Topic identification, selection, and prioritization for health technology assessment in selected countries: a mixed study design.

BACKGROUND: There is limited evidence-informed guidance on TISP processes for countries where health technology assessment (HTA) is in a nascent phase. We aimed to explore the range of topic identification, selection and prioritization (TISP) processes and practices for HTA in selected countries and identify aspects relevant to emerging HTA systems. METHODS: This mixed design study included a systematic literature review, an electronic survey, and individual interviews. We conducted a systematic literature review with criteria that were developed a priori to identify countries deemed to have a recently formalized HTA system. Based on the literature review, a twenty-three item online survey was shared with the identified countries, we completed follow-up interviews with ten participants who have experience with HTA. We analyzed documents, survey responses and interview transcripts thematically to identify lessons related to TISP processes and practices. RESULTS: The literature review identified 29 nine candidate countries as having a "potential" recently formalized HTA system. Twenty-one survey responses were analyzed and supplemented with ten individual interviews. We found variation in countries' approaches to TISP - particularly between pharmaceutical and non-pharmaceutical interventions. Results indicate that TISP is heavily driven by policy makers, expert involvement, and to a lesser extent, relevant stakeholders. The use of horizon-scanning and early warning systems is uncommon. Interviewee participants provided further insight to the survey data, reporting that political awareness and an institutional framework were important to support TISP. TISP can be optimized by stronger national regulations and legislative structures, in addition to education and advocacy about HTA among politicians and decision-makers. In some settings regional networks have been useful, particularly in the development of TISP guidelines and methodologies. Additionally, the technical capacity to conduct TISP, and access to relevant local data were factors limiting TISP in national settings. Increased network collaboration and capacity building were reported as future needs. CONCLUSIONS: This study provides current insights into a topic where there is limited published peer reviewed literature. TISP is an important first step of HTA, and topics should be selected and prioritized based on local need and relevance. The limited capacity for TISP in settings where HTA is emerging may be supported by local and international collaboration to increase capacity and knowledge. To succeed, both TISP and HTA need to be embedded within national health care priority setting and decision-making. More in-depth understanding of where countries are situtated in formalizing the TISP process may help others to overcome factors that facilitate or hinder progress.

Methods, strategies, and incentives to increase response to mental health surveys among adolescents: a systematic review.

BACKGROUND: This systematic review aimed to identify effective methods to increase adolescents' response to surveys about mental health and substance use, to improve the quality of survey information. METHODS: We followed a protocol and searched for studies that compared different survey delivery modes to adolescents. Eligible studies reported response rates, mental health score variation per survey mode and participant variations in mental health scores. We searched CENTRAL, PsycINFO, MEDLINE and Scopus in May 2022, and conducted citation searches in June 2022. Two reviewers independently undertook study selection, data extraction, and risk of bias assessments. Following the assessment of heterogeneity, some studies were pooled using meta-analysis. RESULTS: Fifteen studies were identified, reporting six comparisons related to survey methods and strategies. Results indicate that response rates do not differ between survey modes (e.g., web versus paper-and-pencil) delivered in classroom settings. However, web surveys may yield higher response rates outside classroom settings. The largest effects on response rates were achieved using unconditional monetary incentives and obtaining passive parental consent. Survey mode influenced mental health scores in certain comparisons. CONCLUSIONS: Despite the mixed quality of the studies, the low volume for some comparisons and the limit to studies in high income countries, several effective methods and strategies to improve adolescents' response rates to mental health surveys were identified.

Pulmonary rehabilitation for acute exacerbations of COPD: A systematic review.

INTRODUCTION AND OBJECTIVES: This systematic review summarized the evidence on the effects (benefits and harms) of pulmonary rehabilitation for individuals with acute exacerbations of chronic obstructive pulmonary disease (AECOPD). MATERIAL AND METHODS: We included randomized controlled trials comparing pulmonary rehabilitation to either active interventions or usual care regardless of setting. In March 2022, we searched MEDLINE, Scopus, CENTRAL, CINAHL and Web of Sciences, and trial registries. Record screening, data extraction and risk of bias assessment were undertaken by two reviewers. We assessed the certainty of the evidence using the GRADE approach. RESULTS: This systematic review included 18 studies (n = 1465), involving a combination of mixed settings (8 studies), inpatient settings (8 studies), and outpatient settings (2 studies). The studies were at high risk of performance, detection, and reporting biases. Compared to usual care, pulmonary rehabilitation probably improves AECOPD-related hospital readmissions (relative risk 0.56, 95% CI 0.36 to 0.86; moderate certainty evidence) and cardiovascular submaximal capacity (standardized mean difference 0.73, 95% CI 0.48 to 0.99; moderate certainty evidence). Low certainty evidence suggests that pulmonary rehabilitation may be beneficial on re-exacerbations, dyspnoea, and impact of disease. The evidence regarding the effects of pulmonary rehabilitation on health-related quality of life and mortality is very uncertain (very low certainty evidence). CONCLUSION: Our results indicate that pulmonary rehabilitation may be an effective treatment option for individuals with AECOPD, irrespective of setting. Our certainty in this evidence base was limited due to small studies, heterogeneous rehabilitation programs, numerous methodological weaknesses, and a poor reporting of findings that were inconsistent with each other. Trialists should adhere to the latest reporting standards to strengthen this body of evidence. REGISTRATION: The study protocol was registered in Open Science Framework (https://osf.io/amgbz/).

Effectiveness of non-pharmacological interventions for fibromyalgia and quality of review methods: an overview of Cochrane Reviews.

