Advancing the WHO-INTEGRATE Framework as a Tool for Evidence-Informed, Deliberative Decision-Making Processes: Exploring the Views of Developers and Users of WHO Guidelines.

BACKGROUND: Decision-making on matters of public health and health policy is a deeply value-laden process. The World Health Organization (WHO)-INTEGRATE framework was proposed as a new evidence-to-decision (EtD) framework to support guideline development from a complexity perspective, notably in relation to public health and health system interventions, and with a foundation in WHO norms and values. This study was conducted as part of the development of the framework to assess its comprehensiveness and usefulness for public health and health policy decision-making. METHODS: We conducted a qualitative study comprising nine key informant interviews (KIIs) with experts involved in WHO guideline development and four focus group discussions (FGDs) with a total of forty health decision-makers from Brazil, Germany, Nepal and Uganda. Transcripts were analyzed using MAXQDA12 and qualitative content analysis. RESULTS: Most key informants and participants in the FGDs appreciated the framework for its relevance to real-world decision-making on four widely differing health topics. They praised its broad perspective and comprehensiveness with respect to new or expanded criteria, notably regarding societal implications, equity considerations, and acceptability. Some guideline developers questioned the value of the framework beyond current practice and were concerned with the complexity of applying such a broad range of criteria in guideline development processes. Participants made concrete suggestions for improving the wording and definitions of criteria as well as their grouping, for covering missing aspects, and for addressing overlap between criteria. CONCLUSION: The framework was well-received by health decision-makers as well as the developers of WHO guidelines and appears to capture all relevant considerations discussed in four distinct real-world decision processes that took place on four different continents. Guidance is needed on how to apply the framework in guideline processes that are both transparent and participatory. A set of suggestions for improvement provides a valuable starting point for advancing the framework towards version 2.0.

The moral perils of conditional cash transfer programmes and their significance for policy: a meta-ethnography of the ethical debate.

Conditional cash transfer (CCT) is a compelling policy alternative for reducing poverty and improving health, and its effectiveness is promising. CCT programmes have been widely deployed across geographical, economic and political contexts, but not without contestation. Critics argue that CCTs may result in infringements on freedom and dignity, gender discrimination and disempowerment and power imbalances between programme providers and beneficiaries. In this analysis, we aim to identify the ethical concepts applicable to CCTs and to contextualize these by mapping the tensions of the debate, allowing us to understand the separate contributions as parts of a larger whole. We searched a range of databases for records on public health CCT. Strategies were last run in January 2017. We included 31 dialectical articles deliberating the ethics of CCTs and applied a meta-ethnographic approach. We identified 22 distinct ethical concepts. By analysing and mapping the tensions in the discourse, the following four strands of debate emerged: (1) responsibility for poverty and health: personal vs public duty, (2) power balance: autonomy vs paternalism, (3) social justice: empowerment vs oppression and (4) marketization of human behaviour and health: 'fair trade' vs moral corruption. The debate shed light on the ethical ideals, principles and doctrines underpinning CCT. These were consistent with a market-oriented liberal welfare regime ideal: privatization of public responsibilities; a selective rather than a universal approach; empowerment by individual entrepreneurship; marketization of health with a conception of human beings as utility maximizing creatures; and limited acknowledgement of the role of structural injustices in poverty and health. Identification of key tensions in the public health ethics debate may expose underpinning ideological logics of health and social programmes that may be at odds with public values and contemporary political priorities. Decisions about CCTs should therefore not be considered a technical exercise, but a context-dependent process requiring transparent, informed and deliberative decision-making.

The WHO-INTEGRATE evidence to decision framework version 1.0: integrating WHO norms and values and a complexity perspective.

