Use of qualitative methods alongside randomised controlled trials of complex healthcare interventions: methodological study

Objective To examine the use of qualitative approaches alongside randomised trials of complex healthcare interventions

Portals to Wonderland: Health portals lead to confusing information about the effects of health care

BACKGROUND: The Internet offers a seemingly endless amount of health information of varying quality. Health portals, which provide entry points to quality-controlled collections of websites, have been hailed as a solution to this problem. The objective of this study is to assess the extent to which government-run health portals provide access to relevant, valid and understandable information about the effects of health care. METHODS: We selected eight clinically relevant questions for which there was a systematic review, searched four portals for answers, and compared the answers we found to the results of the systematic reviews. RESULTS: Our searches resulted in 3400 hits, 155 of which mentioned both the condition and the intervention in one of the eight questions. Sixty-three of the 155 web pages did not give any information about the effect of the intervention. Seventy-seven qualitatively described the effects of the intervention. Twenty-six of these had information that was too unclear to be categorised; 15 were not consistent with the systematic review; and 36 were consistent with the review, but usually did not mention what happens without the intervention, what outcomes have been measured or when they were measured. Fifteen web pages quantitatively described effects. Four of these were abstracts from the systematic review, nine had information that was incomplete and potentially misleading because of a lack of information about people not receiving the intervention and the length of follow-up; one had information that was consistent with the review, but only referred to three trials whereas the review included six; and one was consistent with the review. CONCLUSION: Information accessible through health portals is unlikely to be based on systematic reviews and is often unclear, incomplete and misleading. Portals are only as good as the websites they lead to. Investments in national health portals are unlikely to benefit consumers without investments in the production and maintenance of relevant, valid and understandable information to which the portals lead

Stakeholder views on the incorporation of traditional birth attendants into the formal health systems of low-and middle-income countries: a qualitative analysis of the HIFA2015 and CHILD2015 email discussion forums.

BACKGROUND: Health workforce shortages are key obstacles to the achievement of the health-related Millennium Development Goals. Task shifting is seen as a way to improve access to pregnancy and childbirth care. However, the role of traditional birth attendants (TBAs) within task shifting initiatives remains contested. The objective of this study was to explore stakeholder views and justifications regarding the incorporation of TBAs into formal health systems. METHODS: Data were drawn from messages submitted to the HIFA2015 and CHILD2015 email discussion forums. The forums focus on the healthcare information needs of frontline health workers and citizens in low - and middle-income countries, and how these needs can be met, and also include discussion of diverse aspects of health systems. Messages about TBAs submitted between 2007-2011 were analysed thematically. RESULTS: We identified 658 messages about TBAs from a total of 193 participants. Most participants supported the incorporation of trained TBAs into primary care systems to some degree, although their justifications for doing so varied. Participant viewpoints were influenced by the degree to which TBA involvement was seen as a long-term or short-term solution and by the tasks undertaken by TBAs. CONCLUSIONS: Many forum members indicated that they were supportive of trained TBAs being involved in the provision of pregnancy care. Members noted that TBAs were already frequently used by women and that alternative options were lacking. However, a substantial minority regarded doing so as a threat to the quality and equity of healthcare. The extent of TBA involvement needs to be context-specific and should be based on evidence on effectiveness as well as evidence on need, acceptability and feasibility

Optimizing the delivery of contraceptives in low- and middle-income countries through task shifting: a systematic review of effectiveness and safety