BACKGROUND: Fibromyalgia syndrome (FMS) is defined as chronic widespread pain associated with sleep disorders, cognitive dysfunction, and somatic symptoms present for at least three months and cannot be better explained by another diagnosis. OBJECTIVES: To examine efficacy and safety of non-pharmacological interventions for FMS in adults reported in Cochrane Reviews, and reporting quality of reviews. METHODS: Systematic reviews of randomised controlled trials (RCTs) of non-pharmacological interventions for FMS were identified from the Cochrane Database of Systematic Reviews (CDSR 2022, Issue 3 and CDSR 2023 Issue 6). Methodological quality was assessed using the AMSTAR-2 tool and a set of methodological criteria critical for analgesic effects. The primary efficacy outcomes of interest were clinically relevant pain relief, improvement in health-related quality of life (HRQoL), acceptability, safety, and reduction of mobility difficulties as reported by study participants. No pooled analyses were planned. We assumed a clinically relevant improvement was a minimal clinically important difference (MCID) between interventions and controls of 15%, or a SMD of more than 0.2, or a MD of more than 0.5, on a 0 to 10 scale. RESULTS: Ten Cochrane reviews were eligible, reporting 181 randomized or quasi- randomized trials (11,917 participants, average trial size 66 participants). The reviews examined exercise training, acupuncture, transcutaneous electrical nerve stimulation, and psychological therapies. One review was rated moderate according to AMSTAR 2, seven were rated low and two were rated critically low. All reviews met most of the additional methodological quality criteria. All reviews included studies with patient-reported outcomes for pain. We found low certainty evidence of clinically relevant positive effects of aerobic and mixed exercise training and for cognitive behavioural therapies (CBTs) at reducing mobility difficulties and for mixed exercise training and CBTs for improving HRQoL at the end of the intervention. Number needed to treat for an additional beneficial outcome (NNTB) values for a MCID of 15% ranged between 4 and 9. We found low certainty evidence that was clinically relevant for mixed exercise and CBTs for reducing mobility difficulties at an average follow up of 24 weeks. We found low certainty evidence of clinically relevant positive effects of mixed exercise on HRQoL at an average follow up of 24 weeks. NNTB values for a MCID of 15% ranged from 5 to 11. The certainty of evidence of the acceptability (measured by dropouts) of the different non-pharmacological interventions ranged from very low to moderate and the dropout rate for any reason did not differ across the interventions or the controls, except for biofeedback and movement therapies. All the systematic reviews stated that the reporting of adverse events was inconsistent in the studies analysed (very low certainty evidence). AUTHORS' CONCLUSIONS: There is low certainty evidence of clinically relevant reduction of mobility difficulties and of improvement of HRQoL among individuals with FMS by aerobic and mixed exercise training and by CBTs at the end of the intervention. There is low certainty evidence that CBTs and mixed exercise training reduces mobility difficulties post-treatment and that mixed exercise training improves HRQoL at follow-up by clinically meaningful scores.

Using evidence to decision frameworks led to guidelines of better quality and more credible and transparent recommendations.

BACKGROUND AND OBJECTIVES: To determine whether the use of Evidence to Decision (EtD) frameworks is associated to higher quality of both guidelines and individual recommendations. METHODS: We identified guidelines recently published by international organizations that have methodological guidance documents for their development. Pairs of researchers independently extracted information on the use of these frameworks, appraised the quality of the guidelines using the Appraisal of Guidelines, Research and Evaluation II Instrument (AGREE-II), and assessed the clinical credibility and implementability of the recommendations with the Appraisal of Guidelines for REsearch & Evaluation Recommendations Excellence (AGREE-REX) tool. We conducted both descriptive and inferential analyses. RESULTS: We included 66 guidelines from 17 different countries, published in the last 5 years. Thirty guidelines (45%) used an EtD framework to formulate their recommendations. Compared to those that did not use a framework, those using an EtD framework scored higher in all domains of both AGREE-II and AGREE-REX (P < 0.05). Quality scores did not differ between the use of the The Grading of Recommendations Assessment, Development and Evaluation-EtD framework (17 guidelines) or another EtD framework (13 guidelines) (P > 0.05). CONCLUSION: The use of EtD frameworks is associated with guidelines of better quality, and more credible and transparent recommendations. Endorsement of EtD frameworks by guideline developing organizations will likely increase the quality of their guidelines.

Capacity-building and continuing professional development in healthcare and rehabilitation in low- and middle-income countries-a scoping review protocol.