INTRODUCTION: Evidence-to-decision (EtD) frameworks intend to ensure that all criteria of relevance to a health decision are systematically considered. This paper, part of a series commissioned by the WHO, reports on the development of an EtD framework that is rooted in WHO norms and values, reflective of the changing global health landscape, and suitable for a range of interventions and complexity features. We also sought to assess the value of this framework to decision-makers at global and national levels, and to facilitate uptake through suggestions on how to prioritise criteria and methods to collect evidence. METHODS: In an iterative, principles-based approach, we developed the framework structure from WHO norms and values. Preliminary criteria were derived from key documents and supplemented with comprehensive subcriteria obtained through an overview of systematic reviews of criteria employed in health decision-making. We assessed to what extent the framework can accommodate features of complexity, and conducted key informant interviews among WHO guideline developers. Suggestions on methods were drawn from the literature and expert consultation. RESULTS: The new WHO-INTEGRATE (INTEGRATe Evidence) framework comprises six substantive criteria-balance of health benefits and harms, human rights and sociocultural acceptability, health equity, equality and non-discrimination, societal implications, financial and economic considerations, and feasibility and health system considerations-and the meta-criterion quality of evidence. It is intended to facilitate a structured process of reflection and discussion in a problem-specific and context-specific manner from the start of a guideline development or other health decision-making process. For each criterion, the framework offers a definition, subcriteria and example questions; it also suggests relevant primary research and evidence synthesis methods and approaches to assessing quality of evidence. CONCLUSION: The framework is deliberately labelled version 1.0. We expect further modifications based on focus group discussions in four countries, example applications and input across concerned disciplines.

Prognostic factors of prolonged disability in patients with chronic low back pain and lumbar degeneration in primary care: a cohort study.

STUDY DESIGN: A cohort study with 1-year follow-up. OBJECTIVE: To identify prognostic factors in patients with chronic nonspecific low back pain (LBP). SUMMARY OF BACKGROUND DATA: The factors (e.g., sociodemographical, low back-related, radiological, and biological) associated with persistent pain and disability for patients with chronic nonspecific LBP are uncertain. Furthermore, sparse information exists about the relationship between biological factors like impaired fasting glucose tolerance and chronic nonspecific LBP. METHODS: The participants consisted of 250 patients with nonspecific LBP of more than 6 months duration and degenerative lumbar osteoarthritis. The patients were originally recruited for a randomized controlled trial from the clinics of general practitioners, physiotherapists, and chiropractors. Potential predictors were evaluated at baseline. The outcome was absolute level of pain-related disability (Roland-Morris Disability Questionnaire [RMDQ]) at 1 year. The association between potential prognostic factors and the outcome was analyzed with multivariate linear backward regression. RESULTS: At baseline and 1 year, the RMDQ scores were 9.5 and 5.1 points, respectively. Mean (SD) baseline values for body mass index (BMI), EuroQol (EQ)-index, EQ-visual analogue scale were 25.4 (4.3), 0.60 (0.3), and 61.2 (20.8), respectively. Higher pain-related disability levels (1-year RMDQ score) were associated with 6.1 mmol/L or more fasting glucose level at baseline (ß, 3.7; 95% confidence interval [CI], 1.2-6.1; P = 0.00), baseline pain-related disability (ß 0.2; 95% CI, 0.1-0.4; P = 0.00), BMI (ß, 0.2; 95% CI, 0.1-0.3; P < 0.03), EQ-index (ß, -4.5; 95% CI, 6.9 to 2.1; P = 0.00), and EQ-visual analogue scale (ß, 0.3; 95% CI, -0.6 to -0.0; P = 0.03). However, a limited number of patients had 6.1 mmol/L or more of fasting glucose level at baseline (13/250 patients). The imaging findings, modic changes, and high intensity zones had no predictive ability. CONCLUSION: Increased pain-related disability at 1 year was seen in patients with impaired fasting glucose tolerance, greater pain-related disability, higher BMI, and lower quality of life at baseline.

Can lay health workers increase the uptake of childhood immunisation? Systematic review and typology.

