Designing and implementing two facilitation interventions within the ‘Facilitating Implementation of Research Evidence (FIRE)’ study: a qualitative analysis from an external facilitators’ perspective

Background

The ‘Facilitating Implementation of Research Evidence’ study found no significant differences between sites that received two types of facilitation support and those that did not on the primary outcome of documented compliance with guideline recommendations. Process evaluation highlighted factors that influenced local, internal facilitators’ ability to enact the roles as envisaged. In this paper, the external facilitators responsible for designing and delivering the two types of facilitation intervention analyse why the interventions proved difficult to implement as expected, including the challenge of balancing fidelity and adaptation.

Methods

Qualitative data sources included notes from monthly internal-external facilitator teleconference meetings, from closing events for the two facilitation interventions and summary data analyses from repeated interviews with 16 internal facilitators. Deductive and inductive data analysis was led by an independent researcher to evaluate how facilitation in practice compared to the logic pathways designed to guide fidelity in the delivery of the interventions.

Results

The planned facilitation interventions did not work as predicted. Difficulties were encountered in each of the five elements of the logic pathway: recruitment and selection of appropriate internal facilitators, preparation for the role, ability to apply facilitation knowledge and skills at a local level, support and mentorship from external facilitators via monthly teleconferences, working collaboratively and enabling colleagues to implement guideline recommendations. Moreover, problems were cumulative and created tensions for the external facilitators in terms of balancing the logic pathway with a more real-world, flexible and iterative approach to facilitation.

Conclusion

Evaluating an intervention that is fluid and dynamic within the methodology of a randomised controlled trial is complex and challenging. At a practical level, relational aspects of facilitation are critically important. It is essential to recruit and retain individuals with the appropriate set of skills and characteristics, explicit support from managerial leaders and accessible mentorship from more experienced facilitators. At a methodological level, there is a need for attention to the balance between fidelity and adaptation of interventions. For future studies, we suggest a theoretical approach to fidelity, with a focus on mechanisms, informed by prospective use of process evaluation data and more detailed investigation of the context-facilitation dynamic.

     

Exercise-based cardiac rehabilitation in patients with coronary heart disease: a practice guideline

Background

To improve the quality of exercise-based cardiac rehabilitation (CR) in patients with coronary heart disease (CHD) the CR guideline from the Dutch Royal Society for Physiotherapists (KNGF) has been updated. This guideline can be considered an addition to the 2011 Dutch Multidisciplinary CR guideline, as it includes several novel topics.

Methods

A systematic literature search was performed to formulate conclusions on the efficacy of exercise-based interventions during all CR phases in patients with CHD. Evidence was graded (1–4) according the Dutch evidence-based guideline development (EBRO) criteria. In case of insufficient scientific evidence, recommendations were based on expert opinion. This guideline comprised a structured approach including assessment, treatment and evaluation.

Results

Recommendations for exercise-based CR were formulated covering the following topics: preoperative physiotherapy, mobilisation during the clinical phase, aerobic exercise, strength training, and relaxation therapy during the outpatient rehabilitation phase, and adoption and monitoring of a physically active lifestyle after outpatient rehabilitation.

Conclusions

There is strong evidence for the effectiveness of exercise-based CR during all phases of CR. The implementation of this guideline in clinical practice needs further evaluation as well as the maintenance of an active lifestyle after supervised rehabilitation.     

Facilitating Implementation of Research Evidence (FIRE): an international cluster randomised controlled trial to evaluate two models of facilitation informed by the Promoting Action on Research Implementation in Health Services (PARIHS) framework

Background

Health care practice needs to be underpinned by high quality research evidence, so that the best possible care can be delivered. However, evidence from research is not always utilised in practice. This study used the Promoting Action on Research Implementation in Health Services (PARIHS) framework as its theoretical underpinning to test whether two different approaches to facilitating implementation could affect the use of research evidence in practice.