BACKGROUND: A recent world health report suggests that there is a growing rehabilitation human resource crisis. This review focuses on the capacity-building needed to meet present and future rehabilitation challenges in low- and middle-income countries (LMICs). Capacity-building is the process by which individuals and organizations obtain, improve, and retain the skills, knowledge, tools, equipment, and other resources needed to do their jobs competently. The objectives of this review are (1) to determine how capacity-building has been defined, implemented, and evaluated in LMICs and (2) to provide an overview of the effectiveness of capacity-building initiatives. METHODS: In the first of seven stages, we will refine and delimit the research. Then, we will identify relevant studies by searching five biomedical databases, two rehabilitation databases, three regional databases, and three databases of gray literature. Two independent reviewers will then select the studies using a priori selection criteria. We will exclude incomplete records, records published prior to 2000 for databases and 2010 for gray literature, and records written in languages other than English or Spanish. We will also exclude records focusing on entry-to-practice programs in academic settings. For Objective 1, using qualitative analysis software, we will extract and analyze text from included records that define or explains capacity building. For Objective 2, using an online file-sharing platform, one reviewer will extract data describing the effectiveness of capacity-building interventions and a second reviewer will verify the accuracy, with disagreements resolved by consensus. The results will be collated using tables and charts. After synthesizing the results, we will discuss the practicality and applicability of the findings with partners from Honduras and Colombia. We will use several formats and venues including presentations and publications in English and Spanish to present our results. DISCUSSION: To our knowledge, this will be the first attempt to systematically identify knowledge of capacity-building and rehabilitation in LMICs. This scoping review results will offer unique insights concerning the breadth and depth of literature in the area. It is anticipated that results from this scoping review will guide efforts in future capacity-building efforts in rehabilitation in LMICs. REVIEW REGISTRATION: Busch AJ, Deprez D, Bidonde J, Ramírez PA, Araque EP. Capacity building and continuing professional development in healthcare and rehabilitation in low- and middle-income countries-a scoping review. 2021. https://doi.org/10.17605/OSF.IO/7VGXU .

RESUMEN: INTRODUCCIóN: La literatura mundial sugiere que existe una creciente crisis de recursos humanos en el área de rehabilitación. Esta Revisión Sistemática Exploratoria se centra en el desarrollo de capacidades en el área de rehabilitación en países de ingresos bajos y medianos (PIBM). El desarrollo de capacidades es el proceso mediante el cual las personas y las organizaciones obtienen, mejoran y retienen las habilidades, el conocimiento, las herramientas, el equipo y otros recursos necesarios para realizar su trabajo de manera competente. OBJETIVOS: Determinar cómo se ha definido, implementado y evaluado el desarrollo de capacidades en rehabilitación en los PIBM; y proporcionar una síntesis sobre la eficacia de las iniciativas de desarrollo de capacidades en rehabilitación en los PIBM. MéTODOS: En la primera de siete etapas, refinaremos las preguntas de la investigación. Luego, identificaremos estudios relevantes mediante la búsqueda de cinco bases de datos y tres bases de datos de literatura gris. Dos revisores en forma independiente seleccionarán los estudios utilizando criterios definidos a priori. Excluiremos registros (artículos y otra literatura) incompletos, publicados antes de 2000 para bases de datos y 2010 para literatura gris, y escritos en idiomas que no sean inglés o español. También excluiremos registros que sobre programas de ingreso a la práctica profesional (académicos). Para el Objetivo 1, extraeremos y analizaremos el texto que define las estrategias/iniciativas de desarrollo de capacidades en rehabilitación utilizando un software de análisis cualitativo. Para el Objetivo 2, un revisor extraerá datos que describen la efectividad de las intervenciones y un segundo revisor verificará la precisión de los datos utilizando una plataforma electrónica. Los desacuerdos entre revisores se resolverán por consenso. Los resultados se presentarán usando tablas y gráficos. Consultaremos con colegas de PIBM sobre la aplicabilidad de los hallazgos. Para la diseminación de resultados, usaremos presentaciones y publicaciones en inglés y español. DISCUSIóN: Hasta donde sabemos, esta será la primera revisión exploratoria para identificar el desarrollo de capacidades en rehabilitación en los PIBM. Se prevé que los resultados de esta revisión guiarán los esfuerzos futuros de desarrollo de capacidades en la rehabilitación de los PIBM.

Association of post-stroke fatigue with physical activity and physical fitness: A systematic review and meta-analysis.

BACKGROUND: It has been hypothesized that post-stroke fatigue (PSF) is associated with reduced physical activity (PA) and impaired physical fitness (fitness). Understanding associations between PSF and PA, and/or fitness could help guide the development of targeted exercise interventions to treat PSF. AIMS: Our systematic review and meta-analysis aimed to investigate PSF's associations with PA and fitness. SUMMARY OF REVIEW: Following a registered protocol, we included studies with cross-sectional or prospective observational designs, published in English or a Scandinavian language, which reported an association of PSF with PA and/or fitness in adult stroke survivors. We searched MEDLINE, Embase, AMED, CINAHL, PsycINFO, ClinicalTrials.gov, and World Health Organization's International Clinical Trials Registry Platform from inception to November 30, 2022. Risk of bias was assessed using Quality in Prognosis Studies. Thirty-two unique studies (total n = 4721 participants, 55% male), and three study protocols were included. We used random-effects meta-analysis to pool data for PA and fitness outcomes, and vote-counting of direction of association to synthesize data that could not be meta-analyzed. We found moderate-certainty evidence of a weak association between higher PSF and impaired fitness (meta r = -0.24; 95% confidence interval (CI) = -0.33, -0.15; n = 905, 7 studies), and very low-certainty evidence of no association between PSF and PA (meta r = -0.09; 95% CI = -0.34, 0.161; n = 430, 3 studies). Vote-counting showed a higher proportion of studies with associations between higher PSF and impaired fitness (pˆ = 0.83; 95% CI = 0.44, 0.97; p = 0.22, n = 298, 6 studies), and with associations between higher PSF and lower PA (pˆ = 0.75; 95% CI = 0.51, 0.90; p = 0.08, n = 2566, 16 studies). Very low- to moderate-certainty evidence reflects small study sample sizes, high risk of bias, and inconsistent results. CONCLUSIONS: The meta-analysis showed moderate-certainty evidence of an association between higher PSF and impaired fitness. These results indicate that fitness might protect against PSF. Larger prospective studies and randomized controlled trials evaluating the effect of exercise on PSF are needed to confirm these findings.

