Development methods of guidelines and documents with recommendations on physical restraint reduction in nursing homes: a systematic review

The use of physical restraints (PR) in nursing homes is common practice in numerous countries [1, 2]. The main reasons for using PR are safety issues, e.g. to prevent falls or fall-related injuries; other reasons include the control of challenging behaviours and maintenance of medical therapy [3, 4]. However, there is clear evidence that PR use does not lead to a decrease of falls or fall-related injuries [5‐7]. Furthermore, the use of PR is associated with several adverse events, i.e. direct injuries like entrapment or strangulation and indirect events like decreased mobility or reduced psychosocial wellbeing [8‐11]. Therefore, restraint-free nursing care is recommended by various international nursing organisations, in numerous statements (e.g. [5, 12, 13]) and scientific publications [14‐16].

Epidemiological studies revealed pronounced differences in the prevalence of PR between nursing homes [1, 2, 17]. These differences cannot be explained by characteristics of the residents or the facilities (such as staffing level or staff training) [1, 2]. Evidence-based guidelines can be a powerful tool to reduce inappropriate variation in clinical practice and to increase the quality and efficiency of healthcare [18]. Evidence-based guidelines are systematically developed statements offering recommendations to healthcare professionals to select the best available, effective interventions. The validity, clarity and clinical applicability of the recommendations should be guaranteed by a systematic identification and appraisal of the available evidence and by the development of the recommendations by a multidisciplinary expert panel [19]. The U.S. Institute of Medicine proposes the following standards for trustworthy guideline development: 1) establishing transparency, 2) management of conflict of interest, 3) guideline development group composition, 4) clinical practice guideline – systematic review intersection, 5) establishing evidence foundations for and rating strength of recommendations, 6) articulation of recommendations, 7) external review and 8) updating [20]. When clinical practice guidelines are not available, other guiding documents are needed in order to inform clinical practice. However, the recommendations of such documents are often not based on the evidence but on opinions of experts or the position of an organisation.

In 2009, a German evidence-based guideline [21] was developed, during which a systematic search for guidelines and other documents with recommendations was performed. To this date, no evidence-based guidelines aiming to prevent or reduce physical restraints had been identified [22]. The German evidence-based guideline has recently been updated. The systematic review of guidelines and other documents with recommendations aimed at reducing the use of physical restraints in nursing homes has also been updated.

The aim of this systematic document analysis is to describe the development methods used in guidelines and other documents with recommendations aimed at informing clinical practice how to reduce the use of physical restraints in geriatric care.

The search identified a total of 254 documents (see Fig. 1), of which 203 were excluded in the first step. From the 51 documents screened in full text, 28 documents were included in the analysis. The main reasons for exclusion in the second screening were the lack of recommendations and the setting or target group.

This systematic review identified 28 documents with practical recommendations aimed to reduce the use of PR in nursing homes. In most of the documents the development methods were not sufficiently described. For the most part, the recommendations were not based on a systematic literature search or on a critical appraisal of the evidence. Two documents were evidence-based guidelines [12, 20]. In both of these documents the development methods were clearly described and the recommendations were based on both a systematic search and a critical appraisal of the literature.

The reduction of PR was identified as an important issue in the improvement of the quality of nursing [12, 13, 25, 26]. However, the lack of scientific rigour in the development of the recommendations does not reflect the importance of this topic for clinical practice. There is evidence that the implementation of evidence-based guidelines can improve the quality of care [27]. This was confirmed by our own study, which revealed that the implementation of the German evidence-based guideline in nursing homes was effective in reducing PR without increasing adverse effects like falls or fall-related injuries [5]. Currently, the effectiveness and safety of a large-scale implementation of the updated German evidence-based guideline is being investigated in a pragmatic trial [28]. This indicated that the PR use can be reduced by offering recommendations for nursing staff, based on the best available evidence.

Studies investigating the effectiveness of other documents with recommendations for clinical practice are lacking. Evidence-based guidelines using one of the established frameworks for guideline development are expected to ensure valid, transparent, clear and clinically applicable recommendations [20]. Therefore, documents with recommendations on the reduction of PR use in geriatric care should adhere to a methodological framework and rigorous development methods.

This study shows that governmental and professional authorities or initiatives were predominant in initiating the development of the included documents. It remains unclear why these authorities did not initiate the development of evidence-based guidelines. However, the development of a high-quality guideline is a time and cost consuming process. Smaller or local organisations might lack of financial or personal resources. Here, larger networks or cooperation with national agencies like the Institute of Medicine (IOM) or the National Institute for Health and Care Excellence (NICE) might be useful to support the development of guidelines for PR reduction.

We used the criteria of AGREE II [24] to describe the development methods of the included documents. However, most of the included documents were not developed by the use of the methods for evidence-based guidelines. Since the methods recommended for the development of evidence-based guidelines should ensure the validity and clinical relevance of recommendations, the use of these criteria can be judged as a gold standard for developing practice recommendations. Therefore, the criteria used in our analysis reflect the methodological standard and can also be used for other documents offering recommendations for clinical practice.

The reduction of physical restraints has become an important issue for clinical practice in Germany in the last ten years, induced by broad media coverage on this topic. This might be one reason for the large number of documents developed in Germany. Most of the German documents are policy statements made by governmental initiatives or non-profit organisations and often lack a structures dissemination strategy. This fact and the lack of a rigorously developed method might have hampered the national dissemination of most of the German documents. To overcome this gap, several attempts have been made to disseminate the first German evidence-based guideline [21]. The guideline and all corresponding material are freely available; the document has been presented at several scientific conferences; publications addressing nursing and other healthcare professionals as well as informal carers or relatives have been published; and the authors of the guideline have been in contact with other important stakeholders in the field of physical restraints’ reduction in Germany. The same strategy is currently used to support the dissemination and the implementation of the recently updated version of this guideline [26] into clinical practice.

We used a broad search strategy, including databases, relevant organisations and the World Wide Web to identify the documents and included only English and German documents. It is possible that we did not identify all the documents available. However, we identified documents developed in several countries and no further evidence-based guideline was recently listed in the GIN-database. Therefore, chance of missing relevant documents is low.

This study revealed that the majority of publically available documents with recommendations to reduce the use of PR in geriatric care were not developed by the use of recommended scientific rigorous methods. Since the reduction of PR in geriatric care was identified in many countries as an important indicator for a high quality of care for people with dementia, documents with recommendations for clinical practice should adhere to the methodological standards of evidence-based guidelines.