Methods

A pragmatic clustered randomised controlled trial with embedded process and economic evaluation was used. The study took place in four European countries across 24 long-term nursing care sites, for people aged 60 years or more with documented urinary incontinence. In each country, sites were randomly allocated to standard dissemination, or one of two different types of facilitation. The primary outcome was the documented percentage compliance with the continence recommendations, assessed at baseline, then at 6, 12, 18, and 24 months after the intervention.Data were analysed using STATA15, multi-level mixed-effects linear regression models were fitted to scores for compliance with the continence recommendations, adjusting for clustering.

Results

Quantitative data were obtained from reviews of 2313 records. There were no significant differences in the primary outcome (documented compliance with continence recommendations) between study arms and all study arms improved over time.

Conclusions

This was the first cross European randomised controlled trial with embedded process evaluation that sought to test different methods of facilitation. There were no statistically significant differences in compliance with continence recommendations between the groups. It was not possible to identify whether different types and “doses” of facilitation were influential within very diverse contextual conditions. The process evaluation (Rycroft-Malone et al., Implementation Science. doi: 10.1186/s13012-018-0811-0) revealed the models of facilitation used were limited in their ability to overcome the influence of contextual factors.

Trial registration

Current Controlled Trials ISRCTN11598502. Date 4/2/10.The research leading to these results has received funding from the European Union’s Seventh Framework Programme (FP7/2007–2013) under grant agreement no. 223646.

     

Integrating guideline development and implementation: Analysis of guideline development manual instructions for generating implementation advice

ABSTRACT: BACKGROUND: Guidelines are important tools that inform health care delivery based on best available research evidence. Guideline use is in part based on quality of the guidelines, which varies. Others hypothesized this is due to limited instructions in guideline development manuals. The purpose of this study was to examine manual instructions for implementation advice. METHODS: We used a directed and summative content analysis approach based on an established framework of guideline implementability. Six manuals identified by another research group were examined to enumerate implementability domains and elements. RESULTS: Manuals were similar in content but lacked sufficient detail in particular domains. Most frequently this was Accomodation, which includes information that would help guideline users anticipate and/or overcome organizational and system level barriers. In more than one manual information was also lacking for Communicability, information that would educate patients or facilitate their involvement in shared decision making, and Applicability, or clinical parameters to help clinicians tailor recommendations for individual patients. DISCUSSION: Most manuals that direct guideline development lack complete information about incorporating implementation advice. These findings can be used by those who developed the manuals to consider expanding their content in these domains. It can also be used by guideline developers as they plan the content and implementation of their guidelines so that the two are integrated. New approaches for guideline development and implementation may need to be developed. Use of guidelines might be improved if they included implementation advice, but this must be evaluated through ongoing research.     

One hundred years ago : Fashion and medicine

Objective: To determine which attributes of clinical practice guidelines influence the use of guidelines in decision making in clinical practice. Design: Observational study relating the use of 47 different recommendations from 10 national clinical guidelines to 12 different attributes of clinical guidelines—for example, evidence based, controversial, concrete. Setting: General practice in the Netherlands. Subjects: 61 general practitioners who made 12 880 decisions in their contacts with patients. Main outcome measures: Compliance of decisions with clinical guidelines according to the attribute of the guideline. Results: Recommendations were followed in, on average, 61% (7915/12 880) of the decisions. Controversial recommendations were followed in 35% (886/2497) of decisions and non-controversial recommendations in 68% (7029/10 383) of decisions. Vague and non-specific recommendations were followed in 36% (826/2280) of decisions and clear recommendations in 67% (7089/10 600) of decisions. Recommendations that demanded a change in existing practice routines were followed in 44% (1278/2912) of decisions and those that did not in 67% (6637/9968) of decisions. Evidence based recommendations were used more than recommendations for practice that were not based on research evidence (71% (2745/3841) v 57% (5170/9039)). Conclusions: People and organisations setting evidence based clinical practice guidelines should take into account some of the other important attributes of effective recommendations for clinical practice.

