BAC and JSS are joint first authors.
MCF and MW are joint senior authors.
STRENGTHS AND LIMITATIONS OF THIS STUDY
This protocol adheres to the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols guidelines.
Our strategy searches 12 large databases, trial registries, and reference lists of key systematic reviews, and also consults experts to ensure our approach is exhaustive.
Evidence generated by the resulting systematic reviews may be limited by the number and quality of studies identified for inclusion.
We will only include studies published in English, which may limit studies included and bias results.
Introduction
Rationale
Hand hygiene, including washing hands with soap as well as other methods of cleaning hands like use of alcohol-based hand rubs (ABHRs), is a critical public health measure and is particularly important for the control and prevention of infectious diseases.1–3 With relatively low implementation cost,4 hand hygiene interventions yield substantial and cost-effective benefits in disease prevention and healthcare savings.5 Additionally, frequent and correct hand hygiene is an important measure to prevent infection with SARS-CoV-2.6 Despite the importance of hand hygiene, and unprecedented levels of attention and investment during the COVID-19 outbreak, there continues to be insufficient access to basic services and inadequate policies, financing and monitoring for hand hygiene in many low-income and middle-income countries.7–9 Access to hand hygiene facilities and the ability to wash hands may be particularly constrained when people are outside the home and in other public settings. Further, around the world, handwashing is not consistently practiced at critical moments, including after contact with human or animal excreta10 or generally prior to eating and preparing food,11 even among those with access to handwashing facilities.12
Various guidelines for hand hygiene in healthcare settings have been developed by the WHO, including guidelines and an implementation strategy for settings where healthcare is permanently or occasionally performed,13 14 guidelines on core components of infection prevention and control programmes at the national and facility level,15 and practical steps to achieve universal water, sanitation and hygiene (WASH) access in healthcare facilities.16 However, healthcare settings have characteristics that uniquely affect hand hygiene-related health risk factors and the management approaches for addressing them.
Despite evidence of the efficacy of hand hygiene, there are critical gaps in global normative guidance around hand hygiene in settings where healthcare is not routinely delivered (henceforth referred to as ‘community settings’). These community settings have been defined by the Ottawa Charter as settings where ‘health is created and lived by people within the setting of their everyday life; where they learn, work, play, and love’, (WHO 1986) and have been noted to include domestic, public and institutional spaces.17 Several guidelines provide a rationale for hand hygiene investment as a core public health measure,6 18–20 however, few discuss what measures could improve hand hygiene in community settings, nor how to implement these. A recent scoping review of current international guidelines for hand hygiene in community settings highlighted a lack of consistent evidence-based recommendations (ie, less than 10% of recommendations were supported by evidence) and identified four areas where clear recommendations are needed: (1) effective hand hygiene; (2) minimum requirements; (3) behaviour change and (4) government measures.17 The authors propose a conceptual framework where (1) effective hand hygiene refers to definitions and practices (eg, when, for how long and efficacy of products); (2) minimum requirements refer to the infrastructure, products and services required for effective hand hygiene; (3) behaviour change refers to the appropriate interventions that promote and sustain effective hand hygiene practices and (4) government measures concern actions taken by governments to ensure effective hand hygiene, which are categorised according to an established framework21 as follows: policy and strategy; institutional arrangements; sector financing; planning, monitoring and review; and capacity development.
As part of its mandate to address the demand for guidance on clinical or public health areas where there is uncertainty, and in response to demand from governments and non-governmental actors, the WHO is developing Guidelines on hand hygiene in community settings. The Guidelines will provide evidence-based recommendations to governments on how to improve hand hygiene in community settings. Recommendations will focus on areas within existing global guidance where there is persistent uncertainty or controversy in what constitutes effective hand hygiene and what government measures can be implemented to rapidly improve it.17
Previous systematic reviews have synthesised evidence of health outcomes linked with hand hygiene in community settings, including infectious disease outcomes,10 22–24 infectious disease outcomes in the workplace,25 diarrhoeal disease outcomes,26–28 respiratory infection outcomes29–31 and cases of influenza.32 33 More recent reviews have synthesised the effectiveness of handwashing with soap on diarrhoeal disease in children1 and prevention of respiratory infections,2 and the burden of disease attributed to unsafe WASH in domestic settings.3 Reviews that have synthesised evidence on the efficacy of products for removing or inactivating pathogens have focused on soap products used as recommended by the WHO,34–36 as well as ABHR.37 There has been relatively less work done to review effective alternatives for hand hygiene when soap or ABHR are not available or are used ‘imperfectly’,37–40 or for understanding which drying methods prevent recontamination.41 An updated review on the efficacy of various hand hygiene-related resources and practices is needed to incorporate evidence generated during the COVID-19 pandemic and better address realistic use of a range of hand hygiene resources and products for effective and sustained practice.