OBJECTIVES: Lay health workers (LHWs) are used in many settings to increase immunisation uptake among children. However, little is known about the effectiveness of these interventions. The objective of this review was to assess the effects of LHW interventions on childhood immunisation uptake. METHODS: We searched Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, CINAHL, British Nursing Index and Archive, AMED, POPLINE and WHOLIS, reference lists of included papers and relevant reviews, and contacted the authors of relevant papers. We selected randomised and non-randomised controlled trials, controlled before-after studies, and interrupted time series of any intervention delivered by LHWs and designed to increase childhood immunisation uptake. Two authors independently extracted data using a standard form and assessed risk of bias and evidence quality. FINDINGS: We identified twelve studies, ten of which were randomised controlled trials. Seven studies were conducted among economically disadvantaged populations in high-income countries. Five studies were from low- and middle-income countries. In ten studies, LHWs promoted childhood immunisation. In two studies, LHWs vaccinated children themselves. In most of the studies, the control group populations received no intervention or standard care. Most of the studies showed that LHWs increased immunisation coverage. However, study settings were diverse, allowing us to carry out only one meta-analysis including four studies. CONCLUSION: LHWs could make an important contribution to achieving the Millennium Development Goal for child health. However, more high-quality studies are needed, particularly from LMICs. More studies are also needed to assess the effects of using LHWs to vaccinate children themselves.

Still too little qualitative research to shed light on results from reviews of effectiveness trials: a case study of a Cochrane review on the use of lay health workers.

BACKGROUND: Qualitative research is used increasingly alongside trials of complex interventions to explore processes, contextual factors, or intervention characteristics that may have influenced trial outcomes. Qualitative research conducted alongside trials can also be used to shed light on the results of systematic reviews of effectiveness by looking for factors that can help explain heterogeneous results across trials. In a Cochrane review on the effects of using lay health workers on maternal and child health and infectious disease control, we identified 82 trials. These trials showed promising benefits but results were heterogeneous. OBJECTIVE: To use qualitative studies conducted alongside these trials to explore factors and processes that might have influenced intervention outcomes. METHODS: We attempted to identify qualitative research carried out alongside the trials by contacting trial authors, checking papers for references to qualitative research, searching Pubmed for related studies, and carrying out citation searches. For those qualitative studies that we included, we extracted information regarding study objective, data collection and analysis methods, and key themes and categories. RESULTS: For 52 (63%) of the trials, we found no qualitative research that had been conducted alongside the trials. For 16 (20%) trials, some form of qualitative data collection had been done but was unavailable or had been done before the trial. For 14 (17%) trials, qualitative research had been done during or shortly after the trial, although descriptions of qualitative methods and results were often sparse. Most of these 14 studies aimed to elicit trial participants' perspectives and experiences of the intervention. A common theme was participants' appreciation of the lay health workers' shared circumstances, for instance with regard to social background or experience of the health condition. In six studies, researchers explored the experiences of the lay health workers themselves. Issues included the importance of regular supervision and health professionals' support or lack of support. CONCLUSIONS: Qualitative studies carried out alongside trials of complex interventions could offer opportunities to authors of systematic reviews of effectiveness wishing to understand the heterogeneity of trial results. For interventions of lay health worker programmes at least, too few such studies exist at present for these opportunities to be realised.

Effect of glucosamine on pain-related disability in patients with chronic low back pain and degenerative lumbar osteoarthritis: a randomized controlled trial.