Key messages

• Specific attributes of clinical practice guidelines determine whether they are used in practice
• Evidence based recommendations are better followed in practice than recommendations not based on scientific evidence
• Precise definitions of recommended performance improve the use of guidelines
• Testing the feasibility and acceptance of clinical guidelines among the target group is important for effective implementation
• People setting evidence based guidelines need to understand the attributes of effective guidelines

     

Grading quality of evidence and strength of recommendations

Users of clinical practice guidelines and other recommendations need to know how much confidence they can place in the recommendations. Systematic and explicit methods of making judgments can reduce errors and improve communication. We have developed a system for grading the quality of evidence and the strength of recommendations that can be applied across a wide range of interventions and contexts. In this article we present a summary of our approach from the perspective of a guideline user. Judgments about the strength of a recommendation require consideration of the balance between benefits and harms, the quality of the evidence, translation of the evidence into specific circumstances, and the certainty of the baseline risk. It is also important to consider costs (resource utilisation) before making a recommendation. Inconsistencies among systems for grading the quality of evidence and the strength of recommendations reduce their potential to facilitate critical appraisal and improve communication of these judgments. Our system for guiding these complex judgments balances the need for simplicity with the need for full and transparent consideration of all important issues.     

Effectiveness of knowledge brokering and recommendation dissemination for influencing healthcare resource allocation decisions: A cluster randomised controlled implementation trial

BackgroundImplementing evidence into clinical practice is a key focus of healthcare improvements to reduce unwarranted variation. Dissemination of evidence-based recommendations and knowledge brokering have emerged as potential strategies to achieve evidence implementation by influencing resource allocation decisions. The aim of this study was to determine the effectiveness of these two research implementation strategies to facilitate evidence-informed healthcare management decisions for the provision of inpatient weekend allied health services.Methods and findingsThis multicentre, single-blinded (data collection and analysis), three-group parallel cluster randomised controlled trial with concealed allocation was conducted in Australian and New Zealand hospitals between February 2018 and January 2020. Clustering and randomisation took place at the organisation level where weekend allied health staffing decisions were made (e.g., network of hospitals or single hospital). Hospital wards were nested within these decision-making structures. Three conditions were compared over a 12-month period: (1) usual practice waitlist control; (2) dissemination of written evidence-based practice recommendations; and (3) access to a webinar-based knowledge broker in addition to the recommendations. The primary outcome was the alignment of weekend allied health provision with practice recommendations at the cluster and ward levels, addressing the adoption, penetration, and fidelity to the recommendations. The secondary outcome was mean hospital length of stay at the ward level. Outcomes were collected at baseline and 12 months later. A total of 45 clusters (n = 833 wards) were randomised to either control (n = 15), recommendation (n = 16), or knowledge broker (n = 14) conditions. Four (9%) did not provide follow-up data, and no adverse events were recorded. No significant effect was found with either implementation strategy for the primary outcome at the cluster level (recommendation versus control β 18.11 [95% CI −8,721.81 to 8,758.02] p = 0.997; knowledge broker versus control β 1.24 [95% CI −6,992.60 to 6,995.07] p = 1.000; recommendation versus knowledge broker β −9.12 [95% CI −3,878.39 to 3,860.16] p = 0.996) or ward level (recommendation versus control β 0.01 [95% CI 0.74 to 0.75] p = 0.983; knowledge broker versus control β −0.12 [95% CI −0.54 to 0.30] p = 0.581; recommendation versus knowledge broker β −0.19 [−1.04 to 0.65] p = 0.651). There was no significant effect between strategies for the secondary outcome at ward level (recommendation versus control β 2.19 [95% CI −1.36 to 5.74] p = 0.219; knowledge broker versus control β −0.55 [95% CI −1.16 to 0.06] p = 0.075; recommendation versus knowledge broker β −3.75 [95% CI −8.33 to 0.82] p = 0.102). None of the control or knowledge broker clusters transitioned to partial or full alignment with the recommendations. Three (20%) of the clusters who only received the written recommendations transitioned from nonalignment to partial alignment. Limitations include underpowering at the cluster level sample due to the grouping of multiple geographically distinct hospitals to avoid contamination.ConclusionsOwing to a lack of power at the cluster level, this trial was unable to identify a difference between the knowledge broker strategy and dissemination of recommendations compared with usual practice for the promotion of evidence-informed resource allocation to inpatient weekend allied health services. Future research is needed to determine the interactions between different implementation strategies and healthcare contexts when translating evidence into healthcare practice.Trial registrationAustralian New Zealand Clinical Trials Registry ACTRN12618000029291.