Critical perspectives on rehabilitation education, practice and process: northern Honduras case study.

BACKGROUND: Rehabilitation services are an integral part of patient care, but in many developing countries, they are not prioritized and either unavailable or easily accessible to those who need them. Although the need for rehabilitation services is increasing in Honduras, rehabilitation workers are not included in the health care model that guides the care provided to communities, particularly in rural and remote areas. To understand the need for providing impactful rehabilitation services in disadvantaged communities, we explored the education and perception of the community relating to rehabilitation, investigated training available for rehabilitation workers, and examined the rehabilitation processes and practices in Northern Honduras from stakeholders' experiences. METHODS: We utilized a qualitative descriptive and interpretive approach grounded in case study methodology to understand rehabilitation education, process, and practice in Northern Honduras. Three rehabilitation centres were purposefully selected as the cases, and participants consisted of rehabilitation workers and managers from these centres. We collected data via interviews and focus group sessions. We analyzed the data via thematic analysis using NVivo version 12. RESULTS: In Northern Honduras, rehabilitation workers' limited training and continuing education, along with awareness about rehabilitation by community members and other health providers influence rehabilitation care. Although policies and initiatives to support people with disabilities and the broader community in need of rehabilitation exist, most policies are not applied in practice. The sustainability of rehabilitation services, which is rooted in charity, is challenged by the small range of funding opportunities strongly affecting rehabilitation care processes and clinical practices. The lack of trust and awareness from the medical profession towards rehabilitation workers sets a major barrier to referrals, interdisciplinary work, and quality of life for individuals in need of rehabilitation. CONCLUSION: This study advances knowledge of the need to increase understanding of rehabilitation care among community members and health providers, improve care processes and resources, and foster interprofessional practice, to enhance the quality of care and promote equitable care delivery, especially in rural and remote communities.

Evidence to decision frameworks enabled structured and explicit development of healthcare recommendations.

OBJECTIVE: The aim of this study is to identify and describe the processes suggested for the formulation of healthcare recommendations in healthcare guidelines available in guidance documents. METHODS: We searched international databases in May 2020 to retrieve guidance documents published by organizations dedicated to guideline development. Pairs of researchers independently selected and extracted data about the characteristics of the guidance document, including explicit or implicit recommendation-related criteria and processes considered, as well as the use of evidence to decision (EtD) frameworks. RESULTS: We included 68 guidance documents. Most organizations reported a system for grading the strength of recommendations (88%), half of them being the GRADE (Grading of Recommendations Assessment, Development, and Evaluation) approach. Two out of three guidance documents (66%) proposed the use of a framework to guide the EtD process. The GRADE-EtD framework was the most often reported framework (19 organizations, 42%), whereas 20 organizations (44%) proposed their own multicriteria frameworks. Using any EtD framework was related with a more comprehensive set of recommendation-related criteria compared to no framework, especially for criteria like values, equity, and acceptability. CONCLUSION: Although limited, the use of EtD frameworks was associated with the inclusion of relevant recommendation criteria. Among the EtD structured frameworks, the GRADE-EtD framework offers the most comprehensive perspective for evidence-informed decision-making processes.

Developing a tool to assess the skills to perform a health technology assessment.

BACKGROUND: Health technology assessment (HTA) brings together evidence from various disciplines while using explicit methods to assess the value of health technologies. In resource-constrained settings, there is a growing demand to measure and develop specialist skills, including those for HTA, to aid the implementation of Universal Healthcare Coverage. The purpose of this study was twofold: a) to find validated tools for the assessment of the technical capacity to conduct a HTA, and if none were found, to develop a tool, and b) to describe experiences of its pilot. METHODS: First, a mapping review identified tools to assess the skills to conduct a HTA. A medical librarian conducted a comprehensive search in four databases (MEDLINE, Embase, Web of Science, ERIC). Then, incorporating results from the mapping and following an iterative process involving stakeholders and experts, we developed a HTA skills assessment tool. Finally, using an online platform to gather and analyse responses, in collaboration with our institutional partner, we piloted the tool in Ghana, and sought feedback on their experiences. RESULTS: The database search yielded 3871 records; fifteen those were selected based on a priori criteria. These records were published between 2003 and 2018, but none covered all technical skills to conduct a HTA. In the absence of an instrument meeting our needs, we developed a HTA skill assessment tool containing four sections (general information, core and soft skills, and future needs). The tool was designed to be administered to a broad range of individuals who would potentially contribute to the planning, delivery and evaluation of HTA. The tool was piloted with twenty-three individuals who completed the skills assessment and shared their initial impressions of the tool. CONCLUSIONS: To our knowledge, this is the first comprehensive tool enabling the assessment of technical skills to conduct a HTA. This tool allows teams to understand where their individual strengths and weakness lie. The tool is in the early validation phases and further testing is needed. TRIAL REGISTRATION: Not applicable.

Patient-important outcomes reported in randomized controlled trials of pharmacologic treatments for COVID-19: a protocol of a META-epidemiological study.