Reviews have identified behavioural barriers and facilitators to hand hygiene in community settings,42 43 although, the studies included focused only on handwashing with soap and water, which may not reflect the behavioural determinants of hand hygiene practices with other available resources (eg, ARHB or ash). Further, the synthesis of behaviour change theories and techniques used to design hand hygiene interventions is limited to settings with children44 45 and evidence synthesised on hand washing station designs or adaptations are limited to tippy taps and nudges, respectively.46 47 Importantly, no reviews currently synthesise evidence for minimum requirements for the sustained practice of effective hand hygiene, and synthesised evidence on government measures implemented at scale to provide the minimum requirements for hand hygiene is limited to COVID-19 response measures.48
Objectives
The goal of this review is to systematically retrieve and synthesise available evidence on hand hygiene in community settings across four key areas (effective hand hygiene, minimum requirements, behaviour change and government measures). The questions addressed by this review are the result of an extensive consultation carried out during 2022. In brief, experts and leading organisations were consulted to assess questions drafted on the basis of the areas of uncertainty, controversy or gaps in global guidance as identified in an initial scoping review of current guidelines.17 Priority questions were then generated to align with the four key areas, and the WHO and external experts further identified subquestions necessary to address. The overall goal of this integrated review is to address the priority questions and subquestions (tables 1–4).
Table 1Detailed eligibility criteria in PICO(S) format for research question 1 (RQ1) on effective hand hygiene
| Research question | Participants | Interventions | Comparison | Outcome | Study design | |
| RQ1. Which hand hygiene methods are effective at removing or deactivating pathogens associated with disease transmission by hands in community settings? | (1a) How effective are soap products at removing or deactivating key pathogens* (or organisms intended as their surrogates) and how does duration impact effectiveness? | General population in community settings or laboratory-based studies on interventions used in community settings | Handwashing with soap and water methods for varying durations | Handwashing with water alone for varying duration | Microbial load reduction in key pathogens and their surrogates on human hands or fingers from before to after washing | Laboratory and field efficacy studies in which hands are either experimentally inoculated or naturally contaminated |
| (1b) Where soap and/or water are not available, what are appropriate alternatives for hand hygiene? | General population in community settings or laboratory-based studies on interventions used in community settings | Other handwashing materials including antiseptics, friction-generating materials and water alone for varying durations | Handwashing with soap and water | Microbial load reduction in key pathogens and their surrogates on human hands or fingers from before to after washing | Laboratory and field efficacy studies in which hands are either experimentally inoculated or naturally contaminated | |
| (1c) Which hand-drying methods are effective at reducing risk of recontamination of washed hands? | General population in community settings or laboratory-based studies on interventions used in community settings | Any hand drying method after handwashing with water or soap and water | Air drying without assistance | Microbial load increase in key pathogens and their surrogates on human hands or fingers after washing but before drying and after drying | Laboratory and field efficacy studies in which hands are either experimentally inoculated or naturally contaminated | |
| (1d) What microbial water quality is required for effective handwashing with soap? | General population in community settings or laboratory-based studies on interventions used in community settings | Hand washing with soap and water contaminated with microorganisms (naturally or experimentally) | Hand washing with soap and clean water | Microbial load increase in key pathogens and their surrogates on human hands or fingers from before to after washing | Laboratory and field efficacy studies in which water for washing is either experimentally inoculated or naturally contaminated and microbial risks models | |
*Key pathogens are those causing infectious disease, diarrhoeal disease, respiratory infections.
Table 2Detailed eligibility criteria in SPIDER format for research question 2 (RQ2) on minimum requirements
| Research question | Sample | Phenomenon of interest | Design | Evaluation | Research type | |
| RQ2. What are the minimum requirements (material needs) for the sustained practice of effective hand hygiene in community settings? | (2a) What quantity of water is required to enable handwashing with soap and water at key moments? | General population in community settings | Quantity of water required for handwashing with soap at key moments both as recommended and as commonly practiced | Observational study | Hand hygiene practice (ie, any action of hand cleansing for the purpose of removing or deactivating pathogens from hands) | Quantitative, mixed methods |
| (2b) What quantity of soap is required to enable handwashing with soap and water at key moments? | General population in community settings | Quantity of soap required for handwashing with soap at key moments both as recommended and as commonly practiced | Observational study | Hand hygiene practice (ie, any action of hand cleansing for the purpose of removing or deactivating pathogens from hands) | Quantitative, mixed methods | |
| (2c) Where should soap and water or alternatives be located in community settings to enable hand hygiene at key moments? | General population in community settings | Location of soap and water required for handwashing with soap at key moments | Observational study | Hand hygiene practice (ie, any action of hand cleansing for the purpose of removing or deactivating pathogens from hands) | Qualitative, quantitative, mixed methods | |
| (2d) What is the optimal spacing and number of users per hand hygiene facility* in household settings and public places to enable hand hygiene with soap and water at key moments? | General population in community settings | Spacing and number of users per hand hygiene facility required for handwashing with soap at key moments | Observational study | Hand hygiene practice (ie, any action of hand cleansing for the purpose of removing or deactivating pathogens from hands) | Qualitative, quantitative, mixed methods | |
| (2e) What are the main considerations for ensuring equitable† access to minimum material requirements and preventing discrimination in community settings? | General population in community settings | Considerations (including location and design) leading to harm or inequitable access to handwashing with soap at key moments or discrimination | Observational study | Hand hygiene practice (ie, any action of hand cleansing for the purpose of removing or deactivating pathogens from hands) | Qualitative, quantitative, mixed methods | |
*Key factors to consider include total number of users over a given time period, operation and maintenance requirements, security, distancing requirements (eg, COVID-19 response).
