Saturation has attained widespread acceptance as a methodological principle in qualitative research. It is commonly taken to indicate that, on the basis of the data that have been collected or analysed hitherto, further data collection and/or analysis are unnecessary. However, there appears to be uncertainty as to how saturation should be conceptualized, and inconsistencies in its use. In this paper, we look to clarify the nature, purposes and uses of saturation, and in doing so add to theoretical debate on the role of saturation across different methodologies. We identify four distinct approaches to saturation, which differ in terms of the extent to which an inductive or a deductive logic is adopted, and the relative emphasis on data collection, data analysis, and theorizing. We explore the purposes saturation might serve in relation to these different approaches, and the implications for how and when saturation will be sought. In examining these issues, we highlight the uncertain logic underlying saturation—as essentially a predictive statement about the unobserved based on the observed, a judgement that, we argue, results in equivocation, and may in part explain the confusion surrounding its use. We conclude that saturation should be operationalized in a way that is consistent with the research question(s), and the theoretical position and analytic framework adopted, but also that there should be some limit to its scope, so as not to risk saturation losing its coherence and potency if its conceptualization and uses are stretched too widely.

Whilst certain factors have been extensively reviewed (for example, body mass index), more longitudinal studies are needed to investigate the association of physical occupational and other patient-determined factors with future knee OA. The quality of such studies also needs to be improved. However, there are identifiable factors which can be targeted for prevention of disabling knee pain.

Osteoarthritis (OA) is a leading cause of pain and disability and leads to a reduced quality of life. The aim was to determine the current evidence on risk factors for onset of knee pain/OA in those aged 50 and over. A systematic review and meta-analysis was conducted of cohort studies for risk factors for the onset of knee pain. Two authors screened abstracts and papers and completed data extraction. Where possible, pooled odds ratios (OR) were calculated via random effects meta-analysis and population attributable fractions (PAFs) derived. 6554 papers were identified and after screening 46 studies were included. The main factors associated with onset of knee pain were being overweight (pooled OR 1.98, 95% confidence intervals (CI) 1.57-2.20), obesity (pooled OR 2.66 95% CI 2.15-3.28), female gender (pooled OR 1.68, 95% CI 1.37-2.07), previous knee injury (pooled OR 2.83, 95% CI 1.91-4.19). Hand OA (pooled OR 1.30, 95% CI 0.90-1.87) was found to be non-significant. Smoking was found not to be a statistically significant risk or protective factor (pooled OR 0.92, 95% CI 0.83-1.01). PAFs indicated that in patients with new onset of knee pain 5.1% of cases were due to previous knee injury and 24.6% related to being overweight or obese. Clinicians can use the identified risk factors to identify and manage patients at risk of developing or increasing knee pain. Obesity in particular needs to be a major target for prevention of development of knee pain. More research is needed into a number of potential risk factors.

Ethical guidelines in the United Kingdom require written consent from participants in epidemiologic studies for follow-up or review of medical records. This may cause bias in samples used for follow-up or medical record review. The authors analyzed data from seven general population surveys conducted in the United Kingdom (1996-2002), to which over 25,000 people responded. Associations of age, gender, and symptom under investigation with consent to follow-up and consent to review of medical records were examined. Consent to follow-up was approximately 75-95% among survey responders under age 50 years but fell among older people, particularly females. Consent to follow-up was also higher among responders who had the symptom under investigation (pooled odds ratio = 1.61, 95% confidence interval: 1.36, 1.92). Consent to review of medical records followed a similar pattern. Patterns of consent were relatively consistent and represented a high proportion of responders. Males, younger people, and subjects reporting the symptom under investigation were more likely to give consent, and these groups may be overrepresented in follow-up samples or reviews of medical records. Although consent is high among responders, the additive effect of nonresponse and nonconsent can substantially reduce sample size and should be taken into account in epidemiologic study planning.