In a cluster randomized controlled implementation trial, Dr. Mitchell N Sarkies and colleagues examine the effectiveness of knowledge brokering and recommendation dissemination in influencing healthcare resource allocation decisions in Australia and New Zealand.     

Guidelines for Guidelines: Are They Up to the Task? A Comparative Assessment of Clinical Practice Guideline Development Handbooks

Objectives

We conducted a comparative review of clinical practice guideline development handbooks. We aimed to identify the main guideline development tasks, assign weights to the importance of each task using expert opinions and identify the handbooks that provided a comprehensive coverage of the tasks.

Methods

We systematically searched and included handbooks published (in English language) by national, international or professional bodies responsible for evidenced-based guideline development. We reviewed the handbooks to identify the main guideline development tasks and scored each handbook for each task from 0 (the handbook did not mention the task) to 2 (the task suitably addressed and explained), and calculated a weighted score for each handbook. The tasks included in over 75% of the handbooks were considered as ‘necessary’ tasks.

Result

Nineteen guideline development handbooks and twenty seven main tasks were identified. The guideline handbooks’ weighted scores ranged from 100 to 220. Four handbooks scored over 80% of the maximum possible score, developed by the National Institute for Health and Clinical Excellence, Swiss Centre for International Health, Scottish Intercollegiate Guidelines Network and World Health Organization. Necessary tasks were: selecting the guideline topic, determining the guideline scope, identifying relevant existing guidelines, involving the consumers, forming guideline development group,, developing clinical questions, systematic search for evidence, selecting relevant evidence, appraising identifies research evidence, making group decision, grading available evidence, creating recommendations, final stakeholder consultation, guideline implementation strategies, updating recommendations and correcting potential errors.

Discussion

Adequate details for evidence based development of guidelines were still lacking from many handbooks. The tasks relevant to ethical issues and piloting were missing in most handbooks. The findings help decision makers in identifying the necessary tasks for guideline development, provide an updated comparative list of guideline development handbooks, and provide a checklist to assess the comprehensiveness of guideline development processes.     

Evidence based general practice: a retrospective study of interventions in one training practice.

OBJECTIVES--To estimate the proportion of interventions in general practice that are based on evidence from clinical trials and to assess the appropriateness of such an evaluation. DESIGN--Retrospective review of case notes. SETTING--One suburban training general practice. SUBJECTS--122 consecutive doctor-patient consultations over two days. MAIN OUTCOME MEASURES--Proportions of interventions based on randomised controlled trials (from literature search with Medline, pharmaceutical databases, and standard textbooks), on convincing non-experimental evidence, and without substantial evidence. RESULTS--21 of the 122 consultations recorded were excluded due to insufficient data; 31 of the interventions were based on randomised controlled trial evidence and 51 based on convincing non-experimental evidence. Hence 82/101 (81%) of interventions were based on evidence meeting our criteria. CONCLUSIONS--Most interventions within general practice are based on evidence from clinical trials, but the methods used in such trials may not be the most appropriate to apply to this setting.     