Objective: To assess the effectiveness and safety of task shifting for the delivery of injectable contraceptives, contraceptive implants, intrauterine devices (IUDs), tubal ligation and vasectomy in low-and middle-income countries. Methods: Multiple electronic databases were searched up to 25 May 2012 for studies which had assessed the delivery of contraceptives by health workers with lower levels of training, compared to delivery by health workers usually assigned this role, or compared to no organized provision of contraceptives. We included randomized controlled trials, non-randomized controlled trials, controlled before-after studies, and interrupted time series. Data were extracted using a standard form and the certainty of the evidence found was assessed using GRADE. Results: We identified six randomized controlled trials published between 1977 and 1995 that assessed the safety and effectiveness of task shifting for the delivery of long-term contraceptives. Two studies assessed IUD insertion by nurses compared to doctors, two assessed IUD insertion by auxiliary nurse-midwives compared to doctors, one assessed tubal ligation by midwives compared to doctors, and one assessed the delivery of vasectomy by medical students compared to doctors. In general, little or no difference was found in contraceptive outcomes between cadres. Study design limitations and the low number of eligible studies, however, allow only limited conclusions to be drawn. Conclusions: The findings indicate that task shifting for the delivery of long-term contraceptives may be a safe and effective approach to increasing access to contraception. Further research is needed because the certainty of the evidence identified is variable

Optimizing the delivery of contraceptives in low- and middle-income countries through task shifting: a systematic review of effectiveness and safety

Objective: To assess the effectiveness and safety of task shifting for the delivery of injectable contraceptives, contraceptive implants, intrauterine devices (IUDs), tubal ligation and vasectomy in low-and middle-income countries. Methods: Multiple electronic databases were searched up to 25 May 2012 for studies which had assessed the delivery of contraceptives by health workers with lower levels of training, compared to delivery by health workers usually assigned this role, or compared to no organized provision of contraceptives. We included randomized controlled trials, non-randomized controlled trials, controlled before-after studies, and interrupted time series. Data were extracted using a standard form and the certainty of the evidence found was assessed using GRADE. Results: We identified six randomized controlled trials published between 1977 and 1995 that assessed the safety and effectiveness of task shifting for the delivery of long-term contraceptives. Two studies assessed IUD insertion by nurses compared to doctors, two assessed IUD insertion by auxiliary nurse-midwives compared to doctors, one assessed tubal ligation by midwives compared to doctors, and one assessed the delivery of vasectomy by medical students compared to doctors. In general, little or no difference was found in contraceptive outcomes between cadres. Study design limitations and the low number of eligible studies, however, allow only limited conclusions to be drawn. Conclusions: The findings indicate that task shifting for the delivery of long-term contraceptives may be a safe and effective approach to increasing access to contraception. Further research is needed because the certainty of the evidence identified is variable

Completeness of reporting of setting and health worker cadre among trials on antenatal iron and folic acid supplementation in pregnancy: an assessment based on two Cochrane reviews

Abstract Background Poor reporting of medical trials has triggered the development of trial reporting standards within the scientific community. In addition to a description of the proposed intervention, adequate information about the trial setting and the group of health workers (cadre) delivering the intervention would allow a better understanding of the generalizability of the trial findings, facilitate replication of trial interventions and assist with assessment of trials for inclusion in systematic reviews. This study aims to determine the completeness of reporting for trial setting and cadre among trials included in two Cochrane reviews on iron and folic acid supplementation for women during pregnancy. Methods From the 81 trials included in the two Cochrane reviews, we extracted data on the trial setting, including the facility type and geographic location, facility descriptors (i.e. level of care) and population descriptors (i.e. socioeconomic status); and the cadre, including professional qualifications, training and supervision. Results Almost all studies reported the facility type and location (96%). However, only 68% included this information in the “methods” section of the report. Facility descriptors and population descriptors were less commonly reported (26% and 54% respectively). For 34% of the trials, we found some account of the type of health worker that delivered the intervention. Only 4% of the trials reported any training procedures. Conclusions Currently, complete reporting of setting and health worker cadre in iron and folic acid supplementation in pregnancy trials remains far from ideal, limiting assessments of the applicability of the trial findings. Trialists and journals need to ensure that this information is included in trial reports by adhering to and improving current reporting standards and by not making assumptions regarding readers’ knowledge of the context and of the intervention delivery mechanism

Using qualitative research to develop an elaboration of the TIDieR checklist for interventions to enhance vaccination communication: short report

