlled trials, primary healthcare level and non-communicable diseases. Yet, LMICs face different barriers to implement interventions in comparison to high-income countries such as limited human resources, access to health care and skills of health workers to treat chronic conditions especially at primary health care level. Therefore, understanding the challenges of interventions for non-communicable diseases and neglected tropical diseases (diseases that affect poor populations and have chronic sequelae) will be important to improve how process evaluation is designed, conducted and used in research projects in LMICs. For these reasons, in comparison to the study of Liu et al., the current study will expand the search strategy to include different study designs, languages and settings. OBJECTIVE: Map research using process evaluation in the areas of non-communicable diseases and neglected tropical diseases to inform the gaps in the design and conduct of this type of research in LMICs. METHODS: Scoping review of process evaluation studies of randomized controlled trials (RCTs) and non-RCTs of complex interventions implemented in LMICs including participants with non-communicable diseases or neglected tropical diseases and their health care providers (physicians, nurses, technicians and others) related to achieve better health for all through reforms in universal coverage, public policy, service delivery and leadership. The aspects that will be evaluated are as follows: (i) available evidence of process evaluation in the areas of non-communicable diseases and neglected tropical diseases such as frameworks and theories, (ii) methods applied to conduct process evaluations and (iii) gaps between the design of the intervention and its implementation that were identified through the process evaluation. Studies published from January 2008. Exclusion criteria are as follows: not peer reviewed articles, not a report based on empirical research, not reported in English or Spanish or Portuguese or French, reviews and non-human research. DISCUSSION: This scoping review will map the evidence of process evaluations conducted in LMICs. It will also identify the methods they used to collect and interpret data, how different theories and frameworks were used and lessons from the implementation of complex interventions. This information will allow researchers to conduct better process evaluations considering special characteristics from countries with limited human resources, scarce data available and limited access to health care.

EHRA expert consensus statement and practical guide on optimal implantation technique for conventional pacemakers and implantable cardioverter-defibrillators: endorsed by the Heart Rhythm Society (HRS), the Asia Pacific Heart Rhythm Society (APHRS), and the Latin-American Heart Rhythm Society (LAHRS).

With the global increase in device implantations, there is a growing need to train physicians to implant pacemakers and implantable cardioverter-defibrillators. Although there are international recommendations for device indications and programming, there is no consensus to date regarding implantation technique. This document is founded on a systematic literature search and review, and on consensus from an international task force. It aims to fill the gap by setting standards for device implantation.

Impact of obesity on diagnosis and treatment of breast cancer.

In this population-based study, we evaluated the impact of obesity on presentation, diagnosis and treatment of breast cancer. Among all women diagnosed with invasive breast cancer in the canton Geneva (Switzerland) between 2003 and 2005, we identified those with information on body mass index (BMI) and categorized them into normal/underweight (BMI <25 kg/m(2)), overweight (BMI > or =-<30 kg/m(2)) and obese (BMI > or =30 kg/m(2)) women. Using multivariate logistic regression, we compared tumour, diagnosis and treatment characteristics between groups. Obese women presented significantly more often with stage III-IV disease (adjusted odds ratio [OR(adj)]: 1.8, 95% CI: 1.0-3.3). Tumours > or =1 cm and pN2-N3 lymph nodes were significantly more often impalpable in obese than in normal/underweight patients (OR(adj) 2.4, [1.1-5.3] and OR(adj) 5.1, [1.0-25.4], respectively). Obese women were less likely to have undergone ultrasound (OR(adj) 0.5, [0.3-0.9]) and MRI (OR(adj) 0.3, [0.1-0.6]) and were at increased risk of prolonged hospital stay (OR(adj) 4.7, [2.0-10.9]). This study finds important diagnostic and therapeutic differences between obese and lean women, which may impair survival of obese women with breast cancer. Specific strategies are needed to optimize the care of obese women with or at risk of breast cancer.

Education of children and adolescents for the prevention of dog bite injuries.