Laboratory Medicine Best Practice Guideline: Vitamins A,E and the Carotenoids in Blood

Despite apparent method similarities between laboratories there appear to be confounding factors inhibiting uniform reporting and standardisation of vitamin assays. The Australasian Association of Clinical Biochemists (AACB) Vitamins Working Party, in conjunction with The Royal College of Pathologists of Australasia Quality Assurance Programs, has formulated a guideline to improve performance, reproducibility and accuracy of fat-soluble vitamin results. The aim of the guideline is to identify critical pre-analytical, analytical and post-analytical components of the analysis of vitamins A, E and carotenoids in blood to promote best practice and harmonisation. This best practice guideline has been developed with reference to the Centers for Disease Control and Prevention (CDC) “Laboratory Medicine Best Practices: Developing an Evidence-Based Review and Evaluation Process”. The CDC document cites an evaluation framework for generating best practice recommendations that are specific to laboratory medicine. These 50 recommendations proposed herein, were generated from a comprehensive literature search and the extensive combined experience of the AACB Vitamins Working Party members. They were formulated based on comparison between an impact assessment rating and strength of evidence and were classified as either: (1) strongly recommend, (2) recommend, (3) no recommendation for or against, or (4) recommend against. These best practice recommendations represent the consensus views, in association with peer reviewed evidence of the AACB Vitamins Working Party, towards best practice for the collection, analysis and interpretation of vitamins A, E and carotenoids in blood.     

Economic Evaluation of Active Implementation versus Guideline Dissemination for Evidence-Based Care of Acute Low-Back Pain in a General Practice Setting

Introduction

The development and publication of clinical practice guidelines for acute low-back pain has resulted in evidence-based recommendations that have the potential to improve the quality and safety of care for acute low-back pain. Development and dissemination of guidelines may not, however, be sufficient to produce improvements in clinical practice; further investment in active implementation of guideline recommendations may be required. Further research is required to quantify the trade-off between the additional upfront cost of active implementation of guideline recommendations for low-back pain and any resulting improvements in clinical practice.

Methods

Cost-effectiveness analysis alongside the IMPLEMENT trial from a health sector perspective to compare active implementation of guideline recommendations via the IMPLEMENT intervention (plus standard dissemination) against standard dissemination alone.

Results

The base-case analysis suggests that delivery of the IMPLEMENT intervention dominates standard dissemination (less costly and more effective), yielding savings of $135 per x-ray referral avoided (-$462.93/3.43). However, confidence intervals around point estimates for the primary outcome suggest that – irrespective of willingness to pay (WTP) – we cannot be at least 95% confident that the IMPLEMENT intervention differs in value from standard dissemination.

Conclusions

Our findings demonstrate that moving beyond development and dissemination to active implementation entails a significant additional upfront investment that may not be offset by health gains and/or reductions in health service utilization of sufficient magnitude to render active implementation cost-effective.     

Improving the care of people with traumatic brain injury through the Neurotrauma Evidence Translation (NET) program: protocol for a program of research

ABSTRACT: The Neurotrauma Evidence Translation (NET) program was funded in 2009 to increase the uptake of research evidence in the clinical care of patients who have sustained traumatic brain injury. This paper reports the rationale and plan for this five-year knowledge translation research program. The overarching aims of the program are threefold: to improve outcomes for people with traumatic brain injury; to create a network of neurotrauma clinicians and researchers with expertise in knowledge translation and evidence-based practice; and to contribute knowledge to the field of knowledge translation research. The program comprises a series of interlinked projects spanning varying clinical environments and disciplines relevant to neurotrauma, anchored within four themes representing core knowledge translation activities: reviewing research evidence; understanding practice; developing and testing interventions for practice change; and building capacity for knowledge translation in neurotrauma. The program uses a range of different methods and study designs, including: an evidence fellowship program; conduct of and training in systematic reviews; mixed method study designs to describe and understand factors that influence current practices (e.g., semistructured interviews and surveys); theory-based methods to develop targeted interventions aiming to change practice; a cluster randomised trial to test the effectiveness of a targeted theory-informed intervention; stakeholder involvement activities; and knowledge translation events such as consensus conferences.     