†Applying the key elements of United Nations human right to water and sanitation: availability, accessibility, affordability, quality and safety, and acceptability.66
Table 3Detailed eligibility criteria in SPIDER and PICO(S) format for research question 3 (RQ3) on behaviour change
| Research question | Sample / Participants | Phenomenon of interest / Interventions | Design / Comparison | Evaluation / Outcome | Research type / Study design | |
| RQ3.1.* What are key behavioural barriers and enablers to practicing effective hand hygiene in community settings? | General population in community settings | Behavioral barriers and enablers for practicing hand hygiene | Phenomenology, barrier analysis, grounded theory, thematic analyses, cross-sectional/observational | Effective hand hygiene (ie, any practice which removes or deactivates pathogens from hands and thereby limits diseases transmission) | Qualitative, quantitative, mixed methods | |
| RQ3.2. Among interventions to improve hand hygiene in community settings, what theories, barriers and enablers, intervention functions and behaviour change techniques, and design features have been leveraged effectively to improve and sustain hand hygiene in community settings? | (3.2a)* Among interventions to improve hand hygiene in community settings, which have been designed using behaviour change theories? | General population in community settings | Behaviour change theories among interventions to improve hand hygiene in community settings | Experimental or quasi-experimental designs, randomised and non-randomised controlled trials, before-after studies | Effective hand hygiene (ie, any practice which removes or deactivates pathogens from hands and thereby limits diseases transmission) | Mixed methods (includes protocols or formative research referenced in the evaluation studies themselves) |
| (3.2b)* Among interventions to improve hand hygiene in community settings, which have effectively leveraged identified barriers and enablers of hand hygiene in community settings? | General population in community settings | Effective leveraging of identified barriers and enablers of hand hygiene among interventions to improve hand hygiene in community settings | Experimental or quasi-experimental designs, randomised and non-randomised controlled trials, before-after studies | Effective hand hygiene (ie, any practice which removes or deactivates pathogens from hands and thereby limits diseases transmission) | Mixed methods (includes protocols or formative research referenced in the evaluation studies themselves) | |
| (3.2c)* Among interventions to improve hand hygiene in community settings, what behaviour change techniques have been implemented to effectively improve and sustain handwashing practices? | General population in community settings | Behaviour change techniques to promote handwashing among interventions to improve hand hygiene in community settings | Experimental or quasi-experimental designs, randomised and non-randomised controlled trials, before-after studies | Effective and sustained hand hygiene (ie, consistent hand hygiene practices) | Mixed methods (focus on quantitative evaluation and will include any papers linked to the evaluation that may be relevant, eg, protocols, follow-up studies (qual or quant) to assess sustainability) | |
| (3.2d)* Among interventions to improve hand hygiene in community settings, what hand hygiene station designs have been effective at improving and sustaining hand hygiene? | General population in community settings | Hand hygiene station design among interventions to improve hand hygiene in community settings | Experimental or quasi-experimental designs, randomised and non-randomised controlled trials, before-after studies | Effective and sustained hand hygiene | Mixed methods (focus on quantitative evaluation and will include any papers linked to the evaluation that may be relevant, eg, protocols, follow-up studies (qual or quant) to assess sustainability) | |
| (3.2e)† Among interventions to improve hand hygiene in community settings, what hand hygiene station design adaptations (eg, placement, nudges, and cues) have been effective at improving and sustaining hand hygiene? | General population in community settings | Design adaptations (eg, placement, nudges and cues) of hand hygiene stations | No hand hygiene station design adaptation or a different type of adaptation among interventions to improve hand hygiene in community settings | Effective and sustained hand hygiene (ie, consistent hand hygiene practices) | Randomised and non-randomised controlled trials, before-after studies (will include any papers linked to the evaluation that may be relevant, eg, protocols, follow-up studies (qual or quant) to assess sustainability) | |
| (3.2f)† Among interventions to improve hand hygiene in community settings, what level of frequency and intensity of behaviour change interventions is necessary to effectively improve hand hygiene? | General population in community settings | Varying frequencies and intensities of behaviour change interventions to promote effective hand hygiene | Standard frequency and intensity of behaviour change interventions among interventions to improve hand hygiene in community settings | Effective and sustained hand hygiene (ie, consistent hand hygiene practices) | Randomised and non-randomised controlled trials, before-after studies | |