BACKGROUND: The COVID-19 pandemic has led to an increased interest in communication with the public regarding vaccination. Our recent Cochrane qualitative evidence synthesis points to several factors that could influence the implementation and success of healthcare worker communication with older adults about vaccination. However, it is often difficult to assess whether factors identified as potentially important in qualitative studies have been considered in randomized trials because of poor trial reporting. We therefore decided to use our qualitative evidence synthesis findings to encourage better reporting of vaccination communication interventions in trials by developing an elaboration of the TIDieR (Template for Intervention Description and Replication) checklist for intervention reporting. METHODS: We examined the findings from our Cochrane qualitative evidence synthesis on healthcare workers’ perceptions of and experiences with communicating about vaccination with adults over the age of 50 years. We identified factors that could influence the implementation and uptake, and thereby the effectiveness, of vaccination communication interventions. We then drafted a list of the information elements we would need from trial reports to assess whether these factors had been considered in the development of the interventions evaluated in these trials. Finally, we compared our list of information elements to the TIDieR checklist items. We were able to align all of our information elements with the TIDieR items. However, for several of the TIDieR items, we developed a more detailed description to ensure that relevant information would be captured sufficiently in trial reports. RESULTS: We developed elaborations for the following TIDieR items: “Why” (item 2), “What—materials” (item 3), “Who provided” (item 5), “How” (item 6), “Where” (item 7) and “Tailoring” (item 9). CONCLUSIONS: Both qualitative research and trials of intervention effectiveness are critical to furthering our understanding of what works, where, for whom and through which mechanisms. However, a key ingredient for developing this understanding is adequate reporting of intervention design, content and implementation in randomized trials. We hope that this elaboration of the TIDier checklist will improve reporting of interventions in trials focused on vaccine communication with older adults, and thereby enhance the usability of this research for developing future communication strategies

Lay perceptions of evidence-based information – a qualitative evaluation of a website for back pain sufferers

BACKGROUND: In an evidence-informed patient choice the patient has access to research-based information about the effectiveness of health care options and is encouraged to use this information in treatment decisions. This concept has seen growing popularity in recent years. However, we still know relatively little about users' attitudes to the use of research-based information, possibly because people have been unexposed to this type of information. After developing the BackInfo website where the results of Cochrane systematic reviews on the effects of low back pain were adapted and presented to lay users we evaluated how users responded to this information. METHODS: Focus group meetings were held with 18 chronic back pain sufferers, after they had been sent a link to the website before the meetings. RESULTS: The focus groups suggest that the most important challenges to the use of BackInfo's research-based information are not primarily tied to the comprehension or presentation of the information, but are mainly associated with participants' attitudes towards the credibility of research and researchers, and the applicability of research results to themselves as individuals. Possible explanations for participants' lack of trust in research and their apparent difficulties in applying this research to their own situations include aspects that may be typical for the general public including the media's presentation of research, and a lack of familiarity with and feelings of distance to research evidence. Other aspects may be typical for patient groups with chronic and unclear medical conditions, such as a lack of trust in the health care establishment in general. CONCLUSION: In order to enhance the credibility and applicability of research evidence, providers of research-based information could explore a number of possibilities including the use of including personal stories to illustrate the research outcomes

Barriers and facilitators to the implementation of doctor-nurse substitution strategies in primary care: a qualitative evidence synthesis