Delirium,Sedation and Analgesia in the Intensive Care Unit: A Multinational,Two-Part Survey among Intensivists

Analgesia, sedation and delirium management are important parts of intensive care treatment as they are relevant for patients'' clinical and functional long-term outcome. Previous surveys showed that despite this fact implementation rates are still low. The primary aim of the prospective, observational multicenter study was to investigate the implementation rate of delirium monitoring among intensivists. Secondly, current practice concerning analgesia and sedation monitoring as well as treatment strategies for patients with delirium were assesed. In addition, this study compares perceived and actual practice regarding delirium, sedation and analgesia management. Data were obtained with a two-part, anonymous survey, containing general data from intensive care units in a first part and data referring to individual patients in a second part. Questionnaires from 101 hospitals (part 1) and 868 patients (part 2) were included in data analysis. Fifty-six percent of the intensive care units reported to monitor for delirium in clinical routine. Fourty-four percent reported the use of a validated delirium score. In this respect, the survey suggests an increasing use of delirium assessment tools compared to previous surveys. Nevertheless, part two of the survey revealed that in actual practice 73% of included patients were not monitored with a validated score. Furthermore, we observed a trend towards moderate or deep sedation which is contradicting to guideline-recommendations. Every fifth patient was suffering from pain. The implementation rate of adequate pain-assessment tools for mechanically ventilated and sedated patients was low (30%). In conclusion, further efforts are necessary to implement guideline recommendations into clinical practice. The study was registered (ClinicalTrials.gov identifier: {"type":"clinical-trial","attrs":{"text":"NCT01278524","term_id":"NCT01278524"}}NCT01278524) and approved by the ethical committee.     

Use of evidence-based practices in pregnancy and childbirth: South East Asia Optimising Reproductive and Child Health in Developing Countries project

Background

The burden of mortality and morbidity related to pregnancy and childbirth remains concentrated in developing countries. SEA-ORCHID (South East Asia Optimising Reproductive and Child Health In Developing countries) is evaluating whether a multifaceted intervention to strengthen capacity for research synthesis, evidence-based care and knowledge implementation improves adoption of best clinical practice recommendations leading to better health for mothers and babies. In this study we assessed current practices in perinatal health care in four South East Asian countries and determined whether they were aligned with best practice recommendations.

Methodology/Principal Findings

We completed an audit of 9550 medical records of women and their 9665 infants at nine hospitals; two in each of Indonesia, Malaysia and The Philippines, and three in Thailand between January-December 2005. We compared actual clinical practices with best practice recommendations selected from the Cochrane Library and the World Health Organization Reproductive Health Library.Evidence-based components of the active management of the third stage of labour and appropriately treating eclampsia with magnesium sulphate were universally practiced in all hospitals. Appropriate antibiotic prophylaxis for caesarean section, a beneficial form of care, was practiced in less than 5% of cases in most hospitals. Use of the unnecessary practices of enema in labour ranged from 1% to 61% and rates of episiotomy for vaginal birth ranged from 31% to 95%. Other appropriate practices were commonly performed to varying degrees between countries and also between hospitals within the same country.

Conclusions/Significance

Whilst some perinatal health care practices audited were consistent with best available evidence, several were not. We conclude that recording of clinical practices should be an essential step to improve quality of care. Based on these findings, the SEA-ORCHID project team has been developing and implementing interventions aimed at increasing compliance with evidence-based clinical practice recommendations to improve perinatal practice in South East Asia.     

Effect evaluation of a supervised versus non‐supervised implementation of an oral health care guideline in nursing homes: a cluster randomised controlled clinical trial

doi: 10.1111/j.1741‐2358.2010.00418.x
Effect evaluation of a supervised versus non‐supervised implementation of an oral health care guideline in nursing homes: a cluster randomised controlled clinical trial Objective: To compare a supervised versus a non‐supervised implementation of an oral health care guideline in Flanders (Belgium). Background: The key factor in realising good oral health is daily oral hygiene care. In 2007, the Dutch guideline ‘Oral health care in care homes for elderly people’ was developed to improve oral health of institutionalised elderly. Materials and Methods: A random sample of 12 nursing homes was randomly allocated to the intervention or the control group. Representative samples of 30 residents in each home were monitored during a 6‐month study period. The intervention included a supervised implementation of the guideline. Results: At the 6‐month follow‐up, only a small but statistically significant (p = 0.002) beneficial effect (0.32) of the intervention was observed for denture plaque after adjustment for baseline value and the random effect of the institution. In the linear mixed regression models, including a random institution effect, difference in denture plaque level was no longer statistically significant at the 5% level. Conclusion: Only denture hygiene has been improved by the supervised implementation, although with lower benefits than presumed. Factors on institutional level, difficult to assess quantitatively, may play an important role in the final result.     