BACKGROUND: Dog bites can have dramatic consequences for children and adolescents. Educating young people on how to interact with dogs could contribute to reducing dog bite injuries. OBJECTIVES: To determine the effectiveness of educational interventions that target children and adolescents in reducing dog bite injuries and their consequences. SEARCH STRATEGY: We searched the following databases: The Cochrane Injuries Group's Specialised Register, CENTRAL (The Cochrane Library Issue 3, 2008), CAB Abstracts, Zetoc, SIGLE, MEDLINE, EMBASE, ERIC, PsycInfo, SPECTR, CINAHL, National Research Register, LILACs, African Healthline, Science Citation Index, Social Science Citation Index, CurrentClinicalTrials.Gov, Centrewatch, Controlledtrials.com, Vetgate and the WHO database. We checked the bibliographies of relevant reviews and trials and also contacted experts in the field. The searches were carried out to 18 July 2008. SELECTION CRITERIA: We included randomised controlled trials and controlled before-after studies that evaluated the effectiveness of educational interventions, in populations under 20 years old, for preventing dog bites. DATA COLLECTION AND ANALYSIS: Two review authors selected eligible studies based on information from the title and abstract. Two review authors decided on the inclusion of eligible trials and extracted data from the trial reports. We contacted authors of eligible studies to obtain more information. MAIN RESULTS: Two studies met the inclusion criteria. No study looked at our main outcome: dog bite rates. The included studies were randomised controlled trials conducted in kindergarten and primary schools. Their methodology was of moderate quality. One study showed that the intervention group showed less 'inappropriate behaviour' when observed in the presence of a dog after a 30-minute educational intervention. Another study showed an increase in knowledge and in caution after an information programme. AUTHORS' CONCLUSIONS: There is no direct evidence that educational programmes can reduce dog bite rates in children and adolescents. Educating children who are less than 10 years old in school settings could improve their knowledge, attitude and behaviour towards dogs. Educating children and adolescents in settings other than schools should also be evaluated. There is a need for high quality studies that measure dog bite rates as an outcome. To date, evidence does not suggest that educating children and adolescents is effective as a unique public health strategy to reduce dog bite injuries and their consequences.

The impact of pharmaceutical company funding on results of randomized trials of nicotine replacement therapy for smoking cessation: a meta-analysis.

AIMS: To assess whether source of funding affected the results of trials of nicotine replacement therapy (NRT) for smoking cessation. METHODS: We reviewed all randomized controlled trials included in the Cochrane review. There were insufficient non-industry trials of the newer products for these to be included. We included 90 trials of either the nicotine gum (52) or nicotine patch (38). They comprised 18 238 treatment and 16 235 control participants. Forty-nine showed evidence of industry support (18 gum, 31 patch). RESULTS: Industry (31 of 49, 63%) compared with non-industry (seven of 41, 17%, P < 0.001) supported a higher proportion of nicotine patch studies and had larger sample sizes (479 versus 268, P = 0.04). Twenty-five (51%) industry trials reported statistically significant (P < 0.05) results, compared with nine (22%) non-industry trials (OR = 3.70, 95% CI = 1.46-9.35). This difference was not explained by trial characteristics. Industry-supported trials had a pooled odds ratio of 1.90 (1.67-2.16), compared with 1.61 (1.43-1.80) for other studies (chi(2) = 3.6, P = 0.058). There was evidence of funnel-plot asymmetry among industry trials (t = 4.35, P < 0.001), but not among other trials, indicating that several small null-effect industry trials may not have reached publication. After imputation adjustment, the odds ratio for industry trials reduced to 1.64 (1.43-1.89) and the overall NRT odds ratio reduced from 1.73 (1.60-1.90) to 1.62 (1.49-1.77). CONCLUSIONS: Compared with independent trials, industry-supported trials were more likely to produce statistically significant results and larger odds ratios. These differences persisted after adjustment for basic trial characteristics. Although we had no data on the amount of funding for each trial, it is possible that more resources led to higher treatment compliance and therefore greater efficacy in industry-supported trials. Differences can also possibly be explained by publication bias with several small, null-effect industry studies not having reached publication. After adjustment for this possible bias, results for industry trials were lower and similar to non-industry results. Similarly, the overall estimate of the net effect for these products reduces to about 5% attributable 1-year successes. This remains of considerable public health benefit. Registration of clinical trials has become mandatory in many countries since most of the trials considered here were conducted, and this should reduce the potential for publication bias in future.

A qualitative analysis of an internet discussion forum for recent ex-smokers.

We conducted a qualitative analysis of all messages posted in April 2005 on an online discussion forum aimed at recent ex-smokers, on the smoking cessation Web site Stop-tabac.ch. We analyzed only the forum aimed at recent ex-smokers because it was far more active than forums aimed at current smokers. Participants were 97 people who posted a total of 1,033 messages (mean= 10.6 messages per participant). Most (76%) participants were women, the median age was 40 years, and participants had quit smoking for a median of 2 months. Each initial message generated on average 2.7 replies. The most frequent categories of messages covered providing emotional support and encouragements (24% of all messages), stories and opinions (14%), congratulations to other quitters (14%), commonplace remarks (13%), "thank you" messages (11%), giving practical advice and tips (8%), and nicotine replacement therapy (6%). Women were more likely than men to post messages on nicotine replacement therapy, congratulations and emotional support. Men were more likely to post general commentaries and practical advice. No individual participant or group of participants had a clear leadership role. The 10 most active participants posted half (49.8%) of all messages. Of these 10 participants, six were still among the 10 most active in May and 3 in June 2005. Thus, this online discussion forum was used mainly by women as a source of emotional support and encouragement during the first few weeks after a quit attempt. The forum was used less frequently as a source of practical information and quitting tips.