CONTEXT: Chronic low back pain (LBP) with degenerative lumbar osteoarthritis (OA) is widespread in the adult population. Although glucosamine is increasingly used by patients with chronic LBP, little is known about its effect in this setting. OBJECTIVE: To investigate the effect of glucosamine in patients with chronic LBP and degenerative lumbar OA. DESIGN, SETTING, AND PARTICIPANTS: A double-blind, randomized, placebo-controlled trial conducted at Oslo University Hospital Outpatient Clinic, Oslo, Norway, with 250 patients older than 25 years of age with chronic LBP (>6 months) and degenerative lumbar OA. INTERVENTIONS: Daily intake of 1500 mg of oral glucosamine (n = 125) or placebo (n = 125) for 6 months, with assessment of effect after the 6-month intervention period and at 1 year (6 months postintervention). MAIN OUTCOME MEASURES: The primary outcome was pain-related disability measured with the Roland Morris Disability Questionnaire (RMDQ). Secondary outcomes were numerical scores from pain-rating scales of patients at rest and during activity, and the quality-of-life EuroQol-5 Dimensions (EQ-5D) instrument. Data collection occurred during the intervention period at baseline, 6 weeks, 3 and 6 months, and again 6 months following the intervention at 1 year. Group differences were analyzed using linear mixed models analysis. RESULTS: At baseline, mean RMDQ scores were 9.2 (95% confidence interval [CI], 8.4-10.0) for glucosamine and 9.7 (95% CI, 8.9-10.5) for the placebo group (P = .37). At 6 months, the mean RMDQ score was the same for the glucosamine and placebo groups (5.0; 95% CI, 4.2-5.8). At 1 year, the mean RMDQ scores were 4.8 (95% CI, 3.9-5.6) for glucosamine and 5.5 (95% CI, 4.7-6.4) for the placebo group. No statistically significant difference in change between groups was found when assessed after the 6-month intervention period and at 1 year: RMDQ (P = .72), LBP at rest (P = .91), LBP during activity (P = .97), and quality-of-life EQ-5D (P = .20). Mild adverse events were reported in 40 patients in the glucosamine group and 46 in the placebo group (P = .48). CONCLUSIONS: Among patients with chronic LBP and degenerative lumbar OA, 6-month treatment with oral glucosamine compared with placebo did not result in reduced pain-related disability after the 6-month intervention and after 1-year follow-up. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00404079.

The female community health volunteer programme in Nepal: decision makers' perceptions of volunteerism, payment and other incentives.

The Female Community Health Volunteer (FCHV) Programme in Nepal has existed since the late 1980s and includes almost 50,000 volunteers. Although volunteer programmes are widely thought to be characterised by high attrition levels, the FCHV Programme loses fewer than 5% of its volunteers annually. The degree to which decision makers understand community health worker motivations and match these with appropriate incentives is likely to influence programme sustainability. The purpose of this study was to explore the views of stakeholders who have participated in the design and implementation of the Female Community Health Volunteer regarding Volunteer motivation and appropriate incentives, and to compare these views with the views and expectations of Volunteers. Semi-structured interviews were carried out in 2009 with 19 purposively selected non-Volunteer stakeholders, including policy makers and programme managers. Results were compared with data from previous studies of Female Community Health Volunteers and from interviews with four Volunteers and two Volunteer activists. Stakeholders saw Volunteers as motivated primarily by social respect, religious and moral duty. The freedom to deliver services at their leisure was seen as central to the volunteer concept. While stakeholders also saw the need for extrinsic incentives such as micro-credit, regular wages were regarded not only as financially unfeasible, but as a potential threat to the Volunteers' social respect, and thereby to their motivation. These views were reflected in interviews with and previous studies of Female Community Health Volunteers, and appear to be influenced by a tradition of volunteering as moral behaviour, a lack of respect for paid government workers, and the Programme's community embeddedness. Our study suggests that it may not be useful to promote a generic range of incentives, such as wages, to improve community health worker programme sustainability. Instead, programmes should ensure that the context-specific expectations of community health workers, programme managers, and policy makers are in alignment if low attrition and high performance are to be achieved.

Lay health workers in primary and community health care for maternal and child health and the management of infectious diseases.