BACKGROUND: The coronavirus disease 19 (covid-19) pandemic has underscored the need to expedite clinical research, which may lead investigators to shift away from measuring patient-important outcomes (PIO), limiting research applicability. We aim to investigate if randomized controlled trials (RCTs) of covid-19 pharmacological therapies include PIOs. METHODS: We will perform a meta-epidemiological study of RCTs that included people at risk for, or with suspected, probable, or confirmed covid-19, examining any pharmacological treatment or blood product aimed at prophylaxis or treatment. We will obtain data from all RCTs identified in a living network metanalysis (NMA). The main data sources are the living WHO covid-19 database up to 1 March 2021 and six additional Chinese databases up to 20 February 2021. Two reviewers independently will review each citation, full-text article, and abstract data. To categorize the outcomes according to their importance to patients, we will adapt a previously defined hierarchy: a) mortality, b) quality of life/ functional status/symptoms, c) morbidity, and d) surrogate outcomes. Outcomes within the category a) and b) will be considered critically important to patients, and outcomes within the category c) will be regarded as important. We will use descriptive statistics to assess the proportion of studies that report each category of outcomes. We will perform univariable and multivariable analysis to explore associations between trial characteristics and the likelihood of reporting PIOs. DISCUSSION: The findings from this meta-epidemiological study will help health care professionals and researchers understand if the current covid-19 trials are effectively assessing and reporting the outcomes that are important to patients. If a deficiency in capturing PIOs is identified, this information may help inform the development of future RCTs in covid-19. SYSTEMATIC REVIEW REGISTRATIONS: Open Science Framework registration: osf.io/6xgjz .

An institutional ethnographic analysis of public and patient engagement activities at a national health technology assessment agency.

OBJECTIVE: The practice of public and patient engagement (PPE) in health technology assessment (HTA) has spread worldwide, yet gaps in knowledge remain. We carried out an institutional ethnography of the Canadian Agency for Drugs and Technologies in Health (CADTH) public and patient involvement in HTA. METHODS: The research took place over 15 months and included observational work in the institutional settings, text review, and interviews with individuals working for or involved with the agency. RESULTS: We found that despite demonstrated commitment to PPE, organizational history, governance structure, and practices were impediments to a unified approach to PPE. Unclear role descriptions for committee members and differences in philosophy and priority given to PPE across the organization presented challenges to effective participation. The high degree of value given to evidence-based principles at times conflicted with meaningful integration of patient input. A lack of clear goals and processes, roles, and differential treatment of evidence in PPE served to minimize the importance of patient experiences and to displace their validity. An acknowledgment of conflicts between multiple epistemic traditions at work within HTA activities may strengthen organizational approaches to PPE. CONCLUSION: HTA organizations can learn from this study by reflecting on the challenges described and the recommendations offered to address them. We suggest solidifying CADTH's commitment to PPE with clear agency-wide roles and direction, values, and outcomes, a comprehensive framework, and policy and procedures. An acknowledgment of diverse epistemic traditions, as well as leadership and expertise in PPE, will strengthen CADTH's PPE activities and sustain its leadership position in the HTA field.

An algorithm provided as initial guidance for reporting registry records and published protocols in systematic reviews.

OBJECTIVE: We aim to synthesize the available guidance with existing practices by Cochrane reviewers to generate an algorithm as a starting point in assisting reviewers reporting of registry records and published protocols (TRRs/PPs) use in systematic reviews of interventions. STUDY DESIGN: We used existing guidance from major review bodies, assessed the current reporting of TRRs/PPs use in a sample of Cochrane reviews, and engaged in critical analysis. Independent reviewers identified and extracted textual excerpts reporting the use of trial registry records and published protocols and codes following a systematic review framework. Based on these elements, and our initial research, we created an algorithm/graphical aid to visualize initial direction. RESULTS: We included 166 Cochrane systematic reviews published between August 2015 and 2016 from 48 review groups. Review authors' terminology (e.g., ongoing, terminated) varied between and within reviews. Reporting practices were diverse and inconsistent. CONCLUSIONS: This is a timely investigation in an era where evidence synthesis informs health and health care decisions. Our proposed algorithm provides initial direction to systematize the reporting of TRR/PP use. We hope that the algorithm generates further discussion to enhance the transparency of TRR/PP reporting and methodological research into the complexities of using protocols in systematic reviews of interventions.

Analysis of reporting completeness in exercise cancer trials: a systematic review.

BACKGROUND: Exercise is an effective therapeutic intervention for cancer survivors. Concerns about the completeness of reporting of exercise interventions have been raised in the literature, but without any formal analysis. This study aimed to evaluate the completeness of reporting of exercise interventions for cancer survivors in a large sample of randomized clinical trials (RCTs). METHODS: We developed a pre-defined protocol. We searched MEDLINE, EMBASE, and CENTRAL for exercise trials in oncology between 2010 and 2017. Pairs of independent researchers screened the records, extracted study characteristics, and assessed 16 items on the TIDieR checklist (i.e., the 12 items, with item 5 divided into two and item 8 divided into four). For each of these items, the percentage of interventions in the included studies that reported the item was calculated. RESULTS: We included 131 RCTs reporting 138 interventions in the analysis. Breast cancer was the most common type of cancer (69, 50%), and aerobic exercise was the most studied exercise modality (43, 30%) followed by combined aerobic and resistance training (40, 28%). Completeness of reporting ranged from 42 to 96% among the TIDieR items; none of the items was fully reported. 'Intervention length' was the most reported item across interventions (133, 96%), followed by 'rationale' (131, 95%), whereas 'provider' (58, 42%) and 'how well (planned)' (63, 46%) were the two least reported items. Half of the TIDieR items were completely reported in 50 to 70% of the interventions, and only four items were reported in more than 80% of the interventions (Items 2 and 8a to c). The seven items deemed to be core for replication (Items 3 to 9) exhibited a mean reporting of 71%, ranging from 42 to 96%. CONCLUSION: Exercise training interventions for cancer survivors are incompletely reported across RCTs published between 2010 and 2017. The reporting of information about the provider, materials, and modifications require urgent improvements. Stronger reporting will enhance usability of trial reports by both healthcare providers and survivors, and will help to reduce research waste.