Meta-Regression Analyses to Explain Statistical Heterogeneity in a Systematic Review of Strategies for Guideline Implementation in Primary Health Care

This study is an in-depth-analysis to explain statistical heterogeneity in a systematic review of implementation strategies to improve guideline adherence of primary care physicians in the treatment of patients with cardiovascular diseases. The systematic review included randomized controlled trials from a systematic search in MEDLINE, EMBASE, CENTRAL, conference proceedings and registers of ongoing studies. Implementation strategies were shown to be effective with substantial heterogeneity of treatment effects across all investigated strategies. Primary aim of this study was to explain different effects of eligible trials and to identify methodological and clinical effect modifiers. Random effects meta-regression models were used to simultaneously assess the influence of multimodal implementation strategies and effect modifiers on physician adherence. Effect modifiers included the staff responsible for implementation, level of prevention and definition pf the primary outcome, unit of randomization, duration of follow-up and risk of bias. Six clinical and methodological factors were investigated as potential effect modifiers of the efficacy of different implementation strategies on guideline adherence in primary care practices on the basis of information from 75 eligible trials. Five effect modifiers were able to explain a substantial amount of statistical heterogeneity. Physician adherence was improved by 62% (95% confidence interval (95% CI) 29 to 104%) or 29% (95% CI 5 to 60%) in trials where other non-medical professionals or nurses were included in the implementation process. Improvement of physician adherence was more successful in primary and secondary prevention of cardiovascular diseases by around 30% (30%; 95% CI -2 to 71% and 31%; 95% CI 9 to 57%, respectively) compared to tertiary prevention. This study aimed to identify effect modifiers of implementation strategies on physician adherence. Especially the cooperation of different health professionals in primary care practices might increase efficacy and guideline implementation seems to be more difficult in tertiary prevention of cardiovascular diseases.     

The optimized acupuncture treatment for neck pain caused by cervical spondylosis: a study protocol of a multicentre randomized controlled trial

ABSTRACT: BACKGROUND: Neck pain is one of the chief complains of patients with cervical spondylosis (CS). Both in China and worldwide, acupuncture is a well-accepted and widely used complementary therapy for the management of neck pain caused by CS. In this paper, we present a protocol designed for a multi-centre, randomised, controlled trial to evaluate the effects of optimised acupuncture treatment for CS neck pain. The study aims to evaluate the effects of the optimised acupuncture treatment in real practice compared with sham and shallow acupuncture therapy. Methods/design This trial uses a multicentre, three-group, randomised, sham acupuncture and shallow acupuncture, controlled single-blind design. Nine hospitals are involved as trial centres. The sample size is calculated based on the formula for a three-group parallel design with a 0.05 significance level and a power of 0.9. A total of 105 cases in a single centre, and a total of 315 cases per each arm are required across all 9 centres. Patients who meet inclusion criteria are randomly assigned to receive optimised acupuncture treatment, sham acupuncture or shallow acupuncture by a computerised central randomisation system. The interventions last for 4 weeks with 8 to 10 treatments. The group allocations and interventions are concealed to patients and statisticians. The Northwick Park Neck Pain Questionnaire (NPQ) is used as the primary outcome measure, and the McGill Pain Questionnaire (MPQ) and The Short Form (36) Health Survey (SF-36) are applied as secondary outcome measures. The evaluation is performed at baseline, at the end of the intervention, and at the end of the first month and the third month during follow-up. The statistical analyses will include baseline data comparison and repeated measures of analysis of variance (ANOVA) for primary and secondary outcomes of group and time differences. Adverse events (AEs) will be reported if they occur. DISCUSSION: This trial is a multicentre randomised control trial (RCT) on the efficacy of acupuncture for CS neck pain and has a large sample size and central randomisation in China. It will strictly follow the CONSORT statement and STRICTA extension guideline to report high-quality study results. By setting the control groups as sham and shallow acupuncture, this study attempts to reveal the effects of real acupuncture versus placebo or non-classic acupuncture therapy and evaluate whether classic Chinese medical acupuncture is effective on CS neck pain. This study will provide evidence for the effects of acupuncture on CS neck pain. Trial Registration: Chinese Clinical Trial Registry: ChiCTR-TRC-00000184.     

