Netherlands Organisation for Health Research and Development

The European Commission (EC) has proposed redefining ‘unmet medical need’ to steer pharmaceutical innovation and link it to incentives and regulatory tools and procedures. A multistakeholder meeting of the Regulatory Science Network Netherlands (RSNN) discussed the impact of this proposal. Four principles were highlighted (flexibility, feasibility, fairness, and sensitivity to risk) that were not considered sufficiently addressed. Concerns were raised about whether innovation would be incentivised, given the diverse and complex reasons why areas of unmet medical need may remain unaddressed. A more high-level definition of unmet medical need that gives guidance but allows for specification for specific uses throughout the medicine lifecycle was generally preferred. As the legislative process unfolds, stakeholder engagement will be essential to refine the definition to achieve the intended policy goals.

Background: When health-related research funding agencies choose to fund research, they balance a number of competing issues: costs, stakeholder views and potential benefits. The REWARD Alliance, and the related Lancet-REWARD Campaign, question whether those decisions are yielding all the value they could. Methods: A group of health-related research funding agencies, organisations that represent health-related research funding agencies and those that inform and set health-related-research funding policy from around the world have come together since 2016 to share, learn, collaborate and influence emerging practice. This group meets under the name of the Ensuring Value in Research Funders’ Forum (EViR Funders’ Forum). The EViR Funders’ Forum worked together to develop a set of ten Guiding Principles, that if funders adhered to would reduce research waste and ensure value in research. Results: The EViR Funders’ Forum has previously agreed and published a Consensus Statement. The Forum has agreed on a set of ten Guiding Principles to help health-research funders to maximise the value of research by ensuring that: research priorities are justifiable; the design, conduct and analysis of research minimise bias; regulation and management are proportionate to risks; methods and findings are accessible in full; and findings are appropriately and effectively disseminated and used. Conclusions: When setting research funding policy, we must balance multiple stakeholders’ needs and expectations. When funders do this well, they maximise the probability of benefits to society from the research they support - when funders do this badly, they passively allow or actively contribute to research waste. These challenges must be resolved by funders either working together or in conjunction with other actors in the research ecosystem.

Sarcopenia, the age-related loss of skeletal muscle mass and function, is associated with increasing burden of frailty, disability, and mortality for our aging society. Nevertheless, the underlying cellular and molecular mechanisms and the role of life-style factors are insufficiently understood. Exercise is one such factor and recent evidence supports the potential of strength training alone or combined with aerobic exercise to mitigate sarcopenia. Gut microbiota are implicated in the development of muscle loss during aging as well, as recently systematically reviewed in this journal. Consequently, the combination of appropriate exercise programmes and dietary interventions aimed at modifying gut microbiota hold great promise to counteract sarcopenia. However, the evaluation of such combined approaches led to ambiguous results, with one recent meta-analysis supporting favourable effects on aging-related sarcopenia and another not. Herein, we discuss potential reasons for those discrepancies, elucidate the complex interactions between exercise, gut microbiota and skeletal muscle health, and suggest appropriate intervention strategies to prevent aging-related sarcopenia.

BackgroundThe supportive needs for head and neck cancer (HNC) patients during the vulnerable period after treatment are not always met. Therefore, more professional support regarding physical, social and psychological care as well as lifestyle is recommended.ObjectiveEvaluation of a nurse-led aftercare intervention to support patients recovering from HNC treatment.MethodsIntervention group (IG) participants received two extra consultations from a nurse practitioner three and nine months after treatment for HNC. A holistic conversational tool, the Self-Management Web, was developed to guide the nurse through the conversation. Primary outcomes were health-related quality of life (HRQoL) and quality of patient-centered care. A secondary outcome was self-management skills.Results27 patients were included in the IG and 28 in the control group (CG). Differences in HRQoL and self-management between the IG and CG were not statistically significant. For the IG, all domains of the Self-Management Web were perceived important and addressed by the nurse practitioner.ConclusionThis holistic nurse-led aftercare intervention was highly appreciated by HNC patients. Though the intervention met the need for support in recovery after treatment, it did not improve HRQoL or self-management skills.Implications of practiceFor both nurses and patients the intervention is feasible and acceptable in daily practice. Self-management support for patients after their cancer treatment is of added value and has potential to improve the quality of regular follow-up care.

Systematic review and meta-analysis. To give a systematic overview of effectiveness of percutaneous transforaminal endoscopic discectomy (PTED) compared with open microdiscectomy (OM) in the treatment of lumbar disk herniation (LDH). The current standard procedure for the treatment of sciatica caused by LDH, is OM. PTED is an alternative surgical technique which is thought to be less invasive. It is unclear if PTED has comparable outcomes compared with OM. Multiple online databases were systematically searched up to April 2020 for randomized controlled trials and prospective studies comparing PTED with OM for LDH. Primary outcomes were leg pain and functional status. Pooled effect estimates were calculated for the primary outcomes only and presented as standard mean differences (SMD) with their 95% confidence intervals (CI) at short (1-day postoperative), intermediate (3-6 months), and long-term (12 months). We identified 2276 citations, of which eventually 14 studies were included. There was substantial heterogeneity in effects on leg pain at short term. There is moderate quality evidence suggesting no difference in leg pain at intermediate (SMD 0.05, 95% CI -0.10-0.21) and long-term follow-up (SMD 0.11, 95% CI -0.30-0.53). Only one study measured functional status at short-term and reported no differences. There is moderate quality evidence suggesting no difference in functional status at intermediate (SMD -0.09, 95% CI -0.24-0.07) and long-term (SMD -0.11, 95% CI -0.45-0.24). There is moderate quality evidence suggesting no difference in leg pain or functional status at intermediate and long-term follow-up between PTED and OM in the treatment of LDH. High quality, robust studies reporting on clinical outcomes and cost-effectiveness on the long term are lacking.Level of Evidence: 2.

De zorg- en dienstverlening in het sociale domein is volop in beweging. We zijn alweer ruim drie jaar op weg na de decentralisatie van drie belangrijke wetten, de Jeugdwet, de Wet maatschappelijke ondersteuning 2015 (Wmo 2015) en de Participatiewet. Het doel van deze wetten is het bevorderen van participatie van burgers in de samenleving. Bij de decentralisaties bestonden bij aanvang bedenkingen, die te maken hadden met de vraag of gemeenten deze omslag op zo’n korte termijn aankonden en of er voldoende financiele middelen beschikbaar waren. Voor een transformatie van de zorg- en dienstverlening in de welzijnssector bestond echter een breed draagvlak. Burgers zouden meer moeten vertrouwen op hun eigen vermogen en de mogelijkheden van steun uit de sociale omgeving. Professionele hulp wordt ingeschakeld als deze bronnen van zelf- en mantelzorg tekortschieten. We zetten in dit themanummer de veranderingen in de zorg in het kader van de Wmo 2015 en de Jeugdwet centraal, en leggen een relatie met aanpalende sectoren die werken onder de Wet publieke gezondheid en de Participatiewet.