Item does not contain fulltextBACKGROUND: Having nurses take on tasks that are typically conducted by doctors (doctor-nurse substitution, a form of 'task-shifting') may help to address doctor shortages and reduce doctors' workload and human resource costs. A Cochrane Review of effectiveness studies suggested that nurse-led care probably leads to similar healthcare outcomes as care delivered by doctors. This finding highlights the need to explore the factors that affect the implementation of strategies to substitute doctors with nurses in primary care. In our qualitative evidence synthesis (QES), we focused on studies of nurses taking on tasks that are typically conducted by doctors working in primary care, including substituting doctors with nurses or expanding nurses' roles. OBJECTIVES: (1) To identify factors influencing implementation of interventions to substitute doctors with nurses in primary care. (2) To explore how our synthesis findings related to, and helped to explain, the findings of the Cochrane intervention review of the effectiveness of substituting doctors with nurses. (3) To identify hypotheses for subgroup analyses for future updates of the Cochrane intervention review. SEARCH METHODS: We searched CINAHL and PubMed, contacted experts in the field, scanned the reference lists of relevant studies and conducted forward citation searches for key articles in the Social Science Citation Index and Science Citation Index databases, and 'related article' searches in PubMed. SELECTION CRITERIA: We constructed a maximum variation sample (exploring variables such as country level of development, aspects of care covered and the types of participants) from studies that had collected and analysed qualitative data related to the factors influencing implementation of doctor-nurse substitution and the expansion of nurses' tasks in community or primary care worldwide. We included perspectives of doctors, nurses, patients and their families/carers, policymakers, programme managers, other health workers and any others directly involved in or affected by the substitution. We excluded studies that collected data using qualitative methods but did not analyse the data qualitatively. DATA COLLECTION AND ANALYSIS: We identified factors influencing implementation of doctor-nurse substitution strategies using a framework thematic synthesis approach. Two review authors independently assessed the methodological strengths and limitations of included studies using a modified Critical Appraisal Skills Programme (CASP) tool. We assessed confidence in the evidence for the QES findings using the GRADE-CERQual approach. We integrated our findings with the evidence from the effectiveness review of doctor-nurse substitution using a matrix model. Finally, we identified hypotheses for subgroup analyses for updates of the review of effectiveness. MAIN RESULTS: We included 66 studies (69 papers), 11 from low- or middle-income countries and 55 from high-income countries. These studies found several factors that appeared to influence the implementation of doctor-nurse substitution strategies. The following factors were based on findings that we assessed as moderate or high confidence.Patients in many studies knew little about nurses' roles and the difference between nurse-led and doctor-led care. They also had mixed views about the type of tasks that nurses should deliver. They preferred doctors when the tasks were more 'medical' but accepted nurses for preventive care and follow-ups. Doctors in most studies also preferred that nurses performed only 'non-medical' tasks. Nurses were comfortable with, and believed they were competent to deliver a wide range of tasks, but particularly emphasised tasks that were more health promotive/preventive in nature.Patients in most studies thought that nurses were more easily accessible than doctors. Doctors and nurses also saw nurse-doctor substitution and collaboration as a way of increasing people's access to care, and improving the quality and continuity of care.Nurses thought that close doctor-nurse relationships and doctor's trust in and acceptance of nurses was important for shaping their roles. But nurses working alone sometimes found it difficult to communicate with doctors.Nurses felt they had gained new skills when taking on new tasks. But nurses wanted more and better training. They thought this would increase their skills, job satisfaction and motivation, and would make them more independent.Nurses taking on doctors' tasks saw this as an opportunity to develop personally, to gain more respect and to improve the quality of care they could offer to patients. Better working conditions and financial incentives also motivated nurses to take on new tasks. Doctors valued collaborating with nurses when this reduced thei

A summary to communicate evidence from systematic reviews to the public improved understanding and accessibility of information: a randomized controlled trial.

AbstractObjectivesTo evaluate a new format of a summary, which presents research from synthesized evidence to patients and the public.Study Design and SettingWe conducted a randomized controlled trial in 143 members of the public from five countries (Canada, Norway, Spain, Argentina, and Italy). Participants received either a new summary format (a plain language summary [PLS]) or the current format used in Cochrane systematic reviews. The new PLS presents information about the condition and intervention, a narrative summary of results, and a table of results with absolute numbers for effects of the intervention and quality of the evidence using Grading of Recommendations Assessment, Development, and Evaluation.ResultsWith the new PLS, more participants understood the benefits and harms and quality of evidence (53% vs. 18%, P < 0.001); more answered each of the five questions correctly (P ≤ 0.001 for four questions); and they answered more questions correctly, median 3 (interquartile range [IQR]: 1–4) vs. 1 (IQR: 0–1), P < 0.001). Better understanding was independent of education level. More participants found information in the new PLS reliable, easy to find, easy to understand, and presented in a way that helped make decisions. Overall, participants preferred the new PLS.ConclusionThis new PLS format for patients and the public is a promising tool to translate evidence from synthesized research