Flexibility exercise training for adults with fibromyalgia.

BACKGROUND: Exercise training is commonly recommended for adults with fibromyalgia. We defined flexibility exercise training programs as those involving movements of a joint or a series of joints, through complete range of motion, thus targeting major muscle-tendon units. This review is one of a series of reviews updating the first review published in 2002. OBJECTIVES: To evaluate the benefits and harms of flexibility exercise training in adults with fibromyalgia. SEARCH METHODS: We searched the Cochrane Library, MEDLINE, Embase, CINAHL (Cumulative Index to Nursing and Allied Health Literature), PEDro (Physiotherapy Evidence Database), Thesis and Dissertation Abstracts, AMED (Allied and Complementary Medicine Database), the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP), and ClinicalTrials.gov up to December 2017, unrestricted by language, and we reviewed the reference lists of retrieved trials to identify potentially relevant trials. SELECTION CRITERIA: We included randomized trials (RCTs) including adults diagnosed with fibromyalgia based on published criteria. Major outcomes were health-related quality of life (HRQoL), pain intensity, stiffness, fatigue, physical function, trial withdrawals, and adverse events. DATA COLLECTION AND ANALYSIS: Two review authors independently selected articles for inclusion, extracted data, performed 'Risk of bias' assessments, and assessed the certainty of the body of evidence for major outcomes using the GRADE approach. All discrepancies were rechecked, and consensus was achieved by discussion. MAIN RESULTS: We included 12 RCTs (743 people). Among these RCTs, flexibility exercise training was compared to an untreated control group, land-based aerobic training, resistance training, or other interventions (i.e. Tai Chi, Pilates, aquatic biodanza, friction massage, medications). Studies were at risk of selection, performance, and detection bias (due to lack of adequate randomization and allocation concealment, lack of participant or personnel blinding, and lack of blinding for self-reported outcomes). With the exception of withdrawals and adverse events, major outcomes were self-reported and were expressed on a 0-to-100 scale (lower values are best, negative mean differences (MDs) indicate improvement). We prioritized the findings of flexibility exercise training compared to land-based aerobic training and present them fully here.Very low-certainty evidence showed that compared with land-based aerobic training, flexibility exercise training (five trials with 266 participants) provides no clinically important benefits with regard to HRQoL, pain intensity, fatigue, stiffness, and physical function. Low-certainty evidence showed no difference between these groups for withdrawals at completion of the intervention (8 to 20 weeks).Mean HRQoL assessed on the Fibromyalgia Impact Questionnaire (FIQ) Total scale (0 to 100, higher scores indicating worse HRQoL) was 46 mm and 42 mm in the flexibility and aerobic groups, respectively (2 studies, 193 participants); absolute change was 4% worse (6% better to 14% worse), and relative change was 7.5% worse (10.5% better to 25.5% worse) in the flexibility group. Mean pain was 57 mm and 52 mm in the flexibility and aerobic groups, respectively (5 studies, 266 participants); absolute change was 5% worse (1% better to 11% worse), and relative change was 6.7% worse (2% better to 15.4% worse). Mean fatigue was 67 mm and 71 mm in the aerobic and flexibility groups, respectively (2 studies, 75 participants); absolute change was 4% better (13% better to 5% worse), and relative change was 6% better (19.4% better to 7.4% worse). Mean physical function was 23 points and 17 points in the flexibility and aerobic groups, respectively (1 study, 60 participants); absolute change was 6% worse (4% better to 16% worse), and relative change was 14% worse (9.1% better to 37.1% worse). We found very low-certainty evidence of an effect for stiffness. Mean stiffness was 49 mm to 79 mm in the flexibility and aerobic groups, respectively (1 study, 15 participants); absolute change was 30% better (8% better to 51% better), and relative change was 39% better (10% better to 68% better). We found no evidence of an effect in all-cause withdrawal between the flexibility and aerobic groups (5 studies, 301 participants). Absolute change was 1% fewer withdrawals in the flexibility group (8% fewer to 21% more), and relative change in the flexibility group compared to the aerobic training intervention group was 3% fewer (39% fewer to 55% more). It is uncertain whether flexibility leads to long-term effects (36 weeks after a 12-week intervention), as the evidence was of low certainty and was derived from a single trial.Very low-certainty evidence indicates uncertainty in the risk of adverse events for flexibility exercise training. One adverse effect was described among the 132 participants allocated to flexibility training. One participant had tendinitis of the Achilles tendon (McCain 1988), but it is unclear if the tendinitis was a pre-existing condition. AUTHORS' CONCLUSIONS: When compared with aerobic training, it is uncertain whether flexibility improves outcomes such as HRQoL, pain intensity, fatigue, stiffness, and physical function, as the certainty of the evidence is very low. Flexibility exercise training may lead to little or no difference for all-cause withdrawals. It is also uncertain whether flexibility exercise training has long-term effects due to the very low certainty of the evidence. We downgraded the evidence owing to the small number of trials and participants across trials, as well as due to issues related to unclear and high risk of bias (selection, performance, and detection biases). While flexibility exercise training appears to be well tolerated (similar withdrawal rates across groups), evidence on adverse events was scarce, therefore its safety is uncertain.