Do general practitioners act consistently in real practice when they meet the same patient twice? Examination of intradoctor variation using standardised (simulated) patients.

OBJECTIVE: To assess the variation within individual general practitioners facing the same problem twice in actual practice under unbiased conditions. DESIGN: General practitioners were consulted during normal surgery hours by a standardised patient portraying a patient with angina pectoris. Six weeks later the same general practitioners were consulted again by a similar standardised patient portraying a similar case. The patients reported on the consultations. SETTING: Trondheim, Norway. SUBJECTS: Of 87 general practitioners invited by letter, 28 (32%) agreed to participate without hesitation; nine others (10%) wanted more information before consenting. From these 24 were selected and visited. MAIN OUTCOME MEASURES: Number of actions undertaken from a guideline in both rounds of consultations. Duration of consultations. RESULTS: The mean (range, interquartile range) guideline score, total score, and duration of consultation were not significantly different between the first and second patient encounters for the group as a whole. For individual doctors the mean (SD) difference was -0.09 (3.36) for the guideline score, 0.30 (8.1) for the total score, and -0.87 (9.01) for consultation time. CONCLUSIONS: The study shows that assessment of performance in real practice for a group of general practitioners is consistent from the first round of consultations to the second round. However, significant variation occurs in performance of individual physicians.     

SIMPLE: implementation of recommendations from international evidence-based guidelines on caesarean sections in the Netherlands. Protocol for a controlled before and after study

Background

Caesarean section (CS) rates are rising worldwide. In the Netherlands, the most significant rise is observed in healthy women with a singleton in vertex position between 37 and 42 weeks gestation, whereas it is doubtful whether an improved outcome for the mother or her child was obtained. It can be hypothesized that evidence-based guidelines on CS are not implemented sufficiently. Therefore, the present study has the following objectives: to develop quality indicators on the decision to perform a CS based on key recommendations from national and international guidelines; to use the quality indicators in order to gain insight into actual adherence of Dutch gynaecologists to guideline recommendations on the performance of a CS; to explore barriers and facilitators that have a direct effect on guideline application regarding CS; and to develop, execute, and evaluate a strategy in order to reduce the CS incidence for a similar neonatal outcome (based on the information gathered in the second and third objectives).

Methods

An independent expert panel of Dutch gynaecologists and midwives will develop a set of quality indicators on the decision to perform a CS. These indicators will be used to measure current care in 20 hospitals with a population of 1,000 women who delivered by CS, and a random selection of 1,000 women who delivered vaginally in the same period. Furthermore, by interviewing healthcare professionals and patients, the barriers and facilitators that may influence the decision to perform a CS will be measured. Based on the results, a tailor-made implementation strategy will be developed and tested in a controlled before-and-after study in 12 hospitals (six intervention, six control hospitals) with regard to effectiveness, experiences, and costs.

Discussion

This study will offer insight into the current CS care and into the hindering and facilitating factors influencing obstetrical policy on CS. Furthermore, it will allow definition of patient categories or situations in which a tailor-made implementation strategy will most likely be meaningful and cost effective, without negatively affecting the outcome for mother and child.

Trial registration

http://www.clinicaltrials.gov: NCT01261676