This study has used the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) in an unsolicited postal questionnaire to investigate the impact of knee pain and disability in the general older population. The study provides WOMAC population data for those aged over 50 and demographic and psychosocial associations with severity of WOMAC scores. A pilot survey (n=240) and repeatability study (n=80) were undertaken to test completion of the WOMAC in this new setting. The main questionnaire was mailed to 8,995 men and women aged over 50 registered with three general practices in North Staffordshire, UK. Completion rates for WOMAC items were high. Substantial reliability was found for pain and physical function scales (both >0.80). Fourteen percent of the over 50 population in this study had severe knee pain, 20% had severe difficulty with at least one area of physical functioning, 12% had both. The strongest link with severe difficulty with physical functioning was chronicity (odds ratio (OR)=6.49, 95% CI 4.65, 9.04). Other independent links were age over 75 years (odds ratio (OR)=4.11, 95% confidence interval (CI) 3.03, 5.58), depression (OR=2.80, 95% CI 2.22, 3.54), bilateral knee injury (OR=2.23, 95% CI 1.63, 3.06) and body mass index>30 (OR=2.00, 95% CI 1.51, 2.64). Similar associations were found for severe pain. The findings suggest that the WOMAC is a reliable measure for use in postal surveys. It has advantages over other instruments when measuring pain and physical function difficulty related to the knee. Chronicity, older age, injury, obesity and depression were all linked with higher WOMAC scores for knee pain severity and disability among knee pain sufferers in the general older population.

The KNEST is a simple tool for the identification of individuals with knee pain and their health-care use. Focusing only on chronic knee pain will underestimate the total need and demand for health-care in knee pain sufferers in the general older population, as non-chronic as well as chronic knee pain has a significant impact on people's lives and on their use of primary health-care. The KNEST, when combined with the WOMAC, identifies population groups who have potentially diverse health-care needs and who might benefit from effective health-care. These data can be used alongside evidence on effective treatments by service planners when considering needs for the care of older adults in primary care.

Plain English summaryIn the UK, more patients go to primary care than other parts of the health service. Therefore it is important for research into primary care to include the insights and views of people who receive these services. To explore the extent, quality and impact of patient and public involvement (PPI) in primary care research, we examined documents of 200 projects and surveyed 191 researchers.We found that about half of studies included PPI to develop research ideas and during the study itself. Common activities included designing study materials, advising on methods, and managing the research. Some studies did not undertake the PPI activities initially planned and funded for. PPI varied by study design, health condition and study population. We found pockets of good practice: having a PPI budget, supporting PPI contributors, and PPI informing recruitment issues. However, good practice was lacking in other areas. Few projects offered PPI contributors training, used PPI to develop information for participants about study progress and included PPI to advise on publishing findings.Researchers reported beneficial impacts of PPI. Most impact was reported when the approach to PPI included more indicators of good practice. The main cost of PPI for researchers was their time. Many reported difficulties providing information about PPI.In partnership with PPI contributors, we have used these findings to develop:a new Cost and Consequences Framework for PPI highlighting financial and non-financial costs, benefits and harms of PPIFifteen co-produced recommendations to improve the practice and delivery of PPI.AbstractBackground: To improve the lives of patients in primary care requires the involvement of service users in primary care research. We aimed to explore the extent, quality and impact of patient and public involvement (PPI) in primary care research.Methods: We extracted information about PPI from grant applications, reports and an electronic survey of researchers of studies funded by the NIHR School for Primary Care Research (SPCR). We applied recognised quality indicators to assess the quality of PPI and assessed its impact on research.Results: We examined 200 grant applications and reports of 181 projects. PPI was evident in the development of 47 (24%) grant applications. 113 (57%) grant applications included plans for PPI during the study, mostly in study design, oversight, and dissemination. PPI during projects was reported for 83 (46%) projects, including designing study materials and managing the research. We identified inconsistencies between planned and reported PPI. PPI varied by study design, health condition and study population.Of 46 (24%) of 191 questionnaires completed, 15 reported PPI activity. Several projects showed best practice according to guidelines, in terms of having a PPI budget, supporting PPI contributors, and PPI informing recruitment issues. However few projects offered PPI contributors training, used PPI to develop information for participants about study progress, and had PP...

Background: The new Musculoskeletal Services Framework outlines the importance of health care needs assessment. Our aim was to provide a model for this for knee pain and disability, describing felt need (individual assessment of a need for health care) and expressed need (demand for health care). This intelligence is required by health care planners in order to implement the new Framework.