Ethical Challenges Related to Patient Involvement in Health Technology Assessment.

Including information and values from patients in HTA has the potential to improve both the process and outcomes of health technology policy decisions. Accordingly, funding and structural incentives to include patients in HTA activities have increased over the past several years. Unfortunately, these incentives have not yet been accompanied by a corresponding increase in resources, time, or commitment to responsiveness. In this Perspectives piece, we reflect on our collective experiences participating in, conducting, and overseeing patient engagement activities within HTA to highlight the ethical challenges associated with this area of activity. While we remain committed to the idea that patient engagement activities strengthen the findings, relevance, and legitimacy of health technology policy, we are deeply concerned about the potential for these activities to do ethical harm. We use this analysis to call for action to introduce strong protections against ethical violations that may harm patients participating in HTA engagement activities.

Mixed exercise training for adults with fibromyalgia.

BACKGROUND: Exercise training is commonly recommended for individuals with fibromyalgia. This review is one of a series of reviews about exercise training for fibromyalgia that will replace the review titled "Exercise for treating fibromyalgia syndrome", which was first published in 2002. OBJECTIVES: To evaluate the benefits and harms of mixed exercise training protocols that include two or more types of exercise (aerobic, resistance, flexibility) for adults with fibromyalgia against control (treatment as usual, wait list control), non exercise (e.g. biofeedback), or other exercise (e.g. mixed versus flexibility) interventions.Specific comparisons involving mixed exercise versus other exercises (e.g. resistance, aquatic, aerobic, flexibility, and whole body vibration exercises) were not assessed. SEARCH METHODS: We searched the Cochrane Library, MEDLINE, Embase, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), Thesis and Dissertations Abstracts, the Allied and Complementary Medicine Database (AMED), the Physiotherapy Evidence Databese (PEDro), Current Controlled Trials (to 2013), WHO ICTRP, and ClinicalTrials.gov up to December 2017, unrestricted by language, to identify all potentially relevant trials. SELECTION CRITERIA: We included randomised controlled trials (RCTs) in adults with a diagnosis of fibromyalgia that compared mixed exercise interventions with other or no exercise interventions. Major outcomes were health-related quality of life (HRQL), pain, stiffness, fatigue, physical function, withdrawals, and adverse events. DATA COLLECTION AND ANALYSIS: Two review authors independently selected trials for inclusion, extracted data, and assessed risk of bias and the quality of evidence for major outcomes using the GRADE approach. MAIN RESULTS: We included 29 RCTs (2088 participants; 98% female; average age 51 years) that compared mixed exercise interventions (including at least two of the following: aerobic or cardiorespiratory, resistance or muscle strengthening exercise, and flexibility exercise) versus control (e.g. wait list), non-exercise (e.g. biofeedback), and other exercise interventions. Design flaws across studies led to selection, performance, detection, and selective reporting biases. We prioritised the findings of mixed exercise compared to control and present them fully here.Twenty-one trials (1253 participants) provided moderate-quality evidence for all major outcomes but stiffness (low quality). With the exception of withdrawals and adverse events, major outcome measures were self-reported and expressed on a 0 to 100 scale (lower values are best, negative mean differences (MDs) indicate improvement; we used a clinically important difference between groups of 15% relative difference). Results for mixed exercise versus control show that mean HRQL was 56 and 49 in the control and exercise groups, respectively (13 studies; 610 participants) with absolute improvement of 7% (3% better to 11% better) and relative improvement of 12% (6% better to 18% better). Mean pain was 58.6 and 53 in the control and exercise groups, respectively (15 studies; 832 participants) with absolute improvement of 5% (1% better to 9% better) and relative improvement of 9% (3% better to 15% better). Mean fatigue was 72 and 59 points in the control and exercise groups, respectively (1 study; 493 participants) with absolute improvement of 13% (8% better to 18% better) and relative improvement of 18% (11% better to 24% better). Mean stiffness was 68 and 61 in the control and exercise groups, respectively (5 studies; 261 participants) with absolute improvement of 7% (1% better to 12% better) and relative improvement of 9% (1% better to 17% better). Mean physical function was 49 and 38 in the control and exercise groups, respectively (9 studies; 477 participants) with absolute improvement of 11% (7% better to 15% better) and relative improvement of 22% (14% better to 30% better). Pooled analysis resulted in a moderate-quality risk ratio for all-cause withdrawals with similar rates across groups (11 per 100 and 12 per 100 in the control and intervention groups, respectively) (19 studies; 1065 participants; risk ratio (RR) 1.02, 95% confidence interval (CI) 0.69 to 1.51) with an absolute change of 1% (3% fewer to 5% more) and a relative change of 11% (28% fewer to 47% more). Across all 21 studies, no injuries or other adverse events were reported; however some participants experienced increased fibromyalgia symptoms (pain, soreness, or tiredness) during or after exercise. However due to low event rates, we are uncertain of the precise risks with exercise. Mixed exercise may improve HRQL and physical function and may decrease pain and fatigue; all-cause withdrawal was similar across groups, and mixed exercises may slightly reduce stiffness. For fatigue, physical function, HRQL, and stiffness, we cannot rule in or out a clinically relevant change, as the confidence intervals include both clinically important and unimportant effects.We found very low-quality evidence on long-term effects. In eight trials, HRQL, fatigue, and physical function improvement persisted at 6 to 52 or more weeks post intervention but improvements in stiffness and pain did not persist. Withdrawals and adverse events were not measured.It is uncertain whether mixed versus other non-exercise or other exercise interventions improve HRQL and physical function or decrease symptoms because the quality of evidence was very low. The interventions were heterogeneous, and results were often based on small single studies. Adverse events with these interventions were not measured, and thus uncertainty surrounds the risk of adverse events. AUTHORS' CONCLUSIONS: Compared to control, moderate-quality evidence indicates that mixed exercise probably improves HRQL, physical function, and fatigue, but this improvement may be small and clinically unimportant for some participants; physical function shows improvement in all participants. Withdrawal was similar across groups. Low-quality evidence suggests that mixed exercise may slightly improve stiffness. Very low-quality evidence indicates that we are 'uncertain' whether the long-term effects of mixed exercise are maintained for all outcomes; all-cause withdrawals and adverse events were not measured. Compared to other exercise or non-exercise interventions, we are uncertain about the effects of mixed exercise because we found only very low-quality evidence obtained from small, very heterogeneous trials. Although mixed exercise appears to be well tolerated (similar withdrawal rates across groups), evidence on adverse events is scarce, so we are uncertain about its safety. We downgraded the evidence from these trials due to imprecision (small trials), selection bias (e.g. allocation), blinding of participants and care providers or outcome assessors, and selective reporting.