| (3.2g)* Among interventions to improve hand hygiene in community settings, how do hand hygiene practices vary by population groups, risk scenarios or over time? | General population in community settings | Hand hygiene practices among key population groups and risk scenarios in community settings | Experimental or quasi-experimental design randomised and non-randomised controlled trials, before-after studies | Variations in hand hygiene practices | Mixed methods (focus on quantitative evaluation and will include any papers linked to the evaluation that may be relevant, eg, protocols, follow-up studies (qual or quant) to assess variability, subgroups) | |
*Detailed eligibility criteria in SPIDER format
†Detailed eligibility criteria in PICO(S) format
Table 4Detailed eligibility criteria in SPIDER format for research question 4 (RQ4) on government measures
| Research question | Sample | Phenomenon of interest | Design | Evaluation | Research type | |
| RQ4. What government measures* have been implemented to support minimum requirements—water and soap—for equitable and sustained practice of effective hand hygiene in community settings? | (4a) What government measures have increased access to soap for hand hygiene? Was it sustained? Was it equitable? | General population in community settings | Government measures for increasing access to soap for handwashing with soap | Policy documents and grey literature reports | Access to minimum quantity of soap for effective hand hygiene | Qualitative, quantitative, mixed methods |
| (4b) What government measures have increased access to water for hand hygiene? Was it sustained? Was it equitable? | General population in community settings | Government measures for ensuring access to water for handwashing | Policy documents and grey literature reports | Access to minimum quantity of water for effective hand hygiene | Qualitative, quantitative, mixed methods | |
| (4c) What government measures have resulted in changes to end-user hand hygiene practices? Was it sustained? Was it equitable? | General population in community settings | Government measures for delivering behaviour change interventions for promoting handwashing with soap at key moments | Policy documents and grey literature reports | Delivery of interventions for effective hand hygiene | Qualitative, quantitative, mixed methods | |
| (4d) Where have governments intervened to address equality and/or affordability? What government measures specifically targeted equity and affordability of handwashing? | General population in community settings | Government measures for affordable and equal access to minimum requirements for handwashing with soap at key moment | Policy documents and grey literature reports | Affordable and equal minimum requirements for effective hand hygiene | Qualitative, quantitative, mixed methods | |
| (4e) Where have governments intervened to address other intermediate outcomes that could impact end-user access or practices (ie, related to enabling conditions related to questions 4a, 4b, 4c), but that did not measure soap access, water access or end-user practices? | General population in community settings | Government measures for delivering behaviour change interventions for promoting handwashing with soap at key moments | Policy documents and grey literature reports | Delivery of interventions for effective hand hygiene | Qualitative, quantitative, mixed methods | |
*Evaluated using the Sanitation and Water for All (SWA) Building Blocks: sector policy and strategy; institutional arrangements; sector financing; planning, monitoring, and review; capacity development.21
Effective hand hygiene: Which hand hygiene methods are effective at removing or deactivating pathogens associated with disease transmission by hands in community settings? (RQ1)
Minimum requirements: What are the minimum requirements (material needs) for the sustained practice of effective hand hygiene in community settings? (RQ2)
Behaviour change: What are key behavioural barriers and enablers to practicing effective hand hygiene in community settings? (RQ3.1). Among interventions to improve hand hygiene in community settings, what theories, barriers and enablers, intervention functions and behaviour change techniques, and design features have been leveraged effectively to improve and sustain hand hygiene in community settings? (RQ3.2)
Government measures: What government measures have been implemented to support minimum requirements—water and soap—for equitable and sustained practice of effective hand hygiene in community settings? (RQ4)
Methods and analysis
Design
This integrated systematic review entails a two-phased approach for identifying relevant studies (figure 1). Phase 1 involves a broad search to capture all studies on hand hygiene in community settings that are relevant across all research questions. The outcome of phase 1 will be a reduced sample from which further screening, specific to each of the research questions, can be performed. In phase 2, we will use the phase 1 sample to further screen (title and abstract, then full text review) studies for relevance to each of the research questions using specified criteria.