BACKGROUND: Lay health workers (LHWs) are widely used to provide care for a broad range of health issues. Little is known, however, about the effectiveness of LHW interventions. OBJECTIVES: To assess the effects of LHW interventions in primary and community health care on maternal and child health and the management of infectious diseases. SEARCH STRATEGY: For the current version of this review we searched The Cochrane Central Register of Controlled Trials (including citations uploaded from the EPOC and the CCRG registers) (The Cochrane Library 2009, Issue 1 Online) (searched 18 February 2009); MEDLINE, Ovid (1950 to February Week 1 2009) (searched 17 February 2009); MEDLINE In-Process & Other Non-Indexed Citations, Ovid (February 13 2009) (searched 17 February 2009); EMBASE, Ovid (1980 to 2009 Week 05) (searched 18 February 2009); AMED, Ovid (1985 to February 2009) (searched 19 February 2009); British Nursing Index and Archive, Ovid (1985 to February 2009) (searched 17 February 2009); CINAHL, Ebsco 1981 to present (searched 07 February 2010); POPLINE (searched 25 February 2009); WHOLIS (searched 16 April 2009); Science Citation Index and Social Sciences Citation Index (ISI Web of Science) (1975 to present) (searched 10 August 2006 and 10 February 2010). We also searched the reference lists of all included papers and relevant reviews, and contacted study authors and researchers in the field for additional papers. SELECTION CRITERIA: Randomised controlled trials of any intervention delivered by LHWs (paid or voluntary) in primary or community health care and intended to improve maternal or child health or the management of infectious diseases. A 'lay health worker' was defined as any health worker carrying out functions related to healthcare delivery, trained in some way in the context of the intervention, and having no formal professional or paraprofessional certificate or tertiary education degree. There were no restrictions on care recipients. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data using a standard form and assessed risk of bias. Studies that compared broadly similar types of interventions were grouped together. Where feasible, the study results were combined and an overall estimate of effect obtained. MAIN RESULTS: Eighty-two studies met the inclusion criteria. These showed considerable diversity in the targeted health issue and the aims, content, and outcomes of interventions. The majority were conducted in high income countries (n = 55) but many of these focused on low income and minority populations. The diversity of included studies limited meta-analysis to outcomes for four study groups. These analyses found evidence of moderate quality of the effectiveness of LHWs in promoting immunisation childhood uptake (RR 1.22, 95% CI 1.10 to 1.37; P = 0.0004); promoting initiation of breastfeeding (RR = 1.36, 95% CI 1.14 to 1.61; P < 0.00001), any breastfeeding (RR 1.24, 95% CI 1.10 to 1.39; P = 0.0004), and exclusive breastfeeding (RR 2.78, 95% CI 1.74 to 4.44; P <0.0001); and improving pulmonary TB cure rates (RR 1.22 (95% CI 1.13 to 1.31) P <0.0001), when compared to usual care. There was moderate quality evidence that LHW support had little or no effect on TB preventive treatment completion (RR 1.00, 95% CI 0.92 to 1.09; P = 0.99). There was also low quality evidence that LHWs may reduce child morbidity (RR 0.86, 95% CI 0.75 to 0.99; P = 0.03) and child (RR 0.75, 95% CI 0.55 to 1.03; P = 0.07) and neonatal (RR 0.76, 95% CI 0.57 to 1.02; P = 0.07) mortality, and increase the likelihood of seeking care for childhood illness (RR 1.33, 95% CI 0.86 to 2.05; P = 0.20). For other health issues, the evidence is insufficient to draw conclusions regarding effectiveness, or to enable the identification of specific LHW training or intervention strategies likely to be most effective. AUTHORS' CONCLUSIONS: LHWs provide promising benefits in promoting immunisation uptake and breastfeeding, improving TB treatment outcomes, and reducing child morbidity and mortality when compared to usual care. For other health issues, evidence is insufficient to draw conclusions about the effects of LHWs.

Are vaccination programmes delivered by lay health workers cost-effective? A systematic review.