Therapeutic validity of exercise interventions in the management of fibromyalgia.

BACKGROUND: This study aimed to evaluate the therapeutic validity of exercise interventions included in a previous umbrella systematic review of high-quality randomized controlled trials (RCTs) in the management of fibromyalgia and to explore whether exercise interventions with high therapeutic validity and that meet the 2013 American College of Sports Medicine (ACSM) guidelines are positively associated with greater pain relief. METHODS: Therapeutic validity was evaluated based on the CONsensus on Therapeutic Exercise and Training (CONTENT) Scale, in high methodological quality RCTs found in the nine systematic reviews of a previous umbrella review on exercise interventions in the management of fibromyalgia. Additionally, adherence to the 2013 ACSM exercise recommendations for fibromyalgia was analyzed. The effect size for pain relief after the exercise programs was also considered. RESULTS: The CONTENT mean total score was 4.42 out of 9, demonstrating generally low therapeutic validity of the 28 included RCTs. There was poor concordance between therapeutic validity and pain relief (Kappa values ranging between -0.6 to 0.57). Kappa statistic results showed poor concordance (k=0.01) between statistically significant (P<0.05) pain relief values and adherence to the 2013 ACSM exercise recommendations. CONCLUSIONS: The therapeutic validity of exercise intervention programs in fibromyalgia is low. This is mainly due to incomplete descriptions of exercise interventions and adherence. Poor concordance is found between high therapeutic validity and adherence to the ACSM exercise recommendations with pain relief. Improved standardized reporting is recommended to identify optimal exercise prescription for fibromyalgia.

Evaluating Patient, Family and Public Engagement in Health Services Improvement and System Redesign.

As efforts to actively involve patients, family members and the broader public in health service improvement and system redesign have grown, increasing attention has also been paid to evaluation of their engagement in the health system. We discuss key concepts and approaches related to evaluation, drawing particular attention to different and potentially competing goals, stakeholders and epistemological entry points. Evaluation itself can be supported by an increasing number of frameworks and tools, matched to the relevant purpose and approach. The patient engagement evaluation field faces several challenges, including the need for greater specification of both the form and the context of engagement, the need to balance the measurement imperative with the relational aspects of care and the need for supportive organizations with the capacity and commitment to undertake high-quality engagement and its evaluation.

Scoping Review of Dance for Adults With Fibromyalgia: What Do We Know About It?

BACKGROUND: Fibromyalgia is a chronic disorder characterized by widespread muscular tenderness, pain, fatigue, and cognitive difficulties. Nonpharmacological treatment options, such as physical activity, are important for people with fibromyalgia. There are strong recommendations to support engagement in physical activity for symptom management among adults with fibromyalgia. Dance is a mode of physical activity that may allow individuals with fibromyalgia to improve their physical function, health, and well-being. Dance has the potential to promote improved pain processing while simultaneously providing the health and social benefits of engaging in physical activity that contributes to symptom management and overall function rehabilitation. However, we are unaware of current evidence on dance as a nonpharmacological/physical activity intervention for adults with fibromyalgia. OBJECTIVE: The aims of this study were to understand how dance is used therapeutically by individuals with fibromyalgia; to examine the extent, range and nature of research activity in the area; and to determine the value of undertaking a systematic review of interventions. METHODS: We used and adapted the Arksey and O'Malley scoping framework. The search strategy involved a comprehensive search of main health and electronic social databases, trial registries and grey literature without language limits. Pairs of reviewers independently screened and extracted data and evaluated the methodological quality of randomized control trials. RESULTS: Twenty-one unique records for 13 studies met inclusion criteria; the studies included mostly middle-aged women. Types of dance included were aerobic dance, belly dance, dance movement therapy, biodanza and Zumba. Intervention parameters were different among studies. Frequency varied between one to three times a week; all were done in small group settings. Studies evaluated a variety of outcomes in the symptoms, wellness, psychosocial, physical functioning, balance and fitness categories; no studies evaluated the safety or adverse events systematically which is a major weakness of the literature. CONCLUSIONS: There are few studies in the field of dance and fibromyalgia, suggesting research is in its infancy but slowly growing. They are of European and South American origin, focusing on female participants and a limited number of dance modes. Because the body of literature is small, of low quality and highly heterogeneous, we concluded that a systematic review of interventions on dance is not warranted at this time.