Eligibility criteria
The eligibility criteria are based on the Participants, Interventions, Comparison, Outcome, Study design (PICO(S)) framework for characterising studies according to study population, intervention, comparison, outcome and study design49 and Sample, Phenomenon of interest, Design, Evaluation, Research type (SPIDER) characteristics for mixed methods and qualitative studies, and those not using control groups or interventions (ie, characteristics describing the studies’ sample, phenomenon of interest, design, evaluation and research type).50 Eligibility criteria applied to our broad search to capture all relevant studies on hand hygiene in community settings during phase 1 are summarised in the sections below. Tables 1–4 provide detailed eligibility criteria in PICO(S) or SPIDER format for each research question (and their subquestions) that will be applied during phase 2.
Participants/sample
Studies will include general populations in community settings or laboratory-based studies on interventions used in community settings. For this review, the term community settings includes domestic (eg, households), public (eg, markets, public transportation hubs, vulnerable populations (eg, people experiencing homelessness), parks, squares, or other public outdoor spaces, shops, restaurants, and cafes) and institutional (eg, workplace, schools and universities, places of worship, prisons and places of detention, nursing homes and long-term care facilities) spaces.17 Studies will be excluded if they are in healthcare settings or are animal research. There are no geographic restrictions.
Interventions/phenomenon of interest
For this review, hand hygiene refers to any hand cleansing undertaken for the purpose of removing or deactivating pathogens from hands and efficacious hand hygiene is defined as any practice which effectively removes or deactivates pathogens from hands and thereby has the potential to limit disease transmission.14 Phase 1 includes all types of interventions to improve hand hygiene in community settings and approaches to designing or implementing these interventions. Included are a range of hand hygiene methods for effective removal or deactivation of pathogens (eg, handwashing with soap and water or water alone, waterless methods such as ABHR or friction-generation, and hand drying methods) (RQ1); the minimum requirements or material needs for sustained practice (eg, quantity of water and soap, location of hand hygiene products, spacing and number of users per hand hygiene facility, and accessibility requirements) (RQ2); and behaviour change approaches (eg, theories, barriers and enablers, intervention functions and behaviour change techniques, and design features) (RQ3) and government measures (RQ4) that can be implemented to rapidly improve hand hygiene.
Context
Studies will be included regardless of the country’s level of economic development (eg, high-income, middle-income and low-income). The studies must be published on or after January 1980 to March 2023 and published in English—unless the title and abstract have been published in English and/or a non-English language article is referenced in an existing systematic review.
Outcome
For phase 1, the research must involve at least one outcome related to hand hygiene across our four key areas (effective hand hygiene, minimum requirements, behaviour change and government measures). This includes microbial load reduction in key pathogens and their surrogates on human hands or fingers from before and after hand hygiene methods (RQ1), any action of hand cleansing for the purpose of removing or deactivating pathogens from hands (RQ2), effective and sustained hand hygiene (RQ3) and access to minimum quantity of water and soap or hand hygiene intervention delivery (RQ4). Tables 1–4 provide the outcomes of interest aligned with the specific research questions and subquestions.
Types of studies
The types of data and studies to be included will vary by research questions and subquestions; tables 1–4 identify the target study designs or research types for each research question. Publications not based on empirical research (eg, editorial, discussion pieces) will be excluded for RQ1, RQ2 and RQ3. Intervention protocols may be included for RQ3.2 if they provide relevant information about behaviour change interventions. RQ4 can include policy documents and grey literature.
Information sources
Databases, trial registries, expert consultations and hand searches of reference lists will all be used during phase 1 to ensure an exhaustive search.
Databases
For the database search, a comprehensive set of subject headings and keywords will be used in a variety of databases. In addition to peer-reviewed literature, grey literature databases will be used to identify international sources of academic papers, research and committee reports, government reports, conference papers and ongoing research not published in commercial publications.
The following electronic databases will be searched for peer-reviewed and grey literature:
PubMed.
Web of Science.
EMBASE (Elsevier).
CINAHL (EBSCOhost).
Global Health (CAB).
Cochrane Library.
Global Index Medicus.
Scopus (Elsevier).
Public Affairs Information Service (PAIS) Index (ProQuest).
WHO Institutional Repository for Information Sharing (IRIS) (https://apps.who.int/iris/).
UN Digital Library (https://digitallibrary.un.org/).
World Bank eLibrary (https://elibrary.worldbank.org/).
Trial registries
We will search trial registries (International Clinical Trials Registry Platform, clinicaltrials.gov) for trials related to hand hygiene in community settings to identify relevant trials. For any relevant trials, we will search for studies using trial register numbers to identify additional relevant studies to include.
Expert consultations
We will contact content experts and organisations for information on relevant unpublished literature. Snowballing methods will be used to identify and recruit a broad interdisciplinary field of experts. We will start with an initial expert list and then ask each of these experts to identify additional experts. This process will be repeated with each new expert until no new names are generated. All identified experts will be contacted by email up to three times if they fail to respond. Experts on our initial list include those who work for or are affiliated with United Nation agencies, government, non-governmental organisations, global partnerships and fora (eg, Global Handwashing Partnership, Sanitation and Water for All, Hygiene Forum), and academia.
Hand searches of reference lists
We will conduct manual searches of reference lists of key systematic reviews for any additional relevant studies. Preidentified systematic reviews for manual searches are listed in online supplemental material appendix 1. The list of relevant systematic reviews may expand further based on the database search and feedback from expert consultations.
Search strategy
A comprehensive list of search terms for each database is provided in online supplemental material appendix 2. In short, search terms are related to hand hygiene broadly and include restrictions on terms related to healthcare settings in the titles. Search terms are adapted according to the requirements of individual databases.
Study records
Data management
The informationist will execute the searches, retrieve and compile studies from each database, and remove duplicates. Covidence51 will be used as the primary screening tool. All studies identified outside of the database search, such as through trial registries, expert consultations and hand searches of reference lists, will be compiled separately to enable determination of unique studies retrieved using these methods. Through each phase, the number of studies retrieved and excluded will be noted in a Preferred Reporting Items for Systematic Reviews and Meta-Analyses chart.
Selection process
In both phases, screening (phase 1: title and abstract only; phase 2: title and abstract, then full text review) will be performed independently by two reviewers, with discordance between reviewers reconciled by a third reviewer. Studies will be included if at least two reviewers indicate the study should be included and excluded if at least two reviewers indicate the study should be excluded. In line with best practice guidelines,52 we will conduct an introductory title and abstract screening training. During the training, reviewers will learn the inclusion and exclusion criteria by participating in a pilot screening of titles and abstracts of the same 30 studies. The team of reviewers will then review each of the 30 studies and discuss reasons for inclusion and exclusion. Further training will take place if there is a need for more clarity. During phase 2, eligibility criteria will be more specific to the research questions (tables 1–4), thus separate training and piloting will take place for each research question.
Data collection process
The process for data collection and data synthesis is outlined in online supplemental figure. Data will be extracted from the selected studies independently by two reviewers with any discrepancies reconciled by consensus or referral to a third reviewer. Data extraction tables and quality appraisal forms will be piloted on a small sample (eg, 10) of included studies and preliminary analyses will be conducted to ensure that the extraction sheets are capturing standardised, relevant and comprehensive information. Data extraction tools may be updated after the pilot if needed.
Data items
A custom-created data extraction form will be created to standardise the information extracted and aid analyses. For all included studies, the extraction form will reference best practices for systematic reviews53 54 and include relevant bibliographic details, outcomes, study design, geographic information and targeted populations. PICO(S)/SPIDER criteria will inform data extraction relevant for each research question (tables 1–4). A summary of data extraction items to be piloted are provided in online supplemental table. A complete template of the data extraction form will be published with the review findings. Missing and unclear data will be identified in the data extraction.
To extract qualitative data, eligible qualitative and mixed methods studies will be imported into MAXQDA (V.12)55 qualitative analysis software. Following best practice,56 line-by-line coding of the results sections, which present the empirical data from the studies, will be carried out independently by two team members using a code book developed a priori related to the research question. The reviewers will first code a subset of five studies independently and their coding will be compared with assess inter-coder agreement. The code book may be amended if deemed relevant. Any time a new code is added, all studies previously reviewed will be re-reviewed to include the new code.
Outcomes and prioritisation
Primary outcomes for each research question are noted in tables 1–4 under; ‘outcome’ or ‘evaluation’.
Risk of bias in individual studies
We will assess all studies using the Mixed Method Appraisal Tool (MMAT).57 58 Quality appraisals will be performed by two reviewers independently with discrepancies reconciled by consensus. Qualitative and quantitative studies will be assessed using the five-criteria questionnaire. Mixed methods studies will be assessed using the relevant independent questionnaires for qualitative and quantitative work and a five criteria questionnaire for mixed methods; the lowest of the three scores will be used as the quality score. Possible scores are 0–5 across study types (5 is the best).
Although there is no established tool for laboratory study bias assessment, laboratory efficacy studies will also be assessed using a tool developed by Yeargin et al.59 In which each article will be rated as pass or fail across five criteria describing laboratory best practices for a possible score of 0–5 (5 is the best). All studies will be retained regardless of scores.
Data synthesis
We anticipate that our evidence base will include quantitative, qualitative and mixed method research, including impact assessments and other types of project evaluations. All effect measures pertaining to review outcomes will be reported. To summarise and report data, we will use descriptive statistics, forest plots to show point estimates arising from different studies measuring the same outcome, and ‘data-driven’ descriptive themes and the ‘theory-driven’ analytical themes as applicable. To classify and synthesise qualitative data, we will use the ‘best-fit framework synthesis’ approach.60 Using this method, themes are identified as codes a priori from pre-existing, guiding frameworks or models. This synthesis approach allows for the guiding framework or conceptual model to be modified as themes emerge inductively from the data. Our detailed data synthesis plan for each research question is outlined below.
Which hand hygiene methods are effective at removing or deactivating pathogens associated with disease transmission by hands in community settings? (RQ1)
The quantitative studies included in this research question are expected to report results of handwashing and drying using the measurement of an appropriate organism before and after handwashing. These results are typically expressed in terms of log or per cent reduction/increase in organisms on hands. Results will be categorised by both handwashing or drying practices (eg, handwashing with soap, use of antiseptics, material for drying) and by the type of microorganism studied (bacteria, enveloped viruses, non-enveloped viruses) because these conditions are expected to influence handwashing performance. When available, results will be synthesised by performing a meta-analysis of log or per cent reduction results within categories of handwashing practice with five or more data points. A summary mean log reduction value will be calculated for each category available from the literature using a Mantel-Haenszel random effects analysis,61 and the variability in outcomes from the studies will be described using an I2 test with significance determined using a Pearson χ2 test.62
What are the minimum requirements (material needs) for the sustained practice of effective hand hygiene in community settings? (RQ2)
For studies that report observations of handwashing stations, we will qualitatively code information on the location and design characteristics of handwashing stations and will extract quantitative data on the quantity of water and soap reported for use and the number of users. These findings will be summarised narratively, and tables will be used to describe and aggregate summaries. Quantitative data on quantity of water and soap and number of users will be summarised in forest plots and grouped by the reported effectiveness of an intervention when reported if more than five data points are available for the category. A meta-analysis of water and soap quantity will be conducted on results split by hand hygiene outcome (effective/not effective for the stated outcome) and by adherence with WHO standards for handwashing (adherent/not adherent). A summary value will be calculated for each category available from the literature using a Mantel-Haenszel random effects analysis,61 and the variability in outcomes from the studies will be described using an I2 test with significance determined using a Pearson χ2 test.62
What are key behavioural barriers and enablers to practicing effective hand hygiene in community settings? (RQ3.1)
We will use the ‘best-fit framework synthesis’ approach to identify behavioural barriers and enablers of effective hand hygiene practice in community settings and have identified COM-B (Capability, Opportunity, Motivation and Behaviour)63 as the guiding framework. COM-B has been used to categorise barriers and enablers in multiple systematic reviews, including hand hygiene.44 COM-B posits that behaviour is the result of an interaction between three components: capability, opportunity and motivation. Capability can be psychological (knowledge) or physical (skills); opportunity can be social (societal influences) or physical (environmental resources); motivation can be automatic (emotion) or reflective (beliefs, intentions). All studies relevant to this research question will be loaded into MAXQDA for coding and COM-B will be used to develop the codebook a priori to categorise behavioural barriers and enablers to practicing effective hand hygiene in community settings into the six subcomponents of the COM-B framework.
Among interventions to improve hand hygiene in community settings, what theories, barriers and enablers, intervention functions and behaviour change techniques, and design features have been leveraged effectively to improve and sustain hand hygiene in community settings? (RQ3.2)
Research question 3.2 and all subquestions will leverage data from studies that report on interventions to improve hand hygiene in community settings. Data will be synthesised both quantitatively and qualitatively. For question 3.2a, the proportion of interventions that reported the use of a behavioural theory in the intervention design will be reported; protocol documents will be leveraged, if available, to make this determination. What theory was used and whether or not the intervention was effective will also be reported. For question 3.2b, focusing on interventions that effectively leveraged identified barriers and enablers to hand hygiene outcome(s) in community settings, COM-B will again be used to determine which barriers and enablers were targeted and which were effective. For question 3.2c, we will leverage the Behavioural Change Techniques Taxonomy, version 164 to classify and report which behaviour change techniques have been implemented, which have been reported to be effective at improving and sustaining handwashing practices in community settings. For question 3.2d, we will identify all interventions that use hand washing stations and report design features that are reported to be effective at improving and sustaining handwashing practices in community settings. For question 3.2e, we will identify all interventions studies that report assessing adaptation, and report which have been effective at improving and sustaining hand hygiene in community settings. For question 3.2f, we will identify all interventions that indicate varying the frequency or intensity of their behaviour change intervention and report which have been effective at improving hand hygiene. Finally, for question 3.2g, among all hand hygiene interventions studies, we will report if and how handwashing practices are reported to vary by population groups, risk scenarios and over time. An overarching narrative synthesis will be used to summarise the findings and present key learnings across the research subquestions.