BACKGROUND: A recently updated Cochrane systematic review on the effects of lay or community health workers (LHWs) in primary and community health care concluded that LHW interventions could lead to promising benefits in the promotion of childhood vaccination uptake. However, understanding of the costs and cost-effectiveness of involving LHWs in vaccination programmes remains poor. This paper reviews the costs and cost-effectiveness of vaccination programme interventions involving LHWs. METHODS: Articles were retrieved if the title, keywords or abstract included terms related to 'lay health workers', 'vaccination' and 'economics'. Reference lists of studies assessed for inclusion were also searched and attempts were made to contact authors of all studies included in the Cochrane review. Studies were included after assessing eligibility of the full-text article. The included studies were then reviewed against a set of background and technical characteristics. RESULTS: Of the 2616 records identified, only three studies fully met the inclusion criteria, while an additional 11 were retained as they included some cost data. Methodologically, the studies were strong but did not adequately address affordability and sustainability and were also highly heterogeneous in terms of settings and LHW outcomes, limiting their comparability. There were insufficient data to allow any conclusions to be drawn regarding the cost-effectiveness of LHW interventions to promote vaccination uptake. Studies focused largely on health outcomes and did illustrate to some extent how the institutional characteristics of communities, such as governance and sources of financial support, influence sustainability. CONCLUSION: The included studies suggest that conventional economic evaluations, particularly cost-effectiveness analyses, generally focus too narrowly on health outcomes, especially in the context of vaccination promotion and delivery at the primary health care level by LHWs. Further studies on the costs and cost-effectiveness of vaccination programmes involving LHWs should be conducted, and these studies should adopt a broader and more holistic approach.

Back pain and health policy research: the what, why, how, who, and when.

STUDY DESIGN: A background literature, supported by discussion and outcomes on the subject of Health Policy and Back Pain, from the Fifth International Forum on Low Back Pain Research in Primary Care, in Montreal in May 2002. SUMMARY OF BACKGROUND DATA: A multitude of randomized controlled trials and systematic reviews have been completed in the field of back pain research. There has been limited health policy research in the field of back pain but a greater amount of health policy research in other medical fields. METHODS: The focus of the workshop was on the contribution health policy could make in the area of back pain, the methodologies that are appropriate to research in back pain, and the barriers to back pain health policy research. The workshop was supported by the workshop coordinators' literature review. RESULTS: There was consensus about the lack of improved outcomes from randomized controlled trials and individual treatments and general agreement on the importance supporting current research initiatives with health policy research. That policy-makers were developing policy in this area was agreed, and study methodology to support evidence based policy development was explored. CONCLUSIONS: Health policy research is a relatively underdeveloped area of research in back pain. Back pain as a public health problem may be supported by a broader research approach and a collaborative association with policy-makers in this area.

Blind faith? The effects of promoting active sick leave for back pain patients: a cluster-randomized controlled trial.

STUDY DESIGN: A cluster-randomized controlled trial. OBJECTIVE: To evaluate the effects of two strategies to increase the use of active sick leave (ASL) among patients with low back pain (LBP) on improved return to work and quality of life. SUMMARY OF BACKGROUND DATA: Active sick leave is an option provided by the Norwegian National Insurance Administration that enables employees to return to modified duties at the workplace with 100% of normal wages. A proactive implementation strategy increased the use of ASL for LBP patients from 11.5% to 17.7% compared with a passive intervention and a control group ( = 0.006). METHODS: Sixty-five municipalities were randomly assigned to a passive intervention, a proactive intervention, or a control group. The interventions, which were designed to improve the use of ASL, were targeted at patients on sick leave for LBP for more than 16 days (n = 6179), their general practitioners, employers, and local insurance officers. The main outcome measures were the average number of days off work, the proportion of patients returning to work within 1 year, and self-reported quality of life while on sick leave. RESULTS: The median number of days on sick leave was similar in the proactive intervention group (70 days), the passive intervention group (68 days), and the control group (71 days) ( = 0.8). The proportion of patients returning to work before 50 weeks was also similar in the proactive (89%), passive (89.5%), and control groups (89.1%). Response rates for the questionnaires that were sent to patients were low (38%), and no significant differences were observed across the three groups for quality of life or patient satisfaction. CONCLUSIONS: It is not likely that efforts to increase the use of ASL will result in measurable economic benefits or improved health outcomes at the population level. The benefits of ASL for individual patients with LBP are not known.