What government measures have been implemented to support minimum requirements—water and soap—for equitable and sustained practice of effective hand hygiene in community settings? (RQ4)
Government measures concern actions taken by governments to ensure effective hand hygiene. Identified government measures that support minimum requirements for sustained, effective and equitable hand hygiene in community settings will be categorised into the five elements that are the critical ‘Building Blocks’ of a well-functioning WASH sector—policy and strategy; institutional arrangements; sector financing; planning, monitoring, and review; capacity development—according to an established framework developed by Sanitation and Water for All, a United Nations hosted multi-lateral partnership.21 We will qualitatively code all applicable studies in MAXQDA to identify programmatic and policy-relevant Building Blocks, as well as delivery strategies deductively identified during document review. We will extract and analyse quantitative data, and meta-analyse similar studies where we identify at least three similar interventions.
Meta-bias(es)
To assess selective reporting specifically for quantitative findings, we will compare public study protocols and trial registrations against publications. We will review all reported outcomes for trials that include multiple outcomes related to handwashing and check for consistency with their protocols. If discrepancies are found, we will contact the study authors. To assess for publication bias, and where appropriate in terms of study design and focus, we will generate and assess funnel plots for any meta-analyses.
Confidence in cumulative evidence
The quality of evidence for an association between hand hygiene methods and their effectiveness at removing or deactivating pathogens (RQ1) and associations between theories, barriers and enablers, intervention functions and behaviour change techniques, and design features on improve and sustain hand hygiene (RQ3.2) will be evaluated in accordance with the Grading of Recommendations Assessment, Development and Evaluation system.65 This system helps to evaluate the quality of evidence at four levels: high (4), moderate (3), low (2) and very low (1). This rating reflects the confidence in the estimated effect size and is determined by considering factors such as study limitations, inconsistency, indirectness, imprecision, and publication bias. By uploading the meta-analyses relevant to the research questions into the GRADE system, we will be able to report on the confidence of our findings.
Patient and public involvement
As this research will be based on previously published data, there will be no patient and public involvement in the design, interpretation or dissemination of the findings.
Ethics and dissemination
This systematic review is exempt from ethics approval because the work is carried out on published documents. The findings of the reviews will be disseminated in related peer-reviewed journals. We aim to publish a systematic review for each of the priority questions across the four areas of hand hygiene in community settings: (1) effective hand hygiene; (2) minimum requirements; (3) behaviour change and (4) government measures.
Discussion
This systematic review will use a two-phased approach to identify relevant data and studies of hand hygiene in community settings and synthesise available evidence on hand hygiene in community settings across four key areas (effective hand hygiene, minimum requirements, behaviour change and government measures). This two-phased systematic review will synthesise evidence to address a set of research questions in what constitutes effective hand hygiene and what government measures have been implemented to support it. A comprehensive and rigorous retrieval and synthesis of evidence can address lack of consistent and coherent evidence-based recommendations for improving hand hygiene in community settings.
Ethics statements
Patient consent for publication
Not applicable.
BAC and JSS contributed equally.
MCF and MW contributed equally.
Contributors JEM, OC and BG conceived the initial need for the reviews and specific research questions. BAC, MW, MCF are the guarantors of the review and BAC, MW, MCF, JSS and HR conceived and designed the specific strategy described here. JSS, BAC, MW and MCF wrote the protocol. HR, JEM and OC critically appraised the protocol and also contributed to its development by revising different versions. All authors read and approved the final version of the manuscript. BAC and JSS contributed equally as first authors; MW and MCF contributed equally as senior authors.
Funding This work was supported by the World Health Organization (PO number: 203046633).
Competing interests None declared.
Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.
Provenance and peer review Not commissioned; externally peer reviewed.
Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.
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Details
; Snyder, Jedidiah S 2
; Cumming, Oliver 3
; Joanna Esteves Mills 4
; Gordon, Bruce 4 ; Rogers, Hannah 5
; Freeman, Matthew C 2
; Wolfe, Marlene 2
1 Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA
2 Gangarosa Department of Environmental Health, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA
3 Department of Disease Control, London School of Hygiene & Tropical Medicine, London, UK; Water, Sanitation, Hygiene and Health Unit, World Health Organization, Geneva, Switzerland
4 Water, Sanitation, Hygiene and Health Unit, World Health Organization, Geneva, Switzerland
5 Woodruff Health Sciences Center, Emory University, Atlanta, Georgia, USA