A randomized controlled trial of two strategies to implement active sick leave for patients with low back pain.

STUDY DESIGN: Cluster randomized controlled trial. OBJECTIVE: To evaluate the effectiveness of two strategies to improve the use of active sick leave (ASL) for patients with low back pain. SUMMARY OF BACKGROUND DATA: ASL is a public sickness benefit scheme offered to promote early return to modified work for temporarily disabled workers. It was poorly used, and the authors designed two community interventions to strengthen the implementation of ASL based on the results of a study of barriers to use among back pain patients, employers, general practitioners (GPs), and local National Insurance Administration staff. METHODS: Sixty-five municipalities in three counties in Norway, randomly assigned to a passive intervention, a proactive intervention, or a control group. The interventions were targeted at patients on sick leave for low back pain for more than 16 days (n = 6176), their GPs, employers, and local insurance officers. The passive intervention included reminders about ASL on the sick leave form that GPs must complete, a standard agreement to facilitate ASL, targeted information, and a desktop summary for GPs of clinical practice guidelines for low back pain, emphasizing the importance of advice to stay active. The proactive intervention included these elements plus a resource person to facilitate the use of ASL and a continuing education workshop for GPs. The main outcome measure reported here is the proportion of eligible patients that used ASL. RESULTS: ASL was used significantly more in the proactive intervention municipalities (17.7%) compared with the passive intervention and control municipalities (11.5%, P = 0.018). CONCLUSIONS: A passive intervention that addressed identified barriers to the use of ASL did not increase its use. Although modest, a proactive intervention did increase its use. The main impact of the intervention was through direct contact and motivating telephone calls to patients. To the extent that GPs' practice was changed, it was either patient mediated or by patients bypassing their GP.

Active sick leave for patients with back pain: all the players onside, but still no action.

STUDY DESIGN: Semistructured interviews, group discussions, and a mailed survey. OBJECTIVE: To identify barriers to the use of active sick leave (ASL) and to design an intervention to improve the use of ASL by patients with low back pain. SUMMARY OF BACKGROUND DATA: ASL was introduced in Norway in 1993 to encourage people on sick leave to return to modified work. With ASL the National Insurance Administration (NIA) pays 100% of wages, thereby allowing the employer to engage a substitute worker at no extra cost, in addition to the worker on ASL. Arranging ASL requires cooperation between the general practitioner (GP), employer, local NIA staff, and the patient, which may explain why ASL was used in less than 1% of the eligible sick leave cases in 1995, despite strong support from all players. METHODS: The authors conducted five in-depth interviews at a workplace where ASL was successfully implemented. Questionnaires were sent to 89 GPs, 102 workplace representatives, and 22 local NIA officers in three counties. Five patients with back pain who had used ASL were interviewed in a focus group, and 10 patients with back pain who had not used ASL were interviewed using a structured guide. Five workplaces participated in a dialogue conference. Data collection and analysis were iterative, and new data were constantly compared with the previously analyzed materials. RESULTS: About 80% of the GPs, employers, and NIA officers believed ASL is effective in reducing long-term sick leave. Among the barriers identified were lack of information, lack of time, and work flow barriers such as poor communication and coordination of activities between the players required to carry out ASL. Two strategies were designed to improve the workflow between them. A passive implementation strategy was designed to require a minimum amount of economic and administrative support. It included targeted information, clinical guidelines for low back pain, a reminder to GPs in the sick leave form, and a standardized agreement. A proactive strategy included the same four elements plus a kick-off continuing education seminar for GPs and a trained resource person to facilitate the use of ASL. CONCLUSIONS: Having all the players onside may be essential, but it is not sufficient to bring about action in workplace strategies for patients with low back pain. If early return to modified work is effective, implementing it may require interventions targeted